OS Therapies Inc
For the period ended Mar 31, 2026. Filed May 18, 2026.
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Mar 31, 2026 · Filed May 18, 2026
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Notes to the Consolidated Financial Statements (unaudited)
For the Three Months Ended March 31, 2026 and 2025
NOTE 1 — ORGANIZATION AND DESCRIPTION OF BUSINESS, LIQUIDITY, AND RISK FACTORS
OS Therapies Incorporated (“we,” “us,” “our,” the “Company”) is a Delaware corporation incorporated on June 24, 2019. It is based in Rockville, Maryland. The Company is the successor to an LLC formed in 2018.
The Company intends to focus on the identification, development, and commercialization of treatments for Osteosarcoma and other related diseases. As of March 31, 2026, there is one ongoing clinical trial for Osteosarcoma therapy.
OS Animal Health Corp – Subsidiary
On June 25, 2025, the Company formed OS Animal Health Corp, a Delaware corporation and wholly owned subsidiary. The subsidiary had minimal activity during the three months ended March 31, 2026, consisting primarily of investor relations and audit-related expenses. During this period, the Company entered into a license agreement with the subsidiary, pursuant to which it granted the subsidiary rights to use the HER2 Assets (as defined below).
OS Therapies UK LTD – Subsidiary
On August 29, 2025, the Company formed OS Therapies UK LTD, a United Kingdom corporation and wholly owned subsidiary. This subsidiary serves as the Company’s research and development arm and had substantial operating activity during 2025. The Company has transitioned its research and development activities to this subsidiary and intends to enter into an intercompany loan agreement, which is currently pending.
Liquidity
The Company has prepared its consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred significant net losses and negative cash flows from operations. During the three months ended March 31, 2026, the Company incurred a net loss of $10.4 million and used $4.6 million in cash for operating activities.
As of March 31, 2026, the Company had cash and cash equivalents of $917,552. Management has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern withinone year after the date that these consolidated financial statements are issued. The Company’s current cash balance is insufficient to fund operations. During the three months ended March 31, 2026, the Company incurred significant expenses, primarily related to activities in preparation for potential regulatory approvals by the U.S. Food and Drug Administration and other countries regulatory authorities. The Company expects vendor and related costs associated with these efforts to total approximately $20.0 million and continue into the remainder of 2026. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the unaudited consolidated financial statements are issued.
The Company’s ability to continue as a going concern is dependent upon its ability to raise additional capital to fund its research and development and future operations. Management’s plans to mitigate these conditions include:
| ● | Equity and Debt Financing: The Company is actively seeking additional capital through public or private equity offerings or debt financings. |
However, there can be no assurance that the Company will be successful in sequestering additional financing on favorable terms, or at all. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
For the Three Months Ended March 31, 2026 and 2025
NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of U.S. Securities and Exchange Commission (“SEC”). The accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America, and the Company’s fiscal year end is December 31.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries and majority-owned subsidiaries. The Company consolidates all entities in which it has a controlling interest.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in its consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates these estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
Cash
Cash consists primarily of deposits with commercial banks and financial institutions. The Company maintains cash balances at various financial institutions. Both interest and non-interest-bearing accounts with the same insured depository institution are insured by the Federal Deposit Insurance Corporation (FDIC) for a combined total of $250,000. In the normal course of business, the Company may have deposits that exceed the FDIC insured limit. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of March 31, 2026 and December 31, 2025, the JPMorgan Chase Bank checking account had $753,009 and $233,490, respectively. The JPM escrow account had a balance of $50,000 and $0 as of March 31, 2026 and December 31, 2025, respectively. As of March 31, 2026 and December 31, 2025, the JPMorgan Chase savings account had $20,314 and $20,269, respectively. As of March 31, 2026 and December 31, 2025, the Silicon Valley Bank checking account had $12,590 and 6,071, respectively, and the SVB money market account had $10,000 and $10,000, respectively. The JPM Chase checking account was in excess of the FDIC limits for the three months ended March 31, 2026. As of March 31, 2026 and December 31, 2025, the Company maintained balances in UK bank accounts of $71,639 and $0, respectively.
Redeemable Preferred Stock and Mezzanine Equity
The Company’s Series A Senior Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), is classified as mezzanine equity in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 480 (“ASC 480”) due to its redemption features upon the occurrence of a deemed liquidation event, including (i) a merger or consolidation or (ii) the sale, lease, transfer, or other disposition of substantially all of the Company’s assets. Proceeds from the issuance were allocated between the Series A Preferred Stock and the accompanying warrants to purchase shares of common stock (the “Series A Warrants”) on a relative fair value basis. Of the initial $6,050,000 in proceeds, a portion was allocated to the Series A Warrants, with the residual allocated to the Series A Preferred Stock. Similarly, of the subsequent $1,053,000 in proceeds, a portion was allocated to the Series A Warrants, with the residual allocated to the Series A Preferred Stock.
