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Item 8.01 Other Events
On June 18, 2025, Telomir Pharmaceuticals, Inc. (Nasdaq: TELO), a preclinical-stage biotechnology company focused on reversing biological aging and age-related diseases, announced positive new preclinical data demonstrating the cellular protective activity of its lead candidate, Telomir-1, in human progeria cell lines.
Progeria, or Hutchinson-Gilford Progeria Syndrome (HGPS), is an ultra-rare pediatric disorder caused by a mutation in the LMNA gene, leading to the production of progerin—a toxic protein that causes rapid biological aging in children. There are fewer than 30 known patients in the United States, with an average life expectancy of 13 to 15 years. The only approved treatment, Zokinvy® (lonafarnib), extends lifespan by approximately 4.3 years but does not reverse the underlying disease pathology or halt cardiovascular decline, the leading cause of death.
The Company evaluated Telomir-1 in cells taken directly from a child with HGPS. These cells were obtained from The Progeria Research Foundation (www.progeriaresearch.org). The study, conducted by SmartAssays, focused on three critical hallmarks of cellular aging and disease progression in Progeria: loss of viability, oxidative stress, and mitochondrial dysfunction.
Key findings include:
| ● | Telomir-1 significantly increased cell viability, both under basal conditions and even in the presence of toxic levels of iron and copper. | |
| ● | Reactive oxygen species (ROS), elevated in Progeria cells, were normalized by Telomir-1, both under basal conditions and even under oxidative stress conditions. | |
| ● | Calcium overload—a marker of mitochondrial damage—was reversed, restoring mitochondrial function and energy balance. |
Telomir-1 is designed to regulate intracellular metal ions, reduce oxidative stress, restore mitochondrial function, extend telomere length, reverse muscle loss, and reset age-associated DNA methylation patterns—biological pathways that play central roles in Progeria and other degenerative conditions.
The results build on prior studies in zebrafish and C. elegans models of Werner syndrome (adult progeria), where Telomir-1 extended lifespan, restored telomere length, reversed muscle degeneration, and reset epigenetic aging markers.
Telomir Pharmaceuticals is finalizing IND-enabling studies and intends to engage with the U.S. Food and Drug Administration (FDA) to explore regulatory pathways, including the potential for orphan drug designation. The Company is evaluating multiple rare disease indications for initial clinical development.
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: June 18, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |