Indaptus Therapeutics, Inc. · NASDAQ:INDP
Indaptus Therapeutics — Investor Presentation (September 2024)
30 slides from Indaptus Therapeutics's investor presentation, September 2024
Slide 1: Corporate Presentation
September 2024 CORPORATE PRESENTATION NASDAQ: INDP
Slide 2: Disclaimers
DISCLAIMERS This presentation contains forward‐looking statements with the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, Section 27A of the Securities Act of 1933, as amended, and the Private Securities Litigation Reform Act. These include statements regarding manage
Slide 3: Indaptus Opportunity Highlights
DEVELOPING NOVEL, PATENTED SYSTEMICALLY-ADMINISTERED ANTI-CANCER & ANTI-VIRAL IMMUNOTHERAPIES Indaptus Opportunity Highlights Indaptus Therapeutics is a clinical biotechnology company developing novel and patented anti-cancer and anti-viral immunotherapies using gram-negative bacteria to safely prim
Slide 4: Investor Highlights and Key Metrics
INVESTOR HIGHLIGHTS AND KEY METRICS STOCK SYMBOL : INDP (NASDAQ) Recent News Analyst Reports Stock Price (8/21/24) $1.59 52 Week Range $1.56 - $4.08 Average Daily Volume (3 months) 21K Common Shares Outstanding 10.2M Market Capitalization (5/31/24) $16.3M Cash & Equivalents (6/30/24) $7.3M Enterpris
Slide 5: Indaptus' Immunotherapy Pipeline
INDAPTUS’ IMMUNOTHERAPY PIPELINE Broad portfolio of clinical programs utilizing Indaptus’ proprietary platform Optimization Name Description Indication Discovery Preclinical Phase 1 Phase 2 Characterization INDP010 Chemically-Modified (Decoy10) Multiple Platform Strain Proprietary Chemically- Advanc
Slide 6: Low Cure Rates in Advanced Cancers
LOW CURE RATES IN ADVANCED CANCERS Current cancer immunotherapies only address a limited part of the immune system Targeted Antibodies IL-2 and IFN-α T-vec/GM-CSF Checkpoint CAR-T Gamma- TAA Delta Natural Killer T-Cell T-Cell Natural Killer Cell Dendritic Cell INNATE ADAPTIVE Neutrophil CD8+ T-Cell
Slide 7: Potentially First-in-Class Safely Activated Innate and Adaptive Immune Pathways
POTENTIALLY FIRST-IN-CLASS SAFELY ACTIVATED INNATE AND ADAPTIVE IMMUNE PATHWAYS DECOY Targeted Antibodies IL-2 and IFN-α T-vec/GM-CSF Checkpoint CAR-T Gamma- TAA Delta Natural Killer T-Cell T-Cell Natural Killer Cell Dendritic Cell INNATE ADAPTIVE TUMOR Neutrophil CD8+ T-Cell TAA Macrophage CD4+ T-C
Slide 8: Re-Imagining Immunotherapy
RE-IMAGINING IMMUNOTHERAPY A broad, brief immune activation approach Current Immunotherapy Approaches Decoy Platform Approach • Most immunotherapy approaches target • Decoy Therapeutics contain a package of one or only a few immune components immune agonists that activate both innate and adaptive im
Slide 9: Why Utilize Gram-Negative Bacteria?
