Fractyl Health outlines 2026 Revita pivotal data and PMA submission targets as clinical momentum accelerates

Earnings Call Insights: Fractyl Health (GUTS) Q3 2025

MANAGEMENT VIEW

* CEO Harith Rajagopalan stated that "this quarter marked a major inflection point for Fractyl. We delivered the first randomized, double-blind, sham-controlled data showing that a single Revita procedure can sustain weight loss after GLP-1 drug discontinuation." He emphasized that Revita addresses "one of the most urgent challenges in obesity, which is how to maintain success once therapy stops," and that the company is "building momentum toward what I believe will be the most exciting and definitional 12 months in our company's history."
* Rajagopalan explained that Revita is designed to remodel the duodenal lining and reset the gut's metabolic control system, potentially providing durable weight loss and metabolic improvements. Enrollment in the REMAIN-1 pivotal cohort was completed in Q2, with over 60% of patients randomized as of October 31, and full randomization of 315 participants expected early next year.
* The CEO highlighted results from the REMAIN-1 Midpoint Cohort, where "Revita-treated patients lost an additional 2.5% of total body weight, while patients in the sham group regained about 10%, a statistically significant and clinically meaningful separation after the discontinuation of tirzepatide."
* Rajagopalan pointed to the German real-world registry study, stating, "the first 14 patients with 2 years of follow-up maintained an average total body weight loss of 9% and a 1.7% reduction in HbA1c in a patient population with advanced type 2 diabetes, despite a net reduction in medications."
* Looking ahead, the CEO projected "6-month data from the REVEAL 1 open-label cohort this quarter, 6-month randomized data from the REMAIN-1 Midpoint Cohort in the first quarter of 2026 and top line pivotal data and potential PMA submission in the second half of 2026."
* CFO Lisa Davidson reported, "For the quarter ended September 30, research and development expenses were $17.5 million compared to $19.0 million for the same period in 2024." Davidson noted a net loss of $45.6 million, which includes a $23.5 million non-cash accounting change related to warrant valuation. She added, "as of September 30, 2025, we had approximately $77.7 million in cash and cash equivalents. With the proceeds from our recent $83 million in underwritten offerings, we expect our cash runway to extend into early 2027."

OUTLOOK

* Rajagopalan stated, "By this time next year, we expect to have 1-year open-label data in weight maintenance, top line data from our REMAIN-1 pivotal cohort and a larger sample of patients with 2-year data and beyond from our German real-world registry study."
* The CEO projected that if Revita "cuts the rate of weight regain in half, so roughly less than a 5 percentage point weight regain at 6 months, which would represent a clinically meaningful and substantial benefit for patients and a strong validation of Revita's potential."
* Management reiterated plans for "top line pivotal data and potential PMA submission in the second half of 2026," supported by a cash runway into early 2027.

FINANCIAL RESULTS

* Research and development expenses for Q3 2025 were $17.5 million. Selling, general and administrative expenses were $5.2 million. The reported net loss was $45.6 million, attributed primarily to a $23.5 million non-cash accounting change in the fair value of warrants. Cash and cash equivalents stood at $77.7 million as of September 30, 2025, and the company expects its cash position will fund operations into early 2027.

