Financial Data and Key Metrics Changes - As of September 30, 2024, the company's cash, cash equivalents, and investments totaled $50.2 million, down from $52.9 million as of December 31, 2023 [30] - Net cash used in operating activities for the nine months ended September 30, 2024, was $15.6 million compared to $14.9 million in the same period of the prior year [30] - Research and development expenses increased to $5 million for the three months ended September 30, 2024, up from $3.3 million in the prior year period [31] - General and administrative expenses were $1.9 million for each of the three months ended September 30, 2024, and 2023 [33] Business Line Data and Key Metrics Changes - The company is making solid progress on its stroke and preeclampsia programs, with expectations for 2025 to be transformative [4] - The ReMEDy2 trial is seeing updates to its protocol and statistical analysis plan to enhance enrollment rates and improve trial outcomes [11][12] Market Data and Key Metrics Changes - The company anticipates that the activation of top U.S. sites for the AIS study will lead to a significant increase in patient enrollment [5][6] - The preeclampsia program has secured regulatory approval in South Africa, with the first participant enrolled [9] Company Strategy and Development Direction - The company is focused on building momentum with high-quality research institutions and expanding its clinical trial sites [28] - The updates to the ReMEDy2 trial are expected to improve the probability of success and accelerate the timeline for completion [16][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of DM199 in treating preeclampsia and its first and best-in-class potential [9] - The company believes that the changes in the ReMEDy2 trial will lead to a more efficient study and significant cost savings [27] Other Important Information - The company expects its current cash and investments to provide a runway to Q3 of 2026 [30] - The interim analysis for the ReMEDy2 trial is now expected in Q4 2025, with completion anticipated by next summer [50] Q&A Session Summary Question: What prompted the re-evaluation of the ReMEDy2 protocol? - The changes were driven by a combination of wanting to simulate enrollment and extensive discussions with experts [37] Question: At what point will patients now be randomized? - Patients will be randomized into the study only if they do not receive tPA prior to randomization [38] Question: Is the total number of patients for the study still viable? - The total number of patients is expected to be lower than the previously planned 364 based on the new interim analysis [39] Question: What are the assumptions for a quicker final readout with the changes? - The changes allow for greater precision in sample size assessment, potentially reducing the total number of patients needed [42] Question: Will the changes impact DM199's commercial opportunity? - The company believes that expanding the label to include tPA non-responders could significantly increase the patient population and revenue potential [48] Question: Is there any risk of FDA feedback necessitating trial modifications? - The chances of receiving substantive FDA feedback are low at this point, as the company is well past the 30-day mark for comments [55]

Financial Performance - For the nine months ended September 30, 2024, the net loss was $16.5 million, compared to $14.2 million for the same period in 2023, reflecting an increase in losses due to ongoing clinical trials and operational costs[68]. - The company has an accumulated deficit of $132.1 million as of September 30, 2024, with substantial operating losses primarily from product candidate development and R&D activities[68]. - General and administrative expenses were $1.9 million for the three months ended September 30, 2024, consistent with the same period in 2023, while for the nine months, expenses decreased to $5.68 million from $5.99 million[79]. - Net cash used in operating activities was $15.6 million for the nine months ended September 30, 2024, compared to $14.9 million for the same period in 2023, indicating an increase of approximately 4.7%[84]. - The company expects to incur significant expenses and increased operating losses for at least the next several years as it expands its clinical trials and development programs[69]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with no revenue expected for at least three to four years[87]. Research and Development - Research and development expenses increased to $4.98 million for the three months ended September 30, 2024, up from $3.27 million for the same period in 2023, and to $12.59 million for the nine months ended September 30, 2024, up from $9.43 million in 2023[78]. - The ReMEDy2 clinical trial aims to enroll approximately 350 patients globally, with a potential sample size adjustment based on interim analysis results[63]. - The company received regulatory approval to initiate a study of DM199 for the treatment of preeclampsia, which affects up to 8% of pregnancies worldwide[65]. - The first subject in the investigator-sponsored study of DM199 for preeclampsia was enrolled in Q4 2024, with topline data expected to demonstrate initial proof-of-concept[67]. Cash and Liquidity - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $50.2 million, down from $52.9 million as of December 31, 2023, representing a decrease of approximately 5.1%[81]. - The company anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months, although future funding requirements may arise sooner than expected[71]. - Total current liabilities increased to $4.3 million as of September 30, 2024, compared to $2.8 million at the end of 2023, marking a rise of about 53.6%[81]. - Net cash provided by investing activities was $3.4 million for the nine months ended September 30, 2024, a significant improvement from a net cash outflow of $24.4 million in the same period of 2023[85]. - Net cash provided by financing activities decreased to $11.9 million for the nine months ended September 30, 2024, down from $36.8 million in the prior year, a decline of approximately 67.6%[86]. - The company anticipates needing substantial additional capital to support ongoing R&D activities and clinical studies, with current cash resources expected to last for at least the next twelve months[88]. - Future funding requirements will depend on various factors, including the timing and results of ongoing development efforts and the potential expansion of current programs[88]. - The company has historically financed operations primarily through equity sales and expects to continue this practice, with no existing credit facilities available[90]. - If adequate funding is not available, the company may need to scale back operations, which could include cost reduction strategies and potential divestitures[92].

