Latest news with #ProMISNeurosciencesInc
Hamilton Spectator
29-07-2025
- Business
- Hamilton Spectator
ProMIS Neurosciences to Showcase Protein-Misfolding Drug Discovery Platform & PRECISE-AD Trial Design at the 2025 Alzheimer's Association International Conference
Presentation to highlight the Company's proprietary protein-misfolding platform, EpiSelectTM, used to develop PMN310 Posters highlighting PRECISE-AD, the Company's Phase 1b clinical trial design and optimization of biomarkers in AD Progress with trial enrollment following DSMB recommendation to proceed to second dose level CAMBRIDGE, Massachusetts , July 29, 2025 (GLOBE NEWSWIRE) — ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative diseases such as Alzheimer's Disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD), today announced it has been invited to present an overview of its ongoing PRECISE-AD trial in Alzheimer's Disease (AD) and its proprietary Discovery Platform, EpiSelectTM, at the Alzheimer's Association International Conference 2025 (AAIC) taking place in Toronto, Canada from July 27-31, 2025. 'We are pleased to share further details of our ongoing Phase 1b PRECISE-AD clinical trial evaluating PMN310, our novel therapeutic candidate for Alzheimer's disease,' said Dr. Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences. 'PRECISE-AD was intentionally designed with a robust framework to assess both the safety and potential signs of efficacy of PMN310. PMN310 is designed to selectively target toxic amyloid-beta oligomers, which are considered a primary driver of Alzheimer's disease, while aiming to reduce the risk of safety issues observed with other therapies. We were encouraged by the recent recommendation from the independent Data and Safety Monitoring Board (DSMB) to proceed to the second dose level, and we have been enrolling patients swiftly into this second cohort.' 'As of this week, more than 50% of the approximately 128 patients planned for the study have been enrolled, reflecting the pace of our clinical progress and the urgent need for new treatment options. To date, we have not observed any cases of amyloid-related imaging abnormalities (ARIA), including brain swelling or microhemorrhages. In addition, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to PMN310, which we believe recognizes the potential of this program to address an unmet medical need in Alzheimer's disease. We anticipate reporting six-month interim data from the study in the second quarter of 2026, with topline results expected by the fourth quarter of 2026,' added Dr. Altstiel. 'The rapid enrollment in PRECISE-AD is a testament to the urgent need to bring new breakthroughs in treatment to Alzheimer's patients and providers,' Dr. David Watson, Chief Executive and Founder of the Alzheimer's Research and Treatment Center and one of the treating physicians in the PRECISE-AD trial stated. 'I am encouraged by the mechanism of ProMIS's PMN310, which has been designed to specifically target toxic Aβ oligomers, and has the potential to provide a more favorable product profile and significantly improve the quality of life of AD patients.' 'Additionally, we are pleased to have been invited to share data supporting the design process and validation of our proprietary target discovery engine, EpiSelectTM, which utilizes advanced computational discovery technologies to identify and target toxic misfolded proteins implicated in neurodegenerative and other misfolded protein diseases,' said Neil Cashman, M.D., Chief Scientific Officer and Co-founder, ProMIS Neurosciences. 'This precision targeting approach has enabled us to design novel therapeutic antibodies with a high degree of selectivity for the key underlying drivers of these conditions.' Presentation details Title: Protein misfolding-specific epitope identification for passive and active immunotherapy of neurodegenerative diseases Presenter: Neil Cashman, M.D., Chief Scientific Officer and Co-founder, ProMIS Neurosciences Session: Featured Research Session: Advancing Translational Success by Enhancing Predictive Validity in Neurodegenerative Diseases, Thursday, July 31, 2025: 10:00am – 11:30am Eastern Time Abstract Number: 98670 Title: PRECISE-AD, A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients with Early Alzheimer's Disease Presenter: Larry Altstiel, M.D., Ph.D., Chief Medical Officer, ProMIS Neurosciences Session: In Person Poster: Drug Development: Human, Wednesday, July 30, 2025: 7:30am – 4:15pm Eastern Time Poster Number: 103159 Title: Leveraging recent advances in biomarkers to optimize early phase drug development in Alzheimer's Disease Joint Presenter: Garret Duncan, Statistician, Pentara Corporation and Johanne Kaplan, Ph.D., Chief Development Officer, ProMIS Neurosciences Session: In Person Poster: Biomarkers: Biomarkers (non-neuroimaging), Monday, July 28, 2025: 7:30am – 4:15pm Eastern Time Poster Number: 103841 Abstracts will be available on the Poster and Publications page of the Company's website at n following the presentations. About PMN310 and the PRECISE-AD Clinical Trial