CASI Pharmaceuticals, Inc. · OTC:CASIF
CASI Pharmaceuticals — Investor Presentation (August 2022)
30 slides from CASI Pharmaceuticals's investor presentation, August 2022
Slide 1: Corporate Presentation
Corporate Presentation August 2022 Q2 Bringing life-changing therapeutics to China and the world.
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. Forward-looking statements are subject to
Slide 3: CASI "Top Line"
CASI “Top Line” • US based NASDAQ listed company with a major focus on China • Integrated biotech company with proven development and commercial capabilities • EVOMELA® approved for commercial sale in China • Five pipeline assets • Focused on hematology-oncology therapeutic area • With our BD partne
Slide 4: EVOMELA: First Commercial Product
EVOMELA® First Commercial Product 4
Slide 5: EVOMELA Positioned For Continued Success
EVOMELA® Positioned For Continues Success • Only Cyclodextran enabled formulation of injectable melphalan commercially available in China • Used in preparative regimen for autologous stem cell transplant (“ASCT”), 1st line treatment for multiple myeloma. Provides best choice due to: − Lack of propyl
Slide 6: EVOMELA Revenue
EVOMELA® Revenue 10 9 8 7 US $ MILLIONS 6 5 4 3 2 1 0 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Full-year 2021 revenue strong growth over 2020 6
Slide 7: Pipeline Update
Pipeline Update casi
Slide 8: Pipeline
Pipeline China Developed Innovative Cell Therapy with Co-Commercialization Rights Indication Phase 2 NDA Filing & Pre-Clinical CTA Filing & Review Phase 1 Registration Trial Review CNTC19 (Autologous anti-CD19 T-cell Non-Hodgkin’s Lymphoma therapy)1 Acute Lymphoblastic Leukemia Investigational Innov
Slide 9: CNCT19 CD19 CAR-T Therapy
CNCT19 CD19 CAR-T Therapy Partner: Juventas Cell Therapy 9
Slide 10: CNCT19 CD19 directed CAR-T
CNCT19 CD19 directed CAR-T • Juventas Equity Investment: • License agreement included a staged equity investment of $22 million • Juventas has recently completed a Series C financing round, CASI indirectly owns a ~12.01% fully diluted equity stake in Juventas • Key Phase 1 Study Interim Results1: •
Slide 11: CNCT19 – Juventas Development Timeline
CNCT19 – Juventas Development Timeline • B-ALL and B-NHL Phase 2 / registration trials are currently enrolling in China • Breakthrough Therapy Designation received in December 2020 from China CDE for the B-ALL indication. • China B-ALL NDA submission targeted by Juventas for late 2022 • Potential 1s
Slide 12: BI-1206 Checkpoint Inhibitor Targeting FcγRIIB
BI-1206 Checkpoint Inhibitor Targeting FcγRIIB Partner: BioInvent 12
Slide 13: BI-1206 – The First Checkpoint Inhibitor Directed Towards Monoclonal Antibody Receptor Interaction
BI-1206 – The First Checkpoint Inhibitor Directed Towards Monoclonal Antibody Receptor Interaction • First-in-class fully human monoclonal antibody (“mAb”) that targets FcγRIIB • Acts like a Checkpoint Inhibitor, blocking FcγRIIB interaction to unleash antibody- mediated activation of the immune res
Slide 14: BI-1206 Responses in Phase 1/2a
OVERALL TREATMENT RESPONSES PHASE 1 PART OF STUDY RESPONSES FROM SEVEN OF THIRTEEN PATIENTS AS OF Q4, 2021 COMPLETING INDUCTION CYCLE • Objective response rate 54%, Disease control rate 13 62% 12 • 18 patients enrolled 11 PROGRESSIVE 10 DISEASE • 13 patients evaluated for response NUMBER OF PATIENTS
Slide 15: BI-1206 Response Rates in Follicular Lymphoma
BI-1206 ONGOING PHASE 1/2a: IMPRESSIVE RESPONSE RATES IN FOLLICULAR LYMPHOMA RESPONSES FROM SEVEN OF NINE PATIENTS FL SUBGROUP ANALYSIS AS OF Q4, 2021 WITH FOLLICULAR LYMPHOMA 12 • Overall response rate 67%, Disease control rate 78% 10 • 9 Follicular Lymphoma (FL) patients NUMBER OF PATIENTS 8 PROGR
Slide 16: Phase 1/2a Clinical Trial in Combination with Pembrolizumab
Phase 1/2a Clinical Trial in Combination with Pembrolizumab • A multicenter, open label, Phase 1/2a study in adults with advanced solid tumors who have relapsed or are refractory to anti-PD-1 or anti-PD-L1 therapy – approximately 60 patients across sites in the U.S. and SWE • High unmet medical need
