DiaMedica Therapeutics Announces 2020 Financial Results and Provides a Business Update
DiaMedica Therapeutics (Nasdaq: DMAC) announced significant developments in its clinical trials and financial results for 2020. The FDA accepted DMAC's request for a Type B meeting regarding DM199 for acute ischemic stroke, allowing for a streamlined Phase 2/3 trial with about 350 participants. The company reported $27.5 million in cash and equivalents, enough to fund operations through mid-2022. DMAC's R&D expenses increased to $8.3 million, largely due to the REDUX trial. Conference call for results is scheduled for March 11, 2021.
- FDA accepted DMAC's Type B meeting request for DM199, enhancing regulatory pathway.
- Plans to initiate Phase 2/3 trial for acute ischemic stroke, potentially supporting BLA submission.
- Strong cash position of $27.5 million to fund operations through mid-2022.
- R&D expenses increased to $8.3 million, indicating rising costs in clinical development.
- Enrollment in REDUX trial slower than expected due to COVID-19 pandemic.
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 year ended December 31, 2020. DiaMedica will host a conference call Thursday, March 11, 2021, at 7:00 a.m. Central Time to discuss its business update and full year financial results.
Clinical Developments
DM199 for the Treatment of Acute Ischemic Stroke
Productive Type B Meeting with the FDA
Initiation of Phase 2/3 Trial in AIS
The U.S. Food and Drug Administration (FDA) accepted DiaMedica’s request for a Type B Pre-IND meeting request related to its development plan for its product candidate, DM199, in the treatment of acute ischemic stroke (AIS). In written responses to the questions submitted by DiaMedica, the FDA agreed with DiaMedica’s proposals regarding key elements of a Phase 2/3 trial for DM199 in patients with AIS. These plans include an adaptive trial design with a primary endpoint based upon the modified Rankin Scale (mRS) at day 90.
The FDA also acknowledged that, provided the study results qualify, a single trial may support a Biologics License Application (BLA) submission. Additionally, based upon the clinical and preclinical testing performed to date and currently in process, the FDA did not require any additional studies in preparation for an investigational new drug (IND) submission and initiation of the Company’s planned Phase 2/3 trial.
DiaMedica believes that the feedback received from the FDA provided a well-defined regulatory pathway and is proceeding with the preparation of an IND submission to initiate a Phase 2/3 adaptive trial design which will include an interim analysis to allow for an increase in the sample size, if necessary, to improve powering.
DiaMedica plans to submit the IND later this month for its proposed Phase 2/3 AIS trial and initiate it this summer. DiaMedica expects the trial will be a double blinded, placebo controlled, randomized study of approximately 350 participants, based on a
The results of the Company’s ReMEDy Phase 2 trial in AIS will be the subject of oral and poster presentations at the upcoming International Stroke Conference 2021 being held virtually on March 17-19, 2021.
The Company will also be hosting a Stroke KOL webinar on the Treatment of Acute Ischemic Stroke on March 19th at noon Eastern Time. To register for the webinar, please click here.
“We are very pleased with the progress we’ve made in recent weeks advancing our DM199 program for AIS patients,” said Rick Pauls, President and Chief Executive Officer of DiaMedica. “Our Phase 2/3 trial builds on statistically and clinically significant results from our ReMEDy trial, and we’re committed to designing and executing a study that meets the qualifications for and could provide evidence to support a BLA submission.”
DM199 for the Treatment of Chronic Kidney Disease
Completion of Enrollment in CKD Caused by Type II Diabetes Cohort; Data Read-out in Q2 2021
Enrollment Continues in IgA Nephropathy and CKD in African Americans with Hypertension
DiaMedica’s Phase 2 REDUX (Latin for restore) trial is a multi-center, open-label, investigation to assess the safety and efficacy of multiple doses of DM199, administered over 90 days, in participants with chronic kidney disease (CKD) (Stage 2 or 3) targeting enrollment of approximately 90 participants in three equal Cohorts. Cohort 1 of the study is focused on non-diabetic, African Americans with hypertension, a group that is at greater risk for CKD than Caucasians. Additionally, the study is designed to identify African American participants with the APOL1 gene mutation as an exploratory biomarker as these individuals have an even higher risk of developing CKD. Cohort 2 of the study is focused on participants with IgA Nephropathy (IgAN) and Cohort 3 includes participants with diabetic kidney disease (DKD).
As of March 1, 2020, DiaMedica had enrolled a total of 68 subjects, including a fully enrolled DKD Cohort, and approximately
“We look forward to reporting upcoming topline results from our Phase 2 REDUX trial,” commented Dr. Harry Alcorn, Jr., DiaMedica’s Chief Medical Officer. “While we intend to follow the data from all three Cohorts, we anticipate that for CKD, we will have the opportunity to initially position D199 in patients with IgA Nephropathy, an orphan drug indication, and in the longer term provide a treatment option to the overall CKD and DKD patient populations.”
Strengthening the Balance Sheet
During 2020, the Company completed two underwritten public offerings of its common shares receiving gross proceeds of
Financial Results
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Total other income, net was
Balance Sheet and Cash Flow
The Company had cash, cash equivalents and marketable securities of
Net cash used in operating activities was
Conference Call Information
DiaMedica Management will host a conference call to discuss its 2020 financial results and business update on Thursday, March 11 2021, at 7:00 a.m. Central Time:
Date: |
Thursday, March 11, 2021 |
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Time: |
7:00 AM CT / 8:00 AM ET |
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Web access: |
https://event.on24.com/wcc/r/2948450/3CC8FC74172F3DEDB9258000144DA5E4 |
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Dial In: |
(866) 393-4306 (domestic) |
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(734) 385-2616 (international) |
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Conference ID: |
9297319 |
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 March 18, 2021, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 9297319.
