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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

(Mark one)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 1-37897

~~RESHAPE~~VYOME ~~LIFESCIENCES~~HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		26-1828101
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

Harvard Square, One

18Mifflin ~~Technology~~Place, ~~Dr.~~ Suite ~~110~~400, ~~Irvine~~Cambridge, ~~California 92618~~ MA

(Address of principal executive offices, including zip code)

(973) 832-8147

(949) 429-6680

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class		Trading Symbol	Name of Each Exchange on which Registered
Title of Each Class	Trading Symbol	Name of Each Exchange on which Registered
Common stock, $0.001 par value per share		HIND	The Nasdaq Capital Market
Common stock, $0.001 par value per share	RSLS	The Nasdaq Capital Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ◻ ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark if whether the registrant is(1) ~~not~~has ~~required~~filed toall ~~file~~ reports ~~pursuant~~required to be filed by Section 13 or ~~Section~~ 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ~~◻ No~~ ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒

~~Large~~If ~~accelerated~~an ~~filer~~emerging ◻growth company, ~~Accelerated~~indicate ~~filer~~by ◻check ~~Non-accelerated~~mark ~~filer~~if ☒the ~~Smaller~~registrant ~~reporting~~has ~~company~~elected ☒not to ~~Emerging~~use ~~growth~~the ~~company~~extended ◻transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If ansecurities ~~emerging~~are ~~growth~~registered ~~company~~pursuant to Section 12(b) of the Act, indicate by check mark ifwhether the ~~registrant~~financial ~~has~~statements ~~elected~~of ~~not to use~~ the ~~extended~~registrant ~~transition~~included ~~period~~in ~~for~~the ~~complying~~filing ~~with~~reflect ~~any~~the ~~new~~correction of oran ~~revised~~error ~~financial accounting standards provided pursuant~~ to ~~Section~~previously ~~13(a)~~issued offinancial ~~the Exchange Act~~statements. ◻ ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is ~~has filed~~ a ~~report~~shell oncompany ~~and~~(as ~~attestation~~defined toin ~~its~~Rule ~~management’s~~12b-2 ~~assessment~~ of the ~~effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley~~ Act ~~(15 U~~).~~S.C.~~ ~~7262(b))~~Yes by☐ No ~~the registered public accounting firm that prepared or issued its audit report. ◻~~☒

At June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant, based upon the closing price of a share of the registrant’s common stock as reported by the Nasdaq on that date was $6,402,262.

IfAs ~~securities are registered pursuant to Section 12(b)~~ of ~~the~~March ~~Act~~17, ~~indicate~~2026, by7,018,528 ~~check~~shares ~~mark whether the financial statements~~ of the registrant’s ~~included~~common stock inwere ~~the filing reflect the correction of an error to previously issued financial statements~~outstanding. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ◻ No ☒

At June 30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant, based upon the closing price of a share of the registrant’s common stock as reported by the Nasdaq on that date was $5,638,012.

As of April 2, 2025, 11,276,248 shares of the registrant’s Common Stock were outstanding.

Documents Incorporated by Reference

None.

Auditor Firm Id: 200 Auditor Name: Haskell & White LLP Auditor Location: Irvine, California

Table of Contents

Forward-looking statements and associated risks

All statements in this Form 10-K that do not directly and exclusively relate to historical facts constitute “forward-looking statements” ~~and~~within ~~include~~the ~~statements~~meaning of ~~related~~the tosafe ~~our~~harbor ~~ability~~provisions toof ~~successfully remediate~~ the ~~material~~U.S. ~~weaknesses~~Private inSecurities ~~our~~Litigation ~~internal~~Reform ~~control~~Act ~~over~~of ~~financial~~1995. ~~reporting~~We ~~disclosed~~may, in ~~this~~some ~~Form 10-K in the manner currently anticipated. These statements represent current expectations and beliefs~~cases, ~~and~~use noterms ~~assurance can be given that the results described in~~ such ~~statements~~as ~~will be achieved. Such statements are subject to numerous assumptions~~“anticipates, ~~risks~~” “believes,” ~~uncertainties and other factors that~~ “could,” ~~cause~~“estimates,” ~~actual~~“expects,” ~~results~~“intends,” to“may,” “plans,” ~~differ~~“potential,” ~~materially from those described in such statements~~“predicts,” ~~many of which are outside of our control. No assurance can be given that any expectation~~“projects,” ~~belief~~“should,” ~~goal or plan set forth in any forward-looking statement can or~~ “will ~~be achieved~~,” “would” ~~and~~or ~~readers~~similar ~~are~~expressions ~~cautioned~~that ~~not~~convey touncertainty ~~place undue reliance on such statements which speak only as~~ of ~~the~~future ~~date~~events ~~they are made. We do not undertake any obligation to update~~ or ~~release~~outcomes ~~any revisions~~ to ~~any~~identify forward-looking ~~statement or to report any events or circumstances after the date of this Form 10-K or to reflect the occurrence of unanticipated events~~statements.

These statements represent current expectations and beliefs, and no assurance can be given that the results described in such statements will be achieved. Such statements are subject to numerous assumptions, risks, uncertainties and other factors that could cause actual results to differ materially from those described in such statements, many of which are outside of our control. No assurance can be given that any expectation, belief, goal or plan set forth in any forward-looking statement can or will be achieved, and readers are cautioned not to place undue reliance on such statements which speak only as of the date they are made. We do not undertake any obligation to update or release any revisions to any forward-looking statement or to report any events or circumstances after the date of this Form 10-K or to reflect the occurrence of unanticipated events.

You should carefully consider these and other relevant factors, including those risk factors in Item 1A, “Risk Factors” of this Form 10-K and any other information included or incorporated by reference in this report, and information which may be contained in the Company’s other filings with the SEC, when reviewing any forward-looking statement. Investors should understand it is impossible to predict or identify all such factors or risks. As such, you should not consider either foregoing lists, or the risks identified in the Company’s SEC filings, to be a complete discussion of all potential risks or uncertainties associated with an investment in the Company.

VYOME HOLDINGS, INC.

Table of Contents

RESHAPE LIFESCIENCES INC.

FORM 10-K

TABLE OF CONTENTS

PART I

Item 1.	Business	1
Item 1A.	Risk Factors	54
Item 1B.	Unresolved Staff Comments	99
Item 1C.	Cybersecurity	99
Item 2.	Properties	99
Item 3.	Legal Proceedings	99
Item 4.	Mine Safety Disclosures	99

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	100
Item 6.	[RESERVED]	100
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	101
Item 7A	Quantitative and Qualitative Disclosures About Market Risk	112
Item 8.	Financial Statements and Supplementary Data	F-1
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	113
Item 9A.	Controls and Procedures	113
Item 9B.	Other Information	114
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	114

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	115
Item 11.	Executive Compensation	121
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	125
Item 13.	Certain Relationships and Related Transactions, and Director Independence	127
Item 14.	Principal Accounting Fees and Services	127

PART IV

Item 15.	Exhibits and Financial Statement Schedules	128
Item 16.	Form 10-K Summary	128
EXHIBITS		128
SIGNATURES		136


PART I

Item 1.	Business	2
Item 1A.	Risk Factors	26
Item 1B.	Unresolved Staff Comments	65
Item 1C.	Cybersecurity	65
Item 2.	Properties	65
Item 3.	Legal Proceedings	65
Item 4.	Mine Safety Disclosures	66

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	66
Item 6.	[RESERVED]	66
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	67
Item 7A	Quantitative and Qualitative Disclosures About Market Risk	75
Item 8.	Financial Statements and Supplementary Data	76
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	110
Item 9A.	Controls and Procedures	110
Item 9B.	Other Information	112
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	112

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	113
Item 11.	Executive Compensation	116
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	119
Item 13.	Certain Relationships and Related Transactions, and Director Independence	120
Item 14.	Principal Accounting Fees and Services	121

PART IV

Item 15.	Exhibits and Financial Statement Schedules	123
Item 16.	Form 10-K Summary	123

EXHIBITS		124

SIGNATURES		130

Table of Contents

PART I.

ITEM 1. BUSINESS

Our Company

~~ReShape~~On August 15, 2025, ReShape Lifesciences Inc. is(now aknown ~~premier~~as ~~physician-led~~Vyome ~~weight-loss~~Holdings, ~~solutions~~Inc.) ~~company~~(the “Company”) completed the merger pursuant to the Agreement and Plan of Merger, ~~offering~~dated anas ~~integrated~~of ~~portfolio~~July 8, 2024, as amended (the “Merger Agreement”), by and among the Company, Raider Lifesciences Inc., a wholly owned subsidiary of ~~proven~~the ~~products~~Company (“Merger Sub”), and ~~services~~Vyome ~~that~~Therapeutics, ~~manage~~Inc. (“Vyome”). Pursuant to the Merger Agreement, Merger Sub merged with and ~~treat~~into ~~obesity~~Vyome, with Vyome surviving the merger as a subsidiary of the Company (the “Merger”). As a result of the Merger, the Company was renamed “Vyome Holdings, Inc.” and ~~metabolic~~Vyome ~~disease~~continued ~~throughout~~under its name as Vyome Therapeutics, Inc., in each case effective before the ~~care~~open ~~continuum~~of trading on August 15, 2025.

~~Our~~The ~~current~~Company ~~portfolio~~is ~~includes~~a Cambridge, MA/Princeton, NJ/New Delhi, India-based clinical-stage specialty pharmaceutical company working to treat immune-inflammatory and rare diseases of unmet need with next-generation therapeutic solutions, with a business advantage of the UUS-India innovation corridor.S The lead program, VT-1953, is a topical gel that is being developed to treat signs and symptoms of malignant fungating wounds in advanced cancer, a potential orphan drug designation program. The Company has announced positive results from a phase 2 investigator-initiated trial. The Company is planning to have discussions with the Food ~~and~~& Drug Administration (“FDA”) ~~approved~~on ~~and~~a ~~reimbursed~~pivotal ~~Lap-Band®~~phase ~~and~~3 trial design in the ~~recently~~first ~~approved~~half ~~Lap-Band®~~of 22026.0 ~~FLEX~~The ~~systems~~Company also has a Pre-Investigational New Drug application stage ophthalmic drops program, ~~which~~a ~~provide~~potential ~~minimally~~orphan drug ~~invasive~~program, ~~long~~VT-~~term~~1908, ~~treatment~~a ofrepurposed ~~obesity~~immune ~~and~~modulator isto atreat ~~safer~~steroid-sparing ~~surgical~~anterior ~~alternative~~uveitis. Another late clinical-stage program, VB1953, for moderate to ~~more~~severe ~~invasive~~acne, ~~and~~has ~~extreme~~completed ~~surgical~~its ~~stapling~~Phase ~~procedures~~II ~~such~~clinical astrial, ~~the~~and ~~gastric~~this ~~bypass~~program oris ~~sleeve~~Phase ~~gastrectomy~~3-ready.

The Company may experience delays in the conduct of clinical trials of its candidates. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct a clinical trial at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies of clinical trial materials. Any delays in completing the Company’s clinical trials will increase its costs, slow down its product development, timeliness, and approval process, and delay its ability to generate revenue.

~~1ReShape’s~~The ~~Pillars~~Company also has commercialized two novel reformulated topical anti-fungal products based on the technology platform of Molecular Replacement Therapeutics (“MRT”) in India - a dandruff lotion and shampoo. The Company has entered into a licensing and marketing agreement with Sun Pharma Laboratories Limited (“Sun Pharma”) to sell such topical anti-fungal products in India. The Company used third-party entities to manufacture the products. During 2023, the Company amended its arrangement with Sun Pharma such that the Company will no longer be responsible for purchasing ~~Growth~~and selling inventory of the products, but instead will receive a net service fee payment for sales of such products made by Sun Pharma. One of the agreements for the supply of dandruff products to Sun Pharma was terminated in December 2024. The Company has also entered into an agreement with Sun Pharma for the development and licensing of MRT technology-based Luliconazole topical cream for skin fungal diseases for the Indian market

InThe ~~August~~Company ofoperates ~~2022~~in two segments, ~~Paul~~biotechnology ~~F. Hickey joined ReShape as President~~ and ~~Chief~~pharmaceutical ~~Executive Officer~~products. ~~Under~~Our ~~this~~biotechnology ~~new~~segment ~~leadership,~~comprises our ~~Company~~operations ~~has~~around ~~pivoted~~our ~~its~~VT-1953, ~~business~~VT-1908, ~~strategy~~and VB-1953 ~~with~~programs ~~the~~that ~~intent~~are ofin ~~helping~~development, ~~to ensure growth~~ and ~~profitability.~~our ~~Our~~pharmaceutical ~~Company~~segment ~~has~~comprises ~~executed~~our ~~the~~antifungal ~~following three growth strategies, or pillars for growth:~~products.

●Since ~~Growth~~inception, ~~Pillar~~our I:operations have ~~Executing~~focused ~~disciplined,~~on ~~metrics-driven~~organizing and staffing our biotechnology segment, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates, undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales from the biotechnology segment. Our pharmaceutical segment represents the operations of a legacy business, and various licensing agreements with Sun Pharma.

In executing the first growth pillar, our Company is focused on revenue growth and profitability. The timeline for profitability is dependent on many factors, including revenue growth from new product introductions, or strategic investments not yet foreseen.1

~~This~~Our first growth pillar remains, in our Company’s opinion, paramount for ReShape to deliver shareholder value and, ultimately, profitability. Starting shortly after Mr. Hickey’s appointment, ReShape has made several operational changes to help ensure future performance and return on investment by prioritizing investments supporting revenue growth.programs

Thus far, we have developed three programs:

●

VT-1953 — Our lead program, VT-1953, is a dual DNA Gyrase/Topoisomerase inhibitor and immunomodulator in a topical gel formulation. An eye drop with the same active agent as in VT-1953 is approved by the U.S. FDA (NDA#22-308) for the treatment of bacterial conjunctivitis. We have reformulated the active agent in a topical gel for application on skin. We have tested VT-1953 topical gel for safety and efficacy in extensive preclinical studies and in four clinical trials, including phase 1 and phase 2 studies in US, with over 400 patients with moderate to severe inflammatory acne and an investigator initiated study in patients with malodorous malignant fungating wound (MFW), a debilitating immune-inflammatory condition present in approximately 5 – 14% of advanced cancer patients in the United States, according to the “The Microbiome, Malignant Fungating Wounds, and Palliative Care” article by Frontiers. Based on interim analysis, VT-1953 was found to decrease malodor in MFW by over 75% and pain by 50%. We plan to conduct pivotal studies for VT-1953 for treatment of symptoms of malignant fungating wound. We believe that VT-1953’s potential to treat symptoms of this rare and unmet medical condition can be transformative for cancer patients and their caregivers. Based on its mechanism of action, we believe VT-1953 can be expanded in the future to a broad range of potentially large indications, including inflammatory acne, diabetic foot ulcers, and pressure sores.

●

VT-1908 — Our next development program VT-1908, topical eye drop is an inosine 5′-monophosphate dehydrogenase enzyme inhibitor, for treating immunoinflammatory conditions of the eye. We plan to develop VT-1908 for treating anterior uveitis as the first indication, especially in patients where steroid use is contraindicated. Uveitis is a rare immune-inflammatory condition, where activated immune cells attack the uvea of the eye which can lead to blindness. VT-1908 exhibited biological activity statistically comparable to steroid use in an animal model of uveitis. For example, in a study published in 2022 in the journal Eye (The Scientific Journal of the Royal College of Ophthalmologists), investigators from Massachusetts Eye Research and Surgery Institution reported that “monotherapy appears to be an effective and safe treatment in pediatric autoimmune uveitis”. Similarly, another clinical study, the MySTRI study published in 2020 in the journal Eye, concluded “mycophenolate sodium is an effective steroid-sparing drug for the treatment of corticosteroid-refractory non-infectious inflammatory uveitis (CRU)”. We are currently conducting pre-clinical studies and manufacturing activities for VT-1908 in anticipation of enabling clinical trials by the second half of 2025. The FDA has not approved mycophenolate or mycophenolate sodium to treat patients with uveitis and would need to review clinical trial data in order to determine that these drugs are safe and effective to treat uveitis. Based on the mechanism of action, we believe the use of VB-1908 can be extended to a broad range of potential indications, including post-cataract surgery inflammation, scleritis, and blepharitis as a growth strategy, and has the potential to replace steroid use in the eye.

●

Molecular Replacement Therapy — Our innovation engine has also generated a molecular replacement therapy (“MRT”) platform, with the potential of improving the efficacy of existing antifungal agents. We have signed a collaboration and license agreement with Sun Pharma Laboratories Limited (“Sun Pharma”), to develop and commercialize these next-generation antifungal products which incorporate our MRT technology. We intend to continue to leverage our existing pipeline and platform to actively explore and evaluate potential value-creating partnering opportunities.

Our beginnings and vision

Vyome Biosciences Private Limited (“VBPL”) was co-founded in New Delhi, India by Dr. Shiladitya Sengupta, a professor of medicine and of health sciences and technology at Harvard Medical School and Massachusetts Institute of Technology, Dr. Rajesh Gokhale, an immunologist at the National Institute of Immunology in New Delhi and the current secretary of the Department of Biotechnology of the Government of India, and Venkat Nelabhotla, an alumnus of Indian Institute of Management, Ahmedabad. He worked as CEO & Executive Director of Emami Ltd and as Senior Vice President of Aurobindo Pharma Limited. The vision of VBPL was to foster innovation in medical drug development for global impact in a cost-efficient manner by leveraging the best of talents in the US-India corridor. India had made significant strides in the information technology space, and our founders believed that the ecosystem was ripe to pioneer a similar leap-frogging in the bio-technology and healthcare space.

~~Table~~Our ofscientific ~~Contents~~approach is built on this scientific rigor and advanced technology, which, together with the learnings from a resource-poor setting, offers a powerful engine for innovation, differentiation, and cost-efficiency.

~~Our~~As ~~Company~~part ~~has~~of ~~prioritized investments, including marketing automation to support scalable lead acquisition, segmented consumer-centric messaging via an updated website for improved patient engagement, and~~ a ~~frictionless~~corporate ~~booking system with qualified providers. Early metrics from these marketing efforts have been shown to help increase Lap-Band procedures and ultimately revenue~~restructuring, ~~despite~~ the ~~headwinds~~drug ~~created~~development bybusiness ~~the~~of ~~widespread~~VBPL ~~marketing~~was ~~and~~transferred ~~adoption~~in ofDecember ~~GLP-1~~2018 ~~receptor~~to ~~agonists,~~Vyome ~~including~~Therapeutics ~~Wegovy~~Limited, ~~Ozempic, and Zepbound. Additionally,~~ our ~~Company 2024 cost reduction plan~~subsidiary, ~~had~~which ~~led~~was ~~to approximately 43% lower operating expenses~~ formed in ~~2024, compared to last year, excluding one-time costs~~India. ~~Our~~We ~~Company~~were ~~has~~incorporated ~~also~~as ~~taken~~a ~~steps~~Delaware tocompany ~~right-size the organization~~ in ~~several areas to ensure sustainability and scalability~~2017.

●Vyome ~~Growth~~raised ~~Pillar~~its ~~II:~~first ~~Expanding~~American capital from Krishna Gupta and his venture capital firm in 2016 after initially meeting Dr. Sengupta at MIT nearly a decade earlier. Mr. Gupta believed in the ~~product~~science ~~portfolio~~as well as the wider opportunity to build companies together at the intersection of the US and ~~future~~India. ~~product~~We believe ~~pipeline~~the US and India relations are seeing a transformation driven by geopolitical and economic alignments, and Vyome intends to build its platform by taking advantage of the same. In a November 2023 press release, the US Department of State reaffirmed, “The relationship between the United States and India is one of the most strategic and consequential of the 21st century.” We believe we are uniquely poised to leverage this emerging special relationship, especially as the influence of China is curtailed. Not only have billions of dollars of international capital flowed out of China, according to the article “Foreign Investors Pull Record Amount of Money From China” by Bloomberg, laws such as the BIOSECURE Act also limit the ability of US companies to contract with biotechnology companies with ties to the Chinese government.

~~ReShape’s~~We ~~second~~have ~~growth~~and ~~pillar~~will iscontinue to ~~intended~~build our team to ~~further~~reflect ~~differentiate~~this ~~our~~evolving ~~Company~~geopolitical asrelationship. aOur ~~leading~~Indian ~~provider~~subsidiary’s board is chaired by Dr. Ramesh Mashelkar, a fellow of ~~innovative~~the ~~products~~Royal Society (UK) and ~~services~~member toof ~~meet~~National ~~unmet~~Academy ~~customer~~of ~~needs~~Sciences of United States. ~~ReShape~~Dr. isMashelkar ~~committed~~served as the science advisor to ~~drive~~the ~~and~~prime ~~scale~~minister ~~its~~of ~~new~~India, ~~product~~was ~~development~~the director general of Council of Scientific and ~~commercialization~~Industrial ~~capacity~~Research (CSIR) labs, ~~providing~~the alargest ~~cadence~~network of government research laboratories in India, and has served on the board of ~~new~~Reliance ~~product~~Industries, ~~introductions~~Tata Motors, and ~~revenue~~other ~~growth~~reputed companies. Investors ~~The~~in ~~growth~~Vyome ~~can~~include ~~either~~Dr. beRanjan ~~through~~Pai, ~~organic~~a ~~internal~~well-known ~~Research~~Indian ~~and~~businessman ~~Development~~who ~~efforts~~owns Manipal Hospitals, orthe ~~through~~second-largest ~~strategic~~hospital ~~partnerships~~chain in India, ~~mergers~~and Sanjeev Taparia, orwho ~~acquisitions~~built and sold one of the largest women’s health companies in the world. ~~Key~~We ~~growth~~believe ~~drivers~~such ~~within~~networks give ~~second~~us ~~growth~~a ~~pillar~~tremendous ~~include:~~competitive advantage in this rapidly evolving geopolitical market opportunity. We aim to leverage this network to source deals and grow organically.

~~Lap~~Immuno-~~Band~~Inflammatory 2.0 FLEX System — New product revenues for the Lap-Band 2.0 FLEX system (“Lap-Band 2.0”), for which our Company received FDA approval during December 2023 and completed the first successful surgeries in early 2024. Similar to the current Lap-Band, the Lap-Band 2.0 is adjustable, postoperatively, to increase or decrease the opening of the band to optimize an individual’s eating habits and comfort, thereby improving therapy effectiveness. At the same time, a new feature of the Lap-Band 2.0 is a band reservoir technology that serves as a relief valve. Pieces of food that are too large to pass through the narrowed passage, created by the current band, can pass through because the new feature allows the band to relax momentarily and then return to its resting diameter. This could potentially allow for increased Lap-Band constriction and resultant satiety, while helping to minimize discomfort from swallowing large pieces of food, which may otherwise require emergency in-office patient band adjustments. Based on customer feedback, Lap-Band 2.0 will allow us to engage new surgeons and reengage many of those who have used the Lap-Band, historically.Diseases

~~ReShape~~A ~~Obalon~~well-functioning ~~Balloon — The ReShape Obalon® Balloon~~ immune system isforms the ~~first~~foundation ~~and~~of ~~only~~human ~~swallowable~~health, ~~gas~~impacting ~~filled,~~every ~~FDA-approved~~biological ~~balloon~~process and organ system. Inof ~~2023~~the ~~our~~body. ~~company~~The ~~established~~immune ansystem ~~OEM~~acts ~~partnership~~as the ~~with~~defense ~~Biorad~~against ~~Medisys~~any ~~(“Biorad”)~~threats, ~~based~~both inexternal, ~~India~~such ~~that~~as ~~will~~viruses ~~support~~and ~~the~~bacteria, ~~successful relaunch~~ and ~~commercialization~~internal, ofsuch ~~the~~as ~~balloon system~~cancer. WeIt ~~anticipate~~also ~~having~~plays ~~access~~a tocritical ~~the Obalon Balloon system late~~ role in ~~2025~~normal ~~for~~homeostasis, ~~the~~facilitating ~~distribution~~routine incell ~~the~~turnover ~~U.S.~~ and ~~other~~removing ~~regions~~cellular ~~globally. In addition~~debris, ~~the~~such ~~strategic~~as ~~partnership~~in ~~with~~normal ~~Biorad contemplates potential manufacturing transfer of other products to further improve ReShape’s overall gross margin~~healing.

~~DBSN~~However, ~~Device — ReShape~~an ~~remains~~overactive immune ~~committed~~system tocan ~~furthering~~also ~~our~~get ~~proprietary~~inappropriately ~~Diabetes~~directed ~~Bloc-Stim~~to ~~Neuromodulation~~attack ~~(DBSNTM)~~normal ~~technology~~cells ~~that~~and ~~can~~tissues ~~potentially~~to ~~reduce~~cause ~~the~~autoimmune ~~dependence~~diseases onand inflammation, ~~medications~~which byis ~~those~~deleterious ~~with~~for ~~type~~one’s ~~2 diabetes~~health. ~~The~~There ~~DBSN~~are ~~device~~over is80 adiseases ~~technology~~and ~~under~~conditions ~~development~~where asthe aimmune ~~new~~system ~~treatment for type 2 diabetes mellitus~~gets overactivated. ~~The~~According ~~device~~to isthe ~~expected~~National toInstitute ~~use~~of ~~bioelectronics~~Health, tonearly ~~manage~~125 ~~blood~~million ~~glucose~~people in the ~~treatment~~US oflive ~~diabetes~~with ~~and~~some ~~individualized~~form ~~24/7~~of ~~glucose~~chronic inflammatory ~~control~~disease. ~~Preclinical~~Immuno-inflammatory ~~evidence~~diseases onare ~~the~~an ~~DBSN~~active ~~device~~area ~~was~~of ~~presented~~research atand ~~multiple~~development, ~~conferences.~~and ~~The~~a ~~DBSN~~market ~~technology~~opportunity ~~development~~that ~~has~~is over ~~received approximately~~ $~~1.15~~400 ~~million~~billion ~~dollars~~and ofgrowing ~~nondilutive NIH grant support~~rapidly.

●We ~~Growth~~aim ~~Pillar~~to ~~III:~~establish ~~Ensuring~~a ~~that~~leadership position ~~our~~in ~~portfolio~~this ~~spans~~emerging market by taking a pragmatic approach of focusing on unmet rare inflammatory conditions in the ~~weight~~near ~~loss~~term, ~~care~~which we ~~continuum~~believe ~~and~~can isopen ~~evidence~~doors ~~based~~to other disease opportunities in the future.

ReShape’s third growth pillar represents our company’s commitment to collaborate with healthcare professionals worldwide and further develop evidence supporting ReShape’s portfolio of treatment options. Aligned with goal of pillar three, in early 2023, ReShape established their first-ever global Scientific Advisory Board (SAB) to provide needed expertise and feedback on initiatives related to our company’s growth pillars. The SAB is a valuable resource to help validate company strategies to collect and publish data on both our Lap-Band 2.0 and data on Lap-Band patients who are also using GLP-1s as a combination therapy. Combination therapies comprising GLP-1s and other gastric surgeries, including the Lap-Band, are being prescribed today, to help those who have plateaued with their weight loss.

~~Table~~Our ~~of Contents~~Strategy

Our ~~Product~~goals ~~Portfolio~~are to: (1) treat and improve the quality of life of patients with serious immuno-inflammatory conditions; (2) build a cost-efficient innovation model to disrupt the currently expensive drug development process; and (3) commercialize products through strategic business development of our assets and in-licensing of new assets. To achieve our goals, we intend to:

~~Lap~~● Aggressively move our lead program, VT-~~Band~~1953, ~~System~~through clinical development, including a pivotal phase 3 study for the treatment of malodor of malignant fungating wounds in advanced cancer patients. By focusing on the treatment of symptoms, which we anticipate will resolve within 14 days with treatment with VT-1953, we can run a short clinical trial. Typical pivotal oncology trials, especially for rare and unmet indications, require small patient sample sizes. For example, as reported in the Journal of American Medical Association (JAMA), a study on the Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer concluded “Compared with pivotal trials used to approve nonorphan cancer drugs, pivotal trials for recently approved orphan drugs for cancer were more likely to be smaller and to use nonrandomized, unblinded trial designs and surrogate end points to assess efficacy”. Pivotal trials for orphan drugs enrolled fewer patients exposed to the drug per study than those for nonorphan drugs (median, 96 versus 290). Furthermore, we will leverage the India-US network to accelerate our clinical recruitment while lowering costs. We plan to continue a hands-on engagement with all trial sites to ensure timely clinical trial execution and high-quality data collection.

~~The~~● ~~Lap~~Pragmatically build the pipeline with laser-~~Band~~focus ~~System~~on isselecting ~~designed~~rare toand ~~provide~~unmet ~~minimally~~medical ~~invasive~~conditions ~~long-term~~that ~~treatment~~can ofbe ~~severe~~addressed ~~obesity~~using ~~and~~a isclinically-approved andrug. ~~alternative~~We todeploy ~~more~~a ~~invasive~~differentiated ~~surgical~~strategy ~~stapling~~of ~~procedures~~drug ~~such~~development. asIn the ~~gastric~~classical ~~bypass~~drug ordiscovery ~~sleeve~~model, ~~gastrectomy.~~thousands ~~Unlike~~of ~~other~~drugs ~~invasive~~are ~~anatomy~~screened ~~altering~~of ~~procedures,~~which ~~the~~one ~~Lap~~makes it to finish-~~Band~~line ~~System~~as isan ~~adjustable~~approved ~~post-operatively~~drug, ~~via~~making it a ~~saline-filled~~highly ~~silicone~~inefficient ~~band~~and ~~that~~costly isprocess. ~~laparoscopically~~We ~~placed~~start ~~around~~with ~~the~~an ~~upper~~active ~~part~~molecule in an FDA-approved product and map its mechanism of action to the ~~stomach~~mechanism ~~through~~driving ~~small~~a ~~laparoscopic~~rare ~~incisions,~~(orphan) ~~creating~~and aunmet ~~small~~disease ~~pouch~~condition. atThis ~~the~~strategy ~~top~~(a) ofcuts ~~the~~down ~~stomach,~~on ~~which~~development ~~slows~~time ~~the~~as ~~passage~~we ofdo ~~food~~not ~~and~~need ~~creates~~to invent a ~~sensation~~drug from scratch; (b) reduces the risk of ~~fullness.~~the ~~The~~drug ~~procedure~~failing ~~can~~due ~~normally~~to betoxicity, ~~performed~~(c) aspotentially anoffers ~~outpatient~~the ~~procedure~~advantages ~~and~~of ~~patients~~the ~~can~~Orphan goDrug ~~home~~Act, and (d) reduces the ~~day~~cost of ~~the~~clinical ~~procedure~~development ~~without~~as the ~~need~~number of patients in a pivotal study are lower than for annon-orphan ~~overnight~~drugs ~~hospital~~as ~~stay~~described above.

~~Lap~~● Opportunistically evaluate strategic and commercial opportunities to maximize the value of our product candidates by aggressively leveraging our US-~~Band~~India 2footprint to create value and reduce costs.0 ~~FLEX~~We ~~System~~will aggressively pursue business and investment opportunities across both countries, while setting high bars for quality and value creation. For example, we have entered into a license and collaboration agreement with Sun Pharma to commercialize our MRT technology-based products in India. We intend to opportunistically seek partnerships in Europe, Canada, and other markets, and retain the US market for commercialization. We may acquire other products or product candidates that we believe can make a substantial impact on immune-inflammatory diseases and yield high user satisfaction.

~~The~~Continue ~~Lap-Band~~to ~~2.0~~strengthen ~~FLEX,~~our ~~like~~intellectual ~~the~~property portfolio. ~~original~~We ~~Lap-Band~~have ~~System,~~developed isand ~~designed~~continue to ~~provide~~expand ~~minimally~~our ~~invasive~~portfolio ~~long-term~~of intellectual property for the treatment of ~~severe~~immuno-inflammatory diseases. ~~obesity~~Our key programs have patent protection until 2034 and isin ansome ~~alternative~~cases, tountil ~~more~~2043 ~~invasive~~due ~~surgical~~to ~~stapling~~a ~~procedures~~robust ~~such~~intellectual asproperty ~~the~~portfolio underpinned ~~gastric~~by ~~bypass~~issued patents or ~~sleeve~~patent ~~gastrectomy~~applications. ~~Unlike~~We ~~more~~will ~~invasive~~continue ~~and~~to ~~anatomy~~file ~~altering~~additional ~~surgeries~~patents as we generate data, ~~the~~including ~~Lap-Band~~from clinical 2studies.0 isIf ~~adjustable~~one ~~postoperatively~~of toour ~~increase~~product orcandidates ~~decrease~~is ~~the~~approved, ~~pressure~~we tobelieve ~~the~~that ~~band~~it incould ~~order~~be tothe ~~optimize~~first anFDA-approved ~~individual’s~~product ~~comfort~~for an orphan indication and ~~therapy~~would ~~effectiveness.~~then ~~The~~be ~~Lap-Band~~eligible ~~2.0~~for ~~system~~seven ~~includes~~years aof ~~FLEX~~exclusivity ~~reservoir~~in ~~technology~~the ~~designed~~United toStates. ~~minimize~~As ~~postoperative~~of ~~in-office~~the ~~patient~~date ~~band~~of ~~adjustments~~this prospectus, ~~thereby~~we ~~potentially~~have not ~~improving~~yet anreceived ~~individual’s~~orphan ~~tolerance~~drug designation for ~~the~~any ~~Lap-Band~~of 2our programs.0. AsTo ~~of October 2024~~date, we have ~~completed~~not ~~our~~had ~~early~~any ~~launch~~meetings ~~phase~~with of the ~~Lap-Band~~FDA ~~2.0~~regarding ~~FLEX~~Phase ~~and~~3 trial ~~are~~protocols ~~analyzing~~or ~~data~~regarding obtaining orphan drug designation, and ~~metrics~~although we plan to receive orphan drug designation, there is no guarantee that such designation will be ~~used~~granted. We plan to ~~support~~actively ~~our~~seek ~~widespread~~to ~~commercial~~obtain, ~~launch.~~where ~~Additionally~~appropriate, wethe ~~received~~broadest ~~approval~~intellectual property protection possible for ~~the~~our ~~Lap-Band®~~product ~~2.0~~candidates ~~FLEX~~by ~~from~~filing ~~Health~~for ~~Canada~~additional patents or other applicable intellectual property protection covering new or enhanced proprietary technology, ~~which~~including ~~represents~~new ~~yet~~methods ~~another~~of ~~important~~use, ~~growth~~formulations ~~catalyst~~and ~~for~~dosing ~~the~~regimens. ~~Lap~~We also rely on regulatory frameworks, trademarks, trade secrets, know-~~Band~~how, ~~franchise~~and ascontinuing wetechnological ~~look~~innovation and may consider in-licensing opportunities to ~~gain~~develop ~~regulatory~~and maintain ~~approvals~~our ~~world-wide~~proprietary position.

~~ReShape~~Continue ~~Calibration~~to ~~Tubes~~build an experienced team with the capabilities of building a leading healthcare-focused innovation company. We have built a leadership team with extensive experience across successful life science and consumer product companies and who have developed and commercialized multiple biopharmaceutical products and well-known consumer-focused brands. Our leadership team is complemented by a team of leading medical advisors across the immune-inflammation fields. We intend to time the expansion of our commercial capabilities to coincide with the expected timing of any regulatory approval.

The ReShape Calibration tubes are multifunctional devices compared to reusable bougies and disposable gastric tubes. The Calibration tubes are designed to fit the lesser curvature of the stomach more easily and quickly reach the pylorus. In August of 2022, we announced FDA clearance of three new sizes — 32, 36, and 40 French — all designed to simplify bariatric procedures such as laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding. During the first quarter of 2023, we fully released this product and continue to ramp production.

ReShape Obalon Balloon System

The FDA PMA approved Obalon Balloon System, is not currently manufactured and distributed for commercial sales, consists of a swallowable capsule that contains an inflatable balloon attached to a microcatheter; the Obalon Navigation System console, has FDA PMA supplemental approval, is a combination of hardware and software used to dynamically track and display the location of the balloon during placement; the Obalon Touch Inflation Dispenser, which is a semi-automated, hand-held inflation device used to inflate the balloon once it is placed; and a disposable canister filled with our proprietary mixture of gas.

DBSN Device

The DBSN device, that is not currently available for commercial sales, is a technology under development as a new treatment for type 2 diabetes mellitus (T2DM). It combines ReShape Lifesciences’ proprietary Vagus Nerve Block (vBloc) technology platform in combination with Vagus nerve stimulation. This new dual Vagus nerve neuromodulation device selectively modulates vagal blocking and stimulation to the liver and pancreas to manage blood glucose. Our DBSN device is expected to use bioelectronics to manage blood glucose in treatment of diabetes and individualized 24/7 glucose control. The goal is to reduce costs of treatment and complications that arise from poorly controlled blood glucose and non-compliance to T2DM medication.

~~Table~~Vyome’s ofdifferentiated ~~Contents~~development engine

~~Recent~~The ~~Developments~~classical de novo drug discovery process involves many different stages, is time-consuming and expensive. Typically, it can be divided into four main stages: (1) early drug discovery, (2) pre-clinical phase, (3) clinical phases, and (4) regulatory approval (See Figure 1).

OnThe ~~February~~early ~~25,~~discovery ~~2025,~~process weinvolves ~~entered~~many ~~into~~different actions anand ~~exclusive~~testing ~~distribution~~to ~~agreement~~identify ~~with~~and ~~Liaison~~optimize ~~Medical~~potential ~~Ltd.~~leads ~~for~~that ~~the~~elicit ~~Lap-Band®~~a ~~2.0~~desirable ~~FLEX~~effect ~~system~~on ~~and~~a ~~Tubing~~specific ~~Kit,~~biological ~~expanding~~target ~~our~~implicated in ~~commercial~~a ~~presence~~disease, ~~into~~in ~~Canada. Under~~ the ~~terms~~hopes of ~~the~~treating ~~agreement,~~it. ~~Liaison~~It ~~Medical~~involves ~~was~~target ~~granted~~identification ~~the exclusive right to market~~ and ~~distribute~~validation, ~~the~~high ~~covered~~throughput ~~products~~screening toor ~~licensed~~high ~~medical~~content screening, ~~professionals~~hit ~~within~~identification, ~~the~~assay ~~Canadian~~development ~~territory.~~and ~~The initial term of the agreement runs through December 31~~screening, ~~2028, with automatic one~~Hit-~~year~~To-Lead ~~renewal~~(H2L), ~~periods~~lead ~~thereafter~~generation ~~unless~~and ~~terminated~~optimization, byand ~~either~~in ~~party~~vivo ~~with~~and in atvitro ~~least 90 days’ prior written notice before the end of the then-current term~~Assays.

The second stage is the pre-clinical phase, where the leads identified during the early drug discovery phase are refined, optimized, and extensively tested in animal or alternative models. The aim is to provide sufficient evidence of safety and efficacy before clinical trials in humans can begin.

OnClinical ~~February~~trials ~~15,~~are ~~2025~~composed of three phases: In Phase 1, wethe ~~entered~~tolerance ~~into~~and asafety ~~Security~~of ~~Purchase~~the ~~Agreement~~drug tocandidate ~~issue~~is ~~and~~tested ~~sell~~in ~~2,575,107~~a ~~shares~~very small group of ~~common~~healthy ~~stock~~or ~~and~~diseased ~~warrants~~subjects, usually 20 to ~~purchase~~80; upPhase II studies are performed to 2examine the effectiveness,~~575~~ tolerability,~~107~~ ~~shares~~and ofdosage ~~common~~in ~~stock~~a atlarger angroup. ~~initial~~For ~~price~~this, ofthe $5dosage form is first developed.83 ~~per~~Phase ~~share,~~II ~~subject~~studies usually include 100 to ~~adjustments.~~500 ~~The~~adult ~~securities~~patients ~~were~~in atthe astudy; ~~price~~in Phase 3, the drug is tested on thousands of ~~$2.33~~patients ~~per~~to ~~unit.~~see whether the effectiveness and safety can be confirmed in many different patients.

The final stage is regulatory approval for a molecule that is both safe and effective.

OnAt ~~February~~each 3,step ~~2025~~of development, there weis ~~were granted~~ a ~~key~~significant ~~international~~risk ~~patent from the State~~ of ~~Israel~~failure, ~~for its Diabetes Neuromodulation technology. This patent for “Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control Systems~~ and ~~Methods,”~~as ~~will~~a ~~provide protection until December 4~~result, ~~2039.~~of ~~The~~the ~~Diabetes~~thousands ~~Neuromodulation~~of ~~system~~molecules ~~utilizes~~that ~~its~~one ~~proprietary~~starts ~~vagus~~with ~~nerve~~in ~~block~~early ~~(vBlocTM)~~drug ~~technology platform~~discovery, ~~combined~~only one ~~with~~makes ~~vagus~~it ~~nerve~~as ~~stimulation~~a drug, ~~for~~making the ~~treatment~~classical ofdrug ~~Type~~discovery 2model ~~diabetes~~inefficient, atime-consuming ~~prominent~~and ~~disorder~~extremely ~~associated~~expensive ~~with~~(See ~~obesity~~Figure.1).

Figure 1. Vyome’s differentiated drug development model.

OnAt ~~January 13~~Vyome, ~~2025,~~ we ~~provided~~start anfrom ~~update~~a molecule onthat is the ~~definitive~~active ~~merger~~component ~~agreement~~of ~~under~~an ~~which~~already ~~ReShape~~FDA-approved ~~and~~product, ~~Vyome~~shaving ~~will~~off ~~combine~~years inof anexpensive ~~all-stock~~discovery ~~transaction~~and optimization (See Figure 1). ~~The~~In ~~combined~~our ~~company~~differentiated ~~will~~development ~~focus~~strategy, onwe ~~advancing~~carefully analyze the ~~development~~mechanisms of ~~Vyome’s~~action ~~immune-inflammatory~~of ~~assets~~the molecule, and ~~identifying~~then ~~additional~~do an ~~opportunities~~extensive ~~between~~survey of all diseases and disease symptoms that are mechanistically overlapping and therefore can be treated with the ~~world~~drug. This drug mechanism-~~class~~disease ~~Indian~~mapping ~~innovation~~requires ~~corridor~~deep expertise and is our first innovative step allowing us to generate novel use IP, while avoiding the ~~U.S.~~long-drawn ~~market.~~out Wediscovery ~~also~~process ~~provided~~and anrisks ~~update~~of onfailure in those steps. The expertise needed to achieve the ~~asset~~innovative ~~purchase~~first stage ~~agreement~~of ~~with~~drug ~~Biorad~~development ~~Medisys~~can act as a barrier to entry for competition.

Equity Line of Credit and Secured Convertible Note

On December 19, 2024, we entered into a common stock purchase agreement (the “Equity Purchase Agreement”) with Ascent Partners Fund LLC (“Ascent”) pursuant to which Ascent has agreed to purchase from us, at our direction from time to time, in our sole discretion, from and after the effectiveness of the definitive documentation (the “Effective Date”), and until the earlier of (i) the 36-month anniversary of the Effective Date or (ii) the termination of the Equity Purchase Agreement in accordance with the terms thereof (the “Commitment Period”), shares of our common stock having a total maximum aggregate purchase price of $5,000,000 (the “Purchase Shares”), upon the terms and subject to the conditions and limitations set forth therein. See the section titled “Description of Equity Financing Transaction” below for additional information.

In a private transaction, on October 16, 2024, we entered into a securities purchase agreement (the “SPA”) with Ascent. Pursuant to the SPA, we agreed to issue to Ascent a senior secured convertible note in the aggregate original principal amount of $833,333 (the “Note”), and also issued to Ascent 7,983 shares of common stock as “commitment shares” to Ascent. On January 14, 2025, we entered into an amendment to the Note with Ascent to (a) extend the maturity date to the earlier of the closing of the Company’s merger with Vyome or 90 days after the date of the amendment, (b) provide that Ascent would not be obligated to convert any part of the Note at the closing of the merger, (c) reduce the mandatory prepayment provision for funds raised by the Company in subsequent financings from 66% to 50%, and (d) require a $45,000 cash extension fee to be paid by the Company at the maturity of the Note. On February 18, 2025, we repaid the Note in full. See the section titled “Description of Convertible Note Transaction” below for additional information.

Pending Merger and Asset Sale

On July 8, 2024, we entered into an Agreement and Plan of Merger (“Merger Agreement”) with Vyome Therapeutics, Inc. (“Vyome”) and Raider Lifesciences Inc., a Delaware corporation, and a direct, wholly owned subsidiary of ReShape (“Merger Sub”). Pursuant to the Merger Agreement, and subject to the satisfaction or waiver of the conditions specified therein, Merger Sub shall be merged with and into Vyome, with Vyome surviving as a subsidiary of ReShape (the “Merger”). The combined company intends to change its name to Vyome Holdings, Inc. and will focus on Vyome’s business of advancing the development of its immuno- inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market.

~~Table~~We next select a rare indication that has no approved treatments as the target disease for development. In the United States, rare diseases (RDs) are statutorily defined as conditions that impact 200,000 individuals or less. As of ~~Contents~~February 2024, more than 30 million Americans are affected by a rare disease. At the same time, about 5% of rare diseases have a Food and Drug Administration (FDA)-approved treatment and less than 15% have at least one drug either in clinical development or that has demonstrated potential in treatment, diagnosis or prevention. We believe this offers a large blank slate to build a leadership position. We next reformulate the molecule in a topical form for local application to the disease site. This reformulation builds additional IP.

~~Simultaneously~~As ~~with~~compared the execution of the Merger Agreement, we entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Ninjour Health International Limited, a company incorporated under the laws of the United Kingdom (“Ninjour”). Pursuant to the ~~Asset~~classical drug ~~Purchase~~development ~~Agreement~~model, ~~and subject to the satisfaction or waiver of the conditions specified therein,~~ we ~~will~~believe ~~sell substantially all of~~ our ~~assets~~model ~~(excluding cash)~~ to ~~Ninjour~~repurpose ~~(or~~existing andrugs ~~affiliate~~for ~~thereof),~~initial ~~and~~approval ~~Ninjour will assume substantially all of our liabilities,~~ for aorphan ~~purchase~~immune-inflammatory ~~price~~diseases offer ~~of $5.16 million in cash, subject to adjustment based on ReShape’s actual accounts receivable and accounts payable at~~ the ~~closing~~following ~~compared~~regulatory to such amounts as of March 31, 2024 (the “Asset Sale”). Ninjour is an affiliate of Biorad Medisys, Pvt. Ltd., which is party to a previously disclosed exclusive license agreement, dated September 19, 2023, with ReShape for ReShape’s Obalon® Gastric Balloon System.advantages:

OnCost ~~October 1~~and Time Savings: Our model includes lower patient numbers in clinical trials. As compared to hundreds or thousands of patients needed for non-orphan indications, ~~2024~~orphan indications require lesser number of patients for regulatory submissions for approval. There are some orphan diseases, wewhere ~~filed~~even a10 ~~Registration~~patients ~~Statement~~are hard onto ~~Form~~find. ~~S-4~~We inhave ~~connection~~selected ~~with~~disease ~~the~~conditions ~~Merger~~where ~~and~~patients ~~Asset~~are ~~Sale~~readily available. For example, ~~which~~as wereported ~~anticipate~~recently ~~will~~in ~~close~~2011 in the Journal ~~second~~of ~~quarter~~American ofMedical ~~2025~~Association (JAMA), ~~assuming~~a study on the ~~conditions~~Characteristics of Clinical Trials to ~~closing~~Support ~~are~~Approval ~~satisfied.~~of OnOrphan ~~December 6~~vs Nonorphan Drugs for Cancer concluded that “Compared with pivotal trials used to approve nonorphan cancer drugs, ~~2024~~pivotal trials for recently approved orphan drugs for cancer were more likely to be smaller and to use nonrandomized, weunblinded ~~filed~~trial andesigns ~~Amendment~~and ~~No.~~surrogate 1end points to assess efficacy.” This study found that ~~Registration~~pivotal ~~Statement~~trials for orphan drugs enrolled fewer patients exposed to the drug per study than those for nonorphan drugs (median 96 v 290). Lower patient numbers can lower development cost compared with non-orphan indications. Orphan-designated drugs had a shorter FDA review time on ~~Form S~~average (1.6 years) than nonorphans that were approved as new molecular entities (2.2 years) (Seoane-4Vezquez ~~and~~et al., 2008). Additionally, as noted in a 2012 article on ~~January~~approval 15of new agents after phase II trials in the American Society for Clinical Oncology Educational Book, ~~2025~~“A weconfirmatory ~~filed~~phase II trial, which need not be randomized if an ~~Amendment~~active Nocontrol is not available’ (as is our case as there are no approved drugs), can provide sufficient evidence to convince regulatory authorities to grant accelerated approval, and the process can be completed in three years or less.” 2To date, we have not had any meetings with the FDA regarding Phase 3 trial protocols or regarding obtaining orphan drug designation, and although we plan to receive orphan drug designation, there is no guarantee that ~~Registration~~such ~~Statement~~designation onwill ~~Form~~be ~~S-4~~granted.

WeRegulatory ~~entered~~Support: ~~into~~The ~~the~~Orphan ~~Equity~~Drug ~~Purchase~~Act ~~Agreement~~provides special ~~and~~incentives ~~Convertible~~to ~~Note~~manufacturers ~~transactions~~who indevelop ~~order~~drugs to ~~fund~~treat ~~our~~rare ~~operations through the closing of the Merger and Asset Sale. The description of our business set forth above reflects our current business operations~~diseases, ~~but~~including ifgrants ~~the~~to ~~Merger~~perform ~~and~~clinical ~~Asset Sale are completed~~trials, weup ~~will sell substantially all of our assets~~ to ~~Ninjour~~25%% tax ~~Health~~credit ~~International~~for ~~Limited~~clinical ~~(or~~testing ancosts ~~affiliate~~in ~~thereof) and~~ the ~~combined~~USA, ~~company~~and ~~following~~an ~~the~~exclusive ~~Merger~~right ~~intends~~ to ~~focus~~market ~~on Vyome’s business. However,~~ the ~~completion~~drug offor ~~the~~seven ~~Merger~~years ~~and~~after ~~Asset~~regulatory ~~Sale~~approval. Orphan ~~both~~drug ~~remain~~manufacturers ~~subject~~also toreceive awaivers ~~number~~ of ~~conditions~~drug toapplication ~~closing,~~fees ~~including~~up ~~the approval of our stockholders and, with respect~~ to ~~the~~approximately ~~Merger,~~$4 ~~the~~million ~~approval of the Nasdaq Stock Market,~~ and ~~there~~may ~~can~~ be noeligible ~~assurance~~for ~~that~~faster review by the ~~Merger~~FDA. ~~and~~We ~~Asset Sale~~ will bestrive ~~consummated. Failure~~ to ~~complete~~get ~~the~~orphan ~~Merger~~indication ~~and~~status ~~Asset~~for ~~Sale could negatively impact~~ our ~~future~~initial ~~operations, financial results and stock price~~programs.

Regulatory Advantages in Clinical Development: Safety data from clinical trials (in non-orphan indication settings) may expedite the development process, decreasing time to market and accelerating the timeline for potential treatments.

~~Reverse~~In ~~Stock~~parallel ~~Split~~to focusing on rare immune-inflammatory diseases as our initial indications for drug development, we are also mapping non-orphan indications that mechanistically overlap with the orphan indication. For example, fungating wounds can be present in diabetic foot ulcers or pressure sores, and accordingly, we believe VT-1953, mechanistically, should address the symptoms of these chronic wounds. According to JAMA, diabetic foot ulcers affect about 18.6 million people worldwide and 1.6 million in the US annually. Similarly, we believe VT-1908 can be extended from treating steroid-incompatible uveitis to treating immune-inflammation of the eye post-cataract surgery. We believe this opens the possibility for us to address larger indications and markets in the future. However, as discussed earlier, clinical trials for non-orphan indications generally take a longer time and require a larger number of patients, and we anticipate such development efforts will be driven through non-dilutive partnerships so as to achieve capital efficiencies.

Effective September 23, 2024, we effected a 1-for-58 reverse stock split of our issued and outstanding common stock (the “Reverse Stock Split”). All references to shares of our common stock in this Annual Report on Form 10-K refer to the number of shares of common stock after giving effect to the Reverse Stock Split and are presented as if the Reverse Stock Split had occurred at the beginning of the earliest period presented.

Our Strategic Focus

Develop and Commercialize a Differentiated Portfolio of Products/Therapies

ReShape Lifesciences Inc. is the premier physician-led weight-loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. An overarching strategy for our Company is to develop and commercialize products, programs and services portfolio that is differentiated from our competition by offering transformative technologies that consists of a selection of patient-friendly, non-anatomy changing, lifestyle enhancing products, programs and services that provide alternatives to more invasive bariatric surgeries, and help patients achieve healthy and durable weight loss. Current offerings include the Lap-Band System and accessories, and recently approved Lap-Band 2.0. The FDA approved Obalon Balloon System, which has been off the market since March 2020 and was acquired in connection with the Obalon merger in June of 2021, has not yet been re-introduced to the marketplace. We believe that we are well positioned for the existing market and can serve more of the overweight and obese population with our solutions and thereby help expand the addressable market for obesity.

Drive the Adoption of Our Portfolio through Obesity Therapy Experts and Patient Ambassadors

Our clinical development strategy is to collaborate closely with regulatory bodies, healthcare providers, obesity therapy lifestyle experts and others involved in the obesity management process, patients and their advocates and scientific experts. We have established relationships with physicians, obesity therapy experts, patient advocates, media experts and other market drivers we believe will provide important support towards promoting patient awareness and gaining widespread adoption of the Lap-Band, its accessories, Lap-Band 2.0 and the possible re-introduction of the Obalon Balloon System.

~~Table~~Vyome’s ofProduct ~~Contents~~Portfolio

~~Expand~~Leveraging ~~and~~the ~~Protect~~above ~~Our~~strategy, we ~~Intellectual~~have ~~Property~~built ~~Position~~out a robust product portfolio (See Figures 2.1 and 2.2).

Figure 2.1 Pipeline for VT-1953, VT-1908 and VB-1953

We(1) ~~believe~~VB-1953’s ~~that~~CMC, ~~our~~Toxicology ~~issued patents~~ and ~~our~~clinical ~~patent~~safety ~~applications~~data ~~encompass~~will abe ~~broad~~cross ~~platform~~referenced offor ~~therapies~~the ~~focused~~IND onfiling ~~obesity,~~of ~~diabetes,~~VT-1953 ~~hypertension~~program and ~~other~~the ~~gastrointestinal~~MFW ~~disorders.~~Pivotal ~~We intend to continue to pursue further intellectual property protection through U~~study.~~S. and foreign patent applications.~~

(2) Geographic partnerships will be utilized for this indication.

