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CORPORATE PRESENTATION Q2 2017 Targeting Microvascular Circulation

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Page 1: Q2 2017content.equisolve.net/diamedica/media/b3403da09f4130444b... · 2020. 7. 9. · Stroke Treatment Window Tissue Plasminogen Activator (tPA) ONSET 3 –4.5 hours 6 hours 48 HOURS

CORPORATE PRESENTATION

Q2 2017

Targeting Microvascular Circulation

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FORWARD LOOKING

STATEMENT

This presentation may contain forward-looking statements, which reflect

the Company's current expectation regarding future events. These

forward-looking statements involve risks and uncertainties that may cause

actual results, events, or developments to be materially different from any

future results, events, or developments expressed or implied by such

forward-looking statements. Such factors include, but are not limited to,

changing market conditions, the successful and timely completion of

clinical studies, the establishment of corporate alliances, the impact of

competitive products and pricing, new product development, uncertainties

related to the regulatory approval process or the ability to obtain drug

product in sufficient quantity or at standards acceptable to health

regulatory authorities to complete clinical trial or to meet commercial

demand, and other risks detailed from time to time in the Company's

ongoing quarterly and annual reporting. Certain of the assumptions made

in preparing forward-looking statements include but are not limited to the

following: that DM199 and other programs will generate positive efficacy

and safety data in preclinical and future clinical trials; that DiaMedica will

complete preclinical and clinical trials within the timelines communicated.

Except as required by applicable securities laws, we undertake no

obligation to publicly update or revise any forward-looking statements,

whether as a result of existing or new information, future events, or

otherwise.

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CLINICAL STAGED

BIOTECHNOLOGY

COMPANY

De-risked DM199 product (synthetic KLK1 protein)

KLK1 levels are low in patients with kidney diseases, stroke

& hypertension

DM199 being developed to normalize KLK1 levels

KLK1 proof-of-concept established, >$200M US sales in

Asia with human urinary & porcine sourced KLK1 proteins

Validation with strategic investment by Hermed Capital,

investment arm of:Fosun Pharma - one of the largest healthcare companies in

China; and

SK Group - Fortune Global 500 Company

DM199 replacement therapy for worldwide use

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DIAMEDICA: PIPELINE

Acute Ischemic StrokeIV/SQ Delivery - Recombinant KLK1

Optimal IV/SQ dose selection studies completed

Diabetic Kidney DiseaseSQ Delivery - Recombinant KLK1

Optimal IV/SQ dose selection study completed

PRE-CLINICAL PHASE I PHASE II PHASE III

DM199

DM199

Diabetic Kidney DiseaseOral Delivery - Recombinant KLK1

DM399

INDICATION PRODUCT

2017

2017

2017

KLK1-based testCompanion diagnostic

DMDx 2017

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TARGETING IMPAIRED

CAPILLARY BLOOD FLOW

CAUSE

Kidneys fail to rid the body of

wastes. High blood pressure &

diabetes are main causes.

No FDA approved treatments

Diabetic Kidney

Disease

Acute Ischemic Stroke

CAUSE

Blockage of blood flow in the brain

- 85% of strokes are acute ischemic

No FDA approved treatments

Beyond tPA’s 4 hour post stroke windowMulti-Billion Dollar

Therapeutic

Opportunities

Lower KLK1 levels

associated with worsening

kidney function, risk of

stroke & high blood

pressure

Hypertension

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KLK1: LEVELS SIGNIFICANTLY LOWER IN PATIENTS WITH

KIDNEY DISEASE & STROKE

1 Immunopharmacology 44 1999. 183–1922 Annals of Neurology (2011) 70:265-73

Lower KLK1 levels associated with worsening kidney function & risk of recurrent stroke

- Developing DMDx companion diagnostic

0

25

50

75

100

125

Urinary

KLK

1 L

evels

ng K

LK

1/n

g

AR

B

Normal Mild Severe (dialysis)

KLK1 Levels in Kidney Disease Patients1

By stage of Disease

Kidney Function

KLK1 Levels in Stroke Patients Post Stroke2

Event Free Survival at 60 months:

Kaplan-Meier Survival Curves by Quartile

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ACUTE ISCHEMIC STROKE:

DM199 COULD SIGNIFICANTLY EXTEND TREATMENT WINDOW

Stroke Treatment Window

Tissue

Plasminogen

Activator (tPA)

ONSET

3 – 4.5 hours

6 hours

48 HOURS

Relevant to potentially 90 – 95% of stroke patients

Mechanical

Thrombectomy

DM199

2412 36

<10% of stroke patients treated today

48 hours

Multi-billion Market Opportunity with >15 million strokes worldwide each year1

1www.world-stroke.org

1 in 6 people will have a stroke in their lifetime1

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$11+billion2

Chronic kidney disease

market

>11M patients in U.S.1

>100M in China

1USRDS 2013 ADR, CDC2Decision Resources, January 28, 20143Goto et al., 1995; Alhenc-Gelas et al., 2011

DIABETIC KIDNEY DISEASE (DKD)

DM199 COULD PROVIDE A TREATMENT OPTION

No approved treatments for DKD

Current standard of care are anti-hypertensive drugs

ACEi (i.e. Ramipril) & ARB’s (i.e. Valsartan)

However, associated with risk side effects including,

hyperkalemia, angiodemia and persistent cough

DM199 (KLK1) restores depleted KLK1 levelsACEi efficacy requires intact KLK1/bradykinin system3

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PRODUCT KAILIKANG®CARNACULIN &

KALLIDINOGENASEDM199

Source Human Urine KLK1 Porcine KLK1 Recombinant KLK1

CompanyTechpool:

Takeda & Shanghai Pharma J.V.

Sanwa Kagaku Kenkyusho,

Changzhou Qianhong & othersDiaMedica

Pro’s/Con’s

Supply limitations, risk of

endotoxins, impurities &

antibody formation

Risk of endotoxins, antibody

formation & impurities

Synthetic, very low cost,

unlimited supply

indications Acute ischemic strokeDiabetic kidney disease,

retinopathy & hypertension

Diabetic kidney disease &

acute ischemic stroke

Markets Asia Asia Worldwide

Sales/stage $50M+ USD Est. (IMS Health) $150M+ USD Est. (IMS Health) Clinical stage

TWO APPROVED FORMS OF KLK1 PROTEIN IN ASIA

DM199 is a Synthetic Form of KLK1 in Development for Worldwide Use

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DM199 MECHANISM OF ACTION

Restoring KLK1 Levels to Enhance Critical Signaling Molecules

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Issued composition of matter patents (2033)

New worldwide dose, route of administration, formulation & indication

patent coverage pending (2037)

Exclusivity with manufacturer on patented expression system

Manufacturing know-how & trade secrets

FDA exclusivities for new biological drug (12 years)

DM199 (recombinant KLK1) manufactured successfully

Produced at up to 200L (commercial scale) under cGMP

High expression levels and very stable

Very low manufacturing costs

DM199: MANUFACTURING & INTELLECTUAL PROPERTY

Successful

Manufacturing

Intellectual

Property

Successfully manufactured with strong intellectual property position

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121 Data on File, DiaMedica2 Sheng et al., Mudanjuang Medical College, 2016

DM199 AND KAILIKANG®

BOTH IMPROVE CEREBRAL BLOOD FLOW

Kailikang® increased blood flow by 101% vs.

control after 7 days treatment in stroke patientsDM199 increased blood flow by 37%

vs. control after a single dose

DM199 - Preclinical Neurological Model1

• Single dose

0

0.5

1

1.5

2

2.5

3

Baseline After Treatment

co

ntr

ol

contr

ol

uK

LK

1

uK

LK

1

*

Kailikang® (uKLK1) - Increased Blood Flow Post Stroke2

• 7 days daily dosing in 40 stroke patients

*P<0.005

80

120

160

200

co

ntr

ol

DM

19

9

rCB

Fin

isch

em

ic p

en

um

bra

CB

F %

ch

an

ge

fro

m b

ase

line

**P<0.005

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Well tolerated and nice safety profile in patientsDose limiting tolerability, orthostatic hypotension, consistent with mechanism

