One Target: Infinite Hope™
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Corporate Presentation Q1 2018
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TSX: MDNA OTCQX: MDNAF
Forward Looking Statements Certain statements in this presentation - - PowerPoint PPT Presentation
One Target: Infinite Hope Corporate Presentation Q1 2018 TSX: MDNA OTCQX: MDNAF 1 Forward Looking Statements Certain statements in this presentation are forward-looking statements. Any statements that express or involve
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Corporate Presentation Q1 2018
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TSX: MDNA OTCQX: MDNAF
One Target. Infinite Hope™
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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
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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Forward Looking Statements
One Target. Infinite Hope™
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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 10 centers in the U.S. and Europe Exciting pre-clinical IL-2, IL-4 and IL-13 Superkine platform Technology platform protected by 13 patent families Lead program funded with $14M US non- dilutive grant and $14M CAD Private Placement cGMP compliant commercial scale manufacturing process established Seasoned management, advisors and directors
Corporate Highlights
Publicly listed (TSX: MDNA, OTCQX: MDNAF), clinical-stage, Immunotherapy company
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One Target. Infinite Hope™
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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)
INOPERABLE rGBM
75%
Surgery Add’l Chemotherapy
25%
OPERABLE rGBM
One Target. Infinite Hope™
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MDNA55
Targeted Dual-Action Immunotherapeutic
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A Powerful Molecular Trojan Horse
Tumor Targeting Domain
Circularly Permuted Interleukin-4 (cpIL-4)
Tumor Killing “Cytotoxic” Domain
Catalytic domain of Pseudomonas Exotoxin A (PE) Ø Potently toxic to tumor cells with a wide therapeutic window Ø Bypass the Blood Brain Barrier through localized Convection Enhanced Delivery (CED) Ø Simultaneously purges the Tumor Microenvironment (TME) and un-blinds the immune system to cancer cells Ø Proven payload efficacy– identical to Medimmune’s anti-CD22 immunotoxin, Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia
One Target. Infinite Hope™
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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™
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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™
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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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Percent Survival Non-Resectable Recurrent GBM: Survival of Responders vs Non Responders
300 600 900 1200 1500
Days Responders (CR +PR): MS= 379 days(n=14) Non-Responders (SD +PD) MS =98 days(n=11)
SD –Stable disease PD –Progressive disease Investigators Brochure (page 82)
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Log-Rank test p-value is 0.9430 (N=57)
One Target. Infinite Hope™
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2nd Generation Infusion Will Improve Outcomes
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Images courtesy of John Sampson, Duke University
Ø Inaccurate catheter placement Ø Drug leakage due to backflow Ø Inadequate tumor coverage
1st Generation CED: Past Studies
Ø Image-guided catheter placement Ø New catheters prevent backflow Ø Real-time monitoring ensures tumor coverage
2nd Generation CED: Future Studies
Real-Time Monitoring
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
Sampson et al, Congress for Neurosurgery, Oct 9-11, 2017
One Target. Infinite Hope™
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US Sites Participating in the Study
10 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™
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MDNA55 Brain Cancer Market Opportunity
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Tumor Type
Annual Incidence Projected Market
Recurrent Glioblastoma (rGBM) 33,300 $650M Metastatic Brain Cancer 91,500 $1.30B Pediatric Glioma 3,800 $50M TOTAL 133,500 $2.0B
One Target. Infinite Hope™
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Future Indications: 1 Million IL4R Cancers Annually
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B-Cell CLL
Bladder
Head and Neck
Pancreatic
Anaplastic Thyroid
Hodgkins Lymphoma
>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression
NSCLC
Biliary Tract
Breast
Mesothelioma
Colorectal Ovarian
One Target. Infinite Hope™
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Recurrent GBM Brain Metastasis Newly Diagnosed GBM (MGMT + VE) Diffuse Intrinsic Pontine Glioma
Product Pipeline
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INDICATIONS
DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PIVOTAL 2018 2019
Development Plans CANDIDATE MDNA55 MDNA109 MDNA413 Cancer Immunotherapies Atopic Dermatitis, Asthma, Fibrosis, Solid Tumors MDNA132 Solid Tumors: IL13Ralpha2 CAR-T MDNA209 Autoimmne diseases
One Target. Infinite Hope™
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Deep Early Stage Pipeline
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Candidate
Targets Validated by Multiple Big Pharma Transactions
Potential Indications Deal Size Target and Mechanism Recent 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™
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MDNA109 Synergizes With Anti-PD-1 Immunotherapy
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Combination Therapy Produces Robust Responses
Ø MDNA109 and anti-PD-1 produce limited efficacy alone Ø Combination treatment sufficient to cure most mice without increased toxicities
One Target. Infinite Hope™
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Multiple Near Term Value Inflection Milestones
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Milestone Estimated Timing Commenced Enrollment in Phase 2b rGBM Trial ü First Patient In - Phase 2b rGBM Trial ü Commence Phase 2a Trial in other types of Brain Cancer H1/2018 Complete Enrollment in Phase 2b rGBM Trial H1/2018 Report rGBM Phase 2b Interim Top-Line Results H2/2018 End of Phase 2 Meeting with FDA H2/2018 Commence IND Enabling Studies with MDNA109 H2/2018 Pursue Accelerated Approval for rGBM H1/2019 Report Interim Top-Line Results from P2 Brain Cancer Trial H1/2019
Pursue Accelerated Approval for rGBM in 2019
One Target. Infinite Hope™
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Financial Snapshot
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TSX: MDNA OTCQX:MDNAF Ø Cash balance at Sept 30, 2017: CDN$9.5 million Ø Available to be drawn under CPRIT grant: US$6.5 million Ø Expected cash burn: CDN$1 million per month Ø Lead program fully funded Number Issued and Outstanding 24,344,048 Fully Diluted* 29,595,296
* Fully diluted includes 3,294,105 warrants with a CND$2.00 exercise price and 1,957,143 stock options with a weighted average exercise price of CDN$2.00
One Target. Infinite Hope™
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Seasoned Management & Experienced Board
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Management Team
Fahar Merchant, PhD Chairman, President & CEO Former CEO Sophiris Bio (TSX); Former Director, President & CTO at KS Biomedix (LSE); Founder, President & CEO of Avicenna Medica and IntelliGene Expressions Martin Bexon, MD Head of Clinical Development Former Medical Director at CSL Behring; Medical Director at Hoffman La Roche (UK and Switzerland) Shafique Fidai, PhD Head of Corp Development Former VP of Business Development at Sophiris Bio; Formerly with Xenon Pharma, Chromos Elizabeth Williams, CPA,CA Chief Financial Officer Former VP Finance & Admin and interim CFO at Aptose (TSX and Nasdaq); Previously with Ernst & Young Nina Merchant, MESc. Chief Development Officer Former SVP Development at Sophiris Bio; Formerly VP Development at KS Biomedix (LSE); Previously at Avicenna Medica, IntelliGene, Pharmacia and Sanofi Pasteur
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).
William W. Li, M.D. Independent Director
CEO, President and Co- Founder of the Angiogenesis
strategic consultant to pharma in drug development and major investment banks. Director of Leap Therapeutics (NASDAQ)
Chandra Panchal, PhD Independent Director
Founder, 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 Director
Partner at Pillsbury Winthrop Shaw Pittman - leading the Life Sciences Team in Houston,
Ashford Hospitality Prime (NYSE)
Nina Merchant, M.E.Sc Director, Chief Development Officer
One Target. Infinite Hope™
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World Class Advisors and Collaborators
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Clinical & Scientific Advisors
John Sampson, MD, PhD, MBA Duke University
Principal Investigator and Expert in Drug Delivery to the Brain
Sam Denmeade, MD John Hopkins University
Professor of Oncology: Targeted therapies for cancer
Nicholas Butowski, MD University of California San Francisco
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
Collaborators & Inventors
Raj Puri, MD USFDA
Director at CBER Inventor of MDNA55
Aaron Ring, MD, PhD Yale University
Cancer Biology Co-Inventor of IL-2 Superkines
Chris Garcia, PhD Stanford University
Co-Inventor of IL-2, IL-4 and IL-13 Superkines
Haya Loberboum Galski, PhD Hebrew University of Jerusalem
Inventor of Fully Human Payloads)
One Target. Infinite Hope™
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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 Sept. 30, 2017 Source: FactSet & Company filings
All amounts in USD, unless noted otherwise
Company (Listing/Symbol) Price
(25-Jan-2018)
Market Cap (MM) Enterprise Value (MM) Lead Indication (Stage) ZIOPHARM Oncology, Inc.
(NASDAQ:ZIOP)
US$4.72 $670.7 $725.3
Recurrent Glioblastoma (pre-Ph III)
Stemline Therapeutics, Inc.
(NASDAQ:STML)
US$15.60 $452.0 $386.4
Recurrent Glioblastoma (post-Ph II)
Kadmon Holdings, Inc.
(NYSE:KDMN)
US$5.10 $401.1 $400.4
Recurrent Glioblastoma (Ph II)
Agenus Inc.
(NASDAQ:AGEN)
US$3.75 $382.4 $424.2
Newly Diagnosed Glioblastoma (Ph II)
Newlink Genetics Corporation
(NASDAQ:NLNK)
US$8.64 $320.3 $206.0
Malignant Brain Tumors (Ph II)
Tocagen Inc.
(NASDAQ:TOCA)
US$14.39 $285.1 $186.8
Recurrent High Grade Glioma (Ph III)
Vascular Biogenics Ltd.
(NASDAQ:VBLT)
US$7.15 $193.9 $165.7
Recurrent Glioblastoma (Ph III)
Diffusion Pharmaceuticals Inc.
(NASDAQ:DFFN)
US$0.71 $10.4 ($0.3)
Newly Diagnosed Glioblastoma (pre-Ph III)
Average $339.5 $311.8 Median $351.4 $296.2
Medicenna Therapeutics1
(TSX:MDNA)
C$2.59 $51.3
(C$63.1M)
$43.5
Recurrent Glioblastoma (Ph II)
One Target. Infinite Hope™
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Medicenna Corporate Highlights
Focused on ONE TARGET: the IL4R
Number of Cancers Known to Over- Express the IL4R
Annual Incidence of IL4R Positive Cancers
Number of Patents Filed or Issued
Annual Incidence of Glioblastoma and Metastatic Brain Cancer
HOPE
Brain Tumor Patients that can be treated with 1 Gram of MDNA55
Non-Dilutive Grant and Equity (funding in Cdn$)
Potential Market of MDNA55 Market for Brain Cancer ($US)
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Thank You.