Core Insights - Fractyl Health, Inc. reported positive results from the REMAIN-1 Midpoint Cohort, indicating that the Revita procedure can maintain weight loss after discontinuation of GLP-1 therapy, with 6-month data expected in Q1 2026 [1][11] - The company completed $83 million in underwritten offerings, which is anticipated to extend its cash runway through early 2027, supporting upcoming clinical and regulatory milestones [3][20] Company Updates - Fractyl Health is focused on innovative treatments for obesity and type 2 diabetes (T2D), with ongoing momentum in its Revita and Rejuva platforms [3][18] - The REMAIN weight maintenance program includes three cohorts: REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal, aimed at evaluating Revita's effectiveness in sustaining weight loss [5][21] - The REMAIN-1 Midpoint Cohort showed that Revita-treated patients lost an additional 2.5% of total body weight after stopping tirzepatide, while sham-treated patients regained 10% [11] Financial Performance - For Q3 2025, Fractyl reported a net loss of $45.6 million, compared to $23.2 million in Q3 2024, primarily due to a non-cash accounting change related to warrants [20][27] - Research and development expenses were $17.5 million for Q3 2025, down from $19.0 million in the same period of 2024 [20][27] - As of September 30, 2025, the company had approximately $77.7 million in cash and cash equivalents, which is expected to fund operations into early 2027 [20][26] Upcoming Milestones - The company expects to report 6-month data from the REVEAL-1 Cohort in Q4 2025 and pivotal data from the REMAIN-1 Pivotal Cohort in H2 2026 [1][12] - Fractyl anticipates filing a Premarket Approval (PMA) application with the FDA in H2 2026 [12] Research and Development - The Rejuva platform is advancing gene therapies for T2D and obesity, with RJVA-002 showing promising preclinical results, including approximately 30% weight loss in a mouse model [10][13] - The company has submitted the first Clinical Trial Application (CTA) module for RJVA-001, with preliminary data expected in 2026 [22][13]

Core Insights - Fractyl Health, Inc. is set to report its financial results for Q3 2025 on November 12, 2025, at 4:30 p.m. ET [1] - The company focuses on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases [3] Company Overview - Fractyl Health is dedicated to developing new therapeutic approaches for metabolic diseases, particularly obesity and T2D, which are significant contributors to morbidity and mortality in the 21st century [3] - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that target organ-level causes [3] - Fractyl Health has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with various foreign patents [3] - The company is headquartered in Burlington, Massachusetts [3]

Core Viewpoint - Fractyl Health, Inc. has announced a pricing of an underwritten offering of 60 million shares of common stock at $1.00 per share, aiming to raise approximately $60 million in gross proceeds before expenses [1][8]. Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D) [5][12]. - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of metabolic diseases [5][12]. - Fractyl has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with numerous foreign patents [5][12]. Offering Details - The underwritten offering is expected to close on or about September 29, 2025, subject to customary closing conditions [1][8]. - BofA Securities and Evercore ISI are serving as joint book-running managers, while Ladenburg Thalmann is the lead manager for the offering [2][9]. - A shelf registration statement for the offering was filed with the SEC on March 3, 2025, and was declared effective on March 18, 2025 [3][10].

Revita Program - The durable weight maintenance market represents an untapped opportunity of approximately $175 billion[7] - 85% of patients regain weight after stopping GLP-1 drugs, highlighting a significant unmet clinical and economic need[10] - The REMAIN-1 Pivotal Cohort is on track to complete randomization in early 2026, with potential PMA filing in H2 2026[10] - In the REMAIN-1 Midpoint Cohort study, Revita patients experienced a further 2.5% weight loss after stopping GLP-1s, compared to a 10% weight regain in sham-treated patients (p=0.014) at 3 months[54] Rejuva Program - The company submitted the first CTA module in the EU for RJVA-001, with anticipated preliminary data in 2026[10] - Rejuva aims for a cost of goods (COGs) of less than $10,000 per patient, targeting a price benchmark of approximately $10,000 per year based on ICER pricing[92] - Preclinical data showed that Rejuva's RJVA-001 demonstrated glucose-lowering activity and improved weight compared to daily semaglutide in a db/db murine model[101] - In a DIO mouse model, RJVA-001 prototype showed sustained weight loss while preserving lean mass, outperforming semaglutide[104] Intellectual Property - The company has a robust intellectual property estate with 100+ patents issued globally, including 33 U S patents, and 70+ pending patent applications as of June 2025[135]

