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- **Revita Breakthrough**: 2.5% weight loss vs. 10% regain in sham group, with no serious adverse events. 6-month data milestones set for Q1 2026 pivotal readout.
- **German Registry Durability**: 9% weight loss sustained at 2 years in type 2 diabetes patients, with no waning effect.
- **Financial Strength**: $77.7M cash, runway to early 2027. Rejuva preclinical success (30% weight loss) positions for 2026 clinical trials.
- **Commercial Readiness**: Endoscopy center partnerships and scalable manufacturing ensure rapid launch post-approval.

**【CEO Summary Section】**
- **Revita Clinical Milestone**: First randomized, double-blind, sham-controlled data showing Revita-treated patients lost 2.5% of total body weight after GLP-1 discontinuation, while sham group regained 10% (p < 0.001). No serious adverse events reported.
- **Clinical Momentum**: REMAIN-1 pivotal cohort randomization at 60% completion (315 patients), on track for early 2026 completion. 6-month data from REMAIN-1 Midpoint Cohort expected Q1 2026, pivotal readout H2 2026.
- **Durability Evidence**: German real-world registry shows 14 patients with 2-year follow-up maintained 9% weight loss and 1.7% HbA1c reduction, with no waning effect.
- **Market Readiness**: Partnering with high-volume endoscopy centers (e.g., Bariendo) for rapid commercial activation post-approval. Unit economics comparable to advanced endoscopic procedures.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Net loss $45.6M (vs. $23.2M in 2024), driven by $23.5M non-cash warrant adjustment. R&D expenses $17.5M (down 8% YoY), SG&A $5.2M (up 8% YoY due to public offering costs).
- **Cash Position**: $77.7M as of Q3, with $83M August offering extending cash runway into early 2027. Sufficient funding for 6-month data releases, pivotal readout, and PMA submission.

**【Q&A Highlights】**
- **Revita Efficacy**: 6-month data from REVEAL-1 (open-label) and REMAIN-1 Midpoint Cohort expected to validate durability. Lilly's SURMOUNT-4 data shows 10% weight regain at 6 months; Revita aims for <5% regain.
- **Rejuva Progress**: RJVA-002 preclinical data shows 30% weight loss with single dose. RJVA-001 CMC complete, first patient dosing in 2026.
- **Manufacturing**: Sufficient capacity for clinical needs; subassemblies from Tier 1 manufacturers scalable for commercial demand.
- **Reimbursement Strategy**: Working on CPT coding strategy ahead of U.S. approval; details to be shared in future calls.

Fractyl Health, Inc. (GUTS) Q3 2025 Earnings Call Transcript

- **Revita Showcases Long-Term Efficacy**: Up to two years of sustained weight loss and blood sugar control in real-world data, with 3-month randomized data expected in September 2025.
- **Financial Resilience**: $23M capital raise extends cash runway into 2026, with reduced quarterly burn rate to $19.8M.
- **Strategic Growth**: Collaboration with Bariendo to build a commercial network, and Rejuva entering clinical trials in 2026.
- **Market Momentum**: Increasing demand for alternatives to chronic GLP-1 use, aligning with Revita's weight maintenance potential.


**【CEO Summary Section】**
- **Revita Therapy Progress**: Demonstrated up to two years of sustained weight loss and blood sugar control in real-world data from Germany, with greater improvements at two years than one year. Enrollment complete for the REMAIN-1 pivotal study, targeting weight maintenance post GLP-1 discontinuation.
- **Upcoming Milestones**: 3-month randomized data from the REMAIN-1 midpoint cohort (September 2025), 6-month open-label data from REVEAL-1 (Q4 2025), and 1-year open-label data (Q2 2026). PMA submission for Revita in weight maintenance anticipated in H2 2026.
- **Strategic Collaboration**: Letter of intent with Bariendo to establish a distribution network for Revita upon FDA approval.
- **Rejuva Program Update**: Phase I/II clinical trial design agreed with regulators; first patient dosing and preliminary data expected in 2026.
- **Financial Strength**: $23M public offering extended cash runway to fund operations into 2026, with reduced quarterly burn rate from $25.4M to $19.8M.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Net loss of $27.9M (vs. $17.2M in Q2 2024), driven by increased R&D expenses ($21.2M vs. $16.0M) for clinical trials. Cash balance of $22.3M as of June 30, 2025.
- **Expense Management**: SG&A decreased to $4.9M (from $6.2M) due to lower stock-based compensation. Focus on disciplined cash management to support clinical milestones.

**【Q&A Highlights】**
- **September Midpoint Data Focus**: Safety, tolerability, and weight maintenance efficacy (e.g., 3% vs. 5-6% weight regain benchmark). No outliers planned for disclosure; emphasis on pivotal study alignment.
- **Rejuva IND Status**: GMP product nearing lot release; first patient dosing and 2026 data on track.
- **Market Trends**: Growing patient demand for GLP-1 alternatives, with prescribers acknowledging limitations of chronic drug therapy.
- **Revita Durability**: 2-year real-world data shows sustained benefits, with plans to track patients beyond the pivotal study for long-term outcomes.
- **Procedure Preferences**: Patients prioritizing Revita over other weight loss trials, with minimal attrition post-tirzepatide discontinuation.


