• Building on preclinical success demonstrating age reversal, longevity, and increased healthspan, Telomir-1 appears to address insulin resistance at its root, achieving reversal to near pre-diabetic levels

MIAMI, FL / ACCESSWIRE / December 3, 2024 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), an emerging leader in age-reversal science, today announced groundbreaking preclinical results confirming the efficacy of its licensed molecule Telomir-1 in reversing several key parameters of Type 2 diabetes mellitus.

The study demonstrated significant reductions in fasting plasma glucose levels to basal levels, improvements in oral glucose homeostasis, and the reversal of insulin resistance to near pre-diabetic levels. These findings were supported by significantly improved Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) values, a standard measure used to assess insulin sensitivity and resistance.

These effects were also accompanied by increased survival rates in treated subjects. These findings highlight Telomir-1's ability to potentially address the underlying mechanisms of Type 2 diabetes, setting it apart from currently approved diabetes therapies.

According to information published by the International Diabetes Foundation, Type 2 diabetes (both undiagnosed and diagnosed) impacts more than 800 million adults globally, with an annual healthcare cost exceeding $966 billion as of 2021. Current treatments focus on managing blood glucose levels and alleviating symptoms rather than reversing the root causes of the disease. Moreover, these drugs often come with significant shortcomings, including limited impact on insulin resistance, gastrointestinal issues, risk of hypoglycemia, cardiovascular risks, and weight gain.

The new preclinical study results, conducted in a zebrafish diabetes model, suggest that Telomir-1 could offer a novel, transformative approach by targeting the underlying mechanisms of insulin resistance. By normalizing iron metabolism, Telomir-1 directly addresses oxidative stress and beta-cell damage. A key metric of success in this study was the significant reduction in HOMA-IR values. Lower HOMA-IR values indicate improved insulin sensitivity and better glucose regulation, which are critical factors in combating Type 2 diabetes. The reversal of insulin resistance to near pre-diabetes levels achieved by Telomir-1 underscores its groundbreaking potential as a transformative treatment.

Erez Aminov, Chairman and CEO of Telomir, commented "We have not only confirmed age reversal and improved longevity with Telomir-1 but have also observed its potential to reverse key parameters of type 2 diabetes. These findings, demonstrated in preclinical studies, support our belief that Telomir-1 could fundamentally transform the way we age as we expand our research into other age-related diseases."

This announcement aligns with the new Trump administration's healthcare strategy under the proposed leadership of Robert F. Kennedy Jr. as head of the Department of Health and Human Services (HHS). Telomir believes that the new administration's focus on addressing root causes of chronic diseases and supporting transformative therapies complements Telomir's vision of treating disease causes rather than just symptoms.

Study Overview and Results

In collaboration with the India-based research organization Pentagrit, Telomir evaluated two forms of Telomir-1, administered orally at three different doses, in zebrafish models of Type 2 diabetes mellitus induced by a high-calorie diet. The study assessed key metabolic indicators, including fasting glucose levels, Oral Glucose Tolerance Test (OGTT) results, insulin concentrations, and HOMA-IR.

Key findings include:

• Reversal of Hyperglycemia and Insulin Resistance: Telomir-1 demonstrated dose-dependent efficacy in normalizing blood glucose and reducing insulin levels, restoring glucose homeostasis.

• Significantly Reduced HOMA-IR Values: Telomir-1 showed a substantial improvement in insulin sensitivity to near pre-diabetes values, underscoring its potential to mitigate insulin resistance.

• Enhanced Glucose Clearance: Significant improvements in OGTT results highlighted Telomir-1's impact on glucose metabolism.

• Increased Survival Rates: Treated models exhibited improved survival compared to controls, showcasing Telomir-1's comprehensive therapeutic potential.

A Novel Mechanism of Action

Telomir-1's novel mechanism of action focuses on addressing the systemic role of iron metabolism in a large variety of chronic diseases, including Type 2 diabetes. Excess iron levels contribute to oxidative stress, beta-cell damage, and insulin resistance across key tissues. Telomir-1 is designed to normalize iron homeostasis, reducing oxidative stress and improving insulin sensitivity, setting it apart from existing drugs that primarily treat symptoms without addressing these underlying causes.

Expanding Research and Future Directions

Building on these remarkable results, Telomir is advancing additional research, including:

• Progeria Studies: Evaluating Telomir-1's effects on human progeria cell lines and progeria nematode models to investigate its impact on accelerated aging and telomere function and stability.

• Diabetic Mouse Models: Further validating Telomir-1's efficacy in mammalian model of Type 2 diabetes.

• Alzheimer's Disease: Initiating studies to assess Telomir-1's potential in mitigating cognitive decline and neurodegeneration.

• Osteoarthritis and Inflammatory Diseases: Evaluating Telomir-1's role in managing joint health and other age-related inflammatory conditions.

• Cancer Models: Exploring Telomir-1's application in combating age-related oncological conditions.

Dr. Itzchak Angel, Chief Scientific Advisor at Telomir, elaborated: "These findings confirm Telomir-1's potential to not only manage diabetes effectively but to fundamentally change how we view chronic disease treatment. By targeting the root causes of insulin resistance, Telomir-1 offers a potential paradigm shift in diabetes management. We plan on exploring Telomir-1 in other metal-overload related diseases as we seek to realize the molecule's full potential."

About Telomir Pharmaceuticals, Inc.

Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) is a pre-clinical stage pharmaceutical company seeking to lead development in age-reversal science. Telomir is focused on the development of Telomir-1, a novel small molecule designed to lengthen the DNA's protective telomere caps, which are crucial in the aging process. Telomir's goal is to explore the potential of Telomir-1 starting with ongoing research in animals and then in humans.

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 humans and pet animals with an increased chance of contracting a number of degenerative and age-related diseases. Telomir's goal is to develop and gain regulatory approval for Telomir-1, proposed to be dosed orally, with the broader aim of promoting longevity and enhancing overall quality of life.

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.

Telomir-1 is in preclinical development and has not yet been tested in humans. There is no assurance that Telomir-1 will proceed through development or will ultimately receive FDA approval for marketing.

Cautionary Note Regarding Forward-Looking Statements

This press release, statements of Telomir Pharmaceuticals' 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 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 (i) the anticipated benefits of the preclinical testing results described herein, (ii) anticipated timelines and subject matter for additional preclinical and clinical testing of Telomir-1 and (iii) the potential therapeutic benefits of Telomir-1 generally.

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 significant 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 for specific indications 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.

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