
Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported cash and cash equivalents of $15.9 million [38] - Net cash used in operating activities for 2024 totaled $27 million, a decrease from $28.4 million in 2023 [39] - The net loss for Q4 2024 was $8 million, compared to a net loss of $3.9 million in Q4 2023 [41] - For the full year 2024, net loss totaled $31.7 million, up from $27.8 million in 2023 [41] Business Line Data and Key Metrics Changes - The BRACELET-1 study in breast cancer exceeded expectations, showing a clinically meaningful benefit for patients treated with PELA-based combination therapy compared to chemotherapy alone [11][21] - In the goblet study, a 33% objective response rate was reported in relapsed anal cancer patients [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 [13][29] - The potential market for pelareorep in breast cancer is projected to reach $2.4 billion in annual sales across the U.S. and major European markets by 2033 [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 [11] - Plans are in place to initiate a large Phase 2 study of approximately 180 patients to support an accelerated approval submission [22] 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 actively seeking a new CEO to lead the advancement of pelareorep [10] Other Important Information - The company is collaborating with GCAR and PanCAN for ongoing studies in gastrointestinal cancers, with a $5 million grant from PanCAN for the goblet cohort [33][35] Q&A Session Questions and Answers 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 [50] Question: Is there a renaissance in the oncolytic virus space? - Management noted increased interest from pharma and investors in the oncolytic virus space, which is beneficial for the company [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 population that will need alternative treatment options [72]