Fractyl Health Q1 Earnings Call Highlights

Key Points

• Revita remains on track for pivotal six-month data in early Q4 2026, with the company saying the REMAIN-1 trial has enrolled more than 300 patients and retention is above 90%. Fractyl also expects to file for FDA De Novo clearance in late Q4 2026 using the pivotal data plus supporting studies.
• Management highlighted progress on regulatory and reimbursement plans, citing prior favorable FDA feedback on the De Novo pathway and potential eligibility for the CMS/FDA RAPID coverage pathway. The company also plans to submit a Category III CPT code application this summer, which could support future commercialization economics.
• Fractyl advanced its Rejuva gene therapy platform into the clinic after receiving Dutch authorization for a first-in-human phase I/II study of RJVA-001, with first dosing targeted for the second half of 2026. The company ended Q1 with about $63.2 million in cash and said it expects funding into early 2027.

Fractyl Health NASDAQ: GUTS said it remains on track to report pivotal data for its Revita therapy in early fourth quarter 2026, as management highlighted clinical, regulatory and reimbursement developments during the company’s first-quarter 2026 earnings call.

Chief Executive Officer Dr. Harith Rajagopalan framed Revita as a potential treatment option for patients who discontinue GLP-1 therapies and then face weight regain. He said more than 1 million people discontinue GLP-1s each month in the U.S., and cited weight regain of roughly 10% of total body weight within six months and 15% by 12 months after stopping therapy.

“Revita is being built for that moment,” Rajagopalan said, referring to the period after GLP-1 discontinuation when patients may choose between resuming chronic drug therapy or accepting the risk of weight rebound.

Revita pivotal trial remains on schedule

Rajagopalan said the REMAIN-1 pivotal cohort completed randomization in February, enrolling more than 300 participants across more than 30 sites in the United States. He described it as “the largest sham-controlled GI endoscopy pivotal trial ever conducted.”

The company expects top-line six-month primary endpoint data from the pivotal cohort in early Q4 2026. The first co-primary endpoint measures percent total body weight regain at six months in Revita participants versus sham after discontinuation of tirzepatide. The second co-primary endpoint is a 52-week responder rate, defined as the percentage of Revita-treated participants who maintain at least 5% total body weight loss from pre-tirzepatide levels through one year.

Rajagopalan said participant retention in the trial remains “well over 90%,” medication resumption rates remain below the company’s modeled assumptions and the blinded adverse event profile remains consistent with prior studies. He also said the company remains on track for an FDA submission in late Q4 2026 using six-month pivotal data.

Management also pointed to upcoming data releases before the pivotal readout. In Q2, the company expects 12-month open-label data from the REVEAL-1 cohort. In Q3, it expects 12-month randomized sham-controlled data from the REMAIN-1 midpoint cohort. Rajagopalan said the company intends to analyze those data through the same dose-response and run-in weight-loss lenses it previously used.

Company cites external clinical interest

Fractyl said it presented REMAIN-1 midpoint cohort six-month data at Digestive Disease Week, where the study was selected for the meeting’s press program. Rajagopalan said the presentation marked the first peer-reviewed setting in which the company presented dose-response analysis and patient-selection findings to a broad clinical audience.

The company also convened a clinical advisory board with gastroenterologists and metabolic medicine physicians during the meeting. Rajagopalan said discussions supported the company’s view of Revita’s mechanism, procedural rationale and pivotal study design. In response to an analyst question, he said feedback from physicians at the meeting was “incredibly positive,” adding that physicians involved in the clinical infrastructure could form part of a potential commercial foundation if Revita reaches the market.

Regulatory and reimbursement plans advance

Rajagopalan reiterated that Fractyl previously received favorable FDA feedback on its De Novo classification request, which the company said supported its view that Revita’s safety profile is consistent with a moderate-risk, rather than high-risk, device classification.

During the Q&A, Rajagopalan said the De Novo pathway relies on a “totality of clinical evidence” rather than a single statistical result. He said Fractyl intends to submit data from REVEAL-1 and the REMAIN-1 midpoint cohort as part of the regulatory package, along with the pivotal data.

Fractyl also discussed the RAPID coverage pathway announced by CMS and FDA for eligible breakthrough devices. Rajagopalan said the company believes Revita may be positioned to benefit from the pathway because it has FDA breakthrough device designation in weight maintenance after GLP-1 discontinuation and Type 2 diabetes. He said the pathway could potentially accelerate the reimbursement timeline if Revita reaches the market, though he noted it remains early in implementation.

The company said it remains on track to file a Category III CPT code application this summer, with a code expected to become effective in summer 2027. Rajagopalan also said transitional pass-through payment from CMS may support hospital economics if Revita is commercialized.

Rejuva gene therapy enters clinical stage

Fractyl also provided an update on Rejuva, its GLP-1 gene therapy platform. The company recently received authorization from regulatory authorities in the Netherlands to begin a phase I/II first-in-human study of RJVA-001, the first clinical candidate from the platform.

Rajagopalan described RJVA-001 as a one-time beta cell-targeted gene therapy designed to enable nutrient-responsive physiological GLP-1 expression within the pancreas. The therapy is delivered through a minimally invasive endoscopic ultrasound-guided infusion into the pancreas.

The company plans to conduct the study at other sites in Europe and in Australia, where a clinical trial application has been submitted. Feedback from Australian regulators is expected in the third quarter. Subject to site activation, Fractyl expects to dose the first patient and report preliminary data in the second half of 2026.

In response to analyst questions, Rajagopalan said the initial study uses a three-by-three design and that early evaluation will focus on safety and feasibility within the first one to two weeks after dosing. Preliminary pharmacokinetic and pharmacodynamic signals are expected roughly eight weeks after dosing, when GLP-1 expression levels should reach target levels. He said the first dose is intended to be an active dose, while emphasizing a cautious approach because this is the first use of this route of administration for the disease.

First-quarter financial results

Chief Financial Officer Lara Smith Weber said research and development expenses were $15.6 million in the first quarter of 2026, compared with $19.4 million in the same period in 2025. The decrease was primarily tied to reduced spending on Revita and Rejuva, as well as lower personnel-related costs.

Selling, general and administrative expenses were $5.2 million, compared with $5.3 million a year earlier. Fractyl reported net income of $9.2 million, compared with a net loss of $23.7 million in the prior-year period. Smith Weber said the shift was driven by a $30.1 million non-cash accounting change in the fair value of warrant liabilities and “does not reflect a change in our underlying operating performance.”

Adjusted EBITDA was negative $18 million, compared with negative $23 million in the first quarter of 2025. Fractyl ended the quarter with approximately $63.2 million in cash and cash equivalents.

Smith Weber said the company expects its cash position to fund operations into early 2027, beyond the anticipated REMAIN-1 pivotal data readout and through a potential De Novo submission in late Q4 2026. Rajagopalan added that the company’s ATM facility remains closed and said Fractyl does not plan to raise capital before pivotal data are in hand.

About Fractyl Health NASDAQ: GUTS

Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control.

The company's lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine.

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