US Market News
2月前
ProMIS Neurosciences Invited to Participate in the 2026 Bloom Burton & Co. Healthcare Investor ConferenceApril 13, 2026 7:30 AM
NewsfileCambridge, Massachusetts--(Newsfile Corp. - April 13, 2026) - ProMIS Neurosciences, Inc. (NASDAQ: PMN), a clinical-stage biotechnology company developing next-generation therapies for Alzheimer's disease (AD) and other neurodegenerative disorders, today announced that Neil Warma, Chief Executive Officer, will participate in the 2026 Bloom Burton & Co. Healthcare Investor Conference. The conference is being held April 21-22, 2026, at the Metro Toronto Convention Centre in Toronto, Ontario. ProMIS will present on Tuesday, April 21 at 2:30-3:00pm ET and will be available for one-on-one meetings with investors throughout the conference. A webcast of the company presentation will be available to registered attendees via the conference portal.We look forward to sharing our recent progress related to our PRECISE-AD Phase 1b clinical trial and welcoming discussions with investors and industry partners regarding our differentiated approach to targeting toxic misfolded proteins in Alzheimer's and other neurodegenerative diseases. We are on track to complete a six-month interim analysis of blinded safety and biomarker data in mid-2026. Full patient dosing is expected to be completed by year-end 2026, with presentation of unblinded top-line data anticipated in early 2027.About ProMIS Neurosciences Inc.ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies and vaccines selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company's proprietary target discovery engine, EpiSelect™, has been shown to predict novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson's disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN).About PMN310 and the PRECISE-AD Trial for Alzheimer's Disease (AD)PMN310, the Company's lead product candidate for the treatment of AD, is a humanized monoclonal antibody that has been designed to selectively target only the toxic oligomers, avoiding plaque, thereby potentially reducing, or eliminating amyloid-related imaging abnormalities (ARIA) liability. In addition, because PMN310 may not be limited by off-target binding or side effects, PMN310 could potentially offer an improved efficacy profile over other amyloid-directed antibody therapeutics. PMN310 was granted Fast Track designation by the U.S. Food and Drug Administration in July 2025.Based on the encouraging results from the Phase 1a trial (NCT06105528) of PMN310, ProMIS initiated PRECISE-AD, a Phase 1b clinical trial in AD patients. PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses (5, 10, 20 mg/kg) of intravenous PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD (Stage 3 and Stage 4 AD).For further information: Visit us at www.promisneurosciences.com Please submit media inquiries to info@promisneurosciences.com For Investor Relations, please contact: Carie Pierce at carie.pierce@promisneurosciences.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/290087
Original: ProMIS Neurosciences Invited to Participate in the 2026 Bloom Burton & Co. Healthcare Investor Conference
INV4
11月前
ProMIS Neurosciences Announces Private Placement Financing
July 22, 2025
ProMIS Neurosciences, Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzhiemer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD), today announced that it has entered into a purchase agreement (the “Purchase Agreement”) with an existing institutional and accredited investor to issue and sell an aggregate of approximately $2.4 million of warrants (the “Warrants”). The Warrants were sold at a price of $0.1875 per share through a private investment in public equity (“PIPE”) financing.
The Warrants have an exercise price of $1.25 per Warrant Share, are immediately exercisable and will expire five years from the date of initial issuance.
The PIPE financing included participation from an existing healthcare focused institutional investor.
ProMIS anticipates the gross proceeds from the PIPE financing to be approximately $2.4 million, before deducting fees and other offering expenses payable by the Company. In conjunction with the proceeds from the exercise of existing warrants, the total gross proceeds to the Company inclusive of the PIPE Offering will be approximately $9.2 million. The PIPE financing is expected to close on July 24, 2025, subject to customary closing conditions.
Proceeds from the PIPE financing are expected to be used to advance the clinical development of PMN310, ProMIS’ lead therapeutic candidate, as well as for working capital and other general corporate expenses.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (“Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. ProMIS Neurosciences has agreed to file a registration statement with the SEC registering the resale of the Common Shares issuable upon the exercise of the Warrants issued in the PIPE financing.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or other jurisdiction.
About ProMIS Neurosciences Inc.
ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company’s proprietary target discovery engine, EpiSelect™, predicts novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson’s Disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN).
Please submit media inquiries to info@promisneurosciences.com
For Investor Relations, please contact:
Kaytee Bock Zafereo
katherine.bock@promisneurosciences.com
$PMN
INV4
11月前
ProMIS Neurosciences Granted Fast Track Designation by U.S. FDA for PMN310 in the Treatment of Alzheimer’s Disease
July 21, 2025
ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease (AD).
The FDA Fast Track program is intended to accelerate the development of therapies that aim to address serious conditions and fill an unmet medical need. This designation enables enhanced engagement with the FDA, opening the door to a potentially more efficient path to approval for PMN310.
