As filed with the Securities and Exchange Commission on November 29, 2023.

Registration No. 333-275352

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

____________________________

AMENDMENT NO. 1
TO

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

____________________________

SEQUOIA VACCINES, INC.
(Exact name of registrant as specified in its charter)
____________________________

Delaware		2836		46-0813244
(State or other jurisdiction of Incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

1912 Innerbelt Business Center Drive
St. Louis, MO 63114
(314) 373-5181
(Address, including zip code and telephone number, including area code, or registrant’s principal executive offices)

____________________________

Dr. Kevin B. Bacon
Chief Executive Officer
1912 Innerbelt Business Center Drive
St. Louis, MO 63114
(314) 373-5181
(Name, address, including zip code, and telephone number including area code, of agent for service)

____________________________

With copies to:

Darrick M. Mix, Esq.

Justin A. Santarosa, Esq.

Duane Morris LLP

30 South 17th Street

Philadelphia, Pennsylvania 19103

(215) 979-1227

Brad L. Shiffman, Esq.

Blank Rome LLP

1271 Avenue of the Americas

New York, New York 10021

(212) 885-5442

____________________________

Approximate date of commencement of proposed sale to the public:
As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or 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 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

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The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting any offer to buy these securities in any jurisdiction where such offer or sale is not permitted.

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION

DATED NOVEMBER 29, 2023

Shares
Common Stock

Sequoia Vaccines, Inc.

This is a firm commitment initial public offering of shares of common stock of Sequoia Vaccines, Inc. Prior to this offering there has been no public market for our common stock. We anticipate that the initial public offering price of our shares will be between $ and $ per share.

We have applied to list our common stock on the NYSE American under the symbol “SQVI” and this offering is contingent on the listing of our common stock on the NYSE American. No assurance can be given that our application will be approved.

We are an “emerging growth company” and “smaller reporting company” as defined under the U.S. federal securities laws and, as such, will be subject to reduced public company reporting requirements for this prospectus and future filings.

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 11. Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

	Per Share	Total
Initial public offering price
Underwriting discounts and commissions(1)
Proceeds to us, before expenses

(1) Underwriting discounts and commissions do not include a non-accountable expense allowance equal to 1.0% of the public offering price payable to the underwriters. We refer you to “Underwriting” herein for additional information regarding underwriters’ compensation.

We have granted a 45-day option to the representative of the underwriters to purchase up to additional shares of common stock solely to cover over-allotments, if any.

The underwriters expect to deliver the shares to purchasers on or about , 2023.

ThinkEquity

The date of this prospectus is , 2023

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TABLE OF CONTENTS

		Page
PROSPECTUS SUMMARY		1
THE OFFERING		8
SUMMARY FINANCIAL DATA		10
RISK FACTORS		11
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		65
MARKET AND INDUSTRY DATA		67
USE OF PROCEEDS		68
DIVIDEND POLICY		69
CAPITALIZATION		70
DILUTION		72
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		75
BUSINESS		88
MANAGEMENT		126
EXECUTIVE AND DIRECTOR COMPENSATION		132
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS		138
PRINCIPAL STOCKHOLDERS		139
DESCRIPTION OF SECURITIES		141
SHARES ELIGIBLE FOR FUTURE SALE		144
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS		146
UNDERWRITING		150
LEGAL MATTERS		160
EXPERTS		160
WHERE YOU CAN FIND ADDITIONAL INFORMATION		160
INDEX TO FINANCIAL STATEMENTS		F-1

You should rely only on the information contained in this prospectus or in any free writing prospectus that we may specifically authorize to be delivered or made available to you. We and our underwriters have not authorized anyone to provide you with any information other than that contained in this prospectus or in any free writing prospectus to be delivered or made available to you. We take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus may only be used where it is legal to offer and sell securities. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date. We are not making an offer of these securities in any jurisdiction where the offer is not permitted.

For investors outside of the United States: we have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside of the United States.

All trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to with the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

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PROSPECTUS SUMMARY

This summary highlights, and is qualified in its entirety by, information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. You should read this entire prospectus carefully, especially the sections titled “Risk Factors” and Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes appearing elsewhere in this prospectus, before making an investment decision. As used in this prospectus, unless the context otherwise requires, references to “we,” us,” “our,” “the Company,” “Sequoia” and “Sequoia Vaccines” refer to Sequoia Vaccines, Inc.

The share and per share information in this prospectus, other than our financial statements and the notes thereto, reflects a proposed one-for share reverse split of the authorized and outstanding common stock to occur immediately following the date of this prospectus and prior to the closing of this offering.

Company Overview

We are a clinical stage pharmaceutical company developing a vaccine designed to prevent recurrent urinary tract infections (UTIs) and small molecules for treating cancers and bacterial infections. Our lead clinical candidate, SEQ-400, is a vaccine under investigation for the prevention of recurrent UTIs, which received fast track designation by the Food and Drug Administration (FDA) in December 2017. We are planning a UTI observation trial in 2023 which will seek to identify and define a population of patients with culture-verified recurrent UTIs to participate in a subsequent phase 2 efficacy trial of SEQ-400 where enrolled patients will serve as their own control comparing UTI occurrences pre and post vaccination with SEQ-400.

Lead Clinical Candidate

SEQ-400, Vaccine for the prevention of recurrent UTIs

SEQ-400 is designed to generate antibodies that function to reduce the bacterial attachment and colonization of human bladders to prevent UTIs. We successfully completed a phase 1 study which studied the tolerance and immunogenicity of the adjuvanted vaccine in a population of healthy volunteers and women with a history of recurrent UTIs. This study established a recommended phase 2 dose and schedule. The next step in SEQ-400’s development is to conduct a phase 2 clinical trial to evaluate efficacy in a defined population of patients with culture-verified recurrent UTIs. The phase 1 study included 67 women, including 25 women with a two-year documented history of recurrent UTIs. These women had fewer recurrent UTIs after achieving peak antibody responses produced by the vaccine as compared to the 9-month time period preceding peak antibody response. The antibodies generated in these women were evaluated in laboratory studies and were shown to reduce the adherence of bacteria to human bladder cells, which is the intended mechanism of action of the vaccine. Furthermore, patients in the phase 1 study reported very few local (injection site swelling, tenderness, burning, redness) adverse reactions and systemic (headaches, nausea, fatigue) adverse reactions and no severe systemic adverse reactions. Local and systemic adverse reactions generally resolved within seven days. Details of the incidence and severity of adverse reactions are discussed more fully in the section entitled “Business — SEQ-400, Vaccine for the prevention of recurrent UTIs.” Therefore, we believe SEQ-400 is well positioned to begin a phase 2 trial designed to evaluate efficacy and safety in a larger population of patients with recurrent UTIs.

The phase 1 study for SEQ-400 was an open-label, uncontrolled, dose escalation study conducted at six clinical sites in Maryland, Michigan, North Carolina, South Carolina, and Utah. In accordance with the phase 1 study’s protocol, patient participation in the study was 19 months, which included 30 days before the first vaccination and 18 months following the first vaccination. The objectives of the phase 1 study were to evaluate the safety and immunogenicity of the SEQ-400. The study included 67 females, ages 21-64, in 7 cohorts. Subjects received four doses of vaccine at Day 1, Day 30, Day 90 and Day 180. A safety review committee allowed enrollment of subsequent cohorts after review of safety assessments. Subjects in cohorts 1 to 5 did not have a history of UTIs in the previous 24 months prior to enrollment into the study. Subjects in cohorts 6 and 7 had 5 or more documented UTIs in the last 24 months, including at least 1 UTI with a urine culture identifying E. coli. For subjects in cohorts 6 and 7, UTI symptoms were recorded during the study per protocol. Of the 67 enrolled subjects, 57 received all four vaccinations.

In cohorts 6 and 7, 30 subjects with recurrent UTIs were enrolled; 26 received all four vaccinations and 25 completed the 19-month study. These women were 25 to 64 years of age. The 30 women who were enrolled experienced more than 180 UTIs in the 24 months preceding enrollment. Their medical record documentation

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included more than 80 antibiotic susceptibility reports for E. coli identified from clean-catch midstream urine collections. These susceptibility data demonstrated that 15 women each had at least one UTI with E. coli resistant to trimethoprim-sulfamethoxazole, and 14 women each had at least one UTI with E. coli resistant to ciprofloxacin. Despite antibiotic refills being listed in these records, the use of these refills was not investigated or tabulated, so it is probable that some of these 30 women had additional undocumented UTIs in the preceding 24 months. Fourteen of the subjects had been prescribed antibiotic prophylaxis at least once in the previous 24 months.

The UTI Vaccine Market

There are currently no products approved by the FDA to prevent recurrent UTIs. UTIs are one of the most common bacterial infections in the U.S., and antibiotic treatment is the established standard of care. After treatment with antibiotics, UTIs recur when bacteria from the patient’s intestinal tract reinfect their bladders. Prevention of infections reduces patient morbidity, healthcare costs and antibiotic use. When antibiotic use is reduced, emergence of resistant organisms is also reduced. UTIs lead to emergency room visits, hospitalizations including prolonged stay and readmissions, sepsis, septic shock and mortality. Sepsis is one of leading causes of death in the U.S. and the urinary tract is one of the primary sites that can lead to sepsis. The U.S. Department of Health and Human Services (HHS) and three U.S. universities published a study in 2020 forecasting sepsis-related costs for Medicare beneficiaries. The study revealed that the U.S. healthcare system spends more than $62 billion annually on sepsis-admissions and related outcomes. The Centers for Diseases and Control and Prevention (CDC) published a study in 2018 examining the variability in short-term sepsis mortality by hospital among Medicare beneficiaries. This study revealed that UTIs are the leading cause of hospitalizations for severe sepsis and septic shock in patients 65 years of age and older who are covered by Medicare.

Vaccines reduce associated healthcare costs by preventing infections. COVID-19, diphtheria, measles, mumps, pertussis, pneumococcal diseases, polio, rotavirus, rubella, small pox, tetanus, typhoid, varicella, and yellow fever are all infectious disease where vaccination approaches have been successful. The CDC estimates that the vaccination of children born between 1994 and 2018 in the U.S. prevented 419 million illnesses, 26.8 million hospitalizations, 936,000 deaths, and reduce nearly $1.9 trillion in total societal costs. For example, pneumococcal vaccines prevent bacterial infections by Streptococcus pneumoniae. By preventing pneumococcal disease there is reduced use of antibiotics to treat pneumonia, and reduced risk for the development of antibiotic-resistant strains of S. pneumoniae. Antibodies produced by pneumococcal vaccines pass (transude) from blood to the middle ear fluid of humans to prevent ear infections by S. pneumoniae.

The CDC and HHS Antimicrobial Resistance Challenge was implemented to reduce the development of antibiotic resistance and transmission of resistant bacteria into communities and hospitals. This Challenge received commitments from more than 300 health care systems, health insurance companies, medical professionals and government health organizations. Importantly, one of these commitments was to invest in the development of and access to vaccines. The CDC supports accelerating the commercialization of new vaccines. The CDC supports vaccinations against bacteria, including resistant species to reduce the need for antibiotics. The CDC’s Core Elements of Hospital Antibiotic Stewardship program has encouraged hospitals to implement antibiotic stewardship programs which has led to reduced antibiotic prescriptions in outpatient settings. In 1999, the CDC published an article that focused on their strategies to mitigate the threats of infectious diseases as we begin the 21st century that stated, “Antimicrobial resistances is one of the most important emerging infectious disease issues in the United States today, with overprescribing of antibiotics a major contributor to the problem.” Since this time, the CDC has continued to promote antimicrobial stewardship programs to reduce the use of antibiotics. Despite these efforts by the CDC, UTIs caused by multidrug-resistant extended-spectrum beta-lactamase Escherichia coli have been on the rise. The Advisory Committee on Immunization Practices (ACIP) operates at the CDC to make recommendations to the CDC around adoption of new vaccines. While, safety and efficacy determinations are within the exclusive purview of the FDA, the ACIP will consider the safety and effectiveness of the vaccine and severity of the target disease when making recommendations to the CDC. Vaccine recommendations from the ACIP to the CDC are generally adopted by the CDC.

The Centers for Medicare and Medicaid Services (CMS) maintains conditions of participation that healthcare organizations must meet in order to participate in CMS programs. These conditions and rules require implementing methods to prevent the transmission of infections within the hospital and between hospitals and other institutions, and commit to judicious use of antibiotics, in order to reduce the development of antibiotic-resistant organisms. These rules reflect the focus of today’s U.S. healthcare system, which is to prevent infections, prevent the spread of infections, and reduce the use of antibiotics. We believe that SEQ-400 has a potential to prevent recurrent UTIs, reduce the use of antibiotics that treat recurrent UTIs, and subsequently reduce the development of antibiotic-resistant bacteria that cause recurrent UTIs because exposures to antibiotics are reduced.

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Other Clinical Candidates

SEQ-1274, Small Molecule Platform for the treatment of ovarian and potentially other cancers

We are developing small molecule analogs, derived from our lead scaffold SEQ-1274, to treat ovarian and potentially other cancers. Pre-clinical experimental investigations at our laboratory and four independent laboratories and published in the Journal of Medicinal Chemistry on July 11, 2018, have shown that SEQ-1274 has produced in vitro activity against 53 cancer cell lines with a 50% (IC50) inhibitory concentration average of 26 nM. Additionally, the same investigations and published in vitro data has shown SEQ-1274 is 5 to 1000 times more active than paclitaxel when tested against seven cancer cell lines conferring some resistance to paclitaxel, including two ovarian and two lung cancer cell lines. Researchers at Washington University also evaluated SEQ-1274 and paclitaxel against two human tumor cell lines implanted in mice and SEQ-1274 demonstrated anti-tumor activity in animal tumor models performed at four independent laboratories. The researchers found that SEQ-1274 inhibits tumors implanted in mice to a greater degree than paclitaxel. The laboratory of Katherine Fuh, MD, an obstetrician at Washington University, published in 2018 that SEQ-1274 inhibited tumor growth in an ovarian tumor model. The Company also completed a study in which it repeated experiments with SEQ-1274 that were performed at Piedmont Research Center with docetaxel. Preliminary evidence from that study indicates that SEQ-1274 may exhibit less peripheral neuropathy and toxicities than docetaxel.

Natural product-derived lead compounds for the treatment of the lung infections in cystic fibrosis patients

We are conducting lead optimization of compounds that exhibit potent activity against the spreading biofilms of gram-negative bacteria, including Pseudomonas aeruginosa, E. coli, Burkholderia cepacia, and Salmonella enterica. We believe these are first-in-class compounds which inhibit multiple strains (isolates) of different species of bacteria, and this broad spectrum of activity demonstrates potential to establish an additional therapeutic approach for management of chronic lung infection. Two independent academic laboratories have shown that PilY1 is a key mechanism that enables P. aeruginosa to cause infections in cystic fibrosis patients. These two academic laboratories have shown PilY1 and type IV pili are used by P. aeruginosa to attach and colonize human airway tracheobronchial epithelial cells. Data regarding the inhibition of the expression of genes and the protein expression for PilY1 and also type IV pili is disclosed more fully in the section entitled “Business — Sequoia’s Spreading Biofilm Inhibitors Modulate Virulence Pathways in P. aeruginosa and — Type IV pili.” By inhibiting P. aeruginosa biofilms spreading in the lungs of cystic fibrosis patients, we believe these treatments will lead to reduced infections and improved patient morbidity.

Our Pipeline

Our current pipeline consists of the SEQ-400 vaccine for the prevention of recurrent UTIs, one drug platform to treat ovarian and potentially other cancers (SEQ-1274), and a small molecule candidate to inhibit the bacteria biofilm that negatively impact the lung function of cystic fibrosis patients. We view each development opportunity independent of modality (within vaccines or small molecules) based on the scientific evidence supporting development, the clinical development strategy including patient enrollment criteria and trial endpoints, and the potential to positively impact the market.

The table below outlines our current programs, including next anticipated milestone:

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Our Strategy

Our mission is to develop a vaccine to prevent UTI infections and advance our anti-cancer and cystic fibrosis development compounds into humans. As part of our growth strategy, we plan to:

• Conduct a phase 2 trial evaluating SEQ-400 in patients with documented histories of recurrent UTIs;

• Conduct a phase 1B study or enable investigator-initiated studies to evaluate SEQ-400 in children, transplant recipients, paralysis patients, or those patients in life-threatening situations suffering from recurrent UTIs;

• Further optimize commercial manufacturing processes for the antigen and adjuvant drug product of SEQ-400;

• Prepare for the phase 3 study evaluating SEQ-400 in a double-blind, randomized, placebo controlled global trial;

• Establish an IND-enabling research and development (“R&D”) program and a scalable research manufacturing process for a lead derived from SEQ-1274 family analogs;

• Conduct lead optimization of our infectious disease compounds against gram-negative bacteria; and

• Elucidate the upstream mechanism of action of our infectious disease compounds that lead to the inhibition of PilY1 and type IV pili-mediated spreading of Pseudomonas aeruginosa.

Upon completion of future financings, we intend to undertake the following:

• Conduct a phase 3 study evaluating SEQ-400;

• Commercialize SEQ-400 on our own or in partnership with one of more pharmaceutical companies;

• Conduct IND-enabling animal toxicology studies for a clinical candidate derived from our SEQ-1274 platform and file an investigational new drug application (NDA);

• Conduct a phase 1 study evaluating SEQ-1274-derived analogs in patients with ovarian and potentially other cancers;

• Select a clinical development candidate to be evaluated in cystic fibrosis patients;

• Conduct IND-enabling studies of our clinical development candidate to be evaluated in cystic fibrosis patients;

• Conduct a phase 1 study evaluating our clinical candidate in cystic fibrosis patients; and

• Expand our pipeline of investigational products.

Our Management

Our management team is experienced in entrepreneurship, research and development, manufacturing, finance, and operations. Our President and Chief Executive Officer, Dr. Kevin Bacon, has more than thirty years of experience raising capital and leading and managing companies and drug discovery and development programs. Our Chief Financial Officer, James Spellmeyer, has more than forty years of experience leading, managing, and reporting the finances of both private and public companies. Our Vice President of Clinical Development, Jennifer Harris, PharmD, has designed and managed clinical trials for more than twenty years at Merck, GlaxoSmithKline, and smaller biotechnology companies. Our Vice President of Process Development and Manufacturing, Eric Cunningham, has more than twenty years of experience in pharmaceutical manufacturing at Genentech, Biogen, and Pfenex. Following this offering and connection with becoming a public company, we intend to augment our management team and seek to add additional experienced executives to our team.

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Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As such, we may take advantage of certain exemptions from various reporting requirements that are otherwise applicable to public companies. These exemptions include, but are not limited to:

• Being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus;

• An exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting;

• Reduced disclosure obligations regarding executive compensation;

• Exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved; and

• An exemption from compliance with the requirements of the Public Company Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.

We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the completion of this offering. However, if prior to the end such five-year period, (i) our annual gross revenue exceeds $1.235 billion, (ii) we issue more than $1.0 billion of non-convertible debt in the previous three-year period or (iii) we become a “large accelerated filer” (as defined in Rule 12b-2 under the Securities and Exchange Act of 1934, as amended, or the Exchange Act), we will cease to be an emerging growth company prior to the end of such five-year period. We will be deemed to be a “large accelerated filer” at such time that we (a) have an aggregate worldwide market value of our securities held by non-affiliates of $700.0 million or more as of the last business day of our most recently completed second fiscal quarter, (b) have been required to file annual and quarterly reports under the Exchange Act for a period of at least 12 months and (c) have filed at least one annual report pursuant to the Exchange Act.

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus forms a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company; however, we have and may adopt certain new or revised accounting standards early, when early adoption is permitted.

We are also a “smaller reporting company” as defined under the Securities Exchange Act. We may continue to be a smaller reporting company for so long as either (i) the market value of our securities held by non-affiliates is less than $250 million as of the last business day of our most recently completed second fiscal quarter or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is less than $700 million as of the last business day of our most recently completed second quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation, and similar to emerging growth companies, if we are a small reporting company with less than $100 million in annual revenue, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

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Summary Risk Factors

Investing in our common stock involves significant risks. You should carefully consider the risks described in the section titled “Risk Factors” and elsewhere in this prospectus before making a decision to invest in our common stock. If we are unable to successfully address these risks and challenges, our business, financial condition, results of operations or prospects could be materially and adversely affected. In such case, the trading price of our common stock would likely decline, and you may lose all or part of your investment. Below is a summary of some of the risks we face.

• We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.

• We have no history of developing or commercializing our products, which may make it difficult for an investor to evaluate the success of our business to date and assess our future viability.

• Even if this offering is successful, we will need substantial additional funding to meet our financial obligations and to pursue our business objectives. If we are unable to raise sufficient capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

• We have entered into convertible notes secured by all of our assets; indebtedness thereunder could adversely affect our financial position and our ability to raise additional capital and prevent us from fulfilling our obligations.

• All of our product candidates are currently in clinical and preclinical development. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates for the indications we seek, or successfully develop any other product candidates, or experience delays in doing so, our business will be materially harmed.

• Because SEQ-400 and any future product candidates represent novel approaches to the treatment and prevention of disease, there are many uncertainties regarding the development, market acceptance, third-party reimbursement coverage and commercial potential of our product candidates.

• Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates. If we are unable to obtain required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate product revenue will be adversely affected.

• We may experience delays in beginning or conducting clinical trials or numerous unforeseen events before, during or as a result of clinical trials that could delay or prevent our ability to complete clinical trials, receive marketing approval or commercialize our product candidates.

• Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval.

• Our preclinical studies and clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent, delay or limit the scope of regulatory approval of our product candidates, limit their commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.

• Breakthrough therapy designation by the FDA for any product candidate may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.

• Vaccines and pharmaceutical products are complex and difficult to manufacture. We could experience manufacturing problems, or may be unable to access raw materials that result in delays in the development or commercialization of our product candidates or otherwise harm our business.

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• We depend on sole-source third-party suppliers for materials that are necessary for the conduct of clinical and preclinical studies and manufacture our product candidates for clinical trials, and the loss of these third-party suppliers and manufacturers or their inability to supply us with sufficient quantities of adequate materials, or to do so at acceptable quality levels and on a timely basis, could harm our business.

• Any product candidates for which we intend to seek approval as biologic products may face biosimilar competition sooner than anticipated.

• The success of our product candidates will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these therapies.

• If we are unable to obtain, maintain and enforce patent protection for our current and future product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours and our ability to successfully develop and commercialize our product candidates may be adversely affected.

• We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our product candidates.

Corporate Information

We were incorporated under the laws of the State of Delaware on August 16, 2012. On April 30, 2021, we undertook a combination transaction (“Combination Transaction”) to combine the businesses, assets and liabilities of Sequoia Sciences, Inc. (“SSI”) and Sequoia Sciences UTI, LLC (“SSUTI”) with and into us. For certain periods prior to the Combination Transaction, we were a consolidated subsidiary of SSUTI. We are the surviving entity of the Combination Transaction. The merger with SSI (the “SSI Merger”) was accounted for as an asset acquisition by us. The merger with SSUTI (the “SSUTI Merger”) reflects a transaction between entities under common control and was accounted for as a downstream merger, with the transferred assets and liabilities recorded at their historical cost basis.

