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Company Vision & Core Business

• Company vision is to achieve "Sustainable Medicine" through the use of ICT, which is the origin of the company name SUSMED.
• The company operates two core business areas: development and commercialization of prescription therapeutic medical apps, and a clinical trial platform service leveraging blockchain technology. The company is also preparing for future medical big data utilization businesses.

Core Technology & Competitive Advantages

• QDTx (Therapeutic App Development Platform): Enables parallel development of multiple pipelines with minimal internal man-hours even with a team of under 50 employees, and is the foundation of the company's collaborative development with pharmaceutical partners.
• SUSMED SourceDataSync (Clinical Trial System): Uses blockchain to guarantee clinical trial data reliability, is compliant with Japanese MHLW GCP ministerial ordinance, and drives clinical trial efficiency. It has become a core business pillar that now serves external client companies in addition to improving the efficiency of the company's own R&D costs.
• Awesome Intelligence (Machine Learning Automatic Analysis System): A system and cloud service under development for automatic analysis of medical big data, currently in joint research with academic institutions.

Therapeutic App Pipeline Progress

• Insomnia Disorder Therapeutic App: Already obtained manufacturing and marketing approval, completed partial change application approval in September 2025, and submitted an application for national health insurance coverage. The company is currently waiting for final deliberation by the Central Social Insurance Medical Council (Chuikyo). The company has a sales partnership with Shionogi & Co., Ltd., and is fully preparing for nationwide launch immediately after insurance coverage is approved.
• Tinnitus Therapeutic App (co-developed with Kyorin Pharmaceutical): Completed specific clinical research with very positive results, which have been presented at academic conferences. A memorandum of understanding was signed to expand the company's role ahead of commercial launch, resulting in increased milestone revenue and sales-based royalty terms. The parties are actively advancing preparation for the upcoming approval-stage corporate clinical trial as quickly as possible.
• PMS/PMDD Therapeutic App (co-developed with Asuka Pharmaceutical): Specific clinical research is currently ongoing.
• Additional pipelines: Development is also ongoing for therapeutic apps in oncology, nephrology, and diagnostic programmed medical devices in collaboration with academic partners.

Platform Business Operational Progress

• The company's blockchain-based clinical trial system was selected for use in Heartseed's clinical trial for iPS cell-derived cardiomyocyte treatment for heart failure, marking the first ever adoption for a regenerative medicine product using iPS cells.
• The system was previously adopted for Aculus Pharma's Phase III clinical trial, so the company continues to expand its track record across multiple modality types.

• The company expects the insomnia disorder therapeutic app to undergo insurance coverage deliberation at Chuikyo in March 2026 or later, with the earliest expected insurance coverage date of June 1, 2026, and does not currently expect any delays beyond this timeline.
• The company expects that approval of Aculus Pharma's drug (that uses the company's clinical trial platform) will open up adoption opportunities among mid-sized and large pharmaceutical companies, accelerating expansion of the platform business.
• The company maintains its three core strategic priorities for the full 2026 June fiscal year: launch of the insomnia therapeutic app after insurance coverage, continued advancement of downstream therapeutic app pipelines, and accumulation of additional operational track records for the clinical trial platform business, all of which remain on track.

1. Therapeutic App Product Segment: 0 yen of business revenue was recorded in the first half of the current fiscal year. For reference, the segment recorded 300 million yen in milestone revenue in the 2025 June fiscal year. It accounted for 0% of total revenue in the first half of 2026 June fiscal year.
2. DTx Platform Segment: The segment achieved stable revenue performance, bringing total company business revenue to 91 million yen for the first half of the 2026 June fiscal year. It accounted for 100% of total revenue in the reporting period.

• The timing of insurance coverage deliberation and approval for the insomnia therapeutic app is dependent on MHLW and Chuikyo schedules, which could potentially result in delays outside of the company's control.
• Increasing competition in the clinical trial efficiency space may put pressure on the company's market share and pricing, though the company believes its unique position protected by intellectual property limits this risk.
• Pipeline development for therapeutic apps is subject to regulatory and clinical trial risks that could delay or prevent commercial launch.

