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Other Disclosures4593HEALIOS K.K.Pharmaceuticals

A paper on establishing Direct qPCR to evaluate the biodistribution of Helios eNK cells in mice has been published in Regenerative Therapy

A paper on the Direct qPCR method for evaluating the distribution in mice of eNK® cells (HLCN061) developed by Helios was published in the peer-reviewed academic journal "Regenerative Therapy."

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Announced details

eNK® cellsHLCN061(AKT-01)Direct qPCR method
Applicable field (uses covered by this announcement)

Nonclinical in vivo distribution evaluation of cell therapy products; cancer immunocellular therapy

What the company reported numerically
Quantitative Effects

R² above 0.99; PCR amplification efficiency of 90%–110%; RE values within ±25%; CV values within 25% except for 1 case. LLOQ was 0.25 cells/mg of tissue weight in the liver, lungs, kidneys and heart; 1 cell/mg of tissue weight in the spleen and ovaries; and 0.3 cells/μL in blood.

Relationship between the counterparty and the company
HEALIOS K.K.4593
Relationship with the Company

Development partner for the eNK® cell therapy AKT-01/HLCN061. Akatsuki is leading development.

CounterpartyAkatsuki Therapeutics

Head office: 8-1 Kakuda-cho, Kita-ku, Osaka; Representative Director: Yamazaki Junya (山﨑順也). A biotechnology company developing next-generation cellular immunotherapies for cancer and other serious diseases.

Location (as indicated in this announcement)

Kobe Research Institute (Kobe; affiliation of the paper's authors)

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

Peer-reviewed journal "Regenerative Therapy"; Manuscript Number: 33 (2026) 101189

Announced details
ItemDetails
Names of Products / Services CoveredeNK® cells, HLCN061(AKT-01), Direct qPCR method
CounterpartyAkatsuki Therapeutics
Counterparty overviewHead office: 8-1 Kakuda-cho, Kita-ku, Osaka; Representative Director: Yamazaki Junya (山﨑順也). A biotechnology company developing next-generation cellular immunotherapies for cancer and other serious diseases.
Relationship with the CompanyDevelopment partner for the eNK® cell therapy AKT-01/HLCN061. Akatsuki is leading development.
Applicable areaNonclinical in vivo distribution evaluation of cell therapy products; cancer immunocellular therapy
LocationKobe Research Institute (Kobe; affiliation of the paper's authors)
Quantitative EffectsR² above 0.99; PCR amplification efficiency of 90%–110%; RE values within ±25%; CV values within 25% except for 1 case. LLOQ was 0.25 cells/mg of tissue weight in the liver, lungs, kidneys and heart; 1 cell/mg of tissue weight in the spleen and ovaries; and 0.3 cells/μL in blood.
SourcePeer-reviewed journal "Regenerative Therapy"; Manuscript Number: 33 (2026) 101189
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleUsage historyImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To report research findings establishing an effective Direct qPCR method for quantitative evaluation in nonclinical in vivo distribution studies of eNK® cells.

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A paper on establishing Direct qPCR to evaluate the biodistribution of Helios eNK cells in mice has been published in Regenerative Therapy | HEALIOS K.K. (4593) timely disclosure | Komori