FRACTYL HEALTH, INC.

Fractyl Health, Inc. has received a formal notice from Nasdaq indicating its common stock is subject to delisting due to failing to meet the minimum bid price requirement of $1.00 per share for 30 consecutive business days. The company did not regain compliance within the allotted grace period. Fractyl Health plans to request a hearing before the Nasdaq Hearings Panel, which will temporarily halt the delisting process. To address the issue, the company is also seeking shareholder approval for a reverse stock split.

Fractyl Health reported a Q2 2026 net loss of $25.5 million, an improvement from $27.9 million in Q2 2025, driven by reduced R&D expenses. The company announced positive one-year data from its Revita REMAIN-1 Midpoint Cohort, showing patients maintained up to 84% of prior GLP-1-induced weight loss, and REVEAL-1 Cohort data showing 78% maintenance. Fractyl reiterated its cash runway into early 2027 and confirmed REMAIN-1 Pivotal Cohort topline data is on track for early Q4 2026, with a potential FDA De Novo submission later in Q4 2026.

Fractyl Health, Inc. disclosed substantial doubt about its ability to continue as a going concern, with existing cash and cash equivalents of $47.1 million as of June 30, 2026, projected to fund operations only into early 2027. The company also received a Nasdaq notice for non-compliance with the minimum bid price rule. Operationally, Fractyl Health reported a net loss of $(25.5) million for Q2 2026 and is advancing its clinical pipeline, with topline data for the Revita REMAIN-1 Pivotal Cohort expected in early Q4 2026 and the first patient dosing for Rejuva RJVA-001 anticipated in H2 2026.

Fractyl Health, Inc. announced it will report its second-quarter 2026 financial results and provide business updates on Monday, August 10, 2026, at 4:30 p.m. ET. A live webcast of the conference call and presentation will be available on the company's investor relations website, with an archived replay accessible afterward. Fractyl Health is a clinical-stage metabolic therapeutics company focused on obesity and type 2 diabetes.

Fractyl Health, Inc. announced that its Co-Founder and CEO, Harith Rajagopalan, M.D., Ph.D., will participate in three upcoming investor conferences. These include the BTIG Virtual Biotechnology Conference, the Needham & Company MedTech & Diagnostics 1x1 Conference, and the Canaccord Genuity 46th Annual Growth Conference. A live webcast of the Canaccord conference will be accessible on the company's investor relations website.

Fractyl Health announced positive one-year results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating durable weight maintenance after GLP-1 discontinuation. The study showed Revita significantly reduced weight regain compared to sham, with up to 84% of GLP-1 induced weight loss retained in optimized patient populations. The company reported excellent tolerability with no device-related serious adverse events, reinforcing Revita's potential as a procedural therapy for post-GLP-1 weight maintenance. Fractyl anticipates topline six-month data from the pivotal cohort in early Q4 2026 and a potential FDA De Novo submission in late Q4 2026.

Fractyl Health announced positive one-year results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating significant weight loss retention after GLP-1 discontinuation. The data showed Revita maintained up to 84% of GLP-1 induced weight loss in optimized patients compared to 46% with sham, and reduced weight regain by approximately 40% overall. The company anticipates topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026.

Fractyl Health announced positive one-year results from its open-label REVEAL-1 Cohort for the Revita procedure. Patients maintained approximately 78% of their GLP-1-induced weight loss one year after discontinuing GLP-1 therapy and undergoing a single Revita procedure, significantly outperforming the ~15% weight regain seen in third-party studies after GLP-1 withdrawal alone. The study also showed sustained glycemic control and excellent tolerability, with 33% of patients continuing to lose weight.

Fractyl Health reported a net income of $9.2 million for the first quarter ended March 31, 2026, a substantial improvement from a net loss of $23.7 million in the prior year, primarily driven by a $30.1 million positive change in the fair value of warrant liabilities. The company received a Nasdaq notice for non-compliance with the minimum bid price rule and appointed Lara Smith Weber as its new CFO. Fractyl Health also made progress in its clinical programs, completing randomization for the Revita REMAIN-1 Pivotal Cohort and receiving CTA authorization for Rejuva RJVA-001 in the Netherlands, though it noted substantial doubt about its ability to continue as a going concern beyond early 2027 without additional funding.

Fractyl Health reported a net income of $9.2 million for the first quarter of 2026, a significant improvement from a $23.7 million net loss in Q1 2025, primarily driven by a $30.1 million non-cash accounting change in warrant liabilities. The company reiterated its cash runway into early 2027, extending beyond the anticipated pivotal data readout. Key clinical milestones for Revita, including topline 6-month randomized data from the REMAIN-1 Pivotal Cohort, remain on track for early Q4 2026, with a potential FDA De Novo marketing application submission in late Q4 2026. Additionally, the first-in-human dosing of RJVA-001 for T2D is anticipated in the second half of 2026.