Lunai Bioworks Inc. · NASDAQ:LNAI
Lunai Bioworks — Renovaro Biosciences — Investor Presentation (August 2023)
43 slides from Lunai Bioworks's investor presentation, Aug 7, 2023
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: Renovaro Biosciences at a Glance
RENOVARO BIOSCIENCES AT A GLANCE Headquartered in Los Angeles, CA Listed on Nasdaq (Ticker: RENB) Year-End: June 30th Market Cap $49.5M; Share Price of $0.70 as of August 3, 2023 (Source Nasdaq.com) The Company has raised total cash of $82.7M from February 2018 through Total August Funds 2023.to the
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 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 Inadequate therapies 1st Target: Pancreatic cancer Bristol-Myers Squibb’s-wholly ~450,0001 Cases per year worldwide 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 commercialize and maximiz
Slide 8: Our Development Pipeline
OUR DEVELOPMENT PIPELINE Proof of IND- Program Indication Pre-IND IND-SUB Phase 1/2A Concept Enabling Dendritic Cell Therapeutic H1-2024 H1-2024 RENB-DC-11* Vaccine for Pancreatic Cancer Dendritic Cell Therapeutic Vaccine RENB-DC-12-XX for Other Solid Tumors (TBD) RENB-HV-12* HIV Therapeutic Vaccine
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: RENB-DC-11: Oncology Program
RENB-DC-11: ONCOLOGY PROGRAM
Slide 13: Quote from Dr. Anahid Jewett on preclinical results
“I have been working in this field for three decades and designed the mouse model that we have used through my laboratories to study the Company’s potential cancer therapies. The results are among the most impressive I have ever seen. The fact that we saw very similar highly statistically significan
Slide 14: 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 14
Slide 15: 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 15
Slide 16: 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 17: Cutting Edge Personalized Cancer Therapy
Cutting Edge Personalized Cancer Therapy 9] Ship frozen berte Cancer Antigen oe Tumor resection r pulse/uptake cam | Biopsy j it Engineered immature DC differentiati Thaw and into mature Inject engineered DC \ @* \ < : f / 1 a ait 7 Engineered monocyte CD14+ = Vea, | differentiation Mobilized 2 ‘> a
Slide 18: RENB-DC11 Treatment Significantly Reduced Size of Pancreatic Tumors in Humanized Mice
RENB-DC11 TREATMENT SIGNIFICANTLY REDUCED SIZE OF PANCREATIC TUMORS IN HUMANIZED MICE IN 2 INDEPENDENT STUDIES Tumor weight Tumor volume Tumor weight (grams) 0.8 2500 Tumor volume (mm3) ***p= 0.0001 ***p= 0.0006 2000 *p= 0.01 0.6 n=4 **p= 0.001 n=4 1500 0.4 n=4 ***p=0.0003 1000 0.2 n=4 n=6 500 n=1 n
Slide 19: RENB-DC-11: Tumor Size Reduction Correlated with Increases in Immune Response
RENB-DC-11: REDUCTION IN TUMOR SIZE CORRELATED WITH STATISTICALLY SIGNIFICANT INCREASES IN KEY COMPONENTS OF IMMUNE RESPONSE For details, please see slide deck from a scientific presentation at the Innate Killer Summit by Dr. Anahid Jewett, UCLA: https://Renovarobio.com/events-and- presentations/def
Slide 20: RENB-DC-11: Current Status & Potential Near-Term Milestones
RENB-DC-11: CURRENT STATUS & POTENTIAL NEAR- TERM MILESTONES Mouse model of human pancreatic cancer Proof-of-Concept: Substantial tumor size reduction and impressive immune responses IND-enabling Process & Analytical Development ongoing in parallel to move as quickly as possible Pre-IND – June 2023
Slide 21: RENB-DC-11: Platform Could Be Applicable to Multiple Solid Tumors
RENB-DC-11: PLATFORM COULD BE APPLICABLE TO MULTIPLE, DIFFICULT TO TREAT SOLID TUMORS Pre-IND and IND submission to include pancreatic and other solid tumors, for example, triple-negative breast and oral cancers, mesothelioma, etc. 21