Fixed Asset Policy
A capital asset is defined as a unit of property that has an economic useful life that extends beyond 12 months. Any items costing below the threshold or not fitting the definition of a capital asset will be expensed in the consolidated financial statements. All capital assets are recorded at historical cost as of the date acquired. Computer assets will be capitalized and Straight-Line depreciated over five years for financial statement purposes.
Patent Amortization
On April 9, 2025, in connection with the HER2 Purchase Agreement (as defined below), the Company acquired the HER2 Assets (as defined below) from Ayala (as defined below), including the assignment by Ayala of a license agreement with the Trustees of the University of Pennsylvania. These intangible assets are amortized on a straight-line basis over their estimated useful lives, with amortization recorded quarterly. Amortization expense for the three months ended March 31, 2026 and 2025 was $124,243 and $0, respectively.
Patent and License Acquisition
On April 9, 2025, pursuant to the terms of an Asset Purchase Agreement, dated as of January 28, 2025 (the “HER2 Purchase Agreement”), between the Company and Ayala Pharmaceuticals, Inc. (formerly Advaxis, Inc.) (“Ayala”), the Company completed the acquisition of theLm-based immune-oncology programs and related intellectual property assets (the “HER2 Assets”) from Ayala, including the assignment by Ayala of a license agreement with the Trustees of the University of Pennsylvania. The transaction was accounted for as an asset acquisition in accordance with ASC 805.
In connection with the acquisition, the Company assumed certain specified liabilities and paid an aggregate purchase price of $8,000,000, with a fair value of $6,864,438, consisting of: (i) $400,000 to Ayala ($150,000 of which was transferred upon signing of the HER2 Purchase Agreement and the remainder on the closing date); (ii) $100,000 to a third party on behalf of Ayala on the closing date; and (iii) $7,500,000 worth of shares of common stock, or 4,774,637 shares based on the volume-weighted average price of the Company’s common stock over the 30 trading days immediately preceding the closing date of $1.5708. The fair value of the common stock issued was determined using the closing price of $1.34 per share on April 9, 2025, resulting in a total equity value of $6,398,014 and a corresponding reduction in total purchase consideration. The fair value of the purchase consideration is summarized below:
| Cash | $400,000 |
|---|---|
| Legal fees paid on behalf of Ayala | 66,424 |
| Company common stock (4,774,637 shares at $1.34 per share) | 6,398,014 |
| Total fair value of consideration transferred | $6,864,438 |
The acquired intangible assets consist primarily of a portfolio of patents and related licenses, including patents covering “Compositions and Methods for Evaluating Potency of Listeria-Based Immunotherapeutics,” which underpin the Company’s lead programs. These patents have an effective filing date of April 19, 2019 and an estimated remaining useful life of approximately 14 years. The assets are amortized on a straight-line basis over their estimated useful lives.
As of March 31, 2026, expected future amortization expense is as follows:
| Year | |
|---|---|
| From April 1 to December 31, 2026 | $372,730 |
| 2027 | 496,973 |
| 2028 | 496,973 |
| 2029 | 496,973 |
| 2030 | 496,973 |
| 2031 and thereafter | 4,019,267 |
| Total | $6,379,889 |
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets or the asset groups are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the estimated discounted future net cash flows arising from the assets or asset groups. No impairment losses on long-lived assets have been recorded for the three months ended March 31, 2026 or March 31, 2025.
Research and Development Costs
Research and development expenses are charged to operations as incurred. Research and development expenses include, among other things, salaries, costs of outside collaborators and outside services, and supplies.
Stock-Based Compensation
The Company, in accordance with ASC 718, employs the use of stock-based compensation. The compensation expense related to stock granted to employees and non-employees is measured at the grant date based on the estimated fair value of the award and is recognized on a straight-line basis over the requisite service period. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur. Stock-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed.
Short-term Leases
For short-term leases with a term of 12 months or less, the Company recognizes lease expense on a straight-line basis over the lease term. The Company’s current lease arrangements qualify for this short-term lease exemption and are expensed as incurred. The Company did not renew its prior lease due to landlord restrictions related to renovations of the premises and has temporarily relocated its primary office to 115 Pullman Crossing Road, Suite #103, Grasonville, Maryland 21638. This space, which serves as the primary office of the Company’s Chief Financial Officer, is being provided at no cost. In May 2025, the Company entered into a month-to-month lease agreement with JLabs for general office space in New York City, primarily for meetings and use by staff when visiting. The monthly lease payment was $750 and increased to $811 effective January 1, 2026. The lease is scheduled to terminate on May 31, 2026 in connection with a change in ownership of the premises, and the Company is currently awaiting a determination from the new owner regarding a potential renewal.
Income taxes
The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740,Income Taxes(“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is “more likely than not” that some portion or all of the deferred tax assets will not be realized in future periods.
The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the consolidated financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized.
Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the consolidated financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority.
The Company will recognize interest and penalties related to tax positions in income tax expense. As of March 31, 2026 and December 31, 2025, the Company had no unrecognized uncertain income tax positions.
