Fractyl Health, Inc. Common Stock Q2 FY2025 earnings call

• Strengthened balance sheet via a $23 million underwritten public offering of common stock. - Sharpened strategic focus, reducing cash burn from $25.4 million in Q1 to $19.8 million in Q2 by winding down noncritical programs. - Revita showed durable results in the German real-world registry study with up to two years of benefit in weight maintenance and blood sugar control. - REMAIN-1 enrollment is complete, with midpoint 3-month randomized data expected in September. - Collaborated with Bariendo for potential adoption of Revita pending FDA approval. - Granted 2 new U.S. patents, with over 100 granted patents globally. - Rejuva's RJVA-001 completed preclinical efficacy, toxicity, and biodistribution studies, with CMC manufacturing nearly complete and Phase I/II study design agreed with regulators.

In the second quarter of 2025, Fractyl Health's R&D expense was $21.2 million, up from $16.8 million in Q2 2024, reflecting advancement of the REMAIN-1 clinical study and Rejuva program. SG&A expense was $4.9 million, down from $6.2 million in the same quarter of 2024, primarily due to lower stock-based compensation. For Revita, the German real-world registry study showed up to two years of weight maintenance and blood sugar control following a single treatment. Rejuva's RJVA-001 completed preclinical studies, with CMC manufacturing progressing well and Phase I/II study design agreed upon.

• Next month: Expect 3-month randomized data from the REMAIN-1 midpoint cohort. - Q4: Incremental 6-month open-label data from the REVEAL-1 cohort. - Q1 2026: 6-month randomized data from the REMAIN-1 midpoint cohort. - Q2 2026: First 1-year open-label data from the REVEAL-1 cohort. - H2 2026: Top line primary endpoint data from the REMAIN-1 pivotal cohort, and submission of a Premarket Approval application for Revita. - Rejuva: Expect to dose first patients and report preliminary data from the Phase I/II study in 2026.

Forward-looking statements involve risks and uncertainties, which are detailed in Fractyl Health's SEC filings, including the quarterly report on Form 10-Q filed today.

Q: About the midpoint update in September, beyond weight preservation, any other data points to expect?

A: Safety, tolerability, and effectiveness with visibility into population behavior for the pivotal study; additional laboratory measures and DEXA scans (which occur at 6 and 12 months, not 3 months) will be looked at in the months ahead.

Q: What's the status of Rejuva's IND clearance?

A: Tremendous progress behind the scenes; weeks away from lot release of GMP product, with reports wrapping up, and preliminary data expected in 2026 as previously publicized.

Q: Learnings on the evolution of the GLP-1 market and its impact on Revita and Rejuva?

A: Patients increasingly want to stop GLP-1 drugs, and real-world effectiveness of GLPs is worse than clinical trial results; Revita and Rejuva address these unmet needs.

Q: Contribution of GLP-1 to the outcomes in the German 2-year follow-up study?

A: No contribution from GLP-1, as there's a consistent weight loss signal in patients not on GLP-1, and the effect is seen across patients on or off GLP-1.

Q: Details on weight measurement protocols?

A: Scales are calibrated, measurements are consistent, but there's natural day-to-day weight variability; protocols account for this but some variability is expected.

Q: Will the cohorts be tracked longer term?

A: Intention is to follow patients longer and report data as it emerges, including 18- and 24-month durability data when available.

Q: Expectations for DEXA scans in the 6-month time point?

A: Preclinical study showed fat mass loss with duodenal bypass; waiting for data on tirzepatide withdrawal DEXA scans as no prior data exists on this.

Q: Ablation length in the REMAIN-1 study?

A: Average of 16 cm (8 ablations of 2 cm each); no safety/tolerability issues with longer lengths, and analyzing dose-dependent effects; procedure time is about an hour or less.

Q: Status of REVEAL-1's 6-month data?

A: Majority of 22 patients in REVEAL-1 can report 6-month data; no DEXA scans in the open-label cohort, so waiting for randomized data to interpret body composition changes.

Q: Timing for Rejuva's Phase I/II study dosing and data?

A: First patients will be dosed and preliminary data reported in 2026 as previously stated