SK bioscience : Material Business Matters Related to Investment Decisions (Approval of Phase 3 Clinical Trial Plan (IND) on GBP510 booster shot, COVID-19 vaccine)

Material Business Matters Related to Investment Decisions

1. Title	Approval of Phase 3 Clinical Trial Plan (IND) on GBP510 booster shot, COVID-19 vaccine
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, so there is a possibility that the company may change or abandon its commercialization plan. Investors are advised 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 II, Phase III clinical trials to evaluate the immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) using the adjuvant AS03 in 450 adults 18 years or older 2. Clinical trial stage: - 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: March 22, 2022 - Approval date: April 21, 2022 - Approval institution of clinical trial: Ministry of Food and Drug Safety (MFDS) - Clinical trial institution: Korea University Guro Hospital and 15 other institutions (subject to change) 5. Registration number of clinical trial: - To be registered at https://www.clinicaltrials.gov - Approval details and progress for clinical trial can be checked by searching the clinical trial information at Drug Safety Country (https://nedrug.mfds.go.kr). 6. Purpose of clinical trial - To evaluate immunogenicity and safety after receiving GBP510 booster shot 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 or AstraZeneca COVID-19 vaccine in Stage 1 8. Expected benefits - GBP510 is a SARS-CoV-2 recombinant protein nanoparticle vaccine which uses the immune adjuvant AS03. The booster shot significantly improves the immune response, which decreases over time after primary vaccination, and is expected to have high safety. - The booster shots are expected to have a preventive effect on variants such as Omicron.
3. Date of board resolution (decision date) or confirmation date	2022-04-21
- 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 on which this clinical trial plan (IND) was approved by the Ministry of Food and Drug Safety.
※ Related disclosure	2022-03-24 Material Business Matters Related to Investment Decisions(Booster-shot Phase III clinical trial (IND) application for COVID-19 vaccine GBP510)