05/18/2026 | Press release | Distributed by Public on 05/18/2026 04:05
Management's Discussion and Analysis of Financial Condition and Results of Operations.
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.
Cautionary Note Regarding Forward-Looking Statements
This report contains "forward-looking statements" (within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act")), which may include information concerning our beliefs, plans, objectives, goals, expectations, strategies, anticipations, assumptions, estimates, intentions, future events, future revenues or performance, capital expenditures and other information that is not historical information. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. When used in this report, the words "seek," "estimate," "expect," "anticipate," "project," "plan," "contemplate," "plan," "continue," "intend," "believe" and variations of such words or similar expressions are intended to identify forward-looking statements. All forward-looking statements are based upon our current expectations and various assumptions. We believe there is a reasonable basis for our expectations and beliefs, but there can be no assurance that we will realize our expectations or that our beliefs will prove to be correct.
There are a number of risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements contained in this report. Examples of risks and uncertainties that could cause actual results to differ materially from historical performance and any forward-looking statements include, but are not limited to, the risks described under the section below titled "Risk Factors" and in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 31, 2026, as well as any subsequent filings with the SEC.
There may be other factors of which we are currently unaware or which we currently deem immaterial that may cause our actual results to differ materially from the forward-looking statements. All forward-looking statements attributable to us or persons acting on our behalf apply only as of the date they are made and are expressly qualified in their entirety by the cautionary statements included in this report. Except as may be required by law, we undertake no obligation to publicly update or revise any forward-looking statement to reflect events or circumstances occurring after the date they were made or to reflect the occurrence of unanticipated events, or otherwise.
We make available through our Internet website, free of charge, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to such reports and other filings made by us with the SEC, as soon as practicable after we electronically file such reports and filings with the SEC. Our website address is www.ostherapies.com. The information contained on our website is not incorporated by reference into this report.
Overview
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 the first quarter of 2025, we announced that our Phase IIb clinical trial achieved its primary endpoint with statistical significance. In October 2025, we announced final two-year overall survival data from the Phase IIb trial, in which 75% (27 of 36 evaluable patients) of OST-HER2-treated patients achieved two-year overall survival from the most recent pulmonary resection, compared with 40% in historical control patients (p < 0.0001). OST-HER2 was observed to be well-tolerated in the study. In January 2026, we announced positive immune biomarker data from the Phase IIb trial indicating that activation of immune blood biomarkers in the interferon gamma pathway correlated with, and was predictive of, overall survival, distinguishing long-term survivors (≥ two years) from short-term survivors (< one year). These biomarker findings are based on exploratory analyses and have not been validated as surrogate endpoints for clinical benefit.
We have engaged in ongoing regulatory interactions with the FDA, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA) regarding the clinical and biomarker data for OST-HER2 in recurrent, fully resected pulmonary metastatic Osteosarcoma. We anticipate submitting the clinical Biologics License Application (BLA) module following an expected Type B meeting with the FDA in the second quarter of 2026 and completing conditional Marketing Authorization Application (MAA) submissions to both the MHRA and the EMA in the second quarter of 2026. We also anticipate releasing additional biomarker data in the second quarter of 2026 to further characterize immune pathway activation and its relationship to clinical outcomes. We expect to initiate confirmatory clinical studies in the third quarter of 2026 in support of conditional approval pathways. If OST-HER2 receives approval under the FDA's Accelerated Approval Program prior to September 30, 2029, we would become eligible to receive a Priority Review Voucher under the Rare Pediatric Disease Designation Program.
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.
We also own rights to an OST-Tunable Drug Conjugate (OST-tADC) platform, a next generation antibody-drug conjugate (ADC) silicone dioxide linker technology. "Tunable" is a term used in drug development that refers to the properties that can be influenced by chemical modifications, and "antibody-drug conjugate" or ADC is a term used to describe a drug made up of a monoclonal antibody attached to a cytotoxic payload, or a highly active and toxic pharmaceutical molecule, through chemical linkers. The ADC links an antibody that can home in on a targeted tumor to deploy the cytotoxic payload or toxic agent against the tumor. Furthering our founding mission, we intend to investigate clinical indications for OST-tADC in Osteosarcoma and other solid tumors.