Financial Performance - DiaMedica reported total cash, cash equivalents, and investments of $50.2 million as of September 30, 2024, down from $52.9 million as of December 31, 2023[11]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $15.6 million, compared to $14.9 million for the same period in 2023[12]. - Other income for the nine months ended September 30, 2024, was $1.8 million, up from $1.2 million in the same period in 2023, driven by increased interest income[15]. - The net loss for Q3 2024 was $6,274,000, compared to a net loss of $4,471,000 in Q3 2023, representing a 40.3% increase in losses year-over-year[23]. - The company reported a total operating loss of $6,883,000 for Q3 2024, compared to an operating loss of $5,157,000 in Q3 2023, indicating a 33.4% increase in operating losses[23]. - The accumulated deficit increased to $132,102,000 as of September 30, 2024, up from $115,558,000 at the end of 2023, reflecting a 14.3% increase[24]. - The company raised $11,747,000 from the issuance of common shares in Q3 2024, compared to $36,848,000 in Q3 2023, a decrease of 68.2%[25]. Research and Development - Research and development (R&D) expenses increased to $5.0 million for Q3 2024, up from $3.3 million in Q3 2023, and totaled $12.6 million for the nine months ended September 30, 2024, compared to $9.4 million for the same period in 2023[13]. - Research and development expenses for Q3 2024 were $4,983,000, an increase of 52.2% compared to $3,272,000 in Q3 2023[23]. - The Preeclampsia Phase 2 trial has enrolled its first patient, with top-line results from Part 1A expected in the first half of 2025[8][9]. - The ReMEDy2 trial is expected to enroll approximately 350 patients at up to 100 sites globally, with interim results anticipated in Q4 2025, delayed from the previous guidance of Summer 2025[7][17]. - The inclusion of thrombolytic non-responders in the ReMEDy2 trial is expected to enhance treatment response and accelerate enrollment[8]. - The ReMEDy2 trial protocol has been updated to broaden the trial population and increase the sample size for interim analysis, enhancing the probability of success[4][5]. Cash and Assets - Total current assets decreased to $50,767,000 as of September 30, 2024, down from $53,675,000 at the end of 2023, a decline of 5.6%[24]. - Cash and cash equivalents at the end of Q3 2024 were $4,134,000, a decrease from $4,543,000 at the end of 2023, reflecting a 9% decline[24]. - The company has a cash runway extending into Q3 2026, providing sufficient funding for ongoing trials and operations[1]. - The company anticipates future operating expenses and cash runway extending into the third quarter of 2026, contingent on the success of ongoing clinical trials[21]. General and Administrative Expenses - General and administrative (G&A) expenses were $1.9 million for Q3 2024, consistent with Q3 2023, while G&A expenses for the nine months ended September 30, 2024, decreased to $5.7 million from $6.0 million in the same period in 2023[14]. Shareholder Information - The weighted average shares outstanding for basic and diluted calculations increased to 42,751,577 in Q3 2024 from 37,949,422 in Q3 2023, a rise of 12.5%[23].

Group 1: IAMGOLD Corporation (IAG) - IAMGOLD Corporation is an intermediate gold producer with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 30.8% over the last 60 days [1] - IAMGOLD's shares gained 17.2% over the last three months, outperforming the S&P 500's advance of 3.2% [1] - The company has a Momentum Score of A [1] Group 2: DiaMedica Therapeutics Inc. (DMAC) - DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 7.9% over the last 60 days [2] - DiaMedica's shares gained 18.7% over the last three months, also outperforming the S&P 500's advance of 3.2% [2] - The company has a Momentum Score of A [2] Group 3: HIVE Digital Technologies Ltd. (HIVE) - HIVE Digital Technologies Ltd. is a miner and seller of digital currencies with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased by 47.2% over the last 60 days [3] - HIVE's shares gained 17.8% over the last six months, compared to the S&P 500's advance of 14.9% [3] - The company has a Momentum Score of B [3]

