Fractyl Health, Inc. Common Stock Q3 FY2025 earnings call

• Revita delivered first randomized double-blind sham-controlled data showing single procedure can sustain weight loss after GLP-1 discontinuation. REMAIN one pivotal cohort enrollment complete in Q2, with over 60% randomized by Oct 31. Upcoming catalysts include six-month REVEAL one data, six-month REMAIN one midpoint data, top-line pivotal data, and potential PMA submission in 2026.
• Rejuva's preclinical data showed nearly 30% body weight loss in obesity model with no adverse effects. Rejuva-001 completed preclinical CMC and lot release, on track to dose first patients in 2026.

For the quarter ended September 30, 2025, research and development expenses were $17.5 million compared to $19 million for the same period in 2024. The decrease was primarily due to reduced spending on the REVITALIZE one study and lower stock-based compensation expense, partially offset by continued investment in the REMAIN one pivotal study and Rejuva program. Revita is an endoscopic procedural therapy, and Rejuva is a smart GLP-1 platform with preclinical progress reported.

• Expect multiple catalysts in next twelve months: REVEAL one six-month data in Q4, REVEAL one one-year data in Q2, REMAIN one midpoint six-month data in Q1, top-line pivotal data, and potential PMA submission in H2 2026.
• Cash runway extends into early 2027, funding key milestones.

Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from forward-looking statements. A comprehensive list of risk factors is in SEC filings, but no specific detailed risks discussed in depth in the provided transcript.

Q: Could you walk through what you are looking for with the six-month update for REVEAL one in Q4 and also the six-month update for REMAIN one midpoint in Q1?

A: The six-month REVEAL data is first look at patients six months after stopping GLP-1-based therapy and undergoing procedure. Hoping for similar consistency of results between three and six months. Six months is important as it's the timing of the pivotal trial's primary endpoint. For REMAIN midpoint, expecting similar positive read-through to pivotal trial.

Q: On Revita, clarity on German registry data where patients have maintained average total body weight loss of around 9%. What was their average weight loss at one versus two years?

A: No waning of effect between one and two years. 8% weight loss at one year and 8.92% at two years. These are patients with advanced type 2 diabetes, hard to achieve weight loss, but Revita showed sustained results.

Q: On Rejuva-002 for obesity, could you disclose relative GLP versus GIP receptor potency and affinities?

A: Have data on ratios but not disclosed publicly. Rejuva-001 has drug-like efficacy with one-tenth the circulating GLP-1 levels of normal medicines, expecting better tolerability as it acts locally in gut.

Q: On Revita durability in German registry, what's the variability among patients?

A: Remarkably consistent. Error bars in graphs show vast majority of patients maintaining weight loss, no widening error bars over time.

Q: Are there diet and lifestyle measures for patients after Revita procedure?

A: There are ongoing standardized diet and lifestyle measures, modeled after semaglutide and tirzepatide Phase 3 studies: 500 kilocalorie net calorie deficit daily and 30-40 minutes of exercise 3-4 times a week.

Q: Were German study patients type ones or type twos, and percent on pumps vs MDIs?

A: Type 2 diabetics, most on non-insulin medications, average of 1-3 medications, only small number on insulin. Effect of Revita independent of background medicine.

Q: Talk about CPT codes and payer thinking for Revita procedure.

A: No CPT codes today. Actively working with reimbursement experts to develop roadmap for CPT coding ahead of approval.

Q: With Lilly historical data on weight regain, how does Revita's midpoint cohort compare?

A: In midpoint cohort, sham arm patients regained 10% of weight lost on tirzepatide by three months. Lilly data suggests 10% weight regain by six months. Expect linear weight regain over time in midpoint and pivotal cohorts.

Q: Near-term and intermediate-term manufacturing needs for Revita?

A: Near term, good ability to support clinical study. Turning attention to ensuring adequate manufacturing for scale. Revita catheter assembled and tested in facility, with subassemblies by tier-one contract manufacturers potentially taking on larger roles.