Recent Developments
2026 Warrant Exercise Inducement and Exchange Offer
On January 14, 2026, we closed on a warrant exercise inducement and exchange offer (the "2026 Inducement Offering"). The 2026 Inducement Offering was made to less than 10 accredited investors that held certain of our existing warrants to purchase up to an aggregate of 5,382,148 shares of our common stock having a then current exercise price of $3.00 or $2.10 per share during the period beginning January 10, 2026 and ending at 11:59 p.m., Eastern time, on March 2, 2026 (the "2026 Inducement Period").
During the 2026 Inducement Period, we entered into inducement offer letter agreements with such holders, pursuant to which such holders exercised for cash their existing warrants to purchase an aggregate of 2,499,558 shares of our common stock at a reduced exercise price of $1.40 per share and in exchange we issued to such holders new warrants (the "2026 Warrants") to purchase up to an aggregate of 2,499,558 shares of our common stock (the "2026 Warrant Shares") at an exercise price of $1.40 per share, subject to adjustment as provided therein. The 2026 Warrants are exercisable for a period of five years from the date of issuance.
We engaged Ceros Financial Services, Inc. ("Ceros") to act as our exclusive warrant solicitation agent in connection with the 2026 Inducement Offering and paid Ceros a cash fee equal to 8.0% of the total gross cash proceeds received from the exercise by the holders of their respective warrants during the 2026 Inducement Period and in connection with the 2026 Inducement Offering. We also paid Ceros $25,000 for its legal and other expenses.
The gross proceeds to us from the 2026 Inducement Offering, before deducting transaction fees and other 2026 Inducement Offering expenses, were approximately $3.5 million. We are using the net proceeds from the 2026 Inducement Offering 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, lung metastatic Osteosarcoma, provide funding for our wholly owned subsidiary OS Animal Health's proposed spinoff transaction preparations, and for general corporate purposes.
Privately Negotiated Warrant Exercise Inducement and Exchange Agreements
From January 10, 2026 through February 2026, we entered into privately negotiated inducement offer letters, pursuant to which certain holders of our existing warrants having a then current exercise price of $3.00 or $2.10 per share exercised for cash their existing warrants to purchase an aggregate of 123,216 shares of our common stock at a reduced exercise price of $1.40 per share and in exchange we issued 2026 Warrants to purchase up to an aggregate of 123,216 shares of our common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein (such transactions, the "Private Inducement Transactions"). The 2026 Warrants are exercisable for a period of five years from the date of issuance. We received gross proceeds of approximately $172,502 from the Private Inducement Transactions.
2026 Bridge Financing
On March 4, 2026, pursuant to a securities purchase agreement (the "Bridge SPA"), we issued to certain accredited investors in a private placement transaction (i) 10.0% original issue discount unsecured convertible promissory notes in an aggregate principal amount of $2,200,000 (the "Bridge Notes") and (ii) warrants to purchase up to an aggregate of 1,666,667 shares of our common stock (the "Bridge Warrants" and such private placement transaction, the "Bridge Financing"), for aggregate gross proceeds of $2,000,000, before deducting placement agent fees and other Bridge Financing expenses. The Bridge Notes were scheduled to mature on March 4, 2027 and accrued interest at a rate of 4.0% per annum. The Bridge Warrants were immediately exercisable upon issuance, expire five years from the date of issuance and have an exercise price of $1.40 per share, subject to adjustment as provided therein.