“This is a pivotal moment for ProMIS and the Alzheimer’s community, as receiving Fast Track designation not only underscores the potential of PMN310 to address a critical unmet need, but also provides valuable opportunities for regulatory insight as we advance toward key clinical milestones,” said Neil Warma, President and Chief Executive Officer of ProMIS Neurosciences. “We designed PMN310 with a goal of providing Alzheimer’s patients with a safer and more efficacious treatment option, which we believe represents the next generation of Alzheimer’s therapeutics. By selectively targeting only the most harmful, toxic forms of amyloid-beta, we believe PMN310 has the potential to reduce the serious side effects seen with current Alzheimer’s treatments, namely brain swelling and bleeding known as ARIA, while also delivering improved therapeutic benefit to patients.”
The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in patients with early AD. The study is focused on characterizing safety, tolerability, pharmacokinetics, and disease-relevant biomarkers. ProMIS anticipates reporting interim six-month biomarker and safety data in Q2 ‘26 and final results in Q4 ‘26.
AD affects more than 6 million people in the U.S. and remains a leading cause of death and disability among older adults. Despite progress in the field, the need for safer, more targeted treatment options remains urgent.
About PMN310 and the PRECISE-AD Trial for Alzheimer’s Disease (AD)
PMN310, the Company’s lead product candidate for the treatment of AD, is a humanized monoclonal antibody that has been designed to be differentiated in its ability to selectively target only the toxic oligomers, avoiding plaque, thereby potentially reducing or eliminating ARIA liability. In addition, because PMN310 may not be limited by off-target binding or side effects, PMN310 could potentially offer an improved efficacy profile over other amyloid-directed antibody therapeutics.
Based on the encouraging results from the Phase 1a trial (NCT06105528) of PMN310, ProMIS initiated PRECISE-AD, a Phase 1b clinical trial in AD patients. PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses (5, 10, 20 mg/kg) of intravenous PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD (Stage 3 and Stage 4 AD). PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against AßO on biomarkers associated with AD pathology and clinical outcomes. Safety will be a primary outcome of the study with particular emphasis on assessing whether, as a non-plaque binder, PMN310 may have a reduced risk of ARIA. The study is powered to provide 95% confidence for detection of ARIA. The study has been designed with a sample size intended to provide sufficient power to provide meaningful insight into effects of PMN310 on biomarkers and clinical outcomes.
About ProMIS Neurosciences Inc.
ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company’s proprietary target discovery engine, EpiSelect™, predicts novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson’s Disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN).
https://ih.advfn.com/stock-market/NASDAQ/promis-neurosciences-PMN/stock-news/96465125/promis-neurosciences-granted-fast-track-designatio
$PMN
Phoenix300
5年前
ProMIS Neurosciences Completes US$7M (CDN$8.75M) Financing with Distinguished Group of Boston Based Investors
By Promis Neuro Admin on Mar 22, 2021 10:39 am
TORONTO, Ontario and CAMBRIDGE, Mass. — March 22, 2021— ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is pleased to announce today the completion of an US$7M (CDN$8.75M) private placement of convertible unsecured debentures (the “Debentures“).
The investors include Mike Gordon of Fenway Sports Group, the Kraft Group, Henry McCance, co-founder of the Cure Alzheimer’s Fund, and Jeremy Sclar of WS Development Group. “After conducting diligence with a number of experts in the field, we are impressed with the tremendous potential of ProMIS Neurosciences and its unique platform of drug candidates to have a profound impact in the fight against Alzheimer’s and other neurodegenerative diseases. Our group is pleased to provide funding for the next phase of the company’s exciting future”, stated Mike Gordon of Fenway Sports Group.
“We are honored to have the support of such a distinguished group of investors, all of whom are accomplished leaders in the business and life sciences arenas” said Gene Williams, ProMIS Executive Chairman.
Debenture Terms
The Debentures are convertible into ProMIS common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually. At the company’s election, accrued interest may be paid in cash or common shares (such number of shares determined by dividing the interest due by the 5-day volume-weighted average trading price or “VWAP” of the common shares).
The Debenture mature on March 22, 2026. Prior to the maturity date, the Company may force conversion of the Debentures at the conversion price upon raising US$50M 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 (at the then 5-day VWAP less a 10% discount) or a combination thereof at its election. Amounts redeemed in common shares on the Maturity Date will be subject to TSX acceptance.
The investors were granted a right to participate, on a pro rata basis, in subsequent company offerings of equity securities for cash consideration pursuant to a public offering or a private placement.
The Debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Net proceeds will be used for working capital and general corporate purposes.