Acquisition Overview - Roche Holdings AG has agreed to acquire 89bio, Inc. for $2.4 billion, focusing on therapies for liver and cardiometabolic diseases [1] - The acquisition price is set at $14.50 per share, reflecting a 79% premium over 89bio's closing stock price on September 17, 2025, and a 52% premium over its 60-day volume-weighted average price [2] Contingent Value Rights (CVR) - 89bio stockholders will receive a non-tradeable CVR, allowing for contingent payments of up to $6.00 per share based on specific milestones, bringing the total transaction equity value to approximately $3.5 billion on a fully diluted basis [3] - The CVR includes payments of $2.00 per share upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients, $1.50 per share upon reaching annual net sales of $3.0 billion, and $2.50 per share upon reaching annual net sales of $4.0 billion [5] Product Development - 89bio's pegozafermin, an FGF21 analog, is in late-stage development for MASH in moderate to severe fibrotic patients and cirrhotic patients [4] - Roche aims to enhance its pipeline targeting metabolic diseases through this acquisition, with potential best-in-disease efficacy for moderate to severe MASH patients [5] Market Reaction - Following the announcement, 89bio's stock price increased by 85.15%, reaching $14.97 [6]

Core Insights - Fractyl Health, Inc. has appointed Christopher Thompson, M.D. and Ian Sheffield as Independent Directors to strengthen its Board of Directors as it advances its product candidates Revita and Rejuva [1][2][5] Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to transform disease management from symptomatic to disease-modifying therapies [6] - The company has a robust intellectual property portfolio with 33 granted U.S. patents and approximately 40 pending U.S. applications [6] Product Development - Revita is designed to remodel the duodenal lining to reverse damage caused by high-fat and high-sugar diets, and it has received U.S. FDA Breakthrough Device designation for weight maintenance in patients who discontinue GLP-1 based drugs [7] - The pivotal study REMAIN-1 for Revita has been initiated and completed enrollment [7] - The Rejuva platform focuses on developing AAV-based gene therapies for obesity and T2D, with the first Clinical Trial Application submitted for RJVA-001 [8] Leadership Appointments - Christopher Thompson, M.D. brings extensive experience in bariatric endoscopy and has co-founded several start-ups in endoscopic technology, which aligns with Fractyl's upcoming clinical milestones [2][3] - Ian Sheffield has a 20-year track record in healthcare investing and operations, which will aid Fractyl in navigating late-stage development and strategic partnerships [3][5] Strategic Importance - The appointments of Thompson and Sheffield are seen as timely as the company prepares for key milestones and aims to capture significant clinical and economic opportunities in metabolic care [5]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company reported cash and cash equivalents of $17.4 million and short-term deposits of $12 million, totaling $29.5 million, a significant increase from $15.6 million as of December 31, 2024, primarily due to a successful warrant exercise [15][16] - For Q2 2025, the company reported a net loss of $10 million or $0.78 per share, compared to a net loss of $6.3 million or $1.25 per share in Q2 2024 [17] - For the six months ended June 30, 2025, the net loss was $18.2 million or $1.48 per share, compared to a net loss of $12.7 million or $2.62 per share in the same period of 2024 [17] Business Line Data and Key Metrics Changes - The SHIELD II Phase III trial for DPLEX100 demonstrated a statistically significant 38% reduction in the primary endpoint of surgical site infections (SSI) with a p-value below 0.005 [5] - The trial also showed a 58% reduction in the rate of surgical site infections in patients treated with DPLEX100 compared to standard care, with a significant reduction in deep surgical site infections [5][6] - The company is preparing for a New Drug Application (NDA) submission to the FDA in early 2026, following positive Phase III data [8][9] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the US is estimated at over 12 million surgeries annually, with approximately 4.4 million being abdominal surgeries [11] - Surgical site infections are estimated to cost the US healthcare system up to $10 billion annually, highlighting the potential economic impact of DPLEX100 [12] Company Strategy and Development Direction - The company aims to leverage the positive Phase III results to enhance commercial preparations and explore partnership opportunities for DPLEX100 [11][46] - The GLP-1 program is positioned to address unmet needs in the treatment of metabolic diseases, with plans for robust preclinical studies and potential partnerships [9][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of DPLEX100 to significantly reduce surgical site infections and improve patient outcomes, which has generated substantial interest from commercial partners [7][8] - The company is focused on regulatory submissions and commercial preparations, with a strong emphasis on maximizing the value of DPLEX100 [46] Other Important Information - The company appointed Dr. Nuit Tyser Zacks as Chief Medical Officer, bringing extensive expertise to support regulatory efforts and pre-launch activities [10][36] - The company has strengthened its balance sheet through a successful warrant exercise, extending its cash runway well into 2026 [10][15] Q&A Session Summary Question: NDA filing preparations - Management indicated they are in the finalization stages of the CMC and clinical module, preparing for a pre-NDA meeting with the FDA by the end of the year, with NDA submission expected in early 2026 [19][22] Question: Path forward for the GLP-1 program - The GLP-1 program is entering robust preclinical studies, with plans to characterize the risk profile and pursue clinical collaboration with a large player in the field [23][24] Question: Advanced partnership milestones - Management confirmed that milestones are expected from the partnership, with ongoing discussions to finalize pre-launch activities [28][29] Question: Preferred methods for bolstering the balance sheet - The company is looking to collaborate with partners to finance efforts and expects payments from existing and new partners to support financial needs [40]

