Telomir Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Telomir-1 (Telomir-Zn). The IND is for the treatment of advanced and metastatic Triple-Negative Breast Cancer (TNBC). Telomir-1 is described as a first-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways. The submission includes data from completed IND-enabling pharmacology, toxicology, and manufacturing studies. Subject to FDA clearance, 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. The Phase 1 portion will use a 3+3 dose-escalation design to assess safety, tolerability, dose-limiting toxicities, and determine a recommended Phase 2 dose. The Phase 2 portion will evaluate preliminary antitumor activity using a Simon two-stage design, with objective response rate as the primary endpoint. Preclinical studies demonstrated Telomir-Zn's ability to reduce tumor growth and metastatic dissemination in TNBC models, and induce iron-dependent tumor cell mortality across several human TNBC cell lines. IND-enabling Good Laboratory Practice (GLP) safety studies showed no treatment-related adverse or dose-limiting toxicities. The company is continuing to evaluate Telomir-Zn in additional preclinical TNBC models and advancing biomarker strategies. Scientific manuscripts have been submitted to peer-reviewed journals, and data presentations are planned for scientific conferences, including the AACR Annual Meeting 2026.