ProMIS Neurosciences Announces First Quarter 2021 Results
TORONTO and CAMBRIDGE, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS or the Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three months ended March 31, 2021.
In the first quarter of 2021, ProMIS, like much of society, started to emerge from “pandemic lockdown”. Our most important milestone was securing a US $7MM round of financing from a prestigious group of Boston based investors, whose support will allow us to advance our core programs targeting neurodegenerative diseases.
In addition, in collaboration with Dr. David Wishart of the University of Alberta, we have enhanced and extended our unique technology platform. ProMIS Neurosciences has a unique antibody design capability, which not even the largest pharmaceutical companies have to the best of our knowledge based on ongoing discussions with them. We are able rapidly and cost effectively to design and create antibodies or therapeutic vaccines that only target toxic, mis-folded versions of proteins that otherwise play a normal healthy role. This capability has given ProMIS a growing portfolio of potential “best in class” monoclonal antibodies (or corresponding therapeutic vaccines), including our lead program PMN310, targeting toxic oligomers of amyloid in Alzheimer’s. In the Alzheimer’s field, positive results or regulatory steps were announced by Lilly, Cassava, and Biogen, all of which support the science suggesting PMN310 may be “best in class”.
- In January 2021, we announced an outline of our strategic priorities and action plan for 2021. The priorities for 2021 fall into four key areas: near term focus on rare neurodegenerative diseases, especially ALS; use of our proprietary platform to support portfolio expansion; advancement of our PMN310 antibody lead program for Alzheimer’s disease (AD); COVID-19, further progress on serological assays.
- In February 2021, we announced our perspectives on recent progress in the AD field.
- Two important events occurred in January 2021, both of which we consider very positive for the AD field, for the updated amyloid hypothesis and for the Company. The Food & Drug Administration extended the Prescription Drug User Fee Act date for review of Biogen’s aducanumab from March 7 to June 7, 2021. Eli Lilly & Co. announced positive clinical results for their antibody, donanemab, on January 11, 2021, making it the third antibody with positive clinical results in AD, likely due to its targeting of aggregated amyloid-beta (not amyloid monomer). Both these events have positive implications for PMN310.
- In March 2021, we completed a US$7.0 million (CDN$8.75 million) private placement of unsecured convertible debentures (Debentures). The Debentures are convertible into 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.
- Johannes Minho Roth resigned from the ProMIS Board of Directors in February, taking on a senior executive position at UBS Group AG, a Swiss multinational investment bank and financial services company. We thank Johannes for his excellent contributions to the Board and in support of the Company’s progress.
- Michael Grundman, MD, MPH, joins the ProMIS team as senior consultant medical advisor. Dr. Grundman is President and CEO of Global R&D Partners, LLC, a consulting firm that works closely with pharmaceutical and biotechnology companies to develop novel agents for the diagnosis and treatment of serious and life-threatening diseases. Dr. Grundman is Professor of Neurosciences at the University of California San Diego (UCSD). Prior to joining industry, Dr. Grundman was Associate Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California, San Diego (UCSD). He received his BA from New York University magna cum laude with Honors in Biochemistry. He obtained his MD and Neurology training at the Albert Einstein College of Medicine and a Master of Public Health degree from Columbia University.
- Neil K. Warma, MBA, was appointed to the Board of Directors in May 2021. Neil Warma has been a successful healthcare entrepreneur for over 25 years having founded, managed and advised numerous biotech and pharmaceutical companies across the globe. Currently, Mr. Warma is the CEO/General Manager of I-Mab Biopharma U.S., (Nasdaq:IMAB) a publicly traded global biopharmaceutical company with offices and research labs in China (Shanghai, Beijing) and the U.S. (San Diego, Gaithersburg) that focuses on developing and commercializing novel immuno oncology drugs. Previously, as President and CEO of Opexa Therapeutics, a publicly traded biopharmaceutical company, Mr. Warma led the turnaround and rebuilding of the company’s cell therapy platform and oversaw its advance through clinical development in autoimmune and orphan diseases, expansion into China and its eventual merger with Acer Therapeutics. Prior to Opexa, he was CEO of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation.
Results of Operations – Three months ended March 31, 2021 and 2020
Net loss for the three months ended March 31, 2021 was $7,599,417, compared to a net loss of $1,761,919 in the three months ended March 31, 2020. Included in the net loss for the three months ended March 31, 2021 were non-cash expenses of 7,054,543, representing the change in the fair value of an embedded derivative associated with the Debenture financing, reversal of share-based compensation due to the forfeiture of unvested share options, foreign exchange loss, amortization of property and equipment and amortization of an intangible asset, compared to $213,737 for the three months ended March 31, 2020.
