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Fractyl Health(GUTS) - 2024 Q4 - Annual Results
GUTSFractyl Health(GUTS)2025-03-03 21:05

Financial Performance - Fractyl Health reported a net loss of 25.0millionforQ42024,comparedtoanetlossof25.0 million for Q4 2024, compared to a net loss of 19.2 million in Q4 2023, reflecting a 12.2millionincreaseinoperatingexpenses[12].−RevenueforthethreemonthsendedDecember31,2024,was12.2 million increase in operating expenses[12]. - Revenue for the three months ended December 31, 2024, was 3 million, a decrease from 7millioninthesameperiodof2023,whiletotalrevenueforthetwelvemonthsendedDecember31,2024,was7 million in the same period of 2023, while total revenue for the twelve months ended December 31, 2024, was 93 million compared to 120millionin2023[24].−GrossprofitforthethreemonthsendedDecember31,2024,was120 million in 2023[24]. - Gross profit for the three months ended December 31, 2024, was 3 million, down from 5millioninthesameperiodof2023,withatotalgrossprofitof5 million in the same period of 2023, with a total gross profit of 43 million for the twelve months ended December 31, 2024, unchanged from 2023[24]. - The net loss attributable to common stockholders for the three months ended December 31, 2024, was 24.97million,comparedtoalossof24.97 million, compared to a loss of 23.51 million in the same period of 2023, with a total net loss of 70.43millionforthetwelvemonthsendedDecember31,2024,downfrom70.43 million for the twelve months ended December 31, 2024, down from 94.27 million in 2023[24]. - The net loss per share attributable to common stockholders for the three months ended December 31, 2024, was (0.52),comparedto(0.52), compared to (11.18) in the same period of 2023, with a total net loss per share of (1.62)forthetwelvemonthsendedDecember31,2024,downfrom(1.62) for the twelve months ended December 31, 2024, down from (45.29) in 2023[24]. Operating Expenses - Total operating expenses for the three months ended December 31, 2024, increased to 25.2millionfrom25.2 million from 13 million in the same period of 2023, with total operating expenses for the twelve months reaching 93.6millioncomparedto93.6 million compared to 50.9 million in 2023[24]. - Research and development expenses for Q4 2024 were 20.3million,upfrom20.3 million, up from 10.1 million in Q4 2023, primarily due to advancements in the REMAIN-1 clinical study[10]. - Selling, general and administrative expenses increased to 4.9millioninQ42024from4.9 million in Q4 2024 from 2.8 million in Q4 2023, attributed to higher costs associated with being a publicly traded company[11]. - Research and development expenses for the three months ended December 31, 2024, were 20.28million,significantlyhigherthan20.28 million, significantly higher than 10.17 million in the same period of 2023, with total R&D expenses for the twelve months reaching 70.47millioncomparedto70.47 million compared to 38.04 million in 2023[24]. - Selling, general and administrative expenses for the three months ended December 31, 2024, were 4.93million,upfrom4.93 million, up from 2.82 million in the same period of 2023, with total SG&A expenses for the twelve months at 23.1millioncomparedto23.1 million compared to 12.84 million in 2023[24]. Assets and Liabilities - Total assets increased to 108.1millionasofDecember31,2024,comparedto108.1 million as of December 31, 2024, compared to 76.2 million in 2023, while total liabilities decreased to 79.7millionfrom79.7 million from 113.9 million[22]. - As of December 31, 2024, Fractyl had approximately 67.5millionincashandcashequivalents,sufficienttofundoperationsthroughkeyclinicalmilestonesinto2026[13].ClinicalDevelopments−TheREMAIN−1pivotalstudyhasenrolledover189patientsacross13clinicalsiteswithinsixmonthsofinitiation,indicatingstrongdemandforweightmaintenancesolutionspost−GLP−1therapy[4].−ThecompanyplanstosubmitthefirstClinicalTrialApplication(CTA)moduleforRJVA−001intype2diabetesinH12025,withpreliminarydataexpectedin2026ifauthorized[7].−AmidpointdataanalysisfortheREMAIN−1studyisanticipatedinQ22025,withfullenrollmentexpectedbysummer2025[5].−Fractyl′sstrategicfocushasshiftedtoprioritizetheREMAIN−1studyandtheRejuvagenetherapyplatform,pausinginvestmentsinotherRevitaprogramsfortype2diabetes[8].OtherFinancialMetrics−InterestincomeforthethreemonthsendedDecember31,2024,was67.5 million in cash and cash equivalents, sufficient to fund operations through key clinical milestones into 2026[13]. Clinical Developments - The REMAIN-1 pivotal study has enrolled over 189 patients across 13 clinical sites within six months of initiation, indicating strong demand for weight maintenance solutions post-GLP-1 therapy[4]. - The company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes in H1 2025, with preliminary data expected in 2026 if authorized[7]. - A midpoint data analysis for the REMAIN-1 study is anticipated in Q2 2025, with full enrollment expected by summer 2025[5]. - Fractyl's strategic focus has shifted to prioritize the REMAIN-1 study and the Rejuva gene therapy platform, pausing investments in other Revita programs for type 2 diabetes[8]. Other Financial Metrics - Interest income for the three months ended December 31, 2024, was 726,000, an increase from 463,000inthesameperiodof2023,withtotalinterestincomeforthetwelvemonthsat463,000 in the same period of 2023, with total interest income for the twelve months at 4.15 million compared to 1.26millionin2023[24].−Thechangeinfairvalueofwarrantliabilitiesresultedinagainof1.26 million in 2023[24]. - The change in fair value of warrant liabilities resulted in a gain of 466,000 for the three months ended December 31, 2024, compared to a loss of 5.63millioninthesameperiodof2023,withatotalgainof5.63 million in the same period of 2023, with a total gain of 17.91 million for the twelve months compared to a loss of $6.79 million in 2023[24]. - The weighted-average number of common shares outstanding for the three months ended December 31, 2024, was 48,445,979, compared to 2,102,410 in the same period of 2023, with a total of 43,541,527 shares for the twelve months compared to 2,081,328 in 2023[24].