The Future of Cancer Immunotherapy - Briacellbriacell.com/wp-content/uploads/2018/10/BriaCell... · 2019-03-05 · Therapies, HemaQuest, Arch Therapeutics and Cetya Therapeutics Thomas

OTCQB: BCTXFTSX-V: BCT

Investor PresentationOctober 2018

The Future of Cancer Immunotherapy

[email protected] BriaCell.com 1-888-485-6340

1

Forward-Looking Statements

Except for historical information, this presentation contains forward-looking statements, which reflect BriaCell’scurrent expectations regarding future events. These forward-looking statements involve known and unknownrisks 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 andtimely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time totime in our ongoing quarterly and annual filings. The forward-looking statements in this presentation are alsobased 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 of thispresentation and are presented for the purpose of assisting potential investors in understanding BriaCell’sbusiness, 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 asrequired under applicable securities legislation.

Investors are cautioned not to rely on these forward-looking statements and are encouraged to read BriaCell’scontinuous disclosure documents, including its financial statements which are available on SEDAR atwww.sedar.com.

2

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-concept clinical trials➢ Rapid Response Rate; Repeated following re-treatment; Excellent Safety Profile

▪ Completed enrollment in Phase I/IIa clinical trial of Bria-IMT™ with outstanding safety & efficacy data➢ Initiated Phase IIa Combination Study of Bria-IMT™ with Keytruda® (Merck & Co., Inc.) or

Yervoy®(Bristol-Myers Squibb Company)

▪ Developing Bria-OTS™ along with BriaDX™, its companion diagnostic test➢ Ability to match and treat ~90% of patient population with Off-the-Shelf personalized immunotherapy

▪ Experienced Management has been involved in over 10 drug approvals

▪ Significant Near-Term News-flow3

Involved in over 10 drugs brought to the market

Experienced Management Team

Management

William V. Williams, MD, FACP, President & CEO▪ VP, Exploratory Development, Incyte Corporation▪ VP, Experimental Medicine, GlaxoSmithKline▪ Head, Rheumatology Research, University of Pennsylvania▪ Facilitated entry of over 20 compounds into the clinic including ruxolitinib (Jakafi),

baricitinib, & epacadostat. NDAs including Jakafi, Boniva, Bexxar▪ Author of over 120 peer-reviewed publications & over 20 patents

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

Markus Lacher, PhD, Senior Director, R&D▪ Founder, T cell Therapeutics, Inc., an immuno-oncology company▪ Sr. Clinical Scientist, Cesca Therapeutics, Inc., a clinical-stage autologous cell

therapy company▪ Scientist at BioTime, Inc. and OncoCyte Corporation▪ Editorial advisory board; Recent Patents on Anti-Cancer Drug Discovery

Farrah Dean, MSc, MBA, Manager, Corp. Development▪ Investor relations, CytRx Corporation, & CCG Investor Relations▪ Senior Associate Equity Analyst, Oppenheimer & Co., Rodman & Renshaw, &

ThinkEquity LLC

Prior Affiliations

4

Veteran Board of Directors

Board of Directors

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 Ridge. ▪ Director of the Board, Ansell Capital Corp, Parallel Resources, & Galaxy Capital

Corporation

Martin Schmieg, CPA, Director▪ CFO: Sirna Therapeutics, Inc., & Isolagen, Inc.▪ CEO, Freedom-2, Inc. (now PharmaCyte, Inc.)▪ Advisor, Caladrius Biosciences, Inc., Beckman Coulter Genomics, Calimmune,

Cryoport, Vetbiologics, Sapientia Pharma, & Rokk3r Labs

Charles Wiseman, MD, Co-Founder & Director▪ 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, LA

William V. Williams, MD, FACP, President & CEO▪ VP, Exploratory Development, Incyte Corporation▪ VP, Experimental Medicine, GlaxoSmithKline▪ Head, Rheumatology Research, University of Pennsylvania

Prior Affiliations

5

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 Faller, M.D., Ph.D.▪ Professor of Medicine, Pediatrics, Biochemistry, Microbiology, Pathology and

Laboratory Medicine; Hematologist/Oncologist; former Director of the Cancer Center; Boston University School of Medicine.

