Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported total combined cash and investments of $44.1 million, down from $52.9 million at the end of 2023, indicating a decrease due to cash used for operations [34] - Current liabilities increased to $5.4 million from $2.8 million, while working capital decreased to $39.2 million from $50.9 million [34] - Net cash used in operating activities for the full year 2024 was $22.1 million, compared to $18.7 million in 2023, driven by increased net loss and advance deposit funds for the ReMEDy2 trial [35] Business Line Data and Key Metrics Changes - Research and development expenses rose to $19.1 million for the year ended December 31, 2024, up from $13.1 million in the prior year, primarily due to the continuation of the ReMEDy2 clinical trial and increased manufacturing activities [36] - General and administrative expenses decreased to $7.6 million from $8.2 million, attributed to reduced legal fees and lower insurance premiums, partially offset by increased personnel costs [38] Market Data and Key Metrics Changes - The company activated 30 clinical sites for the ReMEDy2 trial, which is expected to generate a steady stream of enrollments [16] - The protocol for the stroke program was updated to allow DM199 to be stored at refrigerated temperatures, expanding the eligible patient population [17] Company Strategy and Development Direction - The company is focused on advancing its clinical programs for DM199 in both stroke and preeclampsia, aiming to provide treatment options for conditions with no current therapeutic alternatives [31][78] - The strategy includes expanding the ReMEDy2 trial globally and increasing site activation and enrollment activities [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential of DM199 as a transformative therapy for patients lacking treatment options [78] - The company anticipates that its current cash and investments will provide a runway into Q3 of 2026, indicating a stable financial outlook for the near term [36] Other Important Information - The independent Data Safety Monitoring Board reviewed safety data and concluded that the ReMEDy2 trial should continue without modification [27] - A peer-reviewed publication analyzing DM199's mechanism of action was released, providing scientific insight into its potential benefits for acute ischemic stroke patients [28] Q&A Session Summary Question: How many of the activated sites are among the top 15 identified? - The majority of the top 15 sites are activated, with many currently enrolling patients [43] Question: What data did the DSMB review for safety? - The DSMB had access to the entire database of patient data up until a specific cutoff date [45] Question: What are the expectations around enrollment rates for the ReMEDy2 trial? - The company anticipates doubling the number of enrolling sites and expects sites to enroll about one to two patients per month [55] Question: Has the amended statistical analysis plan been finalized with the FDA? - Yes, the amended statistical analysis plan has been finalized with the FDA [74]

Financial Performance - DiaMedica Therapeutics Inc. reported net losses of $24.4 million and $19.4 million for the years ended December 31, 2024 and 2023, respectively[375]. - The company had cash, cash equivalents, and marketable securities of $44.1 million as of December 31, 2024, with an accumulated deficit of $140.0 million[375]. - General and administrative (G&A) expenses decreased to $7.6 million in 2024 from $8.2 million in 2023[379]. - Other income, net, increased to $2.3 million in 2024 from $1.9 million in 2023, driven by higher interest income related to increased marketable securities[393]. - Cash, cash equivalents, and marketable securities decreased to $44.1 million as of December 31, 2024, from $52.9 million in 2023, due to net cash used in operating activities[396]. - Net cash used in operating activities was $22.1 million for 2024, compared to $18.7 million in 2023, primarily due to increased net loss and advance deposit funds for the ReMEDy2 trial[397]. - Net cash provided by financing activities was $12.0 million in 2024, down from $36.8 million in 2023, mainly from the June 2024 private placement[399]. - The company expects to incur substantial operating losses until product sales or licensing fees are generated, with operating losses expected to moderately increase as clinical studies continue[401]. - As of December 31, 2024, the company estimates outstanding commitments of approximately $19.3 million, with $14.5 million due within the next 12 months[406]. - Future operating lease obligations total approximately $316,000, with about $90,000 due over the next 12 months[407]. - The company does not expect to generate any revenue from product sales for at least three to four years, pending regulatory approvals[401]. Research and Development - Research and development (R&D) expenses were $19.1 million for 2024, up from $13.1 million in 2023, primarily due to clinical development costs[378]. - Research and development (R&D) expenses increased to $19.1 million for the year ended December 31, 2024, up from $13.1 million in 2023, primarily due to the continuation of the ReMEDy2 clinical trial and expansion of the clinical team[391]. - The ReMEDy2 clinical trial for DM199 aims to enroll approximately 300 participants globally, with a potential final sample size of up to 728 patients[367]. - The Phase 2 trial for preeclampsia (PE) is expected to evaluate up to 90 women, with results from the initial part anticipated in Q2 2025[371]. - DM199 is designed to enhance blood flow and neuronal survival in AIS patients, addressing a critical unmet need as up to 80% of AIS patients are ineligible for current treatments[366]. - The company expects to incur significant expenses and increased operating losses for at least the next few years as it expands its clinical trials[376]. - The company plans to continue monitoring and potentially expanding its clinical development programs based on ongoing results and market conditions[377]. Licensing and Obligations - The company has entered into a license agreement with Catalent Pharma Solutions for gene expression technology and manufacturing of DM199[408]. - A milestone payment obligation remains due upon the first regulatory approval of DM199 for commercial sale as of December 31, 2024[408]. - Following the product launch, the company will incur a royalty obligation of less than 1% of net sales, with an indefinite royalty term[408]. - The license agreement can be canceled by the company with 90 days' prior written notice[408]. - Catalent cannot terminate the license unless the company fails to make required milestone and royalty payments[408].

