TSX: MDNAOTCQB: MDNAF
©2018 Medicenna. All Rights Reserved.
Corporate Overview | Q1 2019
Forward-Looking Statements
Q1 2019 Medicenna Corporate Overview
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 26, 2018. 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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Q1 2019 3
MDNA55 — LEAD PROGRAM SUPERKINE PLATFORM MDNA109
TARGETS IL4R: EXPRESSED IN GBMCompelling Phase 1/2a Data in rGBM
ORPHAN/FAST TRACK Orphan Drug (FDA, EMA)
Fast Track (FDA)
IL-2; IL-4; IL-13Tunable cytokines
BEST IN CLASS IL-2 SUPER-AGONIST
PHASE 2B TRIAL NEARLY COMPLETE
Enrollment at 10 sites in the US including Centers of Excellence
4,000Brain tumor patients can be treated with 1 gram
of MDNA55
GROWING PIPELINE
Oncology, autoimmune andinflammatory
HIGH CD122 SELECTIVITY
250,000Annual incidence
of GBM and metastatic brain cancer2
2 BILLIONPotential market of MDNA55 market for brain cancer ($US)1,3
VALIDATED TARGETS
Industry transactions support further development
TUNABLE PKFc and Albumin Fusions
1. BioXcel Strategic Analysis Report, 2014.2. Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide 2012.3. Decision Resources, Inc Glioblastoma Report, Sept 2013.
Medicenna Corporate Overview
MDNA55A Powerful Molecular Trojan Horse Targeting Glioblastoma
> 300 Patient Biopsies Analyzed Show IL-4R Over-Expression1-7
5
Targeting the IL-4 Receptor in Brain Tumors
Glioblastoma
76%Mixed Adult
Glioma
>83%Mixed Pediatric
Glioma
76%Pediatric DIPG
71%
Medulloblastoma
100%Adult Pituitary
Adenoma
100%Meningioma
77%Normal Brain
Tissue
0%1. Joshi BH, et. al. Cancer Res 2001;61:8058-8061.2. Puri RK, et. al., Cancer Res 1996;56:5631-5637. 3. Kawakami M, et. al., Cancer. 2004 Sep 1; 101(5):1036-42. 4. Berlow NE, et al. PLoS One. 2018 Apr 5; 13(4):e0193565.
5. Joshi BH, et. al. British J of Cancer (2002) 86, 285 –291.6. Chen L, et al. Neurosci Lett. 2007 Apr 24; 417 (1):30-5.7. Puri S, et. al., Cancer. 2005 May 15; 103(10):2132-42.
Q1 2019 Medicenna Corporate Overview
IL-4R Predicts Poor Survival in GBM
6
Kohanbash G et al. Cancer Res 2013;73:6413-6423
IL4R +/+ (n=10); symptom-free survival = 55.5 daysSymptom-free survival = 90 daysIL4R -/- (n=15); symptom-free survival = 90 days
Survival in Subjects with GBM
-- No expression of IL-13Rα1 (n=32): mOS = 693 days-- High expression of IL-13Rα1 (n=65): mOS = 350 days
Survival in Glioma Mouse Model
Han J. and Puri R. J of Neuro-Oncology (2018) 136:463–474
Expression of IL-13Rα1 mRNA positively correlates with IL-4Rα indicating that these two receptors may form a complex in GBM.
Q1 2019 Medicenna Corporate Overview
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TME-Infiltrating MDSCs Express IL-4R and Predict Poor Survival in GBM
MDSC gene signature (based on the combined positive expression of CD11b,CD33, CD45, CD244, and CXCR2) negatively correlates with GBM patientprognosis. Statistical significance of survival was based on log-rank analysis.
Otvos B et. al., (2016). Stem Cells 34:2026–2039Surface expression of IL-4Ra on tumor-infiltrating and splenic CD11b+/Gr-1+ MDSCs from GL26 tumor-bearing mice.