▪ Founder of several successful biotechnology companies

Robert Williams. Ph.D.▪ University Distinguished Professor of Chemistry, Colorado State University▪ Founder of several successful biotechnology companies including Microcide, Xcyte

Therapies, HemaQuest, Arch Therapeutics and Cetya Therapeutics

Thomas Kieber-Emmons, Ph.D.▪ Deputy Director, University of Arkansas Cancer Center▪ Expert in targeted cancer immunotherapies, structural biology and computational

chemistry

Maria Trojanowska, Ph.D.▪ Professor of Medicine, Boston University School of Medicine▪ Director, The Arthritis Center

6

Cancer Immunotherapy Space

The Problems

▪ Checkpoint Inhibitors: Keytruda® (anti-PD-1), Yervoy® (anti-CTLA-4) and others reduce the tumor’s ability tosuppress immune system. They only work in 20%-30% of patients as they depend on a patient’s own weakenedimmune system to kill the tumor and can cause autoimmune disease.

▪ Therapeutic Cancer Vaccines: Have not been successful in solid tumors or blood cancers as they are not specificenough to the patient.

▪ Personalized Immunotherapies:➢ Provenge® is effective for prostate cancer, but must be individually manufactured for each patient and as a

result of the required manufacturing logistics has not been commercially successful.➢ CAR-T therapies are effective in blood cancers (but not in solid tumors) and must also be individually

manufactured in a complex process for each patient (launching in 2018).

BriaCell’s Solution

▪ BriaCell’s Off-the-Shelf Personalized Immunotherapy: Bria-OTS™ consists of 15 individually pre-manufacturedgenetic alleles. BriaCell’s BriaDX™ companion diagnostic reveals a patient’s specific HLA-types and the 2 bestmatching alleles are administered to the patient. BriaCell’s 15 alleles (8 Class I & 7 Class II) cover/match ~90% of thepopulation. This saves time and eliminates the complex manufacturing process associated with other personalizedimmunotherapies.

7

Bria-IMT™Potential Mechanisms of Action in Advanced Breast Cancer

Bria-IMTTM directly stimulates cancerfighting CD4+ and CD8+ T cells(further boosts the response)

Bria-IMTTM produces breastcancer antigens which aretaken up by dendritic cellsand “presented” to CD4+and CD8+ T cells implicatedin tumor destruction.

Bria-IMTTM secretes GM-CSF which further promotes dendritic cell-based antigen presentation (boosts the response) 8

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 drug related AEs➢ Median Overall Survival = 12.1 months

Second Proof-of-Concept Phase I (2005):➢ Used GM-CSF-engineered cell line + cyclophosphamide + interferon-α➢ N = 4 late stage, treatment-refractory (3 breast cancer, and 1 ovarian cancer) patients➢ Well tolerated, no life-threatening drug related adverse events➢ One patient with transient urticaria reported as grade 3, responded to antihistamines➢ Median Overall Survival = 35 months➢ One robust responder with >90% regression during treatment, subsequent relapse (upon halting

treatment) responded to re-treatment

9

Bria-IMT™ Phase IIa Monotherapy Trial

Enrollment Completed:

▪ 30 MBC patients screenedand over 20 dosed

▪ Primary objectives: Safety &tumor response

▪ Exploratory objectives includeimmune response to tumor,biomarkers, Quality of Life

▪ Pre-dose low dosecyclophosphamide to reduceimmune suppression

▪ Post-dose IFN-α2b to boostcell mediated immunity

10

Bria-IMT™ 1,2,3(week 1,3,5)

Bria-IMT™ 4,5(month 2,3)

