1. Date of occurrence of the event: Mar 17, 2021
2. Company name: OBI Pharma Inc.
3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head Office
4. Reciprocal shareholding ratios: No applicable
5. Cause of occurrence: OBI filed the application to EMA for Phase III human clinical study of the active cancer immunotherapy OBI-822, Adagloxad Simolenin, in Spain, German, and Poland.
6. Countermeasures: None
7. Any other matters that need to be specified:
(1) Name of the new drug: active cancer immunotherapy OBI-822 (Adagloxad Simolenin)
(2) Uses: OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
(3) Planned development: Phase III clinical study, new drug registration approval
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Filed application to EMA for Phase III human clinical study in Spain, German, and Poland.
B. Risk and countermeasures for denied applications: Not applicable
C. Outlook for granted applications: No applicable
D. Total invested capital: To be kept confidential to avoid complications in future negotiation of licensing deals, and as for the best interest of shareholders.
(5) Next phase of development:
A. Next phase of development: expected to evaluate primary endpoint in 2025, the actual schedule will be adjusted according to the timeline.
B. Expected obligation: Phase III clinical trial has already started. Milestone royalty of US$1,000,000 to Optimer will be initiated.
(6) Current market: According to public research report of Fortune Business Insights, the global market for anti-tumor drugs is about US$141.3 billion in 2019 with 11.6 % of compound annual growth rate. (CAGR) OBI-822 is still in clinical development; its indications will be evaluated based on unmet medical needs, product opportunities, and company portfolio.
(7) New drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.