The Future of Cancer Immunotherapybriacell.com/wp-content/uploads/2018/07/BriaCell... · 2019-03-05 · Therapies, HemaQuest, Arch Therapeutics and Cetya Therapeutics Thomas Kieber-Emmons,

OTCQB: BCTXFTSX-V: BCT

Investor PresentationJuly 2018

The Future of Cancer Immunotherapy

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

Forward-Looking Statements

Except for historical information, this presentation contains forward-looking statements, which reflectBriaCell’s current expectations regarding future events. These forward-looking statements involve knownand unknown risks and uncertainties that could cause BriaCell’s actual results to differ materially fromthose statements. Those risks and uncertainties include, but are not limited to, our ability to accesscapital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals andother risks detailed from time to time in our ongoing quarterly and annual filings. The forward-lookingstatements in this presentation are also based on a number of assumptions which may prove to beincorrect.

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 as required under applicable securities legislation.

Investors are cautioned not to rely on these forward-looking statements and are encouraged to readBriaCell’s continuous disclosure documents, including its financial statements which are available onSEDAR at www.sedar.com.

(TSXV:BCT, OTCQB: BCTXF) 2

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

▪ Impressive results in 2 completed proof-of-concept human clinical trials:➢ Rapid Response Rate; Successful retreatment following a relapse➢ Excellent Safety Profile (only ~20% with injection site rash)

▪ Bria-IMT™ has completed Phase I clinical trial with topline safety data➢ Currently enrolling in Phase IIa trial with roll-over into Keytruda® & Yervoy® combos

▪ Bria-OTS™ is currently in development along with BriaDX™, its companion diagnostic test➢ Ability to match and treat ~90% of the advanced breast cancer population with Off-the-Shelf

personalized immunotherapy cell lines

▪ Experienced Management has been involved in over 10 drug approvals

▪ Significant Near-Term News-flowKeytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Yervoy® is a registered trademark of Bristol-Myers Squibb Company


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(TSXV:BCT, OTCQB: BCTXF) 4

Prior Affiliations

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 Therapeutics, Dir. of Corp. Development,

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

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, Los Angeles

William V. Williams, MD, FACP, President & CEO▪ VP, Exploratory Development, Incyte Corporation▪ VP, Experimental Medicine, GlaxoSmithKline▪ Head, Rheumatology Research, University of Pennsylvania (TSXV:BCT, OTCQB: BCTXF) 5

Prior Affiliations

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


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’sown weakened immune system to kill the tumor.

▪ Therapeutic Cancer Vaccines: Off-the-Shelf therapeutic cancer vaccines have not been successful in solidtumors or blood cancers as they are not specific enough 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 Solutions▪ BriaCell’s Off-the-Shelf Personalized Immunotherapy: Bria-OTS™ consists of 15 individually pre-

manufactured genetic alleles. BriaCell’s BriaDX™ companion diagnostic reveals a patient’s specific HLA-types and the 2 best matching alleles are administered to the patient. BriaCell’s 15 alleles (8 Class I and 7Class II) cover/match with approximately 90% of the Breast Cancer population while eliminating thecomplex manufacturing logistics required for other personalized immunotherapies.


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


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

3) Bria-IMTTM directly stimulatescancer fighting CD4+ and CD8+ Tcells (unique to Bria-IMTTM)

1) Bria-IMTTM producesbreast cancer antigenswhich are taken up bydendritic cells and“presented” to CD4+ andCD8+ T cells implicatedin tumor destruction.

92) Bria-IMTTM secretes GM-CSF which further promotesdendritic cell-based antigen presentation (boosts the response)

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™



▪ 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


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 11:01 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 -

Proof-of-Concept Results Resulted in BriaCell’s Immunotherapy Strategy:➢ Use BriaDX™ diagnostic to select only those patients matching Bria-IMT™➢ Use BriaDX™ diagnostic 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 metastasesin 2010, and lung metastases in 2017. Previously treated with 7 rounds of chemotherapy with 8different chemotherapy agents. Received 5 cycles of Bria-IMT™ over 3 months, then monthly cycles (6months total). Evaluated after 3 months and 6 months. After 3 months, despite the extensive priortherapy, her scans noted that, “there has been a clear response in the multiple bilateral pulmonarynodules”. The response was maintained 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 11:01 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 -


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

Pre-Treatment Post-Treatment











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 Detectable

0 5 0 1 0 0 1 5 0

0

5 0

1 0 0

1 5 0

2 0 0

2 5 0

D a y s fro m L a u n c h o f B r ia -IM T T re a tm e n t

CD

40

L L

ev

els

(p

g/m

L)

0 5 0 1 0 0 1 5 0

0

1 0 0

2 0 0

3 0 0

4 0 0

D a y s fro m L a u n c h o f B r ia -IM T T re a tm e n t

CD

40

L L

ev

els

(p

g/m

L)

