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Management planning4576D.Western Therapeutics Institute, Inc.Pharmaceuticals

Notice of the Decision on the Domestic Development Plan for the Glaucoma Treatment "H-1337"

A plan has been decided to advance development of the glaucoma treatment H-1337 in Japan ahead of the United States. A clinical trial consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) is planned during fiscal 2026, followed by a small-scale dose-confirmation study in Asians, primarily Japanese, in 2027, and the start of a domestic Phase III clinical trial in 2029.

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Items stated in the management plan

Formulated
Domestic Development Plan for the Glaucoma Treatment H-1337
Date of board resolution 3 September 2026 · Publication date 3 September 2026
Key initiatives
01Conduct a clinical trial consultation with the PMDA during fiscal 2026
02Conduct a small-scale dose-confirmation study in Asians, primarily Japanese, in 2027
03Start a domestic Phase III clinical trial in 2029
04Begin development in Japan with a small-scale dose-confirmation study in Asians, primarily Japanese, and then move promptly to a domestic Phase III clinical trial
05Continue considering commercialization, including future clinical development and out-licensing
Plan assumptionsClinical trials must be conducted in accordance with Japanese regulatory requirements, Make maximum use of development data accumulated overseas to date
Risks identified by the company
Conducting clinical trials in accordance with Japanese regulatory requirements
Development costs
Development risks
Reason for revision or withdrawal

Following the capital and business alliance with Senju Pharmaceutical Co., Ltd., the policy was changed to prioritize development in Japan. A development plan has been adopted that aims to obtain approval while making maximum use of development data accumulated overseas to date and containing the development costs and risks required before commercialization.

Items stated in the management plan
ItemDetails
Plan nameDomestic Development Plan for the Glaucoma Treatment H-1337
Progress against the planFormulated
Plan assumptionsClinical trials must be conducted in accordance with Japanese regulatory requirements, Make maximum use of development data accumulated overseas to date
Key initiativesConduct a clinical trial consultation with the PMDA during fiscal 2026, Conduct a small-scale dose-confirmation study in Asians, primarily Japanese, in 2027, Start a domestic Phase III clinical trial in 2029, Begin development in Japan with a small-scale dose-confirmation study in Asians, primarily Japanese, and then move promptly to a domestic Phase III clinical trial, Continue considering commercialization, including future clinical development and out-licensing
Reason for revision or withdrawalFollowing the capital and business alliance with Senju Pharmaceutical Co., Ltd., the policy was changed to prioritize development in Japan. A development plan has been adopted that aims to obtain approval while making maximum use of development data accumulated overseas to date and containing the development costs and risks required before commercialization.
Risks identifiedConducting clinical trials in accordance with Japanese regulatory requirements, Development costs, Development risks
Date of board resolution3 September 2026
Publication date3 September 2026
Items this document does not state (17)
Plan 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 targetsResults under the previous planSize of the Target Market

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The reasons the company gives

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

The policy was changed to prioritize development in Japan following the capital and business alliance with Senju Pharmaceutical Co., Ltd. The aim is to obtain approval while making maximum use of development data accumulated overseas and containing the development costs and risks required before commercialization.

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Notice of the Decision on the Domestic Development Plan for the Glaucoma Treatment "H-1337" | D.Western Therapeutics Institute, Inc. (4576) timely disclosure | Komori