SEC Form S-1 filed by Azitra Inc

As filed with the Securities and Exchange Commission on December 10, 2025.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

AZITRA, INC.

(Exact name of registrant as specified in its charter)

21 Business Park Drive

Branford, CT 06405

(203) 646-6446

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Francisco D. Salva

21 Business Park Drive

Branford, CT 06405

(203) 646-6446

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Faith L. Charles, Esq.

Todd Mason, Esq.

Thompson Hine LLP

300 Madison Avenue, 27^th Floor

New York, New York 10017-6232

Tel: (212) 344-6101

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes 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, please 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, 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:

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 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 which 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 Commission, acting pursuant to said Section 8(a), may determine.

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

Up to 38,944,662 Shares of Common Stock

Up to 4,151,741 Shares of Common Stock Underlying the November Pre-Funded Warrants

Up to 4,687,500 Shares of Common Stock Underlying the November Common Stock Purchase Warrants

Up to 187,500 Shares of Common Stock Underlying the Placement Agent Warrants

Up to 3,840,890 Shares of Common Stock Underlying the ELOC Warrants

This prospectus relates to the offering and resale by the Selling Stockholders listed herein of up to (i) of up to 535,759 shares (the “November Shares”) of our common stock, par value $0.0001 per share (the “Common Stock”), (ii) up to 4,151,741 shares of Common Stock (the “November Pre-Funded Warrant Shares”) issuable upon exercise of pre-funded warrants (the “November Pre-Funded Warrants”), (iii) up to 4,687,500 shares of Common Stock (the “November Common Stock Purchase Warrant Shares”, together with the November Pre-Funded Warrant Shares, the “November Warrant Shares”) issuable upon exercise of Common Stock purchase warrants (the “November Common Stock Purchase Warrants” together with the November Pre-Funded Warrants, the “November Warrants”), (iv) up to 187,500 shares (the “November Placement Agent Warrant Shares”) of Common Stock underlying the placement agent warrants (the “November Placement Agent Warrants”), (v) up to 3,840,890 shares (the “ELOC Warrant Shares”) of Common Stock issuable upon exercise of the warrants issuable in connection with the ELOC Purchase Agreement (the “ELOC Warrants”) and (vi) up to 38,408,903 shares (the “ELOC Shares”) of Comon Stock issuable pursuant to the ELOC Purchase Agreement.

The November Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the November Pre-Funded Warrants are exercised in full. The November Common Stock Purchase Warrants will be exercisable commencing on the date of stockholder approval of the issuance of the November Common Stock Purchase Warrant Shares (the “Stockholder Approval Date”) and will expire on the five-year anniversary of the Stockholder Approval Date. The November Placement Agent Warrants are exercisable on the six-month anniversary of the issuance date and expire on the five-year anniversary of the commencement of the November Offering.

The November Shares and the November Warrants have been issued and sold to the Selling Stockholder pursuant to the purchase agreement, dated November 24, 2025 (the “November Purchase Agreement”). The November Placement Agent Warrants have been issued and sold to the Selling Stockholder pursuant to the placement agency agreement (the “November Placement Agency Agreement”) dated November 24, 2025. See “The November 2025 Alumni Capital Transaction” for a description of the November Purchase Agreement, the November Placement Agency Agreement and “Selling Stockholders” for additional information. The prices at which the Selling Stockholders may resell the November Shares, the November Warrant Shares and the November Placement Agent Warrant Shares offered hereby will be determined by the prevailing market price for the Common Stock or in negotiated transactions. We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares of Common Stock by the Selling Stockholders. To the extent the November Warrants and November Placement Agent Warrants are exercised for cash, if at all, we may receive aggregate gross proceeds of up to approximately $1.57 million.

The ELOC Shares and the ELOC Warrants may be issued and sold to the Selling Stockholder pursuant to the purchase agreement, dated April 24, 2025, (the “ELOC Purchase Agreement”) entered into with Alumni Capital LP (“Alumni Capital”), as amended by that certain modification agreement dated August 26, 2025. See “The Alumni Capital ELOC Transaction” for a description of the ELOC Purchase Agreement, as amended, and “Selling Stockholders” for additional information regarding Alumni Capital. The prices at which Alumni Capital may resell the ELOC Shares and the ELOC Warrant Shares offered hereby will be determined by the prevailing market price for our Common Stock or in negotiated transactions. We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares of Common Stock by the Selling Stockholder. However, we may receive aggregate gross proceeds of up to approximately $14.0 million from the sale of the ELOC Shares to the Selling Stockholder pursuant to the ELOC Purchase Agreement (in addition to the approximately $6.0 million previously received from sales made pursuant to the ELOC Purchase Agreement prior to the date of this prospectus), and up to approximately $2.5 million upon exercise for cash of the currently issued ELOC Warrants and the ELOC Warrants that may be issued pursuant to this prospectus. Under the registration statement previously filed with the Securities and Exchange Commission, and declared effective on May 1, 2025 (the “Prior Registration Statement”), we have registered 11,047,837 shares of Common Stock, which represents (i) 10,043,488 ELOC Shares that we may issue and sell to Alumni Capital under the ELOC Purchase Agreement and (ii) 1,004,349 shares of Common Stock underlying the ELOC Warrants that are issuable upon exercise of the ELOC Warrants that we may issue to Alumni Capital in connection with any single fixed purchase under the ELOC Purchase Agreement, of which 7,955,823 ELOC Shares and 795,579 ELOC Warrants have been sold to Alumni Capital to date. In accordance with our obligations under the Purchase Agreement, we are registering additional shares of Common Stock under this prospectus.

The Selling Stockholders may sell or otherwise dispose of the November Shares, the November Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares described in this prospectus in a number of different ways and at varying prices. See “Plan of Distribution” for more information about how the Selling Stockholders may sell or otherwise dispose of the November Shares, the November Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares being registered pursuant to this prospectus. The Selling Stockholders and any broker-dealers or agents that are involved in selling the November Shares, the November Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares may be deemed to be an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”).

The Selling Stockholders will pay all brokerage fees and commissions and similar expenses. We will pay the expenses (except brokerage fees and commissions and similar expenses) incurred in registering the November Shares, the November Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares, including legal and accounting fees. See “Plan of Distribution.”

Our Common Stock is listed on the NYSE American under the symbol “AZTR.” The last reported sale price of our Common Stock on the NYSE American on December 9, 2025, was $0.3654 per share.

You should read this prospectus, together with additional information described under the headings “Where You Can Find Additional Information” and “Incorporation of Certain Information by Reference” carefully before you invest in any of our securities.

On August 21, 2025, a reverse stock split of our outstanding shares of common stock took effect at a ratio of one-for-six and sixty six hundredths (1:6.66) (the “Reverse Stock Split”), which was approved by our board of directors (the “Board”) and stockholders, and consummated pursuant to a Certificate of Amendment to our Second Amended and Restated Certificate of Incorporation filed with the Secretary of State of Delaware on August 20, 2025. The Reverse Stock Split did not affect the total number of shares of capital stock, including our common stock, that we are authorized to issue, which remain as set forth pursuant to the Second Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”). Unless the context expressly dictates otherwise, all references to share and per share amounts referred to in this prospectus give effect to the Reverse Stock Split.

Investing in our Common Stock involves a high degree of risk. See “Risk Factors” on page 7 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is _____________, 2025.

Table of Contents

You should rely only on the information contained in this prospectus or incorporated by reference. Neither we nor the Selling Stockholders have authorized any other person to provide you with information different from or in addition to that contained in this prospectus, and neither we nor the Selling Stockholders take responsibility for any other information others may give you. If anyone provides you with different or inconsistent information, you should not rely on it. The Selling Stockholders are not making an offer to sell these securities in any jurisdiction where an offer or sale is not permitted. Except as otherwise stated, you should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus and that the information in any report incorporated by reference is accurate only as of the date of such report. Our business, financial condition, results of operations and prospects may have changed since such dates.

No action is being taken in any jurisdiction outside the United States to permit a public offering of our securities or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction.

As used in this prospectus, unless the context indicates or otherwise requires, “the Company,” “our Company,” “we,” “us,” and “our” refer to Azitra, Inc., a Delaware corporation.

INDUSTRY AND MARKET DATA

This prospectus contains or incorporates by reference observations, statistical data, estimates, and forecasts that are based on independent industry, government and non-government organization publications or other publicly available information, as well as other information based on our internal sources. Although we believe that the third-party sources referred to in this prospectus or incorporated by reference are reliable, estimates as they relate to projections involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” and elsewhere in this prospectus. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

Certain information in the text of this prospectus or incorporated by reference is contained in independent industry government and non-governmental organizational publications. The sources of these publications are provided below:

PROSPECTUS SUMMARY

This summary highlights certain information appearing elsewhere in this prospectus. Investing in our Common Stock involves a high degree of risk. Because it is only a summary, it does not contain all of the information that you should consider before investing in our Common Stock and it is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. Before you decide to invest in our Common Stock, you should read the entire prospectus carefully, including “Risk Factors” beginning on page 7 and the financial statements and related notes included in this prospectus or incorporated by reference.

