DMAC DiaMedica Therapeutics Inc.

4.18
+0.13  (+3%)
Previous Close 4.05
Open 4.09
52 Week Low 3
52 Week High 10.88
Market Cap $78,329,329
Shares 11,956,874
Float 10,738,700
Enterprise Value $48,952,958
Volume 263,596
Av. Daily Volume 228,284
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Drug Pipeline

Drug Stage Notes
DM199 (ReMEDy2)
Acute ischaemic stroke
Phase 2/3
Phase 2/3
Phase 2/3 trial initiated September 13, 2021.
DM199 - REDUX
Chronic Kidney Disease
Phase 2
Phase 2
Phase 2 top-line data released June 29, 2021 - noted only clinically meaningful improvements in kidney function.

Latest News

    •  The ReMEDy2 Trial Will Assess the Potential of DM199 to Both Improve Recovery After a Stroke and Prevent Stroke Recurrence
    • Opportunity to Expand Therapeutic Treatment Window and Eligible Patient Population for Acute Ischemic Stroke for the First Time in Decades

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced the initiation of the first site for its pivotal ReMEDy2 Trial, a Phase 2/3 clinical study of DM199 for the treatment of acute ischemic stroke (AIS).

    The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at 75 sites in the…

    •  The ReMEDy2 Trial Will Assess the Potential of DM199 to Both Improve Recovery After a Stroke and Prevent Stroke Recurrence
    • Opportunity to Expand Therapeutic Treatment Window and Eligible Patient Population for Acute Ischemic Stroke for the First Time in Decades

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced the initiation of the first site for its pivotal ReMEDy2 Trial, a Phase 2/3 clinical study of DM199 for the treatment of acute ischemic stroke (AIS).

    The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at 75 sites in the United States. Patients enrolled in the study will be treated with either DM199 or placebo within 24 hours of the onset of AIS symptoms. The study excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions. The study population is representative of the 80% of AIS patients who do not have treatment options today, primarily due to the short treatment window of 4.5 hours required for administration of tPA.

    The ReMEDy2 trial has two primary endpoints and is powered for success with either endpoint: 1) recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, and 2) the rate of ischemic stroke recurrence at day 30. Recurrent strokes represent 25% of all ischemic strokes, often occur in the first few weeks after an initial stroke and are typically more disabling, costly, and fatal than initial strokes. Secondary endpoints for the study will evaluate participant deaths, mRS shift (which shows the treatment effect on participants across the full spectrum of stroke severity) and additional standard stroke scores (NIHSS and Barthel Index scores).

    "Our investigators are enthusiastic to study a promising new therapy for their patients with the flexibility of a 24-hour treatment window, particularly given the challenges in emergency medicine today," said Rick Pauls, DiaMedica's Chief Executive Officer. "By either or both improving overall recovery and reducing the risk of a recurrent stroke, DM199 could be the first new therapeutic in 25 years that could meaningfully change outcomes for stroke patients. Stroke represents a significant, unmet medical need for approximately 700,000 patients annually in the U.S. and millions more globally."

    "KLK1 has been shown to stabilize plaque and reduce blood pressure, both important factors in stroke patient recovery and prevention of additional strokes," said Scott Kasner, M.D., ReMEDy2 National Principal Investigator and Professor of Neurology and Director of the Comprehensive Stroke Center, University of Pennsylvania. "KLK1's mechanistic activity, clinical data from Asia using the endogenous form of KLK1 in stroke patients and the results from the ReMEDy Phase 2 AIS study provide overwhelming support for our community to study whether a recombinant KLK1 such as DM199 can significantly improve and prolong the lives of our patients."

    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, among other things, 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 a pharmaceutically active recombinant form of the KLK1 protein. The KLK1 protein, in forms 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 acute ischemic stroke and chronic kidney disease.

    About Acute Ischemic Stroke and Stroke Recurrence

    Stroke is characterized by the rapidly developing loss of brain function due to a blockage of blood flow in the brain. As a result, the affected tissues of the brain becomes inactive and may eventually die. AIS is characterized by interruption of the blood supply by a blood clot (ischemia). Risk factors for stroke include, among other things, advanced age, hypertension (high blood pressure), previous stroke or transient ischemic attack (TIA), diabetes, high cholesterol, cigarette smoking, atrial fibrillation, physical inactivity and obesity.

