Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 282

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 282
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company is optimizing manufacturing processes to produce GMP-grade Telomir-1 for IND-enabling studies and future clinical trials. Safety
studies are scheduled for Q2 2025, with IND submission targeted for Q4 2025 and first-in-human trials anticipated in early 2026. Concurrently,
the company aims to secure an INAD to enable veterinary applications, highlighting Telomir-1’s dual potential for both human and
animal health.

Through
these initiatives, Telomir is committed to revolutionizing treatments for age-related and chronic diseases by addressing their root causes
and paving the way for transformative healthcare solutions.

Market
Potential

The
market potential for Telomir-1 is substantial, given its focus on addressing the root causes of age-related diseases and promoting longevity.
Chronic diseases such as diabetes, cancer, Alzheimer’s, and cardiovascular disorders, which are closely tied to aging, account
for over 75% of healthcare spending in the United States, exceeding $4 trillion annually, according to the CDC. As the global population
ages, the demand for innovative therapies targeting the underlying mechanisms of these conditions is expected to grow significantly.
Furthermore, Verified Market Research reports that the anti-aging drug market was valued at approximately $91.05 billion in 2024 and
is projected to reach $160.24 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.32%. With its novel mechanism of
action that regulates cellular metal imbalances and reduces oxidative stress, Telomir-1 is uniquely positioned to capitalize on these
expanding markets, offering transformative potential to enhance health span, slow disease progression, and redefine longevity treatments.

12

Pre-Clinical
IND-Enabling Studies

As
outlined in the table below, we have successfully completed several IND-enabling studies for Telomir-1, demonstrating its non-toxic profile.
In collaboration with Frontage Laboratories, our research has also established the metabolism and maximum tolerated dose (MTD) of Telomir-1,
providing critical data to support its development.

    Type
    of Study
     
    Species
     
    Purpose
     
    Results

    Metabolite
    Identification
     
    CD-1
    mouse, SD-rat, Beagle dog, Cynomolgus monkey and human
     
    To
    determine the metabolic pathways of Telomir-1 across species
     
    Telomir-1