TORONTO and CAMBRIDGE, Mass., Nov. 12, 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 and nine months ended September 30, 2021.
“We are pleased to be ramping up our efforts to advance our lead asset, PMN 310, closer toward the clinic,” said Gene Williams, ProMIS’ Chairman and CEO. “The financing we secured earlier this year is enabling us to unlock the potential of our platform, which we believe could have significant impact on the treatment of several neurological diseases, including Alzheimer’s Disease (AD), Parkinson’s Disease and ALS. The strengthening of our management team and Board this quarter has also enabled us to leverage worldwide development and patent expertise and strengthen our overall competitive position.”
Corporate Highlights
People
On October 22, 2021, the Company announced the expansion of its senior management team. The following changes were announced:
Financial Results
Results of Operations – Three months ended September 30, 2021 and 2020
The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020:
Three Months Ended | ||||||||||||
September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Revenues | $ | 5,101 | $ | - | $ | 5,101 | ||||||
Operating expenses | ||||||||||||
Research and development | $ | 1,192,865 | $ | 1,053,769 | $ | 139,096 | ||||||
General and administrative | 852,695 | 510,264 | 342,431 | |||||||||
Total operating expenses | 2,045,560 | 1,564,033 | 481,527 | |||||||||
Loss from operations | 2,040,459 | 1,564,033 | 476,426 | |||||||||
Other income | (1,078,483 | ) | - | (1,078,483 | ) | |||||||
Net loss | $ | 961,976 | $ | 1,564,033 | $ | (602,057 | ) |
Research and Development
Research and development expenses consist of the following:
Three Months Ended | ||||||||||||
September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Direct research and development expenses by program: | $ | 590,940 | $ | 390,917 | $ | 200,023 | ||||||
Indirect research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 218,210 | 488,888 | (270,678 | ) | ||||||||
Consulting expense | 180,604 | 73,885 | 106,719 | |||||||||
Patent expense | 187,734 | 98,411 | 89,323 | |||||||||
Amortization expense | 15,377 | 1,668 | 13,709 | |||||||||
Total research and development expenses | $ | 1,192,865 | $ | 1,053,769 | $ | 139,096 |
The increase in research and development expense for the three months ended September 30, 2021, compared to the three months ended September 30, 2020, is primarily attributed to increased costs associated with external contract research organizations for internal programs of $200,023 as the company ramps up key internal programs, increased patent expense of $89,323 due to increased maintenance fees, increased outside consultants of $106,719 and increase in amortization of property and equipment and intangible asset of $13,709 offset by decreased contracted research salaries and associated costs of $247,792 due to reduction in compensation to management and attrition of contract staff and decreased share-based compensation of $22,886 due to the forfeiture of share options.
General and Administrative
General and administrative expenses consist of the following:
Three Months Ended September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Personnel related (including stock-based compensation) | $ | 374,055 | $ | 242,571 | $ | 131,484 | ||||||
Professional and consulting fees | 470,493 | 337,446 | 133,047 | |||||||||
Facility-related and other | 8,147 | (69,753 | ) | 77,900 | ||||||||
Total general and administrative expenses | $ | 852,695 | $ | 510,264 | $ | 342,431 |
The increase for the three months ended September 30, 2021, compared to the three same period in 2020, is primarily attributable to by an increase in share-based compensation of $212,237 due to the grant of share options, increased legal expense of $52,959, increased to other professional fees of $150,162 and foreign exchange losses of $88,451 due to the foreign exchange on U.S. denominated assets and liabilities offset by a reduction in contracted corporate salaries and associated facility costs of $91,304 due to reduction in compensation to management and attrition of contracted staff and decreased investor relations of $70,074 due to scale down of investor relations activities and consultants
Other Income
The increase in other income is primarily the change in the fair value of the derivative liability associated with the convertible debenture financing warrant liability arising from the August 2021 financing.