Why Utilize Gram-Negative Bacteria? • Gram-negative bacteria contain many innate and adaptive immune activators • Killed bacteria provide both a short duration of exposure and the ability to stimulate both innate and adaptive pathways • Most steps of innate and adaptive immune activation occur outsi
Slide 10: I.V. Administered Gram-Negative Bacteria Toxicity
I.V. ADMINISTERED GRAM-NEGATIVE BACTERIA TOXICITY Gram-negative bacteria are toxic due to surplus of lipopolysaccharide Lipopolysaccharide (LPS-endotoxin) TLR4 agonist is: • One of the most potent and broadly acting immune system activators • Constitutes about 75% of Gram-negative bacterial cell mem
Slide 11: Decoy Therapeutics: How They Are Produced
DECOY THERAPEUTICS How Decoy Therapeutics are produced Naturally occurring bacteria are challenging for use as a therapy (particularly with regards to toxicity) First, Indaptus starts with a laboratory-strain E.coli that requires a molecule not found in humans so it cannot replicate nor grow in the
Slide 12: Clinical Development Plan
CLINICAL DEVELOPMENT PLAN 2023 2024 2025 2026 1H 2H 1H 2H 1H 2H 1H Dose Escalation Single Ascending Doses Expansion Multiple Doses Select Tumors Ph1b Combination Checkpoint / NSAID/ Low Dose Chemo Key Milestones Anticipated Milestones þ First dosing of Decoy20 in 1Q 2023 o Multi-dose safety data 2H
Slide 13: Summary of Decoy20 Clinical Observations in Phase 1
Summary Of Decoy20 Clinical Observations In Phase 1 Cohort 1 & Cohort 2 Data*: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Observed transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune responses • Tolerability results consistent with the propo
Slide 14: Summary of Decoy20 Clinical Observations in Phase 1 (cont.)
Summary Of Decoy20 Clinical Observations In Phase 1 (cont.) Cohort 1 & Cohort 2 Data*: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Observed transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune responses • Tolerability results consistent with t
Slide 15: Summary of Decoy20 Clinical Observations in Phase 1 (cont.)
Summary Of Decoy20 Clinical Observations In Phase 1 (cont.) Cohort 1 & Cohort 2 Data*: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Observed transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune responses • Tolerability results consistent with t
Slide 16: Plasma Cytokine/Chemokine
PLASMA CYTOKINE/CHEMOKINE Data from 1st Decoy20 clinical cohort Cytokines and Chemokines Responsive Immune Cell Type: Inducing Migration, Activation, Maturation All Participate in and/or Proliferation of Immune Cells Anti-Tumor Immune Responses GM-CSF, IL-1β, IL-4, IL-12, IL-15, IFN-αβ, IFN-γ Dendri
Slide 17: Approved Checkpoint & CAR-T Therapies
APPROVED CHECKPOINT & CAR-T THERAPIES Comparison to approved checkpoint and CAR-T therapies Indaptus’ Decoy Technology – Comparison to Approved Checkpoint and CAR-T Immunotherapies Approved Therapies Immune Polarization/Activation & Key Features Anti-CTLA-4 Anti-PD-(L)1 CAR-T Decoy M1 Macrophages ?
Slide 18: Clinical Trial: Phase 1 Breakdown and Design
CLINICAL TRIAL: Phase 1 Clinical Trial Breakdown and Design Single-Dose Safety/Tolerability Multi-Dose Safety/Tolerability Tumor types: • HCC Cohort 1 Any solid tumor First 3 patients • Urothelial • CRC with liver mets • Pancreatic (7x107 KB) (3x107 KB) • NSCLC • SCCHN If tolerable Dose Staggered Co
Slide 19: Clinical Sites
CLINICAL SITES Clinical sites currently enrolling in phase 1 study USC Norris Comprehensive Atlantic Health System Gabrail Cancer Cancer Center /Morristown Medical Center Center Los Angeles, CA Morristown, NJ Canton, OH Diana L Hanna, MD Angela T Alistar, MD Nashat Gabrail, MD Karmanos Cancer Emory
