Deepening Capital and Business Alliance with ReeNT, a Tokyo Jikei University School of Medicine Venture Company, Towards Commercialization of Regenerative Medical Products for Intractable Diseases in Otorhinolaryngology

We have deepened our capital and business alliance with ReeNT Inc. (Headquarters: Minato-ku, Tokyo; Representative Director: Jotaro Morino; hereinafter "ReeNT"), a venture company spun out from Tokyo Jikei University School of Medicine, which is engaged in research and development. In 2024, we entered into a capital and business alliance agreement and have been exploring the possibility of a strategic business alliance regarding the manufacturing and distribution of regenerative medical products. We are pleased to announce that we have newly entered into a capital and business alliance agreement towards the commercialization of regenerative medical products and will be making an additional investment in the company, as detailed below.

Details

1. Background and Objectives

Cholesteatoma, an intractable disease in the field of otorhinolaryngology, is a condition where abnormal tissue called cholesteatoma forms in the middle ear and gradually destroys surrounding tissues and bone. In addition to hearing loss and ear discharge, it can lead to severe complications such as meningitis and brain abscess if it progresses. The only existing treatment is surgery, and the middle ear mucosa is lost when the cholesteatoma is removed. The exposure of the middle ear bone can lead to granulation tissue formation on the surface of the middle ear bone, obstructing the middle ear space and preventing pressure regulation within the middle ear, raising concerns about recurrence and hearing loss.

For approximately 20 years, research focusing on the regeneration of middle ear mucosa after surgery for cholesteatoma has been ongoing in the Department of Otorhinolaryngology at Tokyo Jikei University School of Medicine. ReeNT was established as a university-spun venture to implement this research outcome into society and is engaged in the development of regenerative medical products for middle ear diseases in the field of otorhinolaryngology. The autologous nasal mucosal epithelial cell sheet being developed by the company is a cell-processed product using the patient's own nasal mucosal cells. Transplantation is expected to promote the regeneration of the middle ear mucosa, prevent the obstruction of the middle ear space, and improve aeration.

The Alfresa Group, which is responsible for the stable supply of pharmaceuticals and other products as social infrastructure, is promoting the establishment of a "Regenerative Medicine Total Supply Chain Service (TSCS*1)" from raw material provision to delivery to medical institutions for regenerative medical products. Cell Resources Inc., a subsidiary responsible for the regenerative medicine-related business, is building a comprehensive CDMO*2 service system, including the provision of domestic cell raw materials (master cells) and the manufacturing of cell products, for the social implementation of regenerative medical products.

To accelerate the social implementation of regenerative medicine technology by leveraging the strengths of both companies, we have decided to deepen our capital and business alliance with ReeNT. Our group will aim for the commercialization of the autologous nasal mucosal epithelial cell sheet developed by ReeNT in Japan and will consider support utilizing the functions of CRO*3, manufacturing, and distribution that constitute the Regenerative Medicine TSCS.

*1 TSCS: Regenerative Medicine Total Supply Chain Service. It refers to the organic integration of various functions held by the Alfresa Group to establish a seamless supply chain, providing integrated services from the introduction/development and manufacturing of pharmaceuticals to logistics/sales and post-marketing surveillance, all as a group.

*2 CDMO: Contract Development and Manufacturing Organization. A specialized organization that undertakes contract services from the development of pharmaceutical manufacturing processes to the manufacturing of clinical trial drugs and commercial products.

*3 CRO: Contract Research Organization. A specialized organization that supports a series of operations related to clinical trials conducted by pharmaceutical companies and research institutions, as well as post-marketing surveillance (PMS) to ensure quality, efficacy, and safety after pharmaceuticals and medical devices are sold.

2. Details of Capital and Business Alliance

(1) Details of Capital Alliance

1 Number of ReeNT shares to be newly acquired: 1,000 common shares

2 Total payment amount: 600 million yen

3 Ratio to issued shares (after this investment): 16.1%

4 Use of funds: Research, development, manufacturing, approval acquisition, launch, and related or reasonably associated business activities for the autologous nasal mucosal epithelial cell sheet and its successors (hereinafter referred to as "the Product") developed by ReeNT.

(2) Details of Business Alliance

We and ReeNT will collaborate towards the development and commercialization of the Product in Japan. In conjunction with ReeNT, our group will provide comprehensive support in each area of clinical development support, manufacturing, and distribution related to the Product, utilizing the CRO, manufacturing, and distribution functions possessed by our group.

3. Company Profile of Counterparty (ReeNT) (As of May 27, 2026)

4. Schedule

Date of Capital and Business Alliance Agreement: May 27, 2026

5. Future Outlook

While the impact of this matter on the current fiscal year's performance is expected to be minor, we believe it will contribute to the improvement of our group's corporate value in the medium to long term.

We will promptly announce any matters that require disclosure regarding this matter in the future.

End