Conference Call and Webcast May 16 at 8:00
am Eastern Time / 7:00 am Central Time
- Company Completed In-Use Study, Results Support Proposed
ReMEDy2 IV Dose Revision
- Company Completed a Phase 1C Study in Healthy Volunteers in
Australia Affirming Proposed Revised DM199 IV Dose of 0.5 µg/kg for
Continuing the ReMEDy2 Trial
- DiaMedica Plans to File Complete Clinical Hold Response This
Week
- Cash Runway Into Q4 2024
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for neurological disorders and kidney diseases, today provided a
business update and financial results for the quarter ended March
31, 2023. Management will host a conference call Tuesday, May 16,
2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time
to discuss its business update and first quarter 2023 financial
results.
Clinical Developments
ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke – Clinical
Hold Update
DiaMedica plans to file complete response requesting hold lift
this week
DiaMedica plans to file a clinical hold response with the U.S.
Food and Drug Administration (FDA) by the end of the week. This
request for lifting the clinical hold will include the submission
of requested additional supporting data to address prior issues
that led to the clinical hold in July 2022. DiaMedica has completed
supplemental in-use studies as requested by the FDA. These studies,
performed at an independent laboratory, were conducted in two
parts. Part 1 simulated actual use of DM199 administration in a
hospital setting and Part 2 evaluated worst-case scenarios such as
varying storage durations, temperature(s) and light exposure to
DM199. DiaMedica believes data from Part 1 confirmed its
conclusions from prior testing that the intravenous (IV) dose
administered in the ReMEDy2 study was higher than planned due to
the change in IV bag materials and was the cause of the
hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 µg/kg
to 0.5 µg/kg should avoid or minimize the risk of clinically
significant hypotension while still reaching what we believe will
be a therapeutic blood concentration level. Additionally, results
from part 2 of the in-use study were substantially consistent with
Part 1 indicating that no special handling instructions should be
required. These results are also similar to the Company’s IV bag
study completed in the fall of 2022. The Company further notes that
there are no proposed changes to the ensuing three weeks of
subcutaneous dosing under the study protocol.
As previously announced, the Company provided responses to FDA
inquiries on a potential trypsin impurity contributing to
hypotension and methods assays to be used to measure results in the
in-use study. The FDA responded to the Company indicating that the
assays developed for the in-use study appeared appropriate and its
assessment of the potential trypsin impurity was also
acceptable.
“With the pending submission of our request to lift the clinical
hold, we are optimistic that we have fully identified the cause for
last year’s unexpected hypotensive events and have provided the FDA
with adequate data to support our position and allow the FDA to
lift the clinical hold,” commented Rick Pauls, DiaMedica’s Chief
Executive Officer. “We look forward to receiving the FDA’s response
and hope to then be able to resume our work advancing the science
of stroke care.”
DiaMedica also completed, in healthy volunteers, a Phase 1C open
label, single ascending dose (SAD) study of DM199, administered
with the polyvinylchloride (PVC) IV bags used in the ReMEDy2 trial.
The purpose of the study was to confirm, with human data, that the
revised IV dose of DM199, 0.5 µg/kg, was well-tolerated in humans
and achieved an appropriate DM199 blood concentration level similar
to prior clinical trials and in the desired therapeutic range. The
results from this study will be included as additional supporting
data in the Company’s clinical hold response package to the
FDA.
“Patient safety is paramount for DiaMedica and we’re pleased to
go above and beyond to achieve that end,” stated Kirsten Gruis,
M.D., DiaMedica’s Chief Medical Officer. “Data developed in our
Phase 1C study at the 0.5 µg/kg IV dose level has demonstrated
similar DM199 exposure with the IV dosing regimen used in our
ReMEDy1 AIS trial. These results, in addition to the in-use study,
give us further assurance that we have identified the correct DM199
IV dose level and we hope that this will also give confidence to
physician investigators once we are able to resume the ReMEDy2
trial.”
Balance Sheet and Cash Flow
DiaMedica reported total cash, cash equivalents and investments
of $28.7 million, current liabilities of $2.8 million and working
capital of $26.9 million as of March 31, 2023, compared to total
cash, cash equivalents and investments of $33.5 million, $2.2
million in current liabilities and $31.7 million in working capital
as of December 31, 2022. The decreases in cash and investments and
in working capital were due primarily to cash used to fund
operating activities during the quarter ended March 31, 2023. After
the end of the quarter, DiaMedica received $750,000 from a private
investment from its newly appointed Chief Business Officer.
Net cash used in operating activities for the three months ended
March 31, 2023 was $5.1 million compared to $3.9 million for the
three months ended March 31, 2022. The increase in cash usage
relates primarily to the increased net loss in the current year
period over the prior year period, partially offset by non-cash
share-based compensation and the effects of changes in operating
assets and liabilities in the current year period.
