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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

 QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended March 31, 2025
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ______________ to ______________
 
Commission File Number 001-41705
form10-k_001.jpg
Azitra, Inc.
(Exact name of registrant as specified in its charter)

Delaware
 46-4478536
(State or other jurisdiction of
incorporation or organization)
 (IRS Employer
Identification No.)
 
21 Business Park Drive
Branford, CT 06405
(Address of principal executive offices and zip code)
 
(203)-646-6446
(Registrant’s telephone number, including area code)


Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock: Par value $0.0001 AZTR NYSE American, LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☒ No ☐




Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
 
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
 
Emerging growth company
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares of the registrant's common stock outstanding as of May 13, 2025 was 16,476,354.







Page
F-1
Item 1.
F-1
F-1
F-3
F-4
F-5
F-6
Item 2.Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 3.Quantitative and Qualitative Disclosures about Market Risk8
Item 4.Controls and Procedures
PART II - OTHER INFORMATION
Item 1A.Risk Factors
Item 6.Exhibits10



PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements.
AZITRA, INC.
CONDENSED BALANCE SHEETS


March 31, 2025December 31, 2024
ASSETS(Unaudited)
Current assets:
Cash and cash equivalents$3,206,710 $4,554,719 
Accounts receivable 233 
Tax credits receivable103,046 101,663 
Deferred offering costs 4,106 
Prepaid expenses561,798 567,569 
Total current assets3,871,554 5,228,290 
Property and equipment, net621,012 653,957 
Financing lease right-of-use asset20,652 24,522 
Operating lease right-of-use asset447,903 527,393 
Intangible assets, net244,140 246,420 
Deferred patent costs620,253 593,802 
Deferred issuance costs35,435 37,477 
Other assets46,942 46,941 
Total assets$5,907,891 $7,358,802 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable558,924 490,255 
Income tax payable 11,572 
Current financing lease liability16,456 16,066 
Current operating lease liability237,647 255,177 
Accrued expenses467,394 602,787 
Total current liabilities1,280,421 1,375,857 
Long-term financing lease liability5,843 10,105 
Long-term operating lease liability213,765 274,161 
Warrant liability238 381 
Total liabilities1,500,267 1,660,504 
Commitments and contingencies (Note 11)
The accompanying notes are an integral part of these unaudited condensed financial statements.
F-1


AZITRA, INC.
CONDENSED BALANCE SHEETS



Stockholders' equity
Preferred stock; $0.0001 par value; 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; 0 shares issued at March 31, 2025 and December 31, 2024
  
Common stock; $0.0001 par value, 100,000,000 shares authorized at March 31, 2025 and December 31, 2024, 14,979,354 and 7,626,056 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively
1,498 763 
Additional paid-in capital65,040,296 63,263,360 
Accumulated deficit(60,634,170)(57,565,825)
Total stockholders' equity4,407,624 5,698,298 
Total liabilities and stockholders' equity$5,907,891 $7,358,802 
F-2
The accompanying notes are an integral part of these unaudited condensed financial statements.

AZITRA, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS




For the Three Months Ended March 31,
20252024
Operating expenses:
General and administrative$1,850,138 $1,488,527 
Research and development1,250,100 1,472,970 
Total operating expenses3,100,238 2,961,497 
Loss from operations(3,100,238)(2,961,497)
Other income (expense):
Interest income37,164 7,609 
Interest expense(1,293)(915)
Change in fair value of warrants143 28,255 
Other expense(4,121)(6,327)
Total other income31,893 28,622 
Loss before income taxes(3,068,345)(2,932,875)
Income tax expense  
Net loss attributable to common shareholders$(3,068,345)$(2,932,875)
Net loss per share, basic and diluted$(0.23)$(4.32)
Weighted average common stock outstanding, basic and diluted13,171,516 678,885 
F-3
The accompanying notes are an integral part of these unaudited condensed financial statements.

AZITRA, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED)
 Preferred StockCommon StockAdditional
Paid-in-Capital
Accumulated Deficit
Total Stockholders' Equity
SharesAmountSharesAmount
Balance - December 31, 2023 $ 403,246 $40 $51,511,439 $(48,598,333)$2,913,146 
Exercise of stock options— — 1,333 — 19,100 — 19,100 
Follow-on public offering, net of issuance costs of $709,426
— — 555,567 56 4,290,618 — 4,290,674 
Stock-based compensation— — — — 34,171 — 34,171 
Net loss— — — — — (2,932,875)(2,932,875)
Balance, March 31, 2024 $ 960,146 $96 $55,855,328 $(51,531,208)$4,324,216 
Preferred StockCommon StockAdditional
Paid-in-Capital
Accumulated DeficitTotal Stockholders' Equity
SharesAmountSharesAmount
Balance - December 31, 2024 $ 7,626,056 $763 $63,263,360$(57,565,825)$5,698,298 
Exercise of stock options— — — — — — — 
Follow-on public offering, net of issuance costs of $269,948
— — 4,857,780 486 1,185,807 — 1,186,293 
Follow-on public offering, net of issuance costs of $133,076
2,495,518 249 560,727 — 560,976 
Stock-based compensation— — — — 30,402 — 30,402 
Net loss— — — — — (3,068,345)(3,068,345)
Balance, March 31, 2025 $ 14,979,354 $1,498 $65,040,296 $(60,634,170)$4,407,624 
F-4
The accompanying notes are an integral part of these unaudited condensed financial statements.

AZITRA, INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
For the Three Months Ended March 31,
20252024
Cash flows from operating activities:
Net loss$(3,068,345)$(2,932,875)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization34,055 32,446 
Amortization of right-of-use assets83,360 82,467 
Change in foreign currency rates on remeasurement of Canadian fixed assets  3,757 
Stock based compensation30,402 34,171 
Change in fair value of warrant liability(143)(28,155)
Gain/Loss on disposal of property and equipment(1,175) 
Changes in operating assets and liabilities:
Accounts receivable233 96,398 
Prepaid expenses5,771 65,126 
Other assets 219 
Tax credits receivable(1,383)(7,133)
Income tax payable/receivable(11,572)(7,399)
Accounts payable and accrued expenses(65,039)(281,096)
Operating lease liability(77,926)(77,934)
Net cash used in operating activities(3,071,762)(3,020,008)
Cash flows from investing activities:
Proceeds from sale of property and equipment3,153  
Deferred patent costs(24,839)(81,078)
Net cash used in investing activities(21,686)(81,078)
Cash flows from financing activities
Principal payments on finance leases(3,872)(3,519)
Proceeds from public offerings, net1,749,311 4,290,674 
Proceeds from exercise of stock options 19,100 
       Net cash provided by financing activities1,745,439 4,306,255 
Net change in cash and cash equivalents(1,348,009)1,205,169 
Cash and cash equivalents at beginning of period4,554,719 1,795,989 
Cash and cash equivalents at end of period$3,206,710 $3,001,158 
F-5
The accompanying notes are an integral part of these unaudited condensed financial statements.

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

1. Organization and Nature of Operations
Azitra, Inc. (the "Company") was founded on January 2, 2014. It is a synthetic biology company focused on screening and genetically engineering microbes of the skin. The mission is to discover and develop novel therapeutics to create a new paradigm for treating skin disease. The Company’s discovery platform is screened for naturally occurring bacterial cells with beneficial effects. These microbes are then genomically sequenced and engineered to make cellular therapies, recombinant therapeutic proteins, peptides and small molecules for precision treatment of dermatology diseases. On May 17, 2023, the Company changed its name to from “Azitra Inc” to “Azitra, Inc.”
In addition to our corporate headquarters located in Branford, Connecticut, the Company maintains a location in Montreal, Canada for certain research activities. The Company also opened a manufacturing and laboratory space in Groton, Connecticut during 2021.
Stock Splits, Change in Par Value, and Initial and Follow-on Public Offerings
In June 2023, the Company completed its initial public offering (IPO) in which it issued and sold 50,000 shares of its common stock at a price to the public of $150.00 per share. The shares began trading on the NYSE American on June 16, 2023 under the symbol “AZTR”. The net proceeds received by the Company from the offering were $6.0 million, after deducting underwriting discounts, commissions and other offering expenses.
Immediately prior to the effectiveness of the Company’s registration statement, the Company effected a 7.1-for-1 forward stock split (the "Forward Stock Split") of its issued and outstanding shares of common stock (the Forward Stock Split). On May 17, 2023, the Company changed the par value of its capital stock from $0.01 to $0.0001. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited condensed financial statements and notes thereto have been adjusted retroactively, unless otherwise noted, to reflect the effect of the Forward Stock Split. Refer to Note 6 for additional details relating to the Forward Stock Split.
At a special meeting of stockholders on February 20, 2025, our stockholders approved a further reverse split of our common stock at a specific ratio, ranging from one-for-two (1:2) to one-for-seven (1:7), with the exact ratio within such range and the timing of any such reverse split to be determined by our Board.
As of the date of this filing, our Board is still evaluating the need for a further reverse split and, if needed, the exact split ratio based on our financing alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.
In February 2024, the Company completed a follow-on public offering in which it issued and sold 555,567 shares of its common stock at a price to the public of $9.00 per share. The net proceeds received by the Company from the follow-on public offering were $4.3 million, after deducting underwriting discounts, commissions and other offering expenses. For further information regarding the February follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
On July 1, 2024, the Company effected a 30-for-1 reverse stock split of its issued and outstanding shares of common stock (the "Reverse Stock Split") and began trading on a split-adjusted basis the same day. There was no change in par value. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited condensed financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the effect of the Reverse Stock Split. Refer to Note 6 for additional details relating to the Reverse Stock Split.
In July 2024, the Company completed a follow-on public offering in which it issued and sold 6,665,000 shares of its common stock at a price of $1.50 per share and Class A Warrants exercisable for an aggregate 13,330,000 shares of common stock. The net proceeds received by the Company from the follow-on public offering were $9.1 million, after deducting placement agent's fees and other offering expenses. For further information regarding the July follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
On January 14, 2025, the Company completed a follow-on offering in which it issued and sold 4,857,780 shares of its common stock at a price of $0.30 per share. The net proceeds received by the Company from the follow-on offering were $1.2 million, after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated January15, 2025. For further information regarding the January follow-on offering, refer to Notes 6 and 7 respectively.
On February 5, 2025, the Company completed a follow-on offering in which it issued 2,495,518 shares of its common stock at a public offering price of $0.28 per share and warrants to purchase up to 2,245,968 shares of common stock at an exercise price of
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
$0.54. The net proceeds received by the Company from the follow-on offering were $560,976 after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated February 6, 2025. For further information regarding the February follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
Going Concern Matters
The financial statements have been prepared on the going concern basis, which assumes that the Company will continue in operation for the foreseeable future, and which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, management has identified the following conditions and events that created an uncertainty about the ability of the Company to continue as a going concern. As of and for the for the period ended March 31, 2025, the Company has an accumulated deficit of $60.6 million, a loss from operations of $3.1 million, used $3.1 million to fund operations and had $2.6 million of working capital. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern.
The Company will require a significant amount of additional funds to complete the development of its product and to fund additional losses which the Company expects to incur over the next few years. The Company is still in its pre-commercialization phase and therefore does not yet have product revenue. Management plans to continue to raise funds through equity and/or debt financing to fund operating and working capital needs, however, there can be no assurance that the Company will be successful in securing additional financing, if needed, to meet its operating needs.
These conditions and events create substantial doubt about the ability of the Company to continue as a going concern for twelve months from the date that the financial statements are available to be issued. The financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

2. Summary of Significant Accounting Policies
Basis of Accounting
The financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”).
Unaudited Interim Financial Information
The unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information, within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements related to the three months are unaudited. Unaudited interim results are not necessarily indicative of the results for the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2024, and notes thereto that are included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 24, 2025.
Use of Estimates
The preparation of the financial statement in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet. While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results could differ from those estimates. The most significant estimates in the Company's condensed financial statements relate to accruals for research and development expenses, valuation of warrants and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Concentration of Credit Risks and other Risks and Uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of risk, consist principally of cash and cash equivalents. The Company’s cash is deposited with a federally insured U.S. financial institution. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
The Company is dependent on contract research organizations ("CRO") to conduct, and manage our on-going clinical trials, and contract manufacturing organizations (“CMO”) to supply products for research and development of its product candidates, including preclinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in either the CRO's or the CMO’s operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components.
Products developed by the Company require approval from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or the Company is unable to maintain approvals received, such events could have a materially adverse impact on the Company.
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Segment Information
The Company operates and manages its business as one operating segment, which is to discover and develop novel therapeutics to create a new paradigm for treating skin diseases. The Chief Executive Officer, who is the Chief Operating Decision Maker ("CODM"), reviews financial information on a aggregate basis, along with cash balances for purposes of allocating resources and evaluating performance. For additional segment disclosures, see Note 15.
Deferred Offering and Deferred Issuance Costs
The Company capitalizes deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other third-party fees relating to the Company’s public offering initiatives associated with the filing of an S-1 Registration Statement. Once the Company completes the public offering, the Company records these amounts against the gross proceeds of these public offerings within the statements of stockholders’ equity.
In July 2024, the Company also filed a Form S-3 Registration Statement and recorded deferred issuance costs as a long-term asset. As shares are issued against the Form S-3 Registration Statement, the Company will record these amounts on a pro-rata basis against the gross proceeds within the statements of stockholders' equity. Additional issuance costs associated with the shares will also be recorded against the gross proceeds within the statements of stockholders' equity.
Leases
The Company elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance, the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months. Leases are classified as either operating or financing leases based on the economic substance of the agreement.
The Company has 3 operating leases for buildings with a ROU asset and lease liability totaling $1,418,502. The basis, terms and conditions of the leases are determined by the individual agreements. The Company’s option to extend certain leases ranges from 3652 months. All options to extend have been included in the calculation of the ROU asset and lease liability. The leases do not contain residual value guarantees, restrictions, or covenants that could incur additional financial obligations to the Company. There are no subleases, sale-leaseback, or related party transactions.
At March 31, 2025, the Company had operating right-of-use assets with a net value of $447,903 and current and long-term operating lease liabilities of $237,647 and $213,765, respectively.
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
In 2023, the Company entered into a lease for the use of certain equipment that is classified as a finance lease. The finance lease has a term of 36 months. At March 31, 2025, the Company had financing right-of-use assets with a net value of $20,652 and current and long-term operating lease liabilities of $16,456 and $5,843, respectively.
Deferred Patent Costs
Deferred patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval. These deferred costs will be reclassed to intangible assets and begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent is not issued, the costs associated with the patent will be expensed in the year the patent was rejected. Deferred patent costs are reviewed for impairment at each reporting period. The costs associated with any impairment are expensed in the period the deferred patent costs are determined to be impaired.
Research and Development
The Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research and Development. Accordingly, research and development costs are expensed as incurred. Research and development costs consist of costs related to labor, materials and supplies, as well as fees paid to consultants, external research fees. Research and development costs incurred were $1,250,100 and $1,472,970 during the three months ended March 31, 2025 and 2024, respectively.
At March 31, 2025 and December 31, 2024, the Company had state tax credit receivables of $65,676 for pending refunds related to the selling of research and development tax credits back to the State of Connecticut. At March 31, 2025 and December 31, 2024, the Company had $27,666 for pending refunds related to Canadian Scientific Research and Experimental Development (SRED) credits. At March 31, 2025 and December 31, 2024, the Company had recorded $9,704 and $8,321, respectively, related to refunds of Canadian Goods and Services Tax (GST) and Quebec Sales Tax (QST). Receipts of refunds are recorded in research and development on the statements of operations.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement: Reporting Comprehensive Income— Expense Disaggregation Disclosures, which requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
Management does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.


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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
3. Property and Equipment
Property and equipment consisted of the following at:
March 31, 2025December 31, 2024
Laboratory equipment$1,070,032 $1,070,032 
Computers and office equipment30,825 30,825 
Furniture and fixtures20,164 24,316 
Leasehold improvements28,855 28,855 
Building equipment14,932 14,932 
Total property and equipment1,164,808 1,168,960 
Less accumulated depreciation & amortization(543,796)(515,003)
Total property and equipment, net$621,012 $653,957 
Depreciation and amortization expense was $30,967 and $29,935 for the three months ended March 31, 2025 and 2024, respectively. Fixed assets are reviewed for impairment each reporting period. The Company recorded gains on disposal of assets of $1,175 and $0 for the three months ended March 31, 2025 and 2024, respectively.


4. Intangible Assets
Intangible assets consisted of the following at:
March 31, 2025:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $ $60,244 
Patents17 years213,931 30,035  183,896 
Intangible assets$274,175 $30,035 $ $244,140 
December 31, 2024:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $ $60,244 
Patents17 years213,122 26,946  186,176 
Intangible assets$273,366 $26,946 $ $246,420 
During the three months ended March 31, 2025 and 2024, amortization expense related to intangible assets was $3,088 and $2,511, respectively.