Financial Data and Key Metrics Changes - The company completed an $11.8 million private placement, extending its cash runway into Q3 of 2026, with net proceeds of approximately $11.7 million [15] - As of June 30, 2024, combined cash, cash equivalents, and investments increased to $54.1 million, up from $52.9 million at the end of 2023 [15] - Net cash used in operating activities for the first half of 2024 was $11.2 million, compared to $10.1 million in the same period of the prior year [16] - Research and development expenses rose to $3.9 million for Q2 2024, up from $2.5 million in Q2 2023, and $7.6 million for the first half of 2024, compared to $6.2 million in the same period of 2023 [16][17] - General and administrative expenses decreased to $1.7 million for Q2 2024, down from $2.2 million in Q2 2023, and $3.8 million for the first half of 2024, down from $4.1 million in the same period of 2023 [18] Business Line Data and Key Metrics Changes - The ReMEDy2 trial is progressing well, with a focus on activating high-quality research institutions [4][8] - The company has identified 15 sites with high enrollment potential, expecting at least 9 of these to be active by the end of Q3 2024 [6][8] Market Data and Key Metrics Changes - The preeclampsia program is gaining momentum, with expectations for initial enrollment to begin in Q4 2024 and top-line results anticipated in the first half of 2025 [13] Company Strategy and Development Direction - The company is focused on expanding the ReMEDy2 trial and engaging with high-quality research sites to facilitate participant enrollment [4][8] - DM-199 is being positioned as a potential first-in-class treatment for preeclampsia, with significant benefits anticipated for patients [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the ReMEDy2 trial and the potential of DM-199 in treating preeclampsia, highlighting the lack of approved therapeutic options in this area [8][12] - The company is addressing challenges related to site activation and participant enrollment due to staffing shortages at research hospitals [5][6] Other Important Information - The company is working with a highly experienced research team for the preeclampsia program, which is expected to enhance the study's credibility and effectiveness [10][11] Q&A Session Summary Question: How many sites are currently active and enrolling? - The company has 13 sites activated, with expectations to have 9 out of the 15 high-enrolling sites operational by the end of Q3 [20] Question: How is the regulatory process for the preeclampsia study going? - The regulatory process in South Africa is being led by Dr. Cluver and her team, and it appears to be progressing well [21] Question: Are there any unexpected issues with the screening criteria? - The company feels confident about the screening process and is continuously looking for ways to improve enrollment rates [22]

Financial Position - DiaMedica completed a $12 million private placement, extending its cash runway into Q3 2026[1] - The company reported total cash, cash equivalents, and investments of $54.1 million as of June 30, 2024, an increase from $52.9 million at the end of 2023[9] - Cash and cash equivalents increased to $14,066,000 as of June 30, 2024, from $4,543,000 at the end of 2023, marking a significant increase of 209.5%[21] - Total assets rose to $56,791,000 as of June 30, 2024, compared to $54,160,000 at the end of 2023, reflecting a growth of 4.8%[21] - Total current liabilities increased to $3,088,000 as of June 30, 2024, compared to $2,786,000 at the end of 2023, indicating a rise of 10.9%[21] - Shareholders' equity increased to $53,415,000 as of June 30, 2024, from $51,057,000 at the end of 2023, representing a growth of 4.6%[21] Research and Development - Research and development (R&D) expenses increased to $3.9 million for Q2 2024, up from $2.5 million in Q2 2023, reflecting ongoing clinical trials[10] - A Phase 2 trial for preeclampsia is set to begin in Q4 2024, with initial proof-of-concept results expected in the first half of 2025[5] - The company has selected 15 research centers in the U.S. for the ReMEDy2 trial, with at least nine expected to be activated this quarter[2] - The company anticipates full enrollment of 144 patients for the interim analysis of the ReMEDy2 trial by Q1 2025[2] - DM199 is intended to lower blood pressure and improve perfusion to maternal organs in preeclampsia, with no approved therapeutics currently available in the U.S. or Europe[3] Income and Expenses - General and administrative (G&A) expenses decreased to $1.7 million for Q2 2024, down from $2.2 million in Q2 2023[11] - Other income increased to $526 thousand for Q2 2024, up from $271 thousand in Q2 2023, driven by higher interest income[12] - The company reported other income of $526,000 for Q2 2024, compared to $271,000 in Q2 2023, an increase of 94.1%[20] - Net cash used in operating activities for the first half of 2024 was $11.2 million, compared to $10.1 million for the same period in 2023[9] - The company generated net cash used in operating activities of $11,172,000 for the six months ended June 30, 2024, compared to $10,119,000 for the same period in 2023, an increase of 10.4%[22] - Cash flows from financing activities provided $11,751,000 in Q2 2024, compared to $36,849,000 in Q2 2023, indicating a decrease of 68.2%[22] Net Loss - The net loss for the six months ended June 30, 2024, was $10,270,000, compared to a net loss of $9,749,000 for the same period in 2023, representing an increase of 5.3%[22] - The company reported a basic and diluted net loss per share of $0.13 for Q2 2024, an improvement from $0.16 in Q2 2023[20]

