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]

Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Cambridge, Massachusetts, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines ...

Core Insights - ProMIS Neurosciences Inc. is advancing its lead product candidate PMN310, a humanized monoclonal antibody designed to selectively target toxic oligomers associated with Alzheimer's disease (AD), potentially improving clinical outcomes and quality of life for patients and caregivers [3][10] - The ongoing PRECISE-AD trial is expected to complete enrollment by the end of 2025, with interim results anticipated in Q2 2026 and top-line results in Q4 2026 [1][11] Group 1: Key Findings and Implications - The study published in Alzheimer's & Dementia highlights the importance of selectively targeting soluble toxic Aβ aggregates, showing a correlation between selectivity for these oligomers and clinical efficacy [2][4] - PMN310 demonstrated the highest resistance to monomer competition among tested antibodies, preserving oligomer binding, which may translate into clinical benefits for patients [6][13] Group 2: Safety and Efficacy - PMN310's lack of binding to plaque or vascular deposits suggests a potentially lower risk of amyloid-related imaging abnormalities (ARIA), a common side effect of current anti-amyloid therapies [5][10] - Preclinical studies indicated that high-dose chronic administration of PMN310 did not produce microhemorrhages in plaque-bearing mice, supporting the hypothesis of reduced ARIA risk [6][10] Group 3: Clinical Trial Design - The PRECISE-AD trial is designed to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD, with a targeted enrollment of 128 patients [11] - This trial will be the first to examine the effects of a monoclonal antibody directed solely against toxic amyloid-beta oligomers on biomarkers associated with AD pathology and clinical outcomes [11][13]

ProMIS Neurosciences (NasdaqCM:PMN) FY Conference December 02, 2025 03:25 PM ET Company ParticipantsNeil Warma - CEOConference Call ParticipantsNone - AnalystNoneOf hosting Neil Warma, CEO of ProMIS Neurosciences. Neil, welcome. Thank you so much for making the trek down here to sunny Miami to be with us. But before we delve into Q&A, I would love to hear the state of the business, key data points to look out for the next 12 months or so.Neil WarmaSure. Well, thanks, Michael. And thanks to the organizers fo ...

Core Viewpoint - Promis Neurosciences (NASDAQ: PMN) is highlighted due to a price target of $18 set by H.C. Wainwright, indicating a potential price increase of approximately 50.5% from its current trading price of $7.21 [1][5] Group 1: Analyst Ratings - The stock has an average rating of "Moderate Buy" from four brokerages, with one sell rating and three buy ratings [2] - Recent analyst reports show a range of opinions, with Wall Street Zen downgrading the stock to "strong sell" and Weiss Ratings reaffirming a "sell (e+)" rating, while H.C. Wainwright and Guggenheim maintained "buy" ratings [3][5] Group 2: Stock Performance - PMN is currently priced at $7.08, reflecting an increase of approximately 4.86% or $0.33, with a trading range today between $6.51 and $7.40 [4] - Over the past year, PMN has experienced a high of $39.75 and a low of $6.27, with a market capitalization of around $9.25 million and a trading volume of 45,812 shares on NASDAQ [4]

Cross-trial analysis supports plasma pTau as a potential early predictor of clinical benefit, reinforcing the biomarker-driven design of ProMIS’ PRECISE-AD trial ProMIS on track to leverage new plasma pTau insights with planned Q2 2026 interim readout Cambridge, Massachusetts, Dec. 01, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines targeting toxic misfolded proteins in ne ...

