CASI Pharmaceuticals, Inc. · OTC:CASIF
CASI Pharmaceuticals — Corporate Update (May 2025)
21 slides from CASI Pharmaceuticals's corporate update, May 21, 2025
Slide 1: Business and Clinical Update
CASI Pharmaceuticals Inc. Business and Clinical Update May 21, 2025 1
Slide 2: Disclaimer
Disclaimer The information contained in this presentation has been prepared by CASI Pharmaceuticals, Inc. (the “Company”) and contains information pertaining to the business and operations of the Company. The information contained in this presentation: (a) is provided as at the date hereof, is subje
Slide 3: Forward-looking statements
Forward-looking statements Except for statements of historical fact, certain information contained herein constitutes forward-looking statements, which include but are not limited to statements regarding: expectations regarding our ability to advance product candidates through preclinical and clinic
Slide 4: Agenda
Agenda CEO Opening Remarks and Business Update Wei-Wu He, Ph.D. Chairman and Chief Executive Officer Pipeline Update Alexander Zukiwski, M.D. Chief Medical Officer and Executive Vice President Q&A 4
Slide 5: Business Highlights
Business Highlights Transforming CASI into an autoimmune innovator Completion of Definitive Agreement for the Divestiture of Assets in China Entered into the agreement regarding Precision Autoimmune Therapeutics. After the consummation of the transaction contemplated thereunder and divestiture of Ch
Slide 6: CID-103 Clinical Update
CID-103 Clinical Update Pharmaceuticals
Slide 7: A promising and advancing pipeline
A promising and advancing pipeline Approach Focus Discovery Preclinical IND/CTA enabling Phase 1 CID-103 (anti-CD38 monoclonal antibody) ITP (Immune Thrombocytopenia) AMR (Anti-body Monotherapy Mediated Rejection) (IV) AA (Aplastic Anemia) PTLD (Post-transplant lymphoproliferative disorder) 7
Slide 8: CID-103 Pre-clinical Summary
CID-103 Pre-clinical Summary • Different binding epitope provides intellectual property coverage, diminished red blood cell binding and decreased pre-transfusion testing interference • Decreased Infusion related reactions relative to other but not all molecules in the class • Preclinical activity in
Slide 9: CID-103: ITP dosing schedule
CID-103: ITP dosing schedule • Priming dose on week 1 to diminish/avoid infusion related reactions • Weekly dosing weeks 2-6 • Q2week dosing week 8, 10 and 12 • Q4week dosing week 16, 20 and 24 for a maximum of 6 months 9
Slide 10: CID-103: Approved ITP Study Design Part A
CID-103: Approved ITP Study Design Part A Study Schematic Dose Escalation Study design allows for the testing of potential lower therapeutic doses and for testing of intermediate/higher dose levels. The dose/response relationship in ITP can be leveraged across other indications. 10
Slide 11: CID-103: Approved ITP Study Design Part A
CID-103: Approved ITP Study Design Part A Study Schematic Dose Escalation Potential of only 1 patient per cohort Study design allows for the testing of potential lower therapeutic doses and for testing of intermediate/higher dose levels. The dose/response relationship in ITP can be leveraged across
Slide 12: CID-103: Approved ITP Study Design Part B
CID-103: Approved ITP Study Design Part B Study Schematic Treatment and Assessment Plan An initial review of safety and efficacy will be completed by the SMC once approximately 24 evaluable subjects (8 subjects per arm) have completed approximately 6 weeks of treatment to determine if there is one o
Slide 13: CASI-CID-103-201 Preliminary Platelet and Safety Data for ITP
CASI-CID-103-201 Preliminary Platelet and Safety Data for ITP 13
Slide 14: Cohort 1 patient #8601001 Platelet Count on 30mg/30mg
Cohort 1 – patient #8601001 Platelet Count on 30mg/30mg 8601001 PLT Count (x 1,000/µl) 250 Patient 8601001 PLT Count (x 1,000/µl) 211 Continuation of 200 Prednisolone and Herombopag Olamine 167 combined treatment 150 Day of CID-103 Administration 95 91 100 77 51 menorrhagia 50 38 24 25 30 11 9 1414
Slide 15: Cohort 2 patient #8601003 Platelet Count on 30mg/150mg
Cohort 2 – patient #8601003 Platelet Count on 30mg/150mg • pre-medication prior to the CID-103 infusion, methylprednisolone 100 mg IV, after 2nd CID-103 infusion, the dose of methylprednisolone was reduced to 60 mg IV. 15
Slide 16: Cohort 3 patient #8601004 Platelet Count on 150mg/300mg
Cohort 3 – patient #8601004 Platelet Count on 150mg/300mg • pre-medication prior to the CID-103 infusion, methylprednisolone 100 mg IV, after 2nd CID-103 infusion, the dose of methylprednisolone was reduced to 60 mg IV. • post CID-103 infusion, oral corticosteroid (20 mg methylprednisolone or equiva
Slide 17: CID-103-201 Summary Safety Data
CID-103-201 Summary Safety Data (cut-off date May 13, 2025) Cohort 3 Cohort 1（30mg/30mg） Cohort 2（30mg/150mg） AEs （150mg/300mg） Total 8601001 8601003 8601004 DLT-Period Post DLT-Period DLT-Period Post DLT-Period DLT-Period DLT 0 NA 0 0 0 0 1 2 (Urine white blood cell (Cold-like symptoms,G1, TEAE inc
Slide 18: CASI-CID-103-202 AMR Study Update
CASI-CID-103-202 AMR Study Update 18
Slide 19: CID-103 IND status/FDA interactions
CID-103 IND status/FDA interactions • Recent FDA feedback via e-mail provided clear guidance, required CASI to submit a “acceptable” written response via e-mail to one last item • If the response is found acceptable by The Division of Transplant Medicine, the revised IND will be submitted ASAP 19
Slide 20: CID-103: AMR Study Design Dose Escalation
CID-103: AMR Study Design Dose Escalation Study design allows for the testing of potential of intermediate dose levels. FDA has requested an End of Phase 1 meeting prior to starting Randomized Phase 2 study. 20
Slide 21: Q&A
Q&A CASI Pharmaceuticals Inc.