Noile-immune Biotech Inc. · TSE:4893

Noile-immune Biotech — Q2 2026 Earnings Presentation

44 slides from Noile-immune Biotech's earnings presentation, Aug 20, 2026

  1. Slide 1: 2Q FY2026 Financial Results Briefing

    Create the Future to Overcome Cancer 2Q FY2026 Financial Results Briefing PRIME technology opens the future of medicine Noile-Immune Biotech, Inc. August 20 2026

  2. Slide 2: Disclaimer

    Disclaimer This presentation material has been prepared solely for the purpose of presenting relevant information regarding Noile-Immune Biotech, Inc. (the “Company”). This document does not constitute an offer to sell or the solicitation of an offer to buy any security in the United States, Japan o

  3. Slide 3: Mission and Vision

    MISSION Create the Future to Overcome Cancer VISION Develop new cancer immunotherapies with excellent safety and efficacy and deliver them to as many patients as possible 3

  4. Slide 4: Index

    1 Company Overview 5P 2 Financial Results 10P INDEX 3 Our Business 14P 4 Growth Strategy 26P 4

  5. Slide 5: 1. Company Overview

    Create the Future to Overcome Cancer 1 Executive Summary 1. Company 2 Company Profile Over view 3 Summary for the Second Quarter of the Fiscal Year Ended December 2026 4 Status of our Product Candidate Pipeline 5

  6. Slide 6: Executive Summary

    1. Company Overview Executive Summary NIB are a clinical-stage biotech created as a spin-off from Yamaguchi University, and aim to establish cancer immunotherapy for solid tumors using PRIME technology, the latest generation of CAR-T technology Advancing development of NIB103, a NIB‘s in-house drug

  7. Slide 7: Company Profile

    1. Company Overview Company Profile Company Noile-Immune Biotech Inc.(Securities Code:4893) Founded April, 2015(Biotechnology company originated by Yamaguchi University) Representative Dr. Koji Tamada, President & CEO Headquarters |T&G Hamamatsucho Bldg. 5th Floor, 2-12-10 Shiba-Daimon, Minato-ku To

  8. Slide 8: Summary for the Second Quarter of the Fiscal Year Ended December 2026

    1. Company Overview Summary for the Second Quarter of the Fiscal Year Ended December 2026 March: First Patient Dosing in NIB103 Phase I Clinical Trial For NIB103, a mesothelin-targeted PRIME CAR-T cell therapy and the Company’s highest-priority pipeline program being developed in Japan for solid tum

  9. Slide 9: Status of our product candidate pipeline

    1. Company Overview Status of our product candidate pipeline ※1 (as of June 2026) Clinical to Commercial Stage Target Cancer expressing Basic Non-clinical Code Partner Status Next milestone antibody target antibody Research Stage Phase III Approval Phase I Phase II or Early /Sales Approval In-house

  10. Slide 10: 2. Financial Results

    Create the Future to Overcome Cancer 1 Summary of Profit and Loss Statement for the Second Quarter of the Fiscal Year Ended December 2026 2. Financial Results Summary of Balance Sheet for the Second Quarter of the Fiscal 2 Year Ended December 2026 3 Summary of Cash Flows for the Second Quarter of th

  11. Slide 11: Summary of Profit and Loss Statement

    2.1. 決算状況:2026年12月期 第2四半期 損益計算書概要 Summary of Profit and Loss Statement for the Second Quarter of the Fiscal Year Ended December 2026 (Unit: JPY M) Second Quarter of the Second Quarter of the Fiscal Year-on-Year Fiscal Year Ended Year Ended December 2025 Comparison December 2026 (Actual) (Actual) (Ra

  12. Slide 12: Summary of Balance Sheet

    2.2. 決算状況:2026年12月期 第2四半期 貸借対照表概要 Summary of Balance Sheet for the Second Quarter of the Fiscal Year Ended December 2026 (Unit: JPY M) Second Quarter of the Fiscal Second Quarter of the Fiscal Year Ended December 2026 Year Ended December 2025 Change (Actual) (Actual) Current assets 3,637 4,357 (720)

  13. Slide 13: Summary of Cash Flows

    2.3. 決算状況:2026年12月期 第2四半期 キャッシュ・フロー概要 Summary of Cash Flows for the Second Quarter of the Fiscal Year Ended December 2026 (Unit: JPY M) Second Quarter of the Second Quarter of the Fiscal Year Ended Fiscal Year Ended December 2026 December 2025 Change Cash flows from operating (373) (357) (16) activi

  14. Slide 14: 3. Our Business

    Create the Future to Overcome Cancer 1 High profile of CAR-T market 3. Our Business 2 Original PRIME CAR-T with potential for application to solid tumors 3 Hybrid business model with in-house drug discovery and technology licensing 14

  15. Slide 15: Cancer is a threat to humanity

    3.1. Our Business: High profile of CAR-T market Cancer is a threat to humanity Lifetime risk of cancer※1 (Japan, 2023) 5-year survival rates by cancer type※1(Japan, UK, U.S.) Breast Colorectal (colon) Uterine cervical 男性 女性 Stomach 61% 50% Ovarian Esophagus One in two people are Lung diagnosed with

  16. Slide 16: Latest cancer cell therapy: CAR-T cell therapy

    3.1. Our Business: High profile of CAR-T market Latest cancer cell therapy: CAR-T cell therapy Introduce CAR genes into T cells to CAR 2 produce CAR-T cells CAR-T cells (Chimeric Antigen Receptor) ⚫ Identify cancer cells efficiently Bind to cancer and is highly effective in killing cancer cells ⚫ Hi

  17. Slide 17: Future CAR-T market for solid tumors

    1 High profile of CAR-T market Future CAR-T market for solid tumors Development status of CAR-T cell therapy Ratio of solid tumors and hematological (representative example) and estimated maximum cancers in new cancer cases worldwide (2022) number of eligible patients Estimated Maximum Development S

  18. Slide 18: CAR-T market attracts attention

    3.1. Our Business: High profile of CAR-T market CAR-T market attracts attention 23.35% CAGR (2024-2033) CAR-T market forecast to 2033 Source:Prepared by the Company based on “https://www.visionresearchreports.com/car-t-cell-therapy-market/40008 ” Trends in CAR-T market • January 2026: AstraZeneca fu

  19. Slide 19: PRIME technology

    3.2. Our Business: Original PRIME CAR-T with potential for application to solid tumors PRIME technology (Proliferation Inducing and Migration Enhancing Technology) CCL19 CCL19 IL-7 gene gene Accumulate immune cells inside the body as well as surrounding PRIME CAR-T cells CAR-T cell IL-7 PRIME CAR-T

  20. Slide 20: PRIME technology in-house drug discovery concept

    3.2. Our Business: Original PRIME CAR-T with potential for application to solid tumors PRIME technology in-house drug discovery concept “What should we do to accumulate and activate immune cells (T cells)?” How do T cells accumulate and become activated in the lymph nodes? B cell zone In the lymph n

  21. Slide 21: Comparison with CAR-T cell therapy in mice

    3.2. Our Business: Original PRIME CAR-T with potential for application to solid tumors Comparison with CAR-T cell therapy in an experiment on mice In vivo luminescence imaging analysis performed 18 days after tumor inoculation Conventional CAR-T cells Conventional PRIME PRIME CAR-T cells CAR-T cells

  22. Slide 22: Therapeutic potential of PRIME CAR-T cells in solid tumor

    3.2. Our Business: Original PRIME CAR-T with potential for application to solid tumors Therapeutic potential of PRIME CAR-T cells in solid tumor 1400 Untreated Generation of organoid from HER2-positive 1200 Tumor volume (mm3) pancreatic cancer’s surgical section 1000 Conv. CAR-T IHC staining of HER2

  23. Slide 23: Multiple approaches to solid tumors using PRIME CAR-T cells

    3.2. Our Business: Original PRIME CAR-T with potential for application to solid tumors Multiple approaches to solid tumors using PRIME CAR-T cells CAR- IL-7 x CCL19 vector PRIME CAR-T CAR IL-7 CCL19 ・・・ ・・・ Image prepared by the Company PRIME technology can be combined with various CARs, enabling cr

  24. Slide 24: Business model

    3.3. Our Business: Hybrid business model with in-house drug discovery and technology licensing Business model Operate two businesses based on PRIME technology (illustrative model) Development Contracting Revenue cost opportunity In-house drug discovery business Aim for The Company develops Higher fu

  25. Slide 25: IP strategy for PRIME technology

    3.3. Our Business: Hybrid business model with in-house drug discovery and technology licensing IP strategy for PRIME technology CAR-T Basic patent ※1 Points of IP strategy 1 ⚫ Protect PRIME technology with multiple basic TCR-T patents Basic patent ⚫ Maximize the exclusivity period of pipeline Pipeli

  26. Slide 26: 4. Growth Strategy

    Create the Future to Overcome Cancer 1 Original pipeline 4.Growth Strategy 2 Future growth strategy and growth potential of market 26

  27. Slide 27: Status of our product candidate pipeline

    4.1. Growth Strategy: Original pipelines Status of our product candidate pipeline ※1 (as of June 2026) Clinical to Commercial Stage Target Cancer expressing Basic Non-clinical Code Partner Status Next milestone antibody target antibody Research Stage Phase III Approval Phase I Phase II or Early /Sal

  28. Slide 28: NIB101: PRIME CAR-T targeting GM2

    4.1. Growth Strategy: Original pipelines NIB101 Estimated number of potential subjects (number/year) ※1 PRIME CAR-T targeting GM2 GM2 GM2 positive Domestic deaths Cancer type incidence domestic deaths in 2022 (Japan, US, Europe) rate※3 (Japan, US, Europe) Anti-GM2 antibody- derived scFv Small-cell l

  29. Slide 29: Results of NIB102 Phase I Clinical Trial

    4.1. Growth Strategy: Original pipelines Results of NIB102 Phase I Clinical Trial ◼ Eleven Japanese patients were enrolled (8 HCCs, 2 Liposarcoma, 1 Gastric NEC). NIB102 ◼ Primary endpoints: Safety and tolerability; Secondary endpoints: Efficacy (ORR, OS, PFS), cellular kinetics (CK). Anti-GPC3 ◼ Si

  30. Slide 30: NIB103: PRIME CAR-T targeting Mesothelin

    4.1. Growth Strategy: Original pipelines NIB103 Estimated number of potential subjects (number/year) ※1 PRIME CAR-T targeting Mesothelin Mesothelin Mesothelin positive Domestic deaths Cancer type incidence domestic deaths in 2022 (Japan, US, Europe) rate※3 (Japan, US, Europe) Anti-Mesothelin antibod

  31. Slide 31: Background of Development and Future Prospects of NIB103

    4.1. Growth Strategy: Original pipelines Background of Development and Future Prospects of NIB103 Jun Completion of a Clinical Trial Notification submission for NIB103 Phase I clinical trial led by Noile-Immune Mar Implementation of First patient dosing in NIB103 Phase I Clinical Trial Completion of

  32. Slide 32: NIB104: Swift PRIME CAR-T targeting EGFRvIII

    4.1. Growth Strategy: Original pipelines NIB104 Swift PRIME CAR-T targeting EGFRvIII Estimated number of potential subjects (number/year) ※1 Anti-EGFRvIII Annual domestic No. of domestic Incidence antibody- Cancer type deaths positive patients rate※2 derived scFv (Japan, US, Europe) (Japan, US, Euro

