Fractyl Health Announces Pricing of $60 Million Underwritten Offering of Common Stock BURLINGTON, Mass., September 26, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the pricing of an underwritten offering of 60 million shares of its common stock at a price of $1.00 per share. All of the securities are being offer ...

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].

Financial Data and Key Metrics Changes - In Q1 2025, the company reported a net loss of $23.7 million, compared to a net loss of $3.3 million in Q1 2024, largely due to fluctuations in the non-cash change in fair value of notes and warrants and increased operating expenses [18] - Research and development expenses increased to $19.4 million from $14.4 million in the same period last year, reflecting advancements in the REMAIN one study and the Rejuva program [17] - Cash and cash equivalents as of March 31, 2025, were approximately $42.1 million, which is expected to fund operations into Q4 2025 [18] Business Line Data and Key Metrics Changes - The REMAIN one pivotal cohort has completed full enrollment, evaluating Revita for durable weight maintenance after GLP-1 discontinuation, significantly ahead of schedule [7] - The REVEAL one cohort showed promising initial results, with participants experiencing only a 1.2% average weight regain after GLP-1 cessation, compared to the typical 3% [9] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in obesity care, as real-world evidence indicates that GLP-1 drugs do not deliver the expected weight loss seen in clinical trials [5] - There is a clear demand for non-drug options to enhance efficacy in weight maintenance after discontinuation of GLP-1 therapy, as patients express a strong interest in alternatives like Revita [11] Company Strategy and Development Direction - The company aims to redefine obesity treatment by offering patient-friendly solutions for durable improvements in weight and metabolic control, focusing on scalable outpatient solutions [4] - The Rejuva platform is designed to deliver a best-in-class GLP-1 based therapy for obesity and metabolic disease, emphasizing potency, durability, and convenience [12] Management's Comments on Operating Environment and Future Outlook - Management anticipates 2025 to be a year of acceleration, with multiple data readouts and regulatory filings expected [4] - The company is confident in its ability to deliver key milestones, including pivotal data from the REMAIN one study and the first CTA module submission for Rejuva [21] Other Important Information - The company has developed a large-scale cGMP manufacturing process for Rejuva, which could significantly lower costs compared to current systemic gene therapy products [15] - Management does not foresee any material impact from current tariff policies on its business operations [19] Q&A Session Summary Question: Regarding the midpoint analysis of REMAIN one - Management confirmed that over 45 patients have achieved the required 15% total body weight loss and anticipates the dataset in Q3 [27][28] Question: Upcoming REVEAL one update - The three-month data will include the majority of previously reported patients, with additional data expected from new participants [31][33] Question: Concerns about FDA shakeup - Management stated that there are no current concerns affecting regulatory interactions, and preparations for the CTA are on track [40][41] Question: Enrollment progress in REMAIN one - Enrollment was approximately three months ahead of schedule, driven by higher than expected demand at individual sites [47] Question: Sham procedure details - The sham procedure involves an upper endoscopy and randomization, ensuring rigorous controls to limit placebo effects [50][52]

Core Insights - Fractyl Health is advancing its metabolic therapeutics, particularly focusing on maintaining weight loss after discontinuation of GLP-1 therapy, with promising early clinical data from its Revita treatment [3][7][15] - The company anticipates significant milestones in 2025, including data updates from various cohorts and the submission of its first Clinical Trial Application for its Rejuva gene therapy platform [2][4][16] Company Updates - Fractyl Health reported first quarter 2025 financial results, highlighting rapid clinical and operational momentum [2] - The company has completed enrollment for the REMAIN-1 Pivotal Cohort ahead of schedule, with 6-month primary endpoint data expected in the second half of 2026 [9] - The REVEAL-1 Cohort has shown encouraging results, with an average weight regain of only 1.2% after GLP-1 discontinuation, compared to the typical 3% [7][8] Clinical Trials and Data - The REVEAL-1 Cohort is designed to provide real-world insights on Revita's performance after GLP-1 therapy cessation, with early data expected in June 2025 [5][7] - The REMAIN-1 Midpoint Cohort, which includes 45 participants, aims to assess Revita's efficacy in maintaining weight loss post-GLP-1 therapy, with initial efficacy analysis planned after 12 weeks of follow-up [6][8] - The Rejuva gene therapy platform is progressing towards first-in-human studies, with the first CTA module submission for RJVA-001 expected in June 2025 [10][16] Financial Performance - For Q1 2025, Fractyl reported a net loss of $23.7 million, an increase from $3.3 million in Q1 2024, primarily due to higher operating expenses [11][23] - Research and development expenses for the quarter were $19.4 million, up from $14.4 million in the same period last year, reflecting ongoing advancements in clinical programs [11][23] - As of March 31, 2025, the company had approximately $42.1 million in cash and cash equivalents, which is expected to fund operations into Q4 2025 [11][20]