The Active Cancer Immunotherapy OBI-822, has been granted by COFEPRIS of Mexico to proceed to Phase III Human Clinical Study

1.Date of occurrence of the event: 2021/12/03

2.New drug name or code: Active cancer immunotherapy OBI-822 (Adagloxad Simolenin)

3.Indication: 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.

4.Planned development stages: Phase III clinical trial and New Drug Application (NDA)

5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): Approval
(2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable
(3)After obtaining official approval or the results of statistically significant sense, the future strategy: Phase III human clinical trial in progress.
(4)Accumulated investment expenditure incurred: As the information is involved in future negotiation of licensing deals, to avoid influence on licensing deals and for best interest of shareholders, it will be kept confidential temporary.

6.Upcoming development plan:
(1)Estimated date of completion: Expected to perform interim analysis in 2023, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline.
(2)Estimated responsibilities: Phase III clinical trial already started. Milestone payment of US$1,000,000 to Optimer will be initiated.

7.Market situation: According to public research report of Fortune Business Insights, the global oncology drugs market size was valued at USD141.3billion in 2019 with 11.6 % of compound annual growth rate (CAGR). While OBI-822 is still in the phase of clinical trial, its indications will be targeted at the unmet medical needs where meaningful clinical benefit is observed. The future development will be determined after comprehensive consideration of product development strategy.

8.Any other matters that need to be specified: None

9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.