Immix Biopharma, Inc. · NASDAQ:IMMX
Immix Biopharma — Investor Presentation (October 2024)
48 slides from Immix Biopharma's investor presentation, October 2024
Slide 1: Clinical Stage CAR-T for AL Amyloidosis and Select Immune-Mediated Diseases
Clinical Stage CAR-T for AL Amyloidosis and Select Immune-Mediated Diseases October 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 (US patients: ~33,000 prevalence, ~4,300 annual incidence, $3bn market) NXC-201: The only CAR-T in AL amyloidosis • Ex-US NXC-201 study: 69% (9/13) Complete response rate in relapsed/refractory A
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 select Immune-Mediated Diseases
Pipeline: Only CAR-T in AL Amyloidosis; Tailor-Made for select Immune-Mediated Diseases Lead Program: NXC-201, a next-generation BCMA-targeting CAR-T for AL Amyloidosis and select immune-mediated diseases Indication Therapy Pre-clinical Phase 1 Phase 2 Upcoming Milestones 4Q 2024: Initial NEXICART-2
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: Sterically-Optimized CD8 Hinge Reduces Cytokine Release
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: ~33,000 relapsed/refractory U.S. Patients With No FDA approved drugs
AL Amyloidosis: ~33,000 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 and dysfunctional plasma cells aggregate He
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 Relapsed/Refractory Estimated relapsed/refractory US Incidence ~4,300 ~3,225 US Prevalence ~33,277 in 2024 (Previously Treated) Eligible R/R ALA Patients ~36
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 ~4,300 daratumumab + CyBorD (four drug combo) 1st Line (± clinical development cand
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
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 (mg/L) dFLC (mg/L) 2×10 5 600 HBI0101 cell/mL Blood 30 days dFLC (mg/L) 1.5×10
Slide 18: NXC-201: High Complete Response Rate in R/R AL amyloidosis at ASGCT 2024
NXC-201: High Complete Response Rate in R/R AL amyloidosis ($3bn market) at ASGCT 2024 APPROVAL OF DARZALEX CyBorD IN FRONT-LINE AL AMYLOIDOSIS BASED ON COMPLETE RESPONSE RATE Relapsed/Refractory AL Amyloidosis NXC-201 Best Hematologic Response, NXC-201 – NEXICART-1 Clinical Data Best Hematologic NX
Slide 19: Ongoing potentially pivotal NEXICART-2 Trial Targeting Relapsed/Refractory AL Amyloidosis Patients
Ongoing potentially pivotal NEXICART-2 Trial Targeting Relapsed/ Refractory AL Amyloidosis Patients Most Likely to Benefit NXC-201 clinical data indicate that R/R Amyloidosis patients with better pre-existing cardiac status and no prior BCMA-targeted bispecifics exposure are more likely to benefit f
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 CABA-201 Grade 4 ICA
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 • Open-label, single-arm Phase 1b/2 study • Lead site Memorial Sloan Kettering and other US sites started mid-2024 • n=40 patients (majority of which expected to
Slide 24: Single-arm potentially pivotal NEXICART-2 trial designed considering NEXICART-1 and precedents in AL
Single-arm potentially pivotal 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)
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 1 One-time treatment NXC-201 uniquely suited for 2 High Complete Response Rates Relapsed/Refractory AL Amyloidosis 3 Low rates of severe infection 4 No ICANS/Neurotoxicity Note: High comple
Slide 26: 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 IMMUNE-MEDIATED DISEASES AL Amyloidosis Neurology Hematology Rheumatology Vascular Infiltrates and damages heart • Myasthenia Gravis • Thrombotic thrombocytopenic purpura •
Slide 27: NXC-201 BCMA CAR-T targeting is uniquely suited to address Immune-Mediated Diseases
NXC-201 BCMA CAR-T targeting is uniquely suited to address Immune-Mediated Diseases NXC-201 BCMA CAR-T TARGETS LONG-LIVED PLASMA CELLS, WHICH ARE OFF-TARGET FOR CD19 THERAPEUTICS NXC-201 ~80% of all auto-antibodies in immune-mediated disease are produced by long-lived plasma cells… BCMA is expressed
Slide 28: 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/2 NXC-201 Relapsed/refractory NEXICART-1: 13 patients dosed Ongoing: Expected enrollment Relapsed/Refractory AL 40 Patients NEXIC
Slide 29: Appendix
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Slide 30: Principal Investigator for NEXICART-2: Heather Landau, MD