Financial Results
Research and development (R&D) expenses increased to $3.6
million for the three months ended March 31, 2023, up $1.6 million
from $2.0 million for the three months ended March 31, 2022. The
increased costs were driven by a number of factors, including
primarily increased manufacturing and process development costs,
the costs for the in-use study performed to address the clinical
hold on the IND for the ReMEDy2 trial, costs incurred for the Phase
1C health volunteer study and increased personnel costs associated
with expansion of the clinical team. These increases were partially
offset by decreased costs incurred in the Phase 2/3 ReMEDy2 trial
due to the clinical hold.
General and administrative (G&A) expenses were $1.9 million
for the three months ended March 31, 2023, up from $1.6 million for
the three months ended March 31, 2022. The increase was primarily
due to recruiting costs incurred in conjunction the expansion of
the Company’s team and increased legal fees incurred in connection
with the Company’s lawsuit against Pharmaceutical Research
Associates Group B.V., which was acquired by and is now a
subsidiary of ICON plc.
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to
discuss its business update and first quarter 2023 financial
results on Tuesday, May 16, 2023, at 8:00 AM Eastern Time / 7:00 AM
Central Time:
Date:
Tuesday, May 16, 2023
Time:
7:00 AM CT / 8:00 AM ET
Web access:
https://app.webinar.net/r4298p1YBXV
Dial In:
(877) 550-1858
Conference ID:
2125#
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 the Company’s website, under
investor relations - events and presentations, following the
earnings call and for 12 months thereafter. A telephonic replay of
the conference call will be available until May 23, 2023, by
dialing (800) 645-7964 (US Toll Free) and entering the replay
passcode: 2125#.
About ReMEDy2 Trial
The ReMEDy2 trial is an adaptive design, randomized,
double-blind, placebo-controlled trial studying the use of the
Company’s product candidate, DM199, to treat acute ischemic stroke
(AIS) patients. The trial is intended to enroll approximately 350
patients at 75 sites in the United States. Patients enrolled in the
trial will be treated for three weeks with either DM199 or placebo,
beginning within 24 hours of the onset of AIS symptoms, with the
final follow-up at 90 days. The trial excludes patients treated
with tissue plasminogen activator (tPA) and/or mechanical
thrombectomy. The study population is representative of the
approximately 80% of AIS patients who do not have treatment options
today, primarily due to the limitations on treatment with tPA or
mechanical thrombectomy. DiaMedica believes that the proposed trial
has the potential to serve as a pivotal registration study of DM199
in this patient population.
About DM199
DM199 is a recombinant (synthetic) form of human tissue
kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that 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
stroke, chronic kidney disease, retinopathy, vascular dementia, and
resistant hypertension where current treatment options are limited
or ineffective. DiaMedica is the first company to have developed
and clinically studied a recombinant form of the KLK1 protein. The
KLK1 protein, produced from the pancreas of pigs and human urine,
has been used to treat patients in Japan, China and South Korea for
decades. DM199 is currently being studied in patients with acute
ischemic stroke (AIS) and patients with chronic kidney disease. In
September 2021, the FDA granted Fast Track Designation to DM199 for
the treatment of AIS.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage
biopharmaceutical company committed to improving the lives of
people suffering from serious diseases. DiaMedica’s lead candidate
DM199 is the first pharmaceutically active recombinant (synthetic)
form of the KLK1 protein, an established therapeutic modality in
Asia for the treatment of acute ischemic stroke and chronic kidney
disease. For more information visit the Company’s website at
www.diamedica.com.
