BriaCell Therapeutics Corp. OTCQB: BCTXF JULY 2016 TSX-V: BCT - - PowerPoint PPT Presentation

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BriaCell Therapeutics Corp. OTCQB: BCTXF JULY 2016 TSX-V: BCT - - PowerPoint PPT Presentation

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BriaCell Therapeutics Corp. OTCQB: BCTXF JULY 2016 TSX-V: BCT Forward-Looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect BriaCells current expectations regarding future

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BriaCell Therapeutics Corp.

OTCQB: BCTXF TSX-V: BCT JULY 2016

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Forward-Looking Statements

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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 actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly and annual filings. The forward-looking statements in this presentation are also based on a number of assumptions which may prove to be incorrect. Forward-looking statements contained in this presentation represent views only as of the date

  • f this presentation and are presented for the purpose of assisting potential investors in

understanding BriaCell’s business, and may not be appropriate for other purposes. BriaCell does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read BriaCell’s continuous disclosure documents, including its financial statements which are available on SEDAR at www.sedar.com.

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 Leading Technology: Novel cancer immunotherapy  Right Timing: Initiating a Ph I/IIa clinical trial to validate the impressive safety and efficacy data of the two preliminary Ph I clinical trials  Unique Approach: Companion diagnostic co-development  Significant Market Potential: Multiple cancer indications. A multi-billion dollar target market.  Solid Management: Experts in immunotherapy, diagnostics, & corporate governance  Poised to Unlock Value: Significantly undervalued. Several short- and long-term

  • milestones. Potential partnerships.

Investment Highlights

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BriaVax™ (SV-BR-1-GM)

  • Breast cancer cell line
  • Allogeneic whole-cell vaccine secreting GM-CSF (“GVAX”).
  • Scalable production - grows as cancer cell line in RPMI + 10% FBS.
  • Irradiation prior to injection to prevent replication.
  • Used in combination with cyclophosphamide, and post-treatment with

interferon-α.

  • Expected Result: Boosting the patient’s overall immune response to the

tumor cells.

Target Population

  • 2nd line use for late stage breast cancer.
  • Potential use for early stage cancers sharing antigen(s) of vaccine cells.
  • Potential use for non-breast cancers sharing antigen(s) of vaccine cells.
  • Maintenance therapy for duration of disease

Cancer Immunotherapy

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  • Dr. C. L. Wiseman (left) helped

pioneer chemotherapies before they were considered a possibility.

BriaVaxTM is a proprietary breast cancer cell vaccine expressing GM-CSF , Impressive safety and efficacy data in a preliminary Phase I clinical trial Planning Phase I/IIa testing of BriaVaxTM as 2nd line treatment for metastatic breast cancer.

BriaVaxTM Development Story

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First Phase I:

  • Used unmodified cell line + GM-CSF + cyclophosphamide
  • N = 14 late stage, treatment-refractory breast cancer patients
  • No significant adverse events, well tolerated
  • Median Overall Survival = 12.1 months

Second Phase I:

  • Used GM-CSF-engineered cell line + cyclophosphamide + interferon-α
  • N = 4 late stage, treatment-refractory (3 breast cancer, and 1 ovarian cancer) patients
  • No significant adverse events, well tolerated
  • Median Overall Survival = 35 months
  • One robust responder with >90% regression during treatment, subsequent relapse (upon

halting treatment) responded to re-treatment

Clinical Data to-date

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Second Phase I (using BriaVaxTM) 1 out of 4 Subjects responded with substantial tumor regression

Clinical Data to-date

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baseline 3 re-inoculations

Lesion 1

baseline 3 re-inoculations

Lesion 2

baseline 3 re-inoculations

Lesion 3

Clinical Data to-date

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Hypothetical Mechanism of Action

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  • Tumor regression in a patient was directly related to rising levels of CD40

Ligand (CD40L), a protein that is expressed on components of the immune system including activated T cells, B cells, platelets, monocytic cells, natural killer (NK) cells, mast cells, and basophils.

  • CD40L is known as one of the strongest stimulants of the immune system

resulting in dendritic cell maturation, and rising serum levels of CD4+, CD8+, and NK cells, i.e., immune cells known for their anti-tumor activities.

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Tumor Regression – Series-I

Baseline Before Treatment 3 Vaccines 6 Weeks Treatment 6 Vaccines 20 Weeks Treatment

Tumor Re-Regression – Series-II

Relapsed 3 Additional Vaccines 8 Weeks

4 months to restart of treatment

CD40L Levels During Treatment Series-I CD40L Levels During Re-Treatment Series-II

Hypothetical Mechanism of Action

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Hypothetical Mechanism of Action: CTA Analysis

  • Cancer Testis Antigens (CTAs): A class of cancer tissue specific antigens
  • PRAME: The CTA expressed in some breast cancers. The PRAME is also expressed in

BriaVax™.

  • BriaVax™ injection may activate the patient T cells by PRAME recognition to cause

tumor destruction.