TME-MDSCs show 12-fold increase in IL-4R⍺expression compared to splenic myeloid cells
p < 0.001
Kamran N, et. al., (2017). Mol Ther 25:232-248
Q1 2019 Medicenna Corporate Overview
MDNA55: A Powerful Molecular Trojan Horse
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Targeteddelivery of toxin
Tumor Targeting Domain
Circularly Permuted Interleukin-4 (cpIL-4)
ENDOCYTOSIS
FURIN PROTEASEADP RIBOSYLATION
Inhibit Protein Synthesis
CELL DEATH
NUCLEUS
Tumor Killing “Cytotoxic” DomainCatalytic domain of Pseudomonas Exotoxin A (PE)
• Potently toxic to tumor cells
• Simultaneously purges the tumor microenvironment (TME)
• Bypass the BBB via convection enhanced delivery (CED)
Medicenna Corporate OverviewQ1 2019
MDNA55 Treatment
Direct infusion into tumor
convection enhanceddelivery (CED)
75%
INOPERABLE rGBM
9
Treatment Pathway for GBM
* Expression of the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT) is responsible for resistance to Temodar used in GBM treatment.
STANDARD OF CARE FOR PATIENTS WITH GBM
DIAGNOSISADJUVANT TEMODARSURGERY
(85-90%) 55% of GBM Temodar-Resistant*
RADIOTHERAPY TEMODAR
RELAPSE
25%
OPERABLE rGBM
GBM IS UNIFORMLY FATAL – VIRTUALLY ALL TUMORS WILL RECUR (rGBM)
MDNA55 treatment can also provide benefit in newly diagnosed and
operable rGBM settings
Q1 2019
Open-Label Single Arm Study in 52 Recurrent GBM Patients (NCT02858895)
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MDNA55-05 Phase 2b Study Design Summary
DIAGNOSIS PLANNING TREATMENT FOLLOW UP
Q1 2019
Optimization: High-flow Image Guided CED Improves Distribution
Q1 2019 Medicenna Corporate Overview 11
PAST STUDIES1st Generation CED
CURRENT STUDIES2nd Generation High-flow CED
Image-guided catheter placement
New catheters prevent backflow
Real-time monitoring ensures
tumor coverage
Inaccurate catheter placement
Drug leakage due to backflow
Inadequate tumor coverageTumor Drug Coverage
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
Sampson et al, Congress for Neurosurgery, Oct 9-11, 2017
3D IMAGE FROM PATIENTIN CURRENT CLINICAL STUDY
Reduced Treatment Duration from 4 Days to 1 Day
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Promising Survival at Low Doses of MDNA55 Compared to Approved Therapies for rGBM
Monotherapy Population (n)Survival
mOS (mos.) OS-6 OS-9 OS-12MDNA55-05
Low Dose Cohorts* rGBM (n=27) 11.8 89% 59% 46%
Avastin1 rGBM (n=50) 8.0 62% 38% 26%
Lomustine1 rGBM (n=46) 8.0 65% 43% 30%
Temozolomide2 rGBM (n=31) 5.6 NA NA NA
Temozolomide3 rGBM (n= 792) NA 65% NA 36.4%
MDNA55-05High Dose Cohorts Currently enrolling
1 Taal et al, Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomised controlled phase 2 trial. Lancet Oncol 2014 Aug;15(9):943-532 Kim et al., Outcome of salvage treatment for recurrent glioblastoma. J Clin Neuroscience 22 (2015) 468–473, 2015.3 Chen et al., The efficacy of temozolomide for recurrent glioblastoma multiforme (Meta-analysis). Eur J Neurol, 2013 Feb; 20(2):223-30.
Q1 2019 Medicenna Corporate Overview
0 200 400 600 800 1000 12000
50
100
Days Elapsed
Perc
ent R
elap
sed
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IL-4R Positivity is Associated with More Aggressive Disease
Time to 1st Relapse from Initial Diagnosis
IL-4R H-Scores (range 0-300)
Median time to 1st Relapse from Initial
Diagnosis
≤ 75 16.7 mos
> 75 10.3 mos
Q1 2019 Medicenna Corporate Overview
Shorter Time to Relapse from Initial Diagnosis
0 100 200 300 400 500 600 7000
50
100
Days elapsed
Perc
ent s
urvi
val
H-Score 0 - 75 (n=11)H-Score > 75 (n=13)
IL4R+ Subjects Show Better Survival Outcomes Following Treatment with MDNA55
IL-4R H-Scores
(range 0-300)OS-6
(n=24)OS-9
(n=24)OS-12(N=21)
≤ 75 73% 36% 30%
> 75 100% 69% 55%
Survival from Start of MDNA55 Treatment
16Q1 2019 Medicenna Corporate Overview
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MDNA55 Presents a Promising Benefit-Risk Profile Especially in IL-4R+ Recurrent GBM
Time to 1st Relapse from Initial Dx (median)
All Subjects 11.3 months
IL-4R+ Subjects 10.3 months
IL-4R- Subjects 16.7 months
Survival After Treatment with MDNA55
mOS (mos.) OS-6 OS-9 OS-12
All Subjects 11.8 89% 59% 46%
IL-4R+ Subjects 15.2 100% 69% 55%
IL-4R- Subjects 8.5 73% 36% 30%
IL-4R+ is associated with more aggressive disease
MDNA55 improves survival outcomes in IL-4R+ rGBM
Q1 2019 Medicenna Corporate Overview
MDNA55 Brain Cancer Market Opportunity
Q1 2019 Medicenna Corporate Overview
Tumor Type Annual Incidence1 Projected Market2
Recurrent Glioblastoma (rGBM) 33,300 $650M
Metastatic Brain Cancer3 91,500 $1.30B
Pediatric Glioma 3,800 $50M
Total 133,500 $2.0B
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1. GLOBOCAN 2012 http://globocan.iarc.fr/Default.aspx2. U.S., Europe and Japan3. Metastatic Brain Cancer numbers from colon, breast and kidney cancer only
Market Size Estimated at $2B Annually
MDNA109: IL-2Super Agonist for Cancer Immunotherapy
A High Potency Agonist for CD122: Preferentially Activates Effector Cells
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CD25 Limits Immuno-Oncology Potential of IL-2
VS
• Expressed on activated T cells, Treg, and pulmonary endothelium• Treg abrogate anti-tumor responses• Pulmonary endothelial cells mediate toxicity (vascular leak
syndrome)• Affinity <10 pM for IL-2
IL-2R⍺(CD25)
High-affinity receptor
• Expressed on effector cells that can recognize and attack tumor cells (naïve T cells, NK cells, and CD8 Tcells)
• Mediates anti-tumor effect• Affinity 1 nM for IL-2
IL-2
IL-2Rβ(CD122) IL-2Rγc
Intermediate affinity receptor
Q1 2019 Medicenna Corporate Overview
MDNA109: >1000-fold Higher Affinity for CD122 (IL-2Rβ) Than Native IL-2
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• Mutations in the core of IL-2 improves affinity to CD122 on CD8 T cells and NK cells
• CD122 affinity is key for the activation of immune cells responsible for cancer killing (CD8+ T cells, naïve T cells, NK cells,…)
IL-2Rβ binding site
Helix C
Helix A
Helix B
Helix D
Levin, Bates, and Ring et. al, Nature, 2012
SPR data (nM) CD25 CD122 CD122-CD132 (ɣc)
IL-2 23 500-1000 0.6
MDNA109 2-20 0.5 0.04
Similar affinity to
CD25
>1000 X increase affinity to
CD122
15 X increase affinity to
intermediate affinity IL2R
Q1 2019 Medicenna Corporate Overview
MDNA109 More Potent and Less Toxic then Wild-type IL-2
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Levin, Bates, and Ring et. al, Nature, 2012
Reduced Adverse Effects in Vivo
Selective Expansion of CD8+ T Cells in Vivo
10
5
0
15
Cel
ls p
er s
plee
n (x
106 )
0.20
0.15
0.10
0.25Pu
lmon
ary
wet
wei
ght (
g) 0.30
PBS IL-2
MDNA109
Anti-tumor response against pulmonary B16F10 nodules. B6 mice received 3x 105 B16F10 cells intravenously, followed by five daily injections of either PBS, 20 μg IL-2, or 20 μg MDNA109, starting three days after tumor injection. Shown are photographs of fixed whole lungs on day 16 after tumor injection.
