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Transcript of one Target: Hope™s21.q4cdn.com/.../Medicenna-Corporate-Presentation... · Primary Efficacy...
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one Target: infinite Hope™Corporate Presentation
Q3, 2017
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Forward Looking Statements
Certain statements in this presentation are “forward-looking statements. Any statements that express or involve discussions with
respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often,
but not always using words or phrases such as “expect”, “seek”, “endeavour”, “anticipate”, “plan”, “estimate”, “believe”, “intend”,
or stating that certain actions, events or results may, could, would, might or will occur or be taken, or achieved) are not
statements of historical fact and may be “forward-looking statements”. Forward-looking statements are based on expectations,
estimates and projections at the time the statements are made that involve a number of risks and uncertainties which would
cause actual results or events to differ materially from those presently anticipated. Forward-looking statements are based on
expectations, estimates and projections at the time the statements are made and involve significant known and unknown risks,
uncertainties and assumptions. A number of factors could cause actual results, performance or achievements to be materially
different from any future results, performance or achievements that may be expressed or implied by such forward-looking
statements. These include, but are not limited to, the risk factors discussed in the public filings made by Medicenna with the
applicable securities commissions in Canada, including the Annual Information Form dated June 15, 2017. Should one or more
of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect,
actual results, performance or achievements could vary materially from those expressed or implied by the forward-looking
statements contained in this document. These factors should be considered carefully and prospective investors should not place
undue reliance on these forward-looking statements. Although the forward-looking statements contained in this document are
based upon what Medicenna currently believes to be reasonable assumptions, Medicenna cannot assure prospective investors
that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by
law, Medicenna does not have any obligation to advise any person if it becomes aware of any inaccuracy in or omission from
any forward-looking statement, nor does it intend, or assume any obligation, to update or revise these forward-looking
statements to reflect new events or circumstances.
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Medicenna: Corporate Highlights
➢ Publicly listed (TSXV: MDNA), clinical-stage, immuno-oncology company
developing a novel therapy targeting the Interleukin-4 Receptor (IL4R) biomarker
➢ Every year >1 million cancer patients afflicted with IL4R tumors1
➢ MDNA55 (lead): highly compelling, Phase II clinical data for recurrent
glioblastoma (rGB), the most common and aggressive form of brain cancer
➢ MDNA55 market opportunity: $650 million in annual sales for rGB; >$2 billion
including other brain cancers1,2
➢ MDNA55 has Orphan Drug (FDA, EMA) & Fast Track Designations (FDA)
➢ Exciting pre-clinical IL-2, IL-4 and IL-13 Superkine platform
➢ Well funded with $14M US non-dilutive grant and $14M CAD Private Placement
➢ Seasoned management with technology platform protected by 12 patent families
1. BioXcel Strategic Analysis Report, 2014.2. Decision Resources, Inc Glioblastoma Report, Sept 2013
3
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Treatment Pathway for Glioblastoma (GB)
Surgery
(85-90%)GB
Diagnosis
Radiotherapy
+
Chemotherapy
Relapse
Chemotherapy
Surgery MDNA55 Treatment(Direct infusion into tumor - CED)
Add’l Chemo.or
Experimental
Therapies
GB is uniformly fatal; virtually all tumors will recur (rGB)
55% of GB
Chemo.
Resistant*
* Expression of the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT) is
responsible for resistance to alkylating agents used in GB treatment.
