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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): April 30, 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

April 30, 2026

Item 7.01. Regulation FD Disclosure.

On April 30, 2026, OS Therapies Incorporated (the “Company”) issued a press release announcing, among other things, that the European Medicines Agency has initiated a rolling review (continuous evaluation) of the Company’s regulatory dossier for OST-HER2 and providing an update on certain other regulatory interactions and related Company developments. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On April 30, 2026, the Company also held a conference call to review OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and to review regulatory updates relating to the OST-HER2 program. A copy of the slide presentation that was used during the conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Cautionary Note Regarding Forward-Looking Statements

This report, including Exhibits 99.1 and 99.2, contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include statements regarding the Company’s expectations, plans, prospects, anticipated timing of regulatory interactions, anticipated timing and outcomes of regulatory review processes, anticipated clinical and regulatory milestones, anticipated commercialization and market access opportunities, anticipated sales and other financial or operating expectations, and other statements that are not historical facts. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “potential,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on management’s current expectations and assumptions as of the date of this report and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others, risks and uncertainties related to regulatory processes and outcomes, the timing and results of clinical trials and data analyses, the Company’s ability to obtain and maintain regulatory approvals, authorizations, designations, and reimbursement, the Company’s ability to execute its development and commercialization strategy and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and other filings the Company may make with the SEC from time to time. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove to be incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements.

The forward-looking statements included in this report are made only as of the date of this report, and except as otherwise required by applicable securities law, the Company assumes no obligation, nor does the Company intend to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.

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Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number |  | Description
99.1 |  | Press Release issued by OS Therapies Incorporated on April 30, 2026.
99.2 |  | Slide Presentation dated April 30, 2026.
104 |  | Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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 30, 2026 | By: | /s/ Paul A. Romness, MPH
|  | Name: | Paul A. Romness, MPH
|  | Title: | President and Chief Executive Officer

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