Q: What is the expected timing of national health insurance coverage for the insomnia disorder therapeutic app, and what is the current status of discussions with the Ministry of Health, Labor and Welfare (MHLW)? How does the ongoing discussion of insurance coverage for in-person cognitive behavioral therapy for insomnia impact the app's approval timeline?

A: In-person cognitive behavioral therapy for insomnia is classified as a technical fee, separate from the therapeutic app's classification as a specified insurance medical device. In mid-January 2026, the Medical Technology Evaluation Subcommittee indicated a direction to approve insurance coverage for in-person cognitive behavioral therapy for insomnia. While the two are evaluated independently, this positive direction for in-person non-drug therapy improves the outlook for the app's approval. SUSMED submitted its insurance coverage application in September 2025, and the average review period is 5 months from the month after submission. This year, the review timeline overlaps with the triennial medical fee revision, and no insurance reviews are held in February at Chuikyo. This means deliberation will occur in March 2026 or later, with no outstanding issues in the review process to date; the MHLW is simply busy with the revision timeline. The in-person therapy's insurance coverage will go into effect June 1, 2026, matching the timing of the 2026 medical fee revision.

Q: Will the therapeutic app's insurance coverage occur at the same time as in-person therapy, or will it be later?

A: It is possible that they will be approved at the same time. Medical device insurance coverage is reviewed at Chuikyo in March, June, September, and December. Given that review cannot occur in February, the earliest target for insurance coverage is June 1, 2026, and we do not expect a delay beyond this timeline at this point.

Q: If insurance coverage is effective June 1, when will Chuikyo hold the deliberation, and will this deliberation be publicly disclosed?

A: Insurance coverage deliberations for medical devices at Chuikyo are publicly disclosed as a meeting agenda, which will be made public in advance. We cannot confirm the exact timing, but for a June 1 effective date, approval must be granted at a Chuikyo meeting before that date, which means deliberation will likely occur in March, April, or possibly May 2026.

Q: Can you share your updated outlook for post-launch sales of the insomnia therapeutic app, given market concerns that existing launched therapeutic apps in Japan have underperformed?

A: Not all therapeutic apps are the same; product positioning, relationship to existing treatment guidelines, and clinical need are the most critical factors. In the insomnia space, there is strong demand for the appropriate use of sleeping pills, and there is a growing policy push to expand non-drug cognitive behavioral therapy. International guidelines already explicitly list cognitive behavioral therapy as the first-line treatment for insomnia, even before pharmacotherapy, and our app fits directly into this high-need positioning. We have received very high levels of interest from physicians, reflected in the large number of speaking invitations we have received at psychiatric academic societies and educational seminars, which is a positive sign for adoption.

Q: How is the competitive landscape changing for the platform business, and does the company's blockchain-based value proposition still hold a unique competitive advantage as more competitors enter the space?

A: It is true that more companies are entering the clinical trial efficiency space, including venture firms that adapt remote care platforms for clinical trial use. However, SUSMED owns patented blockchain technology specifically for clinical trial use, and the Japanese government has formally confirmed that this technology satisfies GCP regulatory requirements for guaranteeing data reliability, which gives us a unique advantage. CRO monitoring activities account for roughly half of all CRO industry revenue, and our technology directly replaces these monitoring activities, creating very large impact on trial costs. In contrast, remote trial platforms only offer the benefit of eliminating the need for patients to visit hospitals, and do not address the large cost portion of monitoring activities like our solution does. The growing number of players reflects how large the unmet need is in this space, and our segment of the market has large impact potential and high barriers to entry due to our intellectual property protection.

Q: What is the current status of Aculus Pharma's corporate clinical trial that uses SUSMED's platform, which is seen as a key milestone for broader platform adoption? What is the expected timeline for approval?

A: Success of this case, leading to final drug approval, is indeed a critical step to expand adoption beyond early-stage bioventures to mid-sized and large pharmaceutical companies, which is a key growth goal for our platform business. Aculus Pharma was acquired by Viatris, and Viatris has already publicly stated that it has submitted the approval application for this drug. In Japan, it generally takes approximately 1 year from approval application to final approval, so we expect this timeline to hold, and we look forward to this milestone that will open up new growth opportunities for our platform.