On November 8, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported its financial results and operational highlights for the quarter ended September 30, 2017 (Press release, Oncolytics Biotech, NOV 8, 2017, View Source [SID1234521802]).

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"Towards the end of the third quarter we made a very important announcement regarding feedback from the FDA following our End-of-Phase 2 meeting. The favorable meeting resulted in the support of our proposed target patient population of hormone receptor positive, HER2 receptor negative metastatic breast cancer patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "With this support and guidance outlining a single, four hundred patient study, we have prepared to file for breakthrough designation which we expect to do very soon, prepared for communications with the European regulators, conducted preliminary preparations to file for a special protocol assessment, or SPA, and advanced our business development activities. We expect to be able to announce the results of these filings and communications with the European regulators over the next several months as we continue to prepare the company to relist its shares on NASDAQ in 2018."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

· Announced a favorable End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients. The agency’s guidance proposed a single, 400 patient registration study to support a future Biologics License Application submission in the U.S.
· Presented mBC data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, that demonstrated a doubling of overall survival benefit for patients with HR double-positive, HER2-negative breast cancer – a major genetic subgroup – when treated with REOLYSIN/paclitaxel combination treatment versus paclitaxel alone.
· Announced the first patient treated in our phase 1b MUK Eleven collaborative study with Myeloma UK and Celgene, studying REOLYSIN in combination with Celgene immunomodulatory drugs (IMiDs), Revlimid or Imnovid as a rescue treatment in relapsing myeloma patients.
· Presented the largest ever safety database for an oncolytic virus at the ESMO (Free ESMO Whitepaper) 2017 Congress, that demonstrated REOLYSIN is safe and well tolerated when administered in combination with chemotherapy.
Corporate Updates

· Appointed Deborah Brown to the Board of Directors, to expand the Board’s experience with product launches, market expansion, regulatory affairs, research and development and business development.
Anticipated Milestones

• First quarter 2018: Results from regulatory filings
• First half of 2018: Update on our exploration of strategic and regional alliances
NASDAQ
Preliminary MUK eleven data
• Mid-2018: Initiate phase 3 registration study in mBC
Q3 2017 Financial Results

· At September 30, 2017, the Company reported $14.0 million in cash and cash equivalents. Cash runway expected to the end of 2018.
· As at November 7, 2017, the Company had an unlimited number of authorized common shares with 140,700,722 common shares issued and outstanding, 7,448,327 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,428,039 RSU’s and PSU’s outstanding.