Briacell Therapeutics Corp · TSX:BCT
Briacell Therapeutics — Investor Presentation (July 2018)
39 slides from Briacell Therapeutics's investor presentation, July 2018
Slide 1: The Future of Cancer Immunotherapy – Investor Presentation July 2018
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Investor Presentation July 2018
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 Investment Highlights
BriaCell Investment Highlights ▪ Developing the First Off-the-Shelf Personalized Immunotherapy ▪ Targeting Advanced Breast Cancer ➢ Unmet medical need (42,000 women died in U.S. during 2017 from Advanced Breast Cancer) ➢ $1 Bil - $5 Bil market opportunity depending on patient treatment stage ▪ Impre
Slide 4: 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 5: Veteran Board of Directors
Veteran Board of Directors Board of Directors Prior Affiliations Saeid Babaei, PhD, MBA, Chairman ▪ Entrepreneur. 20 yrs of biotech leadership roles ▪ Current CEO, AbCelex, ▪ VP, Bus. Develop @ Lorus Therapeutics, Dir. of Corp. Development, Northern Therapeutics Rahoul Sharan, CA, Director ▪ Chairma
Slide 6: Accomplished Scientific Advisory Board
Accomplished Scientific Advisory Board Scientific Advisory Board Current/Prior Affiliations Brian Metcalf, Ph.D. ▪ Recently retired as CSO from Global Blood Therapeutics ▪ Former Head of Research & Development, Incyte Corporation ▪ Former Head of Medicinal Chemistry, SmithKline Beecham Douglas Falle
Slide 7: 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 as they depend on a patient’s own weakened immune system to kill the tumor. ▪ Therapeut
Slide 8: Bria-IMT: Human Proof-of-Concept Trials in Advanced Breast Cancer
Bria-IMT™ Human Proof-of-Concept Trials in Advanced Breast Cancer Bria-IMT™ Non-Personalized Immunotherapy First Proof-of-Concept Phase I (1999-2003): ▪ Used unmodified cell line + GM-CSF + cyclophosphamide ▪ N = 14 late stage, treatment-refractory breast cancer patients ▪ Well tolerated, no severe
Slide 9: Bria-IMT: Potential Mechanisms of Action
Bria-IMT™ Potential Mechanisms of Action in Advanced Breast Cancer 3) Bria-IMTTM directly stimulates 1) Bria-IMTTM produces cancer fighting CD4+ and CD8+ T breast cancer antigens cells (unique to Bria-IMTTM) which are taken up by dendritic cells and “presented” to CD4+ and CD8+ T cells implicated in
Slide 10: Bria-IMT: 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 (2005): ▪ 1 out of 4 patients responded with substantial tumor regression ▪ Patient A002 was the only patient with key HLA matches w
Slide 11: Bria-IMT: Proof-of-Concept Trials (Patient A002)
Bria-IMT™ Human Proof-of-Concept Trials in Breast Cancer (Patient A002) ▪ Approximately 3 months (106 days) after last inoculation, Patient A002’s breast cancer returned and spread to brain, lung and other sites ▪ Patient A002 was then re-treated with 10 inoculations of Bria-IMT™ over 4 months ▪ Rep
Slide 12: Bria-IMT: 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 13: Current Phase I/IIa Data Supports HLA Matching Hypothesis
Bria-IMT™ Current Phase I/IIa Data Supports HLA Matching Hypothesis ▪ Six patients treated in 2017. Bria-IMT™ was safe and well tolerated ▪ Patient 01-002: 73-year-old woman with breast cancer diagnosed in 1995. Developed liver metastases in 2010, and lung metastases in 2017. Previously treated with
Slide 14: Patient 01-002 Lung Lesions
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment (TSXV:BCT, OTCQB: BCTXF) 14
Slide 15: Patient 01-002 Lung Lesions
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment (TSXV:BCT, OTCQB: BCTXF) 15
Slide 16: Patient 01-002 Lung Lesions
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment (TSXV:BCT, OTCQB: BCTXF) 16
Slide 17: Patient 01-002 Lung Lesions
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment (TSXV:BCT, OTCQB: BCTXF) 17
Slide 18: Patient 01-002 Lung Lesions (16 Cleared, Regressed)
Bria-IMT™ Patient 01-002 Lung Lesions (16 Cleared, 5 Regressed) (2017) Pt 01-002 CT Lung Images Site Description Size mm- Pre-Treatment Size mm- 3 months Size mm- 6 months 1 RLL 2.9 Not Detectable Not Detectable 2 LUL apical pleural based 3.4 tiny nodule < 1mm ?scar tiny nodule < 1mm ?scar 3 xxx 3.9
Slide 19: Proposed Diagnostic Test: Biomarker sCD40L
Proposed Diagnostic Test Biomarker sCD40L Points to Clinical Response (Preliminary) Tumor Regression – Treatment Series I Tumor Re-Regression – Treatment Series II sCD40L Levels During Treatment sCD40L Levels During Re-Treatment 400 250 Series-I Series-II C D 4 0 L L e v e ls ( p g /m L ) C D 4 0 L
Slide 20: Bria-IMT & Bria-OTS 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 inhibitors which eliminate tumor
Slide 21: Bria-OTS & BriaDX Off-the-Shelf Immunotherapy
Bria-OTS™ & BriaDX™ Off-the-Shelf Immunotherapy These allele combinations cover/match with ~90% of the advanced breast cancer population Pre-Manufactured Off-the-Shelf Pre-Manufactured Off-the-Shelf HLA Class I Alleles HLA Class II Alleles 1. BriaDX™ reveals the patient’s Class I and Class II HLA Al
Slide 22: Bria-OTS & BriaDX Off-the-Shelf Immunotherapy
Bria-OTS™ & BriaDX™ Off-the-Shelf Immunotherapy ▪ Bria-OTS™ expresses 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 ~90% of the overall advanced breast cancer population ▪ For proof of conc
Slide 23: Clinical Development Strategy
Clinical Development Strategy The confirmatory Bria-IMT™ monotherapy Phase IIa trial is currently enrolling ▪ Additional Support for the HLA-matching hypothesis has been obtained Bria-IMT™ Combination Therapy study: ▪ Combination with immune checkpoint inhibitors ➢ Keytruda® if PD-L1/2 positive (≥1%
Slide 24: Milestones
Milestones Bria-IMT™ Bria-OTS™ ✓ Q2 2018: Published Paper Detailing Mechanism of Action ✓ Q1 2018: Knock-out of endogenous HLA-A ✓ Q2 2018: Presentation at AACR ❑ Q3 2018: Knock-out of endogenous HLA DRB3/4/5 ✓ Q2 2018: Abstract - ASCO ❑ Q3 2018: Re-insertion of HLA-A, -DRB3/4/5 ❑ Q3 2018: Data on f
Slide 25: Milestones (Continued)
Milestones (Continued) ❑ Q3 2018: Scientific Paper Submission (Bria-IMT™/OTS™) ❑ Q3 2018: Provisional patent application(s) (Bria-IMT™/OTS™) ❑ Q3 2018: National Filings for PCT Bria-OTS™ Patent(s) ❑ Q1 2019: Publication of Review Paper (Bria-IMT™/OTS™) ❑ Q1 2019: Publication in peer-reviewed journal
Slide 26: Development Timeline – Breast Cancer
Development Timeline – Breast Cancer 2018 2019 2020 2021 2022 2023 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Currently Enrolling Phase IIa Bria-IMT™ Monotherapy (1Q18 → 2Q20) Note: Both Checkpoint Inhibitors and CAR-T immunotherapies received FDA accelerated Currently E
Slide 27: Ongoing Bria-IMT Phase IIa Monotherapy Trial
Ongoing Bria-IMT™ Phase IIa Monotherapy Trial Currently Recruiting: ▪ Up to 40 stage-IV breast cancer patients ▪ Primary objectives: Safety & tumor response ▪ Exploratory objectives include immune response to tumor, biomarkers, Quality of Life (TSXV:BCT, OTCQB: BCTXF) 27
Slide 28: Rollover Checkpoint Inhibitor
Rollover Checkpoint Inhibitor Currently Recruiting: ▪ Treatment in combination with Keytruda® for PD-L1(+) or PD-L2(+) tumors q3wks x up to 24 cycles, then Bria-IMT™ alone q3wks -OR- ▪ Treatment in combination with Yervoy ® for PD-L1/2(-) tumors q3wks x 4 cycles, then Bria-IMT™ alone q3wks ▪ Imaging
Slide 29: In the Pipeline: Protein Kinase C delta (PKCδ) Inhibitors
In the Pipeline: Protein Kinase C delta (PKCδ) Inhibitors 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 make a Ras inhibitor
Slide 30: BriaCell Investment Highlights
BriaCell Investment Highlights ▪ Developing the First Off-the-Shelf Personalized Immunotherapy ▪ Targeting Advanced Breast Cancer ➢ Unmet medical need (42,000 women died in U.S. during 2017 from Advanced Breast Cancer) ➢ $1 Bil - $5 Bil market opportunity depending on patient treatment stage ▪ Impre
Slide 31: Share Metrics
Share Metrics Ticker: TSX: BCT.V US Ticker: OTCQB:BCTXF Share Price (CAD) as of July 10, 2018 $0.15 52-Week Range (CAD) $0.09-0.19 Shares Outstanding as of July 10, 2018 157.8M Market Cap as of July 10, 2018 (CAD) $23.7M Cash and Short Term Investments as of April 30, 2018 (CAD) $4.4M Total Sharehol
Slide 32: Comparable Valuations
Comparable Valuations BriaCell Has Significantly Lower Enterprise Value vs Peers Trial Stage Shares Debt Enterprise (Breast Development Outstanding Price Market Cap (In Mil Cash Value BriaCell Company Therapeutic Area Cancer) Stage (in Millions) ($US) (In Mil $US) $US) (In Mil $US) (In Mil $US) Disc
Slide 33: 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 07/12/2018 Immatics-Genmab Preclinical Up to $2.8B 04/04/2018 OSE Immunotherapeutics- Preclinical Up to €1.13B Boehringer Ingelheim ($1.39B) 02
Slide 34: The Future of Cancer Immunotherapy
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Investor Presentation July 2018
Slide 35: Appendix
BriaCell Appendix
Slide 36: 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 37: Protein Kinase C delta (PKCδ) Inhibitors
Protein Kinase C delta (PKCδ) Inhibitors Early-Stage Preclinical Program ▪ 30% of all human malignancies display activating RAS mutations with another 60% showing over-activity of Ras- signaling pathways. ▪ BriaCell’s novel, proprietary PKCδ inhibitors have shown activity against multiple RAS transf
Slide 38: Protein Kinase C delta (PKCδ) Inhibitors
Protein Kinase C delta (PKCδ) Inhibitors Rottlerin Staurosporine KAM1 BJE6-106 Generation PKC- IC50 PKC- IC50 PKC-/ PKC- Selectivity Ratio 1 3 M 75 M 28-fold 2 2 M 157 M 56-fold 3 0.05 M 50 M 1000-fold ▪ Structural aspects of first generation inhibitor rottlerin and staurosporine (pan-PKC
Slide 39: PKCδ Inhibitors Block Growth in Various Cancers
PKCδ Inhibitors Block Growth in Various Cancers PKCδ inhibitors inhibit growth of neuroendocrine tumor cell lines (lower is better) PKCδ inhibitors PKCδ inhibitor reduces tumor burden in a decrease tumor size human lung cancer model (lower is better) and improve survival in pancreatic cancer model (
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