Imunon, Inc. · NASDAQ:IMNN
Imunon — Celsion — Investor Presentation (June 2022)
39 slides from Imunon's investor presentation, June 2022
Slide 1: Corporate Presentation
Corporate Presentation Nasdaq: CLSN June 2022
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation and any statements made during any presentation or meeting contain forward-looking statements related to Celsion Corporation (“Celsion”) under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to
Slide 3: Proprietary DNA Plasmid Technology Platforms
Proprietary DNA Plasmid Technology Platforms TheraPlas PLACCINE • Polymeric Nanoparticle Delivers DNA Plasmids Coding • DNA Plasmid vectors engineered for next generation for Therapeutic Proteins vaccine technology • Designed for multiple antigens • Safely Administered to Over 100 Patients To-Date •
Slide 4: Pipeline Milestone Events
Pipeline Milestone Events 2022 - 2023 PROGRAM & INDICATION 2020 2021 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Initiate Phase II Enrollment Phase II GEN-1 Enrollment Complete Phase II Trial* Primary ORR & Surgical Endpoint OVATION 2 Study Data from Phase II (PFS) Ovarian Cancer PFS D
Slide 5: GEN-1 IL-12 Immuno-Oncology Program
GEN-1 IL-12 IMMUNO-ONCOLOGY PROGRAM
Slide 6: IL-12: A Powerful Immune-Modulating Agent
IL-12: A Powerful Immune-Modulating Agent Interleukin-12 Can Induce Anti-cancer Immunity Through Multiple Mechanisms Activation/Proliferation 1 Stimulates the proliferation of CD-8 positive T-cells and natural killer (NK) cells and their cytotoxic activity against the tumor 2 Maturation/Proliferatio
Slide 7: GEN-1 Composition
GEN-1 Composition Three Component Delivery System of Polyethylene Glycol (PEG) Polyethyleneimine (PEI) Cholesterol Combined with IL-12 DNA Plasmid PEI Condenses DNA strands into nanoparticles PEG Cholesterol Improves stability and protects Facilitates uptake and trafficking plasmid from degradation
Slide 8: GEN-1 Targets Ovarian Cancer Metastases Throughout the Peritoneal Cavity
GEN-1 Targets Ovarian Cancer Metastases Throughout the Peritoneal Cavity GEN-1 Intracavity infusion of GEN-1 has demonstrated durable and local expression of Persistent IL-12 in the peritoneum local therapy Peritoneal-plasma barrier minimizes systemic exposure of IL-12, thereby giving a favorable sa
Slide 9: Treatment Options in Advanced Ovarian Cancer Are Limited
Treatment Options in Advanced Ovarian Cancer Are Limited Recurrence Rates are High and Survival Rates Low 75% of Incidence: Stage III/IV Treatment Naïve Population 1st Line GEN-1 + Platinum/Taxane Pre and Post Surgery PFS 12 months | OS 36 months Platinum Sensitive Platinum Resistant Platinum Refrac
Slide 10: OVATION I Ovarian Cancer Study
OVATION I Ovarian Cancer Study Phase I to Determine Dose, Efficacy, and Biological Activity With NAC in Stage III/IV Patients Newly Diagnosed Standard Neoadjuvant Interval Debulking Ovarian Cancer Chemotherapy (NAC) + Surgery Tissue Collection 8 weekly cycles of GEN-1 Tissue Collection Ovarian Cance
Slide 11: OVATION I Study
OVATION I Study Clinical and Molecular Dose Dependent Responses Observed Clinical Responses* GEN-1 Low-Dose Cohorts High-Dose Cohorts 36 mg/mg² & 47 mg/mg² 61 mg/mg² & 79 mg/mg² Objective Tumor Response (CR/PR) RECIST 1.1 66% 100% Interval Debulking Status 33% 88% R0 Resection Rate Chemotherapy Resp
Slide 12: OVATION I: Improved Progression-Free Survival Demonstrated with GEN-1
OVATION I: Improved Progression-Free Survival Demonstrated with GEN-1 Improvements vs Medidata Synthetic Control Arm in Comparable Patient Populations Historically established PFS (Vergote, Kehoe – 250 pts) 12 months OVATION I – ITT 18.4 months Final Median PFS Per OVATION I Protocol 21 months Simil
Slide 13: OVATION I Study Translational Data Sampling
OVATION I Study Translational Data Sampling Marked Dose-Dependent Increase in Anti-Cancer Cytokine Levels Increase in Dendritic and TEM Cells Interleukin-12 Interferon- 14.0 Myeloid Dendritic Cells 30 70 Ascites 12.0 60 Effector Memory T Cells Ascites (pg/mg protein) 25 Ascites Blood 10.0 Fold Chan
Slide 14: GEN-1 OVATION 2 Ovarian Cancer Study
