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Item 8.01 Other Events
Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints
On May 29, 2025, Telomir Pharmaceuticals, Inc. (the “Company”) announced new preclinical data from its ongoing development of Telomir-1, an investigational oral small molecule candidate being developed for the treatment of age-related macular degeneration (“AMD”).
The study was conducted using the Sen57wrn-/-ND6-/+ zebrafish model, which incorporates genetic mutations associated with premature aging (WRN), mitochondrial dysfunction (ND6), and chronic senescence (Sen57). This model mimics key features of dry AMD and geographic atrophy observed in human disease.
Eighteen-month-old animals were administered Telomir-1 orally for a period of 14 days. The following outcomes were observed:
| ● | Functional Vision Improvement: Treated animals demonstrated improved central vision response and motion detection, with significantly enhanced reaction to visual stimuli, including light and movement. | |
| ● | Retinal Structural Restoration: Histological analysis revealed regeneration of several critical retinal layers, including the inner nuclear layer (INL), ganglion cell layer (GCL), inner plexiform layer (IPL), and outer plexiform layer (OPL). Telomir-1 treatment led to measurable increases in layer thickness and improved retinal architecture compared to untreated animals. | |
| ● | Reduction in Oxidative Stress: Reactive oxygen species (ROS) levels, which were elevated approximately fourfold in untreated diseased animals, were reduced by up to 50% following treatment. | |
| ● | Survival Benefit: While untreated animals experienced a 15% mortality rate during the two-week study period, no mortality was observed in any Telomir-1 treated group. |
The Company believes these results represent a significant preclinical milestone, demonstrating that Telomir-1, administered orally, can restore vision-related function, regenerate damaged retinal tissue, reduce oxidative stress, and improve survival in a validated model of AMD. The study utilized endpoints consistent with FDA-recognized surrogate markers for visual function, supporting continued advancement of Telomir-1 toward Investigational New Drug (IND) submission.
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: May 29, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |