Q1 2020 Retail Deckfilecache.investorroom.com/mr5ircnw_medicenna/204/Q1 2020... · 2020. 3. 3. ·...

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.

2

3

Medicenna Investment Highlights


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


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


• 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


“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.


“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 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)


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)


> 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.


High-flow Image Guided Convection-Enhanced Delivery (CED) Improves Distribution to Tumoral & Peritumoral Areas

12

By-Passing the BBB: Single Local Administration of MDNA55


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.


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


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


>2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression

16

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


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


Thank You!Elizabeth WilliamsChief Financial Officer

www.medicenna.com

Fahar Merchant, PhDPresident & CEO

Q1 2020 Retail Deckfilecache.investorroom.com/mr5ircnw_medicenna/204/Q1 2020... · 2020. 3. 3. ·...

Documents

Transcript of Q1 2020 Retail Deckfilecache.investorroom.com/mr5ircnw_medicenna/204/Q1 2020... · 2020. 3. 3. ·...