UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-K


☒	ANNUAL REPORT UNDER 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

For the transition period from to

Commission file Number 001-37853

~~ENTERO~~GRIDAI ~~THERAPEUTICS,~~TECHNOLOGIES ~~INC.~~CORP (Exact name of registrant as specified in its charter)

Delaware		46-4993860
(State or other jurisdiction ofincorporation or organization)		(I.R.S. EmployerIdentification No.)


777 Yamato Road, Suite 502
433 Plaza Real, Suite 275,
Boca Raton, Florida		~~33431~~33432
(Address of principal executive offices)		(Zip Code)

(561) 589-7020

(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
Common stock, par value $0.0001 per share		~~ENTO~~GRDX		The Nasdaq Capital Market

Securities registered under 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 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 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 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	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the 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 securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued 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 a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The aggregate market value of common stock held by non-affiliates of the registrant, based on the closing price of a share of the registrant’s common stock on June 2830, ~~2024~~2025, which is the last business day of the registrant’s most recently completed second fiscal quarter, as reported by ~~the~~ The Nasdaq Capital Market on such date, was approximately $314.69 million.

There were 46,~~765~~200,~~729~~051 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of ~~April~~May 1, ~~2025~~2026.

Table of Contents

~~ENTERO~~GRIDAI ~~THERAPEUTICS, INC.~~TECHNOLOGIES CORP

ANNUAL REPORT ON FORM 10-K

YEAR ENDED DECEMBER 31, ~~2024~~2025

TABLE OF CONTENTS

		Page
PART I		1

Item 1.	Business	1
Item 1A.	Risk Factors	2320
Item 1B.	Unresolved Staff Comments	5156
Item 1C.	Cybersecurity	5156
Item 2.	Properties	5257
Item 3.	Legal Proceedings	5257
Item 4.	Mine Safety Disclosures	5257

PART II		5358

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	5358
Item 6.	Reserved	5359
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	5459
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	6269
Item 8.	Financial Statements and Supplementary Data	6269
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	6269
Item 9A.	Controls and Procedures	6271
Item 9B.	Other Information	6372
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	6372

PART III		6473

Item 10.	Directors, Executive Officers and Corporate Governance	6473
Item 11.	Executive Compensation	6978
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	7382
Item 13.	Certain Relationships and Related Transactions, and Director Independence	7887
Item 14.	Principal Accountant Fees and Services	7988

PART IV		8089

Item 15.	Exhibits and Financial Statement Schedules	8089
Item 16.	Form 10-K Summary	8292

Signatures		8393

Index to Consolidated Financial Statements		F-1

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K, (“or this Annual Report”), contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Annual Report other than statements of historical ~~facts~~fact are forward-looking statements, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market ~~growth,~~opportunities ~~are~~or ~~forward-looking statements~~growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to bediffer materially ~~different~~ from any future results, performance or achievements expressed or implied by the forward-looking statements.

The words “anticipate”,” “believe”,” “estimate”,” “expect”,” “intend”,” “may”,” “plan”,” “predict”,” “project”,” “target”,” “potential”,” “will”,” “would”,” “could”,” “should”,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. ~~These forward-looking statements include, among other things, statements about:~~

●These ~~our~~forward-looking ~~ability~~statements toinclude, ~~maintain~~among ~~compliance~~other ~~with~~things, ~~the~~statements ~~continued listing requirements of The Nasdaq Capital Market;~~regarding:

● our ability to ~~satisfy~~maintain ~~our~~compliance ~~existing~~with ~~payment~~the ~~obligations~~continued ~~and~~listing ~~other~~requirements ~~payment obligations as they become due, including those related to the acquisition~~ of ~~First~~The ~~Wave~~Nasdaq ~~Bio,~~Capital ~~Inc.~~Market

● ~~statements regarding the impact of geopolitical events, including the war in Ukraine and the Middle East, and their effects on~~ our ~~operations,~~ability ~~access~~ to ~~capital,~~satisfy ~~research~~our ~~and~~existing ~~development~~payment ~~and~~obligations ~~clinical trials~~ and ~~potential disruption in the operations and business of third-party vendors, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”),~~ other ~~service~~obligations ~~providers,~~as ~~and~~they ~~collaborators~~become ~~with whom we conduct business;~~due

● the ~~availability~~impact of ~~capital~~geopolitical toevents, ~~satisfy~~including the war in Ukraine and conflicts in the Middle East, on our ~~working~~operations, access to capital, ~~requirements;~~supply chain, third-party relationships and broader market conditions

● ~~our~~the ~~current~~availability ~~and~~of ~~future~~ capital ~~requirements and our ability~~ to ~~raise additional funds to~~ satisfy our working capital ~~needs;~~requirements

● our ~~ability~~current toand ~~consummate~~future ~~our~~capital ~~disposal~~requirements ofand our ~~IMGX~~ability ~~subsidiary~~to ~~and~~raise ~~related~~additional ~~liabilities;~~funds to satisfy those requirements

● the ~~accuracy~~impact of the completed rescission transaction involving our ~~estimates~~former ~~regarding~~IMGX ~~expense~~subsidiary, ~~future~~including ~~revenue~~any retained or assumed liabilities and ~~capital~~related ~~requirements;~~accounting and operational effects

● the accuracy of our ~~ability~~estimates toregarding ~~continue~~expenses, ~~operating~~future asrevenue aand ~~going~~capital ~~concern;~~requirements

● our ~~plans~~ability to ~~develop~~continue ~~and~~operating ~~commercialize~~as ~~our~~a ~~product~~going ~~candidates, including Adrulipase;~~concern

● our ability to ~~initiate~~operate, ~~and~~develop ~~complete our clinical trials~~ and toexpand ~~advance~~the ~~our~~Grid ~~principal~~AI ~~product candidates into additional clinical trials, including pivotal clinical trials,~~ and ~~successfully~~AMPX ~~complete such clinical trials;~~business

● ~~regulatory~~our ~~developments~~plans into ~~the~~preserve, ~~U.S.~~develop ~~and~~or ~~foreign~~commercialize ~~countries;~~our retained legacy biopharmaceutical assets, including Adrulipase

● ~~the performance of~~ our ~~third-party~~ability ~~vendor(s),~~to ~~CROs~~initiate, ~~CDMOs~~continue and ~~other~~complete ~~third-party non-~~clinical trials and ~~clinical~~other development ~~collaborators~~activities ~~and~~for ~~regulatory service providers;~~Adrulipase

● ~~our~~regulatory ~~ability~~developments toin ~~obtain~~the ~~and~~United ~~maintain~~States ~~intellectual~~and ~~property~~foreign ~~protection for our core assets;~~jurisdictions

● the ~~size~~performance of ~~the~~our ~~potential~~third-party ~~markets~~vendors, ~~for~~service ~~our~~providers, ~~product~~consultants, ~~candidates~~collaborators, contract research organizations, contract development and ~~our~~manufacturing ~~ability~~organizations toand ~~serve~~other ~~those~~third ~~markets;~~parties with whom we conduct business

● ~~the~~our ~~rate~~ability ~~and~~to ~~degree~~obtain ofand ~~market~~maintain ~~acceptance~~intellectual ofproperty ~~our~~protection ~~product candidates~~ for ~~any~~our ~~indication~~core ~~once~~assets ~~approved;~~and technologies

● the ~~success~~size of ~~competing~~the ~~products~~potential ~~and~~markets ~~product~~for ~~candidates~~our inproducts, ~~development~~technologies byand ~~others~~product ~~that~~candidates ~~are~~and orour ~~become~~ability ~~available~~to ~~for~~serve ~~the~~those ~~indications that we are pursuing;~~markets

●

the rate and degree of market acceptance of our products, technologies and product candidates

●

the success of competing products, technologies and product candidates developed or commercialized by others

●

our ability to attract and retain key management, technical, operational, scientific and development personnel

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● ~~the~~other ~~loss~~risks ofand ~~key scientific~~uncertainties, ~~clinical~~including ~~and~~those ~~nonclinical~~described ~~development,~~under ~~and/or~~Part ~~management personnel~~I, ~~internally~~Item or1A, ~~from~~“Risk ~~one~~Factors,” of ~~our~~this ~~third-party~~Annual ~~collaborators; and~~Report.

●Factors that may cause actual results to differ materially from current expectations include, among other things, the risks and uncertainties, ~~including~~described ~~those listed~~ under Part I, Item 1A., “Risk Factors,” ofand elsewhere in this Annual Report. Any forward-looking statement in this Annual Report reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, financial condition, industry and growth strategy. Given these uncertainties, you should not place undue reliance on these forward-looking statements as predictions of future events.

Factors that may cause actual results to differ materially from current expectations include, among other things, those set forth in Part I, Item 1A, “Risk Factors,” herein and for the reasons described elsewhere in this Annual Report on Form 10-K. Any forward-looking statement in this Annual Report on Form 10-K reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we ~~assume~~undertake no obligation to update or revise ~~these~~any forward-looking statements ~~for~~contained ~~any~~in ~~reason,~~this ~~even~~Annual ifReport to reflect new information, ~~becomes~~future ~~available~~events inor ~~the~~circumstances, ~~future~~or otherwise.

This Annual Report ~~on Form 10-K~~ also contains estimates, projections and other information concerning our industry, our business and the markets for certain ~~drugs~~products, technologies and ~~consumer~~product ~~products~~candidates, including data regarding ~~the~~ estimated ~~size~~market ~~of those markets~~size, ~~their~~ projected growth rates and the ~~incidence~~prevalence of certain ~~medical~~ conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from ~~events~~those ~~and circumstances~~ reflected in ~~this~~such information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. ~~and~~We we have not independently verified the data obtained from third -party sources., Inand in some cases, we do not expressly ~~refer~~identify to the sources from which ~~these~~such data are derived.

In this Annual Report ~~on Form 10-K~~, unless otherwise stated or as the context otherwise requires, references to “~~Entero~~GridAI,” the “Company,” “we,” “us,” “our” and similar references are to ~~Entero~~GridAI ~~Therapeutics,~~Technologies ~~Inc~~Corp. and its subsidiaries on a consolidated basis. References to “FWB” refer to First Wave Bio, Inc., ~~Entero’s~~a wholly- owned subsidiary of the Company. Reference to “Grid AI Corp.” refer to Grid AI Corp., a Nevada corporation and ~~references~~our wholly owned subsidiary. Reference to “AMPX” refer to AMPX UK Holdings, a Cayman Islands company of which Grid AI holds 75% ownership interest. References to “IMGX” refer to ImmunogenX, LLC (formerly ImmunogenX, Inc.), which ~~has~~was ~~been~~previously ~~Entero’s~~a wholly- owned subsidiary ~~since~~of ~~March~~the 13Company and was disposed of on December 31, ~~2024~~2025 in connection with the rescission transaction.

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Table of Contents

PART I

ITEM 1.BUSINESS

Overview

WeGridAI ~~are~~Technologies ~~engaged~~Corp., informerly ~~the~~known ~~research~~as ~~and~~Entero ~~development~~Therapeutics, ~~of targeted~~Inc., ~~non-systemic~~is ~~therapies~~a ~~for~~diversified ~~the~~technology ~~treatment~~and oflife ~~patients~~sciences ~~with~~company ~~gastrointestinal~~operating through two principal areas: (~~“GI”~~i) ~~diseases.~~energy ~~Non-systemic~~orchestration ~~therapies~~and ~~are~~grid ~~non-absorbable~~optimization ~~drugs~~software ~~that~~solutions ~~act~~through ~~locally,~~our isubsidiary Grid AI Corp.~~e.,~~ inand ~~the~~(ii) ~~intestinal~~legacy ~~lumen,~~biopharmaceutical ~~skin~~development oractivities ~~mucosa,~~centered ~~without~~on ~~reaching~~Adrulipase anfor ~~individual’s~~the ~~systemic~~treatment ~~circulation~~of exocrine pancreatic insufficiency. InEffective ~~May~~December ~~2024~~1, we2025, the Company changed ~~our~~its name from ~~First~~“Entero ~~Wave Biopharma~~Therapeutics, Inc.” to ~~Entero~~“GridAI ~~Therapeutics,~~Technologies ~~Inc~~Corp.” and changed its Nasdaq trading symbol from “ENTO” to “GRDX.”

WeOn ~~are~~September ~~currently~~30, ~~focused~~2025, ~~on developing~~ the ~~biologic~~Company ~~Adrulipase,~~completed a ~~recombinant~~share ~~lipase~~exchange ~~enzyme~~transaction ~~designed~~pursuant to ~~enable~~which ~~the~~it ~~digestion~~acquired 100% of ~~fats~~the ~~and~~outstanding ~~other~~equity ~~nutrients~~interests inof ~~cystic~~Grid ~~fibrosis~~AI ~~and~~Corp., ~~chronic~~a ~~pancreatitis~~Nevada ~~patients with exocrine pancreatic insufficiency~~corporation. ~~Our~~At ~~prior~~the ~~programs~~time ~~consisted~~ of ~~Latiglutenase~~the acquisition, aGrid ~~targeted~~AI ~~oral~~Corp. ~~biotherapeutic~~owned ~~for~~75% ~~celiac~~of ~~disease~~the ~~designed~~issued toand ~~breakdown~~outstanding ~~gluten~~equity ~~into~~interests ~~non-immunogenic~~of ~~peptides;~~AMPX ~~Capeserod~~UK Holdings, a ~~selective~~Cayman ~~5-HT4~~Islands ~~receptor~~company, ~~partial agonist~~ which ~~was~~holds ~~being~~the ~~developed~~operating assubsidiary aAMPX ~~gastroparesis~~Limited. ~~therapeutic;~~Following ~~and~~the ~~Niclosamide~~transaction, anGrid ~~oral~~AI ~~small~~Corp. ~~molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis~~ and ~~Crohn’s~~its ~~disease.~~subsidiaries, Weincluding ~~have~~AMPX, ~~determined~~became toconsolidated ~~discontinue~~subsidiaries of the ~~Latiglutenase, Capeserod and Niclosamide programs~~Company.

InGrid ~~March~~AI ~~2024, we announced the closing of a merger with ImmunogenX, Inc~~Corp. ~~(“IMGX”)~~develops ~~(the~~software ~~Company’s~~and ~~acquisition~~services ofdesigned ~~IMGX,~~to ~~the~~accelerate ~~“Merger”),~~power aavailability private, clinical-stage biopharmaceutical company founded in 2013, which is developing the biologic Latiglutenase for the treatment of celiac disease. As a result of the Merger, IMGX became a limited liability company and ~~our~~optimize ~~wholly~~energy ~~owned~~infrastructure ~~subsidiary. As consideration~~ for ~~the~~artificial ~~Merger~~intelligence ~~we issued the former shareholders of IMGX~~ (AAI) ~~36,830~~data ~~shares~~centers ofand ~~Common~~other ~~Stock~~large ofenergy ~~the Company and (B) 11,777~~users.~~418~~ ~~shares~~Grid ofAi ~~Series G Preferred Stock~~Corp. Inis ~~addition,~~currently wein ~~assumed (i) all ImmunogenX stock options immediately outstanding prior to~~ the ~~Merger,~~development ~~each~~stage ~~becoming~~of an ~~option~~AI todata ~~purchase~~center ~~Common~~platform. ~~Stock~~This ~~subject~~platform toaims ~~adjustment pursuant~~ to ~~the~~use ~~terms of the merger agreement (the “Assumed Options”)~~ and ~~(ii)~~optimize ~~all~~distributed ~~ImmunogenX~~energy ~~warrants immediately outstanding prior to the Merger~~resources, ~~each~~including ~~becoming~~battery aenergy ~~warrant~~storage ~~to purchase Common Stock subject to adjustment pursuant to the terms of the merger agreement (the “Assumed Warrants”). The Assumed Options are exercisable for an aggregate of 200~~systems,~~652~~ ~~shares~~on-site ~~of Common Stock~~generation, ~~have~~and angrid ~~exercise price of $0~~interconnections.81 ~~and expire between February 1~~Currently, ~~2031~~there ~~and~~is ~~June~~no 6,revenue ~~2033.~~generated ~~The~~from ~~Assumed~~this ~~Warrants~~AI ~~are~~data ~~exercisable~~center ~~for~~platform. anGrid ~~aggregate~~Ai ofCorp.’s ~~127,682~~commercial ~~shares~~pipeline ofhas ~~Common~~recently ~~Stock,~~been ~~have~~re-established ~~exercise~~and ~~prices~~is ~~ranging~~continuing ~~from $3.02~~ to ~~$3.92~~develop ~~and~~through ~~expire~~consulting-led ~~between~~engagements ~~September 30, 2032~~ and ~~September~~targeted 6,business ~~2033~~development initiatives.

~~IMGX~~For isthe ~~developing~~year ~~CypCel~~ended December 31, a2025, ~~metabolic~~the ~~marker~~Company’s ~~compound~~consolidated ~~that~~financial ~~can~~statements ~~measure~~include the ~~state of small~~post-~~intestinal~~acquisition ~~recovery~~results of ~~celiac~~Grid ~~patients~~AI ~~undergoing~~Corp. ~~gluten-free~~and ~~diets~~AMPX ~~(“GFDs”).~~beginning Weon ~~have~~September ~~initiated~~30, a2025. ~~plan~~Prior to ~~dispose~~the ofGrid ~~certain~~AI ~~assets~~Corp. ~~and~~acquisition, ~~liabilities~~the ofCompany ~~IMGX,~~operated ~~including~~primarily ~~Latiglutenase~~as ~~and~~a ~~CypCel.~~clinical-stage Asbiopharmaceutical ofcompany ~~December~~focused ~~31,~~on ~~2024~~targeted, ~~these~~non-systemic ~~were~~therapies ~~classified as assets and liabilities held~~ for ~~sale~~gastrointestinal ~~and~~diseases. ~~due~~Non-systemic totherapies ~~the~~are ~~short~~non-absorbable ~~period~~drugs ofthat ~~time~~act ~~since~~locally, ~~the~~such ~~close~~as ofin the ~~Merger~~intestinal lumen, ~~are~~skin ~~reported~~or atmucosa, ~~their~~without ~~fair~~reaching ~~value~~an ~~less~~individual’s ~~cost~~systemic ~~to sell~~circulation. WeIn ~~determined~~May ~~that~~2024, the ~~discontinued~~Company ~~operations~~changed ofits ~~IMGX~~name ~~represents~~from aFirst ~~strategic~~Wave ~~shift~~BioPharma, ~~that~~Inc. ~~will~~to ~~have~~Entero aTherapeutics, ~~major effect on our operations and financial statements~~Inc.

InThe ~~March 2025, we announced that we entered into a rescission agreement (the “Rescission Agreement”), by and among the~~ Company,’s ~~IMGX~~continuing ~~and~~legacy ~~the~~biopharmaceutical ~~former~~focus ~~shareholders~~is ~~of IMGX (the “IMGX Shareholders”). Under the terms of the Rescission Agreement~~Adrulipase, ~~the~~a ~~parties~~recombinant ~~have~~lipase ~~amicably~~enzyme ~~determined~~designed ~~that it is in their collective best interest~~ to: ~~(i)~~enable ~~rescind~~ the ~~issuances~~digestion of ~~the~~fats ~~shares of Common Stock~~ and ~~Series~~other Gnutrients ~~Preferred~~in ~~Stock~~patients ~~that~~with ~~the~~exocrine ~~Company~~pancreatic ~~has issued to the IMGX Shareholders as part of the Merger~~insufficiency, ~~(ii)~~including ~~convey~~patients towith ~~the~~cystic ~~IMGX~~fibrosis ~~Shareholders all of the issued~~ and ~~outstanding~~chronic ~~membership~~pancreatitis. ~~interests~~The ~~(the “Membership Interests”) of IMGX currently held by the~~ Company, ~~(iii)~~plans ~~cancel~~to ~~the~~continue ~~Assumed~~development ~~Options~~activities ~~and~~relating ~~Assumed~~to ~~Warrants, and (iv) provide for such additional agreements as are set forth in the Rescission Agreement~~Adrulipase. ~~Also~~ asThe ~~set forth in the Rescission Agreement, following the closing, the~~ Company ~~will retain up to approximately $695,000 of IMGX~~’s ~~accounts~~former ~~payable,~~Latiglutenase and ~~IMGX~~CypCel ~~will~~programs ~~remain~~were ~~responsible~~part ~~for approximately $9,278,400~~ of ~~IMGX’s~~the ~~secured~~ImmunogenX ~~debt. The~~business, ~~Company~~which ~~expects~~was ~~that~~disposed ~~the closing~~ of ~~the Rescission Agreement will occur~~ on orDecember ~~prior to June 30~~31, 2025, ~~subject~~in toconnection ~~satisfaction~~with ofthe ~~all~~rescission ~~conditions~~transaction ~~for~~described ~~closing,~~below. ~~including~~The ~~obtaining shareholder approval by the~~ Company ~~for~~has ~~the~~also ~~transfer~~discontinued ofits ~~the~~Capeserod ~~Membership~~and ~~Interests~~Niclosamide ~~to the IMGX Shareholders~~programs. ~~After~~The ~~the~~Company ~~transactions~~terminated ~~contemplated~~its bylicense ~~the~~agreement ~~Rescission~~with ~~Agreement~~Sanofi ~~have~~relating ~~been~~to ~~consummated,~~Capeserod ~~IMGX~~on ~~will~~February ~~no longer be a subsidiary of the Company~~26, 2025 and ~~the Company will~~ no ~~longer~~further bepayments ~~holding~~were ~~any~~due ~~interest in IMGX~~thereunder.

OnIn ~~February~~March ~~26,~~ 2025, wethe ~~gave~~Company ~~notice~~entered tointo ~~terminate~~a ~~our~~rescission ~~license~~ agreement with ~~Sanofi~~ImmunogenX, ~~for~~LLC, ~~the~~formerly ~~development~~a wholly owned subsidiary of ~~Capeserod~~the Company, aand ~~selective~~the ~~5-HT4~~former ~~receptor~~shareholders ~~partial~~of ~~agonist~~ImmunogenX. WeUnder ~~anticipate~~the ~~that~~rescission ~~this~~transaction, ~~termination~~the ~~will~~parties beagreed ~~effective~~to unwind the Company’s prior acquisition of ImmunogenX by rescinding the previously issued Common Stock and Series G Preferred Stock issued in ~~April~~the ~~2025.~~transaction, Weconveying ~~may~~the ~~terminate~~equity interests of ImmunogenX back to the ~~license~~former ~~agreement~~ImmunogenX byshareholders, ~~providing~~and ~~Sanofi~~canceling ~~with~~the atassumed ~~least~~ImmunogenX 60options ~~days~~and ~~prior~~warrants. ~~written~~The ~~notice;~~Company ~~provided~~retained approximately $695,814 ~~however~~of ImmunogenX accounts payable, ~~that~~while ~~Sanofi~~ImmunogenX ~~shall~~remained beresponsible ~~entitled~~for toapproximately ~~any~~$9.3 ~~and~~million ~~all~~of ~~payments~~secured ~~due~~debt and ~~owed~~certain toother ~~Sanofi~~obligations. ~~prior~~The torescission transaction closed on December 31, 2025. Following the ~~effective~~closing, ~~date~~ImmunogenX ceased to be a subsidiary of ~~termination.~~the NoCompany, ~~payments~~and ~~are~~the ~~due~~Company no longer held any ownership interest in that business.

As a result, as of December 31, 2025, the Company’s operations consist of (i) its newly acquired subsidiary, Grid AI Corp., and (ii) its continuing Adrulipase development program, which is conducted through its wholly owned subsidiary, First Wave Bio, Inc., together with related corporate activities.

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InOur ~~November~~Grid ~~2024,~~Optimization weSoftware ~~announced a binding term sheet, subject to several closing conditions, for a reverse merger transaction with Journey Therapeutics, Inc. We do not anticipate that this transaction will move forward.~~Solutions

Grid AI Corp. develops software and services designed to accelerate power availability and optimize energy infrastructure for artificial intelligence (AI) data centers and other large energy users. Grid Ai Corp. is currently in the development stage of an AI data center platform. This platform aims to use and optimize distributed energy resources, including battery energy storage systems, on-site generation, and grid interconnections. Currently, there is no revenue generated from this AI data center platform. Grid Ai Corp.’s commercial pipeline has recently been re-established and is continuing to develop through consulting-led engagements and targeted business development initiatives. Current discussions are primarily with battery energy storage system (BESS) providers and energy infrastructure participants, including companies such as Mango Power and Nomad Transportable Power Systems. While prior trial deployments, including in Australia, have not yet resulted in significant commercial revenue, these efforts have informed management’s strategy to focus on lower-friction, near-term opportunities that can be pursued with limited incremental cost. Market conditions vary significantly by geography, and the Company is prioritizing regions and use cases where its platform can be more readily adopted. Grid Ai Corp. does not have any major customers at the present time and in the future aims to primarily serve AI data center developers, hyperscalers (large-scale cloud service providers that operate extensive computing, storage, and networking infrastructure to support enterprise applications and AI workloads), and energy infrastructure developers in North America and Australia.

InNotwithstanding ~~September~~the ~~2024,~~early-stage wenature ~~announced a binding letter~~ of ~~intent~~commercialization, ~~with~~Grid ~~Data~~AI ~~Vault Holdings, Inc~~Corp. ~~(“Data~~continues ~~Vault”),~~to aprioritize ~~privately~~development ~~held~~of ~~technology~~its ~~holding~~data ~~company,~~center toenergy ~~exclusively~~orchestration ~~license~~platform, ~~two~~which ~~technology~~remains ~~product~~its ~~suites~~core ~~owned~~strategic byfocus ~~Data~~and ~~Vault.~~is Weexpected doto ~~not~~serve ~~anticipate~~as ~~that~~the ~~this~~foundation ~~transaction~~for ~~will~~future ~~move~~revenue ~~forward~~generation.

Legacy Technologies

InPrior ~~December~~to ~~2023,~~Grid weAI ~~announced~~Corp.’s ~~that~~acquisition weof AMPX in February 2025, AMPX had ~~entered~~developed ~~into~~and aoperated ~~non~~two principal technology platforms focused on residential and distributed energy management: DLS developed technology and ALICE Home Energy Management Systems (“HEMS”). While Grid Ai Corp. currently supports these technologies, there is very minimal revenue and Grid Ai Corp.’s current focus is on data centers. DLS (Dynamic Load Shaping) is Grid Ai Corp.’s front-~~binding~~of-meter ~~term~~optimization ~~sheet~~platform designed to ~~sell~~manage ~~our~~and ~~Niclosamide~~optimize ~~program.~~large-scale ~~This~~distributed ~~transaction~~energy resources, such as utility-scale battery energy storage systems and solar arrays, by determining when to charge, hold, or discharge energy based on market and grid conditions. ALICE is ~~not~~Grid ~~expected~~AI Corp.’s HEMS platform, which enables residential users to ~~move~~optimize ~~forward~~energy usage across devices such as batteries, solar systems, and household appliances through data-driven orchestration.

~~Our~~While ~~Product~~historical ~~Candidates~~deployments and trial activity, including in Australia, have not yet resulted in significant commercial revenue, management believes these efforts have provided valuable operational insight and market feedback that inform Grid Ai Corp.’s current strategy. Grid Ai Corp. is actively evaluating lower-friction, near-term commercial opportunities related to these technologies, which may be pursued on a limited, low-cost basis as part of its broader development efforts.

~~Our~~Management ~~Adrulipase~~has ~~programs~~not ~~are~~assumed ~~focused~~that onall ~~the~~previously ~~development~~contemplated ofpipeline anopportunities ~~oral,~~related ~~non-systemic,~~to ~~biologic~~these ~~capsule~~legacy ~~for~~platforms ~~the~~will ~~treatment~~be ofrealized; ~~exocrine~~however, ~~pancreatic~~based ~~insufficiency~~on ~~(“EPI”)~~current inmarket ~~patients~~dynamics ~~with~~and ~~cystic~~increasing ~~fibrosis~~demand ~~(“CF”)~~for ~~and~~energy ~~chronic~~optimization ~~pancreatitis~~solutions, ~~(“CP”).~~management ~~Our~~believes ~~goal~~it is toreasonable ~~provide~~that CFcertain ~~and~~opportunities, CPincluding ~~patients~~those ~~with a safe and effective therapy to control EPI~~ that ismay ~~non-animal~~be ~~derived and offers the potential to dramatically reduce their daily pill burden. In July 2023~~delayed, wecould ~~announced~~be ~~topline results from our Phase 2b monotherapy bridging study using a new enteric microgranule formulation of Adrulipase~~achieved. ~~Although the primary efficacy endpoint was not achieved~~Accordingly, ~~data~~management ~~from~~continues ~~the~~to ~~study~~monitor ~~indicated that~~ the ~~enhanced~~commercial ~~Adrulipase~~viability ~~formulation~~of ~~was~~these ~~safe,~~platforms ~~well tolerated~~ and ~~demonstrated~~incorporate ansuch ~~improvement~~assessments ~~over~~into ~~prior~~its ~~formulations~~broader ofstrategic ~~Adrulipase. We are~~ planning toand ~~move~~impairment ~~this program forward in 2025~~analyses.

~~Our~~Strategic ~~Latiglutenase~~Pivot ~~program was focused on the development of an orally administered, minimally-absorbed, biologic for improving multiple gluten-induced symptoms~~ and ~~consequent~~Operational quality of life (“QOL”) due to inadvertent gluten consumption in patients with celiac disease (“CeD”) by breaking down the gluten into non-immunogenic peptides. We are no longer working on this program and have initiated a plan for its disposition.Restructuring

~~Our~~Following ~~Capeserod~~its ~~program~~acquisition ~~was~~of ~~in-licensed~~AMPX, ~~from~~Grid ~~Sanofi~~AI ~~in September 2023~~Corp. ~~Sanofi~~assessed ~~conducted~~the ~~Phase~~commercial 1viability ~~and~~of ~~Phase~~the 2above ~~Central~~platform ~~Nervous~~offerings, ~~System~~in ~~(“CNS”)~~particular ~~trials~~the ~~with~~potential ~~over~~for ~~600 patients~~ALICE. InThis ~~Sanofi’s~~assessment ~~CNS~~was ~~trials,~~informed ~~Capeserod~~through ~~appeared~~discussions ~~safe~~with ~~and~~potential ~~well-tolerated.~~customers, ~~Research~~investors onactive ~~Capeserod~~in ~~and~~the ~~subsequent~~sector ~~artificial intelligence~~ (~~“AI”)~~including ~~empowered~~venture ~~analyses~~capital ~~suggest~~and ~~that~~private ~~the~~equity ~~drug~~firms), ~~possesses~~and aexecutives ~~unique mechanism~~ of ~~action~~adjacent ~~that~~companies isand ~~applicable~~competitors, toas ~~several~~well GIas ~~indications~~feedback ~~underserved~~from bytrial ~~currently available therapeutics~~deployments. WeBased ~~are no longer working~~ on this ~~program~~outreach and ~~have~~market ~~notified~~feedback, ~~Sanofi~~Grid onAI ~~February~~Corp.’s ~~26,~~management ~~2025~~determined ofthat, ~~our~~while ~~termination~~customers ofrecognized the ~~license~~technical ~~agreement.~~capabilities Weof ~~may terminate~~ the ~~license~~platform, ~~agreement~~many ~~with~~were ~~Sanofi~~unwilling byto ~~providing~~replace ~~Sanofi~~existing ~~with~~deployed atsystems ~~least~~that 60were ~~days~~viewed ~~prior~~as ~~written~~sufficiently ~~notice;~~effective. ~~provided,~~The ~~however~~Company, ~~that~~together ~~Sanofi~~with ~~shall~~Grid beAI ~~entitled~~Corp., tois ~~any~~currently ~~and~~re-evaluating ~~all~~these ~~payments~~opportunities ~~due~~across ~~and~~different ~~owed~~geographic tomarkets, ~~Sanofi~~including ~~prior to~~ the ~~effective~~United ~~date~~States, ofUnited ~~termination.~~Kingdom, Onand ~~February 26~~Australia, ~~2025,~~where wemarket ~~provided~~conditions, ~~notice~~customer toneeds, ~~Sanofi to terminate the license agreement. No payments are due to Sanofi~~ and ~~the~~adoption ~~Company~~dynamics ~~expects~~may ~~the~~differ ~~termination~~from toprior ~~be effective in April 2025~~deployments.

Our Niclosamide programs leveraged proprietary oral and topical formulations to address multiple GI conditions, including inflammatory bowel diseases (“IBD”) indications. In 2022 we advanced four separate Phase 2 clinical programs of our Niclosamide formulations, including FW-COV for Severe Acute Respiratory Syndrome Coronavirus 2 (“COVID-19”) GI infections, FW-UP for ulcerative proctitis (“UP”) and ulcerative proctosigmoiditis (“UPS”), FW ICI AC for Immune Checkpoint Inhibitor associated colitis (“ICI AC”), and FW CD for Crohn’s disease. We are no longer actively pursuing these programs.

Our primary drug candidate and clinical program is described below.

Adrulipase

Adrulipase is the active pharmaceutical ingredient (“API”) derived from Yarrowia lipolytica, an aerobic yeast naturally found in various foods such as cheese and olive oil that is widely used as a biocatalyst in several industrial processes. Adrulipase is a secreted lipase naturally produced by Yarrowia lipolytica, known as LIP2, that we are developing through recombinant DNA technology for the treatment of EPI associated with CF and CP. Lipases are enzymes that help with the digestion of lipids and fat.

We previously held the exclusive right to commercialize Adrulipase in the U.S., Canada, South America (excluding Brazil), Asia (excluding China and Japan), Australia, New Zealand and Israel pursuant to a sublicense from Laboratories Mayoly Spindler SAS (“Mayoly”) under the Joint Research and Development Agreement (“JDLA”), which also granted us joint commercialization rights for Brazil, Italy, China and Japan. In March 2019, we purchased all rights, title and interest in and to Adrulipase from Mayoly pursuant to the Mayoly Asset Purchase Agreement (“APA”), provided, however, Mayoly retained exclusive commercial rights in France and Russia.

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~~Background~~Following the above assessment, Grid AI Corp.’s management initiated a strategic pivot in 2025:

~~The~~●Reduced ~~pancreas~~headcount isto ~~both~~lower ancash endocrine gland that produces several important hormones, including insulin, glucagon, and pancreatic polypeptide, as well as a digestive organ that secretes pancreatic juice containing digestive enzymes that assist with the absorption of nutrients and digestion in the small intestine.burn

~~The~~●Scaled ~~targeted~~back ~~indication~~DLS of Adrulipase is the treatment of EPI, which is observed when the exocrine functions of the pancreas are below 10% of normal. The symptomatology of EPI is essentially due to the deficiency of pancreatic lipase, an enzyme that hydrolyses triglycerides into monoglycerides and ~~free~~ALICE fatty acids. The pancreatic lipase enzymatic activity is hardly compensated by extra-pancreatic mechanisms, because gastric lipase has nearly no lipolytic activity in the pH range of the intestine. On the other hand, when they are impaired, the pancreatic amylase and protease (enzymes that break up carbohydrates (starches) and proteins, respectively) activities can be compensated by the salivary amylase, the intestinal glycosidase, the gastric pepsin, and the intestinal peptidases, all of which are components of the gastric juice secreted by the stomach walls. Lipid maldigestion due to ~~lipase~~minimum ~~deficiency~~support ~~is responsible for weight loss, steatorrhea featured by greasy diarrhea, and fat-soluble vitamin deficiencies (i.e. A, D, E and K vitamins).~~levels

~~CP,~~●Focused ~~the~~on ~~most~~new ~~common~~technology ~~cause~~in ~~of EPI, is~~ a ~~long-standing~~fundamentally ~~inflammation~~new ofmarket: ~~the~~energy ~~pancreas~~orchestration ~~that~~for ~~alters~~hyperscale ~~its~~AI ~~normal~~data ~~structure~~center and functions. In the U.S., its prevalence rate is of 42 cases per 100,000 inhabitants, resulting in approximately 132,000 cases. Approximately 60% of patients affected with CP display EPI, resulting in approximately 90,000 patients requiring substitution therapy in the U.S. In Western societies, CP is caused by chronic alcoholic consumption in approximately 55-80% of cases. Other relatively frequent etiologies include the genetic form of the disease that is inherited as an autosomal dominant condition with variable penetrance, pancreatic trauma and idiopathic causes.campuses

~~CF,~~This ~~another~~pivot ~~dominant~~represents ~~etiology of EPI, is~~ a ~~severe~~significant ~~genetic~~shift ~~disease associated with chronic morbidity and life-span decrease of most affected individuals. In most Caucasian populations, CF prevalence is of 7-8 cases per 100,000 inhabitants, but is less common~~ in other populations, resulting in more than 30,000 affected individuals in the U.S. and more than 70,000 affected individuals worldwide. CF is inherited as monogenic autosomal recessive disease due to the defect at a single gene locus that encodes the Cystic Fibrosis Transmembrane Regulator protein, or CFTR, a regulated chloride channel. Mutation of both ~~alleles~~market offocus ~~this chloride channel gene results in the production of thick mucus, which causes a multisystem disease of the upper~~ and ~~lower~~technological ~~respiratory tracts, digestive system, and the reproductive tract~~architecture. The progressive destruction of the pancreas results in EPI that is responsible for malnutrition and contributes to significant morbidity and mortality. About 80-90% of patients with CF develop EPI, resulting in approximately 25,000-27,000 patients in the U.S. that require substitution therapy.

~~Current~~AI ~~treatments~~Data ~~for~~Center ~~EPI~~Developed stemming from CP and CF rely on porcine (pig derived) pancreatic enzyme replacement therapies (“PERTs”), which have been on the market since the late 1800s. PERTs are typically comprised of three digestive enzymes; lipases, proteases, and amylases. The PERT market is well established with estimated sales of approximately $1.4 billion in 2019 in the U.S. and has been growing for the past five years at a compound annual growth rate of approximately 20%. In spite of their long-term use, however, PERTs suffer from poor stability, formulation problems, possible transmission of conventional and non-conventional infectious agents due to their animal origins, and possible adverse events at high doses in patients with CF and limited effectiveness.Technology

~~Pre~~Following Grid AI Corp’s acquisition of AMPX in February 2025, Grid AI Corp. commenced development of a new technology platform focused on AI-~~Clinical~~optimized ~~Program~~energy orchestration for large-scale data center campuses.

~~The~~Grid ~~efficacy~~AI of Adrulipase has been investigated in normal minipigs, which are generally considered to be a relevant model for digestive drug development because of their physiological similarities with humans and their omnivorous dietCorp. ~~Experimental~~plans pancreatitis was induced by pancreatic duct ligation, resulting in severe EPI with baseline CFA around 60% post-ligature. CFA is a measurement obtained by quantifying the amount of fat ingested orally over a defined time period and subtracting the amount eliminated in the stool to ~~ascertain~~generate ~~the~~revenue ~~amount~~from ofits ~~fat~~AI ~~absorbed~~data bycenter ~~the~~platform ~~body. Pigs were treated with either Adrulipase or enteric-coated PERTs, both administered as a single-daily dose.~~through:

At● ~~doses~~Base ~~ranging~~platform ~~from~~fees ~~10.5~~for tooperational ~~211~~visibility ~~mg,~~and Adrulipase increased the CFA by +25 to +29% in comparison to baseline (p<0.05 at all doses), whereas the 2.5 mg dose had milder activity. Similar efficacy was observed in pigs receiving 100,000 U lipase of enteric-coated porcine pancreatic extract. These findings demonstrate the in vivo activity of Adrulipase in a relevant in vivo model at a level similar to the PERTs at dosages of 10.5mg or greater.orchestration

●

Performance-based fees tied to power cost optimization

The platform is designed to deliver AI-optimized infrastructure by integrating data center operations with advanced energy systems. Core functionality includes data integration across site-level assets (including engines, battery systems, substations, and building systems), real-time monitoring through a centralized “single pane of glass” dashboard, historical data access, and reporting capabilities.

The platform also incorporates a proprietary digital twin model of each site, enabling simulation of energy usage, asset behavior, and grid interactions under various scenarios. This is supported by forecasting models for load, generation, and market conditions, which inform optimization decisions.

Based on Grid AI Corp. management’s experience to date, including discussions with data center operators, energy infrastructure participants, and industry consultants, the Company has not identified a direct competitor offering an equivalent fully integrated solution combining data center orchestration and energy optimization at scale; however, Gris Ai Corp. operates in a broader competitive landscape that includes partial or adjacent solutions.

In addition, the platform includes a co-optimization engine that participates in energy markets (including day-ahead, real-time, and reserve markets, where applicable) while prioritizing uninterrupted data center operations. An orchestration control layer ensures that energy assets operate in accordance with both market commitments and the operational requirements of the data center.

Target customers include enterprise and government entities operating large data center campuses.

Based on current projections:

●

A majority of Gris AI Corp.’s projected 2026 revenues are expected to be derived from the AI data center technology.

●

The contribution from this platform is expected to increase substantially in subsequent years.

Gris Ai Corp. markets its legacy technologies and intends to pursue commercial deployment of its AI data center platform through direct sales and strategic partnerships with energy developers, system integrators, engineering firms, and other industry participants. Gris Ai Corp. has commenced early-stage development activities related to its data center orchestration platform in connection with a potential future deployment at a customer site. As of the date of this Current Report on Form 8-K, the platform has not yet been commercially deployed. Initial development and integration activities are ongoing, and any future commercial deployment will depend on the progress of customer projects, including construction and operational readiness milestones, as well as the availability of customer funding.

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ToSources ~~date, two non-clinical toxicology studies have been conducted. Both show that Adrulipase lipase is clinically well tolerated at levels up to 1000mg/kg in rats~~ and ~~250~~Availability ~~mg/kg in minipigs up to 13 weeks. Adrulipase is therefore considered non-toxic in both rodent and non-rodent species up to a maximum feasible dose~~ of ~~1,000~~Raw ~~mg/kg/day in the rats over six months of administration.~~Materials

~~Clinical~~Grid ~~Program~~AI Corp.’s business is primarily software-based and does not rely on raw materials. Customer deployments may depend on third-party equipment and services, including battery systems, generation assets, and grid infrastructure.

WeDependence ~~are~~on ~~developing~~Major ~~Adrulipase for two principal therapeutic indications: (i) children and adults affected by CF, and (ii) adult patients with CP. We have determined to initially pursue the adult indication in CF.~~Customers

~~Chronic~~Grid ~~Pancreatitis~~AI Corp. is in an early stage of commercialization and expects that a limited number of customers may account for a significant portion of revenue in the near term. Amp Z, which is a related party (see Note 16 within financial statements), is a current customer with whom Grid AI Corp. has been engaged in ongoing collaboration since October 1, 2025; however, as of the date of this report, the parties remain under a letter of intent and have not yet finalized a definitive commercial agreement. Grid AI Corp. has not generated material revenue from Amp Z to date. Accordingly, Grid AI Corp. does not have any major customers at the present time.

~~During 2010 and 2011~~Patents, a phase 1/2a clinical trial of Adrulipase was conducted in conjunction with Mayoly in a single center in France. The study was an exploratory study mainly designed to investigate the safety of Adrulipase and was a randomizedTrademarks, ~~double blind, placebo controlled, parallel clinical trial in 12 patients affected with CP or pancreatectomy~~ and severe EPI. The primary efficacy endpoint of the study was defined as the relative change in steatorrhea (an established surrogate biomarker of EPI correction) in comparison to baseline. The study found that Adrulipase was well tolerated with no serious adverse events. Only two adverse events were observed: constipation (two patients out of eight with Adrulipase) and hypoglycemia (two patients out of eight with Adrulipase, and one patient out of four with placebo). A non-statistically significant difference of the primary endpoint, possibly due to the small group size, was found between the two groups both in intention-to-treat, a group that included three patients who received the in-patient facility study diet but did not fulfill the protocol’s inclusion criteria, and per-protocol analysis. This study was not designed, nor did it aim to demonstrate statistically significant changes of CFA or steatorrhea under Adrulipase.Agreements

WeGrid ~~received~~AI ~~regulatory~~Corp. ~~approval~~relies inon ~~Australia~~proprietary ~~and New Zealand in 2016~~software, ~~with~~trade ~~the addition of a 2018 regulatory approval in France~~secrets, to conduct a Phase 2 multi-center dose escalation study of Adrulipase in CP and pancreatectomy. The primary endpoint of this study was to evaluate the safety of escalating doses of Adrulipase in 11 CP patients. The secondary endpoint was to investigate the efficacy of Adrulipase in these patients by analysis of the CFA and its change from baseline. In September 2018trademarks, ~~we announced that in pre-planned analyses, both the study’s primary~~ and ~~secondary~~contractual ~~endpoints were reached with a statistically significant (p=0~~protections.~~002)~~ ~~improvement~~Grid inAI ~~the CFA of 21~~Corp.~~8%,~~ indoes anot ~~per~~currently ~~protocol~~rely ~~analysis, with the highest evaluated dose of 2,240 mg/day of Adrulipase. The statistical significance of the trial results is typically based~~ on ~~widely~~material ~~used,~~labor ~~conventional statistical methods that establish the p-value of the results~~agreements. ~~A p-value of 0.05 or less is required to demonstrate statistical significance. As such, these CFA levels are considered to be statistically significant.~~

~~Cystic~~Government ~~Fibrosis Monotherapy~~Approvals

InGrid ~~October 2018,~~AI ~~the~~Corp.’s ~~FDA~~software ~~cleared~~platform ~~our~~itself ~~IND~~generally ~~application~~does ~~for~~not ~~Adrulipase~~require indirect ~~patients~~government ~~with~~approvals ~~EPI due~~ to CFoperate. ~~In December 2018~~However, weits ~~initiated~~solutions ~~the~~are ~~Phase~~deployed 2within ~~OPTION~~regulated ~~Bridging~~energy ~~Dose~~markets ~~Study~~and toare ~~investigate~~therefore ~~Adrulipase~~indirectly insubject CFto ~~patients~~a ~~with~~range ~~EPI~~of ~~and in February 2019~~federal, ~~we dosed the first patients. The Phase 2 OPTION Bridging Dose Study investigated the safety~~state, ~~tolerability~~ and ~~efficacy~~local ofregulatory ~~Adrulipase in a head-to-head comparison against the current PERT standard of care~~requirements. ~~The OPTION Bridging Dose Study employed a six-week non-inferiority CFA primary efficacy endpoint comparing Adrulipase to PERTs.~~

InCustomer ~~September 2019,~~deployments wemay ~~announced~~require ~~positive~~regulatory ~~results~~approvals, ~~from~~permits, ~~the~~interconnection ~~OPTION Bridging Dose Study. Results showed that the primary efficacy endpoint of CFA was comparable to the CFA in a prior Phase 2 study in patients with CP~~agreements, ~~while~~and ~~using~~market ~~the~~participation ~~same dosage of Adrulipase. The dosage used in the OPTION Bridging Dose Study was 2.2 grams per day~~approvals, which ~~was~~are ~~determined~~typically inobtained ~~agreement~~by ~~with the FDA as a bridging dose from the highest safe dose used in the Phase 2 CP dose escalation study. Although the study was not powered for statistical significance~~customers, ~~the data demonstrated meaningful efficacy results~~utilities, ~~with~~or ~~approximately~~project ~~50%~~partners. ofThese ~~the~~approvals ~~patients~~may ~~showing~~relate ~~CFAs high enough~~ to ~~reach~~grid ~~non-inferiority with standard PERTs. Additionally~~interconnection, ~~the~~participation ~~CNA~~in ~~was~~wholesale ~~comparable~~electricity ~~between the Adrulipase and PERT arms~~markets, ~~93%~~local ~~vs. 97%~~permitting, ~~respectively,~~and incompliance ~~the OPTION Bridging Dose Study. This important finding confirms that protease supplementation is not likely to be required~~ with ~~Adrulipase~~applicable ~~treatment.~~energy ~~A total of 32 patients, ages 18 or older, completed the OPTION Bridging Dose Study~~regulations.

InGrid ~~October 2019,~~AI ~~the~~Corp.’s ~~CFF~~platform ~~DSMB~~is ~~completed~~designed ~~its~~to ~~review~~operate ofwithin ~~our~~complex ~~final~~and ~~results~~evolving ofregulatory ~~the~~frameworks, ~~OPTION~~including ~~Bridging~~those ~~Dose~~governing ~~Study~~distributed ~~and~~energy ~~found~~resources, novirtual ~~safety~~power ~~concerns~~plants, ~~for Adrulipase~~ and ~~supported~~wholesale ~~our~~market ~~plan~~participation. toChanges ~~proceed~~in tolaws, ~~the~~regulations, ~~Phase~~market 2brules, ~~OPTION~~or 2regulatory ~~Trial.~~interpretations Incould ~~December 2019,~~impact ~~we submitted~~ the ~~clinical~~ability ~~trial~~of ~~protocol~~customers to ~~the~~deploy ~~existing~~Grid ~~IND~~AI ~~at the FDA~~Corp.’ ~~In April 2020~~solutions, weparticipate ~~received~~in ~~approval~~energy tomarkets, ~~conduct~~or realize the ~~OPTION~~expected 2economic ~~Trial~~benefits inof ~~Therapeutics Development Network clinical sites in~~ the Uplatform.S.

In addition, Grid AI Corp. relies on integrations with third-party systems and market operators, including utilities, grid operators, and energy market platforms, which are themselves subject to regulatory oversight. Delays in obtaining required approvals, changes in regulatory requirements, or limitations imposed by regulators or market operators could adversely affect Grid AI Corp.’s business, operating results, and financial condition.

