SK bioscience : Material Business Matters Related to Investment Decisions (Booster-shot Phase III clinical trial (IND) application for COVID-19 vaccine GBP510 in Thailand)

Material Business Matters Related to Investment Decisions

1. Title	Booster-shot Phase III clinical trial (IND) application for COVID-19 vaccine GBP510 in Thailand
2. Details	※ Other references useful for making invest decisions The probability that a drug in a clinical trial will be finally approved as a finished drug product is known to be statistically around 10%. In the process of clinical trials and product approval, results may not meet expectations, and there is a possibility that the company may change or abandon its commercialization plan. Investors are encouraged to invest carefully, taking into account the above and the investment risks disclosed in the business report. 1. Title of clinical trial - Multicenter, parallel comparison, observer-blind, active control, randomized, Stage 2, Phase III clinical trials to evaluate the immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) using the adjuvant AS03 in 750 adults 18 years or older 2. Phase of the clinical trial - Phase III clinical trial 3. Target disease (indications) - Prevention of COVID-19 disease caused by SARS-CoV-2 infection 4. Clinical trial application date and approval institution - Application Date: May 19, 2022 - Clinical trial approval institution : Central Research Ethics Committee(CREC) - Clinical trial institution: Armed Forces Research Institute of Medical Sciences (AFRIMS) and 3 other institutions (subject to change) 5. Clinical trial registration number - NCT05007951(To be updated at Clinicaltrials.gov) 6. Purpose of clinical trial - Immunogenicity and safety evaluation after GBP510 booster shot inoculation 7. Clinical trial method - Multicenter, observer-blind, randomized, Stage 2, Phase III trials. Immunogenicity and safety will be evaluated after a GBP510 booster shot (third) on healthy adults who have received two shots of GBP510 and/or AstraZeneca COVID-19 vaccine in Stage 8. Expected effect - GBP510 is a SARS-CoV-2 recombinant protein nanoparticle vaccine which uses the immune adjuvant AS03. The booster shot would be expected to increase the immune response which decreases over time after primary vaccination, and is expected to have acceptable safety profile.
3. Date of board resolution (decision date) or confirmation date	2022-05-23
- Attendance of outside directors	Present(No.)	-
Absent(No.)	-
- Attendance of auditors (members of Audit Committee who are not outside directors)	-
4. Other matters to be factored into investment decisions
- The Confirmation date above is the date of receipt of this clinical trial plan (IND) by CREC.
※ Related disclosure	-