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Occurring Fact4893Noile-Immune Biotech Inc.Pharmaceuticals

Notice of First Patient Dosed in the NIB103 Phase I Clinical Trial

The first patient was dosed in the Phase I clinical trial of NIB103 for solid tumors in Japan. The trial has therefore entered the patient-dosing stage.

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First Patient Dosed in the NIB103 Phase I Clinical Trial

Subject Entity

Noile-Immune Biotech Inc. (co-developing the product in Japan with TAKARA BIO INC.)

Target Locations / Products

Japan; NIB103 (PRIME CAR-T cells)

This disclosure03/24/2026
Accounting period in which recognized

Fiscal year ending December 2026

Impact on Earnings Forecast

The impact of this matter on the Company's results for the fiscal year ending December 2026 is expected to be minor. The Company will promptly disclose any matters requiring disclosure in the future.

Outlook

Based on the results of this trial, the Company plans to conduct the subsequent clinical trials required. The Company will promptly disclose any matters requiring disclosure in the future.

Event that occurred
ItemDetails
Event nameFirst Patient Dosed in the NIB103 Phase I Clinical Trial
Subject EntityNoile-Immune Biotech Inc. (co-developing the product in Japan with TAKARA BIO INC.)
Target Locations / ProductsJapan; NIB103 (PRIME CAR-T cells)
Accounting period in which recognizedFiscal year ending December 2026
Impact on Earnings ForecastThe impact of this matter on the Company's results for the fiscal year ending December 2026 is expected to be minor. The Company will promptly disclose any matters requiring disclosure in the future.
OutlookBased on the results of this trial, the Company plans to conduct the subsequent clinical trials required. The Company will promptly disclose any matters requiring disclosure in the future.
Planned follow-up disclosureThe Company will promptly disclose any matters requiring disclosure in the future.
Items this document does not state (18)
Date of occurrenceDate recognized / date notice receivedCauseAmount of Impact on Business PerformanceType of litigation or proceedingCourt or authorityPlaintiffDefendantDate 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.

No specific reason for dosing is stated. The trial is intended primarily to evaluate safety and tolerability, with antitumor efficacy and cellular kinetics as secondary endpoints.

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Notice of First Patient Dosed in the NIB103 Phase I Clinical Trial | Noile-Immune Biotech Inc. (4893) timely disclosure | Komori