GlobeNewswire

ProMIS Neurosciences Offers Perspectives on Recent Progress in the Alzheimer’s/Amyloid Field

Share

Two positive events in January support PMN310 “best in class” positioning

TORONTO and CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- 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, announced today its perspectives on recent progress in the Alzheimer’s field.

Two important events occurred in January 2021, both of which we consider very positive for the Alzheimer’s field, for the updated amyloid hypothesis, and for ProMIS Neurosciences.   The FDA extended the PDUFA date (Prescription Drug User Fee Act) 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 (not amyloid monomer). Both these events have positive implications for ProMIS and PMN310, ProMIS’ lead antibody therapeutic candidate for AD.

“Several analysts predicted that the FDA might manage its dilemma of believing that aducanumab should be approved despite a negative advisory committee vote by waiting for data to come in from the ongoing high dose extension study, extending the PDUFA date, and then approving the product later. It appears that prediction was correct,” stated Eugene Williams, Executive Chairman of ProMIS Neurosciences. “In line with this assessment, we believe the FDA will issue an approval of aducanumab in the summer of 2021.”

Biogen’s announcement on January 29 was the first update on aducanumab since the events of early November 2020. The FDA came out Nov. 4, 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 we noted in our 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 we agree, that aducanumab at the high dose of 10mg/kg is clinically beneficial and merits approval. We 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. We 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”.

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company whose unique core technology is the ability to rationally predict the site and shape (conformation) of novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of proteins. In neurodegenerative diseases, such as Alzheimer’s, ALS and Parkinson’s disease, the DSEs are misfolded regions on toxic forms of otherwise normal proteins. In the infectious disease setting, these DSEs represent peptide antigens that can be used as an essential component to create accurate and sensitive serological assays to detect the presence of antibodies that arise in response to a specific infection, such as COVID-19. ProMIS proprietary peptide antigens can also be used to create potential therapeutic antibodies, as well as serve as the basis for development of vaccines. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com or follow us on Twitter and LinkedIn.

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

CrossAmerica Partners LP Reports Fourth Quarter and Year-End 2020 Results1.3.2021 22:15:00 CETPress release

Allentown, March 01, 2021 (GLOBE NEWSWIRE) -- CrossAmerica Partners LP Reports Fourth Quarter and Year-End 2020 Results Reported Fourth Quarter 2020 Operating Income of $8.1 million and Net Income of $9.0 million compared to Operating Income of $9.4 million and Net Income of $4.3 million for the Fourth Quarter 2019Generated Fourth Quarter 2020 Adjusted EBITDA of $24.4 million and Distributable Cash Flow of $26.2 million compared to Fourth Quarter 2019 Adjusted EBITDA of $25.6 million and Distributable Cash Flow of $18.8 millionReported Fourth Quarter 2020 Gross Profit for the Wholesale Segment of $36.8 million compared to $32.7 million of Gross Profit for the Fourth Quarter 2019Reported Fourth Quarter 2020 Gross Profit for the Retail Segment of $19.5 million compared to $2.3 million of Gross Profit for the Fourth Quarter 2019Distributed 308.5 million wholesale fuel gallons during the Fourth Quarter 2020 at an average wholesale fuel margin per gallon of 7.8 cents Reported Full Year 2020

Historic Hyperloop Vehicle to be Unveiled to the Public at the Smithsonian FUTURES Exhibition this Fall1.3.2021 21:32:46 CETPress release

Vehicle made history in November 2020 carrying the world’s first hyperloop passengers Virgin Hyperloop joins the ranks of cutting-edge innovations debuted at Smithsonian WASHINGTON, March 01, 2021 (GLOBE NEWSWIRE) -- Just months after the world’s first hyperloop passenger testing, Virgin Hyperloop today announced that the passenger-carrying vehicle, dubbed “Pegasus,” will be making its public debut at the Smithsonian Arts + Industries Building in November 2021. Previously, the Building has showcased world-changing inventions like Edison’s lightbulb, the first telephones, and Apollo rockets. “Growing up, I spent family vacations at the Smithsonian National Air and Space Museum, seeing first-hand how engineers could change the world,” said Josh Giegel, CEO and Co-Founder of Virgin Hyperloop. “Having the vehicle the Virgin Hyperloop team created on display at the Smithsonian, inspiring the next generation of engineers to think big, is truly a dream come true.” The historic Arts + Industri

GOGL – Special General Meeting1.3.2021 21:00:00 CETPress release

1 March 2021 Golden Ocean Group Limited (NASDAQ and OSE: GOGL) (the "Company”) advises that a Special General Meeting of the Company will be held on 26 March 2021 to consider a proposal to increase the Company's authorized share capital. The record date for voting at the Special General Meeting is set to 3 March 2021. The notice, agenda and any associated material will be distributed prior to the meeting. The Board of Directors Golden Ocean Group Limited Hamilton, Bermuda This information is subject of the disclosure requirements pursuant to Euronext Oslo Rule Book II item 4.2.4.

PRESS RELEASE: BIGBEN - DESCRIPTION OF THE SHARE BUY BACK PROGRAMME1.3.2021 18:35:00 CETPress release

Press release Lesquin, 1st March 2021 17:45hrs Description of the share buy back programme authorised by the Combined general meeting of 30 July 2020 and implemented by the Board of directors of 1 March 2021 Bigben Interactive announces the implementation of its share buyback programme authorised by the General Meeting of Shareholders on 30 July 2020. In this respect, the Company has provided an investment services provider, CIC Market Solutions, with a mandate to acquire shares. 1.Legal framework Pursuant to the provisions of Articles L. 225-209 et seq. of the French Commercial Code, Articles 241-1 to 241-7 of the General Regulations of the Autorité des Marchés Financiers (the French Stock Exchange Authority) and EU Regulation No. 596/2014 of the European Parliament and of the European Council of 16 April 2014 on market abuse, the aim of this description is to present the purpose and terms of the Company's share buyback programme. 2. Date of the combined general meeting of shareholder

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER1.3.2021 16:20:00 CETPress release

Bid procedure, 2021-03-03CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2021-09-03 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-02-22 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-03-03Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

RAPALA VMC CORPORATION - NOTICE TO THE ANNUAL GENERAL MEETING1.3.2021 16:00:00 CETPress release

Rapala VMC Corporation Stock Exchange Release March 1, 2021 at 17:00 p.m. RAPALA VMC CORPORATION - NOTICE TO THE ANNUAL GENERAL MEETING Notice is given to the shareholders of Rapala VMC Corporation (“Rapala” or the “Company”) to the Annual General Meeting to be held on Thursday 25 March 2021 starting at 10:00 a.m. (EET) at the address Mäkelänkatu 91, 00610, Helsinki, Finland. The Company’s Board of Directors has resolved on exceptional meeting procedures based on the temporary legislative act to limit the spread of the Covid-19 pandemic (677/2020), which entered into force on 3 October 2020. In order to ensure the health and safety of the shareholders, employees and other stakeholders of the Company, the Annual General Meeting will be organized without shareholders’ and their proxy representatives’ presence at the Annual General Meeting venue. Shareholders can participate in the Annual General Meeting and use their shareholder rights in connection with the Annual General Meeting by vot

Nordic American Tankers Ltd (NYSE: NAT) – Comments on the market – Founder, Chairman & CEO is buying stock again1.3.2021 15:43:20 CETPress release

March 1, 2021 Dear Shareholders and Investors, We released our 2020 numbers last Friday, February 26, 2021. 2020 was a good year. We achieved excellent results for three quarters, whilst the fourth quarter was weak. At this time we clearly see a positive turn in the market for the NAT Suezmaxes. Last week we concluded a spot contract at about USD 20,000 a day and another spot contract at about USD 15,000 a day. A week ago the comparable number was about USD 4,000 a day. Operating costs are covered at USD 8000/day. I would also like to advise you that today I have bought 50,000 shares at USD 3.13. My son, Alexander Hansson and I are among the largest shareholders of NAT. Sincerely, Herbjorn Hansson Founder, Chairman & CEO Nordic American Tankers Ltd. www.nat.bm CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections fo