Fractyl Health (NASDAQ:GUTS) plans to begin a U.S. marketing application for its Revita weight-maintenance procedure in late 2026, with pivotal 12-month trial results expected in the first quarter of 2027, executives said on the company’s third-quarter earnings call.
The company is focusing its resources on Revita after reducing its workforce by approximately 45% and discontinuing internal development of its Rejuva gene therapy program. Chief Financial Officer Lara Smith Weber said Fractyl’s cash should fund operations into the second quarter of 2027, through the planned application and one-year trial data, but that additional capital will be needed to bring Revita to market.
Revita trial advances toward one-year results
Revita is designed as a one-time outpatient procedure that ablates the lining of the duodenum to allow tissue to regenerate. Fractyl is studying it as a way to help patients maintain weight loss after discontinuing GLP-1 therapy.
Chief Executive Officer Harith Rajagopalan said the REMAIN-1 study met its six-month co-primary endpoint with a p-value of 0.0023. The trial’s modified intention-to-treat population included 308 participants, who first lost at least 15% of their body weight on tirzepatide before stopping the drug and being randomized to Revita or a sham procedure.
Participants lost an average of 18.3% of their body weight during approximately 25 weeks on tirzepatide, Rajagopalan said. At six months after stopping the drug, Revita participants retained about 80% of that weight loss. One in three were weight-stable or had lost more weight, while nearly half retained at least 80% of their loss, he said.
Rajagopalan said the gap between Revita and sham widened at each visit through six months. He also said sham participants were about three times as likely to restart an anti-obesity medication, potentially affecting the comparison.
In an exploratory, post-hoc analysis, patients receiving longer ablations had better outcomes, Rajagopalan said. Those treated over at least 20 centimeters experienced less than half the weight regain seen in the sham group. The company expects to examine the relationship further in the 12-month results; key secondary endpoints will be formally tested if both co-primary endpoints are met.
Discussing safety during analyst questions, Rajagopalan said an independent data safety monitoring board had deemed two serious adverse events in one patient possibly related to the device or procedure. The events were gastrointestinal hemorrhage and acute blood loss anemia. He said the patient was taking two non-steroidal anti-inflammatory drugs, which carry a risk of gastrointestinal bleeding, and that examinations did not identify a bleeding source in the duodenum. He said he did not expect the events to change perceptions of Revita’s safety profile.
Regulatory filing and reimbursement plans
Fractyl plans to advance the design, manufacturing and other technical components of its De Novo application in the fourth quarter of 2026, Rajagopalan said. The company is targeting completion of the full clinical package in the first quarter of 2027, after the one-year data are available.
Rajagopalan said Fractyl has not met with the Food and Drug Administration since the six-month readout and does not expect specific agency feedback to be required before it begins its submission. He said a proposed indication has not yet been finalized.
Fractyl sees potential FDA marketing authorization in late 2027 and a possible U.S. launch in early 2028. Its launch plan targets 100 to 200 bariatric and metabolic centers of excellence, subject to authorization, reimbursement and financing.
On reimbursement, Rajagopalan said a dedicated CPT Category III code for the procedure is scheduled to take effect Jan. 1, 2027. The company also expects clarity by early January on whether a proposed Centers for Medicare & Medicaid Services coverage pathway will include an avenue for devices with pivotal trials already underway. Inclusion could improve Revita’s coverage position relative to Fractyl’s base case, he said.
Loss narrows as expenses decline
Fractyl reported a third-quarter net loss of $14.2 million, compared with $45.6 million a year earlier. Smith Weber said the decrease was driven largely by a $25.7 million favorable change in the non-cash fair value of warrant liabilities and a $4 million reduction in operating expenses.
Research and development expenses fell to $12.5 million from $17.5 million, while selling, general and administrative expenses rose to $6.2 million from $5.2 million. Adjusted EBITDA was negative $16 million, compared with negative $20.8 million a year earlier.
The company ended September with $31.5 million in cash and cash equivalents. Cash used in operations was just below $16 million in the third quarter, and Fractyl expects quarterly operating cash spending to decline to approximately $8 million by the end of the second quarter of 2027. It also expects approximately $2 million in severance and related charges, mostly in the fourth quarter.
About Fractyl Health (NASDAQ:GUTS)
Fractyl Health, Inc. is a biotechnology company focused on developing therapies for metabolic diseases, including obesity and type 2 diabetes. The company aims to create treatments that address the underlying biology of these conditions and provide longer-lasting alternatives to frequently administered medicines. Fractyl Health’s technology platforms include Revita, an endoscopic procedure designed to modify the lining of the duodenum and potentially improve metabolic function, and a gene therapy platform intended to enable the body to produce therapeutic levels of metabolic hormones such as glucagon-like peptide-1 (GLP-1).
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