Basic and Diluted Loss per Share
The Company computes loss per share in accordance with ASC 260,Earnings per Share(“ASC 260”). ASC 260 requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statements of operations. Basic EPS is computed by dividing the net loss available to common shareholders (numerator) by the weighted average number of common shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method and convertible notes payable using the if-converted method. Diluted EPS excludes all diluted potential shares if their effect is antidilutive.
Below is a table listing all preferred stock and common stock equivalents:
| Common Stock Equivalents | March 31, 2026 | December 31, 2025 |
|---|---|---|
| Series A Senior Convertible Preferred Stock | 1,401,786 | 1,401,786 |
| Underwriter/Placement Agent Warrants | 347,117 | 319,711 |
| Investor Warrants | 8,585,888 | 7,154,338 |
| Vendor Warrants | 100,000 | - |
| Prepaid Common Stock Investors | 2,172,693 | 1,441,518 |
| Total | 12,607,484 | 10,317,353 |
The Series A Preferred Stock issued on December 31, 2024 and January 14, 2025 is reflected in the table above as of March 31, 2026 because, although the preferred stock itself does not qualify for equity classification, the shares of common stock issuable upon conversion meet the applicable equity classification criteria. Stockholder approval was obtained on April 9, 2025, for the issuance of the shares of common stock underlying the Series A Preferred Stock, which is classified as mezzanine equity, and for the Series A Warrants. Upon approval, the conversion price of the Series A Preferred Stock and the exercise price of the Series A Warrants were automatically adjusted to $1.12 per share, based on the volume-weighted average price of the Company’s common stock for the 10 trading days immediately preceding April 9, 2025. This adjustment established a conversion multiplier of 3.571429 common shares per preferred share. As of March 31, 2026,392,500 non-converted shares of Series A Preferred Stock were outstanding, which, using the conversion multiplier, are exercisable into 1,401,786 shares of common stock.
As of March 31, 2026, a total of 347,117 shares of common stock were underlying outstanding underwriter and placement agent warrants, consisting of 112,000 shares issued in connection with the Company’s initial public offering and 235,117 shares issued to placement agents in connection with the PIPE financing in December 2024 and January 2025.
During the Company’s two warrant exercise inducement and exchange offerings, held June 23 to July 10, 2025, and August 29 to September 1, 2025, warrant holders who exercised their existing warrants received new warrants with an exercise price of $3.00 per share. In total, warrants to purchase 7,154,338 shares of common stock (which included 235,117 agent warrants, separately stated, and 6,919,221 investor warrants) were exercised in exchange for new warrants to purchase an equal number of shares. On January 14, 2026, the Company completed a closing of a third warrant exercise inducement and exchange offering, pursuant to which less than 10 accredited investors that exercised their existing warrants received new warrants to purchase up to an aggregate of 2,499,558 shares of the Company’s common stock at an exercise price of $1.40 per share, resetting the warrant price to $1.40 for all warrant holders. On March 4, 2026, the Company issued to certain accredited investors in the Bridge Financing (as defined below), among other securities, Bridge Warrants (as defined below) to purchase up to an aggregate of 1,666,667 shares of common stock. As of March 31, 2026, the Company had investor warrants to purchase 8,821,005 shares of common stock outstanding as of March 31, 2026.
On January 27, 2026, the Company issued to a vendor a warrant to purchase 100,000 shares of common stock at an exercise price of $2.12 per share, exercisable in September 2026 and expiring in September 2030.
Warrant holders who held 2,391,518 prepaid shares, exercised and received 950,000 of such shares in 2025, resulting in a balance of 1,441,518 prepaid shares of common stock as of December 31, 2025. In connection with the third warrant exercise inducement and exchange offering, an accredited investor pre-funded the exercise of warrants to purchase 731,175 shares, bringing the Company’s outstanding prepaid common stock to 2,172,693 shares.
Fair Value Measurements
The Company applies ASC 820Fair Value Measurement(“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date.
The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.
The carrying value of the Company’s cash, accounts payable, and accrued expenses are approximate fair value because of the short-term maturity of these financial instruments. The redemption feature of the debt instruments is recorded at fair value (See Note 3).
The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.
Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities.
Recent Accounting Pronouncements
The Company has evaluated all recently issued accounting pronouncements and plans to adopt ASU 2024-03, Disaggregated Income Statement Disclosure, in the notes to its audited financial statements for the year ending December 31, 2026. The Company is assessing the impact of adopting ASU 2024-03
No other recently issued accounting pronouncements are expected to have a material impact on the Company’s financial statements at this time.
NOTE 3 — RELATED PARTY TRANSACTIONS
**Accrued Payroll **
As of March 31, 2026 and December 31, 2025, the Company had payroll payable to the CEO of $0 and $36,792, respectively, and related payroll taxes payable of $989 and $1,279, respectively. During the three months ended March 31, 2026 and 2025, the Company made advances on payroll payable, and the CEO repaid amounts previously advanced.
Related Party Accounting Fees
As of March 31, 2026 and December 31, 2025, the Company had accounts payable of $70 and $0, respectively, to Shore Accountants MD Inc., an outside accounting firm that provides payroll, bookkeeping, and tax preparation services. Shore Accountants MD Inc. is wholly owned by Christopher Acevedo, the Company’s Chief Financial Officer.
