Conference Call and Webcast August 15 at
8:00 am Eastern Time / 7:00 am Central Time
- Company Resumes ReMEDy2 Clinical Trial after Clinical Hold
Lifted
- Company Completed a $37.5M “At-The-Market” Private
Placement, Cash Runway Into 2026
- Company Completed an Additional Safety Cohort of ACEi
Patients in its Phase 1C Healthy Volunteer Study
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for neurological disorders and cardio-renal disease, today provided
a business update and financial results for the quarter ended June
30, 2023. Management will host a conference call Tuesday, August
15, 2023, at 7:00AM Central Time/8:00AM Eastern Time to discuss its
business update and second quarter 2023 financial results.
Clinical Developments
Clinical Hold Lifted on ReMEDy2 Phase 2/3 Trial for Acute
Ischemic Stroke
On June 21, 2023, the Company announced that the U.S. Food and
Drug Administration (FDA) fully lifted the clinical hold on
DiaMedica’s investigational new drug application for its ReMEDy2
clinical trial of DM199 in acute ischemic stroke (AIS) patients.
The Company has rapidly re-engaged with its study support vendors
and brought on a new contract research organization (CRO) with
strong stroke experience, to assist with the planning and
preparations for resuming the ReMEDy2 trial with a focus on
ensuring that the right resources are in place to attract high
quality study sites and ensure smooth and efficient clinical
operations as patient enrollment resumes. The enrollment timeline
projections and site selection are being finalized in collaboration
with the new CRO. In addition, the Company is planning for the
inclusion of study sites outside of the United States to increase
the enrollment rate for both the interim analysis and the overall
study. At this time, based upon enrollment rates in recent stroke
trials and discussions with multiple CROs, the Company believes
that full enrollment for the interim analysis can be completed in
2024.
“With the lifting of the clinical hold, we are thrilled to
reengage with doctors and hospitals to work towards developing
DM199 as a significant advance for the treatment of ischemic stroke
patients,” commented Rick Pauls, DiaMedica’s Chief Executive
Officer. “We look forward to keeping you updated on the progress of
our trial.”
DiaMedica also completed an additional cohort of hypertensive
patients (Part B) being treated with angiotensin-converting enzyme
inhibitors (ACEi) in its Phase 1C open label, single ascending dose
(SAD) study of DM199, administered with the polyvinylchloride (PVC)
IV bags used in the ReMEDy2 trial. In the initial part of the study
(Part A), DiaMedica confirmed in healthy volunteers that the
revised IV dose of DM199, 0.5 µg/kg, was well-tolerated and
achieved an appropriate DM199 blood concentration level in the
desired therapeutic range, similar to prior clinical trials. In
Part B, all ACEi patients received the full IV dose at the 0.5
µg/kg level with no instances of hypotension. DiaMedica believes
that these results will provide further assurance to potential
investigators that ACEi patients may be safely included in the
ReMEDy2 trial. This Phase 1C study is now finished and the Company
is completing final closing procedures.
“At-the-Market” Financing
As previously announced, DiaMedica completed a $37.5 million
private placement to accredited investors, including several
members of DiaMedica’s management team. The Company sold
approximately 11.0 million common shares a purchase price of $3.40
per share, equal to the average per share closing price of the
Company’s common shares for the five trading days ended June 20,
2023, except in the case of DiaMedica management who agreed to a
higher purchase price of $3.91 per share, equal to the closing sale
price of the Company’s common shares on June 20, 2023. After
deducting estimated offering expenses, the Company received net
proceeds of approximately $36.1 million.
DiaMedica expects to use the net proceeds from these sales to
continue its clinical and product development activities for DM199
and for other working capital and general corporate purposes.
Balance Sheet and Cash Flow
DiaMedica reported total cash, cash equivalents and investments
of $60.7 million, current liabilities of $1.9 million and working
capital of $39.3 million as of June 30, 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 increases in cash and investments and
in working capital were due primarily to the $36.9 million of net
proceeds from the June and April 2023 private placements, partially
offset by cash used to fund operating activities during the six
months ended June 30, 2023.
Net cash used in operating activities for the six months ended
June 30, 2023 was $10.1 million compared to $6.4 million for the
six months ended June 30, 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 $2.5
million for the three months ended June 30, 2023, up $0.5 million
from $2.0 million for the three months ended June 30, 2022. R&D
expenses increased to $6.2 million for the six months ended June
30, 2023, up from $3.9 million for the six months ended June 30,
2022. The increase for the six-month comparison was due primarily
to costs incurred for the in-use study performed to address the
recently lifted clinical hold on the Company’s ReMEDy2 AIS trial
and costs incurred for the Phase 1C study determining the DM199
blood concentration levels achieved with the IV dose of DM199. Also
contributing to the increase were increased manufacturing and
process development costs, costs incurred to finalize the clinical
data and perform related analyses for the REDUX trial, and
increased personnel costs associated with expanding the clinical
team. These increases were partially offset by decreased costs
incurred for the Phase 2/3 ReMEDy2 AIS trial due to the recently
lifted clinical hold.