The Bridge Notes were sold at a 10% original issue discount, such that for each $100,000 invested by a purchaser, such purchaser received a Bridge Note in the principal amount of $110,000. The Bridge Notes were convertible into shares of our common stock or other of our securities under certain circumstances. Upon the consummation of a "Qualified Offering," defined as a registered public offering or registered direct offering resulting in at least $2.5 million in gross proceeds from new money investments, the outstanding principal, together with all accrued and unpaid interest, were to automatically convert into the securities sold in such offering at the offering price. Additionally, prior to any such Qualified Offering or repayment of the Bridge Notes, holders could elect to convert the Bridge Notes, in whole or in part, into shares of our common stock at a conversion price equal to 90% of the average daily volume-weighted average price of our common stock during the 10 trading days immediately preceding the holder's conversion notice, subject to adjustment.
Upon consummation of the 2026 Registered Direct Offering (as defined below), the Bridge Notes, together with all accrued and unpaid interest thereon, automatically converted into an aggregate of 1,576,311 shares of our common stock and warrants to purchase up to 1,576,311 shares of our common stock. The warrants were issued on the same terms as the common warrants issued in the 2026 Registered Direct Offering.
We are using the net proceeds of the Bridge Financing to fund clinical development activities, including ongoing and planned clinical trials, and advance our research and development programs, as well as for working capital and general corporate purposes.
We engaged Ceros to act as the exclusive placement agent for the Bridge Financing. In connection with the Bridge Financing, we paid to Ceros (a) a cash fee equal to 7.0% of the aggregate gross cash proceeds received by us in connection with the Bridge Financing and (b) a one-time expense reimbursement of $25,000 for its legal and other expenses incurred in connection with the Bridge Financing.
2026 Registered Direct Offering
On April 2, 2026, we completed a registered direct offering, pursuant to which we offered and sold to accredited investors an aggregate of 2,505,073 shares of our common stock and, in lieu thereof, pre-funded warrants to purchase up to 1,250,893 shares of our common stock, and accompanying common warrants to purchase up to 3,755,966 shares of our common stock (the "2026 Registered Direct Offering"). The combined purchase price for each share and common warrant in the 2026 Registered Direct Offering was $1.40, and the purchase price for each pre-funded warrant and common warrant in the 2026 Registered Direct Offering was $1.399, which was equal to the per share and common warrant purchase price, minus $0.001. We received net proceeds from the 2026 Registered Direct Offering of approximately $4.7 million. We are using the net proceeds to fund clinical development activities, including ongoing and planned clinical trials, advance our research and development programs, as well as for working capital and other general corporate purposes.
In connection with the 2026 Registered Direct Offering, Ceros acted as our exclusive placement agent. We paid Ceros a cash fee equal to 7.0% of the gross proceeds raised in the 2026 Registered Direct Offering. We also reimbursed Ceros up to $70,000 for its reasonable and documented out-of-pocket accountable expenses and up to $20,000 for its non-accountable expenses. We also issued to Ceros's designees warrants to purchase up to an aggregate of 187,798 shares of our common stock. The placement agent warrants have an exercise price of $1.54 per share, are exercisable beginning September 2, 2026 and expire five years from April 2, 2026.
Critical Accounting Policies and Estimates
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.
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. Our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing elsewhere in this annual report. There were no critical accounting policies as of March 31, 2026.
Components of Our Results of Operations
Revenue. We did not recognize revenues for the three months ended March 31, 2026 and 2025.
Operating Expenses. Our operating expenses are comprised primarily of research and development expenses (including licensing costs) and general and administrative expenses.
Research and Development Expenses. Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:
| ● | personnel-related costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions; |
| ● | expenses incurred in connection with our research programs, including under agreements with third parties, such as consultants and contractors and CROs; | |
| ● | costs incurred in obtaining technology licenses and asset purchases are charged to licensing costs if the technology licensed has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which has no alternative future use. The licenses purchased by us require substantial completion of research and development and regulatory and marketing approval efforts in order to reach technological feasibility; |
| ● | the cost of developing and scaling our manufacturing process and manufacturing drug substance and drug product for use in our research and preclinical and clinical studies, including under agreements with third parties, such as consultants and contractors and contract development and manufacturing organizations (CDMOs); and |
| ● | the cost of laboratory supplies and research materials. |
We track our direct external research and development expenses on a program-by-program basis. These consist of costs that include fees, reimbursed materials, and other costs paid to consultants, contractors, CDMOs, and CROs in connection with our preclinical, clinical and manufacturing activities. We do not allocate employee costs, costs associated with our discovery efforts, and facilities expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple programs and, as such, are not separately classified.