Q1 2019 Medicenna Corporate Overview
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MDNA109 Shows Superior Efficacy in Syngeneic Mouse Cancer Models
Levin, Bates, and Ring et. al, Nature, 2012
C57BL/6 mice were injected either subcutaneously with 106 B16F10 melanoma cells, 2.5x106 murine colon carcinoma 38, or 106 Lewis lung carcinoma followed by daily injections of either PBS, 20 mg IL-2, or 20mg MDNA109 for 5 days once subcutaneous tumor nodules became visible and palpable. Shown is mean tumor volume in mm3 (+/-s.d.) versus time upon tumor inoculation. Error bars represent SEM., P values refer to comparisons of wild type with the other treatment modalities. *P,0.05; **P,0.01; ***P,0.001.
Q1 2019 Medicenna Corporate Overview
5 10 15 20 25 30 35 40 450
500
1000
1500
2000
Days Post-Implant
Mea
n Tu
mor
Vol
ume
(mm
3 )
PBSanti-PD-1MDNA109 (5 ug q.d.)MDNA109 (25 ug q.d.)anti-PD-1 + MDNA109 (5 ug q.d.)anti-PD-1 + MDNA109 (25 ug q.d.)
9/10 cures
1/10 cures
0/10 cures
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MDNA109 Synergizes with Anti-PD-1 Immunotherapy
• MDNA109 and anti-PD-1 are not fully efficacious alone
• Dose-dependence observed with monotherapy and anti-PD1
• Combination treatment sufficient to cure most mice
• Increased efficacy of combination was well-tolerated
C57BL/6 mice were implanted with 106 MC38 murine colon tumor cellssubcutaneously above hind limb. When tumor reached approximately 125mm3,animals were randomized into groups and dosing was initiated by intraperitonealinjections; q.d. = daily.
**
**
**
***
Combination Therapy Produces Robust Dose-Dependent Responses in Colon Cancer Model
Q1 2019 Medicenna Corporate Overview
0 10 20 30 40 50 60 70 80 900
500
1000
1500
2000
2500
Study Day
Tum
or v
olum
e (m
m3 )
23
TxStart
***
****
***
*
• MDNA109 and anti-CTLA4 (10 mg/kg IV q4d x 3)are not fully efficacious alone
• Significant response observed in combination with anti-CTLA4; sufficient to cure most mice
• Increased efficacy of combination was well-tolerated
• MDNA109 can synergize with checkpoint inhibition to fully unleash the immune system against cancer
MDNA109 Synergizes with Anti-CTLA-4 Immunotherapy
MDNA109 and IL2 administered daily x5 for 2 cycles; anti-CTLA4 administered twice weekly for two cycles; average tumor volume at treatment start was 18 mm3; asterisks indicate significant differences as compared to Isotype control group (*p<0.05; **p<0.01; ***p<0.001; ****p<0.0001).
Combination Therapy Produces Robust Tumor Responses in CT26 Colon Cancer Model
Q1 2019 Medicenna Corporate Overview
30 40 50 60 70 80 900
500
1000
1500
2000
Days Post 1st Implant
Tum
or v
olum
e (m
m3 )
Day of Implant
Tumor Re-challenge Shows Sustained Benefit with MDNA109 + Anti-CTLA-4
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Secondary challenge
Primary challenge
1 2
MDNA109 + Anti-CTLA4 (n=8)IL-2 + Anti-CTLA4 (n=6)
30 40 50 60 70 80 900
500
1000
1500
2000
Days Post 1st Implant
Tum
or v
olum
e (m
m3 )
Day of Implant
1 CR (17%)4 deaths
4 CR (50%)1 PR (13%)
Q1 2019 Medicenna Corporate Overview
0 20 40 60 80 1000
20
40
60
80
100
Days Post Implant
Per
cent
sur
viva
l
MDNA109 + Anti-CTLA-4 Immunotherapy Improves Survival
25
Tumor re-challenge
(Day 32)
Start of Dosing(Day 7)
MDNA109 and IL2 were administered daily x5 for 2 cycles; anti-CTLA-4 administered twice weekly for two cycles*Asterisks indicate statistically significant difference as compared to Isotype group (*p<0.05; **p<0.01; ***p<0.001; ****p<0.0001).
********
**
****
****
Q1 2019 Medicenna Corporate Overview
MDNA109 is Not Immunogenic
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Antibody titers from terminal serum samples fromBalb/c mice. Vehicle group (n=8), Proleukin group(n=8) and MDNA109 group (n=8).
