■The status of business partnership and license agreement of Helios <4593>.

1. Business partnership agreement with Alfresa.

In June 2024, a basic business partnership agreement regarding the distribution and sales of products handled by Alfressa, the top domestic drug distribution company, was concluded, along with the purchase agreement of 1.6 billion yen in ordinary corporate bonds (first and second issues).

The specific contents of the business partnership are as follows: three.

1) Exclusive wholesale distribution rights for pipeline products including HLCM051 within the country, and exclusive rights related to the transportation and distribution of clinical trial products concerning that pipeline domestically.

2) Business development of cultured supernatant of HLCM051 and products using such supernatant as raw materials, as well as the rights for overall dealership or exclusive sales of these products within the country.

3) Business development of the automatic frozen thawing inventory management system SIFU and exclusive sales rights for this product within the country.

Furthermore, the details of the business will be individually contracted through future consultations. This business partnership will resolve logistical issues in expanding operations within the country.

2. A licensing agreement has been concluded with a subsidiary of astellas pharma.

In June 2024, a licensing agreement was concluded with the Astellas Institute for Regenerative Medicine (hereinafter referred to as AIRM), a subsidiary of astellas pharma in the usa, for a non-exclusive license regarding the manufacturing method of iPSC-derived RPE cells shared with RIKEN and osaka universities, as well as the purification method of RPE cells shared with osaka university, covering all areas of the world excluding japan. A one-time payment of 3 million usd was received in July 2024, and there is a possibility of receiving up to 8 million usd as milestone compensation when products developed and manufactured by AIRM using this patent are approved for manufacturing and sale in the usa.

Cells that form the retinal pigment epithelium located outside the neural retinal layer. They are in contact with photoreceptors, which are the light receptors, and have physiological functions for their maintenance and protection. When RPE cells are lost, they do not regenerate, resulting in permanent impairment of visual function. Research on the transplantation of iPSC-derived RPE cells is gaining attention as a treatment method for age-related macular degeneration.

(Written by FISCO guest analyst, Jo Sato)