Bria-IMT™ 6,7,8(month 4,5,6)

Non-progressive response

Progression

Progression

Bria-IMT™ 12,13,14(month 10,11,12)

Bria-IMT™ 9,10,11(month 7,8,9)

Combination Therapy

Restage: Imaging, labs, clinical evaluation

Restage: Imaging, labs, clinical evaluation(before month 10 and vaccine 12)


Baseline: Imaging, labs, clinical evaluation

Restage: Imaging, labs, clinical evaluation(before month 7 and cycle 9)


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 with Bria-IMT™

11


▪ Approximately 3 months (106 days) after last inoculation, Patient A002’s breast cancer returned andspread to brain, lung and other sites

▪ Patient A002 was then re-treated with 10 inoculations of Bria-IMT™ over 4 months

▪ Repeat imaging studies showed normal findings on MRI and PET, consistent with a completeremission of the previous multiple central nervous system metastases as shown in the brain scansbelow:

baseline 3 re-inoculations

Lesion 1

baseline 3 re-inoculations

Lesion 2

12

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 at some metastatic sites

Tumor

Type

Survival

(months)

Tumor

regression

HLA-A

Alleles

HLA-B

Alleles

HLA-DRB3

Alleles

Bria-IMT™ Breast - 24:02 35:08 55:01 01:01 02:02

Patient A001 Breast 40.7 No 02:01 24:02 13:02 41:01 03:01 -

Patient A002 Breast 33.7 YES 02:01 11:01 18:03 44:02 02:02 -

Patient A003 Ovarian 35.6 No 02:01 03:01 07:02 13:02 Negative -

Patient B001 Breast 7.0 No 11:01 - 35:01 40:01 Negative -


13

Proof-of-Concept Results Resulted in BriaCell’s Immunotherapy Strategy:➢ Use BriaDX™ diagnostic to select only those patients matching Bria-IMT™➢ Use BriaDX™ diagnostic test to select Bria-OTS™ alleles matching ~90% of all patients

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 in2010, and lung metastases in 2017. Previously treated with 7 rounds of chemotherapy with 8 differentchemotherapy agents. Received 5 cycles of Bria-IMT™ over 3 months, then monthly cycles (6 months total).Evaluated after 3 months and 6 months. After 3 months, despite the extensive prior therapy, her scans notedthat, “there has been a clear response in the multiple bilateral pulmonary nodules”. The response wasmaintained after 6 months of Bria-IMT™ treatment. She matches Bria-IMT™ at 2 HLA alleles.

▪ The liver tumors were stable to slightly increased at 3 months, and then progressed after 6 months.

➢ This supports our hypothesis of heightened anti-tumor activity in patients with a matched HLA types.➢ Clear path to develop BriaDX™ to select the patients using HLA testing.

Tumor

Type

Survival

(months)

Tumor

Response

HLA-A

Alleles

HLA-B

Alleles

HLA-DRB3

Alleles

Bria-IMT™ Breast - 24:02 35:08 55:01 01:01 02:02

Patient 01002 Breast Ongoing Mixed 03:01 24:02 15:01 51:01 02:02 -

14

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

Pre-Treatment Post-Treatment

15



16



17



18

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 months1 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 Not Detectable Not Detectable

4 4.0 Not Detectable Not Detectable

5 RLL 4.5 Not Detectable Not Detectable

6 LLL 4.9 Not Detectable Not Detectable

7 xxx 5.2 Not Detectable Not Detectable



10 RLL costophrenic recess 5.6 Not Detectable Not Detectable

11 XXX 5.8 Not Detectable Not Detectable

12 LUL 6.0 Not Detectable Not Detectable

13 XXX 6.7 1.5 1.5

14 RUL 7.2 1.5 1.5

15 LLL 7.6 Not Detectable Not Detectable

16 RUL Noncalcified Nodule 7.7 Not Detectable Not Detectable

17 RLL costophrenic recess 7.9 1.0 1.0

18 RUL 8.2 Not Detectable Not Detectable


20 RLL 9.1 < 0.1 < 0.1

21 xxx xxx Not Detectable Not Detectable19

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 advanced or approved drugs for breast cancer when they were at a similar clinical stage of development

