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Occurring Fact4588Oncolys BioPharma Inc.Pharmaceuticals

Notice of Subcommittee Meeting on Marketing Approval for the Oncolytic Virus OBP-301

The Ministry of Health, Labour and Welfare announced that it will hold a subcommittee meeting on 21 May 2026 to deliberate whether to grant marketing approval for the oncolytic virus OBP-301 and other matters. Approval has not yet been decided, but the Company is maintaining its plan to begin sales in the fiscal year ending December 2026.

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Subcommittee Meeting Concerning Marketing Approval for Oncolytic Virus OBP-301

Subject Entity

Oncolys BioPharma Inc.

Target Locations / Products

Oncolytic virus OBP-301 (Suratadenoturev), with esophageal cancer as the initial indication

Occurrence14 May 2026 (the date the subcommittee meeting was announced; the scheduled meeting date is 21 May 2026)
Same day
Awareness or receipt of notice14 May 2026 (announcement by the Ministry of Health, Labour and Welfare)
This disclosure05/14/2026
Amount of Impact on Business Performance

None (there is no impact on the Company's financial results for the fiscal year ending December 2026)

Accounting period in which recognized

Fiscal year ending December 2026

Impact on Earnings Forecast

This matter will have no impact on the Company's financial results for the fiscal year ending December 2026. The Company plans to begin sales of OBP-301 as scheduled during the fiscal year ending December 2026.

Related procedures

Type

Deliberation by the Pharmaceutical Affairs and Food Sanitation Council on whether to grant marketing approval and whether the product qualifies for conditional and time-limited approval

Court or authority

Ministry of Health, Labour and Welfare; Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council

Outlook

The subcommittee will deliberate whether to grant marketing approval for OBP-301 and other matters. The Company plans to begin sales of OBP-301, with esophageal cancer as the initial indication, as scheduled during the fiscal year ending December 2026.

Event that occurred
ItemDetails
Event nameSubcommittee Meeting Concerning Marketing Approval for Oncolytic Virus OBP-301
Date of occurrence14 May 2026 (the date the subcommittee meeting was announced; the scheduled meeting date is 21 May 2026)
Date recognized / date notice received14 May 2026 (announcement by the Ministry of Health, Labour and Welfare)
Subject EntityOncolys BioPharma Inc.
Target Locations / ProductsOncolytic virus OBP-301 (Suratadenoturev), with esophageal cancer as the initial indication
Amount of Impact on Business PerformanceNone (there is no impact on the Company's financial results for the fiscal year ending December 2026)
Accounting period in which recognizedFiscal year ending December 2026
Impact on Earnings ForecastThis matter will have no impact on the Company's financial results for the fiscal year ending December 2026. The Company plans to begin sales of OBP-301 as scheduled during the fiscal year ending December 2026.
Type of litigation or proceedingDeliberation by the Pharmaceutical Affairs and Food Sanitation Council on whether to grant marketing approval and whether the product qualifies for conditional and time-limited approval
Court or authorityMinistry of Health, Labour and Welfare; Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council
OutlookThe subcommittee will deliberate whether to grant marketing approval for OBP-301 and other matters. The Company plans to begin sales of OBP-301, with esophageal cancer as the initial indication, as scheduled during the fiscal year ending December 2026.
Items this document does not state (14)
CausePlaintiffDefendantDate 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.

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Notice of Subcommittee Meeting on Marketing Approval for the Oncolytic Virus OBP-301 | Oncolys BioPharma Inc. (4588) timely disclosure | Komori