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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):
November 11, 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
November 11, 2026
Item 8.01. Other Events.
On November 11, 2026, OS Therapies
UK Ltd. (“OSUK”), a wholly owned subsidiary of OS Therapies Incorporated (the “Company”), received a value added
tax (“VAT”) refund from HM Revenue and Customs (“HMRC”), the U.K. tax authority, of £678,715.46 (approximately
$900,000), representing the recovery of VAT previously paid by OSUK on qualifying expenditures. The Company intends to use these funds
to support the continued clinical development of, and regulatory and commercial-readiness activities for, Herlystic® (OST-HER2), its
leading product candidate for the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma.
On November 12, 2026, the
U.S. Food and Drug Administration (the “FDA”) announced the suspension of its Commissioner’s National Priority Voucher
(“CNPV”) program, under which priority review vouchers are non-transferable. The FDA’s announcement does not affect
the separate rare pediatric disease priority review voucher (“PRV”) program, under which vouchers are transferable. OST-HER2
remains eligible for the rare pediatric disease PRV program, and the FDA’s suspension of the CNPV program does not affect such eligibility.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form
8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the safe harbor created by the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the anticipated use of the
VAT refund proceeds, the clinical development, regulatory review and potential approval and commercialization of OST-HER2, and the Company’s
potential eligibility for, receipt of, and ability to monetize a PRV. Words such as “anticipates,” “believes,”
“expects,” “intends,” “may,” “plans,” “will” and similar expressions are intended
to identify forward-looking statements. These statements are based on the Company’s current expectations and are subject to risks
and uncertainties that could cause actual results to differ materially, including, among others: changes in U.K. tax law or HMRC practice;
fluctuations in foreign currency exchange rates; the outcome and timing of the FDA’s review of OST-HER2; changes in, or the suspension,
expiration or termination of, FDA priority review voucher programs; the Company’s need for substantial additional capital; and the
other risks described under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this report,
and the Company undertakes no obligation to update them, except as required by law.
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: November 12, 2026 |
By: |
/s/ Paul A. Romness, MPH |
| |
|
Name: |
Paul A. Romness, MPH |
| |
|
Title: |
President and Chief Executive Officer |
