CASI Pharmaceuticals, Inc. · OTC:CASIF

CASI Pharmaceuticals — Investor Presentation (January 2026)

28 slides from CASI Pharmaceuticals's investor presentation, January 2026

  1. Slide 1: Developing a Potential Best-in-Class CD38-targeting mAb

    Developing a Potential Best-in-Class, CD38-targeting mAb for Autoimmune Diseases and Organ Transplant Rejection January 2026 Nasdaq: CASI

  2. Slide 2: Disclaimer

    Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals for CASI Pharmaceuticals, Inc. (“our”, the

  3. Slide 3: Investment Highlights

    Investment Highlights Developing CID-103: Anti-CD38 in Solid Organ Transplant Rejection and Autoimmune Diseases Potential Best-in-Class Asset Clinical Catalysts U.S. Operating Plan • Fully human IgG1 anti-CD38 • Immune thrombocytopenic purpura (ITP) • U.S. HQ has been established in monoclonal antib

  4. Slide 4: CID-103 Recognizes a Unique Epitope on CD38

    CID-103 Recognizes a Unique Epitope on CD38 Differentiated Profile CD38 • CID-103 binds to a unique epitope on CD38 • CID-103 selected for: - Increased ADCC (antibody-dependent cellular cytotoxicity) - Increased ADCP (antibody-dependent cellular phagocytosis) - Less CDC (complement-dependent cytotox

  5. Slide 5: Targeting CD38 in Diseases Driven by Pathological Antibodies

    Targeting CD38 in Diseases Driven by Pathological Antibodies Inducing Plasma Cell Death by Binding to CD38 CD38 is Highly Expressed on Plasma and NK Cells o Plasma cells are responsible for production of autoantibodies and donor-specific antibodies Mechanism of Action o Selectively deplete CD38 + pl

  6. Slide 6: CID-103: Franchise-in-a-Product

    CID-103: Franchise-in-a-Product Expansive Unmet Medical Needs in Future Potential Indications CID-103 In Development Future Potential Indications AMR (cardiac, lung) 4K AMR SSc ILD (renal) 40K RA 35K 1200K MS Pemphigus 700K 130K ITP 65K PTLD 65K IgAN IBD (Crohn’s /UC) 130K 3000K Lupus 200K Dermatomy

  7. Slide 7: Anti-CD38 Therapeutic Landscape

    Anti-CD38 Therapeutic Landscape CID-103 Positioned for Success Asset Company Route of Administration Status Darzalex Approved in 2015 (U.S.) for MM J&J IV and SQ (daratumumab) Annual sales in 2024 nearly $12B Sarclisa Approved in 2020 (U.S.) for MM Sanofi IV (isatuximab-irfc) Annual sales in 2024 >

  8. Slide 8: CID-103 Development Plan

    CID-103 Development Plan casi Pharmaceuticals

  9. Slide 9: Clinical Development Plan for CID-103

    Clinical Development Plan for CID-103 Financing to Fund U.S. AMR Study Start and Subcutaneous Formulation Development Indication Phase 1 Phase 2 Status & Upcoming Catalysts ITP • Generating POC for CID-103 Immune Thrombocytopenic • Phase 1 dosing at 600 & 900 mg dose cohort Purpura • x AMR • IND app

  10. Slide 10: Antibody-Mediated Rejection (AMR) in Renal Allograft

    Antibody-Mediated Rejection (AMR) in Renal Allograft • Phase 1 Study Approved by U.S. FDA • Phase 1 / 2 Study Approved by China NMPA 10

  11. Slide 11: Antibody-Mediated Rejection (AMR) of Renal Allografts

    Antibody-Mediated Rejection (AMR) of Renal Allografts Leading Cause of Late Graft Loss in Kidney Transplant Recipients 35K AMR contributes significantly to both acute and chronic transplants/yr rejection and ultimately leads to graft loss of patients develop de novo donor-specific ~25% anti-HLA anti

  12. Slide 12: Approved U.S. Phase 1 Dose-Escalation Study in AMR

    Approved U.S. Phase 1 Dose-Escalation Study in AMR Study Start Planned in Q1 2026 Efficacy Assessment: • Biopsy-demonstrated histologic improvement CID-103 • Donor-derived, cell free DNA 600 mg IV • Donor-specific antibody n=6 CID-103 1+3 design 300 mg IV n=6 12 wks CID-103 Open-label study 1+2+3 de

  13. Slide 13: Approved China Phase 1 Dose-Escalation Study in AMR

    Approved China Phase 1 Dose-Escalation Study in AMR Study Start Planned in Q1 2026 Efficacy Assessment: SMC Review of All Data to • Biopsy-demonstrated histologic improvement Recommend Phase 2 Dose • Donor-derived, cell free DNA CID-103 • Donor-specific antibody 900 mg IV n = 3-6 BL Week 12 Week 24

  14. Slide 14: Approved Phase 2 AMR Study in China

    Approved Phase 2 AMR Study in China Option Following Phase 1 Results Primary Endpoint* : Resolution of AMR on biopsy at Week 24 CID-103 Recommended Dose Based on Phase 1 n = ~40 BL Week 12 Week 24 * Week 52 • QW for Week 1-5; Q2W for Week 7-13; Q4W for Week 17-49 • Open-label study allows for interi

  15. Slide 15: AMR Program Timelines and Anticipated Key Milestones

    AMR Program Timelines and Anticipated Key Milestones Biopsy / PD Marker Data Available for Public Presentation Beginning 2026 2026 2027 2028 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Phase 1 12wk bx 12wk bx End of Ph 1 US FPI 30mg 300mg FDA IND Approved Aug 2025 12wk bx 12wk bx 150mg 600mg Phase 1 CTA / IRB 12w