Effect of Government Regulation

Grid AI Corp. operates in regulated energy markets. Regulatory changes affecting energy storage, distributed energy resources, interconnection, or energy markets could impact its business.

Environmental Compliance

Grid AI Corp.’s operations are primarily software-based and are not expected to incur material environmental compliance costs. Customer projects may be subject to environmental regulations that could affect project timing.

Our Legacy Biopharmaceutical Activities

As of December 31, 2025, our legacy biopharmaceutical activities are centered on Adrulipase, our recombinant lipase enzyme program for the treatment of exocrine pancreatic insufficiency, or EPI. We are no longer developing the Latiglutenase, CypCel, Capeserod or Niclosamide programs. Following the closing of the rescission transaction involving ImmunogenX, LLC on December 31, 2025, the Latiglutenase and CypCel programs are no longer part of our business. We also terminated our license agreement with Sanofi relating to Capeserod in February 2025, and we are no longer actively pursuing Niclosamide.

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~~The~~Our ~~OPTION~~Adrulipase 2program ~~Trial~~is ~~was~~focused ~~designed~~on ~~to investigate~~ the ~~safety,~~development ~~tolerability and efficacy~~ of ~~Adrulipase~~an ~~(2.2~~oral, ~~gram~~non-systemic ~~and~~biologic ~~4.4~~therapy ~~gram~~for ~~doses in enteric capsules) head-to-head versus~~ the ~~current~~treatment ~~standard~~ of ~~care,~~EPI ~~PERT~~in ~~pills.~~patients ~~The~~with ~~OPTION~~cystic ~~2 Trial was an open-label~~fibrosis, ~~crossover~~or ~~study~~CF, ~~conducted in 15 sites in the U.S.~~ and ~~Europe.~~chronic ~~Enrollment~~pancreatitis, ~~included a total of 30 CF patients 18 years~~ or ~~older~~CP. ~~Adrulipase~~Our ~~was~~goal ~~administered~~is ~~in enteric capsules~~ to provide ~~gastric~~CF ~~protection~~ and ~~test~~CP ~~for~~patients ~~optimal~~with ~~delivery~~a oftherapy ~~enzyme~~ to ~~the~~control ~~duodenum.~~EPI ~~Patients~~that ~~were~~is ~~first~~non-animal ~~randomized~~derived ~~into~~and ~~two~~offers ~~cohorts:~~ the ~~Adrulipase~~potential ~~arm,~~to ~~where~~dramatically ~~they~~reduce ~~received~~their ~~a 2.2 gram~~ daily ~~oral~~pill ~~dose~~burden. ofCP, ~~Adrulipase~~the ~~for~~most ~~three~~common ~~weeks;~~cause orof ~~the PERT arm~~EPI, ~~where~~is ~~they~~a ~~received their pre~~long-~~study~~standing ~~dose~~inflammation of ~~PERT~~the ~~pills~~pancreas ~~for~~that ~~three~~alters ~~weeks.~~its ~~After~~normal ~~three~~structure ~~weeks,~~and ~~stools~~functions. ~~were~~In ~~collected~~the ~~for~~U.S., ~~analysis~~its ofprevalence ~~CFA. Patients~~rate ~~were~~is ~~then~~42 ~~crossed~~cases ~~over~~per ~~for~~100,000 ~~another~~inhabitants, ~~three~~resulting ~~weeks~~in ofapproximately ~~the~~132,000 ~~alternative treatment~~cases. ~~After~~Approximately ~~three~~60% ~~weeks~~ of ~~cross-over~~patients ~~therapy,~~affected ~~stools~~with ~~were~~CP ~~again~~display ~~collected~~EPI, ~~for~~resulting ~~analysis~~in ofapproximately ~~CFA.~~90,000 ~~A parallel group of~~ patients ~~was~~requiring ~~randomized~~substitution ~~and~~therapy ~~studied~~ in the ~~same fashion using a 4~~U.4S. ~~gram~~In ~~daily~~Western ~~dose~~societies, ofCP ~~Adrulipase. All~~is ~~patients~~caused ~~were~~by ~~followed~~chronic ~~for~~alcoholic anconsumption ~~additional~~in ~~two~~approximately ~~weeks~~55-80% ~~after~~of ~~completing~~cases. ~~both~~Other ~~crossover~~relatively ~~treatments~~frequent ~~for~~etiologies ~~post~~include ~~study~~the ~~safety~~genetic ~~observation. Patients~~form ~~were~~of ~~assessed~~the ~~using~~disease ~~descriptive~~that ~~methods~~is ~~for~~inherited ~~efficacy,~~as ~~comparing~~an ~~CFA~~autosomal ~~between~~dominant ~~Adrulipase~~condition ~~and~~with ~~PERT~~variable ~~arms~~penetrance, pancreatic trauma and ~~for~~idiopathic ~~safety~~causes.

CF, another dominant etiology of EPI, is a severe genetic disease associated with chronic morbidity and life-span decrease of most affected individuals. In ~~January 2021~~most Caucasian populations, weCF ~~announced~~prevalence anis ~~additional~~of ~~study~~7-8 ~~arm~~cases inper ~~OPTION~~100,000 2inhabitants, ~~Trial~~but ~~using~~is anless ~~immediate~~common ~~release~~in ~~Adrulipase~~other ~~capsules~~populations, resulting in ~~order~~more tothan ~~identify~~30,000 ~~the~~affected ~~optimal~~individuals ~~dose~~in the U.S. and ~~delivery~~more ~~method~~than of70,000 ~~Adrulipase~~affected individuals worldwide. ~~This~~CF ~~extension~~is ~~phase~~inherited ~~tested~~as ~~patients~~monogenic ~~18 years~~autosomal recessive disease due to the defect at a single gene locus that encodes the Cystic Fibrosis Transmembrane Regulator protein, or ~~older~~CFTR, ~~who~~a ~~have~~regulated ~~already~~chloride ~~completed~~channel. Mutation of both alleles of this chloride channel gene results in the ~~crossover~~production ~~phase~~of thick mucus, atwhich ~~higher~~causes ~~doses~~a ~~relative~~multisystem todisease of the ~~previously~~upper ~~conducted~~and ~~OPTION~~lower ~~Bridging~~respiratory ~~Dose~~tracts, ~~Study.~~digestive ~~This~~system, ~~allowed~~and usthe toreproductive ~~compare~~tract. ~~data~~The ~~from~~progressive destruction of the ~~existing~~pancreas ~~crossover~~results ~~arm~~in ~~using~~EPI ~~enteric~~that ~~(delayed~~is ~~release)~~responsible ~~capsules~~for malnutrition and contributes to significant morbidity and mortality. About 80-90% of patients with ~~data~~CF ~~from~~develop EPI, resulting in approximately 25,000-27,000 patients in the ~~new~~U.S. ~~immediate~~that ~~release~~require ~~extension~~substitution ~~arm~~therapy.

In ~~March~~July ~~2021~~2023, we announced topline ~~OPTION~~results 2from ~~data.~~our ~~The~~Phase ~~trial~~2b ~~demonstrated~~pilot ~~that~~monotherapy bridging study using a new enteric microgranule formulation of Adrulipase. Although the primary efficacy endpoint was ~~safe~~not ~~and~~achieved, ~~well-tolerated~~we believe that this may be on account of issues with quality control and ~~data~~clinical approach related to the study. Data from ~~OPTION~~the 2,study ~~and~~indicated that the ~~other~~enhanced Adrulipase ~~Phase~~formulation 2was ~~clinical~~well ~~trials,~~tolerated and demonstrated ~~drug~~an ~~activity.~~improvement ~~However~~over prior formulations of Adrulipase, ~~OPTION~~and 2there ~~did~~was ~~not~~an ~~consistently~~improvement ~~meet~~in the ~~primary~~CFA ~~efficacy~~to ~~endpoint.~~therapeutic ~~Some~~levels in cystic fibrosis patients ~~were~~with ~~able~~exocrine topancreatic ~~achieve~~insufficiency. ~~CFA~~We atplan ~~levels~~to ~~beyond~~have ~~what~~a ismeeting ~~required~~with the FDA to ~~demonstrate~~discuss ~~non-inferiority~~the ~~with~~next ~~PERT~~steps ~~therapies,~~in ~~but~~this regard. We are currently evaluating next steps for the ~~majority~~Adrulipase ~~did~~program, ~~not~~including potential future clinical development, subject to available capital.

We believe that the underlying cause of the drug’s uneven efficacy performance in the OPTION 2 trial was the enteric capsule formulation. While the enteric coating protected the capsule from breaking down in the stomach acid, it also appeared to dissolve too slowly in the small intestine to release the lipase enzyme in time to aid with proper digestion and nutrient absorption.Adrulipase

InAdrulipase ~~August 2021~~is wethe ~~announced~~active ~~that~~pharmaceutical weingredient ~~would~~derived ~~begin~~from ~~development~~Yarrowia oflipolytica, aan ~~new~~aerobic ~~enteric~~yeast ~~microgranule~~naturally ~~formulation~~found ofin ~~Adrulipase.~~various ~~The~~foods ~~new~~such ~~formulation~~as ischeese ~~planned~~and toolive beoil ~~administered~~that ~~with~~is ~~food~~widely used as ana ~~oral~~biocatalyst ~~capsule that dissolves~~ in ~~the~~several ~~stomach~~industrial ~~and~~processes. ~~disperses~~Adrulipase ~~acid-resistant~~is ~~micro-granules~~a ~~that~~secreted ~~thoroughly~~lipase ~~mix~~naturally ~~with~~produced ~~food~~by ~~during~~Yarrowia ~~the~~lipolytica, ~~digestion~~known ~~process.~~as ~~The~~LIP2, ~~resultant~~that ~~mixture~~we ~~then~~are ~~passes~~developing tothrough ~~the~~recombinant ~~small~~DNA ~~intestine~~technology ~~where~~for the ~~lipase~~treatment ~~enzyme~~of ~~breaks~~EPI upassociated ~~fat~~with ~~molecules~~CF soand ~~that they can be absorbed~~CP. WeLipases ~~completed~~are ~~the~~enzymes ~~reformulation~~that ~~work~~help inwith the ~~second~~digestion ~~half~~ of ~~2022~~lipids and fats.

InWe ~~November 2022~~previously weheld ~~announced that we had filed an IND amendment with~~ the ~~FDA~~exclusive ~~for~~right ~~a Phase 2b bridging study with the new enteric microgranulation formulation of Adrulipase. The new trial is designed~~ to ~~investigate~~commercialize ~~the safety, tolerability and efficacy of the new formulation of~~ Adrulipase. ~~It is an open-label study that will be conducted at three sites~~ in the ~~U.S.~~United AStates, ~~total~~Canada, ofSouth 12America ~~cystic~~(excluding ~~fibrosis patients~~Brazil), ~~18 years~~Asia or(excluding ~~older~~China, ~~are~~Hong ~~expected~~Kong, toand beJapan), ~~enrolled.~~Australia, ~~The~~New ~~trial~~Zealand ~~design~~and ~~employs~~Israel apursuant ~~dose titration strategy. Patients will be screened at baseline~~ to ~~ensure that they have~~ a ~~coefficient~~sublicense ~~of fat absorption (CFA) of at least 80%. Eligible patients will then be switched~~ from ~~their~~Laboratories ~~commercial~~Mayoly ~~enzyme~~Spindler ~~product~~SAS, toor ~~Adrulipase.~~Mayoly, ~~Each~~under ~~patient~~the ~~will~~Joint beResearch ~~started~~and onDevelopment aAgreement, ~~low~~or ~~dose of Adrulipase. If the patient is not clinically controlled~~JDLA, ~~the~~which ~~patient~~also ~~will~~granted beus ~~switched~~joint tocommercialization arights ~~medium~~for ~~dose~~Brazil, ~~and if not controlled on this dose~~Italy, ~~the~~China ~~patient~~and ~~will be advanced to a high dose~~Japan. ~~The~~In ~~titrations~~March ~~will~~2019, bewe ~~carried~~purchased ~~out~~all ~~over a three-week period~~rights, ~~after~~title ~~which~~and ainterest ~~CFA~~in ~~will~~and beto ~~obtained.~~Adrulipase ~~End~~from ofMayoly ~~study~~pursuant ~~CFAs will be compared~~ to the ~~baseline~~Mayoly ~~CFAs~~Asset inPurchase aAgreement, ~~descriptive~~or ~~fashion.~~APA, Aalthough ~~post~~Mayoly ~~treatment~~retained ~~safety~~exclusive ~~visit~~commercial ~~will~~rights bein ~~conducted~~France ~~one~~and ~~week after completing the treatment period~~Russia.

Following FDA review of the IND amendment, we initiated the Phase 2b pilot monotherapy trial during the first quarter of 2023 and received topline data in the third quarter of 2023. Although the primary efficacy endpoint was not achieved, data from the study indicated that the enhanced Adrulipase formulation was safe, well tolerated and demonstrated an improvement over prior formulations of Adrulipase. We are planning to move this program forward in 2025 including with the intent to initiate a Ph2b clinical trial in the second half of 2025.Background

~~Combination~~The ~~Therapy~~pancreas is both an endocrine gland that produces important hormones, including insulin, glucagon and pancreatic polypeptide, and a digestive organ that secretes pancreatic juice containing digestive enzymes that assist with nutrient absorption and digestion in the small intestine.

WeThe ~~launched~~targeted indication for Adrulipase is the ~~Phase~~treatment 2of ~~Combination~~EPI, ~~Trial~~which inoccurs ~~Hungary~~when inthe ~~July 2019~~exocrine tofunctions ~~investigate~~of ~~Adrulipase,~~the inpancreas ~~combination~~are ~~with~~reduced ~~PERT,~~to inbelow CFapproximately ~~patients~~10% ~~who~~of ~~suffer~~normal. ~~from~~The ~~severe~~symptoms of EPI ~~but~~are ~~continue~~driven toprimarily ~~experience~~by ~~clinical~~pancreatic ~~symptoms~~lipase ofdeficiency, ~~fat~~which ~~malabsorption~~results ~~despite~~in ~~taking~~impaired ~~the~~digestion ~~maximum~~of ~~daily~~fats ~~dose~~and ofother ~~PERTs~~nutrients. ~~The~~Lipid ~~Combination~~maldigestion ~~Trial~~due isto ~~designed~~lipase todeficiency ~~investigate~~can ~~the~~lead ~~safety,~~to ~~tolerability~~weight ~~and~~loss, ~~efficacy~~steatorrhea, ofgreasy ~~escalating~~diarrhea ~~doses~~and offat-soluble vitamin deficiencies.

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~~Adrulipase~~CP ~~(700~~is ~~mg,~~one ~~1120~~of mgthe ~~and~~principal ~~2240~~causes mgof ~~per~~EPI. ~~day,~~CF ~~respectively),~~is inanother ~~conjunction~~major ~~with~~etiology ~~a stable dose~~ of ~~PERTs,~~EPI ~~in order to increase CFA~~ and ~~relieve~~is ~~abdominal symptoms. In October 2020, we opened~~ a ~~total~~severe ofgenetic ~~five~~disease ~~clinical~~associated ~~sites~~with inchronic ~~Turkey~~morbidity and ~~dosed~~reduced ~~the~~life ~~first~~expectancy. ~~patients~~A insubstantial ~~November 2020.~~percentage Inof ~~March 2021,~~CF wepatients ~~reached~~develop ~~targeted~~EPI ~~minimum~~and ~~enrollment~~require ofenzyme 18substitution ~~patents~~therapy.

WeCurrent ~~announced~~treatments ~~positive~~for ~~interim~~EPI ~~data~~in onCP ~~the~~and ~~first~~CF ~~five~~rely ~~patients~~primarily inon ~~the~~porcine ~~Combination~~pancreatic ~~Trial~~enzyme inreplacement ~~August 2020~~therapies, or PERTs. ~~The~~Although ~~primary~~PERTs ~~efficacy~~are ~~endpoint~~a ~~was~~long-established ~~met~~standard of care, ~~with~~they ~~CFAs~~have ~~greater~~limitations, ~~than~~including ~~80%~~high ~~for~~pill ~~all~~burden, ~~patients~~formulation ~~across~~challenges, ~~all~~variability ~~visits.~~associated ~~For~~with ~~secondary~~animal-derived ~~efficacy~~sourcing ~~endpoints,~~and welimited ~~observed~~effectiveness ~~that~~in ~~stool~~certain ~~weight~~patients. ~~decreased,~~Adrulipase ~~the~~is ~~number~~intended ofto ~~stools~~address ~~per~~EPI ~~day~~using ~~decreased~~a recombinant, ~~steatorrhea~~non-porcine ~~improved,~~lipase ~~and~~approach. ~~body~~Management ~~weight~~believes ~~increased.~~that ~~Additionally,~~this nonon-animal ~~serious~~derived ~~adverse~~profile ~~events~~remains ~~were~~a ~~reported~~meaningful differentiating feature of the program.

In August 2021, we announced topline data collected from the 20 patients enrolled in the study. The data indicated that Adrulipase in combination with PERT led to clinically meaningful improvements in CFA, the primary efficacy endpoint. Patients showed an average gain of more than six percentage points from baseline, compared to the fivePre-~~point~~Clinical ~~improvement in CFA cited by the clinical literature as clinically significant. The study also demonstrated positive improvements in weight gain and other secondary endpoints.~~Program

WeThe ~~believe~~efficacy of Adrulipase has been investigated in normal minipigs, which are generally considered a ~~combination~~relevant ~~therapy~~model for digestive drug development because of ~~PERT~~physiological similarities to humans and ~~Adrulipase~~their ~~has~~omnivorous ~~the~~diet. ~~potential~~Experimental ~~to:~~pancreatitis ~~(i) correct~~was ~~macronutrient~~induced ~~and~~by ~~micronutrient~~pancreatic ~~maldigestion;~~duct ~~(ii) eliminate~~ligation, ~~abdominal~~resulting ~~symptoms~~in ~~attributable~~severe toEPI ~~maldigestion;~~with ~~and~~baseline ~~(iii) sustain~~coefficient ~~optimal~~of ~~nutritional~~fat ~~status~~absorption, onor CFA, around 60% post-ligature. CFA is a ~~normal~~measurement ~~diet~~obtained by quantifying the amount of fat ingested orally over a defined time period and subtracting the amount eliminated in CFstool ~~patients~~to ~~with~~estimate ~~severe~~the ~~EPI~~amount absorbed by the body.

~~Recent~~At ~~Developments~~doses ranging from 10.5 mg to 211 mg, Adrulipase increased CFA by approximately 25% to 29% compared to baseline, while lower doses showed more limited activity. Similar efficacy was observed in pigs receiving enteric-coated porcine pancreatic extract. These findings demonstrated in vivo activity of Adrulipase in a relevant model.

~~Rescission~~Two ~~Agreement~~non-clinical ~~with~~toxicology ~~ImmunogenX~~studies Onhave ~~March~~been 24conducted ~~2025~~to date. Based on those studies, weAdrulipase ~~entered~~appeared ~~into~~to ~~the~~be ~~Rescission~~well ~~Agreement,~~tolerated byat ~~and~~clinically ~~among~~relevant ~~the~~dose ~~Company,~~levels ~~IMGX,~~in both rodent and ~~IMGX~~non-rodent ~~Shareholders~~species.

~~Under~~Clinical the terms of the Rescission Agreement, the parties have amicably determined that it is in their collective best interest to: (i) rescind the issuances of the of the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, (ii) convey to the IMGX Shareholders all of the issued and outstanding Membership Interests of IMGX currently held by the Company, (iii) cancel the Assumed Options and Assumed Warrants; and (iv) provide for such additional agreements as are set forth therein.Program

~~Pursuant~~We tohave ~~the~~historically ~~terms~~evaluated ofAdrulipase ~~the~~for ~~Rescission~~two ~~Agreement~~principal therapeutic settings: (i) ~~each~~children ~~Shareholder agreed to cancel, waive, relinquish~~ and ~~disclaim~~adults inaffected ~~all~~by ~~respects~~CF ~~any~~ and all claims and/or rights to record or beneficial ownership in and to the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, as set forth in the Rescission Agreement, (ii) ~~each~~adult ~~Shareholder~~patients ~~agreed~~with toCP. ~~cancel,~~In ~~waive,~~recent ~~relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the Assumed Options and Assumed Warrants as set forth in the Rescission Agreement~~periods, ~~including~~our ~~any~~primary ~~Common~~focus ~~Stock~~has ~~into which such Assumed Options and Assumed Warrants are not or ever have~~ been ~~converted~~on ~~or are convertible, (iii)~~ the ~~Company~~CF-related ~~agreed~~EPI to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the Membership Interests of IMGX, and (iv) the Company will retain up to approximately $695,000 of IMGX’s accounts payable, and IMGX will remain responsible for approximately $9,278,400 of IMGX’s secured debtopportunity.

InChronic addition, under the terms of the Rescission Agreement, the Company shall have no obligation and will released from any and all obligations with respect to the assets or business of IMGX incurred after the Closing Date, as defined in the Rescission Agreement, or prior to the Closing Date, except as provided in the Rescission Agreement, unless approved in writing by the Company.Pancreatitis

~~The~~During ~~obligations~~2010 ofand ~~each~~2011, ~~party~~a toPhase ~~the~~1/2a ~~Rescission~~clinical ~~Agreement~~trial toof ~~consummate~~Adrulipase ~~the~~was ~~transactions~~conducted ~~contemplated~~in byconjunction ~~the~~with ~~Rescission~~Mayoly ~~Agreement are subject to the fulfillment,~~ at ora ~~prior~~single tocenter ~~the Closing, as defined~~ in ~~the~~France. ~~Rescission~~The ~~Agreement,~~study ofwas ~~each~~primarily ofdesigned ~~the~~to ~~conditions~~investigate ~~set~~safety ~~forth~~ in ~~the~~12 ~~Rescission~~patients ~~Agreement,~~with ~~and~~CP ~~among~~or ~~others,~~pancreatectomy ~~that~~and ~~(i)~~severe ~~the~~EPI. ~~Company~~Adrulipase ~~shall~~was ~~have~~generally ~~obtained~~well ~~approval~~tolerated, ofwith ~~its~~no ~~shareholders~~serious ~~for~~adverse ~~the~~events ~~transfer~~reported. ofAlthough ~~the~~efficacy ~~Membership~~findings ~~Interests~~were tolimited ~~the Shareholders,~~ and ~~the~~not ~~other~~statistically ~~consents~~significant, ~~authorizations or approvals from~~ the ~~parties~~study aswas ~~set~~not ~~forth~~designed ~~in the Rescission Agreement~~ to ~~consummate~~demonstrate ~~the~~statistically ~~transactions~~significant ~~contemplated~~changes ~~by this Agreement, (ii) the Shareholders shall have delivered a mutually satisfactory voting agreement agreeing to, including other things, vote the Shares held by them~~ in ~~favor~~CFA ofor ~~the transactions contemplated by the Rescission Agreement, and (iii) the Company shall have received a resignation letter from Jack Syage resigning from all positions with the Company~~steatorrhea.

We later received regulatory approvals in Australia, New Zealand and France to conduct a Phase 2 multi-center dose escalation study of Adrulipase in CP and pancreatectomy patients. In September 2018, we announced that, in pre-planned analyses, both the study’s primary and secondary endpoints were achieved, including a statistically significant improvement in CFA in a per-protocol analysis at the highest evaluated dose.

Cystic Fibrosis Monotherapy

In October 2018, the FDA cleared our IND application for Adrulipase in patients with EPI due to CF. We then initiated the Phase 2 OPTION Bridging Dose Study to investigate the safety, tolerability and efficacy of Adrulipase in CF patients with EPI compared against standard PERT therapy.

In September 2019, we announced positive results from the OPTION Bridging Dose Study. Although the study was not powered for statistical significance, the data showed meaningful signs of activity, including CFAs in a portion of patients that approached levels required for non-inferiority with standard PERTs. The coefficient of nitrogen absorption, or CNA, was also comparable between Adrulipase and PERT arms, which management considered important because it suggested protease supplementation might not be required with Adrulipase treatment.

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The ~~Rescission~~subsequent ~~Agreement~~OPTION ~~may~~2 beTrial ~~terminated~~was ~~and~~designed to investigate the ~~transactions~~safety, ~~contemplated~~tolerability ~~thereby~~and ~~may~~efficacy beof ~~abandoned~~Adrulipase byin ~~the~~enteric ~~Company~~capsules, orat ~~the~~two ~~Shareholder~~dose ~~Representative~~levels, ascompared ~~defined~~head-to-head inagainst ~~the~~PERT. ~~Rescission~~In ~~Agreement~~March 2021, ifwe ~~the~~announced ~~transactions~~topline ~~contemplated~~OPTION ~~thereby~~2 ~~shall~~data. ~~not~~The ~~have~~trial ~~been~~demonstrated ~~consummated~~that byAdrulipase ~~June~~was 30safe and well tolerated and that prior clinical work had shown evidence of drug activity. However, ~~2025~~OPTION 2 did not consistently meet the primary efficacy endpoint. Some patients achieved CFA levels supportive of non-inferiority to PERT, ~~unless~~but the ~~Company~~overall ~~and~~efficacy ~~Shareholder~~results ~~Representative~~were ~~shall~~uneven. ~~have~~Management ~~consented~~believed that the enteric capsule formulation likely contributed to athese ~~subsequent~~results ~~date~~because the formulation appeared to dissolve too slowly in the small intestine to release the lipase in time to optimize digestion.

~~The~~In ~~foregoing~~response, ~~description~~we began development of ~~the~~a ~~Rescission~~new ~~Agreement~~enteric ~~does~~microgranule ~~not~~formulation ~~purport~~of Adrulipase, designed to beprovide ~~complete~~improved delivery characteristics. Following FDA review of the applicable IND amendment, we initiated a Phase 2b pilot monotherapy study during 2023 and isreceived ~~qualified~~topline data in ~~its~~the ~~entirety~~third byquarter ~~reference~~of to2023. Although the ~~full~~primary ~~text~~efficacy ofendpoint was not achieved, the ~~Merger~~data ~~Agreement~~indicated that the enhanced Adrulipase formulation was safe, ~~which~~well istolerated ~~incorporated~~and byimproved ~~reference~~over toprior ~~this~~formulations. ~~Report~~Management’s aslater ~~Exhibit~~internal [2assessment concluded that the program’s scientific rationale remained intact, although the path forward became narrower and more execution-dependent following these results.~~3].~~

~~License~~As ~~Agreement~~of ~~with~~December ~~Sanofi~~31, 2025, Adrulipase remained our principal retained biopharmaceutical program. No clinical trials were conducted during 2025 as the Company focused on preserving liquidity and restructuring operations. Management has continued to evaluate potential next steps for the program, including future regulatory dialogue and clinical-development options. However, the timing and scope of any further development will depend on available capital, strategic priorities and additional assessment of the clinical and commercial path forward.

OnCombination February 26, 2025, we gave notice to terminate our license agreement with Sanofi for the development of Capeserod, a selective 5-HT4 receptor partial agonist. We anticipate that this termination will be effective in April 2025. We may terminate the license agreement by providing Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled to any and all payments due and owed to Sanofi prior to the effective date of termination. No payments are due to Sanofi.Therapy

~~Revolving~~We ~~Loan~~also ~~Agreement~~evaluated Adrulipase in combination with PERT in CF patients suffering from severe EPI who continued to experience fat malabsorption symptoms despite taking the maximum daily dose of PERTs. The Combination Trial was designed to investigate escalating doses of Adrulipase used together with a stable dose of PERTs in order to improve CFA and relieve abdominal symptoms.

~~Effective~~We ~~January~~previously ~~31,~~announced ~~2025,~~positive weinterim ~~entered~~and ~~into~~topline adata ~~Revolving~~from ~~Loan~~this ~~Agreement~~study ~~dated~~indicating ~~January~~clinically ~~27,~~meaningful ~~2025~~improvements ~~(the~~in ~~“Revolving~~CFA ~~Loan~~and ~~Agreement”),~~other ~~with~~secondary ameasures, ~~Lender~~including ~~pursuant~~stool tocharacteristics ~~which~~and ~~the~~weight-related ~~Lender~~observations. ~~agreed~~Based toon ~~make~~these ~~loans~~results ~~to us. Pursuant to~~ and ~~under~~later ~~the~~internal ~~terms of the Revolving Loan Agreement~~review, wemanagement ~~issued~~believes tothat the ~~Lender~~most acredible ~~revolving~~remaining ~~note~~value ~~dated~~proposition ~~January~~for ~~27,~~Adrulipase ~~2025~~may ininclude ~~the~~an ~~principal~~adjunct-therapy ~~amount~~or oftreatment-burden ~~$2,000,000~~reduction ~~(the “Revolving Note” and such amount~~thesis, ~~the~~rather ~~“Total~~than ~~Outstanding~~solely ~~Amount”).~~a ~~This~~full ~~transaction~~monotherapy isreplacement ~~referred to as the “Financing”~~strategy. ~~The~~While ~~Company~~no ~~shall~~assurance ~~use~~can ~~the~~be ~~proceeds~~given ~~from~~that ~~the~~this ~~Financing~~approach ~~for~~will ~~general~~ultimately ~~corporate purposes~~succeed, ~~including~~management ~~but~~believes ~~not limited to finance~~ the ~~expense~~available ofdata asupport ~~Qualified Public Equity Offering (as defined below) and payment of certain items. Out of~~ the ~~Total~~conclusion ~~Outstanding~~that ~~Amount,~~Adrulipase ~~the~~retained ~~Lender~~a ~~disbursed~~plausible andevelopment ~~initial~~pathway ~~loan~~as ~~amount~~ of ~~$550,000~~December ~~to the Company on January~~ 31, 2025.

~~The~~Recent Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue daily commencing on January 31, 2025 until paid in full. The outstanding principal balance of all outstanding loans under the Financing, all accrued and unpaid interest and all other amounts, costs, expenses and/or liquidated damages are due in full on January 31, 2026. The Revolving Loan Agreement contains customary events of default. If an event of default occurs, the Lender may accelerate the indebtedness under the Revolving Loan Agreement, and an amount equal to 120% of the of the outstanding principal amount and accrued and unpaid interest plus liquidated damages and other amounts, costs, expenses and/or liquidated damages due under or in respect of the Loan Documents (as defined under the Revolving Loan Agreement) for the Financing, if any.Developments

~~The~~Nasdaq ~~Revolving~~Listing ~~Loan Agreement provides that it is a condition of the closing of the Financing that not less than three of the current members of our Board of Directors resign~~ and ~~that~~Compliance three nominees designated by the Lender (“Lender Board Member Candidates”) be appointed to the Board of Directors by the remaining members of the Board of Directors. The Revolving Loan Agreement also provides that we will use our reasonable best efforts to consummate an underwritten or “best efforts” public offering of not less than $5,000,000 by us of our Common Stock and/or any convertible security or warrant, option or other right to subscribe for or purchase any additional shares of our Common Stock (“Qualified Public Equity Offering”) as soon as practicable, and the Lender shall cooperate with us in connection therewith. If, despite the reasonable best efforts of the Borrower, (x) a registration statement with respect to securities to be offered in a Qualified Public Equity Offering (the “QPEO S-1”) is not filed within 45 days following the initial Closing Date, or (y) a Qualified Public Equity Offering is not consummated within the earlier of (A) 120 days from the initial filing of the QPEO S-1 and (B) 30 days of a QPEO S-1 being declared effective by the SEC, then the Lender Board Member Candidates shall, upon the written request of the remaining members of the Board of Directors, resign from all of their respective positions on the Board of Directors.Matters

~~Binding~~On ~~Term~~April ~~Sheet~~22, 2026, the Company received a notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company is not in compliance with ~~Journey~~Nasdaq ~~Therapeutics~~Listing Rule 5250(c)(1) as a result of its failure to timely file its Annual Report on Form 10-K for the period ended December 31, ~~Inc~~2025. The Notice provides that the Company has 60 calendar days to submit a plan to regain compliance. If Nasdaq accepts the Company’s plan, Nasdaq may grant an exception of up to 180 calendar days from the filing’s due date, or until October 12, 2026, for the Company to regain compliance.

OnThe ~~November~~Company 8,intends ~~2024,~~to wesubmit ~~entered~~a ~~into~~plan ato ~~binding~~regain ~~term~~compliance ~~sheet~~within (the ~~“Binding~~required ~~Term~~timeframe; ~~Sheet”)~~however, ~~with~~there ~~Journey~~can ~~Therapeutics,~~be ~~Inc.~~no ~~(“Journey”),~~assurance athat ~~life~~Nasdaq ~~sciences~~will ~~company.~~accept ~~Under~~ the ~~Binding~~Company’s ~~Term~~plan ~~Sheet,~~or ~~Journey~~that ~~and~~the ~~Entero~~Company ~~were~~will ~~subject~~be able to anregain ~~exclusivity~~compliance ~~period~~within ~~that~~any ~~was~~extension aperiod ~~minimum~~that ofmay ~~30 days. (the “Exclusivity Period”). We will not~~ be ~~moving forward with the acquisition~~granted.

During 2025, we were subject to multiple Nasdaq compliance matters.

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~~Letter~~Annual ofMeeting ~~Intent with Data Vault Holdings, Inc.~~Requirement

On ~~September~~January 97, ~~2024~~2025, we ~~entered~~received ~~into~~notice ~~the~~from ~~Letter~~Nasdaq ofthat ~~Intent~~we ~~with~~were ~~Data~~not ~~Vault~~in ~~Holdings,~~compliance ~~Inc.~~with ~~(“DVHI”)~~Nasdaq ~~for~~Listing ~~the~~Rule ~~licensing of certain clinical trial software owned by DVHI and associated intellectual property~~ 5620(~~the “Assets”~~a). ~~The~~because ~~Letter~~we ofhad ~~Intent~~not ~~contemplates~~held aan ~~worldwide~~annual ~~exclusive~~meeting ~~license to the Assets with the right to grant sublicenses, and a right~~ of ~~first~~stockholders ~~refusal for the Company to fully acquire the Assets~~ in ~~exchange~~2024 ~~for~~within the ~~issuance~~required oftime ~~$250,000~~period. ofWe ~~shares~~submitted ~~of the Company’s junior convertible preferred stock (the “Preferred Shares”) priced at~~ a ~~price~~compliance ~~per preferred share equal to 180% of the five (5) trading day Volume-Weighted Average Price (“VWAP”) of the Company’s Common Stock (the “Common Share Price”)~~plan, ~~immediately~~and ~~preceding~~Nasdaq ~~the~~granted ~~closing~~us ofan ~~the~~extension ~~Proposed~~until ~~Transaction~~June ~~multiplied by 1~~30,~~000~~ ~~(the~~2025 ~~“Preferred~~to ~~Share~~regain ~~Price”), and single digit royalties on net sales (the “Proposed Transaction”)~~compliance. ~~Entry~~Following ~~into definitive documentation for~~ the ~~Proposed~~filing ~~Transaction~~of ~~will~~our beproxy ~~conditioned~~statement ~~upon~~on ~~the~~June ~~Company receiving no less than $500~~4,~~000~~ of2025 ~~strategic~~and ~~investment (~~the ~~“Strategic~~holding ~~Investment”), with a target~~ of ~~ultimately~~our ~~securing~~annual upmeeting ~~to $3.0 million~~ of ~~strategic~~stockholders ~~investment~~on ~~with~~June ~~the~~30, ~~assistance~~2025, ofNasdaq ~~DVHI.~~notified ~~There~~us ~~can be no assurance that the Proposed Transaction will be completed~~ on ~~the~~July ~~terms~~3, ~~contemplated~~2025 ~~in the Letter of Intent or otherwise. We do not anticipate~~ that this ~~transaction~~matter ~~will~~was ~~move forward~~closed.

~~Nasdaq~~Minimum ~~Listing~~Bid ~~Compliance~~Price Requirement

WeOn ~~received a letter on~~ September 6, 2024, ~~from~~we ~~the~~received ~~Listing~~notice ~~Qualifications~~from ~~Staff of The~~ Nasdaq ~~Stock~~that ~~Market~~we ~~LLC~~were ~~(“Nasdaq”)~~not ~~indicating~~in ~~that,~~compliance ~~based~~with ~~upon~~ the ~~closing~~minimum bid price ofrequirement ~~our~~under ~~Common~~Nasdaq ~~Stock~~Listing ~~for~~Rule ~~the~~5550(a)(2). ~~last~~On 30March ~~consecutive~~6, ~~business days~~2025, ~~the~~Nasdaq ~~Company~~granted ~~was~~us ~~not~~an inadditional 180-day compliance ~~with~~period, ~~the~~or ~~requirement~~until September 1, 2025, to ~~maintain~~regain acompliance. ~~minimum~~During ~~bid~~2025, ~~price~~we ofeffected $a 1~~.00~~-for-3 ~~per~~reverse ~~share~~stock ~~for~~split, ~~continued~~which ~~listing~~became effective on ~~The~~August 18, 2025. On September 3, 2025, Nasdaq ~~Capital~~notified ~~Market~~us that, asbecause ~~set~~the ~~forth~~closing inbid ~~Nasdaq~~price ~~Listing~~of ~~Rule~~our ~~5550(a)(2).~~Common InStock ~~accordance~~had ~~with~~been ~~Nasdaq~~at ~~Listing~~least ~~Rule~~$1.00 ~~5810(c)(3)(A),~~per weshare ~~were~~for ~~provided~~10 ~~180~~consecutive business days from August 18, or2025 ~~until~~through ~~March~~September 52, 2025, towe ~~regain~~had regained compliance with ~~the~~Listing ~~minimum~~Rule ~~bid~~5550(a)(2), ~~price~~and ~~requirement~~this matter was closed.

OnMinimum ~~March~~Stockholders’ 6,Equity 2025, we received a letter from Nasdaq advising that we had been granted a 180-day extension, or until September 1, 2025, to regain compliance with the minimum bid price requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A). If at any time prior to September 1, 2025, the bid price of our Common Stock closes at $1.00 per share or more for a minimum of 10 consecutive trading days, we will regain compliance with the minimum bid price requirement.Requirement

~~The~~On ~~extension~~April ~~notice~~11, ~~has~~2025, noNasdaq ~~immediate~~notified ~~effect~~us onthat ~~the~~we ~~listing~~were ofnot ~~our~~in ~~Common~~compliance ~~Stock~~with onthe ~~The~~minimum ~~Nasdaq~~stockholders’ ~~Capital~~equity ~~Market~~requirement ~~and~~under ~~does~~Nasdaq ~~not~~Listing ~~affect~~Rule ~~our~~5550(b)(1), ~~reporting~~based ~~requirements~~on ~~with~~stockholders’ ~~the~~deficit ~~Securities~~of ~~and~~$(3,876,738) ~~Exchange~~as ~~Commission.~~reported Ifin weour doAnnual ~~not~~Report ~~regain~~on ~~compliance~~Form ~~with~~10-K ~~the~~for ~~minimum bid price requirement during~~ the ~~additional~~year ~~180-day~~ended ~~extension~~December 31, 2024. Nasdaq ~~will~~also ~~provide~~noted ~~written notification~~ that, ~~our~~as ~~Common~~of ~~Stock~~April ~~will~~10, ~~be delisted. At that time~~2025, we ~~may~~did ~~appeal~~not satisfy the ~~delisting~~alternative ~~determination~~continued-listing tostandards abased ~~hearings~~on ~~panel~~market ~~pursuant~~value toof ~~the~~listed ~~procedures~~securities ~~set~~or ~~forth~~net inincome ~~the~~from ~~applicable~~continuing ~~Nasdaq~~operations. ~~Listing~~We ~~Rules.~~submitted ~~However,~~a ~~there~~compliance ~~can~~plan, beand noon ~~assurance~~June ~~that~~25, if2025 ~~the~~Nasdaq ~~Company~~granted ~~does~~us ~~appeal~~an ~~the~~extension ~~delisting~~until ~~determination~~October by8, ~~Nasdaq~~2025 to ~~the~~regain ~~hearings panel~~compliance, ~~that~~subject ~~such~~to ~~appeal~~specified ~~would~~terms. beOn ~~successful.~~October ~~There~~28, ~~can~~2025, beNasdaq nonotified ~~assurance~~us that, webased ~~will~~on ~~regain~~our ~~compliance~~Form ~~with~~8-K ~~the~~dated ~~minimum~~October ~~bid~~6, ~~price~~2025, ~~requirement~~it ~~during~~had ~~the~~determined ~~additional~~that ~~180-day~~we ~~compliance~~complied ~~period~~with ~~ending~~Listing ~~September~~Rule 5550(b)(1,). ~~2025~~Nasdaq oralso ~~maintain~~stated ~~compliance~~that ~~with~~if ~~any~~we ~~other~~failed ~~Nasdaq listing requirement. We intend~~ to ~~monitor~~evidence ~~the~~compliance ~~closing~~upon ~~bid~~filing ~~price of~~ our ~~Common~~next ~~Stock~~periodic ~~and may~~report, ifwe ~~appropriate,~~could ~~consider~~again ~~implementing~~be ~~available~~subject ~~options~~ to ~~regain compliance with the minimum bid price requirement~~delisting.

OnGridAI ~~January~~Transaction 7,and ~~2025, we received a written notice from the Listing Qualifications department of~~ Nasdaq ~~indicating~~Change ~~that were not in compliance with Nasdaq Listing Rule 5620(a), due to us not holding an annual meeting~~ of ~~stockholders~~Control in 2024 within one year of our 2023 fiscal year end. On February 21, 2025, we submitted a plan to regain compliance. On March 3, 2025, Nasdaq informed us that it has determined to grant us an extension until June 30, 2025 to regain compliance for continued listing.Determination

~~Corporate~~On ~~History~~November 5, 2025, Nasdaq notified us that our proposed transaction with GridAI Corp. constituted a business combination resulting in a “Change of Control” under Nasdaq Listing Rule 5110(a). Nasdaq stated that the post-transaction entity would be required to satisfy all of Nasdaq’s initial listing criteria and complete Nasdaq’s initial listing process, including payment of applicable fees, prior to shareholder approval for the second step of the transaction. Nasdaq further stated that if shareholder approval were obtained for the second step and the post-transaction company failed to qualify for listing or timely complete the initial listing process, Nasdaq would issue a Staff Delisting Determination and commence delisting proceedings. As of the date of this Annual Report, the Company has not received a Staff Delisting Determination from Nasdaq in connection with the transaction and continues to be listed on the Nasdaq Capital Market.

WeAcquisition ~~were incorporated on January 30, 2014 in the State~~ of ~~Delaware~~GridAI ~~under the name AzurRx BioPharma, Inc~~Corp. ~~In May 2014, we entered into a stock purchase agreement with Protea Biosciences Group, Inc. (“Protea Group”)~~ and ~~its~~Corporate wholly-owned subsidiary, Protea Biosciences, Inc. (“Protea Sub” and, together with Protea Group, “Protea”), to acquire 100% of the outstanding capital stock of AzurRx SAS (formerly ProteaBio Europe SAS), a wholly-owned subsidiary of Protea Sub, which was completed in June 2014. In October 2016, we completed an initial public offering, which allowed us to list our shares of Common Stock on the Nasdaq Capital Market.Rebranding

On September 1330, ~~2021~~2025, we completed a share exchange transaction pursuant to which we acquired 100% of the ~~acquisition~~outstanding equity interests of ~~First~~Grid ~~Wave~~AI ~~Bio~~Corp. In the transaction, ~~Inc.~~we ~~(“FWB”)~~issued 424,348 ~~which~~shares ~~became~~of our ~~wholly~~Common Stock and 38,801.546 shares of our Series H Non-Voting Convertible Preferred Stock to the sellers of Grid AI Corp. At the time of closing, Grid AI Corp. owned 75% of the outstanding equity interests of AMPX, which holds the operating subsidiary. InAMPX ~~connection~~Limited. ~~with~~Following the acquisition, ~~AzurRx~~Grid ~~BioPharma,~~AI ~~Inc~~Corp. ~~changed~~and its ~~name~~subsidiaries tobecame ~~First~~consolidated ~~Wave~~subsidiaries ~~BioPharma,~~of ~~Inc~~the Company.

Effective ~~October 26~~December 1, ~~2022~~2025, ~~the~~we ~~AzurRx~~changed ~~SAS~~our ~~subsidiary~~corporate ~~was~~name ~~dissolved~~from Entero Therapeutics, Inc. to GridAI Technologies Corp. and changed our Nasdaq trading symbol from “ENTO” to “GRDX.”

Management and Governance Changes

During the fourth quarter of 2025, we experienced significant management and board changes in connection with the transition of the Company following the Grid AI Corp. acquisition. Effective in December 2025, Jason Sawyer became our Chief Executive Officer.

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OnAlso ~~March~~during ~~13,~~December ~~2024~~2025, wecertain ~~completed~~directors ~~a merger with ImmunogenX~~resigned, ~~Inc., where~~including ~~according~~one toresignation ~~the~~accompanied ~~merger~~by ~~plan~~stated ~~following~~disagreements ~~the~~regarding ~~First Merger~~governance, ~~ImmunogenX,~~diligence ~~Inc. merged with~~ and ~~into~~disclosure ~~Second Merger Sub~~matters, ~~pursuant~~as todisclosed ~~which~~in ~~Second~~our ~~Merger~~Current ~~Sub~~Report ~~became~~on ~~ImmunogenX,~~Form ~~LLC,~~8-K afiled ~~Delaware~~with ~~limited liability company,~~ the ~~surviving~~SEC ~~entity~~on ~~and~~December a4, ~~wholly owned subsidiary of the Company~~2025.

InCorporate ~~May 2024, we changed our name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.~~History

OnWe ~~March~~were 24incorporated on January 30, ~~2025~~2014 in the State of Delaware under the name AzurRx BioPharma, Inc. In May 2014, we entered into a ~~Rescission~~stock ~~Agreement~~purchase agreement with ~~IMGX~~Protea Biosciences Group, Inc. and ~~the~~its ~~IMGX~~wholly ~~Shareholders~~owned subsidiary, Protea Biosciences, Inc., ~~After~~to acquire 100% of the ~~Rescission~~outstanding ~~Agreement~~capital ~~will~~stock ~~Closed,~~of ~~IMGX~~AzurRx ~~will~~SAS, noformerly ~~longer~~ProteaBio beEurope SAS, a wholly owned subsidiary of ~~the~~Protea ~~Company~~Biosciences, ~~and~~Inc. ~~the~~The ~~Company~~acquisition ~~will~~was nocompleted ~~longer~~in beJune ~~holding~~2014. ~~any~~In ~~interest~~October in2016, ~~IMGX~~we completed our initial public offering and listed our Common Stock on the Nasdaq Capital Market.

On September 13, 2021, we completed the acquisition of First Wave Bio, Inc., which became our wholly owned subsidiary. In connection with that acquisition, AzurRx BioPharma, Inc. changed its name to First Wave BioPharma, Inc.

Effective October 26, 2022, our AzurRx SAS subsidiary was dissolved.

On March 13, 2024, we completed our merger with ImmunogenX, Inc. Following the merger, ImmunogenX became part of our corporate structure through ImmunogenX, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company. In May 2024, we changed our name from First Wave BioPharma, Inc. to Entero Therapeutics, Inc.

On March 24, 2025, we entered into a Rescission Agreement with ImmunogenX, LLC and the former shareholders of ImmunogenX, Inc. The rescission transaction was completed on December 31, 2025. Following the closing of that transaction, ImmunogenX, LLC ceased to be a subsidiary of the Company, and we no longer held any ownership interest in that business.

On September 30, 2025, we completed a share exchange transaction pursuant to which we acquired 100% of the outstanding equity interests of Grid AI Corp., a Nevada corporation. At the time of the acquisition, Grid AI Corp. owned 75% of the issued and outstanding equity interests of AMPX, which holds the operating subsidiary AMPX Limited. Following the transaction, GridAI Corp. and its subsidiaries became consolidated subsidiaries of the Company.

Effective December 1, 2025, we changed our corporate name from Entero Therapeutics, Inc. to GridAI Technologies Corp. In connection with this name change, our Nasdaq trading symbol changed from “ENTO” to “GRDX.”

Intellectual Property

Our goal is to obtain, maintain and enforce ~~patent~~intellectual property protection for our technologies, product candidates, formulations, processes, methods, ~~and~~software, ~~any~~trade names and other proprietary ~~technologies~~assets, preserve our trade secrets, and operate without infringing on the proprietary rights of ~~other~~third parties, ~~both~~ in the United States and inforeign ~~other countries~~jurisdictions. Our policy is to ~~actively~~ seek ~~to obtain~~, where appropriate, the broadest intellectual property protection ~~possible~~reasonably available for our current ~~product candidates~~ and ~~any~~ future ~~product~~technologies ~~candidates, proprietary information and proprietary technology~~ through a combination of ~~contractual~~patents, ~~arrangements~~trade ~~and~~secrets, ~~patents~~know-how protection, ~~both~~confidentiality inand ~~the~~invention-assignment ~~United~~agreements, ~~States~~trademarks, copyrights and ~~abroad~~contractual arrangements. However, patent protection may not ~~afford~~provide ~~us with~~ complete protection against competitors ~~who~~that seek to design around or otherwise circumvent our patents, and our proprietary rights may not always provide us with meaningful competitive advantages.

