OS Therapies Inc

Previous wording

The following discussion and analysis of the financial condition and results of operations of OS Therapies Incorporated (“OS Therapies,” the “Company,” “we,” “our” or “us”) should be read in conjunction with the financial statements and notes thereto appearing in Part I, Item 1 of this report. In the following discussions, most percentages and dollar amounts have been rounded to aid presentation, and, accordingly, all amounts are approximations.

Current wording

The following discussion and analysis of the financial condition and results of operations of OS Therapies Incorporated (“OS Therapies,” the “Company,” “we,” “our” or “us”) should be read in conjunction with the consolidated financial statements and notes thereto appearing in Part I, Item 1 of this report. In the following discussions, most percentages and dollar amounts have been rounded to aid presentation, and, accordingly, all amounts are approximations.

Previous wording

We are a clinical stage biopharmaceutical company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. Our mission is to address the significant need for new treatments in cancers of the bone in children and young adults. Osteosarcoma is an extremely challenging and often aggressive cancer that has particular treatment challenges due to its location, changing genotypes and high metastases rates. We are currently seeking to answer the call for new treatments that will prevent metastasis and the recurrence of metastases with our lead core product candidate OST-HER2 (also known as OST31-164), a cancer immunotherapy product candidate that produces a cellular immune response against the cancer antigen HER2. In 2021, we opened a clinical study to produce data for the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of OST-HER2 in patients after resection of recurrent Osteosarcoma, which achieved full enrollment of 41 patients in October 2023. In June 2025, we participated in a Type D meeting with the FDA and subsequently received positive written feedback regarding the design and endpoints of our Phase IIb trial of OST-HER2 to support a potential Biologics License Application (BLA). Based on this feedback, we have submitted a Breakthrough Therapy Designation request and, subject to continued positive regulatory guidance, plan to submit a BLA for OST-HER2 following our End of Phase 2 meeting with the FDA, anticipated in the third quarter of 2025. Upon success in gaining regulatory approval from the FDA with OST-HER2 in Osteosarcoma, we intend to evaluate OST-HER2’s potential use, both alone and in combination with HER2 targeting antibodies such as Herceptin®, in other solid tumors including breast, esophageal and lung cancers. OST-HER2 has potential uses in both the prevention of metastases in solid tumors, and therapeutically against HER2-expressing solid tumors treated with HER targeting antibodies.

Current wording

We are a clinical stage biopharmaceutical company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. Our mission is to address the significant need for new treatments in cancers of the bone in children and young adults. Osteosarcoma is an extremely challenging and often aggressive cancer that has particular treatment challenges due to its location, changing genotypes and high metastases rates. We are currently seeking to answer the call for new treatments that will prevent metastasis and the recurrence of metastases with our lead core product candidate OST-HER2 (also known as OST31-164), a cancer immunotherapy product candidate that produces a cellular immune response against the cancer antigen HER2.

Previous wording

On December 24, 2024, we entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain institutional and accredited investors (collectively, the “Purchasers”), substantially all of whom were existing stockholders of our company, pursuant to which we agreed to issue and sell to the Purchasers immediately separable units (the “Units”), with each Unit being comprised of (i) one share of Series Aseniorc onvertiblep referreds tock (“Series A Preferred Stock”)and (ii) a warrant to purchase one share of common stock (each, a “Series A Warrant” and such shares, the “Warrant Shares”), at a price per Unit of $4.00, for aggregate gross proceeds of not less than $6 million and not more than $10 million (the “PIPE Financing”). At two closings occurring on December 31, 2024 and January 14, 2025, we issued to the PIPE investors an aggregate of (i) 1,775,750 shares of Series A Preferred Stock and (ii) Series A Warrants initially exercisable into 1,775,750 shares of common stock. The gross proceeds from the PIPE Financing, before deducting transaction fees and other estimated PIPE Financing expenses, were approximately $7,103,000.