  16. Slide 16: Subcutaneous Formulation Development for CID-103

    Subcutaneous Formulation Development for CID-103 Developing a High Concentration Protein (HCP) Solution • Subcutaneous formulation of CID-103 to provide self-administration convenience for patients • Option to progress multiple technologies to deliver a high concentration, stable protein solution -

  17. Slide 17: Assessing Multiple Technologies

    Assessing Multiple Technologies Plan to Pursue Parallel SQ Formulation Programs to Ensure Success • Excelse technology: Utilizes customized blends of amino acids to stabilize formulation • Significantly reduces viscosity; allows for concentrations of up 300 mg/mL • Uses stabilizers that are non-acti

  18. Slide 18: Immune Thrombocytopenic Purpura (ITP)

    Immune Thrombocytopenic Purpura (ITP) • Ongoing Phase 1 Study • Interim data presented at ASH 2026, Dec 7, 2025 • Additional interim data released Jan 12, 2026 18

  19. Slide 19: 67th ASH Annual Meeting and Exposition

    DEGEMBER 6-9, 2025 | ORLANDO, FLORIDA 67th ASH Annual Meeting and Exposition Experience the Premier Hematology Event EXPLORE SESSIONS >> casi Phormaceu ieale CASI Pharmaceuticals Announces Upcoming Presentation of Clinical Results for CID-103 at the 67 American Society of Hematology (ASH) Annual Mee

  20. Slide 20: CID-103: Phase 1 Dose-Escalation Study in ITP

    CID-103: Phase 1 Dose-Escalation Study in ITP 3+3 design Primary Efficacy Endpoint CID-103 3+3 design 150 mg / 900 mg IV Platelet count ≥ 50 x 109/L and ≥ 20 x 109/L n = 3+3 above baseline, achieved on at least 2 CID-103 consecutive measurements at ≥ 7 days apart 1+3 design 150 mg / 600 mg IV within

  21. Slide 21: CID-103 ITP Phase 1 Demographic and Disease Characteristics

    CID-103 ITP Phase 1 Demographic and Disease Characteristics 30mg / 30mg 30mg / 150mg 150mg / 300mg 150mg / 600mg 150mg / 900mg Total Demographic and Disease Characteristics N=1 N=1 N=3 N=5 N=6 N=16 Median age, y (range) 32 29 39（26-49） 34（33-55） 45（25-52） 36.5 (25-55) Gender, n (%) Female, n (%) 1 0

  22. Slide 22: CID-103 ITP Phase 1 Preliminary Safety Data

    CID-103 ITP Phase 1 Preliminary Safety Data 30 mg 150 mg 300 mg 600 mg 900 mg Total Preliminary N=1 N=1 N=3 N=5 N=6 N=16 Safety Data n [m]* n [m] n [m] n [m] n [m] n [m] Any AE 1 [13] 1 [6] 3 [10] 3 [14] 5 [28] 13 [71] DLT 0 0 0 0 0 0 Any TEAE 1 [13] 1 [6] 3 [10] 3 [14] 5 [28] 13 [71] ≥G3 TEAE 1 [2]

  23. Slide 23: CID-103 ITP Phase 1 Efficacy

    CID-103 ITP Phase 1 Efficacy Platelet Count (x 1000/L) Primary Endpoint Complete Response ORR = 80% PLT ≥ 50 & No Response Evaluable patients ≥ 100 ≥ 20 above baseline 30 mg 1001 150 mg 1003 1004 * 300 mg 1007 1008 1005 3001 * 600 mg 1006 3003 treatment ongoing 5002 1009 1010 1011 900 mg 1012 3002

  24. Slide 24: CID-103 ITP Phase 1 Pharmacodynamics / Pharmacokinetics

    CID-103 ITP Phase 1 Pharmacodynamics / Pharmacokinetics • Anti-Platelet Antibodies - At baseline (BL), 4 patients had detectable anti-platelet Ab (A-PA) o 2 patients (01005 CR, 01009 CR) reduced A-PA to non-detectable o 2 patients (01006 NR, 01008 CR) substantially reduced A-PA - 1 patient (01003) h

  25. Slide 25: CID-103 ITP Phase 1 Summary & Conclusions

    CID-103 ITP Phase 1 Summary & Conclusions • Demonstrates proof-of-concept for CID-103 as a promising anti-CD38 targeted monoclonal antibody and rationale for future clinical development in diseases involving donor-directed and pathological autoantibodies • Manageable safety profile; only two Grade 3

  26. Slide 26: CASI Corporate: Key Recent Milestone Announcements

    CASI Corporate: Key Recent Milestone Announcements • Divesture Agreement of Business in China • Appointment of New Operating Chief Executive Officer – David Cory • FDA IND Approval for Phase 1 Renal Allograft AMR Study in U.S. • Appointment of Former Morphosys CBO – Barbara Krebs-Pohl – to Board of

  27. Slide 27: CASI U.S. Management Team

    CASI U.S. Management Team Proven Track-Record in Bringing Innovative Therapies to Market Photo of Ingrig Choong David Cory, RPh, MBA Alex Zukiwski, M.D. Junping Chen, MD, PhD Larry Zhang Ingrid Choong, PhD James Goldschmidt, PhD CEO Global CMO China CMO SVP Corporate Development CBO Oriental BioMedi

  28. Slide 28: Thank You

    Thank You Contact: Ingrid Choong, PhD ingridc@casipharmaceuticals.com

CASI Pharmaceuticals — Investor Presentation (January 2026) on 6ix