Invester Relations
Investment Highlights
- Integrated biopharmaceutical platform combining development, manufacturing, and clinical infrastructure
- Direct access to real-world clinical data through a global network
- Established clinical operations generating revenue while supporting development
- Focus on scalable cell-based therapeutics (autologous and allogeneic)
- Positioned for regulatory progression and strategic partnerships
Pipeline
Development programs designed for regulatory progression and regional expansion.
Business Model
Our integrated model combines:
Clinical revenue generation
Data accumulation
Therapeutic development
Licensing and partnerships
Data & Evidence
- 16,000+ clinical cases
- Longitudinal follow-up data
- Real-world evidence generation
- Foundation for regulatory and pricing strategy
Why Now
- Growing demand for cell-based therapeutics
- Regulatory evolution (ATMP frameworks)
- Data-driven development models
- Integrated platforms outperform fragmented models
Global Strategy
London → R&D / regulatory
Tokyo → clinical access / data
UAE → capital / UHNW
Asia → scaling
Partnership Strategy
・Co-development
・Licensing
・Regional expansion
・Data collaboration
Board of Directors
With regard to the Board of Directors, efforts are made to ensure that it is of an appropriate size and composition to enable rapid and accurate decision-making, while strengthening management transparency and supervisory functions.
Candidates for the Board of Directors are selected with due consideration given to the balance and diversity of their knowledge, experience and abilities, so that the Board of Directors as a whole can make professional and comprehensive management decisions. The term of office of directors is set at two years in accordance with the Companies Act.
In principle, the Board of Directors meets once a month with the attendance of directors and auditors to make decisions on important management matters and to supervise the directors' performance of their duties. In order to properly fulfil their roles and responsibilities, directors and auditors are required, in principle, to attend at least 75% of board meetings. In consideration of the time that they can devote to their duties as directors of the Company, in principle, they are allowed to hold no more than four concurrent positions as external directors, etc. outside the Company (i.e. serving as directors of listed companies, etc.).
Skill Matrix of Directors
Skills Matrix of Directors and Auditors
Under the corporate philosophy of Medical Innovation, the Company is promoting the growth strategies ‘Maximising the therapeutic base’, ‘Strengthening the pipeline and accelerating global development’ and ‘Expanding business domains’, as well as strengthening the management foundation, including DX and human resources development. Through our business activities, we also aim to contribute to people's health and increase our corporate value, while continuing to take on the challenge of realising a sustainable society. The Company's Board of Directors as a whole has set out the skill items it considers necessary, with internal directors based on their operational and managerial experience, and external directors and auditors on the areas in which they are expected to supervise, audit and provide advice, respectively.
Cooporate Governance
HELENE Biomed Co., Ltd. defines “Corporate Governance” as the establishment of the organizational structure and the system to foster the corporate ethics in order to achieve our aims: “to value the sum of the benefits of all the stakeholders including our shareholders, employees, business partners, patients of partner medical institutions, consumers and communities to the maximum, and to disclose information fairly and promptly” as well as “to achieve innovative and sustainable growth and increase of stable and lasting corporate values.”
We believe in strengthening “corporate governance.” It is one of the important management issues to achieve the “target”.
Governance System
Board of Directors
The Board of Directors is composed of 4 directors (including three External Directors). As a decision-making organization of our management, the Board of Directors determines the matters stipulated by laws and regulations and the Articles of Incorporation, basic management policies, and other important matters, and also supervises the business execution by the Directors. The regular meetings of the Board of Directors are held once every month in principle and extraordinary meetings are held as necessary to ensure a prompt and efficient decision-making system.
Audit & Supervisory Board
The Audit & Supervisory Board is composed of three External Audit & Supervisory Board Members (one of them is a Full-Time Audit & Supervisory Board Member). As an organization that conducts business audits and accounting audits, the Audit & Supervisory Board makes decisions concerning the execution of the members’ duties, including the development of audit policies, audit plans, and audit procedures. The Audit & Supervisory Board Members receive a report on important matters of audit and make discussions, or make resolutions to supervise and audit the management. The regular meetings of the Audit & Supervisory Board are held once every month in principle and extraordinary meetings are held as necessary to ensure an effective and efficient audit system by sharing the information among the members, including the examination of the progress and results of audits.
Executive Committee
The Executive Committee is chaired by the President and is composed of a total of four members: the President and four Executive Officers. The Executive Committee makes resolutions on the matters mandated through the resolutions of the Board of Directors, the agenda to be presented to the Board of Directors, and other matters stipulated by the company regulations as important matters for management. The regular meetings of the Executive Committee are held at least once every month and extraordinary meetings are held from time to time to discuss issues as they arise. In addition to its members, the Non-Executive Directors and the Full-Time Audit & Supervisory Board Member attend the meetings as observers, and the employees related to individual issues also attend the meetings as necessary.
Compliance and Risk Council
The Compliance and Risk Council is composed of the President, Executive Officers, and other officers and employees nominated by the President, and has meetings every two months. In addition to its members, the Non-Executive Directors, the Full-Time Audit & Supervisory Board Member, and the Company Attorney attend the meetings as observers. As a cross-sectional organization, the Council receives consultation from the President, discusses various matters to be considered in relation to the compliance and management risks and action plans, and makes necessary recommendations, reports, and plans for the President.
Reason We Sel ect the Present Corporate Governance System
We adopt the system of “company with the Audit & Supervisory Board” as we evaluate the system under which the Board of Directors mainly composed of the Directors who are familiar with the company’s business determines by itself the basic policies and execution of important business management matters, and also the Audit & Supervisory Board Members who have a strong legal power audit the business execution of the Directors fr om an independent position is effective to secure the efficiency and soundness of management.
IR Calendar
- Feb 10 2025: YA2024 Financial Report
Message from Founder & Group CEO
We believe that the future of medicine will be defined by cell-based therapeutics, yet the path from clinical practice to scalable and regulated treatments remains fragmented and inefficient. At Helene BioMed, we are addressing this challenge by building an integrated biopharmaceutical platform that connects clinical access, data generation, manufacturing, and therapeutic development within a single system. Our global clinical network provides direct access to patients and longitudinal data, enabling us to generate real-world evidence and continuously refine our therapeutic approaches. By integrating this data with controlled manufacturing and development capabilities, we aim to transition from treatment-based applications to standardized and scalable cell-based therapeutics. We have already established a strong foundation through our clinical operations and accumulated a significant volume of clinical data, which supports our ongoing development programs and regulatory strategies across multiple regions. Looking ahead, our focus is to expand our pipeline, strengthen our manufacturing capabilities, and advance toward regulatory approvals and strategic partnerships. We believe that our integrated model positions us uniquely to accelerate development and create long-term value. While the development of advanced therapeutics presents significant challenges, we are committed to building a sustainable and globally scalable biopharmaceutical business. We remain focused on disciplined execution, scientific rigor, and long-term value creation for our stakeholders.
- Dr. Taka Matsuoka, MD, Ph.D