STOCK TITAN

OS Therapies (OSTX) nets $4.7M, eyes extra $4M non-dilutive funding

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

OS Therapies Incorporated completed a registered direct offering of 2,505,073 shares of common stock, 1,250,893 pre-funded warrants and 3,755,966 common warrants. Investors paid $1.40 per share and common warrant, or $1.399 per pre-funded warrant and common warrant, generating gross proceeds of $5.25 million and net proceeds of approximately $4.7 million.

The company also issued 187,798 placement agent warrants with a $1.54 exercise price. OS Therapies plans to use the cash to fund clinical development, research programs, potential acquisitions, and general corporate purposes, and expects an additional $4 million in non-dilutive VAT and R&D refunds via its U.K. subsidiary.

Positive

  • OS Therapies raised approximately $4.7 million in net proceeds through a registered direct offering and expects about $4 million in additional non-dilutive VAT and R&D refunds, which management indicates should help fund operations and OST-HER2 regulatory milestones into 2027.

Negative

  • None.

Insights

OS Therapies raises cash and expects extra non‑dilutive funding to support pivotal OST-HER2 work.

OS Therapies completed a registered direct offering of equity and warrants, producing gross proceeds of $5.25 million and net proceeds of about $4.7 million. The structure combines common stock, pre-funded warrants and common warrants, plus 187,798 placement agent warrants exercisable at $1.54 per share.

The company states it intends to use the cash for clinical development, research programs, potential complementary assets, and general corporate purposes. It also expects roughly $4 million in additional non-dilutive VAT and R&D refunds via its U.K. subsidiary, which management says should help support operations and key OST-HER2 regulatory milestones in 2026.

Forward-looking statements tie this funding to advancing OST-HER2 toward a planned Biologics License Application under the U.S. Accelerated Approval Program and potential Conditional Marketing Authorisations in Europe and the U.K. Actual outcomes will depend on upcoming regulatory interactions and clinical data, as described in the company’s risk disclosures.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Gross proceeds $5.25 million Registered direct offering of common stock and warrants
Net proceeds approximately $4.7 million After fees and expenses from the offering
Common shares sold 2,505,073 shares Shares of common stock issued in the offering
Pre-funded warrants 1,250,893 shares Shares underlying pre-funded warrants sold
Common warrants 3,755,966 shares Shares underlying common warrants issued
Offering prices $1.40 share+common warrant; $1.399 pre-funded+common warrant Combined purchase prices per unit
Placement agent warrants 187,798 shares at $1.54 5% of shares and pre-funded warrants sold, 110% of offering price
Expected VAT and R&D refunds approximately $4 million Non-dilutive funds via U.K. subsidiary
registered direct offering financial
"the Company offered for sale to the Purchasers in a registered direct offering (the “Offering”)"
A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.
pre-funded warrants financial
"pre-funded warrants to purchase up to 1,250,893 shares of its common stock (the “pre-funded warrants”)"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
common warrants financial
"accompanying warrants to purchase up to 3,755,966 shares of its common stock (the “common warrants”)"
A common warrant is a tradable instrument that gives its holder the right to buy a company’s common shares at a fixed price within a set time period, similar to a coupon that can be redeemed later to purchase stock. Investors care because exercising warrants can boost potential gains if the stock rises, but it can also dilute existing shareholders by increasing the number of shares outstanding, which can lower per-share value.
Variable Rate Transaction financial
"any issuance ... involving a Variable Rate Transaction (as defined in the Purchase Agreement)"
Accelerated Approval Program financial
"requirements for a Biologics License Application (BLA) under the U.S. Accelerated Approval Program (Accelerated Approval)"
A regulatory pathway that lets a drug or treatment reach the market sooner for serious or life‑threatening conditions based on early signs of benefit (such as lab tests or short‑term results) rather than long‑term proof. It matters to investors because it can accelerate revenue and competitive advantage but carries higher risk: the approval depends on follow‑up studies, and if those fail regulators can withdraw the approval, which can sharply affect a company’s value.
Priority Review Voucher financial
"potential eligibility for a Priority Review Voucher (PRV) under our Rare Pediatric Disease Designation (RPDD)"
A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 31, 2026

 

OS THERAPIES INCORPORATED

 

(Exact name of registrant as specified in its charter)

 

Delaware   001-42195   82-5118368
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

115 Pullman Crossing Road, Suite 103
Grasonville, Maryland
  21638
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (410) 297-7793

 

N/A

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share   OSTX   NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

CURRENT REPORT ON FORM 8-K

 

OS Therapies Incorporated

 

March 31, 2026

 

Item 1.01. Entry into a Material Definitive Agreement.

