Telomir-1 / Telomir Pharmaceuticals - LARVOL DELTA

Targeted Intracellular Metal Modulation Attenuates Oxidative Stress and Preserves Retinal Integrity and Function in a Zebrafish Model of Mitochondrial Dysfunction and Age-Related Retinal Degeneration. (PubMed, Int J Mol Sci) - "Telomir-Zn, a Zinc-based intracellular metal modulator, depletes labile Fe2+, potently inhibits multiple JmjC KDMs, and induces epigenetic reprogramming...Complementary studies in human ARPE-19 RPE cells showed attenuation of iron/copper-induced ROS and calcium dysregulation, with reciprocal zinc accumulation and labile Fe2+ depletion. These findings suggest that targeted metal modulation and multi-KDM inhibition may be a novel strategy to mitigate oxidative-epigenetic stress to preserve retinal structure/function in degenerative disease, supporting further investigation and development for AMD."

Journal • Age-related Macular Degeneration • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • WRN

Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: Telomir Pharmaceuticals, Inc. | Initiation date: May 2026 ➔ Oct 2026

First-in-human • Monotherapy • Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Telomir-Zn restores glucose homeostasis and reduces insulin resistance in a diet-induced zebrafish model of type 2 diabetes. (PubMed, Biomed Pharmacother) - "Insulin resistance was markedly reduced, with HOMA-IR values decreasing from approximately 10 to 12 in diabetic fish to approximately 3 in treated groups. These findings demonstrate that Telomir-Zn restores key metabolic parameters associated with insulin resistance in a zebrafish model of T2DM and support further investigation of metal-modulating small molecules as a potential therapeutic strategy for metabolic disease."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: Telomir Pharmaceuticals, Inc.

First-in-human • Monotherapy • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer (ACCESS Newswire) - "The FDA's clearance reflects review of a comprehensive IND submission supporting advancement of Telomir-Zn into clinical evaluation. The submission included pharmacology, toxicology, manufacturing data, and the Company's first-in-human Phase 1/2 clinical study protocol (TELO-001)...Study Overview: First-in-human, multicenter, open-label Phase 1/2 trial; Adult patients with advanced or metastatic TNBC who have received prior systemic therapy; Planned enrollment of approximately 76 patients."

First-in-human • IND • New P1/2 trial • Triple Negative Breast Cancer

Telomir-1: A novel metal ion modulator targeting aging-related disorders and cancer (AACR 2026) - "By bridging metal biology and chromatin control, Telomir-1 introduces a new therapeutic paradigm with potential applications in iron-dependent and epigenetically dysregulated cancers, including triple-negative breast cancer and prostate cancer, as well as broader aging-related pathologies."

Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) submitted an Investigational New Drug application to the U.S. Food and Drug Administration for Telomir-1, its experimental treatment for advanced and metastatic Triple-Negative Breast Cancer (Investing.com) - "The company plans to initiate a Phase 1/2 clinical trial evaluating Telomir-1 as an oral monotherapy in patients with advanced or metastatic TNBC, subject to FDA clearance...Telomir plans to present data at the AACR Annual Meeting 2026."

IND • New P1/2 trial • Triple Negative Breast Cancer

Telomir Pharmaceuticals Demonstrates Broad Tumor Cell Mortality in Human Triple-Negative Breast Cancer Models (ACCESS Newswire) - "Iron-rescue experiments confirmed that the observed tumor cell mortality is iron-dependent, directly supporting Telomir-Zn's proposed intracellular metal-modulating mechanism and distinguishing the effect from nonspecific cytotoxicity....In the newly reported studies, tumor cell mortality observed across TNBC models was significantly attenuated when supplemental iron was introduced, confirming that the effect is mechanistically linked to disruption of tumor iron dependency."

Preclinical • Triple Negative Breast Cancer

Telomir Pharmaceuticals Announces Telomir-1 Significantly Reduced Tumor Growth and Metastases in Aggressive Triple-Negative Breast Cancer Animal Models (ACCESS Newswire) - "In one of these animal models, Telomir-1 demonstrated statistically significant reductions in primary tumor growth and in the spread of cancer cells beyond the primary tumor (metastatic dissemination) in an aggressive TNBC model with limited responsiveness to the chemotherapy agent paclitaxel. In a separate aggressive TNBC model where paclitaxel demonstrated antitumor activity, Telomir-1 produced a comparable reduction in primary tumor growth as a monotherapy, and the combination treatment with Telomir-1 and paclitaxel resulted in greater tumor growth inhibition than either agent alone."

Preclinical • Triple Negative Breast Cancer

Telomir Pharmaceuticals Reports New Data Showing Telomir-1 Significantly Reduces PSA Levels in Human Prostate Cancer Cells (ACCESS Newswire) - "In an in vitro study conducted by SmartAssays, LNCaP prostate cancer cells were stimulated with dihydrotestosterone (DHT), a potent androgen that increases PSA production. Under these conditions, Telomir-1 produced a concentration-related reduction in PSA release, paralleling its inhibitory effects on cellular energy metabolism and cell viability....The PC3 model represents an androgen-independent tumor type, meaning the cancer cells no longer rely on hormones like testosterone to grow and are generally more aggressive and treatment-resistant."

Preclinical • Prostate Cancer

Telomir Pharmaceuticals Announces Telomir-1 Kills Aggressive Human Leukemia Cells (ACCESS Newswire) - "In this study, HL60 leukemia cells were treated with Telomir-1, which produced a clear, dose-dependent reduction in viable leukemia cells, indicating strong activity in this aggressive human model....Findings expand Telomir-1's oncology profile into cancers of the blood..."

