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 first quarter 2023 financial results and
recent highlights.
“In the first quarter, we completed the required steps that
enabled us to file our PMN310 IND in April in order to advance
PMN310 toward the clinic. Last week, we announced that the FDA
cleared our IND for PMN310 in Alzheimer’s disease, which is an
exciting milestone for ProMIS,” said Gail Farfel, Ph.D., Chief
Executive Officer of ProMIS Neurosciences. “Additionally, we
presented key data on PMN310, as well as data supporting an
amyloid-beta vaccine candidate in Alzheimer’s and a new target for
ALS treatment at neurology conferences in March. We look forward to
progressing our programs through the rest of 2023.”
Recent Highlights
Alzheimer’s Disease
Program (PMN310)PMN310, ProMIS’ 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:
- Received clearance from the U.S. Food and Drug Administration
(FDA) for its Investigational New Drug (IND) application for PMN310
for the treatment of AD.
- Presented in vitro preclinical data in which PMN310
demonstrated greater selectivity for target toxic oligomers
compared to other amyloid-beta (Aβ)-directed antibodies, at the
International Conference on Alzheimer’s and Parkinson’s Disease and
Related Neurological Disorders (AD/PD 2023).
- Presented PMN310 preclinical dataset including data showing
PMN310 protected memory function in two rodent models of AD at the
75th American Academy of Neurology (AAN) Annual Meeting.
Discovery
Programs
- ProMIS continues to advance its amyloid-beta vaccine program in
AD based on its oligomer target epitope(s) and gave a platform
presentation on results from mouse vaccination studies at the AAN
Annual Meeting.
- The Company presented preclinical data supporting the receptor
of activated C-kinase 1 (RACK1) as a potential target in ALS and
frontotemporal lobar degeneration with TDP-43-immunoreactive
pathology (FTLD-TDP) at the AAN Annual Meeting.
- Johanne Kaplan, Ph.D., ProMIS’ Chief Development Officer will
chair the upcoming ALS Drug Development Summit taking place on May
16-18 in Boston.
First Quarter
2023 Financial
Highlights
- Cash and cash equivalents were $3.3 million as of March 31,
2023, compared to $5.9 million as of December 31, 2022.
- Research and development expenses were $3.5 million for the
quarter ended March 31, 2023, compared to $1.9 million for the same
period in 2022. The increase was primarily attributable to
increased spending on PMN310 to finalize drug product manufacturing
and costs to complete the IND filing.
- General and administrative expenses were $1.4 million as of
March 31, 2023, compared to $2.0 million for the same period in
2022.
- Net loss was $5.0 million for the quarter ended March 31, 2023,
compared to $2.1 million for the same period in 2022.
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), an
alpha-synucleinopathy. The Company’s proprietary target discovery
engine applies a 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 the Company believes may directly address
fundamental AD pathology (including the belief and understanding
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 initiation of the Company’s first-in-human study in
2023 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, the progression of earlier stage antibody candidates
for ALS (PMN267) and MSA (PMN442), the timing and significance of
presentations related to data, 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 regulatory
filings regarding 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, including, but not
limited to, the Company’s ability to fund its operations and
continue as a going concern, its accumulated deficit and the
expectation for continued losses and future financial results.
