[ESG] Signed 'Joint Business Agreement for Strategic Technology Commercialization' between Inha University, Inha University Hospital, and SCM Lifescience, Inc.
September 28, 2022, we will share the contents of the FAQ announced at this online company briefing session.
The procedure for the inheritance of the largest shareholder promised by notice on our website on April 22 was completed on September 20.
In addition, after the completion of the inheritance procedure for the largest shareholder, the promised buy-back of the executives was also carried out.
We broke away from the CEO-centered IR method conducted quarterly in 2021 and conducted IR activities centered on the general manager 4 times for 4 months from last June to today, directly to institutional investors.
Starting with the announcement of this acute pancreatitis clinical trial results, clinical data that can be evaluated in the financial market will come out sequentially.
Therefore, unlike other bio-listed companies, we do not raise large-scale funds at once, but try to raise funds in an appropriate size by presenting evidence whenever necessary.
You may have a variety of other questions about financing, but we ask for your understanding that we cannot answer any questions that are related to unfair trade due to the use of undisclosed information. We would appreciate it if you could check the announcement of the Board of Directors for more details on financing.
With the recent announcement of the 'National Biotechnology and Biomanufacturing Initiative' executive order from the US government by Biden, interest in the bio market in the US is growing again, but it is expected to hurt Korean CMO companies.
In contrast, SCM Lifescience Inc. is expected to positively affect its negotiating power for overseas technology transfer in that it can utilize the manufacturing facilities of CoImmune, an invested company.
CoImmune’s CFO informed us that it is working to secure optimal investors by negotiating with about 25 financial institutions in preparation for IPO.
On September 22, to strengthen the information protection of the CoImmune management strategy, CoImmune requested us to sign a CDA for the CoImmune information, and we accepted it.
In addition, two meetings were held with Genexine executives who are participating in the CoImmune board of directors. At the meeting, it was discussed that CoImmune's financing, IPO, and strategic M&A would be actively pursued mainly by Korean institutional investors who invested in CoImmune, including Handok and Genexine. We also plan to exercise our authority through the general shareholders' meeting on the matters being promoted.
3. Technology transfer
Currently, we have started early communication about technology transfer through open innovation opportunities with multinational pharmaceutical companies.
Researchers who participated in the clinical trial will directly present the clinical results of our three treatments at domestic and international conferences/forums/societies, and then we plan to conduct a full-fledged discussion on technology transfer.
Among the three treatments, the clinical trial results for acute pancreatitis will be presented at the Korea Digestive Disease Week (KDDW) in December of this year and the International Digestive Disease Week (DDW) in May 2023.
We are also considering a presentation at the Korean Pancreatobiliary Association in Korea.
In the case of atopic dermatitis, clinical results are expected to be released in May next year, so we plan to present them at the World Congress of Dermatology in July and at the Korean Atopic Dermatitis Association.
In the case of the JP Morgan Conference, we will discuss whether to participate as soon as we receive specific information from the JP Morgan team preparing for the conference.
We plan to share our R&D achievements by participating in regenerative medicine-related conferences and cell/gene therapy-related conferences.
4. Acute pancreatitis phase 2b clinical trial plan
The purpose of this phase 2a clinical trial for acute pancreatitis was to verify the exploratory efficacy and safety.
We confirmed the exploratory efficacy of the treatment through the phase 2a clinical trial and derived a successful result confirming the safety of patient administration.
Through the opinions of the medical doctors who participated in the clinical trial, it was confirmed that our mesenchymal stem cell therapy was proven to be safe for patients with moderate to severe acute pancreatitis and was effective in controlling the initial inflammation after administration.
An outline of the clinical trial protocol is being prepared according to the development plan. Through consultation and discussion with regulatory agencies, we aim to complete the application documents for clinical trial plan approval early next year and obtain approval within the first half of next year.