Financial Position - Cash position as of December 31, 2024, was $44.1 million, down from $52.9 million as of December 31, 2023, with a cash runway anticipated into Q3 2026[7] - Total assets decreased from $54,160 million in 2023 to $46,345 million in 2024, a decline of approximately 14.9%[19] - Current liabilities increased significantly from $2,786 million in 2023 to $5,390 million in 2024, an increase of about 93%[19] - Shareholders' equity dropped from $51,057 million in 2023 to $40,718 million in 2024, a decrease of approximately 20.2%[19] - Cash and cash equivalents decreased from $4,543 million at the beginning of the period to $3,025 million at the end, a decline of 33.4%[21] - Total current assets fell from $53,675 million in 2023 to $44,610 million in 2024, a decrease of approximately 16.9%[19] - The company reported an increase in accrued liabilities from $1,777 million in 2023 to $4,347 million in 2024, an increase of about 144.5%[19] Operating Activities - Net cash used in operating activities for 2024 was $22.1 million, an increase from $18.7 million in 2023, primarily due to increased net loss and advance deposits for the ReMEDy2 trial[7] - Net cash used in operating activities was $22,076 million in 2024, compared to $18,728 million in 2023, indicating a 17.9% increase in cash outflow[21] Research and Development - Research and Development (R&D) expenses rose to $19.1 million in 2024 from $13.1 million in 2023, driven by the continuation of the ReMEDy2 trial and expansion of the clinical team[7] - The company expects moderate increases in R&D expenses as it expands the ReMEDy2 trial and the DM199 clinical development program into preeclampsia[7] Net Loss - Net loss for the year ended December 31, 2024, was $24.4 million, or $0.60 loss per share, compared to a net loss of $19.4 million, or $0.60 loss per share, in 2023[7] - Net loss for 2024 was $24,444 million, compared to a net loss of $19,381 million in 2023, representing a 26.5% increase in losses[21] ReMEDy2 Trial - The ReMEDy2 trial has activated 30 study sites as of Q1 2025, with an interim analysis for sample size re-estimation expected in the first half of 2026[3] - The ReMEDy2 trial aims to enroll approximately 300 patients globally, with the final sample size determined by an interim analysis of 200 participants[10] - Preliminary safety and efficacy data from the Phase 2 trial for preeclampsia is anticipated in Q2 2025[4] Corporate Developments - The company appointed Daniel J. O'Connor to the Board in February 2025, who previously led a $2 billion acquisition at Ambrx[6] Cash Flows - Cash flows from investing activities improved, with net cash provided of $8,564 million in 2024 compared to a net cash used of $18,299 million in 2023[21] - Proceeds from the issuance of common shares decreased from $36,848 million in 2023 to $11,747 million in 2024, a decline of about 68.2%[21]

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐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 ...