OnFigure ~~March 9, 2023, we filed a patent infringement complaint against Allurion Technologies, Inc~~2.2 inPipeline ~~the U.S. District Court~~ for ~~the~~MRT District of Delaware. The complaint alleged that Allurion is infringing at least two claims of our U.S. Patent No. 10,463,520, which is related to our intellectual property portfolio, by making the Allurion Gastric Balloon system in the U.S. for exportation and/or sales from the U.S and/or for potential sales in the U.S. relating to Allurion’s application to the FDA to sell the Allurion Gastric Balloon in the U.S. The complaint sought, among other relief, damages for Allurion’s alleged infringement of the ‘520 patent, in an amount not less than a reasonable royalty. On May 31, 2023, we filed a voluntary dismissal, without prejudice, of the complaint, which reserves our right to assert the claim against Allurion. Since that time, in October 2023, we have been issued another patent, U.S. Patent No. 11,779,482, which arises out of the same family as the ‘520 patent, and also applies to the Allurion Gastric Balloon system. We are also pursuing a third patent out of the same family, which we expect to be issued soon. This matter is in its early stages and we are unable to predict its outcome at this time. However, we intend to continue to vigorously protect and enforce our intellectual property rights. Platform

(3) Three antifungal products have been developed using the MRT platform and licensed to Sun Pharma for India rights. As MRT platform uses a GRAS (generally regarded as safe) compound, the commercialized product could be directly tested in patients and not subjected to the traditional IND/ NDA route of development. Two of three such products are clinically tested with positive results in India, and Sun Pharma have commercialized these products. The MRT platform is being leveraged to add more products to the pipeline. When any of these new products include a pharmaceutically-regulated agent, the classical regulatory IND/NDA path needs to be followed.

~~Our~~Program ~~Market~~1- VT-1953 — Topical gel for treating malodor malignant fungating wound (MFW)

Malignant fungating wounds (MFW) is a non-healing wound that occurs when cancer breaks through the skin, causing tissue necrosis resulting in the area becoming infected and inflamed. Although considered a rare condition, which offers the opportunity to access the regulatory advantages of orphan drug status, MFW afflicts approximately 5 – 14% of patients with advanced cancer. It is estimated that in 2025, there will be over six hundred and fifty thousand patients (650,000) living with advanced cancer in the US alone, and over ten million worldwide.

~~The~~MFWs ~~Obesity~~may arise from any type of malignant tumor, but the common primary sites are breast, head, neck, kidney, lung, ovary, colon, penis, skin, bladder, sarcomas, leukemia and ~~Metabolic~~lymphoma. ~~Disease~~Unfortunately, ~~Epidemic~~MFW is extremely distressing to patients given the high burden of symptoms, including extreme malodor,heavy exudate, bleeding, severe pain, leading to feelings of shame, low self-esteem, and social isolation (See Figure 3). In a report, Piggin and Jones, described the meaning of living with a malignant fungating wound from the perspective of five women, in that it caused immense distress, represented a huge new challenge, and changed relationships with family and friends.

The management of symptoms is the mainstay of treatment for MFW. In a survey of nurses, 48% identified malodor as the main challenge, followed by pain and exudate control. In a study, 14 nurses, four patients and one care giver, reported MFW as an intense and unforgettable experience, with most of the distress caused by malodor. This symptom has been described as “odor is a constant day-to-day symptom of the patient, causing nausea and unleashing the progressive worsening of their nutritional status, in addition to afflicting the people with whom they interact, or even health professionals through direct contact”. The malodor associated with MFWs has a significant negative effect on quality of life (QoL) and often inflicts a sense of shame due to the pervasive and pungent smell. Patients report that a reduction in the distressing experience of odor and pain enabled them to live more positively with the wound. Therefore, an effective treatment for malodorous MFW can be transformative for patients.

Obesity is a disease that has been increasing at an alarming rate with significant medical repercussions and associated economic costs. The World Health Organization (“WHO”) currently estimates that more than 2.5 billion adults, approximately 30% of the global population, are considered overweight or obese. This number has a projected increase to 50% by 2030. The global economic impact of obesity is approximately $2.0 trillion, or approximately 2.8% of global GDP. Healthcare costs for severely or morbidly obese adults are 81% higher than for healthy weight adults and obesity is responsible for 5% of deaths worldwide. We believe our products and programs and product candidates could address a $1.64 billion per year and growing global surgical device market. The Bariatric Surgical Device market is projected to be a $2.8 billion worldwide market ($1.8 billion in the U.S.) by 2025, the Virtual Healthcare Delivery market is projected to be $95 billion worldwide by 2026, and the Global Weight Loss and Obesity Management market is expected to rise to an estimated value of $300 billion with a compound annual growth rate of 6.7% from 2019 to 2026.

We believe that this epidemic will continue to grow worldwide given dietary trends in developed nations that favor highly processed sugars, larger meals and fattier foods, as well as increasingly sedentary lifestyles. Despite the growing obesity rate, increasing public interest in the obesity epidemic and significant medical repercussions and economic costs associated with obesity, there continues to be a significant unmet need for effective treatments.

The United States Market

Obesity has been identified by the U.S. Surgeon General as the fastest growing cause of disease and death in the United States. Currently, it is estimated that approximately 160 million American adults are overweight or obese, 74 million American adults are overweight, 78 million American adults are obese or severely obese, and 24 million American adults are morbidly obese. It is estimated that if obesity rates stay consistent, 51% of the U.S. population will be obese by 2030. According to data from the U.S. Department of Health and Human Services, almost 80% of adults with a BMI above 30 have comorbidity, and almost 40% have two or more of these comorbidities. According to The Obesity Society and the CDC, obesity is associated with many significant weight-related comorbidities including Type 2 diabetes, high blood-pressure, sleep apnea, certain cancers, high cholesterol, coronary artery disease, osteoarthritis and stroke. According to the American Cancer Society, 572,000 Americans die of cancer each year, over one-third of which are linked to excess body weight, poor nutrition and/or physical inactivity. Over 75% of hypertension cases are directly linked to obesity, and more than 90% of the approximately 28 million U.S. adults with Type 2 diabetes are overweight or have obesity.

~~Table~~Current oftreatment ~~Contents~~options for MFW

~~Currently,~~The ~~medical~~fetid ~~costs~~odor associated with ~~obesity~~MFW inis ~~the~~attributable ~~U.S. are estimated~~ to bea upcombination ~~to $210.0 billion per year and nearly 21%~~ of ~~medical~~factors ~~costs~~such inas ~~the~~necrotic ~~U.S.~~tissues ~~can~~and bebacteria ~~attributed~~colonizing ~~to obesity. Approximately $1.5 billion was spent in 2015 alone in~~ the Uwound.S. onBacteria ~~approximately~~produce ~~200~~malodorous molecules,~~000~~ ~~bariatric~~which ~~surgical~~tend ~~procedures~~ to ~~treat~~linger ~~obesity.~~and Incan ~~2025,~~cause ~~it is estimated that up to $3.8 billion will be spent in the U.S. on approximately 800~~vomiting,~~000~~ ~~bariatric~~and ~~surgical~~together ~~procedures~~with todebris ~~treat~~from ~~obesity.~~necrotic ~~Researchers~~cells ~~estimate~~can ~~that~~induce iftissue ~~obesity trends continue~~damage, obesity-related medical costs could rise by another $44-$66 billion each year in the U.S. by 2030. The medical costs paid by third-party payers for people who are obese were $2,741 per year, or 42% higher than those of people who are normal weight inflammation and ~~the average cost to employers is $6,627 to $8,067 per year per obese employee (BMI of 35 to 40 and higher)~~pain.

There are currently no FDA-approved treatments for MFW or for symptoms of malodorous malignant fungating wounds. Patients are managed using old obsolete, and suboptimal agents, such as metronidazole, aromatic oils, camphor, honey, or silver-coated dressings. Metronidazole is widely used topically off-label. However, metronidazole poses an occupational health risk as it is a mutagen. More importantly, it is effective only against strict anaerobic bacteria, whereas, recent clinical studies have revealed that MFW wounds are predominantly colonized with aerobic bacteria (and facultative anaerobes), with an average of 3.6 species of aerobes (and facultative anaerobes) to 1.7 species of anaerobes per patient. Some of the common aerobes (and facultative anaerobes) in MFW are Staphylococcus, Pseudomonas, Corynebacterium, Streptococcus, Proteus, Escherichia, Enterococcus, and others. While treatment of malodorous MFW with metronidazole reduces anaerobic bacteria, the aerobes (and facultative anaerobes) remained unchanged after treatment. Recent studies have shown that both aerobic (such as Proteus, Klebsiella, Pseudomonas, Staphylococci) and anaerobic (Bacteroides, Clostridium, etc.) bacteria are responsible for malodor. Indeed, over 40% of patients with only aerobic bacterial colonization of MFW exhibit malodor. Additionally, bacterial load correlates with increased odor, exudates, and pain (See Figure 3). Taken together, an effective treatment of the symptoms of malodorous MFW needs a therapeutic agent that has potent activity against both anaerobic and aerobic bacteria. In addition, such a treatment needs to inhibit the inflammation due to cellular debris and bacterial metabolites.

~~Current~~Figure ~~Treatment~~3. ~~Options~~Mechanistic ~~and~~analysis ~~Their~~of ~~Limitations~~MFW symptoms

Our solution for treating symptoms of MFW

WeVT-1953 ~~believe~~is ~~existing~~being ~~bariatric~~developed as ~~surgery~~a ~~and~~topical ~~endoscopic~~gel ~~procedural~~treatment ~~options~~ for the ~~treatment~~symptoms of ~~obesity~~malodorous ~~have~~MFW. ~~seen~~It ~~limited~~acts ~~adoption~~via toa ~~date,~~dual ~~with~~mechanism ~~approximately 1%~~ of ~~the~~action. ~~obese~~It ~~population~~can ~~qualifying~~bind ~~for~~and ~~treatment~~inhibit ~~actually~~the ~~seeking~~DNA gyrase/topoisomerase ~~treatment,~~IV ~~due~~ to ~~patient~~kill ~~concerns~~the ~~and~~odor-causing ~~potential~~bacteria. ~~side~~Additionally, ~~effects~~molecular ~~including~~docking ~~permanently~~studies ~~altered~~show ~~anatomy~~besifloxacin ~~and~~binds ~~morbidity.~~at ~~The~~the ~~recent adoption surge~~ interface of ~~GLP~~TLR-1MD2 ~~agonists~~interactions. ~~for~~MD2 ~~weight~~is ~~loss~~reported ~~and~~to ~~related~~modulate ~~big-pharma marketing efforts have significantly increased~~ the ~~number~~NLRP3 ofinflammasome ~~overweight~~pathway, and ~~obese~~can ~~individuals~~impact ~~who~~multiple ~~are~~mechanisms ~~seeking~~to ~~medically~~reduce ~~managed~~inflammation (See ~~weight~~Figure ~~loss~~4).

Figure 4. VT-1953 acts via dual mechanisms of action.

The ~~principal~~active ~~treatment~~drug ~~alternatives~~in ~~available~~VT-1953 ~~today~~topical ~~for~~gel ~~obesity~~binds ~~include:~~to DNA gyrase/topoisomerase IV, which kills the odor-causing bacteria colonizing MFWs It also binds at the interface of MD2-TLR immunomodulatory interaction, which can exert an anti-inflammatory effect in MFW.

•Behavioral modification. Behavioral modification, which includes diet and exercise, is an important component in the treatment of obesity; however, most obese patients find it difficult to achieve and maintain significant weight loss with a regimen of diet and exercise alone.

•Pharmaceutical therapy. Pharmaceutical therapies often represent a first option in the treatment of obese patients but carry significant safety risks and may present troublesome side effects and compliance issues.

•Bariatric Surgery and Endoscopic Procedures. In more severe cases of obesity, patients may pursue more aggressive surgical treatment options such as sleeve gastrectomy and gastric bypass. These procedures promote weight loss by surgically restricting the stomach’s capacity and outlet size. While largely effective, these procedures generally result in major lifestyle changes, including dietary restrictions and food intolerances, and they may present substantial side effects and carry short- and long-term safety and side effect risks that have limited their adoption.

Given the limitations of behavioral modification, the inaccessibility, side-effects, and durability of pharmaceutical therapy, and the invasive and irreversible nature of other bariatric surgical approaches, we believe that there is a substantial need for the less invasive, adjustable, and reversable Lab-Band.

Our Competition

The market for obesity treatments is competitive, subject to technological change and significantly affected by new product development. Our primary competition in the obesity treatment market is currently from bariatric laparoscopic and endoscopic procedures, and the recently introduced GLP-1 pharmaceuticals.

Our Lap-Band System competes, and we expect that our Obalon Balloon System may compete, with surgical and endoscopic obesity procedures, including gastric bypass, gastric balloons, sleeve gastrectomy and the endoscopic sleeve. These current surgical procedures are performed in less than 1% of all eligible obese patients today. Outside of the Obalon Balloon System which we recently acquired, other current manufacturers of gastric balloon and suturing products that are approved in the United States include Boston Scientific (ORBERA Intragastric Balloon System and OverStitch Endoscopic Suturing System) and Spatz Medical.

~~Table~~The active agent in VT-1953 topical gel is besifloxacin, a fourth-generation fluoroquinolone molecule. A topical ophthalmic drop with the same active ingredient is approved by the FDA (NDA#22-308) for the treatment of ~~Contents~~bacterial conjunctivitis. Besifloxacin exerts potent efficacy against the range of bacteria commonly colonizing MFW (See Figure 5a-b). Besifloxacin is more potent than metronidazole (currently used off-label to treat MFW) against anaerobes: Bacteroids spp (besifloxacin can kill 50% of the bacteria at concentrations of 0.5μg/ml (MIC50). In comparison, 4X higher concentration of metronidazole is needed to achieve the same level of activity (MIC50 metronidazole=2 μg/ml). Besifloxacin can kill 50% of Clostridium bacteria at concentrations of 0.25μg/ml (MIC50=0.25μg/ml). In comparison, 8X higher concentration of metronidazole is needed to achieve the same level of activity (MIC50 metronidazole=2 μg/ml for Clostridium). Besifloxacin also kills aerobic bacteria. It can kill 50% of propionibacterium at a concentration of 0.25μg/ ml. In comparison, 64 fold higher concentration of metronidazole is needed for similar level of efficacy (MIC50>16 μg/ml). Besifloxacin can kill 50% to 90% of Staphylococcus aureus and S. epidermidis at a concentration range of 0.015-0.5μg/ml (MIC50s/MIC90s range). In comparison, metronidazole does not act against aerobic bacteria. Besifloxacin also demonstrated potent activity against a broad range of streptococci, Enterococcus faecalis and E. faecium, including vancomycin-resistant enterococci, Listeria monocytogenes, Acinetobacter spp., Enterobacter aerogenes, and Proteus spp, and was active against fluoroquinolone-resistant isolates. For the fastidious gram-negative species (Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, and Legionella pneumophila), besifloxacin demonstrated potent activity with MIC90s of 0.03 μg/ml or less. These results show that the active agent in VT-1953 kills a broader range of bacteria that colonize malignant fungating wounds, and at lower concentrations, as compared with metronidazole, which is currently used off-label.

WeIn ~~also~~preclinical ~~compete~~studies, ~~against~~VT-1953 was ~~the~~found ~~manufacturers~~to ofexert ~~pharmaceuticals~~a ~~that~~direct ~~are~~anti-inflammatory ~~directed~~effect atindependent ~~treating~~of ~~obesity and~~ the ~~99%~~antibacterial ofeffect, ~~obese~~reducing ~~patients~~inflammation ~~eligible~~by ~~for~~over ~~surgery that are not willing to pursue a surgical option~~60%. WeIn ~~are~~contrast, FDA-approved ~~aware~~anti- ofinflammatory aagent, ~~number~~dapsone, ofreduced ~~drugs~~inflammation ~~that~~by ~~are~~40% ~~approved for long-term treatment of obesity~~ in the ~~United~~same ~~States:~~study ~~Orlistat,~~(See ~~marketed~~Figure by5c). ~~Roche~~Besifloxacin assignificantly inhibited ~~Xenical~~lipopolysaccharide-induced ~~and~~cytokine ~~GlaxoSmithKline~~product asin ~~Alli,~~a ~~Belviq~~dose-dependent ~~marketed by Arena Pharmaceuticals, Inc~~manner., ~~Qsymia~~Indeed, ~~marketed~~cellular byand ~~VIVUS,~~bacterial ~~Inc.,Contrave,~~debris ~~marketed~~can bytrigger ~~Orexigen~~an innate ~~Therapeutics,~~IL6 ~~Inc.~~immune ~~Wogovy/Ozempic~~response ~~marketed~~via bythe ~~Novo~~TLR ~~Nordisk~~pathway. ~~While~~Treatment ~~considered~~of ahuman ~~competitive~~monocytes ~~therapy,~~with weheat-killed ~~expect~~bacteria ~~that~~resulted in the ~~marketing~~induction of ~~these~~an IL6 ~~pharmaceuticals will increase awareness and help normalize obesity treatment. Further~~response, wewhich ~~some~~was ~~surgeons~~inhibited ~~will~~by ~~use~~VT-1953 ~~pharmaceuticals~~in toa ~~coincide~~concentration-dependent ~~with~~manner a(See ~~Lap-Band~~Figure ~~placement~~5d).

Figure 5.

In(a) ~~addition~~Graph toshows ~~competition~~common ~~from~~aerobic ~~surgical obesity procedures, we compete with several private early-stage companies developing neurostimulation devices for application to the gastric region~~ and ~~related~~anaerobic ~~nerves~~bacteria ~~for~~that ~~the~~colonizes ~~treatment of obesity~~MFW. Further, we know of two intragastric balloon companies in the U.S., Spatz Medical, which received FDA approval of the Spatz3 Adjustable Balloon in October of 2021, and Allurion Technology’s Elipse Balloon, which is in either clinical trials or working toward clinical trials in the U.S. These companies may prove to be significant competitors, particularly through collaborative arrangements with large and established companies. They also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.

(b) These aerobic and anaerobic bacteria are killed at low drug concentrations of besifloxacin, the active agent in VT-1953.

We(c) ~~believe~~Topical ~~that~~application ~~the~~of ~~principal~~VT-1953 ~~competitive~~reduced ~~factors~~inflammation, in ~~our~~vivo, ~~market~~induced ~~include:~~by injection of dead bacteria in rat paw.

(d) VT1953 reduces inflammatory IL6 levels in human monocytes stimulated with heat-killed bacteria. Based on this observation, we anticipate topical application of VT-1953 on MFW will reduce inflammation.

● acceptance by healthcare professionals, patients and payers;

● published rates of safety and efficacy;

● reliability and high-quality performance;

● effectiveness at controlling and/or resolving comorbidities such as diabetes and hypertension;

● invasiveness and the inherent reversibility of the procedure or device;

● cost and average selling price of products and relative rates of reimbursement;

● effective marketing, training, education, sales and distribution;

● regulatory and reimbursement expertise;

● technological leadership and superiority;

● speed of product innovation and time to market.

Many of our competitors are larger than we are, and they may enjoy several competitive advantages over us, including:

● stronger name recognition;

● existing relations with healthcare professionals, customers and third-party payers;

● established distribution networks;

● significant experience in research and development, manufacturing, preclinical testing, clinical trials, obtaining regulatory approvals, obtaining reimbursement and marketing approved products; and

● greater financial and human resources.

As a result, we cannot assure you that we will be able to compete effectively against these companies or their products.

~~Table~~Pre-Clinical ofToxicity ~~Contents~~Studies

~~Market~~Good ~~Opportunity~~Laboratory Practice (GLP) and non-GLP repeat dose studies conducted by us, with besifloxacin topical gel application in rodents and minipigs showed very low blood levels but high drug concentration at the site of application on the skin (See Figure 6). This is important as local high drug concentration is critical for killing the odor-causing bacteria, while low systemic exposure minimizes the risk of systemic side effects. There were no signs of skin or systemic effects which could be related to treatment with besifloxacin. VB-1953 2% topical formulation was devoid of irritation and allergenic potential in animal models.

Figure 6. VT-1953 topical gel builds desired drug concentration at sit of application on skin with minimal systemic exposure.

~~Given~~(a) ~~the~~Graph ~~limitations~~shows ofhigh ~~behavioral~~drug ~~modification,~~concentrations ~~pharmaceutical~~(in ~~therapy~~microgram ~~and~~levels/g ~~traditional~~tissue) ~~bariatric~~in ~~surgical~~the ~~approaches,~~skin weis ~~believe~~retained ~~there~~over is24 ahours. ~~substantial~~This ~~need~~is ~~for~~almost ~~patient-friendly,~~40x ~~safer,~~the ~~effective~~concentration ~~and~~needed ~~durable~~to ~~solutions~~kill ~~that:~~odor-causing bacteria.

(b) In contrast, negligible concentration of drug (in nanograms/g) is reached in systemic circulation, which minimizes the risk of potential systemic side effects.

●The ~~provide~~toxicokinetics ~~proven~~of VT-1953 gel (2% and/or 4%) was evaluated in minipigs following topical application. To model higher systemic exposure, ~~long~~one group was administered the drug via combined topical and subcutaneous administration. In a pilot 7 day non-~~term~~GLP study, animals were administered VT-1953 gel (4%) twice daily (approx. daily besifloxacin dose of 40mg/kg/day) and a separate group received an additional subcutaneous injection of besifloxacin at 5mg/kg/dose (twce daily for 7 days). Low plasma concentrations were detected following dermal application only at day 7 (and not earlier), with the maximum plasma concentration (Cmax) being ~2-7 ng/ml and total concentration over time, i.e. the total systemic drug exposure (area under the curve or AUC) being 8-29 ng.h/ml, supporting minimal systemic exposure. Combined subcutaneous and topical application resulted in a rapid Cmax between 425-540 ng.ml between 0.5-1h (Tmax) and AUC values between 1630-2500 ng.h/ml. There were no test article-related effects on clinical signs, dermal irritation, body weight ~~loss;~~or clinical pathology. These toxicokinetic results mean that while topical application on the skin resulted in minimal systemic exposure, even a 46-154 fold higher exposure on systemic administration was well tolerated.

In a 28 day repeat dose Good Laboratory Practice (GLP) toxicokinetics study required for FDA IND filing, VT-1953 Topical Gel, 0%, 2%, or 4% was applied topically, with resulting daily doses of approximately 0 mg/kg/day, 20 mg/kg/day, and 40 mg/kg/day, respectively (topical dosing alone); a separate group of animals received subcutaneous (SC) injections of 5 mg/kg/dose of besifloxacin twice per day for 28 days followed immediately by dermal application of VT-1953 Topical Gel, 4% to 10% body surface area. A total of 0.4 mg/cm2 or 0.8 mg/cm2 of the gel was applied each day. All animals survived to their scheduled termination and there was no test article related effects on clinical signs, dermal irritation, food consumption (qualitative), ophthalmology, electrocardiogram, coagulation, clinical chemistry, and urinalysis parameters. No test article related gross or microscopic pathological findings or organ weight effects were observed. Overall, the relative bioavailability was low via the topical route compared to the subcutaneous route. When comparing the Day 28 AUC values for topical dosing only and combined systemic and topical in the VT-1953 Topical Gel, 4% groups, the values were 18-39 fold lower with topical application than systemic. In this study, a total of 50mg/kg/day was considered the no-observed-adverse effect-level (NOAEL) dose.

● preserve normal anatomy;

● are adjustable in an office setting for individual patient needs and long term efficacy;

● are “non-punitive” in that they support continued ingestion and digestion of foods and micronutrients such as vitamins and minerals found in a typical, healthy diet while allowing the user to modify his or her eating behavior appropriately without inducing punitive physical restrictions that physically force a limitation of food intake;

● diminish undesirable side-effects;

● facilitate outpatient surgical procedures;

● minimize the risks of re-operations, malnutrition and mortality;

● reduce the natural hunger drive of patients; and

● are reversible, if necessary or desired, while preserving anatomy.

Our Intellectual Property

In order to remain competitive, we must develop and maintain protection of the proprietary aspects of our technologies. We rely on a combination of patents, trademarks, trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights. Our patent applications may not result in issued patents and our patents may not be sufficiently broad to protect our technology. Any patents issued to us may be challenged by third parties as being invalid or unenforceable, or third parties may independently develop similar or competing technology that does not infringe our patents. The laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States.

Lap-Band

As of December 31, 2024, we had approximately 34 total patents, 28 U.S. and 6 foreign, related to our Lap-Band System. The issued patents expire between the years 2025 and 2031.

We also have 59 total U.S. and international trademarks for the Lap-Band brand name.

ReShape Vest

As of December 31, 2024, we had four granted U.S. patents, and 4 granted foreign patents related to our ReShape Vest. The patents expire between the years 2028 and 2038.

We also have U.S. and international trademark applications for the ReShape Vest brand name.

Obalon

As of December 31, 2024, we had 37 granted U.S. patents and 46 granted foreign patents related to our Obalon portfolio. The patents expire between the years 2029 and 2031.

We also have 26 total U.S. and international trademarks for the OBALON brand name.

~~Table~~In another GLP study, VT-1953 topical gel, 0% (thrice daily), 2% (twice daily), or 4% (twice or thrice daily) was applied topically for 91 days in male and female Gottingen minipigs. All animals survived to their scheduled termination and there was no test article related effects on clinical signs, dermal irritation, food consumption (qualitative), ophthalmology, ECG, coagulation, clinical chemistry, and urinalysis parameters. No test article related gross or microscopic pathological findings or organ weight effects were observed. The topical administration of ~~Contents~~VT-1953 (4% gel, thrice a day) reaching a dose of 95.7 mg/kg/day was considered as the NOAEL (No Observed Adverse Effect Level) dose. This NOAEL dose converts to a human equivalent dose (HED) of 5220mg for a 60Kg human.

~~DBSN~~In ~~Device~~a GLP study, besifloxacin was administered once daily by oral route in Sprague Dawley rats at the dose levels of 10 mg/kg/day, 30 mg/kg/day, and 100 mg/kg/day for a period of 90 consecutive days. All animals survived to their scheduled termination and there was no test article related effects on clinical signs, food consumption (qualitative), ophthalmology, functional observational battery, motor activity, and coagulation, clinical chemistry, and urinalysis parameters. No test article related gross or microscopic pathological findings or organ weight effects were observed. Based on the study findings, NOAEL dose was considered to be 100 mg/kg/day for besifloxacin when administered repeatedly by oral gavage for 90 consecutive days in Sprague Dawley rats. The human equivalent dose (HED) is 967 mg for a 60Kg human, significantly higher than the 200mg dose per day that we are planning to use as the pivotal dose. We believe that these preclinical toxicity studies are sufficient to support the use of VT-1953 at the 200mg/kg dose that we will use in our clinical studies.

Phase 1 clinical study. Phase 1 clinical trials involve the initial introduction of the investigational product in a limited population of healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, excretion, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.

AsVT1953 of(earlier ~~December~~known 31as VB-1953) was initially evaluated in a Phase 1 open-label, ~~2024~~safety, wetolerability ~~had~~and pharmacokinetics study by Vyome in 2017 under the USFDA IND #125,335. The study was conducted in 12 Usubjects in the US (conducted by Therapeutics Inc.S. ~~patents~~San ~~issued~~Diego, ~~and~~CA), 13sponsored ~~foreign~~by ~~patents~~Vyome ~~issued.~~Therapeutics Inc), Inwith ~~addition~~moderate to severe facial acne vulgaris (Investigator’s Global Assessment [IGA] of Grade 3 or 4) as representative of inflamed skin, we18 ~~have~~to ~~filed~~45 ayears ~~trademark~~of ~~application~~age, who were treated twice daily for ~~Bloc~~14 days with VT-~~Stim~~1953 ~~Neuromodulation~~topical gel. ~~The~~All ~~USPTO~~subjects ~~Examiner~~applied isVB ~~reviewing~~1953 (2%) gel on the ~~application~~entire face twice daily (every 12 h) from Day 1 morning until Day 15 morning — total number of applications were 29 per subject. The number of subjects (n = 12) in this first-in-man pilot safety, tolerability, and ~~provided~~pharmacokinetic study was typical for studies of this type. All subjects were assigned to a single treatment group. No randomization or blinding was used. All procedures performed in the ~~Company~~study were in accordance with athe ~~disclaimer~~ethical ~~being~~standards ~~required~~of ~~for~~the ~~“Neuromodulation”,~~principles of Good Clinical Practice (GCP) and according to the guidelines (as ~~this~~amended) aof ~~standard~~the ~~requirement~~Declaration of Helsinki. The central Institutional Review Board (IRB), Quorum Review IRB, Seattle, USA approval was sought at the site for ~~words~~the ~~that~~initial ~~are~~protocol inand for protocol amendments. All participants provided written informed consent before commencing any study-related procedures. Quorum Review IRB approved the ~~standard~~informed ~~vernacular~~consent forms (ICF). Study endpoints included:

(a) Safety

~~Sales~~● Incidence (severity and ~~Distribution~~causality) of any local and systemic treatment emergent adverse events (TEAEs).

● Number of subjects with presence (and severity) of each individual local skin reaction (LSR: erythema, edema, scaling/dryness, burning/stinging, and pruritus) at each time point collected.

We● ~~market~~Changes ~~directly~~from toBaseline patients but sell the Lap-Band program to select qualified surgical centers throughout the U.S. and internationally having patients that would like to treat obesity and its comorbidities. The centers then perform the Lap-Band procedure and are most-commonly reimbursed by leading insurance providers in ~~the~~vital ~~U.S.~~signs ~~and~~at ~~government~~Days ~~health services in many areas outside the U.S. Alternatively~~2, ~~surgical centers can offer the Lap-Band as a cash-pay procedure. Our sales representatives are supported by field-based experts who provide training~~5, ~~technical support~~10, and ~~other support services at various medical centers~~15. ~~Our sales representatives help implement consumer marketing programs and provide surgical centers and certified surgeons with educational patient materials.~~

● Changes from Baseline in electrocardiograms (ECGs) at Days 5, 10, and 15.

In● ~~August~~Changes ~~of 2022, we shifted away~~ from ~~national~~Screening ~~advertising campaign initiatives and focusing on digital marketing channels including search engine ads and social media channels. This shift~~ in ~~marketing~~clinical islaboratory ~~100%~~tests ~~aligned with the Company’s focus on expanding Lap-Band use while ensuring a sustainable~~ (~~profitable)~~hematology, ~~business.~~clinical ~~The~~chemistry, ~~shift to a more targeted~~ and ~~regionalized~~urinalysis) ~~marketing~~at ~~program~~Day ~~allows us to better support interested potential Lap-Band patients while also reducing the overall costs for lead generation programs~~15. ~~This strategy also aligns with our key surgeon Lap-Band programs across the U.S.; surgeons who participate in local co-op marketing and educational initiatives in their communities.~~

● Urine pregnancy test (UPT) results (if applicable) at Baseline and Day 15.

During 2024, our international sales efforts were through a combination of agent and distributor sales channels, with a focus on top Lap-Band customers in Australia, the Middle East, Canada and select countries in Europe.

Our Manufacturers and Suppliers

To date, all of the materials and components for our products, as well as any related outside services, are procured from qualified suppliers and contract manufacturers in accordance with our proprietary specifications. All of our key manufacturers and suppliers have experience working with commercial implantable device systems, are ISO certified and are regularly audited by various regulatory agencies including the FDA. Our key manufacturers and suppliers have a demonstrated record of compliance with international regulatory requirements. In July 2021 we announced that we had completed our Lap-Band manufacturing transition from Apollo Endosurgery, Inc. to a Massachusetts-based contract manufacturer.

Given that we rely on third-party manufacturers and suppliers to produce our products, our ability to increase production going forward will depend upon the experience, certification levels and large-scale production capabilities of our suppliers and manufacturers. Qualified suppliers and contract manufacturers have been and will continue to be selected to supply products on a commercial scale according to our proprietary specifications. Our FDA approval process requires us to name and obtain approval for the suppliers of key components of the Lap-Band System.

Many of our parts are custom designed and require custom tooling and, as a result, we may not be able to quickly qualify and establish additional or replacement suppliers for the components of our products. Any new approvals of vendors required by the FDA or other regulatory agencies in other international markets for our products as a result of the need to qualify or obtain alternate vendors for any of our components would delay our ability to sell and market our products and could have a material adverse effect on our business.

~~Table~~(b) ~~of Contents~~Pharmacokinetics

We● believe that our current manufacturing and supply arrangements will be adequate to continue our ongoing commercial sales and our ongoing and planned clinical trials. In order to produce our products in the quantities we anticipate to meet future market demand, we will need our manufacturers and suppliers to increase, or scale up, manufacturing production and supply arrangements by a significant factor over the current level of production. There are technical challenges to scaling up manufacturing capacity and developing commercialConcentration-~~scale~~time ~~manufacturing~~profiles ~~facilities that may require the investment~~ of ~~substantial~~besifloxacin additional funds by our manufacturers and suppliers and hiring and retaining additional management and technical personnel who have the necessary experience. If our manufacturers or suppliers are unable to do so, we may not be able to meet the requirements to expand the launch of the product in ~~the~~plasma ~~United~~after ~~States or launch~~ the ~~product~~first ~~internationally~~dose ~~or to meet future demand, if~~ (at ~~all.~~Day WeI) ~~may also represent only a small portion of our suppliers’ or manufacturers’ business~~ and iffollowing ~~they~~the ~~become~~last ~~capacity~~dose ~~constrained,~~(at ~~they~~Day ~~may choose to allocate their available resources to other customers that represent a larger portion of their business~~15). ~~If we are unable to obtain a sufficient supply of our product, our revenue, business and financial prospects would be adversely affected.~~

● Peak plasma concentration (Cmax), time to achieve peak plasma concentration (Tmax), time to achieve minimum plasma concentration (Cmin), time to achieve minimum plasma concentration (Tmin), and area under concentration-time curve over a dosing interval (i.e., 12 hours, (AUC,)) after the first dose (at Day 1) and following the last dose (at Day 15), accumulation ratio (AR) after the last dose and terminal exponential half-life (t1/2z).

~~Government~~● ~~Regulations~~Trough plasma concentrations (Cl2h) on Days I, 2, 5, I 0, and 15 (-12 hours after the last test article application on the previous day).

~~Our~~(c) ~~products~~Efficacy ~~and~~(exploratory ~~operations~~end are subject to extensive and rigorous regulation by the FDA and other federal, state and local authorities, as well as foreign regulatory authorities. The FDA regulates, among other things, the research, development, testing, design, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of medical devices in the United States to assure the safety and effectiveness of medical products for their intended use. The Federal Trade Commission also regulates the advertising of our products in the United States. Further, we are subject to laws directed at preventing fraud and abuse, which subject our sales and marketing, training and other practices to government scrutiny.points)

There were no predefined efficacy endpoints. The following acne severity measurements were summarized at Baseline and at Day 15 for descriptive purposes only:

~~Regulatory~~● ~~system~~Investigator’s ~~for~~Global ~~medical~~Assessment ~~devices~~(IGA) inscore; ~~the United States~~and

● Inflammatory and non-inflammatory acne lesion counts

~~Unless~~The anresults ~~exemption~~from ~~applies,~~this ~~each~~study have ~~new~~been orpublished ~~significantly modified medical device we seek to commercially distribute~~ in ~~the United States will require either~~ a ~~premarket~~2020 ~~notification~~article totitled ~~the~~“Clinical ~~FDA requesting permission for commercial distribution under Section 510(k) of the Federal Food~~Pharmacokinetics, ~~Drug~~Safety and ~~Cosmetic~~Exploratory ~~Act,~~Efficacy orStudy ~~FFDCA,~~of ~~also referred to as~~ a ~~510(k)~~Topical ~~clearance,~~Bactericidal VB-1953: orAnalysis ~~approval from the FDA~~ of aSingle ~~premarket approval (“PMA”) application. Both the 510(k) clearance~~ and ~~PMA~~Multiple ~~approval~~Doses ~~processes~~in ~~can~~a bePhase ~~resource~~I ~~intensive,~~Trial ~~expensive,~~in ~~and~~Acne ~~lengthy,~~Vulgaris ~~and~~Subjects” ~~require~~published ~~payment~~in ofthe ~~significant~~Clinical ~~user fees~~Drug Investigation, ~~unless~~a anpeer ~~exemption~~reviewed isscientific ~~available~~journal. https://doi.org/10.1007/s40261-019-00883-5.

Of the fifteen subjects assessed, there were three screen failures; one withdrawal by a subject for a personal reason and two who met at least one of the exclusion criteria. The enrolled subjects were both males (33.3%) and females (66.7%) over 18 years of age, with a mean age of 25.3 years (50% whites and 50% Asians).

~~Device~~The ~~Classification~~safety population included all enrolled subjects who applied at least one dose of VT-1953. Safety data results (vital signs, ECG, physical examinations, hematology, chemistry, urinalysis) were all clinically insignificant from baseline to end of the study (Figure 7). UPT results were negative throughout the study. One subject with Treatment -Emergent Adverse Events (TEAE) (vaccination site discomfort) was reported in the study and was not considered related to treatment, was not within the treatment area, did not cause study discontinuation, did not require a change in test article dosing, was non-serious or severe, and resolved within one day after onset. There were no serious adverse events (SAEs). There was a negligible number of LSRs reported during the study, with all LSRs being trace/minimal or mild in severity. The most common LSR was trace erythema at Day 5 and Day 10. By Day 15, the few LSRs reported had spontaneously resolved with continued administration of the test article, save one subject demonstrating trace amounts of erythema. No edema was reported for any subject during the study. The most common LSR was trace erythema seen at Day 5 and Day 10. However, 11 subjects (91.7%) showed no evidence of erythema by the end of study (EOS). All subjects (100%) showed absence of scaling/dryness, stinging/burning, and pruritus by the EOS. No edema was reported for any subject during the study.

Under the FFDCA, medical devices are classified into one of three classes — Class I, Class II or Class III — depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices, which require compliance with the applicable portions of the Quality System Regulations, or QSR, facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials. Some Class I devices, also called Class I reserved devices, also require premarket clearance by the FDA through the 510(k) premarket notification process described below. Most Class I products are exempt from the premarket notification requirements.

Class II devices are those that are subject to the General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, patient registries, FDA guidance documents and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process.

~~Table~~Figure 7. In a phase 1 study, application of VT-1953 ~~Contents~~topical gel induced negligible local skin reactions (LSRs), demonstrating the tolerability of using it topically.

~~Class III~~Pharmacokinetic ~~devices~~parameters were ~~include~~calculated ~~devices~~for ~~deemed~~each bysubject ~~the~~based ~~FDA~~on ~~to pose the greatest risk such as life~~VT-~~supporting~~1953 orplasma ~~life-sustaining~~concentrations ~~devices,~~measured orfrom ~~implantable~~serial ~~devices,~~pharmacokinetic inblood ~~addition~~draws toon ~~those~~Day ~~deemed~~1 ~~novel~~ and on ~~not~~Day ~~substantially~~15. ~~equivalent~~Following ~~following~~ the ~~510(k)~~first ~~process.~~topical ~~The~~application ~~safety and effectiveness~~ of ~~Class III~~~ ~~devices~~(0.5 ~~cannot~~– be1.0) ~~reasonably~~g ~~assured~~of ~~solely~~VT-1953, by the ~~General~~quantifiable ~~Controls~~plasma ~~and~~concentrations ~~Special~~of ~~Controls~~VT-1953 varied ~~described~~between ~~above~~0.0543 ~~Therefore,~~and ~~these~~0.817 ~~devices~~ng/mL ~~are~~until ~~subject~~12 toh ~~the~~with ~~PMA~~mean ~~application~~maximum ~~process,~~plasma ~~which~~concentrations isof ~~generally~~0.317 ~~more~~ng/mL ~~costly~~achieved ~~and~~between ~~time~~6 ~~consuming~~to ~~than~~12 ~~the 510(k) process. Through the PMA application process~~h, ~~the~~a geometric ~~applicant~~mean ~~must~~peak ~~submit~~plasma ~~data~~concentration ~~and~~of ~~information~~approximately ~~demonstrating~~0.264 ~~reasonable~~ng/mL. ~~assurance~~This ofsupports the ~~safety~~preclinical ~~and~~observations, ~~effectiveness~~where oftopical ~~the~~administration resulted ~~device~~in ~~for~~low ~~its~~maximal ~~intended~~systemic ~~use~~drug ~~to the FDA’s satisfaction~~levels. ~~Accordingly,~~The ageometric ~~PMA~~mean ~~application typically includes~~AUCτ, ~~but~~i.e. isthe ~~not~~total ~~limited~~drug toexposure, ~~extensive~~was ~~technical~~approximately ~~information~~1. ~~regarding~~921 ~~device~~(ng × ~~design and development~~h)/mL, ~~pre-clinical~~supporting ~~and~~minimal ~~clinical~~systemic ~~trial~~exposure ~~data,~~over ~~manufacturing~~time. ~~information,~~Tmax ~~labeling~~was ~~and financial disclosure information for the clinical investigators in device studies~~8.729 ~~The~~h ~~PMA~~indicating ~~application~~slow ~~must~~absorption ~~provide~~through ~~valid scientific evidence that demonstrates to~~ the ~~FDA’s~~skin. ~~satisfaction~~Inter-subject variability a(CV) ~~reasonable~~associated ~~assurance~~with ofthese ~~the~~estimates ~~safety~~was ~~and~~approximately ~~effectiveness of the device for its intended use~~72%.

To further understand the pharmacokinetic behavior, trough plasma concentrations of VT-1953 were compared across time (Days 1, 2, 5, 10 and 15) using analysis of variance (ANOVA) with Helmert contrasts. This method compared the concentration over the first collection period versus the mean of all the other trough concentrations. The time at which there was no difference between Day “X” and the mean of all subsequent days was the time to reach steady state. Upon multiple doses, topical application of VT-1953 every 12 h, steady-state was achieved by Day 2 with the trough VT-1953 concentration of 0.13 ng/ml. The difference in VT-1953 plasma concentrations between Day 1 versus subsequent days was highly significant (p < 0.0001). When these analyses were expanded to compare differences between all other groups (Day 2 vs > Day 2, Day 5 vs > Day 5 and Day 10 vs Day 15), there was no significant difference (p > 0.05) indicating that steady state is achieved by Day 2 of topical application, i.e. there is no systemic drug accumulation. At steady-state, plasma concentrations increased ~ twofold [accumulation ratio (AR) = 1.936; 95% confidence interval (CI) = 1.07 to 3.50]. At Day 15, the Cmax or the highest concentration reached in blood was a geometric mean of 0.46 ng/mL, achieved at a median Tmax of 7.967 h. The minimum concentration detected in blood was a geometric mean (Cmin) of 0.13 ng/mL, while the overall total exposure expressed as a geometric mean (AUCτ) was 3.719 (ng × h)/mL occurring between0h to 12 h. The geometric mean AR was 1.936 (95% CI 1.07 – 3.50) indicating an approximately twofold increase in plasma concentration of VT-1953 at steady-state when compared to the first application. Inter-subject variability associated with these estimates ranged from 52.75 to 108.4%. The t1/2z, i.e. the time for 50% of the drug to be cleared out of the body could only be determined in four subjects, ranging from 6.7 to 17.4 h. These studies support the preclinical observations of minimal systemic exposure with topical application and that steady state is reached within 2 days and there is no drug accumulation in the body when the drug is applied everyday twice daily.

The ~~Investigational~~absolute ~~Device~~change ~~Process~~in inflammatory lesions from baseline to Day 15 was − 15.3 (59.77% reduction in lesions) (p value < 0.0001) and the absolute change in non-inflammatory lesions from baseline to Day 15 is − 4.5 (13.05%) after topical application of VT-1953 (2%) gel, emphasizing the anti-inflammatory mechanism of action of VT-1953.

In the United States, absent certain limited exceptions, human clinical trials intended to support medical device clearance or approval require an IDE application. Some types of studies considered to present “non-significant risk” are deemed to have an approved IDE once certain requirements are addressed, and IRB approval is obtained. If the device presents a “significant risk” to human health, as defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE application must be approved in advance by the FDA for a specified number of subjects. Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards at the clinical trial sites. There can be no assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.

All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. Clinical trials must further comply with the FDA’s good clinical practice regulations for institutional review board approval and for informed consent and other human subject protections. Required records and reports are subject to inspection by the FDA. The results of clinical testing may be unfavorable, or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant marketing approval or clearance of a product.

The 510(k) Clearance Process

Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent,” as defined in the statute, to a legally marketed predicate device.

A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence.

~~Table~~Phase 2a ‘Proof of Concept’ ~~Contents~~study. This was a double-blind, randomized, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of VT-1953 2% topical gel (earlier known as VB-1953) when applied daily for 12 Weeks in 160 subjects with moderate to severe facial acne vulgaris as representative of inflamed skin. The study was not powered to test for significance of efficacy. The study was done in 2017 – 2018 at the Instituto Dermatologico, Santo Domingo, Dominican Republic, Hospital Clinica Bendana, San Pedro Sula, Honduras, and the Instituto Dermatológico Cirugía de Piel, Santo Domingo, Dominican Republic, and was sponsored by Vyome. Symbio, LLC, Port Jefferson, NY, was responsible for study monitoring, electronic case report forms (eCRFs), quality assurance, data management, biostatistical analysis, and preparation of clinical study report. International Dermatology Research (IDR), Miami, FL was responsible for study monitoring. CISYS Life Sciences, Raleigh, NC, managed the electronic data capture (EDC) system. Subjects were randomized in a 4:4:1:1 ratio to treatment with VT-1953 OD, VT-1953 BID, vehicle OD, or vehicle BID, respectively, applied to the entire face for 12 weeks. Following a Screening/ Baseline Visit on Day 1, subjects returned for follow-up visits at Weeks 2 (Day 15±2 days),4 (Day 29 ±3 days), 8 (Day 57 ±3 days), and 12 (Day 85±5 days). This study was performed in compliance with the principles of the Declaration of Helsinki, current Good Clinical Practice (GCP) guidelines.

~~After~~Eligible asubjects ~~510(k)~~were ~~premarket~~males or ~~notification~~non-pregnant isfemales ~~submitted,~~who ~~the~~were ~~FDA~~18 ~~determines whether~~ to ~~accept~~45 ityears ~~for~~old ~~substantive~~(inclusive) ~~review.~~with Ifa itclinical ~~lacks~~diagnosis ~~necessary~~of ~~information~~moderate ~~for substantive review, the FDA will refuse~~ to ~~accept~~severe ~~the 510~~(k)Grade ~~notification.~~3 Ifor it4) isfacial acne ~~accepted~~vulgaris ~~for~~as ~~filing,~~determined by the ~~FDA~~Investigator’s ~~begins~~Global aAssessment ~~substantive review. By statute~~(IGA), ~~the~~and ~~FDA~~at isleast ~~required~~20 toand ~~complete~~no ~~its~~more ~~review~~than of40 ainflammatory ~~510~~lesions (kpapules, pustules), ~~notification~~at ~~within~~least ~~90 days~~25 ofand ~~receiving~~no ~~the~~more ~~510(k)~~than ~~notification.~~70 Asnon-inflammatory alesions ~~practical~~(open ~~matter,~~and ~~clearance~~closed ~~often takes longer~~comedones), and ~~clearance~~no ismore ~~never~~than ~~assured.~~2 ~~Although~~nodulocystic lesions ~~many 510~~(knodules/cysts) ~~premarket~~on ~~notifications~~the ~~are~~face, ~~cleared~~including ~~without~~lesions ~~clinical~~on ~~data,~~ the ~~FDA~~nose. ~~may~~Patients ~~require~~treated ~~further~~with ~~information,~~VT-1953 ~~including~~2% ~~clinical~~topical ~~data,~~gel toapplied ~~make~~twice adaily ~~determination~~(BID) received ~~regarding~~a ~~substantial~~mean ~~equivalence,~~total ~~which~~of ~~may~~114.55 ~~significantly~~− ~~prolong the review process~~117.8 Ifg ~~the~~of ~~FDA~~2% ~~agrees~~gel, ~~that~~or ~~the~~73.82 ~~device~~− is84.5 ~~substantially~~g ~~equivalent,~~of it2% ~~will~~gel ~~grant~~if ~~clearance~~applied toonce ~~commercially~~daily ~~market~~(QD) over the ~~device~~12 weeks period.

Overall, in the safety population, 31.9% of subjects were males, mean age was 23.5 years (median was 22.0, range 18 to 40), and the majority of subjects were Black or African-American (64.4%) and the remainder were White (35.6%). The end points of the study were:

If(a) ~~the~~Safety ~~FDA~~assessments: ~~determines~~Safety ~~that~~was assessed by the ~~device~~investigator’s isevaluation ~~not~~of ~~“substantially~~local ~~equivalent”~~and tosystemic aadverse ~~predicate~~events ~~device~~(AEs), orclinical iflaboratory ~~the~~tests ~~device~~(at isSite ~~automatically~~02), ~~classified~~urine ~~into~~pregnancy ~~Class III~~testing, ~~the~~vital ~~device~~signs, ~~sponsor~~12-lead ~~must~~electrocardiograms ~~then~~(ECGs), ~~fulfill~~and ~~the~~physical ~~much~~examination. ~~more~~The ~~rigorous~~investigator ~~premarketing~~assessed ~~requirements~~local ofskin ~~the~~reactions ~~PMA~~(LSRs) ~~approval~~of ~~process~~erythema, oredema, ~~seek~~and ~~reclassification~~scaling/dryness ofand the ~~device~~subject ~~through~~assessed ~~the de~~LSRs ~~novo process~~of stinging/burning and pruritus/itching. AThe ~~manufacturer~~number ~~can~~and ~~also~~percent ~~submit~~of asubjects ~~petition~~reporting ~~for~~treatment-emergent ~~direct de~~adverse ~~novo review~~events if(TEAEs) ~~the~~were ~~manufacturer~~tabulated isby ~~unable~~treatment togroup ~~identify~~with ansummaries ~~appropriate~~presented ~~predicate~~by ~~device~~system organ class and ~~the~~preferred ~~new~~term ~~device~~for orthe ~~new~~safety ~~use~~population. Distributions of ~~the~~severity ~~device~~for ~~presents~~LSRs awere ~~moderate~~summarized ordescriptively ~~low~~by ~~risk~~visit and treatment group. Changes in vital signs (blood pressure, temperature, pulse rate, and respiration rate) and ECGs were summarized with descriptive statistics.

(b) Efficacy assessment: Efficacy was assessed by the IGA of overall acne severity and acne lesion counts at Visits 2, 3, 4, and 5. The primary efficacy endpoints were the absolute change from baseline in inflammatory and absolute change from baseline in non-inflammatory lesion counts at Week 12. The secondary efficacy endpoint was the proportion of subjects achieving IGA success at Week 12 with success defined as a score of “clear” or “almost clear” (IGA Score of 0 or 1, respectively) AND at least a 2-grade (IGA) improvement from Baseline. The proportion of subjects with IGA success at Week 12 was analyzed using the Cochran-Mantel-Haenszel test for general association stratified by site. Post Hoc analysis of study data offered 106 evaluable patients across the treatment groups for efficacy analysis.

~~After~~The astudy ~~device~~enrolled ~~receives~~160 ~~510(k) clearance~~subjects, of ~~any~~which ~~modification~~160 ~~that~~patients ~~could~~were ~~significantly~~analyzed ~~affect~~for ~~its~~ safety oras ~~effectiveness,~~intent-to-treat or(ITT) ~~that~~populations ~~would~~(any ~~constitute~~subject awho ~~new~~was orrandomized ~~major~~and ~~change~~received inat ~~its~~least one ~~intended~~application ~~use,~~of ~~will~~the ~~require~~study amedication) ~~new~~and ~~510(k)~~144 ~~clearance~~were ~~or,~~analyzed ~~depending~~as onper-protocol ~~the~~(PP) ~~modification,~~population ~~could~~(any ~~require~~ITT asubject ~~PMA~~who ~~application~~completed ~~or de~~the ~~novo classification.~~study without ~~The~~any ~~FDA~~significant ~~requires~~protocol ~~each~~deviations). ~~manufacturer~~TEAEs towere ~~determine~~reported ~~whether~~by ~~the~~10.2% ~~proposed~~of ~~change~~total ~~requires~~VT-1953 ~~submission~~subjects ofand a15.6% ~~510(k)~~of ortotal avehicle ~~PMA~~subjects, including 10.6% in the ~~first~~VT-1953 ~~instance~~OD group, ~~but~~9.7% in the ~~FDA~~VT-1953 ~~can~~BID ~~review~~group, ~~any~~18.8% ~~such~~in ~~decision~~the vehicle OD group, and ~~disagree~~12.5% ~~with~~in athe ~~manufacturer’s~~vehicle ~~determination~~BID group. The ~~Many~~most ~~minor~~frequently ~~modifications~~occurring ~~are~~TEAE ~~accomplished~~in bythe atotal ~~letter~~VT-~~to-file~~1953 ingroup was headache (6.3%), which ~~the~~occurred ~~manufacture~~in ~~documents~~a ~~the~~similar ~~change~~proportion inof ansubjects with ~~internal~~OD ~~letter-to-file~~and BID dosing. The ~~letter-to-file~~most isfrequently occurring TEAEs in ~~lieu~~the oftotal ~~submitting~~vehicle agroup ~~new~~were ~~510~~headache and dysmenorrhea (keach 6.3%). toAll TEAEs ~~obtain~~were ~~clearance~~mild ~~for~~or ~~such~~moderate ~~change.~~in ~~The~~severity, ~~FDA~~and ~~can~~none ~~always~~were ~~review~~considered ~~these~~to ~~letters~~be related to ~~file~~study inmedication. anNo ~~inspection.~~deaths Ifor ~~the~~treatment ~~FDA~~emergent ~~disagrees~~serious adverse ~~with~~events a(SAEs) ~~manufacturer’s~~were ~~determination~~reported. ~~regarding~~Study ~~whether~~medication awas ~~new~~not ~~premarket~~interrupted ~~submission~~or iswithdrawn ~~required~~due ~~for~~to ~~the~~TEAEs ~~modification~~for ofany ansubject. ~~existing~~No ~~device,~~differences between the ~~FDA~~OD ~~can~~and ~~require~~BID regimens were demonstrated concerning the ~~manufacturer~~nature, severity, relationship to ~~cease~~study ~~marketing~~medication, ~~and/~~or ~~recall~~frequency ~~the~~of ~~modified~~TEAEs ~~device~~or LSRs. ~~until~~Most ~~510(k)~~subjects ~~clearance~~had ora ~~approval~~score of a“none” ~~PMA~~for ~~application~~each isof ~~obtained~~the application site. InLSRs ~~addition~~evaluated (erythema, inedema, ~~these circumstances~~scaling/dryness, stinging/burning, and pruritus/itching). There were no clinically relevant differences between the ~~FDA~~VT-1953 ~~can~~and ~~impose~~vehicle ~~significant~~groups ~~regulatory~~for ~~fines~~laboratory tests, vital signs, or ~~penalties~~ECG ~~for~~results. ~~failure~~The toinvestigators ~~submit~~concluded that the ~~requisite~~study ~~PMA~~did ~~application(s)~~not demonstrate any safety concerns with the use of VT-1953 OD or BID.

The PMA Approval Process

Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it is not, the agency will refuse to file the PMA. If it is, the FDA will accept the application for filing and begin the review. The FDA, by statute and by regulation, has 180 days to review a filed PMA application, although the review of an application more often occurs over a significantly longer period. During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA. The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information (e.g., major deficiency letter) within a total of 360 days. Before approving or denying a PMA, an FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes. Overall, the FDA review of a PMA application generally takes between one and three years, but may take significantly longer. The FDA can delay, limit or deny approval of a PMA application for many reasons, including:

• device may not be shown safe or effective to the FDA’s satisfaction;

• data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval;

• the manufacturing process or facilities may not meet applicable requirements; and

• changes in FDA approval policies or adoption of new regulations may require additional data.

