Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 284

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 284
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 of Telomir-1 and to estimate the MTD of Telomir-1
     
    There
    were no treatment-related clinical observations, body weights, clinical pathology and anatomic gross pathology findings up to 7.5
    mg/kg/day.

    SafetyScreen44
    TM
     
    N/A
     
    To
    evaluate, in Enzyme, and Radioligand Binding assays, the activity of Telomir-1
     
    No
    significant results noted

13

All
preclinical studies referenced in this Annual Report were conducted in collaboration with third-party organizations, including
Frontage Laboratories, InSilico Trials, Pharmaseed Ltd, Smart Assay Biotechnologies Ltd., Recipharm, Naji Biosciences, and Pantagrit. These partners
played a key role in supporting the execution and analysis of the research.

Our
Clinical Development Plan

Upon
completing toxicology studies and preclinical proof-of-concept studies, we plan to submit an Investigational New Drug (IND) application
to the FDA for Telomir-1. While the specific indication is still being evaluated, we intend to explore additional indications with FDA
guidance as the development program evolves. Our first IND submission for Telomir-1 is targeted for the fourth quarter of 2025. If approved
by the FDA, we plan to initiate a Phase I double-blind, randomized, placebo-controlled trial approximately 30 days post-submission. This
trial will assess the safety, tolerability, and pharmacokinetics of Telomir-1 in 40–60 healthy adult male and female participants.

The
progress of our clinical development program will depend on FDA acceptance of our IND submissions. As discussions with the FDA progress,
we may adjust timelines for filings and associated clinical trials when necessary. It is important to acknowledge that conducting clinical
trials is inherently uncertain, and there can be no assurance that our clinical development activities will proceed according to the
planned timelines outlined above.

Manufacture
of Product for Clinical Development Activities

Anthem
Biosciences, a leading contract development and manufacturing organization, initially developed the large-scale synthesis protocol for
Telomir-1, enabling the production of material required for preclinical studies. The manufacturing and synthesis processes have since
been successfully transferred to Recipharm, a globally recognized CDMO known for its expertise in advanced chemistry, operational excellence,
and commitment to delivering high-quality manufacturing solutions