PMN310, the Company's lead product candidate for the treatment of AD, is a humanized monoclonal antibody that has been designed to be differentiated in its ability to selectively target only the toxic oligomers, avoiding plaque, thereby potentially reducing or eliminating ARIA liability. In addition, because PMN310 may not be limited by off-target binding or side effects, PMN310 could potentially offer an improved efficacy profile over other amyloid-directed antibody therapeutics. Based on the encouraging results from the Phase 1a trial ( NCT06105528 ) of PMN310, ProMIS initiated PRECISE-AD, a Phase 1b clinical trial in AD patients. PRECISE-AD ( NCT06750432 ) is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses (5, 10, 20 mg/kg) of intravenous PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD (Stage 3 and Stage 4 AD). PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against AβO on biomarkers associated with AD pathology and clinical outcomes. Safety will be a primary outcome of the study with particular emphasis on assessing whether, as a non-plaque binder, PMN310 may have a reduced risk of ARIA. The study is powered to provide 95% confidence for detection of ARIA. The study has been designed with a sample size intended to provide sufficient power to provide meaningful insight into effects of PMN310 on biomarkers and clinical outcomes. About ProMIS Neurosciences Inc. ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company's proprietary target discovery engine, EpiSelect™, predicts novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson's Disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN). Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, 'forward-looking information') within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as 'plans', 'pleased to', 'look forward to', 'potential to', 'targets', 'expects' or 'does not expect', 'is expected', 'excited about', 'an opportunity exists', 'is positioned', 'estimates', 'intends', 'assumes', 'anticipates' or 'does not anticipate' or 'believes', or variations of such words and phrases or state that certain actions, events or results 'may', 'could', 'would', 'might', 'will' or 'will be taken', 'occur' or 'be achieved'. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company's progress and expectations for its Phase 1b clinical trial in AD patients, including planned timing for completion and anticipated data readout of interim and full results in the second and fourth quarters of 2026, repsectively, the potential for such studies to provide the first proof-of-concept data for PMN310, the potential for PMN310 to positively benefit patients with AD and to be a more effective and well-tolerated option, the targeting of toxic misfolded proteins in neurodegenerative diseases that the Company believes may directly address fundamental AD pathology (including the belief and understanding that toxic oligomers of Aβ are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity and the Company's expectations regarding the benefits of Fast Track Designation and management's belief that its proprietary target discovery engine can predict and identify toxic misfolded proteins implicated in the development and progression of neurodegenerative and other misfolded protein diseases. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the risk that enrollment may not continue at the current rate, that clinical results or early results may not be indicative of future results, the Company's ability to retain and recognize the incentives conferred by Fast Track Designation for PMN310, the Company's ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the 'Risk Factors' section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2024 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. For further information: Visit us at Please submit media inquiries to info@ For Investor Relations, please contact: Kaytee Bock Zafereo
Toronto Star
22-07-2025
- Business
- Toronto Star
ProMIS Neurosciences Announces $0.8 Million Registered Direct Offering, Priced At-the-Market Under Nasdaq Rules
CAMBRIDGE, Massachusetts, July 22, 2025 (GLOBE NEWSWIRE) — ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzhiemer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD), today announced that it has raised $0.8 million at-the-market from an existing healthcare focused institutional investor. The company has entered into a definitive agreement for the issuance and sale of pre-funded warrants (the 'Pre-Funded Warrants') to purchase 984,736 common shares, no par value (the 'Common Shares'). The Pre-Funded Warrants were sold at a price of $0.8124 per share, which represents the per share offering price for the Common Shares less a $0.0001 per share exercise price for each such Pre-Funded Warrant. The Pre-Funded Warrants will be immediately excercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the Pre-Funded Warrants are exercised in full. The closing of the offering is expected to occur on or about July 24, 2025, subject to the satisfaction of customary closing conditions.
