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TSX: MDNAOTCQB: MDNAF
©2019 Medicenna. All Rights Reserved.
Q1 2020
Forward-Looking Statements
Q1 2020 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 24, 2019. 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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3
Medicenna Investment Highlights
Q1 2020 Medicenna Corporate Overview
LATE STAGE LEAD ASSET : Orphan Drug (US and EU) and Fast Track Status
PRE-CLINICAL ASSET: Industry validated target and deal heavy sector (THOR: $2.5 Billion acquisition Dec 2019)
COMPELLING INTERIM CLINICAL DATA: Phase 2b in recurrent glioblastoma
NEAR TERM MILESTONES: Clinical data set and FDA meeting 1H 2020
SIGNIFICANT MARKET OPPORTUNITY: $2 Billion in brain cancers
FUNDED THROUGH 2020: Public offering of $6.9M completed October 2019; in the money warrants; access to non-dilutive grant funding
SEASONED MANAGEMENT AND WORLD CLASS ADVISORS
4
Multiple Near-Term Value Inflection Milestones
Q1 2020 Medicenna Corporate Overview
MDNA55• Updated clinical data – MDNA55 (1H 2020)• End of Phase 2 meeting with FDA (1H 2020)
MDNA19• Complete non-GLP pharmacodynamic studies (1H 2020)• Pre-IND meeting with US FDA (2H 2020)• Complete IND enabling studies in preparation for Phase 1 clinical trial (2H 2020)• Initiate Phase 1 clinical trial (1H 2021)
Phase 2 clinical results for MDNA55
in rGBM
MDNA19 to be IND Ready
5
Financial Snapshot
Q1 2020 Medicenna Corporate Overview
• Cash balance at December 31, 2019: CDN$7.0 million
• Available to be drawn under CPRIT grant: up to US$1.4 million • No Debt, No Preferred Shares• Funded through 2020
Issued and Outstanding35,321,537
Fully Diluted*46,189,893
* Fully diluted includes 7.9 million warrants with an average exercise price of $1.68 and 3.1 million stock options with a weighted average exercise price of CDN$1.53
TSX: MDNAOTCQB: MDNAF
Robust Oncology and Immunotherapy Pipeline
Q1 2020 Medicenna Corporate Overview 6
Candidate Discovery Pivotal
MDNA55 Recurrent GBM
Brain Metastasis
Newly Diagnosed GBM (MGMT + VE)
Diffuse Intrinsic Pontine Glioma
MDNA57 Solid Tumors
MDNA19 Cancer Immunotherapies
MDNA209 Autoimmune Diseases
MDNA413 Solid Tumors, Atopic Dermatitis, Asthma, Fibrosis
MDNA132 Solid Tumors, IL 13Ralpha2 CAR-T
Preclinical Phase 1 Phase 2
MDNA55A Powerful Molecular Trojan Horse Targeting Glioblastoma
Patients experiencing long term survival after only one treatment vs. 6-8 months with standard of care
8
One Treatment with MDNA55 – Changing Patient Outcomes
Q1 2020 Medicenna Corporate Overview
“Life is too short…but it does not have to be. Every patient with GBM should have the “opportunity to receive MDNA55. I have benefited greatly from the treatment and I’m convinced that it has enriched the quality of my life.
MDNA55 Clinical Trial Patient
Everyday is a great day, but I’m extra grateful today that I ‘graduated’ (completed 12 months) from the MDNA55 phase 2 trial! And now we keep living, making memories, fighting & moving forward.
MDNA55 Clinical Trial Patient
“One year ago, marking progress from the Medicenna MDNA55 trial. Still shocked at how quickly the tumor evaporated. This is a serious breakthrough. I hope being experimented on will help other people access a treatment or cure.”
MDNA55 Clinical Trial Patient
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.