Our principal executive office is located at 1912 Innerbelt Business Center Drive, St. Louis, MO 63114 and our telephone number is (314) 373-5181. Our website is www.sequoiavaccines.com. The information contained on, or accessible through, our website is not incorporated by reference into this prospectus, and you should not consider any information contained in, or that can be accessed through our website as part of this prospectus or in deciding whether to purchase our securities. We have included our website in this prospectus solely as an inactive textual reference.

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THE OFFERING

Common Stock offered by us		shares
Common stock to be outstanding immediately after this offering		shares (or shares if the underwriters exercise in full their option to purchase up to additional shares).
Option to purchase additional shares offered by us		We have granted the underwriters an option for a period of 45 days to purchase up to additional shares of common stock.
Use of proceeds		We estimate the net proceeds from this offering will be approximately $ million, (or approximately $ million if the underwriters exercise in full their option to purchase up to additional shares of common stock), assuming an initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, to fund phase 2 human clinical trial for our UTI vaccine, move our preclinical products toward human studies, establish and optimize manufacturing processes and the remainder for working capital and other general corporate purposes, including development of additional programs in our pipeline. See the section entitled “Use of Proceeds” for additional information.
Risk factors		You should read the section titled “Risk Factors” for a discussion of factors you should consider carefully, together with all the other information included in this prospectus, before deciding to invest in our securities.
Proposed symbol		“SQVI”

The number of shares of common stock to be outstanding immediately after this offering is based on shares of common stock outstanding on , 2023 and excludes

• shares of common stock issuable upon exercise of outstanding stock options;

• the issuance of shares of our common stock upon conversion of the $ principal amount of our convertible promissory notes plus accrued interest as of which will not convert in connection with this offering at a conversion price of $ per share, assuming an offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus;

• shares of our common stock that are available for future issuance under our Incentive Stock Plan;

• shares of our common stock that are available for future issuance under our 2023 Equity Incentive Plan; and

• shares of our common stock issuable upon exercise of the representative’s warrants to purchase up to shares of our common stock at an exercise price per share equal to 125% of the initial public offering price per share or $ , based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, that will be issued to the representative of the underwriters in connection with this offering (the “Representative’s Warrants”).

Except as otherwise indicated, all information in this prospectus reflects or assumes

• the automatic conversion of all outstanding shares of our preferred stock into an aggregate of shares of our common stock upon the closing of this offering;

• no exercise of outstanding options;

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• the filing of our amended and restated certificate of incorporation and the adoption of our amended and restated bylaws, which will occur upon the closing of this offering;

• a one-for- share reverse split of our common stock to be effected immediately prior to the closing of this offering;

• no exercise by the underwriters of their over-allotment option or the warrants to purchase shares of our common stock to cover over-allotments, if any; and

• no exercise of the Representative’s Warrants.

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SUMMARY FINANCIAL DATA

You should read the following summary financial data together with our financial statements and the related notes appearing at the end of this prospectus and the “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this prospectus. We have derived the statement of operations data for the fiscal year ended December 31, 2022 and the period from April 30, 2021 to December 31, 2021 from our audited financial statements appearing at the end of this prospectus and the statement of operations data for the nine months ended September 30, 2023 and 2022 from our unaudited financial statements appearing at the end of this prospectus. Our financial statement presentation includes the periods and activities following the Combination Transaction. These financial statements reflect the fair value of assets acquired and liabilities assumed as a result of the SSI Merger and the incremental shares of us exchanged in the Combination Transaction. The SSI Merger was accounted for as an asset acquisition by us. The SSUTI Merger reflects a transaction between entities under common control and was accounted for as a downstream merger, with the transferred assets and liabilities recorded at their historical cost basis. Our historical results are not necessarily indicative of the results that may be expected in any future period.

	Nine Months Ended						Year ended December 31, 2022			Period from April 30, 2021 to December 31, 2021
	September 30, 2023			September 30, 2022			Year ended December 31, 2022			Period from April 30, 2021 to December 31, 2021
Statements of operations data:
Total operating expenses	$	2,262,790		$	3,233,785		$	4,086,357		$	6,381,793
Loss from operations	$	(2,262,790	)	$	(3,233,785	)	$	(4,086,357	)	$	(6,381,793	)
Net loss	$	(2,333,493	)	$	(3,307,985	)	$	(4,186,131	)	$	(6,447,742	)
Net loss per share attributable to common stockholders, basic and diluted(1)	$	(0.21	)	$	(0.26	)	$	(0.34	)	$	(0.45	)
Weighted-average shares of common stock outstanding, basic and diluted(1)		15,840,724			15,840,724			15,840,724			15,840,724

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(1) See Note 3 — Summary of Significant Accounting Policies to our financial statements included elsewhere in this prospectus for an explanation of the method used to calculate the basic and diluted net loss per share and the number of shares used in the computation of the per share amounts.

	As of September 30, 2023
	Actual			Pro forma(1)	Pro forma as adjusted(2)
	(unaudited)			(unaudited)	(unaudited)
Balance sheet data:
Cash	$	714,118
Working capital	$	421,917
Total assets	$	1,202,575
Total liabilities	$	1,991,508
Convertible preferred stock	$	20,988,387
Accumulated deficit	$	(55,783,549	)
Total stockholders’ equity (deficit)	$	(21,777,320	)

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(1) Reflects the automatic conversion of all outstanding shares of our preferred stock, into an aggregate of shares of common stock upon the closing of this offering.

(2) Reflects our issuance and sale of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

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RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all the information in this prospectus, including our financial statements and related notes, before deciding whether to purchase shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your investment.

Risks Related to our Financial Position and Capital Needs

We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.

Since our inception, we have incurred significant losses, and we expect to continue to incur significant expenses and operating losses for the foreseeable future and our operating losses will increase as we continue to develop our lead clinical candidate, SEQ-400, and our other clinical candidates. Our net losses were approximately $2.3 million, $4.2 million and $6.4 million for the nine months ended September 30, 2023, year ended December 31, 2022 and the period from April 30, 2021 to December 31, 2021, respectively. As of September 30, 2023, we had an accumulated deficit of approximately $55.8 million. Since our inception, we have financed our operations with gross proceeds of $ million raised in our private placements of preferred stock, common stock, membership units and convertible debt.

Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

• Continue to conduct our ongoing clinical trials of SEQ-400 vaccine, including advancement into late-stage global clinical trials, as well as initiate and complete additional clinical trials of future product candidates or current product candidates in new indications or patient populations;

• Continue to advance the preclinical development of our other product candidates;

• Seek regulatory approval for any product candidates that successfully complete clinical trials;

• Pursue marketing approvals and reimbursement for our product categories;

• Acquire or in-license other product candidates, intellectual property or technologies;

• Develop, establish and validate our commercial-scale current Good Manufacturing Practices, or cGMP, manufacturing process;

• Manufacture material under cGMP for clinical trials and potential commercial sales at our contracted manufacturing facility;

• Maintain, expand, enforce, defend and protect our intellectual property portfolio;

• Comply with regulatory requirements established by the applicable regulatory authorities;

• Hire and retain additional personnel including research, clinical, development, manufacturing, quality control, quality assurance, regulatory and finance personnel;

• Add operational, financial, corporate development, management information systems and administrative personnel, including personnel to support our product development; and

• Incur legal, accounting and other expenses in operating as a public company.

To date, we have no products approved for commercialization and have not generated any revenue from product sales and do not expect to do so until one of our clinical candidates obtains marketing approval. To become and remain profitable, we must succeed in developing and eventually commercializing product candidates that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, validating manufacturing processes, obtaining regulatory approval

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and manufacturing, marketing and selling any product candidates for which we may obtain regulatory approval as well as discovering and developing additional product candidates. All or our product candidates are in clinical or preclinical development. We may never succeed in these activities and, even if we do, may never generate any revenue or revenue that is significant enough to achieve profitability.

Because of the numerous risks and uncertainties associated with product candidate development, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform clinical trials or preclinical studies in addition to those currently expected, or if there are delays in the initiation and completion of our clinical trials or the development of any of our product candidates, our expenses could increase.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product approvals, diversify our offerings or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.

We have no history of developing or commercializing our products, which may make it difficult for an investor to evaluate the success of our business to date and assess our future viability.

We are a clinical stage pharmaceutical company with a limited operating history. We commenced operations in August 2012. Our operations to date have been largely focused on organizing and staffing our company, business planning, raising capital, developing our technology and product candidates, developing our manufacturing capabilities and developing our clinical and preclinical product candidates, including undertaking preclinical studies and conducting clinical trials. To date, we have not yet demonstrated our ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a product on a commercial scale, or conduct sales and marketing activities necessary for successful commercialization, and we may not be successful in doing so. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing products.

We will eventually need to transition from a company with a research and clinical focus to a company, if any of our product candidates are approved, capable of supporting commercial activities. We may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. and may not be successful in such a transition.

Even if this offering is successful, we will need substantial additional funding to meet our financial obligations and to pursue our business objectives. If we are unable to raise sufficient capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

Our operations have consumed a substantial amount of cash since inception, and we expect to continue to incur significant expenses and operating losses in the foreseeable future as we continue to develop our product candidate pipeline and build out our manufacturing capabilities for our product candidates, which, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of our products that may not be commercially available for a number of years, if at all. If we obtain marketing approval for any product candidates that we develop or otherwise acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. We also expect an increase in our expenses associated with creating additional infrastructure to support operations as a public company. Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

As of September 30, 2023, we had cash and cash equivalents of $714,118. We believe that the anticipated net proceeds from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements through . This estimate is based on assumptions that may prove to be wrong, and we could exhaust our available resources sooner than expected. We plan to use the net proceeds from this offering to fund a phase 2 human clinical trial for our UTI vaccine, move our preclinical products toward human studies, establish and optimize manufacturing processes and the remainder for working capital and other general corporate purposes, including development of additional programs in our pipeline. The net proceeds from this offering, together with our existing cash and cash equivalents, will not be sufficient to fund any of our product candidates through regulatory approval. Changes may occur beyond our control that would cause us to consume our

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available capital before that time, including changes in and progress of our development activities, acquisitions of additional product candidates and changes in regulation. The timing and amount of our funding requirements will depend on many factors, including:

• The rate of progress in the development of SEQ-400 and our other product candidates;

• The scope, progress, results and costs of non-clinical studies, preclinical development, laboratory testing and clinical trials for SEQ-400 and future product candidates and associated development programs;

• The extent to which we develop, in-license or acquire other product candidates and technologies in our pipeline;

• The scope, progress, results and costs as well as timing of manufacturing scale-up and validation activities associated with SEQ-400 and our future product candidates and other programs as we advance them through preclinical and clinical development;

• The number and development requirements of product candidates that we may pursue;

• The costs, timing and outcome of regulatory review of our product candidates;

• Our headcount growth and associated costs as we expand our research and development capabilities and establish a commercial infrastructure;

• The timing and costs of securing sufficient capacity for commercial supply of our product candidates, or the raw material components thereof;

• The costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

• The costs necessary to obtain regulatory approvals, if any, for products in the United States and other jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;

• The costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

• The entry into new collaborations arrangements and licensing agreements, if at all;

• The need and ability to hire additional research, clinical development, scientific, financial and manufacturing personnel

• The costs we incur in maintaining business operations;

• The need to implement additional internal systems and infrastructure;

• The effect of competing technological, product and market developments;

• The revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and

• The costs of operating as a public company.

We will require additional capital to achieve our business objectives. Additional funds may not be available on a timely basis, on favorable terms or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Further, our ability to raise additional capital may be adversely impacted by potential worsening economic conditions and the recent disruptions and volatility in the credit and financial markets in the United States and worldwide resulting from the COVID-19 pandemic and armed conflicts. If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

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Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, government or private-party grants, debt financings and license and collaboration agreements. We do not currently have any other committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through license and collaboration agreements, such as strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams or product candidates, grant licenses on terms that may not be favorable to us or commit to future payment streams. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We have entered into convertible notes secured by all of our assets; indebtedness thereunder could adversely affect our financial position and our ability to raise additional capital and prevent us from fulfilling our obligations.

As of September 30, 2023, we owed an aggregate of $ in principal and accrued interest on our outstanding Notes, which are convertible into shares of our common stock. In connection with the issuance of the Notes, we entered into a Subordinated Security Agreement with each noteholder. Pursuant to terms of the Subordinated Security Agreement, we have granted liens on substantially all of our assets, including our intellectual property, as collateral, and have agreed to significant covenants, including covenants that materially limit our ability to take certain actions, including our ability to pay dividends, make certain investments and other payments, incur additional indebtedness, encumber and dispose of assets and customary events of default, including failure to pay amounts due, breaches of covenants and warranties, material adverse effect events, certain cross defaults and judgements and insolvency. A failure to comply with the covenants and other provisions of the Notes and the Subordinated Security Agreement, including any failure to make a payment when required, would generally result in events of default under such instruments. The occurrence of any default will cause the interest rate to increase during the period of such default, which could permit acceleration of such indebtedness and could result in a material adverse effect on us. If such indebtedness is accelerated, it would generally also constitute an event of default under our other outstanding indebtedness, permitting acceleration of a substantial portion of our indebtedness. Any required repayment of our indebtedness as a result of acceleration or otherwise would lower our current cash on hand such that we would not have those funds available for use in our business or for payment of other outstanding indebtedness.

If we are unable to make payment on our Notes when due, the holders may foreclose on and sell the assets securing such indebtedness, which includes substantially all of our property, to satisfy our payment obligations, which could prevent us from accessing those assets for our business and conducting our business as planned. Our business, financial condition, prospects and results of operations could be materially adversely affected as a result of any of these events.

Our recurring losses from operations and financial conditions raise substantial doubt about our ability to continue as a going concern.

Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern. In our financial statements for the year ended December 31, 2022, we concluded that our recurring losses from operations and need for additional financing to fund future operations raise substantial doubt about our ability to continue as a going concern. Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the year ended December 31, 2022 with respect to this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding. If we are unable to obtain sufficient funding, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we are unable to raise capital when

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needed or on acceptable terms, we would be forced to delay, limit, reduce or terminate our product development or future commercialization efforts of one or more of our product candidates, or may be forced to reduce or terminate our operations. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our audited financial statements, and it is likely that investors will lose all or part of their investment. After this offering, in our own required quarterly assessment, we may again conclude that there is substantial doubt about our ability to continue as a going concern, and future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors and other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, if at all.

Risks Related to the Development of our Product Candidates

All of our product candidates are currently in clinical and preclinical development. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates for the indications we seek, or successfully develop any other product candidates, or experience delays in doing so, our business will be materially harmed.

We currently have no products approved for commercial sale, and all of our product candidates are currently in clinical and preclinical development. Our first Phase 1 study evaluated SEQ-400 vaccine in two populations of women: those with and without a history of recurrent UTI. This study was an open label, antigen-controlled, rising dose evaluation of the safety, tolerability and immunogenicity of the vaccine. In 2017, we completed the Phase 1 clinical study of the UTI vaccine. At such time, we agreed on indications for the vaccine and received fast track designation from the FDA. We have not conducted any later stage or pivotal clinical trials, have limited experience in preparing, submitting and prosecuting regulatory filings and have not previously submitted a biologics license application, or BLA, for any product candidate.

Our ability to generate revenue from product candidates, which may not occur in the foreseeable future, if ever, will depend heavily on the successful development, regulatory approval, obtaining of manufacturing supply, capacity and expertise and eventual commercialization of our product candidates. The success of SEQ-400 or any other product candidates that we develop or otherwise acquire will depend on several factors, including:

• The timing and progress of preclinical and clinical development activities;

• The number and scope of preclinical and clinical programs we decide to pursue;

• Filing acceptable Investigational New Drug applications, or INDs, with the U.S. Food and Drug Administration, or the FDA, or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;

• Sufficiency of our financials and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities;

• Our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing and successfully develop, obtain regulatory approval, and then successfully commercialize our product candidates;

• Successful enrollment and timely completion of clinical trials, including our ability to generate positive data from any such clinical trials;

• The costs associated with the development of any additional development programs and product candidates we identify in-house or acquire through collaborations;

• Receipt of timely marketing approvals from applicable regulatory authorities;

• Developing and expanding sales, marketing and distribution capabilities and launching commercial sales of products, if approved, whether alone or in collaboration with others.

• Acceptance of the benefits and use of our products, including method of administration, if approved, by patients, the medical community and third-party payors, for their approved indications;

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• The prevalence and severity of adverse events experienced with SEQ-400 or any other product categories;

• The availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate we develop;

• The continuing need for therapies for the treatment and prevention of recurrent UTI or the inability of other available therapies to address recurrent UTI;

• The terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder;

• Our ability to obtain and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protecting our rights in our intellectual property portfolio;

• Our ability to maintain compliance with regulatory requirements, including Good Clinical Practices, or GCPs, current Good Laboratory Practices, or cGLPs, and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;

• Potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines;

• Obtaining and maintaining third-party coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement;

• Our ability to maintain a continued acceptable safety, tolerability and efficacy profile of the products following approval; and

• The impact of any business interruptions to our operations or those of third parties with which we work, particularly in light of the current COVID-19 pandemic.

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience delays or an inability to successfully commercialize the product candidates we develop, and we may not be able to continue our operations.

Because SEQ-400 and any future product candidates represent novel approaches to the treatment and prevention of disease, there are many uncertainties regarding the development, market acceptance, third-party reimbursement coverage and commercial potential of our product candidates.

Although recurrent UTI is not a new disease, the treatment and prevention of it has led to an overuse of antibiotics and the development of new antibiotics is not keeping pace with the disease. Because this is a relatively new and expanding area of therapeutic intervention, there are many uncertainties related to the development, marketing, reimbursement and the commercial potential for our product candidates. There can be no assurance as to the length of the clinical trials, the number of patients the FDA will required to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of antibody products or that the design of or data generated in these trials will be acceptable to the FDA to support marketing approval.

In addition, the FDA may take longer than usual to come to a decision on any Biologics License Application, or BLA, that we submit and may ultimately determine that there is insufficient data, information or experience with our product candidates to support an approval decision. The FDA may also require that we conduct additional post-marketing studies or implement risk management programs, such as Risk Evaluation and Mitigation Strategies, or REMS, until more experience with our product candidates is obtained. Finally, after increased usage, we may find that our product candidates do not have the intended effect or have unanticipated side effects, potentially jeopardizing initial or continuing regulatory approval and commercial prospects.

The success of our business depends in part upon our ability to develop engineered antibodies that can broadly neutralize Escherichia coli (“E. coli”). We may fail to deliver antibodies that are effective in the treatment or prevention of recurrent UTI. Even if we are able to identify and develop such antibodies, we cannot ensure that such product candidates will achieve marketing approval to safely and effectively treat or prevent symptomatic recurrent UTI or other diseases.

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If we uncover any previously unknown risks related to our antibodies, or if we experience unanticipated expenses, problems or delays in developing our product candidates, we may be unable to achieve our strategy of building a pipeline that could identify problems that would potentially harm our business.

There is no assurance that the approaches offered by our product candidates will gain broad acceptance among doctors or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for our proposed product candidates. Since our current product candidates and any future product candidates will represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. Accordingly, we may spend significant capital trying to obtain approval for product candidates that have an uncertain commercial market. The market for any products that we successfully develop will also depend on the cost of the product. We do not yet have sufficient information to reliably estimate what it will cost to commercially manufacture our current product candidates, and the actual cost to manufacture these products could materially and adversely affect the commercial viability of these products. If we do not successfully develop and commercialize products based upon our approach or find suitable and economical sources for materials used in the production of our products, we will not become profitable, which would materially and adversely affect the value of our common stock.

Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates. If we are unable to obtain required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate product revenue will be adversely affected.

All of our product candidates are in clinical and preclinical development and their risk of failure is high. The clinical trials and manufacturing of our product candidates are, and the manufacturing and marketing of our products, if approved, will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. In particular, because our product candidates are subject to regulation as biological products, we will need to demonstrate that they are safe, pure and potent for us in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Failure can occur at any time during the clinical trial process. Even if we demonstrate favorable results in preclinical studies and early-stage clinical trials, we cannot assure you that the results of late-stage clinical trials will be favorable enough to support the continued development of our product candidates. Several companies in the pharmaceutical and biopharmaceutical industries have experienced significant delays, setbacks and failures in all stages of development, including late-stage clinical trials, even after achieving promising results in preclinical testing or early-stage clinical trials. Accordingly, results from completed preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results we may obtain in later-stage trials. Even if our future clinical trials are completed as planned, we cannot be certain that their results will support the safety and effectiveness of our product candidates for their targeted indications or support continued clinical development of such product candidates or be sufficient to support the submission of a New Drug Application, or NDA, or a BLA to obtain regulatory approval from the FDA in the U.S., or other similar regulatory agencies in other jurisdictions, which is required to market and sell the product. Our future clinical trial results may not be successful.

In addition, even if such trials are successfully completed, we cannot guarantee that the FDA, the European Medicines Agency, or EMA, or other foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA, EMA, or other foreign

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regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional preclinical studies or trials for our product candidates either prior to or post-approval, or they may object to elements of our clinical development program, requiring their alteration.

Of the large number of products in development, only a small percentage successfully complete the FDA’s or comparable foreign regulatory authorities’ approval processes and are commercialized. Even if we eventually complete clinical testing and receive approval of a NDA, BLA or foreign marketing application for our product candidates, the FDA or the comparable foreign regulatory authorities may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including post-market clinical trials. The FDA or the comparable foreign regulatory authorities also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally request, and the FDA or comparable foreign regulatory authorities may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization of a product candidate. Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization would delay or prevent commercialization of that product candidate and would adversely impact our business and prospects.

Furthermore, even if we obtain regulatory approval for our product candidates, we may still need to develop a commercial organization, establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from commercial and government payors, including government health administration authorities. If we are unable to successfully commercialize our product candidates, we may not be able to generate sufficient revenue to continue our business.

We may experience delays in beginning or conducting clinical trials or numerous unforeseen events before, during or as a result of clinical trials that could delay or prevent our ability to complete clinical trials, receive marketing approval or commercialize our product candidates.