Q&A

* Chi Meng Fong, BofA Securities, Research Division: Asked about expectations for the upcoming 6-month updates for REVEAL-1 and REMAIN-1 and the implications for Revita's durability profile. Rajagopalan responded that "our hope would be to see a similar consistency of results between 3 months and 6 months," and that achieving less than 5% weight regain at 6 months would be "a very compelling outcome."
* Michael DiFiore, Evercore ISI: Sought clarity on the German registry data's durability and medication use. Rajagopalan stated, "there's absolutely no waning of effect between 1 year and 2 years," with 8% weight loss at 1 year and 8.9% at 2 years, and noted a "substantial reduction in hemoglobin A1c and a significant net reduction in medication utilization."
* Michael Ulz, Morgan Stanley: Inquired about variability in the German registry and preliminary data expectations for Rejuva. Rajagopalan said, "it's remarkably consistent," and for Rejuva, the focus will be on "feasibility, safety and preliminary PK and PD profiles."
* Angela Qian, Canaccord Genuity: Asked about diet and lifestyle measures for post-Revita patients. Rajagopalan explained that standardized measures modeled after phase III studies were maintained throughout the study.
* Jeffrey Cohen, Ladenburg Thalmann: Questioned patient profiles in the German study and CPT code status. Rajagopalan clarified all were type 2 diabetics, mostly on non-insulin meds, and that CPT code development is ongoing with market access experts.
* Joseph Pantginis, H.C. Wainwright: Asked about weight regain in the sham group and manufacturing needs. Rajagopalan described a 10% body weight regain in the sham arm at 3 months and noted ample manufacturing capacity and partnerships with Tier 1 contract manufacturers for scale.

SENTIMENT ANALYSIS

* Analysts focused on durability, efficacy in real-world settings, and upcoming clinical milestones, with a generally positive and constructive tone. Questions were in-depth, reflecting strong interest in the consistency and scalability of outcomes.
* Management maintained a confident and optimistic tone throughout, using phrases like "we are building momentum," "the science is working," and "we feel very, very confident about what this means for Revita's clinical profile."
* Compared to the previous quarter, both analysts and management showed increased optimism, with more emphasis on operational execution, clinical durability, and readiness for commercialization.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter featured the first randomized, double-blind, sham-controlled data for Revita, whereas last quarter focused on open-label and early randomized results.
* Guidance shifted to highlight completion of pivotal cohort enrollment and explicit targets for top line pivotal data and PMA submission in the second half of 2026.
* Management's tone was more assertive on near-term catalysts and readiness for commercial execution, while analysts maintained a focus on clinical durability and scalability.
* Financially, the company strengthened its balance sheet through an $83 million offering, significantly extending its cash runway versus the prior quarter.

RISKS AND CONCERNS

* Management cited no related serious adverse events in ongoing studies but acknowledged the need to secure CPT codes and reimbursement ahead of approval. There was a focus on ensuring adequate manufacturing capacity to meet anticipated demand.
* Analyst questions addressed potential variability in patient response, long-term durability, and the scalability of manufacturing and market access strategies, highlighting ongoing uncertainties tied to regulatory and commercial milestones.

FINAL TAKEAWAY

Fractyl Health is advancing toward a pivotal year, with Revita positioned as a potentially transformative therapy for weight maintenance post GLP-1 discontinuation. The company expects multiple clinical catalysts over the next 12 months, including key 6- and 12-month data readouts and a pivotal data submission in the second half of 2026, all supported by a strengthened financial position that extends its cash runway into early 2027. Management is confident in both the clinical durability of its technology and its readiness for eventual commercialization.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/guts/earnings/transcripts]

MORE ON FRACTYL HEALTH

* Fractyl Health, Inc. (GUTS) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4842866-fractyl-health-inc-guts-q3-2025-earnings-call-transcript]
* Fractyl Health: Best-Case Results; Financing Dilutes But Removes Overhang [https://seekingalpha.com/article/4827136-fractyl-health-best-case-results-financing-dilutes-but-removes-overhang]
* Fractyl Health, Inc. (GUTS) REMAIN-1 Midpoint Cohort Three-Month Results Conference Call (Transcript) [https://seekingalpha.com/article/4826216-fractyl-health-inc-guts-remain-1-midpoint-cohort-three-month-results-conference-call-transcript]
* Fractyl Health reports Q3 results [https://seekingalpha.com/news/4520874-fractyl-health-reports-q3-results]
* Fractyl Health stock gains after pricing of $60M underwritten offering [https://seekingalpha.com/news/4499438-fractyl-health-stock-gains-after-pricing-of-60m-underwritten-offering]