Briacell Therapeutics Corp · TSX:BCT
Briacell Therapeutics — Investor Presentation (October 2018)
43 slides from Briacell Therapeutics's investor presentation, October 2018
Slide 1: The Future of Cancer Immunotherapy – Investor Presentation October 2018
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Investor Presentation October 2018 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 Investment Highlights
BriaCell Investment Highlights ▪ Developing Bria-OTS™, the First Off-the-Shelf Personalized Immunotherapy ▪ Targeting Adv. Breast Cancer: Unmet medical need (42,000 death in the US in 2017 ) ➢ $1 Bil- $5 Bil market opportunity depending on patient treatment stage ▪ Impressive results in 2 proof-of-c
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 Therap, Dir. of Corp. Develop, Northern Therapeutics Rahoul Sharan, CA, Director ▪ Chairman, Potash
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 and can caus
Slide 8: Bria-IMT Potential Mechanisms of Action in Advanced Breast Cancer
Bria-IMT™ Potential Mechanisms of Action in Advanced Breast Cancer Bria-IMTTM directly stimulates cancer Bria-IMTTM produces breast fighting CD4+ and CD8+ T cells cancer antigens which are (further boosts the response) taken up by dendritic cells and “presented” to CD4+ and CD8+ T cells implicated i
Slide 9: 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 10: Phase IIa Monotherapy Trial
Bria-IMT™ Phase IIa Monotherapy Trial Baseline: Imaging, labs, clinical evaluation Enrollment Completed: Bria-IMT™ 1,2,3 ▪ 30 MBC patients screened (week 1,3,5) and over 20 dosed Bria-IMT™ 4,5 ▪ Primary objectives: Safety & (month 2,3) tumor response Restage: Imaging, labs, clinical evaluation ▪ Exp
Slide 11: Human Proof-of-Concept Trials in Breast Cancer (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 12: Human Proof-of-Concept Trials in Breast Cancer (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 13: Human Proof-of-Concept Trials in Breast Cancer (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 14: 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 15: Patient 01-002 Lung Lesions (2017)
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 15
Slide 16: Patient 01-002 Lung Lesions (2017)
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 16
Slide 17: Patient 01-002 Lung Lesions (2017)
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 17
Slide 18: Patient 01-002 Lung Lesions (2017)
Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 18
Slide 19: 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 20: Clinical Development Update – Summary 2018 September
Clinical Development Update – Summary 2018 September 26 ▪ Completed enrollment of Adv. Breast cancer patients in the Phase I/IIa “monotherapy” study of Bria-IMT™ We have confirmed our mechanism of action and achieved proof of concept ➢ Initial safety data appears superior to that of the other advanc
Slide 21: Excellent Safety Data - To Date
Bria-IMT™ Excellent Safety Data - To Date Based on the current study, Bria-IMT™ has an excellent safety profile ▪ To date, Bria-IMT™ has been dosed in 24 patients (4 in 2004-2005, 20 in 2017-2018) Interim Data (20 patients)-Ongoing Phase I/IIa Study (2017-2018) ▪ Bria-IMT™ has been very well tolerat
Slide 22: Efficacy as Predicted
Bria-IMT™ - Efficacy as Predicted ▪ Bria-IMT™ appears to be most effective in patients who match with Bria-IMT ™ at 2 HLA loci (types) further supporting our “HLA Matching Hypothesis”, and the development of Bria-OTS ™ to cover 90% of the patient population ▪ Combination with immune checkpoint inhib
Slide 23: 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 24: Phase IIa Combination Therapy Trial
Bria-IMT™ Phase 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 res
Slide 25: Bria-OTS & BriaDX Off-the-Shelf Personalized Immunotherapy
Bria-OTS™ & BriaDX™ Off-the-Shelf Personalized 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 Cl
Slide 26: 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 27: Clinical Development Strategy
Clinical Development Strategy The confirmatory Bria-IMT™ monotherapy Phase IIa trial has completed enrollment ➢ Additional Support for the HLA-matching hypothesis has been obtained Bria-IMT™ Combination Therapy study with immune checkpoint inhibitors ➢ Keytruda® if PD-L1/2 positive (≥1%), Yervoy® if
Slide 28: 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 Phase I/IIa Bria-IMT™ Monotherapy Currently Enrolling Phase IIa Bria-IMT™ + Checkpoint Inhibitors (1Q18 → 2Q20) Bria-OTS™ Off-the-Shelf Cell Line Bria-OTS™ Off-T
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 d
Slide 30: Upcoming Milestones & Catalysts
Upcoming Milestones & Catalysts ✓ Q3 2018: Data on first 20 Patients ✓ Q3 2018: Initiate Combination Study of Bria-IMT™ with Keytruda or Yervoy ❑ Q4 2018: Switch to a novel frozen Bria-IMT™ formulation ❑ Q4 2018: Safety Data (6 patients) of the Combination Study (San Antonio Breast Cancer meeting) ❑
Slide 31: Share Metrics
Share Metrics Ticker: TSX: BCT.V US Ticker: OTCQB:BCTXF Share Price (CAD) as of Sept 11, 2018 $0.14 52-Week Range (CAD) $0.09-0.19 Shares Outstanding as of Sept 11, 2018 158.9M Market Cap as of Sept 11, 2018 (CAD) $22.2M Cash and Short Term Investments as of April 30, 2018 (CAD) $4.4M Total Sharehol
Slide 32: BriaCell Investment Highlights
BriaCell Investment Highlights ▪ Developing Bria-OTS™, the First Off-the-Shelf Personalized Immunotherapy ▪ Targeting Adv. Breast Cancer: Unmet medical need (42,000 death in the US in 2017 ) ➢ $1 Bil- $5 Bil market opportunity depending on patient treatment stage ▪ Impressive results in 2 proof-of-c
Slide 33: Appendix
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Appendix 33
Slide 34: Comparable Valuations
Comparable Valuations BriaCell Has Significantly Lower Enterprise Value vs Peers Trial Stage Shares Enterprise (Breast Development Outstanding Price Market Cap Debt Cash Value BriaCell Company Therapeutic Area Cancer) Stage (in Millions) ($US) (In Mil $US) (In Mil $US) (In Mil $US) (In Mil $US) Disc
Slide 35: 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-Boehringer Ingelheim Preclinical Up to €1.13B ($1.39B) 02/
Slide 36: Early Stage Clinical Studies (Comparison)
Early Stage Clinical Studies (Comparison) ▪ We compared the interim data of 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 Sta
Slide 37: 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 38: 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 Ibrance (palbociclib) 41 & 18 20%-61%: Gr3/4 Neutropenia 0% response rate
Slide 39: 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 40: 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 41: 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 42: 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 inhibitor reduces tumor burden in a human lung cancer model (lower is better) PKCδ inhibitors decrease tumor size and improve survival in pancreatic cancer model (
Slide 43: The Future of Cancer Immunotherapy
The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT 43
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