We also depend ~~upon~~on the skills, knowledge, experience and know-how of our management, ~~and~~engineering, research and development personnel, as well as ~~that of~~ our advisors, consultants and ~~other~~ contractors. To help protect ~~our~~ proprietary know-how, ~~which~~that ismay not be patentable, ~~and~~or for inventions ~~for~~that ~~which patents~~ may be difficult to enforce, wethrough ~~currently~~patents ~~rely~~alone, ~~and~~we ~~will in the future~~ rely on trade secret protection and confidentiality ~~agreements to protect our interests~~arrangements. ToWe ~~this end, we~~ require ~~all of~~ our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the unauthorized disclosure of confidential information and, where applicable, require disclosure and assignment to us of ~~the~~ ideas, developments, discoveries and inventions important to our business.

Adrulipase

The Adrulipase program is protected by the following issued patents that we had originally licensed under the Mayoly Agreement and now own:

● PCT/FR2006/001352 patent family (including the patent EP2035556 and patent US8,334,130 and US8,834,867) “Method for producing lipase, transformed Yarrowia lipolytica cell capable of producing said lipase and their uses” describes a method for producing Yarrowia lipolytica acid-resistant recombinant lipase utilizing a culture medium without any products of animal origin or non-characterized mixtures such as tryptone, peptone or lactoserum, in addition to its uses. The European patents expire June 15, 2026, U.S. patent 8,334,130 expires September 11, 2028, and U.S. patent 8,834,867 expires July 17, 2026.

In addition, PCT International application was filed in 2021 directed to our proprietary formulation of Adrulipase that has been filed in the United States and certain foreign countries. Any patents issuing from these filings will have an expected expiration in 2041.

PCT International applications were filed in 2022 and nationalized in certain foreign countries outside of the U.S to stable lipase formulations and methods of treatment. Any patents issuing from these filings will have an expected expiration in 2042. These patents are not pending in the U.S.

PCT International Application was filed in 2023 directed to Adrulipase formulations. Any patents issuing from this filing will have an expected expiration in 2043.

We also expect to receive 12-year biologic exclusivity in the United States under the Affordable Care Act and 10-year data exclusivity in the European Union for Adrulipase.

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As of December 31, 2025, our principal retained legacy life sciences intellectual property relates to Adrulipase. We are no longer actively developing the Latiglutenase, CypCel, Capeserod or Niclosamide programs, and following the completion of the rescission transaction involving ImmunogenX, LLC on December 31, 2025, the Latiglutenase and CypCel intellectual property is no longer part of our business. We also terminated the Sanofi license relating to Capeserod in 2025 and are no longer actively pursuing the Niclosamide program.

Our FW-ICI-AC, FW-UP, FW-UC and FW-CD Niclosamide programs are protected by patent filings that include the following:

●US10,912,746; US10,905,666; US10,292,951; US10,772,854; US10,744,103; US10,799,468; US10,849,867; and related continuation applications as well as corresponding worldwide patent filings all entitled “Methods and Compositions for Treating Conditions Associated with an Abnormal Inflammatory Process.” The expiration date of the issued patents is September 1, 2036; and

Our FW-COV Niclosamide programs are protected by patent filings that include the following:

●US10,980,756 and US11,564,896 and corresponding continuation applications directed to the use of Niclosamide for the treatment of COVID 19 gastrointestinal infections. The expiration of the issued patents is March 31, 2040.

Latiglutenase

The Latiglutenase program is protected by U.S. Patent 10,434,150 that expires July 3, 2035, U.S. Patent 8,980,254 that expires April 10, 2030, and U.S. Patent 9,993,531 that expires Sept. 9, 2029.

Manufacturing

We currently outsource all manufacturing, and we intend to use our collaborators and contract development and manufacturing organizations (“CDMOs”) for the foreseeable future.

Adrulipase

The Adrulipase ~~API,~~program ~~including drug substance and drug product,~~ is ~~currently~~protected ~~manufactured~~ by ~~Asymchem, Inc. at~~ a ~~contract~~patent ~~facility~~portfolio ~~located~~that in Tianjin, China. Charles River Laboratories based in Malvern, Pennsylvania is responsible for maintaining our master and working cell banks. We believe there are multiple alternative contract manufacturers capable of producing the product we ~~need~~originally ~~for~~licensed ~~clinical~~under ~~trials; however, there is no guarantee that~~ the ~~processes~~Mayoly ~~are~~arrangements ~~easily reproducible~~ and ~~transferrable~~subsequently acquired.

~~Competition~~This portfolio includes the PCT/FR2006/001352 patent family, including European Patent EP2035556 and U.S. Patents 8,334,130 and 8,834,867, entitled “Method for producing lipase, transformed Yarrowia lipolytica cell capable of producing said lipase and their uses.” These patents describe a method for producing Yarrowia lipolytica acid-resistant recombinant lipase using a culture medium without products of animal origin or non-characterized mixtures such as tryptone, peptone or lactoserum, as well as related uses. The European patents expire on June 15, 2026, U.S. Patent 8,334,130 expires on September 11, 2028, and U.S. Patent 8,834,867 expires on July 17, 2026.

~~The~~In ~~pharmaceutical~~addition, ~~and~~an ~~biotechnology~~international ~~industries~~PCT ~~are~~application ~~characterized~~directed byto ~~rapidly~~our ~~evolving~~proprietary ~~technology~~Adrulipase ~~and~~formulation ~~intense~~was ~~competition.~~filed ~~Many~~in ~~companies~~2021 ~~of all sizes, including major pharmaceutical companies~~ and ~~specialized~~was ~~biotechnology~~subsequently ~~companies,~~filed ~~are engaged~~ in the ~~development~~United ~~and~~States ~~commercialization of therapeutic agents designed for the treatment of the same diseases~~ and ~~disorders~~certain ~~that~~foreign ~~we target~~jurisdictions. ~~Many~~Any ofpatents ~~our~~issuing ~~competitors~~from ~~have~~these ~~substantially~~filings ~~greater~~are ~~financial~~expected ~~and~~to ~~other~~expire ~~resources, larger research and development staff and more experience~~ in ~~the regulatory approval process~~2041. ~~Moreover, potential competitors have or may have patents or other rights that conflict with patents covering our technologies.~~

~~Adrulipase~~Additional international PCT applications were filed in 2022 and nationalized in certain jurisdictions outside the United States relating to stable lipase formulations and methods of treatment. Any patents issuing from these filings are expected to expire in 2042. These applications are not pending in the United States.

~~With~~An ~~respect~~additional toPCT ~~Adrulipase,~~international ifapplication ~~approved,~~directed ~~we would compete with PERTs (pancrelipase), a well-established market that is currently dominated by a few large pharmaceutical companies, including CREON® marketed by AbbVie Inc., ZENPEP® sold~~ to ~~Nestlé~~Adrulipase ~~S.A.~~formulations bywas ~~Allergan plc.~~filed in ~~January 2020, PANCREAZE® marketed by VIVUS, Inc~~2023. ~~and~~Any ~~PERTZYE®~~patents ~~marketed~~issuing byfrom ~~Chiesi~~this ~~Farmaceutici~~filing ~~S.p.A. There~~ are ~~currently~~expected ~~six PERT products that have been approved by the FDA for sale in the U.S. We believe our ability~~ to ~~compete~~expire in this market, if we are successful in developing and obtaining regulatory approval to market Adrulipase, will depend on our ability (or that of a future corporate partner) to convince patients, their physicians, healthcare payors and the medical community of the benefits of using a non-animal-based product to treat EPI, as well as by addressing other shortcomings associated with PERTs, including a large pill burden2043.

~~Government~~We ~~Regulation~~also believe Adrulipase may be eligible, if approved and ~~Product~~if ~~Approval~~the applicable statutory requirements are met, for regulatory exclusivity, including potential biologic exclusivity in the United States and data exclusivity in certain foreign jurisdictions. The availability, scope and duration of any such exclusivity would depend on the final regulatory pathway, product classification, approved indication and applicable law at the time of approval.

~~Government~~Grid ~~authorities~~AI ~~in the United States, at the federal, state~~ and ~~local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping,~~ AMPX

Following our acquisition of Grid AI Corp. on September 30, 2025, our intellectual property portfolio also includes proprietary software, trade secrets, trademarks, and contractual protections associated with the Grid AI Corp. and AMPX energy orchestration platform. In our acquisition accounting, we recognized identifiable intangible assets that included developed technology and trade name rights associated with the acquired business. We believe the principal protectable value of this business resides in developed software, algorithms, platform architecture, implementation know-how, copyrights, trade secrets, brands and contractual rights.

We seek to protect the Grid AI Corp. and AMPX business through a combination of proprietary software ownership, trade secret protection, confidentiality and invention-assignment agreements, copyrights, trade names and contractual arrangements with employees, contractors, customers and partners.

Grid AI Corp. and AMPX offerings depend in part on integration with third-party systems, data feeds, devices, utilities, market operators and software interfaces. As a result, the practical protection and commercial utility of this part of our intellectual property portfolio depends not only on code ownership and trade secret protection, but also on maintaining contractual rights, technical interoperability and commercially reasonable access to relevant third-party ecosystems. If those relationships are disrupted, modified on unfavorable terms or replaced by proprietary ecosystems we cannot access, portions of our services, functionality or market position could be adversely affected.

We may also use open-source software components in portions of our technology stack. Use of open-source software can impose obligations that could require us to make source code available, limit certain licensing strategies, or expose us to cybersecurity

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~~promotion, advertising, distribution, post-approval monitoring~~ and ~~reporting,~~compliance ~~marketing and export and import of products such as those we are developing~~risks. ToWe ~~date,~~maintain ~~our~~policies ~~internal research~~ and ~~development~~procedures ~~efforts~~intended ~~have been conducted in France. We expect~~ to ~~conduct~~manage ~~late-stage~~such ~~development work~~use, ~~including~~but ~~clinical~~we ~~trials~~cannot ~~for~~assure ~~Adrulipase~~compliance inunder ~~both~~all ~~the United States and Europe, as North America is our principal target market for our product candidates that we may successfully develop~~circumstances.

~~U.S.~~Discontinued ~~Government~~and ~~Regulation~~Divested Legacy Programs

InPrior ~~the~~to ~~United States,~~ the ~~FDA~~completion ~~regulates~~of ~~drugs under~~ the ~~Federal~~rescission ~~Food,~~transaction ~~Drug,~~involving ~~and Cosmetic Act~~ImmunogenX, orour ~~FDCA,~~business ~~and~~included ~~its implementing regulations, and biologics under~~ the ~~FDCA~~Latiglutenase and ~~the~~CypCel ~~Public Health Service Act~~programs, ~~or PHSA,~~ and ~~its~~prior ~~implementing~~to ~~regulations.~~2025 ~~FDA~~we ~~approval~~also isheld ~~required~~intellectual ~~before~~property ~~any~~relating ~~new~~to ~~unapproved~~Niclosamide-based ~~drug~~development orprograms ~~dosage form, including a new use of a previously approved drug, can be marketed in the United States. Drugs~~ and ~~biologics~~licensed ~~are~~rights ~~also~~relating ~~subject~~ to ~~other federal, state and local statutes and regulations~~Capeserod. IfAs weof ~~fail~~December to31, ~~comply~~2025, ~~with~~those ~~applicable~~programs ~~FDA~~are orno ~~other~~longer ~~requirements~~part atof ~~any~~our ~~time~~active ~~during the drug~~ development ~~process~~portfolio, ~~clinical testing~~and, ~~the~~in ~~approval process or after approval, we may become subject to administrative or judicial sanctions. These sanctions could include~~ the ~~FDA’s~~case ~~refusal~~of ~~to approve pending applications~~ImmunogenX, ~~license~~are ~~suspension~~no orlonger ~~revocation,~~part ~~withdrawal~~ of anour ~~approval,~~business. ~~warning letters~~Accordingly, ~~product~~we ~~recalls,~~do ~~product~~not ~~seizures,~~view ~~placement~~those onintellectual ~~Import~~property ~~Alerts,~~assets ~~debarment~~as ofpart ~~personnel, employees or officers, total or partial suspension~~ of ~~production~~our orprincipal ~~distribution,~~continuing ~~injunctions,~~operating ~~fines, civil penalties or criminal prosecution~~platform.

~~The process required by the FDA before product candidates may be marketed in the United States generally involves the following:~~Manufacturing

●We ~~completion~~do ofnot ~~extensive~~currently ~~preclinical~~operate ~~laboratory~~our ~~tests,~~own ~~preclinical~~manufacturing ~~animal~~facilities. ~~studies~~Instead, we rely on a combination of contract development and ~~toxicity~~manufacturing ~~data~~organizations (“CDMOs”), ~~all~~third-party ~~performed~~component insuppliers ~~accordance~~and ~~with~~technology ~~the~~partners ~~good~~to ~~laboratory~~support ~~practices,~~our orproduct ~~GLP~~development and platform deployment activities. We expect to continue to rely on third-party manufacturers, ~~regulations;~~software infrastructure providers and integration partners for the foreseeable future.

~~● submission to the FDA of an IND, which must become effective before human clinical studies may begin;~~Adrulipase

●Historically, ~~approval~~the Adrulipase active pharmaceutical ingredient (“API”), including both drug substance and drug product, has been manufactured by anAsymchem, ~~independent~~Inc. ~~IRB~~at ora ~~ethics~~contract ~~committee~~manufacturing ~~representing~~facility ~~each~~located ~~clinical~~in ~~site~~Tianjin, ~~before~~China. ~~each~~Charles ~~clinical~~River ~~study~~Laboratories, ~~may~~based bein ~~initiated;~~Malvern, Pennsylvania, has been responsible for maintaining our master and working cell banks used in the Adrulipase manufacturing process.

●As ~~performance~~ of ~~adequate~~December ~~and~~31, ~~well-controlled~~2025, ~~human~~no active clinical ~~studies~~trials toof ~~establish~~Adrulipase ~~the~~were ~~safety~~being conducted. We believe that multiple contract manufacturers may be capable of producing Adrulipase drug substance and ~~efficacy,~~drug orproduct infor future clinical development if the ~~case~~program ofis aadvanced. ~~biologic~~We anticipate that, if the ~~safety~~program is advanced, ~~purity~~manufacturing ~~and~~activities ~~potency~~would not commence until later in 2026. However, ofbiopharmaceutical ~~the~~manufacturing ~~drug~~processes ~~candidate~~can ~~for~~be ~~each~~complex, ~~proposed~~and ~~indication;~~there can be no assurance that manufacturing processes can be readily reproduced or transferred to alternative manufacturers without additional development work, validation activities or regulatory review.

●Grid ~~preparation~~AI ofCorp. and ~~submission~~AMPX to the FDA of a new drug application, or NDA, or biologics license application, or BLA, which must include data from required pre-clinical studies and all pivotal clinical studies and information showing that the product can be manufactured in a controlled manner;Platform

●Following aour ~~determination~~acquisition byof ~~the~~Grid ~~FDA~~AI ~~within~~Corp., 60our ~~days~~manufacturing ofand ~~its~~deployment ~~receipt~~activities ofalso aninclude ~~NDA~~the orproduction, ~~BLA~~integration toand ~~file~~installation ~~the~~of ~~application~~energy ~~for~~orchestration ~~review;~~systems associated with the AMPX platform.

●The ~~review~~AMPX ofplatform ~~the~~is ~~product~~primarily ~~application~~a bysoftware-driven anenergy ~~FDA~~orchestration ~~advisory~~and ~~committee~~control system that integrates with third-party energy infrastructure, ~~where~~including ~~appropriate~~distributed energy resources, electric vehicle charging systems, batteries, HVAC systems, water heaters, solar systems and ifother ~~applicable;~~connected devices. As a result, our business model relies significantly on software deployment, system integration and third-party hardware ecosystems rather than traditional manufacturing.

●Where ~~satisfactory~~hardware ~~completion~~components ofare anrequired ~~FDA~~for ~~pre~~deployment, including control devices, gateways, communications modules or integration hardware, these components are generally sourced from third-~~approval~~party ~~inspection~~suppliers ofand ~~the~~integrated ~~manufacturing~~into ~~facilities~~our ~~where~~platform environment. Our operations depend on the ~~drug~~availability, ~~candidate~~quality isand ~~produced~~performance toof ~~assess~~these ~~compliance~~third-party ~~with~~hardware ~~cGMP;~~and software components, as well as the reliability of communications networks and cloud infrastructure used to operate the platform.

●Because ~~FDA~~our ~~review~~energy orchestration services depend on integration with devices, utilities, aggregators and ~~approval~~market operators, we rely on a network of anintegration ~~NDA~~partners, orinstallers, ~~BLA~~device ~~prior~~manufacturers and software providers to ~~any~~support ~~commercial~~the ~~marketing~~deployment orand ~~sale~~operation of the ~~drug~~AMPX orplatform. ~~biologic~~Disruptions in the ~~United~~supply ~~States~~of compatible devices, integration partners or cloud infrastructure could adversely affect the deployment, scalability or performance of our platform.

An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies. The IND also includes 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 new drug. An IND must become effective before human clinical studies may begin. An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to the proposed clinical studies. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before clinical studies can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical studies to commence.

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~~Clinical Studies~~Competition

~~Clinical~~Grid ~~studies~~AI ~~involve~~Corp. ~~the~~operates ~~administration of the investigational new drug to human subjects under the supervision of qualified investigators~~ in ~~accordance~~a ~~with~~competitive ~~GCPs,~~and ~~which~~rapidly ~~include~~evolving ~~the~~market ~~requirement~~ that ~~all~~includes ~~research~~energy ~~subjects~~management ~~provide~~software ~~their~~providers, ~~informed~~virtual ~~consent~~power ~~for~~plant ~~their~~(“VPP”) ~~participation~~platforms, inbattery ~~any~~system ~~clinical study. Clinical studies are conducted under protocols detailing~~integrators, ~~among other things~~utilities, ~~the~~engineering ~~objectives of the study~~firms, and ~~the parameters to be used~~ in-house ~~monitoring~~customer-developed ~~safety and the efficacy criteria to be evaluated~~solutions. AGrid ~~protocol~~AI ~~for each clinical study and any subsequent protocol amendments must be submitted to the FDA as part of the IND~~Corp. ~~Additionally, approval must~~ also becompetes ~~obtained~~with ~~from~~emerging ~~each~~technology ~~clinical~~providers ~~study~~focused ~~site’s~~on ~~IRB~~distributed ~~before~~energy ~~the~~resource ~~studies~~optimization ~~may be initiated,~~ and ~~the~~artificial ~~IRB~~intelligence-driven ~~must~~grid ~~monitor the study until completed~~management. ~~There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries, such as ClinicalTrials.gov.~~

~~The~~Competition ~~clinical~~is ~~investigation~~driven by several factors, including software functionality, scalability, interoperability with third-party hardware and market platforms, speed of deployment, regulatory expertise, customer relationships, and pricing. The Company’s solutions must integrate with a ~~drug~~wide orrange ~~biologic~~of isthird-party ~~generally~~systems, ~~divided~~including ~~into~~batteries, ~~three~~control orsystems, ~~four~~and ~~phases.~~energy ~~Although~~market ~~the~~infrastructure, ~~phases~~which are ~~usually~~often ~~conducted~~not ~~sequentially,~~standardized ~~they~~and may ~~overlap~~change orover ~~be combined~~time.

●The ~~Phase~~markets 1.in ~~The~~which ~~drug~~Grid orAI ~~biologic~~Corp. isoperates ~~initially~~are ~~introduced~~highly ~~into~~competitive ~~healthy~~and ~~human~~include ~~subjects~~both orestablished ~~patients~~industry participants with ~~the~~significant ~~target~~financial, ~~disease~~technical, orand ~~condition.~~commercial ~~These~~resources, ~~studies~~as ~~are~~well ~~designed~~as new entrants seeking to ~~evaluate~~capitalize on the ~~safety,~~growth ~~dosage~~of ~~tolerance,~~distributed ~~metabolism~~energy and ~~pharmacologic~~AI-driven ~~actions~~energy ofoptimization. ~~the~~Some ~~investigational~~competitors ~~new~~offer ~~drug~~vertically inintegrated ~~humans~~solutions, ~~the~~including ~~side~~hardware, ~~effects~~software, ~~associated~~and ~~with~~energy ~~increasing doses~~services, ~~and~~while ifothers ~~possible,~~provide topoint ~~gain~~solutions ~~early~~that ~~evidence~~compete onwith ~~effectiveness~~specific components of Grid AI Corp.’s platform.

●Grid ~~Phase~~AI 2Corp.’s ~~The~~ability ~~drug~~to orcompete ~~biologic~~successfully isdepends ~~administered~~on its ability to acontinue ~~limited~~to ~~patient~~innovate, ~~population~~expand its platform capabilities, maintain reliable system performance, and effectively execute its go-to-market ~~evaluate~~strategy. ~~dosage~~Grid ~~tolerance~~AI Corp. also competes based on its ability to convert pilot programs and ~~optimal~~non-binding ~~dosage~~arrangements into long-term commercial contracts, ~~identify~~scale ~~possible~~deployments ~~adverse~~across ~~side~~multiple ~~effects~~jurisdictions, and ~~safety~~adapt ~~risks~~to ~~and~~evolving ~~preliminarily~~regulatory ~~evaluate~~frameworks ~~efficacy~~and market rules.

●In ~~Phase~~addition, 3.customers ~~The~~may ~~drug~~elect orto ~~biologic~~develop isin-house ~~administered~~energy tomanagement ansystems ~~expanded~~or ~~patient~~partner ~~population~~with alternative providers, ~~generally~~which atmay ~~geographically~~reduce ~~dispersed~~demand ~~clinical~~for ~~study~~the ~~sites~~Company’s tosolutions. ~~generate~~As ~~enough~~a ~~data~~result, toGrid ~~statistically~~AI ~~evaluate~~Corp. ~~dosage~~may face pricing pressure, ~~clinical~~longer ~~effectiveness~~sales cycles, and ~~safety,~~increased customer acquisition costs. If Grid AI Corp. is unable to ~~establish~~compete ~~the~~effectively, ~~overall~~it ~~benefit-risk~~may ~~relationship~~lose ofmarket ~~the~~share, ~~investigational~~which ~~product~~could ~~and~~adversely toaffect ~~provide~~its anbusiness, ~~adequate~~operating ~~basis~~results, ~~for~~and ~~product~~financial ~~approval~~condition.

● Phase 4. In some cases, the FDA may condition approval of an NDA or BLA for a drug candidate on the sponsor’s agreement to conduct additional clinical studies after approval. In other cases, a sponsor may commit to conducting or voluntarily conduct additional clinical studies after approval to gain more information about the drug. Such post-approval studies are typically referred to as Phase 4 clinical studies.Adrulipase

AWith ~~confirmatory~~respect ~~or pivotal study is a clinical study that adequately meets regulatory agency requirements for the evaluation of a drug candidate’s efficacy and safety such that it can be used~~ to ~~justify the approval of the product. Generally~~Adrulipase, ~~pivotal~~if ~~studies are Phase 3 studies~~approved, ~~but~~we ~~the~~would ~~FDA~~compete ~~may~~with ~~accept~~pancreatic ~~results~~enzyme ~~from~~replacement ~~Phase~~therapies 2(“PERTs”), ~~studies~~which ifrepresent the ~~study~~current ~~design~~standard ~~provides a well-controlled and reliable assessment~~ of ~~clinical~~care ~~benefit,~~for ~~particularly in situations where there is an unmet medical need and~~ the ~~results~~treatment ~~are~~of ~~sufficiently~~exocrine ~~robust.~~pancreatic Ininsufficiency ~~such cases, FDA may require post-market studies for safety and efficacy to be conducted for the drug candidate~~(“EPI”). The ~~FDA~~PERT ~~may~~market ~~withdraw~~is ~~the~~dominated ~~approval~~by ifa ~~the~~small ~~results~~number ~~indicate~~of ~~that~~established ~~the~~pharmaceutical ~~approved~~products ~~drug~~marketed isby ~~not~~larger ~~safe~~companies, ~~or effective.~~including:

~~The~~● ~~FDA,~~CREON® ~~the~~marketed IRB or the clinical study sponsor may suspend or terminate a clinical study at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Additionally, some clinical studies are overseen by anAbbVie ~~independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee~~Inc. This group provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study. We may also suspend or terminate a clinical study based on evolving business objectives and/or competitive climate.

~~Chemistry,~~● ~~Manufacturing~~ZENPEP® ~~and~~marketed ~~Control~~by ~~Information~~Nestlé Health Science

~~Companies~~● ~~seeking~~PANCREAZE® ~~FDA~~marketed ~~approval~~by of drugs must also develop data and information about the physical characteristics of the components of a product as well as finalize processes for manufacturing the components in commercial quantities in accordance with GMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate andVIVUS, ~~among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final product~~Inc. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the components of a product candidate do not undergo unacceptable deterioration over their shelf life.

●

PERTZYE® marketed by Chiesi Farmaceutici S.p.A.

Several PERT products have been approved by the U.S. Food and Drug Administration for sale in the United States and have been used in clinical practice for many years.

If Adrulipase were successfully developed and approved, we believe competition in this market would depend on several factors, including the ability to demonstrate clinical efficacy and safety relative to existing therapies, regulatory approval, pricing and reimbursement considerations and acceptance by physicians, patients and healthcare payors.

Adrulipase differs from currently available PERT therapies in that it is designed as a recombinant, non-animal derived enzyme. As a result, the product may potentially address certain limitations associated with porcine-derived pancreatic enzyme therapies, including pill burden and sourcing considerations. However, we cannot assure that Adrulipase will ultimately demonstrate advantages over existing therapies or achieve regulatory approval or commercial adoption.

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~~Submission~~Government ofRegulation anand ~~NDA~~Product ~~or BLA to the FDA~~Approval

~~Assuming~~Our ~~successful~~businesses ~~completion~~are ofsubject ~~all~~to ~~required~~extensive ~~testing~~regulation in ~~accordance~~the ~~with~~United ~~all~~States ~~applicable~~and ~~regulatory~~in ~~requirements,~~foreign ~~detailed~~jurisdictions. ~~investigational~~Following ~~new~~our ~~drug~~acquisition ~~product~~of ~~information~~Grid isAI ~~submitted~~Corp. toon ~~the~~September ~~FDA~~30, in2025, ~~the~~our ~~form~~regulatory ofenvironment annow ~~NDA~~includes orboth ~~BLA~~(i) ~~requesting~~pharmaceutical ~~approval~~and biotechnology regulation applicable to ~~market~~our ~~the~~legacy ~~product~~Adrulipase ~~for~~program ~~one~~and orrelated ~~more~~life ~~indications.~~sciences ~~Under~~activities ~~federal~~and ~~law~~(ii) regulatory, ~~the~~compliance, ~~submission~~privacy, ofcybersecurity, ~~most~~contractual ~~NDAs~~ and ~~BLAs~~market-participation isrequirements ~~subject~~applicable to aour ~~substantial~~Grid ~~application~~AI ~~user fee~~Corp. ~~Applications~~and ~~for~~AMPX ~~orphan~~energy ~~drug~~orchestration ~~products~~platform. ~~are~~Failure ~~exempted~~to ~~from~~comply ~~the~~with ~~NDA~~applicable laws and ~~BLA~~regulations ~~application~~could ~~user~~result ~~fees~~in delays, penalties, contractual claims, restrictions on operations, loss of market access or other adverse consequences.

AnEnergy ~~NDA or BLA must include all relevant data available from pertinent preclinical and clinical studies~~Technology, ~~including~~Software ~~negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls~~ and ~~proposed~~Grid ~~labeling,~~Services among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of a product, 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 effectiveness of the investigational product to the satisfaction of the FDA.Regulation

~~Once~~Our anGridAI ~~NDA~~business oroperates ~~BLA~~in ~~has~~a ~~been~~regulatory ~~submitted~~environment that includes federal, ~~the~~state ~~FDA’s~~and ~~goal~~local isenergy tomarket ~~review~~rules, ~~the~~data ~~application~~privacy ~~within~~and ~~ten months~~cybersecurity ~~after~~requirements, itand ~~accepts~~contractual ~~the~~and ~~application~~interconnection ~~for~~standards ~~filing,~~applicable ~~or,~~to ifdistributed ~~the~~energy ~~application~~resources ~~relates~~and togrid-connected ansystems. ~~unmet~~Our ~~medical~~legacy ~~need~~AmpX energy orchestration platform enables participation in awholesale ~~serious~~and orretail ~~life-threatening~~electricity ~~indication,~~markets ~~six months~~and ~~after~~is ~~the~~subject ~~FDA~~to ~~accepts~~oversight by entities such as the Federal ~~application~~Energy ~~for~~Regulatory ~~filing.~~Commission, ~~The~~regional ~~review~~transmission ~~process~~organizations isand ~~often~~independent ~~significantly~~system ~~extended~~operators, byas ~~FDA~~well ~~requests~~as ~~for~~applicable ~~additional~~state ~~information~~public orutility ~~clarification~~commissions.

~~Before~~Participation ~~approving~~in anthese ~~NDA~~markets orrequires ~~BLA,~~compliance ~~the~~with ~~FDA~~market ~~typically~~rules ~~will~~governing ~~inspect~~bidding, ~~the~~dispatch, ~~facility~~settlement, ortelemetry, ~~facilities~~and ~~where~~performance ~~the product is manufactured~~obligations. ~~The~~In ~~FDA~~addition, ~~will~~our ~~not~~platform ~~approve an application unless it determines that the manufacturing processes~~ and ~~facilities~~operations are insubject ~~compliance~~to ~~with~~interconnection ~~cGMP~~ requirements, ~~and~~utility ~~adequate~~tariffs, toand, ~~assure~~where ~~consistent production of the product within required specifications. Additionally~~applicable, ~~before~~certification ~~approving an NDA~~ or ~~BLA,~~registration ~~the~~requirements ~~FDA~~for ~~will~~market ~~typically~~participants ~~inspect one~~ or ~~more~~service ~~clinical sites to assure compliance with GCP~~providers.

~~The~~Our ~~FDA~~business is ~~required~~also tosubject ~~refer an application for an investigational drug or biologic~~ to anevolving ~~advisory~~data ~~committee or explain why such referral was not made. An advisory committee is a panel of independent experts~~privacy, ~~including~~cybersecurity ~~clinicians~~ and ~~other~~critical ~~scientific~~infrastructure ~~experts,~~protection ~~that reviews~~standards, ~~evaluates~~including ~~and~~requirements ~~provides~~related ~~a recommendation as~~ to ~~whether~~ the ~~investigational~~protection ~~product~~of ~~application~~customer ~~should~~data beand ~~approved~~grid ~~and~~reliability. ~~under~~These ~~what~~may ~~conditions.~~include ~~The~~compliance ~~FDA~~with isapplicable ~~not~~standards ~~bound~~established by NERC (the North ~~recommendations~~American ofElectric anReliability ~~advisory committee~~Corporation), ~~but~~as itwell ~~considers~~as ~~such~~federal ~~recommendations carefully when making decisions~~ and ~~typically~~state ~~follows~~data ~~such~~protection ~~recommendations~~laws.

~~The~~Failure ~~FDA’s~~to ~~Decision~~comply with applicable regulatory, market or contractual requirements could result in financial penalties, limitations on anmarket ~~NDA~~participation, termination of customer or ~~BLA~~utility agreements, or other adverse operational impacts. The regulatory framework governing distributed energy resources, virtual power plants and grid orchestration technologies is rapidly evolving, and changes in laws, regulations or market rules could impact our business model, costs and growth opportunities.

~~After~~Biopharmaceutical the FDA evaluates the NDA or BLA and conducts inspections of manufacturing facilities, it may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug or biologic with specific prescribing information for specific indications. 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 may require additional clinical data and/or an additional pivotal Phase 3 clinical study(ies), and/or other significant, expensive and time-consuming requirements related to clinical studies, preclinical studies or manufacturing. Even if such additional information is submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval. The FDA could also approve the NDA or BLA with a REMS to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications or a commitment to conduct one or more post-market studies or clinical studies. Such post-market testing may include Phase 4 clinical studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. The FDA may have the authority to withdraw its approval if post-market testing fails to verify the approved drug’s clinical benefit, if the applicant does not perform the required testing with due diligence, or if the any other evidence demonstrates the approved drug is not safe or effective, among other reasons. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.Regulation

~~Expedited~~Government ~~Review~~authorities in the United States, at the federal, state and ~~Accelerated~~local ~~Approval~~levels, ~~Programs~~and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and import and export of pharmaceutical and biologic products such as Adrulipase. To date, our internal legacy research and development efforts have historically involved activities in Europe and North America, and we expect that any future clinical development of Adrulipase, if pursued, would likely involve the United States and potentially Europe, subject to available capital, strategic priorities and regulatory alignment.

~~The~~In the United States, the FDA ~~has~~regulates ~~various~~drugs ~~programs,~~under ~~including~~the ~~fast~~Federal ~~track~~Food, ~~designation~~Drug, ~~breakthrough~~and ~~therapy~~Cosmetic ~~designation~~Act, ~~accelerated~~or ~~approval~~FDCA, ~~regenerative~~and ~~medicine~~its ~~advanced~~implementing ~~therapy~~regulations, and ~~priority~~regulates ~~review~~biologics under the FDCA, ~~that~~the ~~are~~Public ~~intended~~Health toService ~~expedite~~Act, ~~the~~or ~~development~~PHSA, and their implementing regulations. FDA approval ofis ~~new~~required ~~drugs~~before ~~and~~any ~~biologics~~new ~~that~~unapproved ~~address~~drug ~~unmet~~or ~~medical~~biologic ~~needs~~may be marketed in the ~~treatment~~United ofStates. ~~serious~~Pharmaceutical orand ~~life-threatening~~biologic ~~diseases~~products are also subject to other federal, state and ~~conditions~~local statutes and regulations. ToIf bewe ~~eligible~~fail ~~for~~to acomply ~~fast-track~~with ~~designation~~applicable FDA or other requirements at any point during development, ~~the~~testing, ~~FDA~~review, ~~must~~approval ~~determine~~or after approval, ~~based~~we onmay ~~the~~become ~~request~~subject ofto aadministrative ~~sponsor~~or judicial sanctions, ~~that~~including awarning letters, license suspension or revocation, product isrecalls, ~~intended~~seizures, toinjunctions, ~~treat~~fines, acivil ~~serious~~penalties or ~~life-~~criminal prosecution.

The process required by the FDA before a product candidate may be marketed in the United States generally involves:

●

completion of preclinical laboratory studies, animal studies and other supporting data, generally in accordance with good laboratory practice, or GLP, requirements

●

submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin

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~~threatening~~● ~~disease~~approval orby ~~condition and demonstrates the potential to address~~ an ~~unmet~~independent ~~medical~~institutional ~~need.~~review ~~The~~board, ~~FDA~~or ~~may~~IRB, ~~review~~or ~~sections~~ethics ofcommittee ~~the NDA~~ for aeach ~~fast-track~~clinical ~~product~~site ~~on a rolling basis~~ before ~~the complete application is submitted, if the sponsor provides~~ a ~~schedule~~clinical ~~for~~trial ~~the~~may submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.begin

~~The~~● ~~FDA~~performance ~~may~~of ~~give a priority review designation to drugs that offer major advances in treatment or provide a treatment where no~~ adequate ~~therapy~~and ~~exists.~~well-controlled Ahuman ~~priority~~clinical ~~review~~trials ~~means that the goal for the FDA~~ to ~~review~~establish ansafety ~~application~~and isefficacy, ~~six months~~or, ~~rather~~in ~~than~~ the ~~standard~~case ~~review~~ of ~~ten months~~a ~~under~~biologic, ~~current.~~safety, ~~These~~purity ~~six~~ and ~~ten-month review periods are measured from the “filing” date rather than the receipt date for NDAs for new molecular entities~~potency, ~~which typically adds approximately two months to the timeline~~ for ~~review~~each ~~and~~proposed ~~decision from the date of submission. Most products that are eligible for fast-track designation are also likely to be considered appropriate to receive a priority review.~~indication

In● ~~addition,~~preparation ~~products studied for their safety~~ and ~~effectiveness~~submission into ~~treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on~~ the ~~basis~~FDA of ~~adequate and well-controlled clinical studies establishing that the product has an effect on~~ a ~~surrogate~~marketing ~~endpoint that is reasonably likely to predict clinical benefit~~application, orgenerally on a ~~clinical~~new ~~endpoint~~drug ~~that can be measured earlier than irreversible morbidity or mortality~~application, ~~that is reasonably likely to predict an effect on irreversible morbidity~~ or ~~mortality or other clinical benefit~~NDA, ~~taking into account the severity, rarity~~ or ~~prevalence~~biologics oflicense ~~the condition and the availability or lack of alternative treatments. As a condition of approval~~application, ~~the FDA may require a sponsor of a drug receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity~~ or ~~mortality or other clinical endpoint, and the drug may be subject to accelerated withdrawal procedures.~~BLA

~~Moreover,~~● ~~under the provisions of the~~ FDA ~~Safety~~acceptance ~~and Innovation Act passed in July 2012, a sponsor can request designation~~ of a drug candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the ~~product~~NDA ~~may demonstrate substantial improvement over existing therapies on one~~ or ~~more~~BLA ~~clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are also eligible~~ for ~~the~~filing ~~other expedited review~~ and ~~approval~~substantive ~~programs, including accelerated approval, priority~~ review, regenerative medicine advanced therapy, and fast-track designation. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthrough therapy.

In● ~~addition,~~satisfactory ~~the~~completion 21st Century Cures Act in 2016 made the Regenerative Medicine Advanced Therapy, or RMAT, designation available for investigational drugs that are intended to treat, modify, reverse, or cure a serious condition, with preliminary clinical evidence indicating that the drug has the potential for addressing unmet medical needs for such condition. The RMAT designation is available for cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products that use such therapies or products. The advantages of ~~RMAT~~FDA ~~designation~~inspections ~~include those~~ of ~~breakthrough~~manufacturing ~~and~~facilities ~~fast track designations~~and, ~~such~~where ~~as early interactions with FDA and rolling review of applications~~applicable, ~~and the drug candidate with the RMAT designation may be eligible for accelerated approval. Requests for RMAT designations should be made with the IND application (if preliminary~~ clinical ~~evidence is available), but no later than the end-of-phase-2 meeting.~~sites

~~Even~~● ifFDA areview ~~product~~and ~~qualifies~~approval ~~for one or more~~ of ~~these programs,~~ the ~~FDA~~NDA ~~may~~or ~~later~~BLA ~~decide~~prior ~~that~~to ~~the~~any ~~product~~commercial nomarketing ~~longer meets the conditions for qualification~~ or ~~decide~~sale ~~that~~in the ~~time~~United ~~period for FDA review or approval will not be shortened~~States.

~~Post-Approval~~An ~~Requirements~~IND is a request for authorization from the FDA to administer an investigational product to humans. It includes, among other things, the proposed clinical protocol or protocols, toxicology and pharmacology data, chemistry, manufacturing and controls information and any available prior human data. Unless the FDA raises concerns within 30 days after receipt, the IND becomes effective and clinical trials may begin. However, the FDA may impose a clinical hold at any time if it identifies safety, scientific, manufacturing or other concerns.

~~Drugs~~Clinical and biologics marketed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing, annual user fee requirements.Trials

~~Manufacturers~~Clinical ~~are~~trials ~~subject~~involve tothe ~~periodic~~administration ~~unannounced~~of ~~inspections~~an byinvestigational product to human subjects under the ~~FDA~~supervision ~~and~~of ~~state~~qualified ~~agencies~~investigators ~~for~~in ~~compliance~~accordance with ~~cGMP~~good clinical practice, or GCP, requirements. ~~Changes~~These toinclude the ~~manufacturing~~requirement ~~process~~that ~~are~~all ~~strictly~~subjects ~~regulated~~provide ~~and,~~informed ~~depending~~consent onbefore ~~the~~participating ~~significance~~in ofa ~~the~~study. ~~change,~~Clinical ~~may~~trials ~~require~~must ~~prior~~be ~~FDA~~conducted ~~approval~~under ~~before~~protocols ~~being~~that ~~implemented.~~describe ~~FDA~~the ~~regulations~~study ~~also~~objectives, ~~require~~design, ~~investigation~~methodology, statistical considerations and ~~correction~~other ofrequirements. ~~any~~Protocols ~~deviations~~and ~~from~~protocol ~~cGMP~~amendments ~~and~~are ~~impose~~submitted ~~reporting~~to ~~and~~the ~~documentation~~FDA ~~requirements~~as ~~upon~~part usof the IND, and ~~any~~IRB ~~third-party~~approval ~~manufacturers~~must ~~that~~be weobtained ~~may~~for ~~decide~~each tosite ~~use.~~before enrollment begins.

Clinical development generally proceeds through Phase 1, Phase 2 and Phase 3 studies, although these phases may overlap or be combined in some cases. The FDA may also require or request post-approval, or Phase 4, studies.

As of December 31, 2025, we were not conducting active clinical trials for Adrulipase. Any future advancement of Adrulipase would require additional funding, updated clinical and regulatory planning and continued compliance with applicable FDA and other regulatory requirements. There can be no assurance that we will resume development of Adrulipase on any particular timetable or at all.

Chemistry, Manufacturing and Controls

Companies seeking FDA approval must also provide information regarding the composition, manufacture, stability and quality controls of a product candidate. The manufacturing process must be capable of consistently producing product in accordance with current good manufacturing practice, or cGMP, requirements. Sponsors must develop and validate methods for testing identity, strength, quality, potency and purity and must demonstrate acceptable stability over the proposed shelf life.

Before approving an NDA or BLA, the FDA typically inspects the facility or facilities where the product is manufactured. FDA approval may be withheld if the manufacturing processes or facilities are not in compliance with cGMP or are otherwise deemed inadequate.

FDA Review of NDA or BLA

Once an NDA or BLA is submitted, the FDA conducts a preliminary review to determine whether the application is sufficiently complete for substantive review. The FDA may issue an approval letter or a complete response letter. A complete response letter indicates that the review is complete but the application is not ready for approval in its present form. Such a letter may require additional clinical data, manufacturing information, inspections, analyses or other information, and it can result in significant delays and added

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~~Accordingly,~~expense. ~~manufacturers~~Even ~~must~~if ~~continue~~additional toinformation ~~expend~~is ~~time~~submitted, ~~money and effort in~~ the ~~area~~FDA ofmay ~~production~~still ~~and~~determine ~~quality~~that ~~control~~the toapplication ~~maintain~~does ~~compliance~~not ~~with~~satisfy ~~cGMP~~the ~~and~~standards ~~other~~for ~~aspects of regulatory compliance~~approval.

~~Discovery~~The ofFDA ~~previously unknown problems with a product or the failure to comply with applicable requirements~~ may ~~result~~also inrequire ~~restrictions on~~ a ~~product,~~risk ~~manufacturer~~evaluation orand ~~holder~~mitigation ~~of an approved NDA or BLA~~strategy, ~~including withdrawal~~ or ~~recall of the product from the market or other voluntary~~REMS, ~~FDA~~post-~~initiated~~marketing orstudies, ~~judicial~~labeling ~~action~~changes, ~~that~~additional ~~could~~controls ~~delay~~ or ~~prohibit~~other ~~further~~conditions ~~marketing~~of approval. ~~Also,~~If ~~new~~compliance ~~government~~with regulatory requirements, ~~including~~is ~~those~~not ~~resulting~~maintained ~~from~~after ~~new legislation~~approval, ~~may be established, or~~ the FDA’s ~~policies~~ may ~~change~~impose restrictions, ~~which~~require ~~could~~recalls, ~~delay~~suspend or ~~prevent~~withdraw ~~regulatory~~ approval ofor ~~our~~pursue ~~products~~other ~~under~~enforcement ~~development~~action.

~~The~~Expedited ~~FDA~~Programs ~~may withdraw approval 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; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things.Exclusivity

●The ~~restrictions~~FDA onmaintains ~~the~~programs ~~marketing~~designed to facilitate or ~~manufacturing~~expedite the development and review of ~~the~~products ~~product;~~intended to treat serious or life-threatening diseases or conditions and to address unmet medical needs. These include fast track designation, breakthrough therapy designation, accelerated approval, priority review and, for qualifying products, regenerative medicine advanced therapy, or RMAT, designation.

●Even ~~complete~~if ~~withdrawal~~a ofproduct is eligible for one or more expedited programs, the FDA may later determine that the product ~~from~~no longer qualifies for such program or that expedited review does not shorten the ~~market~~development or ~~product~~review ~~recalls;~~process in practice.

●Adrulipase ~~fines~~may also, ~~warning~~if ~~letters~~approved and if applicable legal requirements are satisfied, potentially benefit from regulatory exclusivity, including orphan drug exclusivity or ~~holds~~biologic exclusivity. However, the scope, availability and duration of any such exclusivity would depend on ~~post-approval~~the ~~clinical~~approved ~~studies;~~product, indication, application pathway and applicable law at the time of approval.

●Post-Approval ~~refusal of the FDA to approve pending NDAs or BLAs or supplements to approved NDAs or BLAs, or suspension or revocation of product licenses or approvals;~~Requirements

●Any ~~product~~approved ~~seizure~~pharmaceutical or ~~detention~~biologic product would remain subject to continuing FDA and other regulatory oversight, orincluding ~~refusal~~requirements for adverse event reporting, manufacturing controls, labeling, advertising and promotion, recordkeeping, periodic reporting, sampling and distribution. Manufacturing establishments are also subject to ~~permit~~periodic inspections. Later discovery of previously unknown problems, adverse events, manufacturing deficiencies or other regulatory noncompliance could result in restrictions on the ~~import~~product or ~~export~~the manufacturer, labeling changes, additional post-marketing requirements, recalls, fines, warning letters, withdrawal of ~~products;~~approval or other enforcement action.

●The ~~injunctions~~FDA oralso ~~the~~strictly ~~imposition~~regulates promotion. Promotional claims may generally be made only for approved indications and in a manner consistent with approved labeling. Improper promotion of ~~civil~~off-label oruses ~~criminal~~may ~~penalties~~subject a company to significant liability.

~~The~~Other ~~FDA~~Healthcare ~~strictly~~Laws ~~regulates marketing, labeling, advertising~~ and ~~promotion~~Compliance of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.Requirements

~~Orphan~~Our ~~Designation~~legacy life sciences business is also subject to healthcare fraud and ~~Exclusivity~~abuse laws, false claims laws, privacy and security laws, physician payment transparency laws and similar requirements in the United States and abroad. These may include, among others, the federal Anti-Kickback Statute, the federal False Claims Act, HIPAA, state data privacy laws and state or federal sunshine laws. Violations may result in civil or criminal penalties, damages, fines, exclusion from government healthcare programs, integrity obligations and reputational harm.

~~Under~~Coverage the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA or 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.Reimbursement

IfSales aof ~~product~~any ~~that~~pharmaceutical ~~has~~or ~~orphan~~biologic ~~drug~~product, ~~designation~~if ~~subsequently~~approved, ~~receives~~depend ~~the~~in ~~first~~part ~~FDA~~on ~~approval for a particular active ingredient for~~ the ~~disease~~extent ~~for~~to which ~~it has~~ such ~~designation, the~~ product is ~~entitled~~covered toby ~~orphan~~third-party ~~product marketing exclusivity~~payors, ~~which~~including ~~means~~federal ~~that~~and ~~the~~state ~~FDA~~healthcare ~~may~~programs, ~~not~~private ~~approve~~insurers ~~any~~and ~~other~~managed ~~applications,~~care ~~including a full BLA~~organizations, toand ~~market~~ the ~~same~~level ~~biologic~~of ~~for~~reimbursement ~~the~~available ~~same use or indication~~ for ~~seven years, except in limited circumstances, such as a showing of clinical superiority to~~ the product. ~~with~~Coverage ~~orphan~~and ~~drug~~reimbursement ~~exclusivity~~decisions orare ifmade ~~FDA~~on ~~finds~~a ~~that~~payor-by-payor ~~the~~basis, ~~holder~~and ofmany ~~the~~payors ~~orphan~~are ~~drug~~seeking ~~exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug~~ to ~~meet~~control ~~the~~costs ~~needs~~by ofreducing ~~patients~~reimbursement ~~with~~levels, ~~the~~narrowing ~~disease~~formularies or ~~condition~~imposing ~~for~~other ~~which~~utilization ~~the drug was designated~~controls. ~~Orphan~~Legislative ~~drug~~and ~~exclusivity~~regulatory ~~does~~changes ~~not~~affecting ~~prevent the FDA from approving a different drug or biologic for the same disease or condition~~pricing, orrebates ~~the~~and ~~same~~reimbursement ~~drug~~may oralso ~~biologic~~adversely ~~for~~affect ~~a different disease or condition. Among~~ the ~~other~~commercial ~~benefits~~opportunity ~~of orphan drug designation are tax credits~~ for ~~certain~~any ~~research~~approved ~~and a waiver of the BLA or NDA application user fee~~product.

Healthcare Reform and Other Legislative Changes

The healthcare industry is subject to continuing legislative and regulatory change. U.S. federal and state governments and foreign governments continue to adopt and consider measures intended to reduce healthcare costs, increase pricing transparency, expand the use of generics and biosimilars and otherwise affect the pricing, reimbursement and commercialization of pharmaceuticals. Such

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Achanges ~~designated~~could ~~orphan~~reduce ~~drug may not receive orphan drug exclusivity if it is approved for a use that is broader than~~ the ~~indication~~commercial ~~for~~potential ~~which~~of itany ~~received~~pharmaceutical ~~orphan~~product ~~designation.~~we ~~In addition, orphan drug exclusive marketing rights in the United States~~ may besuccessfully ~~lost~~develop ifand ~~the~~obtain ~~FDA~~approval ~~later determines that the request~~ for ~~designation~~in ~~was materially defective or, as noted above, if~~ the second applicant demonstrates that its product is clinically superior to the approved product with orphan exclusivity 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 conditionfuture.

