Immix Biopharma, Inc. · NASDAQ:IMMX
Immix Biopharma — Investor Presentation (July 2024)
40 slides from Immix Biopharma's investor presentation, July 2024
Slide 1: CAR-T Clinical Trailblazer in AL Amyloidosis and autoimmune diseases
CAR-T Clinical Trailblazer in AL Amyloidosis and autoimmune diseases July 2024
Slide 2: Disclaimer: Forward Looking Statements & Market Data
Disclaimer: Forward Looking Statements & Market Data This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding Immix Biopharma, Inc.
Slide 3: Immix Biopharma Highlights
Immix Biopharma Highlights • NXC-201 could transform the treatment of Relapsed/Refractory AL amyloidosis (~30,000 prevalence, ~3,000 annual incidence US patients, $3bn market) NXC-201: The only CAR-T in AL amyloidosis • NXC-201 CART construct provides barrier to entry • NEXICART-1: 92% (12/13) overa
Slide 4: Significant Near-Term Milestones
Significant Near-Term Milestones Anticipated Upcoming Milestones Completed Timing NASDAQ IPO 2021 Initial NEXICART-2 clinical data 4Q 2024 presentation in AL Amyloidosis Formed Cell Therapy R&D taskforce in 2022 Report interim clinical data readout for Secured global commercial rights for 2Q/3Q 2025
Slide 5: Pipeline: Only CAR-T in AL Amyloidosis; Tailor-Made for Autoimmune Indications
Pipeline: Only CAR-T in AL Amyloidosis; Tailor-Made for Autoimmune Indications Lead Program: NXC-201, a next-generation BCMA-targeting CAR-T for AL amyloid and autoimmune diseases Indication Therapy Pre-clinical Phase 1 Phase 2 Upcoming Milestones 4Q 2024: Initial NEXICART-2 clinical data presentati
Slide 6: NXC-201 Referenced in June 2024 New England Journal of Medicine Publication
NXC-201 Referenced in June 2024 New England Journal of Medicine Publication Footer Sanchorawala et al. Systemic Light Chain Amyloidosis. New England Journal of Medicine. June 2024. 6
Slide 7: Leadership
World-Class Team David Marks, MBBS, PhD Gerhard Bauer Ilya Rachman, MD, PhD Gabriel Morris, BA Graham Ross, MBChB, FFPM Leadership Chief Medical Officer, Head of Cell Therapy Chief Executive Officer Chief Financial Officer Chief Medical Officer Cell Therapy Manufacturing TECARTUS® Kite/Gilead KYMRIA
Slide 8: N-GENIUS Platform: Sterically-Optimized CAR-T Construct Drives Differentiated NXC-201 Clinical Profile
N-GENIUS Platform: Sterically-Optimized CAR-T Construct Drives Differentiated NXC-201 Clinical Profile ALL BCMA CAR-TS ARE NOT CREATED EQUAL N-GENIUS PLATFORM Our CAR-T is differentiated based on 3 Key Construct Modifications 1 Proprietary Optimized 2 Proprietary Optimized 3 Proprietary Optimized CD
Slide 9: Proprietary Sterically-Optimized CD3ζ + CD8 Delivers “Digital” Intracellular Signaling
1 Proprietary Sterically-Optimized CD3ζ + CD8 Delivers “Digital” Intracellular Signaling, Eliminates Neurotoxicity, Reduces CRS Duration CD3ζ CARs rely on activation of CAR-T cells through CD3ζ derived immunoreceptor tyrosine-based activation motifs (ITAMs), typically 3 ITAM motifs per CAR “In activ
Slide 10: Proprietary Sterically-Optimized CD3ζ + CD8 Delivers “Digital” Intracellular Signaling (CD8 Hinge)
2 Proprietary Sterically-Optimized CD3ζ + CD8 Delivers “Digital” Intracellular Signaling, Eliminates Neurotoxicity, Reduces CRS Duration CD8 Hinge NXC-201: Optimized (Decreased) 216,058 >(90%) 4,050 >(60%) Literature: Optimized (Decreased) CD8 CD8 Hinge Flexibility Resulted In: Hinge Flexibility Res
Slide 11: Sterically-Optimized COBRA Binder Ensures High Expression And Binding Affinity