 

Securities Purchase Agreement

 

On March 31, 2026, OS Therapies Incorporated (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with the purchasers identified on the signature pages thereto (the “Purchasers”), pursuant to which the Company offered for sale to the Purchasers in a registered direct offering (the “Offering”) an aggregate of 2,505,073 shares of its common stock and, in lieu thereof, pre-funded warrants to purchase up to 1,250,893 shares of its common stock (the “pre-funded warrants”), and accompanying warrants to purchase up to 3,755,966 shares of its common stock (the “common warrants”). The shares of common stock, pre-funded warrants and common warrants (including the shares of common stock underlying the pre-funded warrants and common warrants) were offered by the Company pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-289443) filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”) on August 8, 2025 and declared effective by the Commission on August 12, 2025 (the “Registration Statement”), and the prospectus supplement dated March 31, 2026 filed by the Company with the Commission on April 2, 2026 (the “Prospectus Supplement”).

 

The combined purchase price for each share and common warrant in the Offering was $1.40, and the purchase price for each pre-funded warrant and common warrant in the Offering was $1.399, which is equal to the per share and common warrant purchase price, minus $0.001. The closing of the Offering occurred on April 2, 2026. The Company received net proceeds from the Offering of approximately $4.7 million. The Company intends to use the net proceeds to fund clinical development activities, including ongoing and planned clinical trials, advance its research and development programs, and acquire or invest in technologies, product candidates or businesses that are complementary to its strategic objectives, as well as for working capital and other general corporate purposes.

 

The Purchase Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Purchasers, including for liabilities arising under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

 

Pursuant to the Purchase Agreement, the Company agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or any securities convertible into or exercisable or exchangeable for shares of common stock or file any registration statement or prospectus, or any amendment or supplement thereto, for 90 days after the closing date of the Offering, subject to certain exceptions. The Company also agreed not to effect or enter into an agreement to effect any issuance of common stock or any securities convertible into or exercisable or exchangeable for shares of common stock involving a Variable Rate Transaction (as defined in the Purchase Agreement) until 180 days after the closing date of the Offering.

 

Placement Agent Agreement

 

In connection with the Offering, on March 31, 2026, the Company entered into a placement agency agreement (the “Placement Agent Agreement”) with Ceros Financial Services, Inc. (the “Placement Agent”), pursuant to which the Placement Agent agreed to act as the Company’s exclusive placement agent in connection with the Offering. The Company agreed to pay the Placement Agent a cash fee equal to 7.0% of the gross proceeds raised in the Offering. The Company also agreed to reimburse the Placement Agent up to $70,000 for its reasonable and documented out-of-pocket accountable expenses and up to $20,000 for its non-accountable expenses.

 

The Company also issued to the Placement Agent, or its designees, warrants (the “placement agent warrants”) to purchase up to 187,798 shares of the Company’s common stock (equal to 5.0% of the aggregate number of shares of common stock and pre-funded warrants sold in the Offering). The placement agent warrants have an exercise price of $1.54 per share (which represents 110% of the offering price per share and accompanying common warrant), are exercisable beginning six months after the date of issuance and expire five years from April 2, 2026.

 

1

 

In addition to the shares of common stock, the pre-funded warrants and the common warrants (including the shares of common stock underlying the pre-funded warrants and common warrants), the placement agent warrants and the shares of common stock underlying the placement agent warrants were offered by the Company pursuant to the Registration Statement and the Prospectus Supplement.

 

The Placement Agent Agreement contains customary representations, warranties, and agreements by the Company, indemnification obligations of the Company, other obligations of the parties and termination provisions.

 

Terms of the Pre-Funded Warrants

 

The following summary of certain terms and provisions of the pre-funded warrants is not complete and is subject to, and qualified in its entirety by, the provisions of the pre-funded warrants, the form of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Duration and Exercise Price. Each pre-funded warrant is exercisable at any time beginning on the date of issuance and expires only when fully exercised. Each pre-funded warrant entitles the holder thereof to purchase shares of the Company’s common stock at an exercise price equal to $0.001 per share. The exercise price and number of shares of the Company’s common stock issuable upon exercise of each pre-funded warrant is subject to adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock and the exercise price.

 

Exercisability. The holder of the pre-funded warrant may exercise the pre-funded warrant by delivering an exercise notice, completed and duly signed, and payment in cash of the exercise price for the number of shares of the Company’s common stock for which the pre-funded warrant is being exercised. The holder of the pre-funded warrant may also satisfy its obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the pre-funded warrant in shares of common stock determined according to the formula set forth in the pre-funded warrant.

