SK bioscience : Material Business Matters Related to Investment Decisions (Investigational new drug (IND) application for phase III clinical trial of heterologous booster shot of GBP510 in Nepal)

Material Business Matters Related to Investment Decisions

1. Title	Investigational new drug (IND) application for phase III clinical trial of heterologous booster shot of GBP510 in Nepal
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 - A Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in Adults Aged 18 Years and 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: Aug 08, 2022 - Clinical trial approval institution : NHRC(Nepal Health Research Council) - Clinical trial institution: Institution of Medicine(IOM) and Dhulikel Hospital (subject to change) 5. Clinical trial registration number - To be updated at Clinicaltrials.gov 6. Purpose of clinical trial - Immunogenicity and safety evaluation after GBP510 booster shot inoculation 7. Clinical trial method - Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center, Phase III trials. Immunogenicity and safety will be evaluated after a heterologous GBP510 booster shot (third) on healthy adults who have received two shots of other authorized COVID-19 vaccine. 8. Expected effect - GBP510 is a SARS-CoV-2 recombinant protein nanoparticle vaccine which uses the immune adjuvant AS03. The heterologous 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	2022-08-08
- 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 submission of the final investigational new drug (IND) application to NHRC.
※ Related disclosure	-