DiaMedica Therapeutics Inc. (DMAC) announced that it has dosed the first patient in the relaunch of its mid to late-stage stage pivotal study evaluating the safety and efficacy of its lead product candidate, DM199, to treat acute ischemic stroke (AIS). The company’s shares gained 9.7% on Apr 17, following the encouraging news.DM199 is DiaMedica’s recombinant (synthetic) form of human tissue kallikrein-1, which will be developed in the pivotal phase II/III ReMEDy2 study for AIS patients. The investigational ...

DiaMedica Therapeutics, Inc. (DMAC) has been on a downward spiral lately with significant selling pressure. After declining 19.8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spott ...

Financial Data and Key Metrics Changes - As of December 31, 2023, the total combined cash and investments increased to $52.9 million from $33.5 million in 2022, with working capital rising to $50.9 million from $31.7 million [40] - Research and development expenses rose to $13.1 million in 2023, up from $7.8 million in 2022, primarily due to costs related to the ReMEDy2 trial and increased personnel costs [20] - Net cash used in operating activities increased to $18.7 million in 2023 from $11.5 million in the previous year, driven by a higher net loss and increased amortization of discounts on marketable securities [41] Business Line Data and Key Metrics Changes - The ReMEDy2 trial is expected to have 25 to 30 sites active and recruiting by the end of Q2 2024, with a total of approximately 75 sites anticipated by the end of 2024 [15] - The ReMEDy1 trial showed an 18% improvement in full recovery for patients treated with DM199 compared to placebo [38] Market Data and Key Metrics Changes - The Canadian Stroke Consortium has endorsed the ReMEDy2 trial protocol, with six Canadian hospitals identified for participation [7] - The Australian Stroke Trials Network has provisionally endorsed the protocol, with plans to activate study sites by the end of 2024 [14] Company Strategy and Development Direction - The company aims to position DM199 as a potential breakthrough treatment for acute ischemic stroke, focusing on enhancing clinical success probabilities through protocol revisions [17] - The strategy includes expanding clinical operations and engaging reputable stroke research hospitals to increase patient enrollment [13][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ReMEDy2 trial's design and its potential to provide definitive evidence for DM199's efficacy [6] - The company anticipates a substantial ramp-up in site activations and patient enrollment in the second half of 2024, with expectations for the interim analysis to be completed by Q1 2025 [35][37] Other Important Information - The company is currently evaluating options regarding a lawsuit against PRA, with a court finding PRA in breach of the study agreement but not entitling the company to a return of fees paid [43] - Other income increased to $1.9 million in 2023 from $0.4 million in 2022, driven by higher interest rates and increased marketable securities [21] Q&A Session Summary Question: What is the expected lag from site activation to patient enrollment? - Management indicated a reasonable expectation of a 3- to 4-month lag due to multiple layers of IRB approvals at academic institutions [44] Question: Will the interim analysis be representative of the full patient enrollment? - Management anticipates a mix of patients from the U.S., Canada, Australia, and the EU, with full enrollment expected by the end of Q1 2025 [46] Question: What are the expectations around the interim read and study design? - If a drug effect of less than approximately 4% versus placebo is observed, the study will be terminated; otherwise, a resampling size will be determined [49] Question: What is the current status of the PRA lawsuit? - The company is evaluating options regarding the appeal, with a court ruling that they are entitled to the full results of the study but not to a return of fees paid [43][59]

DiaMedica Therapeutics (NASDAQ:DMAC) just reported results for the fourth quarter of 2023.DiaMedica Therapeutics reported earnings per share of -14 cents. This met the analyst estimate for EPS of -14 cents.The company did not report any revenue for the quarter.InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to __________________. Commission file number: 001-36291 DIAMEDICA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) British Columbia (State or other jurisdiction of incorporation or organization) 301 Carlson Parkway, Suite 210 Minneapolis, Minnesota (Address of princ ...

