ProMIS Neurosciences: ProMIS Neurosciences Announces Full Year 2024 Financial Results and Recent Highlights

In This Article: ProMIS Neurosciences Inc. Rapid Enrollment and Dosing of First Patients in PRECISE-AD Trial Underscores the Unmet Need for Better Treatment Options for Alzheimer's Disease PRECISE-AD Six Month Interim Results Expected in 1H 2026 with Topline Results Anticipated by end of 2026 CAMBRIDGE, Massachusetts, March 31, 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) and multiple system atrophy (MSA), today announced financial results for the fiscal year ended December 31, 2024 and provided a corporate update. "2024 was a transformational year for ProMIS Neurosciences as we reached a major milestone with the initiation of our 100-patient Phase 1b clinical trial for PMN310, our lead antibody candidate for AD," said Neil Warma, Chief Executive Officer of ProMIS Neurosciences. "Our strong momentum from 2024 has carried into the first quarter of 2025 as we have successfully dosed multiple patients in the Phase 1b study, which was carefully designed to generate a robust body of clinical data, including biomarker insights and evaluation of potential efficacy and safety signals. PMN310 is uniquely designed to selectively target toxic oligomers of amyloid-beta, which we believe is a key differentiator from both approved treatments and those currently in development. With strong enthusiasm from investigators and patients, we are pleased with the study's momentum and remain on track to deliver interim data in 2026, which we believe could validate PMN310 as a potential best-in-class treatment for AD. This progress was made possible by the successful completion of our Phase 1a trial and securing up to $122.3 million in funding in 2024, providing the financial foundation to advance PMN310 and our broader pipeline." "In addition to our progress in AD, we continue to advance our programs in ALS and Parkinson's disease (PD) while also identifying a lead vaccine candidate, PMN440, targeting multiple synucleopathies," Warma continued. "Our commitment to innovation is further reflected in the expansion of our intellectual property (IP) portfolio, with 23 newly granted or allowed patents since January 2024, seventeen of which relate to PMN310. We also received our first patent allowance relating to PMN442 and PMN440, strengthening our position in the alpha-synuclein space. With a well-funded clinical program, a robust pipeline, and a growing IP estate, ProMIS is well-positioned to drive the next wave of innovation in neurodegenerative diseases." ProMIS Neurosciences Inc. Recent Highlights Alzheimer's Disease Program (PMN310) ProMIS' lead candidate, PMN310, is a humanized IgG1 antibody directed toward toxic amyloid-beta (Ab) oligomers (AβO) that are believed to be a major driver of AD. Based on the encouraging results from the Phase 1a study of PMN310, ProMIS initiated a Phase 1b clinical trial (PRECISE-AD) and has since successfully dosed multiple patients with PMN310. 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 Stage 3 and Stage 4 AD. The study plans to enroll approximately 100 subjects 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- and brain-based markers of treatment effect at baseline and every three months. Frequent MRI scans throughout the study will be conducted to monitor for emergence of ARIA. 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 (incidence of ARIA), with final analysis to include clinical outcome measures. PMN310 successfully completed a Phase 1a clinical study ( NCT06105528 ), a double-blind, placebo-controlled, single ascending dose (SAD) study of the safety, tolerability and pharmacokinetics of PMN310 infusions in healthy volunteers. The trial consisted of five SAD cohorts that included 40 subjects across two active sites in the United States. In October 2024, ProMIS presented positive data from all five cohorts in its first-in-human Phase 1a clinical trial of PMN310 in healthy volunteers at the 17 th Clinical Trials on Alzheimer's Disease (CTAD) Conference. The results showed PMN310 was generally well-tolerated in all five SAD cohorts (2.5, 5, 10, 20 and 40 mg/kg) and, importantly, crossed the blood brain barrier in healthy volunteers in a dose dependent manner with PK suggesting that monthly dosing may provide levels of PMN310 adequate for target engagement in AD patients. The complete dataset from all five cohorts reinforces previously reported data from the first four cohorts announced in July 2024. ProMIS continues to advance its Aβ vaccine program in AD based on its oligomer target epitope(s). ProMIS will present preclinical data at the American Alzheimer's and Parkinson's Disease (AD/PD) International Conference in Vienna, Austria from April 1-4, 2025 and at the Academy of Neurology (AAN) Annual Meeting in San Diego, CA from April 5-9, 2025. The presentations titled, "Novel approach to optimization of Alzheimer's vaccine configuration for maximal targeting of toxic amyloid-beta oligomers" and "Rational design of Alzheimer's vaccine to maximize selective targeting of toxic amyloid-beta oligomers," will highlight data demonstrating that maximal reactivity was observed with immune IgG against the monovalent vaccine containing epitope 301, the target of PMN310. Amyotrophic Lateral Sclerosis Disease Program (PMN267) PMN267 is a humanized IgG1 antibody directed against toxic misfolded TDP-43 as a potential therapeutic target for amyotrophic lateral sclerosis (ALS). ProMIS will present a virtual oral presentation of preclinical data at the 2025 AD/PD Conference 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," providing proof-of-concept evidence that supports selective targeting of misfolded toxic aggregates of TDP-43 as a potentially safe and effective avenue to treat neurodegenerative diseases, which is the target of PMN267. Multiple Synucleinopathies Disease Vaccine Program (PMN440) ProMIS will present preclinical data at the 2025 AD/PD International Conference and at the AAN Annual Meeting 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." These data sets will 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 as a treatment for synucleinopathies, such as PD, dementia with Lewey bodies and MSA. Full Year 2024 Financial Highlights Cash and cash equivalents were $13.3 million as of December 31, 2024, compared to $12.6 million as of December 31, 2023. During the third quarter of 2024, the Company completed a public investment in private equity (PIPE) financing that provided initial upfront funding of $30.3 million and the potential to provide an additional $92.4 million tied to the exercise of warrants. Research and development expenses were $10.6 million for the fiscal year ended December 31, 2024, compared to $7.9 million for the same period in 2023. The increase was primarily attributable to costs related to the execution of the Phase 1a clinical trial and cost related to the initiation of the Phase 1b clinical trial. General and administrative expenses decreased to $6.2 million for the year ended December 31, 2024, compared to $6.4 million for the same period in 2023. Net income was $2.8 million for the full year ended December 31, 2024, compared to a net loss of $13.2 million for the same period in 2023. The net income was primarily attributable to a gain on the change in fair value of our warrant liabilities of $22.6 million. 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 - ProMIS and Collective Coordinates - 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. PMN 310 has successfully completed a Phase 1a clinical study and is dosing Alzheimer's disease patients in a Phase 1b clinical trial in AD patients. 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. 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