25%
75% of rGB is non-operable
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MDNA55: Targeted Dual-Action
ImmunotherapeuticA Powerful Molecular Trojan Horse
➢ Potently toxic to tumor cells with a wide therapeutic window
➢ Simultaneously purges the Tumor Microenvironment (TME) and un-blinds the
immune system to cancer cells
➢ Proven payload efficacy– identical to Medimmune’s anti-CD22 immunotoxin,
Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia1
➢ Reliable, cost-efficient fermentation-based manufacture
1 https://www.medimmune.com/our-therapy-areas/oncology.html
PE AAs 253-364, 381-608
Tumor Targeting Domain Tumor Killing “Cytotoxic” Domain
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MDNA55: Brain Cancer Market Opportunity
Tumor Type Annual Incidence Projected Market
Recurrent Glioblastoma
(rGB)33,3001 $650M2
Metastatic Brain Cancer 91,5003 $1.30B4
Pediatric Glioma 3,8001 $50M4
TOTAL 133,500 $2.0B
1. Decision Resources Glioblastoma Report, Sept 2013
2. Assumes peak sales for rGB monotherapy and combination therapy at $43K per patient – BioXcel Strategic Analysis Report, 2014
3. Breast, Colon and Kidney Cancer Metastasis to Brain – BioXcel Strategic Analysis Report, 2014
4. Assumes 33% treatable with MDNA55 and priced at $43K per patient - BioXcel Strategic Analysis Report, 20146
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Current Therapies Do Not Address
Key Challenges
Therapeutic Challenges Rationale for MDNA55
➢ 55% of GBs are chemo-resistant 1
➢ Immunosuppressive tumor
microenvironment (TME)
comprises 40% of GB tumor mass 2
➢ Blood Brain Barrier (BBB) blocks
transport of therapeutic to tumor
➢ High doses are required due to
BBB causing systemic toxicities
➢ MDNA55 targets resistant tumors3
➢ IL4R over-expressed in GB and its
TME (Myeloid Derived Suppressor
Cells) but not in normal brain 4
➢ Delivery by direct injection (CED) of
MDNA55 by-passes the BBB
➢ Precision delivery achieves high
doses without systemic exposure
1. Hegi ME (2005). N Engl J Med;352(10):997-1003.
2. Kennedy B, et al (2013). J Oncol. Vo; 2013: 486912.
3. Shimamura, et al.(2007.Cancer Res;67:9903-9912.
4. Kohanbash et al (2013).Cancer Res.;73(21):6413-237
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Compelling Efficacy in Non-Resected rGB
(n=25)
Pre-treatment 9 months
Pre-treatment Week 26
Complete
Response
(CR): 5/25
Partial
Response
(PR): 9/25
High
Objective
Response
Rate
8
Kawakami, et al (2003)
Interleukin-4-Pseudomonas exotoxin chimeric fusion protein
for malignant glioma therapy
Journal of Neuro-Oncology Vol 65 p 15-25
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MDNA55: Clinical EfficacyLong Term Survival Results Consistent With Immunotherapy
Benefits
Superior Long Term Survival When Compared to Avastin Despite Poorer Patient Population (N =57)
0 300 600 900 1200 15000
50
100
Days
Pe
rce
nt s
urv
iva
l
Non-Resectable Recurrent GBM:Survival of Responders vs Non Responders
Responders (CR + PR): MS = 379 days (n=14)
Non-Responders (SD + PD) MS = 98 days (n=11)
9
SD – Stable disease
PD – Progressive disease
Investigators Brochure (page 82)
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2nd Generation Infusion Will Improve Outcomes
Images courtesy of John Sampson, Duke University
• Inaccurate catheter
placement
• Drug leakage due to
backflow
• Inadequate tumor
coverage
• Image-guided
catheter placement
• New catheters
prevent backflow
• Real-time monitoring
ensures tumor
coverage
Real-Time
Monitoring
of Drug
Distribution
1st Generation CED: Past Studies 2nd Generation CED: Future Studies
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
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Open-Label Single Arm Study in 43 PatientsPrimary Objectives:
ORR
SECONDARY
OBJECTIVES:MOS
Safety
PFS-6
TERTIARY
OBJECTIVES:Correlate IL4R
Expression with Efficacy
DIAGNOSIS ONE TREATMENT FOLLOW-UP
1 2 3 4
PLANNING
11
Phase 2b Study Design SummaryCED Of MDNA55 in IL4R Up-Regulated GB Patients At First Relapse (COUGAR)
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Efficacy AnalysisStatistical Design and Sample Size
Primary Endpoint: Objective Response Rate (ORR) per modified RANO (Response
Assessment for Neuro-Oncology) Criteria relative to pre-treatment baseline in adult subjects
with GB that has recurred or progressed following standard therapy
Test Hypothesis: Null hypothesis that ORR is 6% (kill) versus the alternative hypothesis
(pursue) that ORR is 18% following treatment with MDNA55. Assumptions regarding primary
end point are based on ORR from previous rGB studies1
Primary Efficacy Analysis: Assessed according to a single-arm, single-stage binomial
design at 1-sided alpha = 0.10. A total of 43 Subjects will provide 80% power.
