- Phase II Study of DM199 in Chronic Kidney Disease Commences
Screening
- REMEDY Phase II Study of DM199 in Acute Ischemic Stroke
Completes Enrollment
- Management Team Strengthens with Sydney Gilman, Ph.D., Vice
President of Regulatory Affairs
- Conference Call with Management Tomorrow, November 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 provided a
business update and reported its financial results for the three
and nine months ended September 30, 2019.
Clinical Developments
DM199 for the Treatment of Chronic Kidney Disease
Phase Ib Clinical Study in Patients with CKD
Completed
DiaMedica has completed its Phase Ib clinical trial of DM199, a
recombinant form of the endogenous human tissue kallikrein protein
(KLK1), in patients with moderate or severe Chronic Kidney Disease
(CKD) caused by Type I or Type II diabetes mellitus. The study was
performed to assess the pharmacokinetics (PK) of three dose levels
of DM199 (3, 5 and 8 µg/kg), administered in a single subcutaneous
dose, as well as the evaluation of safety, tolerability and
secondary pharmacodynamic (PD) endpoints.
The Company previously announced positive interim results. PK
profiles, at the 3µg/kg dose level, were similar between moderate
and severe CKD patients, and consistent with healthy subjects
(normal kidney function) tested previously. Therefore, the Company
does not believe dosing adjustment is warranted, based on the
presence or severity of CKD and a full renal study will likely not
be required. Final study results indicated that DM199 was observed
to be well tolerated with no dose-limiting tolerability. There were
no deaths, no discontinuations due to a treatment-related adverse
event (AE), and no treatment-related significant adverse events
(SAEs). AEs were minor and consistent with standard treatment(s) in
the CKD patient population.
Favorable overall PD results were also observed including
short-term improvements in Nitric Oxide (NO), average increase of
35.2%, Prostaglandin E2 (PGE2), average increase of 41.2%,
estimated glomerular flow rate (eGFR), average increase of 4.08
mL/min/1732, and the urinary albumin to creatinine ratio (UACR),
average decrease of 18.7%. PD results appeared to be drug related
in that greatest improvements occurred at approximately 24 hours
after DM199 administration and subsequently declined.
DiaMedica intends to release full study results at an upcoming
conference, including a breakout analysis of moderate and severe
patients and results by dose level.
Phase II Clinical Study in CKD Caused by IgA
Nephropathy and African Americans with Hypertension – Screening
Commenced
The U.S. Food and Drug Administration (FDA) has accepted the
Company’s Phase II clinical trial protocol for the treatment of CKD
caused by rare or significant unmet diseases. This study is
designed to investigate the safety, efficacy, PK and PD of DM199.
Screening of patients has commenced and the enrollment and dosing
is expected in the near term.
The Phase II trial named REDUX, latin for restore, is a
multi-center, open-label investigation of approximately 60
participants with CKD, who are being enrolled in two cohorts (30
per cohort). The study is being conducted in the United States at
up to 10 sites and will be focused on participants with CKD: Cohort
I is focused on non-diabetic, hypertensive African Americans with
Stage II or III CKD. African Americans are at greater risk for CKD
than Caucasians, and those 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 focused on participants with IgA Nephropathy (IgAN). The study
will evaluate two dose levels of DM199 within each cohort. Study
participants 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 eGFR and
albuminuria, as measured by the UACR.
“We are pleased with the results from our CKD Phase Ib study and
our ability to now commence Phase II studies,” commented Dr. Harry
Alcorn, DiaMedica’s Chief Medical Officer. “We look forward to our
Phase II study building on our successful Phase Ib data and we have
engaged a number of study sites that have the patient populations
and experience in obtaining high quality data to better understand
the potential of DM199 in benefitting individuals suffering with
CKD, whose current treatment options are very limited.”
DM199 for the Treatment of Acute Ischemic Stroke
DM199 Acute Ischemic Stroke Phase II “REMEDY”
Trial Update – Enrollment Completed
DiaMedica has recently completed enrollment in the REMEDY trial,
the Company’s Phase II study assessing the safety, tolerability and
markers of therapeutic efficacy of DM199 in participants suffering
from Acute Ischemic Stroke (AIS). Final enrollment was 92
participants. The markers of therapeutic efficacy will include
multiple plasma-based biomarkers (e.g. C-reactive protein), the
Modified Rankin Scale, National Institutes of Health Stroke Scale
and the Barthel Index. These markers are assessed at multiple
points throughout the study, including 90 days post-stroke.
