Fractyl Health (NasdaqGM:GUTS) Q4 2025 Earnings call March 24, 2026 04:30 PM ET Company ParticipantsAngela Qian - VPBrian Luque - Head of Investor Relations and Corporate DevelopmentHarith Rajagopalan - CEOJeffrey Cohen - Managing Director and Director of Equity ResearchJoseph Pantginis - Managing Director of Equity ResearchLara Smith Weber - CFOMichael DiFiore - Managing DirectorMichael Ulz - Executive Director of Biotechnology Equity ResearchConference Call ParticipantsChi Young - AnalystOperatorGood afte ...

Fractyl Health (NasdaqGM:GUTS) Q4 2025 Earnings call March 24, 2026 04:30 PM ET Company ParticipantsAngela Qian - VPBrian Luque - Head of Investor Relations and Corporate DevelopmentHarith Rajagopalan - CEOJeffrey Cohen - Managing Director and Director of Equity ResearchJoseph Pantginis - Managing Director of Equity ResearchLara Smith Weber - CFOMichael DiFiore - Managing DirectorMichael Ulz - Executive Director of Biotechnology Equity ResearchConference Call ParticipantsChi Young - AnalystOperatorGood afte ...

Fractyl Health (NasdaqGM:GUTS) Q4 2025 Earnings call March 24, 2026 04:30 PM ET Speaker8Good afternoon, and welcome to Fractyl Health fourth quarter and full year 2025 financial results and business update call. As a reminder, this conference call is being recorded. At this time, all participants are in listen-only mode. There will be a Q&A session following management's prepared remarks. I'll now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health. Bria ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41942 Fractyl Health, Inc. (Exact name of Registrant as specified in its Charter) Delaware 27-3553477 (State or ot ...

Financial 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].

Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026 Reports new post-hoc analyses from REMAIN-1 Midpoint Cohort showing statistically significant ablation-length (i.e., dose)-dependent treatment effect on post-GLP-1 weight maintenance at 6 months Patients with greater GLP-1-induced weight loss prior to randomization also exhibited larger sham-adjusted ...

Fractyl Health, Inc. (NASDAQ:GUTS) is one of the 11 Best High Volume Penny Stocks to Buy Now. On March 17, 2026, H.C. Wainwright maintained a Buy rating on Fractyl Health, Inc. (NASDAQ:GUTS) with an $8 price target, addressing a sharp selloff following the company’s January data release. The firm said the update triggered a 65% decline in the shares as investors focused on “critical friction points,” including a lack of statistical significance and weight-regain trends. H.C. Wainwright, however, said the r ...

BURLINGTON, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced that it will report financial results for the fourth quarter and full year 2025 and provide business updates on Tuesday, March 24, 2026, at 4:30 p.m. ET. A live webcast of the conference call and presentation can be accessed in the “Events” section of Fractyl Health ...

Core Viewpoint - Fractyl Health, Inc. has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, particularly influenced by institutional investors [4][6]. Company Performance and Outlook - The upgrade for Fractyl Health, Inc. suggests an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively [5][10]. - The Zacks Consensus Estimate for Fractyl Health, Inc. indicates expected earnings of -$1.50 per share for the fiscal year ending December 2025, with a 4.1% increase in estimates over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7][9]. - Fractyl Health, Inc.'s upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced completion of participant r ...