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Bicara Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
BCAXBicara Therapeutics Inc.(BCAX) GlobeNewswire·2025-05-13 11:30

Core Insights - Bicara Therapeutics is advancing its clinical programs, particularly the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][4] - The company has a strong financial position with approximately 462millionincashandcashequivalents,expectedtofundoperationsintothefirsthalfof2029[1][11]−Updateddatafromongoingclinicaltrialswillbepresentedatthe2025ASCOAnnualMeeting,showcasingthepotentialofficerafuspalfatodemonstratedifferentiateddepthanddurabilityofresponse[2][7]ClinicalDevelopment−EnrollmentisongoingintheFORTIFI−HN01trial,whichisaglobal,randomized,double−blind,placebo−controlledstudyofficerafuspalfaincombinationwithpembrolizumabforfirst−linetreatmentofR/MHNSCC[4]−TheongoingPhase1/1btrialisexpectedtoprovideinsightsintothedrug′sefficacyandmechanismsofaction,withpreliminaryfindingsindicatingeffectiveTGF−βsignalingblockade[11][6]−Severalexpansioncohortsareevaluatingdifferentdosingregimensofficerafuspalfaincombinationwithpembrolizumabforvariouspatientpopulations,includingthosewithHPV−negativeandHPV−positivecancers[7][6]FinancialPerformance−Forthefirstquarterof2025,researchanddevelopmentexpensesincreasedto462 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] - Updated data from ongoing clinical trials will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa to demonstrate differentiated depth and durability of response [2][7] Clinical Development - Enrollment is ongoing in the FORTIFI-HN01 trial, which is a global, randomized, double-blind, placebo-controlled study of ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [4] - The ongoing Phase 1/1b trial is expected to provide insights into the drug's efficacy and mechanisms of action, with preliminary findings indicating effective TGF-β signaling blockade [11][6] - Several expansion cohorts are evaluating different dosing regimens of ficerafusp alfa in combination with pembrolizumab for various patient populations, including those with HPV-negative and HPV-positive cancers [7][6] Financial Performance - For the first quarter of 2025, research and development expenses increased to 34.3 million from 12.0millioninthesameperiodof2024,primarilyduetocostsassociatedwiththeinitiationofclinicaltrials[11][9]−Generalandadministrativeexpensesroseto12.0 million in the same period of 2024, primarily due to costs associated with the initiation of clinical trials [11][9] - General and administrative expenses rose to 7.5 million in Q1 2025 from 3.3millioninQ12024,reflectingincreasedpersonnelcostsandprofessionalfees[11][9]−Thenetlossforthefirstquarterof2025was3.3 million in Q1 2024, reflecting increased personnel costs and professional fees [11][9] - The net loss for the first quarter of 2025 was 36.8 million, compared to a net loss of $12.5 million in the first quarter of 2024 [11][9]