~~Biosimilars~~Foreign Corrupt Practices Act and ~~Exclusivity~~Similar Laws

~~The~~Our ~~Affordable~~business ~~Care~~activities may be subject to the U.S. Foreign Corrupt Practices Act, ~~signed~~or ~~into~~FCPA, ~~law~~and similar anti-bribery and anti-corruption laws in ~~2010,~~other ~~includes~~jurisdictions. aThe ~~subtitle~~FCPA ~~called~~generally ~~the~~prohibits ~~Biologics~~offering, ~~Price~~promising, ~~Competition~~giving ~~and~~or ~~Innovation~~authorizing ~~Act~~anything of ~~2009~~value, directly or ~~BPCIA~~indirectly, ~~which~~to ~~created~~a anforeign ~~abbreviated~~official ~~approval~~for ~~pathway~~the ~~for~~purpose ~~biological~~of ~~products~~obtaining ~~that~~or ~~are~~retaining ~~biosimilar~~business or securing an improper advantage. It also requires public companies to ormaintain ~~interchangeable~~accurate ~~with~~books anand ~~FDA-licensed~~records ~~reference~~and ~~biological~~adequate ~~product~~internal accounting controls. ToBecause ~~date,~~our ~~only~~operations amay ~~handful~~involve ofinteractions ~~biosimilars~~with ~~have~~foreign ~~been~~officials, ~~licensed~~public ~~under~~utilities, ~~the~~public ~~BPCIA~~healthcare systems, ~~although~~customs ~~numerous~~authorities ~~biosimilars~~and ~~have~~other ~~been~~governmental ~~approved~~actors, inany ~~Europe.~~failure ~~The~~by ~~FDA~~us ~~has~~or ~~issued~~our ~~several~~agents, ~~guidance~~contractors, ~~documents~~suppliers, ~~outlining~~collaborators anor ~~approach~~business partners to ~~review~~comply with these laws could result in substantial penalties and ~~approval~~other ofadverse ~~biosimilars~~consequences.

~~Biosimilarity,~~Energy ~~which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety~~Technology, ~~purity~~Grid ~~and~~Services ~~potency, can be shown through analytical studies, human PK~~ and PDData studies, clinical immunogenicity assessments, animal studies and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. However, complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.Regulation

~~Under~~Following ~~the~~our ~~BPCIA,~~acquisition ~~an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval~~ of aGrid ~~biosimilar~~AI ~~product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed~~Corp. ~~During this 12-year period of exclusivity~~, ~~another~~our ~~company~~business ~~may~~is ~~still~~also ~~market~~subject ato ~~competing~~legal ~~version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data~~ and ~~data~~regulatory ~~from~~requirements ~~adequate~~applicable ~~and~~to ~~well~~software-~~controlled~~enabled ~~clinical~~energy ~~studies~~orchestration, todistributed ~~demonstrate~~energy ~~the safety~~resources, ~~purity~~virtual ~~and~~power ~~potency~~plant ~~of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture~~participation, itdemand isresponse ~~unclear whether products deemed “interchangeable” by the FDA will~~activity, indata ~~fact~~handling, becybersecurity ~~readily~~and ~~substituted~~interactions bywith ~~pharmacies~~utilities, ~~which~~market ~~are~~operators, ~~governed~~aggregators byand ~~state~~device ~~pharmacy law~~ecosystems.

AOur ~~biological~~Grid ~~product~~AI ~~can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods~~ and ~~patent~~AMPX ~~terms.~~operations ~~This six-month exclusivity, which runs from the end of other exclusivity protection or patent term,~~ may be ~~granted~~affected ~~based~~by, onamong ~~the~~other ~~voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.~~things:

~~The~~● ~~BPCIA~~utility isrules ~~complex~~ and continues to be interpreted and implemented by the FDA. In addition, recent government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.tariffs

●

grid interconnection and market participation requirements

●

regulations applicable to aggregators, distributed energy resources, demand response and ancillary services participation

●

electrical, communications, device integration and installation standards

●

software, cloud, cybersecurity and critical infrastructure requirements

●

data privacy, data security and consumer protection laws

●

commercial contracting requirements with utilities, retailers, partners and customers

●

export controls, sanctions and anti-corruption laws where international operations or counterparties are involved.

In addition, because our platform may integrate with third-party devices, data feeds, utility systems, cloud infrastructure and market systems, our ability to deploy and scale offerings may depend on continued access to such systems and compliance with contractual and technical requirements imposed by third parties. Regulatory changes affecting demand response, virtual power plants, distributed energy resources, energy market participation, data access, interoperability or cybersecurity may materially affect our business model, implementation costs and growth prospects.

We may also be subject to laws and regulations relating to the collection, processing, use, storage, sharing and protection of customer, consumer, employee, device and operational data. These may include U.S. state privacy laws, international privacy laws and industry cybersecurity expectations. Any failure to comply with these requirements, or any data breach, cybersecurity incident or service disruption, could result in liability, contractual claims, reputational damage, loss of customers, increased compliance costs or regulatory scrutiny.

Because portions of the Grid AI and AMPX business may involve participation in regulated utility or grid-adjacent environments, future growth may depend on evolving regulatory frameworks, market rules, incentive programs and utility procurement models. We cannot predict the extent to which changes in these frameworks will create opportunities or impose burdens on our operations.

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Hatch-Waxman Amendments and Exclusivity

Section 505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a new drug. Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant to rely, in part, on the FDA’s prior findings of safety and efficacy for an existing product, or published literature, in support of its application. Section 505(j) establishes an abbreviated approval process for a generic version of approved drug products through the submission of an ANDA. An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of administration, labeling, performance characteristics and intended use, among other things, to a previously approved product. ANDAs are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug through in vitro, in vivo or other testing. The generic version must deliver the same amount of active ingredients into a subject’s bloodstream in the same amount of time as the innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s drug or a method of using the drug. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.

Upon submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such patent expires; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the referenced product have expired.

If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the paragraph IV certification. If the paragraph IV certification is challenged by an NDA holder or the patent owner(s) asserts a patent challenge to the paragraph IV certification, the FDA may not approve that application until the earlier of 30 months from the receipt of the notice of the paragraph IV certification, the expiration of the patent, when the infringement case concerning each such patent was favorably decided in the applicant’s favor or settled, or such shorter or longer period as may be ordered by a court. This prohibition is generally referred to as the 30-month stay. In instances where an ANDA or 505(b)(2) NDA applicant files a paragraph IV certification, the NDA holder or patent owner(s) regularly take action to trigger the 30-month stay, recognizing that the related patent litigation may take many months or years to resolve.

The FDA also cannot approve an ANDA or 505(b)(2) application until all applicable non-patent exclusivities listed in the Orange Book for the branded reference drug have expired. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon NDA approval of a new chemical entity, or NCE, which is a drug containing an active moiety that has not been approved by FDA in any other NDA. An “active moiety” is defined as the molecule responsible for the drug substance’s physiological or pharmacologic action. During that five-year exclusivity period, the FDA cannot accept for filing (and therefore cannot approve) any ANDA seeking approval of a generic version of that drug or any 505(b)(2) NDA that relies on the FDA’s approval of the drug, provided that that the FDA may accept an ANDA four years into the NCE exclusivity period if the ANDA applicant also files a Paragraph IV certification.

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A drug, including one approved under Section 505(b)(2), may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as a new formulation for a previously approved product, if one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential to the approval of the application and was conducted/sponsored by the applicant. Should this occur, the FDA would be precluded from approving any ANDA or 505(b)(2) application for the protected modification until after that three-year exclusivity period has run. However, unlike NCE exclusivity, the FDA can accept an application and begin the review process during the exclusivity period.

Other Healthcare Laws and Compliance Requirements

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. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security and physician sunshine laws and regulations. If their operations are found to be in violation of any of such laws or any other governmental regulations that apply, they may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs and individual imprisonment.

Coverage and Reimbursement

Sales of any product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state and foreign government healthcare programs, commercial insurance and managed healthcare organizations and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical products, drugs and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales. Even after the FDA approves a product, failure to have the product covered by third-party payors may have material adverse effect on sales. Federal and state governments continue to promulgate new policies and regulations; such policies and regulations may have material adverse effect on sales. These laws and regulations may restrict, prohibit, or preventing us from implementing a wide range of pricing, discounting, marketing, promotion, sales commission, incentive programs, and other business activities. No uniform policy of coverage and reimbursement among third-party payors exists in the United States. Such payors often rely upon Medicare coverage policy establishing their coverage and reimbursement policies. However, each payor makes independent and separate decisions regarding the extent of coverage and amount of reimbursement to be provided.

Legislative and Regulatory Changes, Including Health Care Reform

The laws and regulations that affect our business are subject to change from time to time, and entirely new laws and regulations are sometimes adopted. In particular, healthcare reforms that have been adopted, and that may be adopted in the future, could result in further reductions in coverage and levels of reimbursement for pharmaceutical products, increases in rebates payable under U.S. government rebate programs and additional downward pressure on pharmaceutical product prices. On September 9, 2021, the Biden administration published a wide-ranging list of policy proposals, most of which would need to be carried out by Congress, to reduce drug prices and drug payment. The Department of Health and Human Services, or HHS, plan includes, among other reform measures, proposals to lower prescription drug prices, including by allowing Medicare to negotiate prices and disincentivizing price increases, and to support market changes that strengthen supply chains, promote biosimilars and generic drugs, and increase price transparency. Many similar proposals, including the plans to give Medicare Part D authority to negotiate drug prices, require drug manufacturers to pay rebates on drugs whose prices increase greater than the rate of inflation, and cap out-of-pocket costs, have already been included in policy statements and legislation currently being considered by Congress. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, proposing to encourage importation from other countries and bulk purchasing. It is unclear to what extent these and other statutory, regulatory, and administrative initiatives will be enacted and implemented.

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Foreign Corrupt Practices Act

Our business activities may be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA. There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

European Union Drug Development

In the European Union and the wider European Economic Area, ~~our~~or ~~product~~EEA, ~~candidates~~medicinal products may ~~also~~ be ~~subject~~marketed toonly ~~extensive~~after ~~regulatory~~obtaining ~~requirements~~a marketing authorisation from the competent authorities. AsThe inEEA currently consists of the ~~United~~27 ~~States,~~European ~~medicinal~~Union ~~products~~Member ~~can~~States ~~only~~plus beIceland, ~~marketed~~Liechtenstein ifand aNorway. A centralised marketing ~~authorization~~authorisation ~~from~~granted by the ~~competent~~European ~~regulatory~~Commission ~~agencies~~is ~~has~~valid ~~been~~throughout ~~obtained~~the European Union and the EEA.

~~Similar~~As toin the United States, the ~~various~~preclinical, clinical, manufacturing and post-approval phases of ~~preclinical~~medicinal ~~and~~product ~~clinical~~development ~~research~~in Europe are subject to extensive regulation. Clinical trials in the European Union are ~~subject~~governed by Regulation (EU) No 536/2014, commonly referred to ~~significant~~as ~~regulatory~~the ~~controls~~Clinical Trials Regulation, or CTR, which entered into application on January 31, 2022. The CTR replaced the prior Clinical ~~trials~~Trials ofDirective ~~medicinal~~regime ~~products~~and inwas intended to harmonise and streamline the ~~European~~submission, ~~Union~~review, ~~must~~supervision beand ~~conducted~~transparency inof ~~accordance~~clinical ~~with~~trials across the European Union, ~~national~~through ~~regulations~~a common portal and ~~international~~database ~~standards~~known ~~for~~as ~~good~~the ~~clinical~~Clinical ~~practice~~Trials Information System, or ~~GCP~~CTIS.

Clinical trials ~~are~~in ~~currently~~the ~~governed~~European byUnion EUmust ~~Clinical~~be ~~Trials~~conducted ~~Directive~~in ~~2001/20/EC~~accordance ~~that~~with ~~set~~the ~~out~~CTR, ~~common~~applicable ~~rules~~ national requirements and international standards for good clinical practice, or GCP. Sponsors must submit clinical trial applications through CTIS, and the ~~control~~regulatory and ~~authorization~~ethics ofreview ~~clinical~~process ~~trials~~is incoordinated under the ~~European~~CTR ~~Union~~framework. Trial sponsors are also subject to obligations relating to safety reporting, protocol amendments, trial transparency and public disclosure of results.

To improve the current system, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was adopted in 2014. The Regulation aims at harmonizing and streamlining the clinical trials authorization process, simplifying adverse event reporting procedures, improving the supervision of clinical trials, and increasing their transparency, notably via a clinical trial information system set up by the EMA. The new Regulation expressly provides that it will not be applied before six months after the publication of a notice delivered by the European Commission on the European Union clinical trial portal and database. As such notice requires a successful (partial) audit of the database and as that database is still under development, there is no scheduled application date yet. Pursuant to the transitory provisions of the new regulation, the Clinical Trials Directive 2001/20/EC will still apply for three years after the implementation of the European Union clinical trial portal and database. Thus, the sponsor has the possibility to choose between the requirements of the directive and the regulation for a period of three years from the entry into force of the regulation.

European Union Drug Review and Approval

In the EEA, ~~(which~~medicinal isproducts ~~comprised~~may ofbe ~~the~~authorised 28through ~~Member~~either ~~States~~the ofcentralised ~~the~~procedure ~~European~~or ~~Union~~national ~~plus~~and ~~Norway~~multi-country procedures, ~~Iceland~~depending ~~and~~on ~~Liechtenstein),~~the ~~medicinal~~product ~~products~~and ~~can~~applicable ~~only~~eligibility berules. ~~commercialized~~Under ~~after~~the ~~obtaining~~centralised procedure, a ~~Marketing~~single ~~Authorization~~marketing ~~(“MA”).~~authorisation ~~MAs~~application ~~may~~is besubmitted ~~granted~~to ~~either~~the ~~centrally~~European ~~(Community~~Medicines ~~MA)~~Agency, or ~~nationally~~EMA, ~~(National~~and, ~~MA)~~if approved, the European Commission grants a single marketing authorisation valid across the European Union and the EEA.

The ~~Community~~centralised MAprocedure is ~~issued~~mandatory ~~centrally~~for bycertain ~~the~~categories ~~European~~of ~~Commission~~medicines, ~~through~~including ~~the~~orphan ~~Centralized~~medicinal ~~Procedure,~~products ~~based~~and oncertain ~~the~~biotechnology-derived ~~opinion~~medicines, ofand ~~the~~is ~~CHMP~~optional offor ~~the~~certain ~~EMA~~other ~~and~~innovative isproducts ~~valid~~that ~~throughout~~satisfy the ~~entire~~relevant ~~territory~~eligibility ~~of the EEA~~criteria. ~~The~~Because ~~Centralized~~Adrulipase ~~Procedure~~ is ~~mandatory~~a ~~for~~recombinant ~~certain~~biologic ~~types~~candidate ofand ~~products~~may ~~such~~also aspotentially ~~orphan~~qualify ~~medicinal~~for ~~products~~orphan ~~and~~designation ~~medicinal~~depending ~~products~~on ~~containing~~indication aand ~~new~~development ~~active~~strategy, ~~substance~~any ~~indicated~~future ~~for~~European ~~the~~regulatory ~~treatment~~pathway offor ~~neurodegenerative~~Adrulipase ~~disorders.~~would ~~The~~likely ~~Centralized~~require ~~Procedure~~or isstrongly ~~optional~~favor ~~for~~evaluation ~~products~~under ~~containing~~the acentralised ~~new~~procedure. ~~active~~However, ~~substance not yet authorized in~~ the ~~EEA,~~ultimate orpathway ~~for~~would ~~products~~depend ~~that~~on ~~constitute~~the aproduct ~~significant~~profile, ~~therapeutic~~indication, ~~scientific~~legal orclassification ~~technical~~and ~~innovation~~regulatory oradvice ~~which~~at ~~are in~~ the ~~interest~~time of ~~public~~any ~~health in the European Union~~application.

Before granting a marketing authorisation, the EMA and the competent authorities evaluate the quality, safety and efficacy of the medicinal product and assess whether the benefit-~~19-~~risk balance is favorable.

~~Table~~Paediatric ~~of Contents~~Requirements

~~National~~Under ~~MAs~~the ~~are~~EU ~~issued~~Paediatric ~~nationally~~Regulation, byapplications ~~the~~for ~~competent~~marketing ~~authorities~~authorisation offor ~~the~~new ~~Member~~medicines ~~States~~generally ofmust include either the ~~EEA~~results ~~and~~of ~~only~~studies ~~cover~~performed ~~their~~in ~~respective~~accordance ~~territory.~~with ~~National~~an ~~MAs~~agreed ~~are~~paediatric ~~available~~investigation ~~for~~plan, ~~products~~or ~~not~~PIP, ~~falling~~or ~~within~~a decision granting a waiver or deferral. The EMA reviews compliance with the ~~mandatory~~agreed ~~scope~~PIP as part of the ~~Centralized~~validation ~~Procedure.~~and Wereview doprocess. ~~not~~For ~~foresee~~patented ~~that~~products, ~~any~~successful completion of ~~our~~an ~~current~~agreed ~~product~~PIP ~~candidates~~may ~~will~~make bethe ~~suitable~~product eligible for a ~~National~~six-month MAextension asof ~~they~~the ~~fall~~supplementary ~~within~~protection ~~the~~certificate, ~~mandatory~~if ~~criteria~~any. ~~for~~For orphan medicinal products, compliance with the ~~Centralized~~paediatric ~~Procedure~~requirements may result in a two-year extension of orphan market exclusivity. ~~Therefore~~The EU also provides for a paediatric-use marketing authorisation, ~~our~~or ~~product~~PUMA, ~~candidates~~for ~~will~~certain beproducts ~~approved~~developed ~~through~~exclusively ~~Community~~for ~~MAs~~use in children.

Under the above-described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

The pediatric use marketing authorization, or PUMA, is a dedicated marketing authorization for medicinal products indicated exclusively for use in the pediatric population, with, if necessary, an age-appropriate formulation. Pursuant to Regulation (EC) No. 1901/2006 (The “Pediatric Regulation”), all PUMA applications for marketing authorization for new medicines must include to be valid, in addition to the particulars and documents referred to in Directive 2001/83/EC, the results of all studies performed and details of all information collected in compliance with a pediatric investigation plan agreed between regulatory authorities and the applicant, unless the medicine is exempt because of a deferral or waiver of the EMA.

Before the EMA is able to begin its assessment of a Community MA application, it will validate that the applicant has complied with the agreed pediatric investigation plan. The applicant and the EMA may, where such a step is adequately justified, agree to modify a pediatric investigation plan to assist validation. Modifications are not always possible; may take longer to agree than the period of validation permits; and may still require the applicant to withdraw its marketing authorization application and to conduct additional non-clinical and clinical studies. Products that are granted a MA on the basis of the pediatric clinical trials conducted in accordance with the Pediatric Investigation Plan, or PIP, are eligible for a six-month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan medicinal products, a two-year extension of the orphan market exclusivity. This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

Orphan Drugs

In the European Union, ~~Regulation~~a ~~(EC)~~product Nomay ~~141/2000~~be ofdesignated as an orphan medicinal product if it is intended for the ~~European~~diagnosis, ~~Parliament~~prevention ~~and~~or treatment of a life-threatening or chronically debilitating condition, the ~~Council~~prevalence of ~~December 16,~~the ~~1999~~condition onis ~~orphan~~not ~~medicinal~~more ~~products,~~than asfive ~~amended~~in 10,000 ~~states~~persons ~~that~~in athe ~~drug~~European ~~shall~~Union or the expected return would be ~~designated~~insufficient asto anjustify ~~orphan~~the ~~drug~~investment, ifand ~~its~~no ~~sponsor~~satisfactory ~~can~~method ~~establish~~exists ~~that~~or the ~~three~~product ~~following~~would ~~cumulative~~provide ~~conditions~~significant ~~are~~benefit ~~met:~~over existing methods. Applications for orphan designation must be submitted before filing the marketing authorisation application.

~~● the product is intended for the diagnosis, prevention or treatment of a life~~-~~threatening or chronically debilitating condition;~~17-

● the prevalence of the conditions is not more than five in ten thousand persons in the European Union when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the European Union and that without incentives it is unlikely that the marketing of the drug in the European Union would generate sufficient return to justify the necessary investment; and

● that there is no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Union or, if such method exists, that the drug will be of significant benefit to those affected by that condition.

Pursuant to Regulation (EC) No. 847/2000 of April 27, 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts “similar medicinal product” and “clinical superiority”, an application for the designation of a drug as an orphan drug must be submitted at any stage of development of the drug before filing of a MA application.

The European Union offers incentives to encourage the development of designated orphan medicines (protocol assistance, fee reductions, etc.) and provides opportunities for market exclusivity. Pursuant to the abovementioned Regulation (EC) No. 141/2000, products receiving orphan designation in the European Union can obtain market exclusivity for a certain number of years in the European Union following the marketing approval.

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IfThe aEuropean ~~Community~~Union MAoffers inincentives ~~respect~~to ofencourage anthe ~~orphan~~development ~~drug~~of isorphan ~~granted~~medicines, ~~regulatory~~including ~~authorities~~fee ~~will not~~reductions, ~~for~~protocol aassistance ~~period~~and ofmarket ~~usually~~exclusivity. ~~ten years,~~Once ~~accept~~an ~~another~~orphan ~~application~~medicinal ~~for~~product ais MAauthorised, orit ~~grant~~is agenerally MAentitled orto ~~accept~~ten anyears ~~application~~of tomarket ~~extend~~exclusivity anin ~~existing~~the ~~MA,~~European Union for the ~~same~~approved ~~therapeutic~~orphan indication~~, in respect of a similar drug~~. This ~~period~~exclusivity may ~~however~~ be ~~reduced~~extended toby ~~six~~ two additional years if, at the ~~end~~applicable ofpaediatric ~~the~~requirements ~~fifth year,~~are itsatisfied. isUnder ~~established~~certain circumstances, ~~in respect of the drug concerned~~however, ~~that~~a ~~the~~similar ~~above-mentioned~~product ~~criteria~~may ~~for~~still ~~orphan~~be ~~drug~~authorised, ~~designation~~including ~~are~~with nothe ~~longer~~consent ~~met,~~of inthe ~~other~~original ~~words~~holder, ~~when~~if itthe isoriginal ~~shown~~holder oncannot ~~the~~supply ~~basis~~sufficient ofquantities, ~~available~~or ~~evidence~~if ~~that~~ the later product is ~~sufficiently~~shown ~~profitable not~~ to ~~justify~~be ~~maintenance~~clinically ~~of market exclusivity~~superior.

Pursuant to Regulation No. 1901/2006, for orphan medicinal products, instead of an extension of the supplementary protection certificate, the ten-year period of orphan market exclusivity should be extended to 12 years if the requirement for data on use in the pediatric population is fully met (i.e. when the request contains the results of all studies carried out under the approved PIP and when the declaration attesting the conformity of the request to this PIP is included in the MA).

Notwithstanding the foregoing, a MA may be granted, for the same therapeutic indication, to a similar drug if:

● the holder of the MA for the original orphan drug has given its consent to the second applicant;

● the holder of the MA for the original orphan drug is unable to supply sufficient quantities of the drug; or

● the second applicant can establish in the application that the second drug, although similar to the orphan drug already authorized, is safer, more effective or otherwise clinically superior.

The abovementioned Regulation (EC) No. 141/2000 provides for other incentives regarding orphan medicinal products.

Post-Approval Controls

The holder of a MAEuropean marketing authorisation must comply with EUongoing requirements ~~applicable~~relating to manufacturing, ~~marketing~~pharmacovigilance, labeling, promotion, ~~and~~quality ~~sale~~systems ofand ~~medicinal~~post-authorisation ~~products~~commitments. InThe ~~particular,~~marketing ~~the~~authorisation holder ~~of the MA~~ must ~~establish and~~ maintain aan appropriate pharmacovigilance system and appoint ana ~~individual~~ qualified person for pharmacovigilance, or QPPV, ~~who~~in isthe ~~responsible~~European ~~for~~Union. ~~oversight~~Marketing ofauthorisations ~~that~~for ~~system~~new ~~and~~products ~~who~~generally ~~will~~must ~~reside~~also ~~and~~include ~~operate~~a inrisk ~~the~~management ~~EU.~~plan, ~~Key~~or ~~obligations~~RMP, ~~include~~and ~~safety~~regulators ~~expedited~~may ~~reporting~~impose ofpost-authorisation ~~suspected~~safety ~~serious~~studies, ~~adverse reactions and submission of~~ periodic safety ~~update~~reporting ~~reports,~~and orother ~~PSURs~~risk-minimisation measures.

~~All~~Advertising ~~new MAs must include a risk management plan, or RMP, to submit to the EMA, describing the risk management system that the company will put in place~~ and ~~documenting~~promotion ~~measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition~~ of ~~the~~medicinal ~~MA.~~products ~~Such~~in ~~risk-minimization~~Europe measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies. RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions. All advertising and promotional activities for the product must be consistent with the approved ~~summary of~~ product ~~characteristics,~~information. ~~and therefore all off~~Off-label promotion is prohibited., ~~Direct~~and direct-to-consumer advertising of prescription medicines is ~~also~~generally prohibited in the European Union. ~~Although~~Specific ~~general requirements for~~ advertising and ~~promotion~~promotional ofrules ~~medicinal products~~ are ~~established~~also ~~under~~implemented EUat ~~directives,~~ the ~~details are governed by regulations in each EU~~ Member State level and ~~can~~may differ ~~from~~by ~~one~~ country ~~to another~~.

Reimbursement

~~The~~In the European Union, ~~provides~~pricing ~~options~~and ~~for~~reimbursement ~~its~~are ~~Member~~determined ~~States~~at ~~to restrict~~ the ~~range of medicinal products for which their~~ national ~~health~~level, ~~insurance~~not ~~systems~~centrally ~~provide~~by ~~reimbursement~~the ~~and~~EMA toor ~~control~~ the ~~prices~~European ~~of medicinal products for human use~~Commission. A Member ~~State~~States may ~~approve~~restrict athe ~~specific~~products ~~price~~ for ~~the~~which ~~medicinal~~their ~~product,~~healthcare orsystems itprovide ~~may~~reimbursement ~~instead~~and ~~adopt~~may aimpose ~~system~~price ofcontrols ~~direct~~ or ~~indirect~~other ~~controls~~cost-containment onmeasures. ~~the~~As ~~profitability~~a ofresult, ~~the~~even ~~company~~if ~~placing~~a ~~the~~ medicinal product onreceives ~~the~~a ~~market.~~marketing ~~For example~~authorisation, inthere France, effective market access will be supported by agreements with hospitals and products may be reimbursed by the Social Security Fund. The price of medicines covered by national health insurance is negotiated with the Economic Committee for Health Products, or CEPS. There can be no assurance that ~~any~~it ~~country that has price controls or reimbursement limitations for pharmaceutical products~~ will ~~allow~~receive favorable ~~reimbursement and~~ pricing ~~arrangements~~or ~~for~~reimbursement in any ofparticular ~~our product candidates~~country. Historically, ~~products~~prices ~~launched~~for inmedicinal ~~the~~products ~~European~~in ~~Union~~Europe dohave ~~not~~often ~~follow~~been ~~price~~lower ~~structures~~than ofin the United States, and ~~generally~~reimbursement ~~prices~~negotiations ~~tend~~can to be ~~significantly~~lengthy ~~lower~~and uncertain.

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Other European Regulatory Matters

French Regulatory Framework for Clinical Development

In France, ~~Directive~~clinical development activities involving medicinal products are governed by the applicable provisions of Regulation (EU) No. ~~2001~~ 536/~~20/EC~~2014 ~~has~~on ~~been~~clinical ~~implemented~~trials inon medicinal products for human use, together with the French Public Health Code and related national ~~law,~~implementing ~~establishing~~measures. aFrance ~~system~~also maintains national rules applicable to other categories of ~~prior~~research ~~authorization~~involving ~~and~~human ~~requiring~~participants athat ~~prior~~fall ~~favorable~~outside ~~opinion~~the ~~from~~scope anof ~~ethics~~Regulation ~~committee~~(EU) No. 536/2014.

~~Parties~~For clinical trials of medicinal products conducted in France under the European Union Clinical Trials Regulation, sponsors are generally required to asubmit ~~clinical~~applications ~~trial~~through ~~agreement~~the Clinical Trials Information System, or ~~CTA~~CTIS, ~~must~~with ~~use~~regulatory areview ~~CTA~~coordinated ~~template~~under ~~(“unique~~the ~~agreement”~~European orframework ~~“convention~~and ~~unique”)~~with toFrench ~~organize~~participation by the ~~conduct~~Agence ofnationale ~~interventional~~de ~~clinical~~sécurité ~~trials~~du ~~with~~médicament ~~commercial~~et ~~purpose~~des produits de santé, asor ~~well~~ANSM, asand ~~specific~~the ~~template~~applicable ~~exhibits~~ethics tocommittee, ~~this~~known ~~agreement.~~as ~~Once~~a ~~concluded,~~Comité ~~the~~de ~~CTA~~protection isdes ~~communicated~~personnes, ~~for~~or ~~information~~CPP. byClinical ~~the~~trials ~~sponsor~~must tobe ~~the~~conducted ~~French~~in ~~national~~accordance ~~board~~with ofapplicable ~~physicians~~European ~~(Ordre~~Union ~~national~~law, ~~des~~French ~~médecins)~~law ~~without~~and ~~delay~~good clinical practice requirements.

~~The~~Where ~~processing~~a ofcommercially ~~personal~~sponsored ~~data~~interventional ~~collected~~study ~~during~~is ~~clinical~~conducted ~~trials~~at ~~has~~a toFrench ~~comply with the Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27~~hospital, ~~2016~~health ~~and~~center ~~Law~~or Nosimilar ~~2018-493 of June 20~~site, ~~2018 on~~ the ~~protection~~sponsor ofand ~~personal data, implementing~~ the ~~Regulation~~institution ~~(EU)~~are ~~2016/679~~generally ~~requirements.~~required ~~Regarding~~to ~~automatic~~enter ~~processing~~into ~~operations for~~ the ~~purpose~~applicable form of ~~research or~~ clinical ~~studies~~trial agreement, ~~formalities~~commonly ~~have~~referred to beas ~~completed~~a ~~before~~convention ~~the French data protection authority~~unique, using the ~~Commission~~model ~~Nationale~~required deunder ~~l’Informatique~~French etlaw. ~~des~~France ~~Libertés,~~has orupdated ~~CNIL,~~the somodel asform toover ~~obtain~~time, ~~the~~including ~~authorization~~more torecent ~~process~~ministerial ~~personal~~orders ~~data.~~replacing ~~However,~~earlier ~~there are simplified standards~~templates.

~~Law~~The ~~No. 2011-2012~~processing of ~~December 29,~~personal ~~2011,~~data orin ~~Loi~~connection ~~Bertrand,~~with ~~aimed~~clinical atresearch strengthening the health safety of medicinal and health products, as amended (and its implementing decrees), introduced into French law provisions regarding transparency of fees received by some healthcare professionals from health product industries, i.e. companies manufacturing or marketing health products (Article L.1453-1 of the French Public Health Code). These provisions have been recently extended and redefined by Decree No. 2016-1939 of December 28, 2016, which clarified French “Sunshine” regulations. The decree notably provides that companies manufacturing or marketing health care products (medicinal products, medical devices, etc.) in France ~~shall~~is ~~publicly~~subject ~~disclose~~to ~~(mainly on a specific public website available at: https://www.entreprises-transparence.sante.gouv.fr)~~ the ~~advantages~~General ~~and~~Data ~~fees~~Protection ~~paid~~Regulation, ~~to healthcare professionals amounting to €10~~ or ~~above~~GDPR, astogether ~~well as the agreements concluded~~ with ~~the~~French ~~latter,~~data ~~along~~protection ~~with~~law ~~detailed~~and ~~information~~guidance ~~about each agreement (the precise subject matter~~ of the ~~agreement,~~Commission ~~the~~Nationale ~~date~~de ofl’Informatique ~~signature~~et ofdes ~~the agreement~~Libertés, ~~its~~or ~~end date, the total amount paid to the healthcare professional, etc~~CNIL.). ~~Another~~Depending ~~declaration~~on ~~must also be filed to~~ the ~~competent~~nature ~~healthcare professional body. Law No. 2011-2012 also reinforced the French anti-gift rules and Order No. 2017-49~~ of ~~January 19, 2017 amended~~ the ~~law~~study and ~~expanded~~ the ~~scope~~data ofprocessing ~~the~~involved, ~~general~~sponsors ~~prohibition of payments from pharmaceutical~~ and ~~device~~investigators ~~manufacturers~~may torely ~~healthcare~~on ~~professionals~~CNIL toreference ~~broadly~~methodologies, ~~cover~~including ~~any~~MR-001 ~~company~~for ~~manufacturing~~certain orhealth ~~marketing~~research ~~health~~involving ~~products~~consent, ~~regardless of whether~~ or ~~not~~may ~~payment~~need ~~for the products is reimbursed under the French social security system (new Articles L. 1453-3 et seq. of the French Public Health Code). It also changed the procedure related~~ to ~~the~~complete ~~prior~~other ~~submission~~formalities towhere the ~~national~~project orfalls ~~departmental~~outside ~~board of~~ the ~~relevant~~scope ~~healthcare professional body. Moreover, the penalties incurred for non-compliance with the requirements~~ of ~~the~~an ~~Anti-Gift~~applicable ~~Law~~reference ~~will be doubled to a fine of up to €750,000~~methodology. ~~The changes of the anti-gift rules will only enter into force after the publication of implementing measures.~~

~~Environmental Matters~~-18-

Our operations, properties and products are subject to a variety of U.S. and foreign environmental laws and regulations governing, among other things, air emissions, wastewater discharges, management and disposal of hazardous and non-hazardous materials and waste and remediation of releases of hazardous materials. We believe, based on current information, that we are in material compliance with environmental laws and regulations applicable to us. However, our failure to comply with present and future requirements under these laws and regulations, or environmental contamination or releases of hazardous materials on our leased premises, as well as through disposal of our products, could cause us to incur substantial costs, including clean-up costs, personal injury and property damage claims, fines and penalties, costs to redesign our products or upgrade our facilities and legal costs, or require us to curtail our operations, any of which could seriously harm our business.

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France also imposes transparency, anti-benefit and anti-corruption requirements on companies operating in the health products sector. Companies manufacturing or marketing health products in France are subject to disclosure obligations regarding certain agreements, fees and benefits provided to healthcare professionals and certain other stakeholders, as well as restrictions on prohibited advantages and gifts. Violations may result in significant financial and other penalties under French law. These requirements are sometimes referred to as the French transparency or French sunshine rules and the anti-gift regime.

As a result, any future clinical development activities we may conduct in France, including any future development activity relating to Adrulipase, would be subject not only to European Union clinical trial regulation, but also to French requirements relating to site agreements, investigator and institution interactions, personal data protection, transparency reporting and anti-benefit restrictions.

Environmental Matters

Our operations, properties, technologies and services are subject to a variety of U.S. and foreign environmental, health and safety laws and regulations. These may include laws and regulations governing, among other things, air emissions, wastewater discharges, storage, handling, transport and disposal of hazardous and non-hazardous materials and waste, electronic equipment, batteries, workplace health and safety, site contamination and remediation of releases of hazardous substances.

Historically, our legacy life sciences activities have involved limited direct manufacturing operations, and we have relied on third-party manufacturers, laboratories and contractors for most research, development and manufacturing-related activities. Following our acquisition of Grid AI Corp., our business also includes software-enabled energy orchestration and related deployment activities involving distributed energy resource systems and integration with third-party energy infrastructure, including batteries, electric vehicle charging systems, HVAC systems, water heaters, solar systems and other connected devices. Although we generally do not own or operate large-scale industrial manufacturing facilities, our activities may involve environmental, permitting, storage, transportation, installation, e-waste and site-management considerations through our partners, contractors, suppliers, installers, customers and project environments.

We believe, based on information currently available to us, that we are in material compliance with environmental laws and regulations applicable to our business. However, our failure, or the failure of our contractors, suppliers, installation partners, manufacturers or site operators, to comply with existing or future environmental, health and safety requirements could result in substantial costs or liabilities. These may include cleanup costs, fines, penalties, property damage claims, personal injury claims, costs to redesign products or deployment configurations, costs to replace suppliers or contractors, business interruption, legal expenses or restrictions on operations. In addition, contamination, releases of hazardous materials, improper disposal of waste, battery-related incidents, electrical faults or other environmental events at third-party facilities, customer sites or project locations could adversely affect our business, financial condition and results of operations.

Employees

As of December 31, ~~2024~~2025, we had 2 full-time employees at the parent company level. In addition, we rely on consultants, contractors and employees of our subsidiaries and affiliated entities to support our operations, including software development, engineering, finance, regulatory, administrative and other functions. None of our employees are represented by a labor union, and we consider our employee relations to be good.

Available Information

As a public company, we are required to file ~~our~~ annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A and other information, (including ~~any~~ amendments) to those reports, with the Securities and Exchange Commission, ~~(the~~or “SEC”). The SEC maintains an Internet ~~site~~website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. ~~You~~Our ~~can~~SEC ~~find~~filings ~~our~~are ~~SEC~~available ~~filings~~to the public at the SEC’s website at www.sec.gov.

Our Internet address is ~~www~~https://grid-ai.~~enterothera.~~com. Information contained on our website is not incorporated by reference into and does not constitute part of this Annual Report. Our SEC filings, (including any amendments), will be made available free of charge on ~~www.enterothera.com,~~our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

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ITEM 1A.RISK FACTORS

We are subject to ~~various~~numerous risks and uncertainties that could ~~have~~materially aadversely ~~material~~affect ~~adverse effect on~~ our business, ~~our~~ financial condition, results of operations and ~~our~~the ~~results~~value of ~~operations~~our securities. ~~These~~The risks ~~could~~described ~~cause~~below ~~actual~~are ~~operating~~not ~~results~~the only risks we face. Additional risks and uncertainties not presently known to ~~differ~~us, ~~from~~or ~~those~~that ~~expressed~~we incurrently ~~certain~~consider ~~“forward~~immaterial, ~~looking~~may ~~statements”~~also ~~contained~~materially inadversely ~~this~~affect ~~Annual~~us. ~~Report~~If asany ~~well~~of asthe infollowing ~~other~~risks ~~communications~~occur, our business, financial condition, results of operations and prospects could be materially harmed, and the trading price of our Common Stock could decline, potentially causing investors to lose all or part of their investment.

Summary of Risk Factors

●An ~~Our~~investment ~~current~~in ~~dependency on external funding for~~ our ~~operations~~securities ~~raises~~involves a ~~substantial~~high ~~doubt~~degree ~~about~~of ~~our ability to continue as a going concern~~risk. IfThe weprincipal dorisks ~~not~~relating ~~continue~~to asour abusiness ~~going~~and ~~concern,~~securities ~~investors~~include ~~could~~the ~~lose their entire investment.~~following:

●

Our current dependency on external funding for our operations raises a substantial doubt about our ability to continue as a going concern.

●

Our level of indebtedness and our ability to make payments on or service our indebtedness could adversely affect our business, financial condition, results of operations, cash flow and liquidity.

● We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product candidate development programs, testing efforts or other operations~~, including~~.

● ~~Future~~Additional ~~financings~~offerings in the future may dilute then existing ~~shareholders~~stockholders’ percentage ownership of our ~~company~~Company.

● IfWe weexperienced dosignificant ~~not~~board ~~consummate~~and ~~the~~management ~~transactions~~turnover ~~contemplated~~during by the ~~Rescission~~fourth ~~Agreement,~~quarter ~~we will remain responsible for approximately $9,278,400~~ of ~~secured debt~~2025, and ~~our~~instability ~~level~~in ofgovernance ~~indebtedness~~ and ~~our~~leadership ~~ability to make payments on or service our indebtedness~~ could adversely affect our ~~ability to implement our~~ business ~~plan as currently contemplated, and also adversely affect our financial condition, results of operations, cash flow and liquidity~~. ~~Defaults under this debt could result in a substantial loss of our assets. We may also be required to settle conversion of our Series G Preferred Stock in cash.~~

● We do not expect to consummate certain previously disclosed transactions.

●

We are a clinical stage biopharmaceutical company and have a limited operating history upon which to base an investment decision.

●

We will face intense competition and may not be able to compete successfully.

●

We may incur substantial product liability or indemnification claims relating to the use of our product candidates.

● ~~Geopolitical~~We ~~risks~~may ~~associated~~use ~~with~~biological ~~Russia’s~~materials ~~invasion of Ukraine~~ and ~~Israel’s~~may ~~war~~use ~~with~~hazardous ~~Hamas~~materials, ~~could~~and ~~result~~any inclaims ~~increased~~relating ~~market~~to ~~volatility~~improper ~~and uncertainty~~handling, ~~which~~storage ~~could~~or ~~negatively~~disposal ~~impact~~of ~~our~~these ~~business,~~materials ~~financial~~could ~~condition,~~be ~~and~~time ~~results~~consuming ofor ~~operations~~costly.

~~-23-~~● We will need to grow the size of our organization, and we may experience difficulties in managing this growth.

~~Table~~● Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of ~~Contents~~operations.

●

Adverse global conditions, including economic uncertainty, may negatively impact our financial results.

●

Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.

●

Requirements associated with being a public company will increase our costs significantly and will divert significant company resources and management attention.

●

We operate as a clinical stage biopharmaceutical company with relation to our retained biopharmaceutical assets but have a limited operating history upon which to base an investment decision.

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●

Our product candidates are at an early stage of development and may not be successfully developed or commercialized.

●

Any product candidates we advance into and through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.

●

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

●

Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval.

● WeAny ~~currently~~product ~~have~~candidate nowe ~~commercial~~advance ~~organization.~~into Ifand wethrough ~~are~~clinical ~~unable~~trials tomay ~~establish~~cause ~~satisfactory~~unacceptable ~~sales~~adverse ~~and~~events ~~marketing~~or ~~capabilities~~have other properties that may delay or ~~secure~~prevent atheir ~~sales~~regulatory ~~and~~approval, ~~marketing~~limit ~~partner~~the commercial profile of the approved labeling, weor ~~may~~result ~~not~~in ~~successfully~~significant ~~commercialize~~negative ~~any~~consequences offollowing ~~our~~marketing ~~product~~approval, ~~candidates~~if any.

● IfDelays wein ~~breach~~the ~~our~~commencement ~~license~~ or ~~other~~completion ~~intellectual~~of ~~property-related agreements for~~ our ~~product~~clinical ~~candidates~~trials orcould ~~otherwise~~result ~~experience~~in ~~disruptions~~increased tocosts ~~our~~and ~~business~~delay ~~relationships with~~ our ~~licensor, we could lose the~~ ability to ~~continue~~pursue ~~the~~regulatory ~~development~~approval and commercialization of our product candidates.

● ~~Our~~We ~~success~~may ~~will~~be ~~depend~~required ~~upon~~to ~~intellectual property~~suspend, ~~proprietary~~repeat ~~technologies~~or ~~and~~terminate ~~regulatory~~our ~~market~~clinical ~~exclusivity~~trials ~~periods~~if they are not conducted in accordance with regulatory requirements, ~~and~~the weresults ~~may~~are benegative ~~unable~~or toinconclusive ~~protect~~or ~~our~~the ~~intellectual~~trials ~~property~~are not well designed.

We● ~~have~~The ~~never~~approval ~~paid~~processes ~~and~~of doregulatory ~~not~~authorities ~~intend~~are ~~to pay cash dividends on our Common Stock. As a result~~lengthy, ~~capital~~time ~~appreciation~~consuming, ifexpensive ~~any,~~and ~~will~~inherently ~~be your sole source of gain~~unpredictable.

●

If we are unable to execute our sales and marketing strategy for our products and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business.

●

We are an early-stage operating company in our GridAI business with a limited operating history, and our ability to execute our business plan depends on successful customer deployments, integration with third-party systems, and scaling of our platform and personnel.

●

Our near-term revenue from our GridAI business may depend on a limited number of customers, projects, or counterparties, and the loss, delay, or failure to convert pilot programs or letters of intent into long-term commercial agreements could materially adversely affect our financial condition and results of operations.

●

Our GridAI platform depends on interoperability with third-party hardware, software, and energy market systems, and disruptions or limitations in such third-party systems could impair our ability to deliver services.

●

Our GridAI platform relies on data inputs, forecasting models, and optimization algorithms that may be subject to error or incomplete information, and actual performance may differ from expected results, which could adversely affect customer relationships and our reputation.

●

The markets in which our GridAI business operates are highly competitive, and we face competition from established energy, software, and industrial companies with greater resources, which could adversely affect our ability to grow and maintain market share.

●

Our GridAI business operates in complex and evolving regulatory environments, including energy markets and infrastructure regulations, and changes in such regulations could adversely affect our business and the value of our solutions.

●

Our ability to successfully commercialize our GridAI platform depends on continued adoption of artificial intelligence and energy optimization technologies, which are rapidly evolving and inherently uncertain.

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●

We may require additional capital to fund the development and growth of our GridAI business, and there can be no assurance that such capital will be available on acceptable terms, or at all.

●

Any failure of our information technology systems or those of third parties, or any cybersecurity incident, could materially adversely affect our GridAI operations, customer relationships, and reputation.

●

If we accept digital assets, including stablecoins, as consideration in our transactions, we may be subject to volatility, regulatory uncertainty and accounting complexity, which could adversely affect our financial results and operations.

Risks Related to Our Business, Financial Position and Capital Requirements

Our current dependency on external funding for our operations raises a substantial doubt about our ability to continue as a going concern. If we do not continue as a going concern, investors could lose their entire investment.

The accompanying consolidated financial statements have been prepared as if we will continue as a going concern. We have incurred significant operating losses and negative cash flows from operations since inception. On December 31, ~~2024~~2025, we had cash and cash equivalents of approximately $0.29 million, and an accumulated deficit of approximately $~~202~~208.48 million. We have incurred recurring losses, have experienced recurring negative operating cash flows, and require significant cash resources to execute our business plans. ~~Subsequent to December 31, 2024, we closed on a revolving loan agreement in the principal amount of $2.0 million.~~ Based on cash on hand at December 31, ~~2024~~2025 and the available loan proceeds and assuming successful financing efforts, which we cannot guarantee, we anticipate having sufficient cash to fund planned operations ~~through~~for ~~September~~the ~~2025~~next several months. Historically, our major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. WeAlthough our business changed significantly during 2025 through the acquisition of Grid AI Corp. and the completion of the ImmunogenX rescission transaction, we are dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute our development plans and continue operations.

We have been, and are expected to continue, exploring various potential strategies available including but not limited to raising capital, restructuring our indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that the Company will be able to raise necessary capital on acceptable terms, reach agreement with lenders, or that the strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that it will make any cash distributions to stockholders. Any failure in these efforts could force us to delay, limit or terminate operations, make reductions in our workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

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terminate operations, make reductions in our workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.

Without adequate working capital, we may not be able to meet our obligations and continue as a going concern. These conditions raise substantial doubt about our ability to continue as a going concern one year from the date these financial statements are issued. If the Company is not able to obtain necessary capital, we may be required to terminate operations, liquidate all or a portion of assets and/or seek bankruptcy protection. As a result, we have concluded that our plans at this stage do not alleviate substantial doubt about the ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Our level of indebtedness and our ability to make payments on or service our indebtedness could adversely affect our business, financial condition, results of operations, cash flow and liquidity.

Effective January 31, 2025, we entered into the Revolving Loan Agreement. Pursuant to and under the terms of the Revolving Loan Agreement, we issued to the Lender a revolving note dated January 27, 2025 in the principal amount of $2,000,000. Out of the principal amount, the Lender disbursed an initial loan amount of $550,000 to the Company on January 31, 2025.

The Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue daily commencing on January 31, 2025 until paid in full. The outstanding principal balance, all accrued and unpaid interest and all other amounts, costs, expenses and/or liquidated damages are due in full on January 31, 2026. The Revolving Loan Agreement contains customary events of default. IfAs ~~an event~~ of ~~default~~April ~~occurs~~1, 2026, the ~~Lender~~Company ~~may~~was ~~accelerate~~in ~~the~~default ~~indebtedness~~ under the Revolving Loan Agreement, and an amount equal to 120% of the of the outstanding principal amount and accrued and unpaid interest plus liquidated damages and other amounts, costs, expenses and/or liquidated damages due.

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Revolving Loan Agreement as a result of its failure to repay amounts due at maturity, and the lender has issued a demand for repayment of the outstanding amounts.

If we are not able to repay or refinance our debt as it becomes due, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional debt or equity on terms that may be onerous or highly dilutive, if we can obtain it at all. If we raise equity through the issuance of preferred stock, the terms of the preferred stock may give the holders rights, preferences and privileges senior to those of holders of our Common Stock, particularly in the event of liquidation. Our ability to arrange financing or refinancing will depend on, among other factors, our financial position and performance, as well as prevailing market conditions and other factors beyond our control. We cannot assure you that we will be able to obtain financing or refinancing on terms acceptable to us or at all.

If funds are not available when needed, or available on acceptable terms, we may be required to delay, scale back or eliminate some of our obligations. In addition, we may not be able to grow market share, take advantage of future opportunities or respond to competitive pressures or unanticipated requirements, which could negatively impact our business, operating results and financial condition.