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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
5. Accrued Expenses
Accrued expenses consisted of the following at:
March 31, 2025December 31, 2024
Employee payroll and bonuses$149,991 $410,781 
Vacation64,633 32,969 
Research and development projects73,810 75,047 
Professional fees171,418 82,762 
Other7,542 1,228 
Total accrued expenses$467,394 $602,787 


6. Stockholders’ Equity
On May 17, 2023, the Company effected a 7.1-for-1 Forward Stock Split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s preferred stock. The par value of the common stock was adjusted as a result of the Forward Stock Split from $0.01 to $0.0001 and the authorized shares were increased to 100,000,000 shares of common stock in connection with the Forward Stock Split. In lieu of any fractional shares issued as a result of the split the Company paid a cash amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive effect to the Forward Stock Split for all periods presented. Shares of common stock underlying outstanding stock-based awards and other equity instruments were proportionately increased and the respective per share value and exercise prices, if applicable, were proportionately decreased in accordance with the terms of the agreements governing such securities.
On February 16, 2024, the Company completed a follow-on offering of an aggregate of 555,567 shares of its common stock at a public offering price of $9.00 per share. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, were approximately $5.0 million.
As consideration for ThinkEquity LLC serving as the placement agent for the offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee of 7.5% of the aggregate gross proceeds of the Offering and reimbursed the Placement Agent for certain expenses, legal fees for a total of $537,559, and issued Placement Agent Warrants to designees to the Placement Agent.
On July 1, 2024, the Company effected a 30-for-1 Reverse Stock Split of its issued and outstanding shares of common stock and began trading on a split-adjusted basis the same day. There was no change to the par value of the common stock. In lieu of any fractional shares issued as a result of the split the Company paid a cash amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive effect to the Reverse Stock Split for all periods presented unless otherwise noted. Shares of common stock underlying outstanding stock-based awards and other equity instruments were proportionately decreased and the respective per share value and exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities.
On July 25, 2024, the Company completed a follow-on offering of an aggregate of 6,665,000 shares of its common stock and Class A warrants to purchase 13,330,000 shares of common stock, at a combined public offering price of $1.50. The Class A warrant had an initial exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire on the fifth anniversary of the original issuance date. However, if on the date that was 30 calendar days immediately following the date of issuance of the Class A Warrants, or August 24, 2024 (the “Reset Date”), the Reset Price, as defined below, was less than the exercise price at such time, the exercise price would be decreased to the Reset Price. “Reset Price” is defined as 100% of the trailing five-day VWAP immediately preceding the Reset Date, provided, that in no event would the Reset Price be less than $0.32 (subject to adjustment for reverse and forward stock splits, recapitalizations and similar transactions), which represented 20% of the most recent closing price for the Common Stock at the time of execution of the placement agent agreement with respect to the offering. The Reset Price of the Class A
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Warrants as calculated on the Reset Date was $0.7043. The number of shares of Common Stock issuable upon exercise of the Class A Warrants has not been proportionately adjusted due to the reset of the exercise price.
In consideration for Maxim Group LLC serving as the placement agent of the offering (the “Placement Agent”), the Company paid the Placement Agent a cash fee equal to 7% of the aggregate gross proceeds of the Offering, reimbursed the Placement Agent for certain expenses and legal fees for a total of $809,825, and issued Placement Agent Warrants.
The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $10.0 million.
On January 14, 2025, the Company completed a follow-on offering in which it issued and sold 4,857,780 shares of its common stock at a price of $0.30 per share. The net proceeds received by the Company from the follow-on offering were $1.2 million, after deducting underwriting discounts, commissions and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated January15, 2025.
In consideration for Maxim Group LLC serving as the placement of the Offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds raised in the Offering and the reimbursed the Placement Agent for certain expenses and legal fees of $60,000. The Company also issued warrants to designees of the Placement Agent (the "Placement Agent Warrants").
On February 5, 2025, the Company completed a follow-on offering in which it issued 2,495,518 shares of its common stock at a public offering price of $0.2785 per share and warrants to purchase up to 2,245,968 shares of common stock. The net proceeds received by the Company from the follow-on offering were $561 thousand after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated February 6, 2025.
In consideration for Maxim Group LLC serving as the placement of the Offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee equal to 4.0% of the aggregate gross proceeds raised in the Offering, reimbursed the Placement Agent for certain expenses and legal fees of $35,000, and issued Placement Agent Warrants.
Common Stock
At March 31, 2025 and December 31, 2024, per the Company’s amended and restated Certificate of Incorporation, the Company was authorized to issue 100,000,000 shares of $0.0001 par value common stock.
Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders.
The Company currently has 16,110,501 shares of common stock reserved for future issuance for the potential exercise of stock options and warrants outstanding at March 31, 2025.
Except as otherwise indicated, all share and share price amounts in this report gives effect to a forward stock split effected on May 17, 2023 at a ratio of 7.1-for-1, and the reverse stock split effected on July 1, 2024 at a ratio of 1-for-30. At a special meeting of stockholders on February 20, 2025, our stockholders approved a further reverse split of our common stock at a specific ratio, ranging from one-for-two (1:2) to one-for-seven (1:7), with the exact ratio within such range and the timing of any such reverse split to be determined by our Board.
As of the date of this filing, our Board is still evaluating the need for a further reverse split and, if needed, the exact split ratio based on our financing alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.
Preferred Stock
At March 31, 2025 and December 31, 2024, per the Company’s amended and restated Certificate of Incorporation, the Company has authorized 10,000,000 shares of $0.0001 par value preferred stock.
Upon the close of the Company’s IPO in June 2023, all of the then outstanding preferred stock converted to common stock, resulting in the issuance of shares of common stock in exchange for outstanding Series A (48,608 shares), Series A-1 (98,828 shares), and Series B Preferred Stock (109,485 shares), respectively. There was no gain or loss upon conversion.

7. Warrants
The Company issued warrants to purchase 1,596 shares of common stock in 2018 in conjunction with convertible debt financing that have a redemption provision providing the holder the right to have the Company redeem all or any portion of the warrant (or shares it
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
has converted into) at a purchase price equal to the fair market value of the shares as determined by the board of directors or an independent appraiser. As a result of this redemption provision, the warrants have been classified as a liability in the financial statements based on ASC 480. These warrants have an exercise price of $14.40 per share and a term of 10 years. The warrants are marked to market each reporting period. The fair value was $238 and $381 at March 31, 2025 and December 31, 2024, respectively.
The Company issued 2,000 warrants to its underwriters as part of our initial public offering in fiscal 2023. In fiscal 2024, the Company issued an additional 22,223 warrants in February, and 266,600 warrants in July to its underwriters as part of our follow-on offerings in fiscal 2024. The underwriter warrants have a term of 5 years.
In connection with the February 2024 follow-on offering, the Company also issued warrants to designees to the placement agent exercisable for an aggregate of 22,223 shares of Common Stock at an exercise price of $11.40 per share (125% of the $9.00 public offering price) and which expire on February 16, 2029. The warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
The Company issued 13,330,000 Class A Warrants to investors who participated in the Company's July 2024 follow-on public offering. The Class A Warrants had an initial exercise price of $1.50 per share of Common Stock, however on August 24, 2024 the exercise price was reset to $0.7043. See Note 6. The number of shares of Common Stock issuable upon exercise of the Class A Warrants were not proportionately adjusted in connection with the reset of the exercise price.
The Class A Warrants are exercisable upon issuance and expire five years from the date of issuance. The Class A Warrants contain ownership limitations pursuant to which a holder does not have the right to exercise any portion of their warrants if it would result in the holder (together with its affiliates) beneficially owning more than 4.99% (or, at the election of the holder, 9.99%) of the Company’s outstanding Common Stock. The Class A Warrants are issued pursuant to a Warrant Agent Agreement dated July 25, 2024 (“Warrant Agent Agreement”) between the Company and VStock Transfer LLC, as warrant agent.
In connection with the July 2024 follow-on public offering, the Company evaluated the Class A Warrants and determined they met the criteria for liability classification as they met the criteria in ASC 815 - Derivatives and Hedging due to the reset provision. The Class A Warrants had an initial fair value of $12.1 million. The gross proceeds of $10.0 million from the July 2024 follow-on public offering was allocated to the Class A Warrants resulting in a loss on issuance of common stock of approximately $2.1 million recorded in Other income (expenses). Upon the reset of the Class A Warrant exercise price, the Class A Warrants no longer met the criteria for liability classification pursuant to ASC 815; at which time the Company recorded a gain in Other income (expenses) - Change in fair value of Class A warrants of $4.0 million, and reclassified $1.9 million to equity representing the difference between the change in the fair value, and the loss upon issuance of our common stock.
The Class A Warrants were valued utilizing a probability weighted scenario method with a Monte Carlo simulation model and Black-Scholes Model. The significant assumptions in the Monte Carlo simulation model include a stay public assumption of 90%, and a fundamental transaction assumption of 10%. The significant assumptions utilized in estimating the fair value of the Class A Warrants at issuance include (i) a per share price of common stock range of $1.14 - $1.40; (ii) a dividend yield of 0%; (iii) a risk-free rate range of 4.13% - 4.14%; (iv) expected volatility of 119%; (v) projected stock price and volume weighted average price as of the Reset Date of $1.14; (vi) a strike price range of $1.40 - $1.50; and (vii) expected term of 4.92.
In connection with the July 2024 follow-on offering, the Company also issued warrants to designees of the placement agent exercisable for an aggregate of 266,600 shares of Common Stock. The warrants have substantially the same terms as the Class A Warrants, except that the placement agent warrants have an exercise price equal to $1.875 per share (125% of the $1.50 public offering price), have an initial exercise date of January 23, 2025 and expire on July 23, 2029. The placement agent warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
In connection with the January 2025 follow-on offering, as consideration for Maxim Group LLC serving as the placement agent of the Offering, the Company also issued warrants to designees of the placement agent exercisable for an aggregate of 194,311 shares of Common Stock, which represent 4.0% of the aggregate number of shares of common stock sold in the offering, at an exercise price per share equal to 125% of the public offering price of $0.375. The warrants are exercisable six months from the date of issuance and expire five years from the commencement of the sales in this offering. The warrants may be exercisable via cashless exercise in certain circumstances. The warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
In connection with the February 5, 2025 follow-on offering, the Company issued warrants to purchase up to 2,245,968 shares of common stock at an exercise price of $0.54. The warrants are exercisable on the six-month and one day anniversary of their issuance,
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AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
and their exercise price was calculated as the greater of the (1) book value of the common stock or (ii) market value of the common stock as determined by the NYSE American Rules.
The following table summarizes information about warrants outstanding at March 31, 2025:
Warrants OutstandingWarrant Exercisable
Year GrantedExercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
2018$14.40 1,596 3.0 years$14.40 1,596 3.0 years$14.40 
2019$158.40 7,195 0.9 years$158.40 7,195 0.9 years$158.40 
2023$187.50 2,000 3.2 years$187.50 2,000 3.2 years$187.50 
2024$11.40 22,223 3.9 years$11.40 22,223 3.9 years$11.40 
2024$0.70 13,329,000 4.3 years$0.70 13,329,000 4.3 years$0.70 
2024$1.88 266,600 4.3 years$1.88 266,600 4.3 years$1.88 
2025$0.38 194,311 4.8 years$0.38  0.0 years$ 
2025$0.54 2,245,968 4.9 years$0.54  0.0 years$ 
16,068,893 $0.80 13,628,614 $0.85 

8. Stock Options
In March 2023, the Company’s Board of Directors and stockholders approved the 2023 Stock Incentive Plan (“2023 Plan”). The 2023 Plan allows the Compensation Committee to grant up to 1,211,068 shares of Common Stock in the form of incentive and non-statutory stock options, restricted stock awards, restricted stock units, and other stock-based awards to employees, directors, and non-employees. As of March 31, 2025, options to purchase 1,333 shares of common stock had been granted and were outstanding under the 2023 Plan and 1,209,734 shares of common stock were available for grant under the plan. On October 3, 2024, the Company’s Board of Directors approved amendments to the 2023 Plan that, subject to stockholder approval, would (i) increase the number of shares of Common Stock that may be issued under the 2023 Plan by 1,144,401 shares and (ii) adopt an evergreen provision to the 2023 Plan providing for an automatic 5% annual increase in the shares of Common Stock available for issuance under the 2023 Plan over the next 10 years. Both amendments were approved by the Company’s stockholders at the Company’s annual stockholder meeting held on November 20, 2024.
During 2016, the Company established the Azitra Inc. 2016 Stock Incentive Plan ("2016 Plan") which provides for the grant up to 49,687 shares of Common Stock in the form of stock options and restricted shares to the Company’s employees, officers, directors, advisors and consultants. As of March 31, 2025, options to purchase 40,275 shares of common stock had been granted and 7,457 shares of common stock were available for grant under the 2016 Plan.
At March 31, 2025, there was $50,318 of unamortized compensation expense that will be amortized over the remaining vesting period. At March 31, 2025 and 2024, there were 0 and 13,120 performance-based options outstanding, respectively with fair values of $0 and $109,551, respectively. The Company determined the options qualified as plain vanilla under the provisions of SAB 107 and the simplified method was used to estimate the expected option life.
F-14

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Stock-based compensation expense recognized for options was as follows:
For the Three Months Ended March 31,
20252024
Research and development$570 $626 
General and administrative29,832 33,545 
Total$30,402 $34,171 
The following table summarizes information about options outstanding and exercisable at March 31, 2025:
Options OutstandingOptions Exercisable
Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
$14.32 6,870 0.8 years$14.32 6,870 0.8 years$14.32 
$27.80 6,735 0.6 years$27.80 6,735 0.6 years$27.80 
$51.08 26,671 4.6 years$51.08 26,320 4.6 years$51.08 
$62.10 1,332 8.5 years$62.10 542 8.5 years$62.10 
41,608 40,467 
Total stock option activity for the period ended March 31, 2025, is summarized as follows:
OptionsWeighted Average Exercise PriceWeighted Average Remaining Contractual Term (years)Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 202441,608 $41.60 3.7 years 
Granted  
Exercised  
Forfeited  
Outstanding at March 31, 202541,608 $41.60 3.4 years 
Vested and Exercisable at March 31, 202540,467 41.113.3 years 



F-15

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
9. Fair Value Measurements
The following tables summarize the fair values and levels within the fair value hierarchy in which the fair value measurements fall for assets and liabilities measured on a recurring basis as of:
March 31, 2025

DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$ $ $238 $238 
Total$ $ $238 $238 
December 31, 2024
DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$ $ $381 $381 
Total$ $ $381 $381 
The following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended March 31, 2025:
Balance at December 31, 2024$381 
Changes in fair value of warrants(143)
Balance at March 31, 2025$238 
At March 31, 2025 and December 31, 2024, the Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:
March 31, 2025December 31, 2024
Underlying common stock value$0.30 $0.43 
Expected term (years)3.043.29
Expected volatility175 %172 %
Risk free interest rate4 %4 %
Dividend yield % %

Fluctuations in the fair value of the Company’s common stock, and the expected volatility are the primary drivers for the change in the common stock warrant liability valuation during each year. As the fair value of the common stock, and expected volatility increases the value to the holder of the instrument generally increases.
10. Net Loss Per Share
The following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
F-16

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31,
20252024
Options to purchase shares of common stock41,608 1,248,255 
Warrants outstanding16,068,893 990,416 
Total16,110,501 2,238,671 

11. Commitments and Contingencies
Legal
The Company is subject to legal proceedings or claims which arise in the ordinary course of its business. Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.
License Agreement
Effective January 26, 2022, the Company entered into an Exclusive License Agreement (the License Agreement) with an unrelated third party. Under the License Agreement, the Company is granted an exclusive license for certain patents and a non-exclusive license for certain know-how. The License Agreement continues until the later of the expiration of the last to expire licensed patent or ten years after the first commercial sale of the first licensed therapeutic or non-therapeutic product. The Company may terminate the License Agreement at any time by providing at least 30 days written notice to the third party. The License Agreement is also terminated upon breach of a material obligation under the agreement or bankruptcy. Upon any termination of the License Agreement, neither party is relieved of obligations incurred prior to the termination.
During the three months ended March 31, 2025 and 2024, the Company did not capitalize any payments made under this license.
Operating Leases
The Company leases office and lab space in Branford, CT, Groton, CT, and Montreal, Quebec. The Company’s leases expire at various dates through May 31, 2027. Most leases are for a fixed term and for a fixed amount.
During 2019, the Company entered into a new lease agreement for office and laboratory space in Montreal, Quebec. The Montreal lease required monthly payments of $6,906, CAD which increases approximately 4% in each of the following years. The Montreal lease was increased to $8,130 CAD in 2021 upon leasing additional space. The Montreal lease was initially for a one-year term, renewable annually. The Montreal lease also requires the Company to pay additional common area maintenance.
During 2020, the Company entered into a new lease agreement for the Company’s primary office and laboratory space in Branford, CT. The Branford lease requires monthly payments of $13,033 for the first year of the lease, which increases approximately 2% in each of the following years. The Branford lease also requires the Company to pay a pro-rata share of common area maintenance.
During May 2021, the Company entered into a new lease for office and laboratory space in Groton, CT. The Groton lease required monthly payments of $4,234, which was increased to $6,824 in September 2021 upon leasing additional space. In August 2024, the Company reassessed its needs and released certain lab space resulting in a decrease to the monthly payment to $5,216. The Groton lease is initially for a one-year term, renewable annually for up to three additional years.
Future minimum payments under non-cancelable operating leases with initial or remaining terms in excess of one year during each of the next five years follow:
2025$193,393 
2026203,108 
202766,782 
20286,854 
Total future undiscounted lease payments470,137 
Less interest(18,725)
Present value of minimum lease payments$451,412 

F-17

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Rent expense for all operating leases was $84,714 and $84,714 for the three months ended March 31, 2025 and 2024, respectively. The weighted average lease term for all operating leases is 1.9 years. The weighted average discount rate for all operating leases is 4.25%.
Finance Leases
During 2023, the Company entered into an agreement with Hewlett Packard to lease equipment. The lease requires monthly payments of $1,478, including tax. The lease is for a 3 years term with option of purchase or extension at term end. The remaining lease term is 1.3 years and the discount rate is 9.60%.

The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of March 31, 2025.

2025$13,305 
20268,871 
20271,480 
Total future undiscounted lease payments23,656 
Less interest(1,357)
Present value of minimum lease payments$22,299 
Lease expense for the finance lease was $3,870 and $3,870 for the three months ended March 31, 2025 and 2024, respectively. Interest expense for the finance lease was $562 and $915 for the three months ended March 31, 2025 and 2024, respectively.

12. Retirement Plan
Effective January 1, 2019, the Company sponsors a 401(k) plan that covers substantially all employees. In order to be eligible to participate, an employee must complete two consecutive months of service and work a minimum of two hundred fifty hours or work 1,000 hours in their first year of service. Employees may make pre-tax deferrals upon meeting the Plan eligibility requirements. Effective January 1, 2020, the Plan was transitioned to a safe harbor plan in which highly compensated employees are not eligible for matching contributions and non-highly compensated employees earn 100% match on first 3% contributed and 50% on the next 2% contributed. Total employer matching contributions were $4,581 and $4,126 for the three months ended March 31, 2025 and 2024, respectively.
13. Concentration of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist principally of cash.
The cash balance identified in the balance sheet is held in an account with a financial institution and insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. At times, cash maintained on deposit may be in excess of FDIC limits.