Organizational Update
Dr. Sydney A. Gilman has joined DiaMedica as its Vice President
of Regulatory Affairs. Dr. Gilman has over 30 years of
pharmaceutical industry experience holding senior positions
including at Elan Pharmaceuticals and Amylin Pharmaceuticals. Dr.
Gilman also spent six years as a CMC reviewer with the FDA’s Center
for Drug Evaluation and Research group. In his most recent role as
founder and Senior Regulatory Consultant of Trident Rx Consulting,
Dr. Gilman has been involved in the development and implementation
of strategic plans for drug development and regulatory strategy for
new drugs and biologics. In addition he has lead a variety of
global regulatory submissions, including INDs, NDAs, BLAs, MAAs,
global CTAs, 510Ks, PMAs, orphan and Fast Track submissions, and
clinical study reports.
“We continue to make great progress with our clinical programs
with the commencement of our Phase II CKD studies and the
completion of enrollment in our REMEDY Phase II study, and I wish
to thank our clinical team for their skill and dedication,” stated
Rick Pauls, DiaMedica’s President and CEO. “I would also like to
welcome Dr. Gilman, who is a strong addition at this critical time.
His proven track record in leading regulatory affairs is
instrumental as we transition DM199 into Phase II and Phase III
clinical trials and work to improve the lives of CKD and AIS
patients.”
Financial Results
Research and development (R&D) expenses increased to $1.6
million for the three months ended September 30, 2019, up from $1.2
million for the three months ended September 30, 2018, an increase
of $0.4 million. R&D expenses increased to $6.1 million for the
nine months ended September 30, 2019, compared to $3.1 million for
the nine months ended September 30, 2018, an increase of $3.0
million. The increase for the nine months ended September 30, 2019
was due to costs of approximately $1.4 million incurred for a new
production run of the DM199 drug substance, as well as costs
incurred in conjunction with the Phase Ib and Phase II clinical
studies in CKD patients and related non-clinical testing. Increased
personnel and non-cash share-based compensation costs also
contributed to the increase. The increase for the three months
ended September 30, 2019 was due to costs incurred in conjunction
with the Phase Ib and Phase II CKD studies and non-cash share-based
compensation costs, partially offset by a decline in costs incurred
in conjunction with the REMEDY Phase II stroke study.
General and administrative (G&A) expenses were $1.0 million
for the three months ended September 30, 2019, compared to $777,000
for the three months ended September 30, 2018. G&A expenses
increased to $2.7 million for the nine months ended September 30,
2019, up from $2.1 million for the nine months ended September 30,
2018. These increases were primarily due to costs associated with
our status as a Nasdaq-listed U.S. public reporting company, which
commenced in December 2018, including increased professional
services, compliance and non-cash share-based compensation costs.
Increased personnel costs also contributed to the increase on a
year to date basis.
Total other income increased to $225,000 for the three months
ended September 30, 2019, up from $157,000 for the prior year
period. Total other income decreased to $683,000 for the nine
months ended September 30, 2019, compared to $946,000 for the nine
months ended September 30, 2018. The year-to-date decrease is
primarily related to the initial recognition of R&D incentives
from the Australian Government paid for qualifying research work
performed by DiaMedica Australia Pty Ltd. during the nine months
ended September 30, 2018. The increase in the quarterly comparison
relates to increased study costs, compared to the prior year
period, driving an increase in the eligible R&D incentive. The
year-to-date decrease was partially offset by, and the current
quarter increase was augmented by, increased interest income earned
on marketable securities during the three and nine months ended
September 30, 2019.
Balance Sheet and Cash Flow
The Company had cash and cash equivalents of $4.7 million,
marketable securities of $5.0 million, current liabilities of $1.3
million and working capital of $9.6 million as of September 30,
2019, compared to $16.8 million in cash and cash equivalents, $1.3
million in current liabilities and $16.7 million in working capital
as of December 31, 2018. The decreases in combined cash and cash
equivalents and marketable securities and in working capital are
due primarily to the Company’s operating loss incurred for the nine
months ended September 30, 2019.
Net cash used in operating activities was $7.2 million for the
nine months ended September 30, 2019, compared to $3.8 million for
the nine months ended September 30, 2018. The net cash used in each
of these periods primarily reflects the net loss for these periods,
and was partially offset by non-cash charges for stock-based
compensation and the net effects of changes in operating assets and
liabilities.
Conference Call Information
DiaMedica management will host a conference call to discuss
these results on Thursday, November 14, 2019, at 7:00 a.m. Central
Time:
Date:
Thursday, November 14, 2019
Time:
7:00 AM CT / 8:00 AM ET
Web access:
https://event.on24.com/wcc/r/2120577/625481B71D93A3177784DC7A779612B0
Dial In:
(844) 557-8483 (domestic)
(825) 312-2381
(international)
Conference ID:
4594493
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 our 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 November 21, 2019, by dialing (800) 585-8367 (US
Toll Free), (416) 621-4642 (International), replay passcode
4594493.