~~Table~~Treatment resulted in higher reductions from baseline in inflammatory and non-inflammatory lesion counts at Week 12 than the pooled vehicle group. The primary endpoint results were similar with VT-1953 OD and BID and were numerically better than with vehicle OD and BID, respectively. PostHoc statistical analysis of ~~Contents~~study data offered 106 evaluable patients across the treatment groups. Mean percent changes (reduction) in inflammatory lesion counts were 63.7% with VT-1953 QD and 71.5% with VT-1953 BID vs pooled vehicle (P=0.05). IGA success rate at week 12 was also numerically superior in both treatment groups than in the pooled vehicle group. The secondary efficacy endpoints were evaluated by the percentage of the population that achieved an IGA success rate at week 12. With IGA success defined as a score of “clear” or “almost clear” in both inflammatory and non-inflammatory lesions (IGA Score of 0 or 1) and at least a 2-grade (IGA) improvement from baseline, the success rate at Week 12 was 15.6% with VT-1953 QD, 17.5% with VT-1953 BID, and 9.5% with pooled vehicle.

IfPhase ~~the~~2 ~~FDA~~clinical ~~evaluation~~study: The ofsafety aand ~~PMA~~efficacy isof ~~favorable,~~VT-1953 ~~the~~2% ~~FDA~~Topical ~~will~~Gel, ~~issue~~applied ~~either~~once an(QD) ~~approval letter,~~ or antwice ~~approvable~~daily ~~letter~~(BID), ~~the~~was ~~latter~~tested ofin ~~which~~a ~~usually~~phase ~~contains~~2, ~~several~~randomized, ~~conditions~~multicenter, double-blind, ~~that~~vehicle-controlled, ~~must~~dose-ranging bestudy. ~~met~~Subjects inwith ~~order~~moderate to ~~secure~~severe ~~final~~inflammatory ~~approval~~facial acne vulgaris (representative of ~~the~~inflamed ~~PMA~~skin). ~~When~~The ~~and~~study ifwas ~~those~~sponsored ~~conditions~~by ~~have~~Vyome ~~been~~and ~~fulfilled~~carried toout ~~the~~at ~~satisfaction~~13 ofsites ~~the~~across ~~FDA,~~ the ~~agency~~United ~~will~~States. ~~issue~~A atotal ~~PMA~~of ~~approval~~471 ~~letter~~subjects ~~authorizing~~were enrolled ~~commercial~~in ~~marketing of~~ the ~~device~~study, ~~subject~~and torandomly ~~the~~assigned ~~conditions~~to oftreatment; ~~approval~~157 ~~and~~subjects ~~the~~were ~~limitations~~assigned ~~established~~to in the ~~approval~~VB-1953 ~~letter.~~QD Ifarm, ~~the~~79 ~~FDA’s~~subjects ~~evaluation~~to ofthe aVehicle QD ~~PMA~~arm, ~~application~~156 orsubjects ~~manufacturing~~to ~~facilities~~the isVB-1953 ~~not~~BID ~~favorable~~arm, ~~the~~and ~~FDA~~79 ~~will~~subjects ~~deny~~to ~~approval~~the ofVehicle ~~the~~BID ~~PMA~~arm. orSubjects ~~issue~~with a ~~not~~clinical ~~approvable~~diagnosis ~~letter.~~of ~~The~~moderate ~~FDA~~to severe ~~also~~(Grade ~~may~~3 ~~determine~~or ~~that~~4) ~~additional~~facial ~~tests~~acne orvulgaris, ~~clinical~~as ~~trials~~determined ~~are~~by ~~necessary,~~the inInvestigator’s ~~which~~Global ~~case~~Assessment ~~the~~(IGA), ~~PMA~~were ~~approval~~considered ~~may~~eligible to beparticipate ~~delayed~~in ~~for~~the ~~several months~~study. ~~or years~~Subjects ~~while~~applied the ~~trials~~assigned ~~are~~Test ~~conducted~~product ~~and~~to ~~data~~the isentire ~~submitted~~face, ineither anQD ~~amendment~~or toBID, based on the ~~PMA~~randomization schedule, orfor ~~the~~12 ~~PMA~~Weeks. isA ~~withdrawn~~total ~~and~~of ~~resubmitted~~428 ~~when~~(90.9%) subjects completed the ~~data~~study; ~~are~~while ~~available~~43 (9.1%) subjects discontinued. The ~~PMA~~proportion ~~process~~of subjects ~~can~~who bewere ~~expensive,~~discontinued ~~uncertain~~from ~~and~~the ~~lengthy~~study ~~and~~was ~~several~~comparable ~~devices~~across ~~for~~all ~~which~~treatment ~~the~~arms ~~FDA~~(VB-1953 ~~approval~~QD ~~has~~(10.8%), ~~been~~Vehicle ~~sought~~QD by(8.9%), ~~other~~VB-1953 BID ~~companies~~(7.1%), ~~have~~and ~~never~~Vehicle ~~been~~BID ~~approved~~(10.1%). byNone of the ~~FDA~~subjects ~~for~~were ~~marketing~~discontinued from the study due to AEs.

Safety assessments included monitoring of local and systemic adverse events (AEs), local skin reactions (LSRs), physical examinations, vital signs, clinical chemistry and hematology laboratory tests, urinalysis, electrocardiogram (ECG), and urine pregnancy tests (UPTs).

~~New~~Primary ~~PMA~~efficacy ~~applications~~endpoint was ~~or PMA supplements are required for modification to~~ the ~~manufacturing~~absolute ~~process,~~change equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, ingredients, materials or design of a device that has been approved through the PMA process. PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from ~~the~~Baseline ~~device~~in ~~covered~~inflammatory bylesion ~~the~~counts ~~approved~~in ~~PMA~~each ~~application~~treatment ~~and~~arm ~~may~~at orWeek ~~may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change~~12.

There were no deaths or study drug discontinuations due to Treatment-Emergent Adverse Events (TEAEs) during the study. Severe adverse events (SAEs) of severe appendicitis and mild skin laceration were reported in the VB-1953 BID arm and Vehicle BID arm, respectively. Both SAEs were considered not related to the study drug. Overall, 62 (13.2%) subjects experienced 97 TEAEs. The proportion of subjects experiencing TEAEs following application of the study drug was comparable across all treatment arms. Overall, five TEAEs were considered related to the study drug; supraventricular extrasystoles, eyelid exfoliation, and nasal congestion in the VB-1953 BID arm, alanine aminotransferase increased in the VB-1953 QD arm, and hypocalcemia in the Vehicle BID arm. Overall, the mean and mean changes from Baseline to Week 12 in clinical chemistry, hematology, and urinalysis parameters showed no clinically relevant changes; Three subjects were reported with clinically relevant laboratory values that were recorded as TEAEs; one subject in the VB-1953 QD arm was noted with TEAEs of mild alanine aminotransferase increased (clinically significant (CS), mild blood lactate dehydrogenase increased (not clinically significant (NCS), and mild blood potassium increased (NCS); and a subject in the Vehicle BID arm was noted with a TEAE of mild hypocalcemia (CS); and another subject in the VB-1953 QD arm was noted with a TEAE of mild proteinuria (NCS); The majority of the subjects were recorded with normal urinalysis results at Week 12. However, a few subjects were recorded with shift in the urinalysis results from ‘Normal’ at Baseline to ‘High Normal’ at Week 12. One such shift was in the urine protein level in a subject in the VB-1953 QD arm that was recorded as a NCS TEAE of mild proteinuria; Overall, the mean and mean changes from Baseline to Week 12 in vital sign parameters showed no clinically relevant changes. One subject in the VB-1953 BID arm had an abnormal vital sign measurement which was recorded as an abnormal CS TEAE of mild hypertension at Week 4; No abnormal CS physical examination findings were recorded during the study. There were no severe local skin reactions (LSRs) recorded during the study; The LSRs were recorded to be absent (score = 0) for the majority of subjects at Week 12. The mean change from Baseline to Week 12 for all LSRs remained similar across all treatment arms.

In approving a PMA application, as a condition of approval, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for several years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and effectiveness data for the device. The FDA may also require post-market surveillance for certain devices cleared under a 510(k) notification, such as implants or life-supporting or life-sustaining devices used outside a device user facility. The FDA may also approve a PMA application with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale, distribution and use. Our vBloc, Lap-Band System and Intragastric balloons, including the Obalon Balloon System, Obalon Navigation System and Dispenser are considered Class III medical devices. In order to support a PMA application, the FDA required the Company to conduct rigorous and expensive trials, one of which was a double-blinded, randomized, sham-controlled study. We will be required to file new PMA applications or PMA supplement applications for modifications to our PMA-approved Lap-Band System, Obalon Balloon System and Obalon Navigation System and Dispenser or any of their respective components, including modifications to our manufacturing processes, device labeling and device design, based on the findings of post-approval studies.

Pervasive and Continuing FDA Regulation

After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply. These include:

• The FDA’s QSR, which requires manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

• labeling regulations, unique device identification requirements and FDA prohibitions against the promotion of products for uncleared, unapproved or off label uses;

• advertising and promotion requirements;

• restrictions on sale, distribution or use of a device;

• PMA annual reporting requirements;

• PMA approval of product modifications;

• PMA approval of product;

• Medical device reporting, or MDR, regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;

~~Table~~At Week 12, in the ITT population, there was a significantly (rank ANCOVA p=0.012 and p=0.047) greater reduction of ~~Contents~~inflammatory lesion counts in subjects treated with VB-1953 QD and VB-1953 BID compared to subjects treated with pooled Vehicle. Per protocol analysis corroborated the ITT results. At Week 12, in the PP population, there was a significantly (rank ANCOVA p=0.020 and p=0.031) greater reduction of inflammatory lesion counts in subjects treated with VB-1953 QD and BID compared to subjects treated with Pooled Vehicle. At Week 12, the median percent change from Baseline in inflammatory lesion counts in subjects treated with VB-1953 QD and BID was -73.91% (rank ANCOVA p=0.020 vs vehicle-treatment) and -73.44% respectively, suggesting once daily application was as good as bi-daily application.

•The ~~medical~~majority ~~device~~of ~~correction~~the ~~and~~subjects showed ~~removal~~an ~~reporting~~improvement ~~regulations,~~in ~~which~~the ~~require~~Children’s ~~that~~Dermatology ~~manufacturers~~Life ~~report~~Quality Index (CDLQI) scores from Baseline to Week 12 across all treatment arms with superiority in active treatment arms in comparison with pooled vehicle. In the ~~FDA~~ITT ~~field~~population, ~~corrections~~the proportion of subjects who reported a CDLQI score of 0-1 (i.e., facial acne had no effect at all on subject’s quality of life) was comparable between the VB-1953 QD (70.4%) and ~~product~~BID ~~recalls~~(67.8%) orarms, ~~removals~~and ifhigher ~~undertaken~~than tothe ~~reduce~~Pooled aVehicle ~~risk~~arm to(55.8%) ~~health~~at ~~posed~~Week by12 showing numerical superiority of treatment over vehicle. Similarly, the ~~device~~proportion orof tosubjects ~~remedy~~who reported a ~~violation~~dermatology quality of life index (DLQI) score of 0-1 (i.e., facial acne had no effect at all on subject’s life) was higher in the ~~FDCA~~VB-1953 ~~that~~BID ~~may~~arm ~~present~~(67.0%) aand ~~risk~~VB-1953 toQD ~~health;~~(58.3%) in comparison with the Pooled Vehicle (56.5%) arms at Week 12.

•In ~~recall requirements~~conclusion, ~~including~~the aclinical investigators ~~mandatory~~noted ~~recall if there is a reasonable probability that~~ the ~~device~~following ~~would~~in ~~cause~~their ~~serious adverse health consequences or death;~~report

The primary efficacy endpoint was achieved as statistically significant greater reductions in inflammatory lesion counts from Baseline to Week 12 were observed for both active treatment arms versus the Pooled Vehicle in the ITT population. (2). The proportion of subjects experiencing TEAEs following application of the study drug was comparable between VB-1953 treatment arms and Vehicle arms. There were no deaths or study drug discontinuations due to TEAEs during the study. Two SAEs were reported during the study; severe appendicitis in the VB-1953 BID arm and mild skin laceration in the Vehicle BID arm. Both (3) SAEs were considered not related to the study drug. Overall, the safety profile of topical VB-1953 gel and Vehicle was comparable when applied either QD or BID for 12 weeks.

•(4) anThe ~~order~~results of ~~repair,~~this ~~replacement~~dose-ranging orstudy ~~refund;~~support advancing the VB-1953 QD dose for further investigation in Phase 3 studies after considering the efficacy and safety profile.

The safety and pharmacokinetics data from the above Phase 1 and 2 clinical studies will be included in future NDA applications to the FDA and other regulatory agencies to support the topical use of VT-1953 to treat different inflammatory conditions, including MFW and inflammatory acne.

•Investigator-initiated ~~device~~poc ~~tracking~~ph ~~requirements;~~2 study to evaluate the safety and efficacy of VT-1953 topical gel in advanced cancer patients with malodorous malignant fungating wounds (MFW).

An investigator-initiated POC Ph 2 study to evaluate the safety and efficacy of VT-1953 (also termed as VB-1953) 2% topical gel in advanced cancer patients with malodorous malignant fungating wounds was completed in December 2025. In investigator-initiated trials (IITs), while the investigator is the sponsor of the trial, the test agent is provided by Vyome, and Vyome has the right to reference the data. Male or female subjects aged ≥9 years old, with a diagnosis of malodorous malignant fungating wound malodor corresponding to 0,1 and 2 on the TELER odor scale (where 0= Malodor detected upon entering room (>3m or >10ft) with dressing on; 1= Malodor detected at >2m<3m (between 6-10ft) distance from patient with dressing on; and 2= Malodor detected at ~1m or arm’s length to the patient with dressing on, as judged by the investigators) and with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤3 and an anticipated survival of ≥3 months were included in this study. Subjects who were currently being treated with any antibiotic for bacterial infections or suffering from any infection that may require systemic antibiotics were excluded from the study. The wounds are cleansed with sterile normal saline before treatment. No forceful irrigation techniques and no other cleansing agents were utilized. A total of 7.5g gel was spread evenly across the wound per application. The gel was applied twice daily (B.I.D). The same dressing technique was used throughout the study, consisting of a nonadherent primary dressing and an absorbent (gauze or nonwoven) secondary dressing.

• post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Since February 2017, the FDA has issued three separate letters to healthcare providers warning of serious adverse events, including deaths, which are specific to liquid-filled intragastric balloons. We are aware of the filing of additional reports of serious adverse events, including deaths, associated with liquid- filled balloons since the issuance of the FDA letters to healthcare providers. While the advisory letters were specific to liquid-filled intragastric balloons and not the Obalon gas-filled balloons, these letters could create negative perceptions of the entire gastric balloon category which may cause negative consequences for us including requiring additional warnings, precautions and/or contraindications in the labeling than originally required, delaying or denying approval of our future products, or possible review or withdrawal of our current approval. Since Obalon Therapeutics began selling in United States in January 2017 — before the merger — Obalon Therapeutics has reported adverse events relating to patient injuries associated with use of the Obalon balloon in the FDA’s MAUDE database.

The FDA has broad post-market and regulatory enforcement powers. Medical device manufacturers are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

• warning letters, fines, injunctions, consent decrees and civil penalties;

• unanticipated expenditures, repair, replacement, refunds, recall or seizure of our products;

• operating restrictions, partial suspension or total shutdown of production; the FDA’s refusal of our requests for 510(k) clearance or premarket approval of new products, new intended uses or modifications to existing products;

• FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries;

• withdrawing 510(k) clearance or premarket approvals that have already been granted; and

• criminal prosecution.

Regulatory System for Medical Devices in Europe

The European Union (“EU”) consists of member states residing in the European Union and has a coordinated system for the authorization of medical devices. As of May 26, 2021, the European Union has adopted Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. The Medical Device Regulation 2017/745, or EU MDR repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, as of 26 May 2021. The EU allows a transition period from Directive 93/42/EEC and Directive 90/385/EEC to Regulation (EU) 2017/745, that will end 26 May 2024.

Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until 31 December 2027 for Class IIb implantable (Lap-Band and Obalon Balloon System), or 31 December 2028 for Class IIa devices (ReShape Calibration Tubes, provided the conditions set out in Article 120(3c) MDR are fulfilled. In addition, the “Sell Off” periods have been removed. (Regulation (EU) 2023/607).

~~Table~~The trial followed a sequential recruitment design, with the first 10 patients enrolled in this study being treated with VT-1953 2% gel (also termed as VB-1953 2% gel) and the next 5 patients being treated with the vehicle (control). To put this number in context, in an article “Quantum of ~~Contents~~Effectiveness Evidence in FDA’s Approval of Orphan Drugs” it was noted that Carbaglu (carglumic acid) was approved based on a case series derived from fewer than 20 patients, VPRIV (velaglucerase) was approved based on a pivotal study of 25 patients, Myozyme (alglucosidase alfa) was approved based on a pivotal study that included 18 patients, and Ceprotin (human plasma derived protein C concentrate) was approved based on a study of 18 patients data.

~~These~~● ~~devices~~The ~~are~~primary ~~called~~endpoints ~~‘legacy~~in ~~devices’~~this ~~and~~clinical study were the change in ~~line~~the score of malodor associated with ~~MDCG~~malignant ~~Guidance~~fungating ~~Document~~wounds ~~2021~~(scored by investigators) using a 6 point TELER Scale on Day 14 and Safety Outcome Measures, i.e. Treatment-~~253~~Emergent Adverse Events (TEAEs), ~~‘legacy~~changes ~~devices’~~in ~~should~~vital besigns, ~~understood~~and asseverity ~~devices~~of local skin reactions (stinging/burning, ~~which~~edema)Deodorization of the smell associated with malodorous fungating tumors was used as an endpoint for approval of metronidazole for MFW in the UK. Similarly, in ~~accordance~~a ~~with~~Ph 3 study for approval in Japan, the ~~MDR’s~~percentage ~~transitional~~of ~~provisions~~patients who moved to no or non-offensive smell from a mild, ~~are~~moderate ~~placed~~or onseverely ~~the~~offensive ~~market~~smell ~~after~~was used as the ~~MDR’s~~primary ~~date~~endpoint for approval of ~~application~~metronidazole, ~~(i.e.~~suggesting 26that ~~May 2021)~~we ifhave ~~certain~~a ~~conditions~~viable ~~are~~path ~~fulfilled~~to a regulatory approval. ~~Those~~According ~~devices~~to the December 2018 guidance on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry from the FDA, demonstration of efficacy on a symptom can be: a basis for approval in oncology indications. Secondary efficacy end-points included the percentage of patients who scored 3 to 5 on malodor at Day 7 and 14 using a QOL Component scale, and the score of malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 7.

● Other exploratory endpoints include (a) Change in score of malodors associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale on Day 14 and 7 from baseline; (b) Percentage of patients who score 4,5 on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 14 and 7; (c) Percentage of patients who exhibited ≥ 2-point improvement on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 14 and 7; (d) Score of malodor associated with malignant fungating wounds (scored by patients) using a 10-point VAS Scale at Day 7; (e) Score of malodor associated with malignant fungating wounds (scored by patients) using a 10-point VAS Scale at Day 14; (f) Change in score of malodor associated with malignant fungating wounds (scored by patients) using a 10-point VAS Scale at Day 14 and 7; (g) Pain score associated with the wound as scored by the patient using a 10-point Visual Analog Scale on Day 7 and 14; (h) Change in pain score associated with the wound as scored by the patient using a 10-point Visual Analog Scale on Day 14 and 7; (i) Score of exudates as scored by the caregiver measured on 0-4 scale on Day 7 and 14; (j) Quality of Life (QOL) score on VAS scale at Day 7 and Day 14 as scored by the patient; and (k) Change in Quality of Life (QOL) score on VAS scale at Day 7 and Day 14 as scored by the patient.

•Analysis ~~devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration~~ of ~~conformity~~Safety: ~~was~~No ~~drawn~~significant upTEAEs ~~prior~~or tosafety signals 26or ~~May~~changes ~~2021~~in ~~and~~vital ~~for~~signs ~~which~~were ~~the conformity assessment procedure under the MDR requires the involvement of a notified body;~~noted.

Analysis of Efficacy

•Primary ~~devices~~Endpoint: ~~covered~~Score byof amalodors ~~valid~~associated ~~EC certificate issued in accordance~~ with ~~Directive~~MFW ~~90/385/EEC~~using a ~~(AIMDD)~~6 orpoint ~~the~~TELER ~~MDD~~Scale ~~prior~~on toDay ~~26 May 2021.~~14

The primary outcome measure, the score of malodors associated with malignant fungating wounds using a 6-point TELER scale, was assessed at baseline and on Day 14. Overall, the median malodor score improved from 1.0 (0.0, 1.0) at baseline to 3.0 (1.0, 4.0) on Day 14, with a statistically significant difference between baseline and Day 14 (p = 0.0015). In the VT-1953 Topical Gel treatment group, the median score improved from 0.5 (0.0, 1.0) at baseline to 4.0 (3.0, 4.0) on Day 14, which was statistically significant (p = 0.0020). In contrast, the Vehicle Topical Gel group showed no change in median malodor score, remaining at 1.0 (1.0, 1.0) at both baseline and Day 14, with no statistically significant difference (p > 0.9999). The between-treatment comparison at Day 14 was statistically significant (p=0.0015) indicating that the VT-1953 topical gel group was superior to the Vehicle topical gel in reducing Malodor.

The conditions are set out in Article 120(3c) MDR and include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’. It is essential for legacy devices that their certificates remain valid following changes that are not significant with regard to design or intended purpose and that the required appropriate surveillance is carried out.

The EU MDR aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and considering the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonizes the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.

The system of regulating medical devices operates by way of a certification for each medical device. Each certificated device is marked with CE mark which shows that the device has a Certificat de Conformité. There are national bodies known as Competent Authorities in each member state which oversee the implementation of the EUMDR within their jurisdiction. The means for achieving the requirements for CE mark varies according to the nature of the device. Devices are classified in accordance with their perceived risks, similarly to the U.S. system. The class of a product determines the requirements to be fulfilled before CE mark can be placed on a product, known as a conformity assessment. Conformity assessments for our products have carried out as required by the MDD. Each member state can appoint Notified Bodies within its jurisdiction. If a Notified Body of one member state has issued a Certificat de Conformité, the device can be sold throughout the European Union without further conformance tests being required in other member states.

Per MDD 93/42/EEC on Medical Devices, Annex II excluding Section 4, the Lap-Band System is considered a Class IIb device and few of the system’s components are considered Class IIa devices. The vBloc, was never commercialized in the EU. The Obalon Balloon System, when delivered with a cellulose-based capsule was considered a Class IIb product under MDD. Prior to the merger, Obalon Therapeutics’ management believed the Obalon Navigation System and the Obalon Touch Inflation Dispenser are Class I products not requiring Notified Body approval.

ReShape Lifesciences has engaged with its European Notified Body — British Standards Institute (BSI) to transition our products under EU MDR.

The ReShape Lap-Band System, The Access Port Kit, and the ReShape Calibration Tubes are certified under Medical Device Regulation (EU) 2017/745 (MDR). The Port Applier received a positive recommendation for certification on January 22, 2025, and the. Access Port Needles have yet to receive a positive recommendation for certification.

Table 1: Score of ~~Contents~~Malodors Associated with Malignant Fungating Wounds Using a 6-Point TELER Scale on Day 14

Regulatory frameworks for medical devices in certain countries in Asia Pacific and the Middle East

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	p value Within treatment Baseline vs Day 14	Between-Treatment Comparison at Day 14 p value
Overall	1.0 (0.0, 1.0)	3.0 (1.0, 4.0)		0.0015
VT-1953 Topical Gel	0.5 (0.0, 1.0)	4.0 (3.0, 4.0)	0.0020
Vehicle Topical Gel	1.0 (1.0, 1.0)	1.0 (1.0, 1.0)	>0.9999

Between-treatment comparisons for Day 14 scores were performed using the Wilcoxon Rank-Sum Test.

~~Australia~~Within-treatment comparisons (Baseline versus Day 14) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

Secondary outcome: Percentage of Patients Who Scored 3 to 5 on Malodor at Day 14 Using a QOL Component Scale

~~ReShape~~At ~~Lifesciences~~Day is14, the ~~legal~~proportion ~~manufacturer~~of patients with a malodour score of 4 in the ~~Lap~~VT-~~Band~~1953 ~~System~~Topical ~~and~~Gel ~~accessories~~treatment ~~under~~group ~~the~~was ~~Australian~~70.0% ~~Register~~(7 out of ~~Therapeutic~~10 ~~Goods~~patients), with a 95% confidence interval (~~ARTG~~CI) ranging from 41.6% to 98.4%. In contrast, no patients in ~~Australia~~the Vehicle Topical Gel group (0 out of 10) achieved a malodour score of 4, with a 95% CI of 0.0%. The difference in proportions between the VT-1953 Topical Gel and Vehicle Topical Gel groups was statistically significant, with a 95% CI for the difference ranging from 41.6% to 98.4% and a p-value of 0.0256.

Table 2: Percentage of Patients Who Scored 3 to 5 on Malodor At Day 14 Using a QOL Component Scale

Middle East

Treatment Group	n(%)	95% CI for Proportion	95% CI for Proportion Difference	P Value
VT-1953 Topical Gel	7 (70.0%)	(41.6, 98.4)	(41.6, 98.4)	0.0256
Vehicle Topical Gel	0 (0.0%)	(0.0, 0.0)

95% CIs for proportions and their differences are based on the normal approximation to the binomial distribution P-value calculated using Fisher’s Exact Test between treatment groups

~~Unlike~~Secondary ~~Europe,~~outcome: ~~while~~Score the Gulf Cooperation Council, or GCC, jurisdictions often work together to purchase certain medical products in a coordinated fashion for government hospitals, there is not a coordinated system for the authorization of ~~medical~~Malodor ~~devices.~~Associated ~~Most~~with ~~GCC~~Malignant ~~jurisdictions~~Fungating ~~require~~Wounds ~~that~~Using ~~the official registered distributor of~~ a ~~product~~6-point beTELER ~~wholly~~Scale ~~owned~~at byDay ~~nationals of that particular GCC jurisdiction.~~7

The secondary outcome assessing the score of malodor associated with malignant fungating wounds, as measured by investigators using a 6-point TELER Scale at Day 7, was evaluated. At baseline, the overall median malodor score was 1.0 (0.0, 1.0), which changed to a median of 1.0 (1.0, 2.0) at Day 7, with no statistically significant difference observed (p=0.1883). In the VT-1953 Topical Gel treatment group, the median malodor score improved from 0.5 (0.0, 1.0) at baseline to 1.5 (1.0, 3.0) at Day 7, which was statistically significant (p=0.0156). Conversely, the Vehicle Topical Gel group showed no change in median malodor score, remaining at 1.0 (1.0, 1.0) at both baseline and Day 7, with no significant difference (p>0.9999). The between-treatment comparison of malodor scores at Day 7 did not demonstrate a statistically significant difference (p=0.1883).

~~ReShape~~Table ~~distributes~~3: ~~the~~Score ~~Lap-Band~~of ~~System~~Malodor ~~and~~Associated with ~~accessories~~Malignant inFungating ~~the~~Wounds ~~Middle~~(scored ~~East~~by ~~through~~investigators) Using a ~~distributor.~~6-point ~~Product~~TELER isScale ~~shipped~~at toDay ~~the Kingdom of Saudi Arabia (KSA).~~7

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	p value Within treatment Baseline vs Day 7	Between-Treatment Comparison at Day 7 p value
Overall	1.0 (0.0, 1.0)	1.0 (1.0, 2.0)		0.1883
VT-1953 Topical Gel	0.5 (0.0, 1.0)	1.5 (1.0, 3.0)	0.0156
Vehicle Topical Gel	1.0 (1.0, 1.0)	1.0 (1.0, 1.0)	>0.9999

~~Obalon Therapeutics ceased distribution of~~ Between-treatment comparisons for Day 7 scores were performed using the ~~Obalon System, the Obalon Navigation System and the Obalon Touch Inflation Dispenser in the Middle East prior to the June~~ ~~16, 2021, merger~~Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 7) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

~~Kingdom~~Exploratory Outcome: Change in Score of ~~Saudi~~Malodors Associated ~~Arabia,~~with orMalignant ~~KSA~~Fungating Wounds Using a 6 point TELER Scale on Day 7 from Baseline

The most pertinent regulation is the Interim Regulation for Medical Devices, issued by the Saudi Food & Drug Authority, or SFDA, Board of Directors’ Decree number 1-8-1429 dated approximately December 27, 2008, and the implementing regulations of the same. The SFDA is an independent regulatory body that is responsible for the authorization of medical devices, and current guidelines are generally based on pre-existing approval in one of the five founding member nations of the Global Harmonization Task Force, or GHTF, which are Australia, Canada, United States, European Union and Japan. There are no overt requirements for the provision of safety and effectiveness data in the form of clinical trials or other studies, but these would likely come as a part of the approvals described above that are used as a basis to support approval within the KSA. The SFDA reserves its rights to require its own independent clinical trials as it deems necessary or appropriate. Regulatory authorization is required for all medical devices, regardless of device class. A potential exception to this requirement is for medical devices that were designed and constructed by local health care facility and staff for internal use. Similar to the United States, the SFDA requires post market surveillance to ensure safety and quality. This program is meant to be conducted by the Authorized Representative. With respect to the use of medical devices, it is the responsibility of the health care institution to inform the manufacturer and the SFDA of any adverse events associated with this use.

The SFDA has approved the Medical Device Market Authorization, or MDMA application and the listing of ReShape Lifesciences as the legal manufacturer of the Lap-Band System and accessories in KSA.

Brexit

The UK Medicines & Healthcare Products Regulatory Agency, or MHRA is responsible for regulating medical devices in Great Britain. The MHRA plans changes to the UK’s Medical Devices Regulations 2002 as part of a broader transition away from European Union legal and regulatory systems.

In addition, the Trade Deal between the UK and the EU generally provides for cooperation and exchange of information between the parties in the areas of product safety and compliance, including market surveillance, enforcement activities and measures, standardization related activities, exchanges of officials, and coordinated product recalls. As such, processes for compliance and reporting should reflect requirements from regulatory authorities.

~~Table~~The change in malodor scores associated with malignant fungating wounds, as assessed by investigators using a 6-point TELER Scale, was evaluated on Day 7 from baseline. At baseline, the overall median score was 1.0 (0.0, 1.0), which remained at 1.0 (1.0, 2.0) on Day 7, resulting in a median change of ~~Contents~~0.0 (0.0, 1.0). In the VT-1953 Topical Gel treatment group, the baseline median score was 0.5 (0.0, 1.0), which improved to 1.5 (1.0, 3.0) on Day 7, with a median change of 1.0 (0.0, 2.0). The Vehicle Topical Gel group had a baseline median score of 1.0 (1.0, 1.0), which remained unchanged at 1.0 (1.0, 1.0) on Day 7, with a median change of 0.0 (0.0, 0.0). The between-treatment comparison of the change from baseline to Day 7 demonstrated a statistically significant difference with a p value of 0.0157.

CETable ~~Marks~~4: ~~issued~~Change ~~by EU-recognized notified bodies will continue to be valid~~ in ~~for~~Score ~~medical~~of ~~devices~~Malodors Associated ~~placed~~with onMalignant ~~the~~Fungating ~~Great~~Wounds ~~Britain~~(Scored market — England, Scotland, and Wales until December 31, 2024. Until that date, MHRA accepts the CE Marking and requires registering active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A devices by ~~May 1, 2021. After December 31, 2024, the UK Conformity Assessment (UKCA~~Investigators) ~~marking~~Using ~~will~~a ~~be mandatory. In Northern Island, CE Marking issued by EU~~6-~~recognized~~point ~~notified~~TELER ~~bodies~~Scale will continue to be valid until current CE cert under Medical Device Directive (MDD) expires, after which date, CE marking needs to be approved under EU Medical Device Regulation (EU MDR). ReShape Lifesciences is compliant with the registration requirements and is registered in England, Scotland, Wales, and Northern Ireland. Additionally, the EU no longer recognizes conformity assessment activities performed by UK notified bodies for medical devices placed on ~~the~~Day ~~market~~7 ~~since~~from January 1, 2021. Notified bodies must be located in a European Union member state, or territory where there is a mutual recognition agreement, or MRA; there is currently no such MRA. The new legislation may create an extra hurdle for manufacturers and thereby limit the availability and/or increase prices of our medical devices in the UK.Baseline

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	Change (Day 7-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 7-Baseline) p value
Overall	1.0 (0.0, 1.0)	1.0 (1.0, 2.0)	0.0 (0.0, 1.0)	0.0157
VT-1953 Topical Gel	0.5 (0.0, 1.0)	1.5 (1.0, 3.0)	1.0 (0.0, 2.0)
Vehicle Topical Gel	1.0 (1.0, 1.0)	1.0 (1.0, 1.0)	0.0 (0.0, 0.0)

~~The UK government published Statutory Instruments 2023 No. 627, The Medical Devices~~ Between-treatment comparisons for Change (~~Amendment~~Day 7-Baseline) ~~(Great Britain) Regulations~~ ~~2023 on June~~were ~~9, 2023, to extend~~ performed using the ~~deadlines for placing CE Marked devices on the GB market. The date CE Marked devices can be placed on the Great Britain market has been extended to December~~ ~~31, 2027~~Wilcoxon Rank-Sum Test. ~~After this date the UKCA Mark will be required.~~

Exploratory Outcome: Change in score of malodors associated with malignant fungating wounds using a 6 point TELER Scale on Day 14 from baseline

The UKchange ~~medical~~in ~~device~~malodor ~~regulator~~scores associated with malignant fungating wounds, as assessed by investigators using a 6-point TELER Scale, was evaluated on Day 14 from baseline. Overall, the ~~Medicines~~median score ~~and~~improved ~~Healthcare~~from ~~products~~1.0 ~~Regulatory~~(0.0, ~~Agency~~1.0) at baseline to 3.0 (~~MHRA~~1.0, 4.0) ~~finalized~~on Day 14, with a median change of 2.0 (0.0, 4.0). In the ~~Post~~VT-~~Market~~1953 ~~Surveillance~~Topical Gel ~~statutory~~treatment ~~instrument~~group, the median score improved from 0.5 (~~PMS~~0.0, SI1.0) at baseline to 4.0 (3.0, 4.0) on Day 14, resulting in ~~December~~a 16median change of 2.5 (2.0, ~~2024~~4.0). ~~These~~Conversely, ~~regulations~~the ~~will~~Vehicle ~~come~~Topical ~~into~~Gel ~~force~~group ~~June~~showed 16no change, ~~2025~~with median scores remaining at 1.~~Medical~~0 ~~device~~(1.0, ~~manufacturers~~1.0) ~~doing~~at ~~business~~both baseline inand Day 14, and a median change of 0.0 (0.0, 0.0). The between-treatment comparison on the UKchange ~~will~~from ~~have~~baseline to beDay ~~compliant~~14 ~~with~~demonstrated a ~~PMS~~statistically SIsignificant ~~requirement~~difference, towith ~~maintain~~a ~~market~~p-value ~~access~~of 0.0021.

Table 5: Change in Score of Malodors Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 6-point TELER Scale on Day 14 from Baseline

Our Products

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	Change (Day 14-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 14-Baseline) p value
Overall	1.0 (0.0, 1.0)	3.0 (1.0, 4.0)	2.0 (0.0, 4.0)	0.0021
VT-1953 Topical Gel	0.5 (0.0, 1.0)	4.0 (3.0, 4.0)	2.5 (2.0, 4.0)
Vehicle Topical Gel	1.0 (1.0, 1.0)	1.0 (1.0, 1.0)	0.0 (0.0, 0.0)

DATE: 16OCT25

~~The ReShape Lifesciences’ Lap~~Between-Band System, the Obalon Balloon System, Obalon Navigation system and Obalon Touch Inflation Dispenser, and their respective components are medical devices that required a PMA submission form and approval by the FDA treatment comparisons for ~~commercial use in~~ Change (Day 14-Baseline) were performed using the ~~United States~~ Wilcoxon Rank-Sum Test. ~~ReShape Lifesciences’ vBloc neuromodulation system, which was approved by the FDA for treating obesity is no longer commercialized.~~

Exploratory Outcome: Percentage of Patients Who Score 4,5 on Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 6-point TELER Scale at Day 7

~~FDA~~In ~~approved~~ the ~~Lap~~VT-~~Band~~1953 ~~System~~Topical inGel ~~2001~~treatment group, 1 patient (10.0%) ~~The~~had ~~Lap~~a score of 4, 5 on malodor associated with malignant fungating wounds (scored by investigators) using a 6-~~Band~~point ~~System~~TELER scale ~~was~~at ~~approved~~day ~~for~~7, ~~use~~with ina 95% confidence interval (CI) for the Uproportion ranging from 0.S0% to 28.6%. ~~for~~In contrast, no patients ~~with~~(0.0%) in the Vehicle Topical Gel group had a ~~BMI~~score ~~greater~~of ~~than~~4 or ~~equal~~5 toon 40malodor, orwith a ~~BMI~~95% ~~greater~~CI ~~than~~of or0.0% ~~equal~~ to 300.0%. ~~with~~The ~~one~~95% orCI ~~more~~for ~~obesity~~the difference in proportions between the VT-~~related~~1953 ~~comorbidity~~Topical ~~conditions~~Gel and Vehicle Topical Gel groups was 0.0% to 28.6%.

The Lap-Band System was CE marked in 1997. The method of assessing conformity with applicable regulatory requirements varies depending on the class of the device, but for our Lap-Band System, the method involved a combination issuance of declaration of conformity by the manufacturer of the safety and performance of the device, and a third-party assessment by a Notified Body of the design of the device and of our quality system. A Notified Body is a private commercial entity that is designated by the national government of a member state as being competent to make independent judgments about whether a product complies with applicable regulatory requirements. The assessment included, among other things, a clinical evaluation of the conformity of the device with applicable regulatory requirements. We use BSI as the Notified Body for our CE marking approval process.

The Lap-Band 2.0 FLEX system received approval in December 2023. We had our first successful surgeries with this system in early 2024.

Continued compliance with CE marking requirements is enforced through periodic facility inspections by the Notified Body, which may be unannounced. Because we rely on contract manufacturing sites and service providers, these additional sites may also be subject to these Notified Body unannounced inspections.

The Obalon Balloon System was approved in January 2017 and the Obalon Navigation system and Obalon Touch Inflation Dispenser were approved on December 20, 2018. All of the above-listed devices were approved with post-approval conditions intended to ensure the safety and effectiveness of these devices. ReShape Lifesciences

Table 6: Percentage of ~~Contents~~Patients Who Score 4,5 On Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 6-point TELER Scale at Day 7

assumed and complies with all post market requirements for the Lap-Band System, the Obalon Navigation system, and Obalon Touch Inflation Dispenser.

Treatment Group	n(%)	95% CI for Proportion	95% CI for Proportion Difference
VT-1953 Topical Gel	1 (10.0%)	(0.0, 28.6)	(0.0, 28.6)
Vehicle Topical Gel	0 (0.0%)	(0.0, 0.0)

~~Obalon Balloon System~~95% CIs for proportions and their differences are based on the normal approximation to the binomial distribution

Exploratory Outcome: Percentage of patients who score 4,5 on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 14

~~Obalon~~The ~~Balloon~~exploratory ~~favorable~~outcome ~~safety~~data ~~profile, In~~from the ~~pivotal SMART~~ clinical trial, ~~only~~indicated ~~one~~that of6 ~~336~~patients (060.30%) ~~patients~~in ~~that~~the ~~received~~VT-1953 ~~the~~Topical ~~Obalon~~Gel ~~balloon~~treatment ~~experienced~~group had a ~~serious~~score ~~adverse~~of ~~device~~4, ~~event~~5 on malodor associated with malignant fungating wounds (~~SADE~~scored by investigators) ~~and~~using ina ~~data~~6-point ~~presented~~TELER Scale at ~~the~~day ~~American~~14, ~~Society~~with ~~for~~a ~~Metabolic~~95% ~~and~~confidence ~~Bariatric~~interval ~~Surgery~~(CI) ~~Meeting~~for ~~from~~ the ~~first~~proportion ranging ~~year~~from of29.6% ~~commercial~~to ~~experience,~~90.4%. ~~only~~In ~~two~~contrast, ofno ~~1,343~~patients (0.140%) ~~patients~~in ~~that~~the ~~received~~Vehicle ~~our~~Topical ~~Obalon~~Gel ~~balloon~~group ~~experienced~~had athe ~~SADE.~~score ~~Historically~~of 4, ~~the~~5, ~~reported~~with ~~rate~~a 95% CI of 0.0%. ~~SADEs~~The ~~reported~~95% toconfidence ~~Obalon~~interval for the difference in ~~commercial~~proportions ~~use~~between isthe ~~consistent~~VT-1953 ~~with~~Topical ~~that~~Gel ~~experienced~~and inVehicle ~~the~~Topical ~~pivotal~~Gel ~~SMART~~groups ~~trial~~was 29.6% orto ~~the~~90.4%, ~~data~~demonstrating ~~from~~a ~~their~~notable ~~first~~difference ~~year~~favoring ofthe ~~commercial~~VT-1953 ~~experience~~Topical Gel treatment.

Table 7: Percentage of Patients Who Score 4,5 on Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 6-point TELER Scale at Day 14

In addition, data published and presented from Obalon’s commercial registry demonstrates greater weight loss in the commercial setting as compared to the pivotal clinical study used to support FDA approval. In May 2019, Obalon updated data from their commercial registry to include 1,411 total patients from 143 treatment sites in the United States. In this data set, for those patients receiving three balloons and at least 20 weeks of therapy, the average weight loss was 21.7 pounds, resulting in a 10.2% reduction in total body weight. Of note, 50.7% of patients lost 10% or more total body weight and 77.9% lost 5% or more total body weight.

Treatment Group	n(%)	95% CI for Proportion	95% CI for Proportion Difference
VT-1953 Topical Gel	6 (60.0%)	(29.6, 90.4)	(29.6, 90.4)
Vehicle Topical Gel	0 (0.0%)	(0.0, 0.0)

95% CIs for proportions and their differences are based on the normal approximation to the binomial distribution

~~Obalon~~Exploratory ~~Balloon~~Outcome: ~~improved~~Percentage ~~patient tolerability and comfort. The Obalon balloon is inflated with a proprietary mix~~ of ~~gas.~~Patients ~~This~~Who ~~creates~~Exhibited ~~a light, buoyant balloon that floats at the top of the stomach instead of sinking to the bottom of the stomach like a traditional liquid~~≥ 2-~~filled~~Point ~~intragastric~~Improvement ~~balloon.~~on ~~Further,~~Malodor ~~the~~Associated ~~Obalon~~with ~~Balloon~~Malignant ~~System~~Fungating ~~consists~~Wounds of(Scored ~~three~~by ~~separate~~Investigators) ~~250cc~~Using ~~balloons placed individually over~~ a ~~three~~6-~~month~~point ~~period~~TELER toScale ~~progressively~~at ~~add volume. We believe these design elements have the potential to improve patient comfort and tolerability of our Obalon balloon.~~Day 7

In the VT-1953 Topical Gel group, 3 patients (30.0%) exhibited ≥ 2-point improvement on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 7, with a 95% confidence interval (CI) for the proportion ranging from 1.6% to 58.4%. In contrast, no patients (0.0%) in the Vehicle Topical Gel group exhibited ≥ 2-point improvement on malodor, with a 95% CI for the proportion of 0.0%. The 95% CI for the difference in proportions between the VT-1953 Topical Gel and Vehicle Topical Gel groups was 1.6% to 58.4%.

~~Obalon~~Table ~~Balloon~~8: ~~progressive~~Percentage ~~weight~~of ~~loss~~Patients Who ~~with~~Exhibited ~~durable~~≥ ~~results. In~~2-Point ~~the~~Improvement ~~pivotal SMART trial, patients in the Obalon treatment group lost,~~ on ~~average,~~Malodor ~~approximately~~Associated ~~twice~~With asMalignant ~~much~~Fungating ~~body~~Wounds ~~weight~~(Scored asby ~~patients~~Investigators) inUsing ~~the~~a ~~sham~~6-point TELER ~~control~~Scale group. In addition, patients in the Obalon treatment group showed, on average, progressive weight loss over the balloon treatment period, which we believe is attributable to the individual placement of three separate Obalon balloons over the treatment period. Subsequent data analysis at ~~12 months~~Day also showed that, on average, 89.5% of the weight loss was maintained six months after balloon removal. In May 2019, Obalon analyzed data from their commercial registry on 1,411 total patients from 143 treatment sites in the United States. In this data set, for those patients receiving three balloons and at least 20 weeks of therapy, the average weight loss was 21.7 ~~pounds, resulting in a 10.2% reduction in total body weight.~~

Treatment Group	n(%)	95% CI for Proportion	95% CI for Proportion Difference
VT-1953 Topical Gel	3 (30.0%)	(1.6, 58.4)	(1.6, 58.4)
Vehicle Topical Gel	0 (0.0%)	(0.0, 0.0)

~~Obalon Balloon simple~~ 95% CIs for proportions and convenient placement. The Obalon balloon is placed without anesthesia or an endoscopy through a swallowable capsule that dissolves in the stomach and releases the balloon. These unique features allow patients the flexibility to receive the Obalon balloon discreetly in an outpatient setting. Placement typically occurs in less than fifteen minutes and can be scheduled in the morning before work, during a lunch break or in the evening. Treated patients can return promptly to their ~~normal daily activities. The balloons~~ differences are ~~removed endoscopically under light, conscious sedation six~~ ~~months after~~ based on the ~~first balloon placement. Recently approved new products, the Obalon Navigation System and Obalon Touch Inflation Dispenser, are designed~~ normal approximation to ~~further improve ease of use and convenience of placement.~~ the binomial distribution

Exploratory Outcome: Percentage of Patients Who Exhibited ≥ 2-Point Improvement on Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 6-point TELER Scale at Day 14

In the VT-1953 Topical Gel treatment group, 8 patients (80.0%) exhibited ≥ 2-point improvement on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 14, with a 95% confidence interval (CI) for the proportion ranging from 55.2% to 100.0%. In contrast, no patients (0.0%) in the Vehicle Topical Gel group exhibited ≥ 2-point improvement on malodor, with a 95% CI of 0.0% to 0.0%. The 95% CI for the difference in proportions between the VT-1953 Topical Gel and Vehicle Topical Gel groups was 55.2% to 100.0%, indicating a statistically significant difference favoring the VT-1953 Topical Gel.

Table 9: Percentage of ~~Contents~~patients who exhibited ≥ 2-point improvement on malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 14

Privacy and Security Laws

Treatment Group	n(%)	95% CI for Proportion	95% CI for Proportion Difference
VT-1953 Topical Gel	8 (80.0%)	(55.2, 100.0)	(55.2, 100.0)
Vehicle Topical Gel	0 (0.0%)	(0.0, 0.0)

Medical device companies may be subject to U.S. federal and state and foreign health information privacy, security and data breach notification laws, which may govern the collection, use, disclosure and protection of health-related and other personal information. In the United States, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology 95% CIs for ~~Economic~~ proportions and Clinical Health Act of 2009 (“HITECH”), and all regulations promulgated thereunder, collectively HIPAA, imposes privacy, security and breach reporting obligations with respect to individually identifiable health information upon “covered entities” (health plans, health care clearinghouses and certain health care providers), and their respective business associates, individuals or entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. Although we differences are ~~not a covered entity, we may provide certain services that require the use or disclosure of PHI~~ based on ~~behalf of physicians who are covered entities, and we therefore may be considered to be business associates under HIPAA. HIPAA imposes specified requirements relating to~~ the ~~privacy, security and transmission of individually identifiable health information. HIPAA mandates the reporting of certain breaches of health information~~ normal approximation to the U.S. Department of Health and Human Services, or HHS, affected individuals and if the breach is large enough, the media. Entities that are found to be in violation of HIPAA as the result of a breach of unsecured protected health information or PHI, a complaint about privacy practices or an audit by HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. binomial distribution

Exploratory Outcome: Score Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 10-point VAS Scale at Day 7

~~Even~~The ~~when~~malodor ~~HIPAA~~associated ~~does~~with ~~not~~malignant ~~apply,~~fungating wounds ~~according~~was toassessed ~~the~~using ~~Federal~~a ~~Trade~~10-point ~~Commission~~Visual orAnalog ~~the~~Scale ~~FTC,~~(VAS) ~~failing~~by toinvestigators ~~take~~at ~~appropriate~~baseline ~~steps~~and toDay ~~keep~~7. ~~consumers’~~At ~~personal~~baseline, ~~information~~the ~~secure~~overall ~~constitutes~~median malodor ~~unfair~~score ~~acts~~was or7.0 ~~practices~~(6.0, in8.0), orwhich ~~affecting~~decreased ~~commerce~~to in6.0 ~~violation~~(5.0, of7.0) ~~Section~~at ~~5(a)~~Day of7. In the ~~Federal~~VT-1953 ~~Trade~~Topical ~~Commission~~Gel ~~Act~~treatment group, 15the ~~U.S.C~~median §malodor score 45decreased from 7.5 (a)7.0, ~~The~~9.0) ~~FTC~~at ~~expects~~baseline ato ~~company’s~~5.5 ~~data~~(5.0, ~~security~~6.0) ~~measures~~at toDay be7, ~~reasonable~~showing ~~and~~a ~~appropriate~~statistically insignificant ~~light~~reduction of(p ~~the~~= ~~sensitivity~~0.0020). Conversely, ~~and~~in ~~volume~~the ofVehicle ~~consumer~~Topical ~~information~~Gel ~~it holds~~group, the ~~size~~median ~~and~~malodor ~~complexity~~score ofincreased ~~its~~from ~~business~~6.0 (5.0, ~~and~~6.0) ~~the~~at ~~cost~~baseline ~~of available tools~~ to ~~improve~~7.0 ~~security~~(6.0, ~~and reduce vulnerabilities~~7.0) ~~Individually~~at Day ~~identifiable~~7, ~~health~~which ~~information~~was isnot ~~considered~~statistically ~~sensitive~~significant ~~data~~(p ~~that~~= ~~merits stronger safeguards~~0.0625). The ~~FTC’s~~between-treatment ~~guidance~~comparison ~~for~~at ~~appropriately~~day ~~securing~~7 ~~consumers’~~between ~~personal~~the ~~information~~2 isgroups ~~similar~~was tostatistically significant ~~what is required by the HIPAA security regulations~~(p=0.0499).

Table 10: Score Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using A 10-point VAS Scale at Day 7

In addition, certain state, and non-U.S. laws, such as the European Union General Data Protection Regulation, or GDPR, govern the privacy and security of health information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Further, “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity, are also subject to certain HIPAA privacy and security standards. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	p value Within treatment Baseline vs Day 7	Between-Treatment Comparison at Day 7 p value
Overall	7.0 (6.0, 8.0)	6.0 (5.0, 7.0)		0.0499
VT-1953 Topical Gel	7.5 (7.0, 9.0)	5.5 (5.0, 6.0)	0.0020
Vehicle Topical Gel	6.0 (5.0, 6.0)	7.0 (6.0, 7.0)	0.0625

Between-treatment comparisons for Day 7 scores were performed using the Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 7) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

Exploratory Outcome: Score Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 10-point VAS Scale at Day 14

Overall, the median malodor score decreased from 7.0 (6.0, 8.0) at baseline to 3.0 (2.0, 6.0) at Day 14. In the VT-1953 Topical Gel treatment group, the median score reduced from 7.5 (7.0, 9.0) at baseline to 2.5 (2.0, 3.0) at Day 14, showing a significant improvement (p=0.0020). Conversely, the Vehicle Topical Gel group showed an increase in median malodor score from 6.0 (5.0, 6.0) at baseline to 7.0 (6.0, 7.0) at Day 14, which was not statistically significant (p=0.0625). The between-treatment comparison at day 14 between the VT-1953 topical gel and vehicle topical gel was statistically significant (p=0.0023).

Table of11: ~~Contents~~Score Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 10-point VAS Scale at Day 14

For example, California enacted legislation, the California Consumer Privacy Act or CCPA, which went into effect January 1, 2020. The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes limited exceptions, including for PHI maintained by a covered entity or business associate, it may regulate or impact our expected processing of personal information depending on the context. In Europe, the GDPR went into effect in May 2018 and introduces strict requirements for processing the personal data of European Union data subjects. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. Moreover, the United Kingdom leaving the EU could also lead to further legislative and regulatory changes. It remains unclear how the United Kingdom data protection laws or regulations will develop in the medium to longer term and how data transfer to the United Kingdom from the EU will be regulated, especially following the United Kingdom’s departure from the EU on January 31, 2020 without a deal. However, the United Kingdom has transposed the GDPR into domestic law with the Data Protection Act 2018, which remains in force following the United Kingdom’s departure from the EU.

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	p value Within treatment Baseline vs Day 14	Between-Treatment Comparison at Day 14 p value
Overall	7.0 (6.0, 8.0)	3.0 (2.0, 6.0)		0.0023
VT-1953 Topical Gel	7.5 (7.0, 9.0)	2.5 (2.0, 3.0)	0.0020
Vehicle Topical Gel	6.0 (5.0, 6.0)	7.0 (6.0, 7.0)	0.0625

~~Anti~~Between-~~Kickback Statutes~~treatment comparisons for Day 14 scores were performed using the Wilcoxon Rank-Sum Test.

~~The federal Anti~~Within-~~Kickback~~treatment ~~Statute~~comparisons ~~prohibits persons from~~ (~~among~~Baseline ~~other~~versus ~~things~~Day 14) ~~knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange~~ for oreach totreatment ~~induce~~group ~~the~~were ~~referral~~performed ofusing ~~an individual, or~~ the ~~recommending,~~Wilcoxon ~~furnishing,~~Signed-Rank ~~or arranging for a good or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid~~Test.

~~Courts~~Exploratory ~~have~~Outcome: ~~interpreted~~Change ~~the~~in Score ~~Anti-Kickback~~Of ~~Statute~~Malodor ~~quite~~Associated ~~broadly, holding that the statute will be violated if even one purpose of a payment — though not its sole or primary purpose — is to induce an act prohibited by the statute~~ with aMalignant ~~willful~~Fungating ~~intent~~Wounds to(Scored ~~act~~byInvestigators) ~~improperly.~~Using The statute prohibits many arrangements and practices that are otherwise lawful in businesses outside of the healthcare industry. Prosecutors may infer intent from the surrounding circumstances and, because courts have interpreted the statute to be violated if even one purpose of a payment is to induce the purchase of items or services paid for by federal healthcare programs, prosecutors have broad discretion in choosing arrangements to prosecute under the statute. There are statutory exceptions and regulatory “safe harbors” available to protect certain appropriately structured arrangements that otherwise would implicate the Anti10-~~Kickback~~point ~~Statute.~~VAS ~~Those~~Scale ~~who~~at ~~structure~~Day ~~their business arrangements to satisfy all of the criteria of a safe harbor are protected from liability under the statute.~~ 7

~~Penalties~~At ~~for~~baseline, ~~violation~~the ofoverall ~~the~~median ~~Anti-Kickback~~malodor ~~Statute~~score was ~~are~~7.0 ~~severe~~(6.0, ~~and~~8.0). ~~may~~By ~~include~~Day 7, inthe ~~addition~~overall median score decreased to ~~the~~6.0 ~~fines~~(5.0, ~~and~~7.0), ~~jail~~with ~~time~~a ~~described~~median ~~above~~change from baseline of -1.0 (-3.0, 1.0). ~~penalties~~This ~~imposed~~change ~~under~~was ~~the~~statistically ~~Civil~~significant ~~Monetary~~with ~~Penalties~~a ~~Law,~~between-treatment orcomparison p value of 0.0017. In the ~~CMP~~VT-1953 ~~Law,~~Topical ~~including~~Gel ~~exclusion~~group, the ~~from~~baseline ~~participation~~median inscore ~~Federal~~was ~~healthcare~~7.5 ~~programs~~(7.0, ~~civil~~9.0), ~~monetary~~which ~~penalties~~decreased ~~for~~(improved) ~~each~~to ~~improper~~5.5 ~~act~~(5.0, ~~and~~6.0) ~~damages~~at ofDay up7, toresulting ~~three~~in ~~times~~a ~~the~~median ~~amount~~change of ~~remuneration~~-2.5 (-3.0, at-1.0) ~~issue~~which ~~(regardless~~was ofstatistically ~~whether~~significant. ~~some~~Conversely, of the ~~remuneration~~Vehicle ~~was~~Topical ~~for~~Gel group had a ~~lawful~~baseline ~~purpose)~~median score of 6.0 ~~Because~~(5.0, we6.0), which doincreased ~~not~~(worsened) ~~anticipate~~to ~~that~~7.0 ~~the~~(6.0, ~~Obalon~~7.0) ~~Balloon~~at ~~System~~Day ~~will~~7, bewith ~~reimbursed~~a bymedian ~~any~~change ~~federal~~of ~~healthcare~~1.0 ~~program~~(1.0, we1.0). doThe ~~not~~between-treatment ~~believe~~comparison ~~that~~on wechange from ~~will~~baseline beto ~~subject~~day to7 ~~the~~was ~~federal~~statistical ~~Anti~~significant (p=0.0017), indicating a reduction in malodor scores with VT-~~Kickback~~1953 ~~Statute~~Topical Gel treatment compared the vehicle gel.

