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28Immaterial
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How definitive the wording is.Items stated in the management plan
Annual updateKey initiatives
01Establish a foundation for growth through a clinical-stage pipeline centered on the SMTP compound series
02Bridge Japanese academic drug discovery seeds and the global pharmaceutical industry
03Global Phase 2/3 clinical trial of TMS-007 (JX10), ORION, underway
04TMS-008: Phase 1 clinical trial completed; moving to a Phase 2a clinical trial for acute kidney injury (AKI)
05Status of JX09
06Introduction of new drug discovery seeds and resolvin analogues from Hokkaido University
07Joint research on sEH inhibitors
08Financing
Plan assumptionsPotential expansion of the window for administering TMS-007 after symptom onset to 12 or 24 hours, Estimated potential eligibility rate for TMS-007 of 75%, Assumption that 1 hour is required after arrival at the hospital to determine the treatment policy, Estimated the 2021 t-PA market size at approximately $2.1 billion, using it as the basis for the potential market size of TMS-007
Non-financial targetsIndicator name ORION Part 1 (Phase 2): Start of dosing in the Japan cohort / Target value Implementation / Timing FY26.Q1, Indicator name ORION Part 1 (Phase 2): Completion of dosing / Target value Completion / Timing FY26.H2, Indicator name ORION Part 1 (Phase 2): Data readout / Target value Implementation / Timing FY27.H1, Indicator name ORION (Phase 2/3): Completion / Target value Completion / Timing FY29.H2, Indicator name TMS-008: Design of the next clinical trial (Phase 2a) / Target value Completion / Timing FY26.H2, Indicator name TMS-008 Phase 2a clinical trial notification / Target value Submitted / Timing FY26.H2, Indicator name TMS-008 Phase 2a clinical trial / Target value First patient dosed / Timing FY26.H2, Indicator name JX09 Phase 1 clinical trial with CORXEL / Target value Completion / Timing FY26.H1, Indicator name New oral sEH inhibitor (R-002): pharmacology studies, indication and CMC evaluation / Target value Pharmacology studies completed; indication and CMC evaluation / Timing FY26.H2, Indicator name Planned number of ORION patients / Target value 740 (combined total for Part 1 and Part 2) / Timing 15 May 2025 to 31 December 2029 (planned)
Size of the Target MarketMarket Existing t-PA market for acute ischemic stroke / Scale Approximately $2.1 billion / As of 2021 / Source Informa, Market Number of patients with acute ischemic stroke (total for 7 major countries) / Scale Approximately 1.3 million per year / As of 2018 actual; forecasts for 2028 and 2038 / Source Datamonitor Healthcare, Stroke Epidemiology, Market Number of hospitalized patients with acute kidney injury (US, Japan and 5 European countries) / Scale 11.1 million / As of 2030 forecast / Source Delveinsight, Acute Kidney Injury - Market Insights, Epidemiology, and Market Forecast—2030, Market Global market for cancer cachexia / Scale $2.974 billion / As of 2026 forecast / Source Mordor Intelligence, Global Cancer Cachexia Market (2021–2026)
Risks identified by the company
Forward-looking statements are subject to various risks and uncertainties, and actual results may differ materially from projections
Actual development progress may differ materially from expectations
The accuracy of statistical data and publications is subject to limitations, and may differ from estimated market sizes
The information in this document may be changed without prior notice
| Item | Details |
|---|---|
| Plan name | Business Plan and Growth Potential |
| Plan period | Fiscal 2026 (plans for each project); ORION: 15 May 2025 (actual) to 31 December 2029 (planned) |
| Progress against the plan | Annual update |
| Non-financial targets | Indicator name ORION Part 1 (Phase 2): Start of dosing in the Japan cohort / Target value Implementation / Timing FY26.Q1, Indicator name ORION Part 1 (Phase 2): Completion of dosing / Target value Completion / Timing FY26.H2, Indicator name ORION Part 1 (Phase 2): Data readout / Target value Implementation / Timing FY27.H1, Indicator name ORION (Phase 2/3): Completion / Target value Completion / Timing FY29.H2, Indicator name TMS-008: Design of the next clinical trial (Phase 2a) / Target value Completion / Timing FY26.H2, Indicator name TMS-008 Phase 2a clinical trial notification / Target value Submitted / Timing FY26.H2, Indicator name TMS-008 Phase 2a clinical trial / Target value First patient dosed / Timing FY26.H2, Indicator name JX09 Phase 1 clinical trial with CORXEL / Target value Completion / Timing FY26.H1, Indicator name New oral sEH inhibitor (R-002): pharmacology studies, indication and CMC evaluation / Target value Pharmacology studies completed; indication and CMC evaluation / Timing FY26.H2, Indicator name Planned number of ORION patients / Target value 740 (combined total for Part 1 and Part 2) / Timing 15 May 2025 to 31 December 2029 (planned) |
| Plan assumptions | Potential expansion of the window for administering TMS-007 after symptom onset to 12 or 24 hours, Estimated potential eligibility rate for TMS-007 of 75%, Assumption that 1 hour is required after arrival at the hospital to determine the treatment policy, Estimated the 2021 t-PA market size at approximately $2.1 billion, using it as the basis for the potential market size of TMS-007 |
| Key initiatives | Establish a foundation for growth through a clinical-stage pipeline centered on the SMTP compound series, Bridge Japanese academic drug discovery seeds and the global pharmaceutical industry, Global Phase 2/3 clinical trial of TMS-007 (JX10), ORION, underway, TMS-008: Phase 1 clinical trial completed; moving to a Phase 2a clinical trial for acute kidney injury (AKI), Status of JX09, Introduction of new drug discovery seeds and resolvin analogues from Hokkaido University, Joint research on sEH inhibitors, Financing |
| Size of the Target Market | Market Existing t-PA market for acute ischemic stroke / Scale Approximately $2.1 billion / As of 2021 / Source Informa, Market Number of patients with acute ischemic stroke (total for 7 major countries) / Scale Approximately 1.3 million per year / As of 2018 actual; forecasts for 2028 and 2038 / Source Datamonitor Healthcare, Stroke Epidemiology, Market Number of hospitalized patients with acute kidney injury (US, Japan and 5 European countries) / Scale 11.1 million / As of 2030 forecast / Source Delveinsight, Acute Kidney Injury - Market Insights, Epidemiology, and Market Forecast—2030, Market Global market for cancer cachexia / Scale $2.974 billion / As of 2026 forecast / Source Mordor Intelligence, Global Cancer Cachexia Market (2021–2026) |
| Risks identified | Forward-looking statements are subject to various risks and uncertainties, and actual results may differ materially from projections, Actual development progress may differ materially from expectations, The accuracy of statistical data and publications is subject to limitations, and may differ from estimated market sizes, The information in this document may be changed without prior notice |
| Publication date | March 2026 |
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Sales 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 targetResults under the previous planReason for revision or withdrawalDate of board resolution
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