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 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. (Nasdaq: DMAC) is a clinical stage biopharmaceutical company focused on developing novel treatments to improve the lives of patients with neurological and chronic kidney diseases. To learn more about DiaMedica, visit 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 “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 timing and requirements of its clinical programs, including its anticipated Phase 2/3 trial for DM199 in patients with AIS, and enrollment, clinical results and ability to achieve clinical milestones, including completion of enrollment and readout of results in its REDUX trial, its opportunity to initially position D199 in patients with IgA Nephropathy and in the longer term provide a treatment option to the overall CKD and DKD patient populations, and cash runway timing. 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 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 AIS and CKD 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; 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 AIS and CKD, 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, 2020. 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. |
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Consolidated Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share amounts) |
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Year Ended December 31, |
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2020 |
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2019 |
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Operating expenses: |
|
|
|
|
|
|
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Research and development |
|
8,310 |
|
|
|
7,900 |
|
General and administrative |
|
4,389 |
|
|
|
3,693 |
|
Operating loss |
|
(12,699 |
) |
|
|
(11,593 |
) |
|
|
|
|
|
|
|
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Other (income) expense: |
|
|
|
|
|
|
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Governmental assistance - research incentives |
|
(205 |
) |
|
|
(856 |
) |
Other income, net |
|
(229 |
) |
|
|
(119 |
) |
Total other income, net |
|
(434 |
) |
|
|
(975 |
) |
|
|
|
|
|
|
|
|
Loss before income tax expense |
|
(12,265 |
) |
|
|
(10,618 |
) |
|
|
|
|
|
|
|
|
Income tax expense |
|
27 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
Net loss |
|
(12,292 |
) |
|
|
(10,649 |
) |
|
|
|
|
|
|
|
|
Other comprehensive (income) loss |
|
|
|
|
|
|
|
Unrealized (gain) loss on marketable securities |
|
4 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
Net loss and comprehensive loss |
$ |
(12,296 |
) |
|
$ |
(10,647 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.78 |
) |
|
$ |
(0.89 |
) |
Weighted average shares outstanding – basic and diluted |
|
15,680,320 |
|
|
|
11,987,696 |
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DiaMedica Therapeutics Inc. |
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Consolidated Balance Sheets |
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(In thousands, except share amounts) |
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December 31, 2020 |
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December 31, 2019 |
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ASSETS |
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Current assets: |
|
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
7,409 |
|
|
$ |
3,883 |
|
Marketable securities |
|
|
20,098 |
|
|
|
3,995 |
|
Amounts receivable |
|
|
340 |
|
|
|
823 |
|
Prepaid expenses and other assets |
|
|
64 |
|
|
|
47 |
|
Deposits |
|
|
10 |
|
|
|
88 |
|
Total current assets |
|
|
27,921 |
|
|
|
8,836 |
|
|
|
|
|
|
|
|
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Non-current assets: |
|
|
|
|
|
|
||
Operating lease right-of-use asset |
|
|
100 |
|
|
|
153 |
|
Property and equipment, net |
|
|
74 |
|
|
|
64 |
|
Total non-current assets |
|
|
174 |
|
|
|
217 |
|
|
|
|
|
|
|
|
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Total assets |
|
$ |
28,095 |
|
|
$ |
9,053 |
|
|
|
|
|
|
|
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LIABILITIES AND EQUITY |
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|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
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Accounts payable |
|
$ |
1,099 |
|
|
$ |
182 |
|
Accrued liabilities |
|
|
864 |
|
|
|
1,076 |
|
Finance lease obligation |
|
|
6 |
|
|
|
6 |
|
Operating lease obligation |
|
|
59 |
|
|
|
54 |
|
Total current liabilities |
|
|
2,028 |
|
|
|
1,318 |
|
|
|
|
|
|
|
|
||
Non-current liabilities: |
|
|
|
|
|
|
||
Finance lease obligation, non-current |
|
|
7 |
|
|
|
13 |
|
Operating lease obligation, non-current |
|
|
46 |
|
|
|
105 |
|
Total non-current liabilities |
|
|
53 |
|
|
|
118 |
|
|
|
|
|
|
|
|
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Shareholders’ equity: |
|
|
|
|
|
|
||
Common shares, no par value; unlimited authorized; 18,746,157 and 12,006,874 shares issued and outstanding, as of September 30, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
94,925 |
|
|
|
64,232 |
|
Accumulated other comprehensive income |
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FAQ
What are DiaMedica's latest developments for DM199 regarding acute ischemic stroke?
DiaMedica received FDA acceptance for a Type B meeting to discuss DM199, paving the way for a Phase 2/3 trial.
When does DiaMedica expect to initiate the Phase 2/3 trial for DM199?
The Phase 2/3 trial is planned to be initiated in summer 2021.
What is the financial status of DiaMedica as of December 31, 2020?
DiaMedica reported $27.5 million in cash and equivalents, allowing operations to continue through mid-2022.
What are the projected outcomes for DiaMedica's REDUX trial?
Preliminary topline results from the CKD cohort are expected in Q2 2021.
DiaMedica Therapeutics Inc.
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DMAC Stock Data
194.56M
26.04M
26.23%
31.61%
0.41%
Biotechnology
Pharmaceutical Preparations
United States of America
MINNEAPOLIS
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