~~Many~~Table ~~states~~12: ~~have~~Change ~~adopted~~in ~~laws~~Score ~~similar to the Anti-Kickback Statute, however, and some~~ of Malodor ~~these~~Associated ~~state~~with ~~prohibitions~~Malignant ~~apply~~Fungating toWounds ~~arrangements~~(Scored ~~involving healthcare items or services reimbursed~~ by ~~any~~Patients) ~~source,~~Using ~~and~~A ~~not only by Medicare, Medicaid or another federal healthcare program. These state laws do not always have the same exceptions or safe harbors of the federal Anti~~10-~~Kickback~~point ~~Statute.~~VAS ~~The~~Scale ~~business~~at ~~may~~Day ~~be subject to some of these laws.~~7

Government officials have focused recent enforcement efforts on the marketing of healthcare services and products, among other activities, and have brought cases against companies, and certain individual sales, marketing and executive personnel, for allegedly offering unlawful inducements to potential or existing customers in an attempt to procure their business.

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	Change (Day 7-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 7-Baseline) p value
Overall	7.0 (6.0, 8.0)	6.0 (5.0, 7.0)	-1.0 (-3.0, 1.0)	0.0017
VT-1953 Topical Gel	7.5 (7.0, 9.0)	5.5 (5.0, 6.0)	-2.5 (-3.0, -1.0)
Vehicle Topical Gel	6.0 (5.0, 6.0)	7.0 (6.0, 7.0)	1.0 (1.0, 1.0)

Between-treatment comparisons for Change (Day 7-Baseline) were performed using the Wilcoxon Rank-Sum Test.

Exploratory Outcome: Change in Score of Malodor Associated with Malignant Fungating Wounds (Scored by Investigators) Using a 10-point VAS Scale at Day 14

The analysis of change in Malodor Visual Analog Scale (VAS) scores from baseline to Day 14 demonstrated an improvement in the overall treatment group, with a median change of -4.0 (-6.0, 1.0). Specifically, the VT-1953 Topical Gel group showed a median baseline VAS score of 7.5 (7.0, 9.0) which decreased (improved) to 2.5 (2.0, 3.0) at Day 14, resulting in a median change of -5.0 (-6.0, -4.0). In contrast, the Vehicle Topical Gel group had a median baseline score of 6.0 (5.0, 6.0) which increased (worsened) to 7.0 (6.0, 7.0) at Day 14, with a median change of 1.0 (1.0, 1.0). The between-treatment comparison on change from the baseline to day 14 was statistically significant indicating a significant reduction in malodor severity with VT-1953 Topical Gel compared to the vehicle.

Table 13: Change in Score of Malodor ~~Contents~~Associated with Malignant Fungating Wounds (Scored by patients) Using a 10-point VAS Scale at Day 14

False Claims Laws

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	Change (Day 14-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 14-Baseline) p value
Overall	7.0 (6.0, 8.0)	3.0 (2.0, 6.0)	-4.0 (-6.0, 1.0)	0.0021
VT-1953 Topical Gel	7.5 (7.0, 9.0)	2.5 (2.0, 3.0)	-5.0 (-6.0, -4.0)
Vehicle Topical Gel	6.0 (5.0, 6.0)	7.0 (6.0, 7.0)	1.0 (1.0, 1.0)

~~The federal False Claims Act imposes liability on any individual or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim~~ Between-treatment comparisons for ~~payment by a federal healthcare program. The qui tam or “whistleblower” provisions of~~ Change (Day 14-Baseline) were performed using the ~~False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has violated the False Claims Act and to share in any monetary recovery~~ Wilcoxon Rank-Sum Test. ~~In recent years, the number of lawsuits brought against healthcare industry participants by private individuals has increased dramatically.~~

~~When~~Exploratory anOutcome: ~~entity~~Pain isScore Associated ~~determined~~with ~~to have violated~~ the ~~False~~Wound ~~Claims~~as ~~Act,~~Scored ~~it may be required to pay up to three times the actual damages sustained~~ by the ~~government,~~Patient ~~plus~~Using ~~civil penalties for each separate instance of false claim. As part of any settlement, the government may ask the entity to enter into~~ a ~~corporate~~10-point ~~integrity~~Visual ~~agreement,~~Analog ~~which~~Scale imposes certain compliance, certification and reporting obligations. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The federal government has used the False Claims Act to assert liability on ~~the~~Day basis of inadequate care, kickbacks and other improper referrals, and the provision of inaccurate reimbursement coding advice, in addition to the more predictable allegations as to misrepresentations with respect to the services rendered. In addition, companies have been sued under the False Claims Act in connection with the off-label promotion of products.7

~~Various~~The ~~states~~exploratory ~~have~~outcome ~~also~~assessing ~~enacted~~pain ~~false~~associated with ~~claims~~the ~~laws~~wound ~~that~~was ~~are~~measured ~~analogous~~using toa ~~the~~10-point ~~federal~~Visual ~~False~~Analog ~~Claims~~Scale ~~Act~~(VAS) at baseline and on Day 7. ~~Many~~Overall, ofthe ~~these~~median ~~state~~pain ~~laws~~score ~~apply~~decreased from to6.0 ~~claims~~(5.0, ~~submitted~~7.0) at baseline to ~~any~~5.0 ~~third~~(4.0, 6.0) on Day 7. In the VT-~~party~~1953 ~~payor~~Topical ~~and~~Gel ~~are~~treatment ~~not~~group, ~~limited~~the median pain score significantly decreased from 6.0 (5.0, 7.0) at baseline to ~~claims~~4.5 ~~submitted~~(4.0, 6.0) on Day 7, with a p-value of 0.0020, demonstrating a statistically significant reduction in pain. Conversely, in the Vehicle Topical Gel group, the median pain score remained unchanged at 6.0 (6.0, 6.0) from baseline to Day 7, with a ~~federal~~p-value ~~healthcare~~greater ~~program~~than 0.9999, indicating no change in pain levels. Between-treatment comparison at day 7 was not statistically significant (p=0.0766).

~~Transparency~~Table ~~Laws~~14: Pain Score Associated with the Wound as Scored by the Patient Using a 10-point Visual Analog Scale on Day 7

The federal Physician Payment Sunshine Act, or the Sunshine Act, which was enacted as part of the Patient Protection and Affordable Care Act, or the PPACA, generally requires certain manufacturers of a drug, device, biologic or other medical supply that is covered by Medicare, Medicaid or the Children’s Health Insurance Program and applicable group purchasing organizations to report on an annual basis: (i) certain payments and other transfers of value given to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other health care professionals beginning in 2022, and teaching hospitals and (ii) any ownership or investment interest that physicians, or their immediate family members, have in their company. The payments required to be reported include the cost of meals provided to a physician, travel reimbursements and other transfers of value, including those provided as part of contracted services such as speaker programs, advisory boards, consultation services and clinical trial services. Under the statute, the federal government makes reported information available to the public. Failure to comply with the reporting requirements can result in significant civil monetary penalties, with additional penalties for the knowing failure to report. Additionally, there are criminal penalties if an entity intentionally makes false statements in the reports.

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	p value Within treatment Baseline vs Day 7	Between-Treatment Comparison at Day 7 p value
Overall	6.0 (5.0, 7.0)	5.0 (4.0, 6.0)		0.0766
VT-1953 Topical Gel	6.0 (5.0, 7.0)	4.5 (4.0, 6.0)	0.0020
Vehicle Topical Gel	6.0 (6.0, 6.0)	6.0 (6.0, 6.0)	>0.9999

There has been a recent trend of separate state regulation of payments and transfers of value by manufacturers of medical devices to healthcare professionals and entities, however, and some state transparency laws apply more broadly than does Between-treatment comparisons for Day 7 scores were performed using the ~~federal Sunshine Act~~ Wilcoxon Rank-Sum Test. ~~Our business may be subject to some of these state laws.~~

~~State~~Within-treatment ~~Corporate~~comparisons ~~Practice~~(Baseline ofversus ~~Medicine,~~Day ~~Fee-Splitting~~7) ~~Prohibitions,~~for ~~and~~each ~~Licensure~~treatment ~~Requirements~~group were performed using the Wilcoxon Signed-Rank Test.

~~Other~~Exploratory ~~regulatory~~Outcome: ~~oversight~~Pain ~~includes,~~Score Associated ~~but~~with ~~is not limited to,~~ the ~~corporate~~Wound ~~practice~~as ofScored medicine, fee- splitting prohibitions, and licensure and scope of practice limitations for physicians and other healthcare professionals. Some states have enacted laws and regulations limiting the extent to which physicians and certain other healthcare professionals may be employed by ~~non-physicians or general business corporations, and~~ the ~~scope~~Patient ~~and~~Using ~~provisions of corporate practice of medicines laws and regulations vary by state. These laws are intended to prevent interference in the medical decision-making process by anyone who is not~~ a licensed physician. Violations may result in civil or criminal penalties. In addition, various state laws also generally prohibit the sharing or splitting professional fees with lay entities or persons. The specific restrictions with respect to enforcement of the corporate practice of medicine and fee10-~~splitting~~point ~~laws~~Visual ~~varies~~Analog ~~from~~Scale ~~state~~on toDay ~~state. Violations of these laws could require us to restructure our operations and arrangements and may result in penalties or other adverse action.~~14

The exploratory outcome assessing pain associated with the wound was measured using a 10-point Visual Analog Scale (VAS) on Day 14. At baseline, the overall median pain score was 6.0 (5.0, 7.0). By Day 14, the overall median pain score decreased to 4.0 (3.0, 6.0), demonstrating a statistically significant reduction (p = 0.0026). In the VT-1953 Topical Gel treatment group, the median pain score at baseline was 6.0 (5.0, 7.0), which decreased significantly to 4.0 (3.0, 4.0) on Day 14 (p = 0.0020). Conversely, the Vehicle Topical Gel group showed no change in median pain score, remaining at 6.0 (6.0, 6.0) from baseline to Day 14, with no statistically significant difference observed (p > 0.9999). Between-treatment comparison at Day 14 between the 2 groups was statistically significant (p=0.0026) indicating that VT-1953 topical gel was superior to Vehicle topical gel in reducing pain.

Table of15: ~~Contents~~Pain Score Associated with the Wound as Scored by the Patient Using a 10-point Visual Analog Scale on Day 14

Moreover, each state defines the scope of practice of physicians and other healthcare professionals through legislation and through their respective licensing boards, and we will need to comply with laws related to the physician supervision of services and scope of practice requirements. Activities that qualify as professional misconduct under state law may subject our personnel to sanctions or may even result in loss of their license and could, possibly, subject us to sanctions as well. Some state boards of medicine impose reciprocal discipline, that is, if a physician is disciplined for having committed professional misconduct in one state where he or she is licensed, another state where he or she is also licensed may impose the same discipline even though the conduct occurred in another state.

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	p value Within treatment Baseline vs Day 14	Between-Treatment Comparison at Day 14 p value
Overall	6.0 (5.0, 7.0)	4.0 (3.0, 6.0)		0.0026
VT-1953 Topical Gel	6.0 (5.0, 7.0)	4.0 (3.0, 4.0)	0.0020
Vehicle Topical Gel	6.0 (6.0, 6.0)	6.0 (6.0, 6.0)	>0.9999

~~Foreign Corrupt Practices Act~~Between-treatment comparisons for Day 14 scores were performed using the Wilcoxon Rank-Sum Test.

~~The~~Within-treatment ~~Foreign~~comparisons ~~Corrupt~~(Baseline ~~Practices~~versus ~~Act,~~Day or14) ~~FCPA,~~for ~~prohibits~~each ~~U.S.~~treatment ~~businesses~~group ~~and~~were ~~their~~performed ~~representatives~~using ~~from offering to pay, paying, promising to pay or authorizing~~ the ~~payment~~Wilcoxon ofSigned-Rank money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage in order to obtain or retain businessTest. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records, which in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the corporation, including international subsidiaries, if any, and to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances regarding the reliability of financial reporting and the preparation of financial statements. The scope of the FCPA includes interactions with certain healthcare professionals in many countries.

~~International~~Exploratory ~~Laws~~Outcome: Change in Pain Score Associated with the Wound as Scored by the Patient Using a 10-Point Visual Analog Scale on Day 7

InThe ~~Europe,~~exploratory ~~and~~outcome ~~throughout~~assessing the ~~world~~change in pain score associated with the wound, ~~other~~as ~~countries~~measured ~~have~~by ~~enacted~~the ~~anti~~patient using a 10-~~bribery~~point ~~laws~~Visual ~~and/or~~Analog ~~regulations~~Scale ~~similar~~on toDay 7, demonstrated a reduction in pain in the ~~FCPA~~overall population. ~~Violations~~The ofmedian ~~any~~pain score decreased from 6.0 (5.0, 7.0) at baseline to 5.0 (4.0, 6.0) on Day 7, with a median change of ~~these~~1.0 ~~anti~~(0.0, 2.0. In the VT-~~bribery~~1953 ~~laws~~Topical Gel treatment group, orthe ~~allegations~~median ofpain ~~such~~score ~~violations~~decreased from 6.0 (5.0, ~~could~~7.0) ~~have~~at abaseline to ~~negative~~4.5 ~~impact~~(4.0, 6.0) on ~~our~~Day ~~business~~7, ~~results~~with a median change of ~~operations~~1.5 (1.0, 2.0). In contrast, the Vehicle Topical Gel group showed no change in median pain score, remaining at 6.0 (6.0, 6.0) at both baseline and ~~reputation~~Day 7, with a median change of 0.0 (0.0, 0.0). The between-treatment comparison on change from baseline to day 7 was statistical significant (p=0.0045) indicating that treatment with VT-1953 Topical Gel was associated with a greater reduction in wound-associated pain compared to the vehicle.

~~There~~Table ~~are~~16: ~~also~~Change ~~international~~in ~~privacy~~Pain ~~laws~~Score Associated ~~that~~with ~~impose restrictions on~~ the ~~access,~~Wound ~~use,~~as ~~and~~Scored ~~disclosure~~by ~~of health information. All of these laws may impact our business. Our failure to comply with these privacy laws or significant changes in~~ the ~~laws~~Patient ~~restricting~~Using ~~our~~a ~~ability~~10-point toVisual ~~obtain~~Analog ~~required~~Scale ~~patient~~on ~~information could significantly impact our business and our future business plans.~~ Day

U.S. Healthcare Reform

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	Change (Day 7-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 7-Baseline) p value
Overall	6.0 (5.0, 7.0)	5.0 (4.0, 6.0)	1.0 (0.0, 2.0)	0.0045
VT-1953 Topical Gel	6.0 (5.0, 7.0)	4.5 (4.0, 6.0)	1.5 (1.0, 2.0)
Vehicle Topical Gel	6.0 (6.0, 6.0)	6.0 (6.0, 6.0)	0.0 (0.0, 0.0)

Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our products. By way of example, ACA substantially changed Between-treatment comparisons for Change (Day 7-Baseline) were performed using the ~~way healthcare is financed by both governmental and private insurers, and significantly impacted the medical device industry~~ Wilcoxon Rank-Sum Test.

~~There~~Exploratory ~~will~~Outcome: ~~continue~~Change toin pain bescore ~~proposals~~associated bywith ~~legislators at both~~ the ~~federal~~wound ~~and~~as ~~state~~scored ~~levels,~~by ~~regulators and third-party payors to reduce costs while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on~~ the ~~prices~~patient weusing ~~will~~a be10-point ~~able~~Visual toAnalog ~~charge~~Scale and/or patients’ willingness to pay for our products. While in general it is too early to predict what effect, if any, ACA and its implementation, or any future healthcare reform legislation or policies will have on ~~our~~Day ~~business, current and future healthcare reform legislation and policies could have a material adverse effect on our business and financial condition.~~ 14

~~Employees~~The change in pain score associated with the wound, as assessed by patients using a 10-point Visual Analog Scale (VAS) on Day 14, was evaluated. At baseline, the overall median pain score was 6.0 (5.0, 7.0). By Day 14, the overall median pain score decreased to 4.0 (3.0, 6.0), resulting in a median change from baseline of 2.0 (0.0, 4.0). In the VT-1953 Topical Gel treatment group, the median baseline pain score was 6.0 (5.0, 7.0), which decreased to 4.0 (3.0, 4.0) on Day 14. The median change from baseline in this group was 3.0 (2.0, 4.0). In contrast, the Vehicle Topical Gel group had a median baseline pain score of 6.0 (6.0, 6.0) that remained unchanged at 6.0 (6.0, 6.0) on Day 14, with a median change of 0.0 (0.0, 0.0). The between-treatment comparison on change from baseline to day 14 was statistically significant (p=0.0028) indicating a greater reduction in pain scores in the VT-1953 Topical Gel group compared to the Vehicle Topical Gel group by Day 14.

As of December 31, 2024, we had 18 employees, of which 17 were full-time and 1 was part-time. All of these employees are located in the U.S.

From time to time we also employ independent contractors, consultants and temporary employees to support our operations. None of our employees are subject to collective bargaining agreements. We have never experienced a work stoppage and believe that our relations with our employees are good.

Table of17: ~~Contents~~Change in Pain Score Associated with the Wound as Scored by the Patient Using a 10-point Visual Analog Scale on Day 14

Our Corporate Information

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	Change (Day 14-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 14-Baseline) p value
Overall	6.0 (5.0, 7.0)	4.0 (3.0, 6.0)	2.0 (0.0, 4.0)	0.0028
VT-1953 Topical Gel	6.0 (5.0, 7.0)	4.0 (3.0, 4.0)	3.0 (2.0, 4.0)
Vehicle Topical Gel	6.0 (6.0, 6.0)	6.0 (6.0, 6.0)	0.0 (0.0, 0.0)

We Between-treatment comparisons for Change (Day 14-Baseline) were ~~incorporated under~~ performed using the ~~laws of Delaware on January 2, 2008~~ Wilcoxon Rank-Sum Test. On June 15, 2021, we completed a merger with ReShape Lifesciences Inc. Pursuant to the Merger Agreement, Optimus Merger Sub, Inc , a wholly owned subsidiary of Obalon, merged with and into ReShape, with ReShape surviving the merger as a wholly owned subsidiary of Obalon. As a result of the merger, Obalon, the parent company, was renamed “ReShape Lifesciences Inc.” and ReShape was renamed ReShape Weightloss Inc. ReShape Lifesciences shares of common stock trade on the Nasdaq under the symbol RSLS.

WeScore file reports and other information with the Securities and Exchange Commission (“SEC”) including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and proxy or information statements. Those reports and statements as well as all amendments to those documents filed or furnished pursuant to Section 13(a) or 15(d) of ~~the~~Exudates ~~Securities Exchange Act of 1934,~~ as ~~amended~~Scored ~~(1) are available at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, DC 20549, (2) may be obtained~~ by ~~sending an electronic message to~~ the ~~SEC~~Caregiver atMeasured ~~publicinfo@sec.gov~~on ~~or by sending a fax to the SEC at 1~~0-202-777-1027, (3) are available at the SEC’s internet site (http://www.sec.gov), which contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC and (4) ~~are~~Scale ~~available~~on ~~free~~Day ~~of charge through our website as soon as reasonably practicable after electronic filing with, or furnishing to, the SEC.~~ 7

~~Our~~For ~~principal~~the ~~executive~~overall ~~offices~~population, ~~are~~the ~~located~~median atvalue 18of the ~~Technology~~score ~~Dr,~~of ~~Suite~~exudates ~~110~~as scored by the caregiver measured on 0-4 scale on day 7, ~~Irvine~~remained stable at 4.0 (3.0, ~~California~~5.0) ~~92618~~from baseline to Day 7. In the VT-1953 Topical Gel treatment group, ~~and~~the ~~our~~median ~~telephone~~value ~~number~~decreased isslightly from 4.0 (~~949)~~3.0, ~~429-6680~~4.0) ~~Our~~at ~~website~~baseline ~~addresses~~to ~~are~~3.5 ~~www~~(3.~~reshapelifesciences~~0, 4.~~com~~0) ~~and~~at Day ~~lapband~~7; however, this change was not statistically significant (p=0.~~com~~5000). The ~~information~~Vehicle ~~on,~~Topical orGel ~~that~~group ~~may~~showed beno ~~accessed~~change ~~through~~in median values, remaining ~~our~~at ~~website~~5.0 is(4.0, ~~not~~5.0) ~~incorporated~~at byboth ~~reference~~baseline ~~into~~and ~~this~~Day ~~Annual~~7, ~~Report~~with onno ~~Form~~p ~~10-K~~value ~~and~~reported ~~should~~for ~~not~~within-group becomparison. ~~considered~~Between-treatment acomparison at ~~part~~Day of7 ~~this~~between ~~Annual~~the ~~Report~~2 ongroups ~~Form~~was ~~10-K~~statistically significant (p=0.0268).

Table 18: Score of Exudates as Scored by the Caregiver Measured on 0-4 Scale on Day 7

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	p value Within treatment Baseline vs Day 7	Between-Treatment Comparison at Day 7 p value
Overall	4.0 (3.0, 5.0)	4.0 (3.0, 5.0)		0.0268
VT-1953 Topical Gel	4.0 (3.0, 4.0)	3.5 (3.0, 4.0)	0.5000
Vehicle Topical Gel	5.0 (4.0, 5.0)	5.0 (4.0, 5.0)	-

Between-treatment comparisons for Day 7 scores were performed using the Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 7) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

Exploratory Outcome: Score of Exudates as Scored by the Caregiver Measured on 0-4 Scale on Day 14

Overall, the median exudate score at baseline was 4.0 (3.0, 5.0) and remained unchanged at Day 14 with a median of 4.0 (3.0, 5.0). In the VT-1953 Topical Gel treatment group, the median exudate score decreased from 4.0 (3.0, 4.0) at baseline to 3.5 (3.0, 4.0) at Day 14; however, this change was not statistically significant (p = 0.5000). In the Vehicle Topical Gel group, the median exudate score remained stable at 5.0 (4.0, 5.0) from baseline through Day 14, with no p value reported for within-group comparison. Between-treatment comparison at Day 14 was statistically significant (p=0.0268).

Table 19: Score of Exudates as Scored by the Caregiver Measured on 0-4 Scale on Day 14

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	p value Within treatment Baseline vs Day 14	Between-Treatment Comparison at Day 14 p value
Overall	4.0 (3.0, 5.0)	4.0 (3.0, 5.0)		0.0268
VT-1953 Topical Gel	4.0 (3.0, 4.0)	3.5 (3.0, 4.0)	0.5000
Vehicle Topical Gel	5.0 (4.0, 5.0)	5.0 (4.0, 5.0)	-

Between-treatment comparisons for Day 7 scores were performed using the Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 7) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

~~Table~~Exploratory Outcome: Quality of ~~Contents~~Life (QOL) Score on VAS Scale at Day 7 as Scored by the Patient

At baseline, the overall median QoL score was 5.0 (4.5, 5.8), which decreased to 4.5 (3.8, 5.0) at Day 7. In the VT-1953 Topical Gel treatment group, the median QoL score significantly decreased (i.e. improvement in QoL) from 5.5 (4.5, 6.0) at baseline to 4.1 (3.5, 4.8) at Day 7 (p = 0.0020). Conversely, the Vehicle Topical Gel group showed a non-significant increase in median QoL score (worsening of QoL) from 4.8 (4.3, 4.8) at baseline to 5.0 (4.5, 5.0) at Day 7 (p = 0.0625). No statistically significant difference was observed between the treatment groups at Day 7 (p=0.0937).

Table 20: Quality of Life (QOL) Score on VAS Scale at Day 7 as Scored by the Patient

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	p value Within treatment Baseline vs Day 7	Between-Treatment Comparison at Day 7 p value
Overall	5.0 (4.5, 5.8)	4.5 (3.8, 5.0)		0.0937
VT-1953 Topical Gel	5.5 (4.5, 6.0)	4.1 (3.5, 4.8)	0.0020
Vehicle Topical Gel	4.8 (4.3, 4.8)	5.0 (4.5, 5.0)	0.0625

Between-treatment comparisons for Day 7 scores were performed using the Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 7) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

Exploratory Outcome: Quality of Life (QOL) Score on VAS Scale at Day 14 as Scored by the Patient

In the VT-1953 Topical Gel treatment group, the median QoL score decreased from 5.5 (4.5, 6.0) at baseline to 3.0 (2.8, 3.3) at Day 14, showing a statistically significant improvement in QoL (p = 0.0020). Conversely, the Vehicle Topical Gel group showed a median QoL score of 4.8 (4.3, 4.8) at baseline and 5.0 (4.5, 5.0) at Day 14, with no statistically significant change observed (p = 0.0625). Between-treatment comparison at Day 14 between the 2 groups was statistically significant (p=0.0032).

Table 21: Quality of Life (QOL) Score on VAS Scale at Day 14 as Scored by the Patient

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	p value Within treatment Baseline vs Day 14	Between-Treatment Comparison at Day 14 p value
Overall	5.0 (4.5, 5.8)	3.3 (2.8, 4.5)		0.0032
VT-1953 Topical Gel	5.5 (4.5, 6.0)	3.0 (2.8, 3.3)	0.0020
Vehicle Topical Gel	4.8 (4.3, 4.8)	5.0 (4.5, 5.0)	0.0625

Between-treatment comparisons for Day 14 scores were performed using the Wilcoxon Rank-Sum Test.

Within-treatment comparisons (Baseline versus Day 14) for each treatment group were performed using the Wilcoxon Signed-Rank Test.

Exploratory Outcome: Change in Quality of Life (QOL) score on VAS scale at Day 7 as scored by the patient

In the VT-1953 Topical Gel treatment group, the median QoL score decreased (i.e. improvement in QoL) from 5.5 (4.5, 6.0) at Baseline to 4.1 (3.5, 4.8) at Day 7, with a median change of 1.3 (1.0, 1.5). In contrast, the Vehicle Topical Gel group showed a slight increase in median QoL score from 4.8 (4.3, 4.8) at Baseline to 5.0 (4.5, 5.0) at Day 7, with a median change of 0.3 (0.3, 0.3), i.e. worsening of QoL. The between-treatment comparison on the change from Baseline to Day 7 demonstrated a statistically significant difference favoring the VT-1953 Topical Gel group (p = 0.0021).

Table 22: Statistical Summary of Change QoL Scored by patient from Baseline to Day 7

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	Change (Day 7-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 7-Baseline) p value
Overall	5.0 (4.5, 5.8)	4.5 (3.8, 5.0)	1.0 (0.3, 1.3)	0.0021
VT-1953 Topical Gel	5.5 (4.5, 6.0)	4.1 (3.5, 4.8)	1.3 (1.0, 1.5)
Vehicle Topical Gel	4.8 (4.3, 4.8)	5.0 (4.5, 5.0)	0.3 (0.3, 0.3)

Between-treatment comparisons for Change (Day 7-Baseline) were performed using the Wilcoxon Rank-Sum Test.

Exploratory Outcome: Change in quality of Life (QOL) score on VAS scale at Day 14 as scored by the patient

In the VT-1953 Topical Gel treatment group, the median QOL score improved from 5.5 (4.5, 6.0) at baseline to 3.0 (2.8, 3.3) at Day 14, with a median change of 2.4 (2.0, 3.0), i.e. an improvement in QoL. Conversely, the Vehicle Topical Gel group showed minimal change, with median scores of 4.8 (4.3, 4.8) at baseline and 5.0 (4.5, 5.0) at Day 14, resulting in a median change of 0.3 (0.3, 0.3). The between-treatment comparison on change from baseline to day 7 was not statistical significant (p=0.0024). These results indicate a greater improvement in QOL scores in the VT-1953 Topical Gel group compared to the vehicle control.

Table 23: Change in Quality of Life (QOL) Score on VAS Scale at Day 14 as Scored by the Patient

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	Change (Day 14-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 14-Baseline) p value
Overall	5.0 (4.5, 5.8)	3.3 (2.8, 4.5)	2.0 (0.3, 2.5)	0.0024
VT-1953 Topical Gel	5.5 (4.5, 6.0)	3.0 (2.8, 3.3)	2.4 (2.0, 3.0)
Vehicle Topical Gel	4.8 (4.3, 4.8)	5.0 (4.5, 5.0)	0.3 (0.3, 0.3)

Between-treatment comparisons for Change (Day 14-Baseline) were performed using the Wilcoxon Rank-Sum Test.

Exploratory Outcome: Statistical Summary of Change from Baseline to Day 7 in Exudate Amount on the 5 Point Scale

The exploratory outcome assessing the change from baseline to Day 7 in exudate amount, measured on a 5-point scale, was summarized for both treatment groups. At baseline, the overall median exudate score was 4.0 (3.0, 5.0), which remained unchanged at Day 7 with a median of 4.0 (3.0, 5.0). The median change from baseline to Day 7 was 0.0 (0.0, 0.0) overall, indicating no median change in exudate amount. In the VT-1953 Topical Gel group, the baseline median was 4.0 (3.0, 4.0), which decreased slightly to 3.5 (3.0, 4.0) at Day 7; however, the median change remained 0.0 (0.0, 0.0). In the Vehicle Topical Gel group, the baseline and Day 7 medians were both 5.0 (4.0, 5.0), with a median change of 0.0 (0.0, 0.0). The between-treatment comparison of the change from baseline to Day 7 in exudate amount yielded a p-value of 0.3503, indicating no statistically significant difference between the VT-1953 Topical Gel and Vehicle Topical Gel groups.

Table 24: Statistical Summary of Change from Baseline to Day 7 in Exudate Amount on a 5 Point Scale

Treatment Group	Baseline Median (Q1, Q3)	Day 7 Median (Q1, Q3)	Change (Day 7 - Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 7-Baseline) p value
Overall	4.0 (3.0, 5.0)	4.0 (3.0, 5.0)	0.0 (0.0, 0.0)	0.3503
VT-1953 Topical Gel	4.0 (3.0, 4.0)	3.5 (3.0, 4.0)	0.0 (0.0, 0.0)
Vehicle Topical Gel	5.0 (4.0, 5.0)	5.0 (4.0, 5.0)	0.0 (0.0, 0.0)

Between-treatment comparisons for Change (Day 7-Baseline) were performed using the Wilcoxon Rank-Sum Test.

Exploratory Outcome: Statistical Summary of Change from Baseline to Day 14 in Exudate Amount on the 5 Point Scale (Annexure no 10)

The exploratory outcome assessing the change from baseline to Day 14 in exudate amount, measured on a 5-point scale, was summarized for both treatment groups. At baseline, the median exudate score for the overall population was 4.0 (3.0, 5.0), which remained unchanged at Day 14 with a median of 4.0 (3.0, 5.0). The median change from baseline to Day 14 was 0.0 (0.0, 0.0) for the overall population. Specifically, the VT-1953 Topical Gel group had a baseline median exudate score of 4.0 (3.0, 4.0) and a Day 14 median of 3.5 (3.0, 4.0), resulting in a median change of 0.0 (0.0, 0.0). The Vehicle Topical Gel group had a baseline median of 5.0 (4.0, 5.0) and a Day 14 median of 5.0 (4.0, 5.0), with a median change of 0.0 (0.0, 0.0). The between-treatment comparison on change from baseline to day 14 was not statistical significant (p=0.3503). These results indicated no meaningful change in exudate amount over the 14-day treatment period in either group.

Table 25: Statistical Summary of Change from Baseline to Day 14 in Exudate Amount on a 5 Point Scale

Treatment Group	Baseline Median (Q1, Q3)	Day 14 Median (Q1, Q3)	Change (Day 14-Baseline) Median (Q1, Q3)	Between-Treatment Comparison on Change (Day 14-Baseline) p value
Overall	4.0 (3.0, 5.0)	4.0 (3.0, 5.0)	0.0 (0.0, 0.0)	0.3503
VT-1953 Topical Gel	4.0 (3.0, 4.0)	3.5 (3.0, 4.0)	0.0 (0.0, 0.0)
Vehicle Topical Gel	5.0 (4.0, 5.0)	5.0 (4.0, 5.0)	0.0 (0.0, 0.0)

Between-treatment comparisons for Change (Day 14-Baseline) were performed using the Wilcoxon Rank-Sum Test.

In summary:

VT-1953 significantly reduces the malodor symptom of MFW, consistent with its mechanism of action. A large fraction of the patients reported an improvement in maolodor symptoms with VT-1953 as compared to vehicle treatment. Of all wound related symptoms, malodor is cited by patients and professionals as the most distressing, contributing to social isolation, depression, feelings of guilt and repulsion (Gethin, G., et al. Current practice in the management of wound odour: An international survey. International Journal of Nursing Studies 2014; 51, 865-874, https://doi.org/10.1016/j.ijnurstu.2013.10.013). In a survey of nurses, 48% identified malodor as the main challenge, followed by pain and exudate control (Probst, S.et al. Malignant fungating wounds: a survey of nurses’ clinical practice in Switzerland. Eur J Oncol Nurs 2009; 13, 295-298, doi:10.1016/j.ejon.2009.03.008). Patients report feelings of being totally isolated, attributing the malodor as the main causative factor (Gethin, 2014). The feelings of isolation also result in patients and care givers struggling in their attempts to manage the physical aspects of the wound while simultaneously coping with the psychological impact of its appearance as a constant reminder of underlying malignancy (Gethin, 2014).

Malodor in MFW arises from bacterial colonization (Fromantin I., et al. Bacterial floras and biofilms of malignant wounds associated with breast cancers. J. Clin. Microbiol. 2013; 51, 3368–3373). VT-1953 inhibits DNA Gyr and Topoisomerase 4, and therefore it kills both aerobic and anaerobic bacteria that cause the malodor and associated symptoms of MFW. It can kill bacteria at lower doses than metronidazole, which is currently used off-label to reduce odor even though it only kills anaerobic bacteria.

VT-1953 also reduced pain symptoms associated with the lesion. Fromantin et al had reported that pain correlates with the bacterial load. Inflammation can also contribute to pain. VT-1953 not only kills bacteria but can contribute to reducing inflammation-associated symptoms by inhibiting MD2-TLR signaling. Multiple clinical trials have demonstrated the reduction of inflammation following VT-1953 topical gel application. VT-1953 did not impact exudate, consistent with the mechanism of action not overlapping with the pathology (cancer) driving exudate.

The topical application means high drug concentration is reached locally with minimal systemic exposure, which can increase efficacy and reduce the risks of any systemic side effects. In the clinical trial reports, VT-1953 was reported to be well-tolerated by patients.

Based on the above observations, we aim to initiate a pivotal study to test the efficacy of VT-1953 in alleviating the malodor associated with malodorous MFW. The results from the Ph2 will inform our Ph3 design (We have not had any meetings with the FDA regarding Phase 3 trial protocols). To date, we have submitted an application to the USFDA for an orphan drug designation; there is no guarantee that such designation will be granted.

Market opportunity for VT-1953

MFW afflicts 5 – 14% of advanced cancer patients in the United States, according to the “The Microbiome, Malignant Fungating Wounds, and Palliative Care” article by Frontiers. Although, from a regulatory perspective MFW is a rare indication, researchers at the National Cancer Institute estimated that over 693,000 Americans will have several forms of advanced cancer by the year 2025. Destum Partners, Inc, an independent life sciences advisory firm, conducted a commercial opportunity assessment for VT-1953 for the treatment of malignant fungating wounds (MFW), a severe complication associated with advanced cancers characterized by malodor, pain, and significant quality-of-life impact. The assessment incorporated epidemiology modeling, primary research with oncology and wound care key opinion leaders (KOLs), review of treatment patterns, competitive landscape analysis, and pricing benchmarks. Based on this analysis, Destum Partners estimated approximately 58,000 new MFW cases annually in the United States and identified a significant unmet medical need due to the absence of FDA-approved pharmacologic therapies specifically indicated for this condition. Destum Partners estimated the potential annual addressable U.S. market opportunity for pharmacologic treatment of MFW at approximately $2.2 billion. Using a commercial forecast model and risk-adjusted net present value methodology, Destum Partners projected potential peak annual U.S. net sales for VT-1953 of approximately $600 million, assuming successful clinical development and commercialization. Based on available Phase 2 clinical data and development assumptions at the time of the analysis, the report estimated a risk-adjusted asset value of approximately $455 million, which Destum Partners indicated could increase to approximately $1 billion upon successful completion of Phase 3 clinical development and regulatory approval

Program 2-VT-1908 — Topical drops for treating steroid-incompatible uveitis

Uveitis refers to the inflammation of the uveal tract of the eye (iris, ciliary body and choroid). In the Unites States, the estimated prevalence of non-infectious uveitis is 121/100,000 according to a September 2021 article published in Frontiers in Medicine (Ophthalmology) journal titled “Epidemiology and Risk Factors in Non-infectious Uveitis: A Systematic Review.” In the developed world, it is the 5th or 6th leading cause of blindness, accounting for about 10 – 15% of all cases of blindness according to a 2004 article in the British Journal of Medicine titled “Degree, duration, and causes of visual loss in uveitis” and a 2019 article in the journal Semin Arthritis Rheum titled “New observations and emerging ideas in diagnosis and management of non-infectious uveitis: A review.” Uveitis can occur due to an infection (infectious uveitis), or if the immune system starts attacking normal cells of the uvea (non-infectious uveitis). Etiologies of non-infectious uveitis include HLA-B27 associated anterior uveitis, Fuchs uveitis syndrome, sarcoidosis, Vogt-Koyanagi-Harada (VKH), sympathetic ophthalmia, birdshot chorioretinopathy, multifocal choroiditis, serpiginous choroiditis, and Behçet disease. Non-infectious uveitis represents the majority of uveitis cases (67 – 90%) in the developed world, according to a 2004 article in the Ophthalmology journal titled “Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study” and a 2016 article in the JAMA Ophthalmol titled “Prevalence of Non-infectious Uveitis in the United States: A Claims-Based Analysis.”

Current treatments for Uveitis

Topical steroids are the first line of treatment for non-infectious uveitis. Steroids deplete the immune cells attacking the uvea. However, long-term use of steroids, such as in chronic and recurrent uveitis, can lead to complications, including glaucoma and cataract. Additionally, uveitic glaucoma is a common complication of uveitis affecting some 20% of patients (more commonly associated with anterior uveitis and with chronic forms of uveitis). Such patients cannot be treated with steroids. Off-label oral or systemic immunosuppressants such as methotrexate or mycophenolate are therefore used as second-line treatments. However, systemically administered immunosuppressants have a lot of side-effects and can deplete the immune system globally and increase the risks of infections. Humira is approved for use in intermediate, posterior, and panuveitis. There is an unmet need for a topically administered non-steroidal drug that can be used to treat uveitis.

Our solution for treating uveitis. VT-1908 is the first sterile topical eye drop formulation of mycophenolate (salt or ester of mycophenolic acid, MPA), an inhibitor of inosine monophosphate dehydrogenase (IMPDH) enzyme. MPA is a fivefold more potent inhibitor of the type II isoform of IMPDH, which is expressed in activated lymphocytes, than of the type I isoform of IMPDH, which is expressed in most cell types. MPA therefore has e a more potent inhibitory effect on lymphocytes than on other cell types. MPA can induce apoptosis of activated T-lymphocytes, which may eliminate clones of cells responding to antigenic stimulation, decrease the recruitment of lymphocytes and monocytes into sites of inflammation, and suppresses the production by nitrous oxide, and consequent tissue damage mediated by peroxynitrite.

In preclinical studies, treatment with mycophenolate topical eye drops resulted in significant resolution of uveitis comparable to steroid treatment, and reduced the number of infiltrating immune cells in the eye (See Figure11). Mycophenolate is already approved by the FDA as an oral treatment of transplant rejection, and is already used off-label to clinically treat uveitis. For example, in a peer reviewed prospective clinical study published in 2020 the journal Eye, titled “Mycophenolate sodium (MPS) in the treatment of corticosteroid-refractory non-infectious inflammatory uveitis (MySTRI study)”, the investigators treated forty consecutive patients at a tertiary uveitis referral centre with 6 months of oral MPS with follow-up for 12 months. The main outcome measures were best-corrected visual acuity (BCVA), inflammatory index, steroid-sparing effect of tapering prednisone to ≤10 mg daily and side effects. The investigators concluded that ‘MPS is an effective steroid-sparing drug for the treatment of corticosteroid-refractory uveitis. The effect seen was not only during the 6 months of therapy, but also extended to 12 months to maintain BCVA and inflammation control. The side effects were acceptable’. The switch to the first sterile topical eye drop offers an opportunity to achieve the drug concentrations at the desired location (eye) and minimize the systemic exposure from oral administration. Based on these observations, we are currently conducting additional pre-clinical studies and manufacturing activities for VT-1908 in anticipation of enabling clinical trials by the end of 2025. The FDA has not approved mycophenolate or mycophenolate sodium to treat patients with uveitis and would need to review clinical trial data in order to determine that these drugs are safe and effective to treat uveitis.

Figure. 11. VT-1908 eye drop is effective against uveitis.

Representative eye images showing the different uveitis scoring levels.



Treatment with different mycophenolate topical eye drops (VT1908, VT1908a) are as effective as a steroid (prednisolone) in treating uveitis.		VT1908 Mycophenolate topical eye drops decreased the infiltrating immune cells in the eye to a similar degree as the steroid (pred) treatment.

Market opportunity for VT-1908

The addressable market potential for replacing topical steroids use in ophthalmology in uveitis is estimated to be $2.6 billion by 2032. In addition, the market potential in other ophthalmology indications, such as in dry eye disease, is estimated to be $13 billion by 2030, in scleritis is estimated to be $4.735 billion by 2030, in blepharitis is estimated to be $2.3 billion by 2031, and in post-operative cataract inflammation is estimated to be $8.78 billion by 2033.

The US has approximately 241,665 anterior non-infections uveitis patients. Taking a mere 12% of the 241,665 patients, we believe we can aim for 30,000 patients to be on treatment with VT-1908 in the US, if it is approved by FDA. With a typical treatment period of six months yearly for anterior uveitis, and an estimated moderate pricing of $1,200 monthly prescription, the annual costs per patient would be approximately $7,200, with a potential yearly sale in the US estimated to be approximately $210 million.

Other pipeline opportunities

VB-1953 in inflammatory acne — Acne is an inflammatory disease, which according to the American Academy of Dermatology Association afflicts over 50 million Americans annually. It is associated with a bacteria, P acne, which can colonize the skin and can lead to inflammation in certain conditions. Acne has been extensively treated with two classes of antibiotics such as clindamycin and tetracyclines (doxycycline, minocycline and sarecycline), and as a result, over one in three patients now carry resistant strains, which will not respond to the existing drugs, and as a result, the best response in the reduction of inflammatory lesions with such agents is ~55%. There is a need for novel therapeutics that are active against these resistant strains of P acne as well as can independently reduce inflammation for treating inflammatory acne. As VT-1953 meets these two requirements, it can be developed into a potential product for the treatment of inflammatory acne.

We have labeled VT-1953 for treatment of inflammatory acne as the VB-1953 program, and both terms can be used interchangeably. As described previously, VT-1953 (VB-1953) 2% gel has been tested in multiple clinical trials. Below, we summarize the results from the studies that have been performed in patients with inflammatory acne (for detailed study descriptions, see the Clinical Phase 1 and 2 studies described earlier).

In a Phase 1 open-label study in 12 subjects in the US, with moderate to severe facial acne vulgaris, 18 to 45 years of age, who were treated twice daily for 14 days with VB-1953 Topical Gel, there was a >55% reduction in inflammatory lesions (See Figure 12).

Figure 12. Treatment with VB-1953 topical gel reduces inflammatory lesions and improves IGA scores within 15 days in a Phase 1 clinical study in moderate to severe acne patients.

Investigator-initiated proof of concept phase 2 clinical study of VB-1953 in clindamycin-resistant acne. VB-1953 was studied in an investigator-initiated, open label, single-arm phase 2 clinical study in patients with moderate to severe facial acne vulgaris with poor or no response to previous clindamycin treatment. This study was sponsored by Dr. Rohit Batra, MD (Dermaworld Skin and Hair Clinic, New Delhi) and Vyome and was completed in 2019. This study has been published as a peer reviewed article in the journal Drugs in R&D (2020) for referral.

Healthy male or non-pregnant females aged between 18 and 45 years with a clinical diagnosis of acne vulgaris of moderate to severe grade (grade 3 or 4 as determined by the Investigator’s Global Assessment [IGA]) were included in this study. Subjects had at least 20 inflammatory lesions (papules, pustules and nodules/cysts) and at least 20 noninflammatory lesions (open/closed comedones) on the face. Subjects with more than two facial nodulocystic lesions, active nodulocystic acne, and any skin condition or disease interfering with evaluation were excluded. Furthermore, all subjects enrolled in the study had undergone topical clindamycin or clindamycin fixed-dose combination (FDC) treatment in the past month, did not or poorly responded to clindamycin treatment, and harbored clindamycin-resistant C. acnes strains. Moreover, subjects with serious clinical illness or chronic diseases, and subjects who had taken certain topical or systemic anti-acne treatments that, in the opinion of the investigator, may interfere with the study, were not included.

This was an open label, non-randomised, prospective clinical study evaluating the safety, tolerability and efficacy of VB-1953 in adult subjects with moderate to severe facial acne vulgaris who did not respond, or had low response, to clindamycin treatment. On Visit 1, an initial screening was performed, followed by collection of a bacterial swab from the patient’s face. Thereafter, microbiological testing was performed to check the presence of clindamycin-resistant strains in the samples collected. Of the 80 patients screened, samples from 19 subjects were positive for the above strains, which called for further follow-up visits. On Visit 2, the 19 subjects were enrolled into the study and were assessed for baseline IGA, lesion counts (inflammatory and noninflammatory) and local skin reactions (LSRs). Subjects were instructed to apply VB-1953 (2%) gel on the entire face twice daily for 12 weeks. Visit 2 was then followed by three subsequent visits, i.e. Visits 3, 4 and 5, corresponding to 4, 8 and 12 weeks after Visit 2, respectively. Furthermore, acne swab samples from enrolled patients were collected on Visit 3 (week 4) and Visit 5 (week 12) for microbiology testing. The study was approved by the Independent Ethics Committee (Good Society of Ethical Research [GSER], Delhi, India) and was conducted as per Schedule Y (amended version, 2005) of the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India; ‘Ethical Guidelines for Biomedical Research on Human Participants’ (2006); Indian Council of Medical Research (ICMR); International Conference on Harmonization (ICH) E6-(R1) ‘Guideline for Good Clinical Practice’; and Declaration of Helsinki (2013).

All subjects applied VB-1953 topical gel (2%) twice daily (in the morning and evening) for 12 weeks, and were encouraged to report any adverse incidences that happened during the study period. Safety was assessed by evaluation of local and systemic adverse events (AEs) and physical examination. The LSRs of erythema, edema, and scaling/dryness were estimated using a 5-point scale, and the LSRs of stinging/burning and pruritus/itching were estimated using a 4-point scale.

Efficacy endpoints were acne lesion counts (inflammatory and noninflammatory lesions) and the IGA of overall acne severity (a 5-point static scale). Analysis as per the statistical analysis plan was conducted on the following parameters: (1) absolute change in inflammatory lesions from baseline to week 12; (2) absolute change in noninflammatory lesions from baseline to week 12; (3) proportion of subjects with IGA success. The presence of clindamycin-resistant C. acnes in the acne swab samples collected from patients was checked and quantitated by microbiology and molecular biology testings. Additionally, the detection and quantification of drug- resistant C acnes strains were performed in the laboratory using acne swab samples collected from patients.

Eighty subjects were screened for all study inclusion parameters and 19 subjects were finally enrolled in the trial. All subjects completed the trial and were evaluated for safety and efficacy. The enrolled subjects included both males (63.2%) and females (36.8%) in the 18 – 29 years age group, with a mean age of 21.8 years.

No occurrence of treatment-emergent AEs (TEAEs; local or systemic) or changes in vital signs, physical examinations and urinalysis were reported for any patients during the course of the entire study. A negligible number of LSRs (erythema, edema, scaling, stinging/burning, and pruritus/itching) were reported in the study subjects, with all LSRs being predominantly minimal in severity on all visits, from Visit 2 to Visit 5. One instance of a moderate LSR was observed in a case of stinging/burning and scaling on Visit 2 but was not observed in subsequent visits.

The investigators reported a marked improvement in both inflammatory and noninflammatory lesions after 12 weeks of VB-1953 (2%) topical application, from baseline. The mean inflammatory lesion count decreased from 34.4 ± 6.4 at baseline to 16.7 ± 9.0 at week 12, with a mean reduction from baseline of 53.1% (p < 0.0001) (See Figure 13). Similarly, for noninflammatory lesion count, the mean absolute value reduced from 39.4 ± 7.8 at baseline to 19.5 ± 10.0 at week 12, with a mean reduction from baseline of 52.2% (p < 0.0001). IGA success at week 12 after topical application of VB-1953 gel (2%) was 26.3%, where IGA success was defined as a score of ‘clear’ or ‘almost clear’ (IGA score of 0 or 1) and a grade 2 or higher IGA improvement from baseline. The number of subjects enrolled in the study who had moderate (IGA score of 3) or severe (IGA score of 4) acne at baseline was 18 and 1, respectively. At week 12, five subjects had an IGA score of 1 (almost clear), nine subjects had an IGA score of 2 (mild), and five subjects had an IGA score of 3 (moderate). Overall, 31.6% and 47.1% of subjects exhibited a 2-point and 1-point improvement in IGA score, respectively, while 21.1% of subjects exhibited no change in IGA score compared with baseline at week 12.

C. acnes colonies were isolated from the samples collected from subjects and grown on BHI agar plates. Using the PCR method, the presence of the A2058G mutation on the 23S rRNA gene, and ermX gene detection in DNA extracted from the cells of C. acnes colonies, were performed to test for antibiotic-resistant strains. Of the 19 patients with resistant strains, the A2058G mutation in the 50S ribosomal subunit were identified in swab samples of 10 subjects, samples from 7 subjects had C. acnes isolates that were ermX gene-positive, and swab samples from two subjects exhibited C. acnes strains positive for both the above-mentioned features before start of treatment. At Visit 3 (week 4), acne samples from 10 of 19 subjects enrolled displayed the presence of clindamycin-resistant C. acnes strains; this number further decreased to 8 on Visit 5 (week 12) after topical application of VB-1953 gel. Using RT-PCR, we estimated the number of clindamycin-resistant C. acnes strains in the acne samples. Figure 13 shows that the resistant C. acnes gradually decreased from log 4.9 CFU/mL on Visit 1 to log 3.6 CFU/mL on Visit 5, indicating a decrease in total resistant C. acnes by 94.3 ± 1.0% (p < 0.05) after 4 weeks of topical application of VB-1953.

The clinical investigator concluded, ‘VB-1953 showcased good efficacy in treating both inflammatory and noninflammatory acne lesions without serious adverse effects. While larger studies are necessary to confirm these findings, our present data suggest VB-1953 as a future therapy against acne, even with an underlying resistant C. acnes etiology’.

Figure 13. Treatment with VT-1953 topical gel significantly reduces inflammatory lesions in moderate to severe acne patients carrying clindamycin-resistant bacteria, and non-responsive to clindamycin. Bacterial count shows almost complete eradication of resistant bacteria in the lesions.

Two Phase 2 clinical studies have been conducted by Vyome on VB-1953 in patients with inflammatory acne. The first was a proof-of-concept 12 week study of 160 subjects conducted in the Dominican Republic which exhibited no safety issues (Fig.14).

Figure 14. VB-1953 topical gel was well tolerated in a Ph 2 study safety analysis. Percentage of subjects with Local Skin Reaction (LSR)-Moderate and above grade of the LSR at Week 12

*	Comparative data was collected from published sources. Trial did not involve direct comparison.

In 106 evaluable patients across the treatment groups, VB-1953 significantly reduced inflammatory lesions with an early onset of action. At two weeks of treatment, VB-1953, applied twice daily (b.i.d) reduced inflammatory lesions by >35% (20% for placebo). At 12 weeks of treatment, VB-1953 (b.i.d) reduced inflammatory lesions by over 70% (See Figure 15).

Figure 15. Treatment with VB-1953 topical gel significantly reduces inflammatory lesions in moderate to severe acne patients in a Ph 2 study percent reduction in mean inflammatory Lesion Count

The second Phase 2 dose ranging study was a multi-center, randomized, double-blind, vehicle-controlled, and parallel-arm comparison Phase 2 study in the US in 478 patients with moderate to severe facial acne vulgaris. Subjects treated with VB-1953 had significant reductions (>65%) in inflammatory lesion counts from baseline to week 12. The primary efficacy endpoint was achieved as statistically significant greater reductions in inflammatory lesion counts from Baseline to Week 12 were observed for both active treatment arms versus the Pooled Vehicle in the ITT population. The proportion of subjects experiencing TEAEs and LSRs following application of the study drug was comparable between VB-1953 treatment arms and Vehicle arms (See Figure 16). There were no deaths or study drug discontinuations due to TEAEs during the study. Two SAEs were reported during the study; severe appendicitis in the VB-1953 BID arm and mild skin laceration in the Vehicle BID arm. Both SAEs were considered not related to study drug. Overall, the safety profile of topical VB-1953 gel and Vehicle were comparable when applied either QD or BID for 12 weeks. The clinical investigators concluded in their report that the results of this dose-ranging study support advancing the VB-1953 QD dose for further investigation in Phase 3 studies after considering the efficacy and safety profile.

Figure 16. VB-1953 reduced inflammatory lesions in moderate to severe acne patients in a Ph 2 study and safety and tolerability signals were comparable to vehicle-treated controls

Market opportunity for VB-1953

As discussed earlier, our development strategy is to conduct pivotal studies of our drug candidates for rare inflammatory conditions. While VT-1953 demonstrated excellent efficacy in inflammatory acne clinical study, we will conduct pivotal studies in acne only in partnership and will actively pursue such opportunities. We engaged Destum Partners for a market survey in 2019. Based on qualitative interviews with physicians (n = 20) conducted by Destum Partners, dermatologists are unsatisfied with current topical and oral treatment options for inflammatory acne. Destum Partners further conducted payor interviews (n = 5) reflecting coverage over a total of 103 million commercial lives. Based on the product profile of VB-1953 as “A topical treatment for acne patients”, demonstrating a 55% (base case) reduction in inflammatory lesions and an investigator global assessment (IGA) success rate of 25%” (base case), payers would recommend reimbursement of VB 1953, suggesting a Wholesale Acquisition Cost (WAC) price of $300 – 350 per Rx to ensure optimized coverage, projecting a peak US revenue of approximately $400 million according to a report prepared by Destrum Partners, Inc. for the Company in January 2020.

