Briacell Therapeutics Corp · TSX:BCT
Briacell Therapeutics — Investor Presentation (July 2019)
41 slides from Briacell Therapeutics's investor presentation, July 2019
Slide 1: Biotech Investor Presentation July 2019
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Biotech Investor Presentation July 2019 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect BriaCell’s current expectations regarding future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause BriaCell’s a
Slide 3: BriaCell Corporate Highlights
BriaCell Corporate Highlights ▪ BriaCell utilizes an immunotherapy approach – a type of cancer treatment that boosts the ability of the body’s own cancer-fighting cells to destroy cancerous tumors. ▪ Market focus: Advanced breast cancer (the cause of ~43,000 deaths per year in the U.S.) ▪ Immunother
Slide 4: Advanced Breast Cancer – The Opportunity
Advanced Breast Cancer – The Opportunity Big Pharmaceutical Companies Are Very Active ➢ Significant partnership & collaboration opportunities exist in the advanced breast cancer oncology market… Particularly in immunotherapies, which directly stimulate the body’s own cancer-fighting cells to attack
Slide 5: Cancer Immunotherapy Space
Cancer Immunotherapy Space The Problems ▪ Checkpoint Inhibitors: Keytruda® (anti-PD-1), Yervoy® (anti-CTLA-4) and others reduce the tumor’s ability to suppress immune system. They only work in 20%-30% of patients and can cause autoimmune disease. ▪ Therapeutic Cancer Vaccines: Have not been successf
Slide 6: BriaCell's Patented Immunotherapy: Bria-IMT
BriaCell’s Patented Immunotherapy: Bria-IMT™ Bria-IMT™ is a patented (USPTO) immunotherapy approach that directly stimulates the body’s own cancer-fighting cells to attack and destroy breast cancer tumors. Antigens Tumor Destruction CD8+ Bria-IMT™ CD4+ GM-CSF 1. Bria-IMT™ produces antigens (proteins
Slide 7: Bria-IMT & Bria-OTS
Bria-IMT™ & Bria-OTS™ Potential Mechanisms of Specific Immune Activation in Advanced Breast Cancer 4. Bria-IMT/OTSTM directly stimulates cancer fighting CD4+ and CD8+ T cells (further boosts the response) 3. Breast cancer antigens are taken up by dendritic cells and 5. Bria-IMT/OTSTM “presented” to
Slide 8: Origin of the Technology: Bria-IMT
Origin of the Technology: Bria-IMT™ Positive Human Proof-of-Concept Trials in Advanced Breast Cancer Bria-IMT™ Targeted Immunotherapy Bria-IMT™ was developed from a breast cancer cell line called SV-BR-1 First Proof-of-Concept Phase I with SV-BR-1 (1999-2003): ➢ Used unmodified cell line + cyclophos
Slide 9: Human Proof-of-Concept Trials (Patient A002)
Bria-IMT™ Human Proof-of-Concept Trials in Breast Cancer (Patient A002) Bria-IMT™ Second Proof-of-Concept Phase I (2004-2006): ▪ Patient A002 had breast cancer that had spread to the lungs, soft tissues and bone ▪ She initially responded to chemotherapy, but then relapsed with tumor spread to the br
Slide 10: Human Proof-of-Concept Trials (Patient A002)
Bria-IMT™ Human Proof-of-Concept Trials in Breast Cancer (Patient A002) ▪ Treatment stopped as per FDA requirements, and approximately 3 months (106 days) after the last inoculation, Patient A002’s breast cancer returned and spread to brain, lung and other sites ▪ Patient A002 was then re-treated wi
Slide 11: Human Proof-of-Concept Trials (Patient A002)
Bria-IMT™ Human Proof-of-Concept Trials in Breast Cancer (Patient A002) Bria-IMT™ Non-Personalized Immunotherapy – Given as Monotherapy Second Proof-of-Concept Phase I: ▪ Patient A002 was the only patient matching of a key allele with Bria-IMT™ and experienced tumor regression and complete remission
Slide 12: Working with World-Class Cancer Organizations
Working with World-Class Cancer Organizations Cancer Insight, LLC is BriaCell’s Collaborator and coordinates activities of the Principal Investigators from outstanding clinical sites https://clinicaltrials.gov/ct2/show/NCT03328026 BriaCell’s FDA clinical trial is advancing with world-renowned cancer
Slide 13: Human Proof-of-Concept Trials in Breast Cancer
Bria-IMT™ Human Proof-of-Concept Trials in Breast Cancer ▪ In 2017 we reinitiated treatment with the Bria-IMT™ regimen in an FDA approved clinical trial in advanced breast cancer ▪ 23 patients were dosed in the study, all with very heavily pre-treated advanced breast cancer (median 4 prior systemic
Slide 14: Bria-IMT - Efficacy as Predicted