Fractyl Health, Inc. (GUTS) Q2 2025 Earnings Call Transcript

- **Revita Breakthrough**: REMAIN-1 study enrollment completed 9 months early, with 315 patients set to report pivotal data in H2 2026. Midpoint Cohort (45 patients) targeting 50% better weight retention than GLP-1 withdrawal, with 12-week data in Q3 2025. Reveal-1 Cohort shows 1.2% weight regain at 1 month vs. 3% historical average.
- **Rejuva Innovation**: RJVA-001 gene therapy preserves lean mass while reducing fat, outperforming semaglutide in preclinical models. CTA submission planned for June 2025, with first-in-human dosing in 2026. Scalable manufacturing reduces COGS by 3+ orders of magnitude.
- **Commercial Validation**: GI endoscopy network achieved 90%+ patient adherence to diet/lifestyle programs, with 30% fewer sites needed due to >100% demand. $42.1M cash runway supports operations into Q4 2025.

**【CEO Summary Section】**
- **Revita Weight Maintenance Progress**: Completed full enrollment of REMAIN-1 pivotal study 9 months ahead of schedule, with 315 participants randomized by mid-2026. Midpoint Cohort (45 patients) expected to report 12-week data in Q3 2025, targeting 50% better weight retention vs. GLP-1 withdrawal. Reveal-1 Cohort (15 patients) shows 1.2% weight regain at 1 month vs. 3% historical average, with 3-month data due in June.
- **Rejuva Gene Therapy Advancement**: RJVA-001, a one-time pancreatic GLP-1 gene therapy, achieved preclinical superiority over semaglutide, preserving lean mass while reducing fat. CTA module submission planned for June 2025, with first-in-human dosing in 2026. Scalable AAV manufacturing process reduces COGS by several orders of magnitude compared to systemic gene therapies.
- **Commercial Model Validation**: Hub-and-spoke network of GI endoscopy centers achieved rapid enrollment, demonstrating product-market fit for Revita. Patient demand for non-drug weight maintenance solutions is strong, with 90%+ adherence to diet/lifestyle programs during GLP-1 run-in phase.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: R&D expenses rose 34% YoY to $19.4M, driven by REMAIN-1 enrollment acceleration and Rejuva manufacturing scale-up. Administrative expenses fell 25% YoY to $5.3M due to reduced stock-based compensation. Net loss widened to $23.7M (vs. $3.3M prior year) due to fair value adjustments and operating scale-up. Cash balance of $42.1M as of March 2025, sufficient for operations into Q4 2025.
- **Tariff Impact**: Minimal exposure to current trade policies, with <1% of lab supplies/device components sourced internationally. No material impact expected on near-term financial guidance.

**【Q&A Highlights】**
- **REMAIN-1 Midpoint Cohort Design**: Stratified randomization by baseline BMI and gender to control for variability. Sham procedure includes full endoscopy without duodenal catheter dwell, with blinded post-procedure care scripts to prevent unblinding.
- **Rejuva Regulatory Path**: EU and Australia first-in-human strategy chosen due to CBER instability. Manufacturing readiness for 500L bioreactors demonstrated, with potential for rapid scale-up post-PoC.
- **Enrollment Momentum**: Remain-1 enrollment capped at sites due to >100% demand, reducing required site count by 30%. Reveal-1 Cohort expansion underway, with 3-month data from all 15 patients expected in June.

Fractyl Health, Inc. (GUTS) Q1 2025 Earnings Call Transcript

- **Revita clinical momentum**: 189 patients enrolled in pivotal REMAIN-1 study, 94% satisfaction in real-world registry.
- **Rejuva innovation**: Gene therapy RJVA-001 shows safe pancreatic delivery in preclinical studies, targeting type 2 diabetes.
- **Financial stability**: $67.5M cash runway to 2026, supporting 2025 clinical milestones.
- **2025 catalysts**: REMAIN-1 midpoint data (Q2), REVEAL-1 results (Q1), and Rejuva CTA submission.

**【CEO Opening Remarks】**
- Fractyl is pioneering durable solutions for weight maintenance post GLP-1 drug discontinuation, addressing a $170B annual medical cost burden.
- 2024 milestones include IPO on NASDAQ (GUTS), FDA IDE approval for Revita pivotal study, and Rejuva gene therapy platform advancement.
- 2025 outlook: Key clinical readouts from REMAIN-1 (weight maintenance) and RJVA-001 (type 2 diabetes) trials, with potential CTA submission in H1 2025.

**【CFO Financial Update】**
- Q4 2024 revenue: $1.2M (Germany commercial pilot).
- R&D expenses: $20.3M (vs. $10.1M YoY), driven by clinical trials and gene therapy development.
- SG&A expenses: $4.9M (vs. $2.8M YoY), reflecting public company costs.
- Net loss: $25M (vs. $19.2M YoY), with $67.5M cash runway to 2026.

**【CEO Clinical & Commercial Update】**
- Revita: 189 patients enrolled in REMAIN-1 (13 sites), 94% satisfaction in German real-world registry (7kg weight loss at 12 months).
- Rejuva: RJVA-001 targeting type 2 diabetes, with preclinical data showing safe pancreatic delivery and GLP-1 expression.
- Commercial strategy: Partnering with GI endoscopists for scalable procedure-based care.

**【Q&A Highlights】**
- REMAIN-1: 100+ patients achieved 15% weight loss, no dropouts post-randomization; midpoint analysis expected Q2 2025.
- REVEAL-1: 10-patient data release late Q1 2025, focusing on weight maintenance after Revita procedure.
- Rejuva: CTA submission for RJVA-001 in H1 2025, with 2026 first-in-human trial potential.
- Public payer engagement: Exploring cost-effective solutions for obesity, aligning with REMAIN-1 data.

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