BriaCell Therapeutics Corp · TSX:BCT

BriaCell Therapeutics — Investor Presentation (May 2018)

37 slides from BriaCell Therapeutics's investor presentation, May 2018

  1. Slide 1: 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 May 2018

  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: 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Slide 10: 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

  11. Slide 11: 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

  12. Slide 12: 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

  13. 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

  14. Slide 14: Proposed Diagnostic Test

    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 Series-I 250 Series-II C D 4 0 L L e v e ls ( p g /m L ) C D 4 0 L

  15. 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

  16. 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

  17. 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

  18. Slide 18: 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) 18

  19. 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

  20. Slide 20: 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

  21. 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

  22. 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

  23. 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%

  24. Slide 24: Milestones

    Milestones Bria-IMT™ Bria-OTS™  Q2 2018: Acceptance of Paper Detailing Mechanism of Action  Q1 2018: Knock-out of endogenous HLA-A  Q2 2018: Presentation at AACR  Q2 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

  25. Slide 25: Milestones (Continued)

    Milestones (Continued)  Q2 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Slide 31: Share Metrics

    Share Metrics TSXV: BCT OTCQB:BCTXF Capital Raises (in Mil CAD$) 2014 2015 2016 2017 2018 Share Price (CAD) as of May 16, 2018 $0.10 2.2M --- 3.0M 2.0M 5.3M* 52-Week Range (CAD) $0.10-0.23 Insiders Share Ownership (Mil) Share Ownership Market Cap as of May 16, 2018 (CAD) $15.7M Saeid Babaei, PhD, MB

  32. Slide 32: Comparable Valuations

    Comparable Valuations BriaCell Has Significantly Lower Enterprise Value vs Peers Trial Stage EV (Breast Development (In Mil BriaCell Company Therapeutic Area Cancer) Stage $US) Discount TapImmune Inc. (TPIV) Immuno-oncology (breast cancer) Ph II Ph II 31.4 58% Celldex Therapeutics, Inc. (CLDX) Immun

  33. Slide 33: The Future of Cancer Immunotherapy

    The Future of Cancer Immunotherapy info@BriaCell.com BriaCell.com 1-888-485-6340 CORPORATE OFFICE- CANADA CORPORATE OFFICE- US SUITE 300 – BELLEVUE CENTRE OTCQB: BCTXF 820 HEINZ AVENUE 235 -15TH STREET TSXV: BCT BERKELEY, CA, 94710 WEST VANCOUVER, BC V7T 2X1 TEL: 1-888-485-6340 TEL: 604-921-1810 FAX

  34. Slide 34: Appendix

    BriaCelll Appendix 34

  35. Slide 35: 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

  36. Slide 36: 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

  37. Slide 37: 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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