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Telomir Pharmaceuticals Announces Two Pivotal Milestones for Lead Product Candidate Telomir-1

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Telomir Pharmaceuticals (Nasdaq: TELO) announced significant milestones for its lead product candidate, Telomir-1. The Company began a pivotal study on May 28, 2024, to evaluate the safety and efficacy of Telomir-1 in geriatric laboratory Beagle dogs over 63 days. The initial dosing was well-tolerated by all animals, aiming to treat age-related conditions like gait weakness and joint damage. Additionally, Telomir is treating a 12-year-old German Shepherd named Zeus with Telomir-1, gathering real-world data for future research and regulatory efforts. These studies are key steps towards developing treatments for both veterinary and human age-related diseases.

Positive
  • Commencement of the 63-day safety study of Telomir-1 in geriatric Beagle dogs.
  • Initial dosing of Telomir-1 well-tolerated by all animals in the study.
  • Telomir-1 targets age-related conditions, potentially benefiting millions of pets and humans.
  • Real-world data collection from treating a 12-year-old German Shepherd.
  • Potential pre-clinical animal testing endpoints for human IND purposes.
Negative
  • No human clinical data yet available for Telomir-1.
  • Study results pending; success not guaranteed.
  • to geriatric canines; broader efficacy still uncertain.

Insights

Telomir-1's administration to geriatric canines signifies an important step forward. This pre-clinical study evaluates the drug's safety, providing initial data critical for further human and veterinary applications. The study's results will elucidate Telomir-1's impact on telomere length, a key biomarker in aging and age-related conditions.

Success in these trials could highlight Telomir-1's potential in treating chronic conditions like joint damage and gait weakness in pets, which can lead to broader market acceptance. However, it's important to remain cautious as animal model success doesn't always translate to human application. Investors should monitor the data closely, paying special attention to any adverse effects, which could hinder progress or reveal unexpected safety concerns.

Commencing the study with Telomir-1 is a noteworthy milestone. The focus on telomere length as a treatment angle is unique and could be groundbreaking if proven effective. The information gathered from these studies will be pivotal in designing human clinical trials and expanding the potential therapeutic indications of Telomir-1 beyond veterinary applications.

Given the novelty of telomere lengthening as a therapeutic strategy, this study's success could set a new precedent in age-related disease treatment. Nonetheless, the transition from animal to human trials brings regulatory challenges and potential scientific hurdles. Hence, while promising, the journey ahead remains complex and requires vigilance.

Commences the study, The Safety of Telomir-1 when Administered Orally to Geriatric Laboratory Beagle Dogs for 63 Consecutive Days study to evaluate the safety of Telomir-1 on geriatric canines

Began geriatric canine study on May 28th with initial dosing of Telomir-1 – All Animals Tolerated Dosing Well – Data will explore the potential for treatment of age-related conditions

TAMPA, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Telomir Pharmaceuticals, Inc. (Nasdaq: TELO) (“Telomir” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the development and commercialization of Telomir-1 as the first novel small molecule to lengthen the DNA’s protective telomere caps as a potential treatment for age-related conditions, today announced the commencement of several significant milestones. These events underscore its commitment to advancing innovative treatments to mitigate the effects of aging and the continuation of its groundbreaking work.

“Beginning the telomere length and safety study, it is incredibly important for Telomir as it marks the next phase in the development of Telomir-1 and we believe should provide us with information that will help us to make progress in our efforts to combat many of the diseases of aging,” said Dr. Chris Chapman, Co-Founder, Chairman, CEO, President and CMO of Telomir. These studies are potentially usable for veterinary as well as human IND purposes. “We believe the data from the canine study will provide us with pre-clinical animal testing endpoints to determine Telomir-1’s potential as a treatment for age-related conditions such as gait weakness and joint damage, and will provide us with information on physical examinations, blood collection, urine collection, and telomere length.” Dr. Mike Roizen, special consultant to Telomir reiterated that “the study should not only be used to support further work on benefits and risks in canines, especially those with joint disease, but also provide key information for designing studies in humans.”

Initiation of The Safety of Telomir-1 when Administered Orally to Geriatric Laboratory Beagle Dogs for 63 Consecutive Days Study
On May 28, 2024, Telomir began a pivotal study analyzing telomere length to evaluate the aging process and safety of Telomir-1, in geriatric canines, beginning with four canines receiving active doses and one canine receiving placebo doses. Telomir-1 is the Company’s therapeutic candidate aimed at addressing age-related diseases in humans and animals. We believe this study represents a crucial step in the Company’s efforts to develop effective treatments for chronic conditions, which affects millions of pets and humans alike.  

Dosing of Zeus, A Geriatric German Shepherd
In parallel with the pivotal canine study, the Company also announced that it is currently using Telomir-1 to treat Zeus, a 12-year-old German Shepherd. Zeus has completed over a month of daily dosing. This case will provide valuable insights and real-world data that will inform its ongoing and future research and regulatory initiatives which target age-related diseases, oncology and post-surgery recovery.

About Telomir Pharmaceuticals, Inc.
Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) is a pre-clinical-stage pharmaceutical company focused on the development and commercialization of Telomir-1 as the first novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially reverse age-related conditions. Telomeres are the protective end caps of a chromosome made up of DNA sequences and proteins. As humans age, telomeres shorten, with metal reactivity accelerating the process, which presents us with an increased chance of contracting a number of degenerative and age-related diseases. Telomir’s goal is to develop and commercialize Telomir-1 (which is proposed to be dosed orally) for hemochromatosis (iron overload) and ultimately post-chemotherapy recovery and a broader range of other age-related inflammatory conditions such as osteoarthritis.

The Nobel Assembly at Karolinska Institute (Sweden) awarded the Nobel Prize in Physiology or Medicine in 2009 for the discovery of how chromosomes are protected by telomeres and the enzyme telomerase.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding completion, timing and anticipated size of the initial public offering and the expected commencement of trading on the Nasdaq.

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 and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. 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 and the aging process and safety of Telomir-1 . 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, 2023, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

For further information, please contact:

KCSA Strategic Communications
Phil Carlson
telomir@kcsa.com

Telomir Pharmaceuticals
info@Telomirpharma.com
(813) 864-2558


FAQ

What is Telomir-1?

Telomir-1 is a small molecule aimed at lengthening DNA's telomere caps to treat age-related conditions.

When did Telomir Pharmaceuticals commence the geriatric canine study?

The geriatric canine study commenced on May 28, 2024.

What is the duration of the Telomir-1 safety study in geriatric Beagle dogs?

The study will last 63 consecutive days.

What conditions does Telomir-1 aim to treat?

Telomir-1 aims to treat age-related conditions such as gait weakness and joint damage.

What is the significance of dosing Zeus, the German Shepherd, with Telomir-1?

Treating Zeus provides valuable real-world data to inform ongoing and future research and regulatory initiatives.

How did the initial dosing of Telomir-1 in the study go?

The initial dosing was well-tolerated by all animals in the study.

What is the stock symbol for Telomir Pharmaceuticals?

The stock symbol for Telomir Pharmaceuticals is TELO.

Telomir Pharmaceuticals, Inc.

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