Preeclampsia Overview and Unmet Need - Preeclampsia affects 5-8% of all pregnancies in the U S, impacting 180,000 to 300,000 patients annually[10] - Refractory hypertension drives approximately 50% of deliveries in early-onset preeclampsia cases[51] - Current anti-hypertensives primarily target vascular smooth muscle cells, managing symptoms but not addressing the underlying endothelial dysfunction[53] DM199 Mechanism of Action and Potential Benefits - DM199 aims to increase placental perfusion and repair endothelium, potentially reducing blood pressure[44] - DM199 is not expected to cross the placental barrier, offering a potential safety advantage compared to small molecules[46] - DM199 targets both upstream hypoxia and downstream endothelial dysfunction and blood pressure[44] - DM199 has the potential to safely extend gestation and accelerate fetal growth[45] DM199 Phase 2 Trial - The ongoing Phase 2, Part 1A investigator-sponsored trial is recruiting preeclampsia patients with planned delivery in less than 72 hours[58, 60] - The trial includes dose escalation to identify the optimal dose based on blood pressure reductions[59, 62] - Key endpoints include safety and tolerability, placental transfer analysis, blood pressure reduction, and dilation of intrauterine arteries[62]

Summary of DiaMedica Therapeutics Virtual KOL Event Company and Industry Overview - **Company**: DiaMedica Therapeutics - **Industry**: Pharmaceutical, specifically focusing on treatments for preeclampsia, a serious pregnancy-related condition Key Points and Arguments 1. **Unmet Medical Need**: Preeclampsia affects 5-8% of pregnancies in the U.S., with 180,000 to 300,000 cases annually, leading to severe complications for mothers and babies [3][11][12] 2. **Current Treatment Limitations**: The only definitive treatment is delivery of the placenta, often resulting in premature births. Current medications only manage symptoms rather than address the underlying disease [51][52] 3. **DM199 Potential**: DM199 is a synthetic version of tissue kallikrein that may reduce blood pressure and improve blood flow to the placenta, potentially transforming preeclampsia treatment [5][42][47] 4. **Mechanism of Action**: DM199 may enhance bradykinin signaling, leading to vasodilation and improved endothelial function, which is crucial for managing preeclampsia [34][36][39] 5. **Safety Profile**: DM199 is not expected to cross the placental barrier, reducing concerns about fetal exposure to the drug, which is a significant advantage over small molecule drugs [44][46][47] 6. **Clinical Trial Design**: Ongoing phase two clinical trials are assessing the safety, tolerability, and efficacy of DM199 in pregnant women with preeclampsia, focusing on blood pressure control and uterine artery blood flow [58][61][62] Important but Overlooked Content 1. **Economic Impact**: The cost of managing preterm infants in NICUs can range from $5,000 to $10,000 per day, leading to total costs of $2-3 million for prolonged care, highlighting the economic burden of preeclampsia [77][78] 2. **Long-term Morbidity**: Survivors of preeclampsia-related complications may face long-term health issues, including cerebral palsy and other disabilities, affecting their quality of life and family dynamics [14][78] 3. **Clinical Implications of Blood Pressure Control**: Maintaining systolic blood pressure below 160 mmHg is critical for prolonging pregnancy and reducing the risk of preterm delivery [82][84] 4. **Exploratory Endpoints**: The trials will also measure uterine artery blood flow resistance, which could indicate improved placental perfusion and better outcomes for both mother and baby [61][62] This summary encapsulates the critical insights from the DiaMedica Therapeutics event, emphasizing the significance of DM199 in addressing the unmet needs in preeclampsia treatment and its potential impact on maternal and neonatal health.