Current wording

On December 24, 2024, we entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain institutional and accredited investors (collectively, the “Purchasers”), substantially all of whom were existing stockholders of our company, pursuant to which we agreed to issue and sell to the Purchasers immediately separable units (the “Units”), with each Unit being comprised of (i) one share of Series A senior convertible preferred stock (“Series A Preferred Stock”) and (ii) a warrant to purchase one share of common stock (each, a “Series A Warrant” and such shares, the “Warrant Shares”), at a price per Unit of $4.00, for aggregate gross proceeds of not less than $6 million and not more than $10 million (the “PIPE Financing”). At two closings occurring on December 31, 2024 and January 14, 2025, we issued to the PIPE investors an aggregate of (i) 1,775,750 shares of Series A Preferred Stock and (ii) Series A Warrants initially exercisable into 1,775,750 shares of common stock. The gross proceeds from the PIPE Financing, before deducting transaction fees and other estimated PIPE Financing expenses, were approximately $7,103,000.

Previous wording

Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline”), acted as exclusive placement agent for the issuance and sale of the securities in the PIPE Financing. Weagreed to pay Brookline an aggregate cash fee (the “Cash Fee”) equal to (i) 7% of the gross proceeds received byus from the sale of the securities in the PIPE Financing to Purchasers other than certain Purchasers identified on a schedule thereto (“Reduced Fee Purchasers”) plus (ii) 3% of the gross proceeds received byus from the sale of the securities in the PIPE Financing to Reduced Fee Purchasers, plus expenses; provided that Ceros Financial Services, Inc., Brookline’s selected dealer for the PIPE Financing (“Ceros”), is entitled to up to 33.3% of the Cash Fee.

Current wording

Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline”), acted as exclusive placement agent for the issuance and sale of the securities in the PIPE Financing. We agreed to pay Brookline an aggregate cash fee (the “Cash Fee”) equal to (i) 7% of the gross proceeds received by us from the sale of the securities in the PIPE Financing to Purchasers other than certain Purchasers identified on a schedule thereto (“Reduced Fee Purchasers”) plus (ii) 3% of the gross proceeds received by us from the sale of the securities in the PIPE Financing to Reduced Fee Purchasers, plus expenses; provided that Ceros Financial Services, Inc., Brookline’s selected dealer for the PIPE Financing (“Ceros”), is entitled to up to 33.3% of the Cash Fee.

Previous wording

In addition, weagreed to pay Brookline or its designee a fee in the form of warrants to purchase shares of common stock (the “Agent Warrants”). The Agent Warrants are initially exercisable into a number of shares of common stock equal to (i) 7% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred Stock issued to Purchasers other than Reduced Fee Purchasers in the PIPE Financing plus (ii) 3% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred Stock issuedto the Reduced Fee Purchasers in the PIPE Financing; provided that, Ceros is entitled to up to 33.3% of the Agent Warrants. The terms of the Agent Warrants are substantially similar to the terms of the Series A Warrants. At two closings occurring on December 31, 2024 and January 14, 2025, (i) Brookline received an aggregate cash fee of $159,685 and the right to receive Agent Warrants initially exercisable for an aggregate of 39,918 shares of common stock, and (ii) Ceros received an aggregate cash fee of $79,723 and the right to receive Agent Warrants initially exercisable for an aggregate of 19,930 shares of common stock.

Current wording

In addition, we agreed to pay Brookline or its designee a fee in the form of warrants to purchase shares of common stock (the “Agent Warrants”). The Agent Warrants are initially exercisable into a number of shares of common stock equal to (i) 7% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred Stock issued to Purchasers other than Reduced Fee Purchasers in the PIPE Financing plus (ii) 3% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred Stock issued to the Reduced Fee Purchasers in the PIPE Financing; provided that, Ceros is entitled to up to 33.3% of the Agent Warrants. The terms of the Agent Warrants are substantially similar to the terms of the Series A Warrants. At two closings occurring on December 31, 2024 and January 14, 2025, (i) Brookline received an aggregate cash fee of $159,685 and the right to receive Agent Warrants initially exercisable for an aggregate of 39,918 shares of common stock, and (ii) Ceros received an aggregate cash fee of $79,723 and the right to receive Agent Warrants initially exercisable for an aggregate of 19,930 shares of common stock.