Our Company

We are an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. We have built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by an artificial intelligence and machine learning technology that analyzes, predicts and helps screen our library of strains for drug-like molecules. The platform also utilizes a licensed genetic engineering technology, which can enable the transformation of previously genetically intractable strains. Our initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which we consider to be an optimal therapeutic candidate species for engineering of dermatologic therapies. The particular species demonstrates a number of well-described properties in the skin. As of the date of this prospectus, we have identified among our microbial library over 60 distinct bacterial species that we believe are capable of being engineered to create living organisms or engineered proteins with significant therapeutic effect.

We are a pioneer in genetically engineered bacteria for therapeutic use in dermatology. Our goal is to leverage our platforms and internal microbial library bacterial strains to create new therapeutics that are either engineered living organisms or engineered proteins or peptides to treat skin diseases. Our initial focus is on the development of our current programs, including:

We also have established partnerships with teams from Carnegie Mellon University and the Fred Hutchinson Cancer Center, or Fred Hutch, two of the premier academic centers in the United States. Our collaboration with the Carnegie Mellon based team also takes advantage of the power of whole genome sequencing. This partnership is mining our proprietary library of bacterial strains for novel, drug like peptides and proteins. The artificial intelligence/machine learning technology developed by this team predicts the molecules made by microbes from their genetic sequences. The system then compares the predictions to the products actually made through tandem mass spectroscopy and/or nuclear magnetic resonance imaging to refine future predictions. The predictions can be compared to publicly available 2D and 3D protein databases to select drug like structures.

We hold an exclusive, worldwide license from Fred Hutch regarding the use of its patented SyngenicDNA Minicircle Plasmid, or SyMPL, technologies for all fields of genetic engineering, including to discover, develop and commercialize engineered microbial therapies and microbial-derived peptides and proteins for skin diseases. We are utilizing our licensed patent rights to build plasmids in order to make genetic transformations that have never been previously achieved. To date, our team has successfully engineered our lead therapeutic candidates without the SyMPL technology. However, we believe that SyMPL will open up the ability to make genetic transformations of an expanded universe of microbial species, and we expect that some or all of our future product candidates will incorporate the SyMPL technology.

Our Strategy

Beyond our three lead product candidates, our goal is to develop a broad portfolio of product candidates focused on expanding the application of our platforms for precision dermatology. We believe that we have established a unique position in advancing the development of biologics for precision dermatology.

We intend to create a broad portfolio of product candidates for precision dermatology through our development of genetically engineered proteins selected from our proprietary microbial library of approximately 1,500 unique bacterial strains. Our strategy is as follows:

Our Intellectual Property

As of the date of this prospectus, we own six issued U.S. patents, ten pending U.S. patent applications, two pending PCT application and 88 other foreign patents and patent applications that are important to the development of our business.

Our Leadership Team

We are led by Francisco D. Salva, our chief executive officer, and Dr. Travis Whitfill, our co-founder and chief operating officer, who have more than 35 years of combined experience in the management of biotechnology companies and healthcare investing. Mr. Salva was previously a co-founder of Acerta Pharma, which was sold to AstraZeneca for approximately $6.3 billion in a staged acquisition in 2016. He also worked on the turnaround of Pharmacyclics, which subsequently sold to Abbvie for approximately $21.0 billion in 2015. Before that, Mr. Salva spent almost a decade in life sciences venture capital. Dr. Whitfill served as associate research scientist and serves as assistant professor adjunct at Yale University with appointments in the Departments of Pediatrics and Emergency Medicine. He spent nearly a decade in venture capital as a partner in a biotech-focused venture capital fund, Bios Partners. He has led numerous grant-funded projects, holds nearly a dozen patents and has co-authored over 60 publications. Our Board is comprised of renowned group of senior executives and investors in the biotechnology industry.

Our Competitive Strengths

We are a pioneer in genetically engineering bacteria for therapeutic use in dermatology clinical trials. We have built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that are screened for therapeutic characteristics as well as lead drug candidates. Furthermore, we have exclusively licensed a novel technology, which potentially enables the genetic transformation of previously intractable bacterial microbes. The history of recombinant protein engineering in biotech has traditionally been limited to less than 20 species. Our licensed technology opens up the potential to genetically engineer thousands of microbial species to build proteins and peptides that have never been previously built. Our management team has significant experience in discovering, developing, manufacturing and commercializing therapeutics. The members of our leadership team have specialized expertise developed at companies including Pharmacyclics, Acerta Pharma, Castle Creek Biosciences, VYNE Therapeutics (fka Menlo Therapeutics), Revance Therapeutics, Biogen, Novartis and Connetics Corp.

Our Market Opportunity

We believe there are significant market opportunities to capture in each of our addressable markets. The dermatology market itself has shown considerable growth over the last decade and is predicted to continue to grow. According to Vision Research Reports, the dermatology drug market surpassed $17 billion in 2021 and is expected to grow at a compound annual growth rate of 8.8% through 2030. Our first product candidate to emerge from our platform focuses on the orphan indication of Netherton syndrome. Based on the Barbati and Sun Studies, we believe that this product candidate represents a potential $250 million global sales opportunity by mid-2030. Our second product candidate focuses on papulopustular rash due to EGFR inhibitors. We believe this product candidate represents a potential $1 billion global sales opportunity by 2030. The diseases we intend to target are well characterized, often by a monogenic genetic mutation. Additionally, the era of genomic sequencing has ushered in unprecedented progress in genetic testing. The defined molecular pathophysiology of over 100 rare skin diseases has now been defined.

Recent Developments

NYSE American Minimum Stockholders’ Equity Requirement

On October 1, 2025, the Company received notification from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the minimum stockholders’ equity requirement of Section 1003(a)(ii) of the NYSE American Company Guide (the “Company Guide”) requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years. As of June 30, 2025, September 30, 2025 and December 31, 2024, the Company had stockholders’ equity of approximately $2.2 million, $2.3 million and $5.7 million, respectively, and has had losses in three of its four most recent fiscal years ended December 31, 2024.

November 2025 Private Placement Transaction

See the November 2025 Alumni Capital Transaction for a description of the November 2025 Private Placement Transaction.

Our Corporate Information

We were incorporated under the laws of the state of Delaware on January 2, 2014. Our principal executive offices are located at 21 Business Park Drive, Branford, Connecticut 06405, and our telephone number is (203) 646-6446. Our website address is www.azitrainc.com. The information contained in, 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 Common Stock or Warrants.

We own U.S. and foreign registered trademarks, including our company name. All other trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus are referred to without the symbols ® and ™, but such references should not be construed as any indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Additional Information

For additional information related to our business and operations, please refer to the reports incorporated herein by reference, including our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on February 24, 2025, which we refer to as the 2024 Form 10-K, as described in the section entitled “Incorporation of Certain Documents by Reference” in this prospectus.

Implications of Being an Emerging Growth Company

The Jumpstart Our Business Startups Act, or the JOBS Act, was enacted in April 2012 with the intention of encouraging capital formation in the United States and reducing the regulatory burden on newly public companies that qualify as “emerging growth companies.” We are an emerging growth company within the meaning of the JOBS Act. As an emerging growth company, we may take advantage of certain exemptions from various public reporting requirements, including:

We may take advantage of the exemptions under the JOBS Act discussed above until we are no longer an emerging growth company. We will remain an emerging growth company until the earliest to occur of (1) the last day of the fiscal year in which we have $1.235 billion or more in annual revenue; (2) the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; (3) the date on which we have issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; or (4) the last day of the fiscal year ending after the fifth anniversary of the IPO.

We may choose to take advantage of some, but not all, of the available benefits under the JOBS Act. We have chosen to take advantage of all of the other exemptions discussed above. Accordingly, the information contained herein and in our subsequent filing with the SEC may be different than the information you receive from other public companies in which you hold stock.

Implications of Being a Smaller Reporting Company

Additionally, we are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates equals or exceeds $250 million as of the end of that year’s second fiscal quarter, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates equals or exceeds $700 million as of the end of that year’s second fiscal quarter.

We may choose to take advantage of some, but not all, of the available benefits under the JOBS Act. We have chosen to take advantage of all of the other exemptions discussed above. Accordingly, the information contained herein and in our subsequent filing with the SEC may be different than the information you receive from other public companies in which you hold stock.

Implications of Being a Smaller Reporting Company

Additionally, we are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates equals or exceeds $250 million as of the end of that year’s second fiscal quarter, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates equals or exceeds $700 million as of the end of that year’s second fiscal quarter.

THE OFFERING

(1) The number of shares of our Common Stock to be outstanding after this offering is based on approximately 10,740,697 shares of our Common Stock outstanding as of December 9, 2025, and excludes:

Unless we indicate otherwise or unless the context otherwise requires, all information in this prospectus assumes the following:

RISK FACTORS

Any investment in our securities involves a high degree of risk. You should carefully consider the risks described below and set forth in the section “Risk Factors” in our 2024 Form 10-K, as well as any amendment or update to our risk factors reflected in subsequent filings with the SEC, which are incorporated by reference in this prospectus, and all other information contained in this prospectus and incorporated by reference in this prospectus, before you make a decision to invest in our securities. Please note that the risks highlighted here are not the only ones that we may face. For example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of the following events occur or any additional risks presently unknown to us actually occur, our business, financial condition and operating results may be materially adversely affected. In that event, the trading price of our Common Stock could decline and you could lose all or part of your investment.

