Azitra, Inc.

Previous wording

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 $0.54.

Current wording

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 7,508 shares of our common stock at a public offering price of $999 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 44,802 shares of our common stock. In February 2024, we completed a follow-on public offering in which we issued and sold 83,404 shares of our common stock at a price to the public of $59.94 per share. On July 25, 2024, we completed a follow-on offering of an aggregate of 1,000,750 shares of our common stock, and Class A warrants to purchase up to 2,001,502 shares of common stock, at a combined public offering price of $9.99 per share and accompanying warrants. On January 14, 2025, we completed a follow-on offering in which we issued and sold 729,381 shares of our common stock at a price of $2.00 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 374,696 shares of our common stock at a public offering price of $1.85 per share and warrants to purchase up to 337,232 shares of common stock. The net proceeds received by the Company from the follow-on offering were $561,000 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 $0.54.

Previous wording

On April 24, 2025, the Company entered into a Purchase Agreement (the "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 June 23, 2025, at the Company's annual meeting of stockholders, the Stockholders approved the sale and issuance of more than 19.99% of our outstanding shares of our common stock, including shares of common stock underlying warrants, pursuant to the Purchase Agreement entered into with the Purchaser.

Current wording

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. The Company could not 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 obtained stockholder approval to issue shares of common stock in excess of the Exchange Cap. On June 23, 2025, at the Company's annual meeting of stockholders, the stockholders approved the sale and issuance of more than 19.99% of our outstanding shares of our common stock, including shares of common stock underlying warrants, pursuant to the Purchase Agreement entered into with the Purchaser.

Previous wording

As of August 11, 2025, the Company has sold 8,497,000 shares, and issued 759,700 warrants to Alumni Capital LP under the Purchase Agreement with an estimated gross proceeds of $1.7 million.

Current wording

As of November 12, 2025, the Company has sold 7,955,823 shares, and issued 795,579 warrants to Alumni Capital LP under the Purchase Agreement with an estimated gross proceeds of $6.0 million of which $2.4 million was received subsequent to September 30, 2025.

Previous wording

As of August 11, 2025, we had 23,476,354 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 alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.

Current wording

As of November 12, 2025, we had 10,204,938 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 alternatives and NYSE American compliance considerations. Our financial statements will not reflect the further reverse stock split until such time as it occurs.

Previous wording

•ATR-04, which includes a genetically modified strain of S. epidermidisfor 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 third quarter of 2025.

Current wording

•ATR-04, which includes a genetically modified strain of S. epidermidisfor 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 dosed the first patient in the Phase 1/2 clinical trial in the third quarter of 2025.

Previous wording

•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, 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 third quarter of 2025. We reported initial safety results of the first patients dosed in our Phase 1b clinical trial for our ATR-12 program in Netherton syndrome patients in the first half of 2025.

Current wording

•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, 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 and initiated dosing the first patient in the ATR-04 Phase 1/2 clinical trial in the third quarter of 2025. We reported initial safety results of the first patients dosed in our Phase 1b clinical trial for our ATR-12 program in Netherton syndrome patients in the first half of 2025.

Previous wording

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.

Current wording

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, the development of our initial product candidates and the commencement of phase 1/2 clinical trials related to our ATR-12, and ATR-04 product candidates.

Previous wording

We generated $0 of service revenue under the Bayer JDA during the second quarter of fiscal 2025 compared to service revenue of $7,500 under the JDA for the comparable period in fiscal 2024. The decrease of $7,500 in service revenue is attributable to a decrease in the amount of reimbursable development costs incurred in 2025. We do not expect any further service revenue at this time.

Current wording

We did not recognize any revenue during the third quarter of fiscal years 2025 and 2024. We do not expect any further service revenue at this time.