We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product candidate development programs, testing efforts or other operations, including.

We expect our expenses to increase in connection with our ongoing activities, including with connection to the operating of Grid AI Corp. and AMPX. We also expect to incur significant expenses related to the development, testing, and manufacturing of our product candidates. We cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our products. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any potential future commercialization efforts.

We have based our estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors, including costs required to advance Adrulipase, the pace of commercialization and development of the Grid AI Corp. and AMPX platform, as well as factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially government funding, collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from its day-to-day activities, which may adversely affect our ability to develop our product candidates.

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additional financing may divert our management from its day-to-day activities, which may adversely affect our ability to develop our product candidates.

Our future capital requirements will depend on many factors, including:

●

the costs and timing of manufacturing for our product candidates;

●

the costs associated with hiring additional personnel and consultants as our research and development activities increase;

● ~~the~~operating ~~costs~~and ~~associated~~integrating ~~with~~the ~~advancing~~Grid ~~product~~AI ~~candidates~~Corp. ~~obtained~~and ~~through~~AMPX ~~the~~business ~~Merger;~~ and

●

the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements.

Additional offerings in the future may dilute then existing stockholders’ percentage ownership of our Company.

Given our plans and expectations that we will need additional capital, in the near future we may need to issue additional Common Stock or securities convertible or exercisable for Common Stock, including convertible preferred shares, convertible notes, stock options or warrants. The issuance of additional securities in the future will dilute the percentage ownership of then existing stockholders. Additionally, sales by existing stockholders of a large number of our Common Stock in the public market could also affect the market price of our Common Stock.

In particular, the September 30, 2025 Grid AI Corp. transaction included the issuance of Series H Non-Voting Convertible Preferred Stock that is convertible, subject to conditions, into a substantial number of shares of Common Stock. We doalso ~~not~~have ~~expect~~outstanding warrants and other equity-linked instruments, and we granted equity awards to ~~consummate~~management ~~certain~~and ~~previously~~directors ~~disclosed~~in ~~proposed~~late ~~transactions~~2025 and early 2026.

~~On December 27, 2023, we announced that we entered a non~~-binding term sheet to sell our Niclosamide program. This transaction is not expected to move forward. Development on the Niclosamide program is currently on hold due to capital constraints and we will continue to explore options to out license or sell this program. There can be no assurance that any such out23-licenses or sales will be consummated on terms favorable to us or at all. Additionally, if we fail to consummate such out-licenses or sales, such failure could result in fluctuations to the market price of our Common Stock and may have a material adverse impact on our financial condition and results of operations.

IfTable ~~we do not consummate the transactions contemplated by the Rescission Agreement, we will remain responsible for approximately $9,278,400~~ of secured debt, and our level of indebtedness and our ability to make payments on or service our indebtedness could adversely affect our ability to implement our business plan as currently contemplated, and also adversely affect our financial condition, results of operations, cash flow and liquidity. Defaults under this debt could result in a substantial loss of our assets. We may also be required to settle conversion of our Series G Preferred Stock in cash.Contents

~~The~~These ~~Company~~instruments ~~expects~~may ~~that~~significantly ~~the~~dilute ~~closing~~existing ~~of the Rescission Agreement will occur on or prior to June 30~~stockholders, ~~2025,~~both ~~subject~~economically to satisfaction of all conditions for closing, including obtaining shareholder approval by the Company for the transfer of the Membership Interests to the Shareholders. We cannot guarantee that the closing will occur by June 30, 2025 or at all. If the transactions contemplated by the Rescission Agreement are not consummated, we will remain responsible for an aggregate of approximately $9,278,400 of secured debt owed to Mattress Liquidators, Inc., our director Jack Syage, and ~~to Peter Felker. If we are not able to repay or refinance our debt as it becomes due~~voting-wise, weif ~~will not be able to implement our business plan as currently contemplated and may be required to adopt one or more alternatives~~converted, ~~such~~exercised ~~as selling assets, restructuring debt~~ or ~~obtaining~~settled additional debt or equity on terms that may be onerous or highly dilutive, if we can obtain it at all. If we raise equity through the issuance of preferred stock, the terms of the preferred stock may give the holders rights, preferences and privileges senior to those of holders of our Common Stock, particularly in ~~the event of liquidation~~shares. Our ability to arrange financing or refinancing will depend on, among other factors, our financial position and performance, as well as prevailing market conditions and other factors beyond our control. We cannot assure you that we will be able to obtain financing or refinancing on terms acceptable to us or at all. If funds are not available when needed, or available on acceptable terms, we may be required to delay, scale back or eliminate some of our obligations. In addition, we may not be able to grow market share, take advantage of future opportunities or respond to competitive pressures or unanticipated requirements, which could negatively impact our business, operating results and financial condition.

The issuance of additional securities in the future will dilute the percentage ownership of then existing stockholders. Additionally, sales by existing stockholders of a large number of our Common Stock in the public market could also affect the market price of our Common Stock.

We experienced significant board and management turnover during the fourth quarter of 2025, and instability in governance and leadership could adversely affect our business.

In late 2025, we underwent significant governance and leadership changes, including board resignations, changes in board composition, a new Chief Executive Officer arrangement, a new Interim Chief Financial Officer and new equity awards to management and directors. One director resignation was accompanied by stated disagreements regarding governance, diligence and disclosure matters.

These events could adversely affect us by:

●

disrupting strategic execution

●

weakening internal controls or disclosure controls

●

diverting management attention

●

increasing legal, accounting and administrative burden

●

impairing our ability to recruit, retain and motivate qualified personnel

●

damaging confidence among investors, business partners, regulators, auditors and other stakeholders.

If we are unable to maintain stable and effective leadership, our business and reporting quality may be adversely affected.

Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.

Our operations are subject to risks arising from global economic conditions, supply chain disruptions and volatility in energy markets. These risks may affect the availability, cost and timing of components, infrastructure and third-party services required to support the development and deployment of our energy orchestration platform and related technologies.

Global supply chains have experienced significant disruption in recent years, and ongoing geopolitical conflicts, trade tensions, inflationary pressures and macroeconomic uncertainty continue to impact market conditions. In particular, disruptions affecting the energy sector, data center infrastructure and related equipment could adversely affect our ability to scale our platform, deliver services to customers and execute our business strategy.

In addition, inflationary pressures and volatility in labor, technology and infrastructure costs may increase our operating expenses and reduce our financial flexibility. Any such disruptions or adverse developments could materially and adversely affect our business, financial condition and results of operations.

Adverse global conditions, including economic uncertainty, may negatively impact our financial results.

Global conditions, dislocations in the financial markets, any negative financial impacts affecting United States as a result of tax reform or changes to existing trade agreements or tax conventions, may adversely impact our business.

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global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the Russian invasion of Ukraine, conflicts in the Middle East, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.

Acceptance of digital assets, including stablecoins, as consideration in our transactions may expose us to volatility, regulatory uncertainty and accounting complexity, which could adversely affect our financial results.

We are evaluating the planned acceptance of stablecoins and other digital assets as a form of consideration in certain future transactions. The use of digital assets may expose us to risks, including potential fluctuations in value, even for assets intended to maintain a stable value, as well as risks related to cybersecurity, custody, and reliance on third-party platforms and infrastructure. In addition, the regulatory environment for digital assets continues to evolve, and changes in laws, regulations, or interpretations by regulatory authorities could affect our ability to accept or use such assets or impose additional compliance obligations.

The accounting treatment of digital assets under U.S. GAAP is complex and subject to interpretation. Certain digital assets may be required to be measured at fair value with changes recognized in earnings, which could introduce volatility into our financial results. Other digital assets may be accounted for as indefinite-lived intangible assets and subject to impairment testing, which could result in non-cash impairment charges. Although we did not hold any digital assets as of December 31, 2025, if we elect to accept or hold such assets in the future, these risks could adversely affect our financial condition and results of operations.

Geopolitical risks associated with Russia’s invasion of Ukraine and conflicts in the Middle East, including the U.S. and Israel war with Iran, could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations.

The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine and conflicts in the Middle East, including the U.S. and Israel war with Iran, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain. There can be no certainty regarding the impacts stemming from the invasion, including the imposition of additional sanctions, embargoes, asset freezes or other economic or military measures resulting from the invasion. The impact of these developments, and additional events that may occur as a result, is currently unknown and could adversely affect our business, supply chain, suppliers and customers and potential customers. It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could negatively impact our business, financial condition and results of operations.

Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.

We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.

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costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.

In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Clinical Health Act of 2009, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws.

Under the EU regulation and notably the General Data Protection Regulation, or GDPR, No. 2016/679, which entered into force on May 25, 2018 and is applicable personal data that we process in relation to our presence in the EU, the offering of products or services to individuals in the EU or the monitoring of the behavior of individuals in the EU, we have also a legal responsibility to report personal data breaches to the competent supervisory authority. The EU data protection regulation includes a broad definition and a short deadline for the notification of personal data breaches, which may be difficult to implement in practice and requires that we implement robust internal processes. Under this regulation, we have to report personal data breaches to the competent supervisory authority within 72 hours of the time we become aware of a breach “unless the personal data breach is unlikely to result in a risk to the right and freedoms of natural persons” (Article 33 of the GDPR). In addition, the GDPR requires that we communicate the breach to the Data Subject if the breach is “likely to result in a high risk to the rights and freedoms of natural persons” (Article 34 of the GDPR). In order to fulfil these requirements, we have to implement specific internal processes to be followed in case of a personal data breach, which will allow us to (a) contain and recover the breach, (b) assess the risk to the data subjects, (c) notify, and possibly communicate the breach to the data subjects, (d) investigate and respond to the breach. The performance of these processes implies substantial costs in resources and time.

Moreover, as we may rely on third parties that will also process as processor the data for which we are a data controller—for example, in the context of the manufacturing of our product candidates or for the conduct of clinical trials, we must contractually ensure that strict security measures, as well as appropriate obligations including an obligation to report in due delay any security incident are implemented, in order to allow us fulfilling our own regulatory requirements.

We would also be exposed to a risk of loss or litigation and potential liability for any security breach on personal data for which we are data controller. The costs of above-mentioned processes together with legal penalties, possible compensation for damages and any resulting lawsuits arising from a breach may be extensive and may have a negative impact on reputation and materially adversely affect our business, results of operations and financial condition.

Requirements associated with being a public company will increase our costs significantly and will divert significant company resources and management attention.

Since we are no longer an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, we are no longer able to take advantage of certain exemptions from various reporting requirements that were previously available to us, but which were not available to other public companies that are not emerging growth companies. Accordingly, we will be required to comply with increased disclosure obligations regarding executive compensation in our periodic reports and proxy statements and the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. As a result, we will incur greater expenses associated with such reporting requirements. These expenses would further increase if we ceased to be a “smaller reporting company.” In addition, if we are deemed an accelerated filer or large accelerated filer in the future, we expect to incur additional management time and cost to comply with the more stringent reporting requirements applicable to companies that are deemed accelerated filers or large accelerated filers, including complying with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We have not yet completed the process of compiling the system and processing documentation needed to comply with such requirements. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion when required to do so. In that regard, we currently do not have an internal audit function, and we will need to hire or contract additional accounting and financial staff with appropriate public company experience and technical accounting knowledge.

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~~These~~Our ~~borrowings~~management ~~are secured by substantially all of the assets of IMGX~~ and ~~the~~other ~~patents~~personnel ~~and~~need ~~trademarks~~to ~~owned~~devote bya ~~IMGX.~~substantial Ifamount ~~an event~~ of ~~default~~time ~~under any of such agreements could enable the lenders or creditors thereunder~~ to ~~declare~~these ~~all~~compliance ~~borrowings~~initiatives. ~~outstanding on such debt~~Moreover, ~~together~~these ~~with accrued~~ rules and ~~unpaid~~regulations ~~interest~~will ~~and~~increase ~~fees,~~our tolegal ~~be due~~ and ~~payable.~~financial ~~The~~compliance ~~lenders~~costs ~~could~~and ~~also~~will ~~elect~~make tosome ~~foreclose~~activities onmore ~~our~~time-consuming ~~assets~~and ~~securing such debt~~costly. InWe ~~such~~cannot anpredict ~~event, the Company may not be able to refinance~~ or ~~repay~~estimate ~~all of its indebtedness, have sufficient liquidity to meet operating and capital expenditure requirements, or hold~~ the ~~necessary~~amount ~~intellectual~~of ~~property~~additional ~~rights~~costs towe ~~conduct~~may ~~its~~incur ~~business.~~as ~~Any such acceleration could cause us to lose~~ a ~~substantial~~result ~~portion~~ of ~~our assets and will substantially adversely affect our ability to continue our operations~~this.

~~Further,~~Risks ifRelated the transactions contemplated by the Recission Agreement are not consummated, 11,777.418 shares of our Series G Preferred Stock will remain outstanding. The holders of our outstanding shares of Series G Preferred Stock are entitled to elect to have such shares of Series G Preferred Stock redeemed for cash at a price per share equal to the then-current fair value of the Series G Preferred Stock, as described in the Certificate of Designation of Preferences, Rights and Limitations of the Series G Non-Voting Preferred Stock. Unless we operate profitably, our ~~ability~~Biopharmaceutical ~~to redeem the Series G Preferred Stock would require the availability of adequate “surplus~~Operation,” ~~which~~Clinical ~~is defined as the excess~~Development, ifRegulatory ~~any,~~Approval ofand our net assets (total assets less total liabilities) over our capital. If we do have sufficient “surplus” to effect any requested redemption of the Series G Preferred Stock, our available cash will be negatively impacted. In addition, such reduction in our available cash could decrease the trading price of our Common Stock.Commercialization

We ~~are~~operate as a clinical stage biopharmaceutical company ~~and~~with relation to our retained biopharmaceutical assets but have a limited operating history upon which to base an investment decision.

We ~~are~~operate as a clinical stage biopharmaceutical company with relation to our retained biopharmaceutical assets. ~~Since~~Following ~~inception,~~the wecompletion ~~have~~of ~~engaged~~the ~~primarily~~ImmunogenX inrescission ~~research~~transaction ~~and~~on ~~development~~December ~~activities~~31, of2025, our retained legacy biopharmaceutical focus is primarily Adrulipase. ~~and~~Adrulipase ~~Niclosamide,~~is ~~and~~in ~~more~~the ~~recently~~early ~~Latiglutenase~~stages ~~and~~of ~~Capeserod~~clinical development. We have not generated any revenue from product sales and have incurred significant net losses. We have not demonstrated our ability to perform the functions necessary for the successful commercialization of any product candidates. The successful commercialization of any of our products will require us to perform a variety of functions, including:

●

continuing to undertake pre-clinical development and clinical trials;

●

participating in regulatory approval processes;

●

formulating and manufacturing products; and

●

conducting sales and marketing activities.

Our operations to date have been limited to organizing and staffing, acquiring, developing and securing the proprietary rights for, and undertaking pre-clinical development, manufacturing and clinical trials of Adrulipase~~, Niclosamide, Capeserod and Latiglutenase~~. These operations provide a limited basis for our stockholders and prospective investors to assess our ability to complete development of or commercialize Adrulipase or any other product candidates and the advisability of investing in our securities.

We have incurred significant losses and negative cash flows from our operations since inception. As of December 31, ~~2024~~2025, we had accumulated deficit of approximately $~~202~~208.48 million and negative working capital of approximately $412.36 million. Based on our historical and anticipated rate of cash expenditures, we do not anticipate our existing working capital will be sufficient to sustain our business through the commercialization of our product candidates. Therefore, we are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. We are actively working to obtain additional funding. We cannot make any assurances that additional financings will be available to us and, if available, completed on a timely basis, on acceptable terms or at all. If we are unable to complete an equity and/or debt offering, or otherwise obtain sufficient financing when and if needed, it would negatively impact our business and operations, which would likely cause the price of our Common Stock to decline or ultimately force us to cease our operations.

The development and regulatory approval process take several years, and it is not likely that any such products, even if successfully developed and approved by the FDA or any comparable foreign regulatory authority, would be commercially available for a significant period of time. Many promising drug candidates fail at some stage of their clinical development. Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed, receive required regulatory approvals and successfully commercialized. Our failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of our product candidates, could result in the failure of our business and a loss of all of your investment in our company.

We will face intense competition and may not be able to compete successfully.

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management, scientists and clinical development personnel. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. New developments, including the development of other biological and pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We will also face ~~intense~~ competition from these third parties in recruiting and ~~may~~retaining ~~not~~qualified bepersonnel, ~~able~~establishing toclinical ~~compete~~trial ~~successfully~~sites and patient registration for clinical trials and in identifying and in-licensing new product candidates.

We operate in highly competitive segments of the biotechnology and biopharmaceutical markets. We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Adrulipase, if successfully developed and approved, will compete with established therapies, as well as new treatments that may be introduced by our competitors. Many of our competitors have significantly greater financial, product development, manufacturing and marketing resources than us. Large pharmaceutical companies have extensive experience in clinical testing and obtaining regulatory approval for drugs. We also may compete with these organizations to recruit management, scientists and clinical development personnel. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. New developments, including the development of other biological and pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We will also face competition from these third parties in recruiting and retaining qualified personnel, establishing clinical trial sites and patient registration for clinical trials and in identifying and in-licensing new product candidates.

We may incur substantial product liability or indemnification claims relating to the use of our product candidates.

We face an inherent risk of product liability exposure based on the use of Adrulipase in human clinical trials, or, if obtained, following marketing approval and commercialization. Claims could be brought against us if use or misuse of one of our product candidates causes, or merely appears to have caused, personal injury or death. Although we have and intend to maintain product liability insurance relating to our clinical trials, our coverage may not be sufficient to cover claims that may be made against us and we may be unable to maintain such insurance. Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management and other resources or destroy the prospects for commercialization of the product which is the subject of any such claim. We are unable to predict if we will be able to obtain or maintain product liability insurance for any products that may be approved for marketing. Additionally, we have entered into various agreements where we indemnify third parties for certain claims relating to the testing and use of our product candidates. These indemnification obligations may require us to pay significant sums of money for claims that are covered by these indemnifications.

We cannot predict all of the possible harms or side effects that may result from the use of our products and, therefore, the amount of insurance coverage we currently hold, or that we or our collaborators may obtain, may not be adequate to protect us from any claims arising from the use of our products that are beyond the limit of our insurance coverage. If we cannot protect against potential liability claims, we or our collaborators may find it difficult or impossible to commercialize our products, and we may not be able to renew or increase our insurance coverage on reasonable terms, if at all. The marketing, sale and use of our products and our planned future products could lead to the filing of product liability claims against us if someone alleges that our products failed to perform as designed. A product liability or professional liability claim could result in substantial damages and be costly and time-consuming for us to defend.

Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage. Additionally, any product liability lawsuit could damage our reputation, result in the recall of products, or cause current partners to terminate existing agreements and potential partners to seek other partners, any of which could impact our results of operations.

We may use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.

We may use hazardous materials, including chemicals and biological agents and compounds, that could be dangerous to human health and safety or the environment. Our operations also produce hazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our product development efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage and our property and casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended.

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Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.

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

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We will need to grow the size of our organization, and we may experience difficulties in managing this growth.

As of December 31, ~~2024~~2025, we had 218 full-time employees. As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, research and development, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

●

identifying, recruiting, integrating, maintaining and motivating additional employees;

●

managing our internal development efforts effectively, including the clinical, FDA and international regulatory review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and

●

improving our operational, financial and management controls, reporting systems and procedures.

Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including certain aspects of regulatory approval, clinical management and manufacturing. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants and contractors or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals.

Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.

The disruptions to the global economy in 2020 and into 2024 have impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses. We have taken and may have to take steps to minimize the impact of these disruptions in lead times and increased costs by working closely with our suppliers and other third parties on whom we rely for the conduct of our business. Despite the actions we have undertaken or may have to undertake to minimize the impacts from disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain will not have a material adverse effect on our business, financial condition and results of operations.

Furthermore, inflation can adversely affect us by increasing the costs of clinical trials, the research and development of our product candidates, as well as administration and other costs of doing business. We may experience increases in the prices of labor and other costs of doing business. In an inflationary environment, cost increases may outpace our expectations, causing us to use our cash and other liquid assets faster than forecasted. If this happens, we may need to raise additional capital to fund our operations, which may not be available in sufficient amounts or on reasonable terms, if at all, sooner than expected.

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Adverse global conditions, including economic uncertainty, may negatively impact our financial results.

In addition, the global macroeconomic environment could be negatively affected by, among other things, pandemics or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the Russian invasion of Ukraine, the war between Israel and Hamas and other political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.

Geopolitical risks associated with Russia’s invasion of Ukraine and Israel’s war with Hamas could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations.

The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine and Israel’s war with Hamas, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain. There can be no certainty regarding the impacts stemming from the invasion, including the imposition of additional sanctions, embargoes, asset freezes or other economic or military measures resulting from the invasion. The impact of these developments, and additional events that may occur as a result, is currently unknown and could adversely affect our business, supply chain, suppliers and customers and potential customers. It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could negatively impact our business, financial condition and results of operations.

Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.

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Requirements associated with being a public company will increase our costs significantly and will divert significant company resources and management attention.

Our management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. We cannot predict or estimate the amount of additional costs we may incur as a result of this.

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Risks Related to Clinical Development, Regulatory Approval and Commercialization

Our product candidates are at an early stage of development and may not be successfully developed or commercialized.

We have no products approved for sale. Adrulipase is in the early stages of clinical development. Our product candidates will require substantial capital expenditures, development, testing, and regulatory clearances prior to commercialization. The development and regulatory approval process take several years, and it is not likely that any such products, even if successfully developed and approved by the FDA or any comparable foreign regulatory authority, would be commercially available for a significant period of time. Many promising drug candidates fail at some stage of their clinical development. Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed, receive required regulatory approvals and successfully commercialized. Our failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of our product candidates, could result in the failure of our business and a loss of all of your investment in our company.

The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of our product candidates are subject to extensive regulation by the FDA in the United States and by comparable health authorities in foreign markets, including Health Canada’s Therapeutic Products Directorate, or the TPD, and the European Medicines Agency, or the EMA. In the United States, we are not permitted to market our product candidates until we receive approval of an NDA (New Drug Application) or BLA (Biologic License Application) from the FDA. The process of obtaining such approval is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved. In addition to the significant clinical testing requirements, our ability to obtain marketing approval for these product candidates depends on obtaining the final results of required non-clinical testing, including characterization of the manufactured components of our product candidates and validation of our manufacturing processes. The FDA may determine that our product manufacturing processes, testing procedures or facilities are insufficient to justify approval. Approval policies or regulations may change, and the FDA has substantial discretion in the pharmaceutical approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed.

The FDA, the TPD and/or the EMA can delay, limit or deny approval of a product candidate for many reasons, including, but not limited to:

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disagreement with the design or implementation of our clinical trials;

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failure to demonstrate to their satisfaction that a product candidate is safe and effective for any indication;

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●

failure to accept clinical data from trials which are conducted outside their jurisdiction;

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the results of clinical trials may not meet the level of statistical significance required for approval;

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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

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such agencies may disagree with our interpretation of data from preclinical studies or clinical trials;

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failure to approve the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; or

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changes in the approval policies or regulations of such agencies may significantly change in a manner rendering our clinical data insufficient for approval.

Any delay in obtaining, or inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates.

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If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:

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the patient eligibility criteria defined in the protocol;

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the size of the patient population;

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the proximity and availability of clinical trial sites for prospective patients;

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the design of the trial;

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our ability to recruit clinical trial investigators with the appropriate competencies and experience;

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the availability of other clinical trials and competition for eligible patients;

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our ability to obtain and maintain patient consents; and

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the risk that patients enrolled in clinical trials will drop out of the trials before completion.

Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates. This competition will reduce the number and types of patients and qualified clinical investigators available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors or clinical trial sites may not allow us to conduct our clinical trial at such site if competing trials are already being conducted there. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. We may also encounter difficulties finding a clinical trial site at which to conduct our trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates.

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Pharmaceutical development has inherent risk. We will be required to demonstrate through well-controlled clinical trials that our product candidates are safe and effective with a favorable benefit-risk profile for use in their target indications before we can seek regulatory approvals for their commercial sale. Adrulipase has completed four Phase 2 clinical trials in two separate indications (three Phase 2 in CF patients and one Phase 2 in CP patients). Success in pre-clinical studies or early clinical trials does not mean that later clinical trials will be successful, as product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing. We also may need to conduct additional clinical trials that are not currently anticipated. Drug developers frequently suffer significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.

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Any product candidate we advance into and through clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent their regulatory approval or commercialization or limit their commercial potential.

Unacceptable adverse events caused by Adrulipase in clinical trials could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications and markets. This, in turn, could prevent us from commercializing the affected product candidate and generating revenues from its sale. We have not yet completed testing of any of our product candidates for the treatment of the indications for which we intend to seek product approval in humans, and we currently do not know the extent of adverse events, if any, that will be observed in patients who receive any of our product candidates. If any of our product candidates cause unacceptable adverse events in clinical trials, we may not be able to obtain regulatory approval or commercialize such product or, if such product candidate is approved for marketing, future adverse events could cause us to withdraw such product from the market.

Delays in the commencement or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates.

The commencement and completion of clinical trials can be delayed for a variety of reasons, including delays in:

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obtaining regulatory clearance to commence a clinical trial;

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identifying, recruiting and training suitable clinical investigators;

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reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;

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obtaining sufficient quantities of investigational product (“IP”) for our product candidates for use in clinical trials;

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obtaining Institutional Review Board (“IRB”) or ethics committee approval to conduct a clinical trial at a prospective site;

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identifying, recruiting and enrolling patients to participate in a clinical trial, including delays and/or interruptions resulting from geo-political actions, such as the war in Ukraine, disease or public health epidemics, such as the coronavirus, or natural disasters;

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retaining patients who have initiated a clinical trial but may withdraw due to adverse events from the therapy, insufficient efficacy, changing clinical protocols, fatigue with the clinical trial process, or personal issues;

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retaining patients who may not follow the clinical trial protocols due to factors including the coronavirus epidemic; and

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availability of funds.

Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our product candidates. In addition, many of the factors that cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.-31-

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We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.

Regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Clinical trials must be conducted in accordance with current cGCPs or other applicable foreign government guidelines governing the design, safety monitoring, quality assurance and ethical considerations associated with clinical studies. Clinical trials are subject to oversight by the FDA, other foreign governmental agencies and IRBs at the study sites where the clinical trials are conducted. In addition, clinical trials must be conducted with product candidates produced in accordance with applicable cGMPs, which are the FDA’s regulations governing the design, monitoring and control of manufacturing processes and facilities. Clinical trials may be suspended by the FDA, other foreign governmental agencies, or us for various reasons, including:

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deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

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deficiencies in the clinical trial operations or trial sites;

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the product candidate may have unforeseen adverse side effects;

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deficiencies in the trial design necessary to demonstrate efficacy;

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fatalities or other adverse events arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;

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the product candidate may not appear to be more effective than current therapies; or

●

the quality or stability of the product candidate may fall below acceptable standards.

If we elect or are forced to suspend or terminate a clinical trial for Adrulipase, the commercial prospects for that product candidate will be harmed and our ability to generate product revenue from that product candidate may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these product candidates either by us or by our collaboration partners.

The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions and our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. We have not submitted an NDA or similar filing or obtained regulatory approval for any drug candidate in any jurisdiction and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.

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Adrulipase could fail to receive regulatory approval for many reasons, including any one or more of the following:

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

●

the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

●

the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA, BLA or other submission or to obtain regulatory approval in the United States or elsewhere;

●

the FDA or comparable foreign regulatory authorities may fail to hold to previous agreements or commitments;

●

the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

●

the FDA or comparable foreign regulatory authorities may fail to approve our product candidates;

●

invest significant additional cash in each of the above activities; and

●

the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

The time and expense of the approval process, as well as the unpredictability of clinical trial results and other contributing factors, may result in our failure to obtain regulatory approval to market, in one or more jurisdictions, Adrulipase, or future product candidates, which would significantly harm our business, results of operations and prospects.

In addition, even if we were to obtain regulatory approval in one or more jurisdictions, regulatory authorities may approve Adrulipase for fewer or more limited indications than we request, may not approve the prices we may propose to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with labeling that does not include the claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing circumstances could materially harm the commercial prospects for Adrulipase.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any.

Results of current and future clinical trials of Adrulipase could reveal a high and/or unacceptable severity and frequency of these or other side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Further, any observed drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences could materially harm our business, financial condition and prospects.

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Additionally, if Adrulipase receive marketing approval, and we or others later identify undesirable side effects caused by our products, a number of potentially significant negative consequences could result, including:

●

regulatory authorities may withdraw approvals of such product;

●

regulatory authorities may require additional warnings in the product’s labeling;

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we may be required to create a medication guide for distribution to patients that outlines the risks of such side effects;

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we could be sued and held liable for harm caused to patients; and

●

our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product, if approved, and could significantly harm our business, results of operations and prospects.

If we are unable to execute our sales and marketing strategy for our products and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business.

We ~~are~~operate as a clinical-stage biopharmaceutical company with relation to our Biopharmaceutical assets and have yet to begin to generate revenue from Adrulipase. Our product candidate is in an early stage of clinical development, and, if we obtain marketing approval for any of products in the future, which we anticipate would not occur for several years, if at all.

We may never gain significant market acceptance for our product candidates and therefore may never generate substantial revenue or profits for us. We will need to establish a market for any of our product candidates that receive regulatory approval through physician education, sales and marketing efforts, awareness programs and the publication of clinical data. Gaining acceptance in medical communities requires, among other things, publication in leading peer-reviewed journals of results from our studies. The process of publication in leading medical journals is subject to a peer review process and peer reviewers may not consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals could limit the adoption of Adrulipase. Our ability to successfully market our product candidates that we may develop will depend on numerous factors, including:

●

the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

●

the efficacy and safety as demonstrated in clinical trials;

●

the clinical indications for which the product is approved;

●

the inability to demonstrate effectively that the clinical and other benefits of a product candidate outweigh any safety or other perceived risks;

●

the inability to demonstrate effectively that the efficacy of a product candidate is superior to a competing treatment;

●

conducting clinical utility studies of our product candidates to demonstrate economic usefulness to providers and payers;

●

relative convenience and ease of administration;

●

whether our current or future partners, support our offerings;

●

the success of the sales force and marketing effort;

●

unfavorable publicity relating to the product;

●

whether healthcare providers believe our product candidates provide clinical utility relative to their cost; and

~~● whether private health insurers, government health programs and other third~~-~~party payers will cover our product candidates.~~34-

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whether private health insurers, government health programs and other third-party payers will cover our product candidates.

We currently have no commercial organization. If we are unable to establish satisfactory sales and marketing capabilities or secure a sales and marketing partner, we may not successfully commercialize any of our product candidates.

We have no commercial infrastructure. In order to commercialize products that are approved for marketing, we must either establish our own sales and marketing infrastructure or collaborate with third parties that have such commercial infrastructure.

We may not be able to enter into collaboration agreements on terms acceptable to us or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties. If we elect to establish a sales and marketing infrastructure, we may not realize a positive return on this investment. In addition, we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire, train and retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize our product candidates without strategic partners or licensees include:

●

our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

●

the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our future products;

●

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

●

unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure, or if we do not successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing our product candidates and any we may develop or acquire, which would adversely affect our business, operating results and financial condition. Outside the United States, we may commercialize our product candidates by entering into collaboration agreements with pharmaceutical partners. We may not be able to enter into such agreements on terms acceptable to us or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties.

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

From time to time, we may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to Adrulipase and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. These relationships also may result in a delay in the development of Adrulipase if we become dependent upon the other party and such other party does not prioritize the development of our product candidates relative to its other development activities. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. We rely completely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and expect to continue to rely on third parties to produce commercial supplies of our product candidates, and our dependence on third party suppliers could adversely impact our business.

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We rely completely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and expect to continue to rely on third parties to produce commercial supplies of any approved product candidate, and our dependence on third party suppliers could adversely impact our business.

We do not currently manufacture our product candidates and expect to rely on third parties to ~~manufacture~~do ~~our~~so, if and when required. The proprietary yeast cell line from which the Adrulipase API is derived is kept at a storage facility maintained by Charles River Laboratories Inc. Adrulipase drug substance and drug product ~~candidates~~are currently manufactured at a contract facility located in Tianjin, China owned by Asymchem Life Science Co., Ltd. We believe there are multiple alternative contract manufacturers capable of producing the Adrulipase product we need for clinical trials. There is no guarantee that the processes are easily reproducible and transferrable.

The proprietary yeast cell line from which the Adrulipase API is derived is kept at a storage facility maintained by Charles River Laboratories Inc. Adrulipase drug substance and drug product are currently manufactured at a contract facility located in Tianjin, China owned by Asymchem Life Science Co., Ltd. We believe there are multiple alternative contract manufacturers capable of producing the Adrulipase product we need for clinical trials. There is no guarantee that the processes are easily reproducible and transferrable.

We are completely dependent on these third parties for product supply and our Adrulipase development program would be adversely affected by a significant interruption in our ability to receive such materials. We have not yet entered into long-term manufacturing or supply agreements with any third parties. Furthermore, our third-party suppliers will be required to obtain and maintain compliance with cGMPs and will be subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance. In the event that the FDA or such other authorities determine that our third-party suppliers have not complied with cGMP, our clinical trials could be terminated or subjected to a clinical hold until such time as we are able to obtain appropriate replacement material. Any delay, interruption or other issues that arise in the manufacture, packaging, or storage of our products as a result of a failure of the facilities or operations of our third-party suppliers to pass any regulatory agency inspection could significantly impair our ability to develop and commercialize our products.

We do not expect to have the resources or capacity to commercially manufacture any of our proposed products, if approved, and will likely continue to be dependent upon third party manufacturers. Our dependence on third parties to manufacture and supply us with clinical trial materials and any approved products may adversely affect our ability to develop and commercialize our products on a timely basis or at all.

We rely on third parties to conduct our clinical trials. If these third parties do not meet our deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.

We do not have the ability to conduct all aspects of our preclinical testing or clinical trials ourselves. We use contract research organizations (CROs) to conduct our clinical trials and will rely upon such CROs, as well as medical institutions, clinical investigators and consultants, to conduct our trials in accordance with our clinical protocols. Our CROs, investigators and other third parties will play a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials.

There is no guarantee that any CROs, investigators and other third parties upon which we rely for administration and conduct of our clinical trials will devote adequate time and resources to such trials or perform as contractually required. If any of these third parties fail to meet expected deadlines, fail to adhere to our clinical protocols or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated. If any of our clinical trial sites terminate for any reason, we may experience the loss of follow-up information on patients enrolled in our ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be jeopardized.

We intend to rely on market exclusivity periods that may not be or remain available to us.

We intend to rely on our ability to obtain and maintain a regulatory period of market exclusivity for any of our product candidates, including Adrulipase, that are successfully developed and approved for commercialization. Although this period in the United States is currently 12 years from the date of marketing approval, reductions to this period have been proposed. This exclusivity period in Europe is currently 10 years from the date of marketing approval by the EMA. Once any regulatory period of exclusivity expires, depending on the status of our patent coverage and the nature of the product, we may not be able to prevent others from marketing products that are biosimilar to or interchangeable with our products, which would materially adversely affect us.

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Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

~~We intend to develop a pipeline of product candidates to treat GI and other diseases.~~ Due to the significant resources required for the development of product candidates, we must focus our attention and resources on specific diseases and/or indications and decide which product candidates to pursue and the amount of resources to allocate to each. We are currently focusing our resources on the development of our product candidate, Adrulipase.

Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, any decision to delay, terminate or collaborate with third parties in respect of certain programs or product candidates may subsequently prove to be suboptimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the viability or market potential of any of our programs or product candidates or misread trends in the GI, CF, CP, or biotechnology industry, our business, financial condition and results of operations could be materially adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and indications that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.

If we fail to attract and retain key management and clinical development personnel, we may be unable to successfully develop or commercialize our product candidates.

We are dependent on our management team and clinical development personnel and our success will depend on their continued service, as well as our ability to attract and retain highly qualified personnel. In particular, the continued employment of our senior management team, which includes Richard Paolone, our Chief Executive Officer and Anna Skowron, our Interim Chief Financial Officer, is critical to our success. The market for the services of qualified personnel in the biotechnology and pharmaceutical industries are highly competitive. The loss of service of any member of our senior management team or key personnel could prevent, impair or delay the implementation of our business plan, the successful conduct and completion of our planned clinical trials and the commercialization of any product candidates that we may successfully develop. We do not carry key man insurance for any member of our senior management team.

Healthcare reform and restrictions on reimbursements may limit our financial returns.

Our ability or the ability of our collaborators to commercialize any of our product candidates that we successfully develop may depend, in part, on the extent to which government health administration authorities, private health insurers and other organizations will reimburse consumers for the cost of these products. These third parties are increasingly challenging both the need for and the price of new drug products. Significant uncertainty exists as to the reimbursement status of newly approved therapeutics. Adequate third-party reimbursement may not be available for our product candidates to enable us or our collaborators to maintain price levels sufficient to realize an appropriate return on their and our investments in research and product development.

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Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues.

The potential pricing and reimbursement environment for Adrulipase, and any future drug products may change in the future and become more challenging due to, among other reasons, policies advanced by the current or any new presidential administration, federal agencies, healthcare legislation passed by Congress, or fiscal challenges faced by all levels of government health administration authorities. Members of the government have made public statements in favor of, and may take steps to implement, various regulatory changes that could negatively impact the pharmaceutical industry, including the Company. Those potential changes include some related to personnel and policy changes at the FDA and other government agencies and programs. For example, HHS could undergo changes that could make it more difficult for the FDA to grant regulatory approvals for drugs. Additionally, if the FDA drug user fee programs were eliminated, that could cause significant delays to facility inspections and approvals of new products. It is too early for us to assess which, if any, of the policy changes that have been publicly referenced would be implemented, and we cannot predict what additional future changes in the health care industry in general, or the pharmaceutical industry in particular, will occur; however, any changes could have a material adverse effect on our business, cash flows, results of operations, financial condition and prospects.

If we or any of our independent contractors, consultants, collaborators, manufacturers, vendors or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions, which could result in penalties and affect our ability to develop, market and sell our product candidates and may harm our reputation.

We are subject to federal, state, and foreign healthcare laws and regulations pertaining to fraud and abuse and patients’ rights. These laws and regulations include:

● the U.S. federal healthcare program anti-kickback law, which prohibits, among other things, persons and entities from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for a ~~healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;~~

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healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;

●

the U.S. federal false claims and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting or causing to be presented, claims for payment by government funded programs such as Medicare or Medicaid that are false or fraudulent, and which may apply to us by virtue of statements and representations made to customers or third parties;

●

the U.S. federal Health Insurance Portability and Accountability Act (“HIPAA”), which prohibits, among other things, executing a scheme to defraud healthcare programs;

●

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, imposes requirements relating to the privacy, security, and transmission of individually identifiable health information, and requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;

●

the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, other healthcare providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on an annual basis; and

●

state laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader in scope and also apply to commercial insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security.

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If our operations are found to be in violation of any such health care laws and regulations, we may be subject to penalties, including administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment or restructuring of our operations, loss of eligibility to obtain approvals from the FDA, or exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely affect our financial results. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and could divert our management’s attention from the operation of our business, even if our defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.

Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.

We are exposed to the risk that our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors may engage in misconduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA, EMA and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies; manufacturing standards; healthcare fraud and abuse, data privacy laws and other similar laws; or laws that require the true, complete and accurate reporting of financial information or data. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials, the creation of fraudulent data in our preclinical studies or clinical trials, or illegal misappropriation of product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in governmental healthcare programs, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

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in governmental healthcare programs, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Risks Related to our Intellectual Property in the Biopharmaceutical Industry

Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property.

Our success will depend, in large part, on obtaining and maintaining patent protection and trade secret protection for Adrulipase, and its formulations and uses, as well as successfully defending these patents against third-party challenges. If we or our licensors fail to appropriately prosecute and maintain patent protection for our product candidates, our ability to develop and commercialize these product candidates may be adversely affected and we may not be able to prevent competitors from making, using and selling competing products. This failure to properly protect the intellectual property rights relating to these product candidates could have a material adverse effect on our financial condition and results of operations.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or our partners will be successful in protecting our product candidates by obtaining and defending patents. These risks and uncertainties include the following:

●

patent applications may not result in any patents being issued or any issued patents may not be of sufficient scope to cover our products;

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patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide any competitive advantage;

●

our competitors, many of which have substantially greater resources than we or our partners and many of which have made significant investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products;

●

there may be significant pressure on the United States government and other international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns;

●

countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products;

●

others may allege ownership of our patents or patent applications or those of our licensors, and defense of such allegation or potential proceeding could be expensive, time consuming and unsuccessful; and

●

we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.

In addition to patents, we and our partners also rely on trade secrets and proprietary know-how. Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants and advisors, third parties may still obtain this information or come upon this same or similar information independently. We may become subject to claims that we or consultants, advisors or independent contractors that we may engage or have engaged to assist us in developing Adrulipase, Niclosamide, Capeserod and Latiglutenase have wrongfully or inadvertently disclosed to us or used trade secrets or other proprietary information of their former employers or their other clients.

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If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.

Our success also depends upon our ability and the ability of any of our future collaborators to develop, manufacture, market and sell our product candidates without infringing the proprietary rights of third parties. Numerous United States and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products, some of which may be directed at claims that overlap with the subject matter of our intellectual property. Because patent applications do not publish for 18 months from their priority date, can be filed with a non-publication request in the United States, and can take many years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that our product candidates or proprietary technologies may infringe. Similarly, there may be issued patents relevant to our product candidates of which we are not aware.

There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a third-party claims that we or any of our licensors, suppliers or collaborators infringe the third party’s intellectual property rights, we may have to:

●

obtain licenses, which may not be available on commercially reasonable terms, if at all;

●

abandon an infringing product candidate or redesign our products or processes to avoid infringement;

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pay substantial damages, including the possibility of treble damages and attorneys’ fees, if a court decides that the product or proprietary technology at issue infringes on or violates the third party’s rights;

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pay substantial royalties, fees and/or grant cross licenses to our technology; and/or

●

defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

Our ability to compete may decline if we do not adequately protect our proprietary rights.

Our success depends on obtaining and maintaining proprietary rights to our product candidates for the treatment of age-related diseases, as well as successfully defending these rights against third-party challenges. We will only be able to protect our product candidates, and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them. Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including:

●

we may not have been the first to make the inventions covered by pending patent applications or issued patent;

●

we may not have been the first to file patent applications for our product candidates or the compositions we developed or for their uses;

●

others may independently develop identical, similar or alternative products or compositions and uses thereof;

●

our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability;

●

any or all of our pending patent applications may not result in issued patents;

●

we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity;

●

any patents issued to us may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties;

●

our compositions and methods may not be patentable;

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●

others may design around our patent claims to produce competitive products which fall outside of the scope of our patents;

●

others may identify prior art or other bases which could invalidate our patents.

Even if we have or obtain patents covering our product candidates or compositions, we may still be barred from making, using and selling our product candidates or technologies because of the patent rights of others. Others may have filed, and in the future may file, patent applications covering compositions or products that are similar or identical to ours. There are many issued U.S. and foreign patents relating to chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize. These could materially affect our ability to develop our product candidates or sell our products if approved. Because patent applications do not publish for 18 months from their priority date, can be filed with a non-publication request in the United States, and can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe. These patent applications may have priority over patent applications filed by us.

Obtaining and maintaining a patent portfolio entails significant expense and resources. Part of the expense includes periodic maintenance fees, renewal fees, annuity fees, various other governmental fees on patents and/or applications due in several stages over the lifetime of patents and/or applications, as well as the cost associated with complying with numerous procedural provisions during the patent application process. We may or may not choose to pursue or maintain protection for particular inventions. In addition, there are situations in which failure to make certain payments or noncompliance with certain requirements in the patent process can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If we choose to forgo patent protection or allow a patent application or patent to lapse purposefully or inadvertently, our competitive position could suffer.

Legal actions to enforce our proprietary rights (including patents and trademarks) can be expensive and may involve the diversion of significant management time. In addition, these legal actions could be unsuccessful and could also result in the invalidation of our patents or trademarks or a finding that they are unenforceable. We may or may not choose to pursue litigation or other actions against those that have infringed on our patents or trademarks, or used them without authorization, due to the associated expense and time commitment of monitoring these activities. If we fail to protect or to enforce our intellectual property rights successfully, our competitive position could suffer, which could harm our results of operations.

Risks Related to Grid Ai Corp.’s Business and Industry

Our 2025 business transformation through the acquisition of Grid AI Corp. may not succeed, and we may fail to realize the anticipated benefits of that transaction.

On September 30, 2025, we acquired Grid AI Corp., which indirectly brought into our consolidated business a 75% interest in AMPX. This transaction fundamentally changed the nature of our business. Historically, we operated as a small clinical-stage biopharmaceutical company. Following the transaction, we also operate an energy technology and software-enabled grid orchestration business.

This acquisition creates substantial risks, including:

●

failure to integrate operations, systems, controls and reporting

●

inability to retain or motivate key employees, consultants or management personnel

●

failure to realize expected commercial opportunities

●

inaccurate assumptions regarding the acquired business, including its technology, market position, margins, scalability or customer traction

●

challenges in overseeing a business outside our historical expertise

●

operational complexity arising from international subsidiaries and minority ownership interests

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impairment or write-down risk related to goodwill and intangible assets recorded in connection with the transaction.

If the acquired business underperforms expectations, or if integration is not successful, our business, financial condition and results of operations could be materially adversely affected.

There can be no assurance that we will be able to obtain stockholder approval to issue shares of our Common Stock issuable upon conversion of our Series H Preferred Stock, and our inability to obtain such approval could materially and adversely affect our business, results of operations and the value of our securities; and that if such stockholder approval is obtained, there is no assurance that we will be able to obtain Nasdaq approval of any initial listing filing application that may be required in connection with the acquisition of Grid AI Corp.

As part of the share exchange transaction with Grid AI Corp. and the stockholders of all of the issued and outstanding shares of Grid AI Corp., we issued to such stockholders of Grid AI Corp. (i) 424,348 shares of our Common Stock, which represented 19.99% of the issued and outstanding shares of Common Stock as of the date of entry into the share exchange agreement, and (ii) 38,801.546 shares of our Series H Preferred Stock. The Series H Preferred Stock is convertible into an aggregate of 38,801,546 shares of Common Stock (the “Conversion Shares”), subject to shareholder approval and certain conditions and adjustments as set forth in the Series H Preferred Stock Certificate of Designation. The shares of Common Stock that we issued at the closing together with the maximum number of Conversion Shares represented 82.5% of the issued and outstanding shares of our Common Stock as of the date of entry into the share exchange agreement on an as-converted and fully-diluted basis. Pursuant to the share exchange agreement with Grid AI Corp. and its stockholders, we are obliged to hold a stockholder meeting as promptly as practicable following the closing of the transaction to consider and obtain approval for the conversion of the shares of Series H Preferred Stock into Common Stock. There can be no assurance that we will be able to obtain the required stockholder approval on a timely basis or at all.

If we do not obtain the required stockholder approval, we may be unable to issue the Conversion Shares and, as a result, may not be able to satisfy our obligations under the share exchange agreement. In addition, the share exchange agreement contains recission and unwinding provisions tied to our ability to seek and obtain the required stockholder approval. If we fail to timely file and pursue the proxy statement process and related stockholder meeting(s), or if the required stockholder approval is not obtained after multiple stockholder meetings, the share exchange agreement, and the transaction contemplated therein, could be rescind and unwind. In addition, we may be required to pay the stockholders of Grid AI Corp. an aggregate fee of $1,000,000 upon any rescission or unwinding. If the share exchange agreement is rescinded or unwound, we could be also subject to disputes, litigation, significant costs, and diversion of management attention. In addition, the anticipated benefits of the acquisition of Grid AI Corp., including expected strategic and operational benefits, could be delayed, reduced, or not realized.

Further, even if we do obtain stockholder approval, there is no assurance that Nasdaq will approve any initial listing application filed in connection with the acquisition of Grid AI Corp., and failure to secure such approval may impair our market access and liquidity.

Any of the foregoing could materially and adversely affect our business, financial condition, results of operations, liquidity, and prospects, and could cause the price of our Common Stock to decline.

Our energy technology business exposes us to risks that are different from our historical biopharmaceutical business.

The GridAI and AMPX business operates in a field that differs substantially from our legacy life sciences operations. This business depends on software development, systems integration, device interoperability, market participation, utility and partner relationships, communications infrastructure, customer adoption and evolving regulatory frameworks related to distributed energy resources and grid services.

This business may be affected by:

●

technical failure or underperformance of software and orchestration systems

●

inability to integrate with third-party hardware, devices, utilities, market operators or cloud providers

●

cybersecurity breaches, service interruptions or data loss

●

changes in utility rules, market structures or incentive regimes

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●

longer-than-expected sales cycles or customer concentration

●

inability to scale deployments profitably

●

dependence on third-party installers, hardware providers and integration partners.

Because this business is relatively new within our corporate structure and materially different from our historic operating profile, our management, internal controls and investor disclosures may be subject to heightened execution risk.

Grid AI Corp.’s limited operating history makes evaluating its business and prospects difficult.

