On May 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended March 31, 2019 (Press release, Oncolytics Biotech, MAY 3, 2019, View Source [SID1234535703]). All dollar amounts are expressed in Canadian currency unless otherwise noted.
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”Our primary focus remains the breast cancer program and the timely completion of our AWARE-1 study of pelareorep in combination with the immune checkpoint inhibitor Tecentriq. We remain on track to report interim data in the second half of this year,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. ”We expect the results of this important study to confirm the clinical utility of using T cell clonality as a biomarker for patient response to pelareorep, as well as pelareorep’s ability to prime the immune system to recognize cancer cells and enhance the potential efficacy of checkpoint inhibitors. This data will assist in the final design of our registrational study of pelareorep as a treatment for metastatic breast cancer and serve to confirm the broader utility of this biomarker, currently established in pancreatic cancer and multiple myeloma, across multiple cancer types.”
Selected highlights since January 1, 2019
Clinical & Scientific Updates
Announced the identification of T cell clonality as a potentially predictive and prognostic biomarker of pelareorep therapy in a poster presentation delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 annual meeting
Treated the first patient in the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Published data in the journal Blood Advances highlighting the synergistic effect of pelareorep in combination with proteasome inhibitor bortezomib for the treatment of multiple myeloma
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Chief of Oncology at Asklepios Klinik Altona
Anticipated Milestones
Publish and present findings at leading U.S. and European oncology conferences including ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and ASH (Free ASH Whitepaper)
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Expect to report interim data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1
* Guidance provided by principal investigator
Financial
At March 31, 2019, the company reported $14.2 million in cash and cash equivalents
As at May 2, 2019, the company had an unlimited number of authorized common shares with 20,298,482 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,567,510 options and share units
Operating expense for the first quarter of 2019 was $1.8 million compared to $1.8 million in the first quarter 2018
Research and development expense for the first quarter of 2019 was $3.2 million compared to $2.9 million in the first quarter 2018
The net loss for the first quarter of 2019 was $4.9 million compared to $4.7 million in the first quarter 2018, which equates to a loss of $0.27 per share in 2019 compared to a net loss of $0.31 per share in 2018, on a consolidated basis
About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.