Core Insights - Fractyl Health, Inc. is advancing its Revita and Rejuva platforms aimed at treating obesity and type 2 diabetes (T2D) through innovative approaches [2][3][18] - The company recently completed a $23 million underwritten public offering to extend its cash runway for upcoming clinical milestones [2][18] - Positive early data from the REVEAL-1 Cohort indicates that Revita can help maintain weight loss after discontinuation of GLP-1 drugs [7][20] Financial Performance - For Q2 2025, Fractyl reported a net loss of $27.9 million, compared to a net loss of $17.2 million in Q2 2024, largely due to increased operating expenses [16][27] - Research and development expenses were $21.2 million for the quarter, up from $16.8 million in the same period last year, reflecting ongoing clinical study advancements [16][27] - As of June 30, 2025, the company had approximately $22.3 million in cash and cash equivalents, which is expected to fund operations into 2026 [16][27] Clinical Developments - The REMAIN-1 pivotal study includes three cohorts: REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal, with the latter expected to report 6-month data in H2 2026 [4][9][13] - The REVEAL-1 Cohort showed that 12 out of 13 participants maintained or reduced weight after a single Revita procedure following GLP-1 discontinuation [7][8] - The REMAIN-1 Midpoint Cohort is designed to assess Revita's efficacy in maintaining weight loss after GLP-1 discontinuation, with initial data expected in September 2025 [8][12] Strategic Initiatives - Fractyl has entered a non-binding Letter of Intent with Bariendo Inc. to explore collaboration for Revita as a post-GLP-1 weight maintenance intervention [18] - The company has been issued two new U.S. patents that enhance its duodenal mucosal resurfacing platform, strengthening its intellectual property portfolio [18] - The Rejuva platform is progressing towards clinical trials, with the first-in-human study expected to begin in 2026 [11][14]

Core Viewpoint - Fractyl Health, Inc. has announced a public offering of 19,047,619 shares of common stock, along with Tranche A and Tranche B warrants, aiming for gross proceeds of $20 million to support its metabolic disease treatment programs [1][5]. Offering Details - The shares are priced at $1.05 each, with each share sold together with one Tranche A warrant (2-year term) and one Tranche B warrant (5-year term) [2]. - The exercise price for both warrant tranches is set at $1.05 per share, and the warrants do not have variable priced resetting mechanisms or price-based anti-dilution features [2]. - The Tranche A warrants can be called by the company after the release of 3-month randomized midpoint clinical data from the ongoing REMAIN-1 study, contingent on certain conditions being met [3]. Additional Options - The underwriters have a 30-day option to purchase up to an additional 2,857,142 shares of common stock, along with associated warrants, at the public offering price [4]. Financial Projections - The company expects to receive approximately $20 million from this offering, with potential future proceeds of up to $40 million if the warrants are fully exercised for cash [5]. - The net proceeds will be utilized to support the Revita and Rejuva pipeline programs, as well as for working capital and other general corporate purposes [5]. Company Background - Fractyl is focused on innovative treatments for metabolic diseases, including obesity and type 2 diabetes, aiming to shift from chronic symptomatic management to durable disease-modifying therapies [9]. - The company holds a robust intellectual property portfolio, with 32 granted U.S. patents and around 40 pending U.S. applications, alongside numerous foreign patents [9].

Core Viewpoint - Fractyl Health, Inc. is planning to conduct an underwritten public offering of its common stock and pre-funded warrants to raise capital for its pipeline programs and general corporate purposes [1][2]. Group 1: Offering Details - The company intends to sell shares of its common stock and pre-funded warrants, with each pre-funded warrant priced slightly lower than the common stock price [1]. - Fractyl expects to grant underwriters a 30-day option to purchase up to an additional 15% of the offered shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the final terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to support the Revita and Rejuva pipeline programs, along with working capital and other general corporate purposes [2]. Group 3: Company Overview - Fractyl Health focuses on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes, aiming to shift from chronic management to disease-modifying therapies [5]. - The company holds a robust intellectual property portfolio, including 32 granted U.S. patents and approximately 40 pending applications [5]. - Fractyl is headquartered in Burlington, Massachusetts, and aims to redefine metabolic disease treatment [5].