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One Target. Infinite Hope™…
Corporate PresentationFall 2017
1TSX: MDNA
One Target. Infinite Hope™…TSX: MDNA
Certain statements in this presentation are “forward-looking statements. Any statements that express or involve discussionswith respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events orperformance (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 betaken, 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 thatinvolve a number of risks and uncertainties which would cause actual results or events to differ materially from thosepresently anticipated. Forward-looking statements are based on expectations, estimates and projections at the time thestatements are made and involve significant known and unknown risks, uncertainties and assumptions. A number offactors 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 arenot limited to, the risk factors discussed in the public filings made by Medicenna with the applicable securities commissionsin Canada, including the Annual Information Form dated June 15, 2017. Should one or more of these risks or uncertaintiesmaterialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performanceor achievements could vary materially from those expressed or implied by the forward-looking statements contained in thisdocument. These factors should be considered carefully and prospective investors should not place undue reliance onthese forward-looking statements.
Although the forward-looking statements contained in this document are based upon what Medicenna currently believes tobe reasonable assumptions, Medicenna cannot assure prospective investors that actual results, performance orachievements will be consistent with these forward-looking statements. Except as required by law, Medicenna does nothave any obligation to advise any person if it becomes aware of any inaccuracy in or omission from any forward-lookingstatement, nor does it intend, or assume any obligation, to update or revise these forward-looking statements to reflect newevents or circumstances.
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Forward Looking Statements
One Target. Infinite Hope™…TSX: MDNA
1 Million cancer patients annually diagnosed with tumors with the Interleukin-4 Receptor (IL4R)
MDNA55: Compelling, Phase 1 and 2 clinical data (N=66) for recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer
MDNA55 has Orphan Drug (FDA, EMA) & Fast Track Designations (FDA)
Currently enrolling in a Phase 2b recurrent GBM trial at 9 centers in the U.S.
Exciting pre-clinical IL-2, IL-4 and IL-13 Superkine platform
Technology platform protected by 13 patent families
Well funded with $14M US non-dilutive grant and $14M CAD Private Placement
cGMP compliant commercial scalemanufacturing process established
Seasoned management, advisors and directors
Corporate HighlightsPublicly listed (TSX: MDNA), clinical-stage, immuno-oncology company
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One Target. Infinite Hope™…TSX: MDNA
Treatment Pathway for Glioblastoma (GBM)
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Surgery(85-90%)
GBM Diagnosis
Radiotherapy+ Chemotherapy
Relapse
Chemotherapy
GBM is uniformly fatal; virtually all tumors will recur (rGBM)
55% of GBM Chemo-Resistant*
* Expression of the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT) is responsible for resistance to alkylating agents used in GBM treatment.
MDNA55 Treatment(Direct infusion into tumor - CED)
NON-OPERABLE rGBM
75%
Surgery Add’l Chemotherapyor Experimental Therapies
25%
OPERABLE rGBM
One Target. Infinite Hope™…TSX:MDNA
MDNA55 Targeted Dual-Action Immunotherapeutic
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A Powerful Molecular Trojan Horse
Tumor Targeting DomainCircularly Permuted
Interleukin-4 (cpIL-4)
Tumor Killing “Cytotoxic” DomainCatalytic domain of Pseudomonas Exotoxin A (PE)
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 Leukemia
One Target. Infinite Hope™…TSX:MDNA
Mechanism of Action of MDNA55
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MDNA55
NUCLEUS
Efficient intracellular delivery of Toxin
Payload
ADP Ribosylation
Endocytosis
Inhibits Protein Synthesis - Apoptosis
One Target. Infinite Hope™…TSX: MDNA
Compelling Efficacy in Non-Resected rGBM(n=25)
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Pre-treatment 9 months Pre-treatment Week 26
Complete Response (CR): 5/25
Partial Response(PR): 9/25
High Objective Response Rate
Kawakami, et al (2003)Interleukin-4-Pseudomonas exotoxin chimeric fusion protein for malignant glioma therapy Journal of Neuro-Oncology Vol 65 p 15-25
One Target. Infinite Hope™…TSX:MDNA
MDNA55 Survival Results Consistent with Immunotherapy Benefits
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MDNA55 Overall Survival in Non-Resectable (Phase 1 - Blue) and Resectable (Phase 2 - Red) rGBM
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Perc
entS
urvi
val