Slide 22: HIV Programs
Renovaro Biosciences HIV PROGRAMS
Slide 23: HIV Pipelines
HIV PIPELINES Two Complementary Therapeutic Approaches from Allogeneic Cell Platform: T-cell Vaccine, T-cell Therapy; One sub-licensed Gene Therapy technology Engineered Allogeneic Allogeneic T-Cell Gene Therapy T-Cell Vaccine Therapy Autologous Transplant • RENB-HV-12: • RENB-HV-21: HIV • RENB-HV-0
Slide 24: RENB-HV-12: Gene-Modified Therapeutic Vaccine
RENB-HV-12: GENE- MODIFIED THERAPEUTIC VACCINE
Slide 25: RENB-HV-12: Allogeneic, Gene-Modified T-Cell to Enhance Immune Response Against HIV
RENB-HV-12: ALLOGENEIC, GENE-MODIFIED T-CELL TO ENHANCE THE IMMUNE RESPONSE AGAINST HIV Donor RENB-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 HI
Slide 26: RENB-HV-12: Current Status & Potential Near-Term Milestones
RENB-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 endpoints: preliminary data by late 2023 Pre-IND: Potential H1- 2024 IND-submission: H1- 2
Slide 27: RENB-HV-21: Allogeneic NK & GDT-Cell Therapy
RENB-HV-21: ALLOGENEIC NK & GDT-CELL THERAPY
Slide 28: RENB-HV-21: Allogeneic NK Plus Gamma Delta T Cells as Potential Therapy for HIV
RENB-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 29: Control of HIV Without Antiviral Treatment for 360 Days
CONTROL OF HIV WITHOUT ANTIVIRAL TREATMENT FOR 360 DAYS; A LOWER LEVEL OF VIRUS THAN 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 29
Slide 30: RENB-HV-21: Current Status & Potential Milestones
RENB-HV-21: CURRENT STATUS & POTENTIAL MILESTONES Investigator-initiated Pre-IND completed Potential IND & human trials in 2024 30
Slide 31: RENB-HV-01: Autologous Human Peripheral Stem Cell Transplantation
RENB-HV-01: AUTOLOGOUS HUMAN PERIPHERAL STEM CELL TRANSPLANTATION
Slide 32: RENB-HV-01: Potential to Increase Selection of CAR-T Cells for HIV
RENB-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 33: RENB-HB-01: Hepatitis B Virus Program
RENB-HB-01: HEPATITIS B VIRUS PROGRAM
Slide 34: RENB-HB-01: Target Profile
RENB-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 34
Slide 35: RENB-HB-01: AAV Mechanism of Action
RENB-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 36: RENB-HB-01: Current Status & Potential Near-Term Milestones
RENB-HB-01: CURRENT STATUS & POTENTIAL NEAR-TERM MILESTONES Proof-of-Concept using AAV-delivery system demonstrated potential therapeutic activity of RENB-HB-01 approach in both in vitro & in vivo infection models Pre-IND comments received from FDA for AAV-delivery system Exploring advanced viral ve
Slide 37: Potential Application of DC-11 to Chronic Infections, Including HIV and/or HBV
POTENTIAL APPLICATION OF DC-11 TO CHRONIC INFECTIONS, INCLUDING HIV AND/OR HBV “I have been very impressed by the Company’s resilience and the potential human impact of the recent data from the cancer pipeline with a potential product that could have relevance for other pipelines in HIV and perhaps
Slide 38: Intellectual Property
Renovaro Biosciences INTELLECTUAL PROPERTY
Slide 39: 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 RENOVARO PIPELINE PATENT TITLE/OWNERSHIP LINK
Slide 40: Moving Forward
Renovaro Biosciences MOVING FORWARD
Slide 41: Moving Forward: Summary of Potential Milestones
MOVING FORWARD: SUMMARY OF POTENTIAL MILESTONES • Pre-IND June 2023 pre-clinical to clinical VACCINE PLATFORM: • IND submission H1-2024 RENB-DC-11 • Initiate Phase I/IIa H1-2024 THERAEPEUTIC development • Initiate Phase IIb for other solid tumors • Pre-IND H1-2024 RENB-HV-12 • IND submission H2-2024
Slide 42: Thank You
THANK YOU www.Renovarobio.com
Slide 43: 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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