Proposed Diagnostic TestBiomarker sCD40L Points to Clinical Response (Preliminary)

Tumor Regression – Treatment Series I

4 months to restart of treatment

sCD40L Levels During TreatmentSeries-I

Tumor Re-Regression – Treatment Series II

sCD40L Levels During Re-TreatmentSeries-II

➢ Use of sCD40L Biomarker could provide an early indication of a patient’s response (TSXV:BCT, OTCQB: BCTXF) 19

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™


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 Immunotherapy

▪ Bria-OTS™ expresses both GM-CSF and interferon-α PLUS patient-specific matchingHLA 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 concept

▪ Eventually will be able to cover remaining 10%

▪ Using the BriaDX™ companion diagnostic, the off-the-shelf alleles will be matched andselected for each 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

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%), Yervoy® if PD-L1/2 negative (≤1%)➢ Initially accepting patients from the monotherapy study who develop progressive disease➢ Potential to enroll patients directly into this study, with a monotherapy run-in, to enhance

experienced 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-develop BriaDX™ companion diagnostic for HLA typing▪ Rollover combination therapy clinical trial with immune checkpoint inhibitors for non-responders using

information from the Bria-IMT™ Combination Therapy Study


Bria-IMT™

✓ Q2 2018: Published Paper Detailing Mechanism of Action

✓ Q2 2018: Presentation at AACR

✓ Q2 2018: Abstract - ASCO

❑ Q3 2018: Data on first 12 Patients

❑ Q3 2018: Initiate Combo Therapy with Checkpoint Inhibitor

❑ H2 2018: Corporate Partnership/Collaboration

❑ H2 2018: Data on Combo Therapy with Checkpoint Inhibitor

❑ H2 2018: Switch to novel frozen Bria-IMT™ formulation

❑ Q4 2018: San Antonio Breast Cancer Meeting Presentation

Milestones

Bria-OTS™

✓ Q1 2018: Knock-out of endogenous HLA-A

❑ Q3 2018: Knock-out of endogenous HLA DRB3/4/5

❑ Q3 2018: Re-insertion of HLA-A, -DRB3/4/5

❑ Q3 2018: Insertion of GM-CSF, interferon-α2b

❑ Q4 2018: MCBs of HLA-expressing clones

❑ Q1 2019: WCBs of HLA-expressing clones

❑ Q2-3 2019: CMC Amendment Accepted by FDA

❑ Q3 2019: 1st Patient Dosed

NOTE: Red bullet points indicate potential press releases (TSXV:BCT, OTCQB: BCTXF) 24

Milestones (Continued)

❑ Q3 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 (Submission Q3, 2018)

❑ Q1 2019: Lead Candidate Selection for PKCδ Program

❑ Q3 2019: PCT Patent Application (Bria-IMT™/OTS™)

(TSXV:BCT, OTCQB: BCTXF) 25NOTE: Red bullet points indicate potential press releases

Development Timeline – Breast Cancer


20192018 2020 2021

Currently Enrolling Phase IIaBria-IMT™ Monotherapy (1Q18 → 2Q20)

Currently Enrolling Phase IIBria-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

(2Q19 → 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

Note: Both Checkpoint Inhibitors and CAR-T immunotherapies received FDA accelerated approvals based on Phase II Data (3Q → 3Q23)

Ongoing Bria-IMT™ Phase IIa Monotherapy Trial

Currently Recruiting:

▪ Up to 40 stage-IV breastcancer patients

▪ Primary objectives: Safety& tumor response

▪ Exploratory objectivesinclude immune responseto tumor, biomarkers,Quality of Life


Rollover Checkpoint Inhibitor

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Yervoy® is a registered trademark of Bristol-Myers Squibb Company

Currently Recruiting:

▪ Treatment in combination with Keytruda®for PD-L1(+) or PD-L2(+) tumors q3wks x upto 24 cycles, then Bria-IMT™ alone q3wks

-OR-

▪ Treatment in combination with Yervoy ® forPD-L1/2(-) tumors q3wks x 4 cycles, thenBria-IMT™ alone q3wks

▪ Imaging every 8-12 weeks


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 RAStransformed 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 mousestudies.

▪ PKCδ inhibitors should qualify for an accelerated clinical development plan andregulatory pathway.

▪ Could be in clinic within 24 months.

