BriaCell Therapeutics Corp · TSX:BCT

BriaCell Therapeutics — Investor Presentation (October 2018)

42 slides from BriaCell Therapeutics's investor presentation, October 2018

  1. Slide 1: The Future of Cancer Immunotherapy – Investor Presentation October 2018

    The Future of Cancer Immunotherapy [email protected] BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Investor Presentation October 2018 1

  2. 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

  3. Slide 3: 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

  4. Slide 4: Bria-OTS™ & BriaDX™

    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

  5. Slide 5: 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

  6. Slide 6: Bria-IMT™ - First Product Candidate

    Bria-IMT™ - First Product Candidate 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 

  7. Slide 7: Bria-IMT™ & Bria-OTS™ Potential Mechanisms of Action

    Bria-IMT™ & Bria-OTS™ 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

  8. Slide 8: 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

  9. Slide 9: 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

  10. Slide 10: Bria-IMT™ Patient 01-002 Lung Lesions

    Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 10

  11. Slide 11: Bria-IMT™ Patient 01-002 Lung Lesions

    Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 11

  12. Slide 12: Bria-IMT™ Patient 01-002 Lung Lesions

    Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 12

  13. Slide 13: 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

  14. Slide 14: Upcoming Milestones & Catalysts

    Upcoming Milestones & Catalysts  Q3 2018: Data on first 20 Patients on Bria-IMT™  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 Bria-IMT™ - Keytruda® Combination Study (S

  15. Slide 15: 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

  16. Slide 16: 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

  17. Slide 17: 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

  18. Slide 18: 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

  19. Slide 19: Share Metrics

    Share Metrics Ticker: TSX: BCT.V US Ticker: OTCQB:BCTXF Share Price (CAD) as of Oct 9, 2018 $0.12 52-Week Range (CAD) $0.09-0.19 Shares Outstanding as of Oct 9, 2018 161.1M Market Cap as of Oct 9, 2018 (CAD) $19.3M Cash and Short Term Investments as of July 31, 2018 (CAD) $2.3M Total Shareholder's E

  20. Slide 20: Comparable Valuations

    Comparable Valuations BriaCell Has Significantly Lower Enterprise Value vs Peers Trial Stage Shares Enterprise (Breast Development Outstanding Price Market Cap Debt (In Cash Value BriaCell Company Therapeutic Area Cancer) Stage (in Millions) ($US) (In Mil $US) Mil $US) (In Mil $US) (In Mil $US) Disc

  21. Slide 21: 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

  22. Slide 22: Appendix

    The Future of Cancer Immunotherapy [email protected] BriaCell.com 1-888-485-6340 OTCQB: BCTXF TSX-V: BCT Appendix 22

  23. Slide 23: Bria-IMT™ 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

  24. Slide 24: 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

  25. Slide 25: 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

  26. Slide 26: Bria-IMT™ Patient 01-002 Lung Lesions

    Bria-IMT™ Patient 01-002 Lung Lesions (failed 7 prior chemo regimens) (2017) Pre-Treatment Post-Treatment 26

  27. Slide 27: 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

  28. Slide 28: 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

  29. Slide 29: Bria-IMT™ 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

  30. Slide 30: 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 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

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: 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

  34. Slide 34: 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

  35. 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/

  36. 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

  37. 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/

  38. 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

  39. Slide 39: 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

  40. 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

  41. Slide 41: Protein Kinase C delta (PKCδ) Inhibitors

    Protein Kinase C delta (PKCδ) Inhibitors Rottlerin Staurosporine KAM1 BJE6-106 Generation PKC-δ IC50 PKC-α IC50 PKC-δ/ PKC-α Selectivity Ratio 1 3 µM 75 µM 28-fold 2 2 µM 157 µM 56-fold 3 0.05 µM 50 µM 1000-fold  Structural aspects of first generation inhibitor rottlerin and staurosporine (pan-PKC

  42. 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 (

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