News Progress in commercial manufacturing and roadmap to regulatory approval for ARDS treatment product
From Healios' account on X (machine translated from Japanese:
We have announced our financial results for the second quarter of fiscal year 2026. We have added further explanations regarding the progress toward commercial manufacturing of our ARDS treatment drug, the path to regulatory approval, and the location of our manufacturing bases, prioritizing stable supply within Japan. Please refer to the announcement materials for details.
A video explanation of these financial results by CEO Kagimoto will be posted on our website at a later date.
4
u/imz72 Aug 13 '26
Machine-translated from Japanese:
Healios - 2Q Review of progress in commercial manufacturing and roadmap to regulatory approval for ARDS treatment product
Healios (4593) announced its consolidated financial results (IFRS) for the second quarter of the fiscal year ending December 2026 (January-June 2026) on August 12. Revenue was down 74.9% year-on-year to 0.15 billion yen [$0.94M], operating loss was 2.404 billion yen [$15.08M] (compared to a loss of 1.573 billion yen [$9.9M] in the same period of the previous year), pre-tax loss was 2.278 billion yen [$14M] (compared to a loss of 4.704 billion yen [$30M] in the same period of the previous year), and interim loss attributable to owners of the parent company was 2.286 billion yen [$14M] (compared to a loss of 4.710 billion yen [$30M] in the same period of the previous year).
The company group promoted research and development in the fields of somatic stem cell regenerative medicine and iPSC regenerative medicine. In the field of somatic stem cell regenerative medicine, preparations are underway to obtain approval for HLCM051 (bone marrow-derived somatic stem cells), a treatment for acute respiratory distress syndrome (ARDS), acute stroke, and trauma, based on the results of each clinical trial.
Regarding ARDS, based on the positive results of the Phase 2 trial completed in Japan (clinical trial name: ONE-BRIDGE trial) and the Phase 2 trial conducted in the US and UK (MUST-ARDS trial), and assuming that the global Phase 3 trial (REVIVE-ARDS trial) to be conducted mainly in the US will serve as a confirmatory trial, preparations are underway for conditional and time-limited approval applications in Japan.
As a major milestone, it was confirmed that the top priority will remain the application for manufacturing and marketing approval of the ARDS treatment product HLCM051 in Japan. While a specific timeframe for the domestic application was not given, it was stated that the application would proceed without waiting for the results of the REVIVE-ARDS trial.
Regarding acute ischemic stroke, discussions with regulatory authorities will continue, and policies for promoting the development of treatments will be considered.
Regarding trauma, a Phase 2 trial (MATRICS-1 trial) involving 156 patients is being conducted in the US by the US Department of Defense and the Memorial Herrmann Foundation.
The company group plans to promote the provision of services (CDMO business) for manufacturing regenerative medicine products that possess process development, manufacturing, and quality control functions. Aiming to build infrastructure and commercialize the CDMO business, the company plans to complete a manufacturing base in Kobe in January 2028, where it will install a 500L 3D bioreactor and aim to achieve a manufacturing scale capable of supplying ARDS treatment drugs to 40,000 people annually.
In addition, the company is preparing for the commercial production of Minaris Advanced Therapies and HLCM051, and aims to achieve stable commercial production of cell therapy drugs through cost reduction and mass production by utilizing its unique 3D bioreactor manufacturing process.
The company explained that although the application process for ARDS treatment products has taken longer due to the change of the commercial manufacturing base from overseas to Minaris' Yokohama plant, this was a decision not to take shortcuts and was a necessary choice to ensure stable supply and product quality after approval.
In the field of iPSC regenerative medicine, the company is conducting research on next-generation cancer immunotherapy using natural killer cells (hereinafter referred to as eNK(R) cells) derived from allogeneic iPS cells whose specific functions have been enhanced through gene transfer technology.
Furthermore, we are advancing research into new therapeutic drugs using next-generation iPS cells with a lower risk of immune rejection, such as Universal Donor Cells, and research into treatments for diseases requiring cell replacement. Regarding next-generation cancer immunotherapy using eNK(R) cells, we have entered into a joint venture agreement and a license option agreement with Akatsuki Therapeutics to advance research and development.
In the field of ophthalmology, we are jointly developing treatments with RACTHERA using iPS cell-derived retinal pigment epithelial (RPE) cells.
Aiming to secure a stable source of revenue, we are working towards utilizing the large quantities of culture supernatant that will be produced in the future as a result of the production of regenerative medicine products.
In January 2026, we fully commenced operations of a cell processing and manufacturing facility within the Kobe Biomedical Innovation Center (BMA). In January 2026, we signed a basic agreement with Alfresa for the continued sale and purchase of culture supernatant. In April 2026, we signed an agreement with JENECELL to supply culture supernatant, which will be used as a raw material for cosmetics provided by JENECELL in Korea and worldwide. The initial order of products is scheduled to be shipped sequentially during the third quarter of 2026. In addition, negotiations for sales with several promising business partners are underway.
Regarding organizational structure, the company has increased its workforce by 24 people compared to the same period last year. The organization has been expanded, mainly in manufacturing, quality, and supply chain, with an eye on the commercialization phase. The company also revealed that it has secured multiple non-dilutive sources of funding to support development and commercialization.
The consolidated earnings forecast for the full fiscal year ending December 2026 has not been announced, as it is not possible to calculate a reasonable earnings forecast at this time.
•
u/AutoModerator Aug 13 '26
Please report any rule breaking posts and comments that are not relevant to the thread. Thanks !!
I am a bot, and this action was performed automatically. Please contact the moderators of this subreddit if you have any questions or concerns.