On November 7, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the third quarter ended September 30, 2022 (Press release, Oncolytics Biotech, NOV 7, 2022, View Source [SID1234623267]). All dollar amounts are expressed in Canadian currency unless otherwise noted.
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"Our continued progress in breast cancer and the highly-promising pancreatic cancer data we reported earlier today have pelareorep moving confidently towards pivotal trials in both of these indications for which new treatment options are needed," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "In breast cancer, we remain on track to report an expansive dataset from our randomized BRACELET-1 trial in the first half of next year. This phase 2 trial was carefully designed to validate the statistically significant survival benefit provided by pelareorep in a prior phase 2 study, and its results are expected to inform the optimal design of a subsequent registrational trial. In pancreatic cancer, we plan to discuss our new data with regulators to enable the program’s expeditious advancement into a pivotal study. With these core programs each representing a potential registration opportunity and distinct avenue for value creation, we believe we are entering a new phase in Oncolytics’ evolution."
Third Quarter and Subsequent Highlights
Pancreatic Cancer Program
Reported interim data showing a 70% ORR in phase 1/2 GOBLET trial’s pancreatic cancer cohort
An abstract published as part of the SITC (Free SITC Whitepaper) Meeting, and highlighted in a separate press release issued earlier today, features data from the phase 1/2 GOBLET trial’s cohort in first-line advanced/metastatic pancreatic ductal adenocarcinoma, one of the most difficult-to-treat human cancers. As of the abstract’s data cutoff date (July 28, 2022), seven of ten evaluable patients had achieved a partial response following treatment with pelareorep in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. An additional two patients achieved stable disease, leading to an ORR and clinical benefit rate of 70% and 90%, respectively. The 70% ORR reported as of the cutoff date is nearly triple the average ORR of approximately 25% reported in historical control trials evaluating the combination of gemcitabine and nab-paclitaxel in pancreatic cancer1-4. Together with data from prior clinical studies, these results suggest pelareorep synergizes with checkpoint inhibition and chemotherapy in pancreatic cancer and support Oncolytics’ plan to advance into a registrational pancreatic cancer study pending discussions with regulatory authorities.
Breast Cancer Program
New AWARE-1 data further demonstrate pelareorep’s immune-mediated mechanism of action
An abstract published earlier today as part of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting features new data on the twenty HR+/HER2- breast cancer patients comprising the first two cohorts of the AWARE-1 study. Patients in these cohorts were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab. Flow cytometry analyses of blood samples from these patients showed a statistically significant increase in anti-cancer NK cells on day 21 post-treatment in cohort 2 compared to cohort 1. In addition, cohort 2 patients showed higher levels of HLA-DR expression (a marker of T cell activation) in anti-cancer CD8+ T cells, and better maintained low levels of T cell exhaustion markers on day 21 compared to cohort 1 patients. Together with prior clinical data, these results further demonstrate pelareorep’s immunologic mechanism of action and its potential to synergistically combine with a variety of drug classes.
Corporate Updates
Elected Jonathan Rigby to the Board of Directors
Mr. Rigby has over thirty years of pharmaceutical and biotechnology industry experience. He is currently the Group Chief Executive Officer of Revolo Biotherapeutics and previously co-founded Zogenix, Inc., a CNS-focused specialty pharmaceutical company that was acquired by UCB earlier this year in a transaction valued at up to approximately U.S. $1.9 billion.
Financial Highlights
As of September 30, 2022, the Company reported $32.4 million in cash and cash equivalents.
General and administrative expenses for the third quarter of 2022 were $2.4 million, compared to $2.9 million for the third quarter of 2021.
Research and development expenses for the third quarter of 2022 were $3.7 million, compared to $3.3 million for the third quarter of 2021.
The net loss for the third quarter of 2022 was $4.4 million, compared to a net loss of $4.9 million in the third quarter of 2021. The basic and diluted loss per share was $0.08 in the third quarter of 2022, compared to a basic and diluted loss per share of $0.09 in the third quarter of 2021.
Net cash used in operating activities for the nine months ended September 30, 2022 was $17.4 million, compared to $16.1 million for the nine months ended September 30, 2021.
Anticipated Milestones and Catalysts
Final AWARE-1 study data: Q4 2022
Clinical data from Adlai Nortye’s bridging trial in HR+/HER2- metastatic breast cancer patients: Q4 2022
Overall response rate, progression-free survival, and evolving overall survival data from phase 2 BRACELET-1 metastatic breast cancer study: H1 2023
Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 8:30 a.m. ET today, November 7, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.