Results of Operations – Nine months ended September 30, 2021 and 2020
The following table summarizes our results of operations for the nine months ended September 30, 2021 and 2020:
Nine Months Ended | ||||||||||||
September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Revenues | $ | 5,101 | $ | 1,578 | $ | 3,523 | ||||||
Operating expenses | ||||||||||||
Research and development | 2,451,985 | 2,926,242 | (474,257 | ) | ||||||||
General and administrative | 1,554,509 | 2,051,506 | (496,997 | ) | ||||||||
Total operating expenses | 4,006,494 | 4,977,748 | (971,254 | ) | ||||||||
Loss from operations | 4,001,393 | 4,976,170 | (974,777 | ) | ||||||||
Other expense | 4,857,346 | - | 4,857,346 | |||||||||
Net loss | $ | 8,858,739 | $ | 4,976,170 | $ | 3,882,569 |
Research and Development
Research and development expenses consist of the following:
Nine Months Ended | ||||||||||||
September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Direct research and development expenses by program: | $ | 1,173,873 | $ | 885,179 | $ | 288,694 | ||||||
Indirect research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 476,161 | 1,566,083 | (1,089,922 | ) | ||||||||
Consulting expense | 370,052 | 176,898 | 193,154 | |||||||||
Patent expense | 386,018 | 293,078 | 92,940 | |||||||||
Other operating costs | 45,881 | 5,004 | 40,877 | |||||||||
Total research and development expenses | $ | 2,451,985 | $ | 2,926,242 | $ | (474,257 | ) |
The decrease in research and development expense for the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020, reflects the conservation of cash resources and decreased contract salaries and associated costs of $921,576 due to reduction in compensation to management and attrition of contracted staff and decreased share-based compensation of $168,346 due to forfeiture of unvested/vested share options due to termination of consulting arrangement offset by increased costs associated with external contract research organizations for internal programs of $288,694 as the company ramps up key internal programs, increased patent expense of $92,940 due to increased maintenance fees, increased consulting expense of $193,154 and increase in amortization of property and equipment and intangible asset of $40,877.
General and Administrative
General and administrative expenses consist of the following:
Nine Months Ended September 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Personnel related (including stock-based compensation) | $ | 802,356 | $ | 910,769 | $ | (108,413 | ) | |||||
Professional and consulting fees | 950,285 | 1,083,745 | (133,460 | ) | ||||||||
Facility-related and other | (198,132 | ) | 56,992 | (255,124 | ) | |||||||
Total general and administrative expenses | $ | 1,554,509 | $ | 2,051,506 | $ | (496,997 | ) |
The decrease for the nine months ended September 30, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated facility costs of $342,084 due to reduction in compensation to management and attrition of contracted staff, decreased investor relations of $451,033 due to a reduction of investor relation activities and consultants and foreign exchange gains of $204,561 on U.S. denominated assets and liabilities offset by increased legal expense of $152,531, increased other professional fees of 165,042 and increased share-based compensation of $183,108, related to the grant of share options.
Other Expense
The increase in other expense is primarily the valuation of the derivative liability associated with the convertible debenture financing.
Outlook
Going forward we will focus on therapeutic programs in our core business area of differentiated antibodies for neurodegenerative and other mis-folded protein diseases.
PMN310, ProMIS antibody therapy selective for toxic oligomers in Alzheimer’s disease, is our highest priority. In Q3, we made significant progress, in line with plans, on all the program elements discussed in the prospectus supplement in August 2021, including cell line development, GLP toxicology work, and CMC manufacturing. We are on track to complete all IND enabling work in H2 2022.
The top priority for our scientific validation efforts, largely centered in Dr. Neil Cashman’s lab at UBC, is currently our ALS portfolio. This portfolio includes antibodies targeting mis-folded forms of TDP-43, RACK1, SOD1, and ataxin2. The most advanced of these is the program targeting TDP-43. We have initiated both in vitro assays (assessing the impact of drug on motor neuron cell lines) and in vivo (mouse model) assays and expect readouts over the next several months.
In addition, we are continuing to expand the application of our unique discovery platform, with which we can “rationally design” antibodies to be selective for only mis-folded, pathogenic proteins involved in disease. Our Chief Physics Officer, David Wishart, and his team are pursuing multiple novel targets. We have acquired access to the AlphaFold database of over 300,000 normal protein conformations, which is the starting point for our predictions of conformational epitopes on mis-folded molecular species using our proprietary computational algorithm Collective Coordinates.
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.
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn
For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
[email protected]
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.
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