ProMIS targets neurodegenerative diseases with patented tech platform. Seeking significant funding to support its R&D and growth strategy.
Mar 8th 2023, 10:11 pm
ProMIS Neurosciences did not generate any revenue during the years ended December 31, 2022 and December 31, 2021. Expenses The company incurred net losses of $18.1 million and $9.8 million for the years ended December 31, 2022 and December 31, 2021, respectively. These net losses were primarily due to research and development expenses related to the development of product candidates, as well as general and administrative expenses. The company expects to continue to incur net losses for the foreseeable future, as it continues to invest in the development and regulatory approval of its product candidates. The company anticipates that it will need substantial additional funding to support its continuing operations and pursue its growth strategy. Until it can generate significant revenue from product sales, if ever, the company expects to finance its operations through the sale of equity, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. The company has a number of product candidates in preclinical development, with a focus on antibodies that selectively target misfolded toxic forms of proteins that drive neurodegenerative diseases. These product candidates include PMN310, PMN442, and PMN267. The lead product candidate is PMN310, which has been designed to selectively target toxic, misfolded oligomers of amyloid-beta to treat Alzheimer's disease. PMN442 is the second lead product candidate, showing strong potential to target misfolded toxic a-syn, believed to be a primary driver of disease in synucleinopathies. PMN267 is the third lead product candidate, which has been shown in preclinical studies to selectively recognize misfolded, cytoplasmic TDP-43 aggregates without interacting with normal TDP-43, an important factor in the development of ALS. ProMIS Neurosciences believes that its patented technology platform, which combines protein biology, physics, and supercomputing, provides an advantage in selectively targeting the toxic misfolded proteins with therapeutics and diagnostics. The company expects to pursue regulatory approval of its product candidates and engage in commercialization expenses related to product manufacturing, marketing, sales, and distribution if they receive marketing approval for any product candidates. Forward-looking Analysis Looking ahead, ProMIS Neurosciences plans to continue its investment in the research and development of its product candidates. The company also expects to continue seeking regulatory approval for its product candidates and engaging in commercialization expenses if it receives marketing approval. The company anticipates the need for significant additional funding to support its continuing operations and pursue its growth strategy. While it expects to finance its operations through the sale of equity, debt financings, or other capital sources, these agreements or arrangements may not be available to the company on favorable terms, or at all. The company may be forced to delay, reduce, or eliminate the development and commercialization of any product candidates or delay its pursuit of potential in-licenses or acquisitions if it is unable to raise sufficient capital. ProMIS Neurosciences notes that there are numerous risks and uncertainties associated with product development, making it difficult to predict the timing or amount of increased expenses or when or if they will be able to achieve or maintain profitability. Even if the company is able to generate product sales, it may not become profitable. If the company fails to become profitable or is unable to sustain profitability on a continuing basis, it may not be able to continue its operations at planned levels and may be forced to reduce or terminate its operations. The company notes that there are risks associated with the development of product candidates, including delays in the clinical study process, failure to achieve a positive clinical trial outcome, and difficulty in obtaining regulatory approval. The company faces competition from established pharmaceutical and biotechnology companies, some of whom have greater financial resources and experience in product development and commercialization. The success of the company's product candidates will depend on several factors, including the safety and efficacy of the product candidates, the ability to obtain regulatory approval, and the ability to successfully commercialize the product candidates. Quotes from Management In its MD&A, ProMIS Neurosciences did not provide any direct quotes from management.