Risks Relating to this Offering

Risks Related to this Offering

As an investor, you may lose all of your investment.

Investing in our securities involves a high degree of risk. As an investor, you may never recoup all, or even part, of your investment and you may never realize any return on your investment. You must be prepared to lose all of your investment.

We will need additional financing to execute our business plan and fund operations, which additional financing may not be available on reasonable terms or at all.

As of September 30, 2025, we had total assets of $4,300,279 and working capital of approximately $0.4 million. We believe that net proceeds of this offering, along with our cash on hand as of the date of this prospectus, will not be sufficient to cover our proposed plan of operations over the next 12 months. We intend to seek additional funds through various financing sources, including the sale of our equity, licensing fees for our technology and joint ventures with industry partners. In addition, we will consider alternatives to our current business plan that may enable us to achieve revenue producing operations and meaningful commercial success with a smaller amount of capital. However, there can be no guarantees that such funds will be available on commercially reasonable terms, if at all. If such financing is not available on satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations, in which case you may lose your entire investment.

The report of our independent registered public accounting firm for the year ended December 31, 2024 states that due to our accumulated deficit, recurring and negative cash flow from operations there is substantial doubt about our ability to continue as a going concern.

It is not possible to predict the actual number of ELOC Shares we will sell under the ELOC Purchase Agreement to the Selling Stockholder, or the actual gross proceeds resulting from those sales.

Subject to certain limitations in the ELOC Purchase Agreement and compliance with applicable law, we have the discretion to deliver notices to the Selling Stockholder at any time throughout the term of the ELOC Purchase Agreement. The actual number of ELOC Shares that are sold to the Selling Stockholder may depend based on a number of factors, including the market price of the Common Stock during the sales period. Actual gross proceeds may be less than $20.0 million, which may impact our future liquidity. Because the price per share of each ELOC Share sold to the Selling Stockholder will fluctuate during the sales period, it is not currently possible to predict the number of ELOC Shares that will be sold or the actual gross proceeds to be raised in connection with those sales.

The terms of the ELOC Purchase Agreement limit the amount of ELOC Shares we may issue to the Selling Stockholder, which may limit our ability to utilize the arrangement to enhance our cash resources.

The ELOC Purchase Agreement includes restrictions on our ability to sell our ELOC Shares to Alumni Capital, including, subject to specified limitations, if a sale would cause Alumni Capital to beneficially own more than 4.99% of our issued and outstanding shares of Common Stock we may not sell to Alumni Capital any ELOC Shares. Accordingly, we cannot guarantee that we will be able to sell the full amount of ELOC Shares that Alumni Capital has committed to purchase, if any. If we cannot sell the full amount of ELOC Shares that Alumni Capital has committed to purchase because of these limitations, we may be required to utilize more costly and time-consuming means of accessing the capital markets, which could materially adversely affect our liquidity and cash position.

The market price of our Common Stock may be subject to fluctuation and volatility. You could lose all or part of your investment.

The market price of our Common Stock is subject to wide fluctuations in response to various factors, some of which are beyond our control. Since shares of our Common Stock were sold in our initial public offering (“IPO”) in June 2023 at a price of $999.00 per share, the reported high and low sales prices of our Common Stock have ranged from $1,034.96 to $0.3654 through December 9, 2025. The market price of our Common Stock on the NYSE American may fluctuate as a result of a number of factors, some of which are beyond our control, including, but not limited to:

These factors and any corresponding price fluctuations may materially and adversely affect the market price of our shares and result in substantial losses being incurred by our investors. In the past, following periods of market volatility, public company stockholders have often instituted securities class action litigation. If we were involved in securities litigation, it could impose a substantial cost upon us and divert the resources and attention of our management from our business.

Our charter limits our ability to issue shares.

Our charter authorizes us to issue up to 200,000,000 shares of Common Stock, with 10,740,697 shares of Common Stock, 5,838 options, and 12,047,552 warrants outstanding, as well as 1,436 shares reserved for issue under our 2016 equity plan and 181,642 shares reserved under our 2023 equity incentive plan, 179,834,042 shares of Common Stock remain issuable as of the date of this prospectus, prior to the exercise of any November Warrants or ELOC Warrants. This number may decrease if we enter into any additional capital raising transactions. Additional shares may become issuable with the expiration of currently outstanding warrants or if we effect a reverse share split in the future.

Investors who buy shares at different times will likely pay different prices.

Investors who purchase shares in this offering at different times will likely pay different prices, and so may experience different levels of dilution and different outcomes in their investment results. Alumni Capital may sell such shares at different times and at different prices. Investors may experience a decline in the value of the shares they purchase from the Selling Stockholders in this offering as a result of sales made by us in future transactions at prices lower than the prices they paid.

The issuance of Common Stock to the Selling Stockholders, including the shares of Common Stock issued upon exercise of the November Warrants, the November Placement Agent Warrants and the ELOC Warrants, may cause substantial dilution to our existing stockholders, and the sale of such shares acquired by the Selling Stockholders could cause the price of our Common Stock to decline.

We are registering for resale by the Selling Stockholders up to 51,812,293 shares of Common Stock, comprised of (i) 535,759 shares of Common Stock, (ii) 4,151,741 November Pre-Funded Warrant Shares, (iii) 4,687,500 November Common Stock Purchase Warrant Shares, (iv) 187,500 November Placement Agent Warrant Shares, (v) 38,408,903 ELOC Shares and (vi) 3,840,890 ELOC Warrant Shares. The number of shares of our Common Stock ultimately offered for resale by the Selling Stockholders under this prospectus is dependent upon the number of shares of Common Stock sold by the Selling Stockholders. Depending on a variety of factors, including market liquidity of our Common Stock, the issuance of shares upon exercise of the November Warrants, the November Placement Agent Warrants and the ELOC Warrants to the Selling Stockholders may cause the trading price of our Common Stock to decline.

The sale of a substantial number of shares of our Common Stock by the Selling Stockholders in this offering, or anticipation of such sales, could cause the trading price of our Common Stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise desire.

Our failure to meet the continued listing requirements of the NYSE American could result in a delisting of our Common Stock.

On October 1, 2025, we received written notification from the NYSE American that we are not in compliance with Section 1003(a)(ii) of the NYSE American Company Guide (the “Company Guide”). The Company has submitted a plan to regain compliance to the NYSE American and is awaiting the NYSE American’s determination. If we fail to satisfy the continued listing requirements of the NYSE American, such as the corporate governance requirements or the minimum closing bid price requirement, the NYSE American may take steps to delist our Common Stock. Such a delisting would likely have a negative effect on the price of our Common Stock and would impair your ability to sell or purchase our Common Stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the NYSE American’s minimum bid price requirement or prevent future non-compliance with the NYSE American’s listing requirements.

Future capital raises may dilute your ownership and/or have other adverse effects on our operations.

If we raise additional capital by issuing equity securities, our existing stockholders’ percentage ownership will be reduced and these stockholders may experience substantial dilution. If we raise additional funds by issuing debt securities, these debt securities would have rights senior to those of our Common Stock and the terms of the debt securities issued could impose significant restrictions on our operations, including liens on our assets. If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our intellectual property or candidate products, or to grant licenses on terms that are not favorable to us.

We have not paid dividends on our Common Stock in the past and have no immediate plans to pay such dividends.

We plan to reinvest all of our earnings, to the extent we have earnings, to cover operating costs and otherwise become and remain competitive. We do not plan to pay any cash dividends with respect to our Common Stock in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our Common Stock as a dividend. Therefore, you should not expect to receive cash dividends on the Common Stock we are offering.

Our management will have broad discretion over the use of the net proceeds from the exercise for cash, if any, of the Warrants issued to Alumni Capital, you may not agree with how we use the proceeds and the proceeds may not be invested successfully.

Our management will have broad discretion over the use of proceeds from this offering. We intend to use the net proceeds from this offering, primarily for strategic opportunities, working capital and other general corporate purposes. Our management will have considerable discretion in the application of the net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. The net proceeds, if any, may be used for corporate purposes that do not improve our operating results or enhance the value of our Common Stock. The failure of our management to use these funds effectively could have a material adverse effect on our business, cause the market price of our Common Stock to decline and impair the commercialization of our products and/or delay the development of our product candidates. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing instruments and U.S. government securities. These investments may not yield a favorable return to our stockholders.

The NOVEMBER 2025 Alumni Capital Transaction

General

On November 24, 2025, the Company entered into the November Purchase Agreement with Alumni Capital LP (“Alumni Capital”) pursuant to which the Company agreed to issue and sell to Alumni Capital in a private placement offering priced at a premium to market in accordance with NYSE rules (the “November Offering”) an aggregate of (i) 535,759 shares of Common Stock of the Company, (ii) November Pre-Funded Warrants to purchase up to an aggregate of 4,151,741 shares of Common Stock at an exercise price of $0.0001 per November Pre-Funded Warrant, and (iii) November Common Stock Purchase Warrants to purchase up to an aggregate of 4,687,500 shares of Common Stock at an exercise price of $0.32 per November Common Stock Purchase Warrant. The November Offering price was $0.32 per share of Common Stock or November Pre-Funded Warrant and accompanying November Common Stock Purchase Warrant (the “November Offering Price”). The November Pre-Funded Warrants are immediately exercisable and do not expire until exercised in full. The November Common Stock Purchase Warrants are exercisable upon shareholder approval and will expire on the five-year anniversary of the date of shareholder approval. The November Offering closed on November 25, 2025, resulting in aggregate gross proceeds to the Company of approximately $1.5 million, before deducting the November Placement Agent fees and related November Offering expenses. Additionally, if Alumni Capital exercises its November Warrants for cash in full following the Stockholder Approval, the Company would receive additional gross proceeds of approximately $1.5 million.

