RE:RE:RE:RE:MBC phase 3November 16, 2017 - Oncolytics Biotech® Inc. and Adlai Nortye Enter into USD $86.6 Million Regional Licensing Agreement for REOLYSIN® Terms of The Agreement
Oncolytics will receive an upfront licensing fee and milestone payments to support the phase 3 registration study in metastatic breast cancer (mBC) of USD $21.2 million, and is eligible to receive up to an additional USD $65.4 million upon achievement of clinical, regulatory and commercialization milestones. Oncolytics is also eligible to receive double digit royalty payments associated with the commercialization of REOLYSIN® for all indications, subject to regulatory approval. Included in the USD $21.2 million:
- Upfront payments of USD $5.3 million
- Two milestone payments totalling USD $8 million made up of two common share purchase warrants:
- One common share purchase warrant of USD $2 million whereby, upon exercise, Adlai may purchase Oncolytics' common shares priced at a 120% premium of the five-day weighted average closing price immediately preceding the exercise date. Oncolytics has the right to call this warrant when the first patient is enrolled in the phase 3 mBC study or six months after execution of The Agreement, whichever is later.
- One common share purchase warrant of USD $6 million whereby, upon exercise, Adlai may purchase Oncolytics' common shares priced at a 120% premium of the five-day weighted average closing price immediately preceding the exercise date. Oncolytics has the right to call this warrant upon the enrollment of the 50th patient in the phase 3 mBC study.
- USD $7.9 million based on certain regulatory advancements.
Oncolytics recently had a favorable End-of-Phase 2 Meeting with the United States Food and Drug Administration that outlined a single, 400-patient phase 3 study focused on HR+/HER2- patients. The Company expects to have formal guidance back from the European Medicines Agency (EMA) before the end of the year and to begin enrolling patients in its phase 3 study in mid-2018.
https://www.oncolyticsbiotech.com/press-releases/detail/389/oncolytics-biotech-inc-and-adlai-nortye-enter-into-usd