Antibody titers from terminal serum samples fromC57BL/6 mice. Vehicle group (n=10), Proleukingroup (n=10) and MDNA109 group (n=10).
Isotype Proleukin MDNA1090
500
1000
1500
Treatment Groups
Ant
ibod
y Ti
ter
Isotype
Proleukin
MDNA109
Isotype IL-2 MDNA1090
500
1000
1500
Ant
ibod
y Ti
ter
IsotyperhIL-2
MDNA109
Treatment GroupsTreatment Groups
Vehicle Proleukin MDNA109
Treatment Groups
Vehicle IL-2 MDNA109
Q1 2019 Medicenna Corporate Overview
MDNA109-Fc Has Similar In Vivo Potency But Superior PK Profile
27
• An optimized dose and schedule for the extended PK variant of MDNA109 has been identified
• MDNA109-Fc (0.75mg MDNA109/kg) enables effective B16F10 tumor control with a biweekly schedule, a similar schedule as anti-PD-1 antibodies used in mice
0 5 10 150
1000
2000
3000
Study Day
Tum
or v
olum
es (m
m3 )
Saline IP QD
MDNA109 1 mg/kg IP QD
MDNA109-Fc 2 mg/kg SQ BIW
B16F10 tumor model
Subcutaneous administration• Subcutaneous MDNA109-Fc is an advantageous administration approach for a future immunotherapy drug• Checkpoint inhibitors, Proleukin and competitor IL-2 therapies (NKTR-214, ALKS 4230) all require IV infusion, with
lengthy administration and monitoring time in the clinic• Subcutaneous administration offers fast and convenient administration that is typically preferred by patients for
common targeted cancer therapies (Stoner, 2014, PMID: 25015302; Jin, 2015, PMID: 26170642)
C57BL/6 mice implanted with 3 x 105 B16F10 cells subcutaneously in the right flank. Tumors were allowed to grow for 7 days prior to the initiation of the study. Average tumor volume was 70 mm3 when the animals were randomized. Treatment started on day 7. MDNA109 and IL2 were administered daily; MDNA109-Fc was administered twice weekly.
Treatment Start
****
Q1 2019 Medicenna Corporate Overview
Additional MDNA109 variants with optimized PK/PD properties
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Widening the Therapeutic Window of MDNA109
STAT5 Phosphorylation Assay Using Human PBMCs
Optimized variants that retain high potency towards CD8+ T cells and NK cells but decreased Treg activity (decreased CD25 binding).
****
*** ***
Q1 2019 Medicenna Corporate Overview
MDNA109 Product Concept: IL-2 variants improved drug profile
29
MDNA109: A Best-in-Class IL-2 Cytokine for Cancer Immunotherapy
PRODUCT MANUFACTURING CD122 POTENCY
PROTEIN VERSATILITY HALF-LIFE SAFETY IMMUNOGENICITY
Proleukin® Simple Low High Minutes Poor Low
NKTR-214 Complex Low Low Days Better than IL-2 Low
ALKS 4230 Simple Low Low Minutes to hrs Better than IL-2 N/A
Synthorins Complex Low Low Potentially Days N/A Potentially High
MDNA109-Fc Simple High High Potentially Days
Better than IL-2 Potentially Low
Q1 2019 Medicenna Corporate Overview
Leading the Way
31
Financial Snapshot
Q1 2019 Medicenna Corporate Overview
• Cash and cash receivable balance at September 30, 2018: CDN$3.0 million• Financing completed December 2018: CDN$4.0 million• Available to be drawn under CPRIT grant: up to US$4.1 million • Received to date from CPRIT grant: US$10.0 million• No Debt, No Preferred Shares
Issued and Outstanding28,578,137
Fully Diluted*36,153,562
* Fully diluted includes 3,294,105 warrants with a CND$2.00 exercise price and 2,250,000 stock options with a weighted average exercise price of CDN$2.09
TSX: MDNAOTCQB: MDNAF
Seasoned Management and Experienced Board
Q1 2019 Medicenna Corporate Overview
Management TeamFahar Merchant, PhD Chairman, President & CEOFormer CEO Sophiris Bio (TSX); Former Director, President & CTO at KS Biomedix (LSE); Founder, President & CEO of Avicenna Medica and IntelliGene Expressions
