Komori
Management planning4564OncoTherapy Science,Inc.Pharmaceuticals

Business Plan and Growth Potential

We published an annual document updating our fiscal 2025 results, financing, research and development pipeline, CPM business, and market environment. For OTSA101, we have ended proprietary development and shifted to development within the scope of subsidies and licensing activities, while presenting no new medium-term numerical targets.

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Items stated in the management plan

Annual update
Business Plan and Growth Potential
Publication date 23 June 2026
Total investment planAmount ¥17.5 100 million / Notes Planned amount to be raised through a third-party allotment. Research and development expenses and other uses of funds are indicated, but the total capital investment for the entire plan period is not explicitly stated.
Investment amount by sectorField Research and development expenses in the drug discovery and pharmaceutical research field / Amount ¥3 100 million, Field Research and development expenses in the pharmaceutical development field / Amount ¥4.3 100 million, Field Expenses and research and development expenses related to the cancer precision medicine business / Amount ¥10.1 100 million
Key initiatives
01Liquid biopsy business (diagnostics)
02Clinical sequencing business (selection of drugs and treatment methods)
03Personalized immunotherapy, including neoantigen vaccine therapy
04Leverage our proprietary compound library for new drug discovery target projects
05Develop and apply an AI-enabled drug discovery platform
06Acquire licensees to advance development, regulatory approval, and marketing
07Global expansion: development, regulatory approval, and launch in multiple regions
08Expand indications to other cancer types
Plan assumptionsThe global cancer patient population is expected to increase 47%, from approximately 19.3 million in 2020 to approximately 28.4 million in 2040., Global spending on oncology drugs is projected to increase from US$223 billion in 2023 to US$409 billion in 2028., Average annual growth in oncology drug spending from 2024 to 2028 is projected at 11.5–14.5% globally and 4–7% in Japan.
Size of the Target MarketMarket Global cancer patient population / Figures 2020: approximately 19.3 million; 2040: approximately 28.4 million; +47% / Source GLOBOCAN 2020, Sung et al., CA Cancer J Clin., Market Global oncology drug spending / Figures 2023: US$223 billion; 2028: US$409 billion. Average annual growth: 11.5–14.5% globally and 4–7% in Japan / Source IQVIA Institute, Global Oncology Trends 2024: Outlook to 2028, Market Idiopathic pulmonary fibrosis (IPF) treatments / Figures Global: US$5.268 billion; 2027 forecast / Source Research report by 株式会社グローバルインフォメーション, Market NASH (MASH) treatments / Figures Global: US$84.340 billion; 2029 forecast / Source Research report by 株式会社グローバルインフォメーション, Market Synovial sarcoma / Figures Japan: 227; EU: 2,241; United States: 799; total: 3,267 / Source National Cancer Center Rare Cancer Center, ESMO, The American Cancer Society, and other sources
Risks identified by the company
Many existing drugs have already been launched for leukemia and breast cancer, making revenue projections difficult.
Antibody formulation costs are high, and procedures are complex because radioisotopes are used.
Creating fibrosis model animals and confirming the relevant conditions is taking longer than initially planned.
Reason for revision or withdrawal

Because antibody formulation costs are high and procedures are complex due to the use of radioisotopes, we ended development as our proprietary pipeline after considering economic viability.

Items stated in the management plan
ItemDetails
Plan nameBusiness Plan and Growth Potential
Progress against the planAnnual update
Total investment planAmount ¥17.5 100 million / Notes Planned amount to be raised through a third-party allotment. Research and development expenses and other uses of funds are indicated, but the total capital investment for the entire plan period is not explicitly stated.
Investment amount by sectorField Research and development expenses in the drug discovery and pharmaceutical research field / Amount ¥3 100 million, Field Research and development expenses in the pharmaceutical development field / Amount ¥4.3 100 million, Field Expenses and research and development expenses related to the cancer precision medicine business / Amount ¥10.1 100 million
Plan assumptionsThe global cancer patient population is expected to increase 47%, from approximately 19.3 million in 2020 to approximately 28.4 million in 2040., Global spending on oncology drugs is projected to increase from US$223 billion in 2023 to US$409 billion in 2028., Average annual growth in oncology drug spending from 2024 to 2028 is projected at 11.5–14.5% globally and 4–7% in Japan.
Key initiativesLiquid biopsy business (diagnostics), Clinical sequencing business (selection of drugs and treatment methods), Personalized immunotherapy, including neoantigen vaccine therapy, Leverage our proprietary compound library for new drug discovery target projects, Develop and apply an AI-enabled drug discovery platform, Acquire licensees to advance development, regulatory approval, and marketing, Global expansion: development, regulatory approval, and launch in multiple regions, Expand indications to other cancer types
Reason for revision or withdrawalBecause antibody formulation costs are high and procedures are complex due to the use of radioisotopes, we ended development as our proprietary pipeline after considering economic viability.
Size of the Target MarketMarket Global cancer patient population / Figures 2020: approximately 19.3 million; 2040: approximately 28.4 million; +47% / Source GLOBOCAN 2020, Sung et al., CA Cancer J Clin., Market Global oncology drug spending / Figures 2023: US$223 billion; 2028: US$409 billion. Average annual growth: 11.5–14.5% globally and 4–7% in Japan / Source IQVIA Institute, Global Oncology Trends 2024: Outlook to 2028, Market Idiopathic pulmonary fibrosis (IPF) treatments / Figures Global: US$5.268 billion; 2027 forecast / Source Research report by 株式会社グローバルインフォメーション, Market NASH (MASH) treatments / Figures Global: US$84.340 billion; 2029 forecast / Source Research report by 株式会社グローバルインフォメーション, Market Synovial sarcoma / Figures Japan: 227; EU: 2,241; United States: 799; total: 3,267 / Source National Cancer Center Rare Cancer Center, ESMO, The American Cancer Society, and other sources
Risks identifiedMany existing drugs have already been launched for leukemia and breast cancer, making revenue projections difficult., Antibody formulation costs are high, and procedures are complex because radioisotopes are used., Creating fibrosis model animals and confirming the relevant conditions is taking longer than initially planned.
Publication date23 June 2026
Items this document does not state (15)
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 priceSegment targetNon-financial targetsResults under the previous planDate of board resolution

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.

No reason is provided for the annual update to the overall business plan. Regarding OTSA101, we explain that proprietary development was ended after considering economic viability, because antibody formulation costs are high and procedures are complex due to the use of radioisotopes.

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Business Plan and Growth Potential | OncoTherapy Science,Inc. (4564) timely disclosure | Komori