Oncolytics Biotech (ONCY) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2019, the company reported cash and cash equivalents of C$14.1 million, which is expected to fund continued operations [45] - The reported net loss for 2019 was C$33 million, including a non-cash charge of C$12.6 million, resulting in a loss of C$1.50 per share compared to C$1.6 per share in 2018 [47] - Research and development expenses increased to C$11 million in 2019 from C$9.4 million in 2018, with fourth-quarter R&D expenses at C$2.8 million compared to C$2.5 million in 2018 [49] - Operating costs increased to C$9.6 million for the full year 2019 from C$7.2 million in 2018, with fourth-quarter operating costs at C$4.1 million compared to C$2.4 million in 2018 [50] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical studies, including AWARE-1 and BRACELET-1, targeting breast cancer, pancreatic cancer, and multiple myeloma [30][31] - AWARE-1 is investigating pelareorep in combination with Roche's Tecentriq, while BRACELET-1 is focused on the combination with Pfizer's Bavencio for HR+/HER2- metastatic breast cancer [23][30] - The pancreatic adenocarcinoma study is progressing well, with interim data expected at ASCO in June 2020 [31] Market Data and Key Metrics Changes - The market opportunity for HR+/HER2- metastatic breast cancer is estimated at C$2 billion, with a potential additional market of C$500 million to C$1 billion for triple-negative breast cancer [9][20] - The checkpoint inhibition market is valued at C$56 billion, reflecting significant interest from large pharmaceutical companies [12] Company Strategy and Development Direction - The company aims to advance its breast cancer program into a Phase 3 registrational study while exploring additional opportunities in gastrointestinal indications [56] - The strategy includes leveraging partnerships with major pharmaceutical companies to enhance clinical development and market reach [54] - The focus remains on combining pelareorep with immunotherapy and targeting oncology treatments where there is an unmet need [57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the value creation potential in the biotech market, citing recent acquisitions and increased valuations in the sector [43] - The company is positioned to capture value from upcoming catalysts, with a strong financial position extending its runway into mid-2021 [52][58] - Management highlighted the importance of ongoing collaborations with major pharmaceutical companies to validate clinical results and enhance market opportunities [54][56] Other Important Information - The company welcomed Leonard Kruimer to its Board of Directors, bringing over 30 years of experience in corporate finance and strategy [41] - The company has raised over C$16 million through the exercise of warrants and effective use of its ATM facility, enhancing its financial stability [51] Q&A Session Summary Question: When will the decision on Phase III be made based on AWARE-1 data? - Management indicated that AWARE-1 will help start discussions with the FDA regarding the biomarker, while BRACELET-1 is crucial for validating the biomarker in the intended patient population [60] Question: What can be expected from the interim biomarker data for AWARE-1? - The interim data will include correlations between T cell clonality and tumor inflammation, along with cytokine responses within the tumor mass [65] Question: What focus will be on the NCI-9603 study in multiple myeloma? - The focus will be on both biomarker and efficacy data, with expectations of rapid responses in patients who have failed previous treatments [68] Question: What percentage of patients are expected to show expanded T cell clonality? - It is anticipated that about 80% of patients will have adequate immunological reserve for eligibility, with 70% to 80% showing a strong vaccination effect [73] Question: What other companies are interested in collaborations? - There is interest from CAR-T companies and other oncology firms looking to explore combinations with pelareorep, particularly in enhancing T cell responses [78]