121 Levin VA, Tonge PJ, Gallo JM, et al. CNS Anticancer Drug Discovery and Development Conference White Paper. Neuro-Oncology, v17:1–26, 2015
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13
US Sites Participating in the Study
OSU (Columbus, OH)
Cleveland Clinic (Cleveland,
OH)
Weill Cornell +
MSKCC
(New York, NY)
Duke
(Durham, NC)
UT Southwestern (Dallas, TX)
UT San Antonio (San Antonio, TX)
UCSF
(San Francisco, CA)
JWCI
(Santa Monica, CA)
Marcus Neuroscience
Institute
(Boca Raton, FL)
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Future Indications: 1 Million IL4R Cancers Annually>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression1-14
78%
B-Cell CLL
67%
Hodgkins Lymphoma
56%
Biliary Tract
73%
Bladder
82%
Breast
89%
Colorectal
75%
Head and Neck
79%
NSCLC
96%
Mesothelioma
60%
Ovarian
60%
Pancreatic
91%
Anaplastic Thyroid
1. BioXcel Strategic Analysis Report, 20142. Ishige et al (2008); Int J Cancer;123(12):2915-22.3. Joshi et al (2014 Cancer Med. 3(6):1615-28.4. P. Leland, et al (2000) Mol Med; 6(3): 165–178.5. Koller , et al (2010); Carcinogenesis 31(6), 1010-17
6. Strome SE, et al (2002).Clin Cancer Res.n;8(1):281-6.7. Puri, et al (1996). Cell Immunol.10;171(1):80-6.8. Kawakami, et al (2005) Blood; 105(9): 3707–3713.9. Kay, et al (2005) Leuk Res.;29(9):1009-18.10. Kawakami, at al (2002). Clin Cancer Res.;8(11):3503-11.
11. Burt, et al (2012) Clin Cancer Res;18(6):1568-7712. Kioi, et al (2005) Cancer Res;65(18):8388-9613. Kawakami et al (2002) Cancer Res.;62(13):3575-80.14. Joshi et al (2015) Discov. Med.;20(111):273-84.
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IL-2 Superkines: Tunable Immune Modulators
15
Secured Exclusive World Wide Rights from Stanford University
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TARGET AND
MECHANISMCANDIDATE
POTENTIAL
INDICATION(S)
MDNA109 IL-2 Super-
Agonist
Cancer
Immunotherapy
Autoimmune
Diseases
IL-2 Super-
AntagonistMDNA209
Solid Tumors
Respiratory,
Fibrotic and
Atopic
Diseases
IL4/13 Dual
Super-
Antagonist
MDNA413
RECENT TRANSACTIONS DEAL SIZE
$2 Billion
with $60M
Upfront
UNDISCLOSED
$775M with
$300M
Upfront
UNDISCLOSED
Deep Early Stage PipelineTargets Validated by Multiple Big Pharma Transactions
16
$400M with
$150M
Upfront
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Combination Therapy Produces Robust Responses
➢ MDNA109 and anti-PD-1 produce limited efficacy alone
➢ Combination treatment sufficient to cure most mice without increased toxicities
17
17
MDNA109 Synergizes With Anti-PD-1
Immunotherapy
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Multiple Near Term Value Inflection MilestonesPursue Accelerated Approval for rGB in 2018
Milestone Estimated Timing
Commenced Enrollment in Phase 2b rGB Trial
First Patient In - Phase 2b rGB Trial
Commence Phase 2 Metastatic Brain Cancer Trial Q4/2017
Complete Enrollment in Phase 2b rGB Trial Q4/2017
Report rGB Phase 2b Interim Top-Line Results Q1/2018
End of Phase 2 Meeting with FDA Q2/2018
Commence IND Enabling Studies with MDNA109 Q2/2018
Pursue Accelerated Approval for rGB Q3/2018
Report Interim Top-Line Results from P2 Metastatic Brain
Cancer Trial
Q3/2018
Commence IND Enabling Studies with MDNA57 Q4/2018
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USD$14M Non-Dilutive Grant Validates Platform
➢ Diligence by top-tier scientific, clinical, regulatory, chemistry
