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Occurring Fact4570Immuno-Biological Laboratories Co.,Ltd.Pharmaceuticals

(Progress on Previously Disclosed Matter) Notice Concerning a GLP-Compliant Repeated-Dose Toxicity Study of an Anti-HIV Antibody

The animal study portion of the 4-week repeated-dose toxicity study of the anti-HIV antibody being developed by CURED has been completed as planned. However, the final report, including data analysis and pathological examinations, is still being prepared, and the final assessment, including the no-observed-adverse-effect level, has not yet been finalized.

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Completion of the Animal Study Portion of the GLP-Compliant Repeated-Dose Toxicity Study of an Anti-HIV Antibody

Subject Entity

CURED Co., Ltd.

Target Locations / Products

The anti-HIV antibody being developed by CURED

This disclosure08/26/2026
Impact on Earnings Forecast

No impact from this matter on the Company's consolidated results for the fiscal year ending March 2026 is anticipated.

Related procedures

Court or authority

PMDA (the Pharmaceuticals and Medical Devices Agency)

Outlook

After receiving the final study report, CURED will promptly review its contents and provide a further update as necessary. Based on these results, the company plans to proceed as scheduled with preparations for initiating clinical trials, including consultations with PMDA.

Planned follow-up disclosure

A further update will be provided as necessary after the final study report has been reviewed.

Event that occurred
ItemDetails
Event nameCompletion of the Animal Study Portion of the GLP-Compliant Repeated-Dose Toxicity Study of an Anti-HIV Antibody
Subject EntityCURED Co., Ltd.
Target Locations / ProductsThe anti-HIV antibody being developed by CURED
Impact on Earnings ForecastNo impact from this matter on the Company's consolidated results for the fiscal year ending March 2026 is anticipated.
Court or authorityPMDA (the Pharmaceuticals and Medical Devices Agency)
OutlookAfter receiving the final study report, CURED will promptly review its contents and provide a further update as necessary. Based on these results, the company plans to proceed as scheduled with preparations for initiating clinical trials, including consultations with PMDA.
Planned follow-up disclosureA further update will be provided as necessary after the final study report has been reviewed.
Items this document does not state (18)
Date of occurrenceDate recognized / date notice receivedCauseAmount of Impact on Business PerformanceAccounting period in which recognizedType of litigation or proceedingPlaintiffDefendantDate of filing / date of actionClaim amount / surcharge amountAmount of receivables at risk of non-collection or delayed collectionSuspended operationsScheduled resumption dateInvestigation structureMeasures to prevent recurrenceDirectors' and officers' liabilityVoting rights ownership percentage before the changeVoting rights ownership percentage after the change

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.

The animal study portion was completed as planned, and no serious abnormalities were reported in the animals' general condition observations during the study period. However, the final assessment will be finalized after the final study report has been received and reviewed.

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(Progress on Previously Disclosed Matter) Notice Concerning a GLP-Compliant Repeated-Dose Toxicity Study of an Anti-HIV Antibody | Immuno-Biological Laboratories Co.,Ltd. (4570) timely disclosure | Komori