Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the meeting affirmed the FDA's request for one additional non-clinical, 1. ...

Industry Overview - The biotech industry is projected to reach a size of $3.9 trillion by 2030 and about $8 trillion by 2035 [2] Company Analysis: DiaMedica Therapeutics (DMAC) - DiaMedica Therapeutics is a clinical-stage biopharmaceutical company founded in 2000, developing DM199 for ischemic disorders such as acute ischemic stroke and preeclampsia [4] - DM199 is intended to restore vascular function and reduce ischemia, characterized as a potentially disease-modifying approach to improve blood flow and reduce injury [4] - The market cap of DMAC is valued at $380 million, with the stock up 35% year-to-date [5] - The company is still at the pre-revenue stage, with losses widening to $0.17 per share from $0.15 per share year-over-year, slightly higher than the consensus estimate of a loss of $0.16 per share [6] - Net cash used in operating activities for the nine months ended September 30 widened to $21.3 million from $15.6 million in the previous year, with a cash balance of $3.3 million, significantly higher than short-term debt levels of $109,000 [7] - Cantor Fitzgerald initiated coverage on DMAC with an "Overweight" rating, setting a price target of $25, indicating an upside potential of about 242.5% from current levels [8]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company's cash, cash equivalents, and short-term investments were $55.3 million, an increase from $30 million as of June 30, 2025, and $44.1 million at the end of the previous year [14] - The net cash used in operating activities for the nine months ended September 30, 2025, was $21.3 million, compared to $15.6 million for the same period in 2024, primarily due to an increase in net loss [14][15] - The net losses for the three and nine month periods ending September 30, 2025, were $8.6 million and $24.0 million, respectively, higher than the $6.3 million and $16.5 million reported during the same periods in 2024 [17] Business Line Data and Key Metrics Changes - R&D expenses for the three and nine month periods ending September 30, 2025, were $6.4 million and $17.9 million, respectively, an increase from $5 million and $12.6 million in the same periods of the prior year, driven by the progress of the ReMEDy2 clinical trial and the expansion of the clinical team [16] - General and administrative expenses were $2.6 million and $7.3 million for the three and nine month periods ending September 30, 2025, up from $1.9 million and $5.7 million in 2024, attributed to increased non-cash share-based compensation and personnel costs [16][17] Market Data and Key Metrics Changes - The enrollment rates for the ReMEDy2 stroke trial have been lower than initially projected due to changes in stroke referral patterns, with current enrollment approaching 50% of the target for the interim futility analysis [10][11] - The company is currently utilizing actual enrollment rates from clinical trial sites instead of historical rates for more accurate forecasting [11][36] Company Strategy and Development Direction - The company is focusing on advancing its clinical programs, particularly DM199, which is positioned as a first-in-class treatment for preeclampsia and other vascular-related conditions [3][4] - Plans include expanding clinical studies into early onset preeclampsia and fetal growth restriction cohorts, with a U.S. phase two trial anticipated to begin soon [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position to fund planned clinical studies and operations into the second half of 2027 [14] - The management team remains optimistic about the potential of DM199 based on encouraging interim results and the unique safety profile of the drug [4][22] Other Important Information - The company completed an in-person pre-IND meeting with the FDA, which was deemed productive, and is preparing for a phase two trial in the U.S. [9] - The Independent Data Safety Monitoring Board reported no safety concerns in the ReMEDy2 trial, allowing enrollment to continue without modification [12] Q&A Session Summary Question: Discussion on preeclampsia KOL community engagement and trial site considerations - Management highlighted extensive outreach to KOLs, receiving encouraging feedback regarding DM199's safety profile and efficacy in reducing blood pressure [20][22] Question: Details on protocol amendments and dosing outcomes - Management explained that part 1B will focus on IV dosing until delivery, allowing physicians to adjust dosing as needed based on patient response [23] Question: Clarification on the purpose of the 12 patient expansion cohort - The 12 patient cohort was intended to supplement the original plan for part 1B, focusing on the highest dose observed in cohort 10 [27][28] Question: Expectations for enrollment rates and site activation for the stroke trial - Management noted that historical enrollment rates were around 0.25, but current rates are slightly lower, with over 35 sites activated and more coming on board [35][36] Question: Meaningful change expectations for the modified Rankin Scale score at interim analysis - A 15% absolute improvement in the mRS score is expected to be meaningful, with adjustments made to the protocol to exclude severe stroke patients [42][43]

