Fractyl Health’s Q4 Loss Widens to $43.7M, Cash Runway to Early 2027
Fractyl Health reported a Q4 net loss of $43.7 million on $16.5 million R&D and $6.8 million SG&A, retaining $81.5 million cash to fund operations into early 2027. The FDA gave favorable feedback on Revita’s de novo classification request, potentially granting it Class II device status.
1. Q4 Financial Results
Fractyl Health posted a net loss of $43.7 million in Q4 2025, compared to $25 million a year ago. R&D expenses fell to $16.5 million from $20.3 million, while SG&A rose to $6.8 million from $4.9 million, resulting in a negative adjusted EBITDA of $21.2 million.
2. Cash Position and Runway
Cash and cash equivalents stood at $81.5 million as of December 31, 2025, expected to fund operations into early 2027. This positions the company to advance Revita’s pivotal study without immediate financing needs.
3. FDA Feedback on Revita Classification
The FDA provided favorable feedback on Fractyl’s de novo classification request for Revita, potentially granting it Class II device status. This regulatory pathway could streamline Revita’s market approval and support commercial launch plans.
4. Pivotal Study Confidence and Risks
The Revita pivotal study is powered at over 90% to meet primary endpoints, targeting a minimum 16-centimeter ablation length standard. However, six-month data variability, site-level heterogeneity and long-term payer cost pressures pose challenges to consistent efficacy and adoption.