manufacturing and control, intellectual property & venture capital teams
➢ Solid third-party platform validation
➢ Funds MDNA55 Phase 2b rGB clinical development and next generation
pre-clinical IL-4 Empowered Cytokine program
➢ The USD$14.1M grant effectively provides 2:1 leverage on USD$7M
investment1
➢ Favorable grant repayment terms begin post-launch (low single digit
royalties to a maximum payment amount of 4 times the original grant)
1. http://www.cprit.state.tx.us/images/uploads/rfa-172-txco.pdf
Recipient of Cancer Prevention & ResearchInstitute of Texas (CPRIT) Grant
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Use of Cash Resources
21
Lead Programs Funded Through 2018
Cost Center Status by end of 2018Estimated Cost
(in Cdn)
MDNA55 Clinical Program
- Recurrent Glioblastoma (rGB)
- Metastatic Brain Cancer
Pursue Accelerated Approval
Top-line Phase 2 data
$ 14,300,000
MDNA57 and MDNA109 Pre-Clinical
Research
Complete PoC Studies: Ready for
IND Enabling Studies2,100,000
General and Administrative On-going 6,000,000
Total Projected Spend $22,400,000
Balance of Grant Revenue from CPRIT US$6.5million to be advanced (8,700,000)
Net Cash required $13,700,000
Cash available (as at 3/31/17)* $14,000,000
*As reported June 15, 2017
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Capitalization
22
Publicly Listed as of March 3, 2017
➢ Listed on the Toronto Stock Exchange Venture on March 3, 2017 at
$2.00 per share following a successful Reverse Takeover
➢ Trading under the Ticker “MDNA”
➢ Funded for two years with cash on hand and funds remaining to be
advanced under the CPRIT grant
Number
Issued and Outstanding 24,313,334
Fully Diluted* 28,899,096
* Fully diluted includes 3,294,105 warrants with a $2.00 exercise price
and 1,291,657 stock options with a weighted average exercise price of $1.97
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Medicenna Public Company Comparables
Company (Listing/Symbol) Price(03-Jul-2017)
Market
Cap (MM)
Enterprise
Value (MM)Lead Indication (Stage)
ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP)
US$6.15 $873.9 $936.8 Breast Cancer (PhII), Recurrent or Progressive
Glioblastoma (Ph I)(w/ CED*)
Agenus Inc. (NASDAQ:AGEN)
US$4.00 $396.5 $384.3 Newly Diagnosed Glioblastoma (Ph II)
Tocagen Inc.(NASDAQ:TOCA)
US$12.12 $240.1 $141.8 Recurrent High Grade Glioma (Ph II)
Stemline Therapeutics, Inc. (NASDAQ:STML)
US$9.25 $232.3 $142.7 Recurrent Glioblastoma (Ph II)
Newlink Genetics Corporation (NASDAQ:NLNK)
US$7.50 $219.2 $107.4 Malignant Brain Tumors (Ph II)
Kadmon Holdings, Inc. (NYSE:KDMN)
US$3.98 $206.4 $234.2 Recurrent Glioblastoma (Ph II)
Vascular Biogenics Ltd. (NASDAQ:VBLT)
US$4.50 $120.8 $81.2 Recurrent Glioblastoma (Ph III)
Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN)
US$2.40 $24.8 $15.0 Newly Diagnosed Glioblastoma (Ph II)
Average $289.2 $255.4
Median $225.8 $142.2
Medicenna Therapeutics1
(TSXV:MDNA)C$1.95 $36.5
(C$47.4M)$25.7 Recurrent Glioblastoma (Ph II)
(1) Medicenna market cap estimate based on current basic shares O/S and current share price. Enterprise value estimate based on net debt as of Mar. 31, 2017
Source: FactSet & Company filings23
All amounts in USD, unless noted otherwise
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Seasoned Management and Experienced BoardManagement Team
Fahar Merchant, PhD: Chairman, President & CEOFormer CEO Sophiris Bio (TSX); Former Director, President & CTO at
