Letter received from National Medical Products Administration (NMPA) of China regarding Adagloxad Simolenin (OBI-822) Phase III clinical study to be resubmitted after supplementation

Supplementary announcement for the company to issue ordinary shares through rights offering
April 22, 2019
Board of directors of the company waived subscription rights exceeding half of the total subscribable shares. Shares to be subscribed by designated persons
June 10, 2019
  1. Date of occurrence of the event: May 06, 2019
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
  4. Reciprocal shareholding ratios: N/A
  5. Cause of occurrence: Official letter was received from National Medical Products Administration (NMPA) of China regarding the request for clearance of Phase III clinical study of Adagloxad Simolenin (OBI-822), submitted on Jan 24, 2019. The request shall be resubmitted after supplementation. Adagloxad Simolenin (OBI-822) is an active cancer immunotherapy targeting Globo H; clearance of the Global Phase III studies (indication: TNBC) in the United States, Taiwan, Hong Kong, Australia, Ukraine and Russia was granted and has begun patient screening and enrollment. Korean and EU submission is ongoing.
  6. Countermeasures: OBI will resubmit the application for clearance of Global Phase III of Adagloxad Simolenin (OBI-822) after completing the required studies by NMPA (regarding CMC validation of raw material KLH)
  7. Any other matters that need to be specified:
    (1)Name of the new drug: Adagloxad Simolenin (OBI-822)
    (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.
    https://www.clinicaltrials.gov/ct2/show/NCT03562637
    (3)Planned development: Phase III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: To be resubmitted after supplementation
    B.Risk and countermeasures for denied applications: OBI will resubmit the application for clearance of Global Phase III of Adagloxad Simolenin (OBI-822) after completing the required studies by NMPA (regarding CMC validation of raw material KLH)
    C.Outlook for granted applications: N/A
    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.Expected timeline: Expect to evaluate the primary endpoint by 2023. The actual study timeline will be based on the progress of the clinical trial.
    B.Expected obligation: Milestone royalty of US$1,000,000 to Optimer upon initiation of Phase III clinical trial; now in the request process.
    (6)Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US$100.9 billion in 2017, the largest among the top 10 categories. However, OBI-822 is still in the clinical phase. The development of indications is based on the unmet medical needs where future development of the drug will be determined after a comprehensive consideration of the company’s overall product pipeline and strategy.
    (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.