Announcement • Jul 11
ProMIS Neurosciences to Delist from TSX ProMIS Neurosciences Inc. announced that it intends to consolidate trading of its shares on the Nasdaq exchange and as such has applied and received approval for a voluntary delisting of its common shares from the Toronto Stock Exchange ("TSX"). The last trading day on TSX will be July 21, 2023. The delisting from the TSX will not affect the Company’s listing on the Nasdaq and common shares will continue to trade uninterrupted on the Nasdaq under the symbol “PMN”. ProMIS joined the Nasdaq Capital Market LLC on July 7, 2022, and it has since become the primary market based on trading volume. The Company believes that this consolidation to the Nasdaq will facilitate the opportunity to undertake transactions in accordance with the rules of Nasdaq as its primary market while creating a central marketplace for common shares and providing sufficient liquidity. The Company also believes that delisting from the TSX will lower the expenses of a dual listing and provide savings in time and effort of management, which can be redirected to initiatives intended to generate shareholder value. In accordance with the requirements of the TSX Company Manual, shareholder approval is not required in respect of the voluntary delisting from the TSX as the Company’s common shares are listed on Nasdaq, which is an acceptable alternative market for the listed securities. Announcement • May 09
ProMIS Neurosciences Inc. Announces FDA Clearance of Investigational New Drug Application for PMN310 in Alzheimer’s Disease ProMIS Neurosciences Inc. announced that it has 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. PMN310 is a novel monoclonal antibody which is designed to be highly selective for toxic oligomers of amyloid-beta (Aß) that are believed to be a major driver of AD. In preclinical studies, PMN310 showed strong ex vivo target engagement of toxic oligomers in brain samples from patients with AD, with little or no diversion by Aß monomers or plaque. In a recent presentation of in vitro data at the AD/PD 2023 conference, PMN310 was the least impacted by monomer competition, compared to other Aß-directed antibodies, resulting in an overall greater ability to target toxic oligomers. In addition, PMN310 was not observed to bind to plaque, potentially reducing the risk of Aß-related imaging abnormalities (ARIA) observed with plaque-binding antibodies. The Company believes these data support a potentially differentiated clinical profile when compared to other antibody therapeutic candidates in AD. With the IND clearance for PMN310, the Company plans to initiate a Phase 1a clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of a range of PMN310 doses in healthy adult volunteers. Breakeven Date Change • Mar 09
No longer forecast to breakeven The analyst covering ProMIS Neurosciences no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$47.1m in 2025. New forecast suggests the company will make a loss of US$22.9m in 2025. Announcement • Oct 13
ProMIS Neurosciences, Inc. announced that it has received $7.472277 million in funding from Kraft Group LLC and other investors ProMIS Neurosciences, Inc. announced a fully subscribed private placement of 1,383,755 units at a price of $5.4 per unit for gross proceeds of $7,472,277 on October 12, 2022. Each unit is comprised of one common share of the company and one quarter of one common share purchase warrant. Each full warrant is exercisable for one common share at $7.50 for a period of five years commencing six months from the closing of the offering. The transaction included participation from individual investors, Mike Gordon, Jeremy Sclar, Dave Welch and returning investor, Kraft Group LLC. The securities sold in the offering will be restricted securities under applicable United States federal and state securities laws. Closing of the offering remains subject to the final approval of the Toronto Stock Exchange. Announcement • Sep 14
ProMIS Neurosciences Appoints Gail M. Farfel as Chief Executive Officer ProMIS Neurosciences, Inc. appointed Gail M. Farfel, Ph.D., as Chief Executive Officer, effective September 19, 2022. Gail M. Farfel, Ph.D., is an accomplished pharma development and regulatory leader with over 25 years ofexperience in large and small pharma, including venture-backed and public companies. Gail has a strong record of accomplishments in neuropsychiatric clinical development and global regulatory submissions, including multiple successful investigational new drug (IND), new drug application (NDA) and marketing authorization application (MAA) registrations, U.S. Food and Drug Administration (FDA) Advisory Committee experience, and three successful global “first” indications. On the business side, Gail has played leadership roles in strategic planning and commercial positioning for partnership and launch, IPO, fundraising for publicly traded and private companies, and licensing and asset integration. Prior to joining ProMIS, Gail served as Executive Vice-President and Chief Development Officer of Zogenix Inc, where she delivered successful Phase 3 programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS), leading to approvals from FDA (Dravet and LGS) and European Medicines Agency (EMA) approval for Fintepla in 2020 and 2021. Further, while an executive at Zogenix she supported capital raises in excess of $700 Million; the acquisition of Modis Therapeutics; the alliance with Tevard Biosciences; and the acquisition of Zogenix by UCB Pharma in March 2022. In her earlier career, Gail held positions of increasing responsibility at Smithkline Beecham, Pfizer, Novartis, G. Meredith Consulting and Marinus Pharmaceuticals. Gail obtained her Ph.D. in neuropsychopharmacology from the University of Chicago. Announcement • Jul 28
