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Management planning4594BrightPath Biotherapeutics Co.,Ltd.Pharmaceuticals

Notice Regarding the Review of the Development Pipeline

BP1200, BP1202, BP1210 and BP1209 have been removed from the development pipeline, and the policy is to make no further investments in personnel or funding in these areas. Meanwhile, development of BP1212 and BP1223, among others, will continue, with BP2202 as the core program.

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Items stated in the management plan

Partially revised
Publication date 14 May 2026

This document does not state the plan name, plan period, or numerical targets.

Key initiatives
01Continue to advance the clinical development of the iPS cell-derived CAR-T cell therapy (BP2202) as a core initiative
Risks identified by the company
The leading development programs may fail to demonstrate the efficacy initially expected of them to a sufficient degree, resulting in the discontinuation of development
The possibility of having a clear competitive advantage capable of overturning the results of the leading development programs may be limited
A sharp increase in manufacturing costs due to an increase in the number of peptides incorporated into the product
Competition with mRNA vaccines whose manufacturing costs have been optimized may become difficult
Reason for revision or withdrawal

To strategically review the development pipeline and optimize the allocation of management resources in light of recent changes in the drug discovery business environment. After comprehensively considering the clinical trial results and other factors relating to similar development programs ahead of these programs, the Company determined that the feasibility of obtaining regulatory approval had declined significantly. For BP1209, the sharp increase in the number of peptides incorporated into the product caused manufacturing costs to rise sharply, making competition with mRNA vaccines difficult.

Items stated in the management plan
ItemDetails
Progress against the planPartially revised
Key initiativesContinue to advance the clinical development of the iPS cell-derived CAR-T cell therapy (BP2202) as a core initiative
Reason for revision or withdrawalTo strategically review the development pipeline and optimize the allocation of management resources in light of recent changes in the drug discovery business environment. After comprehensively considering the clinical trial results and other factors relating to similar development programs ahead of these programs, the Company determined that the feasibility of obtaining regulatory approval had declined significantly. For BP1209, the sharp increase in the number of peptides incorporated into the product caused manufacturing costs to rise sharply, making competition with mRNA vaccines difficult.
Risks identifiedThe leading development programs may fail to demonstrate the efficacy initially expected of them to a sufficient degree, resulting in the discontinuation of development, The possibility of having a clear competitive advantage capable of overturning the results of the leading development programs may be limited, A sharp increase in manufacturing costs due to an increase in the number of peptides incorporated into the product, Competition with mRNA vaccines whose manufacturing costs have been optimized may become difficult
Publication date14 May 2026
Items this document does not state (20)
Plan namePlan periodSales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceTotal investment planInvestment amount by sectorSegment targetNon-financial targetsPlan assumptionsResults under the previous planSize of the Target MarketDate of board resolution

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The reasons the company gives

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

To optimize the allocation of management resources in light of recent changes in the drug discovery business environment. Based on the clinical trial results of similar development programs ahead of these programs, among other factors, the Company determined that the feasibility of obtaining regulatory approval and the likelihood of having a clear competitive advantage capable of overturning the results of the leading programs had declined significantly. For BP1209, competition with mRNA vaccines became difficult because the increase in the number of peptides incorporated into the product raised manufacturing costs.

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Notice Regarding the Review of the Development Pipeline | BrightPath Biotherapeutics Co.,Ltd. (4594) timely disclosure | Komori