GEN-1 OVATION 2 Ovarian Cancer Study To Determine Efficacy and Biological Activity With NAC in Stage III/IV Patients 1 : 1 Randomization Added Control Arm to OVATION 2 Newly Diagnosed Neoadjuvant Chemotherapy (NAC) Interval Debulking Adjuvant Chemotherapy Ovarian Cancer + Surgery + Tissue Collection
Slide 15: GEN-1 OVATION 2 Ovarian Cancer Study
GEN-1 OVATION 2 Ovarian Cancer Study Phase I/II Open Label Controlled Trial Phase I Portion (N=14) Completed 100 mg/m² GEN-1 Dose Confirmed 22 Clinical Sites in U.S. and Canada Enrollment Expected to be Completed in Q3 - 2022 Interim Data NACT ONLY NACT + GEN-1 Interval Debulking Surgery (35
Slide 16: GEN-1 Registrational Plan
GEN-1 Registrational Plan Focus on BRCA negative Sub-Group HRP (homologous recombination proficient with no BRCA 1/2 mutations) Median time to progression is about 9 months About 45% of ovarian cancer patients are not getting a clinical benefit from PARP inhibitors Early OVATION 2 data indicates
Slide 17: 2nd GEN-1 Study Accepted by FDA
2nd GEN-1 Study Accepted by FDA GEN-1 + Avastin (BEV) in Advanced Epithelial Ovarian Cancer ICS SLL Maintenance Pac/Carbo x 4-6 Pac/Carbo x 3 BEV BEV x 2 BEV x 2 PARPi (HRD only) NACT R Pac/Carbo x 4-6 Pac/Carbo x 3 BEV BEV x 2 BEV x 2 GEN-1 (HRP only) GEN-1 x 10-16 GEN-1 x 9 PARPi (HRD only) Primar
Slide 18: GEN-1 Summary
GEN-1 Summary GEN-1 offers a novel way to harness the powerful immunological properties of IL-12; The “Master Switch” to the body’s immune system Five completed ovarian cancer trials demonstrate biologic and clinical activity; Strong efficacy signals in Phase I; Mechanism of action confirmed OVATION
Slide 19: PLACCINE Platform
PLACCINE Platform S A R S - C o V- 2 I n i t i a t i ve : P ro o f o f C o n c e p t & Va l i d a t i o n
Slide 20: PLACCINE – A Superior Class of Nucleic Acid Vaccine
PLACCINE* – A Superior Class of Nucleic Acid Vaccine • We are developing a multivalent pDNA based vaccine platform technology enabling vaccines with superior properties to mRNA vaccines • Proof of concept is being demonstrated using SARS-CoV-2 vaccines as a benchmark • Successful results will illust
Slide 21: Multivalent DNA Vaccine
Multivalent DNA Vaccine Next Generation, based on the Novel PLACCINE Vaccine Platform PLACCINE Multivalent DNA Vaccine Technology Platform Single multi-cistronic DNA plasmid vector • Multiple pathogen antigens • Potent immune modifier Delivered with a non-viral, synthetic delivery system Adaptable f
Slide 22: Multi-cistronic Formulated pDNA Vaccine Platform
Multi-cistronic Formulated pDNA Vaccine Platform Proprietary PLACCINE Platform Technologies PLACCINE pDNA System PLACCINE Delivery Systems -Synthetic Delivery Systems • Non-viral • Non-device Expression Vector Nanoparticles/Complexes Antigen DNA 1 Antigen DNA 2 PLACCINE Vaccines Optional Immune modi
Slide 23: First Generation PLACCINE Formulation F1 Improves Gene Transfer
First Generation PLACCINE Formulation F1 Improves Gene Transfer Forty-fold Improvement Over Naked DNA • Gene Luciferase • DNA 25 mg • Formulation F1, naked DNA • Expression data Day 1 (RLU), Day 7 (image) 6 intensity 5 Log RLU 4 3 2 1 0 Naked DNA F1 F1 23
Slide 24: Standard Vaccine Regimen Used For In Vivo Studies
Standard Vaccine Regimen Used For In Vivo Studies • Prime Day 0 • Bost Day 14 • Bleed for IgG Day 14, 35 • IgG (spleen) Day 35 BALB/c mice 24
Slide 25: Latest Vectors Following Optimization of Antigen & Transcription Elements
Latest Vectors Following Optimization of Antigen & Transcription Elements Single Antigen Vectors - IgG titer • Optimized vectors pVac-15, pVac-16 • Spike antigen D614G, Delta • Formulation: F3 • 125 mg DNA • IgG titer (day 35) IgG Titer IgG Titer (day 35 after prime) 10 2 D614G Delta Variant Antigen
Slide 26: Neutralizing Activity of Latest Vectors in a Pseudoviral Assay
Neutralizing Activity of Latest Vectors in a Pseudoviral Assay Single Antigen Vectors- nAb titer • Latest vectors pVac-15, pVac-16 • Spike antigen D614G, Delta • Formulation: F3 • 125 mg DNA • IgG titer (day 35) Neutralizing 6 Antibody Titer e ta 4 4 D614G Variant Delta Variant 3 3 IC50 Titer IC50 T
