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Oncolytics Biotech (ONCY) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported cash and cash equivalents of 15.9million[38]Netcashusedinoperatingactivitiesfor2024totaled15.9 million [38] - Net cash used in operating activities for 2024 totaled 27 million, a slight decrease from 28.4millionin2023[39]ThenetlossforQ42024was28.4 million in 2023 [39] - The net loss for Q4 2024 was 8 million, compared to a net loss of 3.9millioninQ42023,withabasicanddilutedlosspershareof3.9 million in Q4 2023, with a basic and diluted loss per share of 0.10 [41] Business Line Data and Key Metrics Changes - The BRACELET-1 study in breast cancer exceeded expectations, showing a statistically significant near doubling of median overall survival in the IND-213 study [11][20] - In the goblet study, a 33% objective response rate was reported for relapsed anal cancer patients treated with PELA and atezolizumab [15] Market Data and Key Metrics Changes - The company estimates that approximately 55,000 breast cancer patients in the U.S. could benefit from pelareorep, with a potential market of 2.4billioninannualsalesby2033[13][29]CompanyStrategyandDevelopmentDirectionThecompanyisfocusedonadvancingpelareorepforcancerpatients,particularlyinHRpositiveHER2negativemetastaticbreastcancer,andisplanningalargePhase2studytosupportacceleratedapproval[22]ThecompanyisactivelyseekinganewCEOtoleadtheadvancementofpelareorep[10]ManagementsCommentsonOperatingEnvironmentandFutureOutlookManagementexpressedconfidenceinthepotentialofpelareoreptoimprovepatientoutcomes,particularlyindifficulttotreatcancers[42]Thecompanyisoptimisticabouttheongoingbusinessdevelopmentconversationsandtheinterestfrompotentialbiopharmapartners[25][32]OtherImportantInformationThecompanyhasreceiveda2.4 billion in annual sales by 2033 [13][29] Company Strategy and Development Direction - The company is focused on advancing pelareorep for cancer patients, particularly in HR-positive HER2-negative metastatic breast cancer, and is planning a large Phase 2 study to support accelerated approval [22] - The company is actively seeking a new CEO to lead the advancement of pelareorep [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pelareorep to improve patient outcomes, particularly in difficult-to-treat cancers [42] - The company is optimistic about the ongoing business development conversations and the interest from potential biopharma partners [25][32] Other Important Information - The company has received a 5 million grant from the Pancreatic Cancer Action Network to fund the goblet cohort five study [20][34] - The company is in discussions with regulators regarding the design of a registration-enabling breast cancer study [30] Q&A Session Summary Question: What are the total costs and timing for the registration-enabling study in metastatic breast cancer? - The company is finalizing the protocol and expects to begin enrollment in the latter half of the year, with an 18-month enrollment period and a six-month data maturity for PFS readout [48][50] Question: Is there a renaissance in the oncolytic virus space? - Management noted increased interest in the oncolytic virus field, with more discussions with potential partners and investors [56][60] Question: What is the commercial positioning of PELA given the success of ADCs? - The company aims to target patients who progress on ADC therapy, which represents a significant market opportunity [72][78]