Hamilton Spectator
22-07-2025
- Business
- Hamilton Spectator
ProMIS Neurosciences Announces $0.8 Million Registered Direct Offering, Priced At-the-Market Under Nasdaq Rules
CAMBRIDGE, Massachusetts, July 22, 2025 (GLOBE NEWSWIRE) — ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzhiemer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD), today announced that it has raised $0.8 million at-the-market from an existing healthcare focused institutional investor. The company has entered into a definitive agreement for the issuance and sale of pre-funded warrants (the 'Pre-Funded Warrants') to purchase 984,736 common shares, no par value (the 'Common Shares'). The Pre-Funded Warrants were sold at a price of $0.8124 per share, which represents the per share offering price for the Common Shares less a $0.0001 per share exercise price for each such Pre-Funded Warrant. The Pre-Funded Warrants will be immediately excercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the Pre-Funded Warrants are exercised in full. The closing of the offering is expected to occur on or about July 24, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to ProMIS are expected to be approximately $0.8 million, before deducting certain offering expenses. ProMIS intends to use the net proceeds from the offering towards its further advancement of the clinical development of PMN310, its lead therapeutic candidate, as well as for working capital and other general corporate expenses. The securities above are being offering pursuant to a shelf registration statement on Form S-3 (333-274658) that was filed with the Securities and Exchange Commission (the 'SEC') on September 22, 2023, amended on September 27, 2023 and declared effective by the SEC on September 29, 2023. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at . This press release does not constitute an offer to sell or the solicitation of offers to buy any of the securities being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About ProMIS Neurosciences Inc. ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company's proprietary target discovery engine, EpiSelect™, predicts novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson's Disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN). Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, 'forward-looking information') within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as 'plans', 'pleased to', 'look forward to', 'potential to', 'targets', 'expects' or 'does not expect', 'is expected', 'excited about', 'an opportunity exists', 'is positioned', 'estimates', 'intends', 'assumes', 'anticipates' or 'does not anticipate' or 'believes', or variations of such words and phrases or state that certain actions, events or results 'may', 'could', 'would', 'might', 'will' or 'will be taken', 'occur' or 'be achieved'. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the the expected timing for the closing of the offering and the anticipated use of proceeds from the offering. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the Company's ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the risk that clinical results or early results may not be indicative of future results, the Company's ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the 'Risk Factors' section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2024 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. For further information: Visit us at Please submit media inquiries to info@ For Investor Relations, please contact: Kaytee Bock Zafereo
Yahoo
12-05-2025
- Business
- Yahoo
ProMIS Neurosciences Announces First Quarter 2025 Financial Results
First Cohort Completed in PRECISE-AD Trial Evaluating PMN310 in Alzheimer's Disease Six Month Interim Results Expected in 1H 2026 Topline Results Anticipated by end of 2026 CAMBRIDGE, Massachusetts, May 12, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), Parkinson's disease (PD) and multiple system atrophy (MSA), today announced financial results for the first quarter ended March 31, 2025. 'We made significant progress in the first quarter of 2025, advancing our lead clinical program in Alzheimer's disease with rapid enrollment of the first cohort in the PRECISE-AD trial,' said Neil Warma, Chief Executive Officer of ProMIS Neurosciences. 