ProMIS Neurosciences, Inc. to Present At 2022 Alzheimer's Association International Conference ProMIS Neurosciences, Inc. announced it will give a poster presentation at the annual Alzheimer's Association International Conference (AAIC®) to be held July 31-August 4, 2022 at the San Diego Convention Center, San Diego California and online. Poster presentation of study comparing oligomer selectivity of PMN310 to that of other amyloid-beta-directed antibodies Dr. Johanne Kaplan, ProMIS Chief Development Officer, will present the poster entitled: "Distinguishing between amyloid-beta-directed antibodies: ability of PMN310 to target toxic oligomers despite competing species." The poster describes the design and results of a study wherein ProMIS' lead therapeutic candidate PMN310 was compared to other amyloid-beta-directed antibodies for selectivity and ability to maintain interaction with toxic oligomers in the presence of competing monomers. Dr. Kaplan will deliver her poster presentation (P1-090) on July 31 from 12:30 - 2:15 PM local time in person at the San Diego Convention Center Exhibit Hall and online. Please consult the AAIC® website (https://alz.org/aaic/overview.asp) for any further updates. The poster presentation will be available on the ProMIS website (www.promisneurosciences.com) after the AAIC® closes on Aug. 4, 2022. AAIC® is the largest, most influential international meeting focused on advancing dementia science. The annual conference convenes the world's leading basic science and clinical researchers, next-generation investigators, clinicians and the care community to share research discoveries supporting new methods of prevention, treatment and diagnosis of Alzheimer's disease. ProMIS Neurosciences' lead therapeutic candidate, PMN310, is a monoclonal antibody for Alzheimer's disease created with a novel, proprietary method for generating and developing antibodies that can uniquely and precisely target toxic forms of otherwise normal proteins. PMN310 selectively targets the toxic oligomeric species of amyloid-beta (Aß), a root cause of Alzheimer's disease. Preclinical studies have shown that PMN310 demonstrates a high degree of binding to toxic oligomers as opposed to non-toxic forms of Aß, possessing greater selectivity versus other Aß-directed antibodies. Announcement • Jul 09
ProMIS Neurosciences Common Shares Deleted from Other OTC ProMIS Neurosciences, Inc. Common Shares deleted from Other OTC effective July 08, 2022. The deletion is due to Market Center Change Listed on NASDAQ. Recent Insider Transactions • Jun 25
Chairman & CEO recently bought CA$64k worth of stock On the 23rd of June, Eugene Williams bought around 500k shares on-market at roughly CA$0.13 per share. This was the largest purchase by an insider in the last 3 months. This was Eugene's only on-market trade for the last 12 months. Announcement • Apr 20
ProMIS Neurosciences, Inc. Appoints Larry Altstiel as Chief Medical Officer ProMIS Neurosciences, Inc. announced that it has appointed Larry Altstiel M.D. Ph.D., as Chief Medical Officer. Larry Altstiel, M.D., Ph.D. brings decades of medical expertise in neurodegenerative diseases and experience in the pharmaceutical industry. At Pfizer, as vice president and head of neuroscience clinical research, Larry led the selection of drug candidates, development and oversight of multiple preclinical studies and clinical studies from Phase 1 through Phase 3. He is currently part time Chief Medical Officer at Pinteon Therapeutics. He received his Ph.D. in cell biology, virology, and physical chemistry from The Rockefeller University, completed a postdoctoral fellowship in cell biology at Harvard University and received an M.D. from the University of Miami Leonard M. Miller School of Medicine. He also completed a residency in Neurology at the Neurological Institute of New York, Columbia University College of Physicians and Surgeons. Reported Earnings • Mar 19
Full year 2021 earnings: EPS misses analyst expectations Full year 2021 results: CA$0.034 loss per share (down from CA$0.02 loss in FY 2020). Net loss: CA$11.8m (loss widened 108% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 4.2%. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Announcement • Mar 04