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

Early-Stage Preclinical Program


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

▪ Impressive results in 2 completed proof-of-concept human clinical trials:➢ Rapid Response Rate; Successful retreatment following a relapse➢ Excellent Safety Profile (only ~20% with injection site rash)

▪ Bria-IMT™ has completed Phase I clinical trial with topline safety data➢ Currently enrolling in Phase IIa trial with roll-over into Keytruda® & Yervoy® combos

▪ Bria-OTS™ is currently in development along with BriaDX™, its companion diagnostic test➢ Ability to match and treat ~90% of the advanced breast cancer population with Off-the-Shelf

personalized immunotherapy cell lines

▪ Experienced Management has been involved in over 10 drug approvals

▪ Significant Near-Term News-flow

(TSXV:BCT, OTCQB: BCTXF) 30Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Yervoy® is a registered trademark of Bristol-Myers Squibb Company

Share Metrics


Insiders Share Ownership (Mil) Share Ownership

Saeid Babaei, PhD, MBA 0.5 0.3%

Charles Wiseman, MD 13.4 8.5%

Rahoul Sharan, CA 1.8 1.1%

William V. Williams, MD 6.3 4.0 %

Total 22.0 13.9 %

Capital Raises (in Mil CAD$)

2014 2015 2016 2017 2018

2.2M --- 3.0M 2.0M 5.3M*

Ticker: TSX: BCT.V

US Ticker: OTCQB:BCTXF

Share Price (CAD) as of July 10, 2018 $0.15

52-Week Range (CAD) $0.09-0.19

Shares Outstanding as of July 10, 2018 157.8M

Market Cap as of July 10, 2018 (CAD) $23.7M

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, 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

Comparable Valuations

BriaCell Has Significantly Lower Enterprise Value vs Peers


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 138.3 2.82 390.1 8.3 308.4 90.0 83%

Aduro BioTech, Inc. (ADRO) Immuno-oncology Ph I/II 78.7 7.03 553.1 225.8 330.8 448.1 97%

Aileron Therapeutics, Inc. (ALRN) Immuno-oncology Ph I/IIa 14.7 4.96 73.1 4.9 45.7 32.3 52%

BioXcel Therapeutics, Inc. (BTAI) Immuno-oncology & Therapeutics Ph Ib 15.7 11.85 185.5 4.2 56.3 133.4 88%

Dynavax Technologies (DVAX) Immuno-oncology & Therapeutics Ph II/III 62.3 15.10 940.3 129.4 255.4 814.3 98%

Five Prime Therapeutics, Inc. (FPRX) Immuno-oncology & Oncology Ph II 35.2 17.23 606.7 74.2 403.0 277.9 94%

Genprex, Inc. (GNPX) Immunogene therapy Ph II 13.9 8.00 111.2 1428.3 58.4 1481.1 99%

Heat Biologics, Inc. (HTBX) Immuno-oncology Ph II 20.8 2.34 48.7 13.6 10.6 51.7 70%

Neon Therapeutics (NTGN) Immuno-oncology Ph I Ph I 28.2 12.70 358.1 0.0 162.0 196.1 92%

Immune Design Corp. (IMDZ) Immuno-oncology (breast cancer) Ph I Ph II 48.1 4.75 228.6 6.4 135.3 99.6 84%

Immunovaccine Inc (IMV.TO) Immuno-oncology (breast cancer) Ph II 44.9 4.86 218.0 7.8 19.9 205.8 92%

Infinity Pharmaceuticals, Inc. (INFI) Immuno-oncology (breast cancer) Ph Ib Ph Ib 56.1 2.00 112.1 4.6 49.1 67.6 77%

Leap Therapeutics, Inc. (LPTX) Immuno-oncology & Therapeutics Ph II 14.7 8.13 119.5 22.6 38.1 104.0 85%

Loxo Oncology, Inc. (LOXO) Immuno-oncology (breast cancer) Ph II Ph II 30.1 181.00 5444.5 364.2 747.0 5061.6 100%

Rexahn Pharmaceuticals, Inc. (RNN) Oncology (breast cancer) Ph II Ph II 31.7 1.55 49.2 7.6 21.2 35.6 56%

TapImmune Inc. (TPIV) Immuno-oncology (breast cancer) Ph II Ph II 12.8 9.38 119.8 2.3 65.9 56.2 72%

Average 597.4 572.2 84%

BriaCell

(TSX: BCT.V; OTCQB: BCTXF)

Immuno-oncology (breast cancer) Ph I/IIa 157.8 0.11 18.0 1.0 3.3 15.6

Data as of 7/11/2018

Immuno-oncology Deals

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


Date Partnership

Development stage at the time of

the deal Deal size07/12/2018 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

OTCQB: BCTXFTSX-V: BCT

Investor PresentationJuly 2018

The Future of Cancer Immunotherapy

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

Appendix

35

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


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


▪ 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


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)


Documents

The Future of Cancer Immunotherapybriacell.com/wp-content/uploads/2018/07/BriaCell... · 2019-03-05 · Therapies, HemaQuest, Arch Therapeutics and Cetya Therapeutics Thomas Kieber-Emmons,