 

A holder of the pre-funded warrant will not be entitled to exercise any portion of such pre-funded warrant that, upon giving effect to such exercise, would cause the aggregate number of shares of the Company’s common stock beneficially owned by such holder (together with its affiliates and any other persons whose beneficial ownership of common stock would be aggregated with the holder for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) to exceed 4.99% (or, at the holder’s election, 9.99%) of the total number of then issued and outstanding shares of the Company’s common stock, as such percentage ownership is determined in accordance with the terms of the pre-funded warrant and subject to such holder’s rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from such holder to the Company.

 

Fundamental Transaction. In the event of any fundamental transaction, as described in the pre-funded warrants and generally including any merger with or into another entity, sale of all or substantially all of the Company’s assets, tender offer or exchange offer, or reclassification of the Company’s shares of common stock, then upon any subsequent exercise of a pre-funded warrant, the holder will have the right to receive as alternative consideration, for each share of common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor or acquiring corporation of the Company, if it is the surviving corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares of common stock for which the warrant is exercisable immediately prior to such event.

 

Transferability. Subject to applicable laws, a pre-funded warrant may be transferred at the option of the holder upon surrender of the pre-funded warrant to the Company together with the appropriate instruments of transfer and payment of funds sufficient to pay any transfer taxes (if applicable).

 

Exchange Listing. There is no established public trading market available for the pre-funded warrants on any securities exchange or nationally recognized trading system. The Company does not intend to list the pre-funded warrants on the NYSE American or any other securities exchange or nationally recognized trading system.

 

2

 

The Company will initially serve as the warrant agent for the pre-funded warrants.

 

Right as a Stockholder. Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the pre-funded warrants do not have the rights or privileges of holders of the Company’s common stock, including any voting rights, until they exercise their pre-funded warrants.

 

Terms of the Common Warrants

 

The following summary of certain terms and provisions of the common warrants is not complete and is subject to, and qualified in its entirety by, the provisions of the common warrants, the form of which is filed as Exhibit 4.2 to this Current Report on Form 8-K and incorporated herein by reference.

 

Duration and Exercise Price. Each common warrant is immediately exercisable upon issuance and expires five years from the date of issuance. Each common warrant entitles the holder thereof to purchase shares of the Company’s common stock at an exercise price equal to $1.40 per share. The exercise price and number of shares of the Company’s common stock issuable upon exercise of each common warrant is subject to adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock and the exercise price.

 

Exercisability. The holder of the common warrant may exercise the common warrant by delivering an exercise notice, completed and duly signed, and payment in cash of the exercise price for the number of shares of the Company’s common stock for which the common warrant is being exercised. The holder of the common warrant may also satisfy its obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the common warrant in shares of common stock determined according to the formula set forth in the common warrant.

 

A holder of the common warrant will not be entitled to exercise any portion of such common warrant that, upon giving effect to such exercise, would cause the aggregate number of shares of the Company’s common stock beneficially owned by such holder (together with its affiliates and any other persons whose beneficial ownership of common stock would be aggregated with the holder for purposes of Section 13(d) of the Exchange Act) to exceed 4.99% (or, at the holder’s election, 9.99%) of the total number of then issued and outstanding shares of the Company’s common stock, as such percentage ownership is determined in accordance with the terms of the common warrant and subject to such holder’s rights under the common warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from such holder to the Company.

 

Fundamental Transactions. In the event of any fundamental transaction, as described in the common warrants and generally including any merger with or into another entity, sale of all or substantially all of the Company’s assets, tender offer or exchange offer, or reclassification of the Company’s shares of common stock, then upon any subsequent exercise of a common warrant, the holder will have the right to receive as alternative consideration, for each share of common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor or acquiring corporation of the Company, if it is the surviving corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares of common stock for which the warrant is exercisable immediately prior to such event.

 

Transferability. Subject to applicable laws, a common warrant may be transferred at the option of the holder upon surrender of the common warrant to the Company together with the appropriate instruments of transfer and payment of funds sufficient to pay any transfer taxes (if applicable).

 

Exchange Listing. There is no established public trading market available for the common warrants on any securities exchange or nationally recognized trading system. The Company does not intend to list the common warrants on the NYSE American or any other securities exchange or nationally recognized trading system.

 

The Company will initially serve as the warrant agent for the common warrants.