Prior to Grid AI Corp.’s acquisition of AMPX in February 2025, AMPX had developed and operated two principal technology platforms focused on residential and distributed energy management: DLS developed technology and ALICE Home Energy Management Systems (HEMS). While Grid AI Corp. currently supports these technologies, there is very minimal revenue and Grid AI Corp.’s current focus is on data centers. While Grid AI Corp. is looking to develop a data center platform, they have a limited history operating our business at its current scale and under our current strategy, and therefore a limited history upon which you can base an investment decision.

Further, Grid AI Corp.’s ability to execute its business plan depends on successfully completing customer deployments, integrating with third-party hardware and software systems, and scaling its platform and personnel. Delays in implementation, customer adoption, or integration with external systems could adversely affect operating results. Our and Grid AI Corp.’s operating results may fluctuate significantly, which could make our and Grid AI Corp. future results difficult to predict and could cause our and Grid AI Corp. operating results to fall below expectations.

The distributed generation industry is emerging and our distributed generation offerings may not receive widespread market acceptance.

The implementation and use of distributed generation at scale is still not widespread, and we cannot be sure that any potential customers will accept our services and solutions broadly. Enterprises may be unwilling to adopt Grid AI Corp.’s offerings over traditional or competing power sources for any number of reasons, including the perception that our technology is unproven, lack of confidence in our business model, unavailability of back-up service providers to operate and maintain the energy storage systems, and lack of awareness of our related products and services. Because this is an emerging industry, broad acceptance of Grid AI Corp.’s products and services is subject to a high level of uncertainty and risk. If the market develops more slowly than we and Grid AI Corp. anticipate, our and Grid AI Corp. business may be adversely affected.

If renewable energy technologies are not suitable for widespread adoption, or if sufficient demand for our software-enabled services does not develop or takes longer to develop than we anticipate, Grid AI Corp. may not be able to generate sufficient revenue or revenue at all to be financially successful.

The market for renewable, distributed energy generation is emerging and rapidly evolving, and its future success is uncertain. If renewable energy generation proves unsuitable for widespread commercial deployment or if demand for our renewable energy products and services fails to develop sufficiently, our and Grid AI Corp. revenue, market share and profitability would be adversely impacted.

Many factors may influence the widespread adoption of renewable energy generation and demand for Grid AI Corp. products and services, including, but not limited to the cost-effectiveness of renewable energy technologies as compared with conventional and competitive technologies, the performance and reliability of renewable energy products as compared with conventional and non-renewable products, fluctuations in economic and market conditions that impact the viability of conventional and competitive alternative energy sources, increases or decreases in the prices of oil, coal and natural gas, continued deregulation of the electric power industry and broader energy industry, and the availability or effectiveness of government subsidies and incentives. You should consider our and Grid AI Corp. prospects in light of the risks and uncertainties emerging companies encounter when introducing new products and services into a nascent industry.

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Our market estimates and assumptions may prove inaccurate.

While we and Grid AI Corp. anticipate being able to generate revenue and garnering customers, market estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may prove to be inaccurate. Even if the markets in which we compete meet our size estimates and forecasted growth, Grid AI Corp. business could fail to grow at similar rates, if at all. The assumptions relating to Grid AI Corp.’s market opportunities include, but are not limited to (i) general declines in the cost of renewable energy generation assets; (ii) growing deployment of renewable energy assets and energy storage systems; and (iii) continued complexity of the electrical grid and resulting demand for stability and resiliency. Grid AI Corp.’s expected market opportunities are also based on the assumption that Grid AI Corp.’s existing and future offerings will be more attractive to its customers and potential customers than competing products and services. If these assumptions prove inaccurate, our and Grid AI Corp.’s business, financial condition and results of operations could be adversely affected.

We expect to face significant competition in the Grid AI Corp.’s industry.

We expect to face significant competition in the Grid AI Corp.’s industry and market. Grid AI Corp. operates in a competitive and rapidly evolving market that includes energy management software providers, virtual power plant (“VPP”) platforms, battery system integrators, utilities, engineering firms, and in-house customer-developed solutions. Grid AI Corp. also competes with emerging technology providers focused on distributed energy resource optimization and artificial intelligence-driven grid management.

Competition is driven by several factors, including software functionality, scalability, interoperability with third-party hardware and market platforms, speed of deployment, regulatory expertise, customer relationships, and pricing. Grid AI Corp.’s solutions must integrate with a wide range of third-party systems, including batteries, control systems, and energy market infrastructure, which are often not standardized and may change over time.

The markets in which Grid AI Corp. operates are highly competitive and include both established industry participants with significant financial, technical, and commercial resources, as well as new entrants seeking to capitalize on the growth of distributed energy and AI-driven energy optimization. Some competitors offer vertically integrated solutions, including hardware, software, and energy services, while others provide point solutions that compete with specific components of Grid AI Corp.’s platform.

Grid AI Corp.’s ability to compete successfully depends on its ability to continue to innovate, expand its platform capabilities, maintain reliable system performance, and effectively execute its go-to-market strategy. Grid AI Corp. also competes based on its ability to convert pilot programs and non-binding arrangements into long-term commercial contracts, scale deployments across multiple jurisdictions, and adapt to evolving regulatory frameworks and market rules.

We cannot assure that Grid AI Corp. will be able to compete successfully with other players in the market. In such event, our and Grid AI Corp. business may be negatively impacted.

Grid AI Corp. plans to use artificial intelligence in its business, and challenges with properly managing its use could result in harm to our brand, reputation, business or customers, and adversely affect our results of operations.

Grid AI Corp. plans to use AI-enabled software and services offerings and incorporating AI in internal tools that support its business. This emerging technology presents a number of risks inherent in its use. AI algorithms are based on machine learning and predictive analytics, which can create accuracy issues, unintended biases, and discriminatory outcomes that could harm our brand, reputation, business, or customers. Additionally, no assurance can be made that the usage of AI will assist Grid AI Corp. in being more efficient or offset the costs of its implementation. Further, dependence on AI to make certain business decisions may introduce additional operational vulnerabilities by producing inaccurate outcomes, recommendations, or other suggestions based on flaws in the underlying data or other unintended results. Grid AI Corp. competitors or other third parties may incorporate AI into their business, services, and products more rapidly or more successfully than us, which could hinder our ability to compete effectively and adversely affect our results of operations. Implementing the use of AI successfully, ethically and as intended, will require significant resources. In addition, the use of AI may increase regulatory, cybersecurity, and data privacy risks, such as intended, unintended, or inadvertent transmission of proprietary or sensitive information. The technologies underlying AI and their use cases are rapidly developing, and it is not possible to predict all of the legal, operational or technological risks related to the use of AI. Our and Grid AI Corp. obligation to comply with emerging AI initiatives, laws, and regulations, including under proposed or enacted legislation regulating AI in jurisdictions such as the U.S. and European Union, could entail significant costs, negatively affect our and Grid AI Corp. business, or limit our and Grid AI Corp.’s ability to incorporate certain AI capabilities into our business.

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~~Legal~~Grid ~~actions~~Ai ~~to enforce our proprietary rights (including patents and trademarks) can be expensive and may involve the diversion of significant management time~~Corp.’s Infuture ~~addition,~~growth ~~these~~will ~~legal~~depend actions could be unsuccessful and could also result in the invalidation of our patents or trademarks or a finding that they are unenforceable. We may or may not choose to pursue litigation or other actions against those that have infringed on ~~our~~developing ~~patents or trademarks, or used them without authorization, due to the associated expense~~ and ~~time~~commercializing ~~commitment of monitoring these activities. If we fail to protect or to enforce~~ our ~~intellectual~~AI ~~property~~data ~~rights~~center ~~successfully, our competitive position could suffer, which could harm our results of operations~~platform.

IfFollowing weGrid ~~breach~~AI ~~our~~Corp’s ~~license~~acquisition orof ~~other~~AMPX ~~intellectual~~in ~~property-related~~February 2025, ~~agreements~~Grid ~~for~~AI ~~our~~Corp. ~~product~~commenced ~~candidates~~development orof ~~otherwise~~a ~~experience~~new ~~disruptions~~technology toplatform ~~our~~focused ~~business~~on ~~relationships~~AI-optimized ~~with~~energy ~~our~~orchestration ~~licensor~~for large-scale data center campuses. However, weas ~~could~~of ~~lose~~today, ~~the~~this ~~ability~~platform tois ~~continue~~still ~~the~~in ~~development~~an ~~and~~early ~~commercialization~~stage of commercialization and has not been deployed. We cannot assure that this platform will ever be successfully deployed. In such event, our ~~product~~and ~~candidates~~Grid AI Corp.’s business may be unable to achieve anticipated financial growth.

OnFurthermore, ~~September~~Grid ~~13,~~AI ~~2023,~~Corp. wemay ~~entered~~also ~~into~~introduce anew ~~license~~technologies ~~agreement~~or ~~with~~products ~~Sanofi~~that ~~(the~~do ~~“Sanofi~~not ~~License~~work ~~Agreement”),~~in ~~pursuant~~the tofuture, ~~which~~are wenot ~~received~~delivered on a ~~license~~timely tobasis, ~~obtain~~are ~~certain~~not ~~exclusive~~developed ~~worldwide~~according ~~rights~~ to ~~develop~~product and/or ~~commercialize~~cost ~~Capeserod~~specifications, aor ~~selective~~are ~~5-HT4~~not ~~receptor~~well ~~partial~~received ~~agonist~~by ~~which we intend to repurpose and develop for gastrointestinal indications~~customers. ~~Our~~There ~~license~~ may ~~not~~be ~~cover~~fewer ~~all~~opportunities ~~intellectual~~than ~~property~~we ~~rights~~expect ~~owned~~due ~~or controlled by our licensor and relevant~~ to ~~our~~a ~~product~~decline ~~candidates.~~in Ifbusiness weor ~~have~~economic ~~not~~conditions ~~obtained~~or a ~~license~~decreased todemand ~~all~~in ~~intellectual~~these ~~property~~markets ~~rights owned~~ or ~~controlled~~for byGrid ~~our~~AI ~~licensor~~Corp.’s ~~that~~new ~~are~~products ~~relevant~~from to our ~~product candidates~~expectations, weGrid ~~may~~AI ~~need~~Corp.’s toinability ~~obtain additional licenses~~ to ~~such~~successfully ~~intellectual~~execute ~~property~~its ~~rights~~sales ~~which~~and ~~may~~marketing ~~not be available on an exclusive basis~~plans, ~~on commercially reasonable terms~~ or atfor ~~all~~other reasons. In addition, ~~if our licensor breaches such agreement, we may not be able~~ to ~~enforce~~Grid ~~such~~AI ~~agreements against our licensor or their parent entity or affiliates~~Corp.’s ~~Under~~current ~~the~~growth ~~Sanofi License Agreement~~opportunities, inits ~~exchange~~future ~~for~~growth ~~licensing~~may tobe usreliant ~~the~~on ~~right~~its ability to ~~develop~~identify and ~~commercialize~~develop ~~the~~potential ~~applicable~~new ~~product~~growth candidate, Sanofi will be eligible to receive from us milestone payments, tiered royalties from commercial sales of such product candidates, assuming relevant approvals from government authorities are obtained, or other paymentsopportunities. OnThis ~~February~~process ~~26,~~is ~~2025,~~inherently werisky ~~notified~~and ~~Sanofi~~may ofresult ~~our~~in ~~intent~~investments toin ~~terminate~~time ~~this~~and ~~license,~~resources for which we ~~anticipate~~do ~~will~~not beachieve ~~effective~~any inreturn ~~April~~or ~~2025~~value. WeThese ~~may~~risks ~~terminate~~are ~~the~~enhanced ~~Sanofi License Agreement~~ by ~~providing~~attempting ~~Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled~~ to ~~any~~introduce ~~and~~multiple ~~all~~breakthrough ~~payments~~technologies ~~due~~ and ~~owed~~products ~~to Sanofi prior to the effective date of termination~~simultaneously. ~~No payments are due to Sanofi.~~

IfGrid weAI ~~fail~~Corp.’s togrowth ~~meet~~opportunities ~~any of our obligations under our license~~ and ~~intellectual~~those ~~property-related~~opportunities ~~agreements,~~it ~~our licensors~~ may ~~have~~pursue ~~the~~are ~~right~~subject to ~~terminate~~rapidly ~~our~~changing ~~licenses~~ and ~~sublicenses~~evolving technologies and, ~~upon~~industry ~~the effective date of such termination~~standards, ~~have~~and ~~the~~may ~~right~~be toreplaced ~~re-obtain~~by ~~the~~new ~~licensed and sublicensed~~ technology ~~and~~concepts ~~intellectual~~or ~~property~~platforms. If ~~any~~Grid ofAI ~~our~~Corp. ~~licensors~~does ~~terminate~~not ~~any~~develop ofinnovative ~~our~~and ~~licenses~~reliable orproduct ~~sublicenses,~~offerings ~~we will lose the right to develop~~ and ~~commercialize~~enhancements ~~our~~in ~~applicable~~a ~~product~~cost-effective ~~candidates~~ and ~~other~~timely ~~third~~manner ~~parties~~that ~~may~~are beattractive ~~able~~ to ~~market~~customers ~~product~~in ~~candidates~~these ~~similar~~markets; orif ~~identical~~Grid toAI ~~ours~~Corp. Inis ~~such~~otherwise ~~case,~~unsuccessful wein ~~may~~competing bein ~~required~~these tonew ~~provide~~product acategories; ~~grant~~if ~~back license to~~ the ~~licensors~~new ~~under~~product ~~our~~categories ~~own~~in ~~intellectual~~which ~~property with respect to the terminated products. While~~ we ~~would expect to exercise all rights~~ and ~~remedies~~Grid ~~available~~AI toCorp. ~~us,~~invest ~~including~~our ~~seeking~~limited toresources ~~cure~~do ~~any~~not ~~breach~~emerge byas ~~us,~~expected ~~and~~or ~~otherwise~~do ~~seek~~not toproduce ~~preserve~~ the ~~intellectual~~growth ~~property~~or ~~rights~~profitability ~~licensed and sublicensed to us,~~ we ~~may not be able to do so in a timely manner~~expect, ~~at an acceptable cost~~ or atwhen ~~all. In particular, some of the milestone payments are payable upon our product candidates reaching development milestones before~~ we ~~have~~expect ~~commercialized~~it, or ~~received~~if ~~any~~we ~~revenue~~do ~~from,~~not ~~sales~~correctly ofanticipate ~~such~~changes ~~product candidate,~~ and weevolutions ~~cannot~~in ~~guarantee~~technology ~~that~~and ~~we will have sufficient resources to make such milestone payments. Any uncured~~platforms, ~~material breach under the license agreements could result in~~ our ~~loss of exclusive rights~~ and ~~may~~Grid ~~lead~~AI ~~to a complete termination of our rights to the applicable product candidate~~Corp. ~~Any of the foregoing could have a material adverse effect on our~~ business, ~~financial~~and ~~conditions,~~ results of operations ~~and~~may ~~prospects~~be adversely affected.

InGrid ~~addition,~~AI ~~disputes~~Corp.’s business strategy may ~~further~~not ~~arise~~achieve ~~regarding~~anticipated ~~intellectual~~benefits. ~~property~~Grid ~~subject~~AI Corp’s failure to ado ~~license~~so ~~agreement~~could adversely affect our business, ~~including~~financial condition, ~~but~~and ~~not~~results ~~limited~~of ~~to:~~operations.

●Grid ~~the~~AI ~~scope~~Corp. ofplans ~~rights~~to ~~granted~~generate ~~under~~revenue ~~the~~from ~~license~~its ~~agreement~~AI data center platform through base platform fees for operational visibility and ~~other~~orchestration ~~interpretation~~and performance-~~related~~based ~~issues;~~fees tied to power cost optimization. Target customers include enterprise and government entities operating large data center campuses.

●Grid ~~the~~AI ~~extent~~Corp. tohas ~~which~~initiated ~~our~~development ~~technology~~of ~~and~~its ~~processes~~data ~~infringe,~~center ~~misappropriate~~orchestration orplatform ~~otherwise~~in ~~violate~~connection ~~intellectual~~with ~~property~~a potential future deployment at a customer site. Initial development and integration activities are underway. As of the ~~licensor~~date ~~that~~of isthis ~~not~~report, ~~subject~~the toplatform ~~the~~has ~~licensing~~not ~~agreement;~~yet been commercially deployed.

●Any future commercial deployment is expected to occur as customer projects progress through construction and operational readiness milestones. The timing and extent of such deployment will depend on a number of factors, including project development timelines and the ~~sublicensing~~availability of ~~patent~~customer funding. There can be no assurance that the platform will be successfully commercialized. Customer acceptance of our software and ~~other~~service ~~rights~~offerings ~~under~~is critical to our ~~collaborative~~future ~~development~~success. ~~relationships;~~We cannot assure that customers will be attracted to Grid AI Corp.’s platform and software solutions. If market demand for the types of AI-driven energy software and services Grid AI Corp. is developing and will seek to develop in the future does not grow as anticipated, or if competitors offer more attractive products, our and Grid AI Corp.’s revenue growth and market position could be adversely affected. As with all software offerings, there is also a risk that our solutions could be vulnerable to cybersecurity threats or contain errors, bugs, or other issues affecting their functionality, which could negatively affect customer satisfaction and adoption.

●In addition, continuing to execute on the new strategy requires investment in new capabilities and resources, particularly in software development, data management, and AI. Grid AI Corp. may face challenges in recruiting, retaining, and training employees who have the necessary skill sets to support our ~~diligence~~new ~~obligations~~business ~~under~~model. A failure to build or acquire these capabilities in a timely manner could delay the ~~license~~successful ~~agreement~~execution of the strategy and ~~what~~weaken ~~activities~~Grid ~~satisfy~~AI ~~those~~Corp.’s ~~diligence~~competitive ~~obligations;~~position.

●Grid ~~the~~AI ~~inventorship~~Corp. ~~and~~currently ~~ownership~~has ofno ~~inventions~~major ~~and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and~~customers.

Grid AI Corp. has no major customers. Even if Grid AI Corp. acquires customers in the future, the loss of any one of its significant customers, their inability to perform under their contracts, their termination or failure to renew their contracts with Grid AI Corp., or their default in payment could cause Grid AI Corp. revenue and its working capital to decline materially. We cannot assure

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●that Grid AI Corp. will be successful in acquiring or retaining customers in the ~~priority~~future. ofIn ~~invention~~such event, we and Grid AI Corp. may be unable to generate revenue, and our and Grid AI Corp.’s business, results of ~~patented~~operations ~~technology~~and financial condition could be materially and adversely affected.

InIf ~~addition,~~Grid ~~the~~AI ~~agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations~~Corp. ~~The~~is ~~resolution~~unable ~~of any contract interpretation disagreement that may arise could narrow what we believe~~ to beattract ~~the~~and ~~scope~~retain ofkey ~~our~~employees ~~rights~~and tohire ~~the~~qualified ~~relevant intellectual property or technology~~management, ~~or increase what we believe to be our financial or other obligations under the relevant agreement~~technical, ~~either~~engineering ~~of which could have a material adverse effect on our business, financial condition, results of operations,~~ and ~~prospects.~~sales ~~Moreover~~personnel, ifits ~~disputes over intellectual property that we have licensed or sublicensed prevent or impair our~~ ability to ~~maintain~~compete ~~our~~and ~~current licensing arrangements on commercially acceptable terms, we may be unable to~~ successfully ~~develop~~grow ~~and~~its ~~commercialize~~business ~~the affected product candidates, which~~ could ~~have~~be aadversely ~~material adverse effect on our business, financial conditions, results of operations and prospects~~affected.

IfWe webelieve ~~experience~~that ~~disruptions~~Grid AI Corp’s success and its ability to reach its strategic objectives are highly dependent on the contributions of its key management, technical, engineering, and finance personnel. Key leaders include Marshall Chapin, Mike Krastev and Vaclav Moulis. Executive leadership and senior management transitions, reductions in workforce and employee turnover can be time-consuming, difficult to manage, create instability, cause disruption to our business ~~relationships~~and ~~with~~result ~~our~~in ~~licensors,~~the weloss of institutional knowledge. Any of these outcomes could ~~lose~~impede the execution of Grid Ai Corp’s day-to-day operations and its ability to ~~continue~~fully implement its business strategy. These effects could also make it more difficult to ~~source,~~attract ~~develop~~and retain talent. The failure to successfully hire and ~~commercialize~~retain ~~our~~key ~~product~~executives ~~candidates~~and employees or the further loss of any key executives, senior management or employees could have a significant impact on Grid Ai Corp’s operations, including ~~ultimately~~declining ~~losing~~product ~~our~~identity ~~rights~~and competitive differentiation, eroding employee morale and productivity or an inability to ~~such~~maintain ~~product~~internal ~~candidates~~controls, regulatory or other compliance related requirements, any and all of which could in turn adversely impact our business, financial condition, and results of operations.

In addition, Grid AI Corp’s ability to manage its growth effectively, including its ability to expand its market presence, is impacted by its ability to successfully retain its management team, and hire and train new personnel. Grid AI Corp’s success in hiring, attracting and retaining senior management and other experienced and highly skilled employees will depend in part on its ability to provide competitive compensation packages and a high-quality work environment and maintain a desirable corporate culture. To help attract, retain, and motivate qualified employees, Grid AI Corp’s uses stock-based awards, such as restricted stock units and performance-based cash incentive awards, and in the case of its executive officers, it also uses performance stock units. Further sustained declines in Grid AI Corp’s stock price, or lower stock price performance relative to our competitors, can further reduce the retention value of our stock-based awards. We may not be able to attract, integrate, train, motivate or retain current or additional highly qualified personnel, and our failure to do so could adversely affect our business, financial condition and operating results.

Furthermore, there is continued and increasing competition for talented individuals in our field. In addition to longstanding competition for highly skilled and technical personnel, we face increased competitive pressures and employee cost inflation in tighter labor markets. Industry competition and cross-industry labor market pressures may negatively affect Grid AI Corp’s ability to attract and retain its executive officers and other key technology, sales, marketing and support personnel and drive increases in our employee costs, both of which could adversely affect Grid AI Corp’s business, financial condition and results of operations.

Any failure to offer high-quality technical support services may adversely affect Grid AI Corp’s relationships with its customers and adversely affect our financial results.

Grid AI Corp’s customers depend on its support organization to resolve any technical issues relating to our hardware and software-enabled services. In addition, Grid AI Corp’s sales process is highly dependent on the quality of our software and service offerings, on our business reputation and on strong recommendations from our existing customers. Any failure to maintain high-quality and highly-responsive technical support, or a market perception that Grid AI Corp does not maintain high-quality and highly-responsive support, could adversely affect Grid AI Corp’s and our reputation, Grid AI Corp’s ability to sell our products to existing and prospective customers, and our and Grid AI Corp’s business, financial condition and results of operations.

Grid AI Corp offers technical support services with its software and service offerings and may be unable to respond quickly enough to accommodate short-term increases in demand for support services, particularly as it increases the size of its customer base. Grid AI Corp also may be unable to modify the format of its support services to compete with changes in support services provided by competitors. It is difficult to predict demand for technical support services and if demand increases significantly, Grid AI Corp. may be unable to provide satisfactory support services to its customers. Additionally, increased demand for these services, without corresponding revenue, could increase costs and adversely affect our and Grid AI Corp’s business, financial condition and results of operations.

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Severe weather events, including the effects of climate change, are inherently unpredictable and may have a material adverse effect on our financial results and financial condition.

Grid AI Corp’s business, including its customers and suppliers, may be exposed to severe weather events and natural disasters, such as tornadoes, tsunamis, tropical storms (including hurricanes), earthquakes, windstorms, hailstorms, severe thunderstorms, flooding, wildfires and other fires, extreme heatwaves, drought and power shut-offs causing, among other things, disruptions to our supply chain or utility interconnections and/or damage to energy storage systems installed at its customers’ sites. Such damage or disruptions may prevent Grid AI Corp from being able to satisfy its contractual obligations or may reduce demand from its customers for its energy storage systems causing our operating results to vary significantly from one period to the next. Grid AI Corp. may incur losses in its business in excess of: (1) those experienced in prior years, (2) the average expected level used in pricing, or (3) current insurance coverage limits.

The incidence and severity of severe weather conditions and other natural disasters are inherently unpredictable. Climate change is projected to affect the occurrence of certain natural events, such as an increase in the frequency or severity of wind and thunderstorm events, and tornado or hailstorm events due to increased convection in the atmosphere; more frequent wildfires and subsequent landslides in certain geographies; higher incidence of deluge flooding; and the potential for an increase in severity of the hurricane events due to higher sea surface temperatures. Changing market dynamics, global policy developments and the increasing frequency and impact of extreme weather events on critical infrastructure in the U.S. and elsewhere as a result of climate change have the potential to disrupt Grid AI Corp’s business, the business of its suppliers and the business of its customers, and may cause Grid AI Corp to experience higher attrition, losses and additional costs to maintain or resume operations. Additionally, climate change and the occurrence of severe weather events may adversely impact the demand, price, and availability of insurance. Due to significant variability associated with future changing climate conditions, we are unable to predict the impact climate change will have on our and Grid AI Corp’s business.

Increased scrutiny from stakeholders and regulators regarding sustainability practices and disclosures, including those related to sustainability, and disclosure could result in additional costs and adversely impact our business and reputation.

Companies across all industries are facing increased scrutiny regarding their sustainability practices and disclosures and some institutional and individual investors are using sustainability screening criteria in making investment decisions. Our disclosures on these matters or a failure to satisfy evolving stakeholder expectations for sustainability practices and reporting, which may conflict with one another, may potentially harm our reputation and impact employee retention, customer relationships and access to capital. For example, certain market participants use third-party benchmarks or scores to measure a company’s sustainability practices in making investment decisions and customers and supplies may evaluate our sustainability practices or require that we adopt certain sustainability policies as a condition of awarding contracts. In addition, our failure or perceived failure to pursue or fulfill our goals, targets and objectives or to satisfy various reporting standards within the timelines we announce, or at all, could expose us to government enforcement actions and private litigation. Furthermore, complying or failing to comply with existing or future federal, state, local, and foreign legislation and regulations applicable to our sustainability efforts, which may conflict with one another, could cause us to incur additional compliance and operational costs, suffer reputational harm or to become the target of litigation, investigations or other proceedings initiated by government authorities or private actors, which could materially and adversely affect our business, financial condition and results of operations.

Our ability to achieve any goal or objective, including with respect to environmental and diversity initiatives and compliance with sustainability reporting standards, is subject to numerous risks, many of which are outside of our control. Examples of such risks include the availability and cost of technologies and products that meet sustainability and ethical supply chain standards, evolving regulatory requirements affecting sustainability standards or disclosures, our ability to recruit, develop and retain diverse talent in our labor markets, and our ability to develop reporting processes and controls that comply with evolving standards for identifying, measuring and reporting sustainability metrics. Methodologies for reporting sustainability data may be updated and previously reported sustainability data may be adjusted to reflect improvement in availability and quality of third-party data, changes in assumptions, changes in the nature and scope of our operations and other changes in circumstances. Our processes and controls for reporting sustainability matters across our operations and supply chain are evolving along with multiple disparate standards for identifying, measuring, and reporting sustainability metrics, including sustainability-related disclosures that may be required by the SEC, European and other regulators, and such standards may change over time, which could result in significant revisions to our current goals, reported progress in achieving such goals, or ability to achieve such goals in the future. As sustainability best-practices, reporting standards and disclosure requirements continue to develop, we may incur increasing costs related to sustainability monitoring and reporting.

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A failure of our information technology (“IT”) and data security infrastructure could adversely affect our business and operations.

The efficient operation of Grid AI Corp’s business depends on our IT systems. We rely upon the capacity, reliability and security of our IT and data security infrastructure and our ability to effectively manage our business data, accounting, financial, legal and compliance functions, communications, supply chain, order entry and fulfillment, and expand and routinely update this infrastructure in response to the changing needs of our business. Our existing IT systems and any new IT systems we utilize may not perform as expected. If we experience a problem with the functioning of an important IT system or a security breach of our IT systems, including during system upgrades or new system implementations, the resulting disruptions could adversely affect our business.

Despite our implementation of reasonable security measures, our IT systems, like those of other companies, are vulnerable to damages from computer viruses, natural disasters, fire, power loss, telecommunications failures, personnel misconduct, human error, unauthorized access, physical or electronic security breaches, cyber-attacks (including malicious and destructive code, phishing attacks, ransomware, and denial of service attacks), and other similar disruptions. Such attacks or security breaches may be perpetrated by bad actors internally or externally (including computer hackers, persons involved with organized crime, or foreign state or foreign state-supported actors). Cybersecurity threat actors employ a wide variety of methods and techniques that are constantly evolving, increasingly sophisticated, and difficult to detect and successfully defend against. Moreover, we may not have the current capability to detect certain vulnerabilities, which may allow those vulnerabilities to persist in our systems over long periods of time. Additionally, it may take considerable time for us to investigate and evaluate the full impact of incidents, particularly for sophisticated attacks. These factors may inhibit our ability to provide prompt, full and reliable information about the incident to our customers, partners, regulators, and the public. Geopolitical tensions or conflicts, such as Russia’s invasion of Ukraine, may further heighten the risk of cyber-attacks. The emergence and maturation of AI capabilities may also lead to new and/or more sophisticated methods of attack, including fraud that relies upon “deep fake” impersonation technology or other forms of generative automation that may scale up the efficiency or effectiveness of cyber-attacks. We have experienced such incidents in the past, and any future incidents could expose us to claims, litigation, regulatory or other governmental investigations, administrative fines and potential liability. Any system failure, accident or security breach could result in disruptions to our operations. A material network breach in the security of our or our service providers’ IT systems could include the theft of our trade secrets, customer information, human resources information or other confidential data, including but not limited to personally identifiable information. Although past incidents have not had a material adverse effect on our business operations or financial performance, to the extent that any disruptions or security breach results in a loss or damage to our data, or an inappropriate disclosure of confidential, proprietary or customer information, it could cause significant damage to our reputation, affect our relationships with our customers and strategic partners, lead to claims against us from governments and private plaintiffs, and otherwise adversely affect our business. We cannot guarantee that future cyberattacks, if successful, will not have a material effect on our business or financial results.

Many governments have enacted laws requiring companies to provide notice of cyber incidents involving certain types of data, including personal data. If an actual or perceived cybersecurity breach of security measures, unauthorized access to our system or the systems of the third-party vendors that we rely upon, or any other cybersecurity threat occurs, we may incur liability, costs, or damages, contract termination, our reputation may be compromised, our ability to attract new customers could be negatively affected, and our business, financial condition, and results of operations could be materially and adversely affected. Any compromise of our security could also result in a violation of applicable domestic and foreign security, privacy or data protection, consumer and other laws, regulatory or other governmental investigations, enforcement actions, and legal and financial exposure, including potential contractual liability. In addition, we may be required to incur significant costs to protect against and remediate damage caused by these disruptions or security breaches in the future. Further, our contracts may not fully protect us from liabilities, damages, or claims and, although we carry cyber insurance, we cannot be certain that our coverage will be adequate for liabilities actually incurred, that insurance will continue to be available to us on commercially reasonable terms, or at all, or that any insurer will not deny coverage as to any future claim. In addition, any data breach, security incident, or compromise of protected personal information may also result in notification requirements or other disclosure obligations and may subject us to civil fines and penalties, litigation, regulatory investigations or enforcement actions or claims for damages under applicable privacy laws.

Our and Grid AI Corp’s failure to adequately secure, protect and enforce our intellectual property rights may undermine our competitive position, and litigation to protect our intellectual property rights may be costly.

Grid AI Corp’s intellectual property is primarily software-based and may be inherently difficult to protect, as patents and formal protections in this area can be limited and enforcement may be uncertain. Grid AI Corp relies in part on trade secrets, proprietary know-how, and contractual protections, which may be vulnerable to unauthorized use, employee misappropriation, or other forms of

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intellectual property theft. In addition, litigation to enforce intellectual property rights is often complex, time-consuming, and costly, and there can be no assurance that the Company will be successful in protecting its intellectual property.

Monitoring unauthorized use of proprietary technology can be difficult and expensive. For example, many of our software developers reside in California and we cannot legally prevent them from working for a competitor.

Also, litigation may be necessary to enforce our intellectual property rights, protect our trade secrets, or determine the validity and scope of the proprietary rights of others. Such litigation may result in Grid AI Corp’s intellectual property rights being challenged, limited in scope or declared invalid or unenforceable. We cannot be certain that the outcome of any litigation will be in our or Grid AI Corp’s favor, and an adverse determination in any such litigation could impair our or Grid AI Corp’s intellectual property rights and may adversely affect our business, prospects and reputation.

We and Grid AI Corp’s rely primarily on patent, trade secret and trademark laws, and non-disclosure, confidentiality, and other types of contractual restrictions to establish, maintain, and enforce our intellectual property and proprietary rights. However, our or Grid AI Corp’s rights under these laws and agreements afford us and Grid AI Corp. only limited protection and the actions we take to establish, maintain, and enforce our intellectual property rights may not be adequate. For example, Grid AI Corp’s trade secrets and other confidential information could be disclosed in an unauthorized manner to third parties, our owned or licensed intellectual property rights could be challenged, invalidated, circumvented, infringed, or misappropriated or our intellectual property rights may not be sufficient to provide us with a competitive advantage, any of which could have a material adverse effect on our business, financial condition and results of operations. Additionally, we and Grid AI Corp’s rely on our brand names, trade names and trademarks to distinguish our products and services. In the event that our trademarks are successfully challenged and we lose rights to use those trademarks, we could be forced to rebrand our products and services, which could result in the loss of goodwill and brand recognition. In addition, the laws of some countries do not protect proprietary rights as fully as do the laws of the U.S. As a result, we may not be able to protect our proprietary rights adequately abroad.

We may face claims that our use of such technology or components infringes or otherwise violates the rights of others, which would subject us to the risks described above. We may seek indemnification from our licensors or suppliers under our contracts with them, but our rights to indemnification or our suppliers’ resources may be unavailable or insufficient to cover our costs and losses.

Negative attitudes toward renewable energy projects from the U.S. government, other lawmakers and regulators, and activists could adversely affect our business, financial condition and results of operations.

Parties with an interest in other energy sources, including lawmakers, regulators, policymakers, environmental and advocacy organizations or other activists may invest significant time and money in efforts to delay, repeal or otherwise negatively influence laws, regulations and programs that promote renewable energy. Many of these parties have substantially greater resources and influence than we and Grid AI Corp. have. Further, changes in U.S. federal, state or local political, social or economic conditions, including changes in U.S. Presidential administrations or deprioritization of these laws, programs and regulations, could result in their modification, delayed adoption or repeal. Any failure to adopt, delay in implementing, expiration, repeal or modification of these programs and regulations, or the adoption of any programs or regulations that encourage the use of other energy sources over renewable energy, could adversely affect our and Grid AI Corp’s business, financial condition and results of operations.

The installation and operation of Grid AI Corp.’s energy storage systems are subject to environmental laws and regulations in various jurisdictions, and there is uncertainty with respect to the interpretation of certain environmental laws and regulations to Grid AI Corp.’s energy storage systems, especially as these regulations evolve over time.

Grid AI Corp. is subject to national, state and local environmental laws and regulations, as well as environmental laws in those foreign jurisdictions in which it operates. Environmental laws and regulations can be complex and are evolving. These laws can give rise to liability for administrative oversight costs, cleanup costs, property damage, bodily injury, fines and penalties. Grid AI Corp. is committed to compliance with applicable environmental laws and regulations, including health and safety standards, and it routinely reviews the operation of its energy storage systems for health, safety and compliance. Grid AI Corp.’s energy storage systems, like other battery technology-based products of which it is aware, produce small amounts of hazardous wastes and air pollutants, and it seeks to handle these materials in accordance with applicable regulatory standards.

Maintaining compliance with laws and regulations can be challenging given the changing patchwork of environmental laws and regulations that prevail at the U.S. federal, state, regional and local levels and in foreign countries in which we operate. Most existing

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environmental laws and regulations preceded the introduction of battery technology and were adopted to apply to technologies existing at the time, namely large, coal, oil or gas-fired power plants. Currently, there is generally little guidance from these agencies on how certain environmental laws and regulations may, or may not, be applied to our technology.

In many instances, Grid AI Corp.’s technology is moving faster than the development of applicable regulatory frameworks. It is possible that regulators could delay or prevent Grid AI Corp. from conducting its business in some way pending agreement on, and compliance with, shifting regulatory requirements. Such actions could delay the sale to and installation by customers of energy storage systems, require their modification or replacement, result in fines, or trigger claims of performance warranties and defaults under customer contracts that could require Grid AI Corp. to refund hardware or service contract payments, any of which could adversely affect our and Grid AI Corp. business, financial performance and reputation.

Changes in the U.S. trade environment, including the imposition of import tariffs, could adversely affect the amount or timing of our revenues, results of operations or cash flows.

The United States has imposed significant new tariffs on nearly all products and components imported into the United States and could propose additional tariffs or increases to those already in place. Escalating trade tensions, particularly between the United States and China, have led to increased tariffs and trade restrictions, including tariffs applicable to certain materials and components for products used in storage or solar energy projects and the renewable energy market more broadly, such as module supply and availability. More specifically, in March 2018, the United States imposed a 25% tariff on steel imports and a 10% tariff on aluminum imports pursuant to Section 232 of the Trade Expansion Act of 1962 and has imposed additional tariffs on steel and aluminum imports pursuant to Section 301 of the Trade Act of 1974. In February 2025, the United States expanded the Section 232 tariffs on steel and aluminum, raising them to 25% on both metals and eliminating previously available country-level and importer-specific exclusions and exemptions. In June 2025, Section 232 tariffs on steel and aluminum were further increased to 50%, and the scope was broadened to cover the steel and aluminum content of a wider range of derivative products. To the extent Grid AI Corp. sources products that contain overseas supplies of steel and aluminum, these tariffs and any additional or increased tariffs could result in interruptions in the supply chain and negatively affect costs and Grid AI Corp.‘s gross margins.

Additionally, in January 2018, the United States adopted a tariff on imported solar modules and cells pursuant to Section 201 of the Trade Act of 1974. The tariff was initially set at 30%, with a gradual reduction over four years to 15%. In 2022, the United States extended the Section 201 solar tariffs for an additional four years, which declined to a rate of 14% in 2025. The Section 201 solar tariffs expired on February 7, 2026. While this tariff did not apply directly to the components we import, it may have indirectly affected Grid AI Corp. by affecting the financial viability of solar energy projects, which could in turn reduce demand for our products. Furthermore, in July 2018, the United States adopted a 10% tariff on a long list of products imported from China under Section 301 of the Trade Act of 1974, including, inverters and power optimizers, which became effective on September 24, 2018 and has been increased several times since then. In June 2019, the Office of the U.S. Trade Representative increased the rate of such tariffs from 10% to 25%. In September 2024, Section 301 tariffs on Chinese solar cells and modules were increased from 25% to 50%, and in January 2025, new 50% Section 301 tariffs took effect on Chinese polysilicon and solar wafers. The Section 301 tariff on lithium-ion non-electric vehicle batteries from China, including those used in energy storage systems, increased from 7.5% to 25% effective January 1, 2026. While these tariffs are not directly applicable to Grid AI Corp.’s products, they could negatively affect the solar energy projects in which its products are used, which could lead to decreased demand for its products. In 2025, the United States broadly imposed additional 10% tariffs on Chinese goods under the International Emergency Economic Powers Act of 1977.

In addition, the United States currently imposes antidumping and countervailing duties on certain imported crystalline silicon photovoltaic (“PV”) cells and modules from China and Taiwan. Such antidumping and countervailing duties can change over time pursuant to annual reviews conducted by the U.S. Department of Commerce (“USDOC”), and an increase in duty rates could have an adverse impact on our operating results.

In February 2022, Auxin Solar Inc., a U.S. producer of crystalline silicon PV products, petitioned the USDOC to investigate alleged circumvention of antidumping and countervailing duties on crystalline silicon PV cell and module imports assembled and completed in Cambodia, Malaysia, Thailand, and Vietnam. In August 2023, USDOC issued a final determination that certain Chinese producers are circumventing antidumping and countervailing duties by shipping crystalline silicon PV cells and modules through Cambodia, Malaysia, Thailand, and Vietnam for minor processing. However, that two-year moratorium has since expired. In 2024, USDOC initiated a second solar antidumping and countervailing duties case involving these same four countries, and final antidumping and countervailing duties orders were issued in June 2025. Also in 2025, the United States also initiated an antidumping and countervailing duties case for Chinese anode material, which could affect battery prices, and USDOC initiated antidumping and

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countervailing duties investigations into imports of solar cell and modules from India, Indonesia, and Laos. The timing and progress of many of Grid AI Corp.’s customers’ projects depend upon the supply of batteries, PV cells and modules. As a result, the imposition and collection of antidumping and countervailing duties, the expanded scope of antidumping and countervailing duties investigations to additional countries and battery materials, and the stacking of multiple tariff authorities on such products, it could adversely affect Grid AI Corp.’s our business, financial condition and results of operations.

Tariffs, and the possibility of additional or increased tariffs in the future, have created uncertainty in the industry, particularly in light of the recent change in U.S. Presidential administration. This has resulted in, and may continue to result in, some project delays. If the price of solar systems or energy storage systems in the United States increases, the use of these products could become less economically feasible and could reduce Grid AI Corp.’s gross margins or reduce the demand of such systems manufactured and sold, which in turn may decrease demand for our products. Additionally, existing or future tariffs may negatively affect key customers, suppliers, and manufacturing partners. Such outcomes could adversely affect the amount or timing of Grid AI Corp.’s revenues, results of operations or cash flows, and continuing uncertainty could cause sales volatility, price fluctuations or supply shortages, or cause our customers to advance or delay their purchase of Grid AI Corp.’s products. It is difficult to predict what further trade-related actions governments may take, which may include additional or increased tariffs and trade restrictions, and we and Grid AI Corp. may be unable to quickly and effectively react to such actions.

Risks Related to our Securities

Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.

Our Common Stock is currently listed for trading on The Nasdaq Stock Market LLC. We must satisfy the continued listing requirements of Nasdaq, to maintain the listing of our Common Stock on The Nasdaq Stock Market LLC.

On ~~August~~September 176, ~~2023~~2024, we received ~~notice~~a letter from the Listing Qualifications Staff ~~(the “Staff”)~~ of Nasdaq indicating that, webased ~~were~~upon the closing bid price of our Common Stock for the last 30 consecutive business days, the Company was not in compliance with the ~~$2.5~~requirement ~~million~~to maintain a minimum ~~stockholders’~~bid ~~equity~~price ~~requirement~~of $1.00 per share for continued listing ofon ~~the~~The ~~Common~~Nasdaq ~~Stock~~Capital ~~on Nasdaq~~Market, as set forth in Nasdaq Listing Rule 5550(ba)(12). ~~(the~~In ~~“Minimum~~accordance ~~Stockholders’~~with ~~Equity~~Nasdaq Listing Rule~~”).~~ ~~In that regard~~5810(c)(3)(A), we ~~reported~~were aprovided ~~stockholders’~~180 ~~deficit of $(881~~days,~~960)~~ inor ~~our~~until ~~Quarterly~~March ~~Report~~5, on2025, ~~Form~~to ~~10-Q~~regain ~~for~~compliance with the ~~period~~minimum ~~ended~~bid ~~June~~price ~~30,~~requirement. ~~2023~~On ~~(we~~March ~~did not then~~6, ~~and do not now~~2025, ~~meet~~we ~~the~~received ~~alternative~~a ~~compliance~~letter ~~standards~~from ~~relating~~Nasdaq toadvising ~~the~~that ~~market~~we ~~value~~had ofbeen ~~listed~~granted ~~securities~~a of180-day ~~$35~~extension, ~~million~~ or ~~net~~until ~~income~~September ~~from~~1, ~~continuing~~2025, ~~operations~~to ofregain ~~$500,000~~compliance inwith the ~~most~~minimum ~~recently~~bid ~~completed~~price ~~fiscal~~requirement, ~~year or~~ in ~~two~~accordance ofwith ~~the~~Nasdaq ~~last~~Listing ~~three~~Rule ~~most recently completed fiscal years~~5810(c)(3)(A). On ~~October~~September 23, ~~2023~~2025, we ~~submitted~~received a ~~plan~~letter tofrom ~~the~~Nasdaq ~~Staff~~that, toNasdaq ~~regain~~has ~~compliance~~determined ~~with~~that for the ~~Minimum~~last ~~Stockholders’~~10 ~~Equity~~consecutive ~~Rule.~~business Ondays, ~~November~~from 13August 18 to September 2, ~~2023~~2025, wethe ~~filed~~closing ~~our~~bid ~~Quarterly~~price ~~Report~~of onthe ~~Form~~Company’s ~~10-Q~~common ~~for~~stock ~~the~~has ~~period~~been ~~ended~~at ~~September~~$1.00 ~~30,~~per ~~2023~~share or greater. Accordingly, ~~reporting~~the ~~total~~Company ~~stockholders’~~has ~~equity~~regained ofcompliance $3with Listing Rule 5550(a)(2),~~278,805~~ asand ofthis ~~September~~matter ~~30,~~is ~~2023~~now closed.

AsOn weJanuary ~~have previously reported~~7, ~~on August 24~~2025, ~~2023,~~ we received a written notice ~~(the “Minimum Bid Price Notice”)~~ from the ~~Staff~~Listing ~~indicating~~Qualifications ~~that,~~department ~~based upon the closing bid price~~ of ~~our~~Nasdaq ~~Common~~indicating ~~Stock~~that ~~for the last 30 consecutive business days, we~~ were not in compliance with ~~the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The~~ Nasdaq ~~Capital Market, as set forth in Nasdaq~~ Listing Rule ~~5550~~5620(a)~~(2).~~, Wedue ~~were~~to ~~provided~~us anot ~~compliance~~holding ~~period~~an ofannual ~~180~~meeting ~~calendar days from the date~~ of ~~the~~stockholders ~~Notice,~~in ~~or until February 20,~~ 2024, towithin ~~regain~~one ~~compliance~~year ~~with~~of ~~the~~our ~~minimum~~2023 ~~bid~~fiscal ~~price~~year ~~rule, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)~~end. IfOn ~~at any time before~~ February 2021, ~~2024~~2025, ~~the~~we ~~closing~~submitted ~~bid~~a ~~price~~plan ofto ~~the~~regain ~~Common Stock closes at or above $1~~compliance.00 ~~per~~On ~~share~~March ~~for~~3, ~~a minimum of 10 consecutive business days~~2025, ~~subject to~~ Nasdaq’s ~~discretion~~informed tous ~~extend~~that ~~this~~it ~~period~~has ~~pursuant~~determined to ~~Nasdaq~~grant ~~Listing~~us ~~Rule~~an ~~5810(c)(3)(G)~~extension tountil 20June ~~consecutive business days~~30, ~~Nasdaq~~2025 ~~will~~to ~~provide~~regain ~~written notification that we have achieved~~ compliance ~~with~~for ~~the~~continued ~~minimum bid price requirement, and the matter would be resolved~~listing. On ~~January~~July 43, ~~2024~~2025, wethe “Company received ~~notice~~a letter from Nasdaq ~~Listing~~notifying ~~Qualifications stating that~~ the ~~Staff~~Company ~~had determined~~ that, ~~for~~as the ~~prior~~Company ~~eleven~~held ~~consecutive~~its ~~business~~Annual ~~days,~~Meeting ~~from~~on ~~December~~June 1830, ~~2023~~2025, toNasdaq ~~January~~had 3,determined ~~2024,~~that the ~~closing~~Company ~~bid~~has ~~price~~regained ofcompliance ~~our~~with ~~Common~~Nasdaq ~~Stock~~Listing ~~had~~Rule ~~been~~5620(a) ~~at $1.00 per share or greater,~~ and ~~accordingly,~~that ~~we had regained compliance with~~ the ~~Bid~~matter ~~Price~~is ~~Rule.~~now closed.

