- DM199 Met Primary Safety and Tolerability Endpoints in
ReMEDy Study Top-Line Data
- Demonstrated Therapeutic Effect in Patients Not Pre-treated
with Mechanical Thrombectomy
- DiaMedica Completes $8.5M Public Offering of Common
Shares
- Cash and Investments of $12.6 Million; Runway Through
2021
- Conference Call with Management Tomorrow, May 14 at 7am
CT
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for kidney diseases and neurological disorders, today announced
positive top-line results from ReMEDy, its Phase II study in acute
ischemic stroke (AIS), as well as provided a business update and
financial results for the three months ended March 31, 2020.
DiaMedica will host a conference call with slides tomorrow, May 14,
2020, at 7:00 a.m. Central Time to discuss its ReMEDy top-line
data, business update and first quarter financial results. In
conjunction with this release, DiaMedica also issued today a
separate more detailed release on the ReMEDy top-line data.
Clinical Developments
DM199 for the Treatment of Acute Ischemic Stroke
DM199 Acute Ischemic Stroke Phase II “ReMEDy”
Trial – Positive Top-Line Data
DiaMedica today announced positive top-line results from its
ReMEDy trial, a Phase II study assessing the safety, tolerability
and therapeutic potential of DM199 in participants suffering from
AIS. Final enrollment was 92 participants. The markers of
therapeutic efficacy included the National Institutes of Health
Stroke Scale, Modified Rankin Scale and the Barthel Index and
multiple plasma-based biomarkers (e.g. C-reactive protein). These
markers were assessed at multiple points throughout the study,
including 90 days post-stroke.
DM199 met primary safety and tolerability endpoints and no
DM199-related serious adverse events were noted in the study.
According to top-line phase II results, there was also a
demonstrated therapeutic effect in participants who received tissue
plasminogen activator (tPA) prior to enrollment, but not in
participants receiving mechanical thrombectomy.
"We are very excited about the positive top-line results which
continue to demonstrate the excellent safety profile of DM199 and
efficacy signals which are consistent with the approval study for
Kailikang®, the urine-derived form of KLK1 which has been used to
successfully treat stroke patients in China for years,” stated Rick
Pauls, DiaMedica’s President and CEO. “These results strengthen our
belief that DM199 can be a valuable treatment option for stroke
victims, improving outcomes while providing a significantly longer,
up to 24 hours, after onset of the stroke. We look forward to
discussing a path to commercialization with the FDA.”
DM199 for the Treatment of Chronic Kidney Disease
Phase II Clinical Study in CKD Caused by IgA
Nephropathy and in African Americans with Hypertension – Enrollment
Continues
The Phase II REDUX (latin for restore) trial is a multi-center,
open-label investigation of approximately 60 participants with
chronic kidney disease (CKD), who are being enrolled in two cohorts
(30 per cohort). The study is ongoing in the United States at 12
sites and targets participants with CKD: Cohort I is enrolling
non-diabetic, hypertensive African Americans with Stage II or III
CKD, a group which is at greater risk for CKD than Caucasians.
African Americans who have the APOL1 gene mutation are at an even
higher risk. The study is designed to capture the APOL1 gene
mutation as an exploratory biomarker in this cohort. Cohort II is
enrolling participants with IgA Nephropathy (IgAN). The overall
study evaluates two dose levels of DM199. Study participants in
each cohort will receive DM199 by subcutaneous injection twice
weekly for 95 days. The primary study endpoints include safety,
tolerability, blood pressure, proteinuria and kidney function,
which will be evaluated by changes from baseline in estimated
glomerular filtration rate (eGFR) and albuminuria, as measured by
the urinary albumin to creatinine ratio (UACR).
Due to actions implemented to combat the novel strain of the
coronavirus (COVID-19) pandemic, the Company is experiencing slower
than expected enrollment in the REDUX clinical study as activities
are reduced or suspended at the clinical study sites as they
address staff and patient safety concerns.The Company currently
expects a delay in the timing of costs incurred as a result of the
COVID-19 pandemic, but not a significant overall increase. The
Company will continue to assess the effect of the pandemic on its
REDUX trial by monitoring the spread of the COVID-19 virus and the
actions implemented to combat the virus.
“Our highest priority right now is to protect the safety of
subjects and clinical staff participating in the REDUX trial, and
we believe that we have accomplished that” commented Dr. Harry
Alcorn, DiaMedica’s Chief Medical Officer. “While enrollment has
significantly slowed, we believe that the measures taken will allow
our study to resume more normal rates of enrollment as COVID-19
related restrictions are eased.”
Public Offering of Common Shares
On February 13, 2020, the Company issued and sold an aggregate
of 2,125,000 common shares in a public, underwritten offering at a
public offering price of $4.00 per share. As a result of the
offering, the Company received gross proceeds of $8.5 million and
net proceeds of $7.7 million, after deducting the underwriting
discount and offering expenses.
