Financial Data and Key Metrics Changes - In Q3 2024, the company reported a net loss of $23.2 million, an increase from a net loss of $15.7 million in Q3 2023, primarily due to higher operating expenses and noncash losses from changes in fair value of notes payable [54] - Research and development expenses rose to $19 million in Q3 2024 from $9.4 million in the same period in 2023, attributed to progress in clinical studies and increased personnel-related expenses [51][52] - As of September 30, 2024, the company had approximately $84.7 million in cash and cash equivalents, expected to fund operations through key milestones into Q4 2025 [55] Business Line Data and Key Metrics Changes - The company began enrollment in the REMAIN-1 pivotal study for weight maintenance after GLP-1 discontinuation, with rapid progress noted [7] - Enrollment under the expanded protocol for the ReVITALIZE-1 pivotal study for Revita in type-2 diabetes has also commenced, with top-line data expected in mid-2025 [8] - Compelling weight maintenance and blood sugar data from Revita and Rejuva were presented at multiple medical meetings, indicating strong clinical outcomes [8][20] Market Data and Key Metrics Changes - The company highlighted significant challenges in the GLP-1 drug market, including high discontinuation rates and poor real-world effectiveness compared to clinical trial results [10][11] - A study indicated that only 25% of patients remained on GLP-1 drugs after two years, raising concerns about the value delivered to payers [15] - The unmet need for durable weight loss maintenance in obesity was emphasized, positioning the company's therapies as potential solutions [18] Company Strategy and Development Direction - The company aims to pioneer a new weight maintenance category with its Revita and Rejuva platforms, focusing on durable metabolic reset therapies [58] - Plans for controlled expansion in Germany are underway, with the goal of obtaining government reimbursement approval to offer Revita at additional centers [36][37] - The company is preparing for a global launch aligned with U.S. market entry, leveraging real-world data generated in Germany [93] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute against upcoming major value drivers and highlighted the evolving landscape of obesity treatment [9][56] - The company is focused on addressing the root causes of obesity and the need for therapies that provide durable effects, distinguishing itself from existing GLP-1 therapies [57] - Future data from pivotal studies and advancements in the Rejuva program are anticipated to drive significant value for the company [60] Other Important Information - The Revita device has received breakthrough device designation from the FDA for weight maintenance after GLP-1 discontinuation, marking a significant regulatory achievement [24] - The company is implementing an integrated obesity solution combining pharmacology, the Revita procedure, and lifestyle programs, which is expected to create a compelling commercial model [29] Q&A Session Summary Question: Can you remind us the sample size enrolled and the duration of follow-up for the midpoint analysis of REMAIN-1? - The sample size is 45 subjects with a 2:1 treatment allocation of Revita to sham, followed for 12 weeks after discontinuation of tirzepatide [63] Question: What's the current thinking on the venue for the initial data of REVEAL-1 at year-end? - Initial data will include at least 10 patients with a minimum of four weeks of follow-up, aiming to demonstrate weight maintenance [70] Question: How is the Rejuva program tracking towards CTA filing by year-end? - Key CTA-enabling studies will be completed by year-end, with plans to file for the CTA in the first half of 2025 [72]

Revenue and Financial Performance - Revenue for Q3 2024 was generated from the pilot commercial launch in Germany, with no specific figures disclosed[4] - Revenue for the three months ended September 30, 2023, was $14,000, compared to $36,000 for the same period in 2022, representing a decline of 61.1%[11] - Gross profit for the three months ended September 30, 2023, was $7,000, down from $11,000 in the prior year, a decrease of 36.4%[11] - Net loss for Q3 2024 was $23.2 million, an increase from a net loss of $15.7 million in Q3 2023, driven by higher operating expenses and changes in fair value of notes payable[4] - Net loss for the three months ended September 30, 2023, was $23,173, compared to a net loss of $15,747 in the same period last year, an increase of 47.5%[11] - The company reported a total net loss and comprehensive loss of $43,724 for the nine months ended September 30, 2023, compared to $57,911 for the same period in 2022, a decrease of 24.6%[11] Research and Development (R&D) Expenses - R&D expenses increased to $19.0 million in Q3 2024, up from $9.4 million in Q3 2023, primarily due to progress in clinical studies and increased personnel-related expenses[4] - Research and development expenses surged to $19,004, compared to $9,382 in the prior year, marking an increase of 102.0%[11] - The company continues to invest heavily in R&D, with total R&D expenses for the nine months reaching $50,190, up from $27,872 in the previous year, an increase of 80.0%[11] Operating Expenses - SG&A expenses rose to $4.8 million in Q3 2024, compared to $4.5 million in Q3 2023, attributed to professional service expenses and costs associated with being a publicly traded company[4] - Total operating expenses increased to $23,801, up from $13,884 in the same quarter last year, reflecting a rise of 71.5%[11] Cash Position - As of September 30, 2024, Fractyl had approximately $84.7 million in cash and cash equivalents, sufficient to fund operations through key milestones into Q4 2025[4] Clinical Studies and Product Development - The REMAIN-1 pivotal study is progressing rapidly, with mid-point data analysis expected in Q2 2025 and open-label data from the REVEAL-1 cohort anticipated to begin in Q4 2024[1] - Fractyl plans to expand its operations in Germany in 2025, with Revita having received reimbursement authorization through the NUB pathway for T2D treatment[3] - The company presented compelling weight maintenance data at ObesityWeek 2024, highlighting the efficacy of the Revita and Rejuva platforms[2] - Fractyl's first smart GIP/GLP-1 pancreatic gene therapy candidate, RJVA-002, has been nominated for obesity treatment, utilizing a locally administered AAV9 viral vector[3] - The REVITALIZE-1 pivotal study is ongoing, with topline results expected in mid-2025, focusing on patients with adequately controlled T2D[3] Other Financial Metrics - Interest income for the three months was $947, significantly higher than $226 in the same quarter last year, an increase of 319.5%[11] - Total other income (expense), net, was $621, compared to a loss of $1,874 in the prior year, indicating a turnaround[11] - The change in fair value of warrant liabilities resulted in a gain of $2,293, compared to a loss of $1,027 in the prior year[11]

Core Insights - Fractyl Health, Inc. is advancing its pivotal studies on obesity and Type 2 Diabetes (T2D) treatments, with significant data expected in the coming quarters [1][2][3] Company Updates - The company reported compelling weight maintenance data from its Revita® and Rejuva® platforms at ObesityWeek® 2024 [1][3] - Enrollment for the REMAIN-1 pivotal study is progressing rapidly, with mid-point data analysis anticipated in Q2 2025 [1][5] - The REVEAL-1 open-label cohort data is expected to begin reporting in Q4 2024 [1][5] - Fractyl is finalizing in vivo studies for its RJVA-001 candidate aimed at T2D, with plans to initiate a first-in-human study in the first half of 2025 if the Clinical Trial Application (CTA) is approved [2][6] Financial Performance - For Q3 2024, Fractyl reported a net loss of $23.2 million, an increase from a net loss of $15.7 million in Q3 2023, primarily due to higher operating expenses [10][20] - Research and development expenses rose to $19.0 million in Q3 2024, compared to $9.4 million in the same period of 2023, reflecting progress in clinical studies [8][20] - The company had approximately $84.7 million in cash and cash equivalents as of September 30, 2024, sufficient to fund operations through key milestones into Q4 2025 [11][19] Upcoming Milestones - The REMAIN-1 study is a randomized, double-blind pivotal study evaluating Revita's efficacy in maintaining weight loss after GLP-1 therapy discontinuation, with topline results expected in mid-2025 [5][14] - The REVITALIZE-1 study is ongoing, targeting patients with T2D, with topline results anticipated in mid-2025 [5][14] - The company plans to disclose additional data from its German Real-World Registry Study in Q1 2025 [5][6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specified in its Charter) Del ...

BURLINGTON, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that it will present compelling weight maintenance data from both its Revita and Rejuva platforms at The Obesity Society’s Annual Meeting at ObesityWeek 2024, held from November 2-6, 2024, in San Antonio, Texas. Oral Presentation Title: Islet-Targeted GLP-1 R ...

Fractyl Health, Inc. (NASDAQ:GUTS) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Conference Call Participants Michael Ulz - Morgan Stanley Umer Raffat - Evercore Operator Good afternoon, and welcome to Fractyl Health's Second Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-onl ...

| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | Legal Disclaimer Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the size, potential, and promise of the market opportunity for treatments ...

Exhibit 99.1 Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates Updated clinical results from German Real-World Registry demonstrate potential for Revita® to meaningfully sustain weight loss and lower blood sugar for at least one-year post-treatment in a real-world setting Granted U.S. FDA Breakthrough Device designation for Revita in weight maintenance after discontinuation of GLP-1 based drugs REMAIN-1 pivotal study for Revita in weight maintenance now initiated wit ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specifie ...

Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that the U.S. Food and Drug Administ ...