On ~~October~~April 2611, ~~2023~~2025, wethe Company received ~~notice~~a letter from ~~the Staff of~~ Nasdaq indicating that, inthe ~~connection~~Company ~~with~~was ~~our~~not ~~July~~in ~~2023~~compliance ~~Offering,~~with wethe ~~were~~minimum ~~not~~stockholders’ inequity ~~compliance~~requirement ~~with~~for ~~Nasdaq’s~~continued ~~shareholder~~listing ~~approval~~on ~~requirements~~the ~~set~~Nasdaq ~~forth~~Capital inMarket under Listing Rule ~~5635~~5550(db)(1), ~~which~~because ~~requires~~the ~~prior~~Company’s ~~shareholder~~stockholders’ ~~approval~~equity ~~for~~of ~~transactions~~($3,876,738) ~~other~~as ~~than~~reported ~~public~~in ~~offerings~~the Company’s Annual Report on Form 10-K for the period ended December 31, ~~involving~~2024 was below the ~~issuance~~required minimum of ~~20%~~$2.5 ormillion, ~~more~~and because, as of ~~the~~April ~~pre-transaction~~10, ~~shares~~2025, ~~outstanding~~the atCompany ~~less~~did ~~than~~not meet the ~~Minimum~~alternative ~~Price~~compliance standards, ~~defined~~relating asto athe ~~price~~market ~~that~~value isof ~~the~~listed ~~lower~~securities of: ~~(i)~~$35 ~~the~~million ~~Nasdaq~~or ~~official~~net ~~closing~~income ~~Price~~from ~~(as~~continuing ~~reflected~~operations onof ~~Nasdaq.com)~~$500,000 ~~immediately~~in ~~preceding~~ the ~~signing~~most recently completed fiscal year or in two of the ~~binding~~last ~~agreement;~~three ormost ~~(ii)~~recently completed fiscal years. On June 25, 2025, based on the ~~average~~timely ~~Nasdaq~~submission ~~official~~by ~~Closing~~the ~~Price~~Company of a compliance plan, the ~~Common~~Company ~~Stock~~received ~~(as~~a ~~reflected~~letter onfrom Nasdaq~~.com)~~ ~~for~~granting an extension to the ~~five~~Company ~~trading~~until ~~days~~October ~~immediately~~8, ~~preceding~~2025 ~~the~~to ~~signing~~regain ofcompliance with the ~~binding~~minimum ~~agreement~~stockholders’ equity requirement. OnIn ~~December~~the ~~12,~~Form ~~2023,~~8-K ~~during~~filed by the ~~Special~~Company ~~Meeting~~on October 6, ~~our~~2025, the Company disclosed that that it believed that it had stockholders’ ~~ratified~~equity ~~our~~of ~~entry~~at ~~into~~least ~~the~~$2.5 ~~Offering~~million asin wecompliance ~~received~~with the ~~affirmative~~Equity ~~vote~~Rule ofas ~~the~~a ~~majority~~result of the ~~votes~~share ~~cast~~exchange byagreement ~~shares~~dated ofSeptember ~~our~~30, ~~Common~~2025, ~~Stock~~between ~~present~~the orCompany, ~~represented~~Grid byAI ~~proxy~~Corp., and ~~entitled~~the tostockholders ~~vote~~of atall of the ~~Special~~issued ~~Meeting~~and outstanding shares of Grid AI Corp. On ~~March~~October 198, ~~2024~~2025, wethe ~~received~~Company also submitted a letter to Nasdaq stating that the ~~Letter~~Company ofwas ~~Reprimand~~compliant ~~from~~with the ~~Nasdaq~~minimum ~~Listing~~stockholders’ ~~Qualifications~~equity ~~Staff~~requirement ~~stating~~as ~~that,~~a ~~while~~result weof ~~failed~~the toshare ~~comply~~exchange ~~with~~transaction. ~~Nasdaq’s~~On ~~continued~~October ~~listing~~28, ~~requirements~~2025, ~~our~~the ~~violation~~Company ofreceived ~~listing~~a ~~rule~~letter ~~5635(d)~~from ~~does~~Nasdaq ~~not~~confirming ~~appear~~that tobased ~~have~~on ~~been~~ the Form 8-

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~~result~~K offiled aby ~~deliberate~~the ~~intent~~Company toon ~~avoid~~October ~~compliance~~6, ~~and~~2025, asthe ~~such,~~Company is in compliance with the ~~Staff~~Equity ~~does~~Rule. ~~not~~The ~~believe~~Letter also noted that ~~delisting~~if ~~our~~the ~~securities~~Company isfails anto ~~appropriate~~evidence ~~sanction~~compliance ~~and~~upon ~~that~~filing its next periodic report, it ismay ~~appropriate~~be subject to ~~close~~delisting. ~~these~~At ~~matters~~that bytime, ~~issuing~~Nasdaq will provide written notification to the ~~Letter~~Company, ofwhich ~~Reprimand~~may then appeal Nasdaq’s determination to a Hearings Panel.

WeOn April 22 2026, we received anotice ~~letter~~from onNasdaq ~~September~~that 6,we ~~2024~~were ~~from~~not ~~the~~in ~~Listing~~compliance ~~Qualifications~~with ~~Staff~~SEC offilings ~~Nasdaq~~requirements indicating that, ~~based~~it ~~upon~~is ~~the~~not ~~closing~~in ~~bid~~compliance ~~price~~with ofNasdaq ~~our~~Listing ~~Common~~Rule ~~Stock~~5250(c)(1) ~~for~~due ~~the~~to ~~last~~its 30failure ~~consecutive~~to ~~business~~timely ~~days,~~file ~~the~~its ~~Company~~Annual ~~was~~Report ~~not~~on inForm ~~compliance~~10-K ~~with~~for the ~~requirement~~year toended ~~maintain~~December a31, ~~minimum~~2025. ~~bid~~The ~~price~~notice ofprovides ~~$1.00~~the ~~per~~Company ~~share~~with ~~for~~60 ~~continued~~calendar ~~listing~~days, onor ~~The~~until ~~Nasdaq~~June ~~Capital~~22, ~~Market~~2026, asto ~~set~~submit ~~forth~~a inplan ~~Nasdaq~~to ~~Listing~~regain ~~Rule 5550(a)(2)~~compliance. InIf ~~accordance~~the ~~with~~plan is accepted, Nasdaq ~~Listing~~may ~~Rule~~grant ~~5810(c)(3)(A),~~an weexception ~~were~~of ~~provided~~up to 180 calendar days from the original filing due date, or until ~~March~~October 512, ~~2025~~2026, tofor ~~regain compliance with~~ the ~~minimum~~Company ~~bid~~to ~~price~~regain ~~requirement~~compliance.

OnThere ~~March~~can 6,be ~~2025,~~no assurance that we ~~received~~will be able to sustain compliance with all applicable requirements for continued listing on The Nasdaq Stock Market LLC. In 2020, the SEC approved a ~~letter~~previously ~~from~~proposed Nasdaq ~~advising~~rule change to expedite delisting of securities with a closing bid price at or below $0.10 for 10 consecutive trading days during any bid price compliance period and that wehave had ~~been~~one ~~granted~~or more reverse stock splits with a ~~180-day~~cumulative ~~extension,~~ratio of one for 250 or ~~until~~more ~~September~~shares 1,over ~~2025~~the prior two-year period. In addition, toif ~~regain~~a company falls out of compliance with the $1.00 minimum bid price ~~requirement,~~after completing reverse stock splits over the immediately preceding two years that cumulatively result in ~~accordance~~a ~~with~~ratio ~~Nasdaq~~one ~~Listing~~for 250 shares, the company will not be able to avail itself of any bid price compliance periods under Rule 5810(c)(3)(A)., Ifand atNasdaq ~~any~~will ~~time~~instead ~~prior~~require tothe ~~September~~issuance 1,of ~~2025,~~a ~~the~~Staff ~~bid~~delisting ~~price~~determination. ofWe ~~the~~could ~~our~~appeal ~~Common~~the ~~Stock~~determination ~~closes~~to ata ~~$1.00~~hearings ~~per~~panel, ~~share~~which orcould ~~more~~grant ~~for~~us a ~~minimum~~180-day ofexception 10to ~~consecutive~~remain ~~trading~~listed ~~days,~~if it believes we ~~will~~would ~~regain~~be able to achieve and maintain compliance with the ~~minimum~~ bid price requirement. Following the exception, the company would be subject to the procedures applicable to a company with recurring deficiencies (Nasdaq Rule 5815(d)(4)(B)).

~~The~~In ~~extension~~addition, ~~notice has no immediate effect on the listing of our Common Stock on The~~ Nasdaq ~~Capital~~advised ~~Market~~that ~~and does not affect our reporting requirements with~~ the ~~Securities~~Grid ~~and~~AI ~~Exchange Commission~~Corp. Iftransaction weconstituted doa ~~not~~business ~~regain~~combination ~~compliance~~resulting ~~with~~in ~~the~~a ~~minimum~~change ~~bid~~of ~~price~~control ~~requirement~~under ~~during the additional 180-day extension,~~ Nasdaq ~~will~~rules ~~provide~~and ~~written notification~~ that ~~our~~the ~~Common~~post-transaction ~~Stock~~entity ~~will~~would be ~~delisted.~~required ~~At that time, we may appeal the delisting determination~~ to asatisfy ~~hearings~~Nasdaq ~~panel~~initial ~~pursuant~~listing tostandards ~~the~~and ~~procedures~~complete ~~set forth in~~ the applicable Nasdaq ~~Listing~~review ~~Rules.~~process ~~However,~~in ~~there~~connection ~~can~~with ~~be no assurance that, if~~ the ~~Company~~second ~~does~~step ~~appeal~~of the ~~delisting~~transaction. ~~determination~~Failure ~~by Nasdaq~~ to ~~the~~satisfy ~~hearings~~Nasdaq’s ~~panel~~requirements, ~~that~~whether ~~such~~relating ~~appeal~~to ~~would~~stockholders’ beequity, ~~successful. There can be no assurance that we will regain compliance with the minimum~~ bid price, ~~requirement~~corporate ~~during~~governance, ~~the~~shareholder ~~additional 180-day compliance period ending September 1~~approval, ~~2025~~initial ~~or maintain compliance with any other Nasdaq~~ listing ~~requirement.~~criteria Weor ~~intend~~otherwise, tocould ~~monitor~~result ~~the~~in ~~closing~~delisted ~~bid price of~~ our Common Stock ~~and~~from ~~may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirement~~Nasdaq.

On January 7, 2025, we received a written notice from the Listing Qualifications department of Nasdaq indicating that were not in compliance with Nasdaq Listing Rule 5620(a), due to us not holding an annual meeting of stockholders in 2024 within one year of our 2023 fiscal year end. On February 21, 2025, we submitted a plan to regain compliance. On March 3, 2025, Nasdaq informed us that it has determined to grant us an extension until June 30, 2025 to regain compliance for continued listing.

There can be no assurance that we will be able to ultimately regain and sustain compliance with all applicable requirements for continued listing on The Nasdaq Stock Market LLC. In 2020, the SEC approved a previously proposed Nasdaq rule change to expedite delisting of securities with a closing bid price at or below $0.10 for 10 consecutive trading days during any bid price compliance period and that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period. In addition, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any bid price compliance periods under Rule 5810(c)(3)(A), and Nasdaq will instead require the issuance of a Staff delisting determination. We could appeal the determination to a hearings panel, which could grant us a 180-day exception to remain listed if it believes we would be able to achieve and maintain compliance with the bid price requirement. Following the exception, the company would be subject to the procedures applicable to a company with recurring deficiencies (Nasdaq Rule 5815(d)(4)(B)).

In the event that we are unable to regain and sustain compliance with all applicable requirements for continued listing on the Nasdaq, our Common Stock may be delisted from Nasdaq. If our Common Stock were delisted from Nasdaq, trading of our Common Stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our Common Stock on an over-the-counter market, and many investors would likely not buy or sell our Common Stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our Common Stock would be subject to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our Common Stock. In addition, delisting would materially and adversely affect our ability to raise capital on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our Common Stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.

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The limited public market for our securities may adversely affect an investor’s ability to liquidate an investment in us.

Although our Common Stock is currently listed on the Nasdaq Capital Market, there is limited trading activity. We can give no assurance that an active market will develop, or if developed, that it will be sustained. If an investor acquires shares of our Common Stock, the investor may not be able to liquidate our shares should there be a need or desire to do so.

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The market price of our Common Stock may be volatile which could subject us to securities class action litigation and prevent you from being able to sell your shares at or above the offering price.

The market price for our Common Stock has been and may continue to be volatile and subject to wide fluctuations in response to factors including the following:

●

sales or potential sales of substantial amounts of our Common Stock, including sales required for us to regain and maintain compliance with Nasdaq’s continued listing requirements;

●

the Grid AI Corp. transaction, related shareholder approvals, Series H conversion issues or other capital structure developments

●

delay or failure in initiating or completing pre-clinical or clinical trials or unsatisfactory results of these trials;

●

announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;

●

developments relating to the Grid AI and AMPX business

●

developments concerning our licensors or product manufacturers;

●

litigation and other developments relating to our patents or other proprietary rights or those of our competitors;

●

conditions in the pharmaceutical or biotechnology industries;

●

governmental regulation and legislation;

●

variations in our anticipated or actual operating results;

●

change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations; foreign currency values and fluctuations; and

● overall economic, geopolitical or capital markets conditions.

Many of these factors are beyond our control. The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors could reduce the market price of our Common Stock, regardless of our actual operating performance.

We have never paid and do not intend to pay cash dividends on our Common Stock. As a result, capital appreciation, if any, will be your sole source of gain.

We have never paid cash dividends on any of our capital stock and we currently intend to retain future earnings, if any, to fund the development and growth of our business. Our Series B Preferred Stock carries a dividend rate of 9.0% per year, which is cumulative and continues to accrue on a daily basis whether or not declared and whether or not we have assets legally available therefor. We may pay such dividends at our option either in cash or in kind in additional shares of preferred stock. We do not expect to pay any dividends in cash and have paid accrued dividends in kind in additional shares of preferred stock to date. In addition, the terms of future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our Common Stock will be your sole source of gain for the foreseeable future.

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Provisions in our Charter, our amended and restated by-laws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.

Provisions of our Charter, our amended and restated by-laws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:

●

the inability of stockholders to call special meetings;

●

the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our board of directors;

●

advance notice required for any nomination or other business to be properly brought before an annual meeting of stockholders which requires notice to be delivered to our secretary not later than the close of business on the 90th day, nor earlier than the close of business on the 120th day prior to the first anniversary of the preceding year’s annual meeting, subject to certain exceptions;

●

any vacancies on our board of directors that results from the death, disability, resignation, disqualification or removal of any director or from any other cause shall be filled solely by the affirmative vote of a majority of the total number of directors then in office, even if less than a quorum, or by a sole remaining director and shall not be filled by the stockholders; provided that a vacancy created by the removal of a director by the stockholders may be filled by the stockholders; and

●

forum selection provisions that state that unless we consent in writing to the selection of an alternative forum, (A) (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any current or former director, officer, other employee or stockholder of the Company to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware (“DGCL”), the Charter or the by-laws as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware or (iv) any action asserting a claim governed by the internal affairs doctrine of the law of the State of Delaware shall, to the fullest extent permitted by law, be exclusively brought in the Court of Chancery of the State of Delaware or, if such court does not have subject matter jurisdiction thereof, the federal district court of the State of Delaware; and (B) the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

In addition, Section 203 of the DGCL prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.

The existence of the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our Common Stock. They could also deter potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for your Common Stock in an acquisition.

If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendations regarding our shares or if our results of operations do not meet their expectations, our share price and trading volume could decline.

The trading market for our shares is influenced by the research and reports that industry or securities analysts publish about us or our business. We do not have any control over these analysts. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline. Moreover, if one or more of the analysts who cover us downgrade our stock, or if our results of operations do not meet their expectations, our share price could decline.

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We currently have Series B Preferred Stock, ~~and~~ Series G Preferred Stock and Series H preferred Stock outstanding. Our certificate of incorporation authorizes our Board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our Common Stock.

Our Board has the authority to fix and determine the relative rights and preferences of preferred stock. Our Board also has the authority to issue preferred stock without further stockholder approval.

As of ~~April~~May 1, ~~2025~~2026, we have approximately 475.56 shares of Series B Preferred Stock outstanding with a stated value of $7,700 per share, which are currently convertible at the holder’s option at any time, together with any accrued but unpaid dividends thereon, into shares of Common Stock at a conversion price of $3297,~~340~~020, subject to certain adjustments.

Our Series B Preferred Stock gives its holders the preferred right to our assets upon liquidation and the right to receive dividend payments at 9.00% per annum before dividends are distributed to the holders of Common Stock, among other things. The holders of the Series B Preferred Stock, voting as a separate class, also have customary consent rights with respect to certain corporate actions, including the issuance of an increased number of shares of Series B Preferred Stock, the establishment of any capital stock ranking senior to or on parity the Series B Preferred Stock as to dividends or upon liquidation, the incurrence of indebtedness, and certain changes to our Charter or Bylaws including other actions.

Our Board also created the following series of preferred stock: (i) Series C Preferred Stock (“Series C Preferred Stock”), of which 75,000 shares are authorized for issuance, none of which are currently outstanding; (ii) Series D Preferred Stock (“Series D Preferred Stock”), of which 150 shares are authorized for issuance, none of which are currently outstanding; (iii) Series E Preferred Stock (“Series E Preferred Stock”), of which 150 shares are authorized for issuance, none of which are currently outstanding; and (iv) Series F Preferred Stock (“Series F Preferred Stock”), of which 7,000 shares are authorized for issuance, none of which are currently outstanding.

As of ~~April~~May 1, ~~2025~~2026, we ~~also~~ have ~~12,373~~595.~~226~~808 shares of Series G Preferred Stock outstanding, each share of which is convertible into 1,000 shares of Common Stock, upon shareholder approval. InAs ~~consideration~~result ~~for~~of the ~~Merger,~~ImmunogenX werescission ~~issued~~agreement 11,777.418 shares of Series G Preferred Stock tothat ~~the~~we ~~shareholders~~previously ofissued ~~IMGX.~~to ~~Upon consummation of~~ the ~~transactions~~shareholders ~~contemplated in the Rescission Agreement, these shares~~ of ~~Series~~IMGX Gwere ~~Preferred Stock will be~~ cancelled. In addition, in connection with the Merger, we issued 595.808 shares of Series G Preferred Stock to a financial advisor and these shares of Series G Preferred Stock are expected to be exchanged for Common Stock.

As to our Series G Preferred Shares, following shareholder approval of the conversion of the Series G Preferred Stock into Common Stock, if any, in accordance with the listing rules of the Nasdaq Stock Market, each share of Series G Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain limitations, including that a holder of Series G Preferred Stock is prohibited from converting shares of Series G Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion. Except as otherwise required by law, the Series G Preferred Stock does not have voting rights. We do not plan to seek such shareholder approval. However, as long as any shares of Series G Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series G Preferred Stock, make certain corporate actions. The Series G Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.

~~Our~~As ~~obligations to our existing holdersof the preferred stock and any future holders~~ of ~~any~~May ~~additional~~1, ~~series~~2026, ~~of preferred stock~~ we ~~may~~also ~~issue~~have ~~could~~38,801.546 ~~limit~~shares ~~our~~of ~~ability~~Series toH ~~obtain~~Preferred ~~additional~~Stock ~~financing~~outstanding, oreach ~~increase~~share ~~our~~of ~~borrowing costs,~~ which ~~could~~is ~~have~~automatically anconvertible ~~adverse~~into ~~effect~~1,000 onshares ~~our~~of ~~financial~~Common ~~condition~~Stock ~~and~~into ~~hinder~~1,000 ~~the~~shares ~~accomplishment~~ of ~~our~~Common ~~corporate~~Stock, ~~goals~~upon shareholder approval.

InAs ~~addition~~ to our Series H Preferred Stock shares, following shareholder approval of the ~~above-referenced~~conversion ~~preferred~~of ~~stock~~the Series H Preferred Stock into Common Stock, ~~our~~if ~~Board~~any, ~~could~~in ~~authorize~~accordance with the ~~issuance~~listing rules of ~~additional~~the ~~series~~Nasdaq Stock Market, each share of ~~preferred~~Series ~~stock~~H ~~with~~Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain limitations, including that a holder of Series H Preferred Stock is prohibited from converting shares of Series H Preferred Stock into shares of Common Stock if, as a result of such ~~rights~~conversion, ~~preferential~~such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the ~~rights~~holder between 4.9% and 19.9%) of ~~our~~the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion) in six equal installments, ~~including~~with each installment representing one-sixth of the ~~issuance~~aggregate number of Conversion Shares issuable upon conversion of all of the Series H Preferred Stock held by a ~~series~~holder if converted in full automatically and without an action required on the part of ~~preferred~~the ~~stock~~holder ~~that~~thereof ~~has~~within ~~greater~~five business days of the achievement of each of six different milestone events relating to the business of AMPX as set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series H Non-Voting Convertible Preferred Stock. Except as otherwise required by law, the Series H Preferred Stock does not have voting ~~power~~rights. ~~than~~However, ~~our~~as ~~Common~~long as any shares of Series H Preferred Stock are outstanding, the Company will not, without the written consent or ~~that~~affirmative isvote ~~convertible~~of ~~into~~the ~~our~~holders ~~Common~~of a majority of the then outstanding shares of the Series H Preferred Stock, ~~which~~make ~~could~~certain ~~decrease~~corporate actions. With respect to distribution of assets upon liquidation, dissolution or winding up of the ~~relative~~Company, ~~voting~~whether ~~power~~voluntary or involuntary, all shares of ~~our~~Series ~~Common~~H Preferred Stock orshall ~~result~~rank: in(i) ~~dilution~~senior to ~~our~~all ~~existing~~junior ~~stockholders.~~securities; (ii) on parity with the Common Stock any other class or series

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of preferred stock of the Company hereafter created specifically ranking, by its terms, on parity with the Series H Preferred Stock; and (iii) junior to the Series B Convertible Preferred Stock any other class or series of Preferred Stock or other capital stock of the Company hereafter created specifically ranking, by its terms, senior to the Series H Preferred Stock.

Our obligations to our existing holders of the preferred stock and any future holders of any additional series of preferred stock we may issue could limit our ability to obtain additional financing or increase our borrowing costs, which could have an adverse effect on our financial condition and hinder the accomplishment of our corporate goals.

In addition to the above-referenced preferred stock, our Board could authorize the issuance of additional series of preferred stock with such rights preferential to the rights of our Common Stock, including the issuance of a series of preferred stock that has greater voting power than our Common Stock or that is convertible into our Common Stock, which could decrease the relative voting power of our Common Stock or result in dilution to our existing stockholders.

ITEM 1B.UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 1C. CYBERSECURITY

Cybersecurity Risk Management and Strategy

~~Entero~~We ~~Therapeutics,~~maintain ~~Inc. has established~~ a ~~comprehensive~~ cybersecurity risk management program ~~aimed~~designed atto ~~safeguarding~~support the confidentiality, integrity, and availability of our ~~essential~~information systems and ~~information~~data. ~~Central~~Our cybersecurity program is intended to ~~our~~identify, assess, manage and respond to cybersecurity ~~efforts~~risks isaffecting aour ~~robust~~corporate ~~incident~~systems, ~~response~~legacy ~~plan~~life ~~designed~~sciences toactivities ~~address~~and, ~~potential~~following ~~cyber~~the ~~incidents~~acquisition ~~swiftly~~of Grid AI Corp., the software-enabled energy orchestration and ~~effectively~~related digital infrastructure associated with the Grid AI and AMPX businesses.

In designing and evaluating our cybersecurity initiatives, we ~~have~~use ~~adopted~~ the National Institute of Standards and Technology Cybersecurity Framework, (or NIST CSF, ~~2.0)~~ as a ~~guiding~~reference ~~principle.~~point ~~It’s~~for ~~important~~structuring toaspects ~~clarify~~of ~~that~~ our ~~use~~cybersecurity ofrisk ~~the~~identification, ~~NIST~~assessment ~~CSF~~and 2response processes.0 isOur ~~for~~use ~~guidance~~of ~~purposes~~that toframework ~~frame~~is ~~our~~intended ~~risk~~as ~~identification,~~a ~~assessment,~~guiding ~~and~~tool ~~management processes~~ and does not ~~equate~~mean tothat we certify compliance with any ~~specific~~particular technical ~~standards~~standard or ~~requirements~~framework requirement.

Our cybersecurity ~~framework~~processes isare integrated into ~~Entero’s~~our broader enterprise risk management ~~strategy,~~activities ~~sharing~~and ~~methodologies~~are intended to align with our legal, ~~reporting~~compliance, ~~mechanisms~~strategic, operational and ~~governance~~financial ~~structures~~risk ~~with~~oversight ~~other~~processes. ~~risk~~Because ~~domains~~our ~~including~~current ~~legal~~business includes software platforms, ~~compliance~~cloud-based systems, ~~strategic~~third-party integrations, ~~operational~~digital communications and data processing activities, cybersecurity and ~~financial~~information ~~risks~~security are important operational and governance considerations.

Key ~~components~~elements of our cybersecurity risk management program include:

● ~~Conducting~~periodic ~~risk~~assessment ~~assessments~~of ~~to pinpoint~~ material cybersecurity ~~threats~~risks toaffecting our ~~critical~~ systems, data, ~~products,~~software ~~services~~environments, ~~and~~third-party ~~overall~~integrations ITand ~~infrastructure;~~related operations

● Ause ~~dedicated~~of ~~security~~internal ~~consultant~~and ~~overseeing~~external ~~the~~resources ~~risk~~to ~~assessment~~support ~~process,~~cybersecurity ~~maintenance of security controls~~monitoring, assessment and ~~coordination~~response ~~of responses to cybersecurity incidents;~~activities

● ~~Engagement~~incident ~~with~~response ~~external~~planning ~~service~~intended ~~providers~~ to ~~evaluate~~facilitate the identification, ~~enhance~~escalation, orcontainment, ~~support~~investigation ~~our~~and ~~security~~remediation ~~measures;~~of cybersecurity incidents

● ~~Comprehensive~~use ~~cybersecurity~~of ~~training~~employee ~~programs~~awareness ~~for~~measures ~~employees, incident responders,~~ and ~~senior~~security-related ~~management~~processes designed to ~~foster~~reduce ahuman-factor ~~culture of security awareness;~~risk

● Anthird-party ~~incident~~risk ~~response~~management ~~plan~~processes ~~outlining~~intended ~~specific~~to ~~procedures~~evaluate ~~for~~cybersecurity ~~managing~~considerations ~~cybersecurity~~associated ~~incidents;~~with selected vendors, service providers, software providers, infrastructure providers and other external parties

● Acoordination ~~thorough~~among ~~third-party risk~~ management, ~~process~~outside toadvisers ~~evaluate~~ and, ~~manage~~where ~~risks~~appropriate, ~~associated~~the ~~with~~Audit ~~service~~Committee ~~providers,~~and ~~suppliers,~~Board ~~and~~regarding ~~vendors~~significant cybersecurity matters.

ToOur ~~date,~~business werelies ~~have~~on ~~not~~third-party ~~identified~~systems ~~any~~and ~~cybersecurity~~services, ~~threats~~including orcloud ~~past~~infrastructure, ~~incidents~~software ~~that~~tools, ~~have~~communications ~~had~~systems, orexternal ~~are~~consultants, ~~likely~~data toproviders ~~have~~and other vendors. In addition, athe ~~material~~Grid ~~impact~~AI and AMPX business depends in part on ~~our~~integrations ~~Company’s~~with ~~operations~~third-party devices, ~~business~~platforms, ~~strategy~~utilities, ~~financial~~market ~~performance,~~operators orand ~~results~~other ofexternal ~~operations~~systems. As a result, our cybersecurity and operational

Our external security expert has over thirty years of experience with cybersecurity, information technology development and deployment and information technology risk assessment and management, including information security management.-56-

~~Cybersecurity~~Table ~~Governance~~of Contents

~~The~~resilience ~~governance~~may ofalso ~~cybersecurity~~depend ~~risks~~on isthe acybersecurity ~~critical~~practices ~~function~~and ofcontrols ~~our Board~~ of ~~Directors,~~third ~~with~~parties. ~~the~~Although ~~Audit~~we ~~Committee~~seek ~~playing~~to aevaluate ~~key role in the oversight of cybersecurity~~ and ~~related~~manage ~~technology~~these risks., ~~The~~third-party ~~Audit~~systems ~~Committee~~and isservices ~~tasked~~remain ~~with~~a ~~monitoring~~source ~~the effectiveness~~ of ~~our~~potential ~~cybersecurity risk management program as implemented by management~~exposure.

~~The~~As ~~Audit~~of ~~Committee~~the ~~will~~date ~~receive~~of ~~regular~~this ~~updates~~Annual ~~from~~Report, ~~management~~we onhave ~~the~~not ~~state~~identified ofany cybersecurity ~~risks~~incident ~~facing~~that ~~the~~we ~~company.~~believe ~~This~~has ~~will~~materially ~~include~~affected, ~~briefings~~or onis ~~any~~reasonably ~~significant~~likely ~~cyber~~to ~~incidents~~materially affect, our business strategy, results of operations or financial condition. However, like other public companies and technology-enabled businesses, we face ongoing ~~risk~~cybersecurity ~~management~~risks, ~~efforts.~~and ~~These~~there ~~updates~~can ~~will~~be ~~enable~~no ~~the~~assurance ~~Audit~~that ~~Committee~~we towill ~~provide~~not ~~informed~~experience ~~reports~~a onmaterial cybersecurity ~~matters~~incident toin the ~~full Board~~future.

~~-51-~~Cybersecurity Governance

~~Table~~Our Board of ~~Contents~~Directors has oversight responsibility for risk management generally, including cybersecurity risk. The Audit Committee assists the Board in its oversight of cybersecurity and related information technology and data protection risks.

~~Our~~Management ~~Audit~~is ~~Committee~~responsible isfor ~~actively~~the ~~involved~~day-to-day inassessment ~~our~~and management of cybersecurity ~~oversight~~risks. Management uses internal personnel and ~~under~~external ~~our~~advisers, ~~new~~as ~~Cybersecurity~~appropriate, ~~Policy~~to ~~adopted~~support oncybersecurity ~~March~~risk 11identification, ~~2024~~security-related processes, ~~will~~incident ~~receive~~response ~~detailed~~planning ~~briefings~~and ~~from~~evaluation ~~our~~of ~~external~~significant ~~cybersecurity~~cyber-related ~~expert~~issues. Management is also responsible for escalating significant cybersecurity matters to the Audit Committee and Board, as appropriate.

The ~~responsibility~~Audit ~~for~~Committee ~~day-to-day~~receives updates from management ofregarding material cybersecurity risks ~~lies~~and ~~with~~cybersecurity-related ~~our~~developments as management ~~team~~determines appropriate, including ~~the~~updates ~~Chief~~regarding ~~Financial~~significant ~~Officer.~~incidents, ~~This~~if ~~team is at the forefront of our cybersecurity initiatives~~any, ~~coordinating both internal~~ and ~~external~~material ~~resources~~aspects toof ~~anticipate,~~the ~~identify,~~Company’s ~~and~~cybersecurity ~~mitigate~~risk ~~cyber~~management ~~threats~~efforts. ~~Our~~The ~~approach~~Audit ~~includes~~Committee ~~regular~~then ~~updates~~reports ~~from~~to ~~our~~the ~~external security expert~~Board, ~~leveraging~~as ~~intelligence from various sources~~appropriate, ~~and~~on ~~utilizing~~cybersecurity ~~advanced~~matters ~~security~~relevant ~~tools~~ to ~~protect~~the ~~our~~Board’s ~~digital~~oversight ~~environment~~responsibilities.

~~ITEM 2~~Because our business includes software-enabled energy orchestration activities and associated digital infrastructure, our cybersecurity governance processes are intended to consider risks not only to traditional corporate information systems, but also to operational software platforms, third-party-connected environments, data handling practices and other digital elements of the Grid AI Corp.~~PROPERTIES~~ and AMPX business.

ITEM 2.PROPERTIES

~~Facilities~~

~~We lease the space for our principal executive offices at 777 Yamato Road, Suite 502, Boca Raton, FL 334315. We believe that our facility is adequate to meet our current needs.~~Facilities

~~ITEM 3~~The Company no longer maintains a dedicated leased office space and operates using a remote and flexible office model.~~LEGAL PROCEEDINGS~~ The Company believes its current arrangements are adequate to meet its operational needs.

ITEM 3.LEGAL PROCEEDINGS

On December 31, 2024, Mattress Liquidators, Inc. filed a Complaint in the District Court, Boulder County, State of Colorado against Defendants IMGX, Jack A. Syage andElizabeth T. Syage Revocable Trust, Case No. 2024CV31070.

~~Succinctly,~~On ~~Plaintiff~~March ~~complains that it entered into a Credit Agreement on October 3~~17, ~~2022 with IMGX for a loan in the principal amount of $6~~2025,~~000,000. Jack~~ ~~Syage~~Ellenoff ~~and~~Grossman ~~Elizabeth~~& T.Schole ~~Syage~~LLP ~~Revocable~~(“EGS”) ~~Trust~~filed ~~executed~~ a ~~Guaranty~~lawsuit ofagainst ~~Payment~~the ~~that~~Company ~~same~~in ~~day. The Credit Agreement was modified on September 6, 2023, which increased~~ the ~~principal~~Supreme ~~amount~~Court of the ~~loan~~State toof ~~$7,500,000.~~New ~~Once more~~York, onCounty ~~March~~of ~~13,~~New ~~2024~~York, ~~the~~seeking ~~Credit Agreement was modified~~ to ~~increase~~recover ~~the~~unpaid ~~principal~~legal ~~amount~~fees, ofcosts, ~~the~~and ~~loan to $8,212,345~~disbursements.~~17. Plaintiff~~ EGS alleges that in the ~~summer~~Company offailed ~~2024,~~to ~~Defendants~~pay ~~were~~for ~~not~~legal ~~repaying~~services ~~the~~rendered ~~loan~~from soSeptember on2023 ~~August~~through 2,January ~~2024,~~2025 aand ~~Notice~~asserts ofclaims ~~Default~~for ~~was~~breach ~~sent, which demanded immediately payment~~ of ~~the entire balance. After being provided with additional information~~contract, onaccount ~~August 29~~stated, ~~2024, Plaintiff suspended the Notice of Default~~ and ~~demanded~~quantum ~~Defendants~~meruit. ~~provide~~EGS ~~certain~~is ~~financial~~seeking ~~reporting~~monetary ~~information~~damages ~~under Section 7.5~~ of ~~the~~approximately ~~Credit~~$749,301, ~~Agreement. On~~plus ~~October~~applicable 11interest, ~~2024~~costs, ~~November~~and 7,disbursements. ~~2024,~~The ~~and~~parties ~~November~~have ~~14,~~entered ~~2024,~~into ~~Plaintiff~~multiple ~~sent~~stipulations ~~Defendants~~extending ~~letters~~the ofCompany’s ~~non-compliance~~deadline ~~regarding~~to ~~their~~respond ~~financial~~to ~~reporting~~the ~~obligations~~complaint. ~~Thereafter,~~ onMost ~~November 21~~recently, ~~2024,~~on ~~Plaintiff~~July ~~sent Defendants a Notice of Default and Demand for Payment~~28, ~~which accelerated the Loan obligations~~2025, ~~demanded that Defendants cure~~ the ~~financial~~deadline ~~reporting~~to ~~defaults~~answer, ~~and~~move, ~~demanded~~or ~~that~~otherwise ~~Defendants~~respond ~~pay~~was ~~all~~extended ~~loan~~to ~~obligations~~January ~~no later than December 5~~13, ~~2024~~2026.

~~Plaintiff~~On ~~claims~~January ~~that as of December 31~~12, ~~2024~~2026, ~~the~~EGS ~~total~~made ~~amount~~a ~~due~~settlement ~~and~~proposal ~~owing~~to isresolve ~~$7,575,568.91,~~the ~~which~~matter ~~consists~~for of $7450,~~460~~000,~~245.47~~ inconsisting ~~principal,~~of ~~$115,323.44~~an ininitial ~~accrued~~payment ~~contract~~of ~~interest~~$150,000 ~~and~~upon ~~$47,069~~execution inof ~~authorized~~a ~~attorneys’~~settlement ~~fees~~agreement and ~~costs. Plaintiff~~the ~~asserts~~remaining ~~three~~$300,000 ~~causes~~payable ofin ~~action.~~equal ~~The~~monthly ~~first~~installments isover ~~against~~a ~~IMGX~~period ~~for alleged breach~~ of ~~the~~12 ~~Credit~~to ~~Agreement~~16 months. ~~The~~ ~~other~~EGS ~~two~~indicated ~~causes~~that ofit ~~action~~would ~~asserted~~not ~~are~~accept ~~alleged~~payment ~~breaches~~contingent ofon ~~the~~financing ~~Guaranty’s~~or byconsideration ~~Jack~~in ~~Syage, and~~ the ~~Elizabeth~~form T.of ~~Syage Revocable Trust~~equity.

~~After~~The ~~receiving~~Company andeclined ~~extension,~~this ~~IMGX~~proposal ~~timely~~and ~~filed~~has ~~its~~since ~~Answer~~continued onto ~~February~~engage ~~28,~~in ~~2025.~~discussions ~~The~~with ~~case~~EGS isregarding ~~now~~a atpotential ~~issue~~resolution. AAs ~~required~~of ~~meet~~the ~~and~~date ~~confer~~of ~~with~~this ~~counsel~~Annual toReport, ~~discuss~~the ~~drafting~~parties ~~the~~are ~~(proposed)~~actively ~~case~~negotiating ~~management~~a ~~order~~settlement, and toEGS ~~discuss~~has ~~procedural~~proposed ~~matters~~a ~~was~~resolution ~~held~~in onthe ~~March~~range ~~14,~~of ~~2025~~approximately $400,000. ~~Our~~There ~~Initial~~can ~~Disclosures~~be ~~are~~no ~~due~~assurance that the parties will reach a settlement on ~~April~~acceptable 4terms or at all, ~~2025~~or as to the timing of any such resolution. See Note 17 in financial statements.

~~Under~~ITEM 4.MINE ~~the~~SAFETY terms of the Rescission Agreement entered into in March 2025, by and among the Company, IIMGX, and each of the individuals or entities who are the former shareholders of IMGX, upon consummation of the transactions contemplated in Recission Agreement, the Company shall have no further duties, liabilities or obligations in connection with this complaint.DISCLOSURES

~~ITEM 4.MINE SAFETY DISCLOSURES~~

None.

~~None.~~-57-

~~-52-~~Table of Contents

~~Table of Contents~~PART II

~~PART II~~ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

~~ITEM~~Market ~~5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES~~Information

Our Common Stock is listed on The Nasdaq Capital Market ~~Information~~under the symbol “GRDX.”

~~Our~~Holders ~~Common~~of ~~Stock is listed on the Nasdaq Capital Market, or Nasdaq, under the symbol “ENTO”.~~Record

~~Holders~~As of ~~Record~~May 1, 2026, there were 6,200,051 shares of our Common Stock issued and outstanding and approximately 57 holders of record.

~~At April 1, 2025, there were 4,765,729 shares of our Common Stock issued and outstanding and approximately 85 stockholders of record.~~Dividends

~~Dividends~~We did not declare or pay any dividends on our Common Stock during the years ended December 31, 2025 and 2024. We currently intend to retain any future earnings, if any, to fund operations, working capital needs, strategic initiatives and the development of our business. Accordingly, we do not currently anticipate paying cash dividends on our Common Stock in the foreseeable future.

WeAny ~~did not declare any dividends on our Common Stock for the years ended December 31, 2024 and 2023, respectively. Our board of directors does not intend to distribute dividends in the~~ future. ~~Instead,~~determination ~~we plan~~ to ~~retain~~declare ~~any earnings to finance the development of our product candidates~~ and ~~expansion~~pay ~~of our business. The declaration, payment and amount of any future~~ dividends will be ~~made~~ at the discretion of ~~the~~our board of directors, and will depend ~~upon,~~on ~~among~~our ~~other things, the~~ results of ~~our~~ operations, ~~cash flows and~~ financial condition, ~~operating~~cash ~~and~~requirements, capital requirements, contractual restrictions, available surplus and other factors asthat ~~the~~our board of directors ~~considers~~may deem relevant. ~~There is no assurance that future dividends will be paid, and if dividends are paid, there is no assurance with respect to the amount of any such dividend.~~

~~Future~~Cumulative ~~cash~~ dividends, ifon ~~any, will be at~~ the ~~discretion~~shares of our ~~board~~Series ofB ~~directors~~Preferred ~~and~~Stock ~~will~~accrue ~~depend~~at ~~upon~~the ~~our~~rate ~~future~~of ~~operations~~9% ~~and~~of ~~earnings,~~the ~~capital~~stated ~~requirements~~value ~~and~~per ~~surplus~~annum, ~~general~~payable ~~financial~~semi-annually ~~condition,~~on ~~contractual~~June ~~restrictions~~30 and ~~other~~December ~~factors~~31 asof ~~our~~each ~~board~~year, ofcommencing ~~directors~~on ~~may~~December ~~deem~~31, ~~relevant~~2020. WeSuch ~~can pay~~ dividends ~~only~~are ~~out~~payable ofin ~~our~~additional ~~profits~~shares orof ~~other~~Series ~~distributable~~B ~~reserves~~Preferred ~~and~~Stock, ~~dividends~~valued orat ~~distribution~~the ~~will~~stated ~~only~~value, ~~be paid~~ or ~~made~~in ifcash weat ~~are able to pay~~ our ~~debts~~sole ~~as they fall due in the ordinary course of business~~option.

~~Cumulative~~Securities ~~dividends~~Authorized onfor ~~the~~Issuance ~~shares~~Under ofEquity ~~Series~~Compensation B Preferred Stock accrue at the rate of 9% of the Stated Value per annum, payable semi-annually on June 30 and December 31 of each year, commencing on December 31, 2020. Dividends are payable in additional shares of Series B Preferred Stock valued at the Stated Value or in cash at our sole option.Plans

~~Securities~~See ~~Authorized~~Item ~~for~~12. ~~Issuance~~– ~~Under~~Security ~~Equity~~Ownership ~~Compensation~~of ~~Plans~~Certain Beneficial Owners and Management and Related Shareholder Matters.

~~See~~Unregistered ~~Item~~Sales ~~12. – Security Ownership~~ of ~~Certain~~Equity ~~Beneficial Owners and Management and Related Shareholder Matters.~~Securities

~~Unregistered~~During ~~Sales~~the year ended December 31, 2025, we issued securities in transactions exempt from the registration requirements of ~~Equity~~the Securities Act of 1933, as amended, as described below

InDuring ~~March~~the ~~2024,~~year ~~April~~ended ~~2024~~December ~~and~~31, ~~June 2024~~2025, wethe Company issued ancertain ~~aggregate~~securities ofin ~~350,000~~transactions ~~shares~~exempt offrom ~~Common~~the ~~Stock~~registration torequirements aof ~~consultant~~the ~~with~~Securities aAct ~~grant~~of ~~date~~1933, ~~fair~~as ~~value~~amended, ofthat ~~approximately~~were ~~$1.5~~not ~~million~~previously ~~for~~disclosed ~~investor~~in ~~relations~~a ~~services~~Current ~~provided.~~Report ~~Such~~on ~~issuance~~Form ~~was~~8-K ~~exempt~~or ~~from~~Quarterly ~~registration~~Report ~~under~~on ~~4(a)(2)~~Form of10-Q, ~~the~~as ~~Securities~~described ~~Act.~~below:

During the year ended December 31, ~~2024~~2025, ~~there~~the ~~were~~Company noissued ~~other~~an ~~sales~~aggregate of ~~our~~155,000 ~~securities~~shares ~~that~~of ~~were~~its ~~not~~common ~~reported~~stock inupon the vesting of restricted stock units (“RSUs”) granted to certain employees, officers and directors outside of a ~~Current~~registered ~~Report~~equity oncompensation ~~Form 8-K~~plan. orSuch ~~our~~issuances ~~Quarterly~~were ~~Report~~made in reliance on ~~Form 10-Q~~the exemption from registration provided by Section 4(a)(2) of the Securities Act.

~~ITEM 6~~In addition, following the initial closing under the Securities Purchase Agreement dated October 17, 2025, the Company issued additional warrants to purchase shares of its common stock to an investor in subsequent closings under such agreement, which were not previously disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q.~~[RESERVED]~~ These securities were issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

Except as described above, there were no other sales of unregistered securities during the year ended December 31, 2025 that were not previously disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q.

In addition, during the year ended December 31, 2025, the Company issued 155,000 shares of common stock upon the vesting of restricted stock units (“RSUs”) granted to certain employees, officers and directors outside of a registered equity compensation plan. Such issuances were made in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act.

-5358-

Table of Contents

~~ITEM~~During 7.the ~~MANAGEMENT’S~~year ~~DISCUSSION~~ended ~~AND~~December ~~ANALYSIS~~31, OF2025, ~~FINANCIAL~~except ~~CONDITION~~as ~~AND~~otherwise ~~RESULTS~~described OFabove, ~~OPERATIONS~~there were no other sales of unregistered securities required to be disclosed under this item that were not previously reported in a Current Report on Form 8-K or Quarterly Report on Form 10-Q.

~~You should read the following discussion and analysis in conjunction with our consolidated financial statements, including the notes thereto contained in this Annual Report~~ITEM 6. This discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of a variety of certain factors, including those set forth under “Risk Factors Associated with Our Business” and elsewhere in this Annual Report.[RESERVED]

~~Overview~~

WeITEM ~~are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases~~7. ~~Non-systemic~~MANAGEMENT’S ~~therapies~~DISCUSSION ~~are~~AND ~~non-absorbable~~ANALYSIS ~~drugs~~OF ~~that~~FINANCIAL ~~act~~CONDITION ~~locally,~~AND ~~i.e.,~~RESULTS inOF ~~the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.~~OPERATIONS

We are currently focused on developing the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. Our other programs consisted of Latiglutenase, a targeted oral biotherapeutic for celiac disease designed to breakdown gluten into non-immunogenic peptides; Capeserod, a selective 5-HT4 receptor partial agonist which was being developed as a gastroparesis therapeutic; and Niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. We have determined to discontinue the Latiglutenase, Capeserod and Niclosamide programs.

InYou ~~March~~should ~~2024,~~read ~~we announced~~ the ~~closing~~following ofdiscussion aand ~~merger~~analysis together with ~~ImmunogenX,~~our ~~Inc.~~consolidated ~~(“IMGX”)~~financial ~~(the~~statements ~~Company’s~~and ~~acquisition of IMGX,~~ the ~~“Merger”),~~related anotes ~~private,~~included ~~clinical-stage~~elsewhere ~~biopharmaceutical company founded~~ in ~~2013,~~this ~~which~~Annual isReport. ~~developing~~This ~~the~~discussion ~~biologic~~contains ~~Latiglutenase~~forward-looking ~~for~~statements ~~the~~that ~~treatment~~involve ofrisks ~~celiac~~and ~~disease~~uncertainties. ~~IMGX~~Our isactual ~~also~~results ~~developing~~may ~~CypCel,~~differ amaterially ~~metabolic~~from ~~marker~~those ~~compound~~anticipated ~~that~~in ~~can~~these ~~measure the state of small~~forward-~~intestinal~~looking ~~recovery~~statements ofas ~~celiac patients undergoing gluten-free diets (“GFDs”). We have initiated~~ a ~~plan~~result ~~to dispose~~ of ~~certain~~various ~~assets and liabilities of IMGX~~factors, including ~~Latiglutenase~~those ~~and~~described ~~CypCel,~~under ~~within~~Part 12I, ~~months~~Item of1A, ~~the~~“Risk ~~date of the Merger with IMGX. As of December 31~~Factors,” ~~2024, these were classified as assets~~ and ~~liabilities~~elsewhere ~~held~~in ~~for~~this ~~sale~~Annual ~~and due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell~~Report. ~~We determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on our operations and financial statements.~~

In March 2025, we announced that we entered into a rescission agreement (the “Rescission Agreement”), by and among the Company, IMGX and the former shareholders of IMGX (the “IMGX Shareholders”). Under the terms of the Rescission Agreement, the parties have amicably determined that it is in their collective best interest to: (i) rescind the issuances of the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, (ii) convey to the IMGX Shareholders all of the issued and outstanding membership interests (the “Membership Interests”) of IMGX currently held by the Company, (iii) cancel the Assumed Options and Assumed Warrants, and (iv) provide for such additional agreements as are set forth in the Rescission Agreement. Also as set forth in the Rescission Agreement, following the closing, the Company will retain up to approximately $695,000 of IMGX’s accounts payable, and IMGX will remain responsible for approximately $9,278,400 of IMGX’s secured debt. The Company expects that the closing of the Rescission Agreement will occur on or prior to June 30, 2025, subject to satisfaction of all conditions for closing, including obtaining shareholder approval by the Company for the transfer of the Membership Interests to the Shareholders. After the transactions contemplated by the Rescission Agreement have been consummated, IMGX will no longer be a subsidiary of the Company, and the Company will no longer be holding any interest in IMGX.Overview

OnGridAI ~~February~~Technologies ~~26,~~Corp. ~~2025,~~is wea ~~gave~~diversified ~~notice~~technology tocompany ~~terminate our license agreement~~ with ~~Sanofi~~operations ~~for~~that, ~~the~~as ~~development~~ of ~~Capeserod~~December 31, a2025, ~~selective~~consisted ~~5-HT4~~of ~~receptor~~(i) ~~partial~~energy ~~agonist.~~orchestration Weand ~~anticipate~~grid ~~that~~optimization ~~this~~software ~~termination~~solutions ~~will~~through beour ~~effective~~subsidiaries inGrid ~~April~~AI ~~2025~~Corp. Weand ~~may terminate the license agreement by providing Sanofi with at least 60 days prior written notice; provided~~AMPX, ~~however, that Sanofi shall be entitled to any~~ and ~~all~~(ii) ~~payments~~legacy ~~due~~biopharmaceutical ~~and~~development ~~owed~~activities tocentered ~~Sanofi~~on ~~prior~~Adrulipase tofor the ~~effective~~treatment ~~date~~ of ~~termination.~~exocrine Nopancreatic ~~payments are due to Sanofi~~insufficiency.

InHistorically, ~~November~~the ~~2024,~~Company weoperated ~~announced~~primarily as a ~~binding~~clinical-stage ~~term~~biopharmaceutical ~~sheet,~~company ~~subject~~focused toon ~~several~~the ~~closing~~development ~~conditions~~of targeted, non-systemic therapies for gastrointestinal diseases. During 2025, the Company underwent a ~~reverse~~significant ~~merger~~strategic transformation. On September 30, 2025, the Company completed a share exchange transaction ~~with~~pursuant ~~Journey~~to ~~Therapeutics~~which it acquired 100% of the outstanding equity interests of Grid AI Corp. At the time of the acquisition, ~~Inc~~Grid AI Corp. Weowned do75% ~~not~~of ~~anticipate~~the ~~that~~issued ~~this~~and outstanding equity interests of AMPX, which holds the operating subsidiary AMPX Limited. Following the transaction, ~~will~~Grid ~~move~~AI ~~forward~~Corp. and its subsidiaries, including AMPX, became consolidated subsidiaries of the Company. As a result, the Company’s business profile changed materially, and its primary strategic focus shifted toward AI-driven energy technology operations.

