one Target: infinite Hope Corporate Presentation Q2, 2017 Forward - - PowerPoint PPT Presentation

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one Target: infinite Hope Corporate Presentation Q2, 2017 Forward - - PowerPoint PPT Presentation

one Target: infinite Hope Corporate Presentation Q2, 2017 Forward Looking Statements Certain statements in this presentation are forward-looking statements. Any statements that express or involve discussions with respect to predictions,


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  • ne Target: infinite Hope™

Corporate Presentation Q2, 2017

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Forward Looking Statements

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 filing statement dated February 27, 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.

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Medicenna: Corporate Highlights

Ø Publicly listed (TSXV: MDNA), clinical-stage, immuno-oncology company developing a novel therapy targeting the Interleukin-4 Receptor (IL4R) biomarker Ø Every year >1 million cancer patients afflicted with IL4R tumors1 Ø MDNA55 (lead): highly compelling, Phase II clinical data for recurrent glioblastoma (rGB), the most common and aggressive form of brain cancer Ø MDNA55 market opportunity: $650 million in annual sales for rGB; >$2 billion including other brain cancers1,2 Ø MDNA55 has Orphan Drug (FDA, EMA) & Fast Track Designations (FDA) Ø Exciting pre-clinical IL-2, IL-4 and IL-13 Superkine platform Ø Well funded with $14M US non-dilutive grant and $14M CAD Private Placement Ø Seasoned management with technology platform protected by 12 patent families

1. BioXcel Strategic Analysis Report, 2014. 2. Decision Resources, Inc Glioblastoma Report, Sept 2013

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Treatment Pathway for Glioblastoma (GB)

Surgery (85-90%) GB

Diagnosis

Radiotherapy + Chemotherapy Relapse Chemotherapy Surgery

MDNA55 Treatment

(Direct infusion into tumor - CED)

Add’l Chemo.or Experimental Therapies

GB is uniformly fatal; virtually all tumors will recur (rGB)

55% of GB Chemo. Resistant*

* Expression of the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT) is responsible for resistance to alkylating agents used in GB treatment.

25% 75% of rGB is non-operable

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MDNA55: Targeted Dual-Action Immunotherapeutic

A Powerful Molecular Trojan Horse

Ø Potently toxic to tumor cells with a wide therapeutic window 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 Leukemia1 Ø Reliable, cost-efficient fermentation-based manufacture

1 https://www.medimmune.com/our-therapy-areas/oncology.html

PE AAs 253-364, 381-608

Circularly Permuted Interleukin-4 (cpIL-4) Catalytic domain of Pseudomonas Exotoxin A (PE)

Tumor Targeting Domain Tumor Killing “Cytotoxic” Domain

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MDNA55: Brain Cancer Market Opportunity

Tumor T ype Annual Incidence Projected Market

Recurrent Glioblastoma (rGB) 33,3001 $650M2 Metastatic Brain Cancer 91,5003 $1.30B4 Pediatric Glioma 3,8001 $50M4 TOTAL 133,500 $2.0B

1. Decision Resources Glioblastoma Report, Sept 2013 2. Assumes peak sales for rGB monotherapy and combination therapy at $43K per patient – BioXcel Strategic Analysis Report, 2014 3. Breast, Colon and Kidney Cancer Metastasis to Brain – BioXcel Strategic Analysis Report, 2014 4. Assumes 33% treatable with MDNA55 and priced at $43K per patient - BioXcel Strategic Analysis Report, 2014

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Current Therapies Do Not Address Key Challenges

Therapeutic Challenges Rationale for MDNA55 Ø 55% of GBs are chemo-resistant 1 Ø Immunosuppressive tumor microenvironment (TME) comprises 40% of GB tumor mass 2 Ø Blood Brain Barrier (BBB) blocks transport of therapeutic to tumor Ø High doses are required due to BBB causing systemic toxicities Ø MDNA55 targets resistant tumors3 Ø IL4R over-expressed in GB and its TME (Myeloid Derived Suppressor Cells) but not in normal brain 4 Ø Delivery by direct injection (CED) of MDNA55 by-passes the BBB Ø Precision delivery achieves high doses without systemic exposure

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

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Compelling Efficacy in Non-Resected rGB (n=25)