 

Right as a Stockholder. Except as otherwise provided in the common warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the common warrants do not have the rights or privileges of holders of the Company’s common stock, including any voting rights, until they exercise their common warrants.

 

3

 

The foregoing descriptions of the Placement Agent Agreement, the pre-funded warrants, the common warrants, the placement agent warrants and the Purchase Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Placement Agent Agreement and the forms of pre-funded warrant, common warrant, placement agent warrant and Purchase Agreement, copies of which are filed as Exhibits 1.1, 4.1, 4.2, 4.3 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

The representations, warranties and covenants contained in the Purchase Agreement and the Placement Agent Agreement were made only for purposes of each such agreement and as of specific dates, were solely for the benefit of the parties thereto and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement and the Placement Agent Agreement are incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement and the Placement Agent Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

 

The legal opinion, including the related consent, of Olshan Frome Wolosky LLP relating to the issuance and sale of the Company’s securities in the Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

 

This Current Report on Form 8-K does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

 

Item 8.01. Other Events.

 

On April 2, 2026, the Company issued a press release announcing the closing of the Offering, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Forward-Looking Statements

 

This Current Report on Form 8-K, including Exhibit 99.1 hereto, contains forward-looking statements that involve risks and uncertainties, such as statements related to the intended use of the net proceeds from the Offering. The risks and uncertainties involved include the Company’s financial position, market conditions and other risks detailed from time to time in the Company’s periodic reports and other filings with the Commission. You are cautioned not to place undue reliance on forward-looking statements, which are based on the Company’s current expectations and assumptions and speak only as of the date of this Current Report on Form 8-K. The Company does not intend to revise or update any forward-looking statement in this Current Report on Form 8-K as a result of new information, future events or otherwise, except as required by U.S. federal securities law.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number
  Description
1.1   Placement Agency Agreement, dated as of March 31, 2026, by and between OS Therapies Incorporated and Ceros Financial Services, Inc.
4.1   Form of Pre-Funded Warrant.
4.2   Form of Common Warrant.
4.3   Form of Placement Agent Warrant.
5.1   Opinion of Olshan Frome Wolosky LLP.
10.1*   Form of Securities Purchase Agreement.
23.1   Consent of Olshan Frome Wolosky LLP (included in Exhibit 5.1).
99.1   Press Release issued by OS Therapies Incorporated on April 2, 2026.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

*Pursuant to Item 601(a)(5) of Regulation S-K, certain schedules and exhibits have been omitted. The registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the Commission upon its request.

 

4

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  OS THERAPIES INCORPORATED
   
Dated: April 2, 2026 By: /s/ Paul A. Romness, MPH
    Name: Paul A. Romness, MPH
    Title: President and Chief Executive Officer

 

5

 

Exhibit 99.1

 

OS Therapies Completes $5.25M Registered Direct Offering Primarily with Pre-Existing High-Net-Worth Investors

 

Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26

 

Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26

 

Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027

 

Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the second half of 2026

 

New York, NY, April 2, 2026 – OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced it that it has completed a $5.25 million registered direct offering of common stock (or pre-funded warrants in lieu thereof) and warrants, with participation primarily from high-net-worth investors who have invested in several of the Company’s prior financing rounds. Each investor was issued either shares of common stock at a purchase price of $1.40 per share or, in lieu thereof, pre-funded warrants at a purchase price of $1.399 per pre-funded warrant, together with one warrant to purchase one share of common stock at an exercise price of $1.40 per share for each share of common stock issued or issuable upon exercise of the pre-funded warrants. Additional details related to the offering are included in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 2, 2026. Ceros Financial Services, Inc. acted as the exclusive placement agent for the offering.

 

Additionally, the Company announced that it expects to receive approximately $4 million in additional non-dilutive funds from VAT refunds and R&D reclaim funds via its wholly owned U.K. subsidiary that was established in 2025 for the purpose of conducting research & development.

 

“This capital raise, together with the non-dilutive funding we expect to receive from our U.K. subsidiary, is expected to support our operations as we advance toward crucial anticipated 2026 regulatory milestones for OST-HER2 in the U.S., U.K. and Europe, including early market access authorizations and potential eligibility for a Priority Review Voucher (PRV) under our Rare Pediatric Disease Designation (RPDD),” said Paul Romness, President & CEO of OS Therapies. “We are now focused on our upcoming regulatory interactions, including planned meetings later this quarter with the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the Australian Therapeutic Goods Administration (TGA) to review our clinical and biomarker data, as well as our proposed confirmatory Phase 3 trial design. We are hopeful these interactions will support market access for osteosarcoma patients beginning in 2027. This funding is also expected to support the initiation of a Phase 3 confirmatory trial, including the planned activation of an initial trial site in Australia, which is part of the requirements for a Biologics License Application (BLA) under the U.S. Accelerated Approval Program (Accelerated Approval) and for Conditional Marketing Authorisations (CMAs) in the U.K. and Europe.”

