Lunai Bioworks Inc. · NASDAQ:LNAI
Lunai Bioworks — Enochian Biosciences — Investor Presentation (October 2022)
39 slides from Lunai Bioworks's investor presentation, Oct 14, 2022
Slide 1: Enhanced Gene & Cell Therapies Harnessing Immune Response Against Cancer & Infectious Diseases
ENHANCED GENE & CELL THERAPIES HARNESSING IMMUNE RESPONSE AGAINST CANCER & INFECTIOUS DISEASES
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS Certain statements in this presentation that are not strictly historical in nature, regarding our future operations, strategy, potential regulatory treatment, acceptance or changes, preclinical opportunities or activities, potential commercial sales, or outcomes of later c
Slide 3: Enochian Biosciences at a Glance
ENOCHIAN BIOSCIENCES AT A GLANCE Headquartered in Los Angeles, CA Uplisted to Nasdaq in December 2018 (Ticker: ENOB) Year-End: June 30th Market Cap $103.4M; Share Price of $1.95 as of Oct 13, 2022 (Source Nasdaq.com) The Company has raised total cash to date of $75M* Total Funds Available to the Com
Slide 4: Advanced Allogeneic Cell and Gene Therapy Platforms Modulating Immune Response
ADVANCED ALLOGENEIC CELL AND GENE THERAPY PLATFORMS MODULATING IMMUNE RESPONSE Our goal is to provide transformational therapies for potential disease cures Boost patients’ immune response into Highly adaptable platforms for quick long-term remission or cure for expansion to new indications solid tu
Slide 5: Multi-Pronged Approach to Enhance Immune Response with Proprietary Engineered Gene and/or Cell Therapy
MULTI-PRONGED APPROACH TO ENHANCE IMMUNE RESPONSE WITH PROPRIETARY ENGINEERED GENE AND/OR CELL THERAPY Donor The entire immune response is designed to D search and destroy things that are “other/allo.” Allogenicity could enhance a Patient person’s ability to react more aggressively to cancer and vir
Slide 6: Long-Term Remission or Functional Cures Open Doors to Large Unmet Needs
LONG-TERM REMISSION OR FUNCTIONAL CURES OPEN DOORS TO LARGE UNMET NEEDS WITH VALIDATED MARKET OPPORTUNITIES DISEASE STATE UNMET NEED MARKET OPPORTUNITY PRECEDENTS 1st Target: pancreatic cancer Inadequate therapies ~450,0001 Cases per year worldwide Bristol-Myers Squibb’s-wholly owned subsidiary Celg
Slide 7: Strategy: Leverage Innovative Platforms to Create Multiple Shots on Goal
STRATEGY: LEVERAGE INNOVATIVE PLATFORMS TO CREATE “MULTIPLE SHOTS ON GOAL” & NEW INTELLECTUAL PROPERTY Combining novel cell, gene and immunotherapy to build a diverse pipeline across and within diseases to allow for better business decisions to sell, sub-license, partner or manufacture and maximize
Slide 8: Our Development Pipeline
OUR DEVELOPMENT PIPELINE Proof of IND- Program Indication Pre-IND IND-SUB Phase 1/2A Concept Enabling LATE 2023/ ENOB-DC-11* EARLY/MID 2023 EARLY 2024 ENOB-DC-12-XX ENOB-HV-12* MID/LATE 2023 EARLY/MID 2024 ENOB-HV-21 ENOB-HV-01** ENOB-HB-01 CANCER HIV HBV *Tier 1 Programs ** Enochian has entered int
Slide 9: Experienced Leadership: Management Team
EXPERIENCED LEADERSHIP: MANAGEMENT TEAM – Composition of members ~60% Diverse The Hon. Mark Dybul, MD Luisa Puche Francois Binette, PhD Greg Duczynski, PhD Lu Chen, PhD ----------------- ----------------- ----------------- ----------------- ----------------- Chief Executive Officer Chief Financial O
Slide 10: Experienced Leadership: Board of Directors
EXPERIENCED LEADERSHIP: BOARD OF DIRECTORS – Composition of members ~70% Diverse Rene Sindlev Gregg Alton, JD Mark Dybul, MD Jayne McNicol Chairperson Lead Independent Director Chief Executive Officer Director & Director James Sapirstein, RPh, MBA Carol Brosgart, MD Henrik Grønfeldt –Sørensen Direct
Slide 11: Deep Scientific Expertise: Strategic Research Advisors & Collaborators
