Fractyl Health 2025 Q3 Earnings Deepened Losses Amid Clinical Progress

Fractyl Health (GUTS) reported Q3 2025 results on Nov 13, 2025, showing a net loss of $45.6M, a 96.8% increase from $23.17M in 2024 Q3. The company’s losses widened by 47.9% per share, with revenue collapsing to $0. Despite the financial setbacks, clinical advancements in its Revita program and a strengthened cash position of $77.7M were highlighted.

Revenue

The company’s total revenue declined by 100% to $0 in Q3 2025, a stark drop from $14,000 in the same period in 2024.

Earnings/Net Income

Fractyl Health’s losses widened significantly, with a net loss of $45.6M in Q3 2025 compared to $23.17M in 2024 Q3. Earnings per share fell to -$0.71 from -$0.48, reflecting a 47.9% increase in per-share losses. Despite the negative figures, the company noted this marked its highest net loss in two years, underscoring operational challenges.

Price Action

The stock price of Fractyl Health fell 11.11% on the latest trading day, rose 2.75% during the most recent full trading week, and dropped 17.04% month-to-date.

Post-Earnings Price Action Review

The strategy of buying Fractyl Health shares on the date of its revenue raise announcement and holding for 30 days resulted in a significant loss. The 30-day holding period yielded an average return of -18.21%, with a maximum return of -12.5% and a minimum return of -22.3%. This indicates that the strategy was not profitable over the past three years, with the worst return occurring in the first year (-22.3%). The average return of -18.21% represents a clear underperformance compared to a buy-and-hold strategy, which would have at least preserved the value of the investment. The maximum return of -12.5% in the second year suggests a brief partial recovery, but this was followed by another significant drop in the third year.

CEO Commentary

CEO Harith Rajagopalan emphasized Q3’s pivotal progress, including Revita’s first randomized, double-blind data demonstrating sustained weight loss post-GLP-1 therapy. He highlighted strategic priorities: advancing the REMAIN-1 pivotal trial, expanding clinical partnerships, and preparing for regulatory pathways. Rajagopalan expressed confidence in Revita’s “transformative” potential, noting its durability and economic rationale.

Guidance

Fractyl expects 6-month data from REVEAL-1 (Q4 2025) and REMAIN-1 Midpoint Cohort (Q1 2026), with top-line pivotal data and potential PMA submission by H2 2026. The company anticipates cash runway extending into early 2027, supported by $77.7M in cash as of Q3 2025.

Additional News

1. $83M Underwritten Offering: Fractyl completed an $83M underwritten offering, extending its cash runway through 2026 clinical milestones and into early 2027.

2. REMAIN-1 Midpoint Cohort Data: Positive 3-month randomized data showed Revita maintained weight loss after GLP-1 discontinuation, with 6-month results expected in Q1 2026.

3. German Real-World Study: Patients maintained an average 9% weight loss at 2 years, reinforcing Revita’s durability.

Fractyl Health’s Q3 report underscores a high-risk, high-reward trajectory, balancing substantial financial losses with groundbreaking clinical progress. While the stock’s post-earnings volatility reflects investor skepticism, the company’s focus on durable weight-loss solutions and regulatory milestones positions it for potential long-term transformation in metabolic medicine.