'The pace of enrollment exceeded our expectations, reflecting the growing enthusiasm from investigators for PMN310's differentiated profile. Based on its selective targeting of toxic Aβ oligomers and the potential to avoid ARIA—a serious safety concern seen with existing therapies—we believe PMN310 could set a new standard as a best-in-class treatment for Alzheimer's treatment. Delivering a therapy that combines strong efficacy with a substantially improved safety profile would be a transformative milestone for patients and caregivers.' 'While PRECISE-AD is designed as a 12-month, double-blind study, it is powered to detect biomarker changes as early as six months,' Mr. Warma continued. 'We view the planned interim analysis in the first half of 2026 as an important opportunity to generate early insights into PMN310's potential to drive both clinical benefit and improved tolerability, particularly with respect to reducing or avoiding ARIA, a key differentiator in this space. Coupled with our directed targeting of toxic oligomers, we believe the benefit:risk profile will surpass current marketed therapies' Recent Highlights Alzheimer's Disease Program (PMN310) ProMIS' lead candidate, PMN310, is a humanized IgG1 antibody directed toward toxic amyloid-beta oligomers (AβO) that are believed to be a major driver of AD. Announced in early January 2025, ProMIS initiated PRECISE-AD based on the encouraging results from the Phase 1a trial of PMN310 and has since completed enrollment of the first cohort of patients and successfully dosed multiple patients with PMN310 in the Phase 1b trial. PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses (5, 10, 20 mg/kg) of intravenous PMN310 in patients with Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease (Stage 3 and Stage 4 AD). The study plans to enroll approximately 128 patients across 22 active sites in the United States. Eligible patients will be dosed monthly at one of the three dose levels or placebo over 12 months with assessment of safety, tolerability, PK, and pharmacodynamic blood-based markers of treatment effect at baseline and every three months and cerebrospinal fluid biomarkers at baseline and every 6 months. Frequent MRI scans, especially early in treatment, and throughout the study will be conducted to monitor for any emergence of ARIA. Cognitive clinical outcomes will also be assessed at baseline, 6 months and 12 months. Safety will be a primary outcome of the study with particular emphasis on assessing the expectation that, as a non-plaque binder, PMN310 will have a reduced risk of ARIA. The study is powered to provide 95% confidence for detection of ARIA. The study has been designed with a sample size intended to provide sufficient power to provide meaningful insight into effects of PMN310 on biomarkers and clinical outcomes. PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against AβO on biomarkers associated with AD pathology and clinical outcomes. ProMIS expects to report six-month interim results from PRECISE-AD in the first half of 2026, with topline results anticipated by the end of 2026. We anticipate the six-month interim analysis will include impact of biomarkers and safety (including incidence of ARIA), with final analysis to include clinical outcome measures. ProMIS continues to advance its Aβ vaccine program in AD based on its oligomer target epitope(s) – PMN311. In April 2025, ProMIS presented preclinical data at the American Alzheimer's and Parkinson's Disease International Conference (AD/PD Conference) and the Academy of Neurology Annual Meeting (AAN Annual Meeting). Key highlights from the presentation titled, 'Novel approach to optimization of Alzheimer's vaccine configuration for maximal targeting of toxic amyloid-beta oligomers' include: A large body of evidence indicates that soluble toxic AβO are a primary driver of AD. Through computational modeling, four different conformational B cell epitopes of AβOs were identified. A novel approach was utilized to select an optimal vaccine composition amongst 15 possible combinations of one to four epitopes to provide maximal binding to a toxic oligomer-enriched low molecular weight fraction of soluble AD brain extract. Results from the preclinical study showed that immunization with a single conformational epitope, peptide 301, the target of PMN310 antibody, was sufficient to produce maximal reactivity against AD brain oligomers. Amyotrophic Lateral Sclerosis Disease Program (PMN267) PMN267 is a humanized IgG1 antibody directed against toxic misfolded TDP-43 as a potential therapeutic target for ALS. ProMIS presented a virtual oral presentation of preclinical data at the AD/PD