Pre-treatment 9 months Pre-treatment Week 26

Complete Response (CR): 5/25 Partial Response (PR): 9/25

High Objective Response Rate

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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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MDNA55: Clinical Efficacy

Long Term Survival Results Consistent With Immunotherapy Benefits

Superior Long Term Survival When Compared to Avastin Despite Poorer Patient Population (N =57)

300 600 900 1200 1500 50 100

Days Percent survival

Non-Resectable Recurrent GBM: Survival of Responders vs Non Responders

Responders (CR + PR): MS = 379 days (n=14) Non-Responders (SD + PD) MS = 98 days (n=11)

9 SD – Stable disease PD – Progressive disease Investigators Brochure (page 82)

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2nd Generation Infusion Will Improve Outcomes

Images courtesy of John Sampson, Duke University

  • Inaccurate catheter

placement

  • Drug leakage due to

backflow

  • Inadequate tumor

coverage

  • Image-guided

catheter placement

  • New catheters

prevent backflow

  • Real-time monitoring

ensures tumor coverage

Real-Time Monitoring of Drug Distribution 1st Generation CED: Past Studies 2nd Generation CED: Future Studies

Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531 10

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NeuroExact™: Personalized Molecular Neurosurgery

Combining Personalized Therapy with Precision Delivery

DRUG: MDNA55 Selectively Targets Tumor Over-Expressing the IL4R DELIVER: Precise Image Guided Convection Enhanced Delivery of MDNA55 DISTRIBUTE: Ensure Complete Tumor Coverage with MDNA55 Using Real Time Monitoring

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US Sites Participating in the Study

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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Future Indications: 1 Million IL4R Cancers Annually

>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression1-14

78% 78%

B-Cell CLL

67%

Hodgkins Lymphoma

56%

Biliary Tract

73% 73%

Bladder

82% 82%

Breast

89% 89%

Colorectal

75% 75%

Head and Neck Head and Neck

79% 79%

NSCLC NSCLC

96% 96%

Mesothelioma Mesothelioma

60% 60%

Ovarian Ovarian

60% 60%

Pancreatic ancreatic

91% 91%

Anaplastic Thyroid

1. BioXcel Strategic Analysis Report, 2014 2. Ishige et al (2008); Int J Cancer;123(12):2915-22. 3. Joshi et al (2014 Cancer Med. 3(6):1615-28. 4.

  • P. Leland, et al (2000) Mol Med; 6(3): 165–178.

5. Koller , et al (2010); Carcinogenesis 31(6), 1010-17

  • 6. Strome SE, et al (2002).Clin Cancer Res.n;8(1):281-6.

7. Puri, et al (1996). Cell Immunol.10;171(1):80-6. 8. Kawakami, et al (2005) Blood; 105(9): 3707–3713. 9. Kay, et al (2005) Leuk Res.;29(9):1009-18.

  • 10. Kawakami, at al (2002). Clin Cancer Res.;8(11):3503-11.
  • 11. Burt, et al (2012) Clin Cancer Res;18(6):1568-77
  • 12. Kioi, et al (2005) Cancer Res;65(18):8388-96
  • 13. Kawakami et al (2002) Cancer Res.;62(13):3575-80.
  • 14. Joshi et al (2015) Discov. Med.;20(111):273-84.

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IL-2 Superkines: Tunable Immune Modulators

RECENT IL-2 DEAL ACTIVITY IL-2 Agonist: MDNA109

Clinical collaboration for NKTR-214 in combination with Opdivo

RECENT IL-2 DEAL ACTIVITY IL-2 Antagonist: MDNA209

Acquired by Celgene for $300M upfront and $475M in contingent value rights

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Secured Exclusive World Wide Rights from Stanford University

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MDNA109 Synergizes With Anti-PD-1 Immunotherapy

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

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USD$14M Non-Dilutive Grant Validates Platform

Ø Diligence by top-tier scientific, clinical, regulatory, chemistry manufacturing and control, intellectual property & venture capital teams Ø Solid third-party platform validation Ø Funds MDNA55 Phase 2b rGB clinical development and next generation pre-clinical IL-4 Empowered Cytokine program Ø The USD$14.1M grant effectively provides 2:1 leverage on USD$7M investment1 Ø Favorable grant repayment terms begin post-launch (low single digit royalties to a maximum payment amount of 4 times the original grant)

