FRACTYL HEALTH INC (NASDAQ:GUTS) Reports Wider-Than-Expected Q2 2025 Loss Amid Clinical Progress

FRACTYL HEALTH INC (NASDAQ:GUTS) reported its second-quarter 2025 financial results, posting a net loss of $27.9 million, or $0.57 per share, compared to a net loss of $17.2 million in the same period last year. The company reported no revenue for the quarter, in line with analyst estimates of $0.0. However, the earnings per share (EPS) miss was notable, as analysts had expected a loss of $0.37 per share, making the reported loss 54% wider than anticipated.

Key Financial Takeaways

• Revenue: $0.0 (in line with estimates).
• EPS: -$0.57 (vs. estimated -$0.37).
• R&D Expenses: Increased to $21.2 million (up from $16.8 million in Q2 2024).
• Cash Position: $22.3 million as of June 30, 2025, bolstered by a recent $23 million public offering.

The stock reacted negatively in after-hours trading, declining nearly 3%, suggesting investor disappointment with the wider-than-expected loss. Over the past month, shares have declined by roughly 34%, reflecting broader skepticism ahead of the earnings release.

Business Updates and Clinical Progress

Fractyl Health remains focused on advancing its metabolic therapeutics pipeline, particularly its Revita and Rejuva platforms. Key developments include:

Revita Program

• REVEAL-1 Cohort (Open-Label): Positive 3-month data showed that 12 of 13 participants maintained or further reduced weight after discontinuing GLP-1 drugs following a single Revita procedure. Six-month data is expected in Q4 2025.
• REMAIN-1 Midpoint Cohort (Randomized): Enrollment completed, with 3-month data anticipated in September 2025 and 6-month data in Q1 2026.
• REMAIN-1 Pivotal Cohort: Enrollment completed, with top-line 6-month data expected in H2 2026, followed by a PMA submission to the FDA.

Rejuva Gene Therapy Platform

• Preclinical data supports advancement toward first-in-human studies.
• A clinical trial application (CTA) for RJVA-001 was submitted in Europe, with preliminary data expected in 2026.

Market Reaction and Outlook

The market’s negative reaction appears tied to the widening losses and cash burn, despite progress in clinical programs. The company’s recent $23 million public offering extends its cash runway into 2026, but investors may remain cautious until upcoming clinical readouts provide clearer validation of Revita’s efficacy.

Analyst estimates for Q3 2025 project another loss of $0.37 per share, with no expected revenue. Full-year 2025 estimates suggest a loss of $1.56 per share, reinforcing that profitability remains distant.

For more detailed earnings estimates and future projections, see Fractyl Health’s earnings estimates.

Disclaimer: This article is not investment advice. Investors should conduct their own research before making any financial decisions.