ProMIS Neurosciences Reports Q1 2024 Financials and Recent Highlights

ProMIS Neurosciences Inc., a clinical-stage biotechnology firm, has released its financial results for the first quarter ending March 31, 2024, while also providing a corporate update. The company, which focuses on developing antibody therapeutics targeting toxic misfolded proteins linked to neurodegenerative diseases, remains on track to deliver top-line data from its first-in-human Phase 1a clinical trial of PMN310 for Alzheimer's disease (AD) by mid-2024.

Neil Warma, the interim Chief Executive Officer of ProMIS Neurosciences, stated that the company is nearing the completion of its Phase 1a single ascending dose clinical trial of PMN310 in Alzheimer's disease. Warma highlighted that recent data published in bioRxiv underlines the potential of PMN310 as a selective treatment for AD, distinguishing it from other amyloid-beta-directed antibodies. ProMIS aims to commence a Phase 1b multiple ascending dose study for PMN310 in the latter half of 2024, contingent upon resource availability. This study is expected to provide initial proof-of-concept data illustrating PMN310’s efficacy in improving clinical outcomes for AD patients.

The Alzheimer's Disease Program (PMN310) is central to ProMIS' research. PMN310 is a humanized IgG1 antibody targeting toxic amyloid-beta oligomers—a significant driver of AD. The ongoing Phase 1a clinical trial (Study NCT06105528) is a double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of PMN310 infusions in healthy volunteers across five dosing cohorts. The study also measures PMN310 exposure levels in blood and cerebrospinal fluid (CSF). Results from this trial are expected mid-2024.

In April 2024, ProMIS published a paper titled “Relationship between therapeutic activity and preferential targeting of toxic soluble aggregates by amyloid-beta-directed antibodies" in the online journal, bioRxiv. The study findings support the differentiation of PMN310 from other similar antibodies.

ProMIS is also advancing its Amyotrophic Lateral Sclerosis (ALS) Disease Program with PMN267, another humanized IgG1 antibody targeting misfolded TDP-43, a potential therapeutic target for ALS. Preclinical data supporting PMN267 were published in the Journal of Biological Chemistry in April 2024. The paper, titled "Tryptophan residues in TDP-43 and SOD1 modulate the cross-seeding and toxicity of SOD1," underscores PMN267’s potential as a therapeutic agent for ALS.

In January 2024, ProMIS announced the selection of PMN400 as the lead vaccine candidate against multiple synucleinopathies, including multiple system atrophy (MSA), Parkinson’s disease, and Lewy Body Dementia. Utilizing a proprietary computational platform, ProMIS identified unique conformational epitopes of toxic alpha-synuclein, leading to the selection of PMN400 for further testing in mouse models.

At a corporate level, ProMIS named Neil Warma as interim CEO in January 2024. Warma, an experienced biotechnology executive, has served on the company’s Board of Directors for two years and continues to hold a directorial role. In March 2024, ProMIS secured additional U.S. and international patent allowances to protect its monoclonal antibody therapeutic for AD treatment.

Financially, ProMIS reported cash and cash equivalents of $2.5 million as of March 31, 2024, compared to $12.6 million as of December 31, 2023. This decline was mainly due to payments on existing vendor obligations and costs associated with the PMN310 Phase 1a clinical study. Research and development expenses for the first quarter of 2024 were $2.1 million, down from $3.5 million in the same period of 2023. General and administrative expenses saw a modest increase to $1.6 million from $1.4 million year-over-year. Net loss for the first quarter of 2024 was $3.6 million, compared to $5.0 million in the same period of 2023.

ProMIS Neurosciences Inc. remains committed to advancing its pipeline of novel antibody therapeutics targeting neurodegenerative diseases, leveraging its proprietary computational discovery platform to identify and develop new treatments for conditions like AD, ALS, and MSA.