We may experience delays in beginning or conducting any clinical trials, and we do not know whether our clinical trials will begin on time, need to be redesigned, recruit and enroll patients or be completed on schedule; or at all. We may experience numerous unforeseen events before, during or as a result of clinical trials that could delay or prevent our ability to complete such trials or receive marketing approval for or commercialize our product candidates, or that could significantly increase the cost of such trials, including:

• Inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;

• Delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials;

• Delays in developing suitable assays for screening patents for eligibility for trials with respect to certain product candidates;

• Delays in reaching agreement with the FDA, EMA or other regulatory authorities as to the design or implementation of our clinical trials;

• Delays in obtaining regulatory authorization to commence a clinical trial;

• Challenges in reaching an agreement on acceptable terms with clinical trial sites or prospective Contract Research Organization, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

• Delays in obtaining Institutional Review Board, or IRB, approval at each trial site;

• Challenges in recruiting suitable patients to participate in a clinical trial;

• Having patients complete a clinical trial and return for post-treatment follow-up;

• Inspections of clinical trial sites or operations by applicable regulatory authorities, or the imposition of a clinical hold;

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• Clinical sites, CROs or other third parties deviating from trial protocol or dropping out of a trial;

• Failure to perform in accordance with the applicable regulatory requirements, including the FDA’s regulations and GCP requirements, or applicable regulatory requirements in other countries;

• Addressing patient safety concerns that arise during the course of a trial, including the occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

• Having an insufficient number of clinical trial sites;

• Difficulties in manufacturing sufficient quantities of product candidate for use in clinical trials;

• Suspension or terminations by IRBs of the institutions at which such trials are being conducted, by the independent Data Monitoring Committee (DMC), for such trial or by the FDA or other regulatory authorities due to a number of factors including those described above;

• Changes in regulatory requirements or guidance, or feedback from regulatory authorities that requires us to modify the design or conduct of our clinical trials;

• Clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon development programs;

• The number of patients required for clinical trials of our product candidates may be larger than we anticipate, especially if regulatory bodies require the completion of non-inferiority trials, enrollment in these trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

• Our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

• We or our investigators might have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are beings exposed to unacceptable heal risks, which could delay enrollment of our trial and the authorization or approval of SEQ-400;

• The cost of clinical trials of our product candidates may be greater than we anticipate, and we may not have sufficient funds to cover the costs;

• The supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate or may not be able to be procured or distributed as needed;

• Regulatory may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate; and

• Any future collaborators that conduct clinical trials may face any of the above issues and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully and timely complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are any safety concerns, we may:

• Incur unplanned costs;

• Be delayed in obtaining marketing approval for our product candidates or not obtain marketing approval at all;

• Obtain marketing approval in some countries and not in others;

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• Obtain marketing approval for indications or patient populations that are not as broad as intended or desired;

• Obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings or REMS;

• Be subject to additional post-marketing testing requirements;

• Be subject to changes in the way the product is administered; or

• Have regulatory authorities withdraw or suspend their approval of the product or to impose restrictions on its distribution after obtaining marketing approval.

All of our product candidates will require extensive clinical testing before we are prepared to submit a BLA or marketing authorization application, or MAA, for regulatory approval. We cannot predict with any certainty if or when we might complete the clinical development for our product candidates and submit a BLA or MAA for regulatory approval of any of our product candidates or whether any such BLA or MAA will be approved. We may also seek feedback from the FDA, EMA or other regulatory authorities on our clinical development program, and the FDA, EMA or other regulatory authorities may not provide such feedback on a timely basis, or such feedback may not be favorable, which could delay our development programs.

We cannot predict with any certainty whether or when we might complete a given clinical trial. If we experience delays in the conduct or completion of our clinical trials, or if we terminate a clinical trial prior to completion, the commercial prospects of our product candidates could be harmed, and our ability to generate revenues from our product candidates may be delayed or lost. In addition, any delays in our clinical trials could increase our costs, slow down the development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and results of operations. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval.

Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Preclinical test and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules. Success in preclinical or animal studies and early clinical trials does not ensure that later large-scale efficacy trials will be successful nor does it predict final results. For example, we may be unable to identify suitable animal disease models for our product candidates, which could delay or frustrate our ability to progress clinical studies or obtain marketing approval. Our product candidates may fail to show the desired safety and efficacy in clinical development despite having progressed through preclinical and initial clinical trials.

Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks, delays and failures in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our business, financial condition, results of operations and prospects.

Interim, “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim, top-line or preliminary results from our clinical trials. Interim results from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line results also remain subject to audit and verification procedures that may results in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed

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with caution until the final data are available. Differences between preliminary, top-line or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line results that we report may differ from future results of the same studies, or different conclusions or consideration may qualify such results once additional data have been received and fully evaluated.

Further, others, including regulatory agencies may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular development program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure. Any information we determine not to disclose may ultimately be deemed meaningful by you or others with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, product candidates may be harmed, which could significantly harm our business prospects.

Our preclinical studies and clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent, delay or limit the scope of regulatory approval of our product candidates, limit their commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.

To obtain the requisite regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical testing and clinical trials that our product candidates are safe, pure and potent for use in each target indication. These trials are expensive and time consuming, and their outcomes are inherently uncertain. Failures can occur at any time during the development process. Preclinical studies and clinical trials often fail to demonstrate safety or efficacy of the product candidate studied for the target indication, and most product candidates that begin clinical trials are never approved.

We may fail to demonstrate with substantial evidence from adequate and well-controlled trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates are safe and potent for their intended uses.

If our product candidates are associated with undesirable effects in preclinical studies or clinical trials or have characteristics that are unexpected, we may decide or be required to perform additional preclinical studies or to halt or delay further clinical development of our product candidates or to limit their development to more narrow uses or subpopulations in which the undesirable side effect or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the product candidate, if approved. These side effects may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from monoclonal antibody therapy, as with our SEQ-400 product candidate, are not normally encountered in the general patient population and by medical personnel.

If any such adverse events occur, our clinical trials could be suspended or terminated. If we cannot demonstrate that any adverse events were not caused by the drug, the FDA, EMA or foreign regulatory authorities could order us to cease further development, or deny approval of, our product candidates for any or all targeted indications, or require that we conduct additional animal or human studies regarding the safety and efficacy of our product candidates or limiting the scope of the approved indication, if approved. Many product candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the product candidate. Even if we are able to demonstrate that all future adverse events are not product-related, such occurrences could affect patient recruitment or the ability of enrolled patient to complete the trial. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed and our ability to generate product revenues from any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates and may harm our business, financial condition and prospects significantly.

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Additionally, if one or more of our product candidates receives marketing approval, and we or others identify undesirable side effects caused by such products, a number of potentially significant consequences could result, including:

• Regulatory authorities may suspend, withdraw or limit approvals of such product, or seek an injunction against its manufacture or distribution;

• Regulatory authorities may require additional warnings on the label;

• We may be required to create a medication guide outlining the risks of such side effects for distribution to patients or other requirements subject to a REMS;

• We may be required to change the way a product is administered or conduct additional trials;

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

• We may decide to remove the product from the market;

• We may not be able to achieve or maintain third-party payor coverage and adequate reimbursement;

• We may be subject to fines, injunctions or the imposition of civil or criminal penalties; and

• Our reputation and physician or patient acceptance of our products may suffer.

There can be no assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the FDA or foreign regulatory agency in a timely manner or at all. Moreover, any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate if approved and could significantly harm our business, results of operations and prospects.

Lack of awareness of our UTI vaccine and increased public and governmental scrutiny of a vaccine to treat recurrent UTI may adversely impact the development or commercial success of our current and future product candidates.

The clinical and commercial success of our vaccines will depend in part on public acceptance of the use of vaccines to treat recurrent UTI.

More restrictive government regulations or negative public opinion would have a negative effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products once approved. Adverse events in our or others’ clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirements for those products candidates that are approved and a decrease in demand for any such product candidates, all of which would have a negative impact on our business and operations.

We may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, which could prevent our receipt of necessary regulatory approvals.

Successful and timely completion of clinical trials will require that we enroll, and maintain the enrollment of, a sufficient number of patients. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population and competition for patients eligible for our clinical trials with competitors that may have ongoing clinical trials for product candidates that are under development to treat the same indications as one or more of our product candidates, or approved products for the conditions for which we are developing our product candidates.

Clinical trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patient withdrawal. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or foreign regulatory authorities. We cannot predict how successful we will be at enrolling patients in future clinical trials. Patient enrollment is affected by other factors, including:

• The severity and difficulty of diagnosing the disease under investigation;

• The eligibility and exclusion criteria for the trial in question;

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• The size of the patient population and process for identifying patients;

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

• The design of the trial protocol, including but not limited to the use of a placebo control or active comparator;

• The perceived risks and benefits of the product candidate in the trial;

• The availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation;

• The patient referral practices of physicians;

• The ability to monitor patients adequately during and after treatment; and

• The proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll, or maintain the enrollment of, a sufficient number of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their performance.

We have received fast track designation for SEQ-400 and, in the future, may pursue breakthrough designations from the FDA for any product candidates. Even with a fast-track designation, we may be unable to obtain and maintain the benefits associated with such designation. A fast-track designation may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive marketing approval.

To date, SEQ-400 has been granted fast track designation by the FDA. In the future, we may pursue one or more similar designations for other product candidates.

Fast track designation is designed to facilitate the development and expedite the review of therapies for serious conditions with an unmet medical need. Programs with fast-track designation may benefit from early and frequent communications with the FDA, potential priority review and the ability to submit a rolling application for regulatory review. Fast track designation applies to both the product candidate and the specific indication for which it is being studied. However, if we do not continue to meet the criteria of the fast-track designation, or if our clinical trials are delayed, suspended or terminated, or put on clinical hold due to unexpected adverse events or issues with clinical supply, we will not receive the benefits associated with the fast-track program.

Furthermore, fast track designation does not change the standards for approval. Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures. Fast track designation also does not guarantee SEQ-400 or any other product candidate will be approved in a timely manner, if at all.

Breakthrough therapy designation by the FDA for any product candidate may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.

We may, in the future, apply for breakthrough therapy designation, or the equivalent thereof in foreign jurisdictions (where available), for our product candidates. A breakthrough therapy is defined as a product candidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Product candidates designated as breakthrough therapies by the FDA are also eligible for priority review if supported by clinical data at the time of the submission of the BLA.

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Designation as breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a breakthrough therapy designation for a product candidate may not result in a faster development process, review or approval compared to product candidates considered for approval under conventional FDA procedures and it would not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that the product candidate no longer meets the conditions for qualification or it may decide that the time period for FDA review or approval will not be shortened.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and management resources, we must focus on development programs and product candidates that we identify for specific indications. As such, we are currently primarily focused on the development of SEQ-400 for the prevention of recurrent UTI. As a result, we may forego or delay pursuit of opportunities with other product candidates or other indications for these product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuation rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

We may in the future conduct additional clinical trials for our product candidates outside of the United States, and the FDA and similar foreign authorities may not accept data from such trials conducted in locations outside of their jurisdiction.

We may in the future conduct clinical trials outside of the United States. The acceptance of trial data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions or may not be accepted at all. In cases where data from clinical trials conducted outside the United States are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application of the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence in accordance with GCP standards, and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any similar foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any similar foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

We may not be successful in our efforts to build a pipeline of additional product candidates.

We may not be able to continue to identify and develop new product candidates in addition to our current pipeline. Even if we are successful in continuing to build our pipeline, the potential product candidates that we identify may not be suitable for clinical development. For example, product candidates may be shown to have harmful side effect or other characteristics that indicate that they are unlikely to be successfully developed, much less receive marketing approval and achieve market acceptance. If we do not successfully develop and commercialize product candidates based upon our approach, we will not be able to obtain product revenue in future periods, which likely would result in significant harm to our financial positions and adversely affect our stock price.

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Our SEQ-400 and future product candidates may interact with other vaccines, or third-party product candidates used by our patients, which exposes us to additional regulatory risk.

We do not intend to develop SEQ-400 and future product candidates for use in combination with one or more currently authorized or approved vaccines or third-party product candidates, or with vaccines or third-party product candidates that may be authorized or approved in the future. However, our patients may receive other vaccines or third-party product candidates which may cause unintended and unpredictable interaction with our SEQ-400 or future product candidates. In that case, we may be subject to the risk that the FDA, EMA or comparable foreign regulatory authorities could revoke approval of our product candidate or that safety, efficacy, manufacturing or supply issues could arise with our product candidates. This could result in our own products being removed from the market or being less successful commercially.

Risks Related to the Manufacturing of our Product Candidates

Vaccines and pharmaceutical products are complex and difficult to manufacture. We could experience manufacturing problems, or may be unable to access raw materials that result in delays in the development or commercialization of our product candidates or otherwise harm our business.

The manufacture of vaccines and pharmaceutical products is technically complex and necessitates substantial expertise and capital investment. Production difficulties caused by unforeseen events may delay the availability of material for our clinical studies and commercialization efforts.

The manufacturers of pharmaceutical products must comply with strictly enforced cGMP requirements, state and federal regulations, as well as foreign requirements when applicable. Any failure of us or our contract manufacturing organization to adhere to or document compliance to such regulatory requirements could lead to a delay or interruption in the availability of product for clinical trials or commercial use, or enforcement action from the FDA, EMA or foreign regulatory authorities. If we or our manufacturer were to fail to comply with FDA, EMA or other regulatory authorities, it could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recall of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates. Our future dependence upon others for the manufacture of our product candidates may also adversely affect our future profit margins, if any, and ability to commercialize any product candidates that receive regulatory approval on a timely and competitive basis.

Biological products are inherently difficult and time-consuming to manufacture. Our program materials are manufactured using technically complex processes requiring specialized equipment and facilities and other production constraints, including a number of highly specific raw materials, cell lines and reagents with limited suppliers. Even though we aim to have backup supplies of raw materials, cell lines and reagents whenever possible, we cannot be certain they will be sufficient if our primary sources are unavailable. A shortage of a critical raw material, cell line or reagent, or a technical issue during manufacturing, may lead to an inability to manufacture our product candidate, resulting in delays in clinical development or commercialization plans. Any changes in manufacturing of components of the raw materials we use could result in unanticipated or unfavorable effects in our manufacturing processes or product quality, resulting in delays.

Any delay, failure or inability to manufacture on a timely basis can impact the timelines for our clinical trials or our commercialization plans. Such delay, failure or inability to manufacture can result from:

• A failure in the manufacturing process itself, for example by an error in manufacturing process, operator or human error, equipment failure, raw material or reagent failure, failure in any step of the manufacturing process, failure to maintain a cGMP environment or failure in quality systems applicable to manufacture (whether by us or our third-party contract development and manufacturing organization), sterility failures, testing failure or contamination during processing;

• A lack of reliability or reproducibility in the manufacturing process itself leading to variability in process execution or in product quality, which may lead to regulatory authorities placing a hold on a clinical trial or commercial supply and distribution or requesting further information on the process, which could in turn result in delays to the clinical trials or commercial supply and distribution;

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• Inability to obtain manufacturing slots from our Contract Development and Manufacturing Organizations (including contract testing laboratories that perform cGMP operations) (“CDMOs”), or to have enough manufacturing slots to manufacture our product candidates to meet clinical or commercial requirement and demands;

• Inability to procure raw materials and reagents;

• Loss, depletion or performance degradation of the cell line starting material; and

• Loss of or close-down of any manufacturing facility used in the manufacture of our product candidates, or the inability to find alternative manufacturing capability in a timely fashion.

Our lead product candidate is a biologic, and the manufacture of our vaccine and product candidates is complex and subject to extensive regulations. If we or our contract manufacturer fails to comply with such regulations, regulatory authorities may impose sanctions or require remedial measures that could be costly or time-consuming, and our ability to provide supply of our product candidates for clinical trials or any approved products could be delayed or stopped.

All entities involved in the preparation of therapeutics for clinical trials or commercial sales, including our existing contract manufacturer, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP. These regulations govern manufacturing process and procedures (including record keeping) and the implementation and operation of quality systems to control and ensure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of our products candidates that may not be detectable in the final product testing. We or our contract manufacturer must supply all necessary documentation in support of a BLA or MAA on a timely basis. Our facilities and quality systems and the facilities and quality systems of our third-party contractor must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted, and they could put a hold on one or more of our clinical trials if the facilities of our CDMOs do not pass such audit or inspection. If the facilities of our CDMOs do not pass a pre-approval plant inspection, FDA or EMA approval of the products will not be granted.

The regulatory authorities also may, at any time following the approval of a product for sale, inspect or audit our CDMO’s manufacturing facility or those of our third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if compliance discrepancies with our product specifications or violations of applicable regulations occur independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third-parties with whom we contract could harm our business. If we or our CDMO fail to maintain regulatory compliance, the FDA or EMA can impose regulatory sanctions, including, among other things, refusal to approve a pending application for a new drug product, or revocation of a pre-existing approval. As a result, our business, financial condition and results of operations may be harmed. Additionally, if supply from our approved manufacturer is interrupted, there could be a significant disruption in commercial supply. An alternative manufacturer would need to be qualified and approved through a BLA and/or MAA supplement, which could result in further delays. The regulatory agencies may require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired commercial timelines.

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, cause us to incur higher costs and prevent us from commercializing our products successfully, if approved, or could delay commercial supply once approved. Furthermore, if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials or commercial launch may be delayed or we could lose potential revenue.

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We depend on sole-source third-party suppliers for materials that are necessary for the conduct of clinical and preclinical studies and manufacture our product candidates for clinical trials, and the loss of these third-party suppliers and manufacturers or their inability to supply us with sufficient quantities of adequate materials, or to do so at acceptable quality levels and on a timely basis, could harm our business.

Manufacturing our product candidates requires many specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. We currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product candidates. The loss of our CDMO or its failure to supply us with material to support our clinical development program on a timely basis could impair our ability to develop our product candidates or otherwise delay the development process, which could adversely affect our business, financial condition and results of operations.

Some of our CDMO’s raw material suppliers may not have the capacity to support clinical trials and commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers directly, and we or our CDMO’s may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we or our CDMOs may experience delays in receiving key raw materials and equipment to support clinical or commercial manufacturing.

For some of these specialty materials, we and our CDMO rely on and may in the future relay on sole-source vendors or a limited number of vendors. The supply of specialty materials and equipment that are necessary to produce our product candidates could be recalled or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all. Switching suppliers or manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If we change suppliers or manufacturers for commercial production, applicable regulatory agencies may require us to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if the supply of materials is diminished or discontinued, we may not be able to develop, manufacture and market our product candidates in a timely and competitive manner, or at all. An inability to continue to source product from any of these suppliers, which could be due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic development experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

Any contamination or interruption in our manufacturing process, shortages of raw materials or failure of our supplier of reagents to deliver necessary components could result in delays in our clinical development or commercialization schedules.

Given the nature of vaccine manufacturing, there is a risk of contamination, including in the manufacture of raw materials and in the manufacturing of our product candidates, or in the manufacturing facility itself. Any contamination could adversely affect our ability to produce product candidates on schedule and could, therefore, harm our results of operations and cause reputational damage. Some of the raw materials required in our manufacturing process are derived from biologic sources. Such raw materials are difficult to procure and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture of our product candidates could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could adversely affect our development timelines and our business, financial condition, results of operations and prospects.

Changes in methods of product candidate manufacturing or formulations may result in additional costs or delays.

As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize the processes and product characteristics. Such changes carry the risk that they will not achieve our intended objectives. Any such changes could cause our product candidates to perform different or impact product stability and expiry and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes or could impact our planned commercialization schedule. Such changes may also require additional testing, FDA notification or FDA

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approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence sales and generate revenue.

Risks Related to the Commercialization of Our Product Candidates

Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If our product candidates to not achieve an adequate level of acceptance, we may not generate significant revenue and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

• The efficacy, safety and potential advantages compared to alternative treatments, including oral options;

• Our ability to offer our products at competitive prices;

• The convenience and ease of administration compared to alternative treatments;

• Product labeling or product insert requirements of the FDA, EMA or other foreign regulatory authorities, including any limitations or warnings contained in a product’s approved labeling, including any black box warnings or REMS;

• The willingness of the target patient population to try new treatments and of physicians to prescribe these treatments;

• The strength of marketing and distribution support;

• The availability of third-party coverage and adequate reimbursement for SEQ-400 and any other product candidates, once approved;

• The prevalence and severity of any side effects; and

• Any restrictions on the use of our products together with other medications or requirements that our products be used in combination with other products.

If we are unable to establish sales, marketing and distribution capability for SEQ-400 or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.

We may need to establish our commercial infrastructure to support the anticipated marketing and distribution of our product candidates to achieve commercial success for SEQ-400 or any other product candidate for which we may obtain marketing approval. We also may need to build a sales, marketing and market access infrastructure to market our product candidates in the United States and other markets, if they are approved. There are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force could be expensive and time consuming and could delay product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely and unnecessarily incurred these commercialization expenses. This may be costly and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that inhibit our efforts to market our product on our own include:

• Our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

• The lack of coverage and/or adequate reimbursement for our product candidates;

• The inability of sales personnel to obtain access to physicians in order to educate physicians about our product candidates, once approved;

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• The lack of complementary product 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 independent sales, marketing and market access organizations.

If we are unable to establish our own sales and distribution capabilities when we need to do so, and are forced to enter into arrangements with, and rely on, third parties to perform these services, our revenue and profitability, if any, will likely be lower than if we had developed such capabilities ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

The affected populations for our lead product candidate or other product candidates may be smaller than we or third parties project, which may affect the addressable markets for our product candidates.

Our projections of the number of people who are candidates to receive SEQ-400 or are estimates based on our knowledge and understanding of recurrent UTI. These estimates may prove to be incorrect and new studies may further reduce the estimated incidence or prevalence of recurrent UTI. The number of patients in the United States, the European Union, or EU and elsewhere may turn out to be lower than expected, may not be otherwise amendable to treatment with our product candidates or patients may become increasingly difficult to identify and access, all of which would adversely affect our business, financial condition, results of operations and prospects. Further, even if we obtain approval for our product candidates, the FDA or other regulators may limit their approved indications to more narrow uses or subpopulations with the populations for which we are targeting development of our product candidates. Any revenue we are able to generate in the future from product sales will be dependent, in part, upon the size of the market in the United States and other jurisdictions for which we gain regulatory approval and have commercial rights. If the markets or patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, even if approved. Even if we obtain significant market share for any product candidates, if and when approved, if the potential target populations are small, we may never achieve profitability without obtaining market approval for additional indications, including to be used as first- or second-line therapy.

A decline, or widespread perception of a decline, the severity of ongoing recurrent UTI or an increase in available treatments, could reduce the total addressable market for our lead product candidate for the treatment and prevention of recurrent UTI.

The total addressable market opportunity for our product candidates will ultimately depend upon a number of factors, including the diagnosis and treatment criteria included in the final label, if approved for sale in specified indications, acceptance by the medical community, patient access and product pricing and reimbursement. Incidence and prevalence estimates are frequently based on information and assumptions that are not exact and may not be appropriate, and the methodology is forward-looking and speculative. The process we used in developing an estimated total addressable market range for the indications we are targeting has involved using a third-party data. Accordingly, those estimates included in this prospectus may turn out to be inaccurate. Further, the data and statistical information used in the prospectus may turn out to be inaccurate. Further the data and statistical information used in this prospectus, including estimates derived from them, may differ from information and estimates made by our competitors or from current or future current or future studies conducted by independent sources.

Off-label use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, and/or subject us to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any product.

If our product candidates are approved by the FDA, we may only promote or market our product candidates for their specifically approved indications. We will train our marketing and sales force personnel to promote our product candidates for “on label use” only. We cannot, however, prevent a physician from using our products off-label, outside of the approved indications of use, when in the physician’s independent professional medical judgment, he or she deems it appropriate. Furthermore, the use of our products for indications other than those approved by the FDA may not effectively treat such conditions. Any such off-label use of our product candidates could harm our reputation in the

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marketplace among physicians and patients. There may also be increased risk of injury to patients if physicians attempt to use our products for these uses for which they are not approved, or if patients misuse our products despite our or physicians’ instructions of use, which could lead to product liability suits that might require significant financial and management resources and could harm our reputation.

Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the U.S. Federal Trade Commission, the Department of Justice, or the DOJ, the Office of Inspector General of HHS, state attorneys general, members of the U.S. Congress and the public. Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by comparable foreign entities and stakeholders. Violations, including actual or alleged promotion of our products for unapproved of off-label uses, are subject to enforcement letters, inquiries, investigations and civil and criminal sanctions by the FDA, DOJ or comparable foreign bodies. Any actual or alleged failure to comply with labeling and promotion requirements may result in fines, warning letters, mandates to corrective information to healthcare practitioners, injunctions, or civil or criminal penalties.