Core Viewpoint - ProMIS Neurosciences, Inc. is actively engaging with investors and the healthcare community through participation in the 8th Annual Evercore Healthcare Conference, highlighting its focus on developing innovative therapies for Alzheimer's disease and other neurodegenerative disorders [1][2]. Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company dedicated to discovering and developing therapeutic antibodies and vaccines that target toxic oligomers associated with neurodegenerative diseases, including Alzheimer's disease, ALS, FTD, MSA, and PD [3]. - The company utilizes its proprietary EpiSelect™ target discovery engine to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are crucial for developing targeted therapies [3]. Product Development - PMN310 is the lead product candidate designed as a humanized monoclonal antibody that selectively targets toxic oligomers while avoiding plaque, potentially reducing the risk of amyloid-related imaging abnormalities (ARIA) [4]. - PMN310 received Fast Track designation from the U.S. FDA in July 2025, indicating its potential significance in treating Alzheimer's disease [4]. Clinical Trials - Following positive results from the Phase 1a trial, ProMIS initiated the PRECISE-AD Phase 1b clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PMN310 in patients with Mild Cognitive Impairment and mild Alzheimer's disease [5]. - The PRECISE-AD trial is designed as a randomized, double-blind, placebo-controlled study, focusing on the effects of PMN310 on biomarkers and clinical outcomes associated with Alzheimer's disease [5]. EpiSelect Drug Discovery Engine - The EpiSelect platform enables the identification of conformational epitopes on toxic misfolded proteins, facilitating the development of highly selective therapeutic antibodies and vaccines [6]. - PMN310 has demonstrated high selectivity for toxic amyloid-beta oligomers without significant reactivity with other forms, potentially minimizing adverse effects associated with conventional therapies [6].

Core Viewpoint - ProMIS Neurosciences Inc. has announced a one-for-twenty-five reverse stock split to comply with Nasdaq listing requirements and aims to increase the market price of its common shares [1][11]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 12:01 a.m. Eastern Time on November 28, 2025, with shares trading on a split-adjusted basis from that date [2]. - The number of outstanding common shares will decrease from approximately 53,811,110 shares to about 2,152,444 shares [3]. - Proportional adjustments will be made to equity incentive plans, stock options, and outstanding warrants in accordance with the reverse stock split [4]. Group 2: Compliance with Nasdaq - ProMIS received a deficiency letter from Nasdaq on January 8, 2025, indicating that its common shares had not maintained the minimum required closing bid price of at least $1.00 [8]. - The company was granted an additional 180-day compliance period until December 29, 2025, to regain compliance with the Bid Price Rule [10]. - The reverse stock split is part of the company's strategy to cure the deficiency and meet Nasdaq's listing standards [11]. Group 3: Shareholder Information - No fractional shares will be issued; shareholders entitled to fractional shares will receive cash instead [5]. - Stockholders with shares held in book-entry form or through a bank or broker will see the effects of the reverse stock split reflected in their accounts without needing to take action [6]. Group 4: Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative disorders, including Alzheimer's disease [13]. - The company utilizes its proprietary target discovery engine, EpiSelect™, to identify novel targets associated with misfolded proteins [13].

Financial Performance - Operating losses for the three months ended September 30, 2025, were $11.8 million, compared to $4.4 million for the same period in 2024, and for the nine months ended September 30, 2025, losses were $29.4 million, up from $10.8 million in 2024[112]. - The net loss for the nine months ended September 30, 2025, was $29.0 million, compared to a net income of $3.0 million in the same period of 2024, representing a decrease of $32.1 million[134]. - The net loss for the three months ended September 30, 2025, was $11.6 million, compared to a net income of $9.3 million in the same period of 2024, representing a decrease of $20.9 million[140]. - Other income decreased by $13.5 million for the nine months ended September 30, 2025, primarily due to a $17.0 million decrease in the gain on change in fair value of financial instruments[139]. Cash Flow and Funding - As of September 30, 2025, the accumulated deficit reached $119.7 million, with negative cash flows from operations of $18.8 million for the nine months ended September 30, 2025[112]. - The company expects cash of $15.4 million as of September 30, 2025, will not be sufficient to fund operations for at least 12 months, raising concerns about its ability to continue as a going concern[116]. - Cash provided by financing activities was $20.9 million for the nine months ended September 30, 2025, a decrease of $6.5 million compared to $27.4 million in the same period of 2024[158][159]. - The company reported a net increase in cash of $2.1 million for the nine months ended September 30, 2025, down from $8.9 million in the prior year[154]. - The company plans to seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances, and licensing agreements to support future clinical activities[153]. Research and Development - PMN310, the lead product candidate, successfully completed its Phase 1a clinical trial and commenced the Phase 1b clinical trial ("PRECISE-AD") in December 2024, with plans to enroll approximately 100 subjects[116][117]. - Expenditures for PMN310 in the three and nine months ended September 30, 2025, were approximately $8.8 million and $21.5 million, respectively[120]. - PMN267, targeting ALS, is ready to progress to IND-enabling studies, subject to sufficient resources[121]. - PMN442, aimed at MSA and other synucleinopathies, has been humanized and is also ready for IND-enabling studies, pending resource availability[122]. - Research and development expenses increased by $17.7 million, or 280%, for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to a $17.0 million increase related to the PMN310 phase 1b trial[135]. - For the three months ended September 30, 2025, research and development expenses increased by $7.2 million, or 282%, compared to the same period in 2024, largely due to a $6.9 million increase related to the PMN310 trial[141]. Administrative Expenses - General and administrative expenses rose by $0.9 million, or 31%, for the nine months ended September 30, 2025, driven by a $0.5 million increase in employee salaries and benefits[138]. - General and administrative expenses for the three months ended September 30, 2025, increased by $0.1 million, or 4%, compared to the same period in 2024[142]. Shareholder Information - As of September 30, 2025, the total number of issued and outstanding Common Shares and Common Share Equivalents was 124,602,290[166]. - The company sold 1,019,877 Common Shares for net proceeds of $0.7 million during the three and nine months ended September 30, 2025[147]. - The company completed a private placement in July 2024 for aggregate gross proceeds of $30.3 million, selling 9,757,669 common share units at $2.15 each[148]. - The total aggregate gross proceeds from various offerings in July 2025 amounted to $21.6 million before deducting fees and offering expenses[152]. Liquidity and Risk - The company faces liquidity risk as a pre-revenue development stage company, relying on external fundraising to support operations[169]. - The company experienced a significant increase in accrued liabilities by $7.5 million and accounts payable by $2.5 million during the nine months ended September 30, 2025[155]. - There were no cash flows used in investing activities during the nine months ended September 30, 2025 or 2024[157]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards[164].

