Telomir Pharmaceuticals announced that its lead oral small‑molecule candidate, Telomir‑1, completed a full set of IND‑enabling Good Laboratory Practice toxicology and safety pharmacology studies. The studies, performed under GLP conditions, found no treatment‑related adverse toxicity and demonstrated consistent systemic exposure following oral administration.
The results eliminate a major regulatory hurdle, allowing the company to file an Investigational New Drug application and move toward first‑in‑human trials in the first half of 2026. This milestone aligns with Telomir’s development roadmap and positions the company to begin clinical evaluation of its metal‑ion regulator platform, which underpins its age‑reversal and oncology programs.
Telomir remains a preclinical‑stage company with no revenue and a distressed‑stock classification. The company’s financial health is constrained, and it has previously raised modest capital through a $5 million line of credit and a $1 million equity round. The GLP safety data, while encouraging, represent an early step in a long and uncertain drug‑development pathway that still requires regulatory approval, additional clinical studies, and substantial funding.
CEO Erez Aminov said, “The GLP safety profile of Telomir‑1 confirms the robustness of our platform and strengthens our confidence in advancing to human trials. We remain focused on securing the necessary resources to support this critical next phase.” Chief Scientific Advisor Dr. Angel added, “These findings reinforce the therapeutic potential of Telomir‑1 for age‑related diseases and highlight the broader applicability of our metal‑ion regulation strategy.”
The announcement underscores the strategic importance of Telomir’s platform but also highlights the inherent risks of early‑stage drug development. With no revenue to date and a history of financial volatility, the company’s ability to sustain the clinical pipeline will depend on future funding and regulatory success. No market‑reaction data are available for this specific announcement, but the positive safety profile is expected to be viewed favorably by investors who are monitoring the company’s progress toward clinical milestones.
Moving forward, Telomir plans to submit its IND application in the first quarter of 2026, after which it will seek to initiate a phase I study. The company also continues to explore partnership opportunities to leverage its platform across age‑reversal and oncology indications.
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