ProMIS Neurosciences, Inc. Announces Pmn310 Antibody Demonstrates Significant Cognitive Benefit in A Mouse Model of Alzheimer’s Disease ProMIS Neurosciences, Inc. announced that PMN310, its lead antibody therapeutic candidate for Alzheimer’s disease (AD), showed a significant cognitive benefit in a widely recognized animal model of AD. The APP/L mouse is a “transgenic” model of AD in which human amyloid-beta oligomers lead to cognitive deficits. In this model, treatment with PMN310 which selectively targets toxic oligomers of amyloid-beta preserved memory using the water maze readout, to the extent that the PMN310 treated mice were indistinguishable from “non-transgenic” control mice. This positive result builds on earlier in vivo data for PMN310. The company has previously published2 on the protective activity of PMN310 in a novel object recognition model where toxic oligomers of amyloid-beta are injected in the brain of mice to create a memory deficit. In this model, co-injection of PMN310 prevented the loss of memory caused by toxic oligomers. Announcement • Feb 04
ProMIS Neurosciences, Inc. Announces Board Appointments ProMIS Neurosciences, Inc. announced that it has appointed Drs. Guy Rouleau and Alain Dagher to its scientific advisory board (SAB). Dr. Guy Rouleau, MD, PhD, is Director of The Neuro (Montreal Neurological Institute-Hospital), Chair of the Department of Neurology and Neurosurgery of McGill University, Director of the Department of Neuroscience of McGill University Health Centre, and co-founder of the Tanenbaum Open Science Institute. Over the last two decades, Dr. Rouleau and his team have focused on identifying genes associated with neurological and psychiatric diseases, including autism, amyotrophic lateral sclerosis, hereditary neuropathies, epilepsy and schizophrenia, as well as providing a better understanding of the molecular mechanisms that lead to disease symptoms. Dr. Alain Dagher, MD, has been an attending neurologist at the Montreal Neurological Institute since 1997. His clinical specialty is movement disorders, with a focus on Parkinson’s Disease. His main research interest is functional brain imaging to understand the function of the basal ganglia, frontal lobes and dopamine in reward-seeking behaviors. Announcement • Jan 28
ProMIS Neurosciences Appoints Cheryl Wellington to its Scientific Advisory Board ProMIS Neurosciences, Inc. announced that it has appointed Dr. Cheryl Wellington to its scientific advisory board (SAB). Dr. Cheryl Wellington, Professor of Pathology and Laboratory Medicine at the University of British Columbia (UBC). Announcement • Jan 19
ProMIS Neurosciences, Inc. Initiates Program to Develop Monoclonal Antibodies to Treat Schizophrenia and Other Chronic Mental Illnesses ProMIS Neurosciences, Inc. announced that it has initiated a program to develop monoclonal antibodies to treat schizophrenia and other chronic mental illnesses. Schizophrenia is a clinical term for a severely disabling neuropsychiatric disease that disrupts employment, families and communities, and likely has heterogenous biological origins. The biomedical literature has implicated protein misfolding as one cause of schizophrenia. A candidate for a key misfolding protein in schizophrenia was first identified in a Scottish family with a neurodevelopmental syndrome including schizophrenia, such that the gene was named disrupted in schizophrenia (DISC1). DISC1, and its genetically-linked protein interactors in the brain, represent a new platform target for ProMIS, given its outstanding track record of predicting and validating misfolding-specific epitopes using proprietary computational approaches. Announcement • Aug 26
ProMIS Neurosciences, Inc. has completed a Composite Units Offering in the amount of $17.5 million. ProMIS Neurosciences, Inc. has completed a Composite Units Offering in the amount of $17.5 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 109,375,000
Price\Range: $0.16
Discount Per Security: $0.0112
Transaction Features: Regulation S Announcement • May 26
ProMIS Neurosciences, Inc. Initiates Commercialization of Covid-19 Serology Assay ProMIS Neurosciences, Inc. announced that it has initiated commercialization of its COVID-19 serology assay and has appointed Owen Dempsey to lead the commercialization program. Owen’s professional work for the past 25 years has been to build companies founded to discover and commercialize antibodies in applications including life science research, pharmaceutical drug discovery, clinical diagnostics and therapeutic treatment of cancer, AIDS and other serious illness. He has led private, venture-backed as well as NASDAQ-listed companies and is a past board member of ALDA, the Analytical, Life Science & Diagnostics Association. This advanced serology test developed by ProMIS Neurosciences measures not only serum antibodies to SARS-CoV-2, the novel coronavirus causing COVID-19, but also their protective activity against infection. The assay simultaneously assesses antibody levels in the blood of study participants and their neutralizing activity against the original strain of SARS-CoV-2 as well as emerging variants. Additional variants can be added to the assay as they are identified. The assay utilizes an advanced, high-throughput, sensitive and accurate surface plasmon resonance (SPR) technology as opposed to traditional ELISA (enzyme-linked immunosorbent assay) methods. This provides a powerful surrogate measure of antibody immunity without the need for live virus or pseudovirus formats. This and similar collaborative efforts may help to guide the need for boosters or modified vaccines addressing emerging strains and will inform the medical community’s preparedness to meet similar public threats to global health in the years ahead. It is important to note, as stated above that the initial marketing and commercialization of the assay will be directed only to organizations such as vaccine manufacturers, pharmaceutical companies and government organizations at the national and state/provincial level. The assay is not currently available to private individual consumers or the general public. Announcement • May 22