NOTE 4 — CONVERTIBLE DEBT
Bridge Financing
On March 4, 2026, pursuant to a securities purchase agreement (the “Bridge SPA”), the Company 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 Convertible Notes”), accruing interest at 4.0% per annum and maturing on March 4, 2027, and (ii) warrants to purchase up to 1,666,667 shares of common stock at an initial exercise price of $1.40 per share, subject to adjustment as provided therein, and exercisable for a period offive years from the date of issuance (the “Bridge Warrants” and such private placement transaction, the “Bridge Financing”). The Bridge Convertible Notes were sold at a 10% original issue discount, for aggregate gross cash proceeds of $2,000,000, before deducting placement agent fees and other offering expenses.
The Bridge Convertible Notes were convertible into shares of the Company’s common stock or other of its 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 Convertible Notes, holders could elect to convert the Bridge Notes, in whole or in part, into shares of the Company’s common stock at a conversion price equal to 90% of the average daily volume-weighted average price of the Company’s common stock during the 10 trading days immediately preceding the holder’s conversion notice, subject to adjustment. The Bridge Convertible Notes also contained anti-dilution provisions tied to dilutive issuances and certain variable-rate transactions.
The Company evaluated the embedded conversion features under ASC 815-15. The voluntary conversion option was determined to meet the own-equity scope exception in ASC 815-40-15, as its terms allowed for variability to inputs that were indexed to the Company’s own equity. The mandatory conversion, however, is an embedded conversion feature that requires settlement into the securities sold in a future qualified offering, which could consist of units of common stock and warrants or other securities and, as a result, did not qualify for the own-equity scope exception in ASC 815-40-15. The Company determined the fair value of the associated embedded conversion feature related to the mandatory conversion feature is immaterial and, therefore, did not record it separately as a derivative liability.
Proceeds from the Bridge Financing were allocated between the Bridge Convertible Notes and the accompanying Bridge Warrants on a relative fair value basis. Of the $2,000,000 in initial proceeds, $567,402 was allocated to the Bridge Warrants (recorded as additional paid-in capital), with the remaining amount of $1,432,598 allocated to the Bridge Convertible Notes. The resulting debt discount on the Bridge Convertible Notes is being accreted to face value through interest expense using the effective interest method over the contractual term of the Bridge Convertible Notes. For the three months ended March 31, 2026, the Company recognized $6,372 of contractual interest expense on the Bridge Convertible Notes and $68,972 of non-cash interest expense related to the amortization of the debt discount.
NOTE 4 — CONVERTIBLE DEBT (cont.)
The Bridge Warrants were determined to be indexed to the Company’s own stock and to meet the equity-classification conditions in ASC 815-40-25. Although the Bridge Warrants contain a full-ratchet down-round adjustment and a Qualified Offering reset provision, both adjustments operate only to reduce the exercise price (i.e., are conditional and downward-only) and therefore qualify for the down-round carve-out in ASC 815. Accordingly, the Bridge Warrants do not preclude equity classification. If a down-round trigger occurs in a future period, the incremental value delivered to the warrant holders will be recognized as a deemed dividend to common stockholders pursuant to ASC 260.
On April 2, 2026, upon consummation of the 2026 Registered Direct Offering (as defined below), the Bridge Convertible Notes, together with all accrued and unpaid interest thereon, automatically converted into an aggregate of 1,576,311 shares of the Company’s common stock and warrants to purchase up to 1,576,311 shares of the Company’s common stock (See Note 10).
NOTE 5 — TEDCO GRANT
In May of 2021, the Company received the first oftwo tranches from TEDCO’sRural & Underserved Business Recovery from Impact of COVID-19 (RUBRIC) Grantin the amount of $50,000. A second tranche of $50,000 was received in October 2021 for a total reimbursable grant amount of $100,000. The Company is obligated to report on and pay to TEDCO 3% of their quarterly revenues for a five-year period following the reward date. Income from grants and investments are not considered revenues. Royalties due to TEDCO are capped at 150% of the amount of the award or $150,000 total. The Company has the option to eliminate the quarterly royalty obligation by making an advance payment prior to the end of the five-year period, in which case, the Company will receive a 10% reduction of the royalty cap percentage for each year prior to the expiration of thefive-year reimbursement period that the grant is repaid in full. If the Company ceases to meet eligibility requirements the reimbursement obligation will become due to TEDCO immediately; however, the discount for meeting the obligation will still apply.
NOTE 6 — COMMITMENTS AND CONTINGENCIES
Employee Commitments
There are no employee commitments as the Company operates on an at-will employment basis.
Rental Agreement
The Company rents a virtual office on a month-to-month basis at JLabs in New York, New York, a facility owned by Johnson & Johnson. The current monthly rent is $811. Rent expense for the three months ended March 31, 2026 and 2025 was $2,433 and $3,150, respectively.
