1.Date of occurrence of the event:2023/12/20
2.Company name:OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office
4.Reciprocal shareholding ratios: NA
5.Cause of occurrence: After prudent evaluation, the Company’s Board of Directors has determined to terminate the development of BCVax, OBI-866,
and OBI-999, and to focus existing resources on other projects.
(1)BCVax is a novel COVID-19 vaccine based on the Delta spike protein with a nanoparticle saponin as the adjuvant. BCVax can induce neutralizing
antibodies against various COVID-19 variants. This vaccine was approved by the TFDA to proceed to a Phase I clinical trial in June 2023. However,
as the global COVID-19 vaccination rate has increased significantly, and the COVID-19 variants have changed rapidly with most of the infected
patients becoming asymptomatic or mildly symptomatic, it is expected that there will be barriers to enrollment in this clinical trial. After
prudent evaluation, the Company determines to terminate the Phase I clinical trial of BCVax and will focus existing resources on other
projects. About NT$74 million can be saved after the original plan to enroll 60 patients in this trial is terminated.
(2)OBI-866 is an active immunotherapeutic cancer vaccine targeting SSEA-4. A Phase I clinical trial is open for enrollment in Taiwan now. The study
population is patients with terminal cancer who have no treatment options . During the past three years, several patients in this trial have failed
to finish the study due to disease progression. These two factors have caused delays in the enrollment and made it difficult to estimate the
trial completion date. After prudent evaluation, the Company determines to stop further enrollment of patients in this Phase I trial and will
focus existing resources on other projects. About NT$28 million can be saved after the original plan to enroll 12 patients in this trial is
terminated.
(3)OBI-999 is an antibody-drug conjugate (ADC) cancer therapy targeting Globo H. A Phase II clinical trial is open for enrollment in Taiwan and
the United States now. However, OBI-999 has not shown its expected therapeutic potential for the enrolled patients in this trial during past
two years. After prudent evaluation, the Company determines to stop further enrollment of patients in this Phase II trial and will focus
existing resources on other projects. About NT$73 million can be saved after the original plan to enroll 57 patients in this trial is terminated.
After further enrollment in the two clinical trials described above is stopped, the Company will continue providing medical care to the enrolled
patients in accordance with the clinical study protocol and will dispose of unused investigational products in accordance with related regulations and
the Good Clinical Practice.
6.Countermeasures: To terminate the development of above-mentioned projects, and to focus existing resources on other projects.
7.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9
of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of
the securities on public companies.):NA