Bria-IMT™ - Efficacy as Predicted ▪ Bria-IMT™ appears to be most effective in patients who match with Bria-IMT ™ at HLA loci (types) further supporting our “HLA Matching Hypothesis” ▪ This confirms our strategy to develop of Bria-OTS ™ to cover >99% of the patient population ▪ Combination with immun
Slide 15: Bria-IMT: Remarkable Efficacy in Advanced Breast Cancer
Bria-IMT™: Remarkable Efficacy in Advanced Breast Cancer Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Patient with 20 lung metastases all either disappeared or shrunk to tiny scars – 2 HLA Matches Pre-Treatment Post-Treatment 15
Slide 16: Bria-IMT: Remarkable Efficacy in Advanced Breast Cancer
Bria-IMT™: Remarkable Efficacy in Advanced Breast Cancer Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 16
Slide 17: Bria-IMT: Remarkable Efficacy in Advanced Breast Cancer
Bria-IMT™: Remarkable Efficacy in Advanced Breast Cancer Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 17
Slide 18: Immunotherapy Combinations
Bria-IMT™ & Bria-OTS™ Immunotherapy Combinations ▪ Bria-IMT™ and Bria-OTS™ should synergize with existing approved immunotherapies as well as those still under development ▪ This includes immune checkpoint inhibitors such as antibodies to PD-1, CTLA-4, GITR and CD73 and IDO inhibitors which eliminat
Slide 19: Bria-IMT in Combination with KEYTRUDA
Bria-IMT™ in Combination with KEYTRUDA® (by Merck) Bria-IMT™ + by Merck & Co., Inc. How Does KEYTRUDA® Work? ➢ PD-L1 molecules block immune cells from attacking cancer cells ➢ Immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; anti-PD-L1) are designed to neutralize immune suppression in
Slide 20: Bria-IMT Phase I/IIa Combination Therapy Trial
Bria-IMT™ Phase I/IIa Combination Therapy Trial Baseline: Imaging, labs, clinical evaluation Currently Recruiting: Bria-IMT™ 1,2,3, 4 (week 1,4, 7, 10) ▪ Treatment in combination with Keytruda® (Merck & Co., Restage: Imaging, labs, clinical evaluation Inc.) for PD-L1(+) or PD-L2(+) Non-progressive r
Slide 21: Bria-IMT with KEYTRUDA – Synergistic Activity
Bria-IMT™ with KEYTRUDA® – Synergistic Activity Phase I/IIa Combination Study ▪ Patients are being treated with the combination of Bria-IMT™ and anti-PD-1 antibody KEYTRUDA®. ▪ Excellent safety and tolerability profile on the first 6 patients has been reported. ▪ All 6 patients were very heavily pre
Slide 22: Incyte Corporation – Clinical Trial Collaboration
Incyte Corporation – Clinical Trial Collaboration BriaCell & Incyte Collaboration and Supply Agreement Non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates ▪ The clinical study will focus on (but not limited to) BriaCell's lead candidate, Br
Slide 23: Introducing… Bria-OTS
Introducing… Bria-OTS™ Bria-OTS™: Off-The-Shelf Personalized Immunotherapy • BriaCell’s immunotherapy treatment is most effective when the patient’s HLA-type matches the Bria-IMT™ HLA-type • Bria-OTS™ involves a simple method to determine the HLA-type of each patient • Each patient is then treated w
Slide 24: Bria-OTS & BriaDX
Bria-OTS™ & BriaDX™ Personalized Off-the-Shelf Immunotherapy ▪ Bria-OTS™ cell lines are being developed to express both GM-CSF and interferon-α PLUS patient- specific matching HLA types ▪ Cell lines will be pre-manufactured which express HLA alleles covering/matching with >99% of the overall advance
Slide 25: Bria-OTS – Off-The-Shelf Personalized Approach
Bria-OTS™ – Off-The-Shelf Personalized Approach 15 Unique HLA Types for Tailored Immunotherapies A simple test determines the correct “off-the-shelf” immunotherapy to select HLA Class I Types HLA Class II Types 1.Saliva test reveals the patient’s Class I and Class II HLA Types. 2.The correct pre-man
Slide 26: Development Timeline & Catalysts
Development Timeline & Catalysts Milestone 2019 2020 2021 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Bria-IMT™ + KEYTRUDA® – Initial Safety & Efficacy Data Bria-IMT™ + KEYTRUDA® – Additional Safety & Efficacy Data Bria-IMT™ + Incyte Drugs – Initiation of Combination Study Bria-IMT™ + Incyte Drugs – Safety & E
Slide 27: Progress, Upcoming Milestones & Catalysts
Progress, Upcoming Milestones & Catalysts ▪ Q3 2019: Initiation of dosing for Combination Study of Bria-IMT™ with Incyte drugs ▪ Q3 2019: Initiation of Bria-OTS™ GMP manufacturing (UC Davis or KBI BioPharma) ▪ Q4 2019: Publication of BriaCell’s findings at a scientific journal ▪ Q4 2019: Bria-OTS™ A
Slide 28: BriaCell Pipeline
