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]

Upgrades - JPMorgan upgraded MP Materials (MP) to Overweight from Neutral with a price target of $74, down from $75, citing the company's national security importance as underappreciated at current share levels [2] - Jefferies upgraded Gap (GAP) to Buy from Hold with a price target of $30, up from $22, noting a strong turnaround under new management for both Gap and Old Navy brands [2] - Mizuho upgraded TripAdvisor (TRIP) to Neutral from Underperform with a price target of $17, up from $14, believing that the company's traffic weakness is now better reflected in the shares [3] - Loop Capital upgraded Shake Shack (SHAK) to Buy from Hold with a price target of $127, up from $98, arguing that concerns over slower growth in October are overblown [3] - Baird upgraded Circle Internet (CRCL) to Outperform from Neutral with an unchanged price target of $110, viewing Circle's current valuation as reasonable given the outstanding growth of USDC [3] Downgrades - Jefferies downgraded Progressive (PGR) to Hold from Buy with a price target of $232, down from $261, anticipating a lighter growth environment due to increased competition in the personal auto insurance market [4] - BofA downgraded Flowserve (FLS) to Neutral from Buy with a price target of $73, up from $60, believing that near-term nuclear upside is already priced into shares [4] - BofA downgraded StubHub (STUB) to Neutral from Buy with a price target of $19, down from $25, as Q3 revenue and EBITDA beat expectations but lacked guidance for Q4 metrics [5] - Craig-Hallum downgraded Applied Materials (AMAT) to Hold from Buy with a price target of $190, suggesting that better buying opportunities may arise in the coming quarters as industry spending increases are still some time away [5] - Stifel downgraded Home Depot (HD) to Hold from Buy with a price target of $370, down from $440, expressing a cautious bias ahead of the company's Q3 report [6] Initiations - Baird initiated coverage of Microsoft (MSFT) with an Outperform rating and a $600 price target, highlighting its leadership in the AI revolution through partnerships with OpenAI [7] - Loop Capital initiated coverage of Polaris (PII) with a Hold rating and a $59 price target, maintaining a cautious view on the company's long-term outlook [7] - Wells Fargo initiated coverage of United Rentals (URI) with an Overweight rating and a $995 price target, favoring construction machinery stocks over engineering services due to a favorable supply setup [7] - Cantor Fitzgerald initiated coverage of DiaMedica Therapeutics (DMAC) with an Overweight rating and a $25 price target, noting compelling data for DM199 in treating pre-eclampsia [8] - Stephens initiated coverage of Simpson Manufacturing (SSD) with an Equal Weight rating and a $187 price target, expecting subdued U.S. housing starts until at least the second half of 2026 [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]

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]

Summary of DiaMedica Therapeutics Conference Call Company Overview - DiaMedica Therapeutics focuses on developing a recombinant form of tissue kallikrein, a critical protein for treating conditions like preeclampsia and acute ischemic stroke [3][4] Industry Context - Preeclampsia is identified as a significant unmet medical need with a market opportunity exceeding $5 billion in the U.S. alone [5] - The company is also involved in a pivotal trial for acute ischemic stroke, another area with substantial unmet medical needs [5] Key Points on Preeclampsia - Preeclampsia is a hypertensive disorder occurring after 20 weeks of gestation, characterized by high blood pressure and organ dysfunction [13] - Current treatment options are limited, primarily involving alpha and beta blockers and calcium channel blockers, which only delay gestational age by about a week [14] - The root cause of preeclampsia is linked to inadequate remodeling of spiral arteries, leading to a hypoxic placenta [15][16] - The company aims to address the preeclampsia market, particularly focusing on patients diagnosed before 34 weeks of gestation, where the need is greatest [28] Clinical Data and Drug Mechanism - DiaMedica's drug, DM199, has shown promising results in lowering blood pressure, with a reported 25 mmHg drop in systolic blood pressure and a 13 mmHg drop in diastolic blood pressure during trials [46] - The drug was well tolerated, with no increase in fetal heart rates and no detection of DM199 in the placenta, indicating it does not cross the placental barrier [47] - A 13% reduction in the pulsatility index was observed, suggesting improved placental perfusion [48] Future Development Plans - The company is conducting ongoing studies in South Africa and plans to file a U.S. IND for a Phase II trial involving 30 patients [58] - A pivotal trial is anticipated, with a focus on extending gestational days by at least seven days, which could significantly reduce neonatal events [60] - Pricing strategy is expected to reflect orphan drug status, given the small patient population and potential cost savings from avoiding NICU admissions [68] Stroke Program Overview - The drug is also being studied for acute ischemic stroke, with an interim analysis of the pivotal trial expected in Q2 of the following year [72] - Pricing for stroke treatment is projected at $30,000 per patient, with higher dosing levels anticipated for preeclampsia [74] Conclusion - DiaMedica Therapeutics is positioned to address significant unmet medical needs in both preeclampsia and stroke, with promising clinical data supporting the efficacy and safety of DM199. The company is actively pursuing further trials and regulatory approvals to bring their treatments to market.