Previous wording

Because the issuance of the Ayala Consideration Shares would have required us to issue more than 19.99% of our outstanding common stock immediately prior to such issuance (the “NYSE Ownership Limitation”), we issued to Ayala (i) 2,164,215 shares of common stock, and (ii) a warrant to purchase 2,166,381 shares of common stock (the “Ayala Warrant” and the shares of common stock issuable thereunder, the “Ayala Warrant Shares”). Once we obtain stockholder approval in accordance with NYSE American LLC Company Guide Section 713, we will subsequently issue to Ayala the remaining 444,041 shares of common stock (the “Ayala Additional Consideration Shares”), except that, if at that time, the number of shares of common stock beneficially owned by Ayala would exceed 9.99% of the number of shares of our common stock then outstanding, Ayala has the right to require us to issue, in lieu of such shares, a warrant to purchase 444,041 on substantially the same terms of the Ayala Warrant.

Current wording

Because the issuance of the Ayala Consideration Shares would have required us to issue more than 19.99% of our outstanding common stock immediately prior to such issuance (the “NYSE Ownership Limitation”), we issued to Ayala (i) 2,164,215 shares of common stock, and (ii) a warrant to purchase 2,166,381 shares of common stock (the “Ayala Warrant” and the shares of common stock issuable thereunder, the “Ayala Warrant Shares”). On October 21, 2025, we obtained stockholder approval in accordance with NYSE American LLC Company Guide Section 713 and subsequently issued to Ayala the remaining 444,041 shares of common stock (the “Ayala Additional Consideration Shares”).

Previous wording

On July 11, 2025, we completed a final closing of a warrant exercise inducement and exchange offer (the “Offering”). The Offering was made to holders (the “Holders”) of certain of our existing warrants to purchase shares of our common stock, having a then current exercise price of $1.12 per share, originally issued to the Holders pursuant to the PIPE Purchase Agreement (the “Existing Warrants”), during the period beginning on June 20, 2025 and ending at 5:00 p.m., Eastern time, on July 10, 2025 (the “Inducement Period”).

Current wording

On July 11, 2025, we completed a final closing of a warrant exercise inducement and exchange offer (the “First Offering”). On September 2, 2025, we closed on a second warrant exercise inducement and exchange offer (the “Second Offering” and, together with the First Offering, the “Offerings”). The First Offering and Second Offering were made to holders (the “Holders”) of certain of our existing warrants to purchase shares of our common stock, having a then current exercise price of $1.12 per share, originally issued to the Holders pursuant to the PIPE Purchase Agreement (the “Existing Warrants”), during the period beginning on June 20, 2025 and ending on July 10, 2025, with respect to the First Offering (the “First Inducement Period”), and during the period beginning on August 29, 2025 and ending on September 1, 2025, with respect to the Second Offering (the “Second Inducement Period” and, together with the First Inducement Period, the “Inducement Periods”).

Previous wording

During the Inducement Period, we entered into inducement offer letter agreements (the “Inducement Letters”) with the Holders of Existing Warrants, pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 3,764,995 shares of our common stock in consideration of our agreement to issue new warrants (the “New Warrants”) to purchase up to an aggregate of 3,764,995 shares of our common stock (the “New Warrant Shares”) at an exercise price of $3.00 per share, subject to adjustment as provided therein. The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Current wording

During the Inducement Periods, we entered into inducement offer letter agreements (the “Inducement Letters”) with the Holders of Existing Warrants, pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 4,566,391 shares of our common stock in consideration of our agreement to issue new warrants (the “New Warrants”) to purchase up to an aggregate of 4,566,391 shares of our common stock (the “New Warrant Shares”) at an exercise price of $3.00 per share, subject to adjustment as provided therein. The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Previous wording

We engaged an SEC registered broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection with the Offering and agreed to pay the Solicitation Agent a cash fee equal to 5.0% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the Inducement Period. We also agreed to pay the Solicitation Agent up to $15,000 for its reasonable legal and other expenses.

