Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
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Earnings Data
Report Date
Aug 19, 2026Before Open (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.14Last Year’s EPS
-0.57Same Quarter Last Year
Strong Buy
Based on 4 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call emphasizes strong clinical execution, external validation, regulatory and reimbursement progress, and a clear catalyst timeline — all supportive of the company's strategic thesis. Financially, the company has reduced operating spend and improved adjusted EBITDA, but remains cash-limited with a runway into early 2027 and continues to report negative adjusted profitability. Several regulatory and operational uncertainties remain (RAPID implementation, full de novo approval, U.S. regulatory engagement for Rejuva) and the near-term plan is contingent on multiple upcoming clinical readouts. Overall, clinical and regulatory momentum and cost discipline are material positives, but the constrained cash runway and remaining execution/regulatory risks temper the outlook.Company Guidance
Pivotal Trial Fully Randomized and Executing on Plan
REMAIN-1 pivotal cohort completed randomizations in February with >300 participants across >30 U.S. sites; described as the largest sham-controlled GI endoscopy pivotal trial ever conducted. Participant retention exceeds 90% and blinded adverse event profile remains reassuring. Top-line 6-month primary endpoint data expected in early Q4 2026; last patient 6-month visit expected in Q3 2026.
Clear and Growing Clinical Signal
REMAIN-1 midpoint data showed a larger treatment effect in participants with higher run-in GLP-1 weight loss and a statistically significant dose-dependent effect tied to duodenal ablation length. Findings received external validation at DDW (selected for PRESS) and were endorsed by an advisory board of leading clinicians.
Regulatory and Reimbursement Momentum
Favorable FDA feedback on de novo classification (consistent with moderate risk) and Breakthrough Device designation in GLP-1 weight maintenance and Type 2 diabetes. CMS RAPID pathway announced could materially accelerate Medicare national coverage aligned with FDA authorization. Company expects to file a Category III CPT code application this summer (effective 2027) and highlights transitional pass-through payment as a path to favorable hospital margins.
Rejuva Program Advances to Clinical Stage in EU
EU regulatory authorization received to initiate Phase 1/2 first-in-human study of RJVA-001 (Rejuva), described as the first AAV-based gene therapy candidate to enter clinical development for Type 2 diabetes. First-in-human dosing and preliminary data expected in H2 2026, pending site activation. Rejuva clinical development is funded within existing cash runway into early 2027.
Commercial Opportunity and Market Dynamics
Company highlights market tailwinds: tens of millions on GLP-1s, ~1 million patients discontinuing GLP-1s per month, and new oral GLP-1 approvals expanding the population who may later need a durable off-ramp. Management positions Revita as the only potential procedural therapy specifically developed for post-GLP-1 weight maintenance with pivotal data expected within the year.
Cost Discipline and Operating Expense Reductions
Research & development expenses decreased to $15.6M in Q1 2026 from $19.4M in Q1 2025, a reduction of approximately 19.6%, attributed to reduced spending on Revita and Rejuva programs and lower personnel-related costs. Total operating expenses were $3.9M lower versus prior year period.
Improved Adjusted EBITDA and Operating Performance
Adjusted EBITDA improved to negative $18M in Q1 2026 from negative $23M in Q1 2025 (an improvement of $5M). Management attributes decreases in operating expenses as a driver of the improvement.
Capital Plan and Milestone-Focused Runway
Cash and cash equivalents of $63.2M as of 3/31/2026. Management states runway into early 2027, intends no capital raise before pivotal data, and has closed the ATM facility to preserve current capital posture.
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 |
|---|---|---|---|
May 12, 2026 | $0.73 | $0.95 | +29.16% |
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% |
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 Aug 19, 2026, Before Open (Confirmed).
What is Fractyl Health, Inc. (GUTS) earnings time?
Fractyl Health, Inc. (GUTS) earnings time is at Aug 19, 2026, Before Open (Confirmed).
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What is GUTS EPS forecast?
GUTS EPS forecast for the fiscal quarter 2026 (Q2) is -0.14.