On May 5, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that financial results for the quarter ended March 31, 2021 (Press release, DiaMedica, MAY 5, 2021, View Source [SID1234579252]). DiaMedica will host a conference call Thursday, May 6, 2021, at 7:00 a.m. Central Time to discuss its business update and first quarter financial results.
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Clinical Developments
DM199 for the Treatment of Acute Ischemic Stroke
IND Submitted
Initiation of Phase 2/3 Trial of DM199 in AIS in Summer 2021
DiaMedica has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199, the Company’s recombinant form of human tissue kallikrein-1 being developed as a treatment for acute ischemic stroke (AIS) patients. The proposed trial of DM199 is for AIS patients who do not receive tissue plasminogen activator (tPA) and do not have large vessel occlusions, a group that represents up to 80% of all AIS patients. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.
The FDA has confirmed its receipt of the IND and DiaMedica expects the FDA to complete its regulatory review of the IND by mid-May. If authorized by the FDA, the Company anticipates initiating the study this summer. DiaMedica has selected a contract research organization to assist with the conduct of the study and is actively working to identify, qualify and engage clinical study sites—the expected pacing item for initiation of the study.
The clinical trial is proposed to be 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. Secondary endpoints will include stroke recurrence, mRS shift, NIHSS and Barthel Index, deaths, safety and tolerability measures, and biomarkers relating to KLK1. Independent of this study, the Company plans to discuss with the FDA a second study for the evaluation of the efficacy of DM199 in reducing stroke recurrence based upon the statistically significant reduction in severe recurrent strokes observed in its ReMEDy Phase 2 AIS trial.
"We are pleased with the overall progress of our AIS program," commented Rick Pauls, Chief Executive Officer of DiaMedica. "We look forward to initiation of this trial and moving closer to potentially providing stroke patients and physicians a much-needed new treatment option for AIS."
DM199 for the Treatment of Chronic Kidney Disease
Data Read-out Expected in Q2 2021 on CKD Caused by Type II Diabetes Cohort
Enrollment Continues in IgA Nephropathy and CKD in African Americans with Hypertension
DiaMedica’s Phase 2 REDUX 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) which is found more commonly in Asians, Caucasians and people of Eastern Europe and is very rare in Blacks and people of African descent and Cohort 3 includes participants with diabetic kidney disease (DKD) which is defined by elevated urine albumin excretion and/or reduced glomerular filtration rate (GFR) – is a serious complication that occurs in 20% to 40% of all diabetics.
As of April 30, 2021, DiaMedica had enrolled a total of 70 subjects, including a fully enrolled DKD Cohort, and approximately 70% of the IgAN and 60% of the African American Cohorts. The Company has continued to experience slower than expected enrollment in the first two Cohorts of the REDUX trial due to the COVID-19 pandemic. However, with the significant declines in new COVID-19 cases and the anticipated availability and effectiveness of vaccines, the Company currently anticipates completion of Cohort 1 and Cohort 2 in the second half of 2021. Preliminary topline results from the DKD Cohort are expected to be available in the second quarter of 2021.
Financial Results
Research and development (R&D) expenses were $2.4 million for the three months ended March 31, 2021, compared with $1.4 million for the three months ended March 31, 2020, an increase of $1.0 million. The increase was due to a number of factors including a year-over-year increase in costs incurred for the REDUX Phase 2 CKD study, and costs associated with an increase in staff levels, consulting services and non-clinical testing required to support preparation for the ReMEDy2 Phase 2/3 stroke study. These increases were partially offset by a year-over-year decrease in costs incurred for the ReMEDy Phase 2 stroke study which completed during 2020.
General and administrative (G&A) expenses were $1.2 million for the three months ended March 31, 2021, up from $1.1 million for the three months ended March 31, 2020. The increase in G&A expenses resulted primarily from increased directors and officers liability insurance, personnel and non-cash share-based compensation costs.
Balance Sheet and Cash Flow
The Company had cash, cash equivalents and marketable securities of $23.4 million, current liabilities of $1.2 million and working capital of $23.0 million as of March 31, 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 related to the REDUX Phase 2 CKD study and costs associated with preparing for the ReMEDy2 Phase 2/3 stroke study.
Net cash used in operating activities for the three months ended March 31, 2021 was $4.3 million compared to $3.0 million for the three months ended March 31, 2020. This increase relates primarily to the increase in the net loss, partially offset by the effects of the changes in operating assets and liabilities.
Conference Call Information
DiaMedica Management will host a conference call to discuss its business update and first quarter 2021 financial results on Thursday, May 6, 2021, at 7:00 a.m. Central Time:
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 May 13, 2021, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), and entering the replay passcode: 2966016.
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.