➢ Initial efficacy data is similar or superior to those of other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development

▪ Initiated Combination Study of Bria-IMT™ with Keytruda® or Yervoy® in Adv. breast cancer patients expecting even better response rates than those in the “monotherapy” study➢ Initial safety data is expected in 4Q2018➢ Initial efficacy data is expected in 1Q2019

▪ Bria-OTS™, the first off-the-shelf personalized treatment for advanced breast cancer, is expected to enter the clinic in 2019

20

Bria-IMT™ Excellent Safety Data - To Date

▪ 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 tolerated (≥60 doses given to date)

▪ The majority of adverse events (AEs) were limited to expected minor local irritation at the

injection sites

▪ No related grade >3 or unexpected AEs

▪ No related serious AEs

▪ No serious, unexpected, related AEs

▪ Most patients who have dropped out did so due to worsening of their underlying disease

Based on the current study, Bria-IMT™ has an excellent safety profile

21

Bria-IMT™ - Efficacy as Predicted

Interim Data (19 patients)-Ongoing Phase I/IIa Study (2017-2018) & Original Study (2004-2005)

▪ PD-L1 expression on circulating cancer cells & cancer-associated cells in 100% of patients (to date) →Strong rationale for combination with checkpoint inhibitors like Keytruda

22

▪ 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 inhibitors may induce a more potent anti-cancer response, leading to our strategy of combination studies of Bria-IMT ™ with Keytruda or Yervoy

Patients (n) HLA

Match

Tumor

Shrinkage

Biological

Response*4 ≥2 50% 75%

15 ≥1 27% 33%

4 0 0% 0%*Biological response includes tumor shrinkage or lower circulating cancer associated cells

Bria-IMT™ & Bria-OTS™Immunotherapy Combinations

▪ Bria-IMT™ and Bria-OTS™ shouldsynergize with existing approvedimmunotherapies as well as those stillunder development

▪ This includes immune checkpointinhibitors such as antibodies to PD-1,CTLA-4, GITR and CD73 inhibitors whicheliminate tumor immunosuppression

▪ In addition, immunostimulatoryantibodies to molecules such as OX40should enhance responses to Bria-IMT™and Bria-OTS™

23

Bria-IMT™ Phase IIa Combination Therapy Trial

24

Bria-IMT™ 1,2,3, 4(week 1,4, 7, 10)

Bria-IMT™ 5,6,7,8(weeks 13, 16, 19, 22)


Off Study


Baseline: Imaging, labs, clinical evaluation


Progression

Currently Recruiting:

▪ Treatment in combinationwith Keytruda® (Merck & Co.,Inc.) for PD-L1(+) or PD-L2(+)tumors q3wks x up to 24cycles, then Bria-IMT™ aloneq3wks

-OR-

▪ Treatment in combinationwith Yervoy® (Bristol-MyersSquibb Company) for PD-L1/2(-) tumors q3wks x 4cycles, then Bria-IMT™ aloneq3wks

▪ Imaging every 6 -12 weeks

Non-progressive response Bria-IMT™ 9,10,11,12(weeks 25, 28, 31, 34)


Bria-IMT™ 13,14,15,16(weeks 37, 40, 43, 46)



Bria-IMT™ 17,18,19,20(weeks 49, 52, 55, 58)


Continue as long as Clinical Benefit

These allele combinations cover/match with ~90% of the advanced breast cancer population