SEQ-400 may face significant competition from vaccines and other preventative approaches for recurrent UTI that may be in development or may be developed in the future.

Other biotechnology and pharmaceutical companies may develop vaccines or other preventative approaches for recurrent UTI. Many of these companies, which include large pharmaceutical companies, have greater resources for development and established commercialization capabilities. Additional vaccines and therapeutics for this indication may be in development or in the planning stages of development by other pharmaceutical and biopharmaceutical companies. Given the products currently approved or authorized for use as well as those in development by others, any vaccine we may develop could face significant competition. If any other company develops a vaccine more rapidly or effectively than we do, develops a vaccine at a lower cost or is more successful at commercializing it, we may not be able to successfully commercialize SEQ-400 for the prevention of recurrent UTI, even if approved, or compete with other vaccines, which could adversely impact our business and operations.

Many of our potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery, development and manufacture of product candidates, as well as in obtaining regulatory approvals of those product candidates in the United States and in foreign countries. Our potential competitors may also have significantly more experience commercializing drugs, particularly antibodies and other biological products, that have been approved for marketing. Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a small number of our competitors.

Although we are not aware of any over-the-counter products that have statistically significant effects for the prevention of recurrent UTI, we may in the future face competition from other drugs or from other non-drug products that will be developed or approved in the future for the prevention of recurrent UTI. Therefore, our ability to compete successfully will depend largely on our ability to:

• Develop and commercialize drugs that are differentiated from products in the market;

• Demonstrate through our clinical trials that our product candidates are differentiated from existing and future therapies;

• Attract qualified scientific, product development and commercial personnel;

• Obtain patent or other proprietary protection for our medicines;

• Obtain required regulatory approvals;

• Obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payors; and

• Successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.

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The availability of our competitors’ products could limit the demand, and the price we are able to charge, for any product candidate we develop. The inability to compete with existing or subsequently introduced drugs would have an adverse impact on our business, financial condition and prospects. In addition, the reimbursement structure of approved vaccines by other companies could impact the anticipated reimbursement structure of our vaccines, if approved, and our business, financial conditions, results of operations and prospects.

Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make our product candidates less competitive. In addition, any new product that competes with an approved must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. Accordingly, our competitors may succeed in obtaining patent protection, discovering, developing, receiving regulatory and marketing approval for, or commercializing, drugs before we do, which would have an adverse impact of on our business and results of operations.

Any product candidates for which we intend to seek approval as biologic products may face biosimilar competition sooner than anticipated.

If we are successful in achieving regulatory approval to commercialize any biologic product candidate that we develop, it may face competition from biosimilar products. In the United States, our product candidates are regulated by the FDA as biologic products subject to approval under the BLA pathway. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the data the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed by the FDA. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation and meaning are subject to uncertainty. While it is uncertain when such processes intend to be implemented, BPCIA may be fully adopted by the FDA, any such processes could have an adverse effect on the future commercial prospects for our biological products.

There is a risk that any of our product candidates approved as a biological product under a BLA would not qualify for the 12-year period of exclusivity or that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. For example, in May 2021, the Biden administration expressed support for waiving intellectual property protections for COVID-19 vaccines amid concerns about vaccines access in foreign nations. Such waiver, if implemented, could extend to our product candidates. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been subject of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. If competitors are able to obtain marketing approval for biosimilars referencing our candidates, if approved, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and potential adverse consequences.

The success of our product candidates will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these therapies.

We believe our success depends on obtaining and maintaining coverage and adequate reimbursement for our product candidates, including SEQ-400 for the prevention of recurrent UTI, and the extent to which patients will be willing to pay out-of-pocket for such products, in the absence of reimbursement for all or part of the cost. In the United States and in other countries, patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. The availability of coverage and adequacy of reimbursement for our products by third-party payors, including government healthcare programs (e.g., Medicare, Medicaid, TRICARE), managed care providers, private health insurers, health maintenance

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organizations and other organizations is essential for most patients to be able to afford medical services and pharmaceutical products such as our product candidates. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a payor-by-payor basis. One payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage and adequate reimbursement. The principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medical Services, or CMS, an agency within HHS. CMS decides whether and to what extent products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree.

Third-party payors determine which products and procedures they will cover and establish reimbursement levels. Even if a third-party payor covers a particular product or procedure, the resulting reimbursement payment rates may not be adequate for some patients. Patients who are treated in-office for a medical condition generally rely on third-party payors to reimburse all or part of the costs associated with the procedure, including costs associated with produced used during the procedure, and may be unwilling to undergo such procedures in the absence of such coverage and adequate reimbursement. Physicians and other health professionals may be unlikely to offer procedures for such treatment if they are not covered by insurance and may be unlikely to purchase and use our product candidates, if approved, for our stated indications unless coverage is provided and reimbursement is adequate. In addition, for products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs.

Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a procedure is safe, effective and medically necessary; appropriate for the specific patient, cost-effective; supported by peer-reviewed medical journals; including in clinical practice guidelines; and neither cosmetic, experimental nor investigational. Government entities, such as the CDC, the WHO and non-governmental professional societies, such as IDSA and ESCMID, may produce prevention guidelines for the prevention of recurrent UTI, including guidance regarding the use of antibodies in these indications. If SEQ-400 fails to be added to any of these guidelines, or if it receives poor positioning within these guidelines, payors and other customers may be less inclined to add SEQ-400 to their formularies, significantly reducing demand for SEQ-400, if approved.

Further, increasing efforts by third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. In order to secure coverage and reimbursement for any product that might be approved for sale, we may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness or our product, in addition to the costs required to obtain FDA or comparable regulatory approvals. Additionally, we may also need to provide discounts to purchasers, private health plans or government healthcare programs. Our product candidates may nonetheless not be considered medically necessary or cost-effective. If third-party payors do not consider a product to be cost-effective compared to other available therapies, they may not cover the product after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit. We expect to experience pricing pressures from third-party payors in connection with the potential sale of any of our product candidates. 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.

Foreign governments also have their own healthcare reimbursement systems, which vary significantly by country and region, and we cannot be sure that coverage and adequate reimbursement with respect to the treatments in which our products are used under any foreign reimbursement system.

There can be no assurance the SEQ-400 or any other product candidate, if approved for sale in the United States or in other countries, will be considered medically reasonable and necessary, that it will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available or that reimbursement policies and practices in the United States and in foreign countries where our products may be sold will not adversely affect our ability to sell our product candidates profitably, if they are approved for sale.

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Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or vaccines caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

• Decreased demand for any product candidates that we may develop;

• Injury to our reputation and significant negative media attention;

• Withdrawal of clinical trial participants;

• Significant costs to defend the related litigation;

• Product recalls or cessation of marketing of a future product or vaccine;

• Suspension of FDA marketing authorization of a future product or vaccine;

• Substantial monetary awards paid to trial participants or patients;

• Loss of revenue;

• Exhaustion of any available insurance and our capital resources;

• Reduced resources of our management to pursue our business strategy; and

• The inability to commercialize any products that we may develop.

Although we maintain product liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates. Insurance coverage is increasingly expense. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our or our CDMO’s, CRO’s, manufacturers’ contractors’ or collaborators’ cybersecurity.

Despite the implementation of security measures, our internal computer systems and those of third parties on whom we rely, are vulnerable to damage from, among other things, computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, system malfunctions, cyberattacks or cyber-intrusions over the Internet, attachments to emails, phishing attacks, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly though cyberattacks 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. If such an event were to occur, it could lead to loss, destruction, alteration, prevention of access to, disclosure, dissemination of, or damage or unauthorized access to our data (including trade secrets or other confidential information, intellectual property, proprietary business information and personal data) or data that is processed or maintained on our behalf, and cause interruptions in our operations, resulting 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.

We cannot ensure that our data protection efforts and our investment in information technology, or the efforts or investments of CDMO’s, CRO’s, consultants or other third parties with which we work, will prevent breakdowns or breaches in our or their systems or other cybersecurity incidents that cause loss, destruction, unavailability, alteration, dissemination of, or damage or unauthorized access to, our data, including personal data, assets and other data processed or maintained on our behalf, that could have a material adverse effect upon our reputation, business, operations or financial condition. We also rely on third parties to manufacture our product candidates, and any data breaches or other security events relating to their computer systems could also have a material adverse effect on our business. Controls employed by our information technology department and our CDMOs, CROs, consultants and other third parties could prove inadequate, and our ability to monitor such third parties’ data security practices is

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limited. Due to applicable laws, rules, regulations and standards or contractual obligations, we may be held responsible for any information security failure or cyberattack attributed to our third-party service providers as they relate to the information we share with them.

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information or personal data, we could incur material legal claims and liability and damage to our reputation, and the further development of our product candidates could be delayed. Any such even could also compel us to comply with federal and state breach notification laws, and foreign law equivalents, subject us to mandatory corrective action and otherwise subject us to substantial liability under laws, rules, regulations and standards that protect the privacy and security of personal data, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.

Notifications and follow-ups actions related to a data breach or other security incident could impact our reputation and cause us to incur significant costs, including significant legal expenses and remediation costs. We expect to incur significant costs to detect and prevent security incidents, and we may face increased costs and requirements to expend substantial resources in the event of an actual or perceived security incident. However, we cannot guarantee that we will be able to detect or prevent any such incidents, or that we can remediate any such incidents in an effective or timely manner. Our efforts to improve security and protect data from compromise may also identify previously undiscovered instances of data breaches or other cybersecurity incidents. To the extent that any data breach, disruption or security incident were to result in any loss, destruction or alteration of, damage, unauthorized access to or inappropriate or unauthorized disclosure or dissemination of, our data, including personal data, or other information that is processed or maintained on our behalf, we could be exposed to litigations and governmental investigations and inquiries, the further development and commercialization of our product candidates could be delayed and we could be subject to significant fines or penalties for any noncompliance with applicable state, federal and foreign privacy and security laws, rules, regulations and standards.

We are subject to a variety of privacy and data security laws, rules, regulations, policies, industry standards and contractual obligations, and our failure to comply with them could harm our business.

We maintain a large quantity of sensitive information, including confidential business and personal information in connection with the conduct of our clinical trials, related to our employees, and we are subject to laws and regulations governing the privacy and security of such information. In the United States, there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure and protection of personal information, including federal and state health information privacy laws, federal and state security breach notification laws and federal and state consumer protection laws. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues, which may affect our business and is expected to increase our compliance costs and exposure to liability. In the United States, numerous federal and state laws and regulations could apply to our operations or the operations of our partners, including state data breach notification laws, state health privacy laws and federal and state consumer protection laws and regulations, including Section 5 of the Federal Trade Commission Act, that govern the collection, use, disclosure and protection of health-related and other personal information. In addition, we may obtain health information from third parties, including research and institutions from which we obtain clinical trial data, that are subject to privacy and security requirements under the Federal Health Insurance Portability and Accountability Act, or HIPPA, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder. Depending on the facts and circumstances, we could be subject to significant penalties if we obtain, use or disclose individually identifiable health information in a manner that is not authorized or permitted by HIPPA.

In Europe, the General Data Protection Regulation, or the GDPR, took effect in May 2018. The GDPR governs the collection, use, disclosure, transfer or other processing of personal data of individuals within the European Economic Area, or the EEA, including clinical trial data. Among other things, the GDPR imposes requirements regulating the security of personal data and notification of data breaches to the competent national data processing authorities, requires having lawful bases on which personal data can be processed and requires changes to informed consent practices, as well as more detailed notices for clinical trial subjects and investigators. In addition, the GDPR increases the scrutiny of transfer of personal data from the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws; in July 2020, the Court of Justice of the European Union limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the EU-U.S. Privacy Shield and imposing further restrictions on the use of standard contractual clauses,

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which could increase our costs and ability to efficiently process personal data from the EEA. The GDPR imposes substantial fines for breaches and violations (up to the greater of Euro 20 million or 4% of our consolidated annual worldwide gross revenue) and confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR.

Relatedly, following the United Kingdom’s withdrawal from the EEA and the European Union and the expiration of the Transition Period, companies must comply with both the UDPR and the legislation similar to the GDPR as incorporated in UK national law, which provides for significant fines of up to the greater of 17.5 million pounds or 4% of global turnover and exposes companies to tow parallel regimes with potentially divergent enforcement actions for certain violations. On January 1, 2021, the United Kingdom became a third country for purposes of the GDPR. The relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, for example with respect to how data can lawfully be transferred between each jurisdiction, which exposes us to further compliance risk. Pursuant to the EU-UK Trade and Cooperation Agreement of December 24, 2020, transfer of personal data from the European Union to the United Kingdom may continue to take place without a need for additional safeguards during a further transition period, which expires on the earlier of (i) the date on which an adequacy decision with respect to the United Kingdom is adopted by the European Commission; or (ii) the expiry of four months, which shall be extended by a further two months unless either the European Union or the United Kingdom objects. On February 19, 2021 the European Commission published its draft decision finding the United Kingdom to be adequate under the GDPR, though it remains unclear whether the European Commission will formally adopt an adequacy decision with respect to the United Kingdom. In the absence of such decision, after the expiry of the additional transition period we may need to put in place additional safeguards for transfers of personal data from the European Union to the United Kingdom, such as standard contractual clauses approved by the European Commission.

Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules. If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations. Further the laws are not consistent, and compliance in the event of a widespread data breach is costly. In addition, states are constantly adopting new laws or amending existing laws, requiring attention to frequently changing regulatory requirements. For example, California enacted the California Consumer Privacy Act, or the CCPA, which took effect on January 1, 2020, became enforceable by the California Attorney General on July 1, 2020 and has been dubbed the first “GPR-like” law in the United States. The CCPA gives California resident expanded rights to access and delete their personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt out of sales of personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Further the California Privacy Act, or the CPRA, recently passed in California and will impose additional data protection obligations on companies doing business in California, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data and opt outs for certain uses of sensitive data. If also created a new California data protection agency authorized to issues substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required. Although the CCPA currently exempts certain health-related information, including clinical trial data, the CCPA and the CPRA may increase our compliance costs and potential liability. Similar laws have been proposed in other states and at the federal level and, if passed, such laws may have potentially conflicting requirements that would make compliance challenging.

With the CCPA, CPRA and other laws, regulations and other obligations relating to privacy and data protection imposing new and relatively burdensome obligations, and with the substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so. If we expand our business to other jurisdictions, especially those outside the United States, we will be subject to additional laws, regulations and other obligations relating to privacy and data protection in such jurisdictions, which will heighten the challenges and further increase compliance costs and expenses. We are currently in the process of developing and updating our policies and procedures in accordance with the requirements under applicable data privacy and protection laws and regulations. We do not currently have any formal data privacy policies and procedures in place and have not completed formal assessment of whether we are in compliance with all applicable data privacy laws and regulations.

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Additionally, if third parties with which we work, such as vendors and service providers violate applicable laws, rules or regulations or our policies, such violations may also put our or our clinical trial or employee data, including personal data, at risk, which could in turn have an adverse effect on our business.

If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could seriously harm our business.

We, and contract manufacturers and suppliers we engage, are subject to numerous federal, state and local environmental, health and safety laws, regulations and permitting requirements, including those governing laboratory procedures, the generation, handling, use, storage, treatment and disposal of hazardous materials and wastes; the emission and discharge of hazardous materials, including chemicals and biological materials. Our operations also produce hazardous waste. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. Under certain environmental laws, we could be held responsible for costs relating to any contamination at our current facility and at third-party facilities. We also could incur significant costs associated with civil or criminal fines and penalties.

Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research, product development and manufacturing efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. 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 carry specific biological or hazardous waste insurance coverage, and our property, 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 be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could seriously harm our business.

Risks Related to Our Dependence on Third Parties

We currently rely on third parties to conduct, supervise, analyze and monitor a significant portion of our research and preclinical testing and clinical trials for our product candidates, and if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements or otherwise perform satisfactorily, we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed.

We have engaged CROs and other third parties to conduct our planned preclinical studies or clinical trials, including our ongoing clinical trials of SEQ-400, and to monitor and manage data. We expect to continue to rely on third parties, including clinical data management organizations, medical institutions and clinical investigators, to conduct those clinical trials. We also rely on third parties for their research and discovery capabilities. Any of these third parties may terminate their engagements with us, some in the event of an uncured breach and some at any time for convenience. If any of our relationships with third parties terminate, we may not be able to timely enter into arrangements with alternative third parties or to do so on commercially reasonable terms, if at all. Switching or adding CROs involves substantial costs and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition or prospects. Further, the performance of our CROs and other third parties conducting our trials may also be interrupted by the ongoing COVID-19 pandemic, including travel or quarantine policies, heightened exposure of CRO or clinical site or other vendor staff who are healthcare providers to COVID-19 or prioritization of resources toward the pandemic.

In addition, any third parties conducting our clinical trials will not be our employees, and except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our clinical programs. If these third parties do not successfully carry out their contractual duties

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or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to clinical protocols, regulatory requirements or other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Consequently, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase substantially and our ability to generate revenue could be delayed significantly.

We intend to rely on third parties to produce clinical and commercial supplies of our product candidates.

We are currently manufacturing material for our product candidates in partnership with a CDMO. We do not own or operate any facilities for product manufacturing, storage and distribution or testing. We are dependent on third parties to manufacture the clinical and commercial supplies of our current and future product candidates. We have not yet fully manufactured our product candidates on a commercial scale, and we do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing of our product candidates. Certain of our product candidates may have to compete against existing and future products that may have a lower price point. The actual cost to manufacture our product candidates could materially and adversely affect the commercial viability of our product candidates.

The facilities used by our contract manufacturer and contract testing labs to manufacture and test our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit our BLA to the FDA. We do not control the manufacturing process of, and we are completely dependent on, our contract manufacturing partners for compliance with the cGMP requirements. If our contract manufacturer cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we will not be able to secure and/or maintain regulatory approval for our product candidates. In addition, we have limited control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel, including their ability to adequately separate products within their multi-product manufacturing facilities to prevent cross-contamination. If the FDA or a comparable foreign regulatory authority does not approve this facility for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find an alternative manufacturing facility, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

We also intend to rely on third-party manufacturers to supply us with sufficient quantities of our product candidates to be used, if approved for commercialization. If we are not able to meet market demand for any approved product or if we are not able to produce supply at low enough costs, it would negatively impact our ability to generate revenue, harm our reputation, and could have an adverse effect on our business, financial condition, results of operations and prospects.

Further, our reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates ourselves, including:

• Inability to access sufficient manufacturing capacity;

• Inability of our third-party manufacturers to execute our manufacturing procedures and other logistical support requirements appropriately;

• Inability to negotiate additional manufacturing agreements with third parties under commercially reasonable terms, if at all;

• Breach, termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

• Lack of ownership of the intellectual property rights in any improvements made by our third-party manufacturers in the manufacturing process for our product candidates; and

• Disruptions to operations of our third-party manufacturers or suppliers by conditions unrelated to our business operations, including the bankruptcy of the manufacturer or supplier.

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We cannot be sure that single-source suppliers for the manufacturing of our raw materials will remain in business or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these raw materials for our intended purpose. In addition, the lead time needed to establish a relationship with a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would adversely impact our business, financial condition and results of operations.

Any of these events could lead to clinical trial delays or failure to obtain regulatory approval or impact our ability to successfully commercialize our current or any future product candidates, if approved. Some of these events could be the basis for an FDA action, including injunction, request for recall, seizure or total or partial suspension of production.

The third parties upon whom we depend may be adversely affected by earthquakes, wildfire, or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical epidemics or pandemics, power shortage, telecommunication failure or other natural or manmade accidents or incidents that result in the third parties upon whom we depend from being unable to fully utilize their facilities may have a material and adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial reporting and operating conditions. Loss of access to these facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations. Earthquakes, wildfires or other natural disasters could further disrupt our operations, and have a material adverse effect on our business, financial conditions, results of operations and prospects. If a natural disaster, power outage or other event prevented the third parties upon whom we depend from using all or a significant portion of their manufacturing facilities, or otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. Unforeseen natural or manmade accidents or incidents, such as freezer failure, natural disasters or theft, could also result in loss of cell line starting material. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuation plans, which could have a material adverse effect on our business. As part of our risk management policy, we maintain insurance coverage at levels we believe will be sufficient to satisfy any damages and losses. If the third parties on which we rely are unable to operate their facilities because of an accident or incident or for any other reason, even for a short-period of time, any or all of our research and development programs may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects.

We may seek collaborations with third parties for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.

We may seek third-party collaborators for the development and commercialization of our product candidates, including for the commercialization of any of our product candidates that are approved for marketing outside of the United States. Our likely collaborators for any such arrangements include regional and national pharmaceutical companies and biotechnology companies. If we enter into any additional such arrangements with any third parties, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

Collaborations involving our product candidates would pose the following risks to us:

• Collaborators have significant discretion in determining the efforts and resources they will apply to these collaborations;

• Collaborations may not perform their obligations as expected;

• Collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

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• Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stope a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

• Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

• We could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

• Product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or drugs, which may cause collaborators to prioritize their own product, candidates or drugs or cease to devote resources to the commercialization of our product candidates;

• A collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products;

• Disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

• Collaborators may not properly maintain or defend our or their intellectual property rights or may use our or their proprietary information or expose us to potential litigation;

• Collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

• Collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates; and

• Collaborators may not be able to scale or increase manufacturing capacity to meet our potential future supply chain needs, and if so, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If any of our collaborators were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for any collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of the approval by the FDA, EMA or similar regulatory authorities outside of the United States, the potential market for the subject product candidates, the costs and complexities of manufacturing and delivering such product candidates to patients the potential of competing products, the existence of uncertainty with respect or our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of future collaborators.

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We may not be able to negotiate additional collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of such product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate revenue. If a change in collaborator is needed, the program could incur timeline delays for development studies and manufacturing of the product. Increased cost is associated with the identification of a new collaborator, transferring product information, establishing process consistency, and procuring raw materials and production slots.

Risks Related to Our Intellectual Property

If we are unable to obtain, maintain and enforce patent protection for our current and future product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours and our ability to successfully develop and commercialize our product candidates may be adversely affected.

We rely upon a combination of patents, know how, trade secrets and confidentiality agreements to protect the intellectual property related to our product candidates and technologies and to prevent third parties from copying and surpassing our achievements, thus eroding our competitive position in our market.

Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our propriety technology and product candidates. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel discoveries and technologies that are important to our business. Our pending and future patent applications may not result in patents being issued. Although we own twelve patents that contain composition and method of use claims covering recurrent UTI and its adjuvant formulations, these patents may not afford sufficient protection of our therapeutic candidates or their intended uses against competitors, nor can there be any assurances that the issued patents will not be infringed, designed around, invalidated by third parties or effectively prevent other from commercializing competitive technologies, products or therapeutic candidates.

The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. We cannot offer any assurances about the breadth of our patents will be sufficient to stop a competitor from developing and commercializing a product, including a biosimilar product, that would be competitive with one or more of our product candidates. There is no assurance that all potentially relevant prior art relating to our patent and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our product candidates and technologies. We additionally cannot guarantee that our employees, former employees or consultants will not file patent applications claiming our inventions. If a third party can establish that we were not the first to file for patent protection of such inventions, our owned may not issues as patents and, if issued, may be challenged and invalidated or rendered unenforceable. Additionally, an interference proceeding can be provoked by a third party or instituted by the USPTO to determine who was the first to invent any of the subject matter covered by the patent or the patent claims of our applications.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned patents may be challenged in courts or patent offices in the United States and abroad. For example, we may be subject to a third-party submission of prior art to the USPTO, challenging the validity of one or more claims of our owned patents. Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of our owned or licensed patent applications. A third party may also claim that our owned patent rights are invalid or unenforceable in litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable.