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BriaVax™

LUMINAL* STROMAL* BASAL* ERBB3+ ALDH- ERBB3+ ALDH+ ERBB3- ALDH- Nonclonogenic

Normal Breast Cells

*Shehata et al. (2012). GEO DataSet GSE35399. **Lowe et al. (2015). GEO DataSet GSE56718. HMEC**

CEP55 PBK PLAC1 PRAME

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Hypothetical Mechanism of Action: HLA Analysis

  • BriaVax™ caused a significant tumor shrinkage in one patient (Subject A002) - even at

metastatic sites (Wiseman and Kharazi, Breast J 2006).

  • HLA analysis of BriaVax™ and peripheral blood lymphocytes from the 4 patients

showed that the special responder (subject A002) had the same Major Histocompatibility Complexes (MHCs) class I (HLA-A) and class II (HLA-DRB3) alleles as BriaVax™. This double-match may explain BriaVax™ ‘s strong tumor destruction activities in that subject.

12 Subject ID Survival (months) Tumor regression HLA-A HLA-B HLA-DRB3 A001 40.7 No 02:01 24:02 13:02 41:01 03:01

  • A002

33.7 Yes 02:01 11:01 18:03 44:02 02:02

  • A003

35.6 No 02:01 03:01 07:02 13:02 Negative

  • B001

7.0 No 11:01

  • 35:01

40:01 Negative

  • BriaVax

N/A N/A 11:01 24:02 35:08 55:01 01:01 02:02

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Hypothetical Mechanism of Action of BriaVaxTM

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  • BriaVax™ expresses several genes known for their roles in immune cells,

including HLA-A and HLA-DRB3.

  • BriaVax™ may do one or few of the following:
  • A. Directly act as antigen-presenting cells (APCs)
  • B. Cross-Presentation: Dendritic cells may take up degraded BriaVax™ and

present BriaVax™ antigens on their own MHCs to the patients T cells

  • C. Cross-Dressing: Transfer BriaVax™ antigens displayed on MHCs/HLAs to

dendritic cells

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Discovery of Gene Signature of BriaVaxTM – Implications

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  • BriaCell discovered a pair of biomarkers (HLA alleles) present in the top-

responder and BriaVaxTM but not in the 3 other clinical trial subjects

  • Implications:

i. It improves our understanding of how the vaccine works, thus improving the likelihood of clinical success, and may accelerate the clinical development of BriaVaxTM. ii. We plan to develop diagnostic tests to identify the top-responder (the patients for which the vaccine would work best) subgroup of patients.

  • We plan to further validate our discovery using the patients data in the

upcoming Phase I/IIa study

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IND Cleared by FDA in Nov 2015:

  • Up to 24 stage-IV breast cancer patients
  • Primary objective: Safety & tumor response
  • Designed to amend the trial to evaluate:
  • Extending the dosing schedule (not limited

to 6 vaccine injections)

  • Use in combination with other treatments
  • Application to earlier stage, more

favorable to breast cancer patients

  • Application to other tumors

Phase I/II Open Label Clinical Trial

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BriaVax™

Accelerating the Clinical Development of BriaVaxTM

BriaDx™

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Companion diagnostics co-development

Molecular analysis of blood and potentially tumor samples Predict BriaVax™ responsiveness Low development costs

Combination therapy to boost efficacy:

Allogeneic tumor cell line + GM-CSF secretion + Cyclophosphamide + Interferon-α

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  • FDA has allowed the testing of BriaVaxTM for other cancer indications

Targeting a multi-billion dollar market

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Cancer Type Annual Mortality (US) Potential Market (in Million $US)

at $100K/yr

Breast 40,890 $4,089

at $100K/yr

Cancer Type Annual Mortality (US) Potential Market (in Million $US)

at $100K/yr

Lung 158,080 $15,808 Ovary 14,240 $1,424 Prostate 26,120 $2,612 Bladder 16,390 $1,639 Pancreas 41,780 $4,178 Gastric 10,730 $1,073 Brain 16,050 $1,605 Total others (non breast) 324,280 $28,339

Total (breast & others) $32,428

Source: American Cancer Society Facts and Figures 2016

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Upcoming Milestones

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Milestone Expected Timing Completion of manufacturing of BriaVaxTM for Ph I/IIa trial 2H2016 Initiation of Ph I/IIa clinical trials of BriaVaxTM 2H2016 Filing for additional patents 1H2017 Interim Data for Ph I/IIa trial 2H2017 Presentation of clinical data at a major conference 2H2017 Draft protocols for additional Ph II/III trials as counseled by FDA 2H2017

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Management Board Rahoul Sharan, CA, CEO & Director

  • Chairman, Potash Ridge
  • 30 yrs of finance & accounting experience
  • Board of directors of Ansell Capital Corp, Parallel Resources, & Galaxy

Capital Corporation

  • Partner, S&P Group - Led financings in excess of $100M
  • Public Accountant, Coopers & Lybrand