Current wording

We engaged an SEC registered broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection with the Offerings and agreed to pay the Solicitation Agent a cash fee equal to (i) 5.0% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the First Inducement Period and (ii) 1.5% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the Second Inducement Period. We also agreed to pay the Solicitation Agent up to $15,000 for its legal and other expenses.

Previous wording

The gross proceeds to us from the Offering, before deducting transaction fees and other estimated Offering expenses, were approximately $4,216,794. We intend to use the net proceeds to support U.S. and international regulatory and pre-commercial efforts aimed at securing marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma, advance strategic alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

Current wording

The gross proceeds to us from the Offerings, before deducting transaction fees and other estimated Offering expenses, were approximately $6,398,358. We are using the net proceeds from the Offerings to support U.S. and international regulatory and pre-commercial efforts aimed at securing marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma, advance strategic alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

Previous wording

We also agreed to file a registration statement on Form S-3 (or other appropriate form, including on Form S-1, if we are not then eligible to register securities on Form S-3) (the “Resale Registration Statement”) providing for the resale of the shares of common stock issued or issuable upon exercise of the New Warrants, within 30 calendar days of the final closing, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 60 calendar days (or within 90 calendar days in case of “full review” of the Resale Registration Statement by the SEC) following the initial filing of such Resale Registration Statement and to keep the Resale Registration Statement effective at all times until the earlier of (i) the time no holder of the New Warrants owns any New Warrants or New Warrant Shares and (ii) the Delegend Date (as defined in the Inducement Letters).

Current wording

We also agreed to file a registration statement on Form S-3 (or other appropriate form, including on Form S-1, if we are not then eligible to register securities on Form S-3) (the “Resale Registration Statement”) providing for the resale of the shares of common stock issued or issuable upon exercise of the New Warrants, within 30 calendar days of July 11, 2025, with respect to the First Offering, and September 2, 2025, with respect to the Second Offering, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 60 calendar days (or within 90 calendar days in case of “full review” of the Resale Registration Statement by the SEC) following the initial filing of such Resale Registration Statement and to keep the Resale Registration Statement effective at all times until the earlier of (i) the time no holder of the New Warrants owns any New Warrants or New Warrant Shares and (ii) the Delegend Date (as defined in the Inducement Letters).

Previous wording

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Previous wording

Critical accounting policies are those that, in management’s view, are most important to the portrayal of a company’s financial condition and results of operations and most demanding on their calls on judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. While our significant accounting policies are described in more detail in Note 2 to our financial statements appearing elsewhere in this annual report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

Current wording

Critical accounting policies are those that, in management’s view, are most important to the portrayal of a company’s financial condition and results of operations and most demanding on their calls on judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing elsewhere in this annual report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Previous wording

***Revenue.***We did not recognize revenues for the six months ended June 30, 2025 and 2024.

Current wording

***Revenue.***We did not recognize revenues for the nine months ended September 30, 2025 and 2024.

Previous wording

Three and Six Months Ended June 30, 2025 Compared to Three and Six Months Ended June 30, 2024

Current wording

Three and Nine Months Ended September 30, 2025 Compared to Three and Nine Months Ended September 30, 2024

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024:

Previous wording

***Research and Development Expenses.***Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025 compared to approximately $0.8 million for the six months ended June 30, 2024. This increase was primarily due to an increase in vendor expenses associated with our Phase IIb clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with out OST-tADC platform technology.

Current wording

***Research and Development Expenses.***Research and development expenses were approximately $7.6 million for the nine months ended September 30, 2025 compared to approximately $2.0 million for the nine months ended September 30, 2024. This increase was primarily due to an increase in vendor expenses associated with our pursuit for FDA approval on our Phase IIb clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with our OST-tADC platform technology.

