Fractyl Health (GUTS) Q2 2026 earnings summary

Executive summary

• One-year data from REMAIN-1 and REVEAL-1 cohorts show Revita maintained up to 84% of prior GLP-1-induced weight loss, compared to 46% in the sham group, with no serious device-related adverse events.

• Pivotal REMAIN-1 trial is fully enrolled and on track for top-line six-month data in early Q4 2026 and 12-month data in Q1 2027.

• Revita's commercial opportunity is expanding as GLP-1 discontinuation rates remain high and payers seek durable, cost-effective alternatives.

• Rejuva gene therapy program received clinical trial authorization in the Netherlands and ethics approval in Australia, with first-in-human dosing expected in H2 2026.

• Cash and equivalents stood at $47.1M as of June 30, 2026, expected to fund operations into early 2027.

Financial highlights

• R&D expenses were $13.8M in Q2 2026, down from $21.2M in Q2 2025, reflecting reduced spending on Revita and Rejuva.

• SG&A expenses rose to $5.3M from $4.9M year-over-year, mainly due to higher stock compensation.

• Net loss for Q2 2026 was $25.5M, an improvement from $27.9M in Q2 2025, driven by lower operating expenses.

• Adjusted EBITDA was negative $16.3M for Q2 2026, a $7.7M improvement year-over-year.

• Other income (expense), net, was a $6.4M expense in Q2 2026, mainly from losses in fair value of warrant liabilities and notes payable.

Outlook and guidance

• Top-line six-month pivotal data for Revita expected in early Q4 2026; 12-month data in Q1 2027.

• Potential FDA De Novo submission planned for late Q4 2026.

• First-in-human dosing of RJVA-001 gene therapy expected in H2 2026, with preliminary data to follow.

• No capital raise planned before pivotal data; current cash expected to fund operations through key milestones.

• Management notes substantial doubt about long-term liquidity due to insufficient cash for at least twelve months from the report date.