Fractyl Health (GUTS) Q1 2026 earnings summary

Executive summary

• Revita pivotal trial completed randomization with over 300 participants at 30+ US sites, marking the largest sham-controlled GI endoscopy pivotal trial to date.

• Achieved key clinical milestones for Revita and Rejuva, including completion of pivotal cohort randomization and regulatory progress in the EU and Australia.

• Net income for Q1 2026 was $9.2 million, a turnaround from a net loss of $23.7 million in Q1 2025, driven by a $30.1 million non-cash change in warrant liabilities.

• Cash and equivalents stood at $63.2 million as of March 31, 2026, expected to fund operations into early 2027, though substantial doubt exists about the ability to continue as a going concern beyond that period.

• Rejuva, the GLP-1 gene therapy platform, received EU authorization for first-in-human trials, with initial dosing and preliminary data expected in H2 2026.

Financial highlights

• Q1 2026 R&D expenses were $15.6 million, down from $19.4 million in Q1 2025, mainly due to reduced program and personnel costs.

• SG&A expenses were stable at $5.2 million year-over-year.

• Adjusted EBITDA was negative $18.0 million, improving from negative $23.0 million year-over-year.

• Total operating expenses decreased 15.9% year-over-year to $20.8 million.

• Other income, net, was $30.0 million, primarily from the change in fair value of warrant liabilities.

Outlook and guidance

• Top-line six-month pivotal data for Revita expected in early Q4 2026, with De Novo submission planned for late Q4.

• First-in-human dosing of RJVA-001 and preliminary data expected in H2 2026.

• Cash runway extends into early 2027, with no planned capital raise before pivotal data.

• Management expects existing cash to fund operations through multiple key clinical and regulatory milestones in 2026, but not for at least twelve months from the report issuance date.

• Plans to seek additional funding through equity, debt, or collaborations; failure to secure funding may require cost reductions or delay in programs.