
Financial Data and Key Metrics Changes - As of September 30, 2019, the company reported cash and cash equivalents of $12.3 million, which includes gross proceeds of $3.7 million from a public offering, strengthening its financial position [56] - The net loss for Q3 2019 was $3.5 million, compared to $3.3 million in Q3 2018, equating to a loss of $0.16 per share in 2019 versus a loss of $0.20 per share in 2018 [57] - Research and development expenses for Q3 2019 were $1.6 million, down from $1.9 million in Q3 2018, focusing on ongoing clinical studies [58] Business Line Data and Key Metrics Changes - The company is advancing its lead program, pelareorep, in metastatic breast cancer, conducting two key clinical studies, AWARE-1 and BRACELET-1, which are expected to provide data supporting the Phase 3 registration program [8][9] - AWARE-1 is ongoing, with additional data expected before the end of the year, while BRACELET-1 is set to begin enrolling patients in Q1 2020 [10][21] Market Data and Key Metrics Changes - The company is seeing renewed interest from large pharmaceutical companies in oncolytic viruses, with recent deals executed by major players like Merck and BMS [41] - The systemic effect of pelareorep allows it to impact metastatic disease, a critical aspect that IV-administered oncolytic viruses have yet to prove [45] Company Strategy and Development Direction - The company aims to expand its pipeline to access additional markets with unmet needs and explore combination therapies with checkpoint inhibitors and other oncology drug classes [65] - The focus remains on demonstrating the potential synergies of pelareorep with various checkpoint inhibitors and CDK 4/6 inhibitors, which are among the fastest-growing drug classes in oncology [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique position of pelareorep within the oncolytic virus space, highlighting its ability to demonstrate efficient viral replication following systemic delivery [63] - The company anticipates a rich period of data catalysts over the next 21 months, with multiple upcoming milestones expected to enhance shareholder value [66] Other Important Information - The company announced the addition of Leonard Kruimer to its Board of Directors, bringing over 30 years of experience in corporate finance and strategy [40] - The company has seen a significant increase in its share price, which has more than doubled in the last month, leading to the exercise of warrants and additional funding [60] Q&A Session Summary Question: Additional data for AWARE-1 by the end of the year - Management confirmed that additional data from the AWARE-1 study is expected in December, focusing on T cell characterization and inflammatory cell counts [75] Question: Clarification on SITC presentation regarding biopsy timing - Management clarified that biopsies were taken before the administration of Tecentriq, confirming the virus's ability to stimulate T cell expansion [77] Question: Impact of biomarker on patient enrollment - Management indicated that the biomarker will not critically limit patient enrollment, with an anticipated screen failure of no more than one in eight [88] Question: Potential path to market for multiple myeloma program - Management discussed ongoing studies combining pelareorep with proteasome inhibitors, noting impressive responses in early trials [90] Question: Resource use going forward - Management stated that partnerships with major pharmaceutical companies have allowed for a cost-effective strategy, maintaining steady operational costs [93]