Markus Lacher, PhD, Senior Director, R&D

  • Sr. Clinical Scientist, Cesca Therapeutics, Inc.
  • Founder, T cell Therapeutics, Inc., an mmune-oncology company
  • Author of 1st Sequencing of Nuclear DNA of 5 clinical-grade human

embryonic stem cell lines, published in Stem Cell Research

Saeid Babaei, PhD, MBA, Chairman

  • Entrepreneur. 20 yrs of biotech leadership roles
  • CEO, AbCelex - Obtained funds from a top agri-tech/biotech VC
  • VP, Bus. Development, Lorus Therapeutics - Out-licensing a Ph III

immuno-oncology program

  • Dir. of Corp. Development, Northern Therapeutics- Led partnership

to United Therapeutics

Martin Schmieg, CPA, Director

  • 35 yrs of biotech, med-tech, and pharma experience
  • CFO: Sirna Therapeutics, Inc., & Isolagen, Inc.
  • CEO, Freedom-2, Inc. (now PharmaCyte, Inc.)
  • Advisor, Caladrius Biosciences, Inc., Beckman Coulter Genomics,

Calimmune, Inc., Cryoport, Inc., Vetbiologics, a division of U.S. Stem Cell, Inc., Sapientia Pharmaceuticals, Inc., & Rokk3r Labs, LLC

Management and Board

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Charles Wiseman, MD, Co-Founder & Director

  • Oncologist - 45 years experience, pioneered chemotherapies
  • Director, Immunotherapy Lab, St. Vincent Medical Center
  • Chief, Breast Cancer Basic Research Lab, Univ. of Texas MD

Anderson Hospital & Tumour Institute; Assist. Prof., Dept of Molecular Carcinogenesis & Virology, MD Anderson; Acting Chief,

  • Div. of Oncology, White Memorial Medical Center, Los Angeles

Gadi Levin, CA, MBA, CFO

  • CFO of Labstyle Innovations Ltd
  • VP of Finance for two Israeli investment houses in the fields of private

equity, hedge funds and real estate

  • Financial Consultant, various firms
  • Accountant, Arthur Andersen
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Financials

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Data as of 7/11/2016

Ticker TSX: BCT.V Other Listing OTCQB: BCTXF Shares outstanding (in Millions) 91.30 Market Cap (in Million CAD$ ) 15.98

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Recent Deal Values

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Date Partnership Development stage at the time of the deal Deal size Terms

10/20/2014 Ph I Up to $1.15 Bil 6/29/2015 Juno Therapeutics/Celgene Ph I/II Up to $1Bil 8/10/2015 Ph I/II Up to $725M 8/24/2015 BioMarin - Medivation Ph III Up to $570M 9/16/2015 Discovery/Preclinical Up to $1.745 Bil 10/15/2015 Ph I Up to $1.74 Bil $350M upfront payments $1.39 Bil-development & regulatory milestones Royalties in double digits 12/21/2015 Halozyme, Eli Lilly Preclinical Up to $800M $25M upfront. Milestone payments of up to $160M for each of up to five collaboration targets valued at up to $800M-Mid- single digit royalties. 6/28/2016 Xencor-Novartis Preclinical Up to $2.4 Bil $150M upfront payment, with clinical, regulatory and sales milestones for two drug candidates. Inovio Pharmaceuticals, Inc.

  • MedImmune

NewLink Genetics - Genentech Xencor, Inc. - Amgen Five Prime Therapeutics,

  • Inc. - Bristol-Myers Squibb

Company Upfront payment of $150 M; Up to $1 Bil payments for certain milestones ; Escalating double-digit royalties Upfront payment of $27.5 M; Up to $700M-development & commercial milestones; MedImmune pays all developmental costs; Double digit tiered royalties Upfront payment of $150 M; Celgene buys 9.14M shares of Juno's stock at $93/share, & will have the right to buy more equity in Juno in specified windows/market premiums; Both share global costs & profits with 70%-Celgene & 30% -Juno $410M to license the drug worldwide from BioMarin; $160M for certain regulatory & sales-based milestones; Royalties in the mid-single digits $45M Upfront Payment; Up to $1.7 Bil in Clinical, Regulatory & Sales Milestone Payments; Mid to high single-digit royalties for certain candidates

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Near-term Plans

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  • Working closely with Cancer Insight, a CRO specializing in cancer immunotherapy,

to enroll the first 9 patients.

  • Analysis of blood samples from the first few patients in the upcoming Phase I/IIa

clinical trial to further address the hypothesis that previously identified biomarkers indeed correlates with clinical efficacy.

  • Follow up treatments with the patients (the treatment cycle may be extended in

some patients).

  • Discussing combination studies with potential partners including big pharma
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Summary

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  • Proprietary vaccine for 2nd line use for advanced breast cancer with potential

for 1st line use.

  • Initiating Phase I/II a to further validate the impressive preliminary Phase I data:
  • survival was increased by up to 5X
  • rapid response rate with little side effects
  • Planning to co-develop companion diagnostics.
  • Potential use for other cancer indications. Targeting a multi-billion dollar

market.

  • The management consists of leading experts in immuno-oncology, diagnostics,

and corporate governance.

  • Currently undervalued compared to immuno-oncology peers. Partnership

Potentials for combination studies.

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info@BriaCell.com | 1-888-485-6340 | BriaCell.com TSX: BCT.V OTCQB: BCTXF