DEEP SCIENTIFIC EXPERTISE: STRATEGIC RESEARCH ADVISORS & COLLABORATORS RICHARD WHITLEY, MD: SENIOR SCIENTIFIC ADVISOR • Distinguished Professor of Pediatrics, Professor of Microbiology, Medicine and Neurosurgery; Co-Director, Division of Pediatric Infectious Diseases; Senior Scientist, Department of
Slide 12: ENOB-DC-11: Oncology Program
ENOB-DC-11: ONCOLOGY PROGRAM
Slide 13: Adaptive Immunity for Cancer Is Often Inadequate/Insufficient
ADAPTIVE IMMUNITY FOR CANCER IS OFTEN INADEQUATE/INSUFFICIENT Dendritic cells orchestrate the immune response by “presenting” pieces of a tumor (antigens) to stimulate a reaction “Educating” immune cells to recognize and eliminate diseased cells and pathogens *UPMC, CREATED WITH BIORENDER.COM 13
Slide 14: Tumor Cells Can Evade Normal Immune Response
TUMOR CELLS CAN EVADE NORMAL IMMUNE RESPONSE Cancer cells can evolve to evade immune responses by releasing inhibitory signals against, or hiding from, key parts of the system designed to seek and kill tumors *UPMC, CREATED WITH BIORENDER.COM 14
Slide 15: Gene-Enhanced Dendritic Cells: Proprietary Therapeutic Vaccine Platform
GENE-ENHANCED DENDRITIC CELLS: PROPRIETARY THERAPEUTIC VACCINE PLATFORM AIMS TO BYPASS TUMOR IMMUNE RESPONSE EVASION AND ENHANCE TUMOR ERADICATION Induces T-Cell killing and suppresses Regulatory T-Cells Activates cytotoxic T-Cells known to be the most effective immune cell population to kill the ca
Slide 16: ENOB-DC-11 Product Candidate: Allogeneic, Genetically Engineered Dendritic Cells
ENOB-DC-11 PRODUCT CANDIDATE: ALLOGENEIC, GENETICALLY ENGINEERED DENDRITIC CELLS LOADED WITH TUMOR ANTIGENS Cell banking Gene engineering Differentiation into dendritic cells (drug substance) Final Drug product: Pancreas cancer Antigen presenting DC Expand and engineer stem cells for “off-the- Drive
Slide 17: ENOB-DC-11 Significantly Decreased Pancreatic Tumor Size in Humanized Mice
ENOB-DC-11 SIGNIFICANTLY DECREASED PANCREATIC TUMOR SIZE IN HUMANIZED MICE WITH IMPLANTED TUMORS CORRELATED TO INCREASES OF KEY IMMUNE RESPONSES Tumor alone (Control) 1.2 3000 1 2500 Tumor Volume (mm3) 0.8 Tumor Weight (g) 2000 0.6 1500 0.4 1000 0.2 500 Unmodified DC 0 0 Control Unmodified DC-11 Con
Slide 18: ENOB-DC-11: Current Status & Potential Near-Term Milestones
ENOB-DC-11: CURRENT STATUS & POTENTIAL NEAR- TERM MILESTONES Humanized mouse model of human pancreatic cancer Proof-of- Concept: Substantial tumor size reduction and impressive immune responses Process & Analytical Development ongoing Potential Pre-IND – Q1/2 2023 Potential IND Filing – Q4 2023/Q1 2
Slide 19: HIV Programs
HIV PROGRAMS
Slide 20: HIV Pipelines: Three Complementary Therapeutic Approaches
HIV PIPELINES Three Complementary Therapeutic Approaches: T-cell Vaccine, Allogeneic T-cell Therapy, & Gene Therapy Engineered Allogeneic Allogeneic T-Cell Gene Therapy T-Cell Vaccine Therapy Autologous Transplant • ENOB-HV-12: • ENOB-HV-21: • ENOB-HV-01: Gene Therapeutic HIV HIV NK/GDT Treatment Th
Slide 21: ENOB-HV-12: Engineered Therapeutic Vaccine
ENOB-HV-12: ENGINEERED THERAPEUTIC VACCINE
Slide 22: ENOB-HV-12: Allogeneic Engineered T-Cell Designed to Enhance Immune Response Against HIV
ENOB-HV-12: ALLOGENEIC ENGINEERED T-CELL DESIGNED TO ENHANCE IMMUNE RESPONSE AGAINST HIV Donor ENOB-HV-12 Mechanism of Action: Three specific genes to enhance infiltration, killing, and surveillance Healthy Individual Person Living with Engineered CD4 T-Cells (HLA Mismatched) Large volume of cells H
Slide 23: ENOB-HV-12: Current Status & Potential Near-Term Milestones
ENOB-HV-12: CURRENT STATUS & POTENTIAL NEAR- TERM MILESTONES Non-human primate infected with simian-human variant of HIV: begun in early 2021 Manufactured drug product First dose in Monkeys Aug 2022 Monitoring end points: preliminary data by end of 2022/early 2023 IND-enabling: Potential 2023 IND-su
Slide 24: ENOB-HV-21: Allogeneic NK & GDT-Cell Therapy
ENOB-HV-21: ALLOGENEIC NK & GDT-CELL THERAPY