ProMIS Neurosciences Re-Initiates Path to IND for PMM310 with Producer Cell Line Development ProMIS Neurosciences, Inc. announced the initiation of producer cell line development for PMN310. This key first step in the manufacturing of antibody therapeutics will be carried out by Selexis, SA, using Selexis' proprietary SUREtechnology PlatformTM. After two years of setbacks in the Alzheimer's disease (AD) field, 2021 has seen tremendous progress and reason for optimism. Positive data from Lilly and Cassava, in addition to Biogen's June 7 PDUFA date for aducanumab, portend potential positive momentum for AD patients. ProMIS is poised to contribute to the field. PMN310, is a humanized monoclonal antibody that binds with high affinity and selectivity to toxic oligomers of A, a recognized root cause of AD. Importantly, PMN310 does not appreciably bind to A plaque or vascular deposits of A thereby reducing the likelihood of brain swelling (edema), a dose-limiting side effect observed with non-selective therapeutic antibodies that interact with A plaque. The current cell line development is based on an IgG1 isotype format (rather than the originally envisaged IgG4 format) as data from the scientific literature indicate that an IgG1 isotype may achieve greater efficacy via engagement of the immune system to clear damaging A oligomers from the brain. Reported Earnings • Apr 02
Full year 2020 earnings released: CA$0.02 loss per share (vs CA$0.028 loss in FY 2019) Full year 2020 results: Net loss: CA$5.66m (loss narrowed 23% from FY 2019). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 21% per year, which means it is significantly lagging earnings. Announcement • Mar 23
ProMIS Neurosciences, Inc. announced that it has received CAD 8.75 million in funding from Kraft Group LLC and other investors ProMIS Neurosciences, Inc. (TSX:PMN) announced a private placement of convertible unsecured debentures for gross proceeds of CAD 8,750,000 on March 22, 2021. The transaction included participation from new investors Mike Gordon, Kraft Group LLC, Henry McCance and Jeremy Sclar. The debenture carries a coupon 1% per annum and would mature in on March 22, 2026. The debenture is convertible into common share of the company at an exercise price of $0.10 (CAD 0.125) per share. The company may force conversion of the debentures at the conversion price upon raising $50,000,000 (CAD 62,500,000) in equity and/or debt cumulatively. On the maturity date, the company may redeem the outstanding principal amount of the Debentures in either cash or common shares or a combination thereof at its election. Amounts redeemed in common shares on the maturity date will be subject to TSX acceptance. The debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Announcement • Feb 03
ProMIS Neurosciences, Inc. Announces Perspectives on Recent Progress in the Alzheimer's Field ProMIS Neurosciences, Inc. announced its perspectives on recent progress in the Alzheimer's field. Two important events occurred in January 2021, both of which consider very positive for the Alzheimer's field, for the updated amyloid hypothesis, and for ProMIS Neurosciences. The FDA extended the PDUFA date for review of Biogen's aducanumab from March 7 to June 7, 2021, as announced on January 29. Lilly announced positive clinical results for their antibody, donanemab, on January 11, making it the third antibody with positive clinical results in Alzheimer's disease (AD) due to its targeting of aggregated amyloid-beta. Both these events have positive implications for ProMIS and PMN310, ProMIS' lead antibody therapeutic candidate for AD. Biogen's announcement on January 29 was the first update on aducanumab since the events of early November 2020. The FDA came out Nov., 2020 with unequivocally positive support for the approval of aducanumab, but that was followed by a negative advisory committee vote on Nov. 6. As several analysts pointed out at the time, and as noted in communications, the FDA has frequently approved a drug in spite of a negative advisory committee vote, which is non-binding. Historically, the FDA has almost always done so after receiving additional information from the drug sponsor. In this case, it is clear that the FDA review division strongly believes, and agree, that aducanumab at the high dose of 10mg/kg is clinically beneficial and merits approval. Company believe that if the FDA were planning to deny approval, it is highly likely they would have already announced that