Once dear to the investing community like artificial intelligence is nowadays, stocks in the biotech space do not grab as much attention these days. Damning incidents of data breaches at companies like 23andMe (MEHCQ) and fraud against the management of Theranos spooked investors so much that shares of the State Street SPDR S&P Biotech ETF (XBI)—the biggest ETF covering the biotech sector—are down 13% over five years. Yet, the biotech industry remains an exciting investment prospect, with the sector proje ...

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.

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 - The company is in a pivotal phase two/three for ischemic stroke and is simultaneously conducting a phase two study for preeclampsia, with key data expected in the next sixty days [3][34] - The market opportunity for early onset preeclampsia is estimated at about 30,000 patients in the U.S., with a focus on severe cases that require hospitalization [13][14] Business Line Data and Key Metrics Changes - DM199 is a recombinant human tissue kallikrein-1 (KLK1) serine protease enzyme, which has shown potential in increasing perfusion and lowering blood pressure in preeclampsia patients [7][15] - The current treatment options for preeclampsia are described as antiquated and ineffective, highlighting the need for a new therapy like DM199 [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 40,000 live births annually, indicating a significant market potential for DM199 [13][14] - 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 - The company aims to address the unmet need in preeclampsia treatment by providing a therapy that does not cross the placental barrier, thus reducing risks to the fetus [15][19] - The strategy includes leveraging clinical data from existing studies in China to inform the development of DM199 for ischemic stroke and preeclampsia [35][39] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the critical need for effective treatments in preeclampsia, as current medications often fail to manage the disease effectively [19][54] - The company is optimistic about the upcoming data readouts and believes that successful results could validate the efficacy of DM199 in both preeclampsia and ischemic stroke [34][50] Other Important Information - The company is conducting a KOL event on May 28 to discuss the unmet needs in preeclampsia and the design of their clinical trials [58][60] - The pivotal REMEDY two trial for DM199 in acute ischemic stroke is targeting patients who are not eligible for existing treatments, representing a large market opportunity [43][44] 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 simultaneously conducting a phase two study for preeclampsia, with data expected soon [3][34] Question: What is the market opportunity for DM199 in preeclampsia? - The market opportunity is estimated at about 30,000 patients in the U.S., focusing on severe cases that require hospitalization [13][14] Question: Why was South Africa chosen for the preeclampsia trial? - South Africa was selected due to high rates of preeclampsia and the expertise of local investigators in conducting rigorous clinical trials [21][23] Question: What are the key endpoints for the preeclampsia study? - Key endpoints include assessing whether DM199 crosses the placental barrier and its efficacy in lowering blood pressure [30][31] Question: How does DM199 compare to existing treatments for stroke? - DM199 has a 24-hour treatment window, which is significantly longer than existing treatments, potentially allowing more patients to receive effective care [47][49]