Telomir Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
Telomir Pharmaceuticals 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).
The completed studies evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose safety using a combination of in vitro systems and 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.
| TELOMIR PHARMACEUTICALS, INC. | ||
| Dated: December 17, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |