On November 14, 2022 ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), reported its third quarter 2022 financial results and recent highlights (Press release, ProMIS Neurosciences, NOV 14, 2022, View Source [SID1234624035]).

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"We continue to progress our therapeutic antibodies selective for toxic oligomers that are associated with the development and progression of neurodegenerative and other misfolded protein diseases. We are excited that our lead compound, PMN310, is advancing toward clinical stage development. Most notably, we recently closed a $7.4 million private placement, which will be used to advance PMN310 into a first-in-human study. We anticipate enrolling the first subject in the first half of 2023," said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. "We believe our novel discovery platform gives us the potential to advance differentiated next-generation products to address urgent unmet medical needs as in ALS and MSA, and we are excited to continue our transition toward a clinical phase biotechnology company."

Recent Highlights and Anticipated Milestones

Alzheimer’s Disease Program (PMN310)
PMN310, ProMIS’s lead compound, is a novel monoclonal antibody that is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD.

ProMIS completed pilot toxicology, pharmacokinetics (PK) and tissue cross reactivity (TCR) studies and conducted the formal GLP studies to support an IND application to the U.S. Food and Drug Administration (FDA) and anticipate enrollment of the first subject in our Phase 1a trial in the first half of 2023 subject to FDA’s acceptance of the IND.
ProMIS completed the first stage of development towards a high concentration formulation that could potentially support subcutaneous dosing as a future step to improve overall convenience and patient compliance.
Other programs

Using ProMIS’s discovery platform, the Company generated high-affinity monoclonal antibodies that are selective for the misfolded toxic form of TDP-43. In April 2022, the Company announced that it selected monoclonal antibody PMN267 as the drug candidate for an ALS indication based on its binding profile and activity in cell systems and a mouse model of disease. PMN267 is undergoing humanization in a human IgG1 framework for future clinical testing.
ProMIS has selected monoclonal antibody PMN442 as its alpha-synuclein antibody drug candidate. In vivo testing in mouse disease models is ongoing with results expected in the second half of 2022. PMN442 is currently being humanized in a human IgG1 framework for future clinical testing.
ProMIS continues to advance its amyloid-beta vaccine program with the aim of developing an AD vaccine containing its oligomer target epitopes conjugated to a carrier protein in formulation with an adjuvant. A vaccination study in a mouse model of AD is ongoing.

Corporate

In October 2022, ProMIS executed a securities purchase agreement to sell, through a private investment in public equity (PIPE) financing, 1,383,755 Units of the Company at a price of $5.40 per Unit for aggregate gross proceeds of $7.4 million, before deducting placement agent fees and other offering expenses.
In September 2022, the Board of Directors approved the appointment of Gail Farfel, Ph.D., as the Company’s Chief Executive Officer, effective September 19, 2022.
The Company’s co-founder and former Chief Executive Officer, Eugene Williams, remains as Chairman of the Board.

Third Quarter Financial Highlights

Cash and cash equivalents were $4.0 million as of September 30, 2022, compared to $17.0 million as of December 31, 2021. Net proceeds from the October 2022 financing were $6.4 million.
Research and development expenses were $4.6 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same period in 2021. The increase is primarily attributable to increased spending on the PMN310 program.
General and Administrative expenses were $1.4 million for the third quarter ended September 30, 2022, compared to $1.3 million for the same period in 2021.
Net loss was $6.0 million for the third quarter ended September 30, 2022, compared to $1.2 million for the same period in 2021.