Fractyl Health(US:GUTS)2026-01-05 12:05Financial Position - As of December 31, 2025, the company's preliminary unaudited cash and cash equivalents were approximately $81.5 million, which increased to $85.6 million after receiving an additional $4.1 million from Tranche A warrants[9]. - The company anticipates that its current cash position will fund operations through early 2027, supporting planned clinical and regulatory milestones for 2026[9]. - The company had 153,372,044 shares of common stock outstanding as of December 31, 2025, with no Tranche A warrants remaining[10]. - The company’s financial information is preliminary and unaudited, subject to completion of financial closing procedures for the fiscal year ended December 31, 2025[17]. Clinical and Regulatory Milestones - The company plans to advance its Revita program through key clinical and regulatory milestones in 2026, focusing on validation in post-GLP-1 weight maintenance[11]. - The anticipated milestones for the Revita program include 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026 and a potential PMA filing in H2 2026[14]. - The Rejuva gene therapy platform is expected to progress toward clinical validation in 2026, with first-in-human dosing of RJVA-001 anticipated in H2 2026, subject to regulatory authorization[12]. - The company is aligning its clinical development with regulatory strategy and real-world implementation considerations for Revita as it moves through a registrational year[11]. - The company has completed Clinical Trial Applications for RJVA-001 in the EU and Australia, setting the stage for expected dosing of first patients in 2026[12]. - The company’s strategic outlook for 2026 includes anticipated clinical and regulatory milestones across its Revita and Rejuva programs[8].