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Statement from SCM Lifescience Inc. in response to a request for disclosure of corrections from the Korea Exchange regarding acute pancreatitis phase 2a
Notice
2022-11-15

On August 31, SCM Lifescience Inc. completed the disclosure of the clinical results of acute pancreatitis phase 2a through the approval of the Korea Exchange.


Under the KOSDAQ disclosure regulations, the Company disclosed the concept of inclusiveness disclosure of material information as the judgment standard.


First, as a relevance requirement, the information must be directly related to the sales and production activities, financial structure, or corporate management activities of a listed corporation;


Second, as a materiality requirement, the information must have a significant impact on the stock price or investors' investment decisions, or be capable of affecting it;


Third, the concrete requirement is that the information must be concrete facts or decisions.


Regarding the above, the Korea Exchange and the Company have a difference of opinion on “materiality and concrete requirements”.


The first disclosures prepared by our company and approved by the Korea Exchange were prepared based on the CRO's objective clinical phase 2a result report. In this context, the results data of the primary and secondary efficacy endpoints, which are the criteria for judging whether to proceed with the phase 2b clinical trial, are presented in detail.


This is an important matter for investors' investment decision-making.


While discussing the request for correction of disclosure, the Company forwarded the following to the Korea Exchange.


▶ Description of Phase 2 clinical trial a,b system


▶ As a result of clinical phase 2a analysis, statistically significant effects occurred in the primary and secondary efficacy endpoints in the test drug administration group


▶ Since the above is an important criterion for our company to promote phase 2b clinical trials, it must be provided to investors who decide on our investment through the relevant disclosure.


However, the position of the Korea Exchange requesting the correction was clear, and the Company accepted it and made the correction disclosure.


The contents before and after the correction of the disclosure are attached.


Thank You

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