Financial Performance - For the nine months ended September 30, 2025, the net loss was $24.0 million, compared to $16.5 million for the same period in 2024, reflecting an increase of 45.5%[83] - The company has not generated any revenues from product sales and has incurred a net loss in each year since inception[83] - The company expects to continue incurring significant expenses and operating losses for at least the next few years as it advances its clinical development programs[84] - The company expects to incur substantial operating losses as it continues the research and development of its DM199 product candidate, with no revenue expected for at least three to four years[99] Research and Development Expenses - Research and development (R&D) expenses for the three months ended September 30, 2025, were $6.4 million, up from $5.0 million in the same period of 2024, representing a 28.5% increase[90] - R&D expenses for the nine months ended September 30, 2025, increased to $17.9 million from $12.6 million in 2024, marking a 42.0% rise[90] - The company anticipates needing substantial additional capital to complete its R&D activities and support ongoing clinical studies[100] General and Administrative Expenses - General and administrative (G&A) expenses for the three months ended September 30, 2025, were $2.6 million, compared to $1.9 million in 2024, an increase of 36.8%[91] - G&A expenses for the nine months ended September 30, 2025, rose to $7.3 million from $5.7 million in 2024, reflecting a 28.1% increase[91] Cash Flow and Financial Position - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $55.3 million, an increase from $44.1 million as of December 31, 2024, representing a 25% growth[94] - Total shareholders' equity increased to $51.6 million as of September 30, 2025, compared to $40.7 million as of December 31, 2024, reflecting a 27% increase[94] - Net cash used in operating activities for the nine months ended September 30, 2025, was $21.3 million, up from $15.6 million for the same period in 2024, indicating a 36% increase in cash outflow[96] - Net cash used in investing activities was $10.2 million for the nine months ended September 30, 2025, compared to a net cash inflow of $3.4 million for the same period in 2024[97] - Net cash provided by financing activities was $31.8 million for the nine months ended September 30, 2025, compared to $11.9 million for the same period in 2024, showing a 167% increase[98] - Approximately $98.4 million remains available for issuance under the ATM Offering program as of September 30, 2025[93] Future Projections - The interim analysis for the ReMEDy2 trial is expected to be completed in the second half of 2026[82] - Future funding requirements will depend on various factors, including the timing and results of ongoing development efforts and market conditions[100] - The company completed a private placement in July 2025, raising gross proceeds of $30.1 million from the sale of 8,606,425 common shares at $3.50 per share[101]

Financial Performance - Net loss for Q3 2025 was $8.6 million, compared to $6.3 million in Q3 2024, and $24.0 million for the nine months ended September 30, 2025, up from $16.5 million for the same period in 2024[10] - Basic and diluted net loss per share for Q3 2025 was $0.17, compared to $0.15 for Q3 2024[16] - Net loss for the nine months ended September 30, 2025, was $24,026,000, compared to a net loss of $16,544,000 for the same period in 2024, reflecting a deterioration of 45.2%[20] Cash and Investments - DiaMedica reported cash and short-term investments of $55.3 million as of September 30, 2025, an increase from $44.1 million as of December 31, 2024, providing a runway into the second half of 2027[10] - Cash and cash equivalents at the end of the period were $3,326,000, a decrease from $4,134,000 at the end of September 2024[20] - Proceeds from the sale of common shares amounted to $31,527,000, significantly higher than $11,747,000 in the previous year, showing an increase of 168.5%[20] Expenses - Research and Development (R&D) expenses for Q3 2025 were $6.4 million, up from $5.0 million in Q3 2024, and $17.9 million for the nine months ended September 30, 2025, compared to $12.6 million for the same period in 2024[10] - General and Administrative (G&A) expenses increased to $2.6 million for Q3 2025 from $1.9 million in Q3 2024, and $7.3 million for the nine months ended September 30, 2025, compared to $5.7 million for the same period in 2024[10] - Cash flows from operating activities resulted in a net cash outflow of $21,297,000 for the nine months ended September 30, 2025, compared to an outflow of $15,642,000 in 2024[20] Assets and Liabilities - Total assets increased to $57,047,000 as of September 30, 2025, up from $46,345,000 on December 31, 2024, representing a growth of 23.4%[18] - Current assets rose to $56,223,000, compared to $44,610,000 at the end of 2024, marking an increase of 26.2%[18] - Total current liabilities decreased slightly to $5,268,000 from $5,390,000, a reduction of 2.3%[18] - The total non-current liabilities decreased to $157,000 from $237,000, indicating a reduction of 33.8%[18] Shareholder Equity - Shareholders' equity increased to $51,622,000 as of September 30, 2025, up from $40,718,000 at the end of 2024, indicating a growth of 26.9%[18] - The company reported a significant increase in paid-in capital to $215,600,000 from $180,697,000, reflecting a rise of 19.3%[18] Clinical Trials and Development - Enrollment in the ReMEDy2 Phase 2/3 trial for acute ischemic stroke is nearing 50% of the target of 200 patients for the interim analysis expected in the second half of 2026[5] - The completion of cohort 10 in the Preeclampsia Phase 2 IST trial has been achieved, with an expansion cohort now enrolling up to 12 additional participants[6] - The company anticipates screening for participants in the fetal growth restriction cohort to begin in the coming weeks[7] - A pre-IND meeting with the FDA was held to discuss plans for the initiation of a U.S. Phase 2 DM199 study in preeclampsia[5]

