Fractyl Health Announces Q2 2024 Financial Results and Business Updates

Fractyl Health, Inc., a company specializing in metabolic therapeutics aimed at addressing the fundamental causes of obesity and Type 2 Diabetes (T2D), recently announced its second-quarter 2024 financial results and provided significant business updates. Their lead product candidate, Revita®, alongside their Rejuva® platform, are central to these developments.

In August 2024, Fractyl reported promising clinical results from the German Real-World Registry for Revita. Data from 11 patients who completed at least 12 months of follow-up demonstrated a median weight reduction from 111 kilograms to 97 kilograms, translating to nearly 13% total body weight loss. Additionally, the patients' median HbA1c levels dropped from 9.6% to 7.2%. These results indicate that Revita can not only aid in weight loss but also sustain it over a year, showing a notable impact on blood sugar levels. Importantly, weight loss began within one month post-procedure and was generally maintained throughout the year, with no major adverse safety events reported.

Fractyl's Revita has also been granted Breakthrough Device designation by the U.S. FDA for weight maintenance post-discontinuation of GLP-1-based drugs. This designation is significant as it paves the way for priority regulatory review and potentially expedited reimbursement decisions. The REMAIN-1 pivotal study, a randomized, double-blind trial of Revita versus sham treatment, has commenced. Initial open-label data from the study is expected by Q4 2024, with further data anticipated in mid-2025. Revita's existing FDA Breakthrough Device designation for insulin-treated T2D was expanded in June 2024 to include patients inadequately controlled on any glucose-lowering agent, broadening the potential treatment population to approximately 25 million patients in the U.S.

The REVITALIZE-1 study, another pivotal trial, is currently enrolling participants and aims to report topline data in mid-2025. This study targets patients with T2D who are inadequately controlled on at least one glucose-lowering agent.

Alongside Revita, Fractyl's Rejuva platform has shown preclinical promise. New data presented in June 2024 at the ADA’s 84th Scientific Sessions highlighted the platform's potential to maintain weight loss and improve body composition. In a study involving diet-induced obesity (DIO) mice, a single administration of the Rejuva GLP-1 gene therapy candidate significantly reduced fat mass and improved glycemia compared to daily semaglutide injections. Notably, after discontinuing semaglutide, mice treated with Rejuva maintained a 17% fat reduction and 22% weight loss, whereas those without Rejuva treatment showed a rebound in fat mass.

Further preclinical data presented at the Digestive Disease Week 2024 demonstrated Rejuva's ability to reduce liver weight, triglyceride content, and levels of LDL cholesterol, indicating its broader metabolic benefits. Fractyl plans to complete an IND-enabling study for RJVA-001, their first GLP-1 pancreatic gene therapy candidate, by the second half of 2024, aiming to initiate human trials in early 2025.

On the corporate front, Allan Will has stepped down as Chairman of the Board, with Ajay Royan appointed as his successor.

Financially, Fractyl reported an increase in research and development expenses, primarily due to the initiation of the REMAIN-1 study and progress in the REVITALIZE-1 study. Their net loss for the quarter was $17.2 million, a decrease from the previous year, attributed to changes in the fair value of notes payable and warrant liabilities. As of June 30, 2024, Fractyl held approximately $102.4 million in cash and cash equivalents, which is expected to fund operations through key milestones into Q4 2025.

Fractyl Health remains committed to transforming the treatment landscape for metabolic diseases through innovative, durable therapies that target the root causes of obesity and T2D.