The November Purchase Agreement contains customary representations and warranties of the Company, customary conditions to closing, and termination provisions. Pursuant to the terms of the November Purchase Agreement, for 60 days from the closing of the November Purchase Agreement, subject to certain exceptions, the Company may not issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or common stock equivalents, or file any registration statement or any amendment or supplement thereto. Additionally, from the date of the November Purchase Agreement until February 26, 2027, upon any issuance by the Company of Common Stock or common stock equivalents for cash consideration, debt, or a combination of thereof (a “Subsequent Financing”), Alumni Capital shall have the right to participate up to an amount of the Subsequent Financing equal to an aggregate of 25% of the Subsequent Financing. The representations and warranties of each party set forth in the November Purchase Agreement were made solely for the benefit of the other party to the November Purchase Agreement, and such representations and warranties should not be relied on by any other person.

Under the terms of the November Warrants, a holder will not have the right to exercise any portion of the November Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of the Company’s Common Stock outstanding immediately after giving effect to the exercise, as such percentage of ownership is determined in accordance with the terms of the November Warrants. However, upon notice from the holder to the Company, the holder may increase the beneficial ownership limitation to 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise of the November Warrants.

In connection with the November Offering, on November 24, 2025, the Company entered into the November Placement Agency Agreement with Maxim Group LLC, as sole placement agent (the “November Placement Agent”), pursuant to which the Company engaged the November Placement Agent as the exclusive placement agent in connection with the November Offering. Pursuant to the November Placement Agency Agreement and as consideration for the November Placement Agent’s services thereunder, the Company agreed to: (i) pay a cash fee equal to 7.0% of the aggregate gross proceeds received by the Company from the sale of the securities in the November Offering; (ii) issue the November Placement Agent Warrants to purchase up to 187,500 November Placement Agent Warrant Shares, equal to 4.0% of the total number of November Shares and November Pre-Funded Warrants sold in the November Offering, at an exercise price equal to $0.40, or 125% of the November Offering Price; and (iii) reimburse the November Placement Agent for certain out of pocket expenses, including the reasonable fees of legal counsel, in an amount not to exceed $50,000. The November Placement Agent Warrants are exercisable on the six-month anniversary of the issuance date and expire on the five-year anniversary of the commencement of the November Offering. If the November Placement Agent exercises its November Placement Agent Warrants for cash in full, the Company would receive additional gross proceeds of approximately $75,000. The November Placement Agency Agreement also contains representations, warranties, and indemnification and other provisions customary for transactions of this nature.

The November Shares, November Warrants, November Warrant Shares, November Placement Agent Warrants and November Placement Agent Warrant Shares were offered in reliance upon the exemption from the registration requirement of the Securities Act, pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder, and applicable state securities laws. The issuance of the November Shares, November Warrants, November Warrant Shares, November Placement Agent Warrants and November Placement Agent Warrant Shares have not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

Concurrently with entering into the November Purchase Agreement and the November Placement Agency Agreement, on November 24, 2025, the Company and Alumni Capital entered into a registration rights agreement (the “November Registration Rights Agreement”) pursuant to which the Company agreed to file a registration statement (the “Resale Registration Statement”), within 20 days, providing for the resale by Alumni Capital of the November Shares and November Warrant Shares and to have such registration statement declared effective within 60 days (or 90 days, if the SEC conducts a full review), and to maintain the effectiveness of such registration statement until all securities registered pursuant to the Resale Registration Statement (i) have been sold, thereunder or pursuant to Rule 144, or (ii) may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144. Pursuant to the November Placement Agent Warrant, the November Placement Agent is entitled to certain demand and piggyback registration rights. The filing of the registration statement of which this prospectus forms a part was made to satisfy these obligations.

Under the applicable rules of the NYSE American, in no event may we issue more than 2,030,782 November Shares, representing 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the November Purchase Agreement (the “Exchange Cap”) to Alumni Capital under the November Purchase Agreement, unless we obtain stockholder approval to issue shares of Common Stock in excess of the Exchange Cap.

Issuances of our Common Stock to the Selling Stockholders upon exercise of the November Warrants and November Placement Agent Warrants will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of our Common Stock that our existing stockholders own will not decrease, the shares of our Common Stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares of our Common Stock after any such issuance of shares of our Common Stock to the Selling Stockholders upon exercise of the November Warrants and the November Placement Agent Warrants. There are substantial risks to our stockholders as a result of the issuance of Common Stock to the Selling Stockholders under the November Purchase Agreement and the November Placement Agency Agreement. See “Risk Factors.”

The Alumni Capital ELOC Transaction

General

On April 24, 2025, we entered into the ELOC Purchase Agreement with Alumni Capital, as amended by the modification agreement dated August 26, 2025 (the “Modification Agreement”). Pursuant to the ELOC Purchase Agreement, we have the right to sell to Alumni Capital up to an aggregate of $20.0 million (the “Investment Amount”) of the shares of our Common Stock from time to time during the term of the ELOC Purchase Agreement (of which an aggregate of $6.0 million of ELOC Shares and ELOC Warrants have already been sold and issued to Alumni Capital as of the date of this prospectus), subject to certain conditions and limitations. Sales of ELOC Shares pursuant to the ELOC Purchase Agreement, and the timing of any sales, are solely at our option and we are under no obligation to sell securities pursuant to this arrangement. ELOC Shares may be sold by us pursuant to this arrangement over a period ending on the earlier of December 31, 2026, or the date on which Alumni Capital shall have purchased ELOC Shares pursuant to the ELOC Purchase Agreement for an aggregate purchase price of the Investment Amount; provided, however that we can terminate the ELOC Purchase Agreement at any time upon three days’ written notice, subject to the satisfaction of the conditions in the ELOC Purchase Agreement.

Upon the satisfaction of the conditions in the ELOC Purchase Agreement, including that a registration statement that we agreed to file with the SEC pursuant to the ELOC Purchase Agreement is declared effective by the SEC and a final prospectus in connection therewith is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion over the period described above, to direct Alumni Capital to purchase up to a fixed maximum number of ELOC Shares as set forth in the ELOC Purchase Agreement; provided, that Alumni Capital’s maximum commitment under any single fixed purchase will not exceed $750,000. Such limitation may be waived by mutual agreement between us and Alumni Capital, and, in such case, the maximum commitment amount shall be $4.0 million.

Pursuant to the Modification Agreement, the Company may at its election, cause Alumni Capital to make a series of purchases of ELOC Shares either at (i) the lowest daily volume weighted average price of the Common Stock during the period commencing on the date that the Company delivers written notice (the “Purchase Notice”) and ending on the earlier of (a) five (5) business days immediately following the date of a Purchase Notice, and (b) the date on which Alumni Capital notifies the Company that it is prepared to proceed with the closing of the purchase, multiplied by 90% (“Purchase Notice Option 1”) or (ii) the lowest traded price of Common Stock during the period commencing on the date the Company delivers a Purchase Notice and ending on the earlier of (x) the same business day a Purchase Notice is delivered, and (y) the date on which Alumni Capital notifies the Company that it is prepared to proceed with the closing of the purchase, multiplied by 97% (“Purchase Notice Option 2”). Each Purchase Notice delivered by the Company must specify whether Purchase Notice Option 1 or Purchase Notice Option 2 is selected and the number of ELOC Shares to be purchased. There is no upper limit on the price per share that Alumni Capital might be obligated to pay for the Common Stock under the Purchase Agreement.

Upon each purchase, Alumni Capital will receive ELOC Warrants to purchase such number of shares of Common Stock equal to 10% of the number of ELOC Shares purchased in the related single fixed purchase. The exercise price of the ELOC Warrant shall equal 130% of the price per ELOC Share paid upon closing of the related purchase. The ELOC Warrant is exercisable upon stockholder approval and expires five years after issuance. The ELOC Warrants may be exercised via cashless exercise if there is no effective registration statement, or current prospectus available for the resale of the ELOC Warrant Shares. The issuance of the ELOC Shares and the ELOC Warrants to Alumni Capital is being made pursuant to exemptions from the registration requirement of the Securities Act provided by Section 4(a)(2) thereof.

The Company controls the timing and amount of any sales of ELOC Shares to Alumni Capital. Actual sales of ELOC Shares to Alumni Capital under the ELOC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among other things, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding for us and our operations.

On June 23, 2025, the Company received approval from its stockholders to issue an amount greater than 19.99% of the total number of shares of Common Stock issued and outstanding immediately prior to the execution of the ELOC Purchase Agreement. In any event, the ELOC Purchase Agreement provides that the Company may not issue or sell any ELOC Shares under the ELOC Purchase Agreement if such issuance or sale would breach any applicable NYSE American rules.

