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Fractyl Health Inc received an amended Schedule 13G/A reporting that SilverArc Capital Management, LLC and Devesh Gandhi beneficially own 3,606,386 shares of Class A Common Stock, representing 2.3% of the class. The filing lists shared voting and dispositive power over those shares.
Fractyl Health, Inc. reported net income of $9.2 million for the three months ended March 31, 2026, mainly from a $30.1 million non-cash gain on warrant liabilities. Operating expenses were $20.8 million, and Adjusted EBITDA was a loss of $18.0 million, reflecting ongoing investment in Revita and Rejuva.
Cash and cash equivalents were $63.2 million, with management expecting funding to last into early 2027 but disclosing substantial doubt about the ability to continue as a going concern over 12 months from issuance. The company also received a Nasdaq notice for falling below the $1.00 minimum bid price. Clinical progress included midpoint Revita weight-maintenance data and Dutch authorization to begin a first‑in‑human Rejuva RJVA‑001 trial in type 2 diabetes.
Fractyl Health, Inc. reported first quarter 2026 results and reiterated key clinical and cash runway milestones. For the quarter ended March 31, 2026, the company posted net income of $9.2 million, compared with a net loss of $23.7 million a year earlier, mainly due to a $30.1 million non-cash gain from changes in the fair value of warrant liabilities.
Operating expenses fell to $20.8 million from $24.8 million, and Adjusted EBITDA was a loss of $18.0 million versus a loss of $23.1 million in 2025. Cash and cash equivalents were $63.2 million as of March 31, 2026, which the company believes will fund operations into early 2027.
Fractyl highlighted progress for its Revita procedural therapy and Rejuva gene therapy platform, including completion of randomization in the REMAIN-1 pivotal cohort, planned Revita data readouts through Q4 2026, and Clinical Trial Authorization in the Netherlands for first-in-human testing of RJVA-001 in type 2 diabetes in the second half of 2026.
Fractyl Health, Inc. announced that it received Clinical Trial Application authorization in the Netherlands to start a Phase 1/2 first-in-human study of RJVA-001, its lead Rejuva Smart GLP-1 gene therapy candidate for type 2 diabetes. This authorization makes Fractyl a dual clinical-stage company, with Revita in pivotal development for post-GLP-1 weight maintenance and Rejuva entering first-in-human testing.
The company expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026, subject to site activation. Management states that Rejuva’s clinical development is funded within the existing cash runway into early 2027, beyond the anticipated REMAIN-1 pivotal data readout, with no change to capital plans.
Fractyl Health will hold its 2026 annual stockholder meeting virtually on June 10, 2026 at 12:00 p.m. Eastern Time. Holders of common stock as of April 17, 2026, when 158,648,963 shares were outstanding, may vote.
Stockholders are being asked to elect three Class II directors—Marc Elia, Clive Meanwell and Ian Sheffield—for terms ending at the 2029 meeting, and to ratify Ernst & Young LLP as independent auditor for 2026. The proxy also outlines governance practices, board structure, and 2025 executive pay, including salary, bonuses and stock option awards tied to clinical and financial milestones.
Fractyl Health, Inc. is a clinical-stage metabolic therapeutics company developing two main platforms to treat obesity and type 2 diabetes. Its Revita duodenal mucosal resurfacing system is an outpatient endoscopic procedure designed to remodel the duodenum and help maintain weight loss after patients stop GLP-1 drugs.
Revita has FDA Breakthrough Device designation in post‑GLP‑1 weight maintenance, and the pivotal REMAIN‑1 program is fully enrolled, with topline six‑month data from the 315‑patient pivotal cohort expected in early Q4 2026 and a planned De Novo marketing submission later that year.
The company’s Rejuva platform is a locally delivered AAV pancreatic gene therapy approach aimed at durable remission of obesity and type 2 diabetes by reprogramming islet cells to secrete metabolic hormones such as GLP‑1 and dual GIP/GLP‑1 from a single endoscopic intervention.
Fractyl Health reported wider losses for Q4 and full-year 2025 while advancing its obesity and type 2 diabetes programs Revita and Rejuva. For the quarter ended December 31, 2025, research and development expenses were $16.5 million versus $20.3 million a year earlier, reflecting a strategic reprioritization.
Selling, general and administrative expenses rose to $6.8 million from $4.9 million, mainly from underwriters’ commissions on an August 2025 financing. Quarterly net loss increased to $43.7 million from $25.0 million, driven largely by a $20.2 million non-cash change in warrant liability fair value. Adjusted EBITDA was negative $21.2 million versus negative $22.1 million.
Fractyl ended December 31, 2025 with $81.5 million in cash and cash equivalents and later received $4.1 million from warrant exercises, and believes this will fund operations into early 2027. The company completed randomization in the REMAIN-1 Pivotal Cohort, reported dose-dependent six‑month weight maintenance data from the Midpoint Cohort, and plans pivotal six‑month topline results in early Q4 2026 followed by a potential De Novo marketing application in late Q4 2026 after favorable FDA feedback on a Class II device pathway.
Fractyl Health, Inc. has received a notice from Nasdaq that its common stock no longer meets the Nasdaq Global Market requirement for a minimum bid price of $1.00 per share, after trading below that level for 30 consecutive business days.
The company has 180 calendar days, until September 9, 2026, to regain compliance by having its stock close at or above $1.00 for at least 10 consecutive business days. If it fails to do so, it may seek to transfer to the Nasdaq Capital Market, potentially using measures such as a reverse stock split, or face possible delisting, with a right to appeal.
Fractyl Health, Inc. reported completion of participant randomization in REMAIN-1’s pivotal cohort, a randomized, double-blind, sham-controlled study of its Revita® endoscopic procedure for maintaining weight after GLP-1 therapy discontinuation. This marks a key step toward generating definitive clinical evidence in adults with obesity who previously lost at least 15% of body weight on tirzepatide.
The company expects topline 6‑month pivotal data in early Q4 2026 and is targeting a potential U.S. FDA marketing application submission in late Q4 2026, informed by anticipated Q2 2026 FDA feedback on possible De Novo pathway use. Fractyl also reiterated its cash runway guidance into early 2027, positioning it to fund operations through planned 2026 clinical and regulatory milestones for Revita.