GUTS
Fractyl Health, Inc.2.1600
-0.0800-3.57%
Dec 16, 4:00:02 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Q&A boosts ablation confidence
Q&A largely reaffirms prepared remarks on Revita's dose-response from longer ablation lengths, but clarifies pivotal cohort achieved mean/median >16cm versus shorter midpoint ablations, with all operators trained to hit >14cm after just 3-4 cases. Management detailed procedural standardization—counting 2cm balloon ablations longitudinally—as the future operating norm, directly addressing analyst concerns on variability and real-world feasibility. De Novo feedback emphasizes safety over PMA's higher efficacy bar. No walk-backs; tone stays bullish on early Q4 2026 data. Pivotal execution looks dialed in.
Key Stats
Market Cap
296.02MP/E (TTM)
-Basic EPS (TTM)
-2.32Dividend Yield
0%Recent Filings
8-K
Revita randomization complete
Fractyl Health completed randomization in its REMAIN-1 Pivotal Cohort on February 26, 2026, advancing the double-blind, sham-controlled Revita study for post-GLP-1 weight maintenance in obese adults. Topline 6-month data hits early Q4 2026, with potential FDA submission late Q4. Cash lasts into early 2027. Pivotal readout looms.
8-K
Revita cuts post-GLP-1 regain
Fractyl Health released 6-month REMAIN-1 Midpoint Cohort data on January 29, 2026, showing Revita curbed post-GLP-1 weight regain to 4.5% versus 7.5% sham (p=0.07), slashing it ~70% to 4.2% versus 13.3% in high-loss patients (p=0.004). Revita boosted HDL by 15.5 mg/dL and cut sweet cravings while maintaining stellar safety—no device-related serious events. Midpoint not powered for efficacy. FDA De Novo feedback due Q2 2026.
8-K
CFO transition announced
Fractyl Health appointed Lara Smith Weber as CFO effective January 12, 2026, replacing Lisa Davidson who resigned December 31, 2025, without disagreements. Weber, with medtech finance experience at Inari and ONWARD Medical, gets $492,100 base, 40% target bonus, $150,000 signing bonus, and options for 1,036,800 shares. Davidson receives $450,000 severance, $180,000 bonus, full equity vesting, and three-month consulting at $400/hour. Smooth transition bolsters commercial readiness.
8-K
Cash runway to early 2027
Fractyl Health disclosed $85.6 million in preliminary unaudited cash and cash equivalents as of January 2, 2026, after $4.1 million from Tranche A warrant exercises, funding operations through early 2027. The company outlined a packed 2026 with Revita milestones like late-January REMAIN-1 Midpoint data and potential H2 PMA filing for post-GLP-1 weight maintenance, plus Rejuva's first-in-human dosing. Cash supports clinical push. Data remains preliminary and unaudited.
8-K
Calls Tranche A warrants for exercise
Fractyl Health called its 17,063,073 outstanding Tranche A Warrants for cancellation on December 30, 2025, after hitting REMAIN-1 study data and trading milestones—stock VWAP over $1.37 for 15 days with $2M daily volume. Holders can exercise at $1.05 per share (vs. $2.24 close) until then, potentially yielding $17.9M gross proceeds to bolster the balance sheet ahead of 2026 readouts. Full exercise isn't guaranteed.
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