CORPORATE PRESENTATION
Q2 2017
Targeting Microvascular Circulation
2
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.
3
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
4
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
5
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
6
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
7
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
8
$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
9
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
10
DM199 MECHANISM OF ACTION
Restoring KLK1 Levels to Enhance Critical Signaling Molecules
11
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
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
13
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
14
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
15
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
✔ ✔
16
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
17
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
THANK YOU
Targeting Microvascular Circulation
TSXV:DMA OTCQB:DMCAF
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