Conference. Key highlights from the presentation titled, 'Selective targeting of pathogenic TDP-43 with misfolding-specific monoclonal antibodies and intrabodies against a pathogenic loss-of-structure epitope in the N-terminal domain' include: Proof-of-concept evidence that supports selective targeting of misfolded toxic aggregates of TDP-43 by monoclonal antibodies (mAbs) such as PMN267 as a potentially safe and effective avenue to treat ALS and other TDP-43 proteinopathies. TDP-43 mAbs Display high affinity against the misfolded TDP-43 epitope Selectively react with pathological TDP-43 and not normal TDP-43 Inhibit cell-to-cell transmission of misfolded TDP-43 TDP-43 mAbs and corresponding intrabodies specifically react with cytoplasmic aggregates of misfolded TDP-43 Intrabodies accelerate the degradation of misfolded TDP-43 Intrabody reduces TDP-43 aggregates in iPSC-derived ALS motor neurons under chronic stress conditions Multiple Synucleinopathies Disease Vaccine Program (PMN440) In April 2025, ProMIS presented preclinical data at the AD/PD Conference and at the AAN Annual Meeting. Key highlights from the presentation titled, 'Novel approach to optimization of alpha-synuclein vaccine composition for maximal targeting of toxic alpha-synuclein species' and 'Rational design of a vaccine for synucleinopathies using computationally-derived conformational B cell epitopes to selectively target pathogenic alpha-synuclein species' include: Vaccination against pathogenic species of alpha-synuclein (ASyn); (toxic oligomers, small soluble seeding fibrils), has the potential to protect against synucleinopathies, which include PD, dementia with Lewy bodies and MSA. Vaccine constructs containing computationally-derived conformational B cell epitopes of misfolded pathogenic ASyn were tested in mice. The potential advantage of this approach, as opposed to inducing pan-ASyn reactivity, lies in preserving normal ASyn function and minimizing the diversion of active antibody by the more abundant non-toxic forms of the protein in the blood and central nervous system. Results from the preclinical study showed that vaccination with conformational B cell epitopes produced high affinity antibodies with the desired selectivity for pathogenic ASyn and identified optimal vaccine configurations for further development. These data sets showcase the potential of vaccinations with conformational B cell epitopes to produce high affinity antibodies with the desired selectivity for pathogenic Asyn and supports the development of PMN440 vaccine as a treatment for synucleinopathies, such as PD, dementia with Lewy bodies and MSA. First Quarter 2025 Financial Highlights Cash and cash equivalents were $8.4 million as of March 31, 2025, compared to $13.3 million as of December 31, 2024. Research and development expenses were $5.5 million for the first quarter ended March 31, 2025, compared to $2.1 million for the same period in 2024. The increase was primarily attributable to costs related to the execution of the PMN310 Phase 1b clinical trial. General and administrative expenses increased to $2.0 million for the first quarter ended March 31, 2025, compared to $1.6 million for the same period in 2024. Net loss was $7.3 million for the first quarter ended March 31, 2025, compared to a net loss of $3.6 million for the same period in 2024. The net loss was primarily attributable to the increase in clinical trial expenses. About ProMIS Neurosciences Inc. ProMIS Neurosciences Inc. is a clinical stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). The Company's proprietary target discovery engine applies a thermodynamic, computational discovery platform to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. PMN310, the Company's lead product candidate for the treatment of AD, is a differentiated, humanized monoclonal antibody that has been designed to specifically bind toxic Aβ oligomers and to not bind plaque or monomers. Oligomers are known to drive disease progression in AD and PMN310 appears to selectively bind oligomers. PMN310 has successfully completed a Phase 1a clinical study and is dosing AD patients in its Phase 1b clinical trial. ProMIS has offices in Cambridge, Massachusetts and Toronto, Ontario. Forward-looking Statements Nasdaq has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, 'forward-looking information') within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as 'plans', 'targets', 'expects' or 'does not expect', 'is expected', 'excited about', 'an opportunity exists', 'is positioned', 'estimates', 'intends', 'assumes', 'anticipates' or 'does not anticipate' or 'believes', or variations of such words and phrases or state that certain actions, events or results 'may', 'could', 'would', 'might', 'will' or 'will be taken', 'occur' or 'be achieved'. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company's Phase 1b study in AD patients and expectations of such study results, including first cohort completion in the second quarter of 2025,interim results in the first half of 2026 and topline results by the end of 2026, statements relating to the Company's progress, including enrollment and dosing for its Phase 1b clinical trial, the potential for such studies to provide the first proof-of-concept data for PMN310, the potential that PMN310 has the potential to positively benefit patients with AD, the targeting of toxic misfolded proteins in neurodegenerative diseases that the Company believes may directly address fundamental AD pathology (including the belief and understanding that toxic oligomers of Aβ are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity, a computationally-derived Aβ vaccine for AD and the Company's PMN310 antibody and vaccine candidate, management's belief that its patented platform technology has created an antibody candidate specific to toxic misfolded oligomers known to be present in AD, therapeutic activity and preferential targeting of toxic soluble aggregates by Aß-directed antibodies and the potential implications thereof, the Company's pipeline, including application of its platform to other diseases, statements regarding preclinical data, recent presentations of such preclinical data and the takeaways therefrom, the ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its operation and progress, use of capital expenses, future accumulated deficit and other financial results in the future, ability to fund operations, the ability to maintain enough liquidity to execute its business plan and its ability to continue as a going concern. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the risk that preclinical results or early clinical results may not be indicative of future results, the Company's ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the 'Risk Factors' section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2024 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. For further information: Visit us at Please submit media inquiries to info@ For Investor Relations, please contact: Kaytee Bock PROMIS NEUROSCIENCES INC. Consolidated Balance Sheets (expressed in U.S. dollars, except share amounts) (unaudited) March 31, December 31, 2025 2024 Assets Current assets: Cash $ 8,364,301 $ 13,291,167 Short-term investments 33,051 33,051 Prepaid expenses and other current assets 5,249,319 5,587,238 Total current assets 13,646,671 18,911,456 Total assets $ 13,646,671 $ 18,911,456 Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 1,200,162 $ 1,737,463 Accrued liabilities 2,856,086 480,962 Total current liabilities 4,056,248 2,218,425 Share-based compensation liability 113,100 199,263 Warrant liability 5,592 5,592 Total liabilities 4,174,940 2,423,280 Commitments and contingencies Shareholders' equity: Common shares, no par value, unlimited shares authorized, 32,689,190 shares issued and outstanding as of March 31, 2025 and December 31, 2024 — — Additional paid-in capital 107,877,891 107,546,433 Accumulated other comprehensive loss (371,184) (371,184) Accumulated deficit (98,034,976) (90,687,073) Total shareholders' equity 9,471,731 16,488,176 Total liabilities and shareholders' equity $ 13,646,671 $ 18,911,456 PROMIS NEUROSCIENCES INC. Consolidated Statements of Operations (expressed in U.S. dollars, except share amounts) (unaudited) For the For the Three Months Ended Three Months Ended March 31, March 31, 2025 2024 Operating expenses: Research and development $ 5,464,250 $ 2,123,778 General and administrative 1,995,845 1,552,873 Total operating expenses 7,460,095 3,676,651 Loss from operations (7,460,095) (3,676,651) Other income (expense): Change in fair value of financial instruments — (14,132) Interest expense — (76,775) Other income 112,192 132,470 Total other income (expense), net 112,192 41,563 Net Loss $ (7,347,903) $ (3,635,088) Net loss per share, basic and diluted $ (0.21) $ (0.19) Weighted-average shares outstanding of common shares, basic and diluted 34,851,203 19,533,976 Sign in to access your portfolio