3 Sterically-Optimized COBRA Binder Ensures High Expression And Binding Affinity COBRA Binder HSL VH (GGGGS)5 VL 3.6 HSL LSH LSH VL (GGGGS)5 VH 80 COBRA Binder 1.6 Leads with 76 NXC-201 Heavy Chain COBRA Binder: Heavy Day 10 CAR-T Expansion (10^7) Specific Cytotoxicity (%): JeKo1 Chain – Proven Link
Slide 12: AL Amyloidosis: ~30,000 relapsed/refractory U.S. Patients With No FDA approved drugs
AL Amyloidosis: ~30,000 relapsed/refractory U.S. Patients With No FDA approved drugs NXC-201 TARGETS AL AMYLOIDOSIS PLASMA CELLS THAT EXPRESS BCMA ON CELL SURFACE Light chains deposit in organs, damaging organs Light chains produced by Light chains misfold dysfunctional plasma cells Heart • Heart fa
Slide 13: NXC-201 Addresses Sizable U.S. Relapsed/Refractory AL Amyloidosis Patient Population (1/2)
NXC-201 Addresses Sizable U.S. Relapsed/Refractory AL Amyloidosis Patient Population (1/2) Newly Diagnosed Relapsed/Refractory Newly diagnosed US Incidence ~4,000 Relapsed/Refractory Estimated relapsed/refractory ~3,040 US Prevalence ~29,712 in 2023 (Previously Treated) Eligible R/R ALA Patients ~32
Slide 14: NXC-201 Addresses Sizable U.S. Relapsed/Refractory AL Amyloidosis Patient Population (2/2)
NXC-201 Addresses Sizable U.S. Relapsed/Refractory AL Amyloidosis Patient Population (2/2) Prevalence Incidence Standard of Care Autologous stem cell transplant or Newly diagnosed AL Amyloidosis 1st Line US Incidence ~4,000 daratumumab + CyBorD 1st Line (± clinical development candidates Birtamimab
Slide 15: NXC-201 May Be a Curative Treatment for AL Amyloidosis
NXC-201 May Be a Curative Treatment for AL Amyloidosis ALL BCMA CAR-TS ARE NOT CREATED EQUAL AL amyloidosis is caused by dysfunctional plasma cells that can live for years, continuously producing toxic, misfolded amyloid light chain antibody fragments Normal LLPC Clone 1 (e.g. common cold targeted)
Slide 16: NXC-201 Designed for High Activity Against Disease-causing AL Amyloidosis Plasma Cells
NXC-201 Designed for High Activity Against Disease-causing AL Amyloidosis Plasma Cells ALL BCMA CAR-TS ARE NOT CREATED EQUAL a) Uneven BCMA expression and b) frail patient condition has historically prevented conventional, approved CAR-T use in AL Amyloidosis NXC-201 was designed and tested for huma
Slide 17: Primary Efficacy Endpoint for NEXICART-2: Normalization of Diseased Free Light Chains 30 Days after Dosing
Primary Efficacy Endpoint for NEXICART-2: Normalization of Diseased Free Light Chains 30 Days after Dosing NXC-201 RAPIDLY ELIMINATES DISEASED AL AMYLOIDOSIS PLASMA CELLS AND EXITS WITHIN ~30 DAYS NXC-201 HBI0101/mL Blood dFLC (mg/L) 2×10 5 600 HBI0101 cell/mL Blood 30 days dFLC (mg/L) 1.5×10 5 400
Slide 18: NXC-201: High Hematologic Responses in R/R AL amyloidosis ($3bn market) at ASGCT 2024
NXC-201: High Hematologic Responses in R/R AL amyloidosis ($3bn market) at ASGCT 2024 APPROVAL OF DARZALEX CyBorD IN FRONT-LINE AL AMYLOIDOSIS BASED ON HEMATOLOGIC RESPONSE RATE NXC-201 Best Hematologic Response, Best Hematologic NXC-201 – NEXICART-1 Clinical Data NXC-201 Complete Response 92% Only
Slide 19: Ongoing NEXICART-2 Trial to Target Relapsed/Refractory AL Amyloidosis Patients Most Likely to Benefit
Ongoing NEXICART-2 Trial to Target Relapsed/ Refractory AL Amyloidosis Patients Most Likely to Benefit NXC-201 clinical data indicate that R/R Amyloidosis patients with better baseline cardiac status and no prior BCMA-targeted bispecifics exposure are more likely to benefit from treatment Relapsed/R
Slide 20: NEXICART-1: Durable Responses in NXC-201 AL Amyloidosis Clinical Trial
NEXICART-1: Durable Responses in NXC-201 AL Amyloidosis Clinical Trial ONGOING U.S. TRIAL TARGETING R/R AL AMYLOIDOSIS PATIENTS MOST LIKELY TO BENEFIT FROM DURABLE RESPONSES • Complete hematologic response (CR) of 69% (9/13), and CR 75% (9/12) in patients without prior exposure to BCMA-targeted bisp