In ~~September~~March ~~2024~~2025, wethe ~~announced~~Company aentered ~~binding~~into ~~letter~~a ofrescission ~~intent~~agreement with ~~Data~~ImmunogenX, ~~Vault~~LLC, ~~Holdings~~formerly a wholly owned subsidiary of the Company, ~~Inc~~and the former shareholders of ImmunogenX. ~~(“Data~~Under ~~Vault”)~~the rescission transaction, athe ~~privately~~parties ~~held~~agreed ~~technology~~to ~~holding~~unwind ~~company~~the Company’s prior acquisition of ImmunogenX by rescinding the previously issued Common Stock and Series G Preferred Stock issued in the transaction, conveying the equity interests of ImmunogenX back to ~~exclusively~~the ~~license~~former ~~two~~ImmunogenX ~~technology~~shareholders, ~~product~~and ~~suites~~canceling ~~owned~~the byassumed ~~Data~~ImmunogenX ~~Vault~~options and warrants. WeThe doCompany ~~not~~retained ~~anticipate~~$695,814 ~~that~~of ~~this~~ImmunogenX accounts payable, while ImmunogenX remained responsible for approximately $9.3 million of secured debt and certain other obligations. The rescission transaction ~~will~~closed ~~move~~on ~~forward~~December 31, 2025. Following the closing, ImmunogenX ceased to be a subsidiary of the Company, and the Company no longer held any ownership interest in that business.

~~-54-~~As a result, as of December 31, 2025, the Company’s business consists of its newly acquired subsidiaries (Grid AI Corp. and AMPX) together with its continuing Adrulipase development program and related corporate activities

~~Table~~Grid AI Corp. develops software and services designed to accelerate power availability and optimize energy infrastructure for artificial intelligence (AI) data centers and other large energy users. Grid Ai Corp. is currently in the development stage of ~~Contents~~an AI data center platform. This platform aims to use and optimize distributed energy resources, including battery energy storage systems, on-site generation, and grid interconnections. Currently, there is no revenue generated from this AI data center platform. Grid Ai Corp.’s commercial pipeline has recently been re-established and is continuing to develop through consulting-led engagements and targeted business development initiatives.

InFor the year ended December ~~2023~~31, we2025, ~~announced~~the ~~that~~Company’s weconsolidated ~~have~~financial ~~entered~~statements ~~into~~include the post-acquisition results of Grid AI Corp. and AMPX beginning on September 30, 2025. Prior to the Grid AI Corp. acquisition, the Company operated primarily as a clinical-stage biopharmaceutical company focused on targeted, non-~~binding~~systemic ~~term~~therapies ~~sheet~~for togastrointestinal ~~sell~~diseases. ~~our~~Non-systemic ~~Niclosamide~~therapies ~~program~~are non-absorbable drugs that act locally, such as in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. ~~This~~In ~~transaction~~May is2024, ~~not~~the ~~expected~~Company changed its name from First Wave BioPharma, Inc. to ~~move~~Entero ~~forward~~Therapeutics, Inc.

~~Our~~The ~~Product~~Company’s ~~Candidates~~continuing legacy biopharmaceutical focus is Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in patients with exocrine pancreatic insufficiency, including patients with cystic fibrosis and chronic

~~Our Adrulipase programs are focused on the development of an oral, non~~-systemic, biologic capsule for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”) and chronic pancreatitis (“CP”). Our goal is to provide CF and CP patients with a safe and effective therapy to control EPI that is non59-animal derived and offers the potential to dramatically reduce their daily pill burden. In July 2023, we announced topline results from our Phase 2b monotherapy bridging study using a new enteric microgranule formulation of Adrulipase. Although the primary efficacy endpoint was not achieved, data from the study indicated that the enhanced Adrulipase formulation was safe, well tolerated and demonstrated an improvement over prior formulations of Adrulipase. We are planning to move this program forward in 2025.

~~Our~~Table ~~Latiglutenase program was focused on the development~~ of an orally administered, minimally-absorbed, biologic for improving multiple gluten-induced symptoms and consequent quality of life (“QOL”) due to inadvertent gluten consumption in patients with celiac disease (“CeD”) by breaking down the gluten into non-immunogenic peptides. We are no longer working on this program and have initiated a plan for its disposition.Contents

~~Our~~pancreatitis. ~~Capeserod~~The ~~program~~Company ~~was~~plans ~~in-licensed~~to ~~from~~continue ~~Sanofi~~development inactivities ~~September~~relating ~~2023~~to Adrulipase. ~~Sanofi~~The ~~conducted~~Company’s ~~Phase~~former 1Latiglutenase and ~~Phase~~CypCel 2programs ~~Central~~were ~~Nervous~~part ~~System~~of ~~(“CNS”)~~the ~~trials~~ImmunogenX ~~with over 600 patients. In Sanofi’s CNS trials~~business, ~~Capeserod~~which ~~appeared~~was ~~safe~~disposed ~~and~~of ~~well-tolerated. Research~~ on ~~Capeserod~~December ~~and~~31, ~~subsequent~~2025 ~~artificial~~in ~~intelligence~~connection ~~(“AI”)~~with ~~empowered analyses suggest that~~ the ~~drug~~rescission ~~possesses~~transaction adescribed ~~unique~~below. ~~mechanism~~The ofCompany ~~action~~has ~~that~~also isdiscontinued ~~applicable~~its toCapeserod ~~several~~and GINiclosamide ~~indications~~programs. ~~underserved~~The byCompany ~~currently~~terminated ~~available~~its ~~therapeutics.~~license Weagreement ~~are~~with noSanofi ~~longer~~relating ~~working~~to onCapeserod ~~this program and~~ on February 26, 2025, ~~notified~~and ~~Sanofi~~no offurther ~~our~~payments ~~intent~~were todue ~~terminate the license agreement~~thereunder. ~~We anticipate this termination will be effective in April 2025.~~

~~Our~~In ~~Niclosamide~~March ~~programs~~2024, ~~leveraged~~the ~~proprietary~~Company ~~oral~~acquired ~~and~~ImmunogenX, ~~topical~~Inc., ~~formulations~~whose tooperations ~~address~~were ~~multiple~~subsequently GIcarried ~~conditions~~through ImmunogenX, ~~including~~LLC. ~~inflammatory~~During ~~bowel~~2025, ~~diseases~~the ~~(“IBD”)~~Company ~~indications~~determined to unwind that transaction. In ~~2022~~March we2025, ~~advanced~~the ~~four~~Company ~~separate~~entered ~~Phase~~into 2a ~~clinical~~rescission ~~programs~~agreement ofwith ~~our~~ImmunogenX ~~Niclosamide~~and ~~formulations,~~the ~~including~~former ~~FW-COV~~ImmunogenX ~~for~~shareholders, ~~Severe~~which ~~Acute~~was ~~Respiratory~~subsequently ~~Syndrome~~amended ~~Coronavirus~~in 2July ~~(“COVID-19”)~~2025. GIOn ~~infections~~December 31, ~~FW-UP~~2025, ~~for~~the ~~ulcerative~~Company ~~proctitis~~completed ~~(“UP”)~~the ~~and~~rescission ~~ulcerative~~transaction. ~~proctosigmoiditis~~In ~~(“UPS”)~~connection with the closing, FWthe ~~ICI~~Company ACtransferred ~~for~~its ~~Immune~~ownership ~~Checkpoint~~interests ~~Inhibitor~~in ~~associated~~ImmunogenX, ~~colitis~~rescinded ~~(“ICI~~the ~~AC”)~~shares previously issued in the acquisition, cancelled the related assumed options and FWwarrants CDand retained approximately $695,000 of ImmunogenX accounts payable, while ImmunogenX remained responsible for ~~Crohn’s~~approximately ~~disease~~$9.3 Wemillion ~~are~~of its secured debt. As a result, ImmunogenX is no longer ~~actively~~a ~~pursuing~~subsidiary ~~these~~of ~~programs~~the Company.

~~Nasdaq~~On ~~Listing~~February ~~Requirements~~26, 2025, the Company provided notice of termination of its license agreement with Sanofi relating to Capeserod. That termination became effective in April 2025. The Company also determined not to continue pursuing previously announced strategic transactions involving Journey Therapeutics and Data Vault.

WeAs ~~received~~ a ~~letter~~result onof ~~September 6, 2024 from~~ the ~~Listing~~acquisition ~~Qualifications Staff~~ of ~~Nasdaq~~Grid ~~indicating~~AI ~~that~~Corp., ~~based upon~~ the ~~closing~~completion ~~bid price~~ of ~~our Common Stock for~~ the ~~last~~ImmunogenX 30rescission ~~consecutive~~transaction ~~business~~and ~~days,~~ the ~~Company~~discontinuation ~~was~~of ~~not~~several inlegacy ~~compliance~~biotechnology ~~with~~programs, ~~the~~comparability ~~requirement~~between toperiods ~~maintain~~is ~~a minimum bid price of $1~~affected.00 ~~per share for continued listing on~~ The ~~Nasdaq~~Company’s ~~Capital~~2025 ~~Market,~~results asreflect ~~set forth in Nasdaq Listing Rule 5550(~~a~~)(2).~~ Inmaterially ~~accordance~~different ~~with~~business ~~Nasdaq~~profile ~~Listing~~than ~~Rule~~its ~~5810(c)(3)(A),~~2024 ~~we were provided 180 days, or until March 5, 2025, to regain compliance with the minimum bid price requirement~~results.

~~On March 6, 2025, we received a letter from~~ Nasdaq ~~advising that we had been granted a 180-day extension, or until September 1, 2025, to regain compliance with the minimum bid price requirement, in accordance with Nasdaq~~ Listing Rule 5810(c)(3)(A). If at any time prior to September 1, 2025, the bid price of the our Common Stock closes at $1.00 per share or more for a minimum of 10 consecutive trading days, we will regain compliance with the minimum bid price requirement.Matters

~~The~~During ~~extension~~2025, ~~notice has no immediate effect on~~ the ~~listing~~Company ofreceived ~~our~~multiple ~~Common~~notices ~~Stock~~from on The Nasdaq ~~Capital~~Stock Market ~~and~~LLC ~~does~~relating not affect our reporting requirements with the Securities and Exchange Commission. If we do not regain compliance with the minimum bid price requirement during the additional 180-day extension, Nasdaq will provide written notification that our Common Stock will be delisted. At that time, we may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the hearings panel, that such appeal would be successful. There can be no assurance that we will regain compliance with the minimum bid price requirement during the additional 180-day compliance period ending September 1, 2025 or maintain compliance with any other Nasdaq listing ~~requirement. We intend to monitor the closing bid price of our Common Stock and may, if appropriate, consider implementing available options to regain~~ compliance ~~with the minimum bid price requirement~~matters.

On September 6, 2024, the Company received notice that it was not in compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). On March 6, 2025, the Company received notice that Nasdaq had granted an additional 180-~~55-~~day extension, through September 1, 2025, to regain compliance. On September 3, 2025, Nasdaq notified the Company that it had regained compliance with the minimum bid price requirement because the closing bid price of the Company’s common stock had been at least $1.00 per share for the required period, and the matter was closed.

~~Table~~On January 7, 2025, the Company received notice that it was not in compliance with Nasdaq Listing Rule 5620(a) because it had not held an annual meeting of ~~Contents~~stockholders in 2024 within the required time period. The Company held its Annual Meeting on June 30, 2025, and on July 3, 2025, Nasdaq notified the Company that it had regained compliance and that the matter was closed.

On ~~January~~October 728, 2025, wethe Company received a ~~written~~letter ~~notice~~ from ~~the Listing Qualifications department of~~ Nasdaq ~~indicating~~confirming that, ~~were~~based ~~not~~on inthe ~~compliance~~Company’s ~~with~~Form ~~Nasdaq~~8-K ~~Listing~~filed ~~Rule~~on ~~5620(a)~~October 6, ~~due~~2025, tothe usCompany ~~not~~was ~~holding~~in ancompliance ~~annual~~with ~~meeting~~the ofminimum stockholders’ inequity ~~2024~~requirement ~~within~~under ~~one~~Listing ~~year~~Rule ~~of our 2023 fiscal year end~~5550(b)(1). OnNasdaq ~~February~~also ~~21,~~noted ~~2025,~~that weif ~~submitted~~the aCompany ~~plan~~failed to ~~regain~~evidence compliance. Onupon ~~March~~filing 3,its ~~2025,~~next ~~Nasdaq~~periodic ~~informed~~report, ~~us that~~ it ~~has~~could ~~determined~~again tobecome ~~grant~~subject ~~us an extension until June 30, 2025~~ to ~~regain~~delisting ~~compliance for continued listing~~proceedings.

~~Revolving~~On ~~Loan~~November ~~Agreement~~5, 2025, the Company received a letter from Nasdaq stating that the Company’s proposed transaction with GridAI Corp. constituted a business combination resulting in a change of control under Nasdaq Listing Rule 5110(a). Nasdaq indicated that the post-transaction company would be required to satisfy Nasdaq’s initial listing criteria and complete the applicable Nasdaq initial listing review process in connection with the second step of the transaction.

~~Effective~~On ~~January~~April 3122, ~~2025~~2026, wethe ~~entered~~Company ~~into~~received a ~~Revolving~~notice ~~Loan~~from ~~Agreement~~Nasdaq ~~dated~~Listing ~~January~~Qualifications ~~27,~~indicating ~~2025~~that ~~(the~~it ~~“Revolving~~is ~~Loan~~not ~~Agreement”),~~in compliance with aNasdaq ~~Lender~~Listing ~~pursuant~~Rule to5250(c)(1) ~~which~~due ~~the Lender agreed~~ to ~~make~~its ~~loans~~failure to ~~us.~~timely ~~Pursuant~~file toits ~~and~~Annual ~~under~~Report ~~the~~on ~~terms~~Form of10-K ~~the~~for ~~Revolving Loan Agreement, we issued to~~ the ~~Lender~~year aended ~~revolving~~December ~~note dated January 27~~31, 2025. inThe ~~the~~notice ~~principal~~provides ~~amount of $2,000,000 (~~the ~~“Revolving~~Company ~~Note”~~with ~~and~~60 ~~such~~calendar ~~amount~~days, ~~the~~or ~~“Total~~until ~~Outstanding~~June ~~Amount”).~~22, ~~This~~2026, ~~transaction~~to issubmit ~~referred~~a plan to asregain ~~the “Financing”~~compliance. WeIf ~~shall use~~ the ~~proceeds~~plan ~~from~~is ~~the Financing for general corporate purposes~~accepted, ~~including~~Nasdaq ~~but~~may ~~not~~grant ~~limited~~an toexception ~~finance the expense~~ of aup ~~Qualified~~to ~~Public~~180 ~~Equity~~calendar ~~Offering~~days ~~(as~~from ~~defined below) and payment of certain items. Out of~~ the ~~Total~~original ~~Outstanding~~filing ~~Amount~~due date, ~~the~~or ~~Lender~~until ~~disbursed~~October ~~an initial loan amount of $550~~12,~~000~~ ~~to us on January 31~~2026, ~~2025.~~for ~~The Revolving Note bears interest at~~ the ~~rate~~Company ofto ~~18%~~regain ~~per annum~~compliance.

The Revolving Loan Agreement provides that it is a condition of the closing of the Financing that not less than three of the current members of our Board of Directors resign and that three nominees designated by the Lender (“Lender Board Member Candidates”) be appointed to the Board of Directors by the remaining members of the Board of Directors. The Revolving Loan Agreement also provides that we will use our reasonable best efforts to consummate an underwritten or “best efforts” public offering of not less than $5,000,000 by us of our Common Stock and/or any convertible security or warrant, option or other right to subscribe for or purchase any additional shares of our Common Stock (“Qualified Public Equity Offering”) as soon as practicable, and the Lender shall cooperate with us in connection therewith. If, despite the reasonable best efforts of the Borrower, (x) a registration statement with respect to securities to be offered in a Qualified Public Equity Offering (the “QPEO S-1”) is not filed within 45 days following the initial Closing Date, or (y) a Qualified Public Equity Offering is not consummated within the earlier of (A) 120 days from the initial filing of the QPEO S60-1 and (B) 30 days of a QPEO S-1 being declared effective by the SEC, then the Lender Board Member Candidates shall, upon the written request of the remaining members of the Board of Directors, resign from all of their respective positions on the Board of Directors.

~~Rescission~~Table ~~Agreement~~of ~~with ImmunogenX~~ Contents

InRevolving ~~March~~Loan 2024, we announced the closing of a merger with IMGX . As a result of the Merger, IMGX became a limited liability company and our wholly owned subsidiary. As consideration for the Merger we issued the former shareholders of IMGX (A) 36,830 shares of Common Stock of the Company and (B) 11,777.418 shares of Series G Preferred Stock. In addition, we assumed (i) all ImmunogenX stock options immediately outstanding prior to the Merger, each becoming an option to purchase Common Stock subject to adjustment pursuant to the terms of the merger agreement (the “Assumed Options”) and (ii) all ImmunogenX warrants immediately outstanding prior to the Merger, each becoming a warrant to purchase Common Stock subject to adjustment pursuant to the terms of the merger agreement (the “Assumed Warrants”). The Assumed Options are exercisable for an aggregate of 200,652 shares of Common Stock, have an exercise price of $0.81 and expire between February 1, 2031 and June 6, 2033. The Assumed Warrants are exercisable for an aggregate of 127,682 shares of Common Stock, have exercise prices ranging from $3.02 to $3.92 and expire between September 30, 2032 and September 6, 2033.Agreement

InEffective ~~March~~January 31, 2025, wethe ~~announced~~Company ~~that we~~ entered into a ~~rescission~~Revolving Loan Agreement providing for borrowings of up to $2.0 million. The revolving note bears interest at 18% per annum and matured on January 31, 2026. The agreement ~~(the~~includes ~~“Rescission~~customary ~~Agreement”)~~conditions, bycovenants and ~~among~~events ~~the~~of ~~Company~~default, ~~IMGX~~as well as provisions relating to board composition and the ~~former~~Company’s ~~shareholders~~reasonable ofbest ~~IMGX~~efforts ~~(the~~to ~~“IMGX~~pursue ~~Shareholders”).~~a qualified public equity offering.

Under the ~~terms~~Revolving Loan Agreement, the outstanding principal balance of all outstanding loans, all accrued and unpaid interest and all other amounts, costs, expenses and/or liquidated damages were due in full the ~~Rescission~~“Maturity ~~Agreement~~Date”. On April 1, 2026, the ~~parties~~Company ~~have~~received ~~amicably~~a ~~determined~~demand letter from the Lender’s counsel, asserting that itthe Company is in ~~their~~default ~~collective~~of ~~best~~the ~~interest~~Revolving ~~to:~~Loan ~~(i)~~Agreement ~~rescind~~as the ~~issuances~~Maturity ofDate ~~the~~has ofpassed and the ~~shares~~amounts ofdue ~~Common~~under ~~Stock~~the ~~and~~Revolving ~~Series~~Loan GAgreement ~~Preferred~~have ~~Stock~~not ~~that~~been repaid, and demanding the Company ~~has~~to ~~issued~~pay toa ~~the~~total ~~IMGX~~sum ~~Shareholders~~of as$1,014,675, ~~part~~which ofincludes the ~~Merger,~~principal amounts received by the Company (ii$700,000), ~~convey~~interest and a 20% increase of these amounts due to the ~~IMGX~~default ~~Shareholders~~pursuant ~~all~~to the terms of Revolving Loan Agreement. The Company is evaluating the ~~issued~~effects of this event and ~~outstanding~~as ~~Membership~~of ~~Interests~~the date of ~~IMGX~~this ~~currently~~report ~~held~~is byin active discussions with the ~~Company~~Lender. Our ability to repay, ~~(iii)~~refinance ~~cancel~~or ~~the~~otherwise ~~Assumed~~address ~~Options~~this ~~and~~indebtedness ~~Assumed~~on ~~Warrants;~~acceptable terms will affect our liquidity and ~~(iv)~~financial ~~provide~~flexibility. ~~for~~There ~~such~~can ~~additional~~be ~~agreements~~no asassurance ~~are~~that ~~set~~we ~~forth~~will ~~therein~~be able to refinance or satisfy this indebtedness on favorable terms or at all.

~~Pursuant~~Financial toOperations the terms of the Rescission Agreement (i) each Shareholder agreed to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, as set forth in the Rescission Agreement, (ii) each Shareholder agreed to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the Assumed Options and Assumed Warrants as set forth in the Rescission Agreement, including any Common Overview

The Company operates through two reportable segments: (i) its artificial intelligence-~~56-~~driven energy technology business (“AI Segment”) and (ii) its legacy biotechnology operations focused on gastrointestinal therapies (“GI Segment”). The AI Segment consists of operations conducted through Grid AI Corp. and its subsidiaries, including AMPX, while the GI Segment reflects the Company’s retained biopharmaceutical development activities, including Adrulipase. Management evaluates performance and allocates resources across these segments based on strategic priorities and expected returns.

~~Table of Contents~~Revenue

~~Stock~~Historically, ~~into~~the ~~which~~GI ~~such~~Segment ~~Assumed~~did ~~Options and Assumed Warrants are~~ not orgenerate ~~ever~~revenue ~~have~~from ~~been converted or are convertible, (iii)~~ the ~~Company~~sale ~~agreed~~of toapproved ~~cancel,~~biopharmaceutical ~~waive,~~products. ~~relinquish~~Following ~~and~~the ~~disclaim~~acquisition inof ~~all~~Grid ~~respects~~AI ~~any~~Corp. ~~and~~on ~~all~~September ~~claims~~30, ~~and/or rights to record or beneficial ownership in and to the Membership Interests of IMGX~~2025, ~~and (iv)~~ the Company ~~will~~began ~~retain~~generating uprevenue towithin ~~approximately~~its ~~$695,000~~AI ofSegment ~~IMGX’s~~from ~~accounts~~its ~~payable,~~energy ~~and~~technology ~~IMGX~~operations ~~will~~conducted ~~remain~~through ~~responsible~~Grid ~~for~~AI ~~approximately~~Corp. ~~$9,278,400~~and ~~of IMGX’s secured debt~~AMPX.

~~In addition~~Accordingly, ~~under~~beginning in the ~~terms~~fourth quarter of ~~the Rescission Agreement~~2025, ~~the~~our ~~Company~~consolidated ~~shall~~results ~~have~~include norevenue ~~obligation~~associated ~~and~~with ~~will~~the ~~released~~Grid ~~from~~AI ~~any~~Corp. and ~~all~~AMPX ~~obligations~~business. ~~with~~This ~~respect~~revenue tohas ~~the~~been ~~assets~~generated orprimarily ~~business~~from ofsoftware-enabled ~~IMGX~~energy ~~incurred~~orchestration, ~~after~~optimization, ~~the Closing Date~~dispatch, asmonitoring ~~defined~~and inrelated ~~the~~service ~~Rescission~~offerings. ~~Agreement,~~Prior ~~or prior~~ to the ~~Closing~~Grid ~~Date,~~AI ~~except~~Corp. ~~as provided in the Rescission Agreement~~acquisition, ~~unless~~our ~~approved~~legacy inoperations ~~writing~~did bynot ~~the~~generate ~~Company~~product revenue.

~~The~~Looking ~~obligations~~forward, ofwe ~~each~~expect ~~party~~our torevenue ~~the~~profile ~~Rescission Agreement~~ to ~~consummate~~differ ~~the~~materially ~~transactions~~from ~~contemplated~~prior byperiods ~~the~~as ~~Rescission~~a ~~Agreement~~result ~~are~~of ~~subject to~~ the ~~fulfillment,~~inclusion atof ~~or prior to~~ the ~~Closing,~~Grid asAI ~~defined~~Corp. inand ~~the~~AMPX ~~Rescission~~business. ~~Agreement,~~With ofrespect ~~each~~to ofour ~~the~~retained ~~conditions~~legacy ~~set~~biopharmaceutical ~~forth in the Rescission Agreement~~operations, ~~and~~we ~~among~~have ~~others,~~not ~~that~~generated ~~(i)~~revenue ~~the~~from ~~Company~~product ~~shall~~sales ~~have~~and ~~obtained~~do ~~approval~~not ofexpect ~~its~~to ~~shareholders~~do ~~for~~so ~~the~~unless ~~transfer~~and ofuntil ~~the~~a ~~Membership~~product ~~Interests~~candidate toreceives ~~the~~regulatory ~~Shareholders,~~approval and ~~the~~is ~~other~~successfully ~~consents,~~commercialized. ~~authorizations~~We ormay ~~approvals~~also ~~from~~seek ~~the~~to ~~parties~~generate asrevenue ~~set forth~~ in the ~~Rescission~~future ~~Agreement~~from tostrategic ~~consummate~~relationships, ~~the~~licensing ~~transactions~~arrangements, ~~contemplated~~milestone bypayments, ~~this~~service ~~Agreement~~arrangements, ~~(ii)~~grants ~~the~~or ~~Shareholders~~other ~~shall~~sources, ~~have~~although ~~delivered~~there acan ~~mutually~~be ~~satisfactory~~no ~~voting~~assurance ~~agreement~~that ~~agreeing~~any ~~to,~~such ~~including~~revenue ~~other~~will ~~things,~~be ~~vote~~realized. ~~the~~All ~~Shares~~revenue ~~held~~recognized byduring ~~them~~2025 inrelates ~~favor~~to of the ~~transactions~~AI ~~contemplated by the Rescission Agreement~~Segment, ~~and~~as ~~(iii)~~ the ~~Company~~GI ~~shall~~Segment ~~have~~has ~~received~~not agenerated ~~resignation~~product ~~letter from Jack Syage resigning from all positions with the Company~~revenue.

~~The~~Research ~~Rescission Agreement may be terminated~~ and ~~the~~Development transactions contemplated thereby may be abandoned by the Company or the Shareholder Representative, as defined in the Rescission Agreement, if the transactions contemplated thereby shall not have been consummated by June 30, 2025, unless the Company and Shareholder Representative shall have consented to a subsequent date.Expense

~~Financial~~Research ~~Operations~~and ~~Overview~~development expenses relate primarily to the Company’s GI Segment. Prior to 2025, a significant portion of our research and development expenses related to the development of Adrulipase, Niclosamide, Capeserod and Latiglutenase. Following the discontinuation of certain legacy biotechnology programs, the completion of the rescission transaction involving ImmunogenX, LLC on December 31, 2025 and the acquisition of Grid AI Corp. on September 30, 2025, our retained biopharmaceutical research and development activities are primarily focused on Adrulipase.

~~Revenue~~Research and development expenses generally consist of internal and external costs incurred in connection with our legacy product development activities, including, among other things:

To● ~~date,~~personnel-related ~~we have not generated any revenue from the sale of our product candidates or otherwise. In the future~~costs, ~~we expect that we will seek to generate revenue primarily from product sales, but we may also generate non-product revenue from sources~~ including, ~~but not limited to~~salaries, ~~research~~benefits ~~funding, development~~ and ~~milestone payments, and royalties on future product sales in connection with any out~~stock-~~license~~based orcompensation ~~other strategic relationships and/or government grants we may establish. Our product candidates are at an early stage of development and may never be successfully developed or commercialized.~~expense

~~Research and Development Expense~~-61-

~~Conducting~~Table ~~research and development is central to our business. Historically, the majority~~ of our research and development expenses have been focused on the development of Adrulipase, Niclosamide, Capeserod and Latiglutenase. Research and development expenses consist primarily of internal and external costs incurred for our development activities, which include, among other things:Contents

● ~~personnel-related~~fees ~~costs,~~paid ~~which~~to ~~include~~third ~~salaries,~~parties ~~benefits~~in connection with product development, regulatory and ~~stock-based~~related ~~compensation expense;~~activities

● ~~fees~~expenses ~~paid~~incurred tounder ~~third~~agreements ~~parties~~with ~~for~~contract ~~services~~research ~~directly~~organizations, ~~related~~investigative tosites, ~~our~~consultants ~~drug development~~ and ~~regulatory efforts;~~contractors

● ~~Expenses~~costs ~~incurred~~of ~~under~~drug ~~agreements~~substance, ~~with~~drug ~~clinical research organizations (“CROs”)~~product, ~~investigative~~clinical ~~sites~~materials and ~~consultants~~related ~~and~~manufacturing ~~contractors~~support ~~that~~from ~~conduct~~contract ordevelopment ~~provide~~and ~~other~~manufacturing ~~services~~organizations ~~relating to our clinical trials~~ and ~~research~~other ~~activities;~~third parties

● ~~the~~costs ~~cost~~associated ofwith ~~acquiring drug product~~preclinical, ~~drug supply and~~ non-clinical ~~trial materials from contract development~~ and ~~manufacturing organization (“CDMOs”) and third~~regulatory-~~party~~support ~~contractors;~~activities

● costs associated with ~~preclinical~~evaluating and ~~non-clinical~~maintaining ~~activities;~~retained development assets and capabilities.

●Following ~~payments~~the strategic shift in the Company’s business, research and ~~other~~development ~~costs~~expense is expected to reflect a narrower retained life sciences portfolio than in ~~connection~~prior ~~with~~periods. ~~the~~Adrulipase ~~acquisition~~is ~~our~~the ~~product~~Company’s ~~candidates~~only ~~under~~remaining ~~licensing~~active ~~agreements;~~biotechnology ~~and~~development program.

●Because ~~amortization~~the ofCompany ~~intangible~~now ~~assets~~also operates an AI-driven energy technology business through Grid AI Corp. and AMPX, ~~including~~operating ~~patents~~expenses may include technology, inengineering, implementation, systems, data and platform-~~process~~related costs that are distinct from legacy biopharmaceutical research and development activities. The classification of such costs depends on their nature and ~~license~~the ~~agreements~~applicable accounting treatment in the relevant period.

~~-57-~~We expect the composition of our operating expenses to continue to evolve over time as management allocates resources among:

~~Table~~● the continued evaluation and potential advancement of ~~Contents~~Adrulipase

● ~~Costs~~the ~~incurred~~operation, inenhancement ~~connection~~and ~~with~~expansion ~~research~~of ~~and~~the ~~development~~Grid ~~activities~~AI ~~are~~Corp. ~~expensed~~and asAMPX ~~incurred.~~business

We● ~~expect our research and development expenses to increase for the foreseeable future as we focus our efforts on the clinical development of our product candidates~~corporate, ~~including Adrulipase~~compliance, ~~through~~integration ~~late-stage clinical trials, as well as chemistry, manufacturing~~ and ~~controls (“CMC”) efforts. The process of conducting non~~public-~~clinical~~company ~~studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming~~requirements. It is difficult to determine with certainty the duration and costs of any non-clinical study or clinical trial that we may conduct. In addition, if our product development efforts are successful, we expect to incur substantial costs to prepare for potential commercialization of any late-stage product candidates and, in the event any of our product candidates receives regulatory approval, to potentially fund the launch and sales and marketing efforts of the product.

The ~~probability~~process of ~~success~~conducting ~~for~~clinical ~~any~~development ofactivities ~~our~~and ~~current~~expanding ora ~~future~~software-enabled ~~product~~energy ~~candidates~~technology ~~will~~business ~~depend~~is oncostly ~~numerous factors, including competition, manufacturing capability~~ and ~~commercial viability~~time-consuming. WeIt ~~will~~is ~~determine~~difficult ~~which programs~~ to ~~pursue~~predict ~~and~~with ~~how~~certainty ~~much~~the totiming ~~fund~~and ~~each~~level ~~program~~of infuture ~~response~~expenditures, to the ~~scientific~~duration ~~and clinical success~~ of ~~each~~development ~~drug candidate~~activities, asthe ~~well~~pace asof ancommercial ~~assessment~~growth ofor ~~each~~the ~~drug~~timing ~~candidate’s~~of ~~commercial~~future ~~potential~~revenues.

WeThe dosuccess ~~not~~of ~~record~~our oractivities ~~maintain~~depends ~~information regarding costs incurred in research and development~~ on anumerous ~~program~~factors, orincluding ~~project~~clinical ~~specific~~outcomes, ~~basis. Our~~access ~~research~~to ~~and~~capital, ~~development~~technological ~~staff~~performance, ~~outside~~customer ~~consultants~~adoption, ~~contractors,~~regulatory ~~CROs~~considerations, ~~and~~competitive ~~CDMOs~~conditions ~~are deployed across several programs~~ and~~/or~~ ~~indications~~commercial viability. ~~Additionally,~~ ~~many~~Management ofexpects ~~our~~to ~~costs~~continue ~~are~~evaluating ~~not~~the ~~attributable~~allocation toof ~~individual~~capital ~~programs~~ and~~/or~~ ~~indications. Therefore,~~operating weresources ~~believe~~across ~~that allocating costs on~~ the ~~basis~~Company’s ofretained ~~time~~life ~~incurred~~sciences byactivities ~~our~~and ~~personnel~~its ~~does~~energy ~~not~~technology ~~accurately~~operations ~~reflect~~based ~~the~~on ~~actual~~strategic ~~costs~~priorities, ofliquidity aand ~~project~~expected returns.

~~General~~We do not believe that historical program-by-program comparisons are necessarily meaningful for all periods presented, particularly in light of the Company’s significant business transformation during 2025. The AI Segment does not incur research and ~~Administrative~~development ~~Expense~~expenses of the nature associated with biopharmaceutical development.

General and ~~administrative~~Administrative expenses consist primarily of personnel-related expenses, including salaries, benefits and stock-based compensation, related to our executive, finance, business development and support functions, legal fees relating to both intellectual property and corporate matters, insurance, costs associated with operating as a public company, including corporate communications and investor relations expense, information technology, professional fees for accounting, auditing and other professional services, and facility-related costs.Expense

WeGeneral ~~anticipate our general~~ and administrative expenses to ~~increase for~~consist ~~the~~primarily ~~foreseeable~~of ~~future~~personnel-related ~~to support~~expenses, ofincluding ~~our~~salaries, ~~expanded~~benefits ~~research~~ and ~~development~~stock-based ~~activities~~compensation, ~~intellectual~~related ~~property~~to executive, ~~patent~~finance, ~~and~~business ~~corporate~~development, legal ~~expense~~, ~~insurance,~~compliance and ~~costs~~ ~~associated~~other ~~with~~administrative ~~operating~~functions. asGeneral aand ~~public~~administrative ~~company,~~expenses ~~including~~also ~~corporate~~include ~~communications~~legal ~~and~~fees ~~investor~~relating ~~relations~~to ~~expense.~~corporate, ~~Additional~~transactional, ~~increases~~governance ~~in general~~ and ~~administrative~~intellectual ~~expenses~~property ~~are~~matters, ~~expected~~insurance, ininformation ~~connection~~technology ~~with~~costs, ~~increased~~professional ~~business~~fees ~~development~~for ~~efforts~~accounting, ~~including~~auditing, ~~potential~~tax ~~partnership~~ and~~/or~~ ~~collaboration~~other ~~agreements~~advisory ~~and financing activities~~services, ~~expanding~~public ~~infrastructure~~company costs, including ~~information~~corporate ~~technology~~communications ~~administration,~~ and ~~the~~investor ~~hiring~~relations ofexpenses, ~~additional personnel~~ and ~~consultants,~~facility-related ~~among other expenses~~costs.

~~Liquidity~~General and ~~Capital~~administrative ~~Resources~~expenses increased in importance during 2025 as a result of the Company’s acquisition of Grid AI Corp., the integration of the Grid AI Corp. and AMPX business, changes in management and board composition and the continued requirements of operating as a public company.

~~To date, we have not generated any revenues and have experienced net losses and negative cash flows from our activities.~~-62-

AsTable of December 31, 2024, we had cash and cash equivalents of approximately $185,000, negative working capital of approximately $4.3 million, and had sustained cumulative losses attributable to common stockholders of approximately $202.4 million. Subsequent to December 31, 2024, we have closed on a revolving loan agreement in the principal amount of $2.0 million. We have not yet achieved profitability and anticipate that we will continue to incur net losses for the foreseeable future. We expect that our expenses will continue to grow and, as a result, we will need to generate significant product revenues to achieve profitability. We may never achieve profitability. As such, we are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. Without adequate funding, we may not be able to meet our obligations. We believe these conditions may raise substantial doubt about our ability to continue as a going concern.Contents

~~Our~~We ~~primary~~expect ~~sources~~general ofand ~~liquidity~~administrative ~~come~~expenses ~~from~~to ~~capital~~remain ~~raises~~significant ~~through additional equity~~ and~~/or~~ ~~debt~~they ~~financings.~~may ~~This~~increase ~~may~~in befuture ~~impacted~~periods byas ~~geopolitical~~we ~~events,~~continue ~~including~~to ~~war~~support inthe ~~Ukraine~~operation and inintegration of the ~~Middle~~Grid ~~East~~AI Corp. and AMPX business, ~~which~~satisfy ~~are~~public ~~evolving~~company reporting and ~~could~~compliance ~~negatively~~obligations ~~impact~~and ~~our~~incur ~~ability~~costs toassociated ~~raise~~with ~~additional~~corporate ~~capital~~governance, inlegal, ~~the~~accounting, ~~future~~finance, investor relations and information technology infrastructure.

~~-58-~~General and administrative expenses may also increase in connection with business development initiatives, financing activities, strategic transactions, integration efforts and the expansion of our administrative and operational infrastructure, including the engagement of additional personnel, consultants and outside service providers. General and administrative expenses support both the AI Segment and the GI Segment and are managed on a consolidated basis.

~~Table~~Liquidity ofand ~~Contents~~Capital Resources

WeTo date, we have ~~funded~~not ~~our~~generated ~~operations~~revenue tofrom ~~date~~product ~~primarily~~sales ~~through~~and ~~the~~have ~~issuance~~experienced ofnet ~~debt,~~losses ~~convertible~~and ~~debt~~negative ~~securities,~~cash ~~preferred~~flows ~~stock,~~from asoperations. ~~well~~Our ashistorical ~~the~~operations ~~issuance~~were offunded ~~Common~~primarily ~~Stock~~through insales ~~various public~~of ~~offerings~~equity ~~and~~securities, ~~private~~equity-linked ~~placement~~securities ~~transactions.~~and Wedebt ~~expect~~financings. toIn ~~incur~~2025, ~~substantial~~our ~~expenditures~~business inchanged ~~the~~significantly ~~foreseeable~~as ~~future~~a ~~for~~result of the ~~development~~acquisition of ~~Latiglutenase,~~Grid ~~Adrulipase,~~AI ~~Capeserod~~Corp. and ~~Niclosamide.~~the Wecompletion ~~will~~of ~~require~~the ~~additional~~rescission ~~financing~~transaction toinvolving ~~develop our product candidates~~ImmunogenX, ~~run~~LLC. ~~clinical~~Notwithstanding ~~trials,~~those ~~prepare regulatory filings and obtain regulatory approvals~~transactions, ~~fund~~as ~~operating~~of ~~losses,~~December ~~and~~31, ~~if deemed appropriate~~2025, ~~establish~~we ~~manufacturing,~~remained ~~sales~~dependent ~~and~~on ~~marketing~~external ~~capabilities.~~sources ~~Our~~of ~~current~~capital ~~financial~~to ~~condition~~fund ~~raises~~our ~~substantial~~operations, ~~doubt~~satisfy ~~about~~ our ~~ability~~obligations toand ~~continue~~execute asour abusiness ~~going concern~~plan. Our ~~failure to raise~~ capital asrequirements ~~and~~reflect ~~when~~the ~~needed~~combined ~~would~~needs ~~have~~of aboth ~~material~~the ~~adverse~~AI ~~impact~~Segment onand ~~our~~the ~~financial~~GI ~~condition~~Segment, ~~our~~including ~~ability~~funding tofor ~~meet~~platform ~~our obligations~~development, operations and ~~our~~integration ~~ability~~activities towithin ~~pursue~~the ~~our~~AI ~~business~~Segment ~~strategies. We will seek funds through additional equity~~ and~~/or~~ ~~debt~~potential ~~financings,~~future ~~collaborative~~development oractivities ~~other~~within ~~arrangements~~the ~~with~~GI ~~corporate sources, or through other sources of financing~~Segment.

~~Although~~As weof ~~are~~December ~~primarily~~31, ~~focused~~2025, onwe ~~the~~had ~~development~~cash ofand ~~our~~cash ~~product~~equivalents ~~candidate,~~of ~~Adrulipase~~approximately $899,000, weworking ~~are~~capital ~~also~~deficit ~~opportunistically~~of ~~focused~~approximately $12,563,000, onand ~~expanding~~an ~~our~~accumulated ~~product~~deficit ~~pipeline~~ of ~~clinical~~approximately ~~assets~~$208,780,000. ~~through~~We ~~collaborations,~~have not yet achieved profitability and ~~also~~expect ~~through~~to ~~acquisitions~~continue ofto ~~products~~incur ~~and~~losses ~~companies~~for the foreseeable future. WeOur ~~are~~future ~~continually~~capital ~~evaluating~~needs ~~potential~~will ~~asset~~depend ~~acquisitions~~on ~~business~~a ~~combinations~~number of factors, ~~and~~including ~~other~~the ~~partnership~~operating ~~opportunities.~~requirements Toof ~~finance~~the ~~such~~GridAI ~~acquisitions~~and AMPX business, weour ~~might~~corporate ~~raise~~overhead, ~~additional~~debt ~~equity~~service ~~capital~~obligations, ~~incur~~public ~~additional~~company ~~debt~~costs and the extent to which we seek to preserve, resume or ~~both~~advance development activities relating to Adrulipase.

Our ~~ability~~liquidity has been, and we expect will continue to ~~issue~~be, ~~securities~~dependent ison ~~subject~~access to ~~market~~outside ~~conditions~~capital. ~~Each~~We ~~issuance~~may ~~under~~seek ~~the~~additional ~~shelf~~funds ~~registration~~through ~~statements~~public ~~will~~or ~~require~~private ~~the~~offerings ~~filing~~of equity or debt securities, exercises of aoutstanding ~~prospectus~~warrants, ~~supplement~~strategic ~~identifying~~transactions, ~~the~~commercial ~~amount~~partnerships, licensing arrangements, asset sales or other financing alternatives. The availability and terms of financing will depend on many factors, including market conditions, our operating performance, investor sentiment, Nasdaq listing status, the ~~securities~~trading toprice beof ~~issued~~our Common Stock, our capital structure and broader macroeconomic and geopolitical conditions.

~~Consolidated~~In ~~Results~~January 2025, we entered into a revolving loan arrangement that provided for borrowings of ~~Operations~~up to $2.0 million. The facility bears interest at a high rate and matures on January 31, 2026. As of April 1, 2026, the Company was in default under the revolving loan arrangement as a result of its failure to repay amounts due at maturity, and the lender has issued a demand for repayment of the ~~Years~~ ~~Ended~~outstanding ~~December 31~~amounts. As a result of this default, ~~2024~~the lender may accelerate the indebtedness, and ~~2023~~amounts in excess of the outstanding principal, including accrued interest, fees and other costs, may become immediately due and payable. Our ability to repay, refinance or otherwise address this indebtedness on acceptable terms will affect our liquidity and financial flexibility. There can be no assurance that we will be able to refinance or satisfy this indebtedness on favorable terms or at all.

~~The~~During ~~following~~2025, ~~table~~we ~~summarizes~~also ~~our~~completed ~~consolidated~~the ~~results~~acquisition of Grid AI Corp., which expanded our operations ~~for~~beyond our legacy life sciences activities to include software-enabled energy orchestration and grid-edge platform activities through Grid AI Corp. and AMPX. In addition, on December 31, 2025, we completed the ~~periods~~rescission ~~indicated:~~transaction involving ImmunogenX, LLC, pursuant to which that business ceased to be our subsidiary. Following the rescission, we no longer held any ownership interest in ImmunogenX, although we retained certain liabilities as set forth in the related transaction documents. As a result of these transactions, our liquidity and capital resource profile at year-end 2025 differed materially from prior periods.


	Years Ended December 31,				Increase
	2024		2023		(decrease)
Operating expenses:
Research and development expenses	$	903,941	$	5,033,218	$	(4,129,277)
General and administrative expenses		14,717,333		10,737,609		3,979,724
Total operating expenses		15,621,274		15,770,827		(149,553)
Other income (expense)		2,253		(24,156)		(26,409)
Loss from continuing operations		(15,619,021)		(15,794,983)		(175,962)
Loss from discontinued operations		(2,440,315)		—		2,440,315
Net loss	$	(18,059,336)	$	(15,794,983)	$	2,264,353

We expect to continue to incur substantial expenditures in the foreseeable future, including expenditures relating to operation and integration of the Grid AI Corp. and AMPX business, maintenance of our public company infrastructure, professional fees, debt service and evaluation of strategic and financing alternatives. In addition, although Adrulipase remains our principal retained legacy biopharmaceutical asset, any meaningful advancement of that program would require substantial additional capital for manufacturing, clinical development, regulatory activities and related support functions.

Because we do not currently generate revenue from approved pharmaceutical product sales and because the Grid AI Corp. and AMPX business remains in an early stage within our consolidated structure, we expect to continue to rely on external capital resources.

~~Revenues~~-63-

WeTable ~~have not yet achieved revenue-generating status from any~~ of our product candidates. Since inception, we have devoted substantially all of our time and efforts to acquiring and developing our product candidates, including Adrulipase, Niclosamide, Capeserod and Latiglutenase. As a result, we did not have any revenue during the years ended December 31, 2024 and 2023, respectively.Contents

~~Research~~If we are unable to obtain additional financing when needed, on acceptable terms or at all, we may be required to delay, reduce or terminate operating activities, defer strategic initiatives, reduce headcount, dispose of assets, restructure obligations or pursue other alternatives that may materially adversely affect our business, financial condition and ~~Development~~results ~~Expenses~~of operations.

~~Research~~Our ~~and~~access ~~development~~to ~~expenses~~capital ~~for~~may ~~the~~also ~~year~~be ~~ended~~adversely ~~December~~affected ~~31,~~by ~~2024~~factors ~~totaled~~beyond ~~approximately~~our ~~$0.9 million~~control, aincluding ~~decrease~~inflation, ofinterest ~~approximately~~rates, ~~$4.1~~capital ~~million~~markets volatility, orgeopolitical ~~82%~~conflicts, ~~over~~supply ~~the~~chain ~~approximately~~disruption ~~$5.0~~and ~~million~~changing ~~recorded~~investor ~~for~~sentiment ~~the~~toward ~~year~~small-cap ~~ended~~public ~~December~~companies, 31biotechnology issuers, ~~2023~~emerging energy technology companies or issuers with complex capital structures.

~~The~~Based ~~decrease~~on ofour ~~approximately~~cash ~~$4.1~~position, ~~million~~operating inplans, ~~research~~debt obligations and ~~development~~expected ~~expenses~~cash ~~was~~requirements, ~~primarily~~management ~~attributable~~concluded that substantial doubt existed regarding our ability to ~~decrease~~continue as a going concern for a period of ~~approximately~~one ~~$2.2~~year ~~million~~from inthe ~~clinical~~date ~~trial~~of ~~related~~issuance ~~expenses~~of the financial statements, ~~$0.5~~unless ~~million~~we ~~related~~are able to ~~the~~obtain ~~September~~additional ~~2023~~capital ~~upfront~~or ~~payment~~otherwise toimprove ~~Sanofi~~liquidity. ~~per~~The ~~the~~accompanying ~~executed~~financial ~~license~~statements ~~agreement~~have ~~for~~been ~~Capeserod~~prepared assuming that we will continue as a going concern and ~~$0.4~~do ~~million~~not ~~decrease~~include inany ~~personnel~~adjustments ~~costs~~that might result from the outcome of this uncertainty.

~~General~~Our ability to issue additional securities will depend on market conditions, the availability of effective registration statements or applicable exemptions from registration, stockholder approval requirements, Nasdaq rules and ~~Administrative~~the ~~Expense~~terms of our existing securities and financing arrangements. Future equity or equity-linked financings may be dilutive to existing stockholders and may include rights, preferences or privileges senior to those of our Common Stock.

~~General~~Consolidated ~~and~~Results ~~administrative~~of ~~expenses~~Operations for the Years ~~year~~Ended ~~ended~~ December 31, ~~2024~~2025 ~~totaled~~and ~~approximately $14.7 million, an increase of approximately $3.9 million, or 36%, over the approximately $10.7 million recorded for the year ended December 31, 2023.~~2024

The ~~increase~~following intable ~~total~~summarizes ~~general~~our ~~and~~consolidated ~~administrative~~results ~~expenses was due primarily to primarily attributable to $4.0 million~~ of ~~non-cash~~operations ~~expense recorded~~ for the ~~Tungsten~~periods ~~financial advisor fees related to IMGX merger, share based compensation increased by~~ indicated:

-59-


		Years Ended December 31,						Increase
		2025			2024			(decrease)
Revenue		$	36,251			—			36,251
Cost of Services			693,683			—			693,683
Gross loss			(657,432)			—			(657,432)

Operating expenses:
Research and development expenses		$	925,482		$	903,941		$	21,541
General and administrative expenses			5,500,524			14,717,333			(9,216,809)
Total operating expenses

Filing Compare · GridAI Technologies Corp.