On March 8, 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 and year ended December 31, 2018 (Press release, Oncolytics Biotech, MAR 8, 2019, View Source [SID1234534139]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”With a growing number of large pharma collaborations, continued advancement with our registration program in metastatic breast cancer and recently announced biomarker data, we have made tremendous progress in a short period of time,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. ”In 2019 we expect to generate data that will allow us to finalize our registration program in breast cancer, while at the same time advancing studies in indications with prior evidence of clinical activity, as defined by an inflamed phenotype. With the global market for checkpoint inhibitors expected to reach $25 billion in 2022 and checkpoint inhibitors only able to treat approximately twenty percent of patients, the data demonstrating pelareorep’s ability to create an inflamed phenotype and boost PD-L1 expression makes it a potential backbone for this drug class. Furthermore, we believe pelareorep can potentially expand the utility of checkpoint inhibitors into additional indications and this work is already underway with Merck’s Keytruda in both multiple myeloma and pancreatic cancer, Bristol-Myers Squibb’s Opdivo in multiple myeloma and Roche’s Tecentriq in breast cancer.”

Selected highlights since January 1, 2018

Clinical & Scientific Updates

Received confirmation from the FDA and EMA that only a single phase 3 study is required for approval
Granted a Special Protocol Assessment (SPA) from the FDA
Advised to identify a biomarker prior to the final study design
Announced a Master Clinical Supply Agreement (MCSA) with F. Hoffmann-La Roche Ltd (Roche) to supply Tecentriq for use in the company’s clinical development program
Announced an abstract identifying a potentially predictive and prognostic biomarker to be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Entered into a clinical collaboration with SOLTI, a world-leading cooperative group specializing in breast cancer, to conduct our AWARE-1 window of opportunity breast cancer study, to confirm the utility of our recently identified biomarker
Marks the first use of our MCSA with Roche
Presented data highlighting increased expression of PD-L1 on multiple myeloma cells in patients treated with pelareorep at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, leading to our phase 1b combination study with Bristol-Myers Squibb’s Opdivo in multiple myeloma
Presented data suggesting efficacy signal in combination with PD-1 inhibitor at the Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper), leading to a phase 2 combination study with Merck’s Keytruda in second line pancreatic cancer
Presented data at the European Society for Medical Oncology 2018 Congress highlighting patients with KRAS mutant metastatic colorectal cancer who were treated with pelareorep and FOLFIRI/Bevacizumab had progression-free survival of 65.6 weeks and overall survival of 107.5 weeks, exceeding expectations when compared to analogous historical data
Initiated additional clinical collaborations:
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in pancreatic cancer
Pelareorep plus Bristol-Myers Squibb’s checkpoint inhibitor Opdivo in multiple myeloma
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in multiple myeloma
Announced a publication in Cancer Immunology Research demonstrating that intravenously administered pelareorep effectively targets tumors even in the presence of neutralizing antibodies
Corporate Updates

Announced the appointment of Dr. Rita Laeufle, M.D., Ph.D., as Chief Medical Officer
Dr. Laeufle brings more than 15 years of experience in oncology drug development, having previously served at Coherus Biosciences, Clovis Oncology, Roche, Genentech and Novartis
Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY"
Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million
Announced a USD $30.0 million At-the-Market facility with Canaccord Genuity LLC
Entered into a common stock purchase agreement for up to USD $26.0 million with Lincoln Park Capital Fund, LLC
Anticipated Milestones

Initiate AWARE-1 in the coming weeks
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1 data is available
* Guidance provided by principal investigator

Financial

At December 31, 2018, the company reported $13.7 million in cash and cash equivalents
As at March 7, 2019, the company had an unlimited number of authorized common shares with 18,840,010 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,569,326 options and share units
Operating expense for the fourth quarter of 2018 was $2.4 million and $7.2 million for the year 2018, compared to $2.2 million in the fourth quarter 2017 and $6.2 million for the year 2017
R&D expense for the fourth quarter of 2018 was $2.5 million and $9.4 million for the year 2018, compared to $2.5 million in the fourth quarter 2017 and $9.4 million for the year 2017
The net loss for the fourth quarter of 2018 was $4.8 million and $17.0 million for the year 2018, compared to $4.7 million in the fourth quarter 2017 and $15.6 million for the year 2017, which equates to a loss of $1.06 per share in 2018 compared to a net loss of $1.12 per share in 2017, on a consolidated basis
Webcast and Conference Call

Management will host a conference call for Analysts and Institutional Investors at 8:30 a.m. ET, today, Friday, March 8, 2019. The live call may be accessed by dialing (877) 407-9205 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months. A replay of the call will be available approximately two hours after the call has ended at (877) 481-4010, using the replay code 44902 and will remain available for one week.

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.