Financial Results
Research and development (R&D) expenses were $1.4 million
for the three months ended March 31, 2020, compared with $2.6
million for the three months ended March 31, 2019, a decrease of
$1.2 million. The decrease was due to costs incurred during the
first quarter of 2019 which did not reoccur during the first
quarter of 2020, primarily the costs for a production run of the
DM199 drug substance and the Phase Ib study in CKD patients.
Declining costs for the ReMEDy study in the current year period
also contributed to the decrease. These decreases were partially
offset by costs incurred for the REDUX study, which began
enrollment in December 2019, and increased non-cash share-based
compensation costs.
General and administrative (G&A) expenses were $1.0 million
for the three months ended March 31, 2020, up from $814,000 for the
three months ended March 31, 2019. The increase in G&A expenses
resulted primarily from increased non-cash share-based compensation
costs.
Total other (income) expense, net, for the three months ended
March 31, 2020 was a net expense of $12,000, compared with net
income of $178,000 for the three months ended March 31, 2019. The
change was primarily caused by the foreign currency transaction
losses associated with funds held in non-functional currency (US
dollar) accounts, principally Australian dollars. A decrease in
R&D incentives, associated with decreased ReMEDy costs and
reductions in interest income earned on marketable securities
during the three months ended March 31, 2020, also contribute to
this change.
Balance Sheet and Cash Flow
The Company had cash, cash equivalents and marketable securities
of $12.6 million, current liabilities of $0.9 million and working
capital of $13.2 million as of March 31, 2020, compared to $7.9
million in cash, cash equivalents and marketable securities, $1.3
million in current liabilities and $7.5 million in working capital
as of December 31, 2019. The increases in the Company’s combined
cash, cash equivalents and marketable securities and in its working
capital are due primarily to the February 2020 public offering of
common shares.
Net cash used in operating activities was $3.0 million for the
three months ended March 31, 2020, compared to $3.1 million for the
three months ended March 31, 2019. The net cash used in each of
these periods primarily reflects the net loss for these periods,
offset by non-cash charges for stock-based compensation and
adjusted for the net effects of changes in operating assets and
liabilities.
Conference Call Information
DiaMedica Management will host a conference call to discuss both
its first quarter 2020 financial results and the top-line results
from its ReMEDy study on Thursday, May 14, 2020, at 7:00 a.m.
Central Time:
Date:
Thursday, May 14, 2020
Time:
7:00 AM CT / 8:00 AM ET
Web access:
https://event.on24.com/wcc/r/2158468/5BAA62D375A1F892573859D379BAF858
Dial In:
(833) 502-0492 (domestic)
(778) 560-2558
(international)
Conference ID:
8757888
Interested parties may access the conference call by dialing in
or listening to the simultaneous webcast. Listeners should log on
to the website or dial in 15 minutes prior to the call. The webcast
will remain available for play back on DiaMedica’s website, under
investor events and presentations, following the earnings call and
for 12 months thereafter. A telephonic replay of the conference
call will be available until May 21, 2020, by dialing (800)
585-8367 (US Toll Free), (416) 621-4642 (International), replay
passcode 8757888.
About DM199
DM199 is a recombinant (synthetic) form of the human serine
protease, KLK1. The KLK1 protein plays an important role in the
regulation of diverse physiological processes including blood flow,
inflammation, fibrosis, oxidative stress and neurogenesis via a
molecular mechanism that increases production of nitric oxide and
prostaglandin. KLK1 deficiency may play a role in multiple vascular
and fibrotic diseases such as chronic kidney disease, retinopathy,
stroke, vascular dementia, and resistant hypertension where current
treatment options are limited or ineffective. DiaMedica is the
first company to have developed a recombinant form of the KLK1
protein. The KLK1 protein, produced from porcine pancreas and human
urine, has been used to treat patients in Japan, China and Korea
for decades. DM199 is currently being studied in patients with
chronic kidney disease and patients with acute ischemic stroke.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage
biopharmaceutical company focused on developing novel treatments
for chronic kidney diseases and neurological disorders. DiaMedica
shares are listed on The Nasdaq Capital Market under the trading
symbol “DMAC.”