Principal Investigator for NEXICART-2: Heather Landau, MD • Director of the Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York. • Authored more than 100 peer-reviewed publications. • Dr. Landau received her medical d
Slide 31: 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 32: Pathologic Light Chains in AL Amyloidosis are an Antibody Building Block That Are Overproduced
Pathologic Light Chains in AL Amyloidosis are an Antibody Building Block That Are Overproduced by Plasma Cells IN AL, PLASMA CELLS PRODUCE TOO MANY LIGHT CHAINS A LIGHT CHAIN IS A PORTION OF AN ANTIBODY (AND NOT ENOUGH HEAVY CHAINS) Diseased light chains Light chain portion in AL Amyloidosis: of ant
Slide 33: Robust Global Sales of CAR-T Continue
Robust Global Sales of CAR-T Continue Sales of Approved CAR-T ($M) Sales of Approved Bispecifics ($M) 4,800 4,800 Yescarta Tecarus Tecvali Blincyto 4,400 Kymriah Carvykti 4,400 Epkinly Lunsumio 4,000 Abecma Breyanzi 4,000 Columvi 3,600 3,600 3,200 3,200 2,800 2,800 2017 – 2024E 2,400 CAGR: 129% 2,40
Slide 34: Amyloid deposits in AL Amyloidosis are cleared naturally after treatment
Amyloid deposits in AL Amyloidosis are cleared naturally after treatment BEFORE TREATMENT 6-MONTHS AFTER TREATMENT Cytotoxic treatments Pre-treatment imaging (vincristine, Post-treatment imaging shows dense amyloid adriamycin, and dexamethasone) shows clearance of amyloid deposits in liver, bone in
Slide 35: Complete Hematologic Response is correlated with longer survival
Complete Hematologic Response is correlated with longer survival COMPLETE HEMATOLOGIC RESPONSE WAS PRIMARY ENDPOINT IN 2021 DARATUMUMAB APPROVAL STUDY AND ONGOING NEXICART-2 TRIAL Complete Hematologic Response (CR) associated with improved survival in AL 2x survival at 48 months for CR vs PR • Compl
Slide 36: MRD- is Correlated with Improved PFS in AL Amyloidosis
MRD- is Correlated with Improved PFS in AL Amyloidosis MRD negativity is associated with improved Progression Free Survival in AL 2x PFS at 36 months for MRD- vs MRD+ (patients with CR or VGPR) • MRD negative patients have 88% 36-month PFS PFS Probability • MRD positive patients have 46% 36-month PF
Slide 37: 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 38: N-GENIUS Sterically-Optimized CARTs Drive Immix's Immune-Mediated Disease Leadership
N-GENIUS Sterically-Optimized CARTs Drive Immix’s Immune-Mediated Disease 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-le
Slide 39: 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 40: 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 41: 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 42: 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 43: Differentiated NXC-201 safety profile validated in historical Multiple Myeloma data
Differentiated NXC-201 safety profile validated in historical Multiple Myeloma data NXC-201 tolerability data in Relapsed/Refractory Multiple Myeloma Cytokine release syndrome ICANS neurotoxicity Cohort 1 (N=6) Cohort 2 (N=7) Cohort 3 (N=50) Overall (n=63) Cohort 1 (N=6) Cohort 2 (N=7) Cohort 3 (N=5
Slide 44: Relapsed/Refractory Multiple Myeloma: Key Inclusion Criteria
Relapsed/Refractory Multiple Myeloma: Key Inclusion Criteria NXC-201 Abecma Carvykti CART-ddBCMA (NEXICART-1 NCT04720313) (pivotal NCT03361748) (pivotal NCT03548207) (pivotal NCT05396885) Prior lines ≥3 different prior lines of therapy including ≥3 different prior lines of therapy including a ≥3 dif
Slide 45: Relapsed/Refractory Multiple Myeloma: Key Exclusion Criteria
Relapsed/Refractory Multiple Myeloma: Key Exclusion Criteria NXC-201 Abecma Carvykti CART-ddBCMA (NEXICART-1 NCT04720313) (pivotal NCT03361748) (pivotal NCT03548207) (pivotal NCT05396885) Prior BCMA therapy No exclusion BCMA targeted therapy Have received any therapy that is targeted to B- Prior B-c
Slide 46: 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 plasma Genetic Modification Genetically engineered CARs (chimeric antigen receptors) on T ce
Slide 47: 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 48: Clinical Stage CAR-T for AL Amyloidosis and Select Immune-Mediated Diseases
Clinical Stage CAR-T for AL Amyloidosis and Select Immune-Mediated Diseases October 2024
Immix Biopharma — Investor Presentation (October 2024) on 6ix