Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
Earnings Data
Report Date
May 19, 2026Before Open (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.16Last Year’s EPS
-0.48Same Quarter Last Year
Strong Buy
Based on 4 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call communicated several strong clinical, operational, regulatory, and commercial positives: a clear and biologically plausible dose-response for Revita, a fully enrolled and well-powered pivotal (>300 patients) with excellent retention and safety consistency, constructive FDA De Novo feedback, explicit reimbursement pathway planning, and a separate early-stage Rejuva program advancing without competing for capital. Financially, the company reduced R&D spend and slightly improved adjusted EBITDA, and it has cash to reach the pivotal readout. Offsetting risks include a materially larger reported net loss (largely noncash), a relatively short runway beyond early 2027, prior study pauses, and sensitivity of outcomes to procedural dose/training observed in the Midpoint Cohort. On balance, the positive clinical and regulatory progress and preparedness for commercialization materially outweigh the financial and operational risks described.Company Guidance
Clear Dose-Response Signal for Revita
Post-hoc and prespecified dose-response analyses show a statistically significant (p < 0.05) monotonic relationship between ablation length and weight-maintenance effect. Participants receiving >14 cm of ablation regained ~50% of the weight regained by sham; in an optimized subgroup (higher run-in loss + longer ablation) Revita patients experienced 2.9% weight regain vs 9.9% in sham (~70% reduction).
Pivotal Study Fully Enrolled and Well-Powered
REMAIN-1 Pivotal Cohort randomized >300 participants across >30 sites and >20 operators, described as the largest sham-controlled GI endoscopy pivotal trial ever. The pivotal is powered >90% to meet its two co-primary endpoints.
Operational Metrics Tracking Favorably
Retention in the pivotal exceeds 95%, medication resumption rates are below model assumptions, and the blinded adverse event profile is consistent with prior studies—supporting procedural feasibility and trial integrity.
Procedural Scalability and Training Feasible
Mean and median ablation length in the pivotal are >16 cm; investigators were successfully trained to achieve >14 cm consistently. Company states training requires ~3–4 cases to achieve consistent performance, supporting scalability.
Favorable Early FDA Feedback on De Novo Pathway
FDA reviewed safety data and indicated Revita's safety profile is consistent with a Class II moderate-risk De Novo device. Company plans De Novo submission in late Q4 2026 with 6-month pivotal data in hand, a faster and more capital-efficient pathway than PMA.
Commercial and Reimbursement Planning Advancing
Company will file a Category III CPT code application this summer (anticipated effective date ~summer 2027) and plans to pursue CMS transitional pass-through payment upon authorization to cover disposable device costs, positioning hospitals to have positive contribution margins near launch.
Rejuva Program Progressing Without Capital Competition
Clinical trial applications for RJVA-001 in type 2 diabetes submitted in the EU and Australia; regulatory feedback expected Q2 2026 and first-in-human dosing and preliminary data anticipated in H2 2026. Program funded within a disciplined framework that does not compete with Revita for capital.
Improved Operating Efficiency and Adjusted EBITDA
R&D expenses decreased to $16.5M in Q4 2025 from $20.3M in Q4 2024 (≈18.7% decline) due to reprioritization. Adjusted EBITDA improved slightly to negative $21.2M vs negative $22.1M in Q4 2024 (≈4.1% improvement).
Cash Runway to Key Value Inflection
Cash and cash equivalents were $81.5M as of Dec 31, 2025, plus $4.1M in subsequent warrant exercise proceeds (total ≈$85.6M), which management believes funds operations into early 2027 — covering the pivotal data readout and potential De Novo submission.
GUTS Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
GUTS Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Mar 24, 2026 | $0.43 | $0.50 | +16.28% |
Nov 12, 2025 | $1.13 | $1.12 | -0.88% |
Aug 12, 2025 | $0.98 | $1.01 | +3.06% |
May 13, 2025 | $1.77 | $1.54 | -12.99% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Fractyl Health, Inc. (GUTS) report earnings?
Fractyl Health, Inc. (GUTS) is schdueled to report earning on May 19, 2026, Before Open (Confirmed).
What is Fractyl Health, Inc. (GUTS) earnings time?
Fractyl Health, Inc. (GUTS) earnings time is at May 19, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
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What is GUTS EPS forecast?
GUTS EPS forecast for the fiscal quarter 2026 (Q1) is -0.16.