General and administrative (G&A) expenses were $2.2 million
for the three months ended June 30, 2023, up from $1.4 million for
the three months ended June 30, 2022. G&A expenses were $4.1
million for the six months ended June 30, 2023, up from $3.0
million for the six months ended June 30, 2022. The increase for
the six-month comparison was primarily due to increased legal fees
incurred in connection with our lawsuit against PRA Netherlands and
increased personnel costs incurred in conjunction with expanding
the team. Increased professional service fees and non-cash
share-based compensation also contributed to the increase.
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to
discuss its business update and second quarter 2023 financial
results on Tuesday, August 15, 2023, at 8:00 AM Eastern Time / 7:00
AM Central Time:
Date:
Tuesday, August 15, 2023
Time:
7:00 AM CT / 8:00 AM ET
Web access:
https://app.webinar.net/DnqEQYkbk6Z
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 playback 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 August 22, 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 up to 75 sites in the United States with planned global
expansion. 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). 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 with a focus on acute
ischemic stroke. 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 other vascular diseases. 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
timing for the resumption of and full enrollment for the interim
analysis 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, uncertainties relating to regulatory applications and
related filing and approval timelines; 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 cardio-renal 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 cardio-renal
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, including DiaMedica’s quarterly report on Form
10-Q for the quarterly period ended June 30, 2023. 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
2,543
$
1,955
$
6,161
$
3,929
General and administrative
2,198
1,409
4,101
2,971
Operating loss
(4,741
)
(3,364
)
(10,262
)
(6,900
)
Other income:
Other income, net
271
13
527
48
Loss before income tax
expense
(4,470
)
(3,351
)
(9,735
)
(6,852
)
Income tax expense
(7
)
(7
)
(14
)
(14
)
Net loss
(4,477
)
(3,358
)
(9,749
)
(6,866
)
Other comprehensive income
(loss)
Unrealized gain (loss) on
marketable securities
(34
)
(60
)
11
(116
)
Net loss and comprehensive
loss
$
(4,511
)
$
(3,418
)
$
(9,738
)
$
(6,982
)
Basic and diluted net loss per
share
$
(0.16
)
$
(0.13
)
$
(0.36
)
$
(0.26
)
Weighted average shares
outstanding – basic and diluted
27,312,008
26,443,067
26,882,858
26,443,067
DiaMedica Therapeutics
Inc.
Condensed Consolidated Balance
Sheets
(In thousands, except share
amounts)
June 30, 2023
December 31, 2022
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
5,839
$
4,728
Short term marketable
securities
34,529
28,774
Prepaid expenses and other
assets
675
251
Amounts receivable
188
82
Total current assets
41,231
33,835
Non-current assets:
Long term marketable
securities
20,296
Operating lease right-of-use
asset, net
390
424
Property and equipment, net
133
136
Total non-current assets
20,819
560
Total assets
$
62,050
$
34,395
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
856
$
734
Accrued liabilities
1,011
1,365
Operating lease obligation
76
63
Finance lease obligation
3
6
Total current liabilities
1,946
2,168
Non-current liabilities:
Operating lease obligation,
non-current
357
396
Finance lease obligation,
non-current
4
4
Total non-current liabilities
361
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
165,732
128,078
Accumulated other comprehensive
loss
(63
)
(74
)
Accumulated deficit
(105,926
)
(96,177
)
Total shareholders’ equity
59,743
31,827
Total liabilities and
shareholders’ equity
$
62,050
$
34,395
DiaMedica Therapeutics
Inc.
Condensed Consolidated
Statements of Cash Flows
(In thousands)
(Unaudited)
Six Months Ended June
30,
2023
2022
Cash flows from operating
activities:
Net loss
$
(9,749
)
$
(6,866
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Share-based compensation
802
673
Amortization of discount on marketable
securities
(432
)
160
Non-cash lease expense
34
31
Depreciation
14
12
Changes in operating assets and
liabilities:
Amounts receivable
(106
)
42
Prepaid expenses and other assets
(424
)
(445
)
Accounts payable
122
115
Accrued liabilities
(380
)
(106
)
Net cash used in operating activities
(10,119
)
(6,384
)
Cash flows from investing
activities:
Purchase of marketable securities
(52,743
)
(27,510
)
Maturities of marketable securities
27,135
32,258
Purchases of property and equipment
(11
)
(6
)
Net cash (used in) provided by investing
activities
(25,619
)
4,742
Cash flows from financing
activities:
Proceeds from issuance of common shares,
net of offering costs
36,852
—
Principal payments on finance lease
obligations
(3
)
(3
)
Net cash provided by (used in) financing
activities
36,849
(3
)
Net increase (decrease) in cash and cash
equivalents
1,111
(1,645
)
Cash and cash equivalents at beginning of
period
4,728
4,707
Cash and cash equivalents at end of
period
$
5,839
$
3,062
Supplemental disclosure of non-cash
transactions:
Assets acquired under financing lease
$
—
$
10
Cash paid for income taxes
$
20
$
8
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814548974/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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