5. SCM Lifescience Inc. Business Plan by Headquarters
1) Research & Business Innovation Development Division
The Research & Business Innovation Development Division is focusing on the research and development of world-class and innovative cell therapy products.
The R&D department's main business plan is exploring new indications using our global R&D network.
Currently, with a globally competitive research team in the United States and Israel, we want to explore new indications and conduct research and development of stem cell therapies for rare and intractable diseases.
Among them, we plan to secure new indications by establishing a network with Prof. Mudi Shevez of the Weisman Institute in Israel, who is our overseas advisor, and the Yozma Group.
In addition, we are focusing on establishing efficacy indicators and assay systems for three pipelines, discovering clinical biomarkers, and updating MoA for each disease.
We plan to apply for a patent and work on a thesis when clear data is secured through this.
Finally, based on the patents for our original technologies, we are establishing a patent extension strategy to protect our original technologies, and we are working hard to secure new patents.
2) Advanced Therapeutic Medicinal Products Division
The Advanced Therapeutic Medicinal Products Division consists of a manufactory responsible to produce our stem cell treatment products and a clinical development department with individual PMs for each clinical pipeline.
The manufactory currently produces SCM-CGH and SCM-AGH, two formulations of our mesenchymal stem cell therapy, through the quality assurance system in operation and supplies them as clinical trial drugs.
Since our ongoing clinical trials are nearing completion, we are planning to produce therapeutics for follow-up clinical trials in the first half of next year.
In the case of chronic graft-versus-host disease, we aim to complete patient registration within the year, and we have started composing a CTD package for 48 weeks of follow-up after the last patient's hospital visit (required for product approval at the end of next year). To this end, we plan to organize a task force to carry out organic work.
In addition, for the cGMP construction for commercial production, the architectural design is currently in progress, starting with the conceptual design at the end of 2021, and is aiming for operation by the end of 2024.
The newly built facility plans to introduce and operate a 3D bioreactor for mass production, and preparations for this are underway.
As the 3D bioreactor production process optimization has been completed in 2021, we will operate the mass production process through equipment introduction, validation, simulation, and actual production.
As the most urgent task, the Clinical Development Department has begun preparations for follow-up clinical approval based on the safety and exploratory efficacy results obtained with acute pancreatitis phase 1/2a.
According to the development schedule, we plan to receive IND approval in the first half of next year and proceed with phase 2b. We would like to inform you that the details of the clinical trial design are not yet available to the public.
In the case of atopy clinical trials, a report on the results will be released in May next year, so we are discussing the phase 3 progress plan through the Steering Committee with Handok, which has signed a contract with the phase 3 clinical trial.
We aim to complete the protocol development and clinical trial plan application and approval for the phase 3 clinical trial by the fourth quarter of 2023.
3) ESG Management Division
The ESG Management Division is growing into an organization that develops business models that generate profits rather than settle for company-wide management roles.
In preparation for the era of Big Blur, where the boundaries between industry and business model are collapsing recently, we believe that the essential core competencies that we must possess are ‘strategic alliance competencies’.
We divide our business revenue model into two major categories: “exclusive” and “linked.” “Exclusive” has a narrow quantitative range, and “linked” has a small margin.
We are looking for a business profit model that can overcome the shortcomings as well as the advantages of 'exclusive' and 'linkage'.
As a hub where this business revenue model can be created, we selected hospitals as our first target.
Recently, we are trying to develop a bioservice business model that targets the bioservice market in the red bio market, which is often mentioned mainly in hospitals, but not bioservices in the value chain, but at the level of the business ecosystem.
In the green bio market, we would like to focus on the business model of the microbiome research area and the veterinary drug research area, centering on hospitals.
To achieve this, it is very important to establish a strategic alliance model with hospitals + universities + local communities + financial institutions + public research institutes.
Currently, we are making concrete achievements related to this together with CEO Byeong-Kwan Son and Executive Director Hyung-Nam Oh.
In addition, we are actively securing multi-disciplinary majors and social welfare specialists to accom