TORONTO, March 23, 2016 /CNW/ - ProMIS Neurosciences, Inc. announces today its operational and financial results for the year ended December 31, 2015, as well as the financial results for the fourth quarter.
Recent Corporate Highlights
As described below, highlights for the quarter ended December 31, 2015 were the expansion of the exclusive worldwide license agreement with the University of British Columbia (UBC), the acquisition of the license for Collective Coordinates technology for the identification of novel therapeutic targets for neurodegenerative disease, and the identification and provisional patent filing of the Company's first novel Alzheimer's therapeutic target (epitope) on misfolded strains of Amyloid beta.
Subsequent to year end, the Company announced the identification and provisional patent filing of two additional novel therapeutic targets (epitopes) on misfolded strains of Amyloid beta, initiated the validation process that will seek to demonstrate the lead monoclonal antibody (mab) products selectively bind to these newly identified epitopes, and announced a private placement offering of common shares to fund this work.
On October 8, 2015, the Company announced that it had entered into an exclusive license agreement to develop and commercialize intellectual property rights belonging to UBC, expanding upon the original agreement from February 2009, and affording exclusive worldwide rights to intellectual property based on use of the ProMIS™ technology, modifications and enhancements to ProMIS™, as well as eventual new technologies under development.
On November 11, 2015, the Company announced that it had acquired a worldwide license to Collective Coordinates, a method to predict novel therapeutic targets in Alzheimer's and other neurodegenerative diseases.
On November 12, 2015, the Company announced that it had acquired from UBC an exclusive, worldwide license to a novel Alzheimer's disease (AD) target (epitope) identified using the Collective Coordinates technology.
On February 3, 2016, the Company announced the identification of a second, distinct AD target (epitope) on misfolded strains of Amyloid beta, acquired pursuant to its expanded license agreement with UBC.
On February 23, 2016, the Company announced that it is offering on a private placement basis up to 16,666,667 shares at a price of $0.06 per share for gross proceeds of up to CDN $1,000,000. The Company will pay finders' fees of 7% on a portion of the proceeds of the Offering.
The primary use of proceeds will be to validate and optimize the several lead mab products (up to six) ProMIS is developing against different strains of misfolded Amyloid beta (Aβ) in Alzheimer's and Down's syndrome. The program will seek to validate that the lead products selectively bind to the neurotoxic prion, or oligomeric form of Aβ, which the Company believes is the target product profile for successful precision therapies in these deadly diseases. The validation, done in part with cadaveric brain tissue of patients who died with diagnosed Alzheimer's, will also be used to support and enhance ProMIS's patent estate.
On March 18, 2016, the Company announced that it has identified a third novel potential therapeutic target on strains of misfolded Amyloid beta, implicated in the development and progression of AD. In addition, the Company announced that it has initiated the validation process by starting to raise the specific monoclonal antibodies against the multiple targets identified. The validation program is designed to select mabs for drug development that bind selectively and specifically to the neurotoxic, propagating strains of misfolded Amyloid beta.
Commenting on the recent Corporate Highlights, the Company's Executive Chairman, Eugene William stated: "Following on from the successful private placement in July 2015, we have consolidated our science team and significantly expanded our exclusive license agreement with the University of British Columbia. Importantly, we have identified multiple targets believed to be specific for the toxic, propagating strains of misfolded Amyloid beta. Having laid the groundwork for the re-launch of the Company, we are now excited to enter the next phase of the Company's progress as we look forward to validating and selecting mabs for development of precision medicine therapeutics for Alzheimer's disease."
Annual Results of Operations
Effective October 3, 2014, the Company changed its fiscal year end from March 31 to December 31. As a result of that change the current period is for the twelve-month period ended December 31, 2015 while the prior year comparative period is for the nine-month period ended December 31, 2014 and therefore, is not directly comparable to the current twelve-month period.
Since inception, the Company has incurred losses while advancing the research and development of its diagnostic and therapeutic technologies. The net loss for the year ended December 31, 2015 was $2,120,954 as compared to the net loss of $2,141,439 the nine-month period ended December 31, 2014.
For the year ended December 31, 2015, revenue from services and sales were $19,935 as compared with revenues from services and sales of $ 48,205 for the nine-month period ended December 31, 2014. Revenue for both periods relate to the Company's Alzheimer's diagnostic tests. In addition, the Company recognized $209,578 in contract research revenue for the nine-month period ended December 31, 2014. This research project was completed in December, 2014 and no further revenue will be recognized related to this collaboration.
Research and development expenses for the year ended December 31, 2015 were $1,060,142 as compared to $1,318,294 in the nine-month period ended December 31, 2014. Excluding share-based payment expenses of $361,142 for the year ended December 31, 2015 and $155,161, in the comparative period, cash based expenditures were $699,000 for the current year as compared with $1,163,333 in the nine-month period ended December 31, 2014. Share based payment expenses are higher in the current year as compared to the prior nine-month period as a result of the higher number of options granted in the current year resulting in a higher grant date fair value being recognized as expense in the current year as compared to prior period.