Financial Performance - Loss from operations for Q3 2025 was $11.8 million, compared to an operating loss of $4.4 million in Q3 2024, reflecting increased expenditures on clinical trials[11] - The net loss for Q3 2025 was $(11,580,126), contrasting with a net income of $9,275,825 in Q3 2024, indicating a shift of $20,855,951[17] - The total net loss for the nine months ended September 30, 2025, was $(29,045,059), compared to a net income of $3,017,080 for the same period in 2024[17] - The net loss per share, basic, for Q3 2025 was $(0.24), compared to a net income per share of $0.31 in Q3 2024[17] Research and Development - Research and development expenses for Q3 2025 were $9.8 million, a significant increase from $2.6 million in Q3 2024, primarily due to costs associated with the PRECISE-AD Phase 1b clinical trial for PMN310[11] - Research and development expenses for Q3 2025 reached $9,797,418, a significant increase from $2,563,774 in Q3 2024, representing a growth of 283%[17] Assets and Liabilities - Total current assets increased to $21.5 million as of September 30, 2025, compared to $18.9 million as of December 31, 2024[15] - Total liabilities rose to $12.3 million as of September 30, 2025, up from $2.4 million at the end of 2024, primarily due to increased accounts payable and accrued liabilities[15] - The accumulated deficit increased to $119.7 million as of September 30, 2025, compared to $90.7 million as of December 31, 2024[15] Clinical Trials and Product Development - PMN310, the lead candidate for Alzheimer's disease, is over 85% enrolled in the Phase 1b trial, with complete enrollment expected by the end of 2025[1] - The independent Data and Safety Monitoring Board recommended advancing to the third and final dose escalation cohort for PMN310 in the PRECISE-AD trial[5] - PMN310 has been granted Fast Track Designation by the U.S. FDA, indicating its potential to address significant unmet medical needs in Alzheimer's disease[3] - ProMIS is preparing for multiple key anticipated inflection points in 2026, including the reporting of interim data in Q2 2026 and final results in Q4 2026 for PMN310[2] Operating Expenses - Total operating expenses for Q3 2025 were $11,750,432, compared to $4,434,677 in Q3 2024, marking an increase of 165%[17] - General and administrative expenses for Q3 2025 were $1,953,014, slightly higher than $1,870,903 in Q3 2024, showing an increase of 4.4%[17] Shareholder Information - The weighted-average outstanding common shares, basic, increased to 48,833,799 in Q3 2025 from 30,023,675 in Q3 2024, an increase of 62%[17] Other Income - Total other income for Q3 2025 was $170,306, a decrease from $13,710,502 in Q3 2024, reflecting a decline of 98.76%[17]