Operating loss before non-cash expenses for the three months ended March 31, 2021 was $582,331, as compared to $1,761,919 in the three months ended March 31, 2020. The decrease in the operating loss for the three months ended March 31, 2021 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, share-based compensation due to the forfeiture of unvested share options, contracted salaries and associated costs and general corporate expenditures offset by an increase in professional fees.
Research and development expenses for the three months ended March 31, 2021 were $193,923, as compared to $973,586 in the three months ended March 31, 2020. The decrease in research and development expense for the three months ended March 31, 2021, compared to the same period ended March 31, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, reduced patent expense, share-based compensation due to the forfeiture of unvested share options, contracted research salaries and associated costs and external consulting expense.
General and administrative expenses for the three months ended March 31, 2021 were $388,408, as compared to $788,346 in the three months ended March 31, 2019. The decrease for the three months ended March 31, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated costs, share-based compensation and a decrease in foreign exchange losses expense offset by consulting and professional fees.
Going forward ProMIS will focus on accelerating or re-initiating programs in our core business area, best in class therapeutics for neurodegenerative diseases. In addition, we will continue to expand the application of our unique discovery platform, with which we can “rationally design” antibodies or vaccines to be selective for only mis-folded, pathogenic proteins involved in disease.
In Alzheimer’s we will restart IND enabling work for PMN310, our antibody highly selective for toxic oligomers of amyloid. That selectivity may prove to give PMN310 significant competitive advantages in safety and efficacy over products from Biogen, Lilly, and Eisai that appear to provide benefit slowing the progression of Alzheimer’s disease. In addition, starting with the same proprietary technology that creates selective antibodies (“passive” immunotherapy), we are moving forward our program to create therapeutic vaccines (“active” immunotherapy) targeting toxic oligomers of amyloid. Therapeutic vaccines may be a preferred therapy for Alzheimer’s prevention; the ultimate goal in Alzheimer’s treatment is to detect disease in the ~20 year window before symptoms arise and treat to prevent symptoms of cognitive decline.
In ALS we will advance our program targeting toxic TDP-43 with further in vitro and in vivo validation, and we will build on the significant scientific advances we have made targeting RACK1 (Receptor for A Activated C Kinase 1). We will also further advance our alpha-synuclein program with further in vivo and in vitro validation, targeting diseases like Parkinson’s disease and Multiple System Atrophy.
About ProMIS Neurosciences, Inc.
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its 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 PD. 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.
For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
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.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
One Liberty Plaza - 165 Broadway
NY 10006 New York
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
New Zolgensma data demonstrate age-appropriate development when used presymptomatically and rapid, clinically meaningful efficacy in symptomatic children, even those with severe SMA at baseline18.6.2021 18:30:00 CEST | Press release
All children (100%) treated presymptomatically in the SPR1NT two-copy cohort survived without respiratory or nutritional support, and sat independently for ≥30 seconds, most (11/14) within the WHO window of expected normal development The majority of children (82%) treated in STR1VE-EU achieved developmental motor milestones not observed in the natural history of SMA Type 1, including patients with more severe disease More than 1,200 patients have now been treated with Zolgensma globally across clinical trials, managed access programs, and in the commercial setting1 Basel, June 18, 2021– Novartis today announced data that reinforce the transformational benefit of Zolgensma® (onasemnogene abeparvovec), an essential, one-time treatment and the only gene therapy for spinal muscular atrophy (SMA). New late-breaker data from the completed two-copy cohort of the Phase 3 SPR1NT clinical trial demonstrate age-appropriate milestone development in presymptomatic children with SMA without respira
The results of the private placement of Subordinated Convertible Notes and private placement of Secured Notes of AS PRFoods / transactions with persons connected with the issuer18.6.2021 16:22:48 CEST | Press release