Slide 27: Multicistronic Vector Expressing Two SARS-CoV-2 Antigen Variants
Multicistronic Vector Expressing Two SARS-CoV-2 Antigen Variants Spike Delta antigen 4 log fold change Spike D614G 3 antigen 2 Two-Variant Multicistronic Vector 1 0 ctrl C2 ctrl C3 Distinguishing between D614G and Delta by sequence-specific qPCR primers 27
Slide 28: Multicistronic PLACCINE Vaccine Protects Against Multiple Variants
Multicistronic PLACCINE Vaccine Protects Against Multiple Variants IgG and nAb Titers Comparable to a Commercial mRNA Vaccine • Multicistronic vector pVac-17 • Spike antigen D614G, Delta • Formulation: F3 • 125 mg DNA • IgG titer (day 35) IgG Titer Neutralizing Antibody Titer IgG Titer (day 35 after
Slide 29: Immunogenicity of Single & Multiple Antigen PLACCINE Vaccines
Immunogenicity of Single & Multiple Antigen PLACCINE Vaccines Neutralizing Ab Response to All Vaccine Vectors Observed • Vectors: pVac-15 (D614G) pVac-16 (Delta) pVac-17 (D614G+Delta) • Formulation: F3 • 125 mg DNA 4 Neutralizing Antibody Titer • IgG titer (day 35) D614G (Euro) (D614G L Variant) 3 I
Slide 30: PLACCINE Bi-cistronic DNA Vaccine Produces Neutralizing Immune Response Against Two Variants
PLACCINE Bi-cistronic DNA Vaccine Produces Neutralizing Immune Response Against Two Variants • Vectors: pVac-15 (D614G); pVac-16 (Delta); pVac-17 (D614G+Delta) • Formulation: F3 • 125 mg DNA D614G variant Delta variant • IgG titer (day 35) ns ns 4 4 ns ns ✱✱✱✱ ✱✱ 3 3 Titer IC50 Titer IC50 Titer IC50
Slide 31: DNA Vaccine Produces A Long-Term Functional Response (D614G variant)
DNA Vaccine Produces A Long-Term Functional Response (D614G variant) Persistence of Neutralizing Response at 3 months After Boost D614G 1 month ns 2 month 4 ns 3 month ✱ ✱ ✱ 3 IC50 Titer 2 1 pVac15 pVac16 pVac17 mRNA benchmark Variant D614G Delta D614G+Delta Wuhan Antigen 31
Slide 32: DNA Vaccine Produces A Long-Term Functional Response (Delta variant)
DNA Vaccine Produces A Long-Term Functional Response (Delta variant) Persistence of Neutralizing Response at 3 months After Boost Delta ✱ 4 ✱ ns ✱ 3 IC50 Titer 2 1 pVac15 pVac16 pVac17 mRNA benchmark Variant D614G Wuhan Delta D614G+Delta Antigen 32
Slide 33: Mouse Challenge Study (April 2022 start)
Mouse Challenge Study (April 2022 start) • Vector: pVac-15 (D614G), pVac-16 (Delta), pVac-17 (D614G + Delta) • Formulation: F3 Group hACE2 vaccine variant DNA volume dose 1 10* placebo - - 100µl 2 5 pVac-15 D614G 125µg 100µl 3 5 pVac-16 Delta 125µg 100µl 4 10* pVac-17 D614G/Delta 125µg 100µl * Five
Slide 34: NHP Challenge Study (April 2022 start)
NHP Challenge Study (April 2022 start) • PLACCINE Vector pVac-15 (D614G) • Formulation: F3 • 28 cynomolgus (Age 3-6 years) Group NHP vaccine # doses dose variant volume 1 6 placebo 2 - - 1ml 2 6 mRNA 2 100 ug D614 500µl comparator 3 6 pVac 15 2 1.0 mg D614G 1ml 4 6 pVac15 2 5mg D614G 1ml 5* 4 pVac15
Slide 35: Summary & Current Studies
Summary & Current Studies Summary • Evidence of immunogenicity against SARS-CoV-2 antigen • IgG, nAb, and T-cell responses • Activity demonstrated with both single & bi-cistronic vectors • Immune quality is comparable to commercial mRNA vaccine benchmark Current Studies • Immune response durability
Slide 36: Broad Vaccine Pipeline Opportunity Following Proof of Concept
Broad Vaccine Pipeline Opportunity Following Proof of Concept Initial POC/Validation Target Potential Pathogen Targets Future Pipeline Criteria Immediate Next Candidates • Unmet need • CMV • Conventional approaches ineffective • RSV • Suitable for DNA approach • Influenza Applicable to Cancer Target
Slide 37: Financials / Management Team
Financials M a n a g e m e n t Te a m
Slide 38: Financial Overview
Financial Overview Common shares outstanding at Cash + Investments at 3/31/2022 $47.3 million 5/15/2022 7.1 million April 2022 Equity Offer (At-the-Market) + $6.5 million + Stock Options 0.7 million Projected NOL sales – 2022-2024 + $3.5 million + Warrants 0.2 million Total $57.3 million Fully dilut
Slide 39: Corporate Information
Corporate Information Celsion Corporation 997 Lenox Drive Suite 100 Lawrenceville, NJ 08648 P 609-896-9100 F 609-896-2200 www.celsion.com Nasdaq: CLSN