1. BriaDX™ reveals the patient’s Class I andClass II HLA Alleles

2. The pre-manufactured Bria-OTS™ HLAAlleles are selected for the specificpatient

3. The selected Bria-OTS™ cell lines arethen shipped to the clinical site forpatient treatment

Pre-Manufactured Off-the-Shelf HLA Class II Alleles

Pre-Manufactured Off-the-Shelf HLA Class I Alleles

Bria-OTS™ & BriaDX™ Off-the-Shelf Personalized Immunotherapy

25

▪ 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 theoverall advanced breast cancer population

➢ For proof of concept

➢ Eventually will be able to cover remaining 10%

▪ Using the BriaDX™ companion diagnostic, the off-the-shelf alleles will be matched and selected foreach specific patient prior to treatment

▪ RESULT: Therefore, each patient will have a personalized mix and match of off-the-shelf alleles

➢ Personalized therapy without the need for personalized manufacturing

Bria-OTS™ & BriaDX™ Off-the-Shelf Immunotherapy

26

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 PD-L1/2 negative (<1%)➢ Accepting patients from the monotherapy study who develop progressive disease➢ Also enrolling patients directly into this study to enhance experience with the combination➢ In discussion with other pharmaceutical companies to evaluate additional combinations with other

immunotherapies

Bria-OTS™ Off-the-Shelf Personalized Targeted Immunotherapy➢ Developing Bria-OTS™ to co-express GM-CSF and interferon-α➢ Pre-manufacture additional HLA alleles – Total of 15 alleles (8 Class I and 7 Class II)➢ Co-development of BriaDX™ companion diagnostic for HLA typing➢ Combination therapy clinical trial with immune checkpoint inhibitors for non-responders using

information from the Bria-IMT™ Combination Therapy Study

27

Development Timeline – Breast Cancer

20192018 2020 2021

Phase I/IIaBria-IMT™

Monotherapy

Currently Enrolling Phase IIaBria-IMT™ + Checkpoint

Inhibitors (1Q18 → 2Q20)

1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q

2022

3Q 4Q

Currently in discussions with potential partners:Phase II Bria-IMT™ plus Additional Combinations (1Q19 → 4Q22)(e.g. PD-1 Inhibitor, PD-L1 inhibitor, anti-CTLA4, anti-GITR, anti-OX40)

1Q 2Q 3Q 4Q

2023

Bria-OTS™ Off-The-Shelf Personalized ImmunotherapyMonotherapy and Potential Partnered Combo Therapy

(2H19 → Ongoing)

Bria-OTS™Off-the-Shelf Cell Line cGMP Manufacturing

and BriaDX™(1Q18 → 1Q19)

Registration Studies (1Q20 → 2H22)Bria-IMT™ with Checkpoint InhibitorsBria-OTS™ +/- Checkpoint Inhibitors

28

In the Pipeline: Protein Kinase C delta (PKCδ) Inhibitors

▪ 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 drug)

▪ BriaCell’s novel, proprietary PKCδ inhibitors have shown activity against multiple RAS transformed tumors➢ Lung cancer, Melanoma, Breast cancer, Neuroendocrine cancer, Pancreatic cancer, Colorectal cancer

▪ This target has an attractive safety profile based on in vivo studies and knock out mouse studies

▪ PKCδ inhibitors should qualify for an accelerated clinical development plan and regulatory pathway

▪ Could be in clinic within 24 months.

➢ Cost-Effective Additional Shot-on-Goal and additional partnership opportunities

Early-Stage Preclinical Program

29

✓ 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)❑ Q4 2018: Ongoing Corporate Partnership/Collaboration Discussions

❑ Q1 2019: Efficacy Data (6 patients) of the Combination Study ❑ Q2 2019: Additional Safety and Efficacy data for Monotherapy and Combination Study (AACR meeting)❑ Q2 2019: Final data for Monotherapy and Additional Data for the Combination Study (ASCO meeting)❑ H1 2019: Candidate Selection for a PKCδ Inhibitor❑ H1 2019: Initiate additional immunotherapy program❑ H2 2019: Bria-OTS™ Authorization from FDA; First Patient Dosed