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 “anticipates,” “believes,”
“look forward,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “hope,” “should,” or
“will,” 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 Company’s expectations regarding
the timing of its complete clinical hold response, its ability to
resolve the clinical hold imposed by the FDA and the timing
thereof, and its belief that the issues raised by the FDA are
potentially addressable, the resumption of the ReMEDy2 trial, and
the anticipated clinical benefits and success of DM199. 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 risk that the Company may
not be able to provide objective evidence acceptable to the FDA
substantiating the Company’s belief as to the cause of the
hypotension events that occurred and led to the clinical hold or
that its plan to resolve the issues and prevent future events may
not be successful; the risk that the Company may not be able to
address sufficiently the concerns identified by the FDA or may
require the Company to collect additional data or information
beyond what the FDA has currently requested and what the Company
currently expects; the Company’s ability to successfully engage
with the FDA and satisfactorily respond to requests from the FDA
for further information and data regarding the ReMEDy2 trial and
the timing and outcome of the Company’s planned interactions with
the FDA concerning the related clinical hold; the risk that the
Company may not be able to lift the clinical hold or do so in a
timely manner; uncertainties relating to regulatory applications
and related filing and approval timelines, including the risk that
FDA may not remove the clinical hold on the ReMEDy2 trial; the
possibility of additional future adverse events associated with or
unfavorable results from the ReMEDy2 trial; the possibility of
unfavorable results from DiaMedica’s ongoing or future clinical
trials 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 acute ischemic stroke and chronic kidney disease and
its expectations regarding the benefits of DM199; DiaMedica’s
ability to conduct successful clinical testing of DM199 and within
its anticipated parameters, enrollment numbers, costs and
timeframes; the adaptive design of the ReMEDy2 trial and the
possibility that the targeted enrollment and other aspects of the
trial could change depending upon certain factors, including
additional input from the FDA and the blinded interim analysis; the
perceived benefits of DM199 over existing treatment options; the
potential direct or indirect impact of COVID-19, hospital and
medical facility staffing shortages, and worldwide global supply
chain shortages on DiaMedica’s business and clinical trials,
including its ability to meet its site activation and enrollment
goals; DiaMedica’s reliance on collaboration with third parties to
conduct clinical trials; DiaMedica’s ability to continue to obtain
funding for its operations, including funding necessary to complete
planned clinical trials and obtain regulatory approvals for DM199
for acute ischemic stroke and chronic kidney disease, 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, 2022 and
subsequent U.S. Securities and Exchange Commission filings. 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.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except share and
per share amounts)
(Unaudited)
Three Months Ended March
31,
2023
2022
Operating expenses:
Research and development
$
3,618
$
1,974
General and administrative
1,903
1,562
Operating loss
(5,521
)
(3,536
)
Other income:
Other income, net
256
35
Total other income, net
256
35
Loss before income tax
expense
(5,265
)
(3,501
)
Income tax expense
(7
)
(7
)
Net loss
(5,272
)
(3,508
)
Other comprehensive loss
Unrealized loss on marketable
securities
45
(56
)
Net loss and comprehensive
loss
$
(5,227
)
$
(3,564
)
Basic and diluted net loss per
share
$
(0.20
)
$
(0.13
)
Weighted average shares
outstanding – basic and diluted
26,448,941
26,443,067
DiaMedica Therapeutics
Inc.
Condensed Consolidated Balance
Sheets
(In thousands, except share
amounts)
March 31, 2023
December 31, 2022
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
2,147
$
4,728
Marketable securities
26,508
28,774
Prepaid expenses and other
assets
962
251
Amounts receivable
57
82
Total current assets
29,674
33,835
Non-current assets:
Operating lease right-of-use
asset
407
424
Property and equipment, net
136
136
Total non-current assets
543
560
Total assets
$
30,217
$
34,395
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
1,780
$
734
Accrued liabilities
956
1,365
Operating lease obligation
73
63
Finance lease obligation
5
6
Total current liabilities
2,814
2,168
Non-current liabilities:
Operating lease obligation,
non-current
377
396
Finance lease obligation,
non-current
4
4
Total non-current liabilities
381
400
Shareholders’ equity:
Common shares, no par value;
unlimited authorized; 26,464,977 and 26,443,067 shares issued and
outstanding as of March 31, 2023 and December 31, 2022,
respectively
—
—
Paid-in capital
128,500
128,078
Accumulated other comprehensive
loss
(29
)
(74
)
Accumulated deficit
(101,449
)
(96,177
)
Total shareholders’ equity
27,022
31,827
Total liabilities and
shareholders’ equity
$
30,217
$
34,395
DiaMedica Therapeutics
Inc.
Condensed Consolidated
Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended March
31,
2023
2022
Cash flows from operating
activities:
Net loss
$
(5,272
)
$
(3,508
)
Adjustments to reconcile net loss
to net cash used in operating activities:
Share-based compensation
422
308
Amortization of discount on
marketable securities
(205
)
120
Non-cash lease expense
17
15
Depreciation
7
6
Changes in operating assets and
liabilities:
Amounts receivable
25
(38
)
Prepaid expenses and other
assets
(711
)
(699
)
Accounts payable
1,046
(76
)
Accrued liabilities
(418
)
(16
)
Net cash used in operating
activities
(5,089
)
(3,888
)
Cash flows from investing
activities:
Purchase of marketable
securities
(9,824
)
(13,379
)
Maturities of marketable
securities
12,340
15,593
Purchases of property and
equipment
(7
)
—
Net cash provided by investing
activities
2,509
2,214
Cash flows from financing
activities:
Principal payments on finance
lease obligations
(1
)
(1
)
Net cash used in financing
activities
(1
)
(1
)
Net decrease in cash and cash
equivalents
(2,581
)
(1,675
)
Cash and cash equivalents at
beginning of period
4,728
4,707
Cash and cash equivalents at end
of period
$
2,147
$
3,032
Supplemental disclosure of
non-cash transactions:
Assets acquired under financing
lease
$
—
$
10
Cash paid for income taxes
$
14
$
7
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230515005649/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
Paul Papi Corporate Communications Phone: (508) 444-6790
ppapi@diamedica.com
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