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Occurring Fact4588Oncolys BioPharma Inc.Pharmaceuticals

Notice Regarding the Start of Dosing in a Clinical Trial Aimed at Establishing a New Indication for the Oncolytic Virus Telomelysin Injection

Dosing of the first patient has begun in a Phase 1b/2a clinical trial of Telomelysin injection (OBP-301) for lower rectal cancer and anal cancer. Efficacy and safety will be evaluated with six combined doses of preoperative chemoradiotherapy and Telomelysin injection.

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Neutral
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Scale
6
times (number of combination doses)
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Conditional
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Initiation of dosing in a clinical trial aimed at a new indication for the oncolytic virus Telomelysin® injection

Subject Entity

Oncolys BioPharma Inc.

Target Locations / Products

Lower rectal cancer and anal cancer, Telomelysin® injection (development code: OBP-301)

This disclosure10/30/2026
Amount of Impact on Business Performance

Amount: Not disclosed (the impact on financial results for the fiscal year ending December 2026 is immaterial)

Accounting period in which recognized

Fiscal year ending December 2026

Impact on Earnings Forecast

The impact on financial results for the fiscal year ending December 2026 is immaterial.

Outlook

In this trial, we will evaluate efficacy and safety against localized cancer and continue to pursue the realization of a healthcare system that does not require stoma creation.

Event that occurred
ItemDetails
Event nameInitiation of dosing in a clinical trial aimed at a new indication for the oncolytic virus Telomelysin® injection
Subject EntityOncolys BioPharma Inc.
Target Locations / ProductsLower rectal cancer and anal cancer, Telomelysin® injection (development code: OBP-301)
Amount of Impact on Business PerformanceAmount: Not disclosed (the impact on financial results for the fiscal year ending December 2026 is immaterial)
Accounting period in which recognizedFiscal year ending December 2026
Impact on Earnings ForecastThe impact on financial results for the fiscal year ending December 2026 is immaterial.
OutlookIn this trial, we will evaluate efficacy and safety against localized cancer and continue to pursue the realization of a healthcare system that does not require stoma creation.
Items this document does not state (18)
Date of occurrenceDate recognized / date notice receivedCauseType 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 changePlanned follow-up disclosure

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 pursue a new indication and evaluate efficacy and safety in localized lower rectal cancer and anal cancer. In addition, to pursue the realization of a healthcare system that does not require stoma creation.

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Notice Regarding the Start of Dosing in a Clinical Trial Aimed at Establishing a New Indication for the Oncolytic Virus Telomelysin Injection | Oncolys BioPharma Inc. (4588) timely disclosure | Komori