Upcoming Milestones & Catalysts

30

Share Metrics

BCT.V; BCTXF 31

Insider Share Ownership (Mil) Share Ownership (%)

Saeid Babaei, PhD, MBA 0.5 0.3

Charles Wiseman, MD 13.4 8.4

Rahoul Sharan, CA 1.8 1.1

William V. Williams, MD 6.3 4.0

Total 22.0 13.8

2014 2015 2016 2017 2018

2.2 --- 3.0 2.0 5.3*

Capital Raise (in Mil CAD$)

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 Shareholder's Equity as of April 30,2018 (CAD) $3.0M

Number of Warrants @$0.14-$0.35 (CAD) as of April 30, 2018 63.2M

Number of Compensation Warrants @$0.20-$0.30 (CAD) as of April 30, 2018 0.9M

Number of Options @$0.15- $0.26 (CAD$) as of April 30, 2018 6.4M

Data as of 9/11/2018

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-concept clinical trials➢ Rapid Response Rate; Repeated following re-treatment; Excellent Safety Profile

▪ Completed enrollment in Phase I/IIa clinical trial of Bria-IMT™ with outstanding safety & efficacy data➢ Initiated Phase IIa Combination Study of Bria-IMT™ with Keytruda® (Merck & Co., Inc.) or

Yervoy®(Bristol-Myers Squibb Company)

▪ Developing Bria-OTS™ along with BriaDX™, its companion diagnostic test➢ Ability to match and treat ~90% of patient population with Off-the-Shelf personalized immunotherapy

▪ Experienced Management has been involved in over 10 drug approvals

▪ Significant Near-Term News-flow32


Appendix



33

Comparable Valuations

BriaCell Has Significantly Lower Enterprise Value vs Peers

Data as of 9/11/2018

34

Company Therapeutic Area

Trial Stage

(Breast

Cancer)

Development

Stage

Shares

Outstanding

(in Millions)

Price

($US)

Market Cap

(In Mil $US)

Debt

(In Mil $US)

Cash

(In Mil $US)

Enterprise

Value

(In Mil $US)

BriaCell

Discount

Achillion Pharmaceuticals, Inc. (ACHN) Therapeutics Ph II 138.6 3.32 460.1 8.2 295.8 172.5 92%

Aduro BioTech, Inc. (ADRO) Immuno-oncology Ph I/II 79.1 6.75 533.7 222.0 312.3 443.4 97%

BioXcel Therapeutics, Inc. (BTAI) Immuno-oncology & Therapeutics Ph Ib 15.7 9.16 143.4 1.4 51.1 93.7 84%

Dynavax Technologies (DVAX) Immuno-oncology & Therapeutics Ph II 62.6 12.65 792.1 132.6 216.0 708.7 98%

Five Prime Therapeutics, Inc. (FPRX) Immuno-oncology & Oncology Ph II/III 35.6 13.59 483.5 41.0 352.8 171.8 92%

Neon Therapeutics (NTGN) Immuno-oncology Ph I Ph I 28.3 11.20 317.0 7.6 138.6 185.9 92%

Immune Design Corp. (IMDZ) Immuno-oncology (breast cancer) Ph I Ph II 48.2 3.40 163.7 8.0 124.0 47.8 70%

Immunovaccine Inc (IMV.TO) Immuno-oncology (breast cancer) Ph II 44.9 5.46 245.0 10.6 21.5 234.1 94%

Infinity Pharmaceuticals, Inc. (INFI) Immuno-oncology (breast cancer) Ph Ib Ph Ib 56.9 2.26 128.5 5.7 50.4 83.7 83%

Leap Therapeutics, Inc. (LPTX) Immuno-oncology & Therapeutics Ph II 14.7 7.24 106.4 22.6 36.7 92.3 84%

Loxo Oncology, Inc. (LOXO) Immuno-oncology (breast cancer) Ph II Ph II 30.5 170.56 5197.0 324.4 676.7 4844.6 100%