14. Related Parties
There was no related party revenue for the three months ended March 31, 2025 and 2024, respectively. There was no accounts receivable due from the related party at March 31, 2025 and December 31, 2024, respectively.
In July 2024, Bayer was no longer considered a related party as their holdings in the Company no longer exceeded 5% of the total outstanding common stock, and the amounts disclosed above are accordingly presented while they were considered a related party.
15. Segment Information
The Company operates and manages its business as a single reportable segment, which is to discover and develop novel therapeutics to create a new paradigm for treating skin diseases. The Chief Executive Officer, who is the Chief Operating Decision Maker ("CODM"), manages and evaluates the Company's performance on a total Company basis of net loss and assessing how to allocate resources based on the Company cash position. as reported in the Company's balance sheet and statement of operations. The Company's significant expenses are consistent with the expense categories presented in the statement of operations.
As of March 31, 2025, all of the Company's fixed assets were maintained in the United States and Canada on an original costs basis of $893,238 and $271,569, respectively.
F-18

AZITRA, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

16. Subsequent Events
The Company has evaluated events subsequent to the balance sheet date through May 13, 2025, the date these financial statements are issued.
On April 15, 2025 the Company extended its lease for office and lab space in Groton, CT for a period of one year with no change in monthly rent payments.
On April 11, 2025 the Company extended its lease for office and lab space in Montreal, Quebec for a period of one year. Monthly rent payments will increase to $9,436.46 CAD.
On April 24, 2025, the Company entered into a Purchase Agreement with Alumni Capital LP (the "Purchaser"), whereby the Company has the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to an aggregate of $20 million (the "Investment Amount") of shares of the Company’s common stock in a series of purchases. The term of the Purchase Agreement is through December 31, 2026, or the date on which the Purchaser shall have purchased the Shares pursuant to the Purchase Agreement for an aggregate purchase price of the Investment Amount. During the term, the Company may at its election cause the Purchaser to make a series of purchases of Shares, each up to $750,000, or up to $4 million dollars upon consent of the Purchaser. The closing of each purchase pursuant to the Purchase Agreement will be no later than five business days after the Company provides a notice to for the purchase. The purchase price of the Shares that the Company elects to sell to the Purchaser pursuant to the 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 the Purchaser and ending on the earlier to occur of (i) five (5) business days immediately following such date and (ii) the date on which the Purchaser notifies the Company that it is prepared to proceed with the relevant closing, multiplied by 90%. Upon each purchase, the Purchaser will receive 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 “Warrants”). The Exercise Price shall equal 130% of the price per share paid upon closing. The exercise of the Warrant will be subject to stockholder approval 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 Warrant Shares. In no event may the Company issue to the Purchaser under the Purchase Agreement Shares in 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 Purchase Agreement (the “Exchange Cap”), unless the Company obtains stockholder approval to issue shares of Common Stock in excess of the Exchange Cap.
On May 2, 2025, the Company issued 747,000 shares, and 74,700 warrants to Alumni Capital LP under the terms of the Purchase Agreement. Gross proceeds from this offering were approximately $201,000. Additionally, on May 12, 2025, the Company issued an additional 750,000 shares and 75,000 warrants under the Purchase Agreement with an estimated gross proceeds of $200,000.
As of May 13, 2025, the Company is still evaluating the appropriate accounting treatment of the transactions disclosed in our subsequent events footnote.



F-19







Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Cautionary Statement

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and the related notes thereto contained elsewhere in this report. The information contained in this quarterly report on Form 10-Q is not a complete description of our business or the risks associated with an investment in our common stock. We urge you to carefully review and consider the various disclosures made by us in this report and in our other filings with the Securities and Exchange Commission, or SEC, including our Form 10-K for the year ended December 31, 2024 and filed with the SEC on February 24, 2025.
In this report we make statements, and from time to time we otherwise make written and oral statements regarding our business and prospects, such as projections of future performance, statements of management’s plans and objectives, forecasts of market trends, and other matters that are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements containing the words or phrases “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimates,” “projects,” “believes,” “expects,” “anticipates,” “intends,” “target,” “goal,” “plans,” “objective,” “should” or similar expressions identify forward-looking statements, which may appear in our documents, reports, filings with the SEC, and news releases, and in written or oral presentations made by officers or other representatives to analysts, stockholders, investors, news organizations and others, and in discussions with management and other of our representatives.
Our future results, including results related to forward-looking statements, involve a number of risks and uncertainties, including those risks included in the “Risk Factors” section in our Form 10-K for the year ended December 31, 2024 and filed with the SEC on February 24, 2025. No assurance can be given that the results reflected in any forward-looking statements will be achieved. Any forward-looking statement speaks only as of the date on which such statement is made. Our forward-looking statements are based upon assumptions that are sometimes based upon estimates, data, communications and other information from suppliers, government agencies and other sources that may be subject to revision. Except as required by law, we do not undertake any obligation to update or keep current either (i) any forward-looking statement to reflect events or circumstances arising after the date of such statement or (ii) the important factors that could cause our future results to differ materially from historical results or trends, results anticipated or planned by us, or which are reflected from time to time in any forward-looking statement.
General
We were formed in January 2014 as a biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and live biotherapeutic products. We are an early-stage clinical biopharmaceutical company and have not commenced commercial operations.
To date, we have capitalized our operations primarily through a series of private placements of our convertible preferred stock and convertible promissory notes and our initial public offering, IPO, of common stock which closed on June 21, 2023. In connection with our IPO, we issued 50,000 shares of our common stock at a public offering price of $150 per share. Concurrent with the close of our IPO, all of our outstanding shares of convertible preferred stock and convertible promissory notes converted into a total of 298,384 shares of our common stock. In February 2024, we completed a follow-on public offering in which we issued and sold 555,567 shares of our common stock at a price to the public of $9.00 per share. On July 25, 2024, we completed a follow-on offering of an aggregate of 6,665,000 shares of our common stock, and Class A warrants to purchase up to 13,330,000 shares of common stock, at a combined public offering price of $1.50 per share and accompanying warrants. On January 14, 2025, we completed a follow-on offering in which we issued and sold 4,857,780 shares of our common stock at a price of $0.30 per share. The net proceeds received by us from the follow-on offering were $1.2 million, after deducting placement agent's fees and other offering expenses. The shares were offered by us pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated January 15, 2025. On February 5, 2025, we completed a follow-on offering in which we issued 2,495,518 shares of our common stock at a public offering price of $0.2785 per share and warrants to purchase up to 2,245,968 shares of common stock. The net proceeds received by the Company from the follow-on offering were $561 thousand after deducting placement agent's fees and other offering expenses. The shares were offered by us pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated February 6, 2025. The 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 (1) book value of the common stock or (ii) market value of the common stock as determined by the NYSE American Rules.
As of May 13, 2025, we had 16,476,354 shares of our common stock issued and outstanding. Except as otherwise indicated, all share and share price this report gives effect to a reverse stock split effected on July 1, 2024 at a ratio of 30-for-1. As of the date of this filing, our Board is still evaluating the need for a further reverse split and, if needed, the exact split ratio based on our financing
1




alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.
Overview
We 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, 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 report, 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:
ATR-12, which includes a genetically modified strain of S. epidermidis for treating the orphan disease, Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one in every 100,000, but its prevalence may be underestimated due to misdiagnosis caused by similarities to other skin diseases. We received Pediatric Rare Disease Designation for ATR-12 by the United States Food and Drug Administration, or FDA, in 2019. In December 2022, we submitted an investigational new drug application, or IND, for a Phase 1b clinical trial of ATR-12 in Netherton syndrome patients, and on January 27, 2023 we received notification from the FDA that the “study may proceed” with respect to the proposed Phase 1b clinical trial. After submitting post-IND manufacturing reports, we have commenced operating activities for our Phase 1b clinical trial in December 2023, and we dosed our first patient in August 2024. We expect to report initial clinical safety results in the first half of 2025.          
ATR-04, which includes a genetically modified strain of S. epidermidis for treating the papulopustular rash experienced by cancer patients undergoing epidermal growth factor receptor inhibitor, or EGFRi, targeted therapy. In August 2024, we obtained IND clearance from the FDA to commence a Phase 1/2 clinical trial in certain cancer patients undergoing EGFRi targeted therapy. In September 2024, we obtained Fast Track designation by the FDA in this indication. We expect to dose the first patient in the Phase 1/2 clinical trial in the first half of 2025.    
ATR-01, which includes a genetically modified strain of S. epidermidis that expresses an engineered recombinant human filaggrin protein for treating ichthyosis vulgaris, a chronic, xerotic (abnormally dry), scaly skin disease with an estimated incidence and prevalence of 1 in 250, which suggests a total patient population of 1.3 million in the United States. We are planning to perform lead optimization and IND-enabling studies in 2025 to support an IND filing in early 2026.         
Two separate strains of bacterial microbes have been investigated and developed by us and Bayer Consumer Care AG, the consumer products division of Bayer AG, or Bayer, the international life science company. We entered into a Joint Development Agreement, or JDA, with Bayer in December 2019. Under the terms of the JDA, we are responsible for testing our library of bacterial strains and their natural products for key preclinical properties. After screening through hundreds of strains, we and Bayer have selected two particular strains to move forward into further development. Bayer holds the exclusive option to license the patent rights to these strains.


2




Pipeline V2.jpg


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:
Build a sustainable precision dermatology company. Our goal is to build a leading precision dermatology company with a sustainable pipeline of product candidates. To that end, we are focused on rapidly advancing our current pipeline of live biotherapeutic candidates while actively developing additional product candidates. Each of our current product candidates are proprietary and subject to pending patent applications. We expect that most, if not all, genetically engineered product candidates we develop will be eligible for patent protection.
    
Advance our lead programs, ATR-12 and ATR-04, through clinical trials. In 2022, we obtained pre-IND correspondence with the FDA for purposes of discussing our proposed regulatory pathway for the ATR-12 program and obtaining guidance from the FDA on the preclinical plan leading to the filing and acceptance of an IND for ATR-12. In December 2022, we filed an IND for an ATR-12 first-in-human trial in Netherton syndrome patients. On January 27, 2023, we received notification from the FDA that the “study may proceed” with respect to the proposed Phase 1b clinical trial, and in August 2024 we initiated dosing the first patient in the ATR-12 Phase 1b clinical trial. In August 2024, we received IND clearance from the FDA for a first-in-human Phase 1b/2a clinical trial in patients with EGFRi-associated rash, and in September 2024,
3




the FDA granted Fast Track designation for the ATR-04 program. We commenced a Phase 1b trial for our ATR-04 program in certain cancer patients undergoing EGFRi therapy in the fourth quarter of 2024. We expect to dose the first patient in the ATR-04 Phase 1/2 clinical trial in the first half of 2025. We expect to report initial safety results of the first patients dosed in our Phase 1b clinical trial for our ATR-12 program in Netherton syndrome patients in mid-2025 with full results anticipated in the second half of 2025.     
Broaden our platform by selectively exploring strategic partnerships that maximize the potential of our precision dermatology programs. We intend to maintain significant rights to all of our core technologies and product candidates. However, we will continue to evaluate partnering opportunities in which a strategic partner could help us to accelerate development of our technologies and product candidates, provide access to synergistic combinations, or provide expertise that could allow us to expand into the treatment of different types of skin diseases. We may also broaden the reach of our platform by selectively in-licensing technologies or product candidates. In addition, we will consider potentially out-licensing certain of our proprietary technologies for indications and industries that we are not ourselves pursuing. We believe our genetic engineering techniques and technologies have applicability outside of the field of medicine, including cosmetics and in the generation of clean fuels and bioremediation.     
Leverage our academic partnerships. We currently have partnerships with investigators at the Fred Hutchinson Cancer Center, Yale University, Duke University, and Carnegie Mellon University. We expect to leverage these partnerships and potentially expand them or form other academic partnerships to bolster our engineering platforms and expand our research and development pipeline.         
Expand on our other potential product candidates. 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 have a proprietary platform for discovering and developing therapeutic products for precision dermatology. Our platform is built around a microbial library comprised of approximately 1,500 unique bacterial strains to allow screening for unique therapeutic characteristics and utilizes a microbial genetic technology that analyzes, predicts and engineers the proteins, peptides and molecules made by skin microbes. Our ability to genetically engineer intractable microbial species is uniquely leveraged by our exclusive license to the SyMPL technology.

Results of Operations

We are an early-stage clinical biopharmaceutical company, formed in January 2014, and have limited operating history. We have not commenced revenue-producing operations, and our core focus is on the research and development of innovative therapies for precision dermatology using engineered proteins and live biotherapeutic products. To date, our operations have consisted of the development of our proprietary microbial library, the identification, characterization and testing of certain bacterial species from our microbial library that we believe are capable of being engineered to provide significant therapeutic effect and the development of our initial product candidates.

4




Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024

The following table summarizes our results of operations with respect to the items set forth below for the for the three months ended March 31, 2025 and 2024 together with the percentage change for those items.

Three Months Ended March 31,
20252024$ Change% Change
Operating expenses:
General and administrative1,850,138 1,488,527 361,611 24 %
Research and development1,250,100 1,472,970 (222,870)(15)%
Total operating expenses3,100,238 2,961,497 138,741 %
Loss from operations(3,100,238)(2,961,497)(138,741)%
Other income (expense):
Interest income37,164 7,609 29,555 388 %
Interest expense(1,293)(915)(378)41 %
Change in fair value of warrants143 28,255 (28,112)— %
Other expense(4,121)(6,327)2,206 (35)%
Total other income31,893 28,622 3,271 11 %
Loss before income taxes(3,068,345)(2,932,875)(135,470)%
Income tax expense— — — — %
Net loss attributable to common shareholders$(3,068,345)$(2,932,875)$(135,470)%



General and Administrative

General and administrative costs during the first three months of fiscal 2025 increased by $361,611, or 24%, to $1,850,138 from the prior year period. The increase was primarily related to an increase of $209,000 in accounting costs primarily related to an increase in fees paid to external auditors and NYSE, an increase of $48,000 in legal fees, an increase of $40,000 in public relations expenditures, an increase of $35,000 for the use of business consultants, and an increase of $12,000 in repairs and maintenance offset by a decrease of $22,000 in insurance costs, a decrease of $10,000 in rent expenses and a net increase of approximately $50,000 in other overhead expenses.

5




Research and Development

Research and development expenses include salaries and benefits of all research personnel, payments to contract research organizations, payments to research consultants, and the purchase of lab supplies. These expenses are offset by income earned from government grant payments. We generate grant revenue on contracts with various federal agencies and nonprofit research institutions for general research conducted by us. These grant arrangements also do not meet the criteria for revenue recognition and amounts earned under these grant contracts are recorded as a negative research and development expense.
Historically, we have not reported research and development expenses by program or by product candidates due to certain operational and system constraints. During three months ended March 31, 2025 and March 31, 2024, our research and development expenses by category were as follows:
Three Months Ended March 31,
Expense Category:
20252024
Preclinical and clinical research and development activities
$668,759 $538,478 
Chemistry, manufacturing and controls (CMC)
29,728 303,599 
Personnel & consultants related expenses
551,613 630,893 
Total research and development expenses
$1,250,100 $1,472,970 
During the first three months of fiscal 2025, research and development expenses decreased by $222,870, or 15%, to $1,250,100 from the prior year period. The decrease was primarily related to a decrease of $274,000 in CMC costs, $89,000 in consultant costs, and $81,000 in research and development costs primarily associated with our ATR-04 program as the program moves into the clinic offset by an increase of $175,000 in clinical costs associated with our ATR-04 program as we enter the clinic, an increase of $37,000 in research and development costs associated with our ATR-01 program, an increase of $17,000 in lab supply costs, and an overall net decrease of approximately $8,000 in other costs.

We expect our research and development expenses to significantly increase in the future due primarily to our planned clinical trial activity and continued development of product candidates.

Other Income

Our other income consists of interest income, loss on foreign currency translation, change in fair value of warrants, gain on disposal of property and equipment, and interest expense. During the first three months of fiscal 2025, other income increased by $3,271, or 11%, compared to the comparable period in fiscal 2024. The increase was primarily related to a increase of $30,000 in interest income offset by a decrease of $28,000 attributable to the decrease in warrant value, and a net increase of approximately $1,000 attributable to other income.

Financial Condition

As of March 31, 2025, we had total assets of approximately $5.9 million and working capital of approximately $2.6 million. As of March 31, 2025, our liquidity included approximately $3.2 million of cash and cash equivalents. We believe that our cash on-hand as of the date of this report will not be sufficient to cover our proposed plan of operations over the next twelve months. We intend to seek additional funds through various financing sources, including the sale of our equity and debt securities, federal grants, 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.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, our common stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue
6




streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

As of the date of this filing, management has determined there is substantial doubt about our ability to continue as a going concern based on our lack of revenue from commercial operations, significant losses, and the need to raise additional capital to support ongoing operations. Our contractual commitments primarily consist of operating and financing leases with contractual undiscounted balances of $470,137, and $23,656, respectively as of March 31, 2025. Refer to Footnote 11 for more detailed information regarding our lease commitments. Additionally, as we continue to progress our product candidates through clinical trials, we will continue to incur additional costs related to our CRO's. It is common in our industry for the CRO's to require significant up-front cash payments prior to the beginning of such trial phases, and additional cash payments upon the achievement of certain milestones per the contracts' terms.
Cash Flows

The following table shows a summary of our cash flows for the periods indicated:

Three Months Ended March 31,
20252024
Net cash used in operating activities$(3,071,762)$(3,020,008)
Net cash used in investing activities$(21,686)$(81,078)
Net cash provided by financing activities$1,745,439 $4,306,255 
Net increase in cash$(1,348,009)$1,205,169 

Operating Activities

During the first three months of fiscal 2025, operating activities used $3.1 million of cash primarily driven by our net loss of $3.1 million. During the comparable period of fiscal 2024, operating activities used $3.0 million of cash primarily driven by our net loss of $2.9 million and by non-cash items of $0.1 million.

Investing Activities

During the first three months of fiscal 2025, investing activities used $21,686 of cash driven by $24,839 in trademark and deferred patent costs offset by $3,153 in proceeds from the sale of property and equipment. During the comparable period of fiscal 2024, investing activities used $81,078 of cash attributable to trademark and deferred patent costs.