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 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 STATEMENT 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 success of DM199, 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, 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; the perceived benefits of
DM199 over existing treatment options; ability to obtain required
regulatory approvals; the potential size of the markets for DM199
and its ability to serve those markets; the success, cost and
timing of planned clinical trials, as well as reliance on
collaboration with third parties to conduct clinical trials; its
ability 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, 2018, 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 September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Operating revenues:
License revenues
$
—
$
500
$
—
$
500
Operating expenses:
Research and development
1,617
1,210
6,098
3,071
General and administrative
1,044
777
2,725
2,073
Operating loss
(2,661
)
(1,487
)
(8,823
)
(4,644
)
Other (income) expense:
Governmental assistance -
research incentives
(263
)
(196
)
(663
)
(1,046
)
Other (income) expense, net
38
39
(20
)
61
Change in fair value of warrant
liability
—
—
—
39
Total other (income) expense
(225
)
(157
)
(683
)
(946
)
Loss before income tax
expense
(2,436
)
(1,330
)
(8,140
)
(3,698
)
Income tax expense
12
57
29
74
Net loss
(2,448
)
(1,387
)
(8,169
)
(3,772
)
Other comprehensive income
Unrealized (gain) loss on
marketable securities
5
—
(6
)
—
Net loss and comprehensive
loss
$
(2,453
)
$
(1,387
)
$
(8,163
)
$
(3,772
)
Basic and diluted net loss per
share
$
(0.20
)
$
(0.18
)
$
(0.68
)
$
(0.51
)
Weighted average shares
outstanding – basic and diluted
12,006,874
7,836,683
11,981,233
7,406,378
DiaMedica Therapeutics
Inc. Consolidated Balance Sheets (In thousands, except
share amounts)
September 30, 2019
December 31, 2018
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
4,741
$
16,823
Marketable securities
5,002
—
Amounts receivable
664
780
Deposits
310
—
Prepaid expenses and other
assets
89
369
Total current assets
10,806
17,972
Non-current assets:
Operating lease right-of-use
asset
165
—
Property and equipment, net
68
96
Deposits
—
271
Total non-current assets
233
367
Total assets
$
11,039
$
18,339
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
312
$
483
Accrued liabilities
837
808
Finance lease obligation
5
5
Operating lease obligation
51
—
Total current liabilities
1,205
1,296
Non-current liabilities:
Finance lease obligation,
non-current
14
18
Operating lease obligation,
non-current
120
—
Total non-current liabilities
134
18
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
63,831
62,993
Accumulated other comprehensive
income
6
—
Accumulated deficit
(54,137
)
(45,968
)
Total shareholders’ equity
9,700
17,025
Total liabilities and
shareholders’ equity
$
11,039
$
18,339
DiaMedica Therapeutics
Inc. Consolidated Statements of Cash Flows (In
thousands) (Unaudited)
Nine Months Ended September
30,
2019
2018
Cash flows from operating
activities:
Net loss
$
(8,169
)
$
(3,772
)
Adjustments to reconcile net loss
to net cash used in operating activities:
Share-based compensation
763
555
Amortization of discount on
marketable securities
(68
)
—
Non-cash lease expense
36
—
Depreciation
16
10
Change in fair value of warrant
liability
—
39
Changes in operating assets and
liabilities:
Amounts receivable
116
(963
)
Prepaid expenses
280
(99
)
Deposits
(39
)
—
Accounts payable
(171
)
(264
)
Accrued liabilities
(1
)
698
Net cash used in operating
activities
(7,237
)
(3,796
)
Cash flows from investing
activities:
Purchase of marketable
securities
(10,928
)
—
Maturities of marketable
securities
6,000
—
Disposition of property and
equipment, net
12
—
Purchase of property and
equipment
—
(63
)
Net cash used in investing
activities
(4,916
)
(63
)
Cash flows from financing
activities:
Proceeds from the exercise of
stock options
75
43
Principal payments on finance
lease obligations
(4
)
—
Proceeds from issuance of common
shares and warrants, net of offering costs
—
5,840
Proceeds from the exercise of
common share purchase warrants
—
521
Net cash provided by financing
activities
71
6,404
Net increase (decrease) in cash
and cash equivalents
(12,082
)
2,545
Cash and cash equivalents at
beginning of period
16,823
1,353
Cash and cash equivalents at end
of period
$
4,741
$
3,898
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191113005516/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
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