Core Insights - DiaMedica Therapeutics Inc. will participate in the Jefferies Global Healthcare Conference in London from November 17-20, 2025, with CEO Rick Pauls delivering a corporate presentation and engaging in one-on-one investor meetings [1][2] Company Overview - DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke [1][3] - The company's lead candidate, DM199, is the first pharmaceutically active recombinant form of the KLK1 protein to be clinically studied in the United States, with established therapeutic use in China for acute ischemic stroke and other vascular diseases [3] Upcoming Events - The corporate presentation at the Jefferies Global Healthcare Conference is scheduled for November 20, 2025, from 10:00 to 10:25 AM GMT [3] - DiaMedica will report its third quarter 2025 financial results on November 12, 2025, and will host a live conference call on November 13, 2025, to provide a business update [5]

Group 1: Momentum Investing Overview - Momentum investing involves following a stock's recent trend, with the strategy of buying high and selling higher, capitalizing on established price movements [1] - The Zacks Momentum Style Score helps define momentum characteristics, with DiaMedica Therapeutics, Inc. (DMAC) currently holding a Momentum Style Score of B [2][3] Group 2: Performance Metrics - DMAC shares have increased by 15.47% over the past week, while the Zacks Medical - Biomedical and Genetics industry has decreased by 0.11% during the same period [5] - Over the past quarter, DMAC shares have risen by 86.86%, and by 60.23% in the last year, compared to the S&P 500's increases of 10.17% and 18.61%, respectively [6] - The average 20-day trading volume for DMAC is 444,435 shares, indicating a bullish sign if the stock price rises with above-average volume [7] Group 3: Earnings Outlook - In the past two months, one earnings estimate for DMAC has increased, raising the consensus estimate from -$0.72 to -$0.65 [9] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating positive earnings outlook [9] Group 4: Conclusion - DMAC is rated as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [11]

Technical Analysis - DiaMedica Therapeutics, Inc. (DMAC) has reached a key level of support, indicating potential for upward movement [1] - A "golden cross" has occurred, with DMAC's 50-day simple moving average crossing above its 200-day simple moving average, signaling a bullish breakout [1] - Golden crosses are characterized by three stages: a downtrend, the crossover of moving averages, and an upward price trend [2] Performance Metrics - Over the past four weeks, DMAC's stock has gained 56.3%, reflecting strong performance [3] - The company currently holds a 2 (Buy) rating on the Zacks Rank, suggesting it may be poised for further breakout [3] Earnings Outlook - There have been no cuts to earnings estimates for the current quarter, with one revision higher in the past 60 days, indicating a positive earnings outlook [3] - The Zacks Consensus Estimate for DMAC has also increased, reinforcing the bullish sentiment [3][5]

Core Viewpoint - DiaMedica Therapeutics, Inc. (DMAC) has shown a significant price increase of 31.5% over the past four weeks, with a mean price target of $12.33 indicating a potential upside of 100.8% from its current price of $6.14 [1] Price Targets and Analyst Estimates - The mean estimate consists of three short-term price targets with a standard deviation of $1.53, where the lowest estimate of $11.00 suggests a 79.2% increase, and the highest estimate of $14.00 indicates a potential surge of 128% [2] - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price movement direction and magnitude, which can serve as a starting point for further research [7] Earnings Estimates and Analyst Agreement - There is increasing optimism among analysts regarding DMAC's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 9.7% over the past month, with one estimate increasing and no negative revisions [10] Zacks Rank and Investment Potential - DMAC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a strong potential for upside in the near term [11] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a useful guide for potential investment decisions [12]