-
Completed all preclinical studies and manufacturing to support
PMN310 IND submission to U.S. Food and Drug Administration
-
Preclinical data that further characterize ongoing programs,
including PMN310, to be presented in 2023
ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a
biotechnology company focused on the generation and development of
antibody therapeutics targeting toxic misfolded proteins in
neurodegenerative diseases such as Alzheimer’s disease (AD),
amyotrophic lateral sclerosis (ALS) and multiple system atrophy
(MSA), today announced its full year 2022 financial results and
recent highlights.
“This year looks to be a pivotal one for ProMIS as we continue
our plans to advance PMN310, our novel Alzheimer’s disease product
candidate, and expect to file our IND within the next 60 days,”
said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS
Neurosciences. “Progressing to the clinical stage of development
will be a significant step toward our goal of delivering a
next-generation therapy to patients with Alzheimer’s disease who
have limited options to slow cognitive decline. In addition, we are
working to advance two discovery programs, PMN267 and PMN442,
towards IND readiness and advancing our amyloid vaccine for AD. We
look forward to sharing data from our ongoing efforts over the
coming months.”
Recent Highlights and Anticipated
Milestones
Alzheimer’s Disease
Program (PMN310)PMN310, ProMIS’s lead compound, is a novel
monoclonal antibody which is highly selective for toxic oligomers
of amyloid-beta that are believed to be a major driver of AD. The
Company has the following updates:
- Progressed preparation of the PMN310 investigational new drug
application (IND), which is expected to be submitted to the U.S.
Food and Drug Administration (FDA) within the next 60 days.
- Completed successful manufacture and packaging of PMN310 drug
product under good manufacturing process (cGMP) for planned
clinical trials.
- Completed non-human primate toxicology and pharmacokinetics
studies, as well as tissue cross-reactivity studies under good
laboratory practice (GLP) conditions to support first-in-human
studies. PMN310 administered as a 30-minute weekly IV
infusion to cynomolgus monkeys at dose levels of up to 1200
mg/kg/day was not associated with any adverse effects. As a human
equivalent dose, 1200 mg/kg/day in the cynomolgus monkey equates to
5 times higher than the planned highest dose for the Phase 1
trials.
- Plans to initiate a Phase 1a clinical trial of PMN310 subject
to the filing and clearance of an IND application with the FDA. The
planned Phase 1a single ascending dose trial in healthy volunteers
will test single doses in the range of approximately 2.5 to 60
mg/kg in adults.
- Plans to share new preclinical data that further characterize
PMN310 at upcoming medical meetings in March and April 2023.
Discovery programs
- ProMIS continues to advance its amyloid-beta vaccine program
with the aim of developing an AD vaccine based on its oligomer
target epitope(s) conjugated to a carrier protein in formulation
with an adjuvant. The Company plans to provide preclinical data on
vaccine optimization studies at a medical meeting in April
2023.
- In April 2022, ProMIS announced the selection of monoclonal
antibody PMN267 directed against misfolded TDP-43 as the lead
candidate for an ALS indication based on its selective binding
profile and activity in cell systems and a mouse model of disease.
PMN267 has been humanized in a human IgG1 framework for future
testing.
- ProMIS has selected monoclonal antibody PMN442 as its
alpha-synuclein antibody lead candidate for MSA based on its
selective binding and protective activity against pathogenic forms
of alpha-synuclein. PMN442 has been humanized in a human IgG1
framework for future testing.
Full Year 2022 Financial
Highlights
- Cash and cash equivalents were $5.9 million as of December 31,
2022, compared to $16.9 million as of December 31, 2021.
- Research and development expenses were $16.1 million for the
year ended December 31, 2022, compared to $4.6 million for the same
period in 2021. The increase is primarily attributable to increased
spending on the PMN310 program as the Company prepares to file an
IND.
- General and Administrative expenses were $7.3 million for the
year ended December 31, 2022, compared to $3.7 million for the same
period in 2021.
- Net loss was $18.1 million for the year ended December 31,
2022, compared to $9.8 million for the same period in 2021.