In all instances, we may not sell securities to Alumni Capital under the ELOC Purchase Agreement if such sale would result in Alumni Capital beneficially owning more than 4.99% of the Common Stock (the “Beneficial Ownership Limitation”). Alumni Capital may increase the Beneficial Ownership Limitation upon 61 days’ written notice, subject to our approval.

The net proceeds from sales, if any, under the ELOC Purchase Agreement, will depend on the frequency and prices at which we sell ELOC Shares. To the extent we sell ELOC Shares under the Purchase Agreement, we currently plan to use any proceeds therefrom for working capital, and other general corporate purposes.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties, or liquidated damages in the ELOC Purchase Agreement. Alumni Capital has agreed not to cause, or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Common Stock during certain periods.

Pursuant to the ELOC Purchase Agreement, we agreed to file a registration statement with the SEC to register for resale under the Securities Act the ELOC Shares and the ELOC Warrant Shares that may be issued to Alumni Capital under the Purchase Agreement and upon exercise of the ELOC Warrants, respectively. On April 28, 2025, we filed the Prior Registration Statement (File No. 333-286809) with the SEC to register the resale of 11,047,837 shares of Common Stock, which represents (i) 10,043,488 shares that we may issue and sell to Alumni Capital under the ELOC Purchase Agreement and (ii) 1,004,348 shares of Common Stock underlying the warrants that are issuable upon exercise of the warrants that we may issue to Alumni Capital in connection with any single fixed purchase under the ELOC Purchase Agreement, which the SEC declared effective on May 1, 2025.

Pursuant to the ELOC Purchase Agreement, the Company must maintain an effective registration statement for the offering and sale of the ELOC Shares and the shares underlying the ELOC Warrants. The purpose of this registration statement on Form S-1 is to register an additional 38,408,903 ELOC Shares and 3,840,890 ELOC Warrant Shares for resale by Alumni Capital, pursuant to the terms of the ELOC Purchase Agreement. The filing of the registration statement of which this prospectus forms a part was made to satisfy this obligation.

As of the date of this prospectus, we have sold 7,955,823 ELOC Shares and 795,579 ELOC Warrants pursuant to the Purchase Agreement for proceeds of approximately $6.0 million.

The ELOC Purchase Agreement contains customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

We have the right to terminate the ELOC Purchase Agreement at any time, at no cost or penalty, upon three days’ written notice to Alumni Capital except after submitting a purchase notice and before delivering the related ELOC Warrant that is due and owed to Alumni Capital. Neither we nor Alumni Capital may assign or transfer its rights and obligations under the ELOC Purchase Agreement, and no provision of the ELOC Purchase Agreement may be modified or waived by the parties except in writing. We do not know what the purchase price for our Common Stock will be or whether there will occur an exception to the Exchange Cap and therefore cannot be certain as to the number of shares we might issue to Alumni Capital under the ELOC Purchase Agreement after the date of this prospectus.

We are registering for resale under this prospectus 38,408,903 ELOC Shares and 3,840,890 ELOC Warrant Shares that are issuable upon exercise of the ELOC Warrants that we may issue to Alumni Capital in connection with any single fixed purchase under the ELOC Purchase Agreement. Depending on the market prices of our Common Stock at the time we elect to issue and sell ELOC Shares and ELOC Warrants to Alumni Capital under the ELOC Purchase Agreement, we may need to register for resale under the Securities Act additional shares of our Common Stock in order to receive aggregate gross proceeds equal to the full Investment Amount. If all of such ELOC Shares and ELOC Warrant Shares offered hereby were issued and outstanding as of the date of this prospectus, such shares would represent approximately 79% of the total number of outstanding shares of Common Stock.

Issuances of our Common Stock to Alumni Capital under the ELOC Purchase Agreement will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of our Common Stock that our existing stockholders own will not decrease, the shares of our Common Stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares of our Common Stock after any such issuance of shares of our Common Stock to Alumni Capital under the ELOC Purchase Agreement. There are substantial risks to our stockholders as a result of the sale and issuance of Common Stock to Alumni Capital under the ELOC Purchase Agreement. See “Risk Factors” for more information on the potential dilutive impacts of issuances to Alumni Capital.

Conditions to Commencement and for Delivery of Fixed Purchase Notices

Our ability to deliver purchase notices to Alumni Capital under the ELOC Purchase Agreement are subject to the satisfaction by us, of certain conditions, all of which are entirely outside of Alumni Capital’s control, including the following:

● the accuracy in all material respects of our representations and warranties included in the ELOC Purchase Agreement on the date of the ELOC Purchase Agreement and the date of each closing of a purchase and sale under the ELOC Purchase Agreement of;

● the Company having performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the ELOC Purchase Agreement to be performed, satisfied or complied with by the Company;

● the registration statement that includes this prospectus (and amendment or supplement thereto) shall remain effective for the offering and sale of the ELOC Shares and the ELOC Warrant Shares and (i) we shall not have received notice that the SEC has issued or intends to issue a stop order with respect to such registration statement or that the SEC otherwise has suspended or withdrawn the effectiveness of such registration statement, either temporarily or permanently, or intends or has threatened to do so and (ii) no other suspension of the use of, or withdrawal of the effectiveness of, such registration statement or the prospectus shall exist. Alumni Capital shall not have received any notice from us that the registration statement, prospectus and/or any prospectus supplement or amendment thereto fails to meet the requirements of Section 5(b) or Section 10 of the Securities Act;

● the number of ELOC Shares and ELOC Warrants then to be purchased by Alumni Capital shall not exceed the number of such shares that, when aggregated with all other shares of Common Stock then beneficially or deemed beneficially owned by Alumni Capital would result in Alumni Capital owning more than the Beneficial Ownership Limitation;

● trading in the Common Stock shall not have been suspended by the SEC or the NYSE American, or otherwise halted for any reason, and the Common Stock shall have been approved for listing or quotation on and shall not have been delisted from or no longer quoted on the NYSE American;

● the absence of any statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or adopted by any court or governmental authority of competent jurisdiction that prohibits or directly and materially adversely affects any of the transactions contemplated by the ELOC Purchase Agreement, and no proceeding shall have been commenced that may have the effect of prohibiting or materially adversely affecting any of the transactions contemplated by the ELOC Purchase Agreement;

● the Common Stock must be DWAC eligible and not subject to a “DTC chill”;

● since our most recent filing with the SEC of any document required under the Securities Act or the Exchange Act, no event shall have occurred that had or is reasonably likely to have an effect on our business, operations, properties, or financial condition that is material and adverse to us and/or any condition, circumstance, or situation that would prohibit or otherwise materially interfere with our ability to enter into and perform our obligations under the ELOC Purchase Agreement; and

● all reports, schedules, registrations, forms, statements, information and other documents required to have been filed by us with the SEC pursuant to the reporting requirements of the Exchange Act shall have been filed with the SEC.

Termination of the Purchase Agreement

Unless earlier terminated as provided in the ELOC Purchase Agreement, the ELOC Purchase Agreement will terminate automatically on the earliest to occur of:

● December 31, 2026;

● the date on which Alumni Capital shall have purchased Shares for an aggregate purchase price of the Investment Amount; or

● the date on which we commence a voluntary bankruptcy case or any third party commences a bankruptcy proceeding against us, a custodian is appointed us in a bankruptcy proceeding for all or substantially all of its property, or we make a general assignment for the benefit of its creditors.

We have the right to terminate the ELOC Purchase Agreement at any time upon three days’ written notice, at no cost or penalty, except we cannot terminate after submitting a purchase notice and before delivering the related ELOC Warrant that is due and owed to Alumni Capital.

No Short-Selling or Hedging by Alumni Capital

Alumni Capital has agreed that neither it nor any of its affiliates shall engage in any direct or indirect short-selling our Common Stock during any time prior to the termination of the ELOC Purchase Agreement.

Effect of Performance of the Purchase Agreement on our Stockholders

All ELOC Shares registered in this offering that may be issued or sold by us to Alumni Capital under the Purchase Agreement are expected to be freely tradable. The resale by Alumni Capital of a significant number of ELOC Shares and ELOC Warrant Shares registered in this offering at any given time, or the perception that these sales may occur, could cause the market price of our Common Stock to decline and to be highly volatile. Sales of our Common Stock to Alumni Capital, if any, will depend upon market conditions and other factors to be determined by us. If and when we do sell ELOC Shares and ELOC Warrants to Alumni Capital, after Alumni Capital has acquired the ELOC Shares and/or exercised the ELOC Warrants, Alumni Capital may resell all, some or none of those ELOC Shares and ELOC Warrant Shares at any time or from time to time in its discretion. Therefore, sales to Alumni Capital by us under the ELOC Purchase Agreement may result in substantial dilution to the interests of other holders of our Common Stock. In addition, if we sell a substantial number of ELOC Shares and ELOC Warrants to Alumni Capital under the ELOC Purchase Agreement, or if investors expect that we will do so, the actual sales of ELOC Shares and ELOC Warrants or the mere existence of our arrangement with Alumni Capital may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales. However, we have the right to control the timing and amount of any additional sales of ELOC Shares and ELOC Warrants to Alumni Capital, and the ELOC Purchase Agreement may be terminated by us at any time at our discretion without any cost to us, subject to certain conditions.