We expect that our research and development expenses will increase substantially as we advance OST-HER2 and OST-tADC into clinical development and expand our discovery, research and preclinical activities.
General and Administrative Expenses. General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include professional fees for legal, consulting, investor and public relations and accounting and audit services.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.
Interest Expense. Interest expense comprises accretion of interest on the Bridge Notes as well as amortization of related debt issuance costs.
Income Taxes. Since our inception, we have not recognized income tax benefits for the net operating losses ("NOLs") incurred or the research and development ("R&D") tax credits generated each year due to uncertainty regarding the realization of these benefits.
As of December 31, 2025 and 2024, we had federal NOLs of $33,561,091 and $22,236,580, respectively. Our 2019 NOL carryforward of $292,144 will expire in tax years through 2037. NOLs generated in tax years 2020 and later may carry forward indefinitely; however, the deductibility of such NOLs is subject to certain limitations under the Code. Accordingly, we have established a full valuation allowance to offset our deferred tax assets due to uncertainty regarding the realization of these benefits.
Our issuances of common stock have resulted in ownership changes as defined by Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"); however, we have not yet performed a formal Section 382 study, and it is possible that a future analysis in 2026 could conclude that a substantial portion, or potentially all, of our NOL and R&D tax credit carryforwards may be limited or rendered unusable under Sections 382 and 383 of the Code. As a result, a portion of these carryforwards could expire unused. We are subject to U.S. federal tax examinations for the year 2021, given that NOL carryforwards from 2019 and subsequent years may be applied to current or future tax returns.
Results of Operations
Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025
The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:
|
For the Three Months Ended |
For the Three Months Ended |
|||||||
| March 31, | March 31, | |||||||
| 2026 | 2025 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | 7,351,723 | $ | 1,309,155 | ||||
| General and administrative | 2,816,215 | 3,690,331 | ||||||
| Loss from operations | (10,167,938 | ) | (4,999,486 | ) | ||||
| OTHER (EXPENSE) INCOME | ||||||||
| Interest income | 45 | 66 | ||||||
| Interest expense | (75,344 | ) | - | |||||
| Non-operating expenses | (153,594 | ) | - | |||||
| Change in fair value of warrant liability | - | 1,122,561 | ||||||
| TOTAL OTHER (EXPENSE) INCOME | (228,893 | ) | 1,122,627 | |||||
| NET LOSS | (10,396,831 | ) | (3,876,859 | ) | ||||
Research and Development Expenses. Research and development expenses were approximately $7.4 million for the three months ended March 31, 2026 compared to approximately $1.3 million for the three months ended March 31, 2025. This increase was primarily due to an increase in vendor expenses associated with our Phase IIb clinical trial, as we compiled data to submit to various governmental agencies, and a decrease in vendor expenses associated with our OST-tADC platform technology.
General and Administrative Expenses. General and administrative expenses for the three months ended March 31, 2026 were approximately $2.8 million compared to $3.7 million for the three months ended March 31, 2025. These expenses were primarily attributed to marketing and investor relations costs, advisory fees and other compensation related expenses.
Interest Expense. Interest expense for the three months ended March 31, 2026 was approximately $0.1 million compared to $0.0 million for the three months ended March 31, 2025. Interest expense related to amortization of debt issuance costs and accretion of interest on the Bridge Convertible Notes.
Non-Operating Expense. Non-operating expense for the three months ended March 31, 2026 was approximately $0.2 million compared to $0.0 million for the three months ended March 31, 2025 and related to losses on foreign currency transactions.
