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CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates
CGONCG Oncology(CGON) Newsfilter·2025-03-28 11:00

Core Insights - CG Oncology, Inc. reported significant advancements in the fourth quarter of 2024, including topline data from the Phase 3 BOND-003 trial and a successful equity offering to support clinical development and commercial readiness [2][6] - The company anticipates further data readouts from the BOND-003 trial and plans to initiate a Biologics License Application (BLA) submission in the second half of 2025 [2][12] Corporate Highlights - Cretostimogene monotherapy showed a 74.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients [7] - The company completed an oversubscribed public equity offering, raising 238million,extendingitsfinancialrunwayintothefirsthalfof2028[6][12]−NewtranslationaldatapresentedattheEAUCongressindicatedthatcretostimogenelevelspeakedimmediatelyafterinstillationandremainedlocallyeffectivefor4−5days[4]AnticipatedMilestones−FinaldatafromtheBOND−003trialisexpectedtobepresentedatthe120thAmericanUrologicalAssociationAnnualMeeting[12]−ToplinedatafromtheCORE−008trialisanticipatedinthesecondhalfof2025[12]−ThecompanyinitiatedtheCORE−008clinicaltrialforcretostimogeneinhigh−riskNMIBC,expandingintoBCG−exposedpopulations[7][12]FinancialHighlights−CashandcashequivalentsasofDecember31,2024,were238 million, extending its financial runway into the first half of 2028 [6][12] - New translational data presented at the EAU Congress indicated that cretostimogene levels peaked immediately after instillation and remained locally effective for 4-5 days [4] Anticipated Milestones - Final data from the BOND-003 trial is expected to be presented at the 120th American Urological Association Annual Meeting [12] - Topline data from the CORE-008 trial is anticipated in the second half of 2025 [12] - The company initiated the CORE-008 clinical trial for cretostimogene in high-risk NMIBC, expanding into BCG-exposed populations [7][12] Financial Highlights - Cash and cash equivalents as of December 31, 2024, were 742.0 million, up from 540.7millionasofSeptember30,2024[12]−ResearchanddevelopmentexpensesforQ42024were540.7 million as of September 30, 2024 [12] - Research and development expenses for Q4 2024 were 26.8 million, compared to 16.3millionintheprioryear[12]−ThenetlossattributabletocommonstockholdersforQ42024was16.3 million in the prior year [12] - The net loss attributable to common stockholders for Q4 2024 was 31.8 million, or (0.46)pershare,comparedtoanetlossof0.46) per share, compared to a net loss of 22.5 million, or ($4.36) per share, in the prior year [12][16]