Any successful challenge to any patent owned by or licensed to us after patent issuance could put one of more of our owned patents at risk of being invalidated or interpreted narrowly and could deprive us of rights necessary for the successful commercialization of any of our product candidates and technologies that we may develop. Even if they are

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unchallenged or such third-party challenges are unsuccessful, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for our product candidates and technologies or prevent others from designing around our claims. If the breadth or strength of protection provided by the patent and patent applications we hold, obtain or pursue with respect to our product candidates and technologies is challenged, or if they fail to provide meaningful exclusivity for our product candidates and technologies, it could threaten our ability to commercialize our product candidates and technologies. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection, if approved, would be reduced.

The patent prosecution process is expensive and time-consuming. We may not be able to prepare, file and prosecute all necessary or desirable patent applications at a commercially reasonable cost, in a timely manner or in all jurisdictions. It is also possible that we may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection. Moreover, depending on the terms of future in-licenses to which we may become a party, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology in-licensed from third parties. Therefore, these patent and patent application may not be prosecuted and enforced in a manner consistent with the best interests of our business. Any of the foregoing could have an adverse impact on our business and results of operations.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to the protection provided by our patent estate, we rely on trade secret protection and confidentiality agreements to protect proprietary scientific, business and technical information and know-how that is not or may not be patentable or that we elect not to patent. We seek to protect our proprietary information, data and processes, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and partners. Although these agreements are designed to protect our proprietary information, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Although we generally require all of our employees to assign their inventions to us, and all of our employees, consultants, advisors, and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed with all third parties who may have helped to develop our intellectual property or who had access to our proprietary information, or that our agreements will not be breached. If any of the parties to these confidentiality agreements breaches or violates the terms of such agreement, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets as a result.

Enforcing a claim that a third party illegally obtained and is using our trade secrets, like patent litigation, is expensive and time-consuming, and the outcome is unpredictable. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.

Trade secrets and know-how can be difficult to protect as trade secrets and know-how will over time be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from company to company or academic to industry scientific positions. Moreover, our competitors and other third parties may independently develop knowledge, methods and know-how equivalent to our trade secrets. Competitors and other third parties could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe, misappropriate or violate our intellectual property rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets and proprietary know-how were to be disclosed to or independently developed by a competitor or third party, our competitive position would be harmed.

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We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective.

While we have confidence in these individuals, organizations and systems, our agreements or security measures may be breached, and we may not have adequate remedies for any breach. Also, if steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret. In addition, others may independently discover our trade secrets and proprietary information. For example, the FDA is considering whether to make additional information publicly available on a routine basis, including information that we may consider to be trade secrets or other proprietary information, and is not clear at the present time how the FDA’s disclosure policies may change in the future. If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies from third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations, and financial condition.

Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-United States legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from generic and other competing medications. Given the amount of time required for development, testing and regulatory review of new product candidates, patent protecting such candidates may expire before or shortly after such candidates are commercialized. Depending upon timing, duration and conditions of FDA marketing approval of our product candidates, one or more of our United States patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Restoration Act of 1984, referred to as the Hatch-Waxman Amendments, and similar legislation in the European Union. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent may be extended, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may not receive an extension if we fail to apply within deadlines, fail to apply prior to expiration of relevant patents, fail to exercise due diligence during the testing phase or regulatory review process, or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less that we request. If we are unable to obtain patent term extension, or if the term of such extension is less that we request, the period during which we can enforce our patent rights for that product will be shortened, and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, which could have a material adverse effect on our business.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of owned or future owned patents.

Our ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved, and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States. Furthermore, the specific content of patents and patent application that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.

For example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act included a number of significant changes to United States patent law. These included provisions that affect the way patent applications are prosecuted and also affect patent litigation. The USPTO has developed new and untested regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the substantive changes to patent law associate with the Leahy-Smith Act, and in particular, the first to

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file provisions, became effective March 2013. The Leahy-Smith Act has also introduced procedures making it easier for third parties to challenge issued patents, as well as to intervene in the prosecution of patent applications. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivations proceedings. Finally, Leahy-contained new statutory provisions that require the USPTO to issue new regulations for their implementation, and it may take the courts years to interpret the provisions of the new statute. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents. Further, the United States Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increase uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the United States Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents or to enforce patents that we own or that we might obtain in the future. An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.

Similarly, changes in patent laws and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we may obtain in the future. Further, the laws of some foreign counties do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. For example, if the issuance in a given country of a patent covering an invention is not followed by the issuance in other countries of patent covering the same invention, or if any judicial interpretation of the validity, enforceability or scope of the claims or the written description or enablement, in a patent issued in one country is not similar to the interpretation given to the corresponding patent issued in another country, our ability to protect our intellectual property in those countries may be limited. Changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially diminish the value of our intellectual property or narrow the scope of our patent protection.

We may be involved in lawsuits to protect or enforce our future patents, the patents of our licensors or our other intellectual property or proprietary rights, which could be expensive, time consuming and unsuccessful and our future issued patents and the patents covering our product candidates could be found invalid or unenforceable.

Competitors or other third parties may infringe, misappropriate or otherwise violate our patents or any patents issued as a result of our pending or future patent applications. To counter infringement, misappropriation or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid, is unenforceable or is not infringed, or may refuse to stop the other party in such infringement proceeding from using the technology at issue on the grounds that our patents to not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more or our patents or future owned patent applications at risk of being invalidated, held unenforceable or interpreted narrowly, and could put any our future patent applications at risk of not yielding an issued patent.

If we initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product or product candidates is invalid and/or unenforceable. In patent litigation in the United States, counterclaims alleging invalidity and/or unenforceability are common, and there are numerous grounds upon which a third part can assert invalidity or unenforceability of a patent. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, inter partes review and equivalent proceedings in foreign jurisdictions (for example, opposition proceedings, nullity proceedings or litigations or invalidation trials or invalidation proceedings). Such proceedings could result in revocation of or amendment to our future patents in such a way that they no longer cover our product candidates or prevent third parties from competing with our product candidates. The outcome following legal assertions of

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invalidity and unenforceability is unpredictable. With respect to validity of our patent applications, should they issue as patents, for example, we cannot be certain that there is no invalidating prior art of which we, our patent counsel, and the patent examiner were unaware of during prosecution. If a defendant were to prevail on a legal assertion of invalidity/unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates.

Interference or derivation proceedings provoked by third parties may be necessary to determine the priority of inventions or inventorship (and possibly also ownership) of inventions with respect to our patent applications or resulting patents, or patent applications or resulting patents of third parties. An unfavorable outcome in any inventorship or ownership dispute could result in the loss of our exclusive rights in our technology and the associated intellectual property rights, requiring us to cease using the related technology or force us take a license under the patents rights of the prevailing party, if available. Furthermore, our business could be harmed be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Any successful claim of inventorship by a third party could result in the loss of priority for our patent applications, potentially resulting in subsequently filed third-party patent applications having priority over our patent applications. Our defense of litigation or interference proceedings may fail and even if successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent infringement, misappropriate or other violations of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. An adverse result in litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could have a material adverse impact on our business.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be comprised by disclosure during this type of litigation. In addition, we may not have sufficient financials or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock. Any of the foregoing could materially adversely affect our business, results of operations and financial condition.

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

We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, ae complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for commercialization of our product candidates in any jurisdiction. We cannot be sure that we have licensed all intellectual property rights that are relevant or necessary for the commercialization of SEQ-400, and a third party may claim that our development or commercialization of SEQ-400 infringes its intellectual property rights. We could be required to acquire or obtain a license to such intellectual property from such third parties, and we may be unable to do so on commercially reasonable terms or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights, we may be required to redesign our manufacturing process for SEQ-400, which may not be feasible on a technical or commercial bases in a timely manner, and we may have to delay or abandon development of SEQ-400, which could have a material adverse effect on our business.

The scope of a patent claims is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretations of the relevance of the scope of a patent or pending applications may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third-party’s pending applications will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant third-party patents may negatively impact our ability to develop and market our products.

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We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our product candidates.

A third party may hold intellectual property, including patent rights that are important or necessary to the development and commercialization of our product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our product candidates, in which case we would be required to acquire or obtain a license to such intellectual property from these third parties, and we may be unable to do so on commercially reasonable terms or at all. The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over use due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Even if we are able to in-license any such necessary intellectual property, it could be on a non-exclusive basis, thereby giving our competitors and other third parties access to the same intellectual property licensed to us, and we also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property we have, we may be required to redesign our products candidates, which may not be feasible on a technical or commercial basis, and we may have to delay or abandon development of the relevant program or product candidate, which could have a material adverse effect on our business.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain.

Our commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing misappropriating or otherwise violating the patent and proprietary rights of third parties. As our current and future product candidates progress toward commercialization, the possibility of a patent infringement claim against us increases. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation proceedings, post grant reviews, inter partes reviews and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. 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 product candidates, and there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates and technologies. Third parties, including our competitors, may initiate legal proceedings against us alleging that we are infringing, misappropriating or otherwise violating their patents or other intellectual property rights.

We cannot provide assurance that our current and future product candidates do not infringe, misappropriate or otherwise violate other parties’ patents or other proprietary rights, and competitors or other parties may assert that we infringe, misappropriate or otherwise violate their proprietary rights in any event. We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and future product candidates, including oppositions, interference proceedings, reexaminations, post-grant review, inter partes review, or derivations proceedings before the USPTO in the United States or any equivalent regulatory authority in other countries. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a negative impact on our ability to commercialize SEQ-400 or any future product candidates. In order to successfully challenge the validity of any United States patents asserted against us in federal court, we would need to overcome a presumption of validity. As this burden is high and requires us to present clear and convincing evidence as to the invalidity of any such United States patent claims, there is no assurance that a court of competent jurisdiction would agree with us and invalidate the claims of such United States patent. Moreover, given the vast number of patents in our field of technology, we cannot be certain that we do not infringe existing patents or that we will not infringe patents that may be granted in the future.

While we may decide to initiate proceedings to challenge the validity of these or other patent in the future, we may be unsuccessful, and courts or patent offices in the United States and abroad could uphold the validity of any such patent. Furthermore, because patent applications can take many years to issue and may be confidential

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for 18 months or more after filing, and because pending patent claims can be revised before issuance, there may be applications now pending which may later result in in issued patents that may be infringed by the manufacture, use or sale of our products candidates. Regardless of when filed, we may fail to identify relevant third-party patents or patent applications, or we may incorrectly conclude that a third-party patent is invalid or not infringed by our product candidates or activities. If a patent holder believes that one of our product candidates infringes its patent, the patent holder may sue us even if we have received patent protection for our technology. In addition, third parties may obtain patents in the future and claims that our product candidates or technologies infringe upon these patents. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant drug revenue and against whom our own patent portfolio may thus have no detrimental effect. If a patent infringement suit were threatened or brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the drug or product candidates that is the subject of the actual or threatened suit.

If we are found to infringe, misappropriate or otherwise violate a third party’s valid intellectual property rights, we could be required to obtain a license from such third party to continue commercializing our product candidates. However, we may not be able to obtain any required license on commercially reasonable terms or at all. For example, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give our competitors access to the same technology which could limit our ability to generate revenues or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations. Alternatively, we may need to redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. Under certain circumstances, we could be forced, including by court orders, to cease developing, manufacturing and commercializing our product candidates. In addition, in any such proceeding or litigation, we could be found liable for substantial monetary damages, potentially including treble damages and attorneys’ fees, if we are found to have willfully infringed the patent at issue. We may also be required to indemnify collaborators or contractors against such claims. A find of infringement, misappropriation or other violation of third-party intellectual property rights could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could harm our business. Any claims by third parties that we have misappropriated their confidential information or trade secrets could have a similar negative impact on our business.

The cost in defending or initiating any litigation or other proceedings relating to patent or other proprietary rights, even if resolved in our favor, could be substantial, and litigation would divert our management’s attention. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and limit our ability to continue our operations. In addition, the uncertainties associated with litigation could compromise our ability to raise funds necessary to continue our clinical trials, continue our internal research programs or in-license needed technology. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings motions or other interim proceedings or developments. If securities analyst or investors perceive these results to be negative, it could have an adverse effect on the price of our common shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or future sales, marketing or distribution activities.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

We employ individuals who were previously employed at other biotechnology or biopharmaceutical companies, including potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including confidential information of our employees’ former employers or other third parties. We may also be subject to claims that former employers or other third parties have an ownership interest in our future patents. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. There is no guarantee of success in defending these claims, and even if we are successful, litigation cold result in substantial cost and be a distraction to our management and other employees.

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

We may also be subject to claims that former employees, collaborators, or other third parties have an ownership interest in our patents or our patent applications, our future patents issued as a result of our pending or future patent applications or other intellectual property. We may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. Although it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own, and we cannot be certain that our agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we may not have an adequate remedy. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and litigation may be necessary to enforce our rights or to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriate or disclosed.

We rely on third parties to manufacture our product candidates, and we collaborate with additional third parties for the development of such product candidates. We therefore must, at times, share trade secrets with them. We may also conduct joint research and development programs that may require us to share trade secrets under the terms of our research and development partnerships or similar agreements. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become knows by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use of disclose could have an adverse effect on our business and results of operations.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data potentially relating to our trade secrets. Despite our efforts to protect our trade secrets, we may not be able to prevent the unauthorized disclosure or use of technical know-how or other trade secrets by the parties to these agreements. Moreover, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our confidential information or proprietary technology and processes. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective. If any collaborators, scientific advisors, employees, contractors and consultants who are parties to these agreements breaches or violates their terms of any of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets as a result. Moreover, if confidential information that is licensed or disclosed to us by our partners, collaborators, or others is inadvertently disclosed or subject to a breach or violation, we may be exposed to liability to the owner of that confidential information. Enforcing a claim that third-party illegally obtained and is using our trade secrets, like patent litigation, is expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets.

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

Filing and prosecuting patent applications and defending patents covering our product candidates in all countries throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we or our licensors have not obtained patent protection to develop their own products and, further, may export otherwise

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infringing products to territories where we or our licensors have patent protection, but enforcement rights are not as strong as those in the United States or Europe. These products may compete with our product candidates, and our future patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

In addition, our licensors may decide to abandon national and regional patent applications before they are granted. The examination of each national or regional patent application is an independent proceeding. As a result, patent applications in the same family may issue as patents in some jurisdictions, such as in the United States, but may issue as patents with claims of different scope or may even be refused in other jurisdictions. It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology.

While we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual property rights in such counties may be inadequate, which may have an adverse effect on our ability to successfully commercialize our product candidates in all of our expected significant foreign markets. If we encounter difficulties in protecting, or are otherwise precluded from effectively protecting the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those jurisdictions.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The legal systems of certain countries, particularly developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property rights, especially those relating to life sciences, which could make it difficult for us to stop the infringement, misappropriation or other violation of our future patents or marketing of competing products in violation of our proprietary rights generally. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these counties, patents may provide limited or no benefit. Moreover, our and our licensors’ ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.

Proceedings to enforce our or our licensors’ patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert our effects and attention from other aspects of our business, could put our future patents or the patents of our licensors at risk of being invalidated or interpreted narrowly and our patent applications or the patent applications of our licensors at risk of not issuing as patents, and could provoke third parties to assert claims against us. We and our licensors may not prevail in any lawsuits that we or our licensors initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license from third parties.

Some countries also have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, some counties limit the enforceability of patents against government agencies or government contractors. In those countries, the patent owner may have limited remedies, which could materially diminish the value of such patents. If we or our licensors are forced to grant a license to third parties will respect to any patents relevant to our business, our competitive position may be impaired and our business, financial condition, results of operations and prospects may be adversely affected.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with those requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our owned and licensed patents and/or applications and any patent rights we may obtain in the future. Furthermore, the USPTO and various non-United States government patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. We consult reputable law firms and other professional and rely on such third parties to help us comply with these requirements and effect payment of these fees with respect to the patent and patent applications that we own, and we

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rely upon our licensors to comply with these requirements and effect payment of these fees with respect to any patents and patent applications that we license. In many cases, an inadvertent lapse of a patent or patent application can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patents or patent applications, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market, which could have a material adverse effect on our business.

Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business.

We expect to rely on trademarks as one means to distinguish our product candidates, if approved for marketing, from the vaccines of our competitors. Once we select new trademarks and apply to register them, our trademark applications may not be approved. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. Third parties may oppose or attempt to cancel our trademark applications or trademarks, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our vaccines, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe or otherwise violate our trademarks and we may not have adequate resources to enforce our trademarks. Over the long term, if we are unable to establish name recognitions based on our trademarks, then we may not be able to compete effectively, and our competitive position, business, financial condition, results of operations and prospects may be significantly harmed. Moreover, any name we propose to use with our product candidates in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of potential confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Any of the foregoing events may have a material adverse effect on our business.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. The following examples are illustrative:

• Others may be able to make products that are similar to or otherwise competitive with our product candidates but that are not covered by the claims of any of our patents, should they issue;

• An in-license necessary for the manufacture, use, sale, off for sale or importation of one or more of our product candidates may be terminated by the licensor;

• We or our collaborators might not have been the first to make the inventions covered by our future issued patents or our pending patents applications;

• We or our collaborators might not have been the first to file patent applications covering certain of our inventions;

• Others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our intellectual property rights;

• It is possible that our pending patent applications will not lead to issued patents;

• Issued patents that we may own or in-license may be held invalid or unenforceable as a result of legal challenges by our competitors;

• Issued patents that we own or in-license may not provide coverage for all aspects of our product candidates in all countries;

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• Our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major markets;

• We may not develop additional proprietary technologies that are patentable; and

• The patents of others may have an adverse effect on our business.

Should any of these events occur, they could significantly harm our business, results of operations or prospects.

Risks Related to Legal and Regulatory Compliance Matters

Our relationship with customers, healthcare providers, including physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Healthcare providers, including physicians, and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescriptions of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws, including, without limitation, the federal Anti-Kickback Statute, the federal civil and criminal false claims laws and the law commonly referred to as the Physician Payments Sunshine Act and regulations promulgated under such laws. These laws will impact, among other things, our clinical research, proposed sales, marketing and educational programs, and other interactions with healthcare professionals. In addition, we may be subject to patient privacy laws by both the federal government and the states in which we conduct or may conduct our business. The laws that will affect our operations include, but are not limited to:

• The federal Anti-Kickback Statute, which prohibits, among other things, individuals or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, either the referral of an individual, or the purchase, lease, order or arrangement for or recommendation of the purchase, lease, order or arrangement for any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are narrowly drawn. Practices that involved remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person does not need to have actual knowledge of this statue or specific intent to violate it in order to have committed a violation;

• The federal civil and criminal false claims laws, including, without limitation, the federal False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from the federal government, including Medicare, Medicaid and other government payors, that are false or fraudulent or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or to avoid, decrease or conceal an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented to the United States federal government. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses. In addition, the government may assert that a claim, including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for the purposes of the federal False Claims Act;

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• HIPPA, which created additional federal criminal statutes which prohibit, among other things, a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statue or specific intent to violate it in order to have committed a violation;

• The federal transparency laws, including the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, medical devices, biologicals and medical supplies for which payment under Medicare, Medicaid or the State Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to: (i) payment or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and (ii) ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations include transfers of value made during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives; and

• Analogous state and foreign laws and regulations; state laws that require manufacturers to report information related to payment and other transfers of value to physicians and other healthcare providers marketing expenditures or drug pricing; state laws that required pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or that otherwise restrict payments that may be made to healthcare providers; and state and local laws that require the registration of pharmaceutical sales representatives.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violations of any these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including, without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in federal and state funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, diminished profits and future earnings, reputational harm and the curtailment or restructuring of our operations, any of which could harm our business.

The risk of being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.

Even if we obtain regulatory approval for SEQ-400 or any future product candidates, they will remain subject to ongoing regulatory oversight, which may result in significant expense.

Even if we obtain regulatory approval for SEQ-400 or any future product candidates, they will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submission of safety and other post-market information, among other things. Any regulatory approvals that we received for SEQ-400 or any future product candidates may also be subject to a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-marketing testing and surveillance studies, including Phase 4 trials and surveillance to monitor the quality, safety and efficacy of the vaccine. An unsuccessful post-marketing study

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or failure to complete such a study could result in withdrawal of marketing approval. We will further be required to immediately report any serious and unexpected adverse events and certain quality of production problems with our products to regulatory authorities along with other periodic reports.

Any new legislation addressing vaccines safety issues could result in delays in product development or commercialization, or increased costs to assure compliance. We will also have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to vaccines are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, we will not be allowed to promote our products for indications or uses for which they do not have approval, commonly known as off-label promotion. The holder of an approved BLA must submit new or supplemental applications and obtain prior approval for certain changes to the approved product, product labeling, or manufacturing process. A company that is found to have improperly promoted off-label uses of their products may be subject to significant civil, criminal and administrative penalties.

In addition, vaccine manufacturers are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with a vaccines, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that vaccine, the manufacturing facility or us, including requesting a recall or requiring withdrawal of the vaccines from the market or suspension of manufacturing.

If we fail to comply with applicable regulatory requirements following approval of SEQ-400 or any future product candidates, a regulatory authority may:

• Issue an untitled letter or warning letter asserting that we are in violation of the law;

• Seek an injection or impose administrative, civil or criminal penalties or monetary fines;

• Suspend or withdraw regulatory approval;

• Suspend any ongoing clinical trials;

• Refuse to approve a pending marketing application or supplement to an approved application or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

• Restrict the marketing or manufacturing of the vaccines;

• Seize or detain the vaccine or otherwise require the withdrawal of the vaccines from the market;

• Refuse to permit the import or export of products or product candidates; or

• Refuse to allow us to enter into supply contracts, including government contracts.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize SEQ-400 or any future product candidates and harm our business, financial condition, results of operations or prospects.

Even if we obtain regulatory approval of any of our product candidates in the United States, the United Kingdom, the European Union, Japan, Australia or Canada, we may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit our ability to realize their full market potential.

In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy.

Regulatory approval in the United States, the United Kingdom, the European Union, Japan, Australia or Canada does not ensure approval by regulatory authorities in other countries or jurisdictions. However, the failure to obtain approval in a jurisdiction may negatively impact our ability to obtain approval elsewhere. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee approval in any other country.

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Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and increased costs for us and require additional preclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. We do not have any product candidates approved for sale in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approvals in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized.

Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict and regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in the healthcare systems with the stated goals of containing healthcare cost, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the United States pharmaceutical industry. The ACA, among other things contains a number of provisions of particular import to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.

There have been executive, judicial and Congressional challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017, or the Tax Act, included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14, 2018 a judge for the United States District Court for the Northern District of Texas ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act. Additionally, on December 18, 2019, the United States Court of Appeals for the Fifth Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. The United States Supreme Court is currently reviewing the case, although it is unclear when a decision will be made. On February 10, 2021, the Biden administration withdrew the federal government’s support for overturning the ACA. Although the U.S. Supreme Court has not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021 and closed on August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is unclear how the Supreme Court ruling, other such litigation and the healthcare reform measures of the Biden administration will impact the ACA or our business.

Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payment to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013, and due to subsequent legislative amendment to the statute, including the BBA, will remain in effect through 2030 unless additional Congressional action is taken. However, COVID-19 relief legislation suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2021. The American Taxpayer Relief

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Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single-source and innovator multiple-source drugs, beginning January 1, 2024. These laws may result in additional Medicare, Medicaid and other healthcare funding, which could have an adverse effect on customers for our product candidates, if approved, and, accordingly, our financial operations.

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals. As a result, the FDA also released a ruling on September 24, 2020 providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction was required by law. The implementation of the rule has been delayed by the Biden administration from January 1, 2022 to January 1, 2023 in response to ongoing litigation. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which was also delayed pending a review by the Biden administration until January 1, 2023. Further, In November 2020, CMS issued an interim final rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates will be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. The MFN Model regulations mandate participation by identified Part B providers and will apply in all U.S. states and territories for a seven-year period beginning January 1, 2021 and ending December 31, 2027. On December 28, 2020, the United States District Court of the Northern District of California issued a nationwide preliminary injunction against implementation of the interim final rule. The likelihood of the implementation of any other Trump administration reform initiatives is uncertain, particularly in light of the 2020 U.S. president election.

We expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any vaccine. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payment form private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our vaccine. It is also possible that additional government action is taken in response to the COVID-19 pandemic.

In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. For example, the results of the 2022 interim elections may impact our business and our industry. The Trump administration took several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict whether or how these requirements will be interpreted and implemented, or whether they will be rescinded and replaced under the Biden administration. The policies and priorities of the new administration are unknown and could materially impact the regulations governing our product candidates. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes could, among other things, require:

• Additional clinical trials to be conducted prior to obtaining approval;

• Changes to manufacturing methods;

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• Recalls, replacements or discontinuance of one or more of our products, if approved; and

• Additional recordkeeping.

Such changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of SEQ-400 or other product candidates, and could materially harm our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other product would harm our business, financial condition and results of operations.

Risks Related to Employee Matters and Managing Our Growth

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the management, manufacturing, development, clinical, financial and business development expertise of our executive officers. Each of our executive officers may currently terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or employees.

Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of our product pipeline toward scaling up for commercialization, manufacturing and sales and marketing personnel, will also be critical to our success. The loss of the services of our executive officers or other key employees could impede the achievement of our development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy may be limited.

Our directors may have an actual or potential conflict of interest with other companies and may not be able to or may choose not to devote sufficient time and attention to our company.

Certain members of our board of directors serve as employees and directors at other companies. As a result, these directors may not be able to devote their full time and attention to our company, which could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.

Our executive officers, directors, five percent stockholders and their affiliates beneficially own 19.9% of our voting stock as of October 26, 2023. As a result, these persons, acting together, would be able to significantly influence all matters requiring stockholder approval. Some of these persons or entities may have interests different than yours. For example, these stockholders, acting together, may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may believe are in your best interest as one of our stockholders.

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We expect to expand our clinical development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result we may encounter difficulties in managing our growth, which could disrupt our operations.

As of , 2023, we had eight employees. As our development progresses, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of clinical product development, regulatory affairs, manufacturing and, if any of our product candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

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

We are exposed to the risk that our employees, independent contractors, consultants, collaborators, principal investigators, CROs, suppliers and vendors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct that violates FDA regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA, manufacturing standards, federal and state healthcare laws and regulations, and laws that require true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, 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. 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, including the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, fines, disgorgement, imprisonment, exclusion from participating in government healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations.

Risks Related to This Offering, Ownership of Our Common Stock and Our Status as a Public Company

An active trading market for our common stock may not develop and you may not be able to resell your shares of our common stock at or above the initial offering price, if at all.

Prior to this offering, there has been no public market for our common stock. The initial public offering price for our common stock will be determined through negotiations with underwriters and may not be indicative of the price at which our common stock will trade after closing of this offering. Consequently, you may not be able to sell your common stock at or above the initial offering price or at any time that you would like to sell. Although we have applied to have our common stock approved for listing on NYSE American, an active trading market for our shares may never develop or be sustained after this offering. If an active market for our common stock does not develop or is not sustained, it may be difficult for you to sell shares you purchased in this offering at an attractive price or at all.

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The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.

Our stock price may be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of these particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:

• The timing, progress and results of our ongoing clinical trials of SEQ-400 or the commencement, enrollment or results of any future clinical trials we may conduct, or changes in the development status of our product candidates;

• Any delay in our regulatory filings for SEQ-400 or any other product candidate we may develop, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

• Delays in or termination of clinical trials;

• Adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;

• Unanticipated serious safety concerns related to the use of SEQ-400 or any other product candidate;

• Changes in financial estimates by us or by any equity research analysts who might cover our stock;

• Conditions or trends in our industry;

• Announcements by our competitors of new product candidates or technologies, or the results of clinical trials or regulatory decisions;

• Stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

• Publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;

• Announcements by us or our competitors of significant acquisitions, strategic partnerships or divestitures;

• Our relationship with our collaborators;

• Announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us;

• Investors’ general perceptions of our company and our business;

• Recruitment or departure of key personnel;

• Overall performance of the equity markets’

• Trading volume of our common stock;

• Disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

• Significant lawsuits, including patent or stockholder litigation;

• Changes in the structure of healthcare payment systems; and

• Other events or factors, many of which are beyond our control.

The stock market in general, and the NYSE American and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performances of these companies, including very recently in connection with the COVID-19 pandemic, which has results in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their

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underlying business models or prospects. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. The realization of any of the above risks or any of a broad range of other risks, including those described in this section, could have a significant and material adverse impact on the market price of our common stock.

In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock. Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources from our business.

If you purchase shares of our common stock in this offering, you will suffer immediate dilution of your investment.

The initial public offering price of our common stock is substantially higher than the pro forma as adjusted net tangible book value per share of our common stock after this offering. There, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on an assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, you will experience immediate dilution of $ per share, representing the difference between our pro forma as adjusted net tangible book value per share of September 30, 2023, after giving effect to this offering, and the assumed initial public offering price.

In addition, as of September 30, 2023, we had outstanding stock options to purchase an aggregate of shares of common stock at a weighted-average exercise price of $ per shares. To the extent any of these outstanding options are exercised, there will be further dilution to investors in this offering. See “Dilution.”

We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business.

We identified material weaknesses in our internal control over financial reporting that existed as of December 31, 2022. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements may not be prevented or detected on a timely basis. Additionally, these material weaknesses could result in misstatements of the aforementioned account balances or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented or detected.

We concluded that our disclosure controls and procedures were not effective as of December 31, 2022, and that we had, as of such date, we identified the following material weaknesses in our internal control over financial reporting:

• management did not design and maintain appropriate entity-level controls impacting the control environment, risk assessment procedures, and effective monitoring activities to prevent or detect material misstatements to the financial statements. These deficiencies were attributed to: (i) lack of structure and responsibility, insufficient number of qualified resources, and inadequate oversight and accountability over the performance of controls, (ii) ineffective identification and assessment or risks impacting internal control over financial reporting, and (iii) ineffective evaluation and determination as to whether the components of internal control were present and functioning;

• management did not design and maintain appropriate information technology general controls in the areas of user access, vendor management controls, and segregation of duties, including controls over the recording and review of journal entries, related to certain information technology systems that support the Company’s financial reporting process;

• management did not design, implement, and retain appropriate documentation of formal accounting policies, procedures, and controls across substantially all of the Company’s business processes over; (i) the financial reporting process, including management review controls over key disclosures and financial statement support schedules, (ii) the monthly financial close process, including journal entries and account reconciliations and (iii) the completeness and accuracy of information used by control owners in the operation of certain controls, to achieve timely, complete, accurate financial accounting and reporting; and

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• management did not design and implement controls over the accounting, classification, and application of United States Generally Accepted Accounting Principles (“US GAAP”) relating to business combinations, convertible debt, preferred stock, income taxes, and share-based compensation.

We intend to remediate these material weaknesses. While we believe the steps we will take to remediate these material weaknesses will improve the effectiveness of our internal control over financial reporting and will remediate the identified deficiencies, if our remediation efforts are insufficient to address the material weaknesses or we identify additional material weaknesses in our internal control over financial reporting in the future, our ability to analyze, record and report financial information accurately, to prepare our financial statements within the time periods specified by the rules and forms of the SEC and to otherwise comply with our reporting obligations under the federal securities laws may be adversely affected. The occurrence of, or failure to remediate, these material weaknesses and any future material weaknesses in our internal control over financial reporting may adversely affect the accuracy and reliability of our financial statements and have other consequences that could materially and adversely affect our business, including an adverse impact on the market price of our common stock. In addition, we could become subject to investigations by the NYSE American, the SEC or other regulatory authorities, which could require additional financial and management resources.

If we are unable to design and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock in the future may decline.

Ensuring we have adequate internal controls over financial reporting in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be monitored and re-evaluated frequently. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles. In connection with this offering, we intend to begin the process of documenting, reviewing and improving our internal control over financial reporting for compliance with Section 404 of the Sarbanes-Oxley Act, which will require an annual management assessment of the effectiveness of our internal control over financial reporting.

Implementing any appropriate changes to our internal control over financial reporting may distract our officers and employees, entail substantial costs to modify our existing processes, and take significant time to complete. These changes may not, however, be effective in establishing and maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate financial statements on a timely basis, could increase our operating costs and harm our business. If we identify material weaknesses in our internal control over financial reporting; if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner; or if we are unable to assert that our internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could decline, and we could also become subject to investigation by the stock exchange on which our common stock is listed, the Securities and Exchange Commission, or SEC, or other regulatory authorities, which could require additional financial resources.

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that equity research analysts publish about us and our business. As a newly public company, we may have only limited research coverage by equity research analysts. Equity research analysts may elect not to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market price of our common stock. In the event we do have equity research coverage, we will not have any control over the analysts or the content and opinion included in their reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn would cause our stock price or trading volume to decline.

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A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market could occur at any time. If our stockholders sell, or the market perceives that our stockholders intend to sell substantial amounts of our common stock, the market price of our common stock could decline significantly.

Upon the closing of this offering, we will have outstanding shares of common stock, after giving effect to the automatic conversion of our outstanding preferred stock into shares of common stock, and assuming no exercise of outstanding options to purchase shares of our common stock. Of these shares, the shares sold in this offering will be freely tradable and substantially all of the additional shares of common stock will be available for sale in the public market beginning 180 days after the date of this prospectus following the expiration of lock-up agreements between some of our shareholders and the underwriters. The underwriters may release these stockholders from the lock-up agreements with the underwriters at any time and without notice, which would allow for earlier sales of shares in the public market.

In addition, promptly following the closing of this offering, we intend to file one or more registration statements on Form S-8 under the Securities Act of 1933, as amended, or the Securities Act, registering the issuance of shares of common stock subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans. Shares registered under the registrations statement on Form S-8 will be available for sale in the public market subject to vesting arrangements and exercise of options, the lock-up agreement described above and the restrictions of Rule 144 in the case of our affiliates.

Additionally, after this offering, the holders of an aggregate of shares of common stock, or their transferees, will have rights, subject to some conditions, to require us to file one or more registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. If we were to register the resale of these shares, they could be freely sold in the public market. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.

There are provisions in our amended and restated certificate of incorporation and bylaws to be in effect upon the closing of this offering that may make it difficult for a third party to acquire control of our company, even if a change of control was considered favorable by you and other stockholders. For example, our board of directors will have the authority to issue shares of preferred stock. The board of directors can fix the price, rights, preferences, privileges and restrictions of the preferred stock without any further vote or action by our stockholders. The issuance of shares of preferred stock may delay or prevent a change of control transaction. As a result, the market price of our common stock and the voting and other rights to our stockholders may be adversely affected. An issuance of shares of preferred stock may result in the loss of voting control to other stockholders.

Our charter will also contain other provisions that could have an anti-takeover effect, including:

• Stockholders will not be entitled to remove directors other than by a % vote;

• Stockholders will not be permitted to take actions by written consent;

• Stockholders must hold at least xx% of the voting power to call a special meeting of the stockholders; and

• Stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.

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In addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulate corporate acquisitions by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders of those companies. These provisions could discourage potential acquisition proposals and could delay or prevent a change of control transaction. They could also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in your best interest. These provisions may also prevent changes in management or limit the price that investors are willing to pay for our stock.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of this offering. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in the previous three-year period, we will cease to be an emerging growth company prior to the end of such five-year period. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions for certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

• Being permitted to provide only two years of audited financial statements, in addition to any required unaudited financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus.

• An exemption from the compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting;

• Reduced disclosure obligations regarding executive compensation;

• Exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved; and

• An exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical matters in the auditor’s report on the financial statements.

We have taken advantage of the reduced reporting burdens in this prospectus. In particular, we have provided only two years of audited financial statements and we have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be less active trading market for our common stock and our stock price may be reduced or more volatile. In addition, the JOBS Acts provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies.

We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a “smaller reporting company.” We are therefore entitled to rely on certain reduced disclosure requirements for as long as we remain a smaller reporting company, such as an exemption from providing selected financial data and executive compensation information. In addition, for as long as we are a smaller reporting company with less than $100 million in annual revenue, we would be exempt from the requirement to obtain an external audit on the effectiveness of internal control over financial reporting provided in Section 404(b) of the Sarbanes-Oxley Act.

These exemptions and reduced disclosures in our SEC filings due to our status as a smaller reporting company make it harder for investors to analyze our results of operations and financial prospects. We cannot predict if investors will find our common stock less attractive because we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock prices may be more volatile.

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We will have broad discretion in the use of the proceeds from this offering and may invest or spend the proceeds in ways in which you do not agree and in ways that may not increase the value of your investment.

We will have broad discretion over the use of proceeds from this offering. You may not agree with our decisions, and our use of the proceeds may not yield any return on your investment. We expect to use the net proceeds to us from this offering, together with our existing cash and cash equivalents, to fund phase 2 human clinical trial for our UTI vaccine, move our preclinical products toward human studies, establish and optimize manufacturing processes and the remainder for working capital and other general corporate purposes, including development of additional programs in our pipeline. See “Use of Proceeds.” Our failure to apply the net proceeds from this offering effectively could compromise our ability to pursue our growth strategy and we might not be able to yield significant returns, if any, on our investment of these net proceeds. You will not have the opportunity to influence our decisions on how to use our net proceeds from this offering.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.

You should not rely on an investment in our common stock to provide dividend income. We have not declared or paid cash dividends on our common stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Investors seeking cash dividends should not purchase our common stock.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

• Any derivative action of proceeding brought on our behalf;

• Any action asserting a breach of fiduciary duty;

• Any action asserting a claim against us arising under the Delaware Corporation Law, our amended and restated certificate of incorporation, or our amended and restated bylaws; and

• Any action asserting a claim against us that is governed by the internal-affairs doctrine.

This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, amount other considerations, our amended and restated certificate of incorporation further provides that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may result in increased costs for investors to bring a claim. Further, these exclusive form provisions may limit a stockholders’ ability to bring a claim in judicial forums that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

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General Risk Factors

We will incur increased costs and demands upon management as a result of becoming a public company, which could lower our profits or make it more difficult to run our business.

As a public company, and particularly after we are not long an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements. We also have incurred and will continue to incur costs associated with Sarbanes-Oxley Act, and related rules implemented by the SEC and the NYSE American. The expenses generally incurred by public companies for reporting and corporate governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. These laws and regulations also make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on our board committees, or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions, other regulatory action and potentially civil litigation.

In particular, pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, in our second annual report on Form 10-K due to be filed with the SEC after becoming a public company, we will be required to furnish a report by our management on our internal control over financial reporting. However, while we an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing whether such controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting.

Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.

We have incurred substantial losses since inception and do not expect to become profitable in the near future, if ever. To the extent that we continue to generate taxable losses, unused losses will carry forward to offset future taxable income, if any. As of December 31, 2022, we had a U.S. federal net operating loss, or NOL, carryforward of $7.5 million, which may be available to reduce future taxable income, of which $2.1 million have an indefinite carryforward period, while the remaining $5.4 million expire from 2023 through 2039. These NOLs are limited in their usage to an annual deduction equal to 80% of annual taxable income. As of December 31, 2022, we also had a U.S. federal research and development tax credit carryforward of $1.5 million which may be available to reduce future tax liabilities and expire at various dates beginning in 2026 through 2040.

Under the Tax Act, as modified by the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, federal NOLs incurred in taxable years beginning after December 31, 2017 and in future taxable years may carry forward indefinitely, but the deductibility of such federal NOLs incurred in taxable years beginning after December 31, 2020 are limited. It is uncertain how various states will respond to the Tax Act and CARES Act. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provision of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. The completion of this offering, together with private placements and other transactions that have occurred since our inception, may trigger such an ownership change pursuant to Section 382. We have not conducted a study to assess whether any such ownership changes have occurred. We may experience ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our NOL carryforwards is materially limited, it would harm our financial condition and results of operations by effectively increasing our future tax obligations.

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Our business activities will be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery and anti-corruption laws.

As we expand our business activities outside of the United States, including our clinical trial efforts, we will be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we intend to operate. The FCPA generally prohibits offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-United States government official in order to influence official action, or otherwise obtain or retain business. The FCPA also required 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 may involve significant interaction with public officials, including officials of non-United States governments. Additionally, in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their government under the FCPA. Recently, the SEC and Department of Justice have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors or collaborators, of 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.

Disruptions at the FDA, the SEC and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new product can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including most recently from December 22, 2018 to January 25, 2019, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Unfavorable global economic conditions could adversely affect our business, financial conditions or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. Portions of our future clinical trials may be conducted outside of the United States and unfavorable economic conditions resulting in the weakening of the U.S. dollar would make those clinical trials more costly to operate. Furthermore, a severe or prolonged economic downturn, including a recession or depression resulting from the COVID-19 pandemic, increasing inflation or political disruption could result in a variety of risks to our business, including weakened demand for our product candidates or future product candidates, if approved, and our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or political disruption, including any international trade disputes, could also stain our manufacturers or suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our potential products. Any of the foregoing could seriously harm our business, and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could seriously harm our business.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Managements’ Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this prospectus. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would,” or the negative of these words or other similar terms or expressions. These statements speak only as of the date of this prospectus and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements contained in this prospectus include, but are not limited to, statements about:

• Our expectations regarding the potential benefits, coverage and immunogenicity of our vaccine candidate;

• Our expectations regarding our Phase 1 study results potentially being predictive of Phase 2 clinical trial results;

• The timing, progress and results of our clinical trials of SEQ-400 and our preclinical trials of any future product candidates, including statements regarding the timing of our initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

• The timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, our current and future product candidates;

• Our ability to advance vaccine candidates into, and successfully complete, preclinical studies and clinical trials;

• The commercialization of our vaccine candidates, if approved;

• Estimates of our future revenue, expenses, capital requirements and our need for additional financing;

• Our ability to compete effectively with existing competitors and new market entrants;

• Our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement;

• Our and our third-party manufacturers’ manufacturing capabilities and the scalable nature of our manufacturing process;

• Potential effects of extensive government regulation;

• The pricing, coverage and reimbursement of our vaccine candidates, if approved;

• Our ability to hire and retain key personnel;

• Our ability to obtain additional financing;

• Our expectation regarding the time during which we will be an emerging growth company under the Jumpstart our Business Startups Act;

• Our expected use of proceeds from this offering; and

• Business disruptions affecting the initiation, patient enrollment, development and operation of our clinical trials, including public health crises.

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The foregoing list of forward-looking statements is not exhaustive. You should refer to the “Risk Factors” section of this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Other sections of this prospectus may include additional factors that could harm our business and financial performance. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statement in this prospectus will prove to be accurate. Except as required by law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports we will file from time to time with the SEC after the date of this prospectus.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events, although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, the events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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MARKET AND INDUSTRY DATA

We obtained the industry, market and competitive position data used throughout this prospectus from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires. In addition, while we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in the section titled “Risk factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties or by us.

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USE OF PROCEEDS

We estimate that the net proceeds to use from our issuance and sale of shares of our common stock in this offering will be approximately $ million (or approximately $ million if the underwriters exercise in full their option to purchase up to additional shares), assuming an initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deduction estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase or decrease the net proceeds to us from this offering by $ million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase or decrease of 1,000,000 shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase or decrease the net proceeds to us from this offering by $ million, assuming no change in the assumed initial public offering price per share and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We do not expect that a change in the initial public offering price or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.

As of , we had cash and cash equivalents of $ million. We intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, as follows:

• approximately $ to conduct and complete a phase 2 human clinical trial for SEQ-400;

• approximately $ to move our preclinical product candidates toward human studies; and

• the remainder for working capital and other general corporate purposes, including the development of additional programs in our pipeline and to establish and optimize manufacturing processes.

We may also use a portion of the net proceeds from this offering to in-license, acquire or invest in complementary businesses, technologies, products or assets, although we have not current agreements, commitments or understandings to do so.

Based on our current operational plans and assumptions, we expect the net proceeds from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditures requirements through . We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than expected.

The expected use of the net proceeds from this offering and our existing cash and cash equivalents represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the closing of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from preclinical studies or clinical trials we have ongoing or may commence in the future, any collaborations we may enter into with third parties for our product candidates or strategic opportunities that become available to us, as well as any unforeseen cash needs.

Our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of those net proceeds. The timing and amount of our actual expenditures will be based upon many factors, including cash flows from operations and the anticipated growth of our business. Pending their use, we plan to invest the net proceeds from this offering in short-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States.

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DIVIDEND POLICY

We have never declared or paid, and do not anticipate declaring or paying in the foreseeable future, any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects and other factors our board of directors may deem relevant.

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of September 30, 2023:

• On an actual basis;

• On a proforma basis to give effect to (i) the automatic conversion of all outstanding shares of our preferred stock, into an aggregate of shares of common stock upon the closing of this offering and (ii) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the completion of this offering; and

• On a pro forma as adjusted basis to give further effect to our issuance and sale of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

You should read the information in this table together with our financial statements and the related notes appearing at the end of this prospectus and the “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this prospectus.

	As of September 30, 2023
	Actual			Pro Forma	Pro Forma As Adjusted
	(unaudited)			(unaudited)	(unaudited)
Cash and cash equivalents	$	714,118		$	$
Current portion of bank debt		24,745
Bank debt, long-term		37,117
Convertible debentures		955,000
Series A Preferred Stock, $0.0001 par value per share 30,000,000 shares authorized and 14,429,906 shares outstanding, actual; no shares authorized and no shares issued and outstanding, pro forma and pro forma as adjusted		14,839,740
Series A-1 Preferred Stock, $0.0001 par value per share, 7,000,000 shares authorized and 6,248,647 shares outstanding, actual; no shares authorized and no shares issued and outstanding, pro forma and pro forma as adjusted		6,248,647
Subscriptions receivable		(100,000	)

Stockholders’ (deficit):
Common stock, $0.0001 par value per share; 70,000,000 shares authorized, and 15,840,724 shares issued and outstanding, actual; shares authorized, pro forma and pro forma as adjusted and shares issued and outstanding, pro forma and shares issued and shares outstanding, pro forma as adjusted		1,584
Additional paid-in capital		34,052,645
Stock subscriptions		(48,000	)
Accumulated deficit		(55,783,549	)
Total stockholders’ (deficit)		(21,777,320	)
Total capitalization	$	227,929		$	$

The pro forma as adjusted information above is illustrative only, and our capitalization following the completion of this offering will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase in the assumed initial public offering price of $ per share which is the midpoint of the estimated price range set forth on the cover page of this prospectus would increase or decrease the pro forma as

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adjusted amount of each of cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by $ million, assuming no change in the assumed initial public offering price per share and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The number of shares of our common stock to be outstanding is based on shares of our common stock outstanding as of September 30, 2023, assuming the conversion of all outstanding shares of our preferred stock, into an aggregate of shares of common stock, and excludes:

• shares of common stock issuable upon exercise of outstanding stock options;

• shares of our common stock that are available for future issuance under our Incentive Stock Plan;

• shares of our common stock that are available for future issuance under our 2023 Equity Incentive Plan; and

• shares of our common stock issuable upon exercise of the Representative’s Warrants.