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)
Q1 2020 Medicenna Corporate Overview
10
MDNA55: A Potent IL4R Targeted Molecular Trojan Horse
Ø MDNA55: Targets the IL4R expressed in CNS tumors but not healthy brain
Ø Highly Selective: Avoids collateral damage to healthy brain
Ø Disrupts the Tumor Microenvironment (TME): Targets IL4R positive MDSCs and reversesTh2 bias
Ø Immunogenic Cell Death: Anti-tumor immunity is initiated and remains active after MDNA55 is cleared
Targeting DomainCircularly Permuted
Interleukin-4 (cpIL-4)
Lethal PayloadCatalytic domain of Pseudomonas Exotoxin A
ENDOCYTOSIS
FURIN PROTEASEADP RIBOSYLATION
Inhibit Protein Synthesis
CELL DEATH
NUCLEUS
(FDA approved in 2018, Moxetumomab pasudotox)
Q1 2020 Medicenna Corporate Overview
> 300 Patient Biopsies Analyzed Show IL-4R Over-Expression1-7
11
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 2020 Medicenna Corporate Overview
High-flow Image Guided Convection-Enhanced Delivery (CED) Improves Distribution to Tumoral & Peritumoral Areas
12
By-Passing the BBB: Single Local Administration of MDNA55
Q1 2020 Medicenna Corporate Overview
0
20
40
60
80
100
Sur
viva
l Rat
e at
12
mon
ths
(%)
0
2
4
6
8
10
12
14
16
18
20
Med
ian
Ove
rall
Surv
ival
(mon
ths)
Promising Efficacy of MDNA55 Compared to Approved
Therapies for rGBM
13
TMZ1,2Gliadel3 LOM4,5 Avastin4,6
MDNA55
n =
44
IL4R
Hig
h (
n=
21)
IL4
R H
igh
/ M
GM
T U
nm
eth
yl(n
=1
0)
IL4R
Hig
h / L
ow
Ste
ro
id (
n=
7)
n=
138
n=
31
n=
72
n=
46
n=
149
n=
50
n=
85
5.4 5.6
6.5
8.08.6
8.0
9.2
15.0
16.5
11.6
Overall Survival
(months)
OS-12 (%)
TMZ1,2Gliadel3 LOM4,5 Avastin4,6
MDNA55
n =
44
IL4
R H
igh
(n
=2
1)
IL4
R H
igh
/ L
ow
Ste
ro
id (
n=
7)
n=
138
n=
31
n=
72
n=
46
n=
149
n=
50
n=
85
18*
30*
12*
30
34
2622*
57
86
46
80
*Approximations based on Kaplan-Meier curve.
1 Brada et al., Ann Oncol. 2001;12(2):259–266.
2 Kim et al., J Clin Neuroscience 22 (2015) 468–473, 2015.
3 Gliadel FDA Label 2018
15.2
IL4
R H
igh
/ M
GM
T U
nm
eth
yl
(n=
10
)
n=
44
22
(M
GM
T U
nm
eth
yl)
n=
24
<19
(M
GM
T U
nm
eth
yl)