    According to the U.S. Centers for Disease Control:

    • Every year in the United States, approximately 795,000 people experience a stroke (ischemic or hemorrhagic). Approximately 610,000 of these are first events and approximately 25%, or 185,000, are recurrent stroke events.
    • Approximately one of every 20 deaths in the United States is caused by stroke and is the fifth leading cause of death. On average, someone in the United States has a stroke every 40 seconds and someone dies from a stroke every four minutes.
    • Stroke is the leading cause of serious long-term disability and reduces mobility in more than half of stroke survivors aged 65 and over.
    • Risk of having a first stroke is nearly twice as high for African Americans as for Caucasians, and African Americans have the highest rate of death due to stroke.

    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 for the treatment of acute ischemic stroke and chronic kidney disease. For more information visit our 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 "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, which DiaMedica believes will commence in Summer 2021 after an FDA review completion in mid-May and has the potential to serve as a pivotal registration study of DM199 in that patient population, and enrollment, clinical results and ability to achieve clinical milestones, including the timing of completion of enrollment and readout of results in its REDUX trial, 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.

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  1. DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the company will participate in three upcoming investor conferences. Details of the company's participation are as follows:

    Conference: H.C. Wainwright 23rd Annual Global Investment Conference
    Dates: September 13th – 15th, 2021
    Format: One-on-one meetings, on-demand corporate presentation beginning September 13th at 7:00am ET

    Conference: Lake Street Capital Best Ideas Growth (BIG5) Conference
    Dates: September 14th – 15th, 2021
    Format: One-on-one meetings

    Conference: Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit
    Dates: September 20th

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the company will participate in three upcoming investor conferences. Details of the company's participation are as follows:

    Conference: H.C. Wainwright 23rd Annual Global Investment Conference

    Dates: September 13th – 15th, 2021

    Format: One-on-one meetings, on-demand corporate presentation beginning September 13th at 7:00am ET

    Conference: Lake Street Capital Best Ideas Growth (BIG5) Conference

    Dates: September 14th – 15th, 2021

    Format: One-on-one meetings

    Conference: Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit

    Dates: September 20th – 23rd, 2021

    Format: One-on-one meetings

    For more information or to schedule a one-on-one meeting with management, please contact your conference representative.

    About DiaMedica Therapeutics Inc.

    DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Our lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). Based on promising early clinical results, we are advancing DM199 in our REMEDY Phase 2/3 trial in the treatment of AIS and completing enrollment in our REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD. For more information visit our website at www.diamedica.com.

    View Full Article Hide Full Article
    • Phase 2/3 ReMEDy2 Trial in AIS for Stroke Outcomes and Stroke Recurrence on Track for Initiation Summer 2021
    • Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR).
    • Board of Directors Strengthened with Election of Two Pharma Industry Veterans

     Conference Call and Webcast August 12 at 8:00 am Eastern Time / 7:00 am Central Time

    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 June 30, 2021. DiaMedica will host a conference call Thursday…

    • Phase 2/3 ReMEDy2 Trial in AIS for Stroke Outcomes and Stroke Recurrence on Track for Initiation Summer 2021
    • Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR).
    • Board of Directors Strengthened with Election of Two Pharma Industry Veterans

     Conference Call and Webcast August 12 at 8:00 am Eastern Time / 7:00 am Central Time

    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 June 30, 2021. DiaMedica will host a conference call Thursday, August 12, 2021, at 7:00AM Central Time/8:00AM Eastern Time to discuss its business update and second quarter financial results.

    Pivotal Phase 2/3 ReMEDy Trial on Track for Summer 2021 Initiation; Prevention of Stroke Recurrence is being Added as Independent Co-Primary Endpoint

    DiaMedica's Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199 was accepted by the FDA in mid-May 2021, and the Company expects to formally initiate the study by the end of this summer.

