8-K

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the

Securities

Exchange Act of 1934

Dateof Report (Date of earliest event reported): December 17, 2025

TELOMIR

PHARMACEUTICALS, INC.

(ExactName of Registrant as Specified in its Charter)

100SE 2nd St, Suite 2000, #1009

Miami, Florida 33131

(Address of Principal Executive Offices)

Registrant’stelephone number, including area code: (786) 396-6723

NotApplicable

(FormerName 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:

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. ☐

Item8.01 Other Events

TelomirPharmaceuticals Reports Favorable IND-Enabling GLP Safety Results for Telomir-1 Supporting First-in-Human Clinical Development

The completion of IND-enabling GLP safety studies represents a key milestone in the Company’s ongoing clinical development strategy for Telomir-1.

On December 17, 2025, Telomir Pharmaceuticals, Inc. (the “Company”) announced favorable results from a series of completed Good Laboratory Practice (“GLP”) toxicology and safety pharmacology studies for its lead therapeutic candidate, Telomir-1 (Zn-Telomir).

Thecompleted studies evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose safety using a combination of in vitro systemsand in vivo rat and dog models as part of the Company’s ongoing IND-enabling program. Across these studies, Telomir-1 was generally well tolerated, with no treatment-related adverse or dose-limiting toxicities observed. Observed findings were limited, reversible, and considered non-adverse. No findings were identified that would preclude advancement into first-in-human clinical studies, subject to applicable regulatory pathways. Final quality assurance review of the study reports is ongoing, and the Company does not expect the overall conclusions to change.

In non-rodent studies, including in dogs, no test-article-related changes in blood pressure, heart rate, electrocardiogram (ECG) parameters, or body temperature were observed following oral administration of Telomir-1.

Across oral administration studies, Telomir-1 demonstrated consistent systemic exposure, supporting continued advancement toward clinical development.

In parallel with its regulatory preparation activities, the Company is conducting ongoing preclinical animal model studies evaluating Telomir-1 across multiple oncology and age-related disease settings, including triple-negative breast cancer. The Company is also preparing scientific manuscripts for publication submission and targeting abstract submissions and presentations at multiple oncology-focused scientific conferences in 2026.

Based on current expectations and subject to regulatory review and other factors, the Company currently anticipates submitting an Investigational New Drug application in the first quarter of 2026 and initiating first-in-human clinical studies in the first half of 2026.

SIGNATURES

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.