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Regarding HLCM051 for Acute Respiratory Distress Syndrome (ARDS) Caused by COVID -19

TOKYO, March 26, 2020 /PRNewswire/ -- HEALIOS K.K. ("Healios") is developing new treatments for Acute Respiratory Distress Syndrome (ARDS)1 and Ischemic Stroke in Japan using the stem cell product HLCM051 (MultiStem®). Healios continues to make enrolment progress in its Phase 2 clinical study in Japan to confirm the safety and efficacy of HLCM051 in pneumonia-induced ARDS patients (the ONE-BRIDGE study).

ARDS is a general term for the symptoms of acute respiratory failure suddenly occurring in seriously ill patients. The major causes are severe pneumonia, septicemia, trauma, etc. Inflammatory cells are activated in response to these diseases or injuries, causing damage to the tissue of the lungs. As a result, water accumulates in the lungs, leading to acute respiratory failure.

According to the data published on the initial group of cases of the new coronavirus (COVID-19) in Wuhan, 31 to 41.8% of hospitalized patients developed ARDS and 54 to 93% of these patients died1,2, indicating that ARDS is a major cause of mortality in COVID-19 patients.

In Healios' ONE-BRIDGE study, the current inclusion criteria provide that patients who develop pneumonia-induced ARDS caused by COVID -19 are eligible for enrolment. We are currently in discussions with medical specialists and the Pharmaceuticals and Medical Devices Agency (PMDA) regarding how to move forward with COVID-19 patients in relation to our clinical trial.

Healios has received inquiries from various stakeholders regarding this important subject and is therefore announcing the current situation. We will promptly disclose any additional information as required.

On March 16 (local time), Athersys, Inc., our partner company based in the United States, announced that Multistem was designated by the Biomedical Advanced Research and Development Authority (BARDA)3 as "Highly Relevant" for development as a therapeutic agent in relation to COVID-19 induced ARDS.

1   Zhou F, et al. Lancet. 2020 Mar 11. pii: S0140-6736(20)30566-3
2   Wu C , et al. JAMA Intern Med. 2020 Mar 13. doi: 10.1001
(Note) As the above two reports studied the initial group of patients, the incidence rate and mortality of ARDS patients is expected to fluctuate depending on the current situation in each country.
3   BARDA is a division of the United States Department of Health and Human Services that deals primarily with bioterrorism, the threat of chemical weapons and radiation, pandemic influenza and emerging diseases.

About Healios

Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. Its aim is to offer new therapies for patients suffering from diseases without effective treatment options.

Healios's near-term pipeline includes its Somatic Stem Cell (SSC) platform products, with candidate HLCM051 currently being evaluated in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively.  HLCM051 is in-licensed from Athersys, Inc.

Healios is a pioneer in the development of regenerative medicines in Japan, using gene-modified induced pluripotent stem cells (iPSCs) to develop regenerative treatments in ophthalmology, liver diseases, and immuno-oncology cell therapies targeting solid tumors.

Healios was established in 2011 and to date has raised over US$300 million in funds to support its growth and development. The Company is listed on the Tokyo stock exchange in 2015 (TSE Mothers: 4593). www.healios.co.jp

FOR MORE INFORMATION

Healios K.K.
Contact person: Tsuyoshi Taguchi
Email: ir@healios.jp

Citigate Dewe Rogerson
Frazer Hall, Nathaniel Dahan PhD, Mark Swallow PhD
Tel: +44 (0)20-7638-9571
Email: healios@citigatedewerogerson.com