Active in patientsStatistically significant & dose dependent blood pressure changes in two clinical trials

Optimal clinical dosing identified

Based on comparison to approved version in Asia

Economically attractive

DM199 well tolerated & active in patients

Data on File, DiaMedica

Single Ascending, Multiple Ascending, Pharmacokinetics, One-Month Study &

Dosing Bridging Study in 130+ Patients

DM199: FIVE COMPLETED CLINICAL STUDIES

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DM199: IMPROVED BLOOD FLOW IN CLINICAL STUDY

Systolic Blood Pressure Change over 16 Days

DM199 15/25 mg/kg vs. placeboDM199 3 mg/kg vs. placebo

Systo

lic b

lood p

ressure

-supin

e

mm

/hg

Systo

lic b

lood p

ressure

–supin

e

mm

/hg

Time (hours) Time (hours)

Statistically significant decrease in systolic blood pressure

** p < 0.01** p < 0.01

Data on File, DiaMedica

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DM199: REFINED OPTIMAL DOSE HAS BEEN ESTABLISHED

DM199 Subcutaneous (SQ) and Intravenous (IV) Dosing Successful – 36 Patients

Identified optimal dose for Phase II/IIIDM199 IV mimics drug profile of IV urinary KLK1 (Kailikang®)

DM199 SQ superior PK profile that maintains KLK1 levels throughout day & anticipate improved efficacy

Data on File, DiaMedica

DM199 IV vs. SQ Profile

Pharmaco-

kineticsdrug levels

Pharmaco-

dynamicskinin levels

and

Approved

Porcine & Urinary

KLK1 Products

Compared

tovs

✔ ✔

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B O A R D

Rick Pauls, MBA

PRESIDENT & CEO

Previously co-founder &

Managing Director of life

sciences venture capital

fund

Todd Verdoorn, PhD

CHIEF SCIENTIFIC OFFICER

28+ years experience with

several neurological companies

including 5+ years at Bristol

Myer Squibb stroke group

M A N A G E M E N TDavid Gurvey, CPA, CMA

VP, FINANCE

CFO and senior accounting

positions with several public and

private companies

Richard Pilnik, MBA

CHAIRMAN

Former President,

Innovex (a Quintiles

Company), former VP

& Chief Marketing

Officer at Eli Lilly,

former board member

of Elan Pharma

(acquired)

Michael Giuffre, MD, MBA

DIRECTOR

Clinical Professor of

Cardiac Sciences at

University of Calgary, BOD

FoodChek Inc, BOD

Canadian Medical

Association; BOD SCS Inc.

Rick Pauls, MBA

PRESIDENT & CEO

Previously co-founder

& Managing Director of

life sciences venture

capital fund.

Jerry Xiao, PhD

DIRECTOR

Managing Director of

Hermed Capital,

previously Associate

General Manager of

Fosun Pharmaceutical

- deputy chief of IPO

James Parsons, CPA-CA

DIRECTOR

CFO at Trillium, a Nasdaq

listed biotech company.

Has been CFO of life

sciences companies for last

15 years.

Paul Papi

VP BUSINESS

DEVELOPMENT

38+ years life sciences

experience, 28 years Mylan,

10 years investment banking,

business dev., capital markets

& M&A transactions

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SUMMARY DM199 REPLACEMENT THERAPY:

Synthetic KLK1 protein normalizing KLK1 levels in patients with

kidney disease & after ischemic stroke

Proof-of-concept established: >$200M sales of porcine & human KLK1

3rd party validation: Fosun Pharma/SK Group investment

DM199 optimal dose established: vs. approved Asian version

Multi-billion dollar market opportunities: worldwide use

De-risked approach to drug development

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THANK YOU

Targeting Microvascular Circulation

TSXV:DMA OTCQB:DMCAF