About ProMIS Neurosciences
Inc.
ProMIS Neurosciences Inc. is a development stage
biotechnology company focused on generating and developing antibody
therapeutics selectively targeting toxic misfolded proteins in
neurodegenerative diseases such as Alzheimer’s disease (AD),
amyotrophic lateral sclerosis (ALS) and multiple system atrophy
(MSA. 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 MSA. ProMIS has offices in
Toronto, Ontario and Cambridge, Massachusetts. ProMIS is listed on
Nasdaq and the Toronto Stock Exchange under the symbol PMN.
Forward-Looking Statements
Neither the TSX nor Nasdaq has reviewed and
neither accepts responsibility for the adequacy or accuracy of this
release. Certain information in this news release constitutes
forward-looking statements and forward-looking information
(collectively, “forward-looking information”) within the meaning
of applicable securities laws. In some cases, but not necessarily
in all cases, forward-looking information can be identified by the
use of forward-looking terminology such as “plans”, “targets”,
“expects” or “does not expect”, “is expected”, “an opportunity
exists”, “is positioned”, “estimates”, “intends”, “assumes”,
“anticipates” or “does not anticipate” or “believes”, or variations
of such words and phrases or state that certain actions, events or
results “may”, “could”, “would”, “might”, “will” or “will be
taken”, “occur” or “be achieved”. In addition, any statements that
refer to expectations, projections or other characterizations of
future events or circumstances contain forward-looking
information. Specifically, this news release contains
forward-looking information relating to targeting of toxic
misfolded proteins that may directly address fundamental AD
pathology (including that toxic oligomers of amyloid-beta are a
major driver of AD) and have greater therapeutic potential due to
reduction of off-target activity, the Company’s intention to file
an IND for PMN310, the initiation of the Company’s first-in-human
study subject to FDA clearance of its IND, and its ability to
enroll the requisite number of patients, dose each patient in the
intended manner, and progress the study, ProMIS’ pipeline,
management’s belief that its patented platform technology has
created an antibody candidate specific to toxic misfolded oligomers
known to be present in Alzheimer’s disease, which may have greater
therapeutic potential due to off-target activity, management’s
anticipated timing of enrollment of the first subject in our Phase
1a trial in the first half of 2023, the progression of earlier
stage antibody candidates for ALS (PMN267) and MSA (PMN442), the
ability to continue its growth and realize the anticipated
contribution of the members of its board of directors and
executives to its operation and progress, the ability to optimize
the impact of its collaborations on its development programs,
statements regarding the timing of regulaotry filings regardings
its development programs, use of capital expenses, future
accumulated deficit and other financial results in the future,
ability to fund operations, the ability to maintain enough
liquidity to execute its business plan and its ability to continue
as a going concern. Statements containing
forward-looking information are not historical facts but
instead represent management's current expectations, estimates and
projections regarding the future of our business, future plans,
strategies, projections, anticipated events and trends, the
economy and other future conditions. Forward-looking information is
necessarily based on a number of opinions, assumptions and
estimates that, while considered reasonable by the Company as of
the date of this news release, are subject to known and unknown
risks, uncertainties and assumptions and other factors that may
cause the actual results, level of activity, performance or
achievements to be materially different from those expressed or
implied by such forward-looking information. Important factors that
could cause actual results to differ materially from those
indicated in the forward-looking information include, among others,
the factors discussed throughout the “Risk Factors” section of the
Company's most recently filed annual information form available on
www.SEDAR.com, and in Item 1A of each of its Form 10 Registration
Statement and its Quarterly Reports on Form 10-Q for the quarters
ended June 30, 2022 and September 30, 2022, each as filed with the
Securities and Exchange Commission. Except as required by
applicable securities laws, the Company undertakes no obligation to
publicly update any forward-looking information, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
PROMIS
NEUROSCIENCES INC.
