FRACTYL HEALTH, INC. Q4 FY2024 earnings call

• 2024 milestones: Completed IPO, secured FDA IDE approval for Revita's pivotal study, earned Breakthrough Device designation for Revita, initiated REMAIN-1 study, advanced Rejuva platform. - 2025 expectations: Pivotal data readout, regulatory filings for gene therapy, key clinical milestones from REMAIN-1 (Q1 open label data, Q2 midpoint analysis, full enrollment in summer), submit CTA module for RJVA-001 in H1 2025. - Revita details: REVEAL-1 open label cohort data expected end of Q1, REMAIN-1 is double-blind trial for weight maintenance after GLP-1 discontinuation, positive real-world data from German registry study. - Rejuva: Smart GLP-1 gene therapy, RJVA-001 as Type 2 diabetes candidate, RJVA-002 for obesity, preclinical data recognized at ADA, plan to leverage GI endoscopist relationships for commercialization.

In the fourth quarter of 2024, revenue was generated from the commercial pilot in Germany. Research and development expense in Q4 2024 was $20.3 million vs. $10.1 million in 2023, primarily due to progress in clinical studies and platform development. Selling, general and administrative expense was $4.9 million vs. $2.8 million in 2023, due to increased costs of being a public company. Net loss in Q4 2024 was $25 million vs. $19.2 million in 2023. As of Dec 31, 2024, cash and cash equivalents were ~$67.5 million.

• Expect 2025 to be a breakout year with pivotal data readout, regulatory filings. - REMAIN-1: Q1 open label data, Q2 midpoint analysis, full enrollment in summer. - Rejuva: Submit first CTA module for RJVA-001 in H1 2025, preliminary data from RJVA-001 in 2026 if CTA authorized.

Forward-looking statements involve risks and uncertainties; actual results may differ from forward-looking statements. Risks detailed in SEC filings, but no specific operational failures discussed in the transcript.

Q: About REMAIN-1, can you elaborate on patient randomization and dropout rates?

A: As of morning, nearly 100 patients achieved 15% TBW loss, substantial proportion randomized, no patients dropped out due to not wanting the procedure.

Q: On REVEAL-1 data end of month, how many patients and what data will be shared?

A: Plan to share data on ~10 patients, including lab work and assessments.

Q: Status of Rejuva-002?

A: Rejuva-002 is smart GIP/GLP-1 dual incretin in pre-clinical testing, timeline for clinic not provided yet.

Q: Update on first patient in REVEAL-1?

A: No additional info now, but will share more data over time.

Q: On REVEAL-1 data and biomarkers, and weight regain based on drug type?

A: Collecting blood and lab data, weight regain depends on time since GLP-1 discontinuation, not drug type.

Q: Thoughts on public payers and DMR treatment?

A: Had conversations with public payers, proof in REMAIN data needed to articulate value proposition, public payers see need for holistic cost-effective obesity treatment.