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Medicenna corporate presentation renmark fm printable


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Medicenna corporate presentation renmark fm printable

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Medicenna corporate presentation renmark fm printable

  1. 1. One Target. Infinite Hope™… Corporate Presentation Fall 2017 1 TSX: MDNA
  2. 2. 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 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. 2 Forward Looking Statements
  3. 3. 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 scale manufacturing process established Seasoned management, advisors and directors Corporate Highlights Publicly listed (TSX: MDNA), clinical-stage, immuno-oncology company 3
  4. 4. One Target. Infinite Hope™… TSX: MDNA Treatment Pathway for Glioblastoma (GBM) 4 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 Chemotherapy or Experimental Therapies 25% OPERABLE rGBM
  5. 5. One Target. Infinite Hope™… TSX:MDNA MDNA55 Targeted Dual-Action Immunotherapeutic 5 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)  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
  6. 6. One Target. Infinite Hope™… TSX:MDNA Mechanism of Action of MDNA55 6 MDNA55 NUCLEUS Efficient intracellular delivery of Toxin Payload ADP Ribosylation Endocytosis Inhibits Protein Synthesis - Apoptosis
  7. 7. One Target. Infinite Hope™… TSX: MDNA Compelling Efficacy in Non-Resected rGBM (n=25) 7 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
  8. 8. One Target. Infinite Hope™… TSX:MDNA MDNA55 Survival Results Consistent with Immunotherapy Benefits 8 MDNA55 Overall Survival in Non-Resectable (Phase 1 - Blue) and Resectable (Phase 2 - Red) rGBM 100 PercentSurvival 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 disease PD –Progressive disease Investigators Brochure (page 82) 50 Log-Rank test p-value is 0.9430 (N=57)
  9. 9. One Target. Infinite Hope™… TSX: MDNA 2nd Generation Infusion Will Improve Outcomes 9 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
  10. 10. One Target. Infinite Hope™… TSX:MDNA 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)
  11. 11. One Target. Infinite Hope™… TSX:MDNA MDNA55 Brain Cancer Market Opportunity 11 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
  12. 12. One Target. Infinite Hope™… TSX: MDNA Future Indications: 1 Million IL4R Cancers Annually 12 B-Cell CLL 78% Bladder 73% Head and Neck 60% Pancreatic 60% Anaplastic Thyroid 91% 67% Hodgkins Lymphoma >2000 Patient BiopsiesAnalyzed Consistently Show IL4R Over-Expression NSCLC 79% Biliary Tract 56% Breast 82% Mesothelioma 96% 89% 75% Colorectal Ovarian
  13. 13. One Target. Infinite Hope™… TSX: MDNA Deep Early Stage Pipeline 13 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
  14. 14. One Target. Infinite Hope™… TSX:MDNA MDNA109 Synergizes With Anti-PD-1 Immunotherapy 14 Combination Therapy Produces Robust Responses  MDNA109 and anti-PD-1 produce limited efficacy alone  Combination treatment sufficient to cure most mice without increased toxicities
  15. 15. One Target. Infinite Hope™… TSX: MDNA Recurrent GBM Brain Metastasis Newly Diagnosed GBM (MGMT + VE) Pediatric GBM & Medulloblastoma Diffuse Intrinsic Pontine Glioma Product Pipeline 15 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
  16. 16. One Target. Infinite Hope™… TSX:MDNA Regulatory Approval Pathway 16 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 2019/20 2-3 years to market launch 8-17 years to market approval 2019 Potential Approval
  17. 17. One Target. Infinite Hope™… TSX:MDNA Multiple Near Term Value Inflection Milestones 17 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 Q1/2018 Complete Enrollment in Phase 2b rGBM Trial Q1/2018 Report rGBM Phase 2b Interim Top-Line Results Q2/2018 End of Phase 2 Meeting with FDA Q3/2018 Commence IND Enabling Studies with MDNA109 Q3/2018 Pursue Accelerated Approval for rGBM Q1/2019 Report Interim Top-Line Results from P2 Brain Cancer Trial Q4/2018 Commence IND Enabling Studies with MDNA57 Q1/2019 Pursue Accelerated Approval for rGBM in 2019
  18. 18. One Target. Infinite Hope™… TSX:MDNA Seasoned Management & Experienced Board 18 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) 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 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 Foundation. Executive 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, TX. Formerly CEO of Kalon Biotherapeutics. Director of Ashford Hospitality Prime (NYSE) Nina Merchant, M.E.Sc Director, Chief Development Officer
  19. 19. One Target. Infinite Hope™… TSX:MDNA World Class Advisors and Collaborators 19 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 Asst. Prof Immunobiology & 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)
  20. 20. One Target. Infinite Hope™… TSX:MDNA Financial Snapshot 20 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 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 $2.03
  21. 21. One Target. Infinite Hope™… TSX:MDNA Medicenna Public Company Comparables 21 (1) Medicenna market cap estimate based on current basic shares O/S and current share price. Enterprise value estimate based on net debt as of Jun. 30, 2017 Source: FactSet & Company filings
  22. 22. One Target. Infinite Hope™… 22 Medicenna Corporate Highlights 1 Focused on ONE TARGET: the IL4R 20 Number of Cancers Known to Over- Express the IL4R 1 Million Annual Incidence of IL4R Positive Cancers 40 Number of Patents Filed or Issued 250,000 Annual Incidence of Glioblastoma and Metastatic Brain Cancer ∞HOPE 10,000 Brain Tumor Patients that can be treated with 2 Grams of MDNA55 30+ Million Non-Dilutive Grant and Equity (funding in Cdn$) 2 Billion Potential Market of MDNA55 Market for Brain Cancer ($US)
  23. 23. One Target. Infinite Hope™… Thank You. Fahar Merchant, PhD Chairman, President & CEO