Molecular Replacement Therapeutics (“MRT”):

This is our legacy platform technology (MRT™) for treating fungal diseases that has been licensed by Sun Pharma. We developed an innovative platform, where certain pegylated fatty acids are internalized by disease-causing fungus. These pegylated fatty acids are integrated into the fungal cell membrane, leading to instability of the cell membrane and fungal cell death (See Figure 17). The combination of the MRT platform with conventional antifungal agents was shown to overcome fungal resistance against the conventional agents. Sun Pharma has already commercialized one product with the MRT technology. We anticipate expansion of the partnership to other products.

Figure 17. Treatment with PGMC (MRT) disrupts fungal membrane, resulting in clearance of fungal infection

We have partnered with Sun Pharma for the exclusive marketing in India of our dandruff treatment shampoo and lotion, both based on MRT technology. This license was terminated in December 2024.

Additionally, we have licensed our MRT technology-based Luliconazole cream to Sun Pharma for exclusive manufacturing and marketing in India.

Intellectual Property

Overview

In order to remain competitive, we must develop and maintain protection of the proprietary aspects of our technologies. We strive to protect the proprietary technologies that we believe are important to our business, including seeking and maintaining patent protection in the United States and internationally for our current and future product candidates. We also rely on trademarks, copyrights, trade secrets, confidentiality procedures, employee disclosure, invention assignment agreements, know-how, continuing technological innovation and in- licensing opportunities to develop and maintain its proprietary position.

We seek to obtain domestic and international patent protection, and endeavor to promptly file patent applications for new commercially valuable inventions. We also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

We plan to continue to expand our intellectual property estate by filing patent applications directed to platform technologies and improvements thereof, pharmaceutical compositions, methods of treatment, methods of manufacture or identified from its ongoing development of our product candidates. Our success will depend on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to our business, defend and enforce any patents that we may obtain, preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and proprietary rights of third parties.

The patent positions of companies like us are generally uncertain and involve complex legal, scientific and factual questions. In addition, the coverage claimed in a patent may be challenged in courts after issuance. Moreover, many jurisdictions permit third parties to challenge issued patents in administrative proceedings, which may result in further narrowing or even cancellation of patent claims. We cannot guarantee that our pending patent applications, or any patent applications that we may in the future file or license from third parties, will result in the issuance of patents. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or at all, whether the claims of any patent applications, should they issue, will cover our product candidates, or whether the claims of any issued patents will provide sufficient protection from competitors or otherwise provide any competitive advantage. We cannot predict the scope of claims that may be allowed or enforced in its patents. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Consequently, we may not obtain or maintain adequate patent protection for any of our product candidates. Also, due to cost rationalization of patent related expenses and due to lack of financial resources, certain patent applications or patents may get abandoned from time to time.

Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for 18 months or potentially even longer, and because publication of discoveries in the scientific or patent literature often lags behind actual discoveries and patent application filings, we cannot be certain of the priority of inventions covered by pending patent applications. Accordingly, we may not have been the first to invent the subject matter disclosed in some of our patent applications or the first to file patent applications covering such subject matter, and we may have to participate in interference proceedings or derivation proceedings declared by the USPTO to determine priority of invention. For more information regarding the risks related to our intellectual property, see “Risk Factors — Risks Related to Our Intellectual Property.”

Patent Portfolio

We have taken an aggressive approach to file and build a patent portfolio around our technology. We have granted patents and filed patent applications around our VB-1953 product and its use in antibiotic-resistant acne and inflammatory acne conditions. We have also filed patents around VT-1953 for use in treating malodor in MFW and VT-1908 product for use in the treatment of uveitis. We also have patents in the U.S, Japan, India, and South Korea around our MRT technology.

VT 1953: A method of treating Malignant fungating wound using Besifloxacin.
Country	Patent Application Number/ Granted Patent Number	Current Status	Expiry Period	Type of Protection
PCT	Patent Application Number: PCT/US25/33442	National phase application filling due by December 2026.	June 2044	Formulation and use

VT 1908: Formulations and Method for Treatment of Inflammatory Diseases.
Country	Patent Application Number/ Granted Patent Number	Current Status	Expiry Period	Type of Protection
China	Patent Application Number: 202080096982.2	Application under examination	December 2039	Formulation and use
USA	Patent Application Number: 17/787,303	Application under examination	December 2039	Formulation and use

MRT Technology based products
Country	Patent Application Number/ Granted Patent Number	Current Status	Expiry Period	Type of Protection
India	Granted Patent Number: 381425	Granted Patent	December 2031	Formulation and use
Japan	Granted Patent Number: JP6339940B2	Granted Patent	December 2031	Formulation and use
South Korea	Granted Patent Number: KR102009698B1	Granted Patent	December 2031	Formulation and use
USA	Granted Patent Number: US10232047B2	Granted Patent	December 2031	Formulation and use

VB 1953: Treatment of Resistant Acne
Country	Patent Application Number/ Granted Patent Number	Current Status	Expiry Period	Type of Protection
China	Granted Patent Number: 201580016977.5	Granted Patent	January 2034	Formulation and use
China	Patent Application Number: 202110758695.X	Divisional application - Under Examination	January 2034	Formulation and use
Eurasia	Patent Application Number: 201691534	Application under examination	January 2034	Formulation and use
Europe	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
Great Britain	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
France	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
Germany	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
Italy	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
Spain	Granted Patent Number: EP3099301B1	Granted Patent	January 2034	Formulation and use
Hong Kong	Patent Application Number: 42022051670.2	Application under examination	January 2034	Formulation and use
India	Granted Patent Number: 539669	Granted Patent	January 2034	Formulation and use
Mexico	Granted Patent Number: 394441	Granted Patent	January 2034	Formulation and use
New Zealand	Granted Patent Number: 761261	Granted Patent	January 2034	Formulation and use
South Africa	Granted Patent Number: 2016/05946	Granted Patent	January 2034	Formulation and use
USA	Granted Patent Number: US10071103B2	Granted Patent	January 2034	Formulation and use
USA	Granted Patent Number: US11045479B2	Granted Patent	January 2034	Formulation and use

Miscellaneous Patent Applications
Country	Patent Application Number/ Granted Patent Number	Current Status	Expiry Period	Type of Protection
Japan	Granted Patent Number: JP6336902B2	Granted Patent	December 2033	Composition of matter, Formulation and use
USA	Granted Patent Number: US9907812B2	Granted Patent	December 2033	Composition of matter, Formulation and use
Hong Kong	Patent Application Number: 16108710.4	Application under examination	July 2036	Formulation and use
India	Patent Application Number: 6759/CHENP/2015	Application under examination	July 2036	Formulation and use
China	Patent Application Number: 201680054112.2	Application under examination	February 2038	Composition of matter, Formulation and use
India	Granted Patent Number: 466679	Granted Patent	February 2038	Composition of matter, Formulation and use
South Korea	Granted Patent Number: 10-2123365	Granted Patent	February 2038	Composition of matter, Formulation and use
USA	Granted Patent Number: US10570152B2	Granted Patent	February 2038	Composition of matter, Formulation and use

We intend to maintain, deepen, extend and protect our global IP portfolio. We may seek to form strategic alliances, enter into licensing agreement, or collaborate with third parties to strengthen and aid our research and development and IP portfolio. We are also actively engaged in evaluating additional assets and complementary technologies for in-licensing and may execute additional transactions to add to our pipeline. We believe our leadership has a proven track record for identifying and transacting upon de-risked clinical stage assets.

Trade Secrets

In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We typically rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We protect trade secrets and know-how by establishing confidentiality agreements and invention assignment agreements with its employees, consultants, scientific advisors, contractors, and collaborators. These agreements provide that all confidential information developed or made known during the course of an individual or entities’ relationship with us must be kept confidential during and after the relationship. These agreements also provide that all inventions resulting from work performed for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable, shall be our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of its proprietary information by third parties.

Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technologies. Thus, we may not be able to meaningfully protect its trade secrets. For more information regarding the risks related to our intellectual property, see “Risk Factors — Risks Related to Our Intellectual Property.”

Business Development Initiatives

We intend to explore partnerships for licensing or co-developing VB-1953 in the US and other markets worldwide. Additionally, we plan to evaluate and explore in-licensing novel and innovative products that treat immune-inflammatory diseases from companies in the US, India and other countries. as part of our strategic portfolio expansion. We are also continuing to explore opportunities to expand partnerships for our MRT technology products in other countries.

Competition

The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on intellectual property. While we believe that our differentiated technologies and products, scientific expertise, and intellectual property position provide us with competitive advantages, we face potential competition from a variety of companies in these fields. There are several companies that develop treatments for wounds, uveitis, inflammatory acne, and other immune-inflammatory conditions using different technologies including Tarsier Pharma, Eli Lily, Eyepoint Pharmaceuticals, Bausch Health, Sun Pharma, and Almirall. Several additional companies utilize other technologies to develop competing products.

Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which we may obtain approval for our product candidates. This may include other types of therapies, such as small molecule, antibody, and/or protein therapies.

In addition, many of our current or potential competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, and approved products than we do today. Mergers and acquisitions in the pharmaceutical and biotechnology may result in even more resources being concentrated among a smaller number of its competitors. Many of these companies are publicly listed entities and have access to larger financial resources. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. We also compete with these companies in recruiting, hiring, and retaining qualified scientific and management talent, establishing clinical trial sites and patient registration for clinical trials, obtaining manufacturing slots at contract manufacturing organizations, and in acquiring technologies complementary to, or necessary for, its programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, and more effective, particularly if they represent cures, have fewer or less severe side effects, are more convenient, or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our assets, which could result in our competitors establishing a strong market position before we can enter the market. We believe the key competitive factors affecting the success of all of our programs are likely to be their efficacy, safety, convenience, availability of reimbursement, access to capital, and human resources. As a result, we cannot assure that we will be able to compete effectively against these companies or their products.

Commercialization

We have entered into a Development and Licensing Agreement with Sun Pharma, under which we granted to Sun Pharma rights to our technology to develop Luliconazole based cream and lotion formulation, manufacture, and commercialize such products in India. In consideration thereof, Sun Pharma agreed to pay Vyome certain upfront fees and other milestone payments, including the payment of INR 5,000,000 (approximately $59,000), upon the successful completion of certain studies and INR 10,000,000 upon successful launch or first invoicing of the products by Sun Pharma (approximately $118,000). This milestone has already been achieved. Vyome is also entitled to a royalty of 5% of the net sales of each product (inclusive of taxes). The agreement also provides for a payment of INR 10,000,000 (approximately $118,000) upon a positive or satisfactory of the clinical trial study conducted on the product. Since the clinical trial study was not initiated and completed in defined timeline by Sun Pharma, the clinical trial was deemed to be completed with a positive outcome and a payment in the amount of INR 10,000,000 (approximately $118,000) was received in April 2025. In addition, Vyome is entitled to additional sales-linked milestone payments as per the schedule given below:

(1)

Should Sun Pharma decide to launch the product after a positive outcome from the clinical trial then Vyome shall be entitled to sales linked milestone payments in the manner set out below:

(a)

INR 10,000,000 (approximately $118,000) (upon net sales of all products of INR 250,000,000 (approximately $2,965,000) in any consecutive 12 months or any 12 months in any consecutive 24 months whichever is earlier),

(b)

INR 15,000,000 (approximately $178,000) (upon net sales of all products of INR 500,000,000 (approximately $5,931,000) in any consecutive 12 months or any 12 months in any consecutive 24 months whichever is earlier),

(c)

INR 10,000,000 (approximately $118,000) (upon net sales of all products of INR 750,000,000 (approximately $8,896,000) in any consecutive 12 months or any 12 months in any consecutive 24 months whichever is earlier),

(d)

INR 10,000,000 (approximately $118,000) (for every INR 250,000,000 (approximately $2,956,000) incremental sales of all products together upon net sales of INR 1,000,000,000 (approximately $11,862,000) for any consecutive 12 months or any 12 months in any consecutive 24 months whichever is earlier),

The Development and Licensing Agreement is for an initial term of five years, after which the Agreement may be renewed for an additional five years upon mutual agreement of the parties. Each party has the right to terminate the agreement if the other party commits a material breach of such party’s obligations under the agreement upon 90 days’ written notice to cure such breach and if such breach remains uncured. In addition, Vyome has a right to terminate the agreement if Sun Pharma does not launch the products within the timeframe set forth in the agreement. In addition, either party may terminate due to breaches of the confidentiality obligation and the Company shall have a right to terminate upon infringement of the intellectual property rights by Sun Pharma after 45-days’ notice detailing and providing proof of the breach.

Should any of our other product candidates be approved for commercialization, we intend to develop a plan to commercialize them in the United States and other key markets, through internal infrastructure and/or external partnerships in a manner that will enable us to realize the full commercial value of our programs.

Given the company’s stage of development, we have not yet established a commercial organization or distribution capabilities in the USA and other key markets.

Our Manufacturers and Suppliers

To date, all of the materials and components for our products, as well as any related outside services, are procured from qualified suppliers and contract manufacturers in accordance with our proprietary specifications. Our key manufacturers and suppliers have experience working with our MRT technology-based products, VT-1953 and VB-1953 are GMP certified and are regularly audited by various regulatory agencies in India and by the FDA. Our key manufacturers and suppliers have a demonstrated record of compliance with regulatory requirements.

Given that we rely on third-party manufacturers and suppliers for the production of our products, our ability to increase production going forward will depend upon the experience, certification levels, and large-scale production capabilities of its suppliers and manufacturers. Qualified suppliers and contract manufacturers have been and will continue to be selected to supply products on a commercial scale according to our proprietary specifications. The FDA approval process may require us to name and obtain approval for the suppliers of underlying products of our assets.

We may not be able to quickly qualify and establish additional or replacement suppliers for the components of its products. Any new approvals of vendors required by the FDA or other regulatory agencies in other international markets for our products as a result of the need to qualify or obtain alternate vendors for any of our components would delay our ability to sell and market its products and could have a material adverse effect on our business.

We believe that our current manufacturing and supply arrangements can be scaled to support commercial sales and our planned clinical trials. To produce our products in the quantities we anticipate meeting future market demand, we will need our manufacturers and suppliers to increase, or scale up, manufacturing production and supply arrangements by a significant factor over the current level of production. There are technical challenges to scaling up manufacturing capacity and developing commercial-scale manufacturing facilities that may require the investment of substantial additional funds by our manufacturers and suppliers and hiring and retaining additional management and technical personnel who have the necessary experience. If our manufacturers or suppliers are unable to do so, we may not be able to meet the requirements to expand the launch of our products in the United States or launch our products internationally, or to meet future demand, if at all. We may also represent only a small portion of our suppliers’ or manufacturers’ business and if they become capacity-constrained, they may choose to allocate their available resources to other customers that represent a larger portion of their business. If we are unable to obtain a sufficient supply of its product, our revenue, business, and financial prospects will be adversely affected.

Governmental Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, clinical trial, testing manufacture, quality control, import, export, safety, efficacy, labeling, packaging, storage, distribution, recordkeeping, approval, distribution, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs. We, along with our vendors, CROs, clinical investigators, and CMOs will be required to navigate the various preclinical, clinical, manufacturing, and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of its product candidates. The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

Overview of U.S. Drugs Development Process

In the United States, the FDA regulates drug products under the Federal Food, Drug and Cosmetic Act (FD&C Act) and its implementing regulations. Drugs are also subject to other federal, state, and local statutes and regulations. If we fail to be compliant with these regulations, then we may be subject to warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties, or criminal prosecution.

Our product candidates must be approved for therapeutic indications by the FDA before they may be marketed in the United States. For drug product candidates regulated under the FD&C Act, the FDA must approve a New Drug Application or NDA. The process generally involves the following:

●

completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice, or GLP, requirements and applicable requirements for the humane use of laboratory animals or other applicable regulations;

●

completion of the manufacture, under cGMP conditions, of the drug substance and drug product that the sponsor intends to use in human clinical trials along with required analytical and stability testing;

●

submission to the FDA of an Investigational New Drug application, or IND, which must become effective before clinical trials may begin;

●

payment of user fees for FDA review of the NDA;

●

approval by an International Review Board or IRB or independent ethics committee at each clinical trial site before each trial may be initiated;

●

performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, Good Clinical Practice or GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

●

preparation and submission to the FDA of an NDA;

●

a determination by the FDA within 60 days of its receipt of an NDA to file the application for review;

●

satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug product’s identity, strength, quality and purity;

●

satisfactory completion of potential FDA audit of the preclinical study clinical trial sites that generated the data in support of the NDA; and

●

FDA review and approval of the NDA, including, where applicable, consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States.

Preclinical Studies and Clinical Trials for Drugs

Before testing any drug in humans, the product candidate must undergo rigorous preclinical testing.

Preclinical studies include laboratory evaluations of product chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GLP requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND.

An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical trials. The IND also includes the results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. Some long-term preclinical testing may continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and imposes a full or partial clinical hold. FDA must notify the sponsor of the grounds for the hold and any identified deficiencies must be resolved before the clinical trial can begin. Submission of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND. A clinical hold can also be imposed once a trial has already begun, thereby halting the trial until the deficiencies articulated by FDA are corrected.

The clinical stage of development involves the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, who generally are physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirements that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating effectiveness. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable compared to the anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. The FDA, the IRB, or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trials to public registries. Information about clinical trials, including results for clinical trials other than Phase 1 investigations, must be submitted within specific timeframes for publication on www.ClinicalTrials.gov, a clinical trials database maintained by the National Institutes of Health.

Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether or not a clinical trial may move forward at designated check points based on access that only the group maintains to available data from the trial and may recommend halting the clinical trial if it determines that the participants or patients are being exposed to an unacceptable health risk or other grounds, such as no demonstration of efficacy. Other reasons for suspension or termination may be made by us based on evolving business objectives and/or competitive climate.

A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, FDA will nevertheless accept the results of the study in support of an NDA if the study was well-designed and well-conducted in accordance with GCP requirements, including that the clinical trial was performed by a qualified investigator(s); the data are applicable to the U.S. population and U.S. medical practice; and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials to evaluate therapeutic indications to support NDAs for marketing approval are typically conducted in three sequential phases, which may overlap.

Phase 1 — Phase 1 clinical trials involve the initial introduction of the investigational product in a limited population of healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, excretion, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.

Phase 2 — Phase 2 clinical trials typically involve the administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the drug’s potential efficacy, to determine the optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. In certain cases, such as in oncology indications, as articulated in a 2012 article on approval of new agents after phase II trials in the American Society for Clinical Oncology Educational Book , “A confirmatory phase II trial, which need not be randomized if an active control is not available’ (as is our case as there are no approved drugs), can provide sufficient evidence to convince regulatory authorities to grant accelerated approval, and the process can be completed in three years or less.” Similarly, Macaulay, R. in the article entitled ‘EMA Approval of Drugs on the Basis of Pivotal Non-Comparative Phase II Trial Data. Value in Health, Volume 16, Issue 7, A324’ wrote “in conclusion that Pivotal Phase II data can support EMA approval if it demonstrates substantial clinical benefits for small patient populations with severe diseases that lack therapeutic alternatives” (as is the case with MFW). In a recent example, Adaptimmune Therapeutics was reported to be making a submission to the FDA after 42% of patients with sarcoma responded to the company’s investigational therapy in a pivotal phase 2 trial (primary analysis includes 64 patients, and was an open-label study, dubbed IGNYTE-ESO). Hence, it is routine in malignant indications to file for approval and pre-phase 3 studies can serve as pivotal studies for such filings.

Phase 3 — Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy, and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and physician labeling. Generally, two adequate and well-controlled Phase 3 trials are required by the FDA for approval of an NDA.

Post-approval trials, sometimes referred to as Phase 4 clinical trials or post-marketing studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of NDA approval.

Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA. Written IND safety reports must be submitted to the FDA and the investigators fifteen days after the trial sponsor determines the information qualifies for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for human volunteers and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information. During the development of a new drug product, sponsors have the opportunity to meet with the FDA at certain points, including prior to submission of an IND, at the end of Phase 2 and before submission of an NDA. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice on the next phase of development.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing the drug product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity of the final drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

U.S. Review and Approval Process for Drugs

Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. An NDA is a request for approval to market a new drug for one or more specified indications and must contain proof of the drug’s safety and efficacy for the requested indications. The marketing application is required to include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational drug, to the satisfaction of the FDA. FDA must approve an NDA before a drug may be marketed in the United States.

The FDA reviews all submitted NDAs to ensure they are sufficiently complete to permit substantive review before it accepts them for filing and may request additional information rather than accepting the NDA for filing. The FDA must make a decision on accepting an NDA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA. The FDA reviews an NDA to determine, among other things, whether the product is safe and effective for the indications sought and whether the facility in which it is manufactured, processed, packaged or held meets standards, including cGMP requirements, designed to assure and preserve the product’s continued identity, strength, quality and purity. Under the goals and polices agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of a new molecular entity NDA and respond to the applicant, and six months from the filing date of a new molecular entity NDA for priority review. The FDA does not always meet its PDUFA goal dates for standard or priority NDAs, and the review process is often extended by FDA requests for additional information or clarification.

Further, under PDUFA, as amended, each NDA must be accompanied by a substantial user fee. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The FDA also may require submission of a Risk Evaluation and Mitigation Strategies or REMS if it believes that a REMS is necessary to ensure that the benefits of the drug outweigh its risks. A REMS can include use of risk evaluation and mitigation strategies like medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, special monitoring or other risk-minimization tools.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, which reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.

After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter. A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval. A Complete Response Letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response Letter without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the Complete Response Letter, the FDA may require additional clinical or preclinical testing or recommend other actions, such as requests for additional information or clarification, that the applicant might take in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.

Even if the FDA approves a product, depending on the specific risk(s) to be addressed it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a product’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is a disease or condition with either a patient population of fewer than 200,000 individuals in the United States, or a patient population of 200,000 or more individuals in the United States when there is no reasonable expectation that the cost of developing and making the product available in the United States for the disease or condition will be recovered from sales of the product. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, though companies developing orphan products are eligible for certain incentives, including tax credits for qualified clinical testing and user-fee waivers.

If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to a seven-year period of marketing exclusivity during which the FDA may not approve any other applications to market the same therapeutic agent for the same indication, except in limited circumstances, such as a subsequent product’s showing of clinical superiority over the product with orphan exclusivity or where the original applicant cannot produce sufficient quantities of product. Competitors, however, may receive approval of different therapeutic agents for the indication for which the orphan product has exclusivity or obtain approval for the same therapeutic agent for a different indication than that for which the orphan product has exclusivity. Orphan product exclusivity could block the approval of one of our products for seven years if a competitor obtains approval for the same therapeutic agent for the same indication before we do, unless we are able to demonstrate that our product is clinically superior. If an orphan-designated product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan exclusivity. Further, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or the manufacturer of the approved product is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

The FDA may further reevaluate its regulations and policies under the Orphan Drug Act. It is unclear as to how, if at all, the FDA may change the orphan drug regulations and policies in the future.

Expedited Development and Review Programs for Drugs

The FDA maintains several programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening diseases or conditions. These programs include Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval, and the purpose of these programs is to either expedite the development or review of important new drugs to get them to patients more quickly than standard FDA review timelines typically permit.

A new drug is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such disease or condition. Fast track designation applies to the combination of the product candidate and the specific indication for which it is being studied. Fast Track designation provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed. Rolling review means that the FDA may review portions of the marketing application before the sponsor submits the complete application.

In addition, a new drug may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug, alone or in combination with one or more other drugs, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation provides all the features of Fast Track designation in addition to intensive guidance on an efficient product development program beginning as early as Phase 1, and FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.

Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for additional FDA programs intended to expedite the review and approval process, including Priority Review designation and Accelerated Approval. A product is eligible for Priority Review, once an NDA is submitted, if the product that is the subject of the marketing application has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition. Under priority review, the FDA’s goal date to take action on the marketing application is six months compared to ten months for a standard review.

Products are eligible for Accelerated Approval if they can be shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, which is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. Accelerated Approval is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, adequate and well-controlled additional post-approval confirmatory studies to verify and describe the product’s clinical benefit, and under the Food and Drug Omnibus Reform Act of 2022, or FDORA, the FDA may require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Further, under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a product or an indication approved under Accelerated Approval if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products being considered for Accelerated Approval, the FDA generally requires, unless otherwise informed by the agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval review period. After the 120-day period has passed, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval do not change the scientific or medical standards for approval or the quality of evidence necessary to support approval, though they may expedite the development or review process.

U.S. Post-Approval Requirements for Drugs

Drugs manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities.

Although physicians may prescribe approved products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, including not only by company employees but also by agents of the company or those speaking on the company’s behalf, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including investigation by federal and state authorities. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Promotional materials for approved drugs must be submitted to the FDA in conjunction with their first use or first publication. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the development of additional data or preclinical studies and clinical trials.

The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example, the FDA may require post- market testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. In addition, manufacturers and their subcontractors involved in the manufacture and distribution of approved drugs and those supplying products, ingredients and components of them, are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements on sponsors and their CMOs. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that a sponsor may use. Additionally, manufacturers and other parties involved in the drug supply chain for prescription drugs must also comply with product tracking and tracing requirements and for notifying FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Accordingly, manufacturers must continue to expend time money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance. Failure to comply with statutory and regulatory requirements may subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual program user fee for any marketed product.

The FDA may withdraw approval of a product if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things:

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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

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the issuance of safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product;

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fines, warning letters or holds on post-approval clinical trials;

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refusal of the FDA to approve applications or supplements to approved applications, or suspension or revocation of product approvals;

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product seizure or detention, or refusal to permit the import or export of products;

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injunctions or the imposition of civil or criminal penalties;

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consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; and

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mandated modification of promotional materials and labeling and issuance of corrective information.

Privacy and Cybersecurity

Our operations entail the collection, use, disclosure, transfer, and processing of sensitive and personal information. These operations now and in the future are subject to multiple jurisdictions’ privacy and data security laws and regulations, including those within the U.S., the EEA, and the UK. Our operations extend to commercial partnerships and third-party processors, each of which may be governed by their distinct privacy regulations and data security laws. These laws are constantly evolving and subject to varying interpretations, requiring us to periodically update its policies and measures to maintain compliance.

The GDPR in the EU and the UK, which have been incorporated into their respective laws, impose stringent requirements on the processing of health and other sensitive data. These requirements encompass: (i) providing information to individuals regarding data processing activities; (ii) obtaining consent from individuals to whom the data processing relates; (iii) responding to data subject requests; (iv) imposing requirements to notify the competent national data protection authorities and data subjects of personal data breaches; (v) implementing safeguards in connection with the security and confidentiality of the personal data; (vi) accountability requirements; and (vii) taking certain measures when engaging third-party processors. The GDPR is also the regulation that informs us obligations with respect to any clinical trials conducted in the EEA or UK. The GDPR’s definition of personal data includes coded data, and it requires changes to informed consent practices and detailed notices for clinical trial subjects and investigators. Failure to comply with the GDPR can result in significant practical, legal, and financial repercussions, including the destruction of improperly gathered or used personal data, substantial fines of up to €20 million (£17.5 million) or 4% of the company’s global annual turnover, mandatory audits, orders to cease or modify data use, and a private right of action enabling data subjects to seek damages. In addition, the GDPR provides that EU member states or the UK may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric, or health data.

Further, the UK has recently introduced a new Data Protection & Digital Information (No. 2) Bill. This development could reshape the UK’s data protection landscape, distancing it from the EU’s data protection regime. This lack of clarity on future UK laws and regulations and their interaction with those of the EU could add legal risk, uncertainty, complexity, and cost; and any resulting divergence in laws could increase our risk profile and necessitate further compliance measures.

To enable the transfer of personal data outside of the EU or the UK, adequate safeguards must be implemented in compliance with the GDPR. On June 4, 2021, the European Commission issued new forms of standard contractual clauses, or SCCs, for data transfers from controllers or processors in the EU (or otherwise subject to the GDPR) to controllers or processors established outside the EU (and not subject to the GDPR). As of December 27, 2022 the new SCCs replace the SCCs that were adopted previously under the EU Data Protection Directive. The UK is not subject to the European Commission’s new SCCs, and instead it has published the UK International Data Transfer Agreement, or IDTA, and the International Data Transfer Addendum to the new SCCs, or the Addendum, which enable transfers from the UK. For new transfers, the IDTA (or SCCs and Addendum) must be in place, and such measures must be in place for all existing transfers from the UK from March 21, 2024. Companies relying on SCCs or the IDTA to govern transfers of personal data to third countries will also need to assess whether the data importer can ensure sufficient guarantees for safeguarding the personal data under GDPR, including an analysis of the laws in the recipient’s country. When conducting restricted data transfers under the EU and UK GDPR, we will need to implement these new safeguards, and doing so will require significant effort and cost.

Failure to implement valid mechanisms for personal data transfers from Europe may result in increased exposure to regulatory actions, substantial fines and injunctions against processing personal data from Europe. Inability to export personal data may also: (i) restrict our activities outside Europe; (ii) limit the ability to collaborate with partners as well as other service providers, contractors and other companies outside of Europe; and/or (iii) require us to increase its processing capabilities within Europe at significant expense or otherwise cause it to change the geographical location or segregation of its relevant systems and operations — any or all of which could adversely affect its operations or financial results.

In the U.S., privacy and security of personal information are regulated by various federal and state laws, such as health information privacy laws, security breach notification laws, and consumer protection laws.

Compliance with these multifaceted privacy and data security laws can be time-consuming, and failure to comply with any of these regulations could lead to significant fines and penalties (potentially including criminal prosecution), adversely affecting our reputation, business, financial condition, and operational results. Changes in statutes, regulations, or interpretations of existing regulations could impose additional requirements on our operations, such as modifications to data processing arrangements, changes to privacy policies, recall or discontinuation of certain data processing methods, or additional recordkeeping requirements. These changes could adversely affect the operation of our business.

There is a further risk that we may not be able to adequately protect its information systems from cyberattacks. Such breaches could result in the disclosure of confidential, protected, or personal information, damage its reputation, and expose it to significant financial and legal exposure, including potential civil fines and penalties, litigation, and regulatory investigations or enforcement actions under laws such as HIPAA, the GDPR, and the CCPA.

In addition to the risks outlined above, the legal or regulatory actions may also divert our management from their primary operations. Prohibitions, restrictions, or allegations of violations of these laws could materially and adversely affect our business. Hence, ensuring consistent compliance with privacy and data security laws and regulations remains a critical operational imperative for us.

Other Regulatory Matters

Manufacturing, labeling, packaging, distribution, sales, promotion, and other activities of product candidates following product approval, where applicable, or commercialization are also potentially subject to federal and state consumer protection and unfair competition laws, among other requirements to which we may be subject. Additionally, the activities associated with the commercialization of product candidates are subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, which may include the CMS, other divisions of the U.S. Department of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.

The distribution of pharmaceutical drugs is subject to additional requirements and regulations, including extensive recordkeeping, licensing, storage and security requirements intended to prevent the unauthorized sale of such pharmaceutical products.

The failure to comply with any of these laws or regulatory requirements may subject firms to legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, relabeling or repackaging, or refusal to allow a firm to enter into supply contracts, including government contracts. Any claim or action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert its management’s attention from the operation of our business. Prohibitions or restrictions on marketing, sales or withdrawal of future products marketed by us could materially affect our business in an adverse way.

Changes in statutes, regulations, or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling or packaging; (iii) the recall or discontinuation of our products; or additional recordkeeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.

Regulation Outside of the United States

In addition to regulations in the United States, we subject to a variety of regulations in other jurisdictions governing clinical studies, commercial sales, and distribution of our products. Most countries outside of the United States require that clinical trial applications be submitted to and approved by the local regulatory authority for each clinical study. In the EU, for example, an application must be submitted to the national competent authority and an independent ethics committee in each country in which we intend to conduct clinical trials, much like the FDA and IRB, respectively. Under the new CTR (EU) No 536/2014, which replaced the Clinical Trials Directive 2001/20/EC on January 31, 2022, a single application is now made through the Clinical Trials Information System, or CTIS, for clinical trial authorization in up to 30 EU/ EEA countries at the same time and with a single set of documentation. A similar process is followed in other countries like India, China and Japan etc.

Insurance Coverage

In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Our ability to successfully commercialize its product candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations.

Additionally, the process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which products they will pay for and establish reimbursement levels. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a particular indication. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

No Uniform Policy Exists for Coverage and Reimbursement in the U.S.

There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, the principal decisions about reimbursement for new medicines are typically made by the CMS, an agency within the U.S. Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree.

Further, during the COVID-19 pandemic, millions of individuals lost employer-based insurance coverage. It is unclear what effect, if any, the American Rescue Plan will have on the number of covered individuals, which may adversely affect our ability to commercialize its products. A similar situation may happen due to any other pandemic in future.

Other Healthcare Laws

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business that may constrain the financial arrangements and relationships through which we research, as well as sell, market and distribute any products for which we obtain marketing authorization. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, and transparency laws and regulations related to drug pricing and payments and other transfers of value made to physicians and other healthcare providers. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and responsible individuals may be subject to imprisonment.

Affordable Care Act and Legislative Reform Measures

Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies such as those we are developing. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell its products profitably. In particular, in 2010, the ACA was enacted, which, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; created a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of- sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s comparative effectiveness research.

Since its enactment, there have been numerous judicial, administrative, and executive, challenges to certain aspects of the ACA. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, the American Rescue Plan Act of 2021 eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. Further, the Budget Control Act of 2011 and subsequent legislation, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of 2% per fiscal year, which remain in effect through 2031. Medicare payments to providers will be further reduced starting in 2025 absent further legislation. The U.S. American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Further, on May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

The Inflation Reduction Act of 2022, or IRA, includes several provisions that may impact our B business to varying degrees, including provisions that reduce the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025; impose new manufacturer financial liability on certain drugs under Medicare Part D; allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs without generic competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption. Further, judicial challenges to the IRA may have an impact on the implementation of the IRA’s provisions; and the overall effects of the IRA on Bio’s business and the healthcare industry in general is not yet known.

These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

Other U.S. and India Environmental, Health and Safety Laws and Regulations

We may be subject to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

We maintain workers’ compensation insurance for employees in India to cover costs and expenses we may incur due to injuries to its employees as well as insurance for environmental liability, but this insurance may not provide adequate coverage against potential liabilities

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

Employees

As of December 31, 2025, we had 18 employees/retainers, of which 9 were full-time and 9 were part-time. All of these employees are located in the U.S and India.

Legal Proceedings

We are not currently a party to any material litigation, and we are not aware of any pending or threatened litigation against it that could have a material adverse effect on its business, operating results, or financial condition. The industry in which we operate is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various legal proceedings from time to time.

Corporate Information

We were originally incorporated in the state of Delaware in August 2017. On August 14, 2025, we completed a merger with ReShape Lifesciences Inc. Our principal executive offices are located at Harvard Square, One Mifflin Place, Suite 400, Cambridge, MA 02138. Our telephone number is (973) 832-8147. Our website address is www.vyometx.com. The information on, or that may be accessed through, our website is not incorporated by reference into this Annual Report on Form 10-K and should not be considered a part of this Annual Report on Form 10-K.

Our common stock is quoted on the Nasdaq under the symbol “HIND”. We file annual, quarterly, and current reports, proxy statements and other information with the U.S. Securities Exchange Commission (the “SEC”) and are subject to the requirements of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”). These filings are available to the public on the Internet at the SEC’s website at http://www.sec.gov.

ITEM 1A. RISK FACTORS

Summary of risk Factors

The following is a summary of the principal risks and uncertainties that could materially adversely affect our business, results of operations, financial condition, cash flows, prospects and/or the price of our outstanding securities and make an investment in our securities speculative or risky. You should read this summary together with the more detailed description of each risk factor contained below.

Risks Related to ~~our~~Our ~~Business~~Limited Operating History, Financial Condition and ~~Industry~~Capital Requirements

● IfWe wehave ~~are~~a ~~unable~~limited ~~to either substantially improve our~~ operating ~~results~~history orand ~~obtain~~have ~~additional~~not ~~financing,~~taken wea ~~may~~product bethrough ~~unable~~ to ~~continue as a going concern~~commercialization.

● IfWe have incurred losses since inception, and we expect to incur significant losses for the ~~warrants~~foreseeable ~~issued~~future inand ~~our~~may ~~February~~not ~~2025~~be ~~offering~~able ~~are~~to ~~exercised~~achieve byor ~~way~~sustain ofprofitability ain ~~“zero~~the ~~exercise~~future. ~~price”~~We ~~alternative,~~have ~~especially~~not ~~after~~generated any revenue from the ~~reset~~Vyome ~~date~~Assets ~~stockholders~~and may ~~suffer~~never ~~substantial~~generate ~~dilution~~revenue or become profitable.

● WeOur ~~have~~ability ~~recently~~to ~~undertaken~~use anet ~~cost~~operating ~~reduction~~losses ~~plan~~(“NOL”) ~~and~~carryforwards ~~reorganization, and~~ may ~~do so again in the future. The assumptions underlying these activities may prove to~~ be ~~inaccurate, or we may fail to achieve the expected benefits therefrom~~limited.

● WeAdverse ~~may~~developments beaffecting ~~unable~~the tofinancial ~~attract~~services industry could adversely affect our current and ~~retain~~projected ~~management~~business operations and ~~other~~our ~~personnel~~financial wecondition ~~need~~and toresults ~~succeed~~of operations.

● We cannot assure you that we will ever generate substantial revenue or be profitable.

●

Previously, we recorded a non-cash indefinite-lived intangible and definite-lived assets impairment loss, which significantly impacted our results of operations, and we may be exposed to additional impairment losses that could be material.

~~Risks~~● ~~Related~~If we are unable to ~~the~~raise ~~Pending~~capital ~~Merger~~when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.

● ~~Fluctuations~~Due into the ~~market~~significant ~~price~~resources required for the development of ~~our~~VT-1953 ~~common~~and ~~stock~~VT-1908, ~~will~~we ~~affect~~must prioritize the ~~value~~pursuit of ~~the~~treatments ~~Merger~~for ~~Consideration~~certain indications. We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.

● ~~The~~We ~~Exchange~~may ~~Ratio~~ in the ~~Merger~~future ~~Agreement~~license isadditional ~~subject to adjustment based on ReShape’s net cash as of a determination date prior to completion of the Merger~~assets, which ~~could~~may ~~dilute~~require ~~further~~us ~~the~~to ~~ownership~~expend ofadditional ~~either~~resources ~~the~~and ~~ReShape~~raise oradditional ~~Vyome stockholders in the combined company~~capital.

● ~~The~~We ~~ownership~~may ~~percentages~~not ofrealize ~~the~~all ~~ReShape and Vyome stockholders, respectively, that will result from the Exchange Ratio in the Merger Agreement are calculated prior to the completion~~ of the ~~Concurrent~~anticipated ~~Financing,~~benefits ~~which could dilute further the ownership~~ of the ~~ReShape stockholders in the combined company~~Merger.

● ~~The~~We ~~Merger~~have ~~may~~incurred ~~not~~substantial bedirect ~~consummated~~and ~~unless~~indirect ~~important~~costs ~~conditions~~as ~~are~~a ~~satisfied~~result orof ~~waived~~the Merger and ~~there~~expect ~~can~~to beincur nosubstantial ~~assurance~~direct ~~that~~and ~~the~~indirect ~~Merger~~costs ~~will~~following bethe ~~consummated~~Merger.

● ~~Although~~If anthe ~~application~~perceived ~~has~~benefits ~~been~~of ~~filed to list~~ the ~~ReShape~~Merger ~~Shares~~do onnot ~~The~~meet ~~Nasdaq Capital Market, there can be no assurance that~~ the ~~common~~expectations ~~stock~~of ~~will~~investors ~~be so listed~~ or, ifsecurities ~~listed~~analysts, ~~that~~ the ~~Combined~~market ~~Company~~price ~~will~~of beour ~~able~~securities tomay ~~comply with the continued listing standards~~decline.

● Our operating results may fluctuate significantly.

~~Risks~~● ~~Related~~If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the ~~Business~~expectations of ~~the~~securities ~~Combined~~analysts ~~Company~~and ~~After~~investors, resulting in a decline in the ~~Merger~~market price of its common stock.

● ~~Combining~~Certain ~~the~~of ~~two~~our ~~companies~~directors ~~may~~and beexecutive ~~more~~officers ~~difficult,~~also ~~costly~~work orwith ~~time~~other ~~consuming~~companies ~~than~~and ~~expected,~~organizations and ~~the~~such ~~Combined~~other ~~Company~~positions may ~~not~~create ~~realize~~conflicts ~~all~~ of ~~the~~interest ~~anticipated~~in ~~benefits of~~ the ~~Merger~~future.

~~● ReShape and Vyome will incur substantial direct and indirect costs as a result of the Merger and the Combined Company will incur substantial direct and indirect costs following the Merger.~~54

●Risks ~~Both~~Related ~~ReShape and Vyome have operated with a loss and negative cash flows for the entirety of their existence and it is expected the Combined Company will have~~ to ~~raise~~Our ~~significant~~Product ~~capital in the future that could be dilutive to stockholders of the Combined Company.~~Development

● IfWe ~~the~~have ~~perceived~~never ~~benefits~~successfully ofcompleted the ~~Merger~~regulatory doapproval ~~not~~process ~~meet~~for the ~~expectations~~Vyome ~~of investors or securities analysts~~Assets, ~~the~~and ~~market~~we ~~price~~may ofbe ~~ReShape’s~~unable ~~securities~~to ~~or,~~do ~~following~~so ~~the~~for ~~Merger,~~any ~~Vyome~~product ~~Holdings,~~candidates ~~Inc.~~we ~~securities,~~acquire ~~may~~or ~~decline~~develop.

26● We are substantially dependent on the success of VT-1953 and VT-1908, and our anticipated clinical trials of VT-1953 and VT-1908 may not be successful.

~~Table~~● We may find it difficult to enroll patients in our clinical trials for Vyome Assets. If we experience delays or difficulties in the enrollment of ~~Contents~~patients in clinical trials, our successful completion of clinical trials or receipt of marketing approvals could be delayed or prevented.

~~Risks~~● ~~Related~~The toresults of preclinical testing and early clinical trials of the Vyome Assets may not be predictive of the success of our ~~Asset~~later ~~Sale~~clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, or other comparable foreign regulatory authorities.

● ~~While~~Preclinical ~~the~~and ~~ReShape~~clinical ~~Asset~~development ~~Sale~~involves isa ~~pending,~~lengthy itand ~~creates~~expensive ~~unknown~~process ~~impacts~~with onuncertain ~~ReShape’s~~outcomes, ~~future~~and ~~which~~results ~~could~~of ~~materially~~earlier studies and ~~adversely~~trials ~~affect~~may ~~its~~not ~~business,~~be ~~financial~~predictive ~~condition~~of ~~and~~future ~~results~~clinical oftrial ~~operations~~results.

● ~~The~~Preliminary, ~~failure~~interim todata ~~consummate~~from ~~the~~our ~~ReShape~~clinical ~~Asset~~trials ~~Sale~~that ~~may~~we ~~materially~~announce ~~and~~or ~~adversely~~publish ~~affect~~may ~~ReShape’s~~change ~~business,~~as ~~financial~~more ~~condition~~patient data become available and ~~results~~are ofsubject ~~operations~~to audit and verification procedures.

● ~~The~~We ~~Merger~~ may bedevelop ~~consummated~~the ~~despite~~Vyome ~~the~~Assets ~~ReShape~~in ~~Asset~~combination ~~Sale~~with ~~not~~other ~~closing~~therapies, ~~under~~which ~~certain~~exposes ~~circumstances~~us to additional risks related to other agents or active pharmaceutical or biological ingredients used in combination with the Vyome Assets.

● ~~The~~If ~~completion~~the FDA or other regulatory authorities revoke their approval of ~~the~~these ~~Asset~~other ~~Sale~~drugs isor ~~contingent~~revoke ~~upon~~their ~~completion~~approval of, or if safety, efficacy, manufacturing or supply issues arise with, the ~~Merger~~drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.

● VT-1953 and VT-1908 may have a safety profile that could prevent regulatory approval, marketing approval or market acceptance, or limit its commercial potential.

~~Risks~~● ~~Associated~~We ~~with~~face ~~Development~~the ~~and~~risk ~~Commercialization~~ of ~~ReShape~~product liability claims that could be expensive, divert management’s ~~Lap-Band~~attention ~~System,~~and ~~Lap-Band~~harm 2our reputation and business.0 ~~System,~~We ~~Obalon~~may ~~Balloon~~not ~~System,~~be ~~and~~able ~~the~~to ~~DBSN~~obtain ~~Device~~adequate product liability insurance.

●Risks ~~Our~~Related ~~efforts~~ to ~~increase~~Our ~~revenue~~Commercial from our Lap-Band System, Lap-Band 2.0 System, Obalon Balloon System, and commercialize our DBSN device and expanded line of bariatric surgical accessories, including ReShape Calibration Tubes, may not succeed or may encounter delays which could significantly harm our ability to generate revenue.Operations

● We ~~may~~face ~~not~~substantial becompetition, ~~able~~which tomay ~~obtain~~result ~~required~~in ~~regulatory~~others ~~approvals~~discovering, ~~for~~developing, ~~our~~licensing ~~DBSN~~or ~~device~~commercializing inproducts abefore ~~cost-effective manner~~ or atmore ~~all,~~successfully ~~which~~than ~~could~~we ~~adversely affect our business and operating results~~do.

● We ~~depend~~have onundertaken ~~clinical~~a ~~investigators~~cost ~~and~~reduction ~~clinical~~plan ~~sites~~and ~~to enroll patients in our clinical trials~~reorganization, and onmay ~~other~~do ~~third~~so ~~parties~~again toin ~~manage~~ the ~~trials~~future. ~~and~~The toassumptions ~~perform~~underlying ~~related~~these ~~data~~activities ~~collection~~may ~~and~~prove ~~analysis,~~to ~~and,~~be ~~as a result~~inaccurate, or we may ~~face~~fail ~~costs~~to ~~and~~achieve ~~delays~~the ~~that~~expected ~~are~~benefits ~~outside of our control~~therefrom.

● Public health crises such as pandemics or similar outbreaks have affected and could continue to seriously and adversely affect our preclinical studies and anticipated clinical trials, business, financial condition and results of operations.

~~Risks~~● ~~Related~~Our tobusiness, ~~our~~operations, ~~Intellectual~~financial ~~Property~~position and clinical development plans and timelines could be materially adversely affected by the ongoing conflicts in various parts of the world.

● If we are unable to obtain or maintain intellectual property rights relating to our technology and neuroblocking therapy, the commercial value of our technology and any future products will be adversely affected and our competitive position will be harmed.55

●Risks WeRelated ~~may~~to ~~lose~~Our ~~important~~Business ~~patents~~and ~~or patent rights if we do not timely pay required patent fees or annuities.~~Operations

● ~~Many~~We ofare ~~our~~dependent ~~competitors~~on ~~have~~our ~~significant~~key ~~resources~~personnel and ~~incentives~~anticipate tohiring ~~apply~~new ~~for~~key ~~and~~personnel. ~~obtain~~If ~~intellectual~~we ~~property~~are ~~rights~~not ~~that~~successful ~~could~~in ~~limit~~attracting orand ~~prevent~~retaining ~~our~~qualified ~~ability~~personnel, toincluding ~~commercialize~~consultants, ~~our~~we ~~current~~may ornot ~~future~~be ~~products~~able into ~~the~~successfully ~~United~~implement ~~States~~our orbusiness ~~abroad~~strategy.

● We rely on third parties, including consultants, independent clinical investigators and CROs to conduct and sponsor some of the clinical trials of the Vyome Assets. Any failure by a third party to meet its obligations with respect to the clinical development of the Vyome Assets may delay or impair our ability to obtain regulatory approval for the Vyome Assets.

~~Risks~~● ~~Related~~In order to ~~Equity~~successfully ~~Line~~implement our plans and strategies, we will need to grow the size of ~~Credit~~our organization, and we may experience difficulties in managing this growth.

● ~~The~~Our ~~sale~~internal computer systems, or ~~issuance~~those of ~~our~~any ~~common~~of ~~stock~~our toCROs, ~~Ascent~~manufacturers, ~~under~~other ~~our~~contractors ~~proposed~~or ~~equity~~consultants ~~line~~or ofpotential ~~credit~~future ~~transaction~~collaborators, may ~~cause~~fail ~~dilution~~or ~~and~~suffer ~~the~~security ~~sale~~or ofdata ~~the~~privacy ~~shares~~breaches ofor ~~common~~other ~~stock~~unauthorized ~~acquired~~or byimproper ~~Ascent~~access to, use of, or ~~the~~destruction ~~perception~~of ~~that~~our ~~such~~proprietary ~~sales~~or ~~may~~confidential ~~occur~~data, employee data or personal data, which could ~~cause~~result ~~the~~in ~~price~~additional costs, loss of ~~our~~revenue, ~~common~~significant ~~stock~~liabilities, harm to ~~fall~~our brand and material disruption of our operations.

● ~~Ascent~~We ~~will~~generates ~~pay~~all ~~less~~of ~~than~~our ~~the~~revenues ~~then-prevailing~~from ~~market~~one ~~price~~customer, ~~for~~and ~~our~~loss ~~common~~of ~~stock,~~business ~~which~~from ~~could~~such ~~cause~~customer ~~the~~could ~~price~~significantly ofharm our ~~common~~revenues ~~stock~~and ~~to decline~~business.

● ItWe iscurrently ~~not~~rely, ~~possible~~and plan to ~~predict~~rely in the ~~actual~~future, ~~number~~on ofthird ~~shares~~parties weto ~~will~~conduct ~~sell~~and ~~under~~support ~~the~~our ~~Equity~~preclinical ~~Purchase~~studies ~~Agreement~~and toclinical ~~Ascent~~trials. If these third parties do not properly and successfully carry out their contractual duties or ~~the~~meet ~~actual~~expected ~~gross~~deadlines, ~~proceeds~~we ~~resulting~~may ~~from~~not ~~those~~be ~~sales~~able to obtain regulatory approval of or commercialize the Vyome Assets.

● ~~Our~~We ~~commitment~~intend to ~~issue~~rely ~~shares~~on ofthird ~~our~~parties ~~common~~to ~~stock~~produce ~~pursuant~~and process the Vyome Assets. There can be no assurance that we will successfully negotiate agreements with third-party manufacturers to produce the Vyome Assets on acceptable terms ofor ~~the~~at ~~Equity~~all; ~~Purchase~~and ~~Agreement~~furthermore, ~~could~~we ~~encourage~~may ~~short~~fail ~~sales~~to bysuccessfully ~~third~~transfer the manufacturing technology to these third-parties,. ~~which~~Our business could ~~contribute~~be adversely affected if the third-party manufacturers are unable to produce the ~~future~~Vyome ~~decline~~Assets, fail to provide us with sufficient quantities of ~~our~~the ~~stock~~Vyome ~~price~~Assets or fail to do so at acceptable quality levels or prices.

● We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.

27● The increasing use of social media platforms presents new risks and challenges.

~~Table~~● Our disclosure controls and procedures may not prevent or detect all errors or acts of ~~Contents~~fraud.

~~Risks~~● ~~Relating~~If we fail to ~~Ownership~~maintain an effective system of disclosure controls and internal control over financial reporting, our ~~Common~~ability ~~Stock~~to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in us and, as a result, the market price of our common stock.

●

We have identified material weaknesses in our internal control over financial reporting and any failure to maintain effective internal control over financial reporting, may have a material and adverse effect on our business, operating results, financial condition and prospects.

Risks Related to Our Intellectual Property

●

Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.

●

We enjoy only limited geographical protection with respect to our licensed patents and may not be able to protect our intellectual property rights throughout the world.

●

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.

●

Issued patents covering one or more of our drug candidates could be found invalid or unenforceable.

●

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

●

Patent terms may be inadequate to protect our competitive position with respect to the Vyome Assets for an adequate amount of time.

●

If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for the Vyome Assets, our business may be materially harmed.

●

Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect the Vyome Assets.

●

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market the Vyome Assets.

●

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

●

We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing the Vyome Assets.

●

We may not be able to effectively secure first-tier technologies when competing against other companies or investors.

●

Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.

●

If approved, the Vyome Assets that are regulated by FDA, EMA and other regulatory authorities may face competition from generics approved through an abbreviated regulatory pathway.

Risks Related to Government Regulations and Other Legal Compliance Matters

●

The regulatory approval processes of the FDA, EMA, and other comparable foreign regulatory authorities are complex, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for the Vyome Assets, we may not be able to commercialize, or may be delayed in commercializing, the Vyome Assets, and our ability to generate revenue will be materially impaired.

●

Of the large number of drugs in development, only a small percentage successfully complete the FDA, EMA, or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market the Vyome Assets, which would significantly harm our business, results of operations and prospects.

●

We will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with the Vyome Assets.

●

Due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer the Vyome Assets at competitive prices which would seriously harm our business.

●

The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

●

Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

●

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws in USA and India, which could expose us to penalties.

●

The size of the potential market for the Vyome Assets is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for the Vyome Assets may be smaller than our estimates.

●

Healthcare legislative reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business.

●

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act (“ACA”). It is unclear how other healthcare reform measures of the current administration or other efforts, if any, to amend or challenge the ACA, will impact our business.

●

We may be subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.

●

If we fail to comply with environmental, health and safety laws and regulations in the USA, India or where we may have operations in future, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

●

We are subject to laws and regulations related to privacy, data protection, information security and consumer protection across different markets where we conduct our business. Our actual or perceived failure to comply with such obligations could harm our business.

●

We do not have a compliance program in place consistent with Federal agencies’ guidance’s on corporate compliance programs.

●

Our business is subject to certain laws and regulations in the jurisdictions in which it operates, many of which are currently evolving, and the risk of unfavorable interpretations or failure to comply with such laws and regulations could harm our business, financial condition and results of operations.

●

Political changes in the Government of India could delay or affect the further liberalization of the Indian economy and materially and adversely affect economic conditions in India, generally, and our business, in particular.

●

Our Indian subsidiary may not be in compliance with laws applicable to it, and it may face penalties and fines imposed by the Indian government.

Risks Related to Ownership of Our Common Stock

●

The trading price of our common stock has been volatile and is likely to be volatile in the future.

● ~~Sales~~We ofdo anot ~~substantial~~expect ~~number~~to ofpay ~~shares~~cash ofdividends ~~our common stock~~ in the ~~public~~foreseeable ~~market~~future. byAny ~~existing~~return ~~stockholders,~~on orinvestment ~~the~~may ~~perception~~be ~~that~~limited ~~they~~to ~~may~~the ~~occur~~capital appreciation, ~~could~~if ~~cause~~any, ~~our~~of ~~stock~~shares ~~price~~of toour ~~decline~~common stock.

● WeFuture ~~have~~sales of a ~~significant~~substantial number of ~~outstanding~~shares ~~warrants,~~of ~~which may cause significant dilution to~~ our ~~stockholders,~~common ~~have~~stock amay ~~material~~cause ~~adverse impact on~~ the ~~market~~ price of our common stock ~~and make it more difficult for us~~ to ~~raise funds through future equity offerings~~decline.

● You may experience future dilution as a result of future equity offerings and exercise of put/call option under Option Agreements.