Financing Activities

During the first three months of fiscal 2025, financing activities provided $1.7 million in cash primarily driven by proceeds from our January and February 2025 follow-on public offerings. During the comparable period of fiscal 2024, financing activities provided $4.3 million in cash primarily driven by proceeds from our February 2024 follow-on offering.

Critical Accounting Policies

During the three months ended March 31, 2025, there were material changes to our critical accounting policies previously disclosed in our Form 10-K dated December 31, 2024 and filed with the SEC on February 24, 2025. We no longer consider our revenue recognition, and estimating the fair value of our common stock critical accounting policies as we currently do not have transactions that produce revenue, and since we are a publicly traded company, we no longer need to estimate the fair value of our common stock as the Company's common stock is traded on the NYSE American.

7




Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these condensed financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our condensed financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed financial statements prospectively from the date of change in estimates. There were no material changes to our critical accounting estimates as reported in our Form 10-K for the year ended December 31, 2024 and filed with the SEC on February 24, 2025.



8




Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not applicable


Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures, pursuant to Rule 13a-15 of the Securities Exchange Act of 1934, as of March 31, 2025. In the course of that evaluation, we identified a material weakness as it relates to a lack of adequate segregation of accounting functions. We intend to increase staffing within our accounting infrastructure sufficient to facilitate proper segregation of accounting functions and to enable appropriate review of our internally prepared financial statements. Based upon the foregoing, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were not effective as of March 31, 2025.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the three months ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION
Item 1A. Risk Factors

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those forward-looking statements include our expectations, beliefs, intentions and strategies regarding the future. You should carefully consider the risk factors discussed in the “Risk Factors” section in our Form 10-K for the year ended December 31, 2024 as, in light of those risks, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking statements. Other than as set forth below, there have been no material changes in the risk factors included in our 2024 Form 10-K. The risk factors described in our 2024 Form 10-K are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.
Changes in U.S. and international trade policies may adversely impact our business and operating results.

We currently rely on foreign third-party manufacturers and service providers in connection with certain aspects of our clinical operations. The U.S. government and persons involved in the Trump administration have made statements and taken certain actions that have led to, and may continue to lead to, changes to U.S. and international trade policies. In April 2025, the U.S. government commenced collecting a 10% tariff on imports from many countries, with higher levies on goods from larger trading partners. If maintained, tariffs and the potential escalation of trade disputes with foreign countries could pose a risk to our business and could result in higher operating expenses. The extent and duration of any tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the United States and other countries, the response of such countries, exemptions or exclusions that may be granted, availability and cost of alternative sources of supply of materials we purchase from companies targeted with tariffs. The foreign country hardest hit by the U.S. tariffs to date has been China, however we do not currently import any goods or services from China. The tariffs have not been applied to the provision of services by foreign service providers as of the date of this filing, however there can be no assurance that the U.S. administration will not attempt to apply tariffs to the
9




provision of overseas services going forward. There can be no assurance that U.S. policies on tariffs and international trade will not increase the cost of manufacturing our product candidates and supporting materials, and import or export of raw materials and finished product candidates used in our and our collaborators’ preclinical studies and clinical trials.





NumberExhibit DescriptionMethod of Filing
3.1Incorporated herein by reference to the Company’s Current Report on Form 8-K filed on June 21, 2023.
3.2Incorporated herein by reference to the Company’s Current Report on Form 8-K filed on June 21, 2023.
3.3Incorporated herein by reference to the Company's Form S-3 filed on July 1, 2024.
3.4Incorporated herein by reference to the Company's Current Report on Form 8-K filed on August 12, 2024.
4.1Incorporated herein by reference to the Company's Current Report on Form 8-K filed on January 16, 2025
4.2Incorporated herein by reference to the Company's Current Report on Form 8-K filed on February 6, 2025
4.3Incorporated herein by reference to the Company's Current Report on Form 8-K filed on February 6, 2025
4.4Incorporated herein by reference to the Company's Current Report on Form 8-K filed on April 24, 2025
10.1Incorporated herein by reference to the Company's Current Report on Form 8-K filed on April 24, 2025
31.1Filed electronically herewith.
31.2Filed electronically herewith.
32.1Filed electronically herewith.

10




SIGNATURES
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this annual report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.

 
 AZITRA, INC.
 
Date: May 13, 2025
By:/s/ Francisco D. Salva
  Francisco D. Salva,
  President and Chief Executive Officer
(Principal Executive Officer)
Date: May 13, 2025By:/s/ Norman Staskey
Norman Staskey
Chief Financial Officer
(Principal Financial Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capabilities and on the dates indicated.

SignatureTitleDate
/s/ Francisco D. SalvaPresident, Chief Executive Officer and Director
May 13, 2025
Francisco D. Salva,(Principal Executive Officer)
  
/s/ Norman StaskeyChief Financial Officer, and Treasurer
 May 13, 2025
Norman Staskey(Principal Financial and Accounting Officer)
11

EXHIBIT 31.1
CERTIFICATIONS
I, Francisco D. Salva, certify that:
(1)    I have reviewed this annual report on Form 10-Q of Azitra, Inc.;
(2)    Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3)    Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4)    The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
(a)    designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)    designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)    evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the period covered by this report based on such evaluation; and
(d)    disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
(5)    The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
(a)    all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)    any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
AZITRA, INC.
ACTIVE 707481277v1


Date: May 13, 2025By:/s/ Francisco D. Salva
Francisco D. Salva, Chief Executive Officer
(Principal Executive Officer)

ACTIVE 707481277v1

EXHIBIT 31.2
CERTIFICATIONS
I, Norman Staskey, certify that:
(1)    I have reviewed this annual report on Form 10-Q of Azitra, Inc.;
(2)    Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3)    Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4)    The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
(a)    designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)    designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)    evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the period covered by this report based on such evaluation; and
(d)    disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
(5)    The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
(a)    all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)    any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
AZITRA, INC.
Date: May 13, 2025By:
/s/ Norman Staskey
ACTIVE 707481277v1


Norman Staskey, Chief Financial Officer
(Principal Financial Officer)

ACTIVE 707481277v1

EXHIBIT 32.1

CERTIFICATION PURSUANT TO
18 U.S.C. ss.1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Azitra, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Francisco D. Salva, the Chief Executive Officer, and Norman Staskey, the Chief Financial Officer, of the Company, respectively, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1.    The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.    The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
By:
/s/ Francisco D. Salva
Dated: May 13, 2025
Francisco D. Salva
Title:
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Norman Staskey
Dated: May 13, 2025
Norman Staskey
Title:
Chief Financial Officer
(Principal Financial and Accounting Officer)

This certification is made solely for the purposes of 18 U.S.C. Section 1350, subject to the knowledge standard contained therein, and not for any other purpose.