ProMIS plans to accelerate progress toward a number of top priorities, including:
Advancing the PMN310 monoclonal antibody, our potential “best in class” next generation Alzheimer’s treatment, into clinical testing;
Enhancing our partnering prospects for programs under active discussion by allowing us to invest in additional validation data;
Expanding our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
Advancing our partnered diagnostic programs;
Achieving NASDAQ listing;
Expanding our Board of Directors; and
Expanding our management team, capitalizing on the talent pool in Boston, to support a growing and ambitious scope of activity.
Retirement of our CEO
Finally, a note of great appreciation for our CEO, Dr. Elliot Goldstein. Elliot, who just turned 70, has announced his intention to retire from a full time role by the end of 2021. Even though Elliot is irreplaceable, ProMIS has initiated a search for a new CEO to help us achieve our potential. “Elliot has been a close friend and valued business partner for decades,” said Gene Williams, “without his significant contributions, we would not have been able to take ProMIS from just a great science idea to a company with a growing portfolio of therapies that have the potential to be life-altering for patients. On behalf of the entire ProMIS community, and patients who in the future may benefit from our therapies, I offer Elliot our sincere thanks and gratitude”.
“ProMIS Neurosciences was launched six years ago based on a world class scientific platform from our CSO and scientific founder, Dr. Neil Cashman. Playing a key role in this endeavor has been one of the most challenging yet rewarding experiences of my 40 odd years in pharmaceutical drug development. I am delighted for this exciting new phase of the Company”, stated Dr. Elliot Goldstein, ProMIS CEO.
Skydive21
6年前
TORONTO and CAMBRIDGE, Mass., April 15, 2020 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a company with a unique, core technology to predict novel targets on the molecular surface of complex proteins, announced today a collaboration with Dr. Hans Frykman and his team to develop a high-throughput, highly specific serological assay to accurately detect the presence of antibodies against SARS-CoV-2, the virus responsible for the COVID-19 pandemic. A test for COVID-19 immunity is essential to understanding patterns of immunity in the community and support an effective surveillance program, which public health authorities suggest is necessary to restart society.
A specific and sensitive test that could identify who has virus immunity and who remains at risk would enable normal societal function to recommence more effectively. A highly specific serology test for SARS CoV-2 is currently lacking due to its close relationship with other relatively benign (i.e., the common cold) but highly similar strains of coronaviruses. Prominent cross-reactivity between the family of coronaviruses hinders development of specific tests using traditional platforms such as ELISA (enzyme-linked immunosorbent assay).
“Community surveillance of COVID-19 is the largest unmet need of our decade,” stated Dr. Neil Cashman, ProMIS Chief Scientific Officer. “We are very pleased to welcome Dr. Frykman to the ProMIS SAB and to collaborate with him and his team to jointly address this gap. Dr. Frykman’s lab has a substantial track record for developing novel serological assays, including the application of sophisticated techniques such as surface plasmon resonance (SPR), to unambiguously determine specific antibody concentrations in human serum samples.”
Commenting on the collaboration, Dr. Frykman stated: “This exciting collaboration brings together our broad experience in developing sensitive and highly accurate serological tests with ProMIS’ unique ability to create peptide antigens based on rational identification of the site and shape (conformation) of epitope targets on complex protein structures, such as those displayed on the surface of the virus causing COVID-19. We anticipate that the predicted specificity of the ProMIS peptide antigens for the antibody response to COVID-19, without cross-reactivity with other coronavirus infections, will be an essential component for the rapid development of a highly sensitive and accurate serological assay.”
Phoenix300
6年前
News.
ProMIS Neurosciences initiates Natural History Study of Blood-Based Biomarkers in Alzheimer’s Disease
By Promis Neuro Admin on Feb 26, 2020 07:30 am
Biomarkers offer opportunity to make go/no-go decisions for investigational therapies as early as Phase 1
TORONTO, Ontario and CAMBRIDGE, Mass. — February 26, 2020 — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), with Toronto Memory Program, Canada’s largest and most experienced memory clinic and site for drug treatment trials in Alzheimer’s disease (AD) has initiated a pilot longitudinal study to assess the level of blood-based biomarkers in early AD with the support of Parexel, one of the world’s leading global clinical research organizations (CROs). ProMIS will leverage Parexel’s significant data management and central nervous system (CNS) expertise for the study, which it will use as the historical control arm for its anticipated Phase 1 study of PMN310, a novel antibody that selectively targets the toxic oligomeric species of amyloid beta, a root cause of AD. The dataset will help ProMIS detect a treatment signal as early as Phase 1, potentially allowing for rapid proof-of-concept at a fraction of the expense associated with traditional clinical trials. The dataset will be made available as a communal resource for Alzheimer’s researchers.