  • 1. http://www.cprit.state.tx.us/images/uploads/rfa-172-txco.pdf

Recipient of Cancer Prevention & Research Institute of Texas (CPRIT) Grant

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Multiple Near Term Value Inflection Milestones

Pursue Accelerated Approval for rGB in 2018

Milestone Estimated Timing Commenced Enrollment in Phase 2b rGB Trial First Patient In - Phase 2b rGB Trial Commence Phase 2 Metastatic Brain Cancer Trial Q3/2017 Complete Enrollment in Phase 2b rGB Trial Q4/2017 Report rGB 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 rGB Q3/2018 Report Interim Top-Line Results from P2 Metastatic Brain Cancer Trial Q3/2018 Commence IND Enabling Studies with MDNA57 Q4/2018

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Seasoned Management and Experienced Board

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

Sam Denmeade, MD: Chief Scientific Officer

Prof Oncology at JHU; Former CSO at Sophiris Bio; Co-founder and Chief Clinical Advisor of Inspyr Therapeutics

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)

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

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) and Director of Telesta (TSX); Currently Independent Director of Helix Biopharma (TSX). 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 General Counsel and Compliance Officer for the Texas A&M University System. Led formation of bio-manufacturing company, Kalon Biotherapeutics; CEO of Kalon until its sale to FujiFilm Diosynth Biotech. Director of Ashford Hospitality Prime (NYSE) Nina Merchant, M.E.Sc Director, Chief Development Officer

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World Class Advisors and Collaborators

Collaborators & Inventors Clinical & Scientific Advisors

John Sampson, MD, PhD, MBA Duke University:

Principal Investigator and Expert in Drug Delivery to the Brain

Stewart Grossman, MD Johns Hopkins University:

Novel therapies for primary & metastatic brain tumors

Nicholas Butowski, MD UCSF:

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

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

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Capitalization

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Publicly Listed as of March 3, 2017 Ø Listed on the TSX Venture on March 3, 2017 at $2.00 per share following a successful Reverse Takeover Ø Trading under the Ticker “MDNA” Ø Fully funded for two years with cash on hand and funds remaining to be advanced under the CPRIT grant Number Issued and Outstanding 24,307,343 Fully Diluted* 28,852,583

* Fully diluted includes 4,402,383 options and warrants with a $2.00 exercise price and 142,857 options and warrants with a $1.40 exercise price

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Medicenna Public Company Comparables

Company (Listing/Symbol) Price

(10-Mar-17)

Market Cap (MM) Enterprise Value (MM) Lead Indication (Stage) ZIOPHARM Oncology, Inc.

(NASDAQ:ZIOP)

US$6.13 $811.5 $855.7

Breast Cancer (PhII), Recurrent Glioblastoma (Ph I)(w/ CED*)

Newlink Genetics Corporation

(NASDAQ:NLNK)

US$17.54 $512.5 $387.5

Malignant Brain Tumor (Ph II)

Agenus Inc.

(NASDAQ:AGEN)

US$3.35 $329.4 $364.9

Glioblastoma and Recurrent Glioblastoma (Ph II)

Stemline Therapeutics, Inc.

(NASDAQ:STML)

US$8.25 $206.7 $159.8

Recurrent Glioblastoma (Ph I/II)

Kadmon Holdings, Inc.

(NYSE:KDMN)

US$3.21 $166.4 $199.2

Glioblastoma (Ph II)

Vascular Biogenics Ltd.

(NASDAQ:VBLT)

US$5.35 $143.6 $98.4

Recurrent Glioblastoma (Ph III)

Diffusion Pharmaceuticals Inc.

(NASDAQ:DFFN)

US$3.70 $38.3 $37.7

Glioblastoma (Ph II)

Average $315.5 $300.5 Median $206.7 $199.2

Medicenna Therapeutics1

(TSXV:MDNA)

C$2.80 $53.0

(C$70.5M)

$46.0

Recurrent Glioblastoma (Ph II)

(1)Enterprise value based on net debt as of Dec 31, 2016

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All amounts in USD, unless noted otherwise

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Medicenna: Corporate Highlights

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Thank You

  • ne Target: infinite Hope™

www.medicenna.com