Change in Fair Value of Warrant. The Series A warrants issued in connection with our PIPE financing in December 2024 and January 2025 were reclassified from liability to equity in April 2025. The adjustment of the fair value of the warrant liability was $0.0 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively.
Liquidity and Capital Resources
Operating Losses
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 three months ended March 31, 2026 and 2025, we reported a net loss of approximately $10.4 million and $3.9 million, respectively, and had an accumulated deficit of approximately $77.4 million and $67.2 million, respectively. We expect to incur significant expenses at an increasing rate and increasing operating losses for the foreseeable future.
As of March 31, 2026 and December 31, 2025, we had cash of approximately $0.9 million and $0.3 million, respectively. To date, we have primarily funded our operations through the sale of our securities in public offerings and private placements and warrant exercise inducement and exchange transactions, generating total gross proceeds of approximately $52.3 million as of May 15, 2026. We believe that the net proceeds from these transactions, together with our existing cash, will be sufficient to fund our operating expenses and capital expenditures for at least the next twelve months.
Cash Flows
The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025:
|
Three Months Ended March 31, |
||||||||
| (In thousands) | 2026 | 2025 | ||||||
| Cash used in operating activities | $ | (4,564 | ) | $ | (3,442 | ) | ||
| Cash used in investing activities | - | (174 | ) | |||||
| Cash provided by financing activities | 5,211 | 1,053 | ||||||
| Net increase (decrease) in cash | $ | 648 | $ | (2,563 | ) | |||
Operating Activities
During the three months ended March 31, 2026 and 2025, operating activities used approximately $4.6 million and $3.4 million of cash, respectively, resulting from our net loss of approximately $10.4 million and $3.9 million, respectively, offset by net non-cash charges of approximately $1.9 million and $0.7 million, respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately $3.9 million and ($0.3) million, respectively.
Net cash provided by changes in our operating assets and liabilities for the three months ended March 31, 2026 and 2025 consisted primarily of an increase (decrease) in accounts payable of approximately $2.1 million and $(0.05) million, respectively, and an increase (decrease) in accrued expenses of approximately $1.8 million and $(0.2) million, respectively.
Non-cash charges for the three months ended March 31, 2026 and 2025 were primarily the result of the changes in the fair value of our warrant liability of $0 million and $1.1 million, respectively, combined with our common stock shares issued for services and our stock-based compensation of approximately $1.4 million and $1.3 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.
Investing Activities
During the three months ended March 31, 2026 and 2025, net cash used in investing activities was approximately $0.0 million and $(0.2) million, respectively.
Financing Activities
For the three months ended March 31, 2026 and 2025, net cash provided by financing activities was approximately $5.2 million and $1.1 million, respectively. For three months ended March 31, 2026, we saw funds raised from our warrant inducement exercise offering of $3.4 million and net proceeds from the Bridge Financing of $1.8 million.
Warrant Exercise Inducement and Exchange Offers. On July 11, 2025, we completed a final closing of a warrant exercise inducement and exchange offer. On September 2, 2025, we closed on a second warrant exercise inducement and exchange offer. On January 14, 2026, we closed on a third warrant exercise inducement and exchange offer. The first inducement offering and second inducement offering were made to holders of certain of our Series A warrants issued in connection with our PIPE financing in December 2024 and January 2025 to purchase shares of our common stock having a then current exercise price of $1.12 per share.
Pursuant to certain inducement offer letter agreements, holders of such warrants exercised for cash their warrants to purchase an aggregate of 7,154,338 shares of our common stock at the then current exercise price of $1.12 per share and in exchange we issued to such holders new warrants to purchase up to an aggregate of 7,154,338 shares of our common stock at an exercise price of $3.00 per share, subject to adjustment as provided therein.
The third inducement offering was made to less than 10 accredited investors that held warrants issued in connection with the first and second inducement offerings to purchase up to an aggregate of 5,382,148 shares of our common stock having a then current exercise price of $3.00 or $2.10 per share. Pursuant to certain inducement offer letter agreements, such holders of such warrants exercised for cash their warrants to purchase 2,499,558 shares of our common stock at a reduced exercise price of $1.40 per share and in exchange we issued to such holders new warrants to purchase up to an aggregate of 2,499,558 shares of our common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein.