decision, to allow Biogen to get on with the next step. Company believe that the FDA will issue an approval of aducanumab in the summer of 2021. Lilly announced positive data from the 272 subject TRAILBLAZER study of donanemab, an antibody therapeutic that targets pyroglutamated amyloid-beta, a modified form of amyloid found in plaque, but also known to be involved in toxic oligomer formation. A clinical program of a small molecule which reduced the formation of pyroglutamate amyloid oligomers (Vivoryon's PQ 912) showed benefit after just three months of treatment. Patients were treated for 76 weeks in the Lilly trial. It is possible that the efficacy of donanemab may be due in part to the impact of donanemab on toxic oligomer formation. Like aducanumab and Eisai's BAN2401, donanemab is associated with the side effect of brain swelling or ARIA-E (amyloid related imaging abnormality with edema) associated with plaque binding. With these new results, there are now three programs showing clinical benefit due to the targeting of aggregated amyloid, all three of which likely have an impact on toxic oligomers. The 'updated' amyloid hypothesis continues to gain clinical evidence which matches the scientific evidence, and supports the ProMIS view that PMN310, which is highly selective for toxic oligomers, will likely avoid the ARIA-E side effect, can be dosed higher, and have 'best in class efficacy'. Analyst Estimate Surprise Post Earnings • Nov 13
Earnings miss expectations Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 4.2%. Over the next year, revenue is expected to shrink by 100% compared to a 657% growth forecast for the Biotechs industry in Canada. Announcement • Oct 30
ProMIS Neurosciences Adds Dr. David Wishart to Its Scientific Advisory Board ProMIS Neurosciences, Inc. welcomes Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, to its Scientific Advisory Board (SAB). Identified as one of the world’s most highly cited scientists for each of the past 7 years, Dr. Wishart brings more than three decades in protein folding and misfolding research to ProMIS, creating industry-leading depth in this area of therapeutic development for neurodegenerative and other diseases. Dr. Wishart will play a pivotal role in advising ProMIS on the application and further development of its drug discovery and development platform, which is uniquely capable of identifying the sequence and shape (conformation) of novel binding targets—called peptide antigens—on misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s, Parkinson’s and ALS. ProMIS has leveraged its novel platform to create a portfolio of antibody, intrabody and vaccine candidates that are highly selective for the misfolded protein aggregates driving pathogenesis. With Dr. Wishart’s support, ProMIS will continue to expand the application of its platform to the biology of additional misfolded protein diseases. Announcement • Oct 04
ProMIS Neurosciences, Inc. Presents Lead Program for Alzheimer's Disease at Prestigious Keystone Symposia Scientific Conference ProMIS Neurosciences, Inc. will present key data on monoclonal antibody PMN310 for Alzheimer's disease at the Keystone Symposium on Neurodegenerative Diseases: New Insights and Therapeutic Opportunities. Announcement • Sep 24
ProMIS Neurosciences, Inc. Announces Resignation of Anthony Giovinazzo from the Board of Directors ProMIS Neurosciences, Inc. announced the resignation of Anthony Giovinazzo from the Board of Directors. Announcement • Sep 23
ProMIS Neurosciences, Inc. to Develop Multivalent Vaccine for Alzheimer’s Disease ProMIS Neurosciences, Inc. announced initiation of a program to construct and test a multivalent peptide vaccine for Alzheimer’s disease (AD). The critical first steps in vaccine development will be carried out by VIDO-InterVac, a global leader in vaccine research and development. Recent progress in the development of blood-based biomarkers for neurodegeneration is enabling increased screening to diagnose and identify individuals at risk of developing AD. A vaccine capable of inducing an effective antibody response against amyloid-beta toxic oligomers (ABOs) could be administered prophylactically to at-risk individuals to prevent development of symptomatic disease. Additionally, the vaccine could be given therapeutically to individuals living with a diagnosis of AD to inhibit further disease progression. In a proof-of-concept study, ProMIS identified six different peptide epitopes selectively exposed on toxic ABOs. Immunization of mice with each of these individual epitopes produced protective antibodies against ABOs, without undesirable binding to amyloid-beta monomers or fibrils. ProMIS also conducted a successful proof-of-concept vaccination study with one of the peptide epitopes in a mouse model of AD, which demonstrated neuronal protection and improvement in cognitive deficits. Vaccine development will start at the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) with the generation of multivalent vaccine constructs based on the ProMIS peptides linked to a carrier protein and formulated with an adjuvant to maximize induction of a protective antibody response to ABOs. 