License Obligation and Manufacturing Agreements
Advaxis (now Ayala)
In September 2018, the Company entered into an exclusive license agreement with Advaxis, Inc., as amended, under which it acquired the rights to develop and commercialize the Advaxis HER2 Construct, including related patents.
Under the agreement, all milestone payments were non-refundable, non-creditable and payable only once upon the achievement of the corresponding milestone. As of December 31, 2020, the first milestone was achieved and paid ($1,550,000) in January 2021. The second milestone was completed and paid ($1,375,000) in May 2021. No milestone payments were made for the three months ended March 31, 2026 or March 31, 2025. The license agreement was terminated upon the Company’s purchase of the HER2 Assets from Ayala on April 9, 2025, which included a payment of $400,000 and the issuance of common stock and pre-funded warrants as consideration. All common stock and pre-funded warrants were issued to Ayala in 2025.
NOTE 6 — COMMITMENTS AND CONTINGENCIES (cont.)
BlinkBio
In July 2020, the Company entered into a Licensing Agreement with BlinkBio, Inc., to utilize their proprietary technology. As of August 2020, the $300,000 License fee was fully paid and recorded in license expense. These payments have been recorded in the Licensing expenses of the accompanying statement of operations. No payments were due or made in the three months ended March 31, 2026 and 2025. The Company is currently conducting early-stage research on the licensed drug, including studies to support future toxicology evaluations. A payment schedule for future milestones is summarized below.
| Milestone Bearing Event · Milestone Payment | ||
|---|---|---|
| 1. | License Fee to utilize proprietary technology (paid) | $300,000 + $2.4 million Convertible Note |
| 2. | Commencement of a toxicology study commented pursuant to Good Laboratory Practices (per 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 II 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 EU or within the UK | $12,000,000 |
The Company will make the cash payments set forth in the table above by wire transfer of immediately available funds, to BlinkBio within 30 days of the occurrence of each milestone set forth with respect to the first Product to attain each such milestone, except that the first Milestone above will apply with respect to The Company’s first product candidate. During the Royalty Term, the Company will pay BlinkBio a royalty of 6% on Net Sales on a Product-by-Product and country-by-country basis during the Royalty Term, in a country in which no Valid Claim Covers the manufacture, use, or sale of a Product, the royalty on Net Sales of such Product in such country will be reduced to 3%. No royalties were due in the three months ended March 31, 2026 and 2025.
For the avoidance of doubt, each milestone payment will be payable only once, and the aggregate amount of Milestone payments payable hereunder will not exceed $22,375,000. A Milestone may be achieved by the Company or a Commercial Sublicensee.
NOTE 6 — COMMITMENTS AND CONTINGENCIES (cont.)
George Clinical Inc.
In June 2020, the Company entered into a Research Service Agreement, as amended, with George Clinical Inc., to use their clinical research services for the Company’s study: “An Open Label, Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma”. Under the terms of the agreement, the Company was required to pay to George Clinical certain fees described in the fee schedule below. The total budget under the agreement was approximately $2,436,928. For the three months ended March 31, 2026 and 2025, the total research and development expenses recorded in the statement of operations were $0 and $0, respectively. The fee schedule for certain fees and corresponding payment amounts is set forth below.
| George Clinical Payment Schedule · Payment Amount | ||
|---|---|---|
| 1. | Service Fee Advance (paid) | $49,989 |
| 2. | Service Fee Advance of $212,335 minus the amount already paid, plus PTC Fee Advance of $31,325 (paid) | $193,671 |
| 3. | Statistics Fees – 35% on Electronic Data Capture (EDC) Go Live Date | $47,740 |
| 4. | Statistics Fees – 35% on Development of SAP tables | $47,740 |
| 5. | Statistics Fees – 30% on Final Analysis | $40,920 |
| 6. | Service Fees – Remainder Due | Split monthly over course of study |
George Clinical tracked and invoiced the Company for the number of task units completed and pass-through costs were invoiced each month in arrears based on actual costs without mark-up. The PTC Advance Fee was used to offset final pass-through fees payable. As of March 31, 2026, the balance payable to George Clinical was $0, and the services agreement has terminated in accordance with its terms. All fees due under the agreement have been satisfied, and no further obligations to the vendor remain.
Biolacuna Ltd
The Company has 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, the Company paid $6,515,059 in consulting fees, which includes refundable value-added tax (VAT) expenses. As of March 31, 2026 and December 31, 2025, accounts payable related to consulting fees and VAT totaled $9,943,617 and $7,323,386, respectively.
Notes to the Consolidated Financial Statements
NOTE 6 — COMMITMENTS AND CONTINGENCIES(cont.)
Trustees for the University of Pennsylvania
On April 9, 2025, the Company 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, the Company was 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, the Company is required to pay an annual license fee to the Trustees of the University of Pennsylvania. In April 2025, the Company paid a fee of $266,317. In addition, the Company is 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. |
Legal Proceedings
From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, could have a material adverse effect on the Company’s results of operations or financial position. The Company recently participated in an arbitration hearing related to a claim brought by its former investment advisor concerning underwriter compensation for the Company’s initial public offering in August 2024 and any subsequent equity offerings during the following 12 months. The hearing concluded on November 7, 2025, and the arbitrators issued a ruling on January 28, 2026, awarding the former investment advisor $1,055,428 and their attorneys $308,805. The Company also incurred $15,128 in arbitration-related fees.
