One Target. Infinite Hope™
…
Corporate Presentation Fall 2017
1
TSX: MDNA
Forward Looking Statements Certain statements in this presentation - - PowerPoint PPT Presentation
One Target. Infinite Hope Corporate Presentation Fall 2017 TSX: MDNA 1 Forward Looking Statements Certain statements in this presentation are forward-looking statements. Any statements that express or involve discussions with
…
Corporate Presentation Fall 2017
1
TSX: MDNA
One Target. Infinite Hope™ …
TSX: MDNA
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.
2
Forward Looking Statements
One Target. Infinite Hope™ …
MDNA55 (lead): Compelling, Phase 1
and 2 clinical data (N=66) for recurrent glioblastoma (rGBM) Publicly listed (TSX: MDNA), clinical-stage, immuno-oncology company developing novel therapies targeting the Type 2 Interleukin-4 Receptor (IL4R) 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 Well established cGMP compliant commercial scale manufacturing process Seasoned management, advisors and directors
Corporate Highlights
3
One Target. Infinite Hope™ …
Seasoned Management & Experienced Board
4
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 Jay Stoudemire, PhD Chief Scientific Officer Former VP Preclinical Development, Regulatory, and QA at Mirna Therapeutics, previously at Genentech, Ascenta, Chugai-Roche, Cytel, Genetics Institute, and Xoma 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 Elizabeth Williams, CPA,CA Chief Financial Officer Former VP Finance & Admin and interim CFO at Aptose (TSX and Nasdaq); Previously with Ernst & Young Martin Bexon, MD Head of Clinical Development Former Medical Director at CSL Behring; Medical Director at Hoffman La Roche (UK and Switzerland) 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 Development Former 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). William W. Li, M.D. Independent Director CEO, President and Co- Founder of the Angiogenesis
strategic consultant to pharma in drug development and advised leaders at 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™ …
World Class Advisors and Collaborators
5
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
Michael Rosenblum, PhD MD Anderson Cancer Center
Head, Immunopharmacology and Targeted Therapy Collaborator: MDNA57
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™ …
Treatment Pathway for Glioblastoma (GBM)
6
Surgery (85-90%) GB Diagnosis Radiotherapy + Chemotherapy Relapse Chemotherapy
GB is uniformly fatal; virtually all tumors will recur (rGB)
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 Chemotherapy
25%
OPERABLE rGBM
One Target. Infinite Hope™ …
immune system to cancer cells
Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia1
MDNA55
Targeted Dual-Action Immunotherapeutic
7
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)
One Target. Infinite Hope™ …
Mechanism of Action of MDNA55
8
MDNA55
NUCLEUS
Efficient intracellular delivery of Toxin Payload ADP Ribosylation Endocytosis Inhibits Protein Synthesis - Apoptosis
One Target. Infinite Hope™ …
MDNA55 Brain Cancer Market Opportunity
9
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™ …
microenvironment (TME) comprises 40% of GBM tumor mass 2
transport of therapeutic to tumor
BBB causing systemic toxicities
Current Therapies Do Not Address Key Challenges
10
Therapeutic Challenges Rationale for MDNA55
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):6413-23
TME (Myeloid Derived Suppressor Cells) but not in normal brain4
MDNA55 by-passes the BBB
doses without systemic exposure
One Target. Infinite Hope™ …
Compelling Efficacy in Non-Resected rGBM (n=25)
11
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™ …
MDNA55 Survival Results Consistent with Immunotherapy Benefits
12
MDNA55 Overall Survival in Non-Resectable (Phase 1 - Blue) and Resectable (Phase 2 - Red) rGBM
100
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)
50
Log-Rank test p-value is 0.9430 (N=57)
One Target. Infinite Hope™ …
2nd Generation Infusion Will Improve Outcomes
13
Images courtesy of John Sampson, Duke University
catheter placement
due to backflow
tumor coverage
1st Generation CED: Past Studies
catheter placement
prevent backflow
ensures tumor coverage
2nd Generation CED: Future Studies
Real-Time Monitoring
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
One Target. Infinite Hope™ …
US Sites Participating in the Study
14 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™ …
Future Indications: 1 Million IL4R Cancers Annually
15
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™ …
Deep Early Stage Pipeline
16
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™ …
MDNA109 Synergizes With Anti-PD-1 Immunotherapy
17
Combination Therapy Produces Robust Responses
One Target. Infinite Hope™ …
Recurrent GBM Brain Metastasis Newly Diagnosed GBM (MGMT + VE) Pediatric GBM & Medulloblastoma Diffuse Intrinsic Pontine Glioma
Product Pipeline
18
INDICATIONS
DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PIVOTAL 2017/2018 2018/2019
Development Plans CANDIDATE MDNA55 MDNA109 MDNA413 Cancer Immunotherapies Solid Tumors MDNA132 Solid Tumors: IL13Ralpha2 CAR-T
One Target. Infinite Hope™ …
Multiple Near Term Value Inflection Milestones
19
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 Q4/2017 Complete Enrollment in Phase 2b rGBM Trial Q4/2017 Report rGBM 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 rGBM Q4/2018 Report Interim Top-Line Results from P2 Brain Cancer Trial Q3/2018 Commence IND Enabling Studies with MDNA57 Q4/2018
Pursue Accelerated Approval for rGBM in 2018
One Target. Infinite Hope™ …
Financial Snapshot
20
TSX: MDNA
Number Issued and Outstanding 24,344,048 Fully 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 $2.03
One Target. Infinite Hope™ …
Medicenna Public Company Comparables
21
(1) Medicenna market cap estimate based on current basic shares O/S and current share price. Enterprise value estimate based on net debt as of Jun. 30, 2017 Source: FactSet & Company filings
One Target. Infinite Hope™ …
22
Medicenna Corporate Highlights
Focused on ONE TARGET: the IL4R
Number of Cancers Known to Over- Express the IL4R
Annual Incidence of IL4R Positive Cancers
Number of Patents Filed or Issued
Annual Incidence of Glioblastoma and Metastatic Brain Cancer
HOPE
Brain Tumor Patients that can be treated with 1 Gram of MDNA55
Non-Dilutive Grant and Equity (funding in Cdn$)
Potential Market of MDNA55 Market for Brain Cancer ($US)
…
Thank You.
Fahar Merchant, PhD Chairman, President & CEO
fmerchant@medicenna.com www.medicenna.com
23