Rexahn Pharmaceuticals, Inc. (RNN) Oncology (breast cancer) Ph II Ph II 31.8 1.69 53.7 6.8 18.1 42.4 66%

TapImmune Inc. (TPIV) Immuno-oncology (breast cancer) Ph II Ph II 13.7 8.39 115.0 3.7 7.9 110.9 87%

Average 672.2 556.3 87%

BriaCell

(TSX: BCT.V; OTCQB: BCTXF)

Immuno-oncology (breast cancer) Ph I/IIa 158.9 0.11 16.9 1.0 3.3 14.5

Immuno-oncology Deals

Recent deals of small biotechs with big pharma in immuno-oncology

35

Date Partnership

Development stage at the time of

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)

02/09/2018 Pieris Pharmaceuticals-Seattle Genetics Preclinical Up to $1.23B

2/14/2018 Nektar-BMS Ph I/II Up to $3.6B

01/22/2018 Juno-Celgene Ph II $9B (Acquisition)

11/14/2017 Loxo-Bayer Larotrectinib (Ph II); LOXO-195 (Ph I/II) Up to $1.55B

10/3/2017 CytomX-Amgen Preclinical Up to $1.5B

03/20/2017 CytomX--BMS Ph I/II Up to $3.6B

6/28/2016 Xencor-Novartis Preclinical Up to $2.4B

Early Stage Clinical Studies (Comparison)

▪ We compared the interim data of Ph I/IIa study of Bria-IMT™ in advanced breast cancer with thedata in the early stage clinical studies of recently approved breast cancer drugs, and one fasttracked product candidate.

Apples to apples comparison: Early Stage Clinical Studies in oncology are typically done in patientswith no other therapeutic options. Thus, the patients have very advanced disease and response ratesare typically quite low.

The patients in our Ph I/IIa study have been heavily pre-treated (median 4.5 prior regimens)Some recent studies of relevance in breast cancer are noted in the following slides

36

Breast Cancer Market Opportunity

Drug Technology Approved for Market (US)Ibrance (palbociclib) CDK 4/6 Inhibitor HR+/HER2- MBC in combination with

fluvestrant or aromatase inhibitor

$933M in 1Q2018;

$3,126M in 2017

Kisqali (ribociclib) CDK 4/6 Inhibitor 2017: HR+/HER2- MBC in combination with


Peak sales

projected at $2.5B

Verzenio (abemaciclib) CDK 4/6 Inhibitor 2017: HR+/HER2- MBC in combination with


Peak sales

projected at $2B

Lynparza (olaparib) Poly (ADP-ribose)

polymerase (PARP)

inhibitor

2017: ovarian & breast cancer $997M in 2017

Halaven (eribulin mesylate) Tubulin-based

antimitotic

2H2017: 3rd line MBC & liposarcoma $181M in 2017

balixafortide CXCR4 antagonist Fast track designation in 2018 for HER2- MBC

who have failed 2 prior regimens

The market for breast cancer drugs is a multibillion dollar market with new drugs being approvedon an ongoing basis indicating the shortage of safe and effective treatments for this deadly disease

37

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

38

Ibrance (palbociclib) 41 & 18 20%-61%: Gr3/4 Neutropenia

23%-39%: Gr3/4 Leucopenia

0% response rate (n=41); 11% PR (n=18) but only

with letrozole (0% for monotherapy)

Kisqali (ribociclib) 132 27%: Gr3/4 Neutropenia

17%: Gr3/4 Leucopenia

2.3% PR – included 1 in breast cancer (5% of breast

cancer patients)

Verzenio (abemaciclib) 12 17%: Gr3/4 Neutropenia


17% PR – included 1 in breast cancer

Lynparza (olaparib) 28 11%: Gr3+ Neutropenia

8%: Gr3+ Thrombocytopenia

18%: Gr3 Fatigue

25%: Gr3 Hypertension

0% response rate for brteast cancer (8 patients)