Slide 21: NEXICART-1: NXC-201 N-GENIUS Platform “Single-Day CRS” Drives AL Amyloidosis Leadership
NEXICART-1: NXC-201 N-GENIUS Platform “Single-Day CRS” Drives AL Amyloidosis Leadership ALL BCMA CAR-TS ARE NOT CREATED EQUAL NXC-201’s short CRS duration makes it uniquely NXC-201 Anito-cel suitable to treat ALA patients (in whom the #1 source /CARTddBCMA of mortality is heart failure) Others are 4
Slide 22: NEXICART-1: Overcoming Neurotoxicity
NEXICART-1: Overcoming Neurotoxicity ALL BCMA CAR-TS ARE NOT CREATED EQUAL LOW VOLUME DISEASE HIGH VOLUME DISEASE NXC-201 Others NXC-201 Abecma/Carvykti AL Amyloidosis Low volume autoimmune diseases Multiple Myeloma Multiple Myeloma Others are Others are >10x higher 8-10x higher KYV-101 Neurotoxicit
Slide 23: NEXICART-2 US Relapsed/Refractory AL Amyloidosis Trial (NCT06097832)
NEXICART-2 US Relapsed/Refractory AL Amyloidosis Trial (NCT06097832) NEXICART-2 NXC-201 US TRIAL INITIATED IN MID-2024 Study design Status as of July 2024 • Open-label, single-arm Phase 1/2a study • Lead site Memorial Sloan Kettering and other US sites started mid-2024 • n=40 patients Key criteria •
Slide 24: Single-arm NEXICART-2 trial designed considering NEXICART-1 and precedents in AL
Single-arm NEXICART-2 trial designed considering NEXCIART-1 and precedents in AL 2021 daratumumab (DARZALEX) FDA Approval NXC-201 NEXICART-2 Line of Therapy Newly Diagnosed Relapsed/Refractory Standard of Care (SoC) 3-drug combination: Cyclophosphamide, ✓ None (no FDA approvals) at time of trial bor
Slide 25: Advantages of CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis
Advantages of CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Antibody-drug NXC-201 Bispecifics conjugates One-time treatment NXC-201 High Complete Response Rates uniquely suited for Relapsed/Refractory AL Amyloidosis Low rates of severe infection No ICANS/Neurotoxicity Note: High complete respo
Slide 26: Differentiated NXC-201 Clinical Profile Enables Autoimmune Expansion
Differentiated NXC-201 Clinical Profile Enables Autoimmune Expansion POTENTIAL NXC-201 AUTOIMMUNE EXPANSION INDICATIONS Neurology Rheumatology • Myasthenia Gravis • Systemic Lupus Erythematosus • Neuromyelitis Optica Spectrum Disorder • Rheumatoid Arthritis Dermatology Hematology • Pemphigus Vulgari
Slide 27: NXC-201 Clinical Development Plan Through FDA BLA Submissions
NXC-201 Clinical Development Plan Through FDA BLA Submissions RELAPSED/REFRACTORY AL AMYLOIDOSIS CLINICAL TRIAL TO ENROLL 40 PATIENTS PRIOR TO FDA BLA SUBMISSION Phase 1b/2a NXC-201 Relapsed/refractory NEXICART-1: 13 patients dosed Ongoing: Expected enrollment Relapsed/Refractory AL 40 Patients NEXI
Slide 28: Appendix
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Slide 29: CAR-T NXC-201 Targets Plasma Cells (antibody factories of the body)
CAR-T NXC-201 Targets Plasma Cells (antibody factories of the body) ANTIBODY FACTORY PLASMA CELLS PRODUCE ANTIBODIES THAT DRIVE AUTOIMMUNE DISEASES AL Amyloidosis Neurology Hematology Rheumatology Vascular Infiltrates and damages heart • Myasthenia Gravis • Thrombotic thrombocytopenic purpura • Syst
Slide 30: NXC-201 CAR-T cells penetrate tissues and repeat kill disease-causing cells in AL Amyloidosis
NXC-201 CAR-T cells penetrate tissues and repeat kill disease-causing cells in AL Amyloidosis Diseased AL amyloidosis bone These disease-causing plasma AL Amyloidosis pathologic light chains emerge from deep in the marrow contains densely cells generate a high density of bone marrow where they are p
