The Fort Worth Press - Telomir Pharmaceuticals Reports Favorable IND-Enabling GLP Safety Results for Telomir-1 Supporting First-in-Human Clinical Development

MIAMI, FL / ACCESS Newswire / December 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today announced favorable results from a comprehensive series of IND-enabling Good Laboratory Practice (GLP) toxicology and safety pharmacology studies for its lead therapeutic candidate, Telomir-1 (Zn-Telomir).

The studies were conducted as part of the Company's ongoing IND-enabling program and evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose toxicology using a combination of in vitro systems and in vivo rat and dog models. While final quality assurance (QA) review of the study reports is ongoing, the Company does not expect the overall conclusions to change.

Key Safety Findings

• Overall Safety:
  Telomir-1 was well tolerated across all completed GLP safety studies, with no treatment-related adverse or dose-limiting toxicities observed.

• Cardiovascular Safety:
  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. In addition, no concerning cardiac safety signals were identified in a validated GLP assay commonly used to assess arrhythmia risk.

• Repeated-Dose Toxicology:
  Repeated oral administration in both rats and dogs were well tolerated. Observed findings were limited, reversible, and considered non-adverse, with no serious toxicological findings identified.

• Respiratory Safety:
  No clinically meaningful effects on respiratory function were observed.

• Phototoxicity:
  Telomir-1 demonstrated no evidence of phototoxic potential under simulated sunlight conditions.

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

Overall Conclusion

Collectively, these IND-enabling GLP data demonstrate a favorable safety and tolerability profile and consistent systemic exposure upon oral administration for Telomir-1. No treatment-related adverse toxicity was observed, and no findings were identified that would preclude advancement into first-in-human clinical studies, subject to applicable regulatory pathways.

CEO Perspective

"Safety is often the factor that determines whether a drug program can advance," said Erez Aminov, Chief Executive Officer of Telomir. "Many development programs encounter safety limitations that prevent clinical progression. Achieving a broad IND-enabling GLP safety profile with no treatment-related adverse toxicity observed is a critical milestone as we prepare Telomir-1 for first-in-human evaluation."

Scientific Perspective

"In oncology, therapeutic activity must be balanced against tolerability, as safety limitations frequently constrain dosing, duration of therapy, and patient quality of life," said Dr. Itzchak Angel, Chief Scientific Advisor at Telomir. "The GLP safety profile observed with Telomir-1, together with its consistent pharmacologic behavior and good oral absorption across studies, supports continued advancement into first-in-human clinical evaluation, pending regulatory review."

Next Steps

Telomir plans to continue advancing Telomir-1 through its IND-enabling activities and broader regulatory preparations. In parallel, 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, to further characterize its biological activity and therapeutic potential.

In addition, Telomir is actively preparing scientific manuscripts for publication submission and is targeting abstract submissions and presentations at multiple oncology-focused scientific conferences in 2026, as part of its ongoing efforts to share data and engage with the scientific and clinical research community.

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

About Telomir Pharmaceuticals

Telomir Pharmaceuticals (NASDAQ:TELO) is a preclinical biotechnology company developing small-molecule therapeutics designed to target the root epigenetic mechanisms underlying cancer, aging, and degenerative disease. The Company's lead candidate, Telomir-1, has demonstrated activity in preclinical studies involving modulation of DNA and histone methylation, restoration of redox balance, and normalization of cellular function.

Cautionary Note Regarding Forward-Looking Statements

This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1.

Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which are on file with the SEC and available at www.sec.gov. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact Information
[email protected]
(786) 396-6723

SOURCE: Telomir Pharmaceuticals, Inc.

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H.M.Hernandez--TFWP