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,comparedto36,000 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,downfrom11,000 in the prior year, a decrease of 36.4%[11] - Net loss for Q3 2024 was 23.2million,anincreasefromanetlossof15.7 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,comparedtoanetlossof15,747 in the same period last year, an increase of 47.5%[11] - The company reported a total net loss and comprehensive loss of 43,724fortheninemonthsendedSeptember30,2023,comparedto57,911 for the same period in 2022, a decrease of 24.6%[11] Research and Development (R&D) Expenses - R&D expenses increased to 19.0millioninQ32024,upfrom9.4 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,comparedto9,382 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,upfrom27,872 in the previous year, an increase of 80.0%[11] Operating Expenses - SG&A expenses rose to 4.8millioninQ32024,comparedto4.5 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,upfrom13,884 in the same quarter last year, reflecting a rise of 71.5%[11] Cash Position - As of September 30, 2024, Fractyl had approximately 84.7millionincashandcashequivalents,sufficienttofundoperationsthroughkeymilestonesintoQ42025[4]ClinicalStudiesandProductDevelopment−TheREMAIN−1pivotalstudyisprogressingrapidly,withmid−pointdataanalysisexpectedinQ22025andopen−labeldatafromtheREVEAL−1cohortanticipatedtobegininQ42024[1]−FractylplanstoexpanditsoperationsinGermanyin2025,withRevitahavingreceivedreimbursementauthorizationthroughtheNUBpathwayforT2Dtreatment[3]−ThecompanypresentedcompellingweightmaintenancedataatObesityWeek2024,highlightingtheefficacyoftheRevitaandRejuvaplatforms[2]−Fractyl′sfirstsmartGIP/GLP−1pancreaticgenetherapycandidate,RJVA−002,hasbeennominatedforobesitytreatment,utilizingalocallyadministeredAAV9viralvector[3]−TheREVITALIZE−1pivotalstudyisongoing,withtoplineresultsexpectedinmid−2025,focusingonpatientswithadequatelycontrolledT2D[3]OtherFinancialMetrics−Interestincomeforthethreemonthswas947, significantly higher than 226inthesamequarterlastyear,anincreaseof319.5621, compared to a loss of 1,874intheprioryear,indicatingaturnaround[11]−Thechangeinfairvalueofwarrantliabilitiesresultedinagainof2,293, compared to a loss of $1,027 in the prior year[11]
