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Management planning4893Noile-Immune Biotech Inc.Pharmaceuticals

Business Plan and Growth Potential

Updated the business plan and growth potential materials for the fiscal year ending March 2026, indicating a policy of prioritizing the development of NIB103 as the top-priority pipeline, advancing preparations for an investigator-initiated clinical trial of NIB104, and pursuing research and development of next-generation technologies. No changes to the management’s financial targets were indicated.

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Items stated in the management plan

Annual update
Business Plan and Growth PotentialPlan period NIB103: 2024–2031; NIB104: 2025–2033 (outlook for each pipeline)
Publication date 2026.3
Investment amount by sectorField NIB101 development costs / Amount 530 million yen, Field NIB103 development costs / Amount 1,110 million yen, Field Costs of preclinical trials for NIB104 and subsequent programs / Amount 150 million yen, Field Research expenses related to the creation of new pipelines / Amount 130 million yen, Field Research expenses related to new platform technologies / Amount 90 million yen, Field Working capital / Amount 447 million yen
Key initiatives
01Advance development of NIB103, the company’s proprietary drug discovery pipeline, as the priority pipeline
02Accelerate preparations for the start of an investigator-initiated clinical trial for NIB104, the subsequent pipeline
03Strengthen research and development of novel technologies and therapeutic modalities to create next-generation gene and cell therapies
04Accelerate business development based on Swift PRIME CAR-T cells produced using an accelerated manufacturing process and in vivo CAR-T technology
05Maximize the number of concurrent pipelines
06Expand the Addressable Patient Population by using targets held by other companies
07Pursue stable management by securing upfront payments and milestones from joint research pipelines at an early stage
08In partnered pipeline businesses, the company’s costs can be kept to a minimum
09Consider potential license-out transactions in parallel
Plan assumptionsCAR-T market growth rate: 23.35% CAGR (2024–2033), Pipeline development in Japan assumes use of the expedited approval system for regenerative medical products, The timing of applications and approvals for NIB103 and NIB104, among other matters, is not definitive
Size of the Target MarketMarket Size Not disclosed / Growth rate 23.35% CAGR (2024–2033) / Source Vision Research Reports(https://www.visionresearchreports.com/car-t-cell-therapy-market/40008)
Risks identified by the company
Forward-looking statements are subject to various risks and uncertainties
Actual results may differ materially from the forecasts presented in the forward-looking statements
Actual development progress may differ materially from the outlook
The timing of applications and approvals, among other matters, is not definitive
Items stated in the management plan
ItemDetails
Plan nameBusiness Plan and Growth Potential
Plan periodNIB103: 2024–2031; NIB104: 2025–2033 (outlook for each pipeline)
Progress against the planAnnual update
Investment amount by sectorField NIB101 development costs / Amount 530 million yen, Field NIB103 development costs / Amount 1,110 million yen, Field Costs of preclinical trials for NIB104 and subsequent programs / Amount 150 million yen, Field Research expenses related to the creation of new pipelines / Amount 130 million yen, Field Research expenses related to new platform technologies / Amount 90 million yen, Field Working capital / Amount 447 million yen
Plan assumptionsCAR-T market growth rate: 23.35% CAGR (2024–2033), Pipeline development in Japan assumes use of the expedited approval system for regenerative medical products, The timing of applications and approvals for NIB103 and NIB104, among other matters, is not definitive
Key initiativesAdvance development of NIB103, the company’s proprietary drug discovery pipeline, as the priority pipeline, Accelerate preparations for the start of an investigator-initiated clinical trial for NIB104, the subsequent pipeline, Strengthen research and development of novel technologies and therapeutic modalities to create next-generation gene and cell therapies, Accelerate business development based on Swift PRIME CAR-T cells produced using an accelerated manufacturing process and in vivo CAR-T technology, Maximize the number of concurrent pipelines, Expand the Addressable Patient Population by using targets held by other companies, Pursue stable management by securing upfront payments and milestones from joint research pipelines at an early stage, In partnered pipeline businesses, the company’s costs can be kept to a minimum, Consider potential license-out transactions in parallel
Size of the Target MarketMarket Size Not disclosed / Growth rate 23.35% CAGR (2024–2033) / Source Vision Research Reports(https://www.visionresearchreports.com/car-t-cell-therapy-market/40008)
Risks identifiedForward-looking statements are subject to various risks and uncertainties, Actual results may differ materially from the forecasts presented in the forward-looking statements, Actual development progress may differ materially from the outlook, The timing of applications and approvals, among other matters, is not definitive
Publication date2026.3
Items this document does not state (16)
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 planSegment targetNon-financial targetsResults under the previous planReason for revision or withdrawalDate of board resolution

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The reasons the company gives

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

No reason for updating or reviewing the business plan was provided.

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Business Plan and Growth Potential | Noile-Immune Biotech Inc. (4893) timely disclosure | Komori