Financial Performance - DiaMedica reported total cash, cash equivalents, and investments of $52.9 million as of December 31, 2023, an increase from $33.5 million as of December 31, 2022, primarily due to $36.8 million in net proceeds from private placements[7]. - Net loss for 2023 was $19,381,000, compared to a net loss of $13,676,000 in 2022, reflecting a 41.6% increase in losses[20]. - Basic and diluted net loss per share increased to $0.60 in 2023 from $0.52 in 2022[20]. - Total assets grew to $54,160,000 in 2023, up from $34,395,000 in 2022, marking a 57.5% increase[22]. - Total shareholders' equity rose to $51,057,000 in 2023 from $31,827,000 in 2022, an increase of 60.5%[22]. - Proceeds from issuance of common shares amounted to $36,848,000 in 2023, with no proceeds reported in 2022[24]. Expenses - Research and development (R&D) expenses rose to $13.1 million for the year ended December 31, 2023, up from $7.8 million in 2022, driven by costs related to the ReMEDy2 trial and increased personnel costs[9]. - General and administrative (G&A) expenses increased to $8.2 million for the year ended December 31, 2023, compared to $6.2 million in 2022, primarily due to higher legal fees and personnel costs[10]. - Total operating expenses increased to $21,267,000 in 2023 from $14,001,000 in 2022, representing a 52.4% increase[20]. - Research and development expenses rose significantly to $13,110,000 in 2023, up from $7,839,000 in 2022, a 67.5% increase[20]. - Net cash used in operating activities was $18.7 million for the year ended December 31, 2023, compared to $11.5 million in 2022, reflecting a higher net loss and increased amortization of discounts on marketable securities[8]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients across up to 100 sites in the U.S., with full enrollment for the interim analysis expected to be completed in the first quarter of 2025[5][13]. - Six clinical sites in the U.S. were opened in December 2023, with the majority expected to be activated by Q3 2024, and expansions into Canada and Australia planned for later in 2024[2][4]. - The protocol modification submitted to the FDA in October 2023 aims to enhance the probability of clinical success in the ReMEDy2 trial by focusing on moderate acute ischemic stroke patients[3]. Cash and Investments - Other income increased to $1.9 million for the year ended December 31, 2023, compared to $0.4 million in 2022, driven by higher interest income from increased marketable securities[11]. - The company has a cash runway expected to last until 2026, supporting ongoing clinical trials and operations[4][16]. - Cash and cash equivalents decreased slightly to $4,543,000 in 2023 from $4,728,000 in 2022[22]. - Marketable securities increased to $48,352,000 in 2023, up from $28,774,000 in 2022, a 68.2% increase[22]. - Net cash used in operating activities was $18,728,000 in 2023, compared to $11,511,000 in 2022, a 62.5% increase[24]. Management Changes - DiaMedica's management team was strengthened with the appointment of Dr. Lorianne Masuoka as Chief Medical Officer in January 2024, bringing over 25 years of experience in the biopharmaceutical industry[6].

MINNEAPOLIS--(BUSINESS WIRE)--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 year ended December 31, 2023. Management will host a conference call Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and full year 2023 financial results. ReMEDy2 Phase 2/3 AIS Cli ...

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company currently focused on developing recombinant KLK1 (DM199) for the treatment of acute ischemic stroke (AIS), today announced a poster presentation of the design and rationale for ReMEDy2, the planned pivotal phase 2/3 trial of DM199 in AIS patients, at the American Heart Association 2024 International Stroke Conference being held in Phoenix, AZ from February 7 – 9, 2024. For information about t ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q3 2023 Earnings Call Transcript November 14, 2023 8:00 AM ET Company Participants Rick Pauls - President and CEO Scott Kellen - CFO Conference Call Participants Thomas Flaten - Lake Street Capital Alexander Nowak - Craig-Hallum Capital Group Francois Brisebois - Oppenheimer. Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Third Quarter 2023 Conference Call. An audio recording of the webcast will be available shortly after the ...

1 Cautionary Note Regarding Forward-Looking Statements Other risk and uncertainties of which DiaMedica is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All forward-looking statements contained in this presentation speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. DiaMedica undertakes no obligation to publicl ...