“Alzheimer’s patients and their families have endured far too many late-stage therapy failures,” said Sharon Cohen, MD, FRCPC, Medical Director of Toronto Memory Program and Principal Investigator of the study. “A new generation of blood-based biomarkers offers researchers the opportunity to measure treatment success much earlier than with traditional methods. As both a clinician and researcher, being able to detect a treatment signal in Phase 1 allows me to proceed with confidence knowing I’m focused on a validated therapy candidate with credible potential for success with my patients.”
Parexel will support ProMIS on the assimilation and management of this large data set, aimed at helping the industry derive important insights to drive the development of future therapies.
“As a truly patient-focused CRO, it’s an incredibly exciting time to be involved in Alzheimer’s disease therapy research as we await FDA’s decision regarding the first disease-modifying therapy, aducanumab,” shared Sy Pretorius, MD, Executive Vice President and Chief Medical and Scientific Officer, Parexel. “Harnessing the power of biomarker data holds great potential in helping to reach the next generation of innovation with the ultimate goal of bringing more therapies to market for Alzheimer’s patients, their caregivers and their families.”
“The U.S. Food and Drug Administration (FDA) has indicated it will accelerate approval of potential Alzheimer’s disease therapies if researchers can demonstrate meaningful biomarker changes,” said James Kupiec, MD, Chief Medical Officer for ProMIS Neurosciences, the study sponsor. “The Alzheimer’s research community has desperately needed a reliable, reproducible way to measure a drug’s effectiveness earlier than Phase 2 or 3 at which time so much money, patient hardship and time have been expended. The expected dataset could help facilitate the detection of a meaningful signal as early as Phase 1. This is really critical as it may enable us to advance only the best candidates with the highest potential for success. We look forward to using these data to advance PMN310 quickly. In addition, we will offer the biomarker dataset to the research community to help advance additional therapies.”
Several highly sensitive biomarkers are currently in development that could measure neuronal injury more accurately and/or more conveniently than current standards. Significantly, this new generation of blood-based biomarkers may afford drug developers a convenient means to measure the effectiveness of potential disease-modifying therapies as early as Phase 1, sparing patients, investors and researchers the time, expense and anguish associated with late-stage clinical trial failures.
Toronto Memory Program will lead this non-interventional natural history study which will measure the concentrations of neurofilament light chain (NfL) and other blood-based biomarkers on a monthly basis for a period of six months in AD patients with early stage disease. Designed to support multiple centers and up to 100 patients, the study will evaluate the plasma concentration of these biomarkers over the course of the study as well as visit-to-visit variability. The monthly data collection mirrors the design of a Phase 1 interventional trial where monthly blood draws to evaluate plasma biomarker levels coincide with monthly treatments/infusions.
The depth of the biomarker data from the natural history study will offer a powerful historical reference group with multiple monthly data points per patient.
Phoenix300
6年前
ProMIS Neurosciences Announces Gross Proceeds of $1,257,970 Related to the Exercise of Common Stock Warrants
By Promis Neuro Admin on Feb 25, 2020 06:30 am
TORONTO, Ontario and CAMBRIDGE, Mass. —February 25, 2020 — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is pleased to report that a total of 6,289,851 of the common share purchase warrants issued on February 10 and February 21, 2017 in a non-brokered private placement were exercised at a price of $0.20 per share for gross proceeds of $1,257,970, the vast majority of such proceeds having been received in the last month prior to the February 21, 2020 expiry date.
Commenting on today’s announcement, ProMIS Executive Chairman, Eugene Williams, stated: “We are very pleased to receive the proceeds from warrant exercise. The additional funds will now extend our cash life further into 2020. ProMIS remains focused on developing PMN310 as potential best in class therapy for Alzheimer’s disease.”
Phoenix300
6年前
ProMIS discovery platform provides a unique competitive advantage, with an unparalleled track record of creating antibodies highly selective for the toxic molecular species
• ProMIS lead program PMN310 scientifically differentiated from Biogen’s aducanumab.
- Aducanumab is likely to be the first ever disease modifying therapy in AD, on track for potential approval in 2020
- Progress of aducanumab a potential catalyst for ProMIS
• Very active partnering market for preclinical assets in the neurodegenerative disease space, with attractive economics. ProMIS active discussions for alpha-synuclein, TDP43, and tau programs. ProMIS differentiation of highly selective antibodies that avoid physiologically important forms of those proteins critical for vectorization. Nearly all pharma partners interested in gene therapy vectorization
• Recent advances in fluid-based biomarkers will allow for early, cost-effective clinical proof of concept. potential pharma partners confirm strong interest in, and acceptance of, biomarker POC value
• ProMIS unique technology platform expanding the portfolio to additional mis-folded protein targets
• Numerous potential near-and medium-term catalysts
- Progress of aducanumab, approval, enhances expectations for PMN310 - Partnering deals
- Clinical POC
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