Non-Resectable Recurrent GBM: Survival of Responders vs Non Responders
0 300 600 900 1200 1500
0
Days
Responders (CR +PR): MS =379 days (n=14)
Non-Responders (SD +PD) MS= 98 days (n=11)
SD –Stable diseasePD –Progressive diseaseInvestigators Brochure (page 82)
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Log-Rank test p-value is 0.9430 (N=57)
One Target. Infinite Hope™…TSX: MDNA
2nd Generation Infusion Will Improve Outcomes
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Images courtesy of John Sampson, Duke University
Inaccurate catheter placement
Drug leakage due to backflow
Inadequate tumor coverage
1st Generation CED: Past Studies
Image-guided catheter placement
New catheters prevent backflow
Real-time monitoring ensures tumor coverage
2nd Generation CED: Future Studies
Real-Time Monitoring of Drug Distribution
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
One Target. Infinite Hope™…TSX:MDNA
US Sites Participating in the Study
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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)
One Target. Infinite Hope™…TSX:MDNA
MDNA55 Brain Cancer Market Opportunity
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Tumor Type Annual Incidence Projected Market
Recurrent Glioblastoma (rGB) 33,300 $650M
Metastatic Brain Cancer 91,500 $1.30B
Pediatric Glioma 3,800 $50M
TOTAL 133,500 $2.0B
One Target. Infinite Hope™…TSX: MDNA
Future Indications: 1 Million IL4R Cancers Annually
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B-Cell CLL
78%Bladder
73%
Head and Neck
60%Pancreatic
60%Anaplastic Thyroid
91%
67%Hodgkins
Lymphoma
>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression
NSCLC
79%
Biliary Tract
56%
Breast
82%
Mesothelioma
96%
89% 75%Colorectal
Ovarian
One Target. Infinite Hope™…TSX: MDNA
Deep Early Stage Pipeline
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Candidate
Targets Validated by Multiple Big Pharma Transactions
Potential Indications Deal SizeTarget and
MechanismRecent Transactions
MDNA413
MDNA109
MDNA209
IL4/13 Dual Super-
Antagonist
IL2 Super-Agonist
IL2 Super-Antagonist
Solid Tumors, Respiratory, Fibrotic and
Atopic Diseases
Autoimmune Diseases
Cancer Immunotherapy
$2 Billion with $60M
Upfront
$775M with $300M Upfront
Undisclosed
Undisclosed
$400M with $150M Upfront
One Target. Infinite Hope™…TSX:MDNA
MDNA109 Synergizes With Anti-PD-1 Immunotherapy
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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
One Target. Infinite Hope™…TSX: MDNA
Recurrent GBM
Brain Metastasis
Newly Diagnosed GBM (MGMT + VE)
Pediatric GBM &Medulloblastoma
Diffuse Intrinsic Pontine Glioma
Product Pipeline
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INDICATIONS
DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PIVOTAL
2017/2018 2018/2019Development Plans
CANDIDATE
MDNA55
MDNA109
MDNA413
Cancer Immunotherapies
Solid Tumors
MDNA132 Solid Tumors: IL13Ralpha2 CAR-T
One Target. Infinite Hope™…TSX:MDNA
Regulatory Approval Pathway
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Discovery
Pre-clinical
Phase 1
Phase 2
Phase 3
New Drug Application
Market Approval
Traditional regulatory pathway
Discovery
Pre-clinical
Phase 1/2a (66 Patients)
Complete
Accelerated pathway
2-4 years
1 year
2-3 years
1-3 years
2-3 years Complete
Complete
Phase 2b(52 Patients)
In progress –Complete Q1 2018
Breakthrough Therapy
Accelerated Approval
Apply in Q3 2018
Commence Rolling Submission in Q1 2019
Market Approval
1-2 years
Fast Track Status – Potential approval in 2019/202-3 years to market launch
8-17 years to market approval
2019 Potential Approval
One Target. Infinite Hope™…TSX:MDNA
Multiple Near Term Value Inflection Milestones
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Milestone Estimated Timing
Commenced Enrollment in Phase 2b rGBM Trial
First Patient In - Phase 2b rGBM Trial
Commence Phase 2 Trial in other types of Brain Cancer Q1/2018Complete Enrollment in Phase 2b rGBM Trial Q1/2018Report rGBM Phase 2b Interim Top-Line Results Q2/2018End of Phase 2 Meeting with FDA Q3/2018Commence IND Enabling Studies with MDNA109 Q3/2018Pursue Accelerated Approval for rGBM Q1/2019Report Interim Top-Line Results from P2 Brain Cancer Trial Q4/2018Commence IND Enabling Studies with MDNA57 Q1/2019
Pursue Accelerated Approval for rGBM in 2019
One Target. Infinite Hope™…TSX:MDNA
Seasoned Management & Experienced Board
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Management 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 IntelliGeneExpressions
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
Elizabeth Williams, CPA,CA Chief Financial OfficerFormer VP Finance & Admin and interim CFO at Aptose (TSX and Nasdaq); Previously with Ernst & Young
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 DirectorFounder, President and CEO of Alveda Pharmaceuticals until its acquisition by Teligent, Inc. (NASDAQ: TLGT); Former President and CEO of Bioniche (TSX).