Previous wording

Research and development expenses were approximately $2.5 million for the three months ended June 30, 2025 compared to approximately $0.4 million for the three months ended June 30, 2024. This increase was primarily due to an increase in vendor expenses associated with our Phase IIb clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with out OST-tADC platform technology.

Current wording

Research and development expenses were approximately $3.8 million for the three months ended September 30, 2025 compared to approximately $1.2 million for the three months ended September 30, 2024. This increase was primarily due to an increase in vendor expenses associated with our Phase IIb clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with our OST-tADC platform technology.

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2025 and 2024:

Previous wording

For the six months ended June 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and staff payroll fees. In 2025, such expenses were primarily lab fees and related clinical support of approximately $1.0 million attributed to our Phase IIb clinical trial preparation, advisor fees of $1.9 million, and legal costs of $0.1 million as we completed IND-enabling studies. OST-tADC related direct research and development expenses were approximately $0.0 million and $0.0 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

For the nine months ended September 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and staff payroll fees. In 2025, such expenses were primarily lab fees and related clinical support of approximately $1.0 million attributed to our Phase IIb clinical trial preparation, advisor fees of $5.2 million, and legal costs of $0.1 million as we completed IND-enabling studies. OST-tADC related direct research and development expenses were approximately $0.0 million and $0.0 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

For the three months ended June 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and staff payroll fees. In 2025, such expenses were primarily lab fees and related clinical support of approximately $0.6 million attributed to our Phase IIb clinical trial preparation, and advisor fees of $1.4 million, as we completed IND-enabling studies. OST-tADC related direct research and development expenses were approximately $0.0 million and $0.0 million for the three months ended June 30, 2025 and 2024, respectively.

Current wording

For the three months ended September 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and staff payroll fees. In 2025, such expenses were primarily lab fees and related clinical support of approximately $0.03 million attributed to our Phase IIb clinical trial preparation, and advisor fees of $3.3 million, as we completed IND-enabling studies. OST-tADC related direct research and development expenses were approximately $0.0 million and $0.0 million for the three months ended September 30, 2025 and 2024, respectively.

Previous wording

***General and Administrative Expenses.***General and administrative expenses for the six months ended June 30, 2025 were approximately $6.0 million compared to $0.7 million for the six months ended June 30, 2024. These expenses were primarily attributed to marketing and investor relations costs and advisory fees associated with the PIPE Financing and equity line of credit.

Current wording

***General and Administrative Expenses.***General and administrative expenses for the nine months ended September 30, 2025 were approximately $9.2 million compared to $1.9 million for the nine months ended September 30, 2024. These expenses were primarily attributed to marketing and investor relations costs and advisory fees associated with the PIPE Financing and equity line of credit.

Previous wording

General and administrative expenses for the three months ended June 30, 2025 were approximately $2.3 million compared to $0.4 million for the three months ended June 30, 2024. These expenses were primarily attributed to marketing and investor relations costs and advisory fees associated with the PIPE Financing and equity line of credit.

Current wording

General and administrative expenses for the three months ended September 30, 2025 were approximately $3.1 million compared to $1.2 million for the three months ended September 30, 2024. These expenses were primarily attributed to marketing and investor relations costs and advisory fees associated with the PIPE Financing and equity line of credit.

Previous wording

***Interest Expense.***Interest expense for the six months ended June 30, 2025 was approximately $0.0 million compared to $1.6 million for the six months ended June 30, 2024.

Current wording

***Interest Expense.***Interest expense for the nine months ended September 30, 2025 was approximately $0.0 million compared to $2.0 million for the nine months ended September 30, 2024.

Previous wording

Interest expense for the three months ended June 30, 2025 was approximately $0.0 million compared to $0.8 million for the three months ended June 30, 2024.

Current wording

Interest expense for the three months ended September 30, 2025 was approximately $0.0 million compared to $0.4 million for the three months ended September 30, 2024.

Previous wording

The Series A preferred stock coupon dividend requirement of $31,250 for the six months ended June 30, 2024 represents an expense that terminated during the period ended March 31, 2024 upon the conversion of our old Series A preferred shares into shares of our common stock. We issued Series A convertible preferred stock and detachable warrants on December 31, 2024 and January 14, 2025. The adjustment of the fair value of the warrant liability was $1.4 million and $0.0 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

The Series A preferred stock coupon dividend requirement of $31,250 for the nine months ended September 30, 2024 represents an expense that terminated during the period ended March 31, 2024 upon the conversion of our old Series A preferred shares into shares of our common stock. We issued Series A convertible preferred stock and detachable warrants on December 31, 2024 and January 14, 2025. The adjustment of the fair value of the warrant liability was $1.4 million and $0.0 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our product candidates. For the six months ended June 30, 2025 and 2024, we reported a net loss of approximately $8.4 million and $3.0 million, respectively, and had an accumulated deficit of approximately $47 million and $33 million, respectively. We expect to incur significant expenses at an increasing rate and increasing operating losses for the foreseeable future. For the three months ended June 30, 2025 and 2024, we reported a net loss of approximately $4.5 million and $1.6 million, respectively.

Current wording

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our product candidates. For the nine months ended September 30, 2025 and 2024, we reported a net loss of approximately $15.3 million and $5.9 million, respectively, and had an accumulated deficit of approximately $55 million and $38 million, respectively. We expect to incur significant expenses at an increasing rate and increasing operating losses for the foreseeable future. For the three months ended September 30, 2025 and 2024, we reported a net loss of approximately $6.9 million and $2.9 million, respectively.

Previous wording

As of June 30, 2025 and December 31, 2024, we had cash of approximately $2.8 million and $5.5 million, respectively. We have funded our operations to date primarily from the sale of our convertible notes and Series A securities in our private placements and cash exercises of our warrants, as well as the sale of our common stock in our initial public offering, which have provided total gross proceeds of $37.1 million as of June 30, 2025. We believe that the net proceeds from our private placements and initial public offering, together with our existing cash, will enable us to fund our operating expenses and capital expenditure requirements for the next nine to 12 months.

Current wording

As of September 30, 2025 and December 31, 2024, we had cash of approximately $1.9 million and $5.5 million, respectively. We have funded our operations to date primarily from the sale of our convertible notes and Series A securities in our private placements and cash exercises of our warrants, as well as the sale of our common stock in our initial public offering, which have provided total gross proceeds of $41.1 million as of September 30, 2025. We believe that the net proceeds from our private placements and initial public offering, together with our existing cash, will enable us to fund our operating expenses and capital expenditure requirements for the next nine to twelve months.

Previous wording

The following table summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024:

Previous wording

During the six months ended June 30, 2025 and 2024, operating activities used approximately $5.9 million and $1.5 million of cash, respectively, resulting from our net loss of approximately $8.4 million and $3.0 million, respectively, offset by net non-cash charges of approximately $1.4 million and $1.1 million, respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately $1.2 million and $0.4 million, respectively.

Current wording

During the nine months ended September 30, 2025 and 2024, operating activities used approximately $10.5 million and $4.9 million of cash, respectively, resulting from our net loss of approximately $15.3 million and $5.9 million, respectively, offset by net non-cash charges of approximately $2.6 million and $1.4 million, respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately $2.1 million and ($0.4) million, respectively.

Previous wording

Net cash provided by changes in our operating assets and liabilities for the six months ended June 30, 2025 and 2024 consisted primarily of an increase (decrease) in accounts payable of approximately $1.1 million and $(0.05) million, respectively, an increase in accrued interest of approximately $0.0 million and $0.5 million, respectively, and a change in prepaid expenses of approximately $0.4 million and $(0.0) million, respectively. The change in accrued expenses of approximately $(0.15) million and $0.3 million was a portion of the use.

Current wording

Net cash provided by changes in our operating assets and liabilities for the nine months ended September 30, 2025 and 2024 consisted primarily of an increase (decrease) in accounts payable of approximately $1.7 million and $(0.94) million, respectively, an increase in accrued interest of approximately $0.0 million and $0.6 million, respectively, and a change in prepaid expenses of approximately $0.7 million and $(0.03) million, respectively. The change in accrued expenses of approximately $(0.13) million and $0.13 million was a portion of the use.

Previous wording

Non-cash charges for the six months ended June 30, 2025 and 2024 were primarily the result of the changes in the fair value of our warrant liability of $(1.4) million and $0.0 million, respectively, combined with our common stock shares issued for service and our stock-based compensation of approximately $2.7 million and $0.0 million, respectively. Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses and other current assets in all periods were generally due to growth in our business, the advancement of our research programs and the timing of vendor invoicing and payments.

Current wording

Non-cash charges for the nine months ended September 30, 2025 and 2024 were primarily the result of the changes in the fair value of our warrant liability of $(1.4) million and $0.0 million, respectively, combined with our common stock shares issued for services and our stock-based compensation of approximately $3.3 million and $0.0 million, respectively. Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses and other current assets in all periods were generally due to growth in our business, the advancement of our research programs and the timing of vendor invoicing and payments.

Previous wording

During the six months ended June 30, 2025 and 2024, net cash used in investing activities was approximately $0.4 million and $0.0 million, respectively.

Current wording

During the nine months ended September 30, 2025 and 2024, net cash used in investing activities was approximately $0.4 million and $0.0 million, respectively.

Previous wording

For the six months ended June 30, 2025 and 2024, net cash provided by financing activities was approximately $3.5 million and $1.6 million, respectively. For the six months ended June 30, 2025, we saw funds raised from our Series A securities offering of $1.1 million and our warrant inducement exercise offering of $2.5 million.

Current wording

For the nine months ended September 30, 2025 and 2024, net cash provided by financing activities was approximately $7.3 million and $6.7 million, respectively. For the nine months ended September 30, 2025, we saw funds raised from our Series A securities offering of $1.1 million and our warrant inducement exercise offering of $6.3 million.

Previous wording

On July 11, 2025, we completed the final closing of the Offering. During the Inducement Period, we entered into Inducement Letters with the Holders of Existing Warrants, pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 3,764,995 shares of our common stock in consideration of our agreement to issue New Warrants to purchase up to an aggregate of 3,764,995 shares of our common stock at an exercise price of $3.00 per share, subject to adjustment as provided therein. The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Current wording

On July 11, 2025, we completed the final closing of the First Offering. On September 2, 2025, we closed on the Second Offering. During the Inducement Periods, we entered into Inducement Letters with the Holders of Existing Warrants, pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 4,566,391 shares of our common stock in consideration of our agreement to issue New Warrants to purchase up to an aggregate of 4,566,391 shares of our common stock at an exercise price of $3.00 per share, subject to adjustment as provided therein. The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Previous wording

We engaged an SEC registered broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection with the Offering and agreed to pay the Solicitation Agent a cash fee equal to 5.0% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the Inducement Period. We also agreed to pay the Solicitation Agent up to $15,000 for its reasonable legal and other expenses.

Current wording

We engaged the Solicitation Agent to act as our exclusive warrant solicitation agent in connection with the Offerings and agreed to pay the Solicitation Agent a cash fee equal to (i) 5.0% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the First Inducement Period and (ii) 1.5% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the Second Inducement Period. We also agreed to pay the Solicitation Agent up to $15,000 for its legal and other expenses.

