Received FDA clearance for investigational new drug (IND) application for lead therapeutic candidate, PMN310, in Alzheimer’s disease Presented preclinical data supporting target identification and candidate differentiation across pipeline of antibody therapeutics at international neurology conferences
“In the first quarter, we completed the required steps that enabled us to file our PMN310 IND in April in order to advance PMN310 toward the clinic. Last week, we announced that the FDA cleared our IND for PMN310 in Alzheimer’s disease, which is an exciting milestone for ProMIS,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “Additionally, we presented key data on PMN310, as well as data supporting an amyloid-beta vaccine candidate in Alzheimer’s and a new target for ALS treatment at neurology conferences in March. We look forward to progressing our programs through the rest of 2023.” Alzheimer’s Disease Program (PMN310)
PMN310, ProMIS’ lead compound, is a novel monoclonal antibody which is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD. The Company has the following updates:
Received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD.
Presented in vitro preclinical data in which PMN310 demonstrated greater selectivity for target toxic oligomers compared to other amyloid-beta (Aβ)-directed antibodies, at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders (AD/PD 2023). Presented PMN310 preclinical dataset including data showing PMN310 protected memory function in two rodent models of AD at the 75th American Academy of Neurology (AAN) Annual Meeting.
ProMIS continues to advance its amyloid-beta vaccine program in AD based on its oligomer target epitope(s) and gave a platform presentation on results from mouse vaccination studies at the AAN Annual Meeting.
Johanne Kaplan, Ph.D., ProMIS’ Chief Development Officer will chair the upcoming ALS Drug Development Summit taking place on May 16-18 in Boston.
First Quarter 2023 Financial Highlights
Cash and cash equivalents were $3.3 million as of March 31, 2023, compared to $5.9 million as of December 31, 2022.
Research and development expenses were $3.5 million for the quarter ended March 31, 2023, compared to $1.9 million for the same period in 2022. The increase was primarily attributable to increased spending on PMN310 to finalize drug product manufacturing and costs to complete the IND filing.
General and administrative expenses were $1.4 million as of March 31, 2023, compared to $2.0 million for the same period in 2022.
Net loss was $5.0 million for the quarter ended March 31, 2023, compared to $2.1 million for the same period in 2022.
About ProMIS Neurosciences Inc.
ProMIS Neurosciences Inc. is a development 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), an alpha-synucleinopathy. 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. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto, Ontario and Cambridge, Massachusetts. ProMIS is listed on Nasdaq and the Toronto Stock Exchange under the symbol PMN.