Slide 17: BI-1206 Upcoming Key Milestones
BI-1206 Upcoming Key Milestones • Select RP2D, and move to expansion phase (part B) of the study (same patient population) • EoP1 meeting with FDA occurred in the first half of 2022 • Implementation of Phase 2 study in the U.S., Europe and China • Leverage large patient population in China to accele
Slide 18: CASI – BioInvent Partnership
CASI – BioInvent Partnership • Leverages CASI’s expertise, including clinical/medical teams and established relationships with hematology KOLs, hospitals, medical centers and pharmacies to accelerate development and commercialization of BI-1206 in China • Generate clinical data on BI-1206 rapidly in
Slide 19: CB-5339 VCP/P97 Inhibitor
CB-5339 VCP/P97 Inhibitor Partner: Cleave Therapeutics 19
Slide 20: CB-5339 – A Novel Clinical Stage Asset targeting VCP/P97
CB-5339 – A Novel Clinical Stage Asset targeting VCP/P97 • A potent 2nd generation small molecule inhibitor of VCP/p97 • ATP-competitive and binds primarily to the D2 ATPase domain of VCP/p97 • Potential for use in broad range of hematologic malignancies and solid tumors • Phase 1 dose escalation st
Slide 21: CB-5339 Phase 1 Trial Encouraging and Fast Moving
CB-5339 Phase 1 Trial Encouraging and Fast Moving 1a - Escalation AML/MDS/Myeloid Malignancies 1b - Expansion in specific populations Combination R/R AML at RP2D Accelerated Titration 3 + 3 Escalation Monotherapy Combination Int./Higher Risk MDS Int./Higher Risk MDS • CB-5339 dosed orally QD on days
Slide 22: CB-5339 Regulatory Activities
CB-5339 Regulatory Activities • CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation. • For Innovative Products in China, a local Phase 1 (PK/PD) study will be required • Two in
Slide 23: CID-103
CID-103 Fully human IgG1 anti-CD38 mAB 23
Slide 24: CID-103: anti-CD38 monoclonal antibody
CID-103: anti-CD38 monoclonal antibody • Exclusive global rights for all indications • Fully human IgG1 anti-CD38 mAb recognizing a unique epitope • Encouraging preclinical efficacy & safety profile compared to other anti-CD38 mAbs • Binding to human RBC donor samples demonstrates that CID-103 has c
Slide 25: CID-103 Phase 1 Dose Escalation Study
CID-103 Phase 1 Dose Escalation Study • Phase 1 trial ongoing in UK and France • Dose escalation study • Currently enrolling dose level 3 Dose Level Week 1 (fixed dose) Week 2+ (fixed dose) 1 30 mg 150 mg 2 150 mg 300 mg 3 150 mg 600 mg 4 150 mg 900 mg 5 150 mg 1200 mg 6 150 mg 1800 mg • No DLTs obs
Slide 26: Second Quarter 2022 Financial Highlights
Second Quarter 2022 Financial Highlights • Revenues consist primarily of product sales of EVOMELA. Revenue was $8.6 million for the three months ended June 30, 2022, compared to $7.2 million for the three months ended June 30, 2021. • Costs of revenues were $3.6 million for the three months ended Ju
Slide 27: CASI Summary
CASI Summary • EVOMELA® − Q2 2022 sales US $8.6 million − Achieved our goal for full-year 2021 revenue to reach 100% growth • CNCT19 (CD19 CAR-T Cell Therapy) − B-NHL and B-ALL Phase 2 registration trial currently enrolling in China − NDA filing for B-ALL indication anticipated in second half of 202
Slide 28: Global Senior Management Team
Global Senior Management Team Wei-Wu He, PhD Larry Zhang, Chairman and CEO President Alex Zukiwski, MD, Jim Goldschmidt, PhD, Executive Vice President, Chief Business Chief Medical Officer Development Officer 28
Slide 29: CASI China Management Team
CASI China Management Team Thomas Zhang, Junping Chen, PhD Cissy Wang, China Commercial GM VP, Medical COO (CASI China) (CASI China) (CASI China) Jonathan You, Michael Wu, Miao Yue, GM of R&D and Mfg. Site Sr. Regulatory Director Clinical Director (CASI WUXI) (CASI China) (CASI China) 29
Slide 30: Thank You
Thank You
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