●

If we fail to meet all applicable Nasdaq Capital Market requirements, Nasdaq could delist our common stock, which could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.

●

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our shares, our share price and trading volume could decline.

●

Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to the Vyome Assets or its product candidates.

●

Our principal shareholders, directors and executive officers own a significant percentage of our capital shares, and also have significant influence over our management.

RISK FACTORS

An investment in our securities is speculative and involves a high degree of risk and uncertainty. You should carefully consider the risks described below, together with the other information contained in this Annual Report on Form 10-K, including the consolidated financial statements and notes thereto, before deciding to invest in our securities. The occurrence of any of the events described below could have a material adverse effect on our business, financial condition, results of operations, cash flows, prospects or the value of our common stock. These risks are not the only ones that we face. Additional risks not currently known to us or that we currently deem immaterial also may impair our business.

Risks Related to Our ~~Business~~Limited Operating History, Financial Condition and ~~Industry~~Capital Requirements

IfWe wehave ~~are~~a ~~unable~~limited ~~to either substantially improve our~~ operating ~~results~~history orand have ~~obtain~~not ~~additional~~taken ~~financing,~~a weproduct ~~may~~through ~~be unable~~ to ~~continue as a going concern~~commercialization.

We ~~currently~~are doa ~~not~~clinical-stage ~~generate~~company with ~~revenue~~limited ~~sufficient~~operating tohistory. ~~offset~~To ~~operating~~become ~~costs~~ and ~~anticipate~~remain ~~such~~cash ~~shortfalls~~flow topositive ~~continue~~and viable, ~~partially~~we ~~due~~must todevelop ~~the~~(alone ~~introduction~~or ofin ~~GLP-1~~partnership(s)) ~~pharmaceuticals.~~and Aseventually commercialize of(alone ~~December~~or ~~31,~~in ~~2024,~~partnership(s)) wea ~~had~~product ~~cash,~~or ~~cash~~products ~~equivalents~~with ~~and~~significant ~~restricted~~market ~~cash~~potential. ofThis ~~$0.8~~will ~~million~~require ~~and~~us ~~$1.0~~to ~~million~~be successful in a range of ~~accounts~~challenging ~~receivable.~~activities, ~~Based~~including onestablishing our ~~available~~business ~~cash~~model ~~resources~~and key third-party relationships, wecompleting dopreclinical studies ~~not~~and ~~have~~clinical ~~sufficient~~trials ~~cash~~of onour ~~hand~~product tocandidates, ~~fund~~obtaining ~~our~~marketing ~~current~~approval ~~operations~~for this product candidate, manufacturing, marketing and selling those products for ~~more~~which ~~than~~we 12(either ~~months~~alone ~~from~~or ~~the~~in ~~date~~partnership) ofmay ~~filing~~obtain ~~this~~marketing ~~Form~~approval, 10satisfying any post-K.marketing requirements ~~This~~and ~~condition~~otherwise ~~raises~~monetizing ~~substantial~~the ~~doubt~~product, ~~about~~for ~~our~~example ~~ability~~by toselling ~~continue~~or aslicensing athe ~~going~~asset ~~concern~~or the company.

IfOur ~~the~~products ~~warrants~~are ~~issued~~not approved for commercial sale except for two products in India for sale by the subsidiary. Since our ~~February~~inception, ~~2025~~we ~~offering~~have ~~are~~incurred ~~exercised~~significant byoperating losses ~~way~~and have utilized substantially all of aour resources to date planning development of our product candidates, VT-1953, VT-1908 and VB-1953, Molecular Replacement Therapeutics (“~~zero~~MRT”) technology ~~exercise~~based ~~price~~antifungal products and other assets under early stages of development (the “Vyome Assets”) ~~alternative~~and organizing and staffing our company and providing other general and administrative support for our initial operations. We have no significant experience as a company in initiating, ~~especially~~conducting or ~~after~~completing preclinical or clinical trials, including global late-stage clinical trials. As is widespread practice in the ~~reset~~life ~~date~~sciences industry, ~~stockholders~~we ~~may~~would ~~suffer~~be ~~substantial~~unlikely ~~dilution~~to physically conduct those trials ourselves, rather we would engage a third-party clinical trials organization. We cannot be certain that our planned preclinical and clinical trials will begin or be completed on time or at all. Furthermore, we cannot be certain whether our planned preclinical and clinical trials will be on budget or have significant cost overruns. We cannot predict whether the product will have the desired activity in the clinical trials or whether any side effects will be tolerable. In addition, we have not yet demonstrated an ability to obtain marketing approvals, manufacture a product to commercial scale or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to, or arrange for our third-party contractors to:

On● ~~February 15,~~timely ~~2025,~~file ~~we entered into the Securities Purchase Agreement pursuant to which we sold 2,575,107 units, with each unit consisting of one share of our common stock~~ and ~~one~~gain ~~warrant.~~acceptance Under Nasdaq listing rules, the warrants are not exercisable without stockholder approval (the “Warrant Stockholder Approval”). We have agreed to hold a stockholders’ meeting in order to seek such stockholder approvals as may be required by the applicable rules and regulations of ~~the~~investigational ~~Nasdaq~~new ~~Capital~~drug ~~Market~~applications ~~from~~for our ~~stockholders~~programs in order to ~~permit~~commence ~~the~~planned ~~exercise~~clinical oftrials ~~the~~or ~~Warrants.~~future Inclinical ~~the event that we are unable to obtain the Warrant Stockholder Approval, the Warrants will not be exercisable and therefore have no value.~~trials;

~~Assuming~~● ~~the~~successfully ~~Warrant~~enroll ~~Stockholder~~subjects ~~Approval is obtained~~in, a holder of warrants may elect a “zero exercise price” alternative pursuant to which they would receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise of the warrant and ~~(y) 1.2. Under the zero exercise price option under the warrants~~complete, aour ~~warrant~~planned ~~holder~~clinical could elect to receive 1.2 shares of common stock without the holder having to make any exercise payment. If the exercise price of the warrants is reset to the floor price of $1.25 per share, then based on the initial exercise price of $5.83 per share underlying the warrants, the number of shares of common stock underlying each warrant would be increased to 4.664 shares and, if a warrant holder then elected the zero exercise price option, they would receive 5.597 shares of common stock (equal to 1.2 times 4.664 shares). In that scenario, the maximum aggregate number of shares of common stock to be issued upon the zero exercise price alternative of the warrants would be approximately 14,412,359 shares for the warrants issued to the offering investors and 720,616 shares for the placement agent warrants. Therefore, we do not expect to receive any cash proceeds from the exercise of the warrants because it is highly unlikely that a warrant holder will elect to pay an exercise price in cash to receive one share of common stock when they could elect the zero exercise price option and pay no exercise price to receive 1.2 times the number of shares of common stock they would receive if they did pay an exercise price.trials;

28● successfully start and complete our planned preclinical and clinical studies for the VT-1953 and VT-1908 programs;

~~Table~~● initiate and successfully complete all safety and efficacy studies required to obtain U.S. and foreign regulatory approval for the Vyome Assets, and additional clinical trials or other studies beyond those planned to support the approval and commercialization of ~~Contents~~VT-1953, VB-1953 and VT-1908;

We● ~~have~~identify ~~recently undertaken a cost reduction plan and reorganization, and may do so again in~~ the ~~future.~~proper ~~The~~human ~~assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom.~~dose;

In light of recent macroeconomic conditions and the impact of GLP-1 prescriptions for weight loss treatment, we announced a 2024 cost reduction plan and reorganization to promote the long-term sustainability and scalability of ReShape. As part of this plan, we have significantly reduced our workforce. This reduction in force, and any other future reductions, and the attrition that may occur following them, result in the loss of institutional knowledge and expertise and the reallocation and combination of certain roles and responsibilities across the organization, all of which could adversely affect our operations. These actions and other additional measures we might take to reduce costs could strain our workforce, divert management attention, yield attrition beyond our intended reduction in force, reduce employee morale, cause us to delay, limit, reduce or eliminate certain development plans or otherwise interfere with our ability to operate and grow our business effectively, each of which could have an adverse impact on our business, operating results and financial condition. We may not complete the current or any cost reduction plan and reorganization on the anticipated timetable, and even if successfully completed, we may not achieve the anticipated cost savings, operating efficiencies or other benefits of such activities.59

We● ~~may~~successfully bemanage ~~unable~~the toprevalence, ~~attract~~duration and ~~retain~~severity ~~management~~of ~~and~~potential ~~other~~side ~~personnel~~effects weor ~~need~~other tosafety ~~succeed,~~issues ~~particularly~~experienced inwith ~~light of~~ the ~~2024~~Vyome ~~cost~~Assets, ~~reduction~~if ~~plan.~~any;

~~Our~~● ~~success~~obtain depends on the services of our senior management and other key employees. The loss of the services of one or more of our officers or key employees could hinder our sales and marketing efforts, or delay or prevent the commercialization of our Lap-Band System, Lap-Band 2.0, the Obalon Balloon System, and the development of our DBSN device. Our continued growth will require hiring a ~~number~~positive ofreadout qualified clinical, scientific, commercial and administrative personnel. Accordingly, recruiting and retaining such personnel in the future will be critical to our success. There is intense competition from ~~other companies and research and academic institutions for qualified personnel in~~ the ~~areas~~clinical oftrials ~~our~~regarding ~~activities.~~therapeutic If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our development and commercialization activities. In light of our 2024 cost reduction plan, we are unlikely to hire additional management or other personnel.activity;

We● ~~cannot~~obtain ~~assure~~data ~~you~~and ~~that~~review weany ~~will~~comments ~~ever~~to ~~generate~~our ~~substantial~~development ~~revenue~~plans orfor beVT-1953, ~~profitable.~~VB-1953 and VT-1908, which may delay our ability to perform diligence, development and commercialization;

~~The~~● ~~success~~successfully ofdemonstrate ~~our business will depend on our ability~~ to ~~generate~~the ~~increased~~satisfaction ~~sales and control costs, as well as our ability to obtain additional regulatory approvals needed to market new versions~~ of ~~our~~the ~~Lap- Band System~~FDA, ~~Obalon Balloon System~~EMA, or ~~regulatory~~similar ~~approvals~~foreign ~~needed~~regulatory toauthorities ~~market~~the ~~our~~safety ~~DBSN~~and ~~device~~efficacy and ~~any~~acceptable ~~other~~risk ~~products~~to webenefit ~~may~~profiles ~~develop in the future, all~~ of ~~which we may be unable to do. If we are unable to successfully market our Lap~~VT-~~Band System for its indicated use~~1953, ~~successfully re~~VB-~~introduce~~1953 ~~the Obalon Balloon System, or develop~~ and ~~commercialize the DBSN device, we may never become profitable and may have to cease operations as a result.~~VT-1908;

~~Previously,~~● weobtain ~~recorded~~the atimely ~~non-cash~~receipt ~~indefinite-lived~~of ~~intangible~~necessary ~~and~~marketing ~~definite-lived~~approvals ~~assets~~from ~~impairment~~the ~~loss~~FDA, ~~which~~EMA ~~significantly impacted our results of operations,~~ and wesimilar ~~may~~foreign beregulatory ~~exposed to additional impairment losses that could be material.~~authorities;

We● ~~conduct~~establish ~~our~~commercial ~~annual~~manufacturing ~~indefinite-lived~~capabilities ~~intangible assets impairment analysis during the fourth quarter of each year~~ or ~~when~~make ~~circumstances~~arrangements ~~suggest~~with ~~that an indicator for impairment may be present. Previously, we performed a qualitative impairment analysis of the in~~third-~~process~~party ~~research~~manufacturers ~~and development (“IPR&D”). Due to delays in the clinical trials experienced, we revised its expectations of when revenues would commence~~ for ~~the ReShape Vest, thus reducing the projected near-term future net cash flows related to the ReShape Vest. During the quarter ended September 30, 2022, we stopped the~~ clinical ~~trials~~supply ~~for the ReShape Vest~~ and ~~closed~~commercial ~~out~~manufacturing; ~~the~~● ~~previous~~launch ~~trials~~commercial ~~that~~sales occurred, as significant additional clinical work and cost would be required to achieve regulatory approval for the ReShape Vest. In addition, due to continued market decline and projected cash flows the company recorded an impairment of ~~the developed technology related to the Lap-Band and Obalon Balloon System and~~ our ~~tradenames. As such~~products, weif ~~determined the carrying value of the long-lived assets were fully impaired~~ and ~~recognized~~when ~~a non-cash impairment charge of approximately $0.8 million on the statement of operations for the year ended December 31~~approved, ~~2023.~~whether Inalone ~~the~~or ~~future,~~in wecollaboration ~~may~~with have additional impairments requiring us to record an impairment loss related to our remaining finite-lived intangible assets, which could also have a material adverse effect on our results of operations.others;

29● obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payors;

~~Table~~● ofposition ~~Contents~~our product to effectively compete with other therapies;

We● ~~incur~~obtain ~~significant~~and ~~costs~~maintain ashealthcare acoverage ~~result~~and ofadequate ~~operating~~reimbursement asfor ~~a public company, and~~ our ~~management is required to devote substantial time to compliance initiatives.~~product;

As● maintain a ~~public~~continued ~~company,~~acceptable wesafety ~~incur~~profile ~~significant legal, accounting and other expenses. In addition, the Sarbanes- Oxley Act~~ of ~~2002 (the “Sarbanes~~VT-~~Oxley Act”)~~1953, asVB-1953 ~~well as rules subsequently implemented by the SEC have imposed various requirements on public companies, including establishment~~ and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Our management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations result in increased legal and financial compliance costs and will make some activities more timeVT-~~consuming~~1908 ~~and~~following ~~costly.~~approval;

~~The~~● ~~Sarbanes-Oxley~~enforce ~~Act requires, among other things, that we maintain effective internal controls for financial reporting~~ and ~~disclosure.~~defend ~~In particular, we are required to perform system and process evaluation and testing of~~ our ~~internal~~intellectual ~~controls~~property ~~over~~rights financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our testing may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses. We have incurred and ~~continue~~claims; ~~to expect to incur significant expense~~ and devote substantial management effort toward ensuring compliance with Section 404. Moreover, if we do not comply with the requirements of Section 404, or if we identify deficiencies in our internal controls that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would entail expenditure of additional financial and management resources.

~~For~~● ~~example,~~obtain ~~our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024,~~ and ~~determined~~maintain ~~that~~patent our internal control over financial reporting was not effective at a reasonable assurance level due to material weaknesses in our internal control over financial reporting. We had insufficient internal resources with appropriate accounting and ~~finance~~trade ~~knowledge~~secret ~~and~~protection ~~expertise~~or toregulatory ~~design,~~exclusivity ~~implement,~~for ~~document and operate effective internal controls around our financial reporting process. We are currently developing our remediation plan to address~~ the ~~material~~Vyome ~~weaknesses identified above~~Assets.

WeFurthermore, third parties may have ~~identified~~or ~~material~~allege ~~weaknesses~~that inthey ~~our~~have ~~internal~~intellectual ~~control~~property ~~over~~rights ~~financial~~that ~~reporting~~block our commercial activities, and ~~any~~we ~~failure~~may need to ~~maintain~~seek ~~effective~~a ~~internal~~license, which ~~control~~may ~~over~~not ~~financial~~be ~~reporting,~~available or may ~~have~~not be available at a ~~material~~reasonable ~~and~~price. ~~adverse~~We ~~effect~~may onalso ~~our~~have ~~business~~a contractual dispute, ~~operating~~which ~~results~~may take significant resources, ~~financial~~including ~~condition~~the ~~and~~management ~~prospects~~team’s time, to resolve.

~~Our~~Due ~~management~~to ~~assessed~~ the ~~effectiveness~~uncertainties ofand risks ~~our~~associated ~~internal~~with ~~control~~these ~~over~~activities, ~~financial~~we ~~reporting~~are asunable to accurately and precisely predict the timing and amount of ~~December 31~~revenues, ~~2024~~if any, ~~and~~the extent ~~determined~~of ~~that~~any ~~our~~further ~~internal~~losses ~~control~~or ~~over~~if ~~financial~~or ~~reporting~~when ~~was~~we might achieve profitability. Consequently, any predictions we make about our future success or viability may not ~~effective~~be atas aaccurate ~~reasonable~~as ~~assurance~~they ~~level~~could ~~due~~be toif ~~material~~we ~~weaknesses~~had ina ~~our~~longer ~~internal~~operating ~~control~~history ~~over~~or ~~financial~~track ~~reporting~~record of relative success. We ~~had~~may never ~~insufficient~~succeed ~~internal~~in ~~resources~~these ~~with~~activities ~~appropriate~~and, ~~accounting~~even ~~and~~if ~~finance~~we ~~knowledge~~succeed ~~and~~in ~~expertise~~commercializing tothe ~~design,~~Vyome ~~implement~~Assets, ~~document~~we ~~and~~may ~~operate~~never ~~effective~~generate ~~internal~~revenue ~~controls~~that ~~around~~is ~~our~~significant enough ~~financial~~to ~~reporting~~justify ~~process~~the investment in its development, achieve profitability or otherwise successfully monetize the product. WeIf ~~are~~we ~~currently~~do ~~developing~~achieve profitability, ~~our~~we ~~remediation~~may ~~plan~~not be able to ~~address~~sustain ~~the~~or ~~material~~increase ~~weaknesses~~profitability ~~identified~~on ~~above.~~a ~~Such~~quarterly ~~measures~~or ~~include:~~annual ~~designing~~basis and ~~implementing~~we ~~controls~~may continue to ~~formalize~~incur ~~roles~~substantial research and ~~review~~development ~~responsibilities~~and other expenditures to ~~align~~develop ~~with~~and ~~our~~market ~~team’s~~any ~~skills~~additional ~~and~~product ~~experience~~candidates. ~~and~~Our ~~designing~~failure to become and ~~implementing~~remain profitable ~~formalized~~or ~~controls;~~otherwise ~~and~~successfully ~~designing~~monetize the product could decrease the value of our shares and ~~implementing~~impair ~~formal~~our ~~processes~~ability to raise capital, reduce ~~policies~~or eliminate our research and ~~procedures~~development ~~supporting~~efforts, expand our ~~financial~~business ~~close~~or ~~process~~continue our operations. Further, we may encounter unexpected expenses, challenges and complications from known and unknown factors such as a global pandemic.

~~General~~We ~~economic~~have incurred losses since inception, and ~~political~~we ~~conditions~~expect ~~could~~to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have anot ~~material~~generated ~~adverse~~any ~~effect~~revenue onfrom ~~our~~the ~~business~~Vyome Assets and may never generate revenue or become profitable.

~~External~~Investment in biopharmaceutical product development is a highly speculative undertaking and entails substantial upfront costs and capital expenditures over a multi-year timeframe, and ultimately a risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. Such factors can ~~affect~~be ~~our~~binary ~~financial~~in ~~condition~~effect, with development halted should any such factor arise. ~~Such~~We ~~external~~have ~~factors~~no ~~include~~products ~~general~~approved ~~domestic~~for ~~and~~commercial sale, ~~global~~we ~~economic~~have ~~conditions~~not generated any revenue to date, ~~such~~and aswe ~~interest~~continue ~~rates~~to incur research and development, ~~tax~~and ~~law~~other ~~including~~expenses ~~tax~~related ~~rate~~to ~~changes~~our ongoing operations. We do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval from the FDA, EMA and ~~factors~~similar ~~affecting~~foreign ~~global~~regulatory ~~economic~~authorities ~~stability~~of, and then successfully commercialize, the ~~political~~Vyome ~~environment~~Assets in ~~regarding~~one ~~healthcare~~or more indications in ~~general~~one or more territories. We ~~cannot~~may ~~predict~~never tosucceed ~~what~~in ~~extent~~these ~~the~~activities ~~global~~and, ~~economic~~even ~~conditions~~if we do, may ~~negatively~~never ~~impact~~generate revenues ~~our~~that ~~business~~are significant or large enough to achieve profitability. ~~For~~If ~~example,~~we ~~negative~~are ~~conditions~~unable to raise further capital in the ~~credit~~near-term, or partner with third parties that fund all or the vast majority of our costs and capital ~~markets~~expenditures, ~~could~~then ~~impair~~we ~~our~~may ~~ability~~be unable to ~~access~~continue operations. ~~the~~We ~~financial~~do ~~markets~~not ~~for~~expect ~~working~~to ~~capital~~generate ~~and~~sufficient ~~could~~revenue ~~negatively~~through ~~impact~~any means to fund our ~~ability~~operations in the near-term. We cannot assure you that any additional financing that we are able to ~~borrow~~raise would not have a dilutive impact on your ownership interest.

~~We face significant uncertainty in the industry due to government healthcare reform.~~60

InWe have incurred net losses in each period since our incorporation in August 2017. Our net losses were approximately $10.5 million for the ~~United~~year ~~States~~ended December 31, ~~there~~2025. ~~have~~We ~~been~~expect ~~and~~to continue to beincur asignificant losses ~~number~~for ofthe ~~legislative~~foreseeable ~~initiatives~~future. Even after finding a means to ~~contain~~fund ~~healthcare~~the foreseeable, and unforeseeable, costs. ~~The~~to ~~Patient~~develop ~~Protection~~our ~~and~~product, thereafter, ~~Affordable~~the ~~Care~~progress ~~Act~~of asour ~~well~~development, asand ~~any~~the ~~future~~clinical ~~healthcare~~results ~~reform~~achieved, ~~legislation~~will affect, ~~may~~positively ~~have~~or anegatively, ~~significant~~the ~~impact~~value onof our company ~~business~~and accordingly our ability to raise capital. ~~The~~We ~~impact~~will ofcontinue ~~the~~to ~~Affordable~~not ~~Care~~be ~~Act~~profitable oneven ~~the~~if ~~health~~those ~~care~~results ~~industry~~are isfavorable. ~~extensive~~Favorable results ~~and~~may ~~includes~~increase our value, ~~among~~increasing ~~other~~our ~~things,~~ability ~~the~~to ~~federal~~raise ~~government~~capital. ~~assuming~~Unfavorable aresults ~~larger~~are ~~role~~likely into ~~the~~decrease ~~health~~our ~~care~~value ~~system~~and could impair our ability to raise more capital, ~~expanding~~which ~~healthcare~~is ~~coverage~~necessary ofto ~~United~~maintain ~~States~~our ~~citizens~~research and ~~mandating~~development ~~basic~~efforts, ~~healthcare~~expand ~~benefits~~our business and/or continue our operations. A decline in our value could also cause you to lose all or part of your investment.

30Cash and cash equivalents as of March 2, 2026 are anticipated to last until June 2027. We believe our existing cash and cash equivalents will be sufficient to fund all of our anticipated operating expenses, including clinical trial expenses, and capital expenditure requirements up to June 2027. Until such time, if ever, as we are able to successfully develop and commercialize the Vyome Assets, we expect to fund our operations through the sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies or other strategic transactions.

~~Table~~We ofwill ~~Contents~~need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all. If we are unable to raise additional capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. In the future, we may conclude that there is substantial doubt about our ability to continue as a going concern, and future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and we conclude that there is substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

Congress regularly considers legislation to replace or repeal elements or all of the Affordable Care Act. At this time, it is not clear whether the Affordable Care Act will be repealed in whole or in part, and, if it is repealed, whether it will be replaced in whole or in part by another plan and what impact those changes will have on coverage and reimbursement for healthcare items and services covered by plans that were authorized by the Affordable Care Act. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and also indirectly affect the amounts that private payers are willing to pay. In addition, any healthcare reforms enacted in the future may, like the Affordable Care Act, be phased in over a number of years but, if enacted, could reduce our revenue, increase our costs, or require us to revise the ways in which we conduct business or put us at risk for loss of business. In addition, our results of operations, financial position and cash flows could be materially adversely affected by changes under the Affordable Care Act and changes under any federal or state legislation adopted in the future.

We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.

Our operations are directly, or indirectly through customers, subject to various state and federal fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act. These laws may impact, among other things, our sales, marketing and education programs.

The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. The Anti-Kickback Statute is broad and, despite a series of narrow safe harbors, prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Penalties for violations of the federal Anti- Kickback Statute include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.

The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of medical device, pharmaceutical and healthcare companies to have to defend a False Claims Act action. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Various states have also enacted laws modeled after the federal False Claims Act.

We are unable to predict whether we could be subject to actions under any of these laws, or the impact of such actions. If we are found to be in violation of any of the laws described above or other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations.

Table of Contents

Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions or data corruption could materially disrupt our operations and adversely affect our business.

The operation of our business depend on our information technology systems. We rely on our information technology systems to, among other things, effectively manage sales and marketing data, accounting and financial functions, inventory management, product development tasks, clinical data, customer service and technical support functions. Our information technology systems are vulnerable to damage or interruption from earthquakes, fires, floods and other natural disasters, terrorist attacks, power losses, computer system or data network failures, security breaches, data corruption, and cyber-based attacks. Cyber-based attacks can include computer viruses, computer denial-of-service attacks, phishing attacks, worms, and other malicious software programs or other attacks, covert introduction of malware to computers and networks, impersonation of authorized users, and efforts to discover and exploit any design flaws, bugs, security vulnerabilities, or security weaknesses, as well as intentional or unintentional acts by employees or other insiders with access privileges, intentional acts of vandalism by third parties and sabotage. In addition, federal, state, and international laws and regulations, such as the General Data Protection Regulation adopted by the European Union and European Economic Area countries can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail. In addition, a variety of our software systems are cloud-based data management applications, hosted by third-party service providers whose security and information technology systems are subject to similar risks.

We operate in a highly competitive industry that is subject to rapid change. If our competitors are able to develop and market products that are safer or more effective than our products, our commercial opportunities will be reduced or eliminated.

The health care industry is highly competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. The obesity treatment market in which we operate has grown significantly in recent years and is expected to continue to expand as technology continues to evolve and awareness of the need to treat the obesity epidemic grows. Although we are not aware of any competitors in the neuroblocking market, we face potential competition from pharmaceutical and surgical obesity treatments. Many of our competitors in the obesity treatment field have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, obtaining regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly if they pursue competing solutions through collaborative arrangements with large and established companies, such as Allergan, Boston Scientific, LivaNova PLC, Johnson & Johnson, Medtronic or St. Jude Medical. Our competitors may develop and patent processes or products earlier than us, obtain regulatory approvals for competing products more rapidly than we are able to and develop more effective, safer and less expensive products or technologies that would render our products non-competitive or obsolete.

We face external competition from other technologies such as GLP-1’s, and alternative medical procedures and we may not be able to compete effectively.

Companies that may not be deemed competitors in the bariatric surgery space may develop technologies, products or services that may impact the use of our products. For example, certain therapeutic treatments, such as drugs used to treat weight loss such as GLP-1’s, may enhance patient health. If we do not introduce new products and enhancements in a timely manner, there may be a decrease in the use of certain of our products, in which case our operating results could suffer.

Our ability to use net operating losses (“NOL”) carryforwards may be limited.

Our ability to use our federal and state NOL carryforwards to offset potential future taxable income is dependent upon our generation of future taxable income before the expiration dates of the NOL carryforwards, and we cannot predict with certainty when, or whether we will generate sufficient taxable income to use all of our NOL carryforwards. As of December 31, ~~2024~~2025, ~~Reshape~~Vyome Technologies Inc. had U.S. federal net operating loss carryforwards of approximately $~~227~~27.2 9 million. ~~All~~Of the ~~losses~~total ~~have~~U.S. ~~been~~federal net operating loss carryforwards at December 31, 2025, losses generated beginning in ~~2018~~2020 ~~and~~(approximately $16 million) will carryover indefinitely. ~~Reshape~~We had state net operating loss carryforwards of $~~380.1~~27 million at December 31, ~~2024~~2025, and had foreign net operating loss carryforwards of approximately $02.4 2 million at December 31, 2024. ~~Net~~In ~~operating~~connection ~~loss~~with ~~carryforwards~~the ~~are~~merger ~~subject~~into toReshape ~~review~~LifeSciences, ~~and~~Inc. ~~possible~~(renamed Vyome ~~adjustment~~Holdings ~~by the taxing authorities~~Inc.), ~~With~~we ~~certain~~inherited ~~exceptions~~approximately ~~(e.g.~~$230 ~~the~~million ~~net~~of federal net operating loss carryforwards), ~~Reshape~~substantially all isof nowhich ~~longer~~have ~~subject~~no ~~to U~~expiration.~~S. federal~~ However, ~~state~~because orof ~~local~~the ~~examinations~~Section by382 ~~tax~~limitation ~~authorities~~discussed ~~for~~below, ~~years~~we ~~prior~~have topreliminarily ~~2016.~~calculated that ~~There~~we ~~are~~could noonly ~~tax~~use ~~examinations~~approximately ~~currently~~$400,000 inof ~~progress~~such net operating loss carryforwards annually.

32Our net operating loss carryforwards are subject to review and possible adjustment by the taxing authorities. With certain exceptions (e.g. the net operating loss carryforwards), we are no longer subject to U.S. federal, state or local examinations by tax authorities for years prior to 2020. There are no tax examinations currently in progress.

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~~ReShape’s~~Our ability to utilize ~~its~~our net operating loss carryforwards, tax credits, and built-in items of deduction, including capitalized start-up costs and research and development costs, has been, and may continue to be substantially limited due to ownership changes. These ownership changes limit the amount of net operating loss carryforwards, credits and built-in items of deduction that can be utilized annually to offset future taxable income. In general, an ownership change, as defined in IRC Section 382, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of a company by certain stockholders or public groups. Due to the valuation allowance against deferred tax assets at December 31, 2025 and 2024, the net effect of any further limitation will have no impact on results of operations.

Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.

Substantially all of our cash and cash equivalents were held in accounts with Silicon Valley Bank (“SVB”) at the time it was closed by state regulators, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed receiver for SVB, on March 10, 2023. The FDIC created a successor bridge bank for SVB and all deposits of SVB were transferred to the bridge bank under a systemic risk exception approved by the United States Department of the Treasury, the Federal Reserve and the FDIC. If financial institutions in which we hold funds for working capital and operating expenses were to fail, we cannot provide any assurances that such governmental agencies would take action to protect our uninsured deposits in a similar manner.

We subsequently moved and hold a portion of our cash and cash equivalents in accounts with Bank of America. The balance held in these accounts exceeds the FDIC standard deposit insurance limit of $250,000. If a financial institution in which we hold such funds fails or is subject to significant adverse conditions in the financial or credit markets, we could be subject to a risk of loss of all or a portion of such uninsured funds or be subject to a delay in accessing all or a portion of such uninsured funds. Any such loss or lack of access to these funds could adversely impact our short-term liquidity and ability to meet our operating expense obligations.

In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of operations.

In addition, a vendor on which we are reliant could be adversely affected by any of the liquidity or other risks that are described above as factors that could result in material adverse impacts on us, including but not limited to delayed access or loss of access to uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution. Any critical vendor bankruptcy or insolvency, or any breach or default by a critical vendor, or the loss of any significant vendor relationships, may have a material adverse impact on our business.

33Previously, we recorded a non-cash indefinite-lived intangible and definite-lived assets impairment loss, which significantly impacted our results of operations, and we may be exposed to additional impairment losses that could be material.

~~Table~~We conduct our annual indefinite-lived intangible assets impairment analysis during the fourth quarter of ~~Contents~~each year or when circumstances suggest that an indicator for impairment may be present. Previously, we performed a qualitative impairment analysis of the in-process research and development. Due to delays in the clinical trials experienced, we revised our expectations of when revenues would commence for the Vyome Assets, thus reducing the projected near-term future net cash flows related to the Vyome Assets. During 2020, we stopped the clinical trials for the Vyome Assets and closed out the previous trials that occurred, as significant additional clinical work and cost would be required to achieve regulatory approval for the Vyome Assets. While we have not recorded an impairment, in the future, we may have additional impairments requiring us to record an impairment loss related to our remaining finite-lived intangible assets and other investments, which could also have a material adverse effect on our results of operations.

~~Risks Related to the Pending Merger~~62

~~Fluctuations~~If inwe ~~the~~are ~~market~~unable ~~price~~to ofraise ~~our~~capital ~~common~~when ~~stock~~needed, or ~~will~~on ~~affect~~acceptable ~~the~~terms, ~~value~~we may be forced to delay, reduce and/or eliminate one or more of ~~the~~our ~~Merger~~development ~~Consideration~~programs or future commercialization efforts.

AtDeveloping ~~the~~biopharmaceutical products ~~effective~~is ~~time~~a ofvery ~~the~~long, ~~Merger with Vyome (the “Effective Time”)~~time-consuming, ~~each~~expensive ~~share of Vyome common stock~~ and ~~preferred~~uncertain ~~stock~~process ~~(together, the “Vyome Shares”) (other than the shares~~ that ~~are~~takes ~~owned~~years byto ~~ReShape,~~complete. ~~Vyome,~~We orexpect ~~Merger~~our ~~Sub~~expenses ~~and~~to ~~shares~~increase in ~~that~~connection ~~will~~with beour ~~subject~~ongoing toactivities, aparticularly ~~put-call~~as ~~option~~we ~~agreement~~conduct ~~with~~clinical ~~certain~~trials ~~stockholders~~ of, ~~Vyome~~ and ~~Vyome~~seek ~~Therapeutics~~marketing ~~Limited~~approval ~~(“Vyome~~from ~~India”)~~the ~~who~~FDA, ~~are~~EMA, and ~~located~~similar inforeign ~~India)~~regulatory ~~will~~authorities befor ~~converted into~~ the ~~right~~Vyome toAssets. ~~receive~~Even aif ~~number~~anyone of ~~shares~~the ofVyome ~~our~~Assets ~~common~~are ~~stock~~approved ~~(“ReShape~~for ~~Shares”)~~commercial sale, we ~~according~~anticipate toincurring acosts ~~ratio~~associated ~~(the~~with ~~“Exchange~~sales, ~~Ratio”)~~marketing, ~~determined~~manufacturing atand ~~least~~distribution ~~10 days~~activities ~~prior (the “Determination Date”)~~ to alaunch ~~special~~the ~~meeting~~Vyome ofAssets. Our ~~our~~expenses ~~stockholders~~could ~~(the~~increase ~~“ReShape~~beyond ~~Special~~expectations ~~Meeting”)~~if ~~that~~we ~~will~~are ~~result~~required inby the ~~holders~~FDA, ofEMA ~~such~~or ~~Vyome~~other ~~Shares~~regulatory ~~owning~~agencies ~~91.62%~~to ofperform ~~the~~preclinical studies ~~outstanding~~or ~~shares~~clinical oftrials ~~the~~in ~~combined~~addition ~~company~~to ~~(“Combined~~those ~~Company~~that ~~Shares”)~~we ~~immediately~~currently ~~after~~anticipate. ~~the~~Because ~~effective time of~~ the ~~Merger,~~design ~~subject~~and tooutcome ~~adjustment~~of ~~based~~our onplanned ~~ReShape’s~~and ~~net~~anticipated clinical ~~cash~~trials isare ~~greater~~highly ~~than~~uncertain, orwe ~~less~~cannot ~~than~~reasonably $5estimate ~~million; provided that~~ the ~~shares~~actual toamount ~~be received by certain stockholders~~ of ~~Vyome~~funding ~~and~~that ~~Vyome~~will ~~India located in India shall~~ be ~~subject~~necessary to successfully complete the ~~put-call~~development ~~option~~and ~~agreements~~commercialization ~~with~~of the ~~combined~~Vyome ~~company (“Combined Company”)~~Assets. ~~The~~Our ~~Exchange~~future ~~Ratio~~capital ~~remains~~requirements ~~subject~~depend ~~adjustment based~~ on ~~the~~many ~~actual shares outstanding~~factors, ~~and~~including factors ~~ReShape’s~~that ~~actual~~are ~~net~~not ~~cash,~~within asour ~~of the Determination Date~~control.

~~Because~~We ~~the~~do ~~exact~~not ~~number~~have any committed external sources of ~~ReShape~~funds ~~Shares~~and ~~that~~adequate ~~will~~additional befinancing ~~issued~~may innot ~~exchange~~be ~~for~~available ~~each~~to ~~Vyome~~us ~~Share~~on ~~(the~~acceptable ~~“Merger~~terms, ~~Consideration”)~~or ~~will~~at ~~not~~all. We may be ~~determined~~required to ~~until~~seek aadditional ~~later~~funds ~~date~~sooner than planned through public or private equity offerings, ~~the~~debt ~~market~~financings, ~~value~~collaborations ofand licensing arrangements or other sources. Such financing may dilute our shareholders or the ~~Merger~~failure ~~Consideration~~to ~~that~~obtain ~~Vyome~~such ~~stockholders~~financing ~~will~~may ~~receive~~restrict ~~will~~our ~~depend~~operating activities. ~~both~~To onthe extent that we raise additional capital through the ~~number~~sale of ~~ReShape~~equity ~~Shares~~or toconvertible debt securities, your ownership interest will be ~~issued~~diluted, and the ~~price~~terms ~~per~~may ~~ReShape~~include ~~Share~~liquidation ator ~~the~~other ~~Effective~~preferences ~~Time~~and anti-dilution protections that adversely affect your rights as a shareholder. ~~The~~Debt ~~exact~~financing ~~number~~may result in the imposition of ~~ReShape~~debt ~~Shares~~covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through upfront payments or milestone payments pursuant to befuture ~~Vyome~~collaborations with ~~and~~third parties, we may have to relinquish valuable rights to the ~~market~~Vyome ~~price~~Assets, ~~per~~or ~~ReShape~~grant ~~Share~~licenses ~~will~~on terms that are not favorable to us. Our ability to raise additional capital may be ~~known~~adversely atimpacted ~~the~~by ~~time~~potential ofworsening global economic and political conditions and volatility in the ~~ReShape~~credit ~~Special~~and ~~Meeting~~financial markets in the United States and ~~may~~worldwide, which could be ~~less~~exacerbated orby, ~~more~~among ~~than~~other factors, the ~~current~~ongoing ~~market~~war ~~price~~between orRussia and Ukraine and the ~~market~~conflicts ~~price~~in atthe Middle East. Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the ~~time~~scope of, ~~the~~suspend ~~ReShape~~or ~~Special~~eliminate ~~Meeting~~one or more of our research-stage programs, clinical trials or future commercialization efforts.

~~The~~Due ~~exact~~to ~~dollar value of~~ the ~~ReShape~~significant ~~Shares~~resources ~~that~~required for the ~~Vyome~~development ~~stockholders and the ReShape stockholders will hold upon consummation~~ of ~~the~~VT-1953 ~~Merger will not be known at the time of the ReShape Special Meeting~~ and ~~may be greater than~~VT-1908, ~~the~~we ~~same~~must asprioritize ~~or less than~~ the ~~current~~pursuit ~~market price~~ of ~~ReShape~~treatments ~~Shares~~for atcertain ~~the time of the ReShape Special Meeting~~indications. ~~The~~We ~~market~~may ~~price~~expend ofour ~~the~~limited resources ~~ReShape Shares is subject~~ to ~~general~~pursue ~~price~~a ~~fluctuations~~particular inindication ~~the market for publicly traded equity securities~~ and ~~has~~fail ~~experienced~~to ~~volatility~~capitalize inon ~~the~~indications ~~past~~that ~~and~~ may ~~vary~~be ~~significantly~~more ~~from~~profitable ~~the~~or ~~date~~for ofwhich ~~the~~there ~~ReShape~~is ~~Special Meeting. As~~ a greater ~~result~~likelihood of ~~these fluctuations, the value of the Merger Consideration will also vary~~success.

~~Stock~~We ~~price~~intend ~~changes~~to ~~may~~develop ~~result~~therapies for ~~from~~patients awith ~~variety~~serious ofimmune ~~factors,~~system ~~including~~disorders. ~~general~~In ~~market~~particular, ~~industry~~we ~~and~~are ~~economic~~developing ~~conditions,~~a ~~changes~~portfolio inof ~~the~~therapeutic ~~respective~~indications ~~businesses,~~for ~~operations~~VT-1953 and VT-1908 and ~~prospects~~due ofto ~~ReShape,~~our ~~regulatory~~limited ~~considerations~~financing, ~~results~~are ofinitially focused on the ~~ReShape~~development ~~Special~~of ~~Meeting,~~VT-1953 ~~announcements~~in ~~with~~treating ~~respect~~malodor in malignant fungating wounds where we plan to ~~the~~initiate ~~Merger~~a orPhase ~~any~~3 trial subject to FDA approval of the ~~foregoing,~~protocol and ~~other~~development ~~factors~~of ~~beyond~~VT-1908 ~~the~~for ~~control~~uveitis ofwhere we ~~ReShape.~~plan ~~You~~to ~~should~~initiate ~~obtain~~IND ~~current~~enabling ~~market~~studies ~~price~~followed ~~quotations~~by ~~for~~Phases ~~ReShape~~1 ~~Shares,~~and ~~but~~2. asIn ~~indicated~~the ~~above,~~event ~~the~~that ~~price~~we atare ~~the~~required ~~time~~to ~~the~~limit ~~Merger~~our isdevelopment ~~consummated~~plan for VT-1953 and/ or VT-1908, we may be ~~greater~~unable ~~than,~~to initiate clinical trials with the same asscope that we otherwise intended to pursue, or ~~less~~the geographies ~~than~~in ~~such~~which ~~price~~we ~~quotations~~initiate such trials.

Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular indications may not lead to the development of any viable commercial product and may divert resources away from opportunities for other indications that later prove to have greater commercial potential or a greater likelihood of success. The ~~Exchange~~primary ~~Ratio~~end inpoints for the ~~Merger~~Phase ~~Agreement~~3 istrial of VT-1953 for the therapeutic indication of treating malodor in malignant fungating wounds are expected to be in late 2026 subject to ~~adjustment~~FDA ~~based~~approving onthe Phase ~~ReShape’s~~3 ~~net~~trial ~~cash~~protocol. asEven if the primary endpoints of asuch ~~determination~~trials ~~date~~are ~~prior~~met and VT-1953 or VT-1908 demonstrate meaningful results in such therapeutic scores, there is no guarantee that such results will lead to ~~completion~~the market acceptance or commercial success of VT-1953 and VT-1908, if approved. Even if VT-1953 successfully concludes Phase 3 and other required development work, and thereafter receives marketing approval, it may not achieve commercial success. If we do not accurately evaluate the ~~Merger~~commercial potential or target market for VT-1953 and VT-1908, we may relinquish valuable rights to VT-1953 and/ or VT-1908 through future collaboration, licensing or other royalty arrangements in cases in which ~~could~~it ~~dilute~~would ~~further~~have been more advantageous for us to retain sole development and commercialization rights. We may make incorrect determinations regarding the ~~ownership~~viability or market potential of ~~either~~VT-1953 ~~the~~or ~~ReShape~~VT-1908 or ~~Vyome~~misread ~~stockholders~~trends in ~~the~~our ~~Combined Company~~industry.

~~The~~We ~~Exchange~~may ~~Ratio~~ in the ~~Merger~~future ~~Agreement~~license ~~is subject to potential adjustment depending upon the amount of “net cash” of ReShape~~additional assets, aswhich ~~defined~~may inrequire ~~the~~us ~~Merger Agreement and generally consisting of ReShape’s cash and cash equivalents less certain expenses and liabilities, as of a determination date prior~~ to ~~the~~expend ~~closing~~additional ~~date~~resources of the Merger. If ReShape has more or less than $5.0 million of net cash as of the determination date, then the percentage ownership of the current ReShape stockholders will be increased or decreased on a pro rata basis. ReShape currently expects its net cash to be less than $5.0 million as of the determination date. In addition, one of the conditions to Vyome’s obligations to complete the merger is ReShape’s net cash must be at least $1,325,000 and ifraise ~~the~~additional ~~closing occurs after July 31, 2024, with the minimum amount of ReShape’s net cash being reduced by $175,000 on the first day of each month beginning on August 1, 2024~~capital. ~~The items that will constitute ReShape’s net cash at the determination date set forth in the Merger Agreement are subject to a number of factors, some of which are outside the control of ReShape.~~

34We are actively engaged in evaluating additional assets for in-licensing or partnership and may execute additional transactions to add to our pipeline. We have not yet entered into any agreements for any such in- licensing or partnership transactions. Furthermore, there is no guarantee that we will successfully enter into any such agreements. In the event that we do enter into any additional license or partnership agreements, it is likely that we will need to expend additional resources and raise additional capital after the closing of the Merger. The ability to do so, to some extent, is subject to market, economic, financial, competitive, legislative and regulatory factors as well as other factors that are beyond our control. There can be no assurance that our business will generate cash flow from operations, or that additional capital will be available to us, in amounts sufficient to enable us to fund our liquidity needs.

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~~The~~We ~~ownership percentages~~may ofnot ~~the~~realize ~~ReShape~~all ~~and Vyome stockholders, respectively, that will result from the Exchange Ratio in the Merger Agreement are calculated prior to the completion~~ of the ~~Concurrent~~anticipated benefits ~~Financing, which could dilute further the ownership~~ of the ~~ReShape stockholders in the Combined Company~~Merger.

~~The~~We ~~pro~~may ~~forma~~not ownership percentages of the ReShape and Vyome stockholders of the Combined Company of 8.38% and 91.62%, respectively, subject to adjustment, is prior to taking into account the purchase by certain accredited investors of up to $7.3 million in securities of ReShape, Vyome and Vyome India (the “Concurrent Financing”). Therefore, the actual ownership percentages will be ~~different~~able following the completion of the Concurrent Financing and, because certain of the investors in the Concurrent Financing are existing Vyome stockholders, the actual ownership percentage of the ReShape stockholders will be decreased compared to ~~that~~successfully achieve of the ~~Vyome~~anticipated ~~stockholders~~benefits ~~after the closing~~ of the ~~Concurrent Financing. Solely for purposes of illustration, assuming the market price of the common stock of the Combined Company immediately following completion of the~~ Merger ~~is $10.00 per share, the shares of common stock to be issued in the Concurrent Financing would be sold~~ at aall ~~price~~or ofthey ~~$7.00~~may ~~per~~take ~~share~~longer ~~(reflecting a 30% discount~~ to ~~the~~realize ~~market~~than ~~price)~~expected. ~~Therefore,~~The ifdifficulties ~~$6.0 million in shares~~ of ~~common stock of the Combined Company and up to $1.0 million of shares in Vyome India are sold immediately following completion of the~~ operating post-Merger asmay ~~part of the Concurrent Financing~~include, ~~and~~among ReShape’s net cash is $975,000, the Combined Company would issue approximately 538,875 shares of common stock immediately after completion of the Merger. Based on those assumptions, and assuming the actual ownership percentage of the ReShape stockholders of the Combined Company prior to the Concurrent Financing is 11.1%, the shares issued in the Concurrent Financing would reduce the ownership percentage of the ReShape stockholders of the Combined Company to approximately 7.8%.others:

~~The~~● ~~Merger~~the ~~may~~diversion ~~not~~of bemanagement ~~consummated~~attention ~~unless~~to ~~important~~integration ~~conditions~~matters; ~~are~~● ~~satisfied~~difficulties orin ~~waived~~integrating ~~and~~functions, ~~there~~personnel ~~can~~and ~~be no assurance that the Merger will be consummated.~~systems;

The Merger Agreement contains a number of conditions that must be satisfied or waived (to the extent permitted by applicable law) to consummate the Merger. Those conditions include, among others:

● approval of the issuance of the ReShape Shares and the sale of ReShape’s assets (the “Asset Sale”) by the ReShape stockholders;

● the absence of any adverse law or order promulgated, entered, enforced, enacted, or issued by any government entity that prohibits, restrains, or makes illegal the consummation of the Merger or the other transactions contemplated by the Merger Agreement;

● the effectiveness of a registration statement on Form S-4 under the Securities Act of 1933, as amended (the “Securities Act”), which was initially filed by ReShape on October 1, 2024, and the absence of any stop order issued by the Securities and Exchange Commission (the “SEC”) suspending the use of such registration statement;

● the ReShape Shares to be issued in the Merger being approved for listing on The Nasdaq Capital Market and approval of the Combined Company’s continued listing on The Nasdaq Capital Market (certain risks related to obtaining such approvals are described below);

● subject to certain materiality exceptions, the accuracy of certain representations and warranties of each of Vyome and ReShape contained in the Merger Agreement and the compliance by each party with the covenants contained in the Merger Agreement; and

● the absence of a material adverse effect with respect to each of Vyome and ReShape.

These conditions to the consummation of the Merger may not be satisfied or waived (to the extent permitted by applicable law) and, as a result, the Merger may not be consummated at the time expected, or at all. In addition, ReShape or Vyome may elect to terminate the Merger Agreement in certain other circumstances.

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Although an application has been filed to list the ReShape Shares on The Nasdaq Capital Market, there can be no assurance that the common stock will be so listed or, if listed, that the Combined Company will be able to comply with the continued listing standards.

Nasdaq has determined that the proposed transaction constitutes a business combination that results in a change of control pursuant to its listing rules. Accordingly, the Combined Company will be required to satisfy all of Nasdaq’s initial listing criteria and to complete Nasdaq’s initial listing process in order for the ReShape Shares to be listed on Nasdaq. An application to list the ReShape Shares on The Nasdaq Capital Market upon consummation of the Merger has been filed as required by The Nasdaq Capital Market.

Nasdaq’s approval of the listing application is a condition to the closing of the Merger and while ReShape and Vyome can each terminate the Merger Agreement if the condition is not satisfied under certain circumstances (in which case, a $1.0 million termination fee may be payable to the terminating party), the parties can also each choose to waive the condition and consummate the Merger without Nasdaq’s approval of the listing application. In the event ReShape and Vyome waive that condition and consummate the Merger without Nasdaq’s approval of the listing application, the Combined Company would not be listed on The Nasdaq Capital Market.

In addition, if after listing, The Nasdaq Capital Market delists the ReShape Shares from trading on its exchange for failure to meet the continued listing standards, the Combined Company and its stockholders could face significant material adverse consequences including:

● a limited availability of market quotations for its securities;

● a determination that its common stock is a “penny stock” which will require brokers trading in its common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for its common stock;

● a limited amount of analyst coverage; and

● a decreased ability to issue additional securities or obtain additional financing in the future.

The Merger Agreement contains provisions that could discourage a potential competing acquirer of either ReShape or Vyome.

The Merger Agreement contains “no shop” provisions that restrict each of Vyome’s and ReShape’s ability to solicit, initiate or knowingly encourage and induce, or take any other action designed to facilitate competing third-party proposals relating to a merger, reorganization or consolidation of the company or an acquisition of the company’s stock or assets. In addition, the other party generally has an opportunity to offer to modify the terms of the Merger in response to any competing acquisition proposals before the board of directors of the company that has received a third-party proposal may withdraw or qualify its recommendation with respect to the Merger.

The Merger Agreement does not permit either Vyome or ReShape to terminate the Merger Agreement in order to pursue a superior proposal. These provisions could discourage a potential third-party acquirer that might have an interest in acquiring all or a significant portion of Vyome or ReShape from considering or proposing an acquisition, even if it were prepared to pay consideration with a higher per share cash or market value than the market value proposed to be received or realized in the Merger.

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The pendency of the Merger could materially adversely affect the business, financial condition, results of operations or cash flows of ReShape or Vyome.

The announcement and pendency of the Merger could disrupt ReShape’s or Vyome’s businesses, in any of the following ways, among others:

● ReShape’s employees are not expected to continue to be employed by the Combined Company, which might adversely affect ReShape’s ability to retain its employees;

● the attention of ReShape management or Vyome management may be directed toward completion of the Merger and, in the case of ReShape, the Asset Sale, integration planning and transaction- related considerations and may be diverted from the company’s day-to-day business operations and, following the completion of the Merger, the attention of the Combined Company’s management may also be diverted to such matters;

● vendors, suppliers, business partners or others may seek to modify or terminate their business relationship with ReShape or Vyome or the Combined Company following completion of the Merger;

● ReShape or Vyome, or the Combined Company following completion of the Merger, and their respective directors could become subject to lawsuits relating to the Merger; and

● ReShape or Vyome may experience negative reactions from their stockholders and the medical community, among others.

These disruptions could be exacerbated by a delay in the completion of the Merger or termination of the Merger Agreement. Additionally, if the Merger is not consummated, each company will have incurred significant costs and diverted the time and attention of management. A failure to consummate the Merger may also result in negative publicity, reputational harm, litigation against ReShape or Vyome or their respective directors and officers, and a negative impression of the companies in the financial markets. The occurrence of any of these events individually or in combination could have a material adverse effect on either or both companies’ financial statements and ReShape’s stock price.

In addition, the Merger Agreement restricts Vyome and ReShape from taking certain actions until the Effective Time without the consent of the other party, including, among others: the payment of dividends; the issuance of equity (including certain equity incentive awards); certain increases to employee compensation and benefits; capital expenditures; the incurrence of indebtedness; acquisitions and divestitures; and the entry into or amending certain material contracts. Vyome and ReShape are required to conduct business in the ordinary course consistent with past practice. The restrictive covenants, which are subject to various specific exceptions, may prevent Vyome or ReShape from pursuing attractive business opportunities that may arise prior to the consummation of the Merger. Although Vyome and ReShape may be able to pursue such activities with the other company’s consent, the other company may not be willing to provide its consent.

ReShape directors and executive officers and Vyome directors and executive officers have interests in the Merger and Asset Sale that may be different from, or in addition to, the interests of ReShape stockholders and Vyome stockholders.

Certain of the directors and executive officers of ReShape and certain of the directors and executive officers of Vyome negotiated the terms of the Merger Agreement and these individuals have interests in the Merger that may be different from, or in addition to, those of ReShape stockholders and Vyome stockholders, respectively. These interests include, but are not limited to, the continued service of certain of these Vyome individuals as directors and executive officers of the Combined Company, and one ReShape individual continuing to serve as a director of the Combined Company, after the date of the consummation of the Merger, certain other compensation arrangements with the ReShape and Vyome directors and executive officers, and provisions in the Merger Agreement regarding continued indemnification of and advancement of expenses of the directors and executive officers of ReShape. ReShape stockholders should be aware of these interests when they consider their respective Boards of Directors’ recommendations that they vote in favor of the Merger-related proposals.

With respect to the Asset Sale, certain of the executive officers of ReShape may become employees or consultants to Biorad after the closing of the Asset Sale, though no offers for such positions have been made and no terms of such positions have been discussed or negotiated.

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The members of the ReShape Board of Directors (the “Board”) were aware of and considered these interests relating to ReShape, among other matters, in evaluating the Merger Agreement and the Merger, and in recommending that ReShape stockholders approve proposals to be voted upon at the ReShape Special Meeting in connection with the Merger.

The members of the Vyome Board were aware of and considered these interests relating to Vyome, among other matters, in evaluating the Merger Agreement and the Merger, and in recommending that Vyome stockholders approve the Merger Agreement and the Merger.

Following the consummation of the Merger, the composition of the board of directors and management of the Combined Company will be comprised of six directors to be nominated by Vyome and its current stockholders and one current ReShape director and ReShape’s current stockholders will not have a majority ownership and voting interest in the Combined Company. The Combined Company will focus on Vyome’s business of advancing the development of its immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market.

Pursuant to the Merger Agreement, following the consummation of the Merger, the board of directors of the Combined Company will consist of six directors designated by Vyome and one director designated by ReShape and the executive management of the Combined Company will consist of Vyome’s executive officers. No current ReShape officers or employees are expected to continue with the Combined Company.

