Forward Looking Statements Certain statements in this presentation - - PowerPoint PPT Presentation

forward looking statements
SMART_READER_LITE
LIVE PREVIEW

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


slide-1
SLIDE 1

One Target. Infinite Hope™

Corporate Presentation Fall 2017

1

TSX: MDNA

slide-2
SLIDE 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

  • r 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

slide-3
SLIDE 3

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

slide-4
SLIDE 4

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

  • Foundation. Executive

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,

  • TX. Formerly CEO of Kalon
  • Biotherapeutics. Director of

Ashford Hospitality Prime (NYSE) Nina Merchant, M.E.Sc Director, Chief Development Officer

slide-5
SLIDE 5

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

  • 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)

slide-6
SLIDE 6

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

  • r Experimental Therapies

25%

OPERABLE rGBM

slide-7
SLIDE 7

One Target. Infinite Hope™ …

  • 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 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)

slide-8
SLIDE 8

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

slide-9
SLIDE 9

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

slide-10
SLIDE 10

One Target. Infinite Hope™ …

  • 55% of GBMs are chemo-resistant 1
  • Immunosuppressive tumor

microenvironment (TME) comprises 40% of GBM tumor mass 2

  • Blood Brain Barrier (BBB) blocks

transport of therapeutic to tumor

  • High doses are required due to

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

  • MDNA55 targets resistant tumors3
  • IL4R over-expressed in GBM and its

TME (Myeloid Derived Suppressor Cells) but not in normal brain4

  • Delivery by direct injection (CED) of

MDNA55 by-passes the BBB

  • Precision delivery achieves high

doses without systemic exposure

slide-11
SLIDE 11

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

slide-12
SLIDE 12

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)

slide-13
SLIDE 13

One Target. Infinite Hope™ …

2nd Generation Infusion Will Improve Outcomes

13

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

  • f Drug Distribution

Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531

slide-14
SLIDE 14

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)

slide-15
SLIDE 15

One Target. Infinite Hope™ …

Future Indications: 1 Million IL4R Cancers Annually

15

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

slide-16
SLIDE 16

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

slide-17
SLIDE 17

One Target. Infinite Hope™ …

MDNA109 Synergizes With Anti-PD-1 Immunotherapy

17

Combination Therapy Produces Robust Responses

  • MDNA109 and anti-PD-1 produce limited efficacy alone
  • Combination treatment sufficient to cure most mice without increased toxicities
slide-18
SLIDE 18

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

slide-19
SLIDE 19

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

slide-20
SLIDE 20

One Target. Infinite Hope™ …

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

slide-21
SLIDE 21

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

slide-22
SLIDE 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 1 Gram of MDNA55

30+ million

Non-Dilutive Grant and Equity (funding in Cdn$)

2 Billion

Potential Market of MDNA55 Market for Brain Cancer ($US)

slide-23
SLIDE 23

One Target. Infinite Hope™

Thank You.

Fahar Merchant, PhD Chairman, President & CEO

fmerchant@medicenna.com www.medicenna.com

23