ACTIVE 707481277v1
v3.25.1
Cover - shares
3 Months Ended
Mar. 31, 2025
May 13, 2025
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Mar. 31, 2025  
Document Transition Report false  
Entity File Number 001-41705  
Entity Registrant Name Azitra, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 46-4478536  
Entity Address, Address Line One 21 Business Park Drive  
Entity Address, City or Town Branford  
Entity Address, State or Province CT  
Entity Address, Postal Zip Code 06405  
City Area Code (203)  
Local Phone Number 646-6446  
Title of 12(b) Security Common stock: Par value $0.0001  
Trading Symbol AZTR  
Security Exchange Name NYSEAMER  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   16,476,354
Document Fiscal Period Focus Q1  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2025  
Amendment Flag false  
Entity Central Index Key 0001701478  
v3.25.1
CONDENSED BALANCE SHEETS - USD ($)
Mar. 31, 2025
Dec. 31, 2024
Current assets:    
Cash and cash equivalents $ 3,206,710 $ 4,554,719
Accounts receivable 0 233
Tax credits receivable 103,046 101,663
Deferred offering costs 0 4,106
Prepaid expenses 561,798 567,569
Total current assets 3,871,554 5,228,290
Property and equipment, net 621,012 653,957
Financing lease right-of-use asset 20,652 24,522
Operating lease right-of-use asset 447,903 527,393
Intangible assets, net 244,140 246,420
Deferred patent costs 620,253 593,802
Deferred issuance costs 35,435 37,477
Other assets 46,942 46,941
Total assets 5,907,891 7,358,802
Current liabilities:    
Accounts payable 558,924 490,255
Income tax payable 0 11,572
Current financing lease liability 16,456 16,066
Current operating lease liability 237,647 255,177
Accrued expenses 467,394 602,787
Total current liabilities 1,280,421 1,375,857
Long-term financing lease liability 5,843 10,105
Long-term operating lease liability 213,765 274,161
Warrant liability 238 381
Total liabilities 1,500,267 1,660,504
Commitments and contingencies (Note 11)
Stockholders' equity    
Preferred stock; $0.0001 par value; 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; 0 shares issued at March 31, 2025 and December 31, 2024 0 0
Common stock; $0.0001 par value, 100,000,000 shares authorized at March 31, 2025 and December 31, 2024, 14,979,354 and 7,626,056 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 1,498 763
Additional paid-in capital 65,040,296 63,263,360
Accumulated deficit (60,634,170) (57,565,825)
Total stockholders' equity 4,407,624 5,698,298
Total liabilities and stockholders' equity $ 5,907,891 $ 7,358,802
v3.25.1
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares
Mar. 31, 2025
Dec. 31, 2024
Statement of Financial Position [Abstract]    
Preferred stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Preferred stock, shares authorized (in shares) 10,000,000 10,000,000
Preferred stock, shares issued (in shares) 0 0
Common stock, par value per share (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 100,000,000 100,000,000
Common stock, shares issued (in shares) 14,979,354 7,626,056
Common stock, shares outstanding (in shares) 14,979,354 7,626,056
v3.25.1
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Operating expenses:    
General and administrative $ 1,850,138 $ 1,488,527
Research and development 1,250,100 1,472,970
Total operating expenses 3,100,238 2,961,497
Loss from operations (3,100,238) (2,961,497)
Other income (expense):    
Interest income 37,164 7,609
Interest expense (1,293) (915)
Change in fair value of warrant liability 143 28,255
Other expense (4,121) (6,327)
Total other income 31,893 28,622
Loss before income taxes (3,068,345) (2,932,875)
Income tax expense 0 0
Net loss $ (3,068,345) $ (2,932,875)
Net loss per share, basic (in dollars per share) $ (0.23) $ (4.32)
Net loss per share, diluted (in dollars per share) $ (0.23) $ (4.32)
Weighted average common stock outstanding, basic (in shares) 13,171,516 678,885
Weighted average common stock outstanding, diluted (in shares) 13,171,516 678,885
v3.25.1
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)
Total
Follow-On Public Offering One
Follow-On Public Offering Two
Preferred Stock
Common Stock
Common Stock
Follow-On Public Offering One
Common Stock
Follow-On Public Offering Two
Additional Paid-in-Capital
Additional Paid-in-Capital
Follow-On Public Offering One
Additional Paid-in-Capital
Follow-On Public Offering Two
Accumulated Deficit
Preferred stock, beginning balance (in shares) at Dec. 31, 2023       0              
Common stock, beginning balance (in shares) at Dec. 31, 2023         403,246            
Beginning balance at Dec. 31, 2023 $ 2,913,146     $ 0 $ 40     $ 51,511,439     $ (48,598,333)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                      
Exercises of stock options (in shares)         1,333            
Exercise of stock options 19,100             19,100      
Public offering, net of issuance costs (in shares)         555,567            
Public offering, net of issuance costs 4,290,674       $ 56     4,290,618      
Stock-based compensation 34,171             34,171      
Net loss (2,932,875)                   (2,932,875)
Preferred stock, ending balance (in shares) at Mar. 31, 2024       0              
Common stock, ending balance (in shares) at Mar. 31, 2024         960,146            
Ending balance at Mar. 31, 2024 $ 4,324,216     $ 0 $ 96     55,855,328     (51,531,208)
Preferred stock, beginning balance (in shares) at Dec. 31, 2024       0              
Common stock, beginning balance (in shares) at Dec. 31, 2024 7,626,056       7,626,056            
Beginning balance at Dec. 31, 2024 $ 5,698,298     $ 0 $ 763     63,263,360     (57,565,825)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                      
Exercises of stock options (in shares) 0                    
Public offering, net of issuance costs (in shares)           4,857,780 2,495,518        
Public offering, net of issuance costs   $ 1,186,293 $ 560,976     $ 486 $ 249   $ 1,185,807 $ 560,727  
Stock-based compensation $ 30,402             30,402      
Net loss $ (3,068,345)                   (3,068,345)
Preferred stock, ending balance (in shares) at Mar. 31, 2025       0              
Common stock, ending balance (in shares) at Mar. 31, 2025 14,979,354       14,979,354            
Ending balance at Mar. 31, 2025 $ 4,407,624     $ 0 $ 1,498     $ 65,040,296     $ (60,634,170)
v3.25.1
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) (Parenthetical)
3 Months Ended
Mar. 31, 2025
USD ($)
Follow-On Public Offering One  
Stock issuance costs $ 269,948
Follow-On Public Offering Two  
Stock issuance costs $ 133,076
v3.25.1
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Cash flows from operating activities:    
Net loss $ (3,068,345) $ (2,932,875)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 34,055 32,446
Amortization of right-of-use assets 83,360 82,467
Change in foreign currency rates on remeasurement of Canadian fixed assets 0 3,757
Stock based compensation 30,402 34,171
Change in fair value of warrant liability (143) (28,155)
Gain/Loss on disposal of property and equipment (1,175) 0
Changes in operating assets and liabilities:    
Accounts receivable 233 96,398
Prepaid expenses 5,771 65,126
Other assets 0 219
Tax credits receivable (1,383) (7,133)
Income tax receivable (11,572) (7,399)
Accounts payable and accrued expenses (65,039) (281,096)
Operating lease liability (77,926) (77,934)
Net cash used in operating activities (3,071,762) (3,020,008)
Cash flows from investing activities:    
Proceeds from sale of property and equipment 3,153 0
Deferred patent costs (24,839) (81,078)
Net cash used in investing activities (21,686) (81,078)
Cash flows from financing activities    
Principal payments on finance leases (3,872) (3,519)
Proceeds from public offerings, net 1,749,311 4,290,674
Proceeds from exercise of stock options 0 19,100
Net cash provided by financing activities 1,745,439 4,306,255
Net change in cash and cash equivalents (1,348,009) 1,205,169
Cash and cash equivalents at beginning of period 4,554,719 1,795,989
Cash and cash equivalents at end of period $ 3,206,710 $ 3,001,158
v3.25.1
Organization and Nature of Operations
3 Months Ended
Mar. 31, 2025
Accounting Policies [Abstract]  
Organization and Nature of Operations Organization and Nature of Operations
Azitra, Inc. (the "Company") was founded on January 2, 2014. It is a synthetic biology company focused on screening and genetically engineering microbes of the skin. The mission is to discover and develop novel therapeutics to create a new paradigm for treating skin disease. The Company’s discovery platform is screened for naturally occurring bacterial cells with beneficial effects. These microbes are then genomically sequenced and engineered to make cellular therapies, recombinant therapeutic proteins, peptides and small molecules for precision treatment of dermatology diseases. On May 17, 2023, the Company changed its name to from “Azitra Inc” to “Azitra, Inc.”
In addition to our corporate headquarters located in Branford, Connecticut, the Company maintains a location in Montreal, Canada for certain research activities. The Company also opened a manufacturing and laboratory space in Groton, Connecticut during 2021.
Stock Splits, Change in Par Value, and Initial and Follow-on Public Offerings
In June 2023, the Company completed its initial public offering (IPO) in which it issued and sold 50,000 shares of its common stock at a price to the public of $150.00 per share. The shares began trading on the NYSE American on June 16, 2023 under the symbol “AZTR”. The net proceeds received by the Company from the offering were $6.0 million, after deducting underwriting discounts, commissions and other offering expenses.
Immediately prior to the effectiveness of the Company’s registration statement, the Company effected a 7.1-for-1 forward stock split (the "Forward Stock Split") of its issued and outstanding shares of common stock (the Forward Stock Split). On May 17, 2023, the Company changed the par value of its capital stock from $0.01 to $0.0001. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited condensed financial statements and notes thereto have been adjusted retroactively, unless otherwise noted, to reflect the effect of the Forward Stock Split. Refer to Note 6 for additional details relating to the Forward Stock Split.
At a special meeting of stockholders on February 20, 2025, our stockholders approved a further reverse split of our common stock at a specific ratio, ranging from one-for-two (1:2) to one-for-seven (1:7), with the exact ratio within such range and the timing of any such reverse split to be determined by our Board.
As of the date of this filing, our Board is still evaluating the need for a further reverse split and, if needed, the exact split ratio based on our financing alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.
In February 2024, the Company completed a follow-on public offering in which it issued and sold 555,567 shares of its common stock at a price to the public of $9.00 per share. The net proceeds received by the Company from the follow-on public offering were $4.3 million, after deducting underwriting discounts, commissions and other offering expenses. For further information regarding the February follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
On July 1, 2024, the Company effected a 30-for-1 reverse stock split of its issued and outstanding shares of common stock (the "Reverse Stock Split") and began trading on a split-adjusted basis the same day. There was no change in par value. Accordingly, all share and per share amounts for all periods presented in the accompanying unaudited condensed financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the effect of the Reverse Stock Split. Refer to Note 6 for additional details relating to the Reverse Stock Split.
In July 2024, the Company completed a follow-on public offering in which it issued and sold 6,665,000 shares of its common stock at a price of $1.50 per share and Class A Warrants exercisable for an aggregate 13,330,000 shares of common stock. The net proceeds received by the Company from the follow-on public offering were $9.1 million, after deducting placement agent's fees and other offering expenses. For further information regarding the July follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
On January 14, 2025, the Company completed a follow-on offering in which it issued and sold 4,857,780 shares of its common stock at a price of $0.30 per share. The net proceeds received by the Company from the follow-on offering were $1.2 million, after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated January15, 2025. For further information regarding the January follow-on offering, refer to Notes 6 and 7 respectively.
On February 5, 2025, the Company completed a follow-on offering in which it issued 2,495,518 shares of its common stock at a public offering price of $0.28 per share and warrants to purchase up to 2,245,968 shares of common stock at an exercise price of
$0.54. The net proceeds received by the Company from the follow-on offering were $560,976 after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated February 6, 2025. For further information regarding the February follow-on offering and related warrant issuance, refer to Notes 6 and 7, respectively.
Going Concern Matters
The financial statements have been prepared on the going concern basis, which assumes that the Company will continue in operation for the foreseeable future, and which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, management has identified the following conditions and events that created an uncertainty about the ability of the Company to continue as a going concern. As of and for the for the period ended March 31, 2025, the Company has an accumulated deficit of $60.6 million, a loss from operations of $3.1 million, used $3.1 million to fund operations and had $2.6 million of working capital. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern.
The Company will require a significant amount of additional funds to complete the development of its product and to fund additional losses which the Company expects to incur over the next few years. The Company is still in its pre-commercialization phase and therefore does not yet have product revenue. Management plans to continue to raise funds through equity and/or debt financing to fund operating and working capital needs, however, there can be no assurance that the Company will be successful in securing additional financing, if needed, to meet its operating needs.
These conditions and events create substantial doubt about the ability of the Company to continue as a going concern for twelve months from the date that the financial statements are available to be issued. The financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.
v3.25.1
Summary of Significant Accounting Policies
3 Months Ended
Mar. 31, 2025
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies Summary of Significant Accounting Policies
Basis of Accounting
The financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”).
Unaudited Interim Financial Information
The unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information, within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements related to the three months are unaudited. Unaudited interim results are not necessarily indicative of the results for the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2024, and notes thereto that are included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 24, 2025.
Use of Estimates
The preparation of the financial statement in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet. While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results could differ from those estimates. The most significant estimates in the Company's condensed financial statements relate to accruals for research and development expenses, valuation of warrants and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
Concentration of Credit Risks and other Risks and Uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of risk, consist principally of cash and cash equivalents. The Company’s cash is deposited with a federally insured U.S. financial institution. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
The Company is dependent on contract research organizations ("CRO") to conduct, and manage our on-going clinical trials, and contract manufacturing organizations (“CMO”) to supply products for research and development of its product candidates, including preclinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in either the CRO's or the CMO’s operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components.
Products developed by the Company require approval from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or the Company is unable to maintain approvals received, such events could have a materially adverse impact on the Company.
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Segment Information
The Company operates and manages its business as one operating segment, which is to discover and develop novel therapeutics to create a new paradigm for treating skin diseases. The Chief Executive Officer, who is the Chief Operating Decision Maker ("CODM"), reviews financial information on a aggregate basis, along with cash balances for purposes of allocating resources and evaluating performance. For additional segment disclosures, see Note 15.
Deferred Offering and Deferred Issuance Costs
The Company capitalizes deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other third-party fees relating to the Company’s public offering initiatives associated with the filing of an S-1 Registration Statement. Once the Company completes the public offering, the Company records these amounts against the gross proceeds of these public offerings within the statements of stockholders’ equity.
In July 2024, the Company also filed a Form S-3 Registration Statement and recorded deferred issuance costs as a long-term asset. As shares are issued against the Form S-3 Registration Statement, the Company will record these amounts on a pro-rata basis against the gross proceeds within the statements of stockholders' equity. Additional issuance costs associated with the shares will also be recorded against the gross proceeds within the statements of stockholders' equity.
Leases
The Company elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance, the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months. Leases are classified as either operating or financing leases based on the economic substance of the agreement.
The Company has 3 operating leases for buildings with a ROU asset and lease liability totaling $1,418,502. The basis, terms and conditions of the leases are determined by the individual agreements. The Company’s option to extend certain leases ranges from 36 – 52 months. All options to extend have been included in the calculation of the ROU asset and lease liability. The leases do not contain residual value guarantees, restrictions, or covenants that could incur additional financial obligations to the Company. There are no subleases, sale-leaseback, or related party transactions.
At March 31, 2025, the Company had operating right-of-use assets with a net value of $447,903 and current and long-term operating lease liabilities of $237,647 and $213,765, respectively.
In 2023, the Company entered into a lease for the use of certain equipment that is classified as a finance lease. The finance lease has a term of 36 months. At March 31, 2025, the Company had financing right-of-use assets with a net value of $20,652 and current and long-term operating lease liabilities of $16,456 and $5,843, respectively.
Deferred Patent Costs
Deferred patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval. These deferred costs will be reclassed to intangible assets and begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent is not issued, the costs associated with the patent will be expensed in the year the patent was rejected. Deferred patent costs are reviewed for impairment at each reporting period. The costs associated with any impairment are expensed in the period the deferred patent costs are determined to be impaired.
Research and Development
The Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research and Development. Accordingly, research and development costs are expensed as incurred. Research and development costs consist of costs related to labor, materials and supplies, as well as fees paid to consultants, external research fees. Research and development costs incurred were $1,250,100 and $1,472,970 during the three months ended March 31, 2025 and 2024, respectively.
At March 31, 2025 and December 31, 2024, the Company had state tax credit receivables of $65,676 for pending refunds related to the selling of research and development tax credits back to the State of Connecticut. At March 31, 2025 and December 31, 2024, the Company had $27,666 for pending refunds related to Canadian Scientific Research and Experimental Development (SRED) credits. At March 31, 2025 and December 31, 2024, the Company had recorded $9,704 and $8,321, respectively, related to refunds of Canadian Goods and Services Tax (GST) and Quebec Sales Tax (QST). Receipts of refunds are recorded in research and development on the statements of operations.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement: Reporting Comprehensive Income— Expense Disaggregation Disclosures, which requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
Management does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.
v3.25.1
Property and Equipment
3 Months Ended
Mar. 31, 2025
Property, Plant and Equipment [Abstract]  
Property and Equipment Property and Equipment
Property and equipment consisted of the following at:
March 31, 2025December 31, 2024
Laboratory equipment$1,070,032 $1,070,032 
Computers and office equipment30,825 30,825 
Furniture and fixtures20,164 24,316 
Leasehold improvements28,855 28,855 
Building equipment14,932 14,932 
Total property and equipment1,164,808 1,168,960 
Less accumulated depreciation & amortization(543,796)(515,003)
Total property and equipment, net$621,012 $653,957 
Depreciation and amortization expense was $30,967 and $29,935 for the three months ended March 31, 2025 and 2024, respectively. Fixed assets are reviewed for impairment each reporting period. The Company recorded gains on disposal of assets of $1,175 and $0 for the three months ended March 31, 2025 and 2024, respectively.
v3.25.1
Intangible Assets
3 Months Ended
Mar. 31, 2025
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets Intangible Assets
Intangible assets consisted of the following at:
March 31, 2025:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $— $60,244 
Patents17 years213,931 30,035 — 183,896 
Intangible assets$274,175 $30,035 $— $244,140 
December 31, 2024:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $— $60,244 
Patents17 years213,122 26,946 — 186,176 
Intangible assets$273,366 $26,946 $— $246,420 
During the three months ended March 31, 2025 and 2024, amortization expense related to intangible assets was $3,088 and $2,511, respectively.
v3.25.1
Accrued Expenses
3 Months Ended
Mar. 31, 2025
Payables and Accruals [Abstract]  
Accrued Expenses Accrued Expenses
Accrued expenses consisted of the following at:
March 31, 2025December 31, 2024
Employee payroll and bonuses$149,991 $410,781 
Vacation64,633 32,969 
Research and development projects73,810 75,047 
Professional fees171,418 82,762 
Other7,542 1,228 
Total accrued expenses$467,394 $602,787 
v3.25.1
Stockholders’ Equity
3 Months Ended
Mar. 31, 2025
Equity [Abstract]  
Stockholders’ Equity Stockholders’ Equity
On May 17, 2023, the Company effected a 7.1-for-1 Forward Stock Split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s preferred stock. The par value of the common stock was adjusted as a result of the Forward Stock Split from $0.01 to $0.0001 and the authorized shares were increased to 100,000,000 shares of common stock in connection with the Forward Stock Split. In lieu of any fractional shares issued as a result of the split the Company paid a cash amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive effect to the Forward Stock Split for all periods presented. Shares of common stock underlying outstanding stock-based awards and other equity instruments were proportionately increased and the respective per share value and exercise prices, if applicable, were proportionately decreased in accordance with the terms of the agreements governing such securities.
On February 16, 2024, the Company completed a follow-on offering of an aggregate of 555,567 shares of its common stock at a public offering price of $9.00 per share. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, were approximately $5.0 million.
As consideration for ThinkEquity LLC serving as the placement agent for the offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee of 7.5% of the aggregate gross proceeds of the Offering and reimbursed the Placement Agent for certain expenses, legal fees for a total of $537,559, and issued Placement Agent Warrants to designees to the Placement Agent.
On July 1, 2024, the Company effected a 30-for-1 Reverse Stock Split of its issued and outstanding shares of common stock and began trading on a split-adjusted basis the same day. There was no change to the par value of the common stock. In lieu of any fractional shares issued as a result of the split the Company paid a cash amount to the holder of such fractional share. The accompanying financial statements and notes to the financial statements give retroactive effect to the Reverse Stock Split for all periods presented unless otherwise noted. Shares of common stock underlying outstanding stock-based awards and other equity instruments were proportionately decreased and the respective per share value and exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities.
On July 25, 2024, the Company completed a follow-on offering of an aggregate of 6,665,000 shares of its common stock and Class A warrants to purchase 13,330,000 shares of common stock, at a combined public offering price of $1.50. The Class A warrant had an initial exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire on the fifth anniversary of the original issuance date. However, if on the date that was 30 calendar days immediately following the date of issuance of the Class A Warrants, or August 24, 2024 (the “Reset Date”), the Reset Price, as defined below, was less than the exercise price at such time, the exercise price would be decreased to the Reset Price. “Reset Price” is defined as 100% of the trailing five-day VWAP immediately preceding the Reset Date, provided, that in no event would the Reset Price be less than $0.32 (subject to adjustment for reverse and forward stock splits, recapitalizations and similar transactions), which represented 20% of the most recent closing price for the Common Stock at the time of execution of the placement agent agreement with respect to the offering. The Reset Price of the Class A
Warrants as calculated on the Reset Date was $0.7043. The number of shares of Common Stock issuable upon exercise of the Class A Warrants has not been proportionately adjusted due to the reset of the exercise price.
In consideration for Maxim Group LLC serving as the placement agent of the offering (the “Placement Agent”), the Company paid the Placement Agent a cash fee equal to 7% of the aggregate gross proceeds of the Offering, reimbursed the Placement Agent for certain expenses and legal fees for a total of $809,825, and issued Placement Agent Warrants.
The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $10.0 million.
On January 14, 2025, the Company completed a follow-on offering in which it issued and sold 4,857,780 shares of its common stock at a price of $0.30 per share. The net proceeds received by the Company from the follow-on offering were $1.2 million, after deducting underwriting discounts, commissions and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated January15, 2025.
In consideration for Maxim Group LLC serving as the placement of the Offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds raised in the Offering and the reimbursed the Placement Agent for certain expenses and legal fees of $60,000. The Company also issued warrants to designees of the Placement Agent (the "Placement Agent Warrants").
On February 5, 2025, the Company completed a follow-on offering in which it issued 2,495,518 shares of its common stock at a public offering price of $0.2785 per share and warrants to purchase up to 2,245,968 shares of common stock. The net proceeds received by the Company from the follow-on offering were $561 thousand after deducting placement agent's fees and other offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and a final prospectus supplement dated February 6, 2025.
In consideration for Maxim Group LLC serving as the placement of the Offering (the "Placement Agent"), the Company paid the Placement Agent a cash fee equal to 4.0% of the aggregate gross proceeds raised in the Offering, reimbursed the Placement Agent for certain expenses and legal fees of $35,000, and issued Placement Agent Warrants.
Common Stock
At March 31, 2025 and December 31, 2024, per the Company’s amended and restated Certificate of Incorporation, the Company was authorized to issue 100,000,000 shares of $0.0001 par value common stock.
Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders.
The Company currently has 16,110,501 shares of common stock reserved for future issuance for the potential exercise of stock options and warrants outstanding at March 31, 2025.
Except as otherwise indicated, all share and share price amounts in this report gives effect to a forward stock split effected on May 17, 2023 at a ratio of 7.1-for-1, and the reverse stock split effected on July 1, 2024 at a ratio of 1-for-30. At a special meeting of stockholders on February 20, 2025, our stockholders approved a further reverse split of our common stock at a specific ratio, ranging from one-for-two (1:2) to one-for-seven (1:7), with the exact ratio within such range and the timing of any such reverse split to be determined by our Board.
As of the date of this filing, our Board is still evaluating the need for a further reverse split and, if needed, the exact split ratio based on our financing alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.
Preferred Stock
At March 31, 2025 and December 31, 2024, per the Company’s amended and restated Certificate of Incorporation, the Company has authorized 10,000,000 shares of $0.0001 par value preferred stock.
Upon the close of the Company’s IPO in June 2023, all of the then outstanding preferred stock converted to common stock, resulting in the issuance of shares of common stock in exchange for outstanding Series A (48,608 shares), Series A-1 (98,828 shares), and Series B Preferred Stock (109,485 shares), respectively. There was no gain or loss upon conversion.
v3.25.1
Warrants
3 Months Ended
Mar. 31, 2025
Warrants [Abstract]  
Warrants Warrants
The Company issued warrants to purchase 1,596 shares of common stock in 2018 in conjunction with convertible debt financing that have a redemption provision providing the holder the right to have the Company redeem all or any portion of the warrant (or shares it
has converted into) at a purchase price equal to the fair market value of the shares as determined by the board of directors or an independent appraiser. As a result of this redemption provision, the warrants have been classified as a liability in the financial statements based on ASC 480. These warrants have an exercise price of $14.40 per share and a term of 10 years. The warrants are marked to market each reporting period. The fair value was $238 and $381 at March 31, 2025 and December 31, 2024, respectively.
The Company issued 2,000 warrants to its underwriters as part of our initial public offering in fiscal 2023. In fiscal 2024, the Company issued an additional 22,223 warrants in February, and 266,600 warrants in July to its underwriters as part of our follow-on offerings in fiscal 2024. The underwriter warrants have a term of 5 years.
In connection with the February 2024 follow-on offering, the Company also issued warrants to designees to the placement agent exercisable for an aggregate of 22,223 shares of Common Stock at an exercise price of $11.40 per share (125% of the $9.00 public offering price) and which expire on February 16, 2029. The warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
The Company issued 13,330,000 Class A Warrants to investors who participated in the Company's July 2024 follow-on public offering. The Class A Warrants had an initial exercise price of $1.50 per share of Common Stock, however on August 24, 2024 the exercise price was reset to $0.7043. See Note 6. The number of shares of Common Stock issuable upon exercise of the Class A Warrants were not proportionately adjusted in connection with the reset of the exercise price.
The Class A Warrants are exercisable upon issuance and expire five years from the date of issuance. The Class A Warrants contain ownership limitations pursuant to which a holder does not have the right to exercise any portion of their warrants if it would result in the holder (together with its affiliates) beneficially owning more than 4.99% (or, at the election of the holder, 9.99%) of the Company’s outstanding Common Stock. The Class A Warrants are issued pursuant to a Warrant Agent Agreement dated July 25, 2024 (“Warrant Agent Agreement”) between the Company and VStock Transfer LLC, as warrant agent.
In connection with the July 2024 follow-on public offering, the Company evaluated the Class A Warrants and determined they met the criteria for liability classification as they met the criteria in ASC 815 - Derivatives and Hedging due to the reset provision. The Class A Warrants had an initial fair value of $12.1 million. The gross proceeds of $10.0 million from the July 2024 follow-on public offering was allocated to the Class A Warrants resulting in a loss on issuance of common stock of approximately $2.1 million recorded in Other income (expenses). Upon the reset of the Class A Warrant exercise price, the Class A Warrants no longer met the criteria for liability classification pursuant to ASC 815; at which time the Company recorded a gain in Other income (expenses) - Change in fair value of Class A warrants of $4.0 million, and reclassified $1.9 million to equity representing the difference between the change in the fair value, and the loss upon issuance of our common stock.
The Class A Warrants were valued utilizing a probability weighted scenario method with a Monte Carlo simulation model and Black-Scholes Model. The significant assumptions in the Monte Carlo simulation model include a stay public assumption of 90%, and a fundamental transaction assumption of 10%. The significant assumptions utilized in estimating the fair value of the Class A Warrants at issuance include (i) a per share price of common stock range of $1.14 - $1.40; (ii) a dividend yield of 0%; (iii) a risk-free rate range of 4.13% - 4.14%; (iv) expected volatility of 119%; (v) projected stock price and volume weighted average price as of the Reset Date of $1.14; (vi) a strike price range of $1.40 - $1.50; and (vii) expected term of 4.92.
In connection with the July 2024 follow-on offering, the Company also issued warrants to designees of the placement agent exercisable for an aggregate of 266,600 shares of Common Stock. The warrants have substantially the same terms as the Class A Warrants, except that the placement agent warrants have an exercise price equal to $1.875 per share (125% of the $1.50 public offering price), have an initial exercise date of January 23, 2025 and expire on July 23, 2029. The placement agent warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
In connection with the January 2025 follow-on offering, as consideration for Maxim Group LLC serving as the placement agent of the Offering, the Company also issued warrants to designees of the placement agent exercisable for an aggregate of 194,311 shares of Common Stock, which represent 4.0% of the aggregate number of shares of common stock sold in the offering, at an exercise price per share equal to 125% of the public offering price of $0.375. The warrants are exercisable six months from the date of issuance and expire five years from the commencement of the sales in this offering. The warrants may be exercisable via cashless exercise in certain circumstances. The warrants were evaluated in accordance with ASC 718 and recorded within stockholders' equity.
In connection with the February 5, 2025 follow-on offering, the Company issued warrants to purchase up to 2,245,968 shares of common stock at an exercise price of $0.54. The warrants are exercisable on the six-month and one day anniversary of their issuance,
and their exercise price was calculated as the greater of the (1) book value of the common stock or (ii) market value of the common stock as determined by the NYSE American Rules.
The following table summarizes information about warrants outstanding at March 31, 2025:
Warrants OutstandingWarrant Exercisable
Year GrantedExercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
2018$14.40 1,596 3.0 years$14.40 1,596 3.0 years$14.40 
2019$158.40 7,195 0.9 years$158.40 7,195 0.9 years$158.40 
2023$187.50 2,000 3.2 years$187.50 2,000 3.2 years$187.50 
2024$11.40 22,223 3.9 years$11.40 22,223 3.9 years$11.40 
2024$0.70 13,329,000 4.3 years$0.70 13,329,000 4.3 years$0.70 
2024$1.88 266,600 4.3 years$1.88 266,600 4.3 years$1.88 
2025$0.38 194,311 4.8 years$0.38 — 0.0 years$— 
2025$0.54 2,245,968 4.9 years$0.54 — 0.0 years$— 
16,068,893 $0.80 13,628,614 $0.85 
v3.25.1
Stock Options
3 Months Ended
Mar. 31, 2025
Share-Based Payment Arrangement [Abstract]  
Stock Options Stock Options
In March 2023, the Company’s Board of Directors and stockholders approved the 2023 Stock Incentive Plan (“2023 Plan”). The 2023 Plan allows the Compensation Committee to grant up to 1,211,068 shares of Common Stock in the form of incentive and non-statutory stock options, restricted stock awards, restricted stock units, and other stock-based awards to employees, directors, and non-employees. As of March 31, 2025, options to purchase 1,333 shares of common stock had been granted and were outstanding under the 2023 Plan and 1,209,734 shares of common stock were available for grant under the plan. On October 3, 2024, the Company’s Board of Directors approved amendments to the 2023 Plan that, subject to stockholder approval, would (i) increase the number of shares of Common Stock that may be issued under the 2023 Plan by 1,144,401 shares and (ii) adopt an evergreen provision to the 2023 Plan providing for an automatic 5% annual increase in the shares of Common Stock available for issuance under the 2023 Plan over the next 10 years. Both amendments were approved by the Company’s stockholders at the Company’s annual stockholder meeting held on November 20, 2024.
During 2016, the Company established the Azitra Inc. 2016 Stock Incentive Plan ("2016 Plan") which provides for the grant up to 49,687 shares of Common Stock in the form of stock options and restricted shares to the Company’s employees, officers, directors, advisors and consultants. As of March 31, 2025, options to purchase 40,275 shares of common stock had been granted and 7,457 shares of common stock were available for grant under the 2016 Plan.
At March 31, 2025, there was $50,318 of unamortized compensation expense that will be amortized over the remaining vesting period. At March 31, 2025 and 2024, there were 0 and 13,120 performance-based options outstanding, respectively with fair values of $0 and $109,551, respectively. The Company determined the options qualified as plain vanilla under the provisions of SAB 107 and the simplified method was used to estimate the expected option life.
Stock-based compensation expense recognized for options was as follows:
For the Three Months Ended March 31,
20252024
Research and development$570 $626 
General and administrative29,832 33,545 
Total$30,402 $34,171 
The following table summarizes information about options outstanding and exercisable at March 31, 2025:
Options OutstandingOptions Exercisable
Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
$14.32 6,870 0.8 years$14.32 6,870 0.8 years$14.32 
$27.80 6,735 0.6 years$27.80 6,735 0.6 years$27.80 
$51.08 26,671 4.6 years$51.08 26,320 4.6 years$51.08 
$62.10 1,332 8.5 years$62.10 542 8.5 years$62.10 
41,608 40,467 
Total stock option activity for the period ended March 31, 2025, is summarized as follows:
OptionsWeighted Average Exercise PriceWeighted Average Remaining Contractual Term (years)Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 202441,608 $41.60 3.7 years— 
Granted— — 
Exercised— — 
Forfeited— — 
Outstanding at March 31, 202541,608 $41.60 3.4 years— 
Vested and Exercisable at March 31, 202540,467 41.113.3 years— 
v3.25.1
Fair Value Measurements
3 Months Ended
Mar. 31, 2025
Fair Value Disclosures [Abstract]  
Fair Value Measurements Fair Value Measurements
The following tables summarize the fair values and levels within the fair value hierarchy in which the fair value measurements fall for assets and liabilities measured on a recurring basis as of:
March 31, 2025

DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$— $— $238 $238 
Total$— $— $238 $238 
December 31, 2024
DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$— $— $381 $381 
Total$— $— $381 $381 
The following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended March 31, 2025:
Balance at December 31, 2024$381 
Changes in fair value of warrants(143)
Balance at March 31, 2025$238 
At March 31, 2025 and December 31, 2024, the Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:
March 31, 2025December 31, 2024
Underlying common stock value$0.30 $0.43 
Expected term (years)3.043.29
Expected volatility175 %172 %
Risk free interest rate%%
Dividend yield— %— %

Fluctuations in the fair value of the Company’s common stock, and the expected volatility are the primary drivers for the change in the common stock warrant liability valuation during each year. As the fair value of the common stock, and expected volatility increases the value to the holder of the instrument generally increases.
v3.25.1
Net Loss Per Share
3 Months Ended
Mar. 31, 2025
Earnings Per Share [Abstract]  
Net Loss Per Share Net Loss Per Share
The following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
March 31,
20252024
Options to purchase shares of common stock41,608 1,248,255 
Warrants outstanding16,068,893 990,416 
Total16,110,501 2,238,671 
v3.25.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2025
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Commitments and Contingencies
Legal
The Company is subject to legal proceedings or claims which arise in the ordinary course of its business. Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.
License Agreement
Effective January 26, 2022, the Company entered into an Exclusive License Agreement (the License Agreement) with an unrelated third party. Under the License Agreement, the Company is granted an exclusive license for certain patents and a non-exclusive license for certain know-how. The License Agreement continues until the later of the expiration of the last to expire licensed patent or ten years after the first commercial sale of the first licensed therapeutic or non-therapeutic product. The Company may terminate the License Agreement at any time by providing at least 30 days written notice to the third party. The License Agreement is also terminated upon breach of a material obligation under the agreement or bankruptcy. Upon any termination of the License Agreement, neither party is relieved of obligations incurred prior to the termination.
During the three months ended March 31, 2025 and 2024, the Company did not capitalize any payments made under this license.
Operating Leases
The Company leases office and lab space in Branford, CT, Groton, CT, and Montreal, Quebec. The Company’s leases expire at various dates through May 31, 2027. Most leases are for a fixed term and for a fixed amount.
During 2019, the Company entered into a new lease agreement for office and laboratory space in Montreal, Quebec. The Montreal lease required monthly payments of $6,906, CAD which increases approximately 4% in each of the following years. The Montreal lease was increased to $8,130 CAD in 2021 upon leasing additional space. The Montreal lease was initially for a one-year term, renewable annually. The Montreal lease also requires the Company to pay additional common area maintenance.
During 2020, the Company entered into a new lease agreement for the Company’s primary office and laboratory space in Branford, CT. The Branford lease requires monthly payments of $13,033 for the first year of the lease, which increases approximately 2% in each of the following years. The Branford lease also requires the Company to pay a pro-rata share of common area maintenance.
During May 2021, the Company entered into a new lease for office and laboratory space in Groton, CT. The Groton lease required monthly payments of $4,234, which was increased to $6,824 in September 2021 upon leasing additional space. In August 2024, the Company reassessed its needs and released certain lab space resulting in a decrease to the monthly payment to $5,216. The Groton lease is initially for a one-year term, renewable annually for up to three additional years.
Future minimum payments under non-cancelable operating leases with initial or remaining terms in excess of one year during each of the next five years follow:
2025$193,393 
2026203,108 
202766,782 
20286,854 
Total future undiscounted lease payments470,137 
Less interest(18,725)
Present value of minimum lease payments$451,412 
Rent expense for all operating leases was $84,714 and $84,714 for the three months ended March 31, 2025 and 2024, respectively. The weighted average lease term for all operating leases is 1.9 years. The weighted average discount rate for all operating leases is 4.25%.
Finance Leases
During 2023, the Company entered into an agreement with Hewlett Packard to lease equipment. The lease requires monthly payments of $1,478, including tax. The lease is for a 3 years term with option of purchase or extension at term end. The remaining lease term is 1.3 years and the discount rate is 9.60%.

The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of March 31, 2025.

2025$13,305 
20268,871 
20271,480 
Total future undiscounted lease payments23,656 
Less interest(1,357)
Present value of minimum lease payments$22,299 
Lease expense for the finance lease was $3,870 and $3,870 for the three months ended March 31, 2025 and 2024, respectively. Interest expense for the finance lease was $562 and $915 for the three months ended March 31, 2025 and 2024, respectively.
v3.25.1
Retirement Plan
3 Months Ended
Mar. 31, 2025
Retirement Benefits [Abstract]  
Retirement Plan Retirement Plan
Effective January 1, 2019, the Company sponsors a 401(k) plan that covers substantially all employees. In order to be eligible to participate, an employee must complete two consecutive months of service and work a minimum of two hundred fifty hours or work 1,000 hours in their first year of service. Employees may make pre-tax deferrals upon meeting the Plan eligibility requirements. Effective January 1, 2020, the Plan was transitioned to a safe harbor plan in which highly compensated employees are not eligible for matching contributions and non-highly compensated employees earn 100% match on first 3% contributed and 50% on the next 2% contributed. Total employer matching contributions were $4,581 and $4,126 for the three months ended March 31, 2025 and 2024, respectively.
v3.25.1
Concentration of Credit Risk
3 Months Ended
Mar. 31, 2025
Risks and Uncertainties [Abstract]  
Concentration of Credit Risk Concentration of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist principally of cash.
The cash balance identified in the balance sheet is held in an account with a financial institution and insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. At times, cash maintained on deposit may be in excess of FDIC limits.
v3.25.1
Related Parties
3 Months Ended
Mar. 31, 2025
Related Party Transactions [Abstract]  
Related Parties Related Parties
There was no related party revenue for the three months ended March 31, 2025 and 2024, respectively. There was no accounts receivable due from the related party at March 31, 2025 and December 31, 2024, respectively.
In July 2024, Bayer was no longer considered a related party as their holdings in the Company no longer exceeded 5% of the total outstanding common stock, and the amounts disclosed above are accordingly presented while they were considered a related party.
v3.25.1
Segment Information
3 Months Ended
Mar. 31, 2025
Segment Reporting [Abstract]  
Segment Information Segment Information
The Company operates and manages its business as a single reportable segment, which is to discover and develop novel therapeutics to create a new paradigm for treating skin diseases. The Chief Executive Officer, who is the Chief Operating Decision Maker ("CODM"), manages and evaluates the Company's performance on a total Company basis of net loss and assessing how to allocate resources based on the Company cash position. as reported in the Company's balance sheet and statement of operations. The Company's significant expenses are consistent with the expense categories presented in the statement of operations.
As of March 31, 2025, all of the Company's fixed assets were maintained in the United States and Canada on an original costs basis of $893,238 and $271,569, respectively.
v3.25.1
Subsequent Events
3 Months Ended
Mar. 31, 2025
Subsequent Events [Abstract]  
Subsequent Events Subsequent Events
The Company has evaluated events subsequent to the balance sheet date through May 13, 2025, the date these financial statements are issued.
On April 15, 2025 the Company extended its lease for office and lab space in Groton, CT for a period of one year with no change in monthly rent payments.
On April 11, 2025 the Company extended its lease for office and lab space in Montreal, Quebec for a period of one year. Monthly rent payments will increase to $9,436.46 CAD.
On April 24, 2025, the Company entered into a Purchase Agreement with Alumni Capital LP (the "Purchaser"), whereby the Company has the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to an aggregate of $20 million (the "Investment Amount") of shares of the Company’s common stock in a series of purchases. The term of the Purchase Agreement is through December 31, 2026, or the date on which the Purchaser shall have purchased the Shares pursuant to the Purchase Agreement for an aggregate purchase price of the Investment Amount. During the term, the Company may at its election cause the Purchaser to make a series of purchases of Shares, each up to $750,000, or up to $4 million dollars upon consent of the Purchaser. The closing of each purchase pursuant to the Purchase Agreement will be no later than five business days after the Company provides a notice to for the purchase. The purchase price of the Shares that the Company elects to sell to the Purchaser pursuant to the 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 the Purchaser and ending on the earlier to occur of (i) five (5) business days immediately following such date and (ii) the date on which the Purchaser notifies the Company that it is prepared to proceed with the relevant closing, multiplied by 90%. Upon each purchase, the Purchaser will receive 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 “Warrants”). The Exercise Price shall equal 130% of the price per share paid upon closing. The exercise of the Warrant will be subject to stockholder approval 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 Warrant Shares. In no event may the Company issue to the Purchaser under the Purchase Agreement Shares in 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 Purchase Agreement (the “Exchange Cap”), unless the Company obtains stockholder approval to issue shares of Common Stock in excess of the Exchange Cap.
On May 2, 2025, the Company issued 747,000 shares, and 74,700 warrants to Alumni Capital LP under the terms of the Purchase Agreement. Gross proceeds from this offering were approximately $201,000. Additionally, on May 12, 2025, the Company issued an additional 750,000 shares and 75,000 warrants under the Purchase Agreement with an estimated gross proceeds of $200,000.
As of May 13, 2025, the Company is still evaluating the appropriate accounting treatment of the transactions disclosed in our subsequent events footnote.
v3.25.1
Pay vs Performance Disclosure - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Pay vs Performance Disclosure    
Net loss $ (3,068,345) $ (2,932,875)
v3.25.1
Insider Trading Arrangements
3 Months Ended
Mar. 31, 2025
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.25.1
Summary of Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2025
Accounting Policies [Abstract]  
Basis of Accounting
Basis of Accounting
The financial statements of the Company are prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”).
Unaudited Interim Financial Information
Unaudited Interim Financial Information
The unaudited interim financial statements and related notes have been prepared in accordance with U.S. GAAP for interim financial information, within the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). Certain information and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. The unaudited interim financial statements have been prepared on a basis consistent with the audited financial statements and in the opinion of management, reflect all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the results for the interim periods presented and of the financial condition as of the date of the interim balance sheet. The financial data and the other information disclosed in these notes to the interim financial statements related to the three months are unaudited. Unaudited interim results are not necessarily indicative of the results for the full fiscal year. These unaudited interim financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2024, and notes thereto that are included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 24, 2025.
Use of Estimates
Use of Estimates
The preparation of the financial statement in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the balance sheet. While management believes the estimates and assumptions used in the preparation of the financial statement are appropriate, actual results could differ from those estimates. The most significant estimates in the Company's condensed financial statements relate to accruals for research and development expenses, valuation of warrants and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
Concentration of Credit Risks and other Risks and Uncertainties
Concentration of Credit Risks and other Risks and Uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of risk, consist principally of cash and cash equivalents. The Company’s cash is deposited with a federally insured U.S. financial institution. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
The Company is dependent on contract research organizations ("CRO") to conduct, and manage our on-going clinical trials, and contract manufacturing organizations (“CMO”) to supply products for research and development of its product candidates, including preclinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in either the CRO's or the CMO’s operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components.
Products developed by the Company require approval from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or the Company is unable to maintain approvals received, such events could have a materially adverse impact on the Company.
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Segment Information
Segment Information
The Company operates and manages its business as one operating segment, which is to discover and develop novel therapeutics to create a new paradigm for treating skin diseases. The Chief Executive Officer, who is the Chief Operating Decision Maker ("CODM"), reviews financial information on a aggregate basis, along with cash balances for purposes of allocating resources and evaluating performance. For additional segment disclosures, see Note 15.
Deferred Offering and Deferred Issuance Costs
Deferred Offering and Deferred Issuance Costs
The Company capitalizes deferred offering costs, which primarily consisted of direct, incremental legal, professional, accounting, and other third-party fees relating to the Company’s public offering initiatives associated with the filing of an S-1 Registration Statement. Once the Company completes the public offering, the Company records these amounts against the gross proceeds of these public offerings within the statements of stockholders’ equity.
In July 2024, the Company also filed a Form S-3 Registration Statement and recorded deferred issuance costs as a long-term asset. As shares are issued against the Form S-3 Registration Statement, the Company will record these amounts on a pro-rata basis against the gross proceeds within the statements of stockholders' equity. Additional issuance costs associated with the shares will also be recorded against the gross proceeds within the statements of stockholders' equity.
Leases
Leases
The Company elected to account for non-lease components as part of the lease component to which they relate. Lease accounting involves significant judgments, including making estimates related to the lease term, lease payments, and discount rate. In accordance with the guidance, the Company recognized ROU assets and lease liabilities for all leases with a term greater than 12 months. Leases are classified as either operating or financing leases based on the economic substance of the agreement.
Deferred Patent Costs
Deferred Patent Costs
Deferred patent costs represent legal and filing expenses incurred related to the submission of patent applications for patents pending approval. These deferred costs will be reclassed to intangible assets and begin to be amortized over their estimated useful lives upon the formal approval of the patent. If the patent is not issued, the costs associated with the patent will be expensed in the year the patent was rejected. Deferred patent costs are reviewed for impairment at each reporting period. The costs associated with any impairment are expensed in the period the deferred patent costs are determined to be impaired.
Research and Development
Research and Development
The Company accounts for research and development costs in accordance with Accounting Standards Codification (ASC) subtopic 730-10, Research and Development. Accordingly, research and development costs are expensed as incurred. Research and development costs consist of costs related to labor, materials and supplies, as well as fees paid to consultants, external research fees.
Recent Accounting Pronouncements
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement: Reporting Comprehensive Income— Expense Disaggregation Disclosures, which requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
Management does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.
v3.25.1
Property and Equipment (Tables)
3 Months Ended
Mar. 31, 2025
Property, Plant and Equipment [Abstract]  
Schedule of Property And Equipment
Property and equipment consisted of the following at:
March 31, 2025December 31, 2024
Laboratory equipment$1,070,032 $1,070,032 
Computers and office equipment30,825 30,825 
Furniture and fixtures20,164 24,316 
Leasehold improvements28,855 28,855 
Building equipment14,932 14,932 
Total property and equipment1,164,808 1,168,960 
Less accumulated depreciation & amortization(543,796)(515,003)
Total property and equipment, net$621,012 $653,957 
v3.25.1
Intangible Assets (Tables)
3 Months Ended
Mar. 31, 2025
Goodwill and Intangible Assets Disclosure [Abstract]  
Schedule of Intangible Assets
Intangible assets consisted of the following at:
March 31, 2025:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $— $60,244 
Patents17 years213,931 30,035 — 183,896 
Intangible assets$274,175 $30,035 $— $244,140 
December 31, 2024:
Estimated Useful LifeGross AmountAccumulated AmortizationImpairmentNet Amount
TrademarksIndefinite$60,244 $— $— $60,244 
Patents17 years213,122 26,946 — 186,176 
Intangible assets$273,366 $26,946 $— $246,420 
v3.25.1
Accrued Expenses (Tables)
3 Months Ended
Mar. 31, 2025
Payables and Accruals [Abstract]  
Schedule of Accrued Expenses
Accrued expenses consisted of the following at:
March 31, 2025December 31, 2024
Employee payroll and bonuses$149,991 $410,781 
Vacation64,633 32,969 
Research and development projects73,810 75,047 
Professional fees171,418 82,762 
Other7,542 1,228 
Total accrued expenses$467,394 $602,787 
v3.25.1
Warrants (Tables)
3 Months Ended
Mar. 31, 2025
Warrants [Abstract]  
Schedule of Warrants Outstanding
The following table summarizes information about warrants outstanding at March 31, 2025:
Warrants OutstandingWarrant Exercisable
Year GrantedExercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Warrants at 03/31/2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
2018$14.40 1,596 3.0 years$14.40 1,596 3.0 years$14.40 
2019$158.40 7,195 0.9 years$158.40 7,195 0.9 years$158.40 
2023$187.50 2,000 3.2 years$187.50 2,000 3.2 years$187.50 
2024$11.40 22,223 3.9 years$11.40 22,223 3.9 years$11.40 
2024$0.70 13,329,000 4.3 years$0.70 13,329,000 4.3 years$0.70 
2024$1.88 266,600 4.3 years$1.88 266,600 4.3 years$1.88 
2025$0.38 194,311 4.8 years$0.38 — 0.0 years$— 
2025$0.54 2,245,968 4.9 years$0.54 — 0.0 years$— 
16,068,893 $0.80 13,628,614 $0.85 
v3.25.1
Stock Options (Tables)
3 Months Ended
Mar. 31, 2025
Share-Based Payment Arrangement [Abstract]  
Share-Based Payment Arrangement, Expensed and Capitalized, Amount
Stock-based compensation expense recognized for options was as follows:
For the Three Months Ended March 31,
20252024
Research and development$570 $626 
General and administrative29,832 33,545 
Total$30,402 $34,171 
Schedule of Options Outstanding and Exercisable
The following table summarizes information about options outstanding and exercisable at March 31, 2025:
Options OutstandingOptions Exercisable
Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise PriceNumber of Options at March 31, 2025Weighted Average Remaining Contractual LifeWeighted Average Exercise Price
$14.32 6,870 0.8 years$14.32 6,870 0.8 years$14.32 
$27.80 6,735 0.6 years$27.80 6,735 0.6 years$27.80 
$51.08 26,671 4.6 years$51.08 26,320 4.6 years$51.08 
$62.10 1,332 8.5 years$62.10 542 8.5 years$62.10 
41,608 40,467 
Schedule of Stock Option Activity
Total stock option activity for the period ended March 31, 2025, is summarized as follows:
OptionsWeighted Average Exercise PriceWeighted Average Remaining Contractual Term (years)Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 202441,608 $41.60 3.7 years— 
Granted— — 
Exercised— — 
Forfeited— — 
Outstanding at March 31, 202541,608 $41.60 3.4 years— 
Vested and Exercisable at March 31, 202540,467 41.113.3 years— 
v3.25.1
Fair Value Measurements (Tables)
3 Months Ended
Mar. 31, 2025
Fair Value Disclosures [Abstract]  
Schedule of Fair Value Measurements for Assets and Liabilities
The following tables summarize the fair values and levels within the fair value hierarchy in which the fair value measurements fall for assets and liabilities measured on a recurring basis as of:
March 31, 2025

DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$— $— $238 $238 
Total$— $— $238 $238 
December 31, 2024
DescriptionLevel 1Level 2Level 3Total
Liabilities
Common stock warrants$— $— $381 $381 
Total$— $— $381 $381 
Schedule of Changes in Level 3 Instruments Measured on a Recurring Basis
The following table presents the changes in Level 3 instruments measured on a recurring basis for the period ended March 31, 2025:
Balance at December 31, 2024$381 
Changes in fair value of warrants(143)
Balance at March 31, 2025$238 
Schedule of Fair Value of Warrants Using Black Scholes Option Pricing Model
At March 31, 2025 and December 31, 2024, the Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:
March 31, 2025December 31, 2024
Underlying common stock value$0.30 $0.43 
Expected term (years)3.043.29
Expected volatility175 %172 %
Risk free interest rate%%
Dividend yield— %— %
v3.25.1
Net Loss Per Share (Tables)
3 Months Ended
Mar. 31, 2025
Earnings Per Share [Abstract]  
Schedule of Calculation of Diluted Net Loss Per Share
The following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
March 31,
20252024
Options to purchase shares of common stock41,608 1,248,255 
Warrants outstanding16,068,893 990,416 
Total16,110,501 2,238,671 
v3.25.1
Commitments and Contingencies (Tables)
3 Months Ended
Mar. 31, 2025
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Future Minimum Payments Under Operating Leases
Future minimum payments under non-cancelable operating leases with initial or remaining terms in excess of one year during each of the next five years follow:
2025$193,393 
2026203,108 
202766,782 
20286,854 
Total future undiscounted lease payments470,137 
Less interest(18,725)
Present value of minimum lease payments$451,412 
Schedule of Future Minimum Payments Under Finance Leases
The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of March 31, 2025.