 

 

 

 

OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and RPDD from the FDA, and ODD, FTD and ATMP from the EMA. Under the RPDD program, if the Company receives a BLA in the United States, it will become eligible to receive a PRV that it intends to sell, subject to market conditions. The most recent publicly disclosed PRV transaction occurred in February 2026 at a reported value of $205 million; however, there can be no assurance that the Company would realize a comparable value, if any, in connection with any future PRV sale. The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026.

 

The securities described above were offered pursuant to a “shelf” registration statement on Form S-3 (File No. 333-289443) filed by the Company with the SEC on August 8, 2025 and declared effective by the SEC on August 25, 2025. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered were filed with the SEC and are available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Ceros Financial Services, Inc. at 1445 Research Boulevard, Rockville, Maryland 20850, or e-mail Ahmed Gheith, Managing Director at Ceros at agheith@cerosfs.com.

 

No Offer to Sell or Solicit

 

This press release is for informational purposes only and does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

 

About OS Therapies

 

OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. The Company is the world leader in listeria-based cancer immunotherapies. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and has received ODD, FTD and ATMP from the European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study and the overall survival (OS) secondary endpoint. The Company anticipates receiving a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma in 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The Company also anticipates receiving Conditional Marketing Authorisations from the U.K.’s Medicines and Healthcare products Regulatory Agency and the EMA for OST-HER2 in 2026. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. The Company also anticipates reading out data from a Phase 1b study of OST-504 in castration resistant prostate cancer in the first half of 2026.

 

2

 

 

In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.

 

Forward-Looking Statements

 

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to our expected to provide cash runway into 2027, the intended use of net proceeds from the offering, the potential approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

OS Therapies Contact Information:

Investor Relations

Harrison Seidner, PhD

WaterSeid Partners

OSTX@waterseid.com

 

Public Relations

Stephanie Chen

Elev8 New Media

media@ostherapies.com

 

https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/

 

3

FAQ

What did OS Therapies (OSTX) raise in its latest financing?

OS Therapies completed a registered direct offering of common stock, pre-funded warrants and common warrants, generating gross proceeds of $5.25 million and net proceeds of about $4.7 million. The securities were issued under an effective shelf registration statement and a related prospectus supplement.

What securities were issued by OS Therapies (OSTX) in the offering?

The company issued 2,505,073 shares of common stock, pre-funded warrants to purchase up to 1,250,893 shares, and accompanying common warrants to purchase up to 3,755,966 shares. It also issued 187,798 placement agent warrants, equal to 5% of the common stock and pre-funded warrants sold.

What were the pricing terms of OS Therapies’ (OSTX) offering?

Each share of common stock and accompanying common warrant was priced at $1.40. Each pre-funded warrant and accompanying common warrant was priced at $1.399. The common warrants have an exercise price of $1.40 per share, while the placement agent warrants have a $1.54 exercise price.

How will OS Therapies (OSTX) use the net proceeds from this capital raise?

OS Therapies plans to use the approximately $4.7 million in net proceeds to fund clinical development activities and trials, advance research and development programs, pursue acquisitions or investments aligned with its strategy, and for working capital and other general corporate purposes, according to its disclosure.

What additional non-dilutive funding does OS Therapies (OSTX) expect?

The company announced it expects about $4 million in additional non-dilutive funds from VAT refunds and R&D reclaim funds via its wholly owned U.K. subsidiary, which was established to conduct research and development activities and supports its overall funding plan.

What lock-up and financing restrictions did OS Therapies (OSTX) agree to?

Under the Securities Purchase Agreement, OS Therapies agreed not to issue most new equity or similar securities, or file new registration statements, for 90 days after closing. It also agreed not to enter Variable Rate Transactions for 180 days, subject to specified exceptions in the agreement.

How does this funding relate to OS Therapies’ OST-HER2 development plans?

Management links this capital raise and anticipated non-dilutive funding to supporting 2026 regulatory milestones for OST-HER2 in multiple regions, including interactions with FDA, EMA, MHRA and TGA, and initiation of a Phase 3 confirmatory trial required for accelerated or conditional approvals.

Filing Exhibits & Attachments

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