Fractyl Health, Inc. Common Stock Q4 FY2025 earnings call

• Dr. Harith Rajagopalan discussed Revita as a lead asset for post-GLP-1 weight maintenance, Rejuva as a smart GLP-1 platform. - Shared six-month data from Remain One midpoint cohort, detailed dose response of ablation length, patient selection based on weight loss. - Pivotal study progress: enrolled population with high run-in weight loss, mean run-in weight loss 18.3%, over 300 participants across over 30 sites, retention over 95%, on track for top-line six-month primary endpoint data in early Q4 2026. - Regulatory progress: received favorable FDA feedback on de novo classification request, on track for de novo submission in late Q4 2026 with six-month pivotal data. - Commercial opportunity: large and growing GLP-1 user population, post-GLP-1 unmet need intensifying, payer landscape shifting, plan to file category three CPT code application. - Rejuva program advancing within discipline spending framework. - Anticipated catalyst-rich path ahead including Q2 regulatory feedback on Rejuva, Q3 one year Remain One midpoint cohort randomized data, early Q4 top line six month randomized data from Remain One pivotal study, late Q4 potential de novo marketing application submission for Revita. - Laura Smith Weber discussed financials: R&D, SG&A, net loss, adjusted EBITDA, cash position. - Harith addressed capital strategy: closed ATM facility, no plans to raise capital before pivotal data, funded to key pivotal value inflection point without planned incremental capital raise.

Research and development expenses were $16.5 million for the quarter ended December 31st, 2025, compared to $20.3 million for the same period in 2024. SG&A expenses were $6.8 million for Q4 2025, compared to $4.9 million for the same period in 2024. Net loss was $43.7 million for Q4 2025, compared to $25 million in Q4 2024. Adjusted EBITDA was negative $21.2 million for Q4 2025 compared to negative $22.1 million for Q4 2024. As of December 31st, 2025, had approximately $81.5 million cash and cash equivalent. Revita is the lead asset for post-GLP-1 weight maintenance, Rejuva is a smart GLP-1 platform. Revita's Remain One midpoint cohort had six-month data, with a clear dose response between ablation length and weight maintenance, mean and median ablation length in pivotal study over 16 cm. Rejuva submitted clinical trial applications for type 2 diabetes and expects regulatory feedback and human dosing data.

• Q2: see one year Remain 1 open label data and receive CTA regulatory feedback on Rejuva 001. - Q3: see one year Remain One midpoint cohort randomized data. - Early Q4: anticipate top line six month randomized data from Remain One pivotal study. - Late Q4 2026: potential de novo marketing application submission for Revita. - Second half of year: see human dosing of Rejuva-001 and preliminary safety and PK data.

Q: How is ablation length determined and what's the operating standard going forward?

A: Ablation length is calculated by counting number of ablations along duodenum. Operating standard going forward is ablation length greater than or equal to 16 cm, built into pivotal study secondary endpoints.

Q: To what extent does efficacy play in de novo pathway determination?

A: De novo pathway determination is principally a safety consideration, efficacy threshold for de novo is reasonable assurance of safety and effectiveness.

Q: Can you provide more color on post-op analysis for midpoint data set and ablation length in pivotal cohort?

A: Post-hoc analysis in midpoint cohort was pre-specified in pivotal study. Pivotal cohort mean and median ablation length greater than 16 cm, average longer than midpoint cohort, confident in pivotal study.

Q: How long does it take to train physicians for adequate ablation?

A: Takes less than 3 - 4 cases to train physician.

Q: How to view totality of regulatory submissions over next year?

A: Three main packages: design history file, manufacturing file, clinical data. Will have full package of six month data by end of 2026, ready to submit 12 month data in Q1 2027 if necessary