FRACTYL HEALTH, INC. Q1 FY2025 earnings call

• Completed full enrollment of REMAIN-1 Pivotal Cohort for Revita, ahead of schedule. - REMAIN-1 Midpoint Cohort completed enrollment in Q4 2024. - Reveal-1 Cohort had initial encouraging weight regain results. - Rejuva's RJVA-001 nominated as first clinical candidate, preclinical data shared, regulatory alignment in Europe. - Q1 2025 R&D expense $19.4M vs $14.4M in 2024, net loss $23.7M vs $3.3M in 2024, cash and equivalents $42.1M as of March 31, 2025.

The company has two main segments: Revita and Rejuva. For Revita, the REMAIN-1 Pivotal Cohort for durable weight maintenance after GLP-1 discontinuation completed full enrollment, with expectations to complete randomization in first half of 2026 and report pivotal data in second half of 2026. The REMAIN-1 Midpoint Cohort completed enrollment in Q4 2024, with expected blinded controlled data in Q3 2025. The Reveal-1 Cohort had initial results with low weight regain. For Rejuva, the RJVA-001 clinical candidate is advancing, with regulatory alignment in Europe, plan to submit first CTA module in June, and expect to dose first patients and report data in 2026.

• Expect three major catalysts in 2025: incremental three-month data from Reveal-1 Cohort in June, first CTA module submission for RJVA-001 in June, midpoint randomized data from REMAIN-1 Midpoint Cohort in Q3. - Existing cash and equivalents expected to fund operations into Q4 2025.

• Forward-looking statements involve risks and uncertainties detailed in SEC filings. - Monitoring tariff policies, but minimal impact on near-term financials currently.

Q: Regarding the midpoint analysis of Remain-1, asked about randomization of 45 patients and effect size delta between sham and Revita.

A: Harith said well over 45 patients hit 15% total body weight loss, goal is to be at least 50% better than tirzepatide withdrawal effect.

Q: About Reveal-1 update in June, enrollment of patients and sham procedure details.

A: Majority of 15 patients in Reveal-1 will have three-month follow-up, sham procedure involves upper endoscopy with catheter, and factors like patient adherence and stratification on BMI/gender for randomization are monitored.