Slide 20: Decoy Therapeutics Are More Broadly Active Than Mono-Specific TLR Agonists
DECOY THERAPEUTICS ARE MORE BROADLY ACTIVE THAN MONO- SPECIFIC TLR AGONISTS Secretion by Human PBMCs CpG Poly(I:C) R848 LPS Decoy10* In Vitro (TLR9) (TLR3) (TLR7/8) (TLR4) (TLR2,4,8,9) pg/mL Anti-Tumor Cytokine (triplicate full titration peak average from two exp) GM-CSF 0 2 136 27 1,246 IFNγ 7 248
Slide 21: Single Agent Activity
SINGLE AGENT ACTIVITY Metastatic mouse pancreatic carcinoma & orthotopic CT26 mouse colorectal carcinoma No Decoy Gem Decoy Tumor fragments were sewn onto the cecal Treatment 5x10^7 2x10^8 wall on Day 0 (7 mice/group) Median 35 Days 41 Days 75 Days Survival 27 Days P<0.01 P<0.01 P<0.01 100 No Treatm
Slide 22: Decoy + NSAID Safely Eradicates Subcutaneous Mouse HCC
DECOY + NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SAFELY ERADICATES SUBCUTANEOUS MOUSE HEPATOCELLULAR CARCINOMAS (HCC) Treat 6 mice per group with Decoy 2x per week i.v. for 7 weeks / Start treatment at 103 mm 3 NSAIDS reduce myeloid-derived immune suppressive cells Decoy + NSAID NSAID alone 4,00
Slide 23: Combination with Anti-PD-1 Produces Up to 100% Complete Responses with HCC
COMBINATION WITH ANTI-PD-1 CHECKPOINT THERAPY PRODUCES UP TO 100% COMPLETE RESPONSES WITH HCC 3,500 3 ± SEM) All animals also received NSAID Control Control (6 mice per group) Indomethacin 3 ± SEM) 3,000 Decoy 2x10^8 Indomethacin i.v. 1xDecoy10 + 2x10^8 per week x6 x6 1x/week Anti-PD-1 1/6 CR (mm An
Slide 24: Immunological Memory
IMMUNOLOGICAL MEMORY Immunological memory is seen when “cured” mice are re-challenged Mice cured by DECOY + NSAID + Checkpoint Inhibitor and Re-Challenged on Day 91 on the opposite flank with fresh HCC tumor cells reject the tumors 800 700 600 Tumor Volume (mm3) 500 400 Fresh tumor 300 re-challenge
Slide 25: Systemic Administration of Decoy Therapy Induces Innate Immune Pathways in HCC Tumors
SYSTEMIC ADMINISTRATION OF DECOY THERAPY (1 I.V. DOSE), NSAID AND ANTI-PD1 INDUCES INNATE IMMUNE PATHWAYS IN HCC TUMORS oy ec t D + en ID o y I D -1 y 1 D -1 m ID oy -1 o - I o N re a t SA D SA c SA PD A D e c P D N S -P ec P N De N a- D a- T N D a- + + + a + H22 HCC Model NanoString 770 gene expres
Slide 26: Potential Utility as Anti-Viral Therapy
POTENTIAL UTILITY AS ANTI-VIRAL THERAPY Utility as an anti-viral therapy for Hepatitis B Virus (HBV), HIV and others • HBV is a chronic liver infection affecting 257 million people world-wide ⎼ Only 2% treated with current therapies / Major cause of cirrhosis and HCC / 887,000 deaths per year • Cyto
Slide 27: Target Indications Include 5 of the World's 12 Deadliest Cancers
TARGET INDICATIONS INCLUDE 5 OF THE WORLD’S 12 DEADLIEST CANCERS 12 Deadliest Cancers World-Wide High Unmet Medical Need (Potential Initial Tumor Types) 3% - 17% % of Yearly % of Yearly Deaths Cases 1 Lung 18.4 11.6 Percent five-year survival 2 Colorectal 9.0 10.0 for patients with metastatic diseas
Slide 28: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM Leadership experience in new modalities and early development Jeffrey Meckler - Chief Executive Officer Jeffrey Meckler currently serves as our Chief Executive Officer, bringing more than 30 years of financial and healthcare leadership experience to the company. Most rece
Slide 29: Board of Directors
BOARD OF DIRECTORS Leadership experience in new modalities and early development Roger J. Pomerantz, M.D. Chairman Michael J. Newman, Ph.D. Founder, CSO, Director Decoy Biosystems Jeffrey A. Meckler CEO, Director Anthony J. Maddaluna Director W. Brad Hayes Director Robert Martell, PH.D., M.D. Direct
Slide 30: Investor & Media Relations
Investor & Media Relations: investors@indaptusrx.com
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