Financial Data and Key Metrics Changes - DiaMedica Therapeutics is in a pivotal phase two/three for ischemic stroke and simultaneously conducting a phase two study for preeclampsia, with key data expected in the next sixty days [3][34] - The company estimates a market opportunity of about 30,000 patients for early onset preeclampsia in the U.S., with a focus on severe cases that require hospitalization [13][14] Business Line Data and Key Metrics Changes - The primary asset, DM199, is a recombinant human tissue kallikrein-1 enzyme aimed at treating ischemic diseases, specifically targeting preeclampsia and ischemic stroke [1][3] - Current treatment options for preeclampsia are described as antiquated and ineffective, highlighting the potential for DM199 to fill a significant unmet need [14][19] Market Data and Key Metrics Changes - In the U.S., early onset preeclampsia occurs in up to 1% of pregnancies, translating to approximately 30,000 patients annually [13] - The company anticipates a high penetration rate for DM199 in the market due to the lack of effective current treatments [13][15] Company Strategy and Development Direction - DiaMedica aims to position DM199 as a disease-modifying therapy that is endothelial protective and lowers blood pressure, addressing the underlying dysfunction in preeclampsia [19][30] - The company is also exploring the acute ischemic stroke market, targeting patients who are not eligible for existing treatments like mechanical thrombectomy or tPA [43][49] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the critical need for effective treatments in preeclampsia, noting that current medications often fail to manage symptoms effectively [19][54] - The company believes that the unique properties of DM199, such as its large molecular size, will provide a safety advantage by not crossing the placental barrier [15][30] Other Important Information - The clinical trial for preeclampsia is being conducted in South Africa due to high rates of the condition and access to experienced investigators [21][23] - Upcoming key opinion leader (KOL) event scheduled for May 28, 2025, to discuss the unmet need in preeclampsia and the trial design [58][60] Q&A Session Summary Question: Can you discuss the clinical development of DM199 for preeclampsia? - The company is in a pivotal phase two/three for ischemic stroke and a phase two for preeclampsia, with data expected in the next sixty days [3][34] Question: What is the market opportunity for DM199? - The estimated market opportunity for early onset preeclampsia in the U.S. is about 30,000 patients, with a focus on severe cases [13][14] Question: Why was South Africa chosen for the preeclampsia trial? - South Africa was selected due to high rates of preeclampsia and access to leading investigators who can conduct rigorous clinical trials [21][23] Question: How does DM199 differ from current treatments? - DM199 is a large molecule that does not cross the placental barrier, providing a safety advantage over current small molecule treatments [15][30] Question: What are the next steps for the company? - The company is preparing for a KOL event to discuss the unmet need in preeclampsia and the trial design, with data readouts expected in late June to early July [58][60]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [11] - Current liabilities were reported at $4.7 million, compared to $5.4 million in the previous quarter, while working capital decreased to $32.8 million from $39.2 million [11] - Net cash used in operating activities for Q1 2025 was $7.1 million, an increase from $6.7 million in Q1 2024, primarily due to an increased net loss [12] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, driven by costs associated with the REMEDY two clinical trial and global expansion [12][13] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [13] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [9] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is currently the only novel agent being studied in pregnant women with this condition [8] - The management is also working on expanding the stroke program's enrollment and maintaining momentum through site engagement [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both clinical programs and highlighted the importance of upcoming milestones, including preliminary results from the preeclampsia trial and interim analysis from the stroke program [43] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a focus on sustaining operations while advancing clinical trials [12] Other Important Information - A key opinion leader call regarding preeclampsia is scheduled for May 28, 2025, to educate stakeholders about the disease and the company's clinical trial design [6][8] - The company is actively engaging with high-volume sites to drive enrollment in the stroke program, with a focus on maintaining relationships and expanding geographic reach [33] Q&A Session Summary Question: Clarification on laboratory test results for DM199 - Management confirmed that the main variable affecting the timeline for results is the placental transfer assay, which is being finalized [17] Question: Triggers for Parts 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger the fetal growth restriction cohort, with more details to be shared after upcoming results [19][20] Question: Anticipated read-through from preeclampsia data to AIS development - Management noted that while the indications are unique, positive results in preeclampsia would confirm the activity of the protein being studied [25] Question: Update on stroke program enrollment - Management reported that high-enrolling sites are seeing one to two patients per month, and overall enrollment is above plan, with encouraging momentum [31][32] Question: Expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, but the current focus remains on completing Part 1a and moving into Part 1b [39]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [10] - Current liabilities decreased to $4.7 million from $5.4 million, while working capital fell to $32.8 million from $39.2 million [10] - Net cash used in operating activities for Q1 2025 was $7.1 million, compared to $6.7 million for Q1 2024, reflecting an increase in net loss [11] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, primarily due to costs associated with the REMEDY two clinical trial and global expansion [11][12] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [12] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [8] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is expected to release preliminary top-line results between June and July [5][6] - The company plans to sponsor a preeclampsia key opinion leader call to educate stakeholders on the disease and treatment options [6][7] - Future expansion of the preeclampsia study to the U.S. is planned, with a focus on obtaining results from Part 1a before moving to Parts 1b, 2, and 3 [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both the preeclampsia and stroke programs, highlighting the importance of upcoming milestones [39] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a stable financial position for ongoing operations [11] Other Important Information - The company has engaged an experienced stroke neurologist to support site engagement during a key team member's medical leave, ensuring continued enrollment momentum [8] Q&A Session Summary Question: Clarification on laboratory test results timing - Management confirmed that the main variable affecting the timing of results is the placental transfer assay, which is being finalized [15][16] Question: Triggers for advancing to Part 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger movement to the fetal growth restriction cohort [17][18] Question: Anticipated read-through from preeclampsia data to stroke development - Management noted that positive preeclampsia data would confirm the activity of the protein being studied, which is also used in stroke treatment [22][24] Question: Update on stroke program enrollment and high-volume centers - Management reported that some high-enrolling sites are achieving one to two patients per month, with overall enrollment momentum building [26][28] Question: Future expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, contingent on results from the current phases [34][36]

For the quarterly period ended March 31, 2025 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 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 in its charter) ...

Exhibit 99.1 DiaMedica Therapeutics Reports First Quarter 2025 Financial Results And Provides Business Highlights Conference Call and Webcast May 14 at 8:00 AM Eastern Time / 7:00 AM Central Time Minneapolis, Minnesota – May 13, 2025 (Business Wire) – DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for acute ischemic stroke and preeclampsia, today provided a business update and financial results for the quarter ended March 31, 202 ...

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 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 to vendors [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 currently lacking effective therapies [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 acknowledged challenges in site engagement and enrollment due to lower staffing levels in research units post-COVID, but expressed optimism about increasing enrollment rates in 2025 [22][24] - 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 recent publication analyzed the mechanism of action of DM199, 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 interim analysis? - The company anticipates doubling the number of enrolling sites and targeting sites that can 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].