  33. Slide 33: NIB104: Swift PRIME CAR-T

    4.1. Growth Strategy: Original pipelines NIB104:Swift PRIME CAR-T Swift PRIME CAR-T Generation of PRIME CAR-T cells by Short-term manufacture 2 transducing T cells with PRIME CAR gene ⚫ ⚫ Enhanced killing activity ⚫ Decreased manufacturing cost PRIME CAR gene Injection into patient 3 after short-ter

  34. Slide 34: NIB104: Manufacturing by short-term culture method

    4.1. Growth Strategy: Original pipelines NIB104:Manufacturing by short-term culture method Repetitive stimulations with tumor cells every 3-4 days Whole CD4 CD8 35.6 38.6 69.1 15 NIB104 T cell number (x 105 cells) Swift PRIME CAR-T 10 62 CD45RA CD8 35.2 17.8 30.4 5 Standard PRIME CAR-T 0 22.4 0 3 7

  35. Slide 35: NIB104: Therapeutic effects in glioblastoma (Animal models)

    4.1. Growth Strategy: Original pipelines NIB104:Therapeutic effects in glioblastoma (Animal models) Intracranial tumor model: Intraventricular injection of NIB104 8 x 109 100 Tumor size (Total flux: p/s) Survival of mice (%) 6 x 109 80 60 4 x 109 40 2 x 109 P<0.001 P<0.05 20 0 0 0 10 20 30 40 0 20 4

  36. Slide 36: Background of Development and Future Prospects of NIB104

    4.1. Growth Strategy: Original pipelines Background of Development and Future Prospects of NIB104 Implementation of manufacturing Initiation of the process development and non- investigator-initiated clinical trials phase I clinical trial 2025 2026 2027 2028 2029 2030 2031 2032 2033 Preparing for an

  37. Slide 37: Direction of PRIME technology's market penetration

    4.2. Growth Strategy: Future growth strategy and growth potential of market Direction of PRIME technology’s market penetration 【Existing pipeline compounds】 ・Progress of pipeline development (NIB103) ・Investigator-initiated trial (NIB104) ・Combination with other drugs (1) Develop and expand in-house

  38. Slide 38: Further advancement of our R&D activities

    4.2. Growth Strategy: Future growth strategy and growth potential of market Further advancement of our R&D activities Modalities to which ※This is an image created by the Company. The information represents the PRIME technology may be applied potential for the future technological application, and d

  39. Slide 39: Cancer therapy by in vivo CAR-T cells

    4.2. Growth Strategy: Future growth strategy and growth potential of market Control Group CAR No.1 CAR No.2 Development of novel technology: Cancer therapy by in vivo CAR-T cells Disappearance of hematologic tumors Long-term Survival of mice (%) survival of mice Control Group CAR No.1 CAR No.2 Days

  40. Slide 40: "Ultra" short-term infection viral vectors

    4.2. Growth Strategy: Future growth strategy and growth potential of market Development of novel technology: “Ultra” short-term infection viral vectors In vivo CAR-T New Viral Vectors Conventional lentiviral vectors “Ultra” short-term Infectious manufacturing period 18~ 24h 1h Infection :○ ○ ○ Infec

  41. Slide 41: Concept of Bedside CAR-T

    4.2. Growth Strategy: Future growth strategy and growth potential of market Development of novel technology: Concept of Bedside CAR-T Basic Concept and Advantages of Bedside CAR-T Example of a Bedside CAR-T ❶ PBMC collection ❷ Exposure to ❸ Short-term ❹ Re-administration implementation model via aph

  42. Slide 42: Future Outlook for Growth Potential

    4.2. Growth Strategy: Future growth strategy and growth potential of market Future Outlook for Growth Potential Revenue expansion ✓ Providing truly effective therapeutic drugs for cancer patients ✓ Enhancing corporate value through Business growth based on steady business growth further advanced inn

  43. Slide 43: We contribute to health and welfare of people around the world

    We contribute to health and welfare of people around the world by providing innovative cancer immunotherapy

  44. Slide 44: Noile-Immune Biotech

    if Noile-Ilmmune Biotech

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