The following table sets forth the amount of gross proceeds we would receive from Alumni Capital from our sale of shares of Common Stock to Alumni Capital under the ELOC Purchase Agreement at varying purchase prices:

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains or incorporates by reference forward-looking statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following:

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section of our 2024 Form 10-K and elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations, except as required by law.

You should read this prospectus and our 2024 Form 10-K which is incorporated herein by reference and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

TRADEMARKS, SERVICE MARKS AND TRADE NAMES

We own or have rights to use a number of registered and common law trademarks, service marks and/or trade names in connection with our business in the United States and/or in certain foreign jurisdictions.

Solely for convenience, the trademarks, service marks, logos and trade names referred to in this prospectus are without the ® and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

USE OF PROCEEDS

This prospectus relates to shares of Common Stock that may be offered and sold from time to time by the Selling Stockholders. We will not receive any proceeds from the resale of shares of Common Stock by the Selling Stockholders. We may receive up to $1.57 million if the November Warrants and November Placement Agent Warrants are exercised for cash and we may receive up to an additional approximate amount of $14 million in aggregate gross proceeds if we issue to Alumni Capital Shares under the ELOC Purchase Agreement (in addition to the $6.0 million previously received from sales made pursuant to the ELOC Purchase Agreement prior to the date of this prospectus). We estimate that the net proceeds to us from the sale of ELOC Shares to Alumni Capital pursuant to the ELOC Purchase Agreement would be up to $19.9 million, assuming that we sell the full amount of our Common Stock that we have the right, but not the obligation, to sell to Alumni Capital under the ELOC Purchase Agreement, and after deducting other estimated fees and expenses. See “Plan of Distribution” elsewhere in this prospectus for more information. We may also receive up to $1.8 million if the ELOC Warrant Shares being offered hereunder are exercised for cash.

See “Plan of Distribution” elsewhere in this prospectus for more information.

Any proceeds from the Selling Stockholders that we receive from the exercise of November Warrants, November Placement Agent Warrants and ELOC Warrants are currently expected to be used primarily for working capital and general corporate purposes. Pending these uses, we expect to invest the net proceeds in short-term, interest-bearing securities. We have broad discretion in determining how the proceeds of this offering will be used, and our discretion is not limited by the aforementioned possible uses. Our Board believes the flexibility in application of the net proceeds is prudent. As we are unable to predict the timing or amount of warrants that may be exercised, we cannot specify with certainty all of the particular uses for the net proceeds that we will have. Accordingly, our management will have broad discretion in the application of the net proceeds. We may use the proceeds for purposes that are not contemplated at the time of this prospectus. It is possible that no warrants will be exercised.

We will incur all costs associated with this prospectus and the registration statement of which it is a part.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our Common Stock and we do not anticipate paying any cash dividends on our Common Stock in the foreseeable future. Investors should not purchase our Common Stock with the expectation of receiving cash dividends. The payment of dividends on our Common Stock, if any, in the future is within the discretion of our Board and will depend on our earnings, capital requirements and financial condition and other relevant facts. We currently intend to retain all future earnings, if any, to finance the development and growth of our business.

DESCRIPTION OF SECURITIES

General

The following description summarizes the most important terms of our capital stock. Because it is only a summary, it does not contain all the information that may be important to you. For a complete description of the matters set forth in this “Description of Securities,” you should refer to our amended and restated certificate of incorporation and amended and restated bylaws and investor rights agreement, which are included as exhibits to the registration statement of which this prospectus forms a part, and to the applicable provisions of Delaware law.

Our authorized capital stock consists of 200,000,000 shares of Common Stock, $0.0001 par value per share, and 10,000,000 shares of undesignated preferred stock, $0.0001 par value per share.

There are 10,740,697 shares of our Common Stock outstanding and no shares of our preferred stock outstanding as of the date of this prospectus. As of the date of this prospectus, we had 14 stockholders of record.

Common Stock

The holders of Common Stock are entitled to one vote for each share of Common Stock. The holders of Common Stock are entitled to any dividends that may be declared by the Board out of funds legally available for payment of dividends at such times and in such amounts as the Board in its discretion. In the event of any liquidation, dissolution or winding up of the Company, holders of Common Stock are entitled to receive the assets of the Company available for distribution to its stockholders ratably in proportion to the number of shares of Common Stock held by the holders of Common Stock. The holders of shares of Common Stock have no preemptive, conversion, subscription rights or cumulative voting rights.

Dividends

We do not anticipate the payment of cash dividends on our Common Stock in the foreseeable future.

Anti-Takeover Effects of Certain Provisions of Delaware Law and Our Charter Documents

The following is a summary of certain provisions of Delaware law and our amended and restated certificate of incorporation and amended and restated bylaws. This summary does not purport to be complete and is qualified in its entirety by reference to the corporate law of Delaware and our amended and restated certificate of incorporation and amended and restated bylaws.

Delaware Law

We are subject to Section 203 of the Delaware General Corporation Law, an anti-takeover law. In general, Section 203 prohibits a Delaware corporation from engaging in any business combination (as defined below) with any interested stockholder (as defined below) for a period of three years following the date that the stockholder became an interested stockholder, unless:

Section 203 defines “business combination” to include the following:

In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation, or who beneficially owns 15% or more of the outstanding voting stock of the corporation at any time within a three-year period immediately prior to the date of determining whether such person is an interested stockholder, and any entity or person affiliated with or controlling or controlled by any of these entities or persons.

Our Charter Documents

Our charter documents include provisions that could have the effect of discouraging others from making tender offers for our shares and may have the effect of deterring hostile takeovers or delaying changes in our control or management. These provisions are intended to enhance the likelihood of continued stability in the composition of our Board and its policies and to discourage certain types of transactions that may involve an actual or threatened acquisition of us. These provisions are also designed to reduce our vulnerability to an unsolicited acquisition proposal and to discourage certain tactics that may be used in proxy fights. However, such provisions may have the effect of discouraging, delaying or preventing a change in control or an unsolicited acquisition proposal that a stockholder might consider favorable, including a proposal that might result in the payment of a premium over the market price for the shares held by our stockholders. Certain of these provisions are summarized in the following paragraphs.

Effects of authorized but unissued Common Stock and preferred stock. One of the effects of the existence of authorized but unissued Common Stock and preferred stock may be to enable our Board to make more difficult or to discourage an attempt to obtain control of our Company by means of a merger, tender offer, proxy contest or otherwise, and thereby to protect the continuity of management. If, in the due exercise of its fiduciary obligations, the Board were to determine that a takeover proposal was not in our best interest, such shares could be issued by the Board without stockholder approval in one or more transactions that might prevent or render more difficult or costly the completion of the takeover transaction by diluting the voting or other rights of the proposed acquirer or insurgent stockholder group, by putting a substantial voting block in institutional or other hands that might undertake to support the position of the incumbent Board, by effecting an acquisition that might complicate or preclude the takeover, or otherwise.

Cumulative Voting. Our amended and restated certificate of incorporation does not provide for cumulative voting in the election of directors, which would allow holders of less than a majority of the stock to elect some directors.

Vacancies. Our amended and restated bylaws provide that all vacancies may be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum.

Special Meeting of Stockholders and Stockholder Action by Written Consent. A special meeting of stockholders may only be called by our Board or the chairperson of our Board. All stockholder actions must be effected at a duly called meeting of stockholders and not by written consent.

Advance Notice Provisions. Our amended and restated bylaws provide advance notice procedures for stockholders seeking to bring business before our annual meeting of stockholders or to nominate candidates for election as directors at our annual meeting of stockholders. Our amended and restated bylaws will also specify certain requirements regarding the form and content of a stockholder’s notice. These provisions might preclude our stockholders from bringing matters before our annual meeting of stockholders or from making nominations for directors at our annual meeting of stockholders if the proper procedures are not followed. We expect that these provisions may also discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company.

Choice of Forum. Our amended and restated certificate of incorporation and amended and restated bylaws will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation or our bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine.

Transfer Agent and Registrar

The transfer agent and registrar for our shares of Common Stock is VStock Transfer, LLC. The transfer agent and registrar’s address is 18 Lafayette Place, Woodmere, New York 11598.

National Securities Exchange Listing

Our Common Stock is listed on the NYSE American under the symbol “AZTR.”

Selling StockholderS

The Common Stock being offered by the Selling Stockholders are those previously issued to the Selling Stockholders, and those issuable to the Selling Stockholders, upon exercise of the November Warrants, the November Placement Agent Warrants and the ELOC Warrants. For additional information regarding the issuance of Common Stock covered by this prospectus, see the sections titled “The November 2025 Alumni Capital Transaction” and “The Alumni Capital ELOC Transaction” above. We are registering the shares of Common Stock pursuant to the provisions of the Registration Rights Agreement that we entered into with Alumni Capital on November 24, 2025, the November Placement Agency Agreement, the November Placement Agent Warrant and the ELOC Purchase Agreement, in order to permit the Selling Stockholders to offer the November Shares, the November Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares for resale from time to time.