The total amount of $1,379,361 has been accrued in the Company’s financial statements as of March 31, 2026 and December 31, 2025 and is recorded within accrued expenses. The Company does not intend to challenge the ruling. In accordance with ASC 450, the obligation is considered both probable and reasonably estimable.
NOTE 7 — EQUITY
Common Stock
In 2021, the Company’s common stock was initially split into two classes:50,000,000 shares of Class A common stock, $0.001 par value per share (“Class A Common Stock”), and 20,000,000 shares of Class B common stock, $0.001 par value per share (“Class B Common Stock”). On February 9, 2024, the Company combined the two classes under the name common stock with 50,000,000 shares authorized. On October 21, 2025, stockholders approved an increase in authorized common stock from 50,000,000 to 150,000,000 shares. As of March 31, 2026 and December 31, 2025, the Company had 39,278,192 and 37,113,082 shares of common stock outstanding, respectively. Common stock has voting rights.
During the three months ended March 31, 2025, the Company issued (i)157,407 shares of common stock in connection with its equity line of credit, (ii)300,000 shares of common stock to a scientific and technical advisor in exchange for scientific and technical services, which will be amortized over a 12-month period with the remaining balance in prepaid expenses, and (iii)20,000 shares of common stock to an advisor in exchange for services.
During the three months ended March 31, 2026, the Company issued 1,891,077 shares of common stock to investors in connection with its third warrant exercise inducement and exchange offering conducted in January 2026 and received payment for an additional 731,175 shares of prepaid common stock during the same period. The Company also issued 148,695 shares of common stock to vendors as compensation and reconciled investor accounts for 125,338 shares of common stock relating to 2025 transactions.
Preferred Stock
In 2021, the Company authorized 5,000,000 shares of Preferred Stock, of which 1,400,000 were designated as Series A Preferred Stock. A total of 1,302,082 shares of Series A Preferred Stock were issued, which carried a 5% cumulative dividend and liquidation preference over common stock. Dividends were computed at 5% of the principal annually and recorded monthly.
On February 9, 2024, all outstanding Series A Preferred Stock was converted into common stock on a one-for-two basis pursuant to the filing of the Company’s third amended and restated certificate of incorporation. As of that date, the Company had 5,000,000 shares of authorized Preferred Stock, with none outstanding.
The Series A Preferred Stock dividend for the three months ended March 31, 2026 and 2025 was $0 and $0, respectively, resulting in a total accrued dividend payable of $375,000 as of both March 31, 2026 and December 31, 2025.
The Preferred Stock has the following rights and privileges:
Voting— Votes together with the common stock on all matters on an as-converted basis. Approval of a majority of the New Preferred Stock voting as a separate class will be required to, among other things: (i) adversely change rights of the New Preferred Stock, (ii) change the authorized number of shares of New Preferred Stock.
Conversion— Each share of New Preferred Stock is convertible into one share of common stock (subject to proportional adjustments for stock splits, stock dividends and the like) at any time at the option of the holder. Conversion ratio will be subject to adjustment on a broad-based, weighted average basis in the event of subsequent issuances at a price less than the original issue price (as adjusted) subject to customary exceptions. The conversion into common stock occurred on February 9, 2024.
Liquidation— One times the original issue price of the New Preferred Stock plus declared but unpaid dividends on each share of New Preferred Stock (or, if greater, the amount that the New Preferred Stock would receive on an as-converted basis) will be paid first on each share of New Preferred Stock, and the balance of proceeds to be paid to common stock. A merger, reorganization, or similar transaction (including a sale, exclusive license or other disposition of all or substantially all of the assets of the Company or its subsidiaries) will be treated as a liquidation, thereby triggering payment of the liquidation preference described above. For the avoidance of doubt, the liquidation preference is intended to provide the Investor (and its permitted assigns) with an aggregate liquidation payment of $2,500,000.
NOTE 7 — EQUITY(cont.)
Stock Options
The following table summarizes the common stock options issued to employees and consultants for services during the three months ended March 31, 2026:
| Common Stock Options | ||||
|---|---|---|---|---|
| Shares | Weighted Average Exercise Price | Weighted Average Remaining Years | Intrinsic Value | |
| Outstanding at January 1, 2026 | 6,771,250 | $1.83 | 4.43 | - |
| Granted | 2,050,500 | $1.47 | 4.82 | - |
| Forfeited | (463,750) | $1.86 | 3.68 | - |
| Exercised | - | - | - | - |
| Outstanding at March 31, 2026 | 8,357,500 | $1.74 | 4.37 | - |
| Exercisable at March 31, 2026 | 2,400,000 | $1.86 | 3.68 | - |
The fair value of the options granted during the three months ended March 31, 2026 was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
| Volatility (based on peer companies) | 112% |
|---|---|
| Risk Free Interest Rate | 3.77% |
| Dividends | None |
| Estimated Life in years | 4 |
During the three months ended March 31, 2026 and 2025, the Company recognized combined share-based compensation expense of $1,435,362 and $941,283, respectively, related to these common stock options. At the Company’s annual meeting on October 21, 2025, stockholders approved an amendment to the Company’s 2023 Incentive Compensation Plan, increasing the shares of common stock authorized for issuance thereunder from 4 million to 10 million.