4 Taal et al., Lancet Oncol 2014 Aug;15(9):943-53.
5 Wick et al., N Engl J Med. 2017 Nov 16;377(20):1954-1963.
6 Friedman et al., J Clin Oncol. 2009 Oct 1;27(28):4733-40.
Q1 2020 Medicenna Corporate Overview
Improved Survival with MDNA55 Particularly in IL4R High Patients
14
Group N mOS(months) OS-12
MDNA55 44 11.6 46%
Group N mOS(months) OS-12
IL4R High 21 15.0 57%
IL4R Low 19 8.4 33%
44 Subjects (40 of 44 Subjects Evaluable for IL4R)
0 10 20 300
50
100
Months From Start of MDNA55 Treatment
Per
cent
sur
viva
l MDNA55 (n=44)
0 10 20 300
50
100
Months From Start of MDNA55 Treatment
Per
cent
sur
viva
l IL4R High (n= 21)
IL4R Low (n=19)
Log-rank p-value = 0.2175
Q1 2020 Medicenna Corporate Overview
Brain Cancer Market Opportunity for MDNA55
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
15
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
Q1 2020 Medicenna Corporate Overview
>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression
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Future Opportunity: 1 Million IL4R Cancers Annually
Glioblastoma
76%
Bladder
73%Breast
82%Colorectal
89%Head and Neck
75%
NSCLC
79%Mesothelioma
96%Ovarian
60%Pancreatic
60%
Medicenna Corporate OverviewQ1 2020
MDNA19: IL-2Super Agonist for Cancer Immunotherapy
Product Concept: Improved Version of Native IL-2 Proleukin®
18
Rationale for an Engineered IL-2 (MDNA19)
Why IL-2?• It has been proven to work as single-agent and can combine well with
other immunotherapy agents • At high doses, it stimulates the body’s immune system (T cells) to fight
cancer • Durable complete remissions in 5-8% of patients (kidney cancer and
Melanoma)
Why is improvement necessary? • Native IL2 causes vascular leak syndrome and other toxic side effects• Must be dosed in Intensive care unit due to life threatening toxicity • Frequent (3 times per day) high doses of Proleukin are required to
stimulate cancer fighting T cells which increases the toxic side effect
MDNA19 has been engineered to enhance efficacy of IL-2, improve safety AND reduce dosing to once every 2 weeks.
Atkins et. al, Cancer J Sci Am., 2000
ORR = 16%; 6% CR, 10% PR
Survival of Melanoma Patients Treated with
Proleukin
Q1 2020 Medicenna Corporate Overview
19
Charych, D. et al, Clin Cancer Res, 2016
Q1 2020
MDNA109-Alb + anti-CTLA4 (n=9/group)
MDNA109-Alb: 2.5 mg/Kg; 2x weekly for 2 weeks⍺CTLA4: 200 µg/dose; 2x weekly for 2 weeks
NKTR-214: 0.9 mg/kg every 9 days for 3 cycles⍺CTLA4: 100 µg/dose; 2x weekly
] Treatment duration0 10 20 30 40 50 60 100 150 200
0
200
400
600
800
1000
1200
1400
1600
1800
Days Post Treatment
Mea
n tu
mor
vol
ume
(mm
3 ±
SE
M)
Vehicle
Anti-CTLA-4
MDNA109-Alb
MDNA109-Alb + Anti-CTLA4
Re-challenge Re-challengeRe-challenge
0 25 50 75 100 150 175 200
0
200
400
600
800
1000
1200
1400
1600
1800
Days Post Treatment
Mea
n tu
mor
vol
ume
(mm
3 ±
SE
M)
Vehicle
Anti-CTLA-4
MDNA109-Alb
MDNA109-Alb + Anti-CTLA4
Anti-CTLA4
CT26 Colon Cancer Efficacy – MDNA vs. NKTRTumor controlled for 200 days and after 3 re-challenges compared with growth after 30 days after NKTR-214
Medicenna Corporate Overview
20
MDNA19: A Best-in-Class IL-2 Superkine for Cancer Immunotherapy
PRODUCT MANUFACTURING CD122 POTENCY HALF-LIFE SAFETY
Proleukin® Simple Low Minutes PoorMarketed product
NKTR-214 Complex Low Hours Better than IL-2$3.6 Billion licensing transaction
NL 201 Simple Similar to MDNA19 Similar to Proleukin Unknown
Pre-clinical US$400M market cap
Synthorins Complex Low Unknown Unknown$2.5 billion acquisition
MDNA19 Simple HighPotentially
HoursBetter than
IL-2Entering the clinic in 2021
Q1 2020 Medicenna Corporate Overview
Thank You!Elizabeth WilliamsChief Financial Officer
www.medicenna.com
Fahar Merchant, PhDPresident & CEO