    The clinical trial design is a double blinded, placebo controlled, randomized study of approximately 350 participants, based on a 90% powering for statistical significance on the primary endpoint of modified Rankin Scale (mRS) at day 90 with 24-hour treatment window from onset of stroke symptoms. The prevention of stroke recurrence is being added as an independent co-primary endpoint for this study based on the statistically significant 13% absolute reduction in severe recurrent strokes observed in the ReMEDy Phase 2 study. Secondary endpoints will include mRS shift, NIHSS and Barthel Index scores, deaths, safety and tolerability measures, and biomarkers relating to KLK1.

    The trial population includes acute ischemic stroke (AIS) patients who are not eligible for and/or who do not receive tissue plasminogen activator (tPA) and do not have large vessel occlusions. This group represents up to 80% of all AIS patients, for whom there is no treatment option other than supportive care. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

    DM199 for the Treatment of Chronic Kidney Disease (CKD)

    Interim data from the Phase 2 REDUX trial was announced in June 2021. The Company highlights that DM199 demonstrated clinically meaningful improvements in kidney function in IgA Nephropathy as measured by simultaneously stabilizing estimated glomerular filtration rate (eGFR) and decreasing urinary albumin-to-creatinine ratio (UACR). Interim data from 11 subjects with moderate to severe albuminuria (baseline UACR>500) showed an average decrease in UACR of -33% (P=0.002) with stable eGFR.

    Additionally, DM199 was well tolerated across all cohorts, with no DM199 related severe adverse events or discontinuations due to drug-related adverse events (AEs). The AEs observed were generally mild to moderate in severity, with the most common being local injection site irritation that resolved without medical intervention.

    DiaMedica is preparing to provide a more complete update on the interim study results to be presented at the American Society of Nephrology Annual Meeting in November 2021.

    As of July 31, 2021, DiaMedica had enrolled 75 subjects, including 20 African American subjects into Cohort I, 22 subjects with IgAN into Cohort II and completed enrollment with 33 subjects with Type 2 diabetes, hypertension and albuminuria into Cohort III. The Company has continued to experience slower than expected enrollment in the first two Cohorts of the REDUX study and believes this is due to continued concerns of potential study subjects related to visiting clinical study sites. DiaMedica is evaluating the effects of the recent surge in COVID-19 infections related to the Delta variant and will provide an update on the anticipated completion of Cohort I and Cohort II when the Company is able to reasonably estimate timing.

    Two Pharma Industry Veterans Added to DiaMedica Board of Directors

    In July 2021, the Company announced the election of two experienced executives to its Board of Directors. Joining the Board are:

    • Amy Burroughs, has held senior leadership and advisory roles with a broad range of public and private biopharmaceutical companies over the last 20 years. She is currently president and chief executive officer of Cleave Therapeutics, a clinical stage, venture backed oncology company. Previously, she served as executive in residence at 5AM Ventures, a leading venture capital firm focused on building next-generation life science companies, and a senior advisor to Crinetics (NASDAQ:CRNX). She began her biopharmaceutical career at Genentech, where she held key roles in commercial strategy and planning across the portfolio and led the neurology commercial team.
    • Charles Semba, M/D., has over 20 years of drug development experience in public and private biotechnology companies and is a recognized expert in endovascular therapy, thrombolysis, mechanical thrombectomy, and endovascular surgery. He is Chief Medical Officer (CMO) at Eluminex Biosciences and has served as CMO for SARcode Bioscience (acquired by Shire/Takeda), ForSight VISION5 (acquired by Allergan), and Graybug Vision (NASDAQ:GRAY). He has held senior leadership roles as Vice President Ophthalmic Medicine at Shire/Takeda and Ophthalmology Group Head at Genentech. Dr. Semba led the clinical development of ranibizumab (LUCENTIS®) and lifitegrast (XIIDRA®). He also led FDA approval for CathFlo Activase® (Alteplase) for ischemic stroke.