Elizabeth Williams, CPA,CA Chief Financial OfficerFormer VP Finance & Admin and interim CFO at Aptose (TSX and Nasdaq); Previously with Ernst & Young
Martin Bexon, MD Head of Clinical DevelopmentFormer Medical Director at CSL Behring; Medical Director at Hoffman La Roche (UK and Switzerland)
Nina Merchant, MESc. Chief Development OfficerFormer SVP Development at Sophiris Bio; Formerly VP Development at KS Biomedix (LSE); Previously at Avicenna Medica, IntelliGene, Pharmacia and Sanofi Pasteur
Shafique Fidai, PhD Head of Corp DevelopmentFormer VP of Business Development at Sophiris Bio; Formerly with Xenon Pharma, Chromos
Board of DirectorsFahar Merchant, PhD Chairman, President & CEO
Albert Beraldo, CPA, CA Independent DirectorFounder, 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 DirectorCEO, 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 DirectorFounder, 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 DirectorPartner 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
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World Class Advisors and Collaborators
Q1 2019 Medicenna Corporate Overview 33
Clinical and Scientific Advisors Collaborators and InventorsJohn Sampson, MD, PhD, MBADuke UniversityChair CAB and Expert in CNS immunotherapy and Drug Delivery to the Brain
David Reardon, MDDana Farber/HarvardClinical Director: Novel treatments for CNS Cancers
Krys Bankeiwicz, MD, PhDUniv of California San FranciscoProf of Neurosurgery: Expert in Convection Enhanced Delivery
Guido Kroemer, MD, PhDUniversity of ParisChair: SAB and Expert in Cancer Immunotherapy
Amy Heimberger, MDMD Anderson Cancer CenterProfessor of Neurosurgery and expert in GBM Immunotherapy
Sam Denmeade, MDJohn Hopkins UniversityProfessor of Oncology: Targeted therapies for cancer
Raj Puri, MDUSFDADirector at CBERInventor of MDNA55
Aaron Ring, MD, PhDYale UniversityAsst. Prof Immunobiology & Cancer BiologyCo-Inventor of IL-2 Superkines
Chris Garcia, PhDStanford UniversityCo-Inventor of IL-2, IL-4 and IL-13 Superkines
Haya Loberboum Galski, PhDHebrew University of JerusalemInventor of Fully Human Payloads
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Multiple Near-Term Value Inflection Milestones
Q1 2019 Medicenna Corporate Overview
MDNA55• Complete enrollment in Phase 2b rGBM trial• Report rGBM Phase 2b interim top-line results• End of Phase 2 meeting with FDA• Commence Phase 2a clinical trial in newly diagnosed brain cancer
MDNA109• Select lead candidate with extended half life• Complete dose range finding studies for pre-IND meeting with FDA• Complete IND enabling studies in preparation for Phase 1 clinical trial
Phase 2 clinical results for MDNA55
in rGBM
MDNA109 to be IND Ready
Q1 2019 35
MDNA55 — LEAD PROGRAM SUPERKINE PLATFORM MDNA109
TARGETS IL4R: EXPRESSED IN GBMCompelling Phase 1/2a Data in rGBM
ORPHAN/FAST TRACK Orphan Drug (FDA, EMA)
Fast Track (FDA)
IL-2; IL-4; IL-13Tunable cytokines
BEST IN CLASS IL-2 SUPER-AGONIST
PHASE 2B TRIAL NEARLY COMPLETE
Enrollment at 10 sites in the US including Centers of Excellence
4,000Brain tumor patients can be treated with 1 gram
of MDNA55
GROWING PIPELINE
Oncology, autoimmune andinflammatory
HIGH CD122 SELECTIVITY
250,000Annual incidence
of GBM and metastatic brain cancer2
2 BILLIONPotential market of MDNA55 market for brain cancer ($US)1,3
VALIDATED TARGETS
Industry transactions support further development
TUNABLE PKFc and Albumin Fusions
1. BioXcel Strategic Analysis Report, 2014.2. Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide 2012.3. Decision Resources, Inc Glioblastoma Report, Sept 2013.
Medicenna Corporate Overview
Thank You!Fahar Merchant, PhDPresident and Chief Executive [email protected]