We engaged a Ceros to act as our exclusive warrant solicitation agent in connection with these inducement offerings and paid Ceros a cash fee equal to 5.0%, 1.5% and 8.0% of the total gross cash proceeds received from the exercise by the holders of their respective warrants in connection with the first inducement offering, second inducement offering and third inducement offering, respectively. We also paid Ceros $15,000 and $25,000 for its reasonable legal and other expenses in connection with the first inducement offering and third inducement offering, respectively.
The gross proceeds to us from these inducement offerings, before deducting transaction fees and other offering expenses, were approximately $11.5 million. We are using the net proceeds from the inducement 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, provide funding for our wholly owned subsidiary OS Animal Health's proposed spin-off transaction preparations, and for general corporate purposes.
Privately Negotiated Warrant Exercise Inducement and Exchange Agreements. From January 10, 2026 through March 2026, we entered into privately negotiated inducement offer letters, pursuant to which certain remaining holders of warrants issued in the first and second inducement offerings exercised for cash their warrants to purchase an aggregate of 123,216 shares of our common stock at a reduced exercise price of $1.40 per share and in exchange we issued new warrants to purchase up to an aggregate of 123,216 shares of our common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein. We received gross proceeds of approximately $172,502 from the exercise of these new warrants.
2026 Bridge Financing. On March 4, 2026, pursuant to the Bridge SPA, we issued to certain accredited investors in the Bridge Financing (i) Bridge Notes in an aggregate principal amount of $2,200,000 and (ii) Bridge Warrants to purchase up to an aggregate of 1,666,667 shares of our common stock, for aggregate gross proceeds of $2,000,000, before deducting placement agent fees and other Bridge Financing expenses. The Bridge Notes were sold at a 10% original issue discount, such that for each $100,000 invested by a purchaser, such purchaser received a Bridge Note in the principal amount of $110,000. We are using the net proceeds of the Bridge Financing to fund clinical development activities, including ongoing and planned clinical trials, and advance our research and development programs, as well as for working capital and general corporate purposes.
We engaged Ceros to act as the exclusive placement agent for the Bridge Financing. In connection with the Bridge Financing, we paid to Ceros (a) a cash fee equal to 7.0% of the aggregate gross cash proceeds received by us in connection with the Bridge Financing and (b) a one-time expense reimbursement of $25,000 for its legal and other expenses incurred in connection with the Bridge Financing.
2026 Registered Direct Offering. On April 2, 2026, we the 2026 Registered Direct Offering. We received net proceeds from the 2026 Registered Direct Offering of approximately $4.7 million. We are using the net proceeds to fund clinical development activities, including ongoing and planned clinical trials, advance our research and development programs, as well as for working capital and other general corporate purposes.
In connection with the 2026 Registered Direct Offering, Ceros acted as our exclusive placement agent. We paid Ceros a cash fee equal to 7.0% of the gross proceeds raised in the 2026 Registered Direct Offering. We also reimbursed Ceros up to $70,000 for its reasonable and documented out-of-pocket accountable expenses and up to $20,000 for its non-accountable expenses. We also issued to Ceros's designees warrants to purchase up to an aggregate of 187,798 shares of our common stock. The placement agent warrants have an exercise price of $1.54 per share, are exercisable beginning September 2, 2026 and expire five years from April 2, 2026.
Contractual Obligations and Other Commitments
We enter into contracts in the normal course of business with our CDMOs, CROs and other third parties to support preclinical research studies and testing and other development activities. These contracts are generally cancellable by us. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
License Obligations
BlinkBio. In August 2020, we entered into a licensing agreement with BlinkBio, Inc., a privately held developer of drug conjugate therapies designed to facilitate the treatment of cancer. Pursuant to this agreement, BlinkBio granted a license to us that allows us to utilize BlinkBio's proprietary technology to develop, manufacture and commercialize certain of our products. BlinkBio granted us an exclusive license for tunable drug conjugates that are directed towards, binds to or modifies the folate receptor alpha and a co-exclusive license for tunable drug conjugates that are directed towards, binds to or modifies any target other than the folate receptor alpha, such as HER2.