Previous wording

General and administrative costs during the second quarter of fiscal 2025 decreased by $79,715, or 5%, to $1,469,513 from the comparable prior period. The decrease was primarily related to an increase of $80,000 in the use of business consultants which was primarily attributed to increased hours due to incremental public company compliance initiatives and business development efforts, an increase of $71,000 in legal fees primarily related to patent expenses and public company compliance initiatives, an increase of $30,000 in public relations costs related to an increase in our base rate and additional services provided, and an increase $21,000 in software and equipment offset by a decrease of $208,000 in financing costs primarily attributable to the 2024 payment to the previous investment bank, ThinkEquity, a decrease of $25,000 in accounting costs, a decrease of $14,000 in insurance costs, a decrease of $13,000 in conference costs and a net decrease of $21,000 in other overhead expenses.

Current wording

General and administrative costs during the third quarter of fiscal 2025 decreased by $324,994, or 17%, to $1,588,406 from the comparable prior period. The decrease was primarily related to a decrease of $328,000 in legal fees primarily related to the write off of certain patent expenses and public company compliance initiatives, a decrease of $119,000 in payroll and benefits primarily related to a decrease in stock option expense as options vest, a decrease of $17,000 in hiring costs primarily related to a compensation consultant, and a net decrease of $20,000 in other overhead expenses offset by an increase of $89,000 in financing costs primarily related to work performed to establish our equity line of credit, an increase of $15,000 in the use of business consultants which was primarily attributed to increased hours due to incremental public company compliance initiatives and business development efforts, an increase of $24,000 in public relations costs related to an increase in our base rate and additional services provided, an increase of $10,000 in accounting and auditing expense, an increase $8,000 in software and equipment, and an increase of $14,000 in insurance costs.

Previous wording

During the second quarter of fiscal 2025, research and development expenses increased by $283,287, or 25%, to $1,401,839 from the comparable prior period. The increase was primarily related to a net increase of $175,000 in research and development and clinical trial costs for our ATR-12 program as the program progresses its clinical trial, a net increase of $120,000 in research and development and clinical trial costs for our ATR-04 program as the program has entered it's clinical trial phase, an increase of $23,000 in research and development costs for our ATR-01 program, an increase of $22,000 in payroll and benefits due merit increases and an additional new hire, and an increase of $9,000 for lab supplies offset by a decrease of $83,000 in clinical consultant expenditures related to our programs prior to entering into their clinical phases, and a net increase of $17,000 in other miscellaneous costs. There were no government and nonprofit grant revenue received for the periods ended June 30, 2025 and 2024. There were no refundable tax credits for the periods ended June 30, 2025 and 2024.

Current wording

During the third quarter of fiscal 2025, research and development expenses increased by $164,271, or 16%, to $1,180,078 from the comparable prior period. The increase was primarily related to a net increase of $239,000 in research and development and clinical trial costs for our ATR-04 program as the program progresses through its clinical trial, an increase of $48,000 in research and development costs for our ATR-01 program, an increase of $29,000 in payroll and benefits due merit increases and an additional new hire, and an increase of $11,000 for lab supplies offset by a net decrease of $104,000 in research and development and clinical trial costs for our ATR-12 program as the program progresses its clinical trial, a decrease of $65,000 in clinical consultant expenditures related to our programs prior to entering into their clinical phases, and a net increase of $6,000 in other miscellaneous costs. There were no government and nonprofit grant revenue received for the periods ended September 30, 2025 and 2024. There were no refundable tax credits for the periods ended September 30, 2025 and 2024.

Previous wording

Our other income (expense) consists of interest income, interest expense, change in the valuation of warrants carried at fair value, and loss on foreign currency. During the second quarter of fiscal 2025, other income (expense) decreased by $45,928, or 162%, compared to the comparable period in fiscal 2024. The decrease was primarily related to a increase of $41,000 attributable to the loss on foreign currency and by a net increase of $5,000 attributable to other income and expense.

Current wording

Our other income consists of interest income, interest expense, loss on issuance of stock, change in the valuation of warrants carried at fair value, and loss on foreign currency. During the third quarter of fiscal 2025, other income decreased by $1,915,760, or 100%, compared to the comparable period in fiscal 2024. The decrease was primarily related to a decrease of $4,000,000 attributable to the change in the valuation of the warrants, a decrease in interest income of $42,000 offset by a decrease of $2,200,000 attributable to the loss on issuance of stock.

Previous wording

We expect our future other income (expense) to be consistent with prior periods.

Current wording

We expect our future other income to be consistent with prior periods.