Previous wording

The gross proceeds to us from the Offering, before deducting transaction fees and other estimated Offering expenses, were approximately $4,216,794. We intend to use the net proceeds to support U.S. and international regulatory and pre-commercial efforts aimed at securing marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma, advance strategic alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

Current wording

The gross proceeds to us from the Offerings, before deducting transaction fees and other estimated Offering expenses, were approximately $6,798,159. We are using the net proceeds from the Offerings to support U.S. and international regulatory and pre-commercial efforts aimed at securing marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma, advance strategic alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

Previous wording

***Advaxis.*In November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.) (“Advaxis”), a clinical-stage biotechnology company focused on the development and commercialization of proprietaryLm (Listeria monocytogenes)-LLO (Listeriolysin O) cancer immunotherapies. Pursuant to this agreement, Advaxis granted a license to us that allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2, our lead product candidate (OST-HER2). The agreement was subsequently amended in April 2021 to modify the payment amounts for Milestones 2 and 3 listed in the table below. Under the terms of the amended agreement, we are required to pay to Advaxis (i) a one-time, non-refundable payment of $1,550,000 (the “License Commencement Payment”) and (ii) certain amounts based on the achievement of the milestones described in the payment schedule below. For the six months ended June 30, 2025 and for the year ended December 31, 2024, no payments were made. A $400,000 payment was made to Ayala, together with payment of stock consideration, in connection with our purchase of the HER2 Assets on April 9, 2025, terminating this license agreement. The payment schedule for milestones and corresponding payment amounts were as set forth below.

Current wording

***Advaxis.*In November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.) (“Advaxis”), a clinical-stage biotechnology company focused on the development and commercialization of proprietaryLm (Listeria monocytogenes)-LLO (Listeriolysin O) cancer immunotherapies. Pursuant to this agreement, Advaxis granted a license to us that allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2, our lead product candidate (OST-HER2). The agreement was subsequently amended in April 2021 to modify the payment amounts for Milestones 2 and 3 listed in the table below. Under the terms of the amended agreement, we are required to pay to Advaxis (i) a one-time, non-refundable payment of $1,550,000 (the “License Commencement Payment”) and (ii) certain amounts based on the achievement of the milestones described in the payment schedule below. For the nine months ended September 30, 2025 and for the year ended December 31, 2024, no payments were made. A $400,000 payment was made to Ayala, together with payment of stock consideration, in connection with our purchase of the HER2 Assets on April 9, 2025, terminating this license agreement. The payment schedule for milestones and corresponding payment amounts were as set forth below.

Previous wording

In addition, we have agreed to pay an annual fee to the Trustees of the University of Pennsylvania. In April 2025, the Company paid a fee of $266,317 for the six months ended June 30, 2025 for the period from April 9, 2025 through April 8, 2026.

Current wording

In addition, we have agreed to pay an annual fee to the Trustees of the University of Pennsylvania. In April 2025, the Company paid a fee of $266,317 for the nine months ended September 30, 2025.

Previous wording

***George Clinical.***In June 2020, we entered into a services agreement, as amended, with George Clinical, Inc., a clinical contract research organization. Pursuant to this agreement, we engaged George Clinical to use its clinical research services for our study entitled “An Open Label, Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma.” Under the terms of the agreement, we are required to pay to George Clinical certain fees described in the fee schedule below. The total new budget under the agreement is approximately $2,436,928. For the six months ended June 30, 2025 and 2024, we paid $0 and $86,687, respectively, to George Clinical. These payments have been recorded as research and development expenses in our Statement of Operations and Comprehensive Loss. The fee schedule for certain fees and corresponding payment amounts is set forth below.

Current wording

***George Clinical.***In June 2020, we entered into a services agreement, as amended, with George Clinical, Inc., a clinical contract research organization. Pursuant to this agreement, we engaged George Clinical to use its clinical research services for our study entitled “An Open Label, Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma.” Under the terms of the agreement, we are required to pay to George Clinical certain fees described in the fee schedule below. The total new budget under the agreement is approximately $2,436,928. For the nine months ended September 30, 2025 and 2024, we paid $0 and $86,687, respectively, to George Clinical. These payments have been recorded as research and development expenses in our Statement of Operations and Comprehensive Loss. The fee schedule for certain fees and corresponding payment amounts is set forth below.