Under the terms of the agreement, we are required to pay to BlinkBio (i) an upfront, non-refundable, non-creditable license fee of $300,000 (the "Up-Front Fee"), (ii) a royalty of 6% of net sales of our products that were made using BlinkBio's proprietary technology, subject to potential reductions on such royalty, and (iii) certain amounts based on the achievement of the milestones described in the payment schedule below.
As of March 31, 2026, we had paid the Up-Front Fee. The payment schedule for milestones and corresponding payment amounts is set forth below.
| Milestone Bearing Event |
Milestone Payment |
|||||
| 1. | License Fee to utilize proprietary technology (paid) |
Up-front fee + $2.4 million Convertible Note |
||||
| 2. | Commencement of a toxicology study commented pursuant to Good Laboratory Practices (under 21 CFR Part 58), such that any resulting positive data would be admissible to applicable Regulatory Authorities to support an IND (commonly referred to as "GLP-Tox") | $ | 375,000 | |||
| 3. | Completion of a Phase I Clinical Trial | $ | 1,500,000 | |||
| 4. | Completion of a Phase IIb Clinical Trial | $ | 2,500,000 | |||
| 5. | Filing of an NDA, BLA or MAA registration (or the equivalent in any other territory around the world) | $ | 6,000,000 | |||
| 6. | Regulatory Approval in the first of the United States, within the European Union or within the United Kingdom | $ | 12,000,000 | |||
We are required to make the above cash payments to BlinkBio within 30 days of the achievement of each milestone with respect to the first product to attain each such milestone, except that the first milestone only applies to our first product candidate. The aggregate amount of payments relating to milestones 2 through 6 payable thereunder cannot exceed $22,375,000.
Biolacuna Ltd. We have contracted with Biolacuna Ltd, a global life sciences advisory firm, to assist with the following agencies requirements to register OST-HER2 and gain approval of its use in the respective regions:
| ● | European Medicines Agency (EMA, Europe); |
| ● | Medicines Evaluation Board (MEB, Netherlands); |
| ● | Medicines and Healthcare products Regulatory Agency (MHRA, United Kingdom); and |
| ● | U.S. Food and Drug Administration (FDA, United States). |
For the three months ended March 31, 2026, we paid $6,515,059 in consulting fees, which includes refundable value-added tax ("VAT") expenses. As of March 31, 2026, accounts payable related to consulting fees and VAT totaled $9,943,617.
University of Pennsylvania. On April 9, 2025, we acquired from Ayala the HER2 Assets. Pursuant to the terms of the HER2 Purchase Agreement, the amended and restated development, license and supply agreement with Advaxis terminated. In connection with the acquisition of the HER2 Assets, we were assigned by Ayala a license agreement with the Trustees of the University of Pennsylvania covering the use of HER2 construct patents. Under the terms of the license agreement, we are required to pay an annual license fee to the Trustees of the University of Pennsylvania. In April 2025, we paid a fee of $266,317 for the year ended December 31, 2025. In addition, we are obligated to pay a royalty equal to 1.5% of net sales related to:
| ● | OST-HER2-related sales; |
| ● | ADXS-503-related sales; |
| ● | ADXS-504-related sales; and |
| ● | Sales related to any new immunotherapy drug candidates created from the Lm platform during the term of such licensing agreement. |
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to Notes to the Consolidated financial statements appearing elsewhere in this report.
The JOBS Act
The JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to avail ourselves of the extended transition period for complying with new or revised financial accounting standards.
We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the date on which we are deemed to be a "large accelerated filer" under the rules of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates; (iii) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years; or (iv) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering.