ProMIS Neurosciences Inc. reported a challenging financial performance for the fiscal year ending December 31, 2024, with operating losses amounting to $16.8 million and a cumulative deficit of $90.7 million. The company has not generated any revenue from product sales, and it anticipates continued losses for the foreseeable future. As of the end of 2024, ProMIS had working capital of approximately $17 million, raising substantial doubt about its ability to continue as a going concern without additional financing. The company is actively seeking partnerships and funding to support its ongoing research and development efforts, particularly for its lead product candidate, PMN310, which is in the early stages of clinical trials.

In terms of strategic developments, ProMIS has made significant progress in advancing its clinical pipeline, particularly with PMN310, a monoclonal antibody designed to target toxic misfolded forms of amyloid-beta for the treatment of Alzheimer’s disease. The company received clearance from the FDA for its Investigational New Drug (IND) application in May 2023 and initiated a Phase 1a clinical trial in November 2023. The trial is designed to assess the safety and tolerability of PMN310 in healthy volunteers, with topline data expected to be released in mid-2024. Additionally, ProMIS is preparing to launch a Phase 1b trial, PRECISE-AD, aimed at evaluating PMN310 in patients with early Alzheimer’s disease.

Operationally, ProMIS has a small workforce, employing seven full-time and one part-time employee as of December 31, 2024, with additional personnel engaged through consulting agreements. The company is focused on expanding its pipeline and enhancing its corporate visibility through targeted investor engagement and potential partnerships. However, it faces significant competition in the neurodegenerative disease space, with several large pharmaceutical companies developing similar therapies. The market for Alzheimer’s treatments is particularly competitive, with recent approvals of disease-modifying therapies such as Eisai and Biogen’s lecanemab and Lilly’s donanemab.

The company’s outlook remains uncertain, as it must navigate the complexities of clinical development, regulatory approval processes, and market acceptance. ProMIS acknowledges the inherent risks associated with drug development, particularly in the Alzheimer’s space, which has historically seen high failure rates. The company is also subject to various risks related to intellectual property, regulatory compliance, and potential product liability claims. ProMIS is committed to advancing its product candidates while seeking to secure the necessary funding and partnerships to support its long-term growth strategy.

About ProMIS Neurosciences Inc.

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