HEALIOS K.K.

Business Details

The company advances R&D across two areas: somatic stem cell-based regenerative medicine products (HLCM051) and iPSC-based regenerative medicine products (eNK® cells, UDC, RPE cells, etc.). Revenue mainly consists of upfront license payments, milestone income, and culture supernatant sales. The company is in a pre-commercialization investment phase and continues to record operating losses. As of 1Q FY2026, it held ¥10,868 million in cash and cash equivalents, but material events exist regarding going concern assumptions.

Recent Overview

Raised ¥6,098 million through new share issuance, doubling cash on hand; preparations for the REVIVE-ARDS trial completed

In the first quarter of FY2026 (ending December 2026) (January to March), the company secured ¥7,146 million in cash flow from financing activities, mainly due to ¥6,109 million in proceeds from new share issuance, increasing cash and cash equivalents from ¥5,679 million to ¥10,868 million. Meanwhile, revenue declined sharply to ¥8 million (down 78.2% year-on-year), and the operating loss expanded to ¥1,130 million due to increased R&D expenses (¥798 million, up 65.5% year-on-year). Financial expenses of ¥2,659 million pushed the pre-tax loss to ¥3,464 million. The clinical trial notification for the REVIVE-ARDS trial was accepted by the PMDA in February 2026, completing preparations for the start of the trial. As a subsequent event, on April 30, 2026, the company reduced capital stock and capital reserve by ¥1,215 million each, transferring a combined ¥2,430 million to retained earnings to offset accumulated deficit. Material events regarding going concern assumptions continue to exist, but it has been determined that no note regarding going concern assumptions is required in the financial statements.

Key Products

Growth Drivers

• The clinical trial notification for the REVIVE-ARDS trial was accepted by the PMDA in February 2026, concretizing the path toward a domestic conditional and time-limited approval application
• Proceeds of ¥6,109 million from new share issuance (financing cash flow of ¥7,146 million) increased cash on hand to ¥10,868 million, securing funds to continue development
• Advancement of the CDMO Business through selection for a subsidy under the Ministry of Economy, Trade and Industry's FY2024 supplementary budget for regenerative/cell medicine and gene therapy manufacturing facility investment support (Kobe facility completion planned for January 2028)
• The joint business agreement with Akatsuki Therapeutics has improved funding flexibility and efficiency for eNK® cell R&D
• Establishment of a new revenue source through the start of full-scale culture supernatant production (Kobe BMA facility operation) and supply agreements concluded with Alfresa, JENECELL, and others
• Establishment of a commercial production partnership with Minaris Advanced Therapies (cost reduction and mass production through 3D bioreactor manufacturing process)
• An academic paper on the antitumor effects of eNK® cells against lung cancer was published in a peer-reviewed journal in March 2026, accumulating scientific evidence
• The grant of a Japanese patent for UDC (August 2025) formally recognized its uniqueness as a next-generation technology platform, expanding licensing-out opportunities

Risks

• Material events regarding going concern assumptions exist (1Q FY2026 operating loss of ¥1,130 million, operating cash flow of ¥(1,270) million); if fundraising is unsuccessful, additional cost reductions such as pipeline review and personnel expense cuts may be required
• Revenue is extremely low at ¥8 million (down 78.2% year-on-year), resulting in significantly low revenue stability and predictability
• R&D expenses surged to ¥798 million (up 65.5% year-on-year), accelerating the pace of cash consumption ahead of monetization
• Risk that discussions with regulatory authorities regarding conditional and time-limited approval applications for ARDS and acute cerebral infarction may not succeed
• Risk of delayed patient enrollment or trial failure in global Phase 3 trials such as REVIVE-ARDS
• Risk that fundraising will fall short of expected amounts if exercise of stock acquisition rights (21st, 22nd, 26th, and 27th series) does not proceed as planned
• Risk that clinical trial initiation and approval acquisition for the iPSC pipeline, including eNK® cells and UDC, may be prolonged
• Financial expenses remained high at ¥2,659 million (up 26.2% year-on-year), substantially expanding losses due to financial costs
• No earnings forecast has been disclosed (reasonable estimation is difficult), continuing to make it difficult for investors to assess the earnings outlook
• New revenue sources such as culture supernatant remain at the contract-signing stage, with actual sales contribution still limited