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] - The subscription for Biotech Analysis Central is priced at $49 per month, with a yearly plan available at a discounted rate of $399, reflecting a 33.50% discount [1] Group 2 - The article does not contain any stock, option, or similar derivative positions in the companies mentioned, nor does it plan to initiate any such positions within the next 72 hours [3] - Seeking Alpha clarifies that past performance does not guarantee future results and that no specific investment recommendations are provided [4]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and short-term investments were $30 million, down from $44.1 million as of December 31, 2024. However, including net proceeds from a July private placement, the pro forma cash position is approximately $60 million, which is expected to fund planned clinical studies and operations into 2027 [14][15][17] - The net loss for the three and six months ending June 30, 2025, was $7.7 million and $15.4 million, respectively, compared to $5.1 million and $10.3 million for the same periods in 2024, indicating an increase in net loss year-over-year [17] Business Line Data and Key Metrics Changes - Research and Development (R&D) expenses increased to $5.8 million and $11.5 million for the three and six months ended June 30, 2025, compared to $3.9 million and $7.6 million for the same periods in 2024, primarily due to costs associated with the REMEDY two clinical trial and expansion of the clinical team [15] - General and administrative expenses also rose to $2.2 million and $4.7 million for the three and six months ended June 30, 2025, compared to $1.7 million and $3.8 million in the prior year, driven by increased personnel costs and non-cash share-based compensation [16] Market Data and Key Metrics Changes - DiaMedica was added to the US small cap Russell 2000 and Russell 3000 indexes, enhancing visibility among institutional investors and the broader investment community [12] Company Strategy and Development Direction - The company is advancing its DM199 program for preeclampsia, with plans to conduct a Phase 2B trial in the US and other countries, and is preparing an FDA IND application [8][9] - The company aims to finalize a dosing regimen for the ongoing clinical trials and expand its indications to include fetal growth restriction [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position and its ability to fund clinical studies into 2027, despite an increase in net losses [14][17] - The interim results from the preeclampsia program were described as highly promising, with DM199 showing significant efficacy in managing maternal hypertension [6][9] Other Important Information - The company completed a $30 million private placement of common shares, which extends its cash runway into 2027 [9] - The new Chief Medical Officer, Dr. Julie Krop, brings extensive experience in the biopharma industry, particularly in women's health and preeclampsia [12][13] Q&A Session Summary Question: Why did Dr. Krop join the company, and what are her thoughts on the stroke program? - Dr. Krop expressed a strong commitment to women's health and excitement about the company's programs, highlighting the unmet needs in preeclampsia and ischemic stroke [20][21] Question: Can the company provide a timeline for the upcoming cohorts in the preeclampsia study? - Management indicated that Cohort 10 of Part 1B would start soon, with plans to push dosing higher and move into Part 2 and the fetal growth restriction cohort concurrently [25][27] Question: What is the current status of enrollment in the stroke study? - The company is currently at approximately 40 sites and is seeing an encouraging uptick in enrollment, with expectations for interim analysis to be completed in Q2 2026 [33][34] Question: Will the Phase 2B study have a primary endpoint that reflects pivotal regulatory endpoints for Phase 3? - Management stated that they are finalizing the protocol and are confident about the primary endpoint based on recent FDA feedback, but details will be shared once finalized [40]

Summary of DiaMedica Therapeutics Conference Call Company and Industry - **Company**: DiaMedica Therapeutics - **Industry**: Biotechnology, specifically focusing on treatments for hypertensive disorders during pregnancy, such as preeclampsia Core Points and Arguments 1. **Clinical Trial Overview**: The call discussed the interim results from the Phase II Part 1a clinical trial of DM199 for preeclampsia, marking a critical milestone in addressing hypertensive disorders during pregnancy [3][6][34] 2. **Preeclampsia Statistics**: Preeclampsia affects over 10 million women globally each year, with nearly 200,000 cases in the US annually, particularly in early onset cases [5][6] 3. **Treatment Challenges**: Common treatments like ACE inhibitors and ARBs are contraindicated in pregnancy due to risks to the fetus, highlighting the need for safe alternatives like DM199 [6][26] 4. **Trial Objectives and Results**: - **Safety**: No placental transfer of DM199 was observed, confirming its safety profile [7][26] - **Blood Pressure Reduction**: Achieved significant reductions in both systolic (up to 35 mmHg) and diastolic blood pressure (up to 15 mmHg) at various time points [8][9][28] - **Intrauterine Artery Dilation**: A 13% reduction in the pulsatility index was noted, indicating improved placental perfusion [10][32] 5. **Future Directions**: Plans to expand research into fetal growth restriction, a related condition with no current FDA-approved treatments [6][35] Important but Overlooked Content 1. **Demographics of Participants**: The trial included women with severe hypertension, with a median gestation of around 37 weeks, primarily from black and mixed-race backgrounds [16][17] 2. **Cesarean Section Rates**: Approximately 70% of participants underwent cesarean sections due to the severity of their condition [20] 3. **Adverse Events**: While some expected complications occurred, the incidence was lower than anticipated, with no serious adverse events linked to DM199 [22][23] 4. **Pharmacokinetics and Future Dosing**: Ongoing analysis of pharmacokinetics will inform future dosing strategies, including potential titration based on individual patient needs [39][56] 5. **FDA Engagement**: Plans to submit data to the FDA later in the year for potential larger Phase II/III studies [69] This summary encapsulates the key findings and future directions discussed during the conference call, emphasizing the potential of DM199 as a breakthrough treatment for preeclampsia and related conditions.