    Financial Results

    Research and development (R&D) expenses increased to $2.2 million for the three months ended June 30, 2021, up from $1.6 million for the three months ended June 30, 2020, an increase of $0.6 million. R&D expenses increased to $4.6 million for the six months ended June 30, 2021, compared to $2.9 million for the six months ended June 30, 2020, an increase of $1.7 million. The increase for the six-month comparison was primarily due to a number of factors including costs incurred for the pivotal ReMEDy2 clinical study, increased year-over-year costs related to manufacturing process development and the REDUX Phase 2 CKD study, as well as increased personnel costs associated with additional staff added to support R&D operations. These increases were partially offset by decreased costs incurred for the ReMEDy Phase 2 stroke study which completed in the prior year.

    General and administrative (G&A) expenses were $1.2 million for the three months ended June 30, 2021, up from $1.1 million for the three months ended June 30, 2020. G&A expenses increased to $2.4 million for the six months ended June 30, 2021, up $0.2 million from $2.2 million for the six months ended June 30, 2020. The increase for the six-month comparison was primarily due to increased professional services costs and increased personnel costs to support the Company's expanding clinical programs.

    Balance Sheet and Cash Flow

    The Company had cash, cash equivalents and marketable securities of $21.3 million, current liabilities of $1.4 million and working capital of $20.2 million as of June 30, 2021, compared to $27.5 million in cash, cash equivalents and marketable securities, $2.0 million in current liabilities and $25.9 million in working capital as of December 31, 2020. The decreases in combined cash, cash equivalents and marketable securities and in working capital are due primarily to increased clinical study costs associated with preparing for the ReMEDy2 Phase 2/3 stroke study, costs related to the REDUX Phase 2 CKD study and increased costs related manufacturing development.

    Net cash used in operating activities for the six months ended June 30, 2021 was $6.4 million compared to $3.8 million for the six months ended June 30, 2020. This increase relates primarily to the increase in the net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

    Conference Call and Webcast Information

    DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2021 financial results on Thursday, August 12, 2021, at 7:00AM Central Time:

    Date:

    Thursday, August 12, 2021

    Time:

    7:00 AM CT / 8:00 AM ET

    Web access:

    https://event.on24.com/wcc/r/3192933/FBC5C2BE41E26E2C70F89B28EC5DB100

    Dial In:

    (844) 557-8483 (domestic)

    (825) 312-2381 (international)

    Conference ID:

    4148874

    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 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 19, 2021, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), and entering the replay passcode: 4148874.

    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 South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

    About DiaMedica Therapeutics Inc.

    DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. DiaMedica's lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). For more information visit our 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 "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, which DiaMedica believes will commence in Summer 2021 and has the potential to serve as a pivotal registration study of DM199 in that patient population, and enrollment, 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 DiaMedica's ongoing or future clinical trials of DM199, including the fact that the interim REDUX study data previously released is preliminary and interim and final results may differ materially from the data previously released; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the possibility of unfavorable results from subsequent analysis of existing or future data from the REDUX study or future studies of DM199; 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, including its clinical trials; 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 and subsequent U.S. Securities and Exchange Commission 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.

    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,

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

    Research and development

    $

    2,156

     

     

    $

    1,600

     

     

    $

    4,562

     

     

    $

    2,949

     

    General and administrative

     

    1,209

     

     

     

    1,108

     

     

     

    2,422

     

     

     

    2,163

     

    Operating loss

     

    (3,365

    )

     

     

    (2,708

    )

     

     

    (6,984

    )

     

     

    (5,112

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Other income:

     

     

     

     

     

     

     

     

     

     

     

    Governmental assistance - research incentives

     

    -

     

     

     

    (65

    )

     

     

    -

     

     

     

    (180

    )

    Other income, net

     

    (98

    )

     

     

    (178

    )

     

     

    (102

    )

     

     

    (51

    )

    Total other income

     

    (98

    )

     

     

    (243

    )

     

     

    (102

    )

     

     

    (231

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Loss before income tax expense

     

    (3,267

    )

     

     

    (2,465

    )

     

     

    (6,882

    )

     

     

    (4,881

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Income tax expense

     

    7

     

     

     

    9

     

     

     

    14

     

     

     

    18

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss

     

    (3,274

    )

     

     

    (2,474

    )

     

     

    (6,896

    )

     

     

    (4,899

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Other comprehensive income (loss)

     

