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Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints

1. Telomir-1 shows retinal regeneration in zebrafish model of AMD. 2. Restores vision, reduces oxidative stress significantly in treated models. 3. No mortality observed in drug-treated groups, marking substantial efficacy. 4. First oral drug to demonstrate such regenerative capacity for AMD. 5. CEO emphasizes shift from symptom management to addressing root causes.

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FAQ

Why Very Bullish?

The results position Telomir-1 as a potentially groundbreaking treatment for AMD, which can significantly impact market perception and investor confidence, similar to past breakthroughs in other biotech companies like Regeneron Pharmaceuticals with Eylea.

How important is it?

The innovative approach and the preclinical success represent a significant advancement in ocular therapeutics, likely attracting attention from investors and potential partnerships.

Why Long Term?

If successful in clinical trials, Telomir-1 could open substantial market opportunities for Telomir, akin to how Novartis transformed its business with gene therapy approaches.

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A unique oral drug candidate that is shown to restore vision and regenerate the retina in an animal model, addressing a major unmet need in ocular therapeutics Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), an emerging leader in age-reversal science, today announced compelling preclinical results from a study evaluating its novel oral therapeutic, Telomir-1, in a genetically modified zebrafish model of age-related macular degeneration (AMD). Following a 14-day oral dosing regimen, Telomir-1 reversed central vision response and vision acuity, restored retinal degeneration and architecture, and significantly reduced oxidative stress-achieving improvements across several FDA-recognized surrogate endpoints relevant to AMD.The study utilized the Sen57wrn-/-ND6-/+ zebrafish model, which combines genetic mutations associated with premature aging (WRN), mitochondrial dysfunction (ND6), and chronic senescence (Sen57). These animals exhibit progressive retinal degeneration, visual impairment, and oxidative stress-closely modeling dry AMD and geographic atrophy in humans.Model Transformation: From Degeneration to RecoveryBefore treatment, the aged (18-month-old) zebrafish demonstrated clear signs of neurodegeneration and visual impairment. Mutant animals showed sluggish, uncoordinated swimming behavior and delayed responses to visual stimuli such as light and movement-evidence of significant vision loss.Microscopic analysis of their retinas revealed approximately 15% total retinal degeneration, affecting several critical layers:The inner nuclear layer (INL) was thinned. This layer acts as the retina's central processing zone, where signals from light-sensitive photoreceptors are refined before being passed deeper into the eye.The ganglion cell layer (GCL) was degraded. This layer contains neurons that form the optic nerve, which sends visual information to the brain. Damage here disrupts vision at its source.The inner plexiform layer (IPL) volume was reduced. IPL is a retinal layer located between the inner nuclear layer (INL) and the ganglion cell layer (GCL). It may contribute to disease processes through inner retinal changes, inflammation, or vitreoretinal interactions.The outer plexiform layer (OPL) showed early deterioration. This layer connects photoreceptors to other retinal cells and is essential for detecting changes in light and contrast.In addition to retinal damage, the diseased animals exhibited reactive oxygen species (ROS) levels nearly four times higher than healthy controls-indicating intense oxidative stress-and suffered a 15% mortality rate during the two-week study window.After receiving Telomir-1, treated animals demonstrated marked recovery:The zebrafish resumed active, coordinated swimming and responded significantly better to light and movement, reflecting restored vision.Retinal architecture was structurally restored, including:Full recovery of INL thickness, restoring core signal processing in the retina.Improved GCL integrity, reactivating the transmission of visual information to the brain.Significant augmentation of IPL size, indicating improved processing of visual signalsImprovement of OPL structure, maintaining input from photoreceptors.ROS levels were reduced by up to 50%, and no mortality occurred in any Telomir-1 treatment group.Histological cross-sections confirmed Telomir-1's ability to regenerate not only the inner retinal layers, but also additional retinal structures-supporting improved-laminar retinal restoration and function.Collectively, these results demonstrate Telomir-1's ability to restore visual function, reverse retinal degeneration, reduce oxidative stress, and improve survival-all from a short oral treatment regimen."This breakthrough reinforces our vision at Telomir: to redefine how we treat age-related diseases by going beyond symptom management and targeting the root mechanisms of degeneration," said Erez Aminov, Chief Executive Officer of Telomir. "To our knowledge, no oral drug has ever demonstrated this level of retinal restoration and vision recovery in any AMD model-this is a meaningful leap forward for patients and the field.""The preclinical success achieved in this AMD model is truly remarkable," added Dr. Angel, Chief Scientific Advisor of Telomir. "Telomir-1 when studied orally, restored both structure and function in the retina, demonstrating not just neuroprotection, but true regenerative capacity-a property rarely seen in ophthalmic drug development."Cautionary Note Regarding Forward-Looking StatementsThis 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 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, 2024, 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.Contact InformationHelga Moya [email protected](786) 396-6723SOURCE: Telomir Pharmaceuticals, Inc

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