THIS NOTICE IS NOT INTENDED FOR PUBLICATION, ALLOCATION OR TRANSMISSION, IN PART OR WHOLLY, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, OR ELSEWHERE THE DISCLOSURE OR TRANSMISSION OF THIS INFORMATION IS NOT ALLOWED. By a company announcement dated 04.06.2021, AS PRFoods (hereinafter "PRFoods") informed investors that it was conducting an issue of subordinated convertible notes, whereunder PRFoods is to issue up to 350 subordinated convertible notes, with the maximum aggregate nominal value of up to EUR 3,500,000, nominal value of EUR 10,000 per subordinated convertible note, interest rate of 7% per annum and maturity date on 01.10.2025 (hereinafter the “ConvertibleNotes”). The subscription period for the Convertible Notes ended on 14.06.2021. In course of the private placement, investors subscribed for 237 Convertible Notes, with the aggregate nominal value of EUR 2,370,000, i.e. for approximately 67% of the m
CONDITIONS FOR PURCHASES OF CORPORATE BONDS18.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-23BondsBonds issued in SEK by Swedish non-financial undertakings. The following bonds are eligible for delivery: RIKSHEM AB: SE0011452507, 2023-07-18 RIKSHEM AB: SE0011869981, 2023-05-08 EPIROC AB: XS1918042364, 2023-12-06 EPIROC AB: XS2258568778, 2026-05-18 SCANIA CV AB: XS2042641121, 2022-08-22 SCANIA CV AB: XS2332891089, 2023-04-19 AB INDUSTRIVARDEN: SE0011869668, 2022-02-28 AB INDUSTRIVARDEN: SE0012676724, 2023-02-20 SVENSK FASTIGHETS FIN: SE0012194058, 2022-02-28 SVENSK FASTIGHETS FIN: SE0012676872, 2022-09-07 Delivery of a Bond may not occur if the Counterparty has purchased the Bond from the issuer more recently than one month prior to the date of announcement of the Special terms, that is, the purchase may not have taken place after: 2021-05-23Bid date2021-06-23Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0011452507: 30 mln SEK +/-30 mln SEK SE0011869981: 30 mln SEK +/-30 mln SEK XS1918042364: 30 mln SEK
CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS18.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-22BondsKOMMUNINVEST I SVERIGE: 2311. SE0010948240. 2023-11-13 KOMMUNINVEST I SVERIGE: 2505, SE0011414010, 2025-05-12 KOMMUNINVEST I SVERIGE: 2805, SE0015660139, 2028-05-12 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2021-06-22Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)2311: 500 mln SEK +/-250 mln SEK 2505: 1000 mln SEK +/-500 mln SEK 2805: 750 mln SEK +/-350 mln SEK Highest permitted bid volume (corresponding nominal amount)2311: 500 mln SEK per bid 2505: 1000 mln SEK per bid 2805: 750 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-06-24Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383General Terms and ConditionsGeneral Terms and Conditions General Terms and Condition
CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER18.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-23CertificateCommercial 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 2021-12-23 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 2021-06-11 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 date2021-06-23Bid 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
Eolus förvärvar två fullt tillståndsgivna svenska vindkraftsprojekt18.6.2021 16:15:00 CEST | Pressemelding
Hässleholm den 18 juni 2021 Eolus har tecknat avtal med RWE om att förvärva två fullt tillståndsgivna svenska vindkraftsprojekt. Projekten som omfattar 99 MW är lokaliserade i SE3 och Eolus kommer under sommaren att påbörja försäljningsprocessen med ambitionen att teckna avtal med en investerare under hösten 2021. Projekten är belägna i Avesta kommun (Skallberget/Utterberget) och Hedemora kommun (Tjärnäs) och omfattar totalt vardera 74,4 MW och 24,8 MW. Projekten är fullt tillståndsgivna. Eolus kommer under sommaren att påbörja försäljningsprocessen med ambitionen att teckna ett avtal med en investerare under hösten 2021. Planerad driftsättning är under 2023. För ytterligare information kontakta: Per Witalisson, VD, telefon +46 (0)70-265 16 15 Johan Hammarqvist, kommunikationschef, telefon +46 (0)720-50 59 11 Kort om Eolus Eolus Vind är en av Nordens ledande projektörer av vindkraftsanläggningar. Eolus skapar värden i alla led inom ramen för projektutveckling och drift av vindkraftsanl
Eolus acquires two fully permitted wind power projects in Sweden18.6.2021 16:15:00 CEST | Press release
Hässleholm, Sweden, June 18, 2021 Eolus has signed an agreement to acquire two fully permitted wind power projects in Sweden from RWE. The projects located in SE3 totals about 99 MW and Eolus will during summer initiate the sales process with the ambition to sign an agreement with an investor during the autumn of 2021. The projects are located in Avesta municipality (Skallberget/Utterberget) and Hedemora municipality (Tjärnäs) and totals respectively 74.4 MW and 24.8 MW. The projects are fully permitted. Eolus will during the summer initiate the sales process with the ambition to sign an agreement with an investor during the autumn of 2021. Planned commissioning is during 2023. For further information contact: Per Witalisson, CEO, +46 70-265 16 15 Johan Hammarqvist, Head of Communications, +46 720 50 59 11 About Eolus: Eolus Vind AB is one of the leading wind power developers in the Nordics. Eolus is active in the whole value chain from development of green field projects to constructi