BriaCell Pipeline Therapeutic Indication Preclinical Phase I Phase II Phase III Anticipated Milestone Bria-IMT™ with Advanced Breast Cancer Registration Study Start 2020 KEYTRUDA® (3rd+ line) Launch 2023 with partner Bria-IMT™ with Breast Cancer IND filing 2019 Incyte drugs Bria-OTS™ Breast Cancer I
Slide 29: Experienced Management Team
Experienced Management Team Involved in over 10 drugs brought to the market Management Prior Affiliations William V. Williams, MD, FACP, President & CEO ▪ VP, Exploratory Development, Incyte Corporation ▪ VP, Experimental Medicine, GlaxoSmithKline ▪ Head, Rheumatology Research, University of Pennsyl
Slide 30: Experienced Board of Directors
Experienced Board of Directors Board of Directors Prior Affiliations Jamieson Bondarenko, CFA, CMT, Chairman ▪ Advisor to Lexaria Bioscience Corp., MustGrow Biologics Corp. ▪ Previous Equity Capital Markets and Corporate Finance roles with Eight Capital, Dundee Securities, Wellington West Capital Ma
Slide 31: Accomplished Scientific Advisory Board
Accomplished Scientific Advisory Board Scientific Advisory Board Current/Prior Affiliations Brian Metcalf, PhD ▪ Recently retired as CSO from Global Blood Therapeutics ▪ Former Head of Research & Development, Incyte Corporation ▪ Former Head of Medicinal Chemistry, SmithKline Beecham Douglas Faller,
Slide 32: Drug Approvals by BriaCell Management Team
Drug Approvals by BriaCell Management Team ▪ Bexxar® (tositumomab and Iodine I131 tositumomab) ▪ Treatment of CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma. ▪ Myleran® (busulfan) for chronic myelogenous leukemia ▪ Defense of formulation
Slide 33: Financial Information & Insider Ownership
Financial Information & Insider Ownership Data as of June 20, 2019 BCT: TSX Venture Insiders Shares % Basic BCTXF: OTCQB Jamieson Bondarenko 28,659,500 14.6% Dr. Charles Wiseman 13,381,287 6.8% Recent Share Price (C$) $0.090 Dr. William Williams 11,447,849 5.8% Basic Shares Outstanding (MM) * 196.4
Slide 34: Comparable Valuations
Comparable Valuations BriaCell Has Significantly Lower Enterprise Value vs Peers Trial Stage Enterprise BriaCell (Breast Development Market Cap Value EV Company Therapeutic Area Technology Cancer) Stage (In Mil $US) (In Mil $US) Discount Achillion Pharmaceuticals, Inc. (ACHN) Therapeutics Complement
Slide 35: Scientific Findings and Clinical Plans
Scientific Findings and Clinical Plans Bria-IMT™ and Bria-OTS™ (Personalized immunotherapy without the need for personalized manufacturing): ▪ Manufactured from Breast cancer cell lines ▪ Show immune (dendritic) cell characteristics, expresses multiple breast cancer associated antigens, and immune s
Slide 36: Appendix
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Appendix 36
Slide 37: Immuno-oncology Deals
Immuno-oncology Deals Recent deals of small biotechs with big pharma in immuno-oncology Development stage at the time of Date Partnership the deal Deal size Dec-18 Molecular Partners-Amgen Preclinical Up to $547 Dec-18 Aduro-Lilly Ph I Up to $632M Oct-18 Endocyte - Novartis Ph III $2.1B (Acquisition
Slide 38: Early Stage Clinical Studies (Comparison)
Early Stage Clinical Studies (Comparison) ▪ We compared the interim data of our Ph I/IIa study of Bria-IMT™ in advanced breast cancer with the data in the early stage clinical studies of recently approved breast cancer drugs, and one fast tracked product candidate. Apples to apples comparison: Early
Slide 39: Breast Cancer Market Opportunity
Breast Cancer Market Opportunity The market for breast cancer drugs is a multibillion dollar market with new drugs being approved on an ongoing basis indicating the shortage of safe and effective treatments for this deadly disease Drug Technology Approved for Market (US) Ibrance (palbociclib) CDK 4/
Slide 40: Competitors- Phase I/II Clinical Data
Competitors- Phase I/II Clinical Data Bria-IMT™ shows superior safety and similar to superior efficacy data compared with those of the multi- billion dollar drugs when they were at a similar early stage of clinical development Drug Patient # (n) Safety Efficacy Ibrance (palbociclib) 41 & 18 20%-61%:
Slide 41: In the Pipeline: Protein Kinase C delta (PKCδ) Inhibitors
In the Pipeline: Protein Kinase C delta (PKCδ) Inhibitors Growth Opportunity: Early-Stage Preclinical Program ▪ 30% of all human malignancies display activating RAS mutations ➢ Another 60% showing over-activity of Ras-signaling pathways ▪ Ras has been termed “undruggable” (no one has been able to ma
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