Each share of our preferred stock will be automatically converted into common stock at the conversion ratio then in effect upon either (a) the closing of the sale of shares of our common stock to the public in a firm-commitment underwritten public offering, resulting in at least $25,000,000 in gross proceeds, or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the holders of a majority of the then outstanding shares of convertible preferred stock.

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted immediately to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible value per share of our common stock immediately after this offering.

Our historical net tangible book value (deficit) as of September 30, 2023 was $(21.8) million, or $(1.37) per share of common stock. Our historical net tangible book value (deficit) is the amount of our total tangible assets less our total liabilities and the carrying value of our preferred stock, which is not included within stockholders’ equity (deficit). Historical net tangible book value (deficit) per share represents historical net tangible book value (deficit) divided by the 15,840,724 shares of our common stock outstanding as of September 30, 2023.

Our pro forma net tangible books value as of September 30, 2023 was $ million, or $ per share of common stock. Proforma net tangible book value represents the amount of our tangible assets less our total liabilities, after giving effect to the automatic conversion of all outstanding shares of our preferred stock upon the closing of this offering into an aggregate of shares of common stock. Pro forma net tangible book value per share represents pro forma net tangible book value divided by the number of shares outstanding as of September 30, 2023, after giving effect to the pro forma adjustments described above.

After giving further effect to our issuance and sale of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2023 would have been $ million, or $ per share. This represents an immediate increase in pro forma as adjusted net tangible book value per share of $ to existing stockholders and an immediate dilution of $ in pro forma as adjusted net tangible book value per share to new investors participating in this offering. Dilution per share to net investors is determined by subtracting pro forma as adjusted net tangible book value per share after this offering from the assumed initial public offering price per share paid by new investors. The following table illustrated this dilution on a per share basis:

Initial public offering price per share			$
Historical net tangible book value (deficit) per share as of September 30, 2023	$	(1.37)
Increase per share attributable to the pro forma adjustments described above	$
Pro forma net tangible book value (deficit) per share as of September 30, 2023	$	( )
Increase in pro forma as adjusted net tangible book value per share attributable to new investors participating in this offering	$
Pro forma as adjusted net tangible book value per share after this offering			$
Dilution per share to new investors purchasing common stock this offering			$

The dilution information discussed above is illustrative only and will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase or decrease our pro forma as adjusted net tangible book value per shares after this offering by $x million and dilution per share to investors participating in this offering by $ , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase of shares in the number of shares offered by us, as set for on the cover page of this prospectus, would increase our pro forma as adjusted net tangible book value per share after this offering by $ million and decrease the dilution per share to new investors participating in this offering by $ , assuming no change in the assumed initial public offering price per share and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each decrease of shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would decrease our pro forma as adjusted net tangible book value per share after this offering by $ and increase the dilution per share to new investors participating in this offering by $ , assuming no change in the assumed initial public offering price after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

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If the underwriters exercise in full their option to purchase additional shares of common stock, our pro forma as adjusted net tangible book value per share after this offering would be $ , representing an immediate increase in the pro forma as adjusted book value per share of $ to existing stockholders and immediate dilution in pro forma as adjusted net tangible book value per share of $ to new investors participating in this offering, assuming an initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable to us.

The following table summarizes, as of September 30, 2023 (adjusted for the automatic conversion of the outstanding preferred stock with an aggregate of shares of common stock upon the consummation of this offering), the total number of common stock purchased from us on an as converted to common stock basis, the total consideration and the average price per shares (i) paid by existing stockholders and (ii) to be paid by new investors participating in this offering at the assumed initial public offering price of $ per share, which is the midpoint of the estimated stock price range set forth on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. As the table shows, new investors participating in this offering will pay an average price substantially higher than our existing stockholders paid.

	Shares Purchased			Total Consideration			Average Price Per Share
	Number	Percent		Amount	Percent		Average Price Per Share
Existing stockholders		%		$	%		$
New investors in this offering		%		$	%		$
Total		100	%	$	100	%

Each $1.00 increase or decrease in the assumed initial public offering price of $ per shares, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase or decrease the total consideration paid by new investors participating in this offering by $ million and, in the case of an increase, would increase the percentage of total consideration paid by new investors participating in this offering by percentage points and, in the case of a decrease, would decrease the percentage of total consideration paid by new investors by percentage points, assuming that the number of shares offered by us, as set forth on the coverage page of this prospectus, remains the same. Each increase or decrease of shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase or decrease the total consideration paid by new investors by percentage points and, in the case of a decrease, would decrease the percentage of total consideration paid by new investors by percentage points, assuming no change in the assumed initial public offering price per share.

The table assumes no exercise of the underwriters’ option to purchase additional shares in this offering. If the underwriters exercise in full their option to purchase additional shares of our common stock, the number of shares of common stock held by existing stockholders would be reduced to % of the total number of shares of our common stock outstanding after this offering, and the number of shares of common stock held by new investors participating in this offering would be increased to % of the total number of shares of our common stock outstanding after this offering.

The number of shares of our common stock to be outstanding after this offering is based on shares of our common stock outstanding as of September 30, 2023, assuming conversion of all outstanding shares of our preferred stock, into an aggregate of shares of common stock upon the closing of this offering, and excludes:

• shares of common stock issuable upon exercise of outstanding stock options;

• shares of our common stock that are available for future issuance under our Incentive Stock Plan;

• shares of our common stock that are available for future issuance under our 2023 Equity Incentive Plan; and

• shares of our common stock issuable upon exercise of the Representative’s Warrants.

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To the extent that outstanding stock options are exercised, new stock options or warrants are issued, or we issue additional shares of common stock, other equity securities or convertible debt securities in the future, there will be further dilution to our stockholders, including new investors participating in this offering. In addition, we may choose to raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders, including new investors participating in this offering.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with the “Selected Financial Data” section of this prospectus and our financial statements and related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this prospectus, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

Our current pipeline consists of the SEQ-400 vaccine for the prevention of recurrent UTIs, one drug platform to treat ovarian and potentially other cancers (SEQ-1274), and a small molecule candidate to inhibit the bacteria biofilm that negatively impacts the lung function of cystic fibrosis patients. We view each development opportunity independent of modality (within vaccines or small molecules) based on the scientific evidence supporting development, the clinical development strategy including patient enrollment criteria and trial endpoints, and the potential to positively impact the market.

We were incorporated on August 16, 2012 as a Delaware corporation and funded by Sequoia Sciences, Inc. (“SSI”), Sequoia Sciences UTI, LLC (“SSUTI”), Prolog Ventures and Holton Capital to develop its vaccine for the prevention of recurrent UTIs. For the purpose of simplifying our corporate structure, streamlining the accounting and management functions, and eliminating the need to account for intercompany transactions, we undertook a reorganization on April 30, 2021, in which we merged with a sister company and acquired the assets and assumed the liabilities of another sister company (the “Combination Transaction”). As a result of those transactions SSI was merged into us and all of the assets and liabilities of SSI became ours and SSI ceased to have a separate corporate existence. As consideration of the merger, the stockholders of SSI received common stock and Series A preferred stock issued by us in exchange for surrendering their SSI stock. In addition, SSUTI, transferred all of its assets (excluding its ownership of the Company) to the Company in exchange for the Company’s assumption of all of SSUTI’s liabilities. After the transfer, SSUTI’s only asset was its equity ownership in the Company. Pursuant to a Plan of Dissolution and Liquidation, SSUTI distributed its Company stock to its members in a complete liquidation. Our financial statement presentation includes the periods and activities following the Combination Transaction. The financial statements reflect the fair value of assets acquired and liabilities assumed as a result of the SSI Merger and the incremental shares exchanged in the Combination Transaction. The SSI Merger was accounted for as an asset acquisition by us. The SSUTI Merger reflects a transaction between entities under common control and was accounted for as a downstream merger, with the transferred assets and liabilities recorded at their historical cost basis.

Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research activities, developing and progressing our pipeline, establishing arrangements with third parties for the manufacture of our programs and component materials, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from the sale of our common stock, preferred stock and convertible notes.

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Subsequent to December 31, 2022, we sold approximately 2,200,000 additional Series A-1 preferred shares, yielding gross proceeds to us of approximately $2,200,000. Without giving effect to the anticipated net proceeds from this offering, as of December 31, 2022, we expect that our existing cash, restricted cash and proceeds from sales of our preferred stock will be sufficient to fund our operating expenses and capital expenditure requirements through December 2023. Beyond that point, we will need to raise additional capital to finance our operations, which cannot be assured. We concluded as of August 24, 2023, the issuance date of our financial statements for the period ended December 31, 2022, that this circumstance raised substantial doubt about our ability to continue as a going concern within one year of the issuance date of those financial statements. See “Liquidity and Capital Resources.”

We believe that the net proceeds from this offering, together with our existing cash and restricted cash, will be sufficient to fund our operating expenses and capital expenditures through . We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources.”

In its report on our financial statements for the period ended December 31, 2022, our independent registered public accounting firm included an explanatory paragraph stating that our recurring losses from operations, expectation of generating operating losses in the foreseeable future and need for additional capital to finance our future operations raise substantial doubt about our ability to continue as a going concern.

Factors and Trends Affecting Our Business and Results of Operations

The following trends and uncertainties either affected our financial performance historically or are likely to impact our results of operations in the future:

• As our small-molecule vaccine’s market potential is seen by others, more competitors may enter the market which may lead to price competition and a decline in profit margins;

• We anticipate that our general and administrative expenses will increase in the future as a result of increased costs associated with being a public company. These increases will likely include increases related to hiring of additional personnel and fees to outside consultants, attorneys, and accountants, and personnel-related share-based compensation costs, among other expenses, and, in the case of public company-related expenses, services associated with strengthening our internal control over financial reporting, maintaining compliance with NYSE American listing and SEC reporting requirements, director and officer liability insurance costs and investor and public relations costs, among other expenses.

• Inflationary pressures are also a concern as it is difficult to make reliable projections for the cost of components.

• The rising interest rate will lead to higher borrowing costs. It will increase our costs for any potential future borrowing and financing activities. Higher interest rates reduce consumer spending and business investments, causing the economy to contract, which may impact our business.

COMPONENTS OF OUR RESULTS OF OPERATIONS

Revenue

To date, we have not generated any revenue from product sales. If our development efforts for our products are successful and result in regulatory approval or collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements that we may enter into with third parties, or any combination thereof.

Operating Expenses

Research and Development Expense

The nature of our business and primary focus of our activities generates a significant amount of research and development costs. Research and development expenses represent costs incurred by us for:

• The non-clinical development of our product candidates, including our discovery efforts;

• The procurement of our product candidates from third-party manufacturers; and

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• The global clinical development of our product candidates.

Such costs consist of:

• Personnel-related expenses, including salaries, benefits and other compensation-related costs, including share-based compensation, for employees engaged in research and development functions;

• Expenses incurred under agreements with third parties, such as consultants, contractors and CRO’s, that conduct non-clinical and pre-clinical studies and clinical trials of our product candidates and research programs;

• Costs of procuring manufactured product candidates for use in non-clinical studies, preclinical studies and clinical trials from third-party CDMO’s;

• Costs of outside consultants and advisors, including their fees;

• Payments made under third-party licensing agreements; and

• Other expenses incurred as a result of research and development activities.

We expense research and development costs as incurred. Non-refundable advance payments that we make for goods and services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or services rendered.

Our primary focus since inception has been the development of SEQ-400. Our research and development costs consist primarily of external costs, such as fees paid to CDMOs, CROs and consultants in connection with our non-clinical studies, preclinical studies and clinical trials. We do not allocate employee-related costs, costs associated with our discovery efforts and other internal or indirect costs to specific research and development programs or product candidates because these resources are used and these costs are deployed across multiple programs under development and, as such, are not separately classified.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase significantly in the near term as we advance SEQ-400 through clinical development on a global basis, pursue regulatory approval of SEQ-400, continue to discover and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts, including the manufacturing activities.

At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:

• The timing and progress of preclinical and clinical development activities;

• The number and scope of preclinical and clinical programs we decide to pursue;

• Filing acceptable investigational new drug applications with the U.S. FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;

• Sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete the regulatory activities;

• Our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and successfully develop, obtain regulatory approval or EUA for our product candidates;

• Successful enrollment and timely completion of clinical trials, including our ability to generate positive data from such clinical trials;

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• The costs associated with the development of any additional development programs and product candidates we identify in-house or acquire through collaborations;

• The prevalence and severity of adverse events experienced with FimH or any other product candidates;

• The terms and timing of collaboration, license or other arrangements, including the terms of milestone payments thereunder;

• Our ability to develop and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protect our rights in our intellectual property portfolio;

• Receipt of timely marketing approvals from applicable regulatory authorities;

• Our ability to maintain compliance with regulatory requirements, including good clinical practices, current good laboratory practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;

• Potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; and

• The impact of any business interruptions on our operations or those of third parties with which we work.

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. In addition, we may never succeed in obtaining regulatory approval or EUA for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and benefits, third-party and other related costs, including share-based compensation, for our personnel and external advisors involved in our executive, finance, legal and business development and other administrative functions. General and administrative expenses also include costs incurred for outside services associated with such functions, including legal fees relating to patent and corporate matters, professional fees for accounting, auditing, tax and administrative consulting services, insurance costs, market research costs, and other general and administrative expenses. These costs relate to the operation of the business, unrelated to research and development function, or any individual program.

We anticipate that our general and administrative expenses will increase significantly in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the potential commercialization expenses prior to any regulatory approval or EUA of our product candidates as we continue to expand our commercial function to support future product launches. We also anticipate that we will incur increased expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services, director and officer insurance premiums and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file additional patent applications to protect innovations arising from our research and development activities.

Interest Expense

Interest expense consists of interest on both our bank debt and our convertible debentures. Unless we raise capital through new debt financing, we expect our interest expense to decrease slightly as we pay down our bank debt and as and if our convertible debentures are converted or redeemed.

Income Taxes

Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development credits generated in each period as we believe, based upon the weight of the available evidence, that it is more likely than not that all of our net operating loss, or NOL, carryforwards and tax credit carryforwards will not be realized.

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As of December 31, 2022, we had U.S. federal NOL carryforwards of $2.1 million, which have an indefinite carryforward period but are limited in their usage to an annual deduction equal to 80% of annual taxable income. The Company conducts intensive research and experimentation activities, generating research and development credits for federal and state purposes, equal to an aggregate of $1.5 million. However, the Company has not performed a formal study validating these credits claimed in tax returns. Once a study is prepared, the amount of R&D tax credit available could vary from what was originally claimed on the tax returns.

Results of Operations

For the Nine Months Ended September 30, 2023 and 2022

The following table summarizes our results of operations for the periods ended September 30, 2023 and 2022, together with the dollar change in those items from period to period:

	Nine Months Ended September 30, 2023			Nine Months Ended September 30, 2022			$ Change
General and administrative expenses	$	1,338,245		$	1,333,785		$	4,460

Research and development expenses		924,545			1,900,000			(975,455	)
Total operating expenses		2,262,790			3,233,785			(970,995	)
Operating loss		(2,262,790	)		(3,233,785	)		970,995
Other income		2,807			450			2,357
Interest expense		(73,510	)		(74,650	)		1,140
Net loss	$	(2,333,493	)	$	(3,307,985	)	$	974,492

General and Administrative Expenses

Our general and administrative expenses increased by $4,460 from $1,333,785 for the period ended September 30, 2022 to $1,338,245 for the period ended September 30, 2023. General and administrative expenses remained relatively flat for the comparable period.

Research and Development

We expense research and development costs as incurred. Our research and development costs decreased by $975,455 from $1,900,000 for the period ended September 30, 2022 to $924,545 for the period ended September 30, 2023 as our research and development costs are limited by our ability to raise additional capital. The decrease was attributable to a $1,125,690 decrease in CRO expenses, partially offset by an increase in salaries and related employee costs of $91,615. All research and development expenses for the periods presented are attributable to SEQ-400.

Other Income

Other income increased by $2,357 from $450 for the period ended September 30, 2022 to $2,807 for the period ended September 30, 2023. The increase was attributable to interest income on our cash balances as interest rates have increased during this period.

Interest Expense

Interest expense decreased by $1,140 from $74,650 for the period ended September 30, 2022 to $73,510 for the period ended September 30, 2023. The decrease is attributable to the lower balance on our bank debt.

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For the Year Ended December 31, 2022 and Period Ended December 31, 2021

The following table summarizes our results of operations for the year ended December 31, 2022 and for the period from April 30, 2021 through December 31, 2021, together with the dollar change in those items from period to period:

	Year Ended December 31, 2022			Period from April 30, 2021 through December 31, 2021			$ Change
General and administrative expenses	$	1,809,254		$	616,142		$	1,193,112
In-Process research and development expenses		—			4,498,580			(4,498,580	)
Research and development		2,277,103			1,267,071			1,010,032
Total operating expenses		4,086,357			6,381,793			(2,295,436	)
Operating Loss		(4,086,357	)		(6,381,793	)		2,295,436
Other income		604			409			195
Interest expense		(100,378	)		(66,358	)		(34,020	)
Net loss	$	(4,186,131	)	$	(6,447,742	)	$	2,261,611

General and Administrative Expenses

Our general and administrative expenses increased by $1,193,112 from $616,142 for the period from April 30, 2021 to December 31, 2021 to $1,809,254 for the year ended December 31, 2022. The majority of this increase is due to a $595,961 increase attributable to legal, accounting and auditing work required in preparation for going public. The remaining increase is due to the impact of the 2021 fiscal year being eight months as compared to the full 12 months in 2022.

In-Process research and development

On April 30, 2021, we undertook a Plan of Merger and Combination to combine the businesses, assets and liabilities of Sequoia Sciences, Inc. and Sequoia Sciences UTI, LLC with and into the Company (the “Merger”). The in-process research and development expense of $4,498,580 for the period from April 30, 2021 to December 31, 2021 reflects the in-process research and development assets acquired in the combination transaction. This in-process research and development relates to the cancer drug and cystic fibrosis platforms.

Research and Development

We expense research and development costs as incurred. Our research and development costs increased by $1,010,032 from $1,267,071 for the period from April 30, 2021 to December 31, 2021 to $2,277,103 for the year ended December 31, 2022. This comparison is impacted by the 2021 fiscal year being eight months as compared to the full 12 months in 2022. All research and development expenses for the periods presented are attributable to SEQ-400.

Other Income

Other income increased by $195 from $409 for the period from April 30, 2021 to December 31, 2021 to $604 for the year ended December 31, 2022. This comparison is impacted by the 2021 fiscal year being eight months as compared to the full 12 months in 2022. We expect our other income will increase as we invest the cash we receive from the net proceeds from this offering.

Interest Expense

Interest expense increased by $34,020 from $66,358 for the period from April 30, 2021 to December 31, 2021 to $100,378 for the year ended December 31, 2022. This comparison is impacted by the 2021 fiscal year being eight months as compared to the full 12 months in 2022.

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Liquidity and Capital Resources

Sources of Liquidity

Since our inception in 2012, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. To date, we have funded operations with proceeds from sales of our common and preferred stock and from the issuance of convertible debt. In 2022, we received net proceeds of $2.1 million from sales of our preferred stock. As of December 31, 2022, we had cash of $306,547 and restricted cash of $118,697.

Cash Flows

For the Nine Months Ended September 30, 2023 and 2022

The following table summarizes our sources and uses of cash for each of the periods presented:

	Period Ended September 30, 2023			Period Ended September 30, 2022
Net cash (used in) operating activities	$	(2,092,766	)	$	(3,157,700	)
Net cash (used in) investing activities		(3,874	)		(4,650	)
Net cash provided by financing activities		2,447,588			1,882,627
Net increase (decrease) in cash and cash equivalents	$	350,948		$	(1,279,723	)

Operating Activities

During the period ended September 30 2023, operating activities used $2,092,766 of cash, primarily due to our net loss of $2,333,493, partially offset by stock compensation of $142,859 and an increase in our liabilities of $93,978.

During the period ended September 30, 2022, operating activities used $3,157,700 of cash, primarily due to our net loss of $3,307,985, partially offset by an increase in our liabilities of $109,104 and by stock compensation of $31,360.

Investing Activities

During the period ended September 30, 2023, we used $3,874 for the purchase of office equipment.

During the period ended September 30, 2022, we used $4,650 for the purchase of office equipment.

Financing Activities

During the period ended September 30, 2023, net cash provided by financing activities was $2,447,588, primarily from the sales of preferred stock and receipt of a deposit for preferred stock issuance, partially offset by payments on bank debt.

During the period ended September 30, 2022, net cash provided by financing activities was $1,882,627, primarily from the sales of preferred stock, partially offset by payments on bank debt.

For the Year Ended December 31, 2022 and Period Ended December 31, 2022

The following table summarizes our sources and uses of cash for each of the periods presented:

	Year Ended December 31, 2022			Period from April 30, 2021 through December 31, 2021
Net cash (used in) operating activities	$	(3,985,887	)	$	(1,705,600	)
Net cash (used in) provided by investing activities		(7,700	)		23,930
Net cash provided by financing activities		2,076,440			1,625,000
Net decrease in cash and cash equivalents	$	(1,917,147	)	$	(56,670	)

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Operating Activities

During the year ended December 31, 2022, operating activities used $3,985,887 of cash, primarily due to our net loss of $4,186,131, partially offset by an increase in liabilities of $259,070.

During the period from April 30, 2021 to December 31, 2021, operating activities used $1,705,600 of cash, primarily due to our net loss of $6,447,742, partially offset by the non-cash in-process research and development charge of $4,498,580 and an increase in liabilities of $186,780.

Investing Activities

During the year ended December 31, 2022, we used $7,700 for the purchase of office equipment.

During the period from April 30, 2021 to December 31, 2021, we used $8,670 for the purchase of office equipment. In addition, we received $32,600 in net cash from our acquisition of SSI.

Financing Activities

During the year ended December 31, 2022, net cash provided by financing activities was $2,076,440, primarily from the sales of preferred stock, partially offset by payments on bank debt.

During the period from April 30, 2021 to December 31, 2021, net cash provided by financing activities was $1,625,000, primarily from the sales of preferred stock, partially offset by payments on bank debt.

Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the planned phase 2 clinical trial of SEQ-400 and preclinical studies of our product candidates. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including:

• The rate of progress in the development of SEQ-400 and our other product categories;

• The scope, progress results, and costs of clinical studies, preclinical development, laboratory testing and clinical trials for SEQ-400 and future product candidates and associated development programs;

• The extent to which we develop, in-license or acquire other product candidates and technologies in our pipeline;

• The scope, progress, results, costs as well as timing of process development and manufacturing scale-up and validation activities associated with SEQ-400 and our future product candidates and other programs as we advance them through preclinical and clinical development;

• The number and development requirements of product candidates that we may pursue;

• The costs, timing and outcome of regulatory review of our product candidates;

• The headcount growth and associated costs as we expand our research and development capabilities and establish a commercial infrastructure;

• The timing and costs of securing sufficient capacity for commercial supply of our product candidates, or the raw material components thereof;

• The costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

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• The continuation of existing collaboration arrangements and entry into new collaboration arrangements, if required;

• The need and ability to hire additional research, clinical, development, scientific and manufacturing personnel;

• The costs we incur in maintaining business operations;

• The need to implement additional internal systems and infrastructure;

• The effect of competing technological, product and market developments;

• The revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and

• The costs of operating as a public company.

We believe that the net proceeds from offering, together with our existing cash and restricted cash, will enable us to fund our operating expenses and capital expenditure requirements through . We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Until such time, if ever, as we generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, government or private-party grants, debt financings, collaborations, strategic alliances and licensing agreements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making acquisitions or capital expenditures or declaring dividends, which could adversely constrain our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute your ownership interest. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or through other sources, when needed, we may be required to delay, limit, reduce or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.

The Company has experienced recurring net losses and negative cash flows from operations since inception. As of December 31, 2022, the Company had cash of $306,547 and an accumulated deficit of $53,450,056. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital and performing research and development. The Company expects to continue to incur operating losses and negative cash flows from operations for the foreseeable future, factors which create substantial doubt about the Company’s ability to continue as a going concern for twelve months from the issuance of our financial statements.

To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. From inception, the Company has been funded by a combination of equity and debt financings. The Company plans to meet its capital requirements primarily through the issuance of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all.

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Contractual Obligations and Commitments

We have a manufacturing agreement with Cytovance Biologics Inc., a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell cultures and microbial fermentation. Cytovance is producing the antigen of Sequoia’s vaccine for its future human studies. The manufacturing agreement outlines the terms and conditions under which the antigen is manufactured for commercial use. The Company is contractually obligated to spend approximately $3.0 million for the commercial supply of product over the next three years.

We enter into contracts in the normal course of business with CRO’s and other third parties for clinical trials, research and testing and other services. These contracts do not contain any minimum purchase commitments and provide for termination upon prior written notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation including non-cancelable obligations of our services providers and, in some cases, wind-down costs. The exact amounts of such obligations are dependent on the timing of termination and the terms of the associated agreement.

We have outstanding convertible debentures of $955,000. The principal and accumulated interest on these obligations are convertible at the option of the noteholder into 0.27 shares of Series A Preferred Stock and 0.53 shares of Common Stock at $0.80 per unit. These debentures are subordinated in the right of payment to the Company’s Small Business Administration (“SBA”) loan and will mature on March 12, 2026 after the maturity of the SBA loan.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with US GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amount of expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Footnote 3 — Summary of Significant Accounting Policies to our financial statements appearing at the end of this prospectus, we believe the following accounting policies used in the preparation of our financial statements require the most significant judgments and estimates.

Share-Based Compensation

We grant share-based awards to employees and non-employees in the form of stock options to purchase shares of our common stock. We measure stock options with service-based vesting granted to employees, directors and non-employees based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes options-pricing model uses as input the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options, and our expected dividend yield. We have issued awards with only service-based vesting conditions through December 31, 2022. Compensation expense for awards granted to employees and non-employees for their service is recognized on a straight-line basis over the requisite service period of the respective award, which is generally the vesting period of the award.

In future periods, we expect share-based compensation expense to increase due to additional share-based awards we expect to grant to continue to attract new hires and retain our existing employees.

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Determination of Fair Value of Common Stock

As there has been no public market for our common stock prior to this offering, the estimated fair value of our common stock underlying our share-based awards has been determined by our board of directors as of each option grant date with input from management and our board of directors’ assessment of additional objective and subjective factors that it believed were relevant, including:

• The prices at which we sold our preferred stock;

• The progress of our research and development programs, including the status of clinical and preclinical trials for our product candidates;

• Our stage of development and our business strategy;

• External market conditions affecting the biotechnology industry and trends within the biotechnology industry;

• The competitive landscape for similar products for treatment of recurrent UTIs;

• Our financial position, including cash on hand, and our historical and forecasted performance and operating results;

• The lack of an active market for our common stock;

• The likelihood of achieving a liquidity event, such as an initial public offering, or IPO, or a sale of our Company, given prevailing market conditions; and

• The analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry.

The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if we had used significantly different assumptions or estimates, the fair value of our common stock and our share-based compensation expense could be materially different.

Once a public trading market for our common stock has been established with the completion of this offering, it will no longer be necessary for our board of directors to estimate the fair value of our common stock in connection with our accounting for granted stock options and other such awards as we may grant, as the fair value of our common will be based on the quoted market price of our common stock.

Option Grants

On April 30, 2021, the Company undertook a Plan of Merger and Combination. Pursuant to the Plan, outstanding options of SSI, a sister company, were exchanged for options of the Company with the following stipulations:

• The purchase price of the shares will be $1.00 per share which is believed to be the fair market value of the Company’s shares as of this date;

• Each option remains fully vested;

• Each option will expire on April 30, 2031; and

• There remain 544,810 options outstanding.

The Company issued 965,000 stock options with a fair value of $0.23 per share during the year ended December 31, 2022, and 300,000 options with a fair value of $0.22 per share during the period from April 30 through December 31, 2021, respectively.

The Company issued 1,700,000 stock options with a fair value of $0.35 per share during the period ended September 30, 2023. An additional 805,000 stock options were forfeited/expired during the period ended September 30, 2023. Outstanding options as of September 30, 2023 were 2,704,810.

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Off-Balance Sheet Arrangements

With the exception of the Sales Transaction Payment Agreement, the Company did not have during the periods presented any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.

Sales Transaction Payment Agreement

The Company has entered into a Sales Transaction Payment Agreement with certain of its employees and former employees which provides that 10% of the net proceeds from the sale of the Company or any of its product lines or assets of up to a maximum net proceeds of $6.8 million will be distributed to such individuals. A sales transaction is limited to a transaction where the holders of the Company’s stock receive cash or other assets in a liquidating event. Net proceeds are defined as the proceeds from a sales transaction offset by its expenses including investment banking, legal, accounting and other costs and claims pertaining to disputes which may arise involving the Sales Transaction. The obligation remains an obligation of the Company in the event the Company is sold or merges with another company pursuant to a sales transaction. This public offering does not generate any payout under the agreement, as the offering does not qualify as a triggering transaction under the agreement.

Internal Control over Financial Reporting

We identified material weaknesses in our internal control over financial reporting that existed as of December 31, 2022.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements may not be prevented or detected on a timely basis. Additionally, these material weaknesses could result in misstatements of the aforementioned account balances or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented or detected.

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We intend to remediate these material weaknesses. We currently are assessing and improving our processes and control procedures to ensure they will operate at an acceptable level of assurance. We will seek to hire and train additional personnel and outside consultants to fill accounting functions. We believe these actions and other actions to be implemented, when complete, will remediate the control weaknesses. However, the weaknesses will not be considered fully remediated until the applicable controls operate for a sufficient period of time for management to test the results for operating effectiveness. Once implemented, we intend to continue periodic testing and reporting of the internal controls to ensure continuity of compliance.

Emerging Growth Company Status

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company; however, we have and may adopt certain new or revised accounting standards early, when early adoption is permitted.

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BUSINESS

Overview

We are a clinical stage pharmaceutical company developing a vaccine designed to prevent recurrent urinary tract infections (UTIs) and small molecules treating cancers and bacterial infections. Our lead clinical candidate, SEQ-400, is a vaccine for the prevention of recurrent UTIs, and it has received fast track designation by the Food and Drug Administration (FDA). After successful completion of our phase 1 study, the next step is to conduct a phase 2 trial to evaluate efficacy of SEQ-400 in an expanded population of patients with culture-verified recurrent UTIs. Our phase 1 study observed 67 women, including 25 women with a two-year documented history of recurrent UTIs. These women had fewer recurrent UTIs after achieving peak antibody responses produced by the vaccine when comparing UTIs in two consecutive 9-month time periods pre- and post-vaccination. In addition, antibodies generated in these women and evaluated in laboratory studies reduced the adherence of bacteria to human bladder cells, which is the intended mechanism of action of the vaccine. The vaccine is designed to help patients with recurrent UTIs by producing antibodies that function to reduce the bacterial attachment and colonization of their bladders to prevent UTIs. Additionally, very few local (swelling, tenderness, burning and redness) adverse reactions and systemic (nausea, headaches, fatigue) adverse reactions, and no severe systemic adverse reactions were reported in the phase 1 population. All local and systemic adverse reactions resolved within seven days. Therefore, we believe SEQ-400 is well positioned to begin a phase 2 clinical trial designed to evaluate safety and efficacy in a larger population of patients with recurrent UTIs. Our pipeline also includes small molecule anticancer agents to treat ovarian and potentially other cancers, and small molecules to inhibit the bacteria that destroy the lung function of cystic fibrosis patients.

There are currently no products approved by the FDA indicated to prevent recurrent UTIs. UTIs are one of the leading bacterial infections in the U.S., and the standard of care is to treat UTIs with antibiotics. After treatment with antibiotics, UTIs recur because bacteria reinfect their bladders primarily from the patient’s intestinal tract. We believe our strategy to prevent UTIs is superior to treating UTIs with antibiotics because preventing infections reduces healthcare costs and patient suffering and mortality. UTIs lead to emergency room visits, hospitalizations including prolonged stays and readmissions, sepsis, severe sepsis, septic shock, and mortality, and transmission of bacteria in communities and hospitals. Sepsis is one of leading causes of death in the U.S. Employees of U.S. Department of Health and Human Services (HHS) and three U.S. universities published a study in 2020 forecasting the costs for Medicare beneficiaries of sepsis admissions and its outcomes. This study revealed that the U.S. healthcare system spends more than $62 billion annually on sepsis and its outcomes. The urinary tract is one of the primary sites that may lead to sepsis. Employees of the Centers for Diseases and Control and Prevention (CDC) published a study in 2018 examining the variability in short-term sepsis mortality by hospital among Medicare beneficiaries. This study revealed that UTIs are the leading cause of hospitalizations from severe sepsis and septic shock in patients 65 years of age and older covered by Medicare.

Vaccines are preferred to treatments because they prevent infections and reduce associated healthcare costs. By preventing infections, vaccines have reduced the costs of COVID-19, diphtheria, measles, mumps, pertussis, pneumococcal diseases, polio, rotavirus, rubella, smallpox, tetanus, typhoid, varicella, and yellow fever. The CDC estimates that the vaccination of children born between 1994 and 2018 in the U.S. will prevent 419 million illnesses, 26.8 million hospitalizations, 936,000 deaths, and reduce about $1.9 trillion in total societal costs. For example, pneumococcal vaccines prevent bacterial infections by Streptococcus pneumoniae. These vaccines have reduced pneumococcal disease among vaccinated and non-vaccinated individuals, reduced the use of antibiotics to treat pneumonia, and reduced the development of antibiotic-resistant strains of S. pneumoniae. Antibodies produced by pneumococcal vaccines pass (transude) from blood to the middle ear fluid of humans to prevent ear infections by S. pneumoniae.

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The U.S. Healthcare Infrastructure Supports the Development of Vaccines and the Reduction of the Use of Antibiotics

The CDC and HHS led the Antimicrobial Resistance Challenge in 2018 and 2019 which received commitments from more than 300 healthcare systems, health insurance companies, medical professionals, and government health organizations to implement strategies to reduce the development of antibiotic resistance. One of these commitments was to invest in the development of and access to vaccines. The CDC supports accelerating the commercialization of new vaccines. The CDC supports vaccinations against antibiotic resistant bacteria to reduce the need for antibiotics. The CDC’s Core Elements of Hospital Antibiotic Stewardship program has encouraged hospitals to implement antibiotic stewardship programs which have reduced antibiotic prescriptions in outpatient settings. Since 1999 when the CDC published an article that focused on their strategies to mitigate the threats of infectious diseases as we begin the 21st century that stated “Antimicrobial resistances is one of the most important emerging infectious disease issues in the United States today, with overprescribing of antibiotics a major contributor to the problem,” the CDC has continually promoted antimicrobial stewardship programs to improve the use of antibiotics. Despite the efforts by the CDC, UTIs caused by multidrug-resistant extended-spectrum beta-lactamase Escherichia coli have continued to increase because of the use of antibiotics. The Advisory Committee on Immunization Practices (ACIP) operates at the CDC to make recommendations to the CDC to adopt the use of new vaccines. The ACIP considers the safety and effectiveness of the vaccine and severity of the disease when making recommendations to the CDC. Vaccine recommendations from the ACIP are widely adopted.

The Centers for Medicare and Medicaid Services (CMS) develops conditions of participation that healthcare organizations must achieve in order to participate in CMS programs. These conditions and rules require implementing methods to prevent the transmission of infections within the hospital and between hospitals and other institutions, improve the use of antibiotics, and reduce the development of antibiotic-resistant organisms. These rules reflect the focus of today’s U.S. healthcare system which is to prevent infections, prevent the spread of infections, and reduce the use of antibiotics. We believe that SEQ-400 has a potential to prevent recurrent UTIs, reduce the use of antibiotics that treat recurrent UTIs, and subsequently reduce the development of antibiotic-resistant bacteria that cause recurrent UTIs because exposures to antibiotics are reduced.

Mechanism of Action of Antibodies Elicited by SEQ-400

Based on data generated in our Phase 1 study, we believe that SEQ-400 has the potential to prevent recurrent UTIs in humans. Antibodies collected from women in the study following vaccination reduced attachment of bacteria to human bladder cells in vitro. This is consistent with the animal study results generated by multiple independent laboratories that led to the clinical development of SEQ-400. The bacteria causing UTIs in humans primarily migrate from the intestinal tract and these bacteria enter the patient’s bladder following bowel movements. Despite attempts at post bowel movement washing or front to back wiping techniques, patients who suffer from recurrent UTIs reinfect their bladders repeatedly. SEQ-400 is a vaccine which generates antibodies that function to reduce the bacterial attachment and colonization of human bladders to prevent recurrent UTIs. We believe the antibodies elicited by SEQ-400 pass (transude) from capillaries to the bladder surface, and separately are produced by antibody producing immune cells at the bladder surface to prevent the attachment and colonization of mammalian bladders.

The antigen of the vaccine is FimH, an essential binding protein on the tip of type 1 pili of E. coli and Klebsiella spp. that cause UTIs. An illustration of type 1 pili with FimH at its tip is shown below. Type 1 pili are hair-like appendages produced by these bacteria that enable them to adhere to and colonize mammalian bladders. Each single bacterial cell can produce about ten to more than 100 type 1 pili to assist adherence to bladders. An image of E. coli adhering to a murine bladder using type 1 pili is shown below. SEQ-400 elicits antibodies against FimH, and these

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antibodies block FimH to reduce the attachment and colonization of bladders by bacteria. This mechanism of action, blocking FimH, by either active immunization including SEQ-400, passive immunization, or administering small molecules has been demonstrated in publications by multiple independent laboratories in animal studies.

Waksman et al. Nat. Rev. Microbiol. 2009, 7, 765-774; Schilling et al. J Infect Dis. 2001;183:S36-S40.

Standard of Care for Recurrent UTIs Patients is to Treat with Antibiotics Based on UTI Symptoms

For patients with recurrent UTIs, a UTI diagnosis is based on symptoms which primarily consist of pain during urination, frequent urination, urgency to urinate, and/or discomfort in the lower abdomen, and a documented history of recurrent UTIs. For bacteria susceptible to antibiotics, acute antibiotic regimens typically suppress UTI symptoms within 2 to 6 days, but the infections recur within about 30 to more than 90 days. The time between recurrent UTIs is unpredictable, ranging from two to more than ten recurrences per year, as shown in our published phase 1 study. Patients are prescribed antibiotics that frequently include refills, so they can have antibiotics on hand to treat as soon as symptoms recur without visiting a physician. Therefore, physicians allow recurrent UTI patients to self-diagnose symptoms of UTIs and begin antibiotic treatment as needed. In addition, daily antibiotic prophylaxis is prescribed in the U.S. to prevent UTIs from recurring frequently. These dosing regimens consist of taking antibiotics daily for one to four months or longer. Despite the frequent use of antibiotics, UTIs recur and can lead to emergency room visits, hospitalizations including prolonged stays and readmissions, sepsis, severe sepsis, septic shock, and mortality, and transmission of bacteria in communities and hospitals.

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Pipeline

Our current pipeline consists of a vaccine for the prevention of recurrent UTIs (SEQ-400), small molecule anticancer agents to treat ovarian and potentially other cancers (novel small molecule analogs derived from the lead scaffold SEQ-1274), and small molecules to inhibit the bacteria that negatively impact the lung function of cystic fibrosis patients. We view each development opportunity independent of modality (within vaccines or small molecules) based on the scientific evidence supporting development, the clinical development strategy including patient enrollment criteria and trial endpoints, and the potential to positively impact the market.

SEQ-400, Vaccine for the prevention of recurrent UTIs

The phase 1 study for SEQ-400 was an open-label, uncontrolled, dose escalation study conducted at six clinical sites in Maryland, Michigan, North Carolina, South Carolina, and Utah. In accordance with the phase 1 study’s protocol, the length of study was up to 19 months, which included 30 days before the first vaccination and 18 months after the first vaccination. The objectives of the phase 1 study were to evaluate the safety and immunogenicity of the SEQ-400. The study included 67 females, ages 21-64, in 7 cohorts. A safety review committee allowed enrollment of subsequent cohorts after review of safety assessments. Subjects in cohorts 1 to 5 did not have a history of UTIs in the previous 24 months prior to enrollment into the study. Subjects in cohorts 6 and 7 had 5 or more documented UTIs in the last 24 months, including at least 1 UTI with a urine culture identifying E. coli. For subjects in cohorts 6 and 7, UTI symptoms were recorded during the study per protocol. No objectives or endpoints involving UTI symptoms were in the protocol. Of the 67 enrolled subjects, 57 received all four vaccinations.

In cohorts 6 and 7, 30 subjects were enrolled, 26 received all four vaccinations, and 25 completed the 19-month study. These women were 25 to 64 years of age with body mass indices from 20 to 33 kg/m2. The 30 women who were enrolled presented medical documentation for more than 180 UTIs, in the aggregate, in the previous 24 months. This documentation included more than 80 antibiotic susceptibility reports of E. coli identified from clean-catch midstream urine collections. These susceptibility data demonstrated that 15 women each had at least one UTI with E. coli resistant to trimethoprim-sulfamethoxazole, and 14 women each had at least one UTI with E. coli resistant to ciprofloxacin. Despite antibiotic refills being listed in these records, the use of these refills was not investigated or tabulated, so it is reasonable to assume these 30 women had additional undocumented UTIs in the previous 24 months. 14 of the subjects had been prescribed antibiotic prophylaxis at least once in the previous 24 months.

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The table below lists FimH antibody responses by cohort. All 57 subjects who received four vaccinations were seropositive thirty days after the fourth vaccination (day 210). Subjects in cohorts 1, 2, 3/4, 5, 6, and 7 demonstrated fold increases in anti-FimH antibody responses at day 210 of 78, 72, 142, 341, 158, and 235, respectively. Of 56 subjects at day 360, 52 (93%) were seropositive. Subjects in cohorts 3/4, 5, 6, and 7 demonstrated fold increases in anti-FimH antibody responses at day 360 of 16, 51, 19, and 20, respectively. For the 26 subjects in cohorts 6 and 7 that received the fourth and final vaccination, functional antibody responses evaluated at 30 days after the fourth vaccination were published. In summary, 24 of 26 subjects demonstrated an increase in functional antibody responses.

	Cohort 1			Cohort 2			Cohorts 3 and 4			Cohort 5			Cohort 6			Cohort 7
Day	107 µg FimCH			50 µg FimCH 10 µg adjuvant			50 µg FimCH 20 µg adjuvant			50 µg FimCH 40 µg adjuvant			50 µg FimCH 40 µg adjuvant			107 µg FimCH 43 µg adjuvant
	N	GMT	95% CI	N	GMT	95% CI	N	GMT	95% CI	N	GMT	95% CI	N	GMT	95% CI	N	GMT	95% CI
1	5	—	—	8	—	—	16	—	—	8	—	—	16	—	—	14	4	3-6
30	5	10	1,76	8	14	4,47	16	8	4,19	7	20	4,93	15	20	6,65	14	15	7,33
60	4	65	6,764	8	63	16,240	13	124	47,329	7	456	139,1498	15	125	48,323	14	155	53,453
90	4	32	3,400	8	40	13,124	14	61	27,137	7	223	62,804	14	82	34,197	13	89	29,278
120	4	149	2,9253	7	125	26,607	14	435	180,1051	7	426	121,1505	14	389	228,662	13	322	153,678
180	3	22	5,97	7	51	13,202	14	95	46,197	7	188	36,991	13	141	72,275	13	105	39,280
210	3	235	9,5872	7	215	71,651	14	427	175,1043	7	1024	263,3993	13	473	247,904	13	706	294,1691
360	3	22	6,82	7	23	6,84	14	49	24,102	6	154	47,507	13	57	28,116	13	61	24,154

N is the number of subjects enrolled at the listed day during the study. GMT is the geometric mean titer, which is the antibodies determined by an assay in the sera of the subjects in each listed cohort on the listed day. At day 1 the subjects did not have antibodies to the antigen of the vaccine SEQ-400 as determined by the assay, so no values are listed. As the subjects received SEQ-400, their GMT, or antibodies to the antigen, increased in their sera. Peak antibody responses occurred at day 210 or month 7. Fold increase was determined by dividing their GMT by three, which is ½ the limit of quantitation of the assay. For example, Cohort 1 GMT at day 210 is 235. 235 divided by three is 78.

As shown in the table below, the majority of local injection site reactions reported by subjects within seven days after vaccination were mild and moderate pain and burning, erythema/redness, tenderness and induration. Severe local injection site reactions reported by subjects within seven days after vaccination consisted primarily of pain, burning and tenderness. These local injection site reactions all resolved within seven days. Across all of the 249 vaccinations, very few systemic reactions were reported by subjects within seven days after vaccination. These reported systemic reactions included eight mild and two moderate headaches, two reports of mild nausea, and four reports of mild and moderate fatigue. No subject reported severe systemic reactions. These systemic reactions all resolved. Unsolicited adverse events (AEs) were reported by 72% of subjects. The most frequent unsolicited AEs were UTIs, nasopharyngitis, arthralgia, back pain, fatigue, and headache. No clinically significant hematological, biochemical, or urine values were reported. Three serious adverse events were reported during the study. All were determined to be not related to the vaccine. No deaths or life-threatening AEs occurred during the study. No AEs of special interest were reported. A review of the type and frequency of reported adverse events across cohorts did not indicate any trends within or across cohorts.

Local Injection Site Reactions

Cohort 1

Cohort 2

Cohorts 3 & 4

Cohort 5

Cohort 6

Sequoia Vaccines, Inc. S-1/A