Forfeitures during the three months ended March 31, 2026 included the cancellation of 300,000 common stock options previously awarded to the CEO in December 2024. The cancellation was approved to better align outstanding common option awards with annual approved award limits pursuant to the Company’s 2023 Incentive Compensation Plan. All forfeited awards were fully vested in previous years, resulting in no share-based compensation expense recorded in the three months ended March 31, 2026.
As of March 31, 2026, the total unrecognized share-based compensation expense related to unvested common stock options was $ $4,578,955 and will be recognized upon vesting.
Warrants for Underwriter and Placement Agents — Brookline Capital Markets
On August 2, 2024, the Company issued a warrant to Brookline Capital Markets to purchase 112,000 shares of the Company’s common stock, pursuant to an underwriting agreement entered into between the Company and Brookline. The warrant is exercisable 180 days after July 31, 2024, terminates on July 31, 2029, and has an exercise price of $4.40 per share.
Notes to the Consolidated Financial Statements
NOTE 7 — EQUITY(cont.)
On December 24, 2024, the Company entered into a securities purchase agreement, dated as of December 24, 2024 (the “Purchase Agreement”), and, in connection therewith, Brookline earned warrants initially exercisable for 39,918 shares at $4.40 per share. These warrants were subsequently adjusted to 156,821 shares at an exercise price of $1.12 per share, subject to further adjustment as provided in the agreement. The warrants are exercisable forfive years from April 9, 2025. As of March 31, 2026, warrants to purchase 156,821 shares remained outstanding.
Warrant Inducements
Third Warrant Exercise Inducement and Exchange Offering*.*On January 14, 2026, the Company closed on a third warrant exercise inducement and exchange offering, pursuant to which less than 10 accredited investors holding existing warrants to purchase up to an aggregate of 5,382,148 shares of common stock at then-current exercise prices of $3.00 or $2.10 per share exercised for cash their warrants to purchase 2,499,558 shares of common stock at a reduced exercise price of $1.40 per share. In exchange, the Company issued to such holders new warrants to purchase up to an aggregate of 2,499,558 shares of common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein, immediately exercisable from issuance for a period offive years.
Privately Negotiated Warrant Exercise Inducement and Exchange Agreements*.*During the period from January 10, 2026 to March 31, 2026, the Company entered into privately negotiated warrant exercise inducement and exchange agreements, pursuant to which certain holders of existing warrants exercised for cash their existing warrants to purchase 74,108 shares of common stock at a reduced exercise price of $1.40 per share, and in exchange the Company issued to such holders new warrants to purchase up to an aggregate of 74,108 shares of common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein, immediately exercisable from issuance for a period offive years.
Gross cash proceeds from both inducements was $3,671,152, and related issuance costs was $294,892. In each case, the inducement transactions were accounted for as warrant modifications under ASC 470. The incremental fair value delivered to the inducement participants, measured as the difference between the fair value of the new warrants issued and the fair value of the existing warrants immediately before modification, both determined using a binomial lattice model, was recognized as an inducement charge through additional paid-in capital and is presented as a deduction from net income available to common stockholders for purposes of computing earnings per share. For the three months ended March 31, 2026, the inducement charges totaled $927,576 for the third warrant exercise inducement and exchange offering and $21,791 for the privately negotiated warrant exercise inducement and exchange transactions ($949,367 in aggregate). Both the original exercised warrants and the new warrants issued were equity-classified under ASC 815; accordingly, the modification accounting was affected entirely within stockholders’ equity with no income statement impact other than the EPS-numerator adjustment described above.
NOTE 8 — REDEEMABLE PREFERRED STOCK, MEZZANINE EQUITY AND WARRANT LIABILITY
Securities Purchase Agreement
On December 24, 2024, the Company entered into the Purchase Agreement with various institutional and accredited investors. The Company completed the initial closing on December 31, 2024 and sold an aggregate of 1,512,500 immediately separable units (the “Units”), each Unit consisting of (i) one share of the Company’s Series A Preferred Stock, and (ii) a Warrant to purchaseone share of common stock, at a price per Unit of $4.00. The Warrant has an exercise price of $4.40 per share, subject to adjustment therein, and a term of five years from the date stockholder approval of the common stock issuances contemplated by the Purchase Agreement is obtained. The gross proceeds from the initial closing to the Company, before deducting transaction fees and other estimated expenses, was $6,050,000. On January 14, 2025, the Company sold and issued an additional 263,250 Units. The gross proceeds from the second closing to the Company, before deducting transaction fees and other estimated expenses, was $1,053,000.
