Fractyl Health Inc (NAS:GUTS)

Q3 2025 Fractyl Health Inc Earnings Call Transcript

Nov 12, 2025 / 09:30 PM GMT

Release Date Price: $1.13 (+2.73%)

Transcript 10-Q8-K

Key Points

Positve

Fractyl Health Inc (GUTS) delivered the first randomized double-blind sham controlled data showing sustained weight loss after GLP-1 drug discontinuation with their Revida procedure.
The company has strengthened its balance sheet to support clinical and regulatory milestones into early 2027.
Enrollment and randomization in the Remain one pivotal cohort are progressing ahead of schedule, with over 60% of patients randomized by October 31st.
The German real-world registry study shows durable outcomes, with patients maintaining an average total body weight loss of 9% after two years.
Fractyl Health Inc (GUTS) is well-capitalized with approximately $77.7 million in cash and cash equivalents, extending their cash runway into early 2027.

Negative

The company reported a net loss of $45.6 million for the quarter, compared to $23.2 million in the same period of 2024.
There is no current CPT code for the Revida procedure, and the company is still working on developing a reimbursement strategy.
The pivotal cohort for the Remain one study is still in the process of randomization, with completion expected in early 2026.
The company faces risks and uncertainties that may cause actual results to differ materially from forward-looking statements.
Fractyl Health Inc (GUTS) is still in the process of ensuring adequate manufacturing capacity to meet future demand.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

GUTS.OQ - Fractyl Health Inc
Q3 2025 Fractyl Health Inc Earnings Call
Nov 12, 2025 / 09:30PM GMT

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Presentation
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Unidentified_1 [1]
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Good afternoon and welcome to Fractals Health Third quarter 2025 financial results and business updates call. As a reminder, this conference call is being recorded. At this time, all participants are listen-only mode. There will be a Q&A session following management repair remarks. I'll now turn the call over to Brian Luque, head of investor relations and corporate development at Fractal. Brian, you may not begin.

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Unidentified_2 [2]
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Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. This release is

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