Medicenna corporate presentation renmark fm printable

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One Target. Infinite Hope Corporate Presentation Fall 2017 1 TSX: MDNA

Transcript of Medicenna corporate presentation renmark fm printable

Page 1: Medicenna corporate presentation renmark fm printable

One Target. Infinite Hope™…

Corporate PresentationFall 2017

1TSX: MDNA

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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

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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

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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

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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

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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

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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

100

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)

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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)

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One Target. Infinite Hope™…

Thank You.Fahar Merchant, PhD Chairman, President & [email protected]