     

     

     

     

     

     

     

     

     

     

    Unrealized gain (loss) on marketable securities

     

     

     

     

    (13

    )

     

     

    1

     

     

     

    27

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss and comprehensive loss

    $

    (3,274

    )

     

    $

    (2,487

    )

     

    $

    (6,895

    )

     

    $

    (4,872

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted net loss per share

    $

    (0.17

    )

     

    $

    (0.17

    )

     

    $

    (0.37

    )

     

    $

    (0.36

    )

    Weighted average shares outstanding – basic and diluted

     

    18,786,157

     

     

     

    14,139,074

     

     

     

    18,776,461

     

     

     

    13,623,400

     

    DiaMedica Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (In thousands, except share amounts)

     

     

     

    June 30, 2021

     

    December 31, 2020

     

     

    (unaudited)

     

     

     

    ASSETS

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    2,228

     

     

    $

    7,409

     

    Marketable securities

     

     

    19,067

     

     

     

    20,098

     

    Amounts receivable

     

     

    16

     

     

     

    340

     

    Prepaid expenses and other assets

     

     

    318

     

     

     

    74

     

    Total current assets

     

     

    21,629

     

     

     

    27,921

     

     

     

     

     

     

     

     

    Non-current assets:

     

     

     

     

     

     

    Operating lease right-of-use asset

     

     

    72

     

     

     

    100

     

    Property and equipment, net

     

     

    73

     

     

     

    74

     

    Total non-current assets

     

     

    145

     

     

     

    174

     

     

     

     

     

     

     

     

    Total assets

     

    $

    21,774

     

     

    $

    28,095

     

     

     

     

     

     

     

     

    LIABILITIES AND EQUITY

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    239

     

     

    $

    1,099

     

    Accrued liabilities

     

     

    1,132

     

     

     

    864

     

    Finance lease obligation

     

     

    5

     

     

     

    6

     

    Operating lease obligation

     

     

    64

     

     

     

    59

     

    Total current liabilities

     

     

    1,440

     

     

     

    2,028

     

     

     

     

     

     

     

     

    Non-current liabilities:

     

     

     

     

     

     

    Finance lease obligation, non-current

     

     

    5

     

     

     

    7

     

    Operating lease obligation, non-current

     

     

    11

     

     

     

    46

     

    Total non-current liabilities

     

     

    16

     

     

     

    53

     

     

     

     

     

     

     

     

    Shareholders' equity:

     

     

     

     

     

     

    Common shares, no par value; unlimited authorized; 18,786,157 and 18,746,157 shares issued and outstanding, as of June 30, 2021 and December 31, 2020, respectively

     

     

     

     

     

     

    Paid-in capital

     

     

    96,126

     

     

     

    94,925

     

    Accumulated other comprehensive loss

     

     

    (3

    )

     

     

    (2

    )

    Accumulated deficit

     

     

    (75,805

    )

     

     

    (68,909

    )

    Total shareholders' equity

     

     

    20,318

     

     

     

    26,014

     

    Total liabilities and shareholders' equity

     

    $

    21,774

     

     

    $

    28,095

     

    DiaMedica Therapeutics Inc.

    Condensed Consolidated Statements of Cash Flows

    (In thousands)

    (Unaudited)

     

     

     

    Six Months Ended June 30,

     

     

    2021

     

    2020

    Cash flows from operating activities:

     

     

     

     

    Net loss

     

    $

    (6,896

    )

     

    $

    (4,899

    )

    Adjustments to reconcile net loss to net cash used in operating activities:

     

     

     

     

    Share-based compensation

     

     

    957

     

     

     

    829

     

    Amortization of premium (discount) on marketable securities

     

     

    38

     

     

     

    (23

    )

    Non-cash lease expense

     

     

    28

     

     

     

    26

     

    Depreciation

     

     

    12

     

     

     

    11

     

    Changes in operating assets and liabilities:

     

     

     

     

    Amounts receivable

     

     

    324

     

     

     

    504

     

    Prepaid expenses and other assets

     

     

    (244

    )

     

     

    (146

    )

    Accounts payable

     

     

    (860

    )

