1.Date of occurrence of the event:2022/07/04
2.Company name:OBI Pharma Inc.
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):Head office
4.Reciprocal shareholding ratios:Not applicable
5.Name of the reporting media:2022/7/4 TechNews and InfoTimes, etc.
6.Content of the report:
“OBI announces discontinuation of the Phase II Study of OBI-888……
However, the discontinuation leads to the concerns regarding therapeutic effect of new drugs targeting Globo H…… ”
7.Cause of occurrence:Supplementary explanation on news article
(1)Please refer to the Company’s material information announcement on 2022/7/1. The yield rate drops under mass production, which makes the manufacturing costs increase dramatically. If the Company continues enrollment, or even Phase III clinical study, expensive production costs in addition to development costs and revenue after the new drug releases will make the price unbearable for patients, which decrease the market value substantially.
(2)OBI has three more new drugs targeting Globo H, including Active Cancer Immunotherapy, OBI-822, OBI-833, and Antibody Drug Conjugate, OBI-999. The fact that all these products are in the stage of Phase II and III clinical studies demonstrates OBI’s confidence towards Globo H targeting new drugs and the Company will continue to develop the new drugs actively.
(3)The above-mentioned OBI-999, which uses antibody of OBI-888 as intermediate to target the cancer cell, is at the stage of Phase II clinical study. As the amount of monoclonal antibody needed during the manufacture of OBI-999 and the frequency of treatments are less than OBI-888, there are less concerns toward unbearable production costs after commercialization once the new drug succeeds. Consequently, the Company decides to dedicate our organizational focus on development of OBI-999, discontinues OBI-888 and looks for new strategy after production optimization of next-gen antibody, which we believe will be a preferred strategy of most new drug companies. It is obviously a faulty inference to deny the possibility of Globo H as a target of a cancer therapy and disregards the fact that OBI still has three more products sharing the same target. As some of the patients enrolled demonstrate anti-cancer activity and tumor shrinkage, the Company still considers Globo H antigen antibody platform based on OBI-888 valuable for development.
9.Any other matters that need to be specified: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 investment decisions.