Preclinical • Leukemia

Telomir Pharmaceuticals Reports Telomir-1 Outperforms FDA-Approved Gold-Standard Iron Chelator Deferoxamine (DFO) in Reducing Intracellular Iron in a Human Cell Line (ACCESS Newswire) - "HaCaT cells were incubated with Telomir-1 or DFO for various time points. After three, six and sixteen hours, fluorescence microscopy revealed a markedly lower intracellular iron signal in Telomir-1-treated cells, indicating strong cell penetration and iron-modulating capacity relative to DFO at the same concentrations."

Preclinical • Oncology

Telomir Pharmaceuticals Reports New Data Showing Telomir-1 Resets Cancer's “Kill-and-Clean” Defense Systems in an Aggressive Prostate Cancer Model, Outperforming Rapamycin and Chemo (ACCESS Newswire) - "When Telomir-1 was administered with chemotherapy, both CASP8 and GSTP1 showed lower methylation than with chemotherapy alone, suggesting that Telomir-1 may help counteract chemotherapy related epigenetic silencing in this setting."

Preclinical • Prostate Cancer

Telomir Pharmaceuticals Announces New Data Showing That Telomir-1 Kills Aggressive Pancreatic Cancer Cells, One of the Deadliest Forms of Cancer (ACCESS Newswire) - "In laboratory studies using human pancreatic cancer (PANC-1) cells, Telomir-1 produced a concentration-dependent reduction in cancer cell survival and mitochondrial activity. These data suggest Telomir-1 influences cellular pathways related to energy metabolism and oxidative balance...Telomir-1's effects in pancreatic-cancer cells were partially reversed by iron re-addition....The incomplete reversal supports the interpretation that additional metabolic or epigenetic mechanisms are also engaged."

Preclinical • Pancreatic Cancer

Telomir Pharmaceuticals Announces New Findings in a Prostate Cancer Model… (ACCESS Newswire) - "Findings show that Telomir-1 restores the body's natural tumor suppressor defenses by reversing abnormal DNA methylation of MASPIN and RASSF1A - genes that help block invasion, limit metastasis, and improve chemotherapy responsiveness in aggressive prostate cancer models."

Preclinical • Prostate Cancer

Telomir Pharmaceuticals Reports Discovery That Telomir-1 Selectively Kills Aggressive Triple-Negative Breast Cancer Cells (ACCESS Newswire) - "...New findings demonstrating that Telomir-1 significantly decreases the viability of aggressive triple-negative breast cancer (TNBC) cells - a highly invasive form of breast cancer that lacks hormone and HER2 receptors, offers limited treatment options, and carries one of the poorest survival rates among breast cancer subtypes."

Preclinical • Triple Negative Breast Cancer

Telomir Pharmaceuticals Announces New Cancer Data in Aggressive Human Prostate Cancer Cells Showing Telomir-1 Resets DNA Methylation to Reactivate CDKN2A, a Master Tumor Suppressor, Outperforming Rapamycin and Chemotherapy (ACCESS Newswire) - "In aggressive human prostate cancer cell models (PC3 xenografts), Telomir-1 inhibited CDKN2A DNA methylation more effectively than both Rapamycin and chemotherapy. These results complement Telomir's previously reported data showing that Telomir-1 also resets STAT1, a master regulator of immune surveillance."

Preclinical • Prostate Cancer

Telomir Demonstrates Telomir-1 Reverses Epigenetic Gene Silencing of STAT1, Restoring Tumor Suppressor in Human Prostate Cancer Cells, Outperforming Chemotherapy and Rapamycin (ACCESSWIRE) - "Telomir Pharmaceuticals...announced compelling new preclinical findings highlighting Telomir-1's ability to reverse epigenetic gene silencing in aggressive human prostate cancer cells-achieving greater efficacy than Paclitaxel and Rapamycin in restoring the STAT1 tumor suppressor....In this newly reported study, Telomir-1 administered orally over 21 days in a mouse model implanted with aggressive human prostate cancer cells (PC3 xenograft) fully reversed this hypermethylation in a dose-dependent fashion. In contrast, Paclitaxel (PTX) showed no effect, and Rapamycin achieved only partial reduction of hypermethylation of STAT1....This mechanism offers a potential explanation for the tumor shrinkage observed by Telomir-1 and highlights a biological pathway not addressed by standard chemotherapy."

Preclinical • Prostate Cancer

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

Preclinical • Age-related Macular Degeneration

Telomir Pharmaceuticals Announces Significant Anti-Cancer Effects in Prostate Cancer Animal Model Using Highly Aggressive Human Prostate Cancer Cells (ACCESSWIRE) - "Telomir Pharmaceuticals...announced groundbreaking preclinical findings demonstrating that Telomir-1 reduces tumor size by approximately 50% in a prostate cancer animal model using highly aggressive human prostate cancer cells....Key findings include: (i) Telomir-1 alone at both low and high doses reduced tumor growth by approximately 50%; (ii) Contrary to concerns that telomere-elongating drugs may promote cancer, Telomir-1 demonstrated the opposite effect-actively suppressing tumor development, while selectively benefiting healthy cells; (iii) In the group treated with Paclitaxel alone, severe toxicity was observed, leading to significant weight loss and mortality of one-third of the animals. However, when low-dose Telomir-1 was added to Paclitaxel, no mortality occurred....The company is prioritizing the fastest pathway to clinical trials and aims to submit its Investigational New Drug (IND) application by year-end."

IND • Preclinical • Prostate Cancer