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- Phase 2\/3 ReMEDy2 Trial in AIS for Stroke Outcomes and Stroke Recurrence on Track for Initiation Summer 2021<\/i><\/b><\/li>\n
- Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR). <\/i><\/b><\/li>\n
- Board of Directors Strengthened with Election of Two Pharma Industry Veterans<\/i><\/b><\/li>\n<\/ul>\n
\n\u00a0Conference Call and Webcast August 12 at 8:00 am Eastern Time \/ 7:00 am Central Time<\/i><\/b><\/p>\n
MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica 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.\n<\/p>\nPivotal Phase 2\/3 ReMEDy Trial on Track for Summer 2021 Initiation; Prevention of Stroke Recurrence is being Added as Independent Co-Primary Endpoint <\/i><\/b><\/p>\n
\nDiaMedica\u2019s 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.\n<\/p>\n
\nThe 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.\n<\/p>\n
\nThe 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.\n<\/p>\n
DM199 for the Treatment of Chronic Kidney Disease (CKD) <\/i><\/b><\/p>\n
\nInterim 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.\n<\/p>\n
\nAdditionally, 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.\n<\/p>\n
\nDiaMedica is preparing to provide a more complete update on the interim study results to be presented at the American Society of Nephrology<\/i> Annual Meeting in November 2021.\n<\/p>\n
\nAs 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.\n<\/p>\n
Two Pharma Industry Veterans Added to DiaMedica Board of Directors<\/i><\/b><\/p>\n
\nIn July 2021, the Company announced the election of two experienced executives to its Board of Directors. Joining the Board are:\n<\/p>\n
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- \nAmy 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.\n<\/li>\n
- \nCharles 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\u00ae) and lifitegrast (XIIDRA\u00ae). He also led FDA approval for CathFlo Activase\u00ae (Alteplase) for ischemic stroke.\n<\/li>\n<\/ul>\n
Financial Results <\/b><\/p>\n
\nResearch 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.\n<\/p>\n
\nGeneral 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\u2019s expanding clinical programs.\n<\/p>\n
Balance Sheet and Cash Flow<\/b><\/p>\n
\nThe 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.\n<\/p>\n
\nNet 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.\n<\/p>\n
Conference Call and Webcast Information <\/b><\/p>\n
\nDiaMedica 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:\n<\/p>\n
- Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR). <\/i><\/b><\/li>\n
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