The decrease in research and development expenses reflects the lower salaries, fees and short term benefits and lower non-salary program expenses that resulted from the closing of the Company's research facility in Mississauga, Ontario in January, 2015. Salaries expenses were lower due to the lower headcount and program costs were lower as a result of the Alzheimer's diagnostic and cancer therapeutic programs which were put on hold. This decrease is offset slightly by the initiation of Alzheimer's therapeutics program in the current year.
General and administrative expenses for the year ended December 31, 2015 were $946,765 as compared with $1,080,928 for the nine-month period ended December 31, 2014. Excluding share-based payment expenses of $196,105 for the year ended December 31, 2015 and $524,085, in the comparative period, cash based expenditures were $750,660 for the current year as compared with $556,843 in the nine- month period ended December 31, 2014.
The increase in general and administrative expenditures reflects higher expenses for salaries, higher professional fees and higher investor relations and filing fees, and are a result of comparing a twelve-month period in the current year to a nine-month period in the comparative year. Share based payment expenses is lower in the current year as compared to the prior nine-month period mostly due to the fact that stock option compensation for the current year reflects expense related to stock options of which the majority were granted in the last fiscal quarter, whereas in the comparative period, the compensation reflected stock options that were granted earlier in the nine-month period and therefore covered a longer service period.
In January 2015, the Company announced that it was closing its research facilities at its Mississauga, Ontario operations. Related to this announcement, the Company recorded a restructuring provision in the amount of $110,000. The restructuring costs were mostly for an onerous lease for the vacated lab space.
Results of Operations – Three months ended December 31, 2015 and 2014
The net loss for the three months ended December 31, 2015 was $699,785 compared to a net loss of $521,617 for the three months ended December 31, 2014. The increased net loss in the current period results mainly from higher stock option compensation and higher investor relations expenses and offset by lower salaries expense.
There was no revenue recognized in the current period. For the three months ended December 31, 2014 revenue was $63,738, which was mostly related to a research project that was completed in the prior period.
Research and development expenses for the three months ended December 31, 2015 were $348,719 as compared to $355,916 in the three month ended December 31, 2014. In the current period, salaries were lower related to the closure of the facility in January of 2015. This was offset by higher stock option compensation than in the comparable period last year, a non cash item.
General and administrative expenses for the three months ended December 31, 2015 were $344,814 as compared to $229,439 in the three months ended December 31, 2014. Excluding share-based payment expenses of $104,488 for the three months ended December 31, 2015 and $47,906, in the comparative period, cash based expenditures were $240,325 for the current period as compared with $181,533 in the comparative period.
The increased expenses in the current period resulted mainly from higher investor relations expenses and by higher stock option compensation.
The Company had working capital of $523,111 as at December 31, 2015. At present, the Company's cash resources are expected to be fully depleted in the second quarter of fiscal 2016.
The Company's priorities for the next year are to focus on identifying and developing precision medicine therapeutics for AD and ALS.
Regarding AD, the Company will continue to expand its Intellectual Property (IP) estate by identifying novel epitope targets on misfolded strains of proteins Amyloid beta and Tau. The Company's complementary proprietary techniques, ProMISTM and Collective Coordinates, will be employed to identify and confirm such novel targets.
As recently announced on March 18th, the Company has initiated the validation process by starting to raise the specific monoclonal antibodies ("mabs") against the multiple targets identified. The validation program is designed to select mabs for drug development that bind selectively and specifically to the toxic, propagating strains of Amyloid beta. Subsequent to such validation, the Company will be in a position to use the mab(s) with the desired target profile for development of precision therapeutic product(s) for AD.
Regarding ALS, and given the Company's robust IP estate, in particular relating to misfolded SOD1 in ALS, ProMIS Neurosciences is actively looking to achieve a collaborative development partnership in this field.
Additional information about the Company, including the MD&A and financial results may be found on SEDAR at www.sedar.com.
About ProMIS Neurosciences, Inc.
The mission of ProMIS Neurosciences is to discover and develop precision medicine therapeutics for the early detection and effective treatment of neurodegenerative diseases, in particular Alzheimer's disease and ALS.
ProMIS Neurosciences' 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 (DSEs) on the molecular surface of misfolded proteins. Using this unique "precision medicine" approach, ProMIS Neurosciences aims to develop novel antibody therapeutics and specific companion diagnostics for Alzheimer's disease and ALS. The company has also developed two proprietary technologies to specifically identify very low levels of misfolded proteins in a biological sample. In addition, ProMIS Neurosciences owns a portfolio of therapeutic and diagnostic patents relating to misfolded SOD1 in ALS, and currently has a preclinical monoclonal antibody therapeutic against this target.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release may contain 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.
For further information, please consult the Company's website at: www.promisneurosciences.com,
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