OBI-888 completes Phase I safety evaluation and demonstrates its safety and tolerability with no major concerns

Announcement of the company’s cash capital increase and base date
June 14, 2019
Clarification on new article by Economy Daily News dated Jun 16, 2019
June 17, 2019
  1. Date of occurrence of the event: Jun 15, 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: OBI-888 completed safety evaluation in a phase I dose escalation phase. Trial results demonstrated OBI-888’s safety and tolerability with no major safety concerns. Safety Review Committee suggests to proceed to phase 2 Cohort Expansion Phase as planned.
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1)Name of the new drug: passive immunotherapeutic monoclonal antibody OBI-888
    (2)Uses: An immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer.
    https://www.clinicaltrials.gov/ct2/show/NCT03573544
    (3)Planned development: Phase I, II, III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: OBI-888 completed safety evaluation in a phase I dose escalation phase with 12 last stage patients with solid tumor. The trial evaluated three dose levels of OBI-888 at 5 mg/kg, 10 mg/kg and 20 mg/kg. Results indicates the safety of OBI-888 at all dose levels tested and are well tolerated. No dose limiting toxicity (DLT) nor OBI-888-related AE were observed. Safety Review Committee suggests to proceed to phase 2 Cohort Expansion Phase as planned. Single clinical trial result may not accurately reflect the possibility of drug commercialization. Investors shall make prudent judgments and investments.
    B.Risk/impact and countermeasures for clinical trial (include interim analysis) results not meeting statistical significance or other key events: N/A
    C.Company outlook for clinical trial (include interim analysis) results meeting statistical significance or other key events: Phase 2 clinical trial—cohort expansion phase
    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: Phase II Cohort Expansion Phase
    A.Expected timeline: To be completed in 2019. Actual project timeline will be adjusted based on the actual study plans.
    B.Expected obligation: None
    (6)Current market: According to IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-888 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.