The Combined Company will focus on Vyome’s business of advancing the development of its immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. In addition, immediately following completion of the Merger and the issuance of the ReShape Shares to the Vyome stockholders at the Effective Time, ReShape’s current stockholders in the aggregate will not have a majority ownership and voting interest in the Combined Company, which will result in ReShape stockholders having less influence on the Combined Company’s management and policies. As a result, current ReShape stockholders will have less influence on the Combined Company’s management and policies than they currently have.

The opinion of ReShape’s financial advisor does not reflect changes in circumstances that may have occurred or that may occur between the signing of the Merger Agreement and the consummation of the Merger.

The opinion rendered to the Board by Maxim Group LLC was provided in connection with, and at the time of, the Board’s evaluation of the Merger. Maxim also acted as the placement agent in Reshape’s February 2025 offering. The opinion was based on the financial analysis performed, which considered market and other conditions then in effect, and financial forecasts and other information made available to Maxim, as of the date of its opinion, which may have changed, or may change, after the date of the opinion. The Board has not obtained an updated opinion from its financial advisor as of the date of this prospectus or as of any other date, nor does it expect to receive an updated, revised or reaffirmed opinion prior to the consummation of the Merger. Changes in the operations and prospects of ReShape or Vyome, general market and economic conditions and other factors that may be beyond the control of ReShape or Vyome, and which changes were not taken into account by ReShape’s financial advisor in rendering its opinion, may significantly alter the value of ReShape or Vyome or the price of ReShape Shares by the time the Merger is consummated. The opinion does not speak as of the time the Merger will be consummated or as of any date other than the date of such opinion. Because there are no plans for ReShape’s financial advisor to update their opinion, the opinion does not address the fairness of the Exchange Ratio or the Merger Consideration, as applicable, from a financial point of view, at any time other than the time such opinion was issued.

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Failure to consummate the Merger could negatively impact respective future operations and financial results of ReShape and Vyome and the future stock price of ReShape.

If the Merger is not consummated for any reason, ReShape and Vyome may be subjected to a number of material risks, including the following:

● a decline in the market price of the shares of our common stock to the extent that the current market price reflect a market assumption that the Merger will be consummated and will be beneficial to the value of ReShape after the closing date of the Merger;

● having to pay certain costs related to the proposed Merger, such as legal, accounting, financial advisory, printing and mailing fees, which must be paid regardless of whether the Merger is consummated;

● addressing the consequences of operational decisions made since the signing of the Merger Agreement, including because of restrictions on ReShape’s or Vyome’s operations imposed by the terms of the Merger Agreement and decisions to delay or defer capital expenditures;

● returning the focus of management and personnel to operating ReShape or Vyome, as applicable, on a standalone basis, without any of the benefits expected to have been provided by the consummation of the Merger or, in the case of ReShape, the Asset Sale;

● negative reactions from their respective stockholders, suppliers, employees, and the medical community;

● Vyome’s product development plans may get slowed down or discontinued; and

● Vyome and its subsidiary (Vyome India) may lose employees and consultants.

In addition to the above risks, ReShape and Vyome may be required, under certain circumstances, to pay to the other party a termination fee of $1.0 million, which may materially adversely affect such party’s financial condition. The business of ReShape or Vyome may be adversely impacted by the failure to pursue other beneficial opportunities due to the focus of ReShape and Vyome management on the Merger. A failure to consummate the Merger may also result in negative publicity, reputational harm, litigation against ReShape or Vyome or their respective directors and officers, and a negative impression of the companies in the financial markets.

If the Merger is not consummated, we cannot assure the Vyome stockholders or the ReShape stockholders that these risks will not materialize and will not materially adversely affect the business, financial results and stock price of the respective companies. Because each of the Merger and the Asset Sale are conditioned upon the other transaction being consummated, neither transaction may be completed if the proposals required for the consummation of both transactions are not approved.

The Merger may disrupt attention of ReShape management and Vyome management from ongoing business operations.

Each of ReShape and Vyome has expended, and expects to continue to expend, significant management resources to consummate the Merger. The attention of each company’s management may be diverted away from the day-to-day operations of the businesses of ReShape and Vyome, respectively, including implementing initiatives to improve performance, execution of existing business plans and pursuing other beneficial opportunities, in an effort to consummate the Merger. This diversion of management resources could disrupt ReShape’s or Vyome’s operations and may have an adverse effect on the respective businesses, financial conditions, results of operations and cash flows of the two companies or the Combined Company after the closing date of the Merger.

The market price for ReShape Shares following completion of the Merger will continue to fluctuate and may be affected by factors different from those that historically have affected ReShape Shares.

Following the completion of the Merger, Vyome stockholders and ReShape stockholders will be stockholders in the Combined Company. ReShape’s business differs in important respects from that of Vyome and the Combined Company’s business will differ from that of ReShape prior to the completion of the Merger. Accordingly, the results of operations of the Combined Company and the market price of ReShape Shares after the completion of the Merger may be affected by factors different from those currently affecting the independent results of operations of each of Vyome and ReShape.

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Risks Related to the Business of the Combined Company After the Merger

Combining the two companies may be more difficult, costly or time consuming than expected, and the Combined Company may not realize all of the anticipated benefits of the Merger.

ReShape and Vyome have operated and, until the consummation of the Merger, will continue to operate, independently. The Combined Company may not be able to successfully achieve the anticipated benefits of the Merger at all or they may take longer to realize than expected. The difficulties of operating the Combined Company may include, among others:

● the diversion of management attention to integration matters;

● difficulties in integrating functions, personnel and systems;

●

declines in results of operations, financial condition or cash flows;

● a decline in the market price of ReShape Shares;

●

contingent liabilities that are larger than expected;

●

potential unknown liabilities, adverse consequences and unforeseen increased expenses associated with the Merger;

●

disruption of existing relationships with patients, doctors, business partners, and other constituencies; and

●

the disruption of, or the loss of momentum in, ongoing research and development, including ongoing clinical trials.

Many of these factors are outside ~~the~~our control ~~of ReShape and Vyome~~, and any one of them could result in increased costs, decreased expected revenues and diversion of management time and energy, which could materially impact ~~the~~our business, financial condition, results of operations and cash flows ~~of the Combined Company~~. ~~These factors could cause dilution to the earnings per share of the Combined Company, decrease or delay the expected benefits of the Merger and negatively impact the price of ReShape Shares.~~ As a result, it cannot be assured that ~~the~~we ~~Combined Company~~ will realize the full benefits anticipated from the Merger within the anticipated time frames, or at all.

InWe ~~addition,~~have ~~following~~incurred ~~the~~substantial ~~Merger,~~direct ~~ReShape will become responsible for Vyome’s liabilities~~ and indirect ~~obligations,~~costs ~~including~~as ~~with~~a ~~respect to legal, financial, regulatory, and compliance matters. These obligations will~~ result inof ~~additional cost and investment by ReShape and, if ReShape has underestimated~~ the ~~amount~~Merger ~~of these costs~~ and ~~investments~~expect ~~or if ReShape fails~~ to ~~satisfy~~incur ~~any~~substantial ~~such~~direct ~~obligations, ReShape~~ and ~~Vyome~~indirect ~~may~~costs ~~not~~following ~~realize~~ the ~~anticipated benefits of the~~ Merger. Further, it is possible that there may be unknown, contingent or other liabilities or problems that may arise in the future, the existence and/or magnitude of which ReShape and Vyome was previously unaware. Any such liabilities or problems could have an adverse effect on the Combined Company’s business, financial condition, results of operations or cash flows.

~~Further,~~We ~~following~~incurred ~~completion~~substantial ofexpenses in ~~the~~connection ~~Merger,~~with ~~the~~and ~~Combined~~as ~~Company~~a ~~will~~result ~~be susceptible to many~~ of consummating the ~~risks~~Merger, ~~described herein~~ and ~~risks~~over ~~related~~a toperiod ~~Vyome’s~~of ~~business.~~time Tofollowing the ~~extent~~consummation ~~any~~ of the ~~events in the risks occur~~Merger, ~~those~~we also ~~events~~expect ~~could~~to ~~cause~~incur ~~the~~substantial ~~potential~~expenses ~~benefits~~as ofa ~~the~~result. ~~Merger~~These ~~not~~expenses tocould beadversely ~~realized~~affect ~~and~~our ~~the~~financial ~~market~~condition, ~~price~~results of ~~the~~operations and ~~Combined~~cash ~~Company’s common stock to decline~~flows.

~~ReShape~~If ~~and~~the ~~Vyome~~perceived ~~will~~benefits ~~incur substantial direct and indirect costs as a result~~ of the Merger do ~~and~~not meet the ~~Combined~~expectations ~~Company~~of ~~will~~investors ~~incur~~or ~~substantial~~securities ~~direct~~analysts, ~~and~~the ~~indirect~~market ~~costs~~price ~~following~~of ~~the~~our ~~Merger~~securities may decline.

~~ReShape~~If ~~and Vyome will incur substantial expenses in connection with and as a result of consummating~~ the ~~Merger,~~perceived ~~and over a period~~ benefits of ~~time following~~ the ~~consummation of the~~ Merger, ~~ReShape~~do ~~also~~not ~~expects~~meet ~~to incur substantial expenses as a Combined Company. A portion of~~ the ~~transaction~~expectations ~~costs related to the Merger will be incurred regardless~~ of ~~whether~~investors ~~the~~or ~~Merger~~securities ~~is consummated. While ReShape and Vyome have assumed that a certain level of transaction expenses will be incurred~~analysists, ~~factors beyond ReShape’s and Vyome control could affect~~ the ~~total~~market ~~amount~~price ~~or the timing~~ of ~~these~~our ~~expenses.~~securities ~~These~~may ~~expenses could adversely affect the financial condition, results of operations and cash flows of the Combined Company following the consummation of the Merger~~decline.

40In addition, fluctuations in the price of our securities could contribute to the loss of all or part of a shareholder’s investment. Prior to the Merger, there was no public market for our common stock. Accordingly, the valuation ascribed to us in the Merger may not be indicative of the price that will prevail in the trading market following the Merger. The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. If an active market for our securities develops and continues, the market price of our common stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:

~~Table~~● ofour ~~Contents~~ability to commercialize the Vyome Assets or their corresponding product candidates, if approved;

~~Both~~● ~~ReShape~~the status and ~~Vyome~~cost ~~have~~of ~~operated~~our ~~with~~marketing acommitments ~~loss and negative cash flows~~ for the ~~entirety~~Vyome ofAssets ~~their existence~~ and ittheir isproduct ~~expected the Combined Company will have to raise significant capital in the future that could be dilutive to stockholders of the Combined Company.~~candidates;

~~Both~~● ~~ReShape~~announcements ~~and~~regarding ~~Vyome~~results ~~have operated with a loss and negative cash flows for the entirety~~ of ~~their~~any ~~existence.~~clinical ~~The~~trials ~~Combined~~relating ~~Company may not be able~~ to ~~raise~~our ~~capital~~product to continue operations in the future which could result in bankruptcy or liquidation of the Combined Company. Adequate funding may not be available to the Combined Company on acceptable terms, or at all.candidates;

If● ~~the~~unanticipated ~~perceived~~serious ~~benefits~~safety ofconcerns ~~the~~related ~~Merger~~to ~~do not meet~~ the ~~expectations~~use of ~~investors or securities analysts,~~ the ~~market~~Vyome ~~price~~Assets ~~of ReShape’s securities~~ or, ~~following~~any ~~the~~of ~~Merger,~~our ~~the~~product ~~Combined Company’s securities, may decline.~~candidates;

If the perceived benefits of the Merger do not meet the expectations of investors or securities analysists, the market price of ReShape’s securities prior to the closing of the Merger may decline. The market value of ReShape’s securities at the time of the Merger may vary significantly from their prices on the date of the Merger Agreement was executed, the date of this prospectus, or the date of the ReShape Special Meeting.

In addition, following the Merger, fluctuations in the price of the Combined Company’s securities could contribute to the loss of all or part of a shareholder’s investment. Prior to the Merger, there has not been a public market for Vyome common stock. Accordingly, the valuation ascribed to the Combined Company in the Merger may not be indicative of the price that will prevail in the trading market following the Merger. The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. If an active market for the Combined Company’s securities develops and continues, the market price of its common stock may fluctuate significantly in response to numerous factors, some of which are beyond the Combined Company’s control, such as:

● The Combined Company’s ability to commercialize Vyome’s assets or their corresponding product candidates, if approved;

● the status and cost of the Combined Company’s marketing commitments for Vyome’s assets and their product candidates;

● announcements regarding results of any clinical trials relating to the Combined Company’s product candidates;

● unanticipated serious safety concerns related to the use of Vyome’s assets or any of the Combined Company’s product candidates;

●

adverse regulatory decisions;

● changes in laws or regulations applicable to the Vyome’s ~~assets~~Assets or ~~the~~our ~~Combined Company’s~~ product candidates, including but not limited to clinical trial requirements for approvals;

● violation of or non-compliance with applicable laws and regulations (including any laws relating to taxation) in the countries of operation of ~~the~~Vyome ~~Combined Company~~ and its subsidiaries (including India and the U.S.);

● legal disputes (such as infringements, non-allowances, etc.) or other developments relating to proprietary rights, including patents, litigation matters and ~~the~~our ~~Combined Company’s~~ ability to obtain patent protection for the Vyome’s ~~assets~~Assets or the product candidates, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent or shareholder litigation;

● ~~The~~our ~~Combined Company’s~~ decision to initiate a clinical trial, not initiate a clinical trial or to terminate an existing clinical trial;

~~● The Combined Company’s dependence on third parties;~~64

●

our dependence on third parties;

●

reduction in revenues received by Vyome India going forward on account of reduced business from its existing partnerships with third-parties;

● announcements of the introduction of new products by ~~the~~our ~~Combined Company’s~~ competitors;

●

market conditions and trends in the pharmaceutical and biotechnology sectors;

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●

announcements concerning product development results or intellectual property rights of others;

●

future issuances of common stock or other securities;

●

the recruitment or departure of key personnel;

● failure to meet or exceed any financial guidance or expectations regarding product development milestones that ~~the~~we ~~Combined Company~~ may provide to the public;

●

actual or anticipated variations in quarterly operating results;

● ~~The~~our ~~Combined Company’s~~ failure to meet or exceed the estimates and projections of the investment community;

● overall performance of the equity markets and other factors that may be unrelated to ~~the~~our ~~Combined Company’s~~ operating performance or the operating performance of its competitors, including changes in market valuations of similar companies;

● announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by ~~the~~our ~~Combined Company’s~~ or its competitors;

● changes in financial estimates by ~~the~~us ~~Combined Company~~ or by any securities analysts who might cover its shares;

● fluctuation of the market values of any of ~~the~~our ~~Combined Company’s~~ potential strategic investments;

●

issuances of debt or equity securities;

● compliance with ~~the~~our ~~Combined Company’s~~ contractual obligations;

● sales of shares of our common stock ~~of the Combined Company~~ by ~~the~~us ~~Combined Company~~ or ~~its~~our shareholders in the future;

● trading volume of shares of our common stock ~~of the Combined Company~~;

● ineffectiveness of ~~the~~our ~~Combined Company’s~~ internal controls;

● publication of research reports about ~~the~~us ~~Combined Company~~ or ~~its~~our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;

●

general political and economic conditions;

● effects of natural or man-made catastrophic events;

	●	effects of natural or man-made catastrophic events;

	●	effects of public health crises, pandemics and epidemics, such as the COVID-19 pandemic or other similar outbreaks; and

● ~~effects~~other ofevents ~~public~~or ~~health crises~~factors, ~~pandemics~~many ~~and~~of ~~epidemics,~~which ~~such~~are asbeyond ~~the~~our ~~COVID-19 pandemic or other similar outbreaks; and~~control.

●Further, ~~other~~the ~~events~~equity ormarkets in ~~factors,~~general ~~many~~have recently experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of shares of our common stock, which ~~are~~could ~~beyond~~cause a decline in the ~~Combined~~value ~~Company~~of its common stock. Price volatility of shares of our common stock might worsen if the trading volume of its common stock is low. In the past, shareholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ shares. Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention ~~control~~and resources from our business. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors”, could have a dramatic and material adverse impact on the market price of shares of our common stock.

Further, the equity markets in general have recently experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of shares of common stock of the Combined Company, which could cause a decline in the value of its common stock. Price volatility of shares of common stock of the Combined Company might worsen if the trading volume of its common stock is low. In the past, shareholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ shares. Such litigation, if instituted against the Combined Company, could cause it to incur substantial costs and divert management’s attention and resources from its business. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors”, could have a dramatic and material adverse impact on the market price of shares of common stock of the Combined Company.65

~~You~~Our ~~may~~operating ~~not~~results ~~have~~may ~~the~~fluctuate ~~same benefits as an investor in an underwritten public offering~~significantly.

~~The~~We ~~Combined~~expect ~~Company~~our ~~will~~operating ~~become~~results to abe ~~publicly~~subject ~~listed~~to ~~company~~quarterly, ~~upon~~and ~~the~~possibly ~~completion~~annual, ~~of the Merger~~fluctuations. ~~The~~Our ~~Merger~~net ~~and~~loss ~~the transactions related thereto are not an underwritten initial public offering of shares of common stock of the Combined Company or Vyome’s securities~~ and ~~differ~~other ~~from~~operating anresults ~~underwritten initial public offering in several significant ways, which include, but~~ are ~~not~~affected ~~limited~~by ~~to,~~numerous ~~the following~~ factors., including:

42● variations in the level of expenses related to our development programs;

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Like other Mergers and spin-offs which are an underwritten initial public offering, in connection with the Merger, you will not receive the benefits of the diligence performed by underwriters in an underwritten public offering. Investors in an underwritten public offering may benefit from the role of the underwriters in such an offering. In an underwritten public offering, an issuer initially sells its securities to the public market via one or more underwriters, who distribute or resell such securities to the public. Underwriters have liability under the U.S. securities laws for material misstatements or omissions in a registration statement pursuant to which an issuer sells securities. Because the underwriters have a “due diligence” defense to any such liability by, among other things, conducting a reasonable investigation, the underwriters and their counsel conduct a due diligence investigation of the issuer. Due diligence entails engaging legal, financial and/or other experts to perform an investigation as to the accuracy and completeness of an issuer’s disclosure regarding, among other things, its business and financial results. Auditors of the issuer will also deliver a “comfort” letter with respect to the financial information contained in the registration statement. In making their investment decision, investors have the benefit of such diligence in underwritten public offerings. In contrast, Vyome and ReShape have engaged financial advisors (rather than an underwriter) in connection with the Merger. The role of a financial advisor differs from that of an underwriter. For example, financial advisors do not act as intermediaries in the sale of securities.

In addition, because there are no underwriters engaged in connection with the Merger, prior to the opening of trading on Nasdaq on the trading day immediately following the closing of the Merger, there will be no book building process and no price at which underwriters initially sold shares to the public to help inform efficient and sufficient price discovery with respect to the initial post-closing trades on Nasdaq. Therefore, buy and sell orders submitted prior to and at the opening of initial post-closing trading of shares of common stock of the Combined Company on Nasdaq will not have the benefit of being informed by a published price range or a price at which the underwriters initially sold shares to the public, as would be the case in an underwritten initial public offering. There will be no underwriters assuming risk in connection with an initial resale of shares of common stock of the Combined Company or helping to stabilize, maintain or affect the public price of such shares following the closing of the Merger. Moreover, we will not engage in, and have not and will not, directly or indirectly, request the financial advisors to engage in, any special selling efforts or stabilization or price support activities in connection with such shares that will be outstanding immediately following the closing of the Merger. All of these differences from an underwritten public offering of shares of common stock of the Combined Company could result in a more volatile price for shares of common stock of the Combined Company.

Further, we will not conduct a traditional “roadshow” with underwriters prior to the opening of initial post-closing trading of shares of common stock of the Combined Company on Nasdaq. There can be no guarantee that any information disclosed or filed with the SEC will have the same impact on investor education as a traditional “roadshow” conducted in connection with an underwritten initial public offering. As a result, there may not be efficient or sufficient price discovery with respect to shares of common stock of the Combined Company or sufficient demand among potential investors immediately after the closing of the merger, which could result in a more volatile price for shares of common stock of the Combined Company.

Such differences from an underwritten public offering may present material risks to unaffiliated investors that would not exist if Vyome became a publicly listed company through an underwritten initial public offering instead of upon completion of the Merger.

The Combined Company does not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of shares of common stock of the Combined Company.

Vyome has not paid cash dividends on its common stock and the Combined Company does not anticipate paying cash dividends on its common stock in the foreseeable future. The payment of dividends on capital shares of the Combined Company will depend on its earnings, financial condition and other business and economic factors affecting the Combined Company at such time as its board of directors may consider relevant. Since the Combined Company does not intend to pay dividends, a shareholder’s ability to receive a return on such shareholder’s investment will depend on any future appreciation in the market value of its common stock. There is no guarantee that shares of common stock of the Combined Company will appreciate or even maintain the price at which its shareholders have purchased it.

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An active trading market for the Combined Company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all.

Prior to the Merger, there had been no public market for Vyome’s common stock. An active trading market for the Combined Company’s shares of common stock may never develop or be sustained. If an active market for its common stock does not develop or is not sustained, it may be difficult for its stockholders to sell their shares at an attractive price or at all.

Future sales of a substantial number of shares of common stock of the Combined Company may cause the price of its common stock to decline.

If the Combined Company’s existing shareholders sell, or indicate an intention to sell, substantial amounts of the shares of common stock of the Combined Company after the closing of the Merger, the trading price of the shares of common stock of the Combined Company could decline and it could impair the Combined Company’s ability to raise capital through the sale of additional equity securities. Certain Vyome shareholders are subject to lock-up provisions that restrict their ability to transfer shares of common stock of the Combined Company or enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any security convertible into or exercisable or exchanged for the Combined Company until 360 days from the date of closing of the Merger, provided that 20% of the shares subject to the lock-up will be released from the restrictions in the lock-up agreement on the 91st day after the closing and the remainder will be released from the restrictions in equal increments every 30 days thereafter.

You may experience future dilution as a result of future equity offerings by the Combined Company.

In order to raise additional capital for general corporate purposes, in the future the Combined Company may offer additional shares of its common stock or other securities convertible into or exchangeable for our common stock at prices that may be lower than the current price per share of our common stock. In addition, investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which the Combined Company sells additional shares of its common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors in prior offerings.

Post consummation of the Merger, the Combined Company may have outstanding warrants, which may cause dilution to its stockholders, have a material adverse impact on the market price of its common stock and make it more difficult for it to raise funds through future equity offerings.

Under the terms of the Merger Agreement, as a condition to consummation of the Merger Agreement, all outstanding Warrants to purchase ReShape Shares (“ReShape Warrants”), except for a number of ReShape Warrants exercisable for ReShape Shares representing not more than 2.75% of the fully diluted ReShape Shares as of the date of the Merger Agreement, shall have been exercised in accordance with their terms in exchange for ReShape Shares or shall have been otherwise settled on terms agreed upon between ReShape and the holder thereof such that the ReShape Warrants would be canceled and terminated prior to the Effective Time. Accordingly, even if the aforementioned condition is satisfied by ReShape to the satisfaction of Vyome, ReShape Warrants up to 2.75% of the fully diluted ReShape Shares may not be exercised prior to the consummation of the Merger. These outstanding ReShape Warrants would give the holders a right to exercise in exchange for receiving shares of common stock of the Combined Company. The issuance of such shares of common stock upon the exercise of warrants by the Combined Company would dilute the percentage ownership interest of stockholders, might dilute the book value per share of the Combined Company’s common stock and would increase the number of its publicly traded shares, which could depress the market price of its common stock.

In addition to the dilutive effects described above, the perceived risk of dilution as a result of the significant number of outstanding warrants may cause common stockholders of the Combined Company to be more inclined to sell their shares, which would contribute to a downward movement in the price of its common stock. Moreover, the perceived risk of dilution and the resulting downward pressure on the Combined Company’s common stock price could encourage investors to engage in short sales of its common stock, which could further contribute to price declines. The fact that the Combined Company’s stockholders and warrant holders can sell substantial amounts of common stock in the public market, whether or not sales have occurred or are occurring, could make it more difficult for it to raise additional funds through the sale of equity or equity-related securities in the future at a time and price that the Combined Company deems reasonable or appropriate, or at all.

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The Combined Company’s operating results may fluctuate significantly.

The Combined Company expects its operating results to be subject to quarterly, and possibly annual, fluctuations. The Combined Company net loss and other operating results will be affected by numerous factors, including:

● variations in the level of expenses related to the Combined Company development programs;

●

the addition or termination of clinical trials;

● any intellectual property infringement lawsuit in which ~~the~~we ~~Combined Company~~ may become involved;

● regulatory developments affecting the Vyome’s ~~assets~~Assets or ~~the~~our ~~Combined Company’s~~ product candidates, regulatory approvals of its product candidates, and the level of underlying demand for such products and purchasing patterns; and

● ~~The~~Our ~~Combined Company’s~~ execution of any collaborative, licensing or similar arrangements, and the timing of payments ~~The~~we ~~Combined Company~~ may make or receive under these arrangements.

If ~~the~~our ~~Combined Company’s~~ quarterly or annual operating results fall below the expectations of investors or securities analysts, the price of ~~its~~our common stock could decline substantially. Furthermore, any quarterly or annual fluctuations in ~~the~~our ~~Combined Company’s~~ operating results may, in turn, cause the price of ~~its~~our common stock to fluctuate substantially.

If ~~securities~~our estimates or ~~industry~~judgments ~~analysts~~relating doto our ~~not~~critical ~~publish~~accounting ~~research~~policies orare ~~reports~~based ~~about~~on ~~the~~assumptions ~~Combined~~that ~~Company’s~~change ~~business~~or prove to be incorrect, orour ifoperating ~~they~~results ~~issue~~could anfall ~~adverse~~below our ~~opinion~~publicly ~~regarding~~announced ~~its~~guidance ~~share,~~or ~~its~~the ~~share~~expectations ~~price~~of securities analysts and ~~trading~~investors, ~~volume~~resulting ~~could~~in a decline in the market price of its common stock.

The ~~trading~~preparation ~~market~~of ~~for~~financial statements ~~shares~~in ofconformity ~~common~~with ~~stock~~U.S. ofgenerally ~~the~~accepted ~~Combined~~accounting ~~Company~~principles ~~will~~requires bemanagement ~~influenced~~to bymake ~~the~~estimates ~~research~~ and ~~reports~~assumptions that affect ~~industry~~the oramounts ~~securities~~reported ~~analysts~~in ~~publish~~our ~~about~~financial ~~the~~statements ~~Combined~~and ~~Company~~accompanying ~~or its business~~notes. IfWe nobase orour ~~few~~estimates ~~securities~~on orhistorical ~~industry~~experience ~~analysts~~and ~~commence~~on various ~~coverage~~other ofassumptions ~~the~~that ~~Combined~~we ~~Company,~~believe ~~the~~to ~~trading price for its shares would~~ be ~~negatively~~reasonable ~~impacted.~~under In the ~~event~~circumstances, the ~~Combined~~results ~~Company~~of ~~obtains~~which ~~securities~~form orthe ~~industry~~basis ~~analyst~~for ~~coverage,~~making ifjudgments about ~~any of~~ the ~~analysts~~carrying ~~who~~values ~~cover~~of ~~it issues an adverse opinion regarding the Combined Company~~assets, ~~its business model~~liabilities, ~~its intellectual property or its share performance~~equity, orrevenue ~~if its clinical trials~~ and ~~operating~~expenses ~~results~~that ~~fail~~are tonot ~~meet~~readily ~~the~~apparent ~~expectations~~from ofother ~~analysts, its share price would likely decline~~sources. If ~~one~~our assumptions change or ~~more~~if ofactual ~~these~~circumstances ~~analysts~~differ ~~cease~~from ~~coverage~~our ofassumptions, ~~the~~our ~~Combined~~operating ~~Company~~results ormay ~~fail~~be toadversely ~~publish~~affected ~~reports~~and oncould itfall below ~~regularly,~~ the ~~Combined~~expectations ~~Company~~of ~~could~~securities ~~lose~~analysts ~~visibility~~and ~~in the financial markets~~investors, ~~which~~resulting in ~~turn~~a ~~could~~decline ~~cause~~in ~~its~~the ~~share~~market price orof ~~trading~~shares ~~volume~~of toour ~~decline~~common stock.

~~Raising~~Certain ~~additional~~of ~~capital~~our ~~may~~directors ~~cause~~and ~~dilution~~executive toofficers also ~~the~~work ~~Combined~~with ~~Company’s~~other ~~existing~~companies ~~shareholders,~~and ~~restrict~~organizations ~~its~~and ~~operations~~such orother ~~require~~positions itmay tocreate ~~relinquish~~conflicts ~~rights~~of tointerest ~~Vyome’s~~in ~~assets~~the ~~or its product candidates~~future.

~~The~~Some ~~Combined~~of ~~Company~~our ~~will~~officers ~~likely~~and ~~issue~~directors serve ~~additional~~only ~~equity~~part-time ~~securities to fund future expansion~~ and ~~pursuant~~are subject to ~~equity~~conflicts ~~incentive~~of ~~or employee benefit plans~~interest. ItEach ~~may~~of ~~also~~such ~~issue~~officers ~~additional~~and ~~equity~~directors ~~for~~devote ~~other~~part ~~purposes.~~of ~~These~~their ~~securities~~working ~~may~~time ~~have~~to other ~~the~~endeavors, ~~same~~including ~~rights~~consulting asrelationships ~~shares~~with ofother ~~common stock of the Combined Company or~~entities, ~~alternatively,~~and may have ~~dividend,~~responsibilities ~~liquidation~~to orthese other ~~preferences~~entities. toSuch ~~shares~~conflicts may ofalso ~~common~~include ~~stock~~deciding ofhow ~~the~~much ~~Combined~~time ~~Company,~~to ~~including~~devote ~~shares~~to ofour ~~common stock of the Combined Company issued in connection with the Merger~~affairs. ~~The~~Because ~~issuance~~ of ~~additional~~these ~~equity~~relationships, ~~securities~~our ~~will~~officers ~~dilute the holdings of existing shareholders~~ and directors may ~~reduce~~be ~~the~~subject to ~~share~~conflicts ~~price~~ of ~~shares of common stock of the Combined Company~~interest.

InFor ~~accordance~~example, ~~with~~Venkat ~~the~~Nelabhotla, our ~~Merger~~Chief ~~Agreement~~Executive Officer, ~~each~~devotes ~~Vyome~~approximately ~~stock~~40 ~~option~~hours ~~and~~per ~~restricted~~week ~~stock~~to ~~share~~our ~~outstanding~~business, ~~immediately~~but ~~prior~~as tomuch ~~the~~time ~~Effective~~as ~~Time,~~necessary. ~~whether~~Mr. ~~vested~~Nelabhotla oralso works ~~unvested~~part-time ~~shall~~in bea ~~converted~~consulting/advisory ~~into~~capacity for Pulse Pharmaceuticals Private Limited and ~~exchangeable~~Newvojax Health and Wellness Private Limited for ~~stock~~approximately ~~options~~15 orhours ~~restricted~~per ~~stock~~week. ~~units~~Mr. Shiladitya Sengupta, ~~respectively~~one of our directors, toworks ~~receive~~full-time aas ~~number~~an Associate Professor of ~~ReShape~~Medicine at ~~Shares~~the ~~equal~~Brigham toand ~~the~~Women’s ~~number~~Hospital ofand ~~shares~~Harvard ofMedical ~~Vyome~~School ~~common~~and dedicates ~~stock~~his ~~issuable~~time ~~upon~~to ~~exercise~~us ofon ~~such~~a ~~Vyome~~limited, ~~stock~~as-needed ~~options~~basis. orMr. ~~restricted~~Sengupta ~~stock~~also ~~units~~works ~~multiplied~~in bya ~~the~~consulting ~~Exchange~~capacity ~~Ratio~~for ~~with,~~Alyssum inTherapeutics ~~the~~Inc, CBCC, ~~case~~Invictus ofOncology ~~stock~~Pvt ~~options~~Ltd, anIndia ~~exercise~~Innovation ~~price~~Research ~~equal~~Center tofor ~~the~~approximately ~~exercise~~4 ~~price~~hours ofper ~~such~~week. ~~Vyome~~Further, ~~stock~~Robert ~~option~~Dickey, ~~divided~~our byChief Financial ~~the~~Officer, ~~Exchange~~works ~~Ratio~~with ~~and~~us ~~otherwise~~for in50% ~~accordance~~of ~~with~~his ~~the~~available ~~terms~~time ~~and~~or ~~conditions~~a minimum of ~~such~~80 ~~Vyome~~hours ~~stock~~per ~~option~~month. InWhile ~~addition,~~our ~~post~~management ~~consummation~~has ~~of the Merger~~not, ifand ~~the~~we believe ~~board~~that ofour ~~directors~~management ofwill ~~the~~not, ~~Combined~~encounter ~~Company~~any ~~elects~~issue toas ~~institute~~a ~~new~~result ~~equity~~of ~~incentive~~such ~~plans~~additional orroles/responsibilities, ~~increase~~ the ~~number~~duties ofto ~~shares~~such ~~available~~businesses/organizations may compete for ~~future~~such ~~grant~~persons’ ~~under~~full ~~its~~attention ~~existing~~to ~~equity~~our ~~incentive~~business; ~~plan~~accordingly, they ~~stockholders~~ may ~~experience~~have ~~additional~~conflicts ~~dilution,~~of ~~which~~interest ~~could~~in ~~cause~~allocating ~~the~~time ~~Combined~~between ~~Company’s~~the ~~stock~~separate ~~price~~business ~~to fall~~activities.

4566

~~Table~~Risks ofRelated ~~Contents~~to Our Product Development

~~Pursuant~~We tohave ~~certain~~never ~~Registration~~successfully ~~Rights~~completed ~~Agreements entered into in connection with~~ the ~~Merger,~~regulatory ~~certain~~approval process ~~shareholders of Vyome can each demand that the Combined Company register their registrable securities under certain circumstances and will each also have piggyback registration rights~~ for ~~these securities. In addition, following~~ the ~~closing~~Vyome ~~of the Merger~~Assets, ~~the~~and ~~Combined~~we ~~Company~~may ~~will~~ be ~~required~~unable to ~~file~~do ~~and~~so ~~maintain~~for anany ~~effective~~product ~~registration~~candidates ~~statement~~we ~~under~~acquire ~~the~~or ~~Securities Act covering such securities and certain of its other securities~~develop. The registration of these securities will permit the public sale of such securities, subject to certain contractual restrictions imposed by the Lock-Up Agreements with certain Vyome stockholders and the Merger Agreement. The presence of these additional shares of common stock trading in the public market may have an adverse effect on the market price of the Combined Company’s securities.

IfWe ~~the~~have ~~Combined~~not ~~Company~~yet ~~raises~~demonstrated our ~~additional~~ability ~~funds~~to ~~through~~successfully ~~collaboration,~~complete ~~licensing~~clinical ortrials, ~~other~~obtain ~~similar~~regulatory ~~arrangements~~approvals, itmanufacture ~~may~~a ~~have~~commercial toscale ~~relinquish~~product, ~~valuable~~or ~~rights~~arrange for toa ~~Vyome’s~~third ~~assets~~party orto ~~any~~do ~~product~~so ~~candidates~~on our behalf, or ~~grant~~conduct ~~licenses~~sales onand ~~terms~~marketing ~~unfavorable~~activities tonecessary ~~the~~for ~~Combined~~successful ~~Company~~commercialization. If ~~adequate~~we are ~~funds~~required ~~are~~to ~~not~~conduct ~~available,~~additional preclinical studies or clinical trials of the ~~Combined~~Vyome ~~Company’s~~Assets ~~ability~~beyond tothose ~~achieve~~that ~~profitability~~we orcurrently tocontemplate, if ~~respond~~we are unable to ~~competitive~~successfully ~~pressures~~complete ~~would~~clinical betrials ~~significantly~~of ~~limited~~the ~~and~~Vyome Assets or other testing, or if the ~~Combined~~results ~~Company~~of ~~may~~these betrials ~~required~~or totests are ~~delay,~~not ~~significantly~~positive ~~curtail~~or are only modestly positive or ~~eliminate~~if ~~the~~there ~~development~~are ofsafety ~~Vyome’s~~concerns, ~~assets.~~we may:

~~The~~● ~~Combined~~be ~~Company’s~~delayed ~~principal~~in ~~shareholders,~~obtaining ~~directors~~regulatory ~~and~~approval ~~executive~~from ~~officers~~the ~~will own a significant percentage of its capital shares~~FDA, ~~and~~EMA ~~also~~or ~~have~~other ~~significant~~regulatory ~~influence~~authorities ~~over~~for the ~~Combined~~Vyome ~~Company’s management.~~Assets;

~~Following~~● ~~the~~obtain ~~closing~~regulatory ofapproval ~~the~~for ~~Merger,~~indications ~~the Combined Company’s directors, executive officers, holders of 5%~~ or ~~more~~patient ofpopulations ~~the~~that ~~Combined Company’s capital shares and their respective affiliates~~ are ~~expected~~not toas ~~beneficially~~broad ~~own,~~as inintended the aggregate, approximately 62.92% of the Combined Company’s outstanding voting shares. This concentration of voting power may make it less likely that any other holder of shares of common stock of the Combined Company will be able to affect the way the Combined Company is managed and could delay or prevent an acquisition of the Combined Company on terms that other shareholders may desire. This could prevent transactions in which shareholders might otherwise recover a premium for their shares over current market prices. See above for additional information regarding Vyome’s influence and control in the Combined Company.desired;

~~Further,~~● ~~under~~continue ~~the~~to ~~Merger Agreement, KKG Enterprises, LLC (an entity under the control of Krishna K. Gupta, who shall~~ be ~~the~~subject ~~Chairman of the Combined Company) and Shiladitya Sengupta, each have a right~~ to ~~appoint~~post-marketing 2testing ~~(two)~~requirements ~~directors~~from on the ~~board of directors of the Combined Company~~FDA, ~~which~~EMA shall in total comprise of 7 (seven) members. Accordingly, the aforesaid individuals will have control over the appointment of a majority of directors on the board of the Combined Company, and directly or ~~indirectly~~other beregulatory ~~able~~authorities; ~~to affect the decisions of the board, and, through their recommendations, of the shareholders of the Combined Company.~~or

If● ~~the~~experience ~~Combined~~having Company’s estimates or judgments relating to its critical accounting policies are based on assumptions that change or prove to be incorrect, its operating results could fall below its publicly announced guidance or the ~~expectations~~product ofremoved ~~securities~~from ~~analysts and investors, resulting in a decline in~~ the market ~~price~~after ofobtaining ~~its~~regulatory ~~common stock~~approval.

~~The~~We ~~preparation~~are ofsubstantially ~~financial~~dependent statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the Combined Company’s financial statements and accompanying notes. The Combined Company bases its estimates on ~~historical experience and on various other assumptions that it believes to be reasonable under~~ the ~~circumstances, the results~~ success of ~~which~~VT-1953 ~~form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue~~ and ~~expenses that are not readily apparent from other sources. If the Combined Company’s assumptions change or if actual circumstances differ from its assumptions~~VT-1908, ~~its operating results may be adversely affected~~ and ~~could~~our ~~fall~~anticipated ~~below~~clinical ~~its~~trials ~~publicly announced guidance or the expectations~~ of ~~securities~~VT-1953 ~~analysts~~ and ~~investors,~~VT-1908 ~~resulting~~may innot abe ~~decline in the market price of shares of common stock of the Combined Company~~successful.

~~The~~Our ~~Combined~~future ~~Company’s~~success is substantially dependent on our ability to ~~use~~successfully ~~net~~develop ~~operating~~VT-1953 ~~losses~~and ~~(“NOL”)~~VT-1908 ~~carryforwards~~for ~~may~~future bemarketing ~~limited~~approval, and then successful commercialization. We are investing a majority of our efforts and financial resources into the research and development of VT-1953 and VT-1908. We plan to commence a Phase 3 trial for VT-1953 in the first half of 2025 subject to approval of protocol by FDA. We expect to have primary-end point readouts in late 2026. The Company is yet to have the meeting with FDA on Phase 3 trial protocol and also for obtaining orphan drug designation. We also plan to initiate IND enabling studies followed by Phases 1 and 2 commencing in the fourth quarter of 2025 for VT-1908.

~~The~~VT-1953 ~~Combined~~and ~~Company’s~~VT-1908 ~~ability~~will torequire additional ~~use~~clinical ~~its~~development, ~~federal~~evaluation ~~and~~of ~~state~~clinical, ~~NOL~~preclinical ~~carryforwards~~and tomanufacturing ~~offset~~activities, ~~potential~~marketing ~~future~~approval ~~taxable~~in ~~income~~multiple ~~may~~jurisdictions, substantial beinvestment ~~dependent~~and ~~upon~~significant ~~its~~marketing ~~generation~~efforts ~~of future taxable income~~ before ~~the~~we ~~expiration~~generate ~~dates~~any ofrevenues ~~the~~from ~~NOL~~product ~~carryforwards,~~sales. ~~and~~We weare ~~cannot~~not ~~predict~~permitted ~~with~~to ~~certainty when,~~ market or ~~whether~~promote itVT-1953 ~~will~~and ~~generate~~VT-1908 ~~sufficient~~before ~~taxable~~we ~~income~~receive tomarketing ~~use~~approval ~~all~~from ofthe ~~our NOL carryforwards. As of December 31~~FDA, ~~2024,~~EMA ~~ReShape~~and ~~had~~comparable ~~U.S.~~foreign ~~NOL~~regulatory ~~carryforwards of $220.9 million~~authorities, ~~state NOL carryforwards of $380.1 million~~ and we ~~foreign~~may ~~NOL~~never ~~carryforwards~~receive ofsuch ~~$0.4~~marketing ~~million~~approvals. ~~All losses have been generated beginning in 2018 and will carryover indefinitely.~~

46The success of VT-1953 and VT-1908 will depend on a variety of factors. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any third parties with whom we choose to collaborate in the future. Accordingly, we cannot assure you that we will ever be able to generate revenue through the sale of VT-1953 and VT-1908, even if approved. If we are not successful in commercializing VT-1953 and VT-1908, or are significantly delayed in doing so, our business will be materially harmed.

~~Table~~We may find it difficult to enroll patients in our clinical trials for Vyome Assets. If we experience delays or difficulties in the enrollment of ~~Contents~~patients in clinical trials, our successful completion of clinical trials or receipt of marketing approvals could be delayed or prevented.

~~The~~We ~~Combined~~may ~~Company’s~~not ~~ability~~be able to ~~utilize~~initiate or ~~its~~continue ~~net~~clinical ~~operating~~trials ~~loss~~for ~~carryforwards,~~the ~~tax~~Vyome ~~credits,~~Assets if we are unable to locate and ~~built-in~~enroll ~~items~~a sufficient number of ~~deduction,~~eligible ~~including~~patients ~~capitalized~~to ~~start-up~~participate in ~~costs~~these ~~and~~trials. ~~research~~Patient ~~and~~enrollment ~~development~~may ~~costs,~~be ~~has~~affected ~~been~~by various factors, ~~and~~including ~~may~~if ~~continue~~our tocompetitors behave ~~substantially~~ongoing ~~limited~~clinical ~~due~~trials tofor product ~~ownership~~candidates ~~changes.~~that ~~These~~are ~~ownership~~under ~~changes~~development ~~limit~~for the ~~amount~~same ofindications ~~net~~as ~~operating~~the ~~loss~~Vyome ~~carryforwards~~Assets, ~~credits~~ and ~~built-in~~patients ~~items~~instead ofenroll ~~deduction~~in ~~that~~such ~~can~~clinical trials. beOur ~~utilized~~inability ~~annually~~ to ~~offset~~enroll ~~future~~a ~~taxable~~sufficient ~~income.~~number Inof ~~general,~~patients anwould ~~ownership~~result ~~change,~~in assignificant ~~defined~~delays in ~~IRC~~completing ~~Section 382,~~clinical ~~results~~trials ~~from~~or areceipt of ~~transaction~~marketing approvals and increased development costs or ~~series~~may ofrequire ~~transactions~~us ~~over~~to aabandon ~~three-year~~one ~~period~~or ~~resulting~~more inclinical antrials ~~ownership~~altogether. ~~change~~In ofaddition, disruptions ~~more~~that ~~than~~can ~~50%~~be ofcaused by any pandemic may increase the ~~outstanding~~likelihood ~~stock~~that ofwe aencounter ~~company~~such bydifficulties ~~certain~~or ~~stockholders~~delays in initiating, enrolling, conducting or ~~public~~completing ~~groups~~our planned and ongoing clinical trials.

Adverse developments affecting the financial services industry could adversely affect the Combined Company’s current and projected business operations and its financial condition and results of operations.67

IfThe ~~financial~~results ~~institutions~~of inpreclinical ~~which~~testing ~~the~~and ~~Combined~~early clinical ~~Company~~trials ~~holds~~of ~~funds~~the ~~for~~Vyome ~~working~~Assets ~~capital~~may ~~and~~not ~~operating~~be ~~expenses~~predictive ~~were~~of tothe ~~fail,~~success ~~there~~of ~~can~~our belater noclinical ~~assurance~~trials, ~~that~~and ~~such~~the ~~governmental~~results ~~agencies~~of ~~would~~our ~~take~~clinical trials ~~action~~may tonot ~~protect~~satisfy the ~~Combined~~requirements ~~Company’s~~of ~~uninsured~~the ~~deposits~~FDA, inEMA, aor ~~similar~~other ~~manner~~comparable foreign regulatory authorities.

IfWe awill ~~financial~~be ~~institution~~required into ~~which~~demonstrate with substantial evidence through well-controlled clinical trials that the ~~Combined~~Vyome ~~Company~~Assets ~~holds~~are ~~such~~safe ~~funds~~and ~~fails~~effective before we can seek marketing approvals for commercial sale. Demonstrations of efficacy or isan ~~subject~~acceptable safety profile in prior preclinical studies of the Vyome Assets do not mean that future clinical trials will yield the same results, and the translational work that we need to ~~significant~~conduct ~~adverse~~may ~~conditions~~fail. inFor instance, we do not know whether the ~~financial~~Vyome Assets will perform in future preclinical or ~~credit~~clinical ~~markets,~~trials itas ~~could~~the beVyome ~~subject~~Assets have performed in preclinical studies and early clinical trials conducted. Vyome Assets may fail to ademonstrate ~~risk~~in oflater-stage ~~loss~~clinical trials sufficient safety and efficacy to the satisfaction of ~~all~~the orFDA, aEMA, ~~portion~~and other comparable foreign regulatory authorities despite having progressed through preclinical studies and earlier stage clinical trials. Regulatory authorities may also limit the scope of ~~such~~later-stage ~~uninsured~~trials ~~funds~~until we orhave bedemonstrated ~~subject~~satisfactory tosafety aor ~~delay~~efficacy results in ~~accessing~~preclinical ~~all~~studies or aearlier-stage ~~portion~~trials, ofwhich ~~such~~could ~~uninsured~~prevent ~~funds~~us from conducting the clinical trials we currently anticipate. ~~Any~~There ~~such~~is ~~loss~~no guarantee that the FDA, EMA, and other comparable foreign regulatory authorities will consider the data obtained from prior trials sufficient to allow us to initiate the planned trials for Vyome products within the timelines we anticipate, or ~~lack~~at ofall. ~~access~~Even if we are able to ~~these~~initiate ~~funds~~our ~~could~~planned ~~adversely~~clinical ~~impact~~trial on schedule, there is no guarantee that we will be able to complete such trial on the ~~Combined~~timelines ~~Company’s~~we ~~short-term~~anticipate ~~liquidity~~or ~~and~~that such trial will produce positive results. Any limitation on our ability to ~~meet~~conduct ~~its~~clinical ~~operating~~trials ~~expense~~could ~~obligations~~delay or prevent regulatory approval or limit the size of the patient population that can be treated by the Vyome Assets, if approved.

InPreclinical ~~addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs~~ and ~~tighter~~clinical ~~financial~~development ~~and~~involves a ~~operating~~lengthy ~~covenants, or systemic limitations on access to credit~~ and ~~liquidity~~expensive ~~sources,~~process ~~thereby~~with ~~making~~uncertain ~~it more difficult for the Combined Company to acquire financing on acceptable terms or at all. Any decline in available funding or access to the Combined Company’s cash and liquidity resources could~~outcomes, ~~among other risks, adversely impact its ability to meet its operating expenses, financial obligations or fulfill our other obligations, result in breaches of its financial~~ and~~/or~~ ~~contractual~~results ~~obligations or result in violations~~ of ~~federal~~earlier orstudies ~~state wage~~ and ~~hour~~trials ~~laws.~~may ~~Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors~~ not ~~described~~be ~~above,~~predictive ~~could~~of ~~have~~future ~~material~~clinical trial ~~adverse impacts on the Combined Company’s liquidity and our current and/or projected business operations and financial condition and~~ results ~~of operations~~.

InBefore ~~addition~~obtaining marketing approval from regulatory authorities for commercialization of the Vyome Assets, awe ~~vendor~~must oncomplete ~~which~~clinical trials to demonstrate the ~~Combined~~safety and ~~Company~~efficacy isof ~~reliant~~the ~~could~~Vyome Assets in humans and in selected diseases. Our clinical trials may not be ~~adversely~~conducted ~~affected~~as byplanned or completed on schedule, if at all, and a failure of one or more clinical trials can occur at any stage. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the ~~liquidity~~success orof ~~other~~later ~~risks~~clinical ~~that~~trials, ~~are~~and ~~described~~the ~~above~~outcome asof ~~factors~~preclinical ~~that~~studies ~~could~~and ~~result~~early-stage clinical intrials ~~material~~for ~~adverse~~a ~~impacts,~~product ~~including~~candidate ~~but~~for a particular indication may not ~~limited~~be predictive of the success of preclinical studies and early-stage clinical trials for the same product candidate for a different indication. In particular, we plan to ~~delayed~~initiate ~~access~~a orPhase ~~loss~~3 oftrial ~~access~~evaluating VT-1953 in patients for treating malodor in malignant fungating wounds subject to ~~uninsured~~protocol ~~deposits~~is orapproved ~~loss~~by ofFDA. If these Phase 3 trials are successful, we could potentially file a new drug application with the ~~ability~~FDA. The above Phase 3 trial and next steps are likely to ~~draw~~require additional funding. Although data generated till now on ~~existing~~VT-1953 ~~credit~~in ~~facilities~~patients ~~involving~~with malignant fungating wounds may not yield similar results. If a ~~troubled~~Phase 3 study is conducted for VT-1953 in patients with malignant fungating wounds the outcome may be different than desired outcome or outcome based on any earlier data. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed ~~financial~~to ~~institution~~obtain marketing approval of their product candidates.

~~Any~~We ~~critical~~cannot ~~vendor~~guarantee ~~bankruptcy~~that any clinical trials will be initiated or ~~insolvency~~conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of an investigational new drug application (“IND”) or similar application for any ~~breach~~of our products will result in the FDA, EMA, or ~~default~~other byregulatory authority, as applicable, allowing clinical trials to begin in a ~~critical~~timely ~~vendor~~manner, if at all. Moreover, even if these trials begin, issues may arise that could cause regulatory authorities to suspend or ~~the~~terminate ~~loss~~such clinical trials. Events that may prevent successful or timely initiation or completion of ~~any~~clinical ~~significant~~trials include: ~~vendor~~inability ~~relationships~~to generate sufficient preclinical, ~~may~~toxicology ~~have~~or other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a ~~material~~consensus ~~adverse~~with ~~impact~~regulatory authorities on study design or implementation of the ~~Combined~~clinical ~~Company~~trials; delays or failure in obtaining regulatory authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; delays in identifying, recruiting and training suitable clinical investigators; delays in obtaining required institutional review board (“IRB”) approval at each clinical trial site; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of the Vyome Assets for use in clinical trials or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or ~~business~~any other regulatory authority’s good clinical practice requirements (“GCPs”) or applicable regulatory guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial; changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; transfer of manufacturing processes to larger- scale facilities operated by a contract manufacturing organization (“CMO”) and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; and third parties being unwilling or unable to satisfy their contractual obligations to us. In addition, disruptions caused by any pandemic may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials.

If the Combined Company is unable to develop and maintain an effective system of internal control over financial reporting, it may not be able to accurately report its financial results in a timely manner, which may adversely affect investor confidence in the Combined Company and materially and adversely affect its business and operating results.68

AWe ~~material~~could ~~weakness~~also isencounter delays if a ~~deficiency~~clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such clinical trials are being conducted, by the Data Safety Monitoring Board, if any, for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspend or terminate a ~~combination~~clinical trial due to a number of ~~deficiencies~~factors, including failure to conduct the clinical trial in ~~internal~~accordance ~~control~~with ~~over~~regulatory requirements ~~financial~~or ~~reporting~~our ~~such~~clinical ~~that~~trial ~~there~~protocols, isinspection of the clinical trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition of a ~~reasonable~~clinical ~~possibility~~hold, ~~that~~unforeseen safety issues or adverse side effects, failure to demonstrate a benefit ~~material~~from ~~misstatement~~the Vyome Assets, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical ~~Combined~~trial. ~~Company’s~~If ~~annual~~we are required to conduct additional clinical trials or ~~interim~~other ~~financial~~testing ~~statements~~of ~~will~~the Vyome Assets beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of the Vyome Assets, if the results of these trials are not bepositive or ~~prevented~~are only moderately positive or ~~detected~~if there are safety concerns, our business and ~~corrected~~results onof aoperations ~~timely~~may ~~basis~~be adversely affected and we may incur significant additional costs.

~~Effective~~Preliminary, ~~internal~~interim ~~controls~~data ~~are~~from ~~necessary~~our toclinical trials ~~provide~~that ~~reliable~~we ~~financial~~announce ~~reports~~or ~~and~~publish ~~prevent~~may ~~fraud.~~change ~~While~~as ~~the~~more ~~Combined~~patient ~~Company~~data ~~intends~~become toavailable ~~have systems~~ and ~~processes~~are insubject ~~place~~ to ~~identify~~audit and ifverification ~~necessary, continues to evaluate steps to remediate the material weakness~~procedures. ~~These remediation measures may be time consuming and costly and there is no assurance that these initiatives will ultimately have the intended effects.~~

47From time to time, we may publicly disclose preliminary data from our preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. We might also make assumptions, estimations, calculations and conclusions as part of our analyses of these data without the opportunity to fully and carefully evaluate complete data. As a result, the preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.

~~Table~~From time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data are subject to the risk that one or more of the ~~Contents~~clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the Vyome Assets and our company in general. In addition, the information we choose to publicly disclose regarding a particular preclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the preliminary, or interim data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, the Vyome Assets may be harmed, which could harm our business, operating results, prospects or financial condition.

IfWe ~~the~~may ~~Combined~~develop ~~Company~~the ~~identifies~~Vyome ~~any~~Assets ~~new material weaknesses~~ in ~~the~~combination with ~~future~~other therapies, ~~any~~which ~~such~~exposes ~~newly~~us ~~identified~~to ~~material~~additional ~~weakness~~risks ~~could~~related ~~limit its ability~~ to ~~prevent~~other agents or ~~detect~~active apharmaceutical ~~misstatement of its accounts~~ or ~~disclosures~~biological ~~that~~ingredients used ~~could result~~ in acombination ~~material misstatement of its annual or interim financial statements. In such case, the Combined Company may be unable to maintain compliance~~ with ~~securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in~~ the ~~Combined~~Vyome ~~Company’s financial reporting and its share price may decline as a result~~Assets.

