Fractyl Health(US:GUTS)2025-11-12 21:05Financial Performance - For the nine months ended September 30, 2025 and 2024, the company incurred net losses of $97.2 million and $43.7 million, respectively, with an accumulated deficit of $512.5 million as of September 30, 2025[130]. - The net loss for the three months ended September 30, 2025, was $45.6 million, a 96.8% increase from a loss of $23.2 million in 2024[166]. - Net loss for the nine months ended September 30, 2025, was $97.2 million, an increase of $53.5 million or 122.4% from a loss of $43.7 million in 2024[175]. - The company reported a net loss of $97.2 million for the nine months ended September 30, 2025, adjusted for non-cash expenses of $28.4 million[212]. - The company may face substantial doubt about its ability to continue as a going concern for at least one year after the issuance of its financial statements due to liquidity concerns[202]. Revenue and Expenses - Revenue for the nine months ended September 30, 2025, was $0, a decrease of $90,000 or 100.0% compared to $90,000 in 2024[175]. - Cost of goods sold for the same period was $0, down from $50,000, representing a 100.0% decrease[175]. - Research and development expenses totaled $17.5 million for the three months ended September 30, 2025, a decrease of 8.1% compared to $19.0 million in 2024[166]. - Research and development expenses increased by $7.9 million, or 15.6%, to $58.0 million compared to $50.2 million in 2024, driven by advancements in Revita and Rejuva programs[177]. - Selling, general and administrative expenses increased by $0.4 million, or 9.2%, during the three months ended September 30, 2025, primarily due to professional service fees[171]. - Selling, general and administrative expenses decreased by $2.7 million, or 14.8%, to $15.5 million, primarily due to a $3.7 million decrease in stock-based compensation[181]. - Other expense, net, was $22.9 million for the three months ended September 30, 2025, primarily due to a $21.2 million loss from the change in fair value of warrant liabilities[172]. - Other net expense was $23.7 million for the nine months ended September 30, 2025, compared to other income of $24.6 million in 2024, reflecting a change of $48.3 million or 196.3%[182]. Cash Flow and Financing - The net cash used in operating activities for the nine months ended September 30, 2025, was $68.992 million, compared to $48.487 million for the same period in 2024[211]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $79.739 million, primarily from common stock issuances, while for the same period in 2024, it was $101.159 million[215][216]. - The company received approximately $20.7 million in net proceeds from the August 2025 Offering, which included the issuance of 19,047,619 shares of common stock[196]. - The September 2025 Offering generated approximately $56.0 million in net proceeds from the sale of 60,000,000 shares at $1.00 per share[199]. - The company expects to seek additional funds through equity or debt financings, collaborations, or licensing transactions to support its operations[203]. - The company expects to incur substantial operating losses and negative cash flows for the foreseeable future, necessitating additional funding to achieve business objectives[200]. Clinical Trials and Research - The Revita DMR System has received reimbursement authorization in Germany and a CE mark in Europe, with a limited commercial pilot initiated in Düsseldorf, Germany[121]. - The REMAIN-1 Midpoint Cohort (n=45) demonstrated a statistically significant 2.5% further weight loss with Revita after GLP-1 discontinuation, compared to a 10% weight regain in sham-treated patients (n=16) with a p-value of 0.014[136]. - The REMAIN-1 Pivotal Cohort has completed enrollment of 315 participants, with randomization of 194 participants as of October 31, 2025, and no serious adverse effects reported[139]. - The first Clinical Trial Application module for RJVA-001 has been submitted, with preliminary data expected in 2026[128]. - RJVA-002 showed a robust, dose-dependent reduction in body weight in preclinical studies, with mid- and high-dose cohorts losing a mean of 18% (p<0.01) and 29% (p<0.0001) of body weight, respectively[144]. - The company anticipates presenting 6-month data for the REVEAL-1 Cohort in Q4 2025 and 1-year data in Q2 2026[135]. - The company expects to complete randomization for the REMAIN-1 Pivotal Cohort in early 2026, with 6-month topline primary endpoint data anticipated in the second half of 2026[140]. Weight Loss Outcomes - After a single Revita procedure, participants achieved a mean total body weight loss of 8.0%, decreasing from 102 kg to 94 kg at 3 months, sustained at 94 kg for 1 year[152]. - Mean HbA1c decreased by 1.0% at 3 months, from 8.8% at baseline to 7.7%, and this improvement was maintained at 7.9% throughout 1 year post-procedure[152]. - Among 30 participants, 28 lost weight, with 20 experiencing at least a 5% reduction and 12 achieving 10% or more[152]. - For 14 participants followed for 2 years, mean weight loss was 7.9% at 1 year, from 104 kg to 95 kg, maintained at 94 kg after 2 years[155]. - The Germany Real-World Registry study initiated in 2023 included participants with a mean age of 60 years, mean weight of 102 kg (225 lbs), and mean HbA1c of 8.8% despite treatment with up to three glucose-lowering agents[151]. Patent and Market Risks - The company has built a patent portfolio that includes 33 issued U.S. patents and approximately 45 pending U.S. applications as of September 30, 2025[149]. - The company is exposed to various market risks, including interest rate risk and credit risk, which could impact its financial condition[224]. - Future contractual commitments for leases as of September 30, 2025, totaled $53.8 million, with $52.8 million related to operating leases[218]. - The company may need to implement cost reduction strategies if it is unable to obtain additional financing[203].