Slide 25: ENOB-HV-21: Allogeneic NK Plus Gamma Delta T Cells as Potential Therapy for HIV
ENOB-HV-21: ALLOGENEIC NK PLUS GAMMA DELTA T (GDT) CELLS AS POTENTIAL THERAPY FOR HIV GDT have been reported to be both a potential reservoir for, and effector T-Cells to kill, HIV-infected cells Allogenicity is a potent immuno-stimulator Allogeneic GDT could be a potential therapy for HIV, in parti
Slide 26: Control of HIV Without Antiviral Treatment for 360 Days
CONTROL OF HIV WITHOUT ANTIVIRAL TREATMENT FOR 360 DAYS; A LOWER LEVEL OF VIRUS THAN WHEN WITH ANTIVIRAL TREATMENT 7 6 5 HIV RNA Log10 4 3 2 1 0 -5 0 6 14 30 100 115 145 175 211 245 280 340 400 430 DAYS Presented at 2021 annual conference of the American Society of Gene and Cell Therapy at 255 days
Slide 27: ENOB-HV-21: Current Status & Potential Milestones
ENOB-HV-21: CURRENT STATUS & POTENTIAL MILESTONES Investigator-initiated Pre-IND completed Potential IND & human trials in 2024 27
Slide 28: ENOB-HV-01: Autologous Human Peripheral Stem Cell Transplantation
ENOB-HV-01: AUTOLOGOUS HUMAN PERIPHERAL STEM CELL TRANSPLANTATION
Slide 29: ENOB-HV-01: Potential to Increase Selection of CAR-T Cells for HIV
ENOB-HV-01: POTENTIAL TO INCREASE SELECTION OF CAR-T CELLS FOR HIV TREATMENT OR CURE • Caring Cross, a non-profit corporation, has shown that their proprietary CAR-T cells cure HIV in a mouse model; studies in humans have begun • CAR-T is a promising therapy, but the selection of the cells is diffic
Slide 30: ENOB-HB-01: Hepatitis B Virus Program
ENOB-HB-01: HEPATITIS B VIRUS PROGRAM
Slide 31: ENOB-HB-01: Target Profile
ENOB-HB-01: TARGET PROFILE Two to three dose treatment regimen Therapeutic approach aims to eliminate all HBV rapidly (“seek and kill”), versus interrupting replication and slowly reducing persistent infection (ccc-DNA) Applicable for early disease to maximize impact Low risk of toxicity 31
Slide 32: ENOB-HB-01: AAV Mechanism of Action
ENOB-HB-01: AAV MECHANISM OF ACTION • A novel adeno-associated virus (AAV) vector that expresses a non-functional RNA which is designed to engage with HBV polymerase enzyme to produce a kill gene to kill HBV infected cells only • Inducing preferential death of HBV-infected hepatocytes with very high
Slide 33: ENOB-HB-01: Current Status & Potential Near-Term Milestones
ENOB-HB-01: CURRENT STATUS & POTENTIAL NEAR-TERM MILESTONES Proof-of-Concept using AAV-delivery system demonstrated potential therapeutic activity of ENOB-HB-01 approach both in vitro & in vivo infection models Pre-IND comments received from FDA for AAV-delivery system Exploring advanced viral vecto
Slide 34: Intellectual Property
INTELLECTUAL PROPERTY
Slide 35: Intellectual Property
INTELLECTUAL PROPERTY Our intellectual property covering our innovative platform gene and gene-modified cell therapies in the US and abroad includes: • Patents and patents applications for composition of matter and methods of use • Trade secrets/knowhow ENOCHIAN PIPELINE PATENT TITLE/OWNERSHIP LINK
Slide 36: Moving Forward
MOVING FORWARD
Slide 37: Moving Forward: Summary of Potential Milestones
MOVING FORWARD: SUMMARY OF POTENTIAL MILESTONES • Pre-IND Q1/Q2 2023 pre-clinical to clinical VACCINE PLATFORM: ENOB-DC-11 • IND submission late 2023-early 2024 • Initiate Phase I/IIA 2024 THERAEPEUTIC development • Pre-IND Q2-3 2023 ENOB-HV-12 • IND submission 2024 • Initiate Phase I/IIA later 2024
Slide 38: Thank You
THANK YOU www.enochianbio.com
Slide 39: Appendix I: Data Sources
APPENDIX I: DATA SOURCES 1 https://www.wcrf.org/dietandcancer/pancreatic-cancer-statistics/ 2 https://www.cancer.net/cancer-types/pancreatic-cancer/statistics 3 https://www.sec.gov/Archives/edgar/data/14272/000001427222000051/bmy-20211231.htm 4 https://www.unaids.org/en/resources/fact-sheet 5 https:
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