Clinical Trials - DM199 clinical trial (ReMEDy2) is currently enrolling approximately 350 patients globally, with an adaptive design allowing for sample size adjustments based on interim analysis results [61]. - The ReMEDy2 trial aims for a primary endpoint of physical recovery from stroke, measured by the modified Rankin Scale (mRS) at day 90 [62]. - The company plans to conduct a Phase 2 trial for DM199 in treating preeclampsia, with an estimated cost of approximately $1.5 million and initial results expected in the first half of 2025 [65]. - The Phase 2 trial for preeclampsia is expected to begin enrolling subjects in Q4 2024, with a total of up to 120 subjects planned for evaluation [65]. Financial Performance - The company reported net losses of $10.3 million for the six months ended June 30, 2024, compared to $9.7 million for the same period in 2023, with an accumulated deficit of $125.8 million as of June 30, 2024 [66]. - Net cash used in operating activities was $11.2 million for the six months ended June 30, 2024, compared to $10.1 million for the same period in 2023, reflecting an increase of approximately 10.9% [81]. - Net cash provided by financing activities was $11.7 million for the six months ended June 30, 2024, down from $36.8 million in the same period of 2023, a decrease of approximately 68.2% [83]. - The company has not generated any revenues from product sales and does not expect to do so for at least three to four years, indicating ongoing reliance on external funding [84]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with anticipated increases in losses compared to prior periods [84]. Expenses - Research and Development (R&D) expenses increased to $3.9 million for Q2 2024, up 54% from $2.5 million in Q2 2023; for the six months ended June 30, 2024, R&D expenses were $7.6 million, up 23% from $6.2 million in the same period of 2023 [74]. - General and Administrative (G&A) expenses decreased to $1.7 million for Q2 2024, down 23% from $2.2 million in Q2 2023; for the six months ended June 30, 2024, G&A expenses were $3.8 million, down 7% from $4.1 million in the same period of 2023 [75]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $54.1 million as of June 30, 2024, compared to $52.9 million as of December 31, 2023 [77]. - As of June 30, 2024, the company had working capital of $51.9 million, an increase from $50.9 million as of December 31, 2023, reflecting a growth of approximately 2% [80]. - The company received net proceeds of $11.7 million from a private placement in June 2024, but expects to need substantial additional capital for ongoing R&D activities [85]. - Future funding requirements will depend on various factors, including the timing and results of ongoing clinical trials, indicating potential volatility in cash flow needs [85]. - The company may need to seek additional funding through equity or debt financing, which could dilute existing shareholders' interests [88]. - If adequate funding is not available, the company may be forced to scale back operations or delay product development, impacting long-term growth prospects [90]. Other Income - Other income increased to $526 thousand for Q2 2024, compared to $271 thousand in Q2 2023, driven by higher interest income from increased marketable securities [76].

Group 1 - DiaMedica Therapeutics, Inc. (DMAC) is outperforming the Medical sector with a year-to-date return of 15.5%, compared to the sector average of 7.1% [4] - The Zacks Consensus Estimate for DMAC's full-year earnings has increased by 8.7% over the past 90 days, indicating improving analyst sentiment [4] - DMAC is ranked 2 (Buy) in the Zacks Rank system, which focuses on earnings estimates and revisions [3] Group 2 - DiaMedica Therapeutics, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 500 stocks and currently ranks 87 in the Zacks Industry Rank [6] - Stocks in the Medical - Biomedical and Genetics industry have gained approximately 1.4% year-to-date, indicating that DMAC is performing better than its peers in this specific industry [6] - Elutia Inc. (ELUT), another stock in the Medical sector, has a year-to-date return of 69% and also holds a Zacks Rank of 2 (Buy) [5]

DiaMedica Therapeutics (NASDAQ:DMAC) is expected to complete enrollment for an interim futility analysis of its phase 2/3 ReMEDy2 clinical trial, using DM199 for the treatment of patients with acute ischemic stroke [AIS]. Enrollment of 144 patients for such an analysis is expected by Q1 of 2025, barring that there are no delays in recruitment. Having said that, this sets up a chance for it to target a very large multibillion-dollar market, where there are no FDA approved therapies. The company is in the pro ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q1 2024 Results Conference Call May 9, 2024 8:00 AM ET Company Participants Rick Pauls - President, CEO & Director Lorianne Masuoka - Chief Medical Officer Scott Kellen - CFO & Company Secretary Conference Call Participants Chase Knickerbocker - Craig-Hallum Thomas Flaten - Lake Street François Brisebois - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2024 Conference Call. An audio recording of the w ...