Except as set forth below, the Selling Stockholders have not had any material relationship with us within the past three years:

The table below presents information regarding the Selling Stockholders and the shares of Common Stock that it may offer from time to time under this prospectus. This table is prepared based on information supplied to us by the Selling Stockholders, and reflects holdings as of December 9, 2025. The number of shares in the column “Maximum Number of Shares of Common Stock to be Offered Pursuant to this Prospectus” represents all of the shares of Common Stock that the Selling Stockholders may offer under this prospectus. The Selling Stockholders may sell some, all or none of their shares of Common Stock in this offering. We do not know how long the Selling Stockholders will hold the shares of Common Stock before selling them, and we currently have no agreements, arrangements or understandings with the Selling Stockholders regarding the sale of any of the shares of Common Stock. See “Plan of Distribution.”

Under the terms of the warrants and other warrants held by Selling Stockholders, a Selling Stockholder may not exercise the warrants to the extent such exercise would cause such Selling Stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of such warrants which have not been exercised. The number of shares in the second and fourth columns do not reflect this limitation.

Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC under the Exchange Act, and includes shares of Common Stock with respect to which the Selling Stockholders have voting and investment powers. The percentage of shares of Common Stock beneficially owned by the Selling Stockholders prior to the offering shown in the table below is based on an aggregate of 10,740,697 shares of our Common Stock outstanding on December 9, 2025. The fourth column assumes the sale of all of the shares offered by the Selling Stockholders pursuant to this prospectus.

* Represents less than 1% ownership.

PLAN OF DISTRIBUTION

The Selling Stockholders of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on the NYSE American or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. The Selling Stockholders may use any one or more of the following methods when selling securities:

The Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus.

Alumni Capital is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act. Such sales will be made at prices and at terms then prevailing or at prices related to the then current market price.

Alumni Capital has informed us that it intends to use one or more registered broker-dealers to effectuate all sales, if any, of our ELOC Shares and ELOC Warrants that it may in the future acquire from us pursuant to the ELOC Purchase Agreement. Each such registered broker-dealer will be an underwriter within the meaning of Section 2(a)(11) of the Securities Act. Alumni Capital has informed us that each such broker-dealer will receive commissions from Alumni Capital that will not exceed customary brokerage commissions.

Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.

Except as set forth in the ELOC Purchase Agreement, in connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. Except as set forth in the ELOC Purchase Agreement, the Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. The Selling Stockholders have informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.

The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.

Pursuant to the November Purchase Agreement, we agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.

The offering of the ELOC Shares and ELOC Warrants will terminate on the date that all ELOC Shares and ELOC Warrant Shares offered by this prospectus have been sold by Alumni Capital.

Alumni Capital has represented to us that at no time prior to the date of the ELOC Purchase Agreement has Alumni Capital or its agents, representatives or affiliates engaged in or effected, in any manner whatsoever, directly or indirectly, any short sale (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of our Common Stock, which establishes a net short position with respect to our Common Stock. Alumni Capital has agreed that during the term of the ELOC Purchase Agreement, neither Alumni Capital, nor any of its agents, representatives or affiliates will enter into or effect, directly or indirectly, any of the foregoing transactions.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

We estimate that the total expenses for the offering will be approximately $50,000.

Our Common Stock is currently listed on the NYSE American under the symbol “AZTR.”

LEGAL MATTERS

Thompson Hine LLP, New York, New York, will pass upon the validity of the November Shares, the November Common Stock Purchase Warrant Shares, the November Pre-Funded Warrant Shares, the November Placement Agent Warrant Shares, the ELOC Shares and the ELOC Warrant Shares offered hereby.

EXPERTS

The financial statements as of and for the fiscal years ended December 31, 2024 and 2023 incorporated by reference in this prospectus have been so incorporated by reference reliance on the report of Grassi & Co., CPAs, P.C., an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

The SEC permits us to “incorporate by reference” the information and reports we file with it. This means that we can disclose important information to you by referring to another document. The information that we incorporate by reference is considered to be part of this prospectus, and later information that we file with the SEC automatically updates and supersedes this information. We incorporate by reference the documents listed below, except to the extent information in those documents is different from the information contained in this prospectus, and all future documents filed with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items unless such Form 8-K expressly provides to the contrary) until we terminate the offering of these securities:

To the extent that any statement in this prospectus is inconsistent with any statement that is incorporated by reference and that was made on or before the date of this prospectus, the statement in this prospectus shall supersede such incorporated statement and the incorporated statement shall not be deemed, except as modified or superseded, to constitute a part of this prospectus or the registration statement. Statements contained in this prospectus as to the contents of any contract or other document are not necessarily complete and, in each instance, we refer you to the copy of each contract or document filed as an exhibit to our various filings made with the SEC.

You may request a copy of these filings, at no cost, by writing or telephoning us at the following address or telephone number:

Azitra, Inc.

21 Business Park Drive,

Branford, Connecticut 06405

Attention: Corporate Secretary

Telephone: (203) 646-6446

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of Common Stock offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all the information set forth in the registration statement, some of which is contained in exhibits to the registration statement as permitted by the rules and regulations of the SEC. For further information with respect to us and our shares of Common Stock, we refer you to the registration statement, including the exhibits filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of any contract or any other document is not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement is this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The SEC maintains an Internet website that contains reports, proxy statements and other information about issuers, like us, that file electronically with the SEC. The address of that website is www.sec.gov.

In addition, we file annual, quarterly and current reports and proxy statements and other information with the SEC. Our SEC filings are available on the SEC’s website at www.sec.gov. These filings are also available free of charge to the public on, or accessible through, our corporate website at www.azitrainc.com. Our website and the information contained on, or that can be accessed through, our website is not deemed to be incorporated by reference in, and is not considered part of, this prospectus. You should not rely on any such information in making your decision whether to purchase our Common Stock.

We have not authorized anyone to give you any information or to make any representations about us or the transactions we discuss in this prospectus other than those contained in this prospectus. If you are given any information or representations about these matters that is not discussed in this prospectus, you must not rely on that information. This prospectus is not an offer to sell or a solicitation of an offer to buy securities anywhere or to anyone where or to whom we are not permitted to offer or sell securities under applicable law.

Up to 38,944,662 Shares of Common Stock

Up to 4,151,741 Shares of Common Stock Underlying the November Pre-Funded Warrants

Up to 4,687,500 Shares of Common Stock Underlying the November Common Stock Purchase Warrants

Up to 187,500 Shares of Common Stock Underlying the Placement Agent Warrants

Up to 3,840,890 Shares of Common Stock Underlying the ELOC Warrants

PRELIMINARY PROSPECTUS

                  , 2025

PART II - INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth the various expenses to be incurred in connection with the sale and distribution of our Common Stock being registered hereby, all of which will be borne by us (except any placement agent fees and expenses incurred for brokerage, accounting, tax or legal services or any other expenses incurred in disposing of the shares). All amounts are estimated except the SEC registration fee and the FINRA filing fee.

Item 14. Indemnification of Directors and Officers.

The following summary is qualified in its entirety by reference to the complete text of any statutes referred to below and the Second Amended and Restated Certificate of Incorporation, or Certificate of Incorporation, of Azitra, Inc., a Delaware corporation.

Section 145 of the General Corporation Law of the State of Delaware (the “DGCL”) permits a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the person’s conduct was unlawful.

In the case of an action by or in the right of the corporation, Section 145 of the DGCL permits a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation and except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses that the Court of Chancery or such other court shall deem proper.

Section 145 of the DGCL also permits a Delaware corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the corporation would have the power to indemnify such person against such liability under Section 145 of the DGCL.

Our Certificate of Incorporation states that to the fullest extent permitted by the DGCL our directors shall not be personally liable to us or to our stockholders for monetary damages for breach of fiduciary duty as a director. If the DGCL is amended after the date hereof to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of our directors shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended.

Our Certificate of Incorporation requires us, to the fullest extent permitted by applicable law, to provide indemnification of (and advancement of expenses to) our directors and officers, and authorizes us, to the fullest extent permitted by applicable law, to provide indemnification of (and advancement of expenses to) to other employees and agents (and any other persons to which the DGCL permits us to provide indemnification) through bylaw provisions, agreements with such directors, officers, employees, agents or other persons, vote of stockholders or disinterested directors or otherwise, subject only to limits created by the DGCL with respect to actions for breach of duty to our corporation, our stockholders and others.

Our Certificate of Incorporation provides that we shall, to the maximum extent and in the manner permitted by the DGCL, indemnify each of our directors, officers and all other persons we have the power to indemnify under Section 145 of the DGCL against expenses (including attorneys’ fees), judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was a director of the Company. We may maintain insurance, at our expense, to protect the Company and any of our directors, officers, employees or agents against any such expense, liability or loss, whether or not we have the power to indemnify such person.

We have entered into indemnification agreements with each of our directors and executive officers that may be broader than the specific indemnification provisions contained in the DGCL. These indemnification agreements require us, among other things, to indemnify our directors and executive officers against liabilities that may arise by reason of their status or service. These indemnification agreements also require us to advance all expenses incurred by the directors and executive officers in investigating or defending any such action, suit, or proceeding. We believe that these agreements are necessary to attract and retain qualified individuals to serve as directors and executive officers.

