DiaMedica Therapeutics(DMAC)

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DiaMedica Therapeutics (DMAC) Update / Briefing Transcript
2025-05-28 13:00
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.
DiaMedica Therapeutics(DMAC) - 2025 FY - Earnings Call Transcript
2025-05-20 20:30
DiaMedica Therapeutics (DMAC) FY 2025 Conference May 20, 2025 03:30 PM ET Speaker0 Matthew Caulfield. I'm a senior biotech analyst here at H. C. Wainwright. Our next company is DiaMedica Therapeutics. I'm joined by David Wenbecki, chief business officer. So thank you to DiaMedica for being here. Thanks for having us, Matt. We really appreciate it. Absolutely. So maybe to start things off at a high level, DMedica has a platform focused on ischemic diseases with biologic asset DM199. Can you talk to us about ...
DiaMedica Therapeutics(DMAC) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:02
DiaMedica Therapeutics (DMAC) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Rick Pauls - President and Chief Executive OfficerScott Kellen - CFO & Secretary Conference Call Participants Thomas Flaten - Senior Research AnalystMatthew Caufield - VP - Senior Healthcare AnalystChase Knickerbocker - Senior Equity Research Analyst - Healthcare Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio reco ...
DiaMedica Therapeutics(DMAC) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:00
DiaMedica Therapeutics (DMAC) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before DiaMedica proceeds with its remarks, please note that the company will be making forward looking statements on today's call. These ...
DiaMedica Therapeutics(DMAC) - 2025 Q1 - Quarterly Report
2025-05-13 20:31
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) ...
DiaMedica Therapeutics(DMAC) - 2025 Q1 - Quarterly Results
2025-05-13 20:30
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 ...
DiaMedica Therapeutics(DMAC) - 2024 Q4 - Earnings Call Transcript
2025-03-18 20:21
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]
DiaMedica Therapeutics(DMAC) - 2024 Q4 - Earnings Call Transcript
2025-03-18 14:27
DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2024 Earnings Conference Call March 18, 2025 8:00 AM ET Company Participants Rick Pauls - President and CEO Lorianne Masuoka - CMO Scott Kellen - CFO Conference Call Participants Thomas Flaten - Lake Street Chase Knickerbocker - Craig-Hallum Matthew Caufield - H.C. Wainwright Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Full Year 2024 Conference Call. An audio recording of the webcast will be available shortly after the c ...
DiaMedica Therapeutics(DMAC) - 2024 Q4 - Annual Report
2025-03-17 20:32
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].
DiaMedica Therapeutics(DMAC) - 2024 Q4 - Annual Results
2025-03-17 20:30
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]