~~The~~In ~~Combined~~the ~~Company~~future, ~~will~~we ~~incur~~may ~~increased~~develop the ~~costs~~Vyome asAssets ato ~~result~~be used with one or more currently approved other therapies. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or other regulatory authorities could revoke approval of ~~operating~~the astherapy aused ~~public~~in ~~company~~combination with the Vyome Assets or that safety, efficacy, ~~and~~manufacturing ~~its~~or ~~management~~supply ~~will~~issues ~~devote~~could ~~substantial~~arise ~~time~~with tothese ~~related~~existing ~~compliance~~therapies. ~~initiatives~~This could result in our own products being removed from the market or being less successful commercially.

AsIf ~~a public company,~~ the ~~Combined~~FDA ~~Company~~or ~~will incur significant legal, accounting and~~ other ~~expenses~~regulatory ~~that~~authorities revoke ~~Vyome~~their ~~did~~approval ~~not~~of ~~incur~~these asother adrugs ~~private~~or ~~company.~~revoke ~~The~~their ~~Combined~~approval ~~Company will be subject to the reporting requirements~~ of ~~the Securities Exchange Act of 1934~~, asor ~~amended~~if ~~(the “Exchange Act”)~~safety, ~~the Sarbanes-Oxley Act~~efficacy, ~~the~~manufacturing ~~Dodd-Frank~~or ~~Wall~~supply ~~Street~~issues ~~Reform~~arise ~~and Consumer Protection Act (the “Dodd-Frank Act”)~~with, ~~as well as rules and regulations adopted, and to be adopted, by~~ the ~~SEC~~drugs ~~and~~we ~~Nasdaq.~~choose ~~The Combined Company’s management and other personnel will need~~ to ~~devote~~evaluate ain ~~substantial~~combination ~~amount~~with ofany ~~time~~product tocandidate ~~these~~we ~~compliance initiatives. Moreover~~develop, ~~the~~we Combined Company expects these rules and regulations to substantially increase its legal and financial compliance costs and to make some activities more time-consuming and costly, which will increase its operating expenses. For example, the Combined Company expects these rules and regulations to make it more difficult and more expensive for the Combined Company to obtain directors’ and officers’ liability insurance and the Combined Company may be ~~required~~unable to ~~incur~~obtain ~~substantial costs to maintain sufficient coverage~~approval. The Combined Company cannot predict or estimate the amount or timing of additional costs it may incur to respond to these requirements. The impact of these requirements could also make it more difficult for the Combined Company to attract and retain qualified persons to serve on its board, its board committees or as executive officers. Advocacy efforts by shareholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase costs.

AsWe amay ~~public~~also ~~company,~~evaluate the ~~Combined~~Vyome Assets ~~Company~~and ~~will~~other befuture ~~required~~product tocandidates ~~incur additional costs and obligations~~ in ~~order~~combination ~~to comply~~ with ~~SEC~~one ~~rules that~~or ~~implement~~more ~~Section 404~~other oftherapies ~~the~~that ~~Sarbanes-Oxley~~have ~~Act.~~not ~~Under~~yet ~~these~~been ~~rules,~~approved ~~the~~for ~~Combined~~marketing by ~~Company will be required to make a formal assessment of~~ the ~~effectiveness~~FDA ofor ~~its~~other ~~internal~~regulatory ~~control~~authorities. ~~over~~We ~~financial~~will ~~reporting,~~not ~~and once it ceases to~~ be anable ~~emerging growth company, the Combined Company will be required~~ to ~~include~~market anany ~~attestation~~product ~~report~~candidate onwe ~~internal~~develop ~~control~~in ~~over~~combination ~~financial~~with ~~reporting~~any ~~issued~~such unapproved bytherapies ~~its~~that ~~independent~~do ~~registered~~not ~~public~~ultimately ~~accounting~~obtain ~~firm~~marketing approval. ToIn ~~achieve~~addition, ~~compliance~~unapproved ~~with~~therapies ~~Section 404~~face of the ~~Sarbanes-Oxley~~same ~~Act~~risks ~~within~~described with ~~the~~respect ~~prescribed~~to ~~period,~~ the ~~Combined~~Vyome ~~Company~~Assets ~~will~~currently ~~be engaging~~ in adevelopment ~~process to document~~ and ~~evaluate~~clinical ~~its internal control over financial reporting~~trials, ~~which~~including ~~is both costly and challenging. In this regard,~~ the ~~Combined~~potential ~~Company~~for ~~will~~serious ~~need~~adverse ~~to continue to dedicate internal resources~~effects, ~~potentially~~delays in ~~engage~~their ~~outside~~clinical ~~consultants~~trials and ~~adopt~~lack ~~a detailed work plan to assess and document the adequacy~~ of ~~its~~FDA internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reportingapproval.

The rules governing the standards that must be met for management to assess the Combined Company’s internal control over financial reporting are complex and require significant documentation, testing and possible remediation to meet the detailed standards under the rules. During the course of its testing, the Combined Company’s management may identify material weaknesses or deficiencies which may not be remedied in time to meet the deadline imposed by the Sarbanes-Oxley Act. These reporting and other obligations place significant demands on the Combined company’s management and administrative and operational resources, including accounting resources.69

48VT-1953 and VT-1908 may have a safety profile that could prevent regulatory approval, marketing approval or market acceptance, or limit its commercial potential.

~~Table~~If VT-1953 and VT-1908 is associated with undesirable side effects or has unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or INDs, we may need to interrupt, delay or abandon VT-1953 and VT-1908 development or limit development to more narrow uses or subpopulations in which such potential undesirable side effects or other characteristics (including but not limited, to local safety at the site of ~~Contents~~application, and systemic side effects based on the levels systemic drug concentrations and any other unknown adverse events) may be less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may prevent us from achieving or maintaining market acceptance of VT-1953 and VT-1908, and may adversely affect our business, financial condition and prospects significantly.

~~In addition~~Additionally, ~~changing~~after ~~laws~~VT-1953 or VT-1908 may receive marketing approval, ~~regulations~~we ~~and~~or ~~standards~~others ~~relating~~may tolater ~~corporate~~identify ~~governance~~undesirable ~~and~~side ~~public~~effects ~~disclosure~~or ~~are~~adverse ~~creating~~events ~~uncertainty~~caused ~~for~~by ~~public~~VT-1953 or ~~companies,~~VT-1908. ~~increasing~~In ~~legal~~such ~~and~~cases, ~~financial~~regulatory ~~compliance~~authorities ~~costs~~may ~~and~~suspend, ~~making~~limit ~~some~~or ~~activities~~withdraw ~~more~~approvals ~~time~~of VT-~~consuming.~~1953 ~~These~~or ~~laws,~~VT-1908 ~~regulations~~or ~~and~~seek ~~standards~~an ~~are~~injunction against ~~subject~~its tomanufacture ~~varying~~or ~~interpretations~~distribution, inrequire ~~many~~additional ~~cases~~warnings ~~due~~on tothe ~~their~~label, ~~lack~~including ~~of specificity~~“boxed” warnings, ~~and,~~or asissue asafety ~~result~~alerts, ~~their~~require ~~application~~press inreleases ~~practice~~or ~~may~~other ~~evolve~~communications ~~over~~containing ~~time~~warnings asor ~~new~~other ~~guidance~~safety isinformation ~~provided~~about VT-1953 byor ~~regulatory~~VT-1908, ~~and~~require ~~governing~~us ~~bodies.~~to ~~This~~change ~~could~~the ~~result~~way inVT-1953 ~~continuing~~or ~~uncertainty~~VT-1908 ~~regarding~~is ~~compliance~~administered ~~matters~~or ~~and~~conduct ~~higher~~additional ~~costs~~clinical ~~necessitated~~trials byor ~~ongoing~~post-approval studies, ~~revisions~~require us to ~~disclosure~~create a risk evaluation and ~~governance~~mitigation ~~practices.~~strategy ~~The~~(“REMS”) which ~~Combined~~could ~~Company~~include ~~intends~~a tomedication ~~invest~~guide ~~resources~~outlining the risks of such side effects for distribution to ~~comply~~patients ~~with~~or ~~evolving~~impose ~~laws~~fines, ~~regulations~~injunctions or ~~and~~criminal ~~standards,~~penalties. We could also be sued and ~~this~~held ~~investment~~liable ~~may~~for ~~result~~harm incaused ~~increased~~to ~~general~~patients, and ~~administrative~~our ~~expenses~~reputation ~~and~~may asuffer. ~~diversion~~Any of ~~its~~these events ~~management’s~~could ~~time~~prevent ~~and~~us ~~attention~~ from ~~revenue-generating~~achieving ~~activities~~or tomaintaining ~~compliance~~market ~~activities.~~acceptance Ifof ~~the~~VT-1953 ~~Combined~~or ~~Company’s~~VT-1908, ~~efforts~~if toapproved, ~~comply~~and ~~with~~could ~~new~~seriously ~~laws,~~harm ~~regulations~~our business. ~~and~~In ~~standards~~addition, ~~differ~~approval ~~from~~policies, regulations, or the ~~activities~~type ~~intended~~and byamount ~~regulatory~~of preclinical or ~~governing~~clinical ~~bodies~~data ~~due~~necessary to ~~ambiguities~~gain ~~related~~approval may tochange ~~their~~during ~~application~~the course of clinical development of VT-1953 and ~~practice,~~VT-1908 ~~regulatory~~and ~~authorities~~may vary among jurisdictions, which may ~~initiate~~cause ~~legal~~delays ~~proceedings~~in the ~~against~~approval or the ~~Combined~~decision ~~Company~~not ~~and~~to ~~there~~approve ~~could~~an beapplication. aRegulatory ~~material~~authorities ~~adverse~~have ~~effect~~substantial ondiscretion in the ~~Combined~~approval ~~Company’s~~process and ~~business,~~may ~~financial~~refuse ~~condition~~to accept any application or may decide that our data is insufficient for approval and ~~results~~require ofadditional ~~operations~~preclinical, clinical or other studies.

Certain of the Combined Company’s proposed directors and executive officers also work with other companies and organizations and such other positions may create conflicts of interest in the future.

Some of the Combined Company’s officers and directors will serve only part-time and are subject to conflicts of interest. Each of such officers and directors will be devoting part of their working time to other endeavors, including consulting relationships with other entities, and may have responsibilities to these other entities. Such conflicts may also include deciding how much time to devote to the Combined Company’s affairs. Because of these relationships, our officers and directors may be subject to conflicts of interest.

For example, Venkat Nelabhotla, Vyome’s Chief Executive Officer and who will be the Chief Executive Officer of the Combined Company, will be devoting approximately 40 hours per week to the Combined Company’s business. Mr. Nelabhotla also works part-time in a consulting/ advisory capacity for Pulse Pharmaceuticals Private Limited and Newvojax Health and Wellness Private Limited for approximately 15 hours per week. Mr. Shiladitya Sengupta, one of the co-founders and directors of Vyome, will also be a director on the board of the Combined Company. He works full-time as an Associate Professor of Medicine at the Brigham and Women’s Hospital and Harvard Medical School and will be dedicating his time to the Combined Company on a limited, as-needed basis. Mr. Sengupta also works in a consulting capacity for Alyssum Therapeutics Inc, CBCC, Invictus Oncology Pvt Ltd, India Innovation Research Center for approximately 4 hours per week. Further, Robert Dickey, Vyome’s Chief Financial Officer and who will be the Chief Financial Officer of the Combined Company, will be working with the Combined Company for 50% of his available time or a minimum of 80 hours per month. While Vyome has not, and Vyome believes that the Combined Company will not, encounter any issue as a result of such additional roles/ responsibilities, the duties to such businesses/ organizations may compete for such persons’ full attention to the Combined Company’s business; accordingly, they may have conflicts of interest in allocating time between the separate business activities.

General economic and political conditions could have a material adverse effect on the Combined Company.

External factors can affect our financial condition. Such external factors include general domestic and global economic conditions, such as interest rates, tax law including tax rate changes, and factors affecting global economic stability, and the political environment regarding healthcare in general. We cannot predict to what extent the global economic conditions may negatively impact the Combined Company’s business. For example, negative conditions in the credit and capital markets could impair our ability to access the financial markets for working capital and could negatively impact our ability to borrow.

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If the Combined Company’s competitors are able to develop and market products that are safer or more effective than the Combined Company’s products, its commercial opportunities will be reduced or eliminated.

The health care industry is highly competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. The immune-inflammatory disease market in which the Combined Company intends to operate has grown significantly in recent years and is expected to continue to expand as technology continues to evolve and awareness of the need to treat immune-inflammatory diseases grows. The Combined Company will face potential competition from several big pharma and mid/small size biotech and pharma companies. Many of the Combined Company’s competitors will likely have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, obtaining regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly if they pursue competing solutions through collaborative arrangements with large and established companies. The Combined Company’s competitors may develop and patent processes or products earlier than it, obtain regulatory approvals for competing products more rapidly than the Combined Company is able to and develop more effective, safer and less expensive products or technologies that would render its products non-competitive or obsolete.

The Combined Company may face significant uncertainty in the industry due to government healthcare reform.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. The Patient Protection and Affordable Care Act, as amended, (the “Affordable Care Act”) as well as any future healthcare reform legislation, may have a significant impact on our business. The impact of the Affordable Care Act on the health care industry is extensive and includes, among other things, the federal government assuming a larger role in the health care system, expanding healthcare coverage of United States citizens and mandating basic healthcare benefits.

Congress regularly considers legislation to replace or repeal elements or all of the Affordable Care Act. At this time, it is not clear whether the Affordable Care Act will be repealed in whole or in part, and, if it is repealed, whether it will be replaced in whole or in part by another plan and what impact those changes will have on coverage and reimbursement for healthcare items and services covered by plans that were authorized by the Affordable Care Act. Additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and also indirectly affect the amounts that private payers are willing to pay. In addition, any healthcare reforms enacted in the future may, like the Affordable Care Act, be phased in over a number of years but, if enacted, could reduce the Combined Company’s revenue, increase our costs, or require us to revise the ways in which we conduct business or put it at risk for loss of business. In addition, our results of operations, financial position and cash flows could be materially adversely affected by changes under the Affordable Care Act and changes under any federal or state legislation adopted in the future.

The Combined Company may be subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and the Combined Company may become subject to such litigation. If the Combined Company is unable to, or have not fully complied with such laws, it could face substantial penalties.

The Combined Company’s operations, directly or indirectly through customers, may be subject to various state and federal fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act. These laws may impact, among other things, our sales, marketing and education programs.

The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. The Anti- Kickback Statute is broad and, despite a series of narrow safe harbors, prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.

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The Combined Company may be unable to predict whether it could be subject to actions under any of these laws, or the impact of such actions. If the Combined Company is found to be in violation of any of the laws described above or other applicable state and federal fraud and abuse laws, it may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring of its operations.

Failure to protect the Combined Company’s information technology infrastructure against cyber-based attacks, network security breaches, service interruptions or data corruption could materially disrupt its operations and adversely affect its business.

The operation of the Combined Company’s business will depend on our information technology systems. It will rely on its information technology systems to, among other things, effectively manage sales and marketing data, accounting and financial functions, inventory management, product development tasks, clinical data, customer service and technical support functions. Its information technology systems may be vulnerable to damage or interruption from earthquakes, fires, floods and other natural disasters, terrorist attacks, power losses, computer system or data network failures, security breaches, data corruption, and cyber-based attacks. Cyber-based attacks can include computer viruses, computer denial-of-service attacks, phishing attacks, worms, and other malicious software programs or other attacks, covert introduction of malware to computers and networks, impersonation of authorized users, and efforts to discover and exploit any design flaws, bugs, security vulnerabilities, or security weaknesses, as well as intentional or unintentional acts by employees or other insiders with access privileges, intentional acts of vandalism by third parties and sabotage. In addition, federal, state, and international laws and regulations, such as the General Data Protection Regulation adopted by the European Union and European Economic Area countries can expose the Combined Company to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if the Combined Company’s information technology security efforts fail.

The Combined Company may in the future become involved in lawsuits, to protect or enforce its intellectual property, which can be expensive and time consuming and could result in the diversion of significant resources.

Adverse proceedings such as litigation or challenges to the validity of our patents can be expensive, time consuming and may divert the efforts of our technical and managerial personnel, which could in turn harm its business, whether or not it receives a favorable determination. In addition, in an infringement or other adverse proceeding, a court may decide that the patent the Combined Company seeks to enforce is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that the patent in question does not cover the technology in question. An adverse result in any litigation or proceeding could place one or more of the Combined Company’s patents at risk of being invalidated, interpreted narrowly or found unenforceable. Some of its competitors may be able to devote significantly more resources to intellectual property litigation, and may have significantly broader patent portfolios to assert against the Combined Company, if it asserts rights against them.

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The Combined Company may lose important patents or patent rights if it does not timely pay required patent fees or annuities.

Non-payment or delay in payment of patent fees or annuities, whether intentional or unintentional, may result in loss of patents or patent rights important to the Combined Company’s business. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States, particularly in the field of medical products.

Many of the Combined Company’s competitors may have significant resources and incentives to apply for and obtain intellectual property rights that could limit or prevent its ability to commercialize our current or future products in the United States or abroad.

Many of the Combined Company’s competitors who have significant resources and have made substantial investments in competing technologies may seek to apply for and obtain patents that will prevent, limit or interfere with our ability to make, use or sell our products either in the U.S. or in international markets. The Combined Company’s U.S. or foreign patents may be challenged, circumvented by competitors or others or may be found to be invalid, unenforceable or insufficient. In most cases in the United States patent applications are published 18 months after filing the application, or corresponding applications are published in other countries, and since publication of discoveries in the scientific or patent literature often lag behind actual discoveries, there can be no certainty that the Combined Company was the first to make the inventions covered by each of its pending patent applications, or that it was the first to file patent applications for such inventions.

If the Combined Company is unable to protect the confidentiality of our proprietary information and know-how, the value of its technology and products could be adversely affected.

In addition to patented technology, the Combined Company may rely on its unpatented proprietary technology, trade secrets, processes and know-how. It would generally seek to protect this information by confidentiality agreements with employees, consultants, scientific advisors and third parties. These agreements may be breached, and the Combined Company may not have adequate remedies for any such breach. In addition, its trade secrets may otherwise become known or be independently developed by competitors. To the extent that the Combined Company’s employees, consultants or contractors use intellectual property owned by others in their work for the Combined Company, disputes may arise as to the rights in related or resulting know-how and inventions.

Intellectual property litigation is a common tactic in the biotech industry to gain competitive advantage. If the Combined Company becomes subject to a lawsuit, it may be required to expend significant financial and other resources and our management’s attention may be diverted from its business.

There has been a history of frequent and extensive litigation regarding patent and other intellectual property rights in the biotech industry, and companies in the biotech industry have employed intellectual property litigation to gain a competitive advantage. Accordingly, the Combined Company may become subject to patent infringement claims or litigation in a court of law, or interference proceedings declared by the U.S. Patent and Trademark Office (“USPTO”) to determine the priority of inventions or an opposition to a patent grant in a foreign jurisdiction. It may also become subject to claims or litigation seeking payment of royalties based on sales of its product in connection with licensing or similar joint development arrangements with third parties or in connection with claims of patent infringement.

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The defense and prosecution of intellectual property suits, USPTO interference proceedings, reexamination proceedings, or under more recently promulgated Inter Partes Review proceedings, depending on when the patent application was filed, or opposition proceedings and related legal and administrative proceedings, are both costly and time consuming and could result in substantial uncertainty to us. Litigation or regulatory proceedings may also be necessary to enforce patent or other intellectual property rights of ours or to determine the scope and validity of other parties’ proprietary rights. Any litigation, opposition or interference proceedings, with or without merit, may result in substantial expense to us, cause significant strain on the Combined Company’s financial resources, divert the attention of its technical and management personnel and harm its reputation. The Combined Company may not have the financial resources to defend its patents from infringement or claims of invalidity. An adverse determination in any litigation could subject us to significant liabilities to third parties, require it to seek licenses from or pay royalties to third parties or prevent it from manufacturing, selling or using our proposed products, any of which could have a material adverse effect on its business and prospects.

As a result of patent infringement claims, or to avoid potential claims, the Combined Company may choose or be required to seek a license from a third-party and be required to pay license fees or royalties, or both. A license may not be available at all or on commercially reasonable terms, and the Combined Company may not be able to redesign its products to avoid infringement. Modification of our products or development of new products could require it to conduct additional clinical trials and to revise our filings with the FDA and other regulatory bodies, which would be time-consuming and expensive. Even if the Combined Company were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be forced to cease some aspect of its business operations if, as a result of actual or threatened patent infringement claims, it is unable to enter into licenses on acceptable terms. This could harm our business significantly.

Risks Related to the Asset Sale

While the Asset Sale is pending, it creates unknown impacts on our future which could materially and adversely affect its business, financial condition and results of operations.

While the Asset Sale is pending, it creates unknown impacts on our future. Therefore, our current or potential business partners may decide to delay, defer or cancel entering into new business arrangements with ReShape pending consummation of the Asset Sale. The occurrence of these events individually or in combination could materially and adversely affect our business, financial condition and results of operations.

The failure to consummate the Asset Sale may materially and adversely affect our business, financial condition and results of operations.

The Asset Sale is subject to various closing conditions including, among others, the approval of the Asset Sale by ReShape’s stockholders. ReShape cannot control these conditions and cannot assure you that they will be satisfied. If the Asset Sale is not consummated, ReShape may be subject to a number of risks, including the following:

● we may not be able to identify an alternate transaction, or if an alternate transaction is identified, such alternate transaction may not result in equivalent terms as compared to what is proposed in the Asset Sale;

● the trading price of our common stock may decline to the extent that the current market price reflects a market assumption that the Asset Sale will be consummated;

● doubt as to our ability to effectively implement its current and future business strategies;

● our costs related to the Asset Sale, such as legal, accounting and financial advisory fees, must be paid even if the Asset Sale is not completed; and

● our relationships with its customers, suppliers and employees may be damaged and its business may be harmed.

The occurrence of any of these events individually or in combination could materially and adversely affect our business, financial condition and results of operations, which could cause the market value of our common stock to decline.

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The Merger may be consummated despite the Asset Sale not closing under certain circumstances.

While the closing of the Merger is conditioned on the closing of the Asset Sale, if we fail to consummate the Asset Sale, the Merger may still proceed, provided that the closing condition related to the closing of the Asset Sale contained in the Merger Agreement is waived by Vyome. The occurrence of these events would result in the Combined Company continuing to own the assets currently contemplated to be sold to Ninjour as part of the Asset Sale following the closing of the Merger, which could cause the Combined Company to incur unanticipated costs and expenses in connection with continued ownership of such assets, or pursuit of an alternative disposition of such assets. Further, in such an event, the Combined Company may also be subject to any disputes/ litigation filed in respect of the assets to be sold as part of the Asset Sale. Any such liabilities or problems could have an adverse effect on the Combined Company’s business, financial condition, results of operations or cash flows.

Risks Associated with Development and Commercialization of ReShape’s Lap-Band System, Lap-Band 2.0 System, Obalon Balloon System, and the DBSN Device

Our efforts to increase revenue from our Lap-Band System, Lap-Band 2.0 System, and commercialize our DBSN device and expanded line of bariatric surgical accessories, including ReShape Calibration Tubes, may not succeed or may encounter delays which could significantly harm our ability to generate revenue.

Our ability to generate revenue will depend upon the sales of our Lap-Band System, expanded line of bariatric surgical accessories and successful commercialization of our DBSN device (if approved for sale). Our efforts to commercialize these products may not succeed for a number of reasons, including:

● we may not be able to obtain the regulatory approvals required for our DBSN device;

● we may not be able to produce the Obalon Balloon System cost-effectively;

● if we are able to produce the Obalon Balloon System, we may not be able to re-introduce the system into the marketplace;

● our products may not be accepted in the marketplace by physicians, patients and third-party payers;

● the price of our products, associated costs of the surgical procedure and treatment and the availability of sufficient third-party reimbursement for the system implantation and follow-up procedures;

● appropriate reimbursement and/or coding options may not exist to enable billing for the system implantation and follow-up procedures for our DBSN device;

● coverage policies for bariatric surgeries and procedures, including Lap-Band and balloons may be restricted in the future;

● we may not be able to sell our products at a price that allows us to meet the revenue targets necessary to generate enough revenue for profitability;

● the frequency and severity of any side effects of our products;

● physicians and potential patients may not be aware of the perceived effectiveness and sustainability of the results of our products;

● we, or the investigators of our products, may not be able to have information on the outcome of the trials published in medical journals;

● the availability and perceived advantages and disadvantages of alternative treatments, including pharmaceutical treatments;

● any rapid technological change may make our products obsolete;

● we may not be able to have our products manufactured in commercial quantities or at an acceptable cost;

● we may not have adequate financial or other resources to complete the development and commercialization of our products or to develop sales and marketing capabilities for our products; and

● we may be sued for infringement of intellectual property rights and could be enjoined from manufacturing or selling our products.

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Besides requiring physician adoption, market acceptance of our products will depend on successfully communicating the benefits of our products to three additional constituencies involved in deciding whether to treat a particular patient using our products: (1) the potential patients themselves; (2) institutions such as hospitals, where the procedure would be performed and opinion leaders in these institutions; and (3) third-party payers, such as private healthcare insurers and governmental payers, such as Medicare and Medicaid in the United States, which would ultimately bear most of the costs of the various providers and equipment involved in our Lap-Band System, Obalon Balloon System, and DBSN device (if approved for sale). Marketing to each of these constituencies requires a different marketing approach, and we must convince each of these groups of the efficacy and utility of our products to be successful.

During the years ended December 31, 2024 and 2023, there was minimal revenue for ReShapeCare and ReShape Marketplace. There was no revenue or gross profit recorded for the DBSN device for the year ended December 31, 2024 and 2023 as this product is still in the research stage of development. There was also no revenue recorded for the Obalon line.

If our products, or any other therapy or products that we may develop for other gastrointestinal diseases and disorders that we may develop, do not achieve an adequate level of acceptance by the relevant constituencies, we may not generate significant product revenue and may not become profitable. This estimated timeline could be compressed or extended depending on many factors, including revenue growth from new product introductions, strategic investments not yet foreseen, and other risks and uncertainties due to the general business, economic, regulatory, market and financial conditions. Therefore, the plans cannot be deemed probable of being implemented. As a result, the Company’s plans do not alleviate substantial doubt about our ability to continue as a going concern.

We may not be able to obtain required regulatory approvals for our DBSN device in a cost-effective manner or at all, which could adversely affect our business and operating results.

The production and marketing of our DBSN device, and our ongoing research and development, preclinical testing and future potential clinical trial activities are subject to extensive regulation and review by numerous governmental authorities both in the United States and abroad. U.S. and foreign regulations applicable to medical devices are wide-ranging and govern, among other things, the development, testing, marketing and premarket review of new medical devices, in addition to regulating manufacturing practices, reporting, advertising, exporting, labeling and record keeping procedures. We are required to obtain regulatory approval before we can market our DBSN device in the United States and certain foreign countries. The regulatory process will require significant time, effort and expenditures to bring products to market, and it is possible that our DBSN device will not be approved for sale. Even if regulatory approval of our DBSN device is granted, it may not be granted within the timeframe that we expect, which could have an adverse effect on our operating results and financial condition. Even after our DBSN device is approved by the FDA, we may have ongoing responsibilities under FDA regulations, non-compliance of which could result in the subsequent withdrawal of such approvals, or such approvals could be withdrawn due to the occurrence of unforeseen problems following initial approval. We also are subject to medical device reporting regulations that require us to report to the FDA if any of our products causes or contributes to a death or serious injury or if a malfunction were it to occur might cause or contribute to a death or serious injury. Any failure to obtain regulatory approvals on a timely basis or the subsequent withdrawal of such approvals could prevent us from successfully marketing our products, which could adversely affect our business and operating results.

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We depend on clinical investigators and clinical sites to enroll patients in our clinical trials, and on other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays that are outside of our control.

While we currently do not have any active clinical trials enrolling patients, we may in the future need to rely on clinical investigators and clinical sites to enroll patients in our clinical trials and other third parties to manage the trials and to perform related data collection and analysis. However, we may not be able to control the amount and timing of resources that clinical sites may devote to our clinical trials. If these clinical investigators and clinical sites fail to enroll a sufficient number of patients in our clinical trials, ensure compliance by patients with clinical protocols or comply with regulatory requirements, we will be unable to complete these trials, which could prevent us from obtaining or maintaining regulatory approvals for our product. Our agreements with clinical investigators and clinical trial sites for clinical testing place substantial responsibilities on these parties and, if these parties fail to perform as expected, our trials could be delayed or terminated. If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated, or the clinical data may be rejected by the FDA, adversely affecting our ability to successfully commercialize our product.

Modifications to the Lap-Band and Lap-Band 2.0 system may require additional approval from regulatory authorities, which may not be obtained or may delay our commercialization efforts.

The FDA and our European Notified Body require medical device companies to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance; however, some of these regulatory authorities can review a company’s decision. Any modifications to an approved device that could significantly affect its safety or efficacy, or that would constitute a major change in its intended use could require additional clinical studies and separate regulatory applications. Product changes or revisions will require all the regulatory steps and associated risks discussed above possibly including testing, regulatory filings and clinical studies. We may not be able to obtain approval of supplemental regulatory approvals for product modifications, new indications for our product or new products. Delays in obtaining future clearances would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our commercialization efforts and future growth.

If we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated product problems, our Lap-Band system could be subject to restrictions or withdrawal from the market.

Any product for which we obtain marketing approval, along with the manufacturing processes, post- approval clinical data and promotional activities for such product, will be subject to continual review and periodic inspections by our European Notified Body and the FDA and other regulatory bodies. In particular we and our manufacturers and suppliers are required to comply with ISO requirements, Good Manufacturing Practices, which for medical devices is called the Quality System Regulation (“QSR”), and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain marketing approval. The FDA enforces the QSR through inspections, which may be unannounced, and the CE system enforces its certification through inspections and audits as well. Our quality system has received certification of compliance to the requirements of ISO 13485:2016 and will have to continue to successfully complete such inspections to maintain regulatory approvals for sales outside of the United States. Failure by us or one of our manufacturers or suppliers to comply with statutes and regulations administered by the FDA, CE authorities and other regulatory bodies, or failure to adequately respond to any observations, could result in enforcement actions against us or our manufacturers or suppliers, including, restrictions on our product or manufacturing processes, withdrawal of the product from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties.

If any of these actions were to occur it would harm our reputation and cause our product sales to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements. If the FDA or any other regulatory body finds their compliance status to be unsatisfactory, our commercialization efforts could be delayed, which would harm our business and our results of operations.

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Additionally, if the FDA determines that our promotional materials, training or other activities constitute promotion of an unapproved use, we could be subject to significant liability, the FDA could request that we cease, correct or modify our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

We are subject to medical device reporting regulations that require us to report to the FDA, national bodies known as Competent Authorities or other governmental authorities in other countries if our products cause or contribute to a death or serious injury or malfunction in a way that would be reasonably likely to contribute to death or serious injury if the malfunction were to recur. The FDA and similar governmental authorities in other countries have the authority to require the recall of our products in the event of material deficiencies or defects in design or manufacturing. A government mandated, or voluntary, recall by us could occur as a result of component failures, manufacturing errors or design defects, including defects in labeling. Any recall would divert managerial and financial resources and could harm our reputation with customers. There can be no assurance that there will not be product recalls in the future or that such recalls would not have a material adverse effect on our business. Once the product is approved and implanted in a large number of patients, infrequently occurring adverse events may appear that were not observed in the clinical trials. This could cause health authorities in countries where the product is available to take regulatory action, including marketing suspension and recall.

For example, on January 18, 2023, we received a letter from the FDA requesting additional information regarding Medical Device Reports submitted in 2021 related adverse events associated with a Lap-Band device and pregnancy. The FDA’s letter indicates a concern for an increased risk for Lap-Band complications in pregnant patients and requests that we provide, among other information, any actions planned or implemented which might reduce the likelihood of such events, which we are in the process of responding to. We believe there is robust peer-reviewed published data that supports our belief that concerns raised by the FDA are anomalies and rare occurrences. For example, a June 2022 consensus statement on laparoscopic adjustable gastric band (LAGB) management, which includes the Lap-Band, by the ASMBS found that (i) a tailored approach to LAGB management during pregnancy allows patients and providers to monitor weight gain, nutritional adequacy, and fetal growth for a healthy pregnancy outcome and (ii) evidence supports LAGB placement as safe and well tolerated during pregnancy with close LAGB monitoring. While improbable, if there are additional, or more serious, adverse events for pregnant Lap-Band patients, or if the FDA issues a warning regarding, or restricts the use of, the Lap-Band with pregnant patients, or patients who may become pregnant, our business could be harmed. One of the goals of our direct-to-consumer marketing campaign is to help people understand that the Lap-Band offers unique benefits for a variety of obese patients, including patients who may become pregnant. If there is a perception that the Lap-Band is not safe for pregnant patients, it could harm our reputation and cause our Lap-Band sales to suffer.

We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to obtain adequate product liability insurance.

Our business exposes us to a risk of product liability claims that is inherent in the testing, manufacturing and marketing of medical devices. The medical ~~device~~ industry has historically been subject to extensive litigation over product liability claims. We have previously reported adverse events associated with the Lap-Band system, including as related to pregnant patients, and may be subject to product liability claims if our products cause, or appear to have caused, an injury. Claims may be made by consumers, healthcare providers, third-party strategic collaborators or others selling our products.

WeOur ~~have~~subsidiary, Vyome Therapeutics Limited, has obtained product liability insurance, which covers the use of our products in our clinical trials and any commercial sales, in an amount we believe is appropriate. Our current product liability insurance may not continue to be available to us on acceptable terms, if at all, and, if available, the coverage may not be adequate to protect us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost and on acceptable terms for an adequate coverage amount, or otherwise to protect against potential product liability claims, we could be exposed to significant liabilities, which may harm our business. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition and results of operations. These liabilities could prevent or interfere with our product commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert management attention and might result in adverse publicity, which could result in the withdrawal of, or inability to recruit, clinical trial volunteers or result in reduced acceptance of our products in the market.

57We may be subject to product liability claims even if it appears that the claimed injury is due to the actions of others. For example, despite label instruction, storing products in higher than ideal temperature conditions and products being exposed to heat and sunlight may cause product deterioration and lead to resulting complaints and liability claims. If personnel/ parties are not properly trained or are negligent, the therapeutic effect of our products may be diminished or the patient may suffer critical injury, which may subject us to liability. In addition, an injury that is caused by the negligence of one of our suppliers in supplying us with a defective component that injures a patient could be the basis for a claim against us. A product liability claim, regardless of its merit or eventual outcome, could result in decreased demand for our products; injury to our reputation; diversion of management’s attention; withdrawal of clinical trial participants; significant costs of related litigation; substantial monetary awards to patients; product recalls or market withdrawals; loss of revenue; and the inability to commercialize our products under development.

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WeRisks ~~may~~Related ~~be subject~~ to ~~product~~Our ~~liability~~Commercial claims even if it appears that the claimed injury is due to the actions of others. For example, we rely on the expertise of surgeons and other associated medical personnel to perform the medical procedure to implant and remove our products and to perform the related therapy. If these medical personnel are not properly trained or are negligent, the therapeutic effect of our products may be diminished or the patient may suffer critical injury, which may subject us to liability. In addition, an injury that is caused by the negligence of one of our suppliers in supplying us with a defective component that injures a patient could be the basis for a claim against us. A product liability claim, regardless of its merit or eventual outcome, could result in decreased demand for our products; injury to our reputation; diversion of management’s attention; withdrawal of clinical trial participants; significant costs of related litigation; substantial monetary awards to patients; product recalls or market withdrawals; loss of revenue; and the inability to commercialize our products under development.Operations

~~Risks~~We ~~Related~~face tosubstantial ~~our~~competition, ~~Intellectual~~which ~~Property~~may result in others discovering, developing, licensing or commercializing products before or more successfully than we do.

IfWe weface ~~are~~substantial ~~unable~~competition from tomajor ~~obtain~~pharmaceutical orcompanies ~~maintain~~and ~~intellectual~~biotechnology ~~property~~companies ~~rights~~worldwide. ~~relating~~Many toof our ~~technology~~competitors ~~and~~have ~~neuroblocking~~significantly ~~therapy~~greater financial, technical ~~the~~and ~~commercial~~human ~~value~~resources. ofSmaller ~~our~~and ~~technology~~early-stage ~~and~~companies ~~any~~may ~~future~~also ~~products~~prove ~~will~~to be ~~adversely~~significant ~~affected~~competitors, particularly through collaborative arrangements with large and established companies. As a result, our ~~competitive~~competitors ~~position~~may ~~will~~discover, bedevelop, ~~harmed~~license or commercialize products before or more successfully than we do.

~~Our~~Furthermore, ~~commercial~~pharmaceutical companies ~~success~~that ~~depends~~develop ~~in part on our ability to obtain protection in the United States~~ and/or ~~other~~market ~~countries~~products for ~~our~~the ~~Lap-Band~~indications ~~System,~~we ~~Obalon~~are ~~Balloon~~pursuing ~~System,~~are ~~and~~likely ~~DBSN device by establishing and maintaining intellectual property rights relating~~ to orrepresent ~~incorporated~~substantial ~~into our technology and products~~competition. WeWhile VT-1953 ~~own~~represents ~~numerous~~a ~~U.S.~~novel ~~and~~mechanism ~~foreign patents and have numerous patent applications pending, most~~ of ~~which~~action ~~pertain~~in to treating ~~gastrointestinal~~malodor ~~disorders~~in ~~and~~malignant ~~the~~fungating ~~treatment~~wounds, ofall ~~obesity. We have also received or applied for additional patents outside~~ the ~~United~~above ~~States.~~mechanisms ~~Our~~are ~~pending~~also ~~and~~of potential ~~future~~therapeutic ~~patent~~use ~~applications~~in ~~may~~one ~~not issue as patents~~ or, ifmore ~~issued,~~of ~~may~~the ~~not~~indications ~~issue~~we inplan ~~a form that will provide us any competitive advantage. We expect~~ to ~~incur~~pursue ~~substantial costs~~ in ~~obtaining~~the ~~patents~~Phase ~~and,~~3 ifprogram. ~~necessary~~Similarly, ~~defending~~while ~~our~~VT-1908 ~~proprietary~~represents a ~~rights.~~novel ~~The~~mechanism ~~patent positions~~ of ~~medical~~action ~~device~~in ~~companies,~~treating ~~including ours~~uveitis, ~~can~~all ~~be highly uncertain and involve complex and evolving legal and factual questions. We do not know whether we will obtain~~ the ~~patent~~above ~~protection~~mechanisms weare ~~seek,~~also ~~or that the protection we do obtain will be found valid and enforceable if challenged. If we fail to obtain adequate protection~~ of ~~our~~potential ~~intellectual~~therapeutic ~~property, or if any protection we obtain is reduced or eliminated, others could~~ use ~~our intellectual property without compensating us, resulting~~ in ~~harm~~one ~~to our business. We may also determine that it is in our best interests to voluntarily challenge a third-party’s products~~ or ~~patents in litigation or administrative proceedings, including patent interferences, re-examinations or under~~ more ~~recently~~of ~~promulgated Inter Partes Review proceedings, depending on when~~ the indications ~~patent application was filed. In the event that~~ we ~~seek~~plan to ~~enforce~~pursue any of our owned or exclusively licensed patents against an infringing party, it is likely that the party defending the claim will seek to invalidate the patents we assert, which, if successful could result in the ~~loss~~later ofphases. ~~the~~If ~~entire~~VT-1953 ~~patent~~ or ~~the~~VT-1908 ~~relevant~~do ~~portion of our patent, which would~~ not beoffer ~~limited~~sustainable toadvantages ~~any~~over ~~particular~~competing ~~party. Any litigation to enforce or defend our patent rights~~products, ~~even if~~ we ~~were~~may tootherwise ~~prevail,~~not ~~could~~ be ~~costly~~able ~~and~~to ~~time-consuming~~successfully ~~and~~compete ~~could~~against ~~divert~~current ~~the attention of our management~~ and ~~key~~future ~~personnel from our business operations. Even if we were to prevail in any litigation, we cannot assure you that we can obtain an injunction that prevents our~~ competitors ~~from~~and ~~practicing~~off ~~our~~label ~~patented technology. Our competitors may independently develop similar or alternative technologies or~~ products ~~without infringing any of our patent or other intellectual property rights, or may design around our proprietary technologies~~.

WeOur ~~cannot~~competitors ~~assure~~may ~~you that we will~~ obtain regulatory ~~any~~approval ~~patent~~of ~~protection~~their ~~that~~products wemore ~~seek,~~rapidly ~~that~~than ~~any protection~~ we domay ~~obtain will be found valid and enforceable if challenged~~ or ~~that~~may itobtain ~~will confer any significant commercial advantage. U.S. patents and~~ patent ~~applications~~protection ~~may also be subject to interference proceedings and U.S. patents may be subject to re-examination proceedings in the USPTO,~~ or ~~under~~other ~~more~~intellectual ~~recently~~property ~~promulgated~~rights ~~Inter~~that limit ~~Partes~~our ~~Review~~ability ~~proceedings, depending on when the patent application was filed, and foreign patents may be subject~~ to ~~opposition~~develop or ~~comparable~~commercialize ~~proceedings~~VT-1953 ~~in the corresponding foreign patent offices, which proceedings could result in either loss of the patent~~ or ~~denial~~VT-1908. ofOur ~~the~~competitors ~~patent~~may ~~application,~~also ordevelop ~~loss~~drugs orthat ~~reduction~~are ~~in the scope of one or~~ more ~~of the claims of~~effective, ~~the patent or patent application. In addition~~more convenient, ~~such~~more ~~interference,~~widely ~~re-~~used ~~examination~~ and ~~opposition~~less ~~proceedings may be~~ costly. ~~Moreover,~~or ~~the U.S. patent laws~~ have ~~recently~~a ~~changed~~better ~~with~~safety ~~the~~profile ~~adoption~~than ~~of the America Invents Act (“AIA”), possibly making it easier to challenge patents. Some of our technology was,~~ VT-1953-and ~~continues~~VT-1908 ~~to be, developed in conjunction with third parties,~~ and ~~thus~~these ~~there is a risk that such third parties may claim rights in our intellectual property. Thus, any patents that we own or license from others may provide limited or no protection against~~ competitors. ~~Our pending patent applications, those we~~ may ~~file~~also inbe more ~~the~~successful ~~future,~~than orus ~~those we may license from third parties, may not result~~ in ~~patents~~manufacturing ~~being~~and ~~issued.~~marketing Iftheir ~~issued, they may not provide us with proprietary protection or competitive advantages against competitors with similar technology~~products.

58Furthermore, we also face competition more broadly across the market for existing cost-effective treatments. VT-1953 and VT-1908, if approved, may compete with these existing drug and other therapies but may not be competitive with them in price. We expect that if VT-1953 and VT-1908 is approved, it will be priced at a premium over generic, including branded generic, products. As a result, obtaining market acceptance of, and gaining significant share of the market for, VT-1953 and VT-1908 will pose challenges.

~~Table~~We ofhave ~~Contents~~undertaken a cost reduction plan and reorganization, and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom.

In light of recent macroeconomic conditions, we announced a 2024 cost reduction plan and reorganization to promote our long-term sustainability and scalability. As part of this plan, we have significantly reduced our workforce. This reduction in force, and any other future reductions, and the attrition that may occur following them, result in the loss of institutional knowledge and expertise and the reallocation and combination of certain roles and responsibilities across the organization, all of which could adversely affect our operations. These actions and other additional measures we might take to reduce costs could strain our workforce, divert management attention, yield attrition beyond our intended reduction in force, reduce employee morale, cause us to delay, limit, reduce or eliminate certain development plans or otherwise interfere with our ability to operate and grow our business effectively, each of which could have an adverse impact on our business, operating results and financial condition. We may ~~lose~~not ~~important~~complete ~~patents~~the current or ~~patent~~any ~~rights~~cost reduction plan and reorganization on the anticipated timetable, and even if successfully completed, we domay not ~~timely~~achieve ~~pay~~the ~~required~~anticipated ~~patent~~cost ~~fees~~savings, operating efficiencies or ~~annuities~~other benefits of such activities.

We have, from time to time, experienced delays in the payment of required patent fees or annuities. Non-payment or delay in payment of patent fees or annuities, whether intentional or unintentional, may result in loss of patents or patent rights important to our business. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States, particularly in the field of medical products and procedures.71

~~Many~~Public ofhealth ~~our~~crises ~~competitors~~such ~~have~~as ~~significant~~pandemics ~~resources~~or similar ~~and~~outbreaks ~~incentives~~have toaffected ~~apply for~~ and ~~obtain~~could ~~intellectual~~continue ~~property~~to ~~rights~~seriously ~~that~~and ~~could~~adversely ~~limit~~affect ~~or prevent~~ our ~~ability~~preclinical tostudies ~~commercialize~~and ~~our~~anticipated ~~current~~clinical trials, orbusiness, ~~future~~financial ~~products~~condition inand ~~the~~results ~~United~~of ~~States or abroad~~operations.

~~Many~~In ofMarch ~~our~~2020, ~~competitors~~the ~~who~~World ~~have~~Health Organization ~~significant~~(“WHO”) declared ~~resources~~COVID-19 ~~and~~a ~~have~~global ~~made~~pandemic. ~~substantial~~In ~~investments~~response to the COVID-19 pandemic, “shelter in ~~competing~~place” ~~technologies~~orders ~~may~~and ~~seek~~other topublic ~~apply~~health ~~for~~guidance measures were implemented across much of United States and ~~obtain~~India, ~~patents~~including ~~that~~in ~~will~~the ~~prevent~~locations of our offices, ~~limit~~clinical ortrial ~~interfere~~sites, ~~with~~key vendors and partners. Specifically, the COVID-19 pandemic impacted our ability to ~~make~~raise financing on desirable terms, ~~use~~and oralso ~~sell~~led ~~our~~to reduced sales as a result of sales being impacted for therapeutic products ~~either~~across inmost of the Uindustry.S. As a result of the COVID-19 pandemic, or similar pandemics, and related “shelter in ~~international~~place” orders ~~markets.~~and ~~Our~~other ~~current~~public orhealth guidance measures, we may in the future Uexperience disruptions that could seriously harm our business.S. Potential disruptions include but are not limited to: delays or ~~foreign~~difficulties ~~patents~~in ~~may~~enrolling bepatients ~~challenged~~in, ~~circumvented~~initiating byor ~~competitors~~expanding our clinical trials, including delays or ~~others~~difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff; increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19 or ~~may~~other behealth conditions ~~found~~or being forced to bequarantine; ~~invalid~~interruption of key clinical trial activities, ~~unenforceable~~such as clinical trial site data monitoring and efficacy, safety and translational data collection, processing and analyses, due to limitations on travel imposed; recommendations by federal, state or ~~insufficient.~~local Ingovernments, ~~most~~employers ~~cases~~and inothers or interruptions of clinical trial subject visits, which may impact the ~~United~~collection and ~~States~~integrity ~~patent~~of ~~applications~~subject ~~are~~data ~~published~~and ~~18 months~~clinical ~~after~~trial ~~filing~~endpoints; diversion of healthcare resources away from the ~~application~~conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; delays or ~~corresponding~~disruptions ~~applications~~in ~~are~~preclinical ~~published~~experiments and IND-enabling studies due to restrictions of on-site staff and unforeseen circumstances at CROs and vendors; interruption or delays in ~~other~~the ~~countries~~operations of the FDA, EMA, and ~~since~~comparable ~~publication~~foreign regulatory authorities including delays in receiving approval from local regulatory authorities to initiate our planned clinical trials; interruption of, ~~discoveries~~or delays in receiving, supplies of the ~~scientific~~Vyome orAssets ~~patent~~due ~~literature~~to ~~often~~staffing ~~lags~~shortages, ~~behind~~raw ~~actual~~materials ~~discoveries~~shortages, weproduction ~~cannot~~slowdowns beor ~~certain~~stoppages and disruptions in delivery systems; and limitations on employee or other resources that wewould ~~were~~otherwise be focused on the ~~first~~conduct toof ~~make~~Vyome’s clinical ~~the~~trials ~~inventions~~and ~~covered~~preclinical bywork, ~~each~~including because of ~~our~~sickness ~~pending~~of ~~patent~~employees ~~applications~~or their families, the desire of employees to avoid travel or ~~that~~contact wewith ~~were~~large ~~the~~groups ~~first~~of topeople, ~~file~~an ~~patent~~increased ~~applications~~reliance ~~for~~on ~~such~~working ~~inventions~~from home, school closures or mass transit disruptions.

IfThe weCOVID-19 ~~are~~pandemic ~~unable~~or tosimilar outbreaks ~~protect~~may also affect the ~~confidentiality~~ability of ~~our~~the ~~proprietary~~FDA, ~~information~~EMA, and ~~know-how~~other regulatory authorities to perform routine functions. If global health concerns prevent the FDA, EMA, or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ~~value~~ability of ~~our~~the ~~technology~~FDA, EMA, or other regulatory authorities to timely review and ~~products~~process Vyome’s regulatory submissions, which could behave ~~adversely~~a ~~affected~~material adverse effect on Vyome’s business.

InThe ~~addition~~extent to ~~patented~~which ~~technology,~~the weCOVID-19 pandemic ~~rely~~or onsimilar ~~our~~outbreaks ~~unpatented~~may ~~proprietary~~affect ~~technology,~~Vyome’s ~~trade~~clinical ~~secrets~~trials, business, ~~processes~~financial condition and ~~know-how.~~results Weof ~~generally~~operations ~~seek~~will todepend ~~protect~~on ~~this~~future ~~information~~developments, bywhich ~~confidentiality~~are ~~agreements~~highly ~~with~~uncertain ~~our~~and ~~employees,~~cannot ~~consultants,~~be ~~scientific~~predicted at ~~advisors~~this ~~and~~time, ~~third~~such ~~parties.~~as ~~These~~the ~~agreements~~duration ~~may~~of bethe ~~breached~~pandemic, ~~and~~new weor ~~may~~continued ~~not~~travel ~~have~~restrictions ~~adequate~~and ~~remedies~~actions ~~for~~to ~~any~~contain ~~such~~the ~~breach.~~outbreak Inor ~~addition~~treat its impact, ~~our~~such ~~trade~~as ~~secrets~~social ~~may~~distancing ~~otherwise~~and ~~become~~quarantines ~~known~~ or belock-downs ~~independently~~in ~~developed~~the byUnited ~~competitors.~~States, ToIndia ~~the~~and ~~extent~~other ~~that our employees~~countries, ~~consultants~~business closures or ~~contractors~~business ~~use~~disruptions ~~intellectual~~and ~~property~~the ~~owned~~effectiveness byof ~~others~~actions taken in ~~their~~the ~~work~~United ~~for us~~States, ~~disputes~~India ~~may~~and ~~arise~~other ascountries to contain and treat the disease. ~~rights~~Future developments in ~~related~~these orand ~~resulting~~other ~~know-how~~areas present material uncertainty and ~~inventions~~risk with respect to Vyome’s clinical trials, business, financial condition and results of operations.

~~Intellectual~~The ~~property~~COVID-19 ~~litigation~~pandemic isor other asimilar ~~common~~outbreaks ~~tactic~~may inalso have the ~~medical~~effect ~~device~~of ~~industry~~heightening tomany ~~gain~~of ~~competitive~~the ~~advantage. If we become subject to a lawsuit, we may be required to expend significant financial and~~ other ~~resources~~risks ~~and~~described ~~our~~in ~~management’s~~this ~~attention~~“Risk Factors” ~~may be diverted from our business~~section.

~~There~~Our ~~has~~business, ~~been~~operations, afinancial ~~history of frequent~~ position and ~~extensive~~clinical ~~litigation~~development ~~regarding~~plans ~~patent~~ and ~~other~~timelines ~~intellectual~~could ~~property~~be ~~rights~~materially inadversely ~~the~~affected ~~medical~~by ~~device industry, and companies in~~ the ~~medical~~ongoing ~~device~~conflicts ~~industry have employed intellectual property litigation to gain a competitive advantage. Accordingly, we may become subject to patent infringement claims or litigation~~ in avarious ~~court~~parts of ~~law, or interference proceedings declared by~~ the ~~USPTO to determine the priority of inventions or an opposition to a patent grant in a foreign jurisdiction~~world. We may also become subject to claims or litigation seeking payment of royalties based on sales of our product in connection with licensing or similar joint development arrangements with third parties or in connection with claims of patent infringement.

~~The~~As ~~defense~~a ~~and~~result ~~prosecution~~ of ~~intellectual~~military ~~property~~actions by ~~suits,~~the ~~USPTO~~Russian ~~interference~~Federation ~~proceedings,~~in ~~reexamination proceedings~~Ukraine, oras ~~under~~well ~~more~~as ~~recently~~the ~~promulgated~~ongoing ~~Inter~~conflicts ~~Partes~~in ~~Review proceedings, depending on when~~ the ~~patent~~Middle ~~application was filed~~East, ~~or opposition proceedings~~ and related ~~legal~~economic ~~and~~sanctions ~~administrative~~imposed ~~proceedings~~by certain governments, ~~are~~our ~~both~~financial ~~costly~~position and ~~time~~operations ~~consuming~~may ~~and~~be ~~could~~materially ~~result~~and inadversely ~~substantial uncertainty to us~~affected. ~~Litigation~~As orour ~~regulatory~~ability ~~proceedings~~to ~~may~~continue ~~also be necessary~~ to ~~enforce~~operate ~~patent~~is dependent oron ~~other~~raising ~~intellectual~~debt ~~property~~and ~~rights~~equity offinance, ~~ours~~any oradverse impact to ~~determine~~those ~~the~~markets ~~scope~~as ~~and~~a ~~validity~~result of ~~other~~this ~~parties’~~military ~~proprietary~~action, ~~rights.~~including ~~Any~~due ~~litigation~~to increased market volatility, ~~opposition~~decreased oravailability ~~interference~~in ~~proceedings,~~third-party ~~with~~financing and/or ~~without~~a ~~merit,~~deterioration ~~may result~~ in ~~substantial~~the ~~expense~~terms toon ~~us,~~which ~~cause~~it ~~significant~~is ~~strain~~available (if onat ~~our financial resources~~all), ~~divert~~could ~~the~~negatively ~~attention~~impact of our ~~technical~~business, ~~and~~operations ~~management~~or ~~personnel~~financial ~~and~~position. ~~harm~~In ~~our~~addition, ~~reputation.~~disruption Weof ~~may~~critical ~~not~~infrastructure, supply ~~have~~chains ~~the~~and ~~financial~~logistics, ~~resources~~possible tocyberattacks ~~defend~~and ~~our~~data ~~patents~~breaches from ~~infringement~~hostile oractors ~~claims~~who ofmay ~~invalidity.~~take Anadvantage ~~adverse~~of ~~determination~~the inchaos, ~~any~~increased cost ~~litigation~~and ~~could~~possible ~~subject~~shortages usof tooil ~~significant~~and ~~liabilities~~natural togas ~~third~~and ~~parties,~~other ~~require~~necessary usmaterials, tointerruption ~~seek licenses from~~ or ~~pay~~loss ~~royalties~~of tocustomers, ~~third~~counterparties ~~parties~~ or potential ~~prevent~~relationships uswith ~~from~~partners ~~manufacturing~~in affected regions, ~~selling~~may orresult ~~using~~due ~~our~~to ~~proposed~~the ~~products,~~destabilizing ~~any~~effects ofcaused ~~which~~by ~~could~~such ~~have~~action. aThe ~~material~~extent of ~~adverse~~any

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