Prior to the closing of this offering, we plan to enter into an underwriting agreement, which will provide that the underwriters are obligated, under some circumstances, to indemnify our directors, officers and controlling persons against specified liabilities.

Item 15. Recent Sales of Unregistered Securities.

The following list sets forth information regarding all unregistered securities sold by us over the three-year period preceding the date of the prospectus that forms a part of this registration statement.

In January 2022, we sold to one investor an unsecured convertible promissory note in the principal amount of $1.0 million. In January 2023, the principal amount of the note, along with all accrued interest, was converted into 3,518 shares of our Series B convertible preferred stock. Subsequently, these shares were converted into common stock upon the consummation of the IPO.

In September 2022, we conducted the placement of our unsecured convertible promissory notes in the aggregate principal amount of $4.35 million to five investors. The principal amount of the notes, along with all accrued and unpaid interest thereunder, converted into 9,239 shares of our common stock upon the consummation of the IPO.

No underwriters were involved in the foregoing issuances of securities. We believe the offers, sales and issuances of the above securities by us were exempt from registration under the Securities Act by virtue of Section 4(a)(2) of the Securities Act and Rule 506 thereunder as transactions not involving a public offering. All of the investors were accredited investors as such term is defined in Rule 501 under the Securities Act. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed upon the stock certificates, notes and warrants issued in these transactions. All recipients had adequate access, through their relationships with us, to information about our Company. The sales of these securities were made without any general solicitation or advertising.

On January 14, 2025, the Company entered into a placement agency agreement (the “January 2025 Placement Agency Agreement”) with Maxim Group LLC (the “Maxim”) in connection with the offer and sale to investors of up to 729,396 shares (the “January 2025 Shares”) of the Company’s common stock, at an offering price of $2.00 per Share (the “January 2025 Offering”). In connection with the January 2025 Offering, the Company entered into a securities purchase agreement (the “January 2025 Purchase Agreement”) with certain of the purchasers in the January 2025 Offering. The aggregate gross proceeds to the Company from the January 2025 Offering were approximately $1.5 million, before deducting placement agent fees and other estimated offering expenses. The January 2025 Offering closed on January 16, 2025.

Maxim acted as the Company’s exclusive placement agent in the January 2025 Offering. Pursuant to the terms of the January 2025 Placement Agency Agreement, the Company agreed to pay Maxim a cash fee equal to 7.0% of the aggregate gross proceeds raised in the January 2025 Offering. The Company also agreed to reimburse Maxim for certain expenses. As additional compensation, the Company agreed to issue to Maxim (or its designees) an unregistered warrant (the “Placement Agent Warrant”) to purchase an aggregate of 29,175 shares of Common Stock (the “Placement Agent Warrant Shares”), which represents 4.0% of the aggregate number of Shares sold in the Offering, at an exercise price per share equal to 125% of the offering price of each Share, or $2.53. The Placement Agent Warrants are exercisable six (6) months from the date of issuance and expire five years from the commencement of sales in the January 2025 Offering. The Placement Agent Warrant may be exercisable via “cashless exercise” in certain circumstances.

The Placement Agent Warrants and the shares of Common Stock issuable upon exercise of the Placement Agent Warrants have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of any state, and are being offered and sold in reliance on the exemption from registration under the Securities Act afforded by Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder as transactions by an issuer not involving any public offering.

On February 6, 2025, the Company closed an offering of 374,702 shares (the “February 2025 Shares”) of the Company’s common stock to certain investors (the “Investors”) pursuant to the Securities Purchase Agreement (the “SPA”) dated February 4, 2025, between the Company and the Investors, as amended on February 5, 2025. On February 6, 2025, in connection with the Investors’ agreement to enter into the amendment to the SPA, the Company and the Investors entered into a letter agreement (the “Letter Agreement”), pursuant to which the Company will (i) issue the Investors warrants to purchase up to 337,232 shares of Common Stock, in the aggregate (the “February 2025 Warrants”), and (ii) grant the investors a right for two years from the closing date of the Letter Agreement, to participate in future financings of the Company in an aggregate amount equal to 50% of such financings. Pursuant to the terms of the Letter Agreement, the Company filed a registration statement covering the issuance of the shares Common Stock underlying the February 2025 Warrants on July 18, 2025 (File No. 333-288766), which the SEC declared effective on July 23, 2025. The February 2025 Warrants are exercisable on the six-month and one day anniversary of their issuance, and their exercise price is equal to the greater of the (i) book value or (ii) market value of the Common Stock as determined under NYSE American Rules. The February 2025 Warrants and the shares of common stock issuable upon exercise of the February 2025 Warrants have not been registered under the Securities Act, or the securities laws of any state, and are being offered and sold in reliance on the exemption from registration under the Securities Act afforded by Section 4(a)(2) under the Securities Act and/or Regulation D promulgated thereunder as transactions by an issuer not involving any public offering.

On April 24, 2025, the Company entered into the ELOC Purchase Agreement with Alumni Capital, whereby the Company has the right, but not the obligation, to sell to Alumni Capital, and Alumni Capital is obligated to purchase up to the Investment Amount of shares of the Company’s common stock in a series of purchases. The purchase price of the shares that the Company elects to sell to Alumni Capital pursuant to the ELOC Purchase Agreement will be equal to the lowest daily volume weighted average price of the common stock during the period commencing on the date that the Company delivers a notice requiring the purchase of shares by Alumni Capital and ending on the earlier to occur of (i) five (5) business days immediately following such date and (ii) the date on which Alumni Capital notifies the Company that it is prepared to proceed with the relevant closing, multiplied by 90%. Upon each purchase, Alumni Capital receives warrants to purchase such number of shares of the Company’s common stock equal to 10% of the number of shares purchased in the related purchase. The exercise price of the warrants equals 130% of the price per share paid upon closing. The exercise of the warrants were subject to stockholder approval, which the Company received at its annual meeting of shareholders held on June 23, 2025, and expire five years after issuance. The warrants may be exercised via cashless exercise if there is no effective registration statement, or current prospectus available for, the resale of the shares underlying the warrants. The issuance of the shares and the warrants to Alumni Capital were or will be made pursuant to exemptions from the registration requirement of the Securities Act provided by Section 4(a)(2) thereunder. In accordance with the ELOC Purchase Agreement, the Company registered the offering and resale by Alumni Capital of up to 10,043,488 shares of the Company’s common stock and up to 1,004,349 shares underlying the warrants issuable upon exercise of the warrants on Form S-1 (File No. 333-286809), which was declared effective by the SEC on May 1, 2025.

On November 24, 2025, the Company entered into the November Purchase Agreement with Alumni Capital, pursuant to which the Company agreed to issue and sell to Alumni Capital in the November Offering an aggregate of 535,759 November Shares, (ii) November Pre-Funded Warrants to purchase up to an aggregate of 4,151,741 shares of Common Stock at an exercise price of $0.0001 per November Pre-Funded Warrant, and (iii) November Common Stock Purchase Warrants to purchase up to an aggregate of 4,687,500 shares of Common Stock at an exercise price of $0.32 per November Common Stock Purchase Warrant. The November Offering Price was $0.32 per share of Common Stock or November Pre-Funded Warrant and accompanying November Common Stock Purchase Warrant. The November Pre-Funded Warrants are immediately exercisable and do not expire until exercised in full. The November Common Stock Purchase Warrants are exercisable upon shareholder approval and will expire on the five-year anniversary of shareholder approval. The November Common Stock Purchase Warrants may be exercised via cashless exercise if, after the six month anniversary of the issuance date, there is no effective registration statement, or current prospectus available for, the resale of the shares underlying the November Common Stock Purchase Warrant. The issuance of the November Common Stock Purchase Warrants and November Pre-Funded Warrants to Alumni Capital were made pursuant to exemptions from the registration requirement of the Securities Act provided by Section 4(a)(2) thereunder.

In connection with the November Offering, on November 24, 2025, the Company entered into the November Placement Agency Agreement with the November Placement Agent, pursuant to which the Company engaged the November Placement Agent as the exclusive placement agent in connection with the November Offering. Pursuant to the November Placement Agency Agreement and as consideration for the November Placement Agent’s services thereunder, the Company agreed to, among other compensation described herein, issue the November Placement Agent Warrants to purchase 187,500 shares of Common Stock, equal to 4.0% of the total number of November Shares and November Pre-Funded Warrants sold in the November Offering, at an exercise price equal to $0.40, or 125% of the November Offering Price. The November Placement Agent Warrants are exercisable on the six-month anniversary of the issuance date and expire on the five-year anniversary of the commencement of the November Offering.

Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits.

+ Indicates management compensatory plan, contract or arrangement.

** Filed herewith.

(b) Financial Statement Schedules.

All schedules have been omitted because they are not required or are not applicable.

Item 17. Undertakings.

The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreements, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes:

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Branford, State of Connecticut, on December 10, 2025.

POWER OF ATTORNEY

Each person whose signature appears below constitutes and appoints Francisco D. Salva, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement, any subsequent registration statements pursuant to Rule 462 of the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. This power of attorney may be executed in counterparts.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.