Previous wording

The following table summarizes our results of operations with respect to the items set forth below for the for the six months ended June 30, 2025 and 2024 together with the percentage change for those items.

Current wording

The following table summarizes our results of operations with respect to the items set forth below for the for the nine months ended September 30, 2025 and 2024 together with the percentage change for those items.

Previous wording

We generated $0 of service revenue under the Bayer JDA during the first six months of fiscal 2025 compared to service revenue of $7,500 under the JDA for the comparable period in fiscal 2024. The decrease of $7,500 in service revenue is attributable to a decrease in the amount of reimbursable development costs incurred in 2025. We do not expect any further service revenue at this time.

Current wording

We generated $— of service revenue under the Bayer JDA during the first nine months of fiscal 2025 compared to service revenue of $7,500 under the JDA for the comparable period in fiscal 2024. The decrease of $7,500 in service revenue is attributable to a decrease in the amount of reimbursable development costs incurred in 2025. We do not expect any further service revenue at this time.

Previous wording

General and administrative costs during the first six months of fiscal 2025 increased by $281,896, or 9%, to $3,319,651 from the prior year period. The increase was primarily related to an increase of $185,000 in accounting costs primarily related to an increase in fees paid to external auditors and NYSE, an increase of $120,000 for the use of business consultants which was primarily attributed to increased hours due to incremental public company compliance initiatives and business development efforts, an increase of $120,000 in legal fees primarily related to patent expenses and public company compliance initiatives, an increase of $70,000 for public relations expenditures which increased due to additional services and an increase in our base rates, an increase of $24,000 for software and equipment, an increase of $23,000 in repairs and maintenance and an increase of $19,000 in salaries and benefits primarily due to merit and bonus increases, offset by a decrease of $212,000 in financing costs attributable to the 2024 payment to the previous investment bank, ThinkEquity, a decrease of $36,000 in insurance expense and a net decrease of approximately $31,000 in other overhead expenses.

Current wording

General and administrative costs during the first nine months of fiscal 2025 decreased by $43,098, or 1%, to $4,908,057 from the prior year period. The decrease was primarily related to a decrease of $209,000 in legal fees primarily related to the write off of certain patent expenses and public company compliance initiatives, a decrease of $98,000 in salaries and benefits primarily due to a decrease in stock option expense as options vest, a decrease of $123,000 in financing costs primarily attributable to the 2024 payment to the previous investment bank offset by the increase costs associated with the establishment of our equity line of credit, a decrease in hiring costs of $20,000 primarily related to a compensation consultant, a decrease of $23,000 in insurance expense and a net decrease of approximately $26,000 in other overhead expenses offset by an increase of $195,000 in accounting costs primarily related to an increase in fees paid to external auditors and NYSE American, an increase of $134,000 for the use of business consultants which was primarily attributed to increased hours due to incremental public company compliance initiatives and business development efforts, an increase of $94,000 for public relations expenditures which increased due to additional services and an increase in our base rates, an increase of $33,000 for software and equipment.

Previous wording

During the six months ended June 30, 2025 and 2024 our research and development expenses by category were as follows:

Current wording

During the nine months ended September 30, 2025 and 2024 our research and development expenses by category were as follows:

Previous wording

During the first six months of fiscal 2025, research and development expenses increased by $60,417, or 2%, to $2,651,939 from the prior year period. The increase was primarily related to an net increase of $158,000 in research and development and clinical trial costs related to our ATR-12 program as the program progresses its clinical trial, an increase of $60,000 in research and development costs related to our ATR-01 program as the program continues to progress, and an increase in payroll and benefits of $31,000 due merit increases and an additional new hire, offset by a decrease of $152,000 in clinical consultant expenditures elated to our programs prior to entering into their clinical phases, a net decrease of $19,000 in research and development and clinical trial costs in our ATR-04 program primarily due to the timing of when the program was progressing from its research and development to clinical stage, and an overall net decrease of approximately $18,000 in other costs.