Halaven (eribulin

mesylate)

12 100%: Gr3/4 Neutropenia

83%: Gr3/4 Leukopenia

25%: Gr3/4 Lymphopenia

8%: Gr3/4 Febrileneutropenia

8% PRs

balixafortide 56 41%: Gr3/4 Neutropenia


11%: Gr3/4 Febrileneutropenia

2: Related mortalities

30% PRs in combination with Halaven

Bria-IMTTM 24 (safety)

19 (efficacy)

Injection site reactions

No related SAEs or SUSARs

Tumor vol. ↓ &/or ↓ circul. tumor cells

All Comers: 21%(4/19), 26%(5/19)

One or More HLA matches: 27%(4/15), 33%(5/15)

Two or More HLA matches: 50% (2/4), 75% (3/4)

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 change sNDA.

▪ Hycamtin® (topotecan) for ovarian cancer▪ Pediatric use sNDA

▪ Navelbine® (vinorelbine tartrate) for non-small cell lung cancer▪ Pediatric use sNDA

▪ Boniva® (ibandronate) monthly oral treatment of osteoporosis.

▪ Boniva® (ibandronate) quarterly intraveous treatment of osteoporosis.

▪ Zofran® (ondansetron) for prevention of nausea and vomiting▪ Pediatric use sNDA.

▪ Jakafi® (ruxolitinib) for myelofibrosis

▪ Jakafi® (ruxolitinib) for polycythemia vera

▪ Olumiant® (baricitinib) for rheumatoid arthritis▪ Approved in USA, Japan and Europe

39

Protein Kinase C delta (PKCδ) Inhibitors

Activated PKCδ inhibits RAS degradation which in turn stimulates tumor growth.

Koo et al Oncotarget 6:21328, 2016

▪ 30% of all human malignancies display activating RASmutations with another 60% showing over-activity of Ras-signaling pathways.

▪ BriaCell’s novel, proprietary PKCδ inhibitors have shownactivity against multiple RAS transformed tumors.

▪ This target has an attractive safety profile based on in vivostudies and knock out mouse studies.

▪ PKCδ also has potential activity as an immunotherapeuticby blocking TGFβ signaling.

▪ PKCδ inhibitors are applicable to specific niche tumor typeswhich provide an accelerated clinical development plan.

▪ Could be in clinic within 24 months

➢ Provides Cost-Effective Additional Shot-on-Goal andadditional partnership opportunities.

Early-Stage Preclinical Program

40

▪ Structural aspects of first generation inhibitor rottlerin and staurosporine (pan-PKC activator) were combined to create second generation inhibitor KAM1

▪ Third generation inhibitors such as BJE6-106 have improved potency and selectivity.▪ Fourth generation inhibitors under development to optimize drug-like characteristics.▪ PKCδ inhibitors lack endothelial cell cytotoxicity & PKCδ deficient mice develop normally and are fertile ➢ Potentially no marked intrinsic toxicity by inhibiting PKCδ

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-fold2 2 M 157 M 56-fold3 0.05 M 50 M 1000-fold

BCT.V; BCTXF 41

PKCδ Inhibitors Block Growth in Various Cancers

PKCδ inhibitor reduces tumor burden in a human lung cancer model (lower is better)

PKCδ inhibitors block growth ofmelanoma cells (lower is better)

PKCδ inhibitors inhibit growth of neuroendocrine tumor cell lines (lower is better)

PKCδ inhibitors decrease tumor size and improve survival in pancreatic cancer model(A) lower is better(B) higher is better)

BCT.V; BCTXF 42




43

Documents

The Future of Cancer Immunotherapy - Briacellbriacell.com/wp-content/uploads/2018/10/BriaCell... · 2019-03-05 · Therapies, HemaQuest, Arch Therapeutics and Cetya Therapeutics Thomas