     

     

    370

     

    Accrued liabilities

     

     

    239

     

     

     

    (494

    )

    Net cash used in operating activities

     

     

    (6,402

    )

     

     

    (3,822

    )

     

     

     

     

     

    Cash flows from investing activities:

     

     

     

     

    Purchase of marketable securities

     

     

    (25,244

    )

     

     

    (8,799

    )

    Maturities of marketable securities

     

     

    26,235

     

     

     

    6,000

     

    Purchases of property and equipment

     

     

    (13

    )

     

     

    (2

    )

    Proceeds from disposition of property and equipment

     

     

    2

     

     

     

     

    Net cash provided by (used in) investing activities

     

     

    980

     

     

     

    (2,801

    )

     

     

     

     

     

    Cash flows from financing activities:

     

     

     

     

    Proceeds from issuance of common shares, net of offering costs

     

     

     

     

     

    7,682

     

    Proceeds from the exercise of stock options

     

     

    244

     

     

     

    16

     

    Principal payments on finance lease obligations

     

     

    (3

    )

     

     

    (3

    )

    Net cash provided by financing activities

     

     

    241

     

     

     

    7,695

     

     

     

     

     

     

    Net increase (decrease) in cash and cash equivalents

     

     

    (5,181

    )

     

     

    1,072

     

    Cash and cash equivalents at beginning of period

     

     

    7,409

     

     

     

    3,883

     

    Cash and cash equivalents at end of period

     

    $

    2,228

     

     

    $

    4,955

     

     

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  2. DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that its second quarter 2021 financial results will be released after the markets close on Wednesday, August 11th. DiaMedica will host a live conference call on Thursday, August 12th at 7:00 AM Central Time to discuss its business update and financial results.

    Conference Call details:

    Date:

    Thursday, August 12, 2021

    Time:

    7:00 AM CT / 8:00 AM ET

    Web access:

    https://event.on24.com/wcc/r/3192933/FBC5C2BE41E26E2C70F89B28EC5DB100

    Dial In:

    (844) 557-8483 (domestic)

    (825) 312-2381 (international)

    Conference ID:

    4148874

    Interested…

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that its second quarter 2021 financial results will be released after the markets close on Wednesday, August 11th. DiaMedica will host a live conference call on Thursday, August 12th at 7:00 AM Central Time to discuss its business update and financial results.

    Conference Call details:

    Date:

    Thursday, August 12, 2021

    Time:

    7:00 AM CT / 8:00 AM ET

    Web access:

    https://event.on24.com/wcc/r/3192933/FBC5C2BE41E26E2C70F89B28EC5DB100

    Dial In:

    (844) 557-8483 (domestic)

    (825) 312-2381 (international)

    Conference ID:

    4148874

    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 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 19, 2021, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), and entering the replay passcode: 4148874.

    About DiaMedica Therapeutics Inc.

    DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Our lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). Based on promising early clinical results, we are advancing DM199 in our REMEDY Phase 2/3 trial in the treatment of AIS and completing enrollment in our REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD. For more information visit our website at www.diamedica.com.

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  3. DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the Rick Pauls, President and Chief Executive Officer, will be available for one-on-one meetings and will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 10:00 am ET. Mr. Pauls looks forward to meeting investors to discuss DiaMedica's clinical development programs and business strategy.

    If you are interested in arranging a one-on-one meeting or listening to the live event, please contact your BTIG conference representative.

    About DiaMedica Therapeutics

    DiaMedica Therapeutics is a clinical stage…

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the Rick Pauls, President and Chief Executive Officer, will be available for one-on-one meetings and will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 10:00 am ET. Mr. Pauls looks forward to meeting investors to discuss DiaMedica's clinical development programs and business strategy.

    If you are interested in arranging a one-on-one meeting or listening to the live event, please contact your BTIG conference representative.

    About DiaMedica Therapeutics

    DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Our lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). Based on promising early clinical results, we are advancing DM199 in our REMEDY Phase 2/3 trial in the treatment of AIS and completing enrollment in our REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD. For more information visit our website at www.diamedica.com.

    View Full Article Hide Full Article
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