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, in Item 1A of its
Annual Report on Form 10-K for the year ended December 31, 2022 and
the section entitled “Risk Factors” in its Post-Effective Amendment
No. 1 to Form S-1, filed March 17, 2023, 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)
| |
|
|
|
|
|
|
|
| |
|
March 31, |
|
December 31, |
|
| |
|
2023 |
|
|
2022 |
|
|
| Assets |
|
|
|
|
|
|
|
| Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
3,331,801 |
|
|
$ |
5,875,796 |
|
|
|
Short-term investments |
|
|
31,134 |
|
|
|
31,009 |
|
|
|
Prepaid expenses and other current assets |
|
|
1,045,671 |
|
|
|
996,682 |
|
|
|
Total current assets |
|
|
4,408,606 |
|
|
|
6,903,487 |
|
|
| Property and equipment,
net |
|
|
— |
|
|
|
321 |
|
|
| Intangible assets, net |
|
|
19,668 |
|
|
|
20,838 |
|
|
| Total assets |
|
$ |
4,428,274 |
|
|
$ |
6,924,646 |
|
|
| Liabilities and
Shareholders' (Deficit) Equity |
|
|
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,987,026 |
|
|
$ |
2,975,398 |
|
|
|
Accrued liabilities |
|
|
1,718,573 |
|
|
|
3,437,646 |
|
|
|
Total current liabilities |
|
|
8,705,599 |
|
|
|
6,413,044 |
|
|
| Warrant liability |
|
|
1,901,722 |
|
|
|
1,859,374 |
|
|
| Total liabilities |
|
|
10,607,321 |
|
|
|
8,272,418 |
|
|
| |
|
|
|
|
|
|
|
| Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
|
| Shareholders' deficit: |
|
|
|
|
|
|
|
|
Series 1 Convertible Preferred Shares, no par value, 70,000,000
shares authorized, 70,000,000 shares issued and outstanding as of
March 31, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
|
|
Common shares, no par value, unlimited shares authorized, 8,579,284
shares issued and outstanding as of March 31, 2023 and
December 31, 2022 |
|
|
— |
|
|
|
— |
|
|
|
Additional paid-in capital |
|
|
79,233,571 |
|
|
|
79,101,061 |
|
|
|
Accumulated other comprehensive loss |
|
|
(199,723 |
) |
|
|
(195,369 |
) |
|
|
Accumulated deficit |
|
|
(85,212,895 |
) |
|
|
(80,253,464 |
) |
|
| Total shareholders'
deficit |
|
|
(6,179,047 |
) |
|
|
(1,347,772 |
) |
|
| Total liabilities and
shareholders' deficit |
|
$ |
4,428,274 |
|
|
$ |
6,924,646 |
|
|
PROMIS
NEUROSCIENCES INC.
Consolidated Statements of Operations and
Comprehensive Loss
(expressed in US dollars, except share
amounts)
| |
|
|
|
|
|
|
|
| |
|
March 31, |
|
March 31, |
|
| |
|
2023 |
|
|
2022 |
|
|
| Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,510,252 |
|
|
$ |
1,902,832 |
|
|
|
General and administrative |
|
|
1,460,419 |
|
|
|
2,035,686 |
|
|
|
Total operating expenses |
|
|
4,970,671 |
|
|
|
3,938,518 |
|
|
| Loss from operations |
|
|
(4,970,671 |
) |
|
|
(3,938,518 |
) |
|
| |
|
|
|
|
|
|
|
| Other income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of financial instruments |
|
|
(41,665 |
) |
|
|
1,980,672 |
|
|
|
Interest expense on convertible debt |
|
|
— |
|
|
|
(147,773 |
) |
|
|
Other income |
|
|
52,905 |
|
|
|
10,774 |
|
|
|
Total other income (expense), net |
|
|
11,240 |
|
|
|
1,843,673 |
|
|
| |
|
|
|
|
|
|
|
| Net loss |
|
|
(4,959,431 |
) |
|
|
(2,094,845 |
) |
|
| Other comprehensive loss |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(4,354 |
) |
|
|
47,841 |
|
|
| Comprehensive loss |
|
$ |
(4,963,785 |
) |
|
$ |
(2,047,004 |
) |
|
| |
|
|
|
|
|
|
|
| Net loss per share, basic and
diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.29 |
) |
|
| |
|
|
|
|
|
|
|
| Weighted-average shares
outstanding of common shares, basic and diluted |
|
|
8,579,284 |
|
|
|
7,195,529 |
|
|
For further information: Visit us at
www.promisneurosciences.com
For Investor Relations, please contact: Stern
Investor RelationsSuzanne Messere, Managing
Directorsuzanne.messere@sternir.comTel. 212 698-8801
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