Slide 31: In AL Amyloidosis, NXC-201 Overcomes Limitations of Other Modalities in Performance and Tolerability
In AL Amyloidosis, NXC-201 Overcomes Limitations of Other Modalities in Performance and Tolerability Challenges of bispecifics/ T-cell engagers NXC-201 overcomes these challenges • No clinical trials with clinical data • 75% CR in relapsed/refractory AL available in relapsed/refractory AL amyloidosi
Slide 32: N-GENIUS Sterically-Optimized CARTs Drive Immix’s Autoimmune Leadership
N-GENIUS Sterically-Optimized CARTs Drive Immix’s Autoimmune Leadership N-GENIUS Platform Through partnership Hadassah Medical Organization, Jerusalem and Bar-Ilan University, Immix is a pioneer in sterically-optimized CAR-T construct development, driving our next-generation industry-leading CAR-Ts
Slide 33: N-GENIUS Platform has produced sterically-optimized BCMA CAR-T NXC-201 with COBRA binder and EXPAND technology
N-GENIUS Platform has produced sterically-optimized BCMA CAR-T NXC-201 with COBRA binder and EXPAND technology ALL BCMA CAR-TS ARE NOT CREATED EQUAL N-GENIUS PLATFORM 3 Key Elements Produced NXC-201 NXC-201 Purpose-Built Cell Therapy Evidence EXPAND Technology + COBRA Binder Capture Engine + Relatio
Slide 34: NXC-201 MoA: Sterically-Optimized BCMA-targeted CAR-T
NXC-201 MoA: Sterically-Optimized BCMA-targeted CAR-T NXC-201: STERICALLY-OPTIMIZED BCMA CAR-T GENERATED BY THE N-GENIUS PLATFORM NXC-201 NXC-201 — Key Characteristics High Transduction Efficiency 100% BCMA (Ensuring efficient manufacturing) BCMA Expressing % CAR+ Surface *Carvykti data presented at
Slide 35: Proprietary EXPAND Technology and COBRA Binding Domain Are Differentiated Innovations
Proprietary EXPAND Technology and COBRA Binding Domain Are Differentiated Innovations N-GENIUS TECHNOLOGY PLATFORM: STERICLALLY-OPTIMIZED BCMA CAR-T NXC-201 Abecma Carvykti CART-ddBCMA NXC-201 with COBRA Binding Domain γ N-GENIUS EXPAND Technology γ Note: Graphic representation. COBRA = Codon Optimi
Slide 36: NXC-201 Best-in-Class AL Amyloidosis Clinical Results
NXC-201 Best-in-Class AL Amyloidosis Clinical Results Relapsed/Refractory Light chain (AL) Amyloidosis Darzalex Combination Birtamimab NXC-201 (with cyclophosphamide, CAEL-101 Combined with Monotherapy bortezomib, and/or SOC CyBorD dexamethasone) Dosing frequency 1X Weekly Weekly Weekly Patient #s:
Slide 37: Ongoing Clinical Study Design (NEXICART-1/NCT04720313)
Ongoing Clinical Study Design (NEXICART-1/NCT04720313) RECOMMENDED PHASE 2 DOSE (RP2D) ALREADY DETERMINED AT 800X10^6 As of May 2024 ✓ RP2D already determined at 800x10^6 ✓ 63 patients in MM ✓ 13 in AL 800x10^6 CAR+ T cells Dosing ongoing… N=63 450x10^6 CAR+ T cells N=7 150x10^6 CAR+ T cells N=6 Sou
Slide 38: What is autologous chimeric antigen receptor (CAR)-T cell therapy?
What is autologous chimeric antigen receptor (CAR)-T cell therapy? NXC-201 IS A NEXT-GENERATION BCMA TARGETED AUTOLOGOUS CAR-T CELL THERAPY Patient Specific Personalized treatment using patient’s own T cells Genetic Modification Genetically engineered CARs (chimeric antigen receptors) on T cell surf
Slide 39: N-GENIUS Platform Process
N-GENIUS Platform Process 1 2 3 4 5 Problem Identification Research Group Platform Foundation Candidate Creation Final Candidate CAR-T Toxicity Main Block to Formation N-GENIUS Platform with EXPAND Entire CAR-T construct optimized with N- Selection Widespread Use: Neurotoxicity Technology aims to ac
Slide 40: CAR-T Clinical Trailblazer in AL Amyloidosis and autoimmune diseases
CAR-T Clinical Trailblazer in AL Amyloidosis and autoimmune diseases July 2024