PolyPid (PYPD) Q2 2025 Earnings Call August 13, 2025 08:30 AM ET Speaker0Greetings, and welcome to Polypeed's Second Quarter twenty twenty five Conference Call. At this time, participants are in a listen only mode. As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Juda Liebla from ARTS Capital Markets. Mr.Liebla, you may begin.Speaker1Thank you all for participating in Polypid's second quarter twenty twenty five earnings conference call. Joining me on ...

BURLINGTON, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the pricing of its underwritten public offering of 19,047,619 shares of common stock and accompanying Tranche A and Tranche B warrants, for gross proceeds of $20 million before deducting underwriting discounts, commissions, and offering expen ...

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]