2025$13,305 
20268,871 
20271,480 
Total future undiscounted lease payments23,656 
Less interest(1,357)
Present value of minimum lease payments$22,299 
v3.25.1
Organization and Nature of Operations (Details)
1 Months Ended 3 Months Ended
Feb. 20, 2025
Feb. 05, 2025
USD ($)
$ / shares
shares
Jan. 14, 2025
USD ($)
$ / shares
shares
Jul. 25, 2024
$ / shares
shares
Jul. 01, 2024
Feb. 16, 2024
$ / shares
shares
May 17, 2023
$ / shares
Jul. 31, 2024
USD ($)
$ / shares
shares
Feb. 29, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
$ / shares
shares
Mar. 31, 2025
USD ($)
$ / shares
Mar. 31, 2024
USD ($)
Dec. 31, 2024
USD ($)
$ / shares
May 16, 2023
$ / shares
Dec. 31, 2018
$ / shares
Property, Plant and Equipment [Line Items]                              
Sale of stock, price per share (in dollars per share) | $ / shares       $ 1.50   $ 9.00                  
Proceeds from initial public offering | $                     $ 1,749,311 $ 4,290,674      
Stock split conversion ratio         0.0333   7.1                
Common stock, par value per share (in dollars per share) | $ / shares             $ 0.0001       $ 0.0001   $ 0.0001 $ 0.01  
Exercise price of warrants (in dollars per share) | $ / shares                             $ 14.40
Accumulated deficit | $                     $ 60,634,170   $ 57,565,825    
Loss from operations | $                     3,100,238 2,961,497      
Net cash used in operating activities | $                     3,071,762 $ 3,020,008      
Working capital | $                     $ 2,600,000        
Minimum                              
Property, Plant and Equipment [Line Items]                              
Stock split conversion ratio 0.5                            
Maximum                              
Property, Plant and Equipment [Line Items]                              
Stock split conversion ratio 0.1429                            
Class A Warrant                              
Property, Plant and Equipment [Line Items]                              
Warrants issued to underwriters (in shares) | shares       13,330,000       13,330,000              
Exercise price of warrants (in dollars per share) | $ / shares       $ 1.50                      
Follow-On Public Offering Warrants                              
Property, Plant and Equipment [Line Items]                              
Exercise price of warrants (in dollars per share) | $ / shares   $ 0.54                          
IPO                              
Property, Plant and Equipment [Line Items]                              
Shares issued in connection with public offering (in shares) | shares                   50,000          
Sale of stock, price per share (in dollars per share) | $ / shares                   $ 150.00          
Proceeds from initial public offering | $                   $ 6,000,000.0          
Follow-On Public Offering                              
Property, Plant and Equipment [Line Items]                              
Shares issued in connection with public offering (in shares) | shares   2,495,518 4,857,780 6,665,000   555,567   6,665,000 555,567            
Sale of stock, price per share (in dollars per share) | $ / shares   $ 0.2785 $ 0.30         $ 1.50 $ 9.00            
Net proceeds from follow-on public offering | $   $ 560,976 $ 1,200,000         $ 9,100,000 $ 4,300,000            
Follow-On Public Offering | Follow-On Public Offering Warrants                              
Property, Plant and Equipment [Line Items]                              
Warrants issued to underwriters (in shares) | shares   2,245,968                          
v3.25.1
Summary of Significant Accounting Policies (Details)
3 Months Ended
Mar. 31, 2025
USD ($)
lease
segment
Mar. 31, 2024
USD ($)
Dec. 31, 2024
USD ($)
Dec. 31, 2023
Property, Plant and Equipment [Line Items]        
Number of operating segments | segment 1      
Number of operating leases | lease 3      
Obtaining a right-of-use asset in exchange for lease liability $ 1,418,502      
Operating lease right-of-use asset 447,903   $ 527,393  
Current operating lease liability 237,647   255,177  
Long-term operating lease liability 213,765   274,161  
Lessee, finance lease, renewal term       36 months
Financing right-of-use assets, net value 20,652   24,522  
Finance lease liability current 16,456   16,066  
Long term finance lease liability 5,843   10,105  
Research and development 1,250,100 $ 1,472,970    
State tax credit receivable 65,676   65,676  
Deferred tax assets, tax credit carryforwards, research 27,666   27,666  
Deferred tax assets, tax credit carryforwards, other $ 9,704   $ 8,321  
Minimum        
Property, Plant and Equipment [Line Items]        
Lessee, operating lease, remaining lease term 36 months      
Maximum        
Property, Plant and Equipment [Line Items]        
Lessee, operating lease, remaining lease term 52 months      
v3.25.1
Property and Equipment - Schedule of Property And Equipment (Details) - USD ($)
Mar. 31, 2025
Dec. 31, 2024
Property, Plant and Equipment [Line Items]    
Total property and equipment $ 1,164,808 $ 1,168,960
Less accumulated depreciation & amortization (543,796) (515,003)
Total property and equipment, net 621,012 653,957
Laboratory equipment    
Property, Plant and Equipment [Line Items]    
Total property and equipment 1,070,032 1,070,032
Computers and office equipment    
Property, Plant and Equipment [Line Items]    
Total property and equipment 30,825 30,825
Furniture and fixtures    
Property, Plant and Equipment [Line Items]    
Total property and equipment 20,164 24,316
Leasehold improvements    
Property, Plant and Equipment [Line Items]    
Total property and equipment 28,855 28,855
Building equipment    
Property, Plant and Equipment [Line Items]    
Total property and equipment $ 14,932 $ 14,932
v3.25.1
Property and Equipment - Narrative (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Property, Plant and Equipment [Abstract]    
Depreciation $ 30,967 $ 29,935
Loss on disposal of property and equipment $ 1,175 $ 0
v3.25.1
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Finite-Lived Intangible Assets, Gross [Abstract]      
Accumulated Amortization $ 30,035   $ 26,946
Impairment 0 $ 0  
Intangible Assets, Net (Excluding Goodwill) [Abstract]      
Gross Amount 274,175   273,366
Accumulated Amortization 30,035   26,946
Impairment 0 0  
Net Amount 244,140   246,420
Trademarks      
Indefinite-Lived Intangible Assets (Excluding Goodwill) [Abstract]      
Gross Amount 60,244   60,244
Impairment 0 0  
Net Amount $ 60,244   $ 60,244
Patents      
Finite-Lived Intangible Assets, Gross [Abstract]      
Estimated Useful Life 17 years   17 years
Gross Amount $ 213,931   $ 213,122
Accumulated Amortization 30,035   26,946
Impairment 0 0  
Net Amount 183,896   186,176
Intangible Assets, Net (Excluding Goodwill) [Abstract]      
Accumulated Amortization 30,035   $ 26,946
Impairment $ 0 $ 0  
v3.25.1
Intangible Assets - Narrative (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Goodwill and Intangible Assets Disclosure [Abstract]    
Amortization of intangible assets $ 3,088 $ 2,511
v3.25.1
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($)
Mar. 31, 2025
Dec. 31, 2024
Payables and Accruals [Abstract]    
Employee payroll and bonuses $ 149,991 $ 410,781
Vacation 64,633 32,969
Research and development projects 73,810 75,047
Professional fees 171,418 82,762
Other 7,542 1,228
Total accrued expenses $ 467,394 $ 602,787
v3.25.1
Stockholders’ Equity (Details)
1 Months Ended 3 Months Ended
Feb. 20, 2025
Feb. 05, 2025
USD ($)
$ / shares
shares
Jan. 14, 2025
USD ($)
$ / shares
shares
Jul. 25, 2024
USD ($)
$ / shares
shares
Jul. 01, 2024
Feb. 16, 2024
USD ($)
$ / shares
shares
May 17, 2023
$ / shares
shares
Jul. 31, 2024
USD ($)
$ / shares
shares
Feb. 29, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
$ / shares
shares
Mar. 31, 2025
vote
$ / shares
shares
Mar. 31, 2024
USD ($)
Dec. 31, 2024
$ / shares
shares
Aug. 24, 2024
$ / shares
May 16, 2023
$ / shares
Dec. 31, 2018
$ / shares
Class of Stock [Line Items]                                
Stock split conversion ratio         0.0333   7.1                  
Common stock, par value per share (in dollars per share) | $ / shares             $ 0.0001       $ 0.0001   $ 0.0001   $ 0.01  
Common stock, shares authorized (in shares) | shares             100,000,000       100,000,000   100,000,000      
Sale of stock, price per share (in dollars per share) | $ / shares       $ 1.50   $ 9.00                    
Placement agent fee, percentage of gross offering proceeds       0.07   0.075                    
Placement agent fee | $       $ 809,825   $ 537,559                    
Exercise price of warrants (in dollars per share) | $ / shares                               $ 14.40
Warrants outstanding, term                               10 years
Stock issuance costs | $                       $ 709,426        
Common stockholders, number of votes | vote                     1          
Common stock reserved for future issuance (in shares) | shares                     16,110,501          
Preferred stock, shares authorized (in shares) | shares                     10,000,000   10,000,000      
Preferred stock, par value (in dollars per share) | $ / shares                     $ 0.0001   $ 0.0001      
Minimum                                
Class of Stock [Line Items]                                
Stock split conversion ratio 0.5                              
Maximum                                
Class of Stock [Line Items]                                
Stock split conversion ratio 0.1429                              
Class A Warrant                                
Class of Stock [Line Items]                                
Warrants issued to underwriters (in shares) | shares       13,330,000       13,330,000                
Exercise price of warrants (in dollars per share) | $ / shares       $ 1.50                        
Warrants outstanding, term       5 years                        
Reset price, number of days following issuance       30 days                        
Warrant reset price, percentage of volume weighted average price       1                        
Class of warrant or right, volume weighted average price, number of trading days       5 days                        
Reset price, floor (in dollars per share) | $ / shares       $ 0.32                        
Warrant reset price, floor, percentage of closing stock price       0.20                        
Reset price (in dollars per share) | $ / shares                           $ 0.7043    
Follow-On Public Offering Warrants                                
Class of Stock [Line Items]                                
Exercise price of warrants (in dollars per share) | $ / shares   $ 0.54                            
Follow-On Public Offering                                
Class of Stock [Line Items]                                
Shares issued in connection with public offering (in shares) | shares   2,495,518 4,857,780 6,665,000   555,567   6,665,000 555,567              
Sale of stock, price per share (in dollars per share) | $ / shares   $ 0.2785 $ 0.30         $ 1.50 $ 9.00              
Proceeds from follow-on public offering | $           $ 5,000,000                    
Placement agent fee, percentage of gross offering proceeds   0.040 0.070                          
Gross proceeds from follow-on public offering | $       $ 10,000,000                        
Net proceeds from follow-on public offering | $   $ 560,976 $ 1,200,000         $ 9,100,000 $ 4,300,000              
Stock issuance costs | $   $ 35,000 $ 60,000                          
Follow-On Public Offering | Follow-On Public Offering Warrants                                
Class of Stock [Line Items]                                
Warrants issued to underwriters (in shares) | shares   2,245,968                            
IPO                                
Class of Stock [Line Items]                                
Shares issued in connection with public offering (in shares) | shares                   50,000            
Sale of stock, price per share (in dollars per share) | $ / shares                   $ 150.00            
Series A Preferred Stock | IPO                                
Class of Stock [Line Items]                                
Convertible preferred stock, shares issued upon conversion (in shares) | shares                   48,608            
Series A-1 Convertible Preferred Stock | IPO                                
Class of Stock [Line Items]                                
Convertible preferred stock, shares issued upon conversion (in shares) | shares                   98,828            
Series B Preferred Stock | IPO                                
Class of Stock [Line Items]                                
Convertible preferred stock, shares issued upon conversion (in shares) | shares                   109,485            
v3.25.1
Warrants - Narrative (Details)
3 Months Ended 12 Months Ended
Aug. 24, 2024
USD ($)
$ / shares
Jul. 25, 2024
USD ($)
$ / shares
yr
shares
Mar. 31, 2025
USD ($)
Mar. 31, 2024
USD ($)
Dec. 31, 2018
$ / shares
shares
Feb. 05, 2025
$ / shares
shares
Jan. 14, 2025
$ / shares
shares
Dec. 31, 2024
USD ($)
Jul. 31, 2024
$ / shares
shares
Feb. 29, 2024
$ / shares
shares
Feb. 16, 2024
$ / shares
shares
Dec. 31, 2023
shares
Class of Warrant or Right [Line Items]                        
Exercise price of warrants (in dollars per share)         $ 14.40              
Warrants outstanding, term         10 years              
Sale of stock, price per share (in dollars per share)   $ 1.50                 $ 9.00  
Warrant liability | $     $ 238         $ 381        
Change in fair value of warrant liability | $     $ (143) $ (28,155)                
Reclass of warrant liability | $ $ 1,900,000                      
Measurement Input, Expected Dividend Rate                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   0                    
Measurement Input, Price Volatility                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.19                    
Measurement Input, Volume Weighted Average Price                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.14                    
Measurement Input, Expected Term                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input | yr   4.92                    
Minimum | Measurement Input, Share Price                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.14                    
Minimum | Measurement Input, Risk Free Interest Rate                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   0.0413                    
Minimum | Measurement Input, Strike Price                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.40                    
Maximum | Measurement Input, Share Price                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.40                    
Maximum | Measurement Input, Risk Free Interest Rate                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   0.0414                    
Maximum | Measurement Input, Strike Price                        
Class of Warrant or Right [Line Items]                        
Derivative liability, measurement input   1.50                    
Class A Warrant                        
Class of Warrant or Right [Line Items]                        
Exercise price of warrants (in dollars per share)   $ 1.50                    
Warrants outstanding, term   5 years                    
Warrants issued to underwriters (in shares) | shares   13,330,000             13,330,000      
Reset price (in dollars per share) $ 0.7043                      
Class of warrant or right, expiration term   5 years                    
Class of warrant or right, ownership limitation percentage   4.99%                    
Class of warrant or right, ownership limitation, election of the holder   9.99%                    
Warrant liability | $   $ 12,100,000                    
Loss on issuance of common stock | $   $ 2,100,000                    
Change in fair value of warrant liability | $ $ 4,000,000.0                      
Placement Agent Warrants                        
Class of Warrant or Right [Line Items]                        
Exercise price of warrants (in dollars per share)   $ 1.875                 $ 11.40  
Warrants issued to underwriters (in shares) | shares   266,600                 22,223  
Follow-On Public Offering Warrants                        
Class of Warrant or Right [Line Items]                        
Exercise price of warrants (in dollars per share)           $ 0.54            
Underwriter                        
Class of Warrant or Right [Line Items]                        
Warrants outstanding, term     5 years                  
Over-Allotment Option | Underwriter                        
Class of Warrant or Right [Line Items]                        
Warrants issued to underwriters (in shares) | shares                 266,600 22,223   2,000
Follow-On Public Offering                        
Class of Warrant or Right [Line Items]                        
Sale of stock, price per share (in dollars per share)           $ 0.2785 $ 0.30   $ 1.50 $ 9.00    
Gross proceeds from follow-on public offering | $   $ 10,000,000                    
Follow-On Public Offering | Placement Agent Warrants                        
Class of Warrant or Right [Line Items]                        
Exercise price of warrants (in dollars per share)             $ 0.375          
Warrants issued to underwriters (in shares) | shares             194,311          
Class of warrant or right, expiration term             5 years          
Percentage of shares issued in transaction             4.00%          
Class of warrant or right, exercise term             6 months          
Follow-On Public Offering | Follow-On Public Offering Warrants                        
Class of Warrant or Right [Line Items]                        
Warrants issued to underwriters (in shares) | shares           2,245,968            
Class of warrant or right, exercise term           6 months 1 day            
Common Stock                        
Class of Warrant or Right [Line Items]                        
Convertible debt, warrants issued (in shares) | shares         1,596              
Warrant                        
Class of Warrant or Right [Line Items]                        
Fair value of warrants | $     $ 238         $ 381        
v3.25.1
Warrants - Schedule of Warrants Outstanding (Details) - $ / shares
3 Months Ended
Mar. 31, 2025
Dec. 31, 2018
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share)   $ 14.40
Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 16,068,893  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 0.80  
Number of Warrants Exercisable (in shares) 13,628,614  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 0.85  
2018    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 14.40  
2018 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 1,596  
Warrants Outstanding, Weighted Average Remaining Contractual Life 3 years  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 14.40  
Number of Warrants Exercisable (in shares) 1,596  
Weighted Average Remaining Contractual Life, Warrants Exercisable 3 years  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 14.40  
2019    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 158.40  
2019 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 7,195  
Warrants Outstanding, Weighted Average Remaining Contractual Life 10 months 24 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 158.40  
Number of Warrants Exercisable (in shares) 7,195  
Weighted Average Remaining Contractual Life, Warrants Exercisable 10 months 24 days  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 158.40  
2023    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 187.50  
2023 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 2,000  
Warrants Outstanding, Weighted Average Remaining Contractual Life 3 years 2 months 12 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 187.50  
Number of Warrants Exercisable (in shares) 2,000  
Weighted Average Remaining Contractual Life, Warrants Exercisable 3 years 2 months 12 days  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 187.50  
2024    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 11.40  
2024 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 22,223  
Warrants Outstanding, Weighted Average Remaining Contractual Life 3 years 10 months 24 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 11.40  
Number of Warrants Exercisable (in shares) 22,223  
Weighted Average Remaining Contractual Life, Warrants Exercisable 3 years 10 months 24 days  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 11.40  
2024    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 0.70  
2024 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 13,329,000  
Warrants Outstanding, Weighted Average Remaining Contractual Life 4 years 3 months 18 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 0.70  
Number of Warrants Exercisable (in shares) 13,329,000  
Weighted Average Remaining Contractual Life, Warrants Exercisable 4 years 3 months 18 days  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 0.70  
2024    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 1.88  
2024 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 266,600  
Warrants Outstanding, Weighted Average Remaining Contractual Life 4 years 3 months 18 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 1.88  
Number of Warrants Exercisable (in shares) 266,600  
Weighted Average Remaining Contractual Life, Warrants Exercisable 4 years 3 months 18 days  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 1.88  
2025    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 0.38  
2025 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 194,311  
Warrants Outstanding, Weighted Average Remaining Contractual Life 4 years 9 months 18 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 0.38  
Number of Warrants Exercisable (in shares) 0  
Weighted Average Remaining Contractual Life, Warrants Exercisable 0 years  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 0  
2025    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise Price (in dollars per share) $ 0.54  
2025 | Warrant    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Warrants Outstanding (in shares) 2,245,968  
Warrants Outstanding, Weighted Average Remaining Contractual Life 4 years 10 months 24 days  
Weighted Average Exercise Price, Warrants Outstanding (in dollars per share) $ 0.54  
Number of Warrants Exercisable (in shares) 0  
Weighted Average Remaining Contractual Life, Warrants Exercisable 0 years  
Weighted Average Exercise Price, Warrants Exercisable (in dollars per share) $ 0  
v3.25.1
Stock Options - Narrative (Details)
1 Months Ended 3 Months Ended 12 Months Ended
Oct. 03, 2024
shares
Mar. 31, 2023
shares
Mar. 31, 2025
USD ($)
shares
Mar. 31, 2024
USD ($)
shares
Dec. 31, 2016
shares
Performance Shares          
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]          
Unamortized compensation expense | $     $ 50,318    
Number of performance-based options outstanding (in shares)     0 13,120  
Fair value of stock options | $     $ 0 $ 109,551  
Common Stock          
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]          
Stock options granted (in shares)     0    
2023 Stock Incentive Plan | Common Stock          
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]          
Stock options granted (in shares)   1,211,068 1,333    
Stock options available for grants (in shares)     1,209,734    
Additional shares authorized (in shares) 1,144,401        
Automatic increase, percentage of stock 0.05        
Automatic increase, number of years 10 years        
2016 Stock Incentive Plan | Common Stock          
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]          
Stock options granted (in shares)     40,275   49,687
Stock options available for grants (in shares)     7,457    
v3.25.1
Stock Options - Stock Compensation Expense Allocation (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock compensation expense $ 30,402 $ 34,171
Research and development    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock compensation expense 570 626
General and administrative    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock compensation expense $ 29,832 $ 33,545
v3.25.1
Stock Options - Schedule of Options Outstanding and Exercisable (Details) - $ / shares
3 Months Ended 12 Months Ended
Mar. 31, 2025
Dec. 31, 2024
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Number of Options Outstanding (in shares) 41,608 41,608
Options Outstanding, Weighted Average Remaining Contractual Life 3 years 4 months 24 days 3 years 8 months 12 days
Number of Options Exercisable (in shares) 40,467  
Weighted Average Remaining Contractual Term, Vested and Exercisable 3 years 3 months 18 days  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 41.11  
Exercise Price $14.32    
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Options Outstanding, Weighted Average Exercise Price (in dollars per share) $ 14.32  
Number of Options Outstanding (in shares) 6,870  
Options Outstanding, Weighted Average Remaining Contractual Life 9 months 18 days  
Number of Options Exercisable (in shares) 6,870  
Weighted Average Remaining Contractual Term, Vested and Exercisable 9 months 18 days  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 14.32  
Exercise Price $27.80    
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Options Outstanding, Weighted Average Exercise Price (in dollars per share) $ 27.80  
Number of Options Outstanding (in shares) 6,735  
Options Outstanding, Weighted Average Remaining Contractual Life 7 months 6 days  
Number of Options Exercisable (in shares) 6,735  
Weighted Average Remaining Contractual Term, Vested and Exercisable 7 months 6 days  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 27.80  
Exercise Price $51.08    
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Options Outstanding, Weighted Average Exercise Price (in dollars per share) $ 51.08  
Number of Options Outstanding (in shares) 26,671  
Options Outstanding, Weighted Average Remaining Contractual Life 4 years 7 months 6 days  
Number of Options Exercisable (in shares) 26,320  
Weighted Average Remaining Contractual Term, Vested and Exercisable 4 years 7 months 6 days  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 51.08  
Exercise Price $62.10    
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Options Outstanding, Weighted Average Exercise Price (in dollars per share) $ 62.10  
Number of Options Outstanding (in shares) 1,332  
Options Outstanding, Weighted Average Remaining Contractual Life 8 years 6 months  
Number of Options Exercisable (in shares) 542  
Weighted Average Remaining Contractual Term, Vested and Exercisable 8 years 6 months  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 62.10  
v3.25.1
Stock Options - Schedule of Stock Option Activity (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 12 Months Ended
Mar. 31, 2025
Dec. 31, 2024
Options    
Outstanding, beginning balance (in shares) 41,608  
Exercised (in shares) 0  
Forfeited (in shares) 0  
Outstanding, ending balance (in shares) 41,608 41,608
Weighted Average Exercise Price    
Outstanding, beginning balance (in dollars per share) $ 41.60  
Granted (in dollars per share) 0  
Exercised (in dollars per share) 0  
Forfeited (in dollars per share) 0  
Outstanding, ending balance (in dollars per share) $ 41.60 $ 41.60
Stock Options Additional Disclosures    
Options Outstanding, Weighted Average Remaining Contractual Life 3 years 4 months 24 days 3 years 8 months 12 days
Vested and Exercisable (in shares) 40,467  
Options Exercisable, Weighted Average Exercise Price (in dollars per share) $ 41.11  
Weighted Average Remaining Contractual Term, Vested and Exercisable 3 years 3 months 18 days  
Aggregate Intrinsic Value, Outstanding $ 0 $ 0
Aggregate Intrinsic Value, Vested and Exercisable $ 0  
v3.25.1
Fair Value Measurements - Schedule of Fair Value Measurements for Assets and Liabilities (Details) - Fair Value, Recurring - USD ($)
Mar. 31, 2025
Dec. 31, 2024
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Common stock warrants $ 238 $ 381
Total 238 381
Level 1    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Common stock warrants 0 0
Total 0 0
Level 2    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Common stock warrants 0 0
Total 0 0
Level 3    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Common stock warrants 238 381
Total $ 238 $ 381
v3.25.1
Fair Value Measurements - Schedule of Changes in Level 3 Instruments Measured on a Recurring Basis (Details) - Warrant Liability
3 Months Ended
Mar. 31, 2025
USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]  
Beginning balance $ 381
Changes in fair value of warrants (143)
Ending balance $ 238
v3.25.1
Fair Value Measurements - Schedule of Fair Value of Warrants Using Black Scholes Option Pricing Model (Details) - $ / shares
3 Months Ended 12 Months Ended
Mar. 31, 2025
Dec. 31, 2024
Fair Value Disclosures [Abstract]    
Underlying common stock value (in dollars per share) $ 0.30 $ 0.43
Expected term (years) 3 years 14 days 3 years 3 months 14 days
Expected volatility 175.00% 172.00%
Risk free interest rate 4.00% 4.00%
Dividend yield 0.00% 0.00%
v3.25.1
Net Loss Per Share - Schedule of Calculation of Diluted Net Loss Per Share (Details) - shares
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Common stock equivalents excluded from calculation of diluted net loss per share because including them would have had an anti-dilutive effect (in shares) 16,110,501 2,238,671
Options to purchase shares of common stock    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Common stock equivalents excluded from calculation of diluted net loss per share because including them would have had an anti-dilutive effect (in shares) 41,608 1,248,255
Warrants outstanding    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Common stock equivalents excluded from calculation of diluted net loss per share because including them would have had an anti-dilutive effect (in shares) 16,068,893 990,416
v3.25.1
Commitments and Contingencies - Narrative (Details)
1 Months Ended 3 Months Ended 12 Months Ended
Aug. 31, 2024
USD ($)
Sep. 30, 2021
USD ($)
May 31, 2021
USD ($)
Mar. 31, 2025
USD ($)
Mar. 31, 2024
USD ($)
Dec. 31, 2023
USD ($)
Dec. 31, 2021
CAD ($)
Dec. 31, 2020
USD ($)
Dec. 31, 2019
CAD ($)
Jan. 26, 2022
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                    
License agreement, term                   10 years
License agreement, length of written notice required for termination       30 days            
Rent expense for operating leases       $ 84,714 $ 84,714          
Operating lease, weighted average remaining lease term       1 year 10 months 24 days            
Operating lease, weighted average discount rate       4.25%            
Finance lease monthly payments           $ 1,478        
Finance lease term           3 years        
Finance lease, remaining lease term           1 year 3 months 18 days        
Finance lease, discount rate           9.60%        
Finance lease expense       $ 3,870 3,870          
Finance lease, interest expense       $ 562 $ 915          
Montreal, Quebec                    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                    
Operating lease payments             $ 8,130   $ 6,906  
Operating lease payments, percentage increase per year                 0.04  
Operating lease, initial lease term                 1 year  
Branford. CT                    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                    
Operating lease payments               $ 13,033    
Operating lease payments, percentage increase per year       0.02            
Groton. CT                    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                    
Operating lease payments $ 5,216 $ 6,824 $ 4,234              
Operating lease, initial lease term     1 year              
Operating lease, renewal term     3 years              
v3.25.1
Commitments and Contingencies - Schedule of Future Minimum Payments Under Non-cancelable Operating Leases (Details)
Mar. 31, 2025
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2025 $ 193,393
2026 203,108
2027 66,782
2028 6,854
Total future undiscounted lease payments 470,137
Less interest (18,725)
Present value of minimum lease payments $ 451,412
v3.25.1
Commitments and Contingencies - Schedule of Future Minimum Payments Under Finance Leases (Details)
Mar. 31, 2025
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2025 $ 13,305
2026 8,871
2027 1,480
Total future undiscounted lease payments 23,656
Less interest (1,357)
Present value of minimum lease payments $ 22,299
v3.25.1
Retirement Plan (Details)
3 Months Ended
Mar. 31, 2025
USD ($)
hour
Mar. 31, 2024
USD ($)
Retirement Benefits [Abstract]    
Consecutive months of service required 2 months  
Minimum work hours 250  
Minimum work hours in their first year of service 1,000  
Percent of match on first three percent 100.00%  
Employer matching contribution, percent of employees' gross pay 3.00%  
Percent of match on next two percent 0.50  
Employer matching contribution, additional percent of employees' gross pay 0.02  
Employer matching contributions | $ $ 4,581 $ 4,126
v3.25.1
Related Parties (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Related Party Transaction [Line Items]      
Accounts receivable $ 0   $ 233
Related Party      
Related Party Transaction [Line Items]      
Revenues 0 $ 0  
Accounts receivable $ 0   $ 0
v3.25.1
Segment Information (Details)
3 Months Ended
Mar. 31, 2025
USD ($)
segment
Segment Reporting, Asset Reconciling Item [Line Items]  
Number of reportable segments | segment 1
UNITED STATES  
Segment Reporting, Asset Reconciling Item [Line Items]  
Fixed assets, original cost basis $ 893,238
CANADA  
Segment Reporting, Asset Reconciling Item [Line Items]  
Fixed assets, original cost basis $ 271,569
v3.25.1
Subsequent Events (Details)
May 12, 2025
USD ($)
shares
May 02, 2025
USD ($)
shares
Apr. 11, 2025
CAD ($)
Apr. 24, 2025
USD ($)
Apr. 15, 2025
May 31, 2021
Subsequent Event | Alumni Capital            
Subsequent Event [Line Items]            
Purchase agreement, maximum aggregate issuance value       $ 20,000,000    
Purchase agreement, series purchase limit       750,000    
Purchase agreement, aggregate purchase limit       $ 4,000,000    
Purchase agreement, closing period       5 days    
Purchase agreement, share price, volume weighted average price, number of days       5 days    
Purchase agreement, share price, volume weighted average price multiplier       90.00%    
Subsequent Event | Alumni Capital | Purchase Agreement            
Subsequent Event [Line Items]            
Shares issued in connection with public offering (in shares) | shares 750,000 747,000        
Gross proceeds from issuance of stock and warrants $ 200,000 $ 201,000        
Subsequent Event | Alumni Capital | The Warrants            
Subsequent Event [Line Items]            
Purchase agreement, warrants sold, as a percentage of shares sold       10.00%    
Purchase agreement, warrant exercise price, percentage of price paid upon closing       130.00%    
Class of warrant or right, expiration term       5 years    
Class of warrant or right, ownership limitation percentage       19.99%    
Warrants outstanding (in shares) | shares 75,000 74,700        
Groton. CT            
Subsequent Event [Line Items]            
Operating lease, renewal term           3 years
Groton. CT | Subsequent Event            
Subsequent Event [Line Items]            
Operating lease, renewal term         1 year  
Montreal, Quebec | Subsequent Event            
Subsequent Event [Line Items]            
Operating lease, renewal term     1 year      
Operating lease, monthly payment     $ 9,436.46      

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