Consolidated Balance Sheets
(expressed in US dollars, except share
amounts)
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash |
|
$ |
5,875,796 |
|
|
$ |
16,943,905 |
|
Short-term investments |
|
|
31,009 |
|
|
|
33,248 |
|
Prepaid expenses and other current assets |
|
|
996,682 |
|
|
|
737,316 |
|
Total current assets |
|
|
6,903,487 |
|
|
|
17,714,469 |
|
Property and equipment,
net |
|
|
321 |
|
|
|
4,671 |
|
Intangible assets, net |
|
|
20,838 |
|
|
|
27,614 |
|
Total assets |
|
$ |
6,924,646 |
|
|
$ |
17,746,754 |
|
Liabilities and
Shareholders' (Deficit)
Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,975,398 |
|
|
$ |
408,981 |
|
Accrued liabilities |
|
|
3,437,646 |
|
|
|
520,093 |
|
Total current liabilities |
|
|
6,413,044 |
|
|
|
929,074 |
|
Convertible debt, net of
issuance costs and debt discount |
|
|
— |
|
|
|
3,906,057 |
|
Derivative liability |
|
|
— |
|
|
|
5,379,878 |
|
Warrant liability |
|
|
1,859,374 |
|
|
|
1,871,687 |
|
Total liabilities |
|
|
8,272,418 |
|
|
|
12,086,696 |
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
Shareholders' (deficit)
equity: |
|
|
|
|
|
|
Series 1 Convertible Preferred Shares, no par value, 70,000,000
shares authorized, 70,000,000 and 0 shares issued and outstanding
as of December 31, 2022 and December 31, 2021,
respectively |
|
|
— |
|
|
|
— |
|
Common shares, no par value, unlimited shares authorized, 8,579,284
and 7,195,529 shares issued and outstanding as of
December 31, 2022 and 2021, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
79,101,061 |
|
|
|
68,039,178 |
|
Accumulated other comprehensive loss |
|
|
(195,369 |
) |
|
|
(187,919 |
) |
Accumulated deficit |
|
|
(80,253,464 |
) |
|
|
(62,191,201 |
) |
Total shareholders' (deficit)
equity |
|
|
(1,347,772 |
) |
|
|
5,660,058 |
|
Total liabilities and
shareholders' (deficit) equity |
|
$ |
6,924,646 |
|
|
$ |
17,746,754 |
|
PROMIS
NEUROSCIENCES INC.
Consolidated Statements of Operations and
Comprehensive Loss
(expressed in US dollars, except share
amounts)
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
16,087,168 |
|
|
$ |
4,627,386 |
|
General and administrative |
|
|
7,292,744 |
|
|
|
3,663,707 |
|
Total operating expenses |
|
|
23,379,912 |
|
|
|
8,291,093 |
|
Loss from operations |
|
|
(23,379,912 |
) |
|
|
(8,291,093 |
) |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Change in fair value of financial instruments |
|
|
4,176,767 |
|
|
|
(1,095,636 |
) |
Interest expense on convertible debt |
|
|
(282,064 |
) |
|
|
(416,286 |
) |
Gain on extinguishment of convertible debt and derivative
liability |
|
|
1,307,421 |
|
|
|
— |
|
Other income |
|
|
115,525 |
|
|
|
12,909 |
|
Total other income (expense), net |
|
|
5,317,649 |
|
|
|
(1,499,013 |
) |
|
|
|
|
|
|
|
Net loss |
|
|
(18,062,263 |
) |
|
|
(9,790,106 |
) |
Other comprehensive loss |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(7,450 |
) |
|
|
(137,188 |
) |
Comprehensive loss |
|
$ |
(18,069,713 |
) |
|
$ |
(9,927,294 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(2.41 |
) |
|
$ |
(1.69 |
) |
|
|
|
|
|
|
|
Weighted-average shares
outstanding of common shares, basic and diluted |
|
|
7,502,609 |
|
|
|
5,785,617 |
|
For further information: Visit us at
www.promisneurosciences.com
Please submit media inquiries to
info@promisneursciences.com.
For Investor Relations, please contact: Stern
Investor RelationsSuzanne Messere, Managing
Directorsuzanne.messere@sternir.com Tel. 212 698-8801
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