William W. Li, M.D. Independent DirectorCEO, President and Co-Founder of the Angiogenesis Foundation. Executive strategic consultant to pharma in drug development and major investment banks. Director of Leap Therapeutics (NASDAQ)
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, JD Independent DirectorPartner at Pillsbury Winthrop Shaw Pittman - leading the Life Sciences Team in Houston, TX. Formerly CEO of KalonBiotherapeutics. Director of Ashford Hospitality Prime (NYSE)
Nina Merchant, M.E.ScDirector, Chief Development Officer
One Target. Infinite Hope™…TSX:MDNA
World Class Advisors and Collaborators
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Clinical & Scientific Advisors
John Sampson, MD, PhD, MBADuke UniversityPrincipal Investigator and Expert in Drug Delivery to the Brain
Sam Denmeade, MDJohn Hopkins UniversityProfessor of Oncology: Targeted therapies for cancer
Nicholas Butowski, MDUniversity of California San FranciscoPrincipal Investigator; Novel therapies for brain cancer
Guido Kroemer, MD, PhDUniversity of ParisChair: SAB and Expert in Cancer Immunotherapy
Ralph Smalling, MScRegulatory AdvisorFormer VP Regulatory Affairs at Amgen; Filed 40 INDs; 5 NDAs
Collaborators & Inventors
Michael Rosenblum, PhD MD Anderson Cancer CenterHead, Immunopharmacology and Targeted TherapyCollaborator: MDNA57
Raj Puri, MDUSFDADirector at CBERInventor of MDNA55
Aaron Ring, MD, PhDYale UniversityAsst. Prof Immunobiology & Cancer BiologyCo-Inventor of IL-2 Superkines
Chris Garcia, PhDStanford UniversityCo-Inventor of IL-2, IL-4 and IL-13 Superkines
Haya Loberboum Galski, PhDHebrew University of JerusalemInventor of Fully Human Payloads)
One Target. Infinite Hope™…TSX:MDNA
Financial Snapshot
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TSX: MDNA
Cash balance at June 30, 2017: CDN$12 million
Available to be drawn under CPRIT grant: US$6.5 million
Expected cash burn: CDN$1 million per month
Cash available to fund operations until Q1 2019
NumberIssued and Outstanding 24,344,048Fully Diluted* 29,024,096
* Fully diluted includes 3,294,105 warrants with a $2.00 exercise price and 1,382,143 stock options with a weighted average exercise price of $2.03
One Target. Infinite Hope™…TSX:MDNA
Medicenna Public Company Comparables
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(1) Medicenna market cap estimate based on current basic shares O/S and current share price. Enterprise value estimate based on net debt as of Jun. 30, 2017 Source: FactSet & Company filings
One Target. Infinite Hope™…22
Medicenna Corporate Highlights
1Focused on ONE
TARGET: the IL4R
20Number of Cancers
Known to Over-Express the IL4R
1 MillionAnnual Incidence of IL4R
Positive Cancers
40Number of Patents
Filed or Issued
250,000Annual Incidence of Glioblastoma and
Metastatic Brain Cancer
∞HOPE
10,000Brain Tumor Patients
that can be treated with 2 Grams of MDNA55
30+ MillionNon-Dilutive Grant and Equity
(funding in Cdn$)
2 BillionPotential Market of
MDNA55 Market for Brain Cancer ($US)
One Target. Infinite Hope™…
Thank You.Fahar Merchant, PhD Chairman, President & [email protected]