ENVALITH
株式会社ヘリオス logo

HEALIOS K.K.

4593・Growth Market・Pharmaceuticals

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株式会社ヘリオス logo
HEALIOS K.K.4593

Business

Helios K.K., under the mission "To Grow Life. Explosively.", is a single-segment biotech company engaged in the research, development, and manufacturing of somatic stem cell regenerative medicines (HLCM051) and iPSC-derived regenerative medicines (eNK cells, RPE cells, liver bud, etc.). The company targets disease areas with high unmet medical needs for which no existing treatment exists, such as ARDS, acute-phase cerebral infarction, trauma, solid tumors, and age-related macular degeneration, and aims to obtain regulatory approval while collaborating with regulatory authorities, research institutions, and pharmaceutical companies both in Japan and overseas. The company listed on the Tokyo Stock Exchange Mothers market (now the Growth Market) in 2015. It operates its business as a group including 7 consolidated subsidiaries.

Business Model

Current revenue consists primarily of upfront and milestone payments under licensing agreements (¥104 million in FY2025), with no product sales revenue generated yet. Research and development expenses (¥2,024 million in FY2025) and selling, general and administrative expenses (¥1,265 million in the same period) precede revenue generation, resulting in continued operating losses. Funding is secured through diverse means including third-party allotment capital increases, share subscription rights, corporate bond issuance, government subsidies, and fund investments from external investors. Following regulatory approval, the company aims to generate revenue through product sales, the CDMO Business, and culture supernatant sales.

Company Strengths

In April 2024, the company acquired substantially all assets of the bankrupt U.S. company Athersys, gaining global development, manufacturing, and marketing rights to MultiStem (HLCM051). It has received Fast Track and RMAT designations from the U.S. FDA, and in Japan has obtained Orphan Regenerative Medicine Product designation and SAKIGAKE Designation, securing multiple regulatory advantages.

For the ARDS treatment HLCM051, the company has reached general agreement with the PMDA on manufacturing method, quality control, and clinical sections. In January 2026, it submitted a clinical trial notification for the REVIVE-ARDS study to the PMDA, concretizing the path toward a domestic conditional and time-limited approval application. The company also reached agreement with the U.S. FDA in September 2024 on the design of a global Phase 3 trial.

The company has built multilayered external partnerships across funding, sales channels, and manufacturing, including a business alliance with Alfresa (wholesale distribution rights and culture supernatant sales), a joint business agreement on eNK cells with Akatsuki Therapeutics, a commercial production collaboration framework with Minaris Advanced Therapies, and selection for a Ministry of Economy, Trade and Industry subsidy (FY2024 supplementary budget CDMO support).

ENVALITH's Perspective

The PMDA acceptance in February 2026, which enabled initiation of the REVIVE-ARDS trial, is a positive development that has made concrete progress toward the path to conditional and time-limited approval application in Japan. However, the timeline for completion of the Phase 3 trial, filing, approval, and commercial launch remains uncertain, making it difficult to forecast the timing of monetization. As an external tailwind, strengthened government support for the regenerative medicine field (such as the establishment of a conditional approval system for iPSC-derived products) is favorable, but this is not sufficient to offset the company-specific development risks.

Revenue for the first quarter of FY2026 (ending December 2026) fell sharply to ¥8 million (down 78.2% year on year), while the operating loss widened to ¥1,130 million (versus ¥744 million in the same period of the prior year). Research and development expenses also increased substantially to ¥798 million (versus ¥482 million in the same period of the prior year), and this cost increase trend is expected to continue as the REVIVE-ARDS trial moves into full swing. Within the pre-tax loss of ¥3,464 million, financial expenses account for ¥2,659 million, a structure that warrants close attention. New revenue sources such as culture supernatant sales are only just getting started and remain too small in scale to offset the losses.

The number of shares outstanding increased approximately 16.7%, from 115,727,200 shares at the end of the previous fiscal year to 135,002,200 shares at the end of the current quarter, reflecting continuous dilution. Operating cash outflow is running at a pace of ¥1,270 million per quarter, and while the cash on hand of ¥10,868 million is equivalent to roughly two years of operating cash flow, self-sustaining operation without additional fundraising is difficult. The earnings report explicitly states that there is a situation raising material doubt about the going concern assumption, and earnings guidance is undisclosed due to the difficulty of reasonable estimation. These factors are the primary constraints on investment decisions regarding the stock.

Growth Strategy

Building near-term momentum toward conditional approval of HLCM051 while establishing mid- to long-term revenue foundations through the CDMO Business, culture supernatant, and eNK® cells

The clinical trial notification for the REVIVE-ARDS trial was accepted by the PMDA in February 2026, and following the first patient enrollment in Japan, global expansion centered on the U.S. is being accelerated. Building on favorable results from both the ONE-BRIDGE and MUST-ARDS trials, the company aims to file for conditional approval.

With support from a subsidy awarded by the Ministry of Economy, Trade and Industry, completion of the Kobe manufacturing site is planned for January 2028. A 500L 3D bioreactor will be installed, targeting an annual supply capacity of ARDS treatment for 40,000 patients. A commercial production collaboration framework with Minaris Advanced Therapies is also being established.

The cell processing manufacturing facility within Kobe BMA began full-scale operation in January 2026. A basic sales agreement was concluded with Alfresa (January 2026), and a supply agreement was concluded with JENECELL (April 2026); raw material supply to AND medical has also commenced. Negotiations with several other leading business partners are ongoing.

Research and development of eNK® cells is being made more efficient through a joint business agreement with Akatsuki Therapeutics. Consultations with the PMDA and the U.S. FDA are underway ahead of trial initiation, and in March 2026 a paper on the anti-tumor effects against lung cancer was published in a peer-reviewed journal, accumulating scientific evidence.

For UDC (Universal Donor Cell), for which a Japanese patent was granted in August 2025, the company is evaluating applicability through cell provision to 10 or more companies in Japan and overseas. The liver disease field (HLCL041) is being carved out in preparation for joint development with venture capital firms and others. Licensing out to pharmaceutical companies aims to reduce development and financial risk.

Last updated: July 17, 2026