Telomir Pharmaceuticals, Inc. Common Stock

Telomir Pharmaceuticals has reached a significant regulatory milestone with the submission of an Investigational New Drug application to the FDA for its lead candidate, Telomir-1, in advanced and metastatic triple-negative breast cancer. This submission, which includes data from IND-enabling pharmacology, toxicology, and manufacturing studies, represents the company's transition from preclinical to clinical development. Upon FDA clearance, the company plans to initiate a Phase 1/2 clinical trial evaluating Telomir-1 as an oral monotherapy. The Phase 1 portion will utilize a standard 3+3 dose-escalation design to assess safety and determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate preliminary antitumor activity using objective response rate as the primary endpoint. Telomir-1's mechanism of action involves modulating intracellular metal homeostasis, specifically reducing redox-active iron and increasing zinc availability, which preclinical studies associate with inhibition of iron-dependent epigenetic enzymes and transcriptional repression. The company reported that Telomir-Zn demonstrated reduced tumor growth and metastatic dissemination in TNBC models, along with iron-dependent tumor cell mortality across several human TNBC cell lines. Importantly, IND-enabling GLP safety studies showed no treatment-related adverse or dose-limiting toxicities. The company is continuing preclinical evaluation in additional TNBC models, advancing biomarker strategies, and plans to present data at scientific conferences including the AACR Annual Meeting 2026. This development represents a critical step in Telomir's pipeline progression and potential value creation for investors.