Current wording

During the first nine months of fiscal 2025, research and development expenses increased by $224,688, or 6%, to $3,832,017 from the prior year period. The increase was primarily related to an net increase of $58,000 in research and development and clinical trial costs related to our ATR-12 program as the program progresses through its clinical trial, an increase of $189,000 in research and development and clinical trial costs in our ATR-04 program as the program progresses through its clinical trial, an increase of $109,000 in research and development costs related to our ATR-01 program as the program continues to progress, an increase in payroll and benefits of $76,000 due merit increases and an additional new hire, and an increase in lab supplies of $43,000 offset by a decrease of $211,000 in consultant expenditures related to our programs prior to entering into their clinical phases, and an overall net decrease of approximately $40,000 in other costs.

Previous wording

Our other income consists of interest income, loss on foreign currency translation, change in the valuation of warrants carried at fair value, gain on disposal of property and equipment, and interest expense. During the first six months of fiscal 2025, other income decreased by $42,657, or 75%, compared to the comparable period in fiscal 2024. The decrease was primarily related to a decrease of $33,000 attributable to the decrease in warrant value, an increase of $38,000 attributable to the loss on foreign currency, and a net increase of approximately $1,000 attributable to other expense, offset by an increase in interest income of $29,000.

Current wording

Our other income consists of interest income, loss on issuance of stock, loss on foreign currency translation, change in the valuation of warrants carried at fair value, loss on issuance of common stock, gain on disposal of property and equipment, and interest expense. During the first nine months of fiscal 2025, other income decreased by $1,958,417, or 99%, compared to the comparable period in fiscal 2024. The decrease was primarily related to a decrease of $4,000,000 attributable to the change in the valuation of the warrants, a net decrease of $48,000 in other (expense) income, a decrease of $14,000 of interest income, offset by decrease of $2,200,000.

Previous wording

As of June 30, 2025, we had total assets of approximately $4.0 million and working capital of approximately $0.3 million. As of June 30, 2025, our liquidity included approximately $1.0 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.

Current wording

As of September 30, 2025, we had total assets of approximately $4.3 million and working capital of approximately $0.4 million. As of September 30, 2025, our liquidity included approximately $1.4 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.

Previous wording

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 $587,638, and $19,217, respectively as of June 30, 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.

Current wording

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 $507,394, and $14,788, respectively as of September 30, 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.

Previous wording

During the first six months of fiscal 2025, operating activities used $5.9 million of cash primarily driven by our net loss of $6.0 million. During the comparable period of fiscal 2024, operating activities used $5.1 million of cash primarily driven by our net loss of $5.6 million and by non-cash items of $0.5 million.

Current wording

During the first nine months of fiscal 2025, operating activities used $8.3 million of cash primarily driven by our net loss of $8.7 million. During the comparable period of fiscal 2024, operating activities used $7.6 million of cash primarily driven by our net loss of $6.6 million and by non-cash items of $1.0 million.

Previous wording

During the first six months of fiscal 2025, investing activities used $57,973 of cash driven by $49,000 in trademark and deferred patent costs and $12,000 for the purchase of equipment offset by $3,000 in proceeds from the sale of property and equipment. During the comparable period of fiscal 2024, investing activities used $155,826 of cash attributable to trademark and deferred patent costs.

Current wording

During the first nine months of fiscal 2025, investing activities used $99,051 of cash driven by $87,000 in trademark and deferred patent costs and $15,000 for the purchase of equipment offset by $3,000 in proceeds from the sale of property and equipment. During the comparable period of fiscal 2024, investing activities used $263,714 of cash driven by $255,000 in trademark and deferred patent costs and $9,000 for the purchase of equipment.

Previous wording

During the first six months of fiscal 2025, financing activities provided $2.4 million in cash primarily driven by proceeds from our January and February 2025 follow-on public offerings and draws on our equity line of credit. 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.

Current wording

During the first nine months of fiscal 2025, financing activities provided $5.3 million in cash primarily driven by proceeds from our January and February 2025 follow-on public offerings and draws on our equity line of credit. During the comparable period of fiscal 2024, financing activities provided $13.3 million in cash primarily driven by proceeds from our February 2024 follow-on offering.

Previous wording

During the six months ended June 30, 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.

Current wording

During the nine months ended September 30, 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.