TORONTO, ON and
CAMBRIDGE, MA, March 15, 2019 /PRNewswire/ - 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, today announced its
operational and financial results for the year ended December 31, 2018.
"Over the course of the past year, the value of our unique
discovery and development platform was further evidenced as ProMIS
made considerable progress in expanding its portfolio of
opportunities across multiple neurodegenerative diseases", stated
Eugene Williams, ProMIS' Executive
Chairman.
"PMN310, our lead antibody therapeutic candidate for Alzheimer's
disease, showed further significant positive differentiation in
both potential efficacy and safety compared to competitive antibody
therapeutics currently in development. In addition, antibody
candidates selectively targeting toxic forms of alpha-synuclein for
Parkinson's disease and toxic, aggregated forms of TDP43 for
amyotrophic lateral sclerosis (ALS) were identified and further
characterized to support initiation of pharmaceutical partnering
discussions."
Corporate Highlights
- During 2018, we completed private placements providing
aggregate gross proceeds of approximately $7,240,000
- In the course of 2018, we received proceeds from the exercise
of warrants and stock options in the amount of $1,797,640
- Alzheimer's disease (AD) program
-
- In January 2018, our lead product candidate for
Alzheimer's disease, PMN310, showed potential for an improved
safety profile and improved therapeutic potency in head-to-head
comparisons to other amyloid beta- directed antibodies.
- In August 2018, we announced
further evidence supporting potential for an improved safety
profile in direct comparison to other amyloid beta-directed
antibodies in clinical development. PMN310 showed no binding to
amyloid beta (Aβ) plaque in AD brain samples in contrast to BAN2401
(Biogen/Eisai) and aducanumab, which both displayed robust
Aβ plaque reactivity. Binding of therapeutic antibodies to Aβ
deposits in brain tissue, in particular blood vessels, is believed
to underlie the development of ARIA-E (amyloid-related imaging
abnormalities with edema) or brain swelling in treated AD
patients.
- In June 2018, we announced the
initiation of producer cell line development for PMN310, the first
major step in the manufacturing process for therapeutic
antibodies.
- In October 2018, we announced
identification of novel targets on misfolded,
pathological forms of tau. The development of antibody therapeutics
that selectively block these toxic forms of tau constitutes an
exciting approach to treating AD and other neurodegenerative
diseases.
- Parkinson's disease (PD) and ALS programs
-
- In June 2018, we announced
several antibody candidates selectively targeting the aggregated,
toxic forms of alpha-synuclein, implicated in the development and
progression of PD, as well as TDP43 (TAR DNA binding protein),
implicated in the development of ALS.
- In October 2018, the
neuroprotective effect of our antibodies was evaluated on rat
primary dopaminergic neurons injured by exposure to toxic oligomers
of alpha-synuclein, an in vitro model of PD. In the test, several
of our antibodies, selectively targeting toxic forms of
alpha-synuclein, significantly blocked the death of neurons induced
by these toxic forms.
- People
-
- In March 2018, Sharon Cohen, M.D., was appointed to our
Scientific Advisory Board. Dr. Cohen is Medical Director and
Principal Investigator of the Toronto Memory Program, an
independent medical facility for dementia care and research. Her
memory clinic and dementia clinical trials program are the largest
and most active in Canada and have
contributed substantially to patient care and to global clinical
trial cohorts.
- In September 2018, James Kupiec, M.D., was appointed Chief Medical
Officer. Dr. Kupiec is a physician-scientist with over two
decades of broad, hands-on experience in translational, early- and
late-stage neuroscience drug development in the pharmaceutical
industry.
- In December 2018, Rudolph Tanzi, Ph.D., was appointed to our
Scientific Advisory Board. Dr. Tanzi is a renowned neuroscientist
and geneticist with scientific expertise in Alzheimer's disease and
brain health. He serves as Vice-chair of Neurology, Director of the
Genetics and Aging Research Unit, and as a Director of the Henry
and Allison McCance Center for Brain Health at Massachusetts
General Hospital. He is also the Joseph P. and Rose F. Kennedy
Professor of Neurology at Harvard Medical
School.
- In January 2019, we completed a
private placement providing aggregate gross proceeds of
approximately $2,198,800.
Financial Results
Annual Results of Operations
The Company's net loss for the year ended December 31, 2018 was $10,167,050, compared to a net loss of
$6,019,970 for the year ended
December 31, 2017. Included in
the net loss for the year ended December 31,
2018 were non-cash expenses of $1,081,600, representing share-based compensation
and amortization of an intangible asset, compared to $700,953 for the year ended December 31, 2017. The increase in the net
loss for the year ended December 31,
2018 is mainly related to the costs associated with
developing the Company's AD therapeutics program, increased
contracted resources and associated costs, supporting its patent
portfolio, associated general corporate expenditures and higher
share-based compensation.
Research and development expenses for the year ended
December 31, 2018 were $7,409,546, as compared to $3,704,010 in the year ended December 31, 2017. The increase in research and
development expense for the year ended December 31, 2018 is primarily attributed to
higher research program costs for the AD therapeutics program,
increased contracted resources, share-based compensation,
recruiting and travel expense.
General and administrative expenses for the year ended
December 31, 2018 were $2,757,979, as compared to $2,318,752 in the year ended December 31, 2017. The increased
expenditures for 2018 is primarily attributable to increased
investor relations/public relations, salaries and associated costs
and other professional fees, offset by foreign exchange gain on
U.S. dollar denominated expenses decreased legal expense and
share-based compensation.
Outlook
As a prelude to the first PMN310 clinical trial in AD, ProMIS
anticipates using a novel biomarker approach that may show evidence
of slowing of neuronal death early in the development program. To
accomplish this, we plan to initiate a natural history evaluation
of biomarker changes in untreated, early AD patients.
We anticipate potential initial results of the first clinical
trial with PMN310 in late 2020.
The Company will also continue to further characterize the
potential benefits of its programs selectively targeting toxic
aggregates of TDP43 in ALS and toxic forms of alpha-synuclein in PD
to further support on-going pharmaceutical partnering
discussions.
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 platform is based on the use of two complementary
thermodynamic, computational discovery engines -ProMIS and
Collective Coordinates – to predict novel targets known as Disease
Specific Epitopes on the molecular surface of misfolded proteins.
Using this unique precision 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.
Company documents relating to the fiscal year 2018 annual report
can be viewed on the System for Electronic Document Analysis and
Retrieval (SEDAR) at the link below:
https://www.sedar.com/search/search_en.htm
Visit us at www.promisneurosciences.com or follow us
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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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SOURCE ProMIS Neurosciences Inc.