Fractyl Health (NASDAQ:GUTS – Get Free Report) posted its earnings results on Monday. The company reported ($0.12) earnings per share for the quarter, topping analysts’ consensus estimates of ($0.14) by $0.02, Zacks reports.
Here are the key takeaways from Fractyl Health’s conference call:
- Revita’s one-year randomized data showed durable weight maintenance: patients retained more than 80% of prior GLP-1-induced weight loss versus 46% for sham, with no device- or procedure-related serious adverse events reported.
- The company said the REMAIN-1 pivotal trial is fully randomized with more than 300 participants across 30-plus sites, and remains on track to report six-month top-line data in early Q4 2026 and potentially submit for FDA De Novo authorization in late Q4.
- Management sees a sizable commercial opportunity driven by continued GLP-1 use and discontinuation, payer concerns over indefinite treatment costs and frailty, and a targeted center-of-excellence launch model with potential CMS transitional pass-through reimbursement.
- Fractyl ended Q2 with $47.1 million in cash and said its runway extends into early 2027, beyond pivotal data and a potential De Novo submission; however, the regulatory pathway remains contingent on FDA review of the complete safety dataset, and no capital raise is planned before pivotal data.
- The company received authorization in the Netherlands and ethics approval in Australia to begin the first-in-human Phase I/II study of its Rejuva gene-therapy candidate, with initial safety and delivery-feasibility data expected in the second half of 2026.
Fractyl Health Price Performance
GUTS traded down $0.00 on Wednesday, reaching $0.70. The company had a trading volume of 154,309 shares, compared to its average volume of 3,353,863. The business has a 50 day simple moving average of $0.76 and a 200 day simple moving average of $0.69. The company has a market cap of $110.85 million, a price-to-earnings ratio of -0.79 and a beta of 2.32. The company has a debt-to-equity ratio of 1.41, a quick ratio of 4.28 and a current ratio of 4.28. Fractyl Health has a 52-week low of $0.38 and a 52-week high of $2.44.
Analyst Upgrades and Downgrades
Get Our Latest Stock Report on GUTS
Insider Buying and Selling
In related news, Director Ian Sheffield purchased 35,000 shares of the business’s stock in a transaction on Wednesday, June 10th. The stock was acquired at an average price of $0.73 per share, with a total value of $25,550.00. Following the purchase, the director directly owned 35,000 shares in the company, valued at approximately $25,550. This represents a ∞ increase in their ownership of the stock. The purchase was disclosed in a legal filing with the Securities & Exchange Commission, which is available through this link. Also, Director William Bradley purchased 68,493 shares of the firm’s stock in a transaction dated Wednesday, June 10th. The stock was bought at an average cost of $0.73 per share, for a total transaction of $49,999.89. Following the acquisition, the director directly owned 84,622 shares in the company, valued at approximately $61,774.06. The trade was a 424.66% increase in their ownership of the stock. The SEC filing for this purchase provides additional information. In the last three months, insiders acquired 171,493 shares of company stock valued at $127,150. Corporate insiders own 8.52% of the company’s stock.
Institutional Inflows and Outflows
Institutional investors have recently added to or reduced their stakes in the company. Jane Street Group LLC bought a new stake in Fractyl Health during the second quarter worth about $31,000. Scientech Research LLC bought a new position in shares of Fractyl Health during the 3rd quarter valued at about $49,000. Prelude Capital Management LLC bought a new position in shares of Fractyl Health during the 3rd quarter valued at about $55,000. Jump Financial LLC purchased a new position in shares of Fractyl Health during the 4th quarter valued at about $57,000. Finally, Centiva Capital LP purchased a new position in shares of Fractyl Health during the 3rd quarter valued at about $78,000.
About Fractyl Health
Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control.
The company’s lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine.
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