Based on the terms of the Series A Preferred Stock and the Company’s Certificate of Designation, and in accordance with ASC 480, the Series A Preferred Stock is accounted for as mezzanine equity due to the redemption feature upon a deemed liquidation event: (i) a merger or consolidation, or (ii) the sale, lease, transfer or other disposition of substantially all the assets of the Company. $1,971,975 of the initial cash proceeds of $6,050,000 were allocated to the Warrants and $4,078,025 of the residual proceeds were allocated to the Series A Preferred Stock. $330,781 of the additional cash proceeds of $1,053,000 were allocated to the Warrants and $722,219 of the residual proceeds were allocated to the Series A Preferred Stock from the January 14, 2025 settlement, with all the same terms as the first settlement above.
NOTE 8 — REDEEMABLE PREFERRED STOCK, MEZZANINE EQUITY AND WARRANT LIABILITY(cont.)
Since inception (April 9, 2025) through March 31, 2026, Mezzanine Equity converted into 4,939,808 shares of common stock. As of March 31, 2026,392,500 shares of Series A Preferred Stock remain outstanding, convertible into 1,401,786 shares of common stock.
Based on the terms of the Warrants and in accordance with ASC 815, the Warrants are accounted for as a liability due to the variable exercise price subject to adjustment. Currently, there is not an observable market for this type of derivative. Due to the lack of relevant and market reflective Level 1 and Level 2 inputs, the Company valued the Warrant liability using Level 3 inputs, which require significant judgment and estimates on behalf of management in developing model assumptions. The Company determined the value of the Warrant liability using a Binomial Simulation, which takes into consideration the fair market value of the Company’s stock, the variable nature of the exercise price, the estimated exercise period, the volatility of its common stock, and the risk-free interest rate.
The following assumptions were made as of December 31, 2024 in the model: (1) a variable exercise price with a floor of $4.40 per share, (2) current common stock price of $4.28 per share December 31, 2024, (3) discount rate of 4.38%, and (4) expected stock price volatility of 24.90%. As of December 31, 2024, the carrying value of the Warrant liability in aggregate was $1,971,975. The following assumptions were made as of January 14, 2025 in the model: (1) a variable exercise price with a floor of $4.40 per share, (2) current common stock price of $4.16 per share on January 14, 2025, (3) discount rate of 4.59%, and (4) expected stock price volatility of 25.77%. As of January 14, 2025 the carrying value of the 263,250 issued warrants was $330,781.
The following assumptions were made as of April 9, 2025 based on stockholder approval in the model for the aggregate warrants: (1) a fixed exercise price of $1.12 per share, which automatically reset and resulted in a reclassification of the warrant liability on April 9, 2025 to equity per ASC 815; (2) then-current common stock price of $1.34 per share on April 9, 2025; (3) discount rate of 4.06%; and (4) expected stock price volatility of 23.26%.
As of March 31, 2026 and December 31, 2025, the carrying value of the Warrant liability in aggregate was$0 and $0, respectively. During the three months ended March 31, 2026 and 2025, the Company recorded a gain on the change in fair value of the Warrant Liability in the amount of $0 and $1,122,561, respectively.
NOTE 9 — SEGMENT AND GEOGRAPHIC INFORMATION
The Company operates asone operating segment. The Company’s chief operating decision maker (“CODM”) is its Chief Executive Officer, who reviews financial information presented on a consolidated basis. The CODM uses consolidated operating margin and net income to assess financial performance and allocate resources. These financial metrics are used by the CODM to make key operating decisions, such as the determination of the rate at which the Company seeks to grow global operating margin and the allocation of budget between cost of revenues, sales and marketing, technology and development, and general and administrative expenses.
The following table presents selected financial information with respect to the Company’s single operating segment 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) |
NOTE 10 — SUBSEQUENT EVENTS
Registered Direct Offering and Conversion of Bridge Convertible Notes
On April 2, 2026, the Company completed a registered direct offering, pursuant to which it offered and sold to accredited investors an aggregate of 2,505,073 shares of common stock and, in lieu thereof, pre-funded warrants to purchase up to 1,250,893 shares of common stock, and accompanying common warrants to purchase up to 3,755,966 shares of 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. Proceeds received from the 2026 Registered Direct Offering were approximately $4.7 million.
The 2026 Registered Direct Offering qualified as a “Qualified Offering” under the terms of the Bridge Convertible Notes (as defined in Note 4 above), thereby triggering the automatic conversion provisions of such notes. Concurrent with the closing of the 2026 Registered Direct Offering, the $2,200,000 outstanding principal balance of the Bridge Convertible Notes, together with all accrued and unpaid interest thereon, automatically converted into the securities sold in 2026 Registered Direct Offering at the applicable offering price. The conversion eliminated the Bridge Convertible Note balance and the related unamortized debt discount, and the Company expects to recognize a non-cash extinguishment charge in the second quarter of 2026 reflecting the difference between the carrying amount of the Convertible Bridge Notes and the fair value of the securities issued upon conversion.
The Company is finalizing its accounting analysis for the April 2, 2026 transaction and will reflect the related debt extinguishment and equity issuance in its second quarter 2026 financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.