FRACTYL HEALTH, INC. Q3 FY2024 earnings call

• Enrollment began in the REMAIN-1 pivotal study for weight maintenance after GLP-1 discontinuation, with enrollment for the midpoint analysis completed.
• Anticipate REVEAL 1 open-label cohort data in Q4 2024.
• Enrollment under the expanded protocol for the REVITALIZE-1 pivotal study for Revita in type-2 diabetes started, with top line data expected in mid-2025.
• Presented compelling weight maintenance and blood sugar data from Revita and Rejuva at medical meetings.
• Rejuva program progressing, with key CTA-enabling studies to be completed by year-end and first-in-human study planned for first half of 2025.
• Revita German commercialization plans involve controlled expansion to obtain reimbursement approval and fit into GI endoscopy workflow.

In the third quarter of 2024, revenue was generated from the commercial pilot in Germany and enabling patients to enroll in the German real-world registry study. Research and development expense in Q3 2024 was $19 million (vs. $9.4 million in Q3 2023), primarily due to progress in clinical studies and Rejuva development. Selling, general and administrative expenses in Q3 2024 were $4.8 million (vs. $4.5 million in Q3 2023), driven by professional services and personnel-related costs. Revita is an outpatient endoscopic procedural therapy targeting the duodenum, and Rejuva is an innovative pancreatic gene therapy platform.

• Expect midpoint analysis of the REMAIN-1 study in Q2 2025.
• Anticipate REVEAL 1 open-label cohort data in Q4 2024.
• Top line data from the REVITALIZE-1 study in mid-2025.
• Rejuva CTA filing expected in first half of 2025, with first-in-human study in first half of 2025.

• Uncertainty in clinical trial outcomes and regulatory approvals for Revita and Rejuva.
• Market acceptance of the integrated care solution for obesity.
• Dependence on existing cash and cash equivalents to fund operations, with potential risks if funding is insufficient.

Q: Regarding REMAIN-1, can you remind us the sample size enrolled and duration of follow-up for the midpoint analysis?

A: Sure, the sample size is 45 subjects with a 2:1 treatment allocation of Revita to sham, and we will follow these patients for 12 weeks after the discontinuation of tirzepatide and randomization to either Revita or sham.

Q: What's the current thinking on the venue for the initial data at year-end for REVEAL-1?

A: We will have initial data from 10 patients with at least four weeks of follow-up, aiming to demonstrate weight maintenance.

Q: How is the Rejuva program tracking towards CTA filing by year-end?

A: The key CTA-enabling studies will be completed by year-end, and we aim to file for the CTA in the first half of 2025, with a first-in-human study planned for the first half of 2025.