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and forward-looking information that are based on the beliefs
of management and reflect management’s current expectations. When
used in this press release, the words “estimate,” “believe,”
“anticipate,” “intend,” “expect,” “plan,” “continue,” “look
forward,” “will,” “may” or “should”, the negative of these words or
such variations thereon or comparable terminology and the use of
future dates are intended to identify forward-looking statements
and information. The forward-looking statements and information in
this press release include statements regarding the anticipated
clinical benefits and success of DM199, the safety and efficacy of
DM199; the assessment of the data from the ReMEDy study and the
future publication and sharing of the full study results, and
regulatory path forward, the timing and requirements of its
clinical programs, including enrollment and clinical results and
ability to achieve clinical milestones. Such statements and
information reflect management’s current view and DiaMedica
undertakes no obligation to update or revise any of these
statements or information. By their nature, forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause actual results, performance or
achievements, or other future events, to be materially different
from any future results, performance or achievements expressed or
implied by such forward-looking statements. Applicable risks and
uncertainties include, among others, the possibility of unfavorable
results from additional clinical trials of DM199 or from subsequent
analysis of existing data from the ReMEDy study or existing or new
data received from additional ongoing and future studies of DM199;
the risk that existing preclinical and clinical data may not be
predictive of the results of ongoing or later clinical trials;
DiaMedica’s plans to develop, obtain regulatory approval for and
commercialize its DM199 product candidate for the treatment of CKD
and AIS and its expectations regarding the benefits of DM199;
DiaMedica’s ability to conduct successful clinical testing of DM199
and within its anticipated parameters, costs and timeframes; the
perceived benefits of DM199 over existing treatment options; the
potential direct or indirect impact of the COVID-19 pandemic on
DiaMedica’s business; its reliance on collaboration with third
parties to conduct clinical trials; its ability to continue to
obtain funding for its operations, including funding necessary to
complete planned clinical trials and obtain regulatory approvals
for DM199 for CKD and AIS, and the risks identified under the
heading “Risk Factors” in DiaMedica’s annual report on Form 10-K
for the fiscal year ended December 31, 2019, and subsequent SEC
filings by DiaMedica. The forward-looking information contained in
this press release represents the expectations of DiaMedica as of
the date of this press release and, accordingly, is subject to
change after such date. Readers should not place undue importance
on forward-looking information and should not rely upon this
information as of any other date. While DiaMedica may elect to, it
does not undertake to update this information at any particular
time except as required in accordance with applicable laws.
DiaMedica Therapeutics
Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and
per share amounts)
(Unaudited)
Three Months Ended
March 31,
2020
2019
Operating expenses:
Research and development
$
1,381
$
2,607
General and administrative
1,023
814
Operating loss
(2,404
)
(3,421
)
Other (income) expense:
Governmental assistance -
research incentives
(115
)
(174
)
Other (income) expense, net
127
(4
)
Total other (income) expense
12
(178
)
Loss before income tax
expense
(2,416
)
(3,243
)
Income tax expense
9
9
Net loss
(2,425
)
(3,252
)
Other comprehensive income
Unrealized gain on marketable
securities
40
3
Net loss and comprehensive
loss
$
(2,385
)
$
(3,249
)
Basic and diluted net loss per
share
$
(0.19
)
$
(0.27
)
Weighted average shares
outstanding – basic and diluted
13,107,725
11,956,874
DiaMedica Therapeutics
Inc.
Consolidated Balance
Sheets
(In thousands, except share
amounts)
March 31, 2020
December 31, 2019
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
3,300
$
3,883
Marketable securities
9,348
3,995
Amounts receivable
985
823
Prepaid expenses and other
assets
337
47
Deposits
195
88
Total current assets
14,165
8,836
Non-current assets:
Operating lease right-of-use
asset
140
153
Property and equipment, net
60
64
Total non-current assets
200
217
Total assets
$
14,365
$
9,053
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
444
$
182
Accrued liabilities
435
1,076
Finance lease obligation
6
6
Operating lease obligation
50
54
Total current liabilities
935
1,318
Non-current liabilities:
Finance lease obligation,
non-current
11
13
Operating lease obligation,
non-current
96
105
Total non-current liabilities
107
118
Shareholders’ equity:
Common shares, no par value;
unlimited authorized; 12,006,874 and 11,956,874 shares issued and
outstanding, as of September 30, 2019 and December 31, 2018,
respectively
—
—
Additional paid-in capital
72,323
64,232
Accumulated other comprehensive
income
42
2
Accumulated deficit
(59,042
)
(56,617
)
Total shareholders’ equity
13,323
7,617
Total liabilities and
shareholders’ equity
$
14,365
$
9,053
DiaMedica Therapeutics
Inc.
Consolidated Statements of
Cash Flows
(In thousands)
(Unaudited)
Three Months Ended March
31,
2020
2019
Cash flows from operating
activities:
Net loss
$
(2,425
)
$
(3,252
)
Adjustments to reconcile net loss
to net cash used in operating activities:
Share-based compensation
393
130
Amortization of discount on
marketable securities
(14
)
(26
)
Non-cash lease expense
13
12
Depreciation
6
6
Changes in operating assets and
liabilities:
Amounts receivable
(162
)
(150
)
Prepaid expenses
(290
)
72
Deposits
(107
)
—
Accounts payable
262
201
Accrued liabilities
(654
)
(127
)
Net cash used in operating
activities
(2,978
)
(3,134
)
Cash flows from investing
activities:
Purchase of marketable
securities
(8,799
)
(10,928
)
Maturities of marketable
securities
3,500
—
Purchase of property and
equipment
(2
)
—
Net cash used in investing
activities
(5,301
)
(10,928
)
Cash flows from financing
activities:
Proceeds from issuance of common
shares, net of offering costs
7,682
—
Proceeds from the exercise of
stock options
16
—
Principal payments on finance
lease obligations
(2
)
(2
)
Net cash provided by financing
activities
7,696
(2
)
Net increase (decrease) in cash
and cash equivalents
(583
)
(14,064
Cash and cash equivalents at
beginning of period
3,883
16,823
Cash and cash equivalents at end
of period
$
3,300
$
2,759
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200513005761/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
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