KS Biomedix (LSE); Founder, President & CEO of Avicenna Medica
and IntelliGene Expressions
Jay Stoudemire, PhD: Chief Scientific OfficerFormer VP Preclinical Development, Regulatory, and QA at Mirna
Therapeutics, previously at Genentech, Ascenta, Chugai-Roche, Cytel,
Genetics Institute, and Xoma
Elizabeth Williams, CPA,CA: Chief Financial OfficerFormer VP Finance & Admin and interim CFO at Aptose (TSX and Nasdaq); Previously with Ernst & Young
Martin Bexon, MD: Head of Clinical DevelopmentFormer Medical Director at CSL Behring; Medical Director at Hoffman La Roche (UK and Switzerland)
Nina Merchant, MESc.: Chief Development OfficerFormer SVP Development at Sophiris Bio; Formerly VP Development
at KS Biomedix (LSE); Previously at Avicenna Medica, IntelliGene,
Pharmacia and Sanofi Pasteur
Patrick Ward, MBA: Chief Operating Officer Former COO of Aviara Pharma; President/COO at Ocusoft, Executive
Director at Encysive Pharma
Shafique Fidai, PhD: Head of Corp DevelopmentFormer VP of Business Development at Sophiris Bio; Formerly with
Xenon Pharma, Chromos
Board of Directors
Fahar Merchant, PhD
Chairman, President & CEO
Albert Beraldo, CPA, CA
Independent Director
Founder, President and CEO of Alveda Pharmaceuticals until its
acquisition by Teligent, Inc. (NASDAQ: TLGT); Former President
and CEO of Bioniche (TSX) and Director of Telesta (TSX); Currently
Independent Director of Helix Biopharma (TSX).
Chandra Panchal, PhD
Independent DirectorFounder, Chairman and CEO of Axcelon; Former Co-Founder, President, and CEO of Procyon Biopharma Inc (TSX); Former Senior Executive VP of Business Development at Ambrilia Biopharma Inc. (TSX)
Andrew Strong, JDIndependent DirectorPartner at Pillsbury Winthrop Shaw Pittman - leading the Life Sciences Team in Houston, TX. Formerly General Counsel and Compliance Officer for the Texas A&M University System. Led formation of bio-manufacturing company, Kalon Biotherapeutics; CEO of Kalon until its sale to FujiFilm Diosynth Biotech. Director of Ashford Hospitality Prime (NYSE)
Nina Merchant, M.E.Sc
Director, Chief Development Officer
16
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World Class Advisors and Collaborators
Collaborators & InventorsClinical & Scientific Advisors
John Sampson, MD, PhD, MBA
Duke University: Principal Investigator and Expert in Drug Delivery to the Brain
Sam Denmeade, MD Johns Hopkins University:
Professor of Oncology: Targeted therapies for cancer
Nicholas Butowski, MD
UCSF:Principal Investigator; Novel therapies for brain cancer
Guido Kroemer, MD, PhD
University of Paris:Chair: SAB and Expert in Cancer Immunotherapy
Ralph Smalling, MSc
Regulatory Advisor: Former VP Regulatory Affairs at Amgen; Filed 40 INDs; 5 NDAs
Michael Rosenblum, PhD MD Anderson Cancer CenterHead, Immunopharmacology and Targeted TherapyCollaborator: MDNA57
Raj Puri, MD
USFDADirector at CBER
Inventor of MDNA55
Aaron Ring, MD, PhD
Yale UniversityAsst. Prof Immunobiology & Cancer Biology
Co-Inventor of IL-2 Superkines
Chris Garcia, PhDStanford UniversityCo-Inventor of IL-2, IL-4 and IL-13 Superkines
Haya Loberboum Galski. PhD
Hebrew University of JerusalemInventor of Fully Human Payloads
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Medicenna: Corporate Highlights
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Thank Youone Target: infinite Hope™
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