ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage
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 financial results for the second quarter
ended June 30, 2024 and provided a corporate update.
“We are coming off a very important and successful few months
for ProMIS as we reported positive top-line Phase 1a data and
closed on a strong financing, which could bring in up to $122.7
million to support our Alzheimer’s candidate and pipeline
compounds,” said Neil Warma, CEO of ProMIS Neurosciences.
“We believe these events have transformed ProMIS and now place
us at the forefront of companies developing therapies for dementia,
as we advance one of the most promising candidates in the clinic
for Alzheimer’s disease. Top-line data from the first four of five
cohorts in the Phase 1a clinical trial showed PMN310 to be
generally safe and well-tolerated and, importantly, showed that
PMN310 crossed into the central nervous system in quantities
suggesting we may see potential target engagement in the upcoming
Phase 1b clinical study.”
“Given that PMN310 is designed to bind only to toxic oligomeric
forms of amyloid beta and to avoid any binding to amyloid beta
plaque, we do not expect to see elevated levels of swelling or
bleeding of the brain known as ARIA, a serious side effect that has
been associated with almost all of the plaque-binding drugs on the
market and in development. The apparent selectivity of PMN310 could
potentially differentiate it significantly in its efficacy and
safety profile as it continues through clinical development in an
upcoming Phase 1b trial. This randomized, placebo controlled,
double blind clinical trial is expected to enroll 100 patients and
will not only evaluate critical biomarkers and incidence of ARIA
but will also extend for 12 months to enable us to measure
important clinical endpoints. The trial design is particularly
robust and comprehensive for a Phase 1b study, in order to validate
PMN310’s significant differentiation on efficacy and safety. We are
excited to be moving quickly to initiate this clinical study in the
coming months,” added Mr. Warma.
Recent Highlights
Alzheimer’s Disease Program (PMN310)
ProMIS’ lead candidate, PMN310, is a humanized IgG1 antibody
directed toward toxic amyloid-beta (Ab) oligomers (AβO) that are
believed to be a major driver of Alzheimer’s disease (AD).
- The Phase 1a clinical trial was a randomized, double-blind,
placebo-controlled trial evaluating the safety and tolerability of
PMN310 in healthy normal volunteers (NCT06105528). The trial
consisted of five single-ascending dose (SAD) cohorts and was
designed to evaluate the safety, tolerability, and pharmacokinetics
(PK), of intravenous doses of PMN310. The trial completed
enrollment of all 40 subjects across 2 active sites in the United
States. The trial was initiated based on encouraging nonclinical
studies of PMN310 that support the selective targeting of
AβOs.
- In July 2024, ProMIS reported positive data from the first four
cohorts in its first-in-human Phase 1a clinical trial of PMN310 in
healthy volunteers. PMN310 was well-tolerated through the first
four SAD dose cohorts (2.5, 5, 10, 20 mg/kg), with no
treatment-emergent serious adverse events (SAEs) observed after
administration of PMN310. Cerebrospinal fluid (CSF) was collected
on days 3 and 29 after PMN310 administration. Tests showed that the
levels of PMN310 in the CSF increased proportionally with the
dosage on both days 3 and 29. Even at the lowest dose, PMN310
appeared to be present at over 100 times the concentration of the
oligomers in the CNS. The half-life of PMN310 in CSF was
approximately 25 days, which is supportive of once per month
dosing.
- The Company expects to report topline results from all five
cohorts in the second half of 2024 and to present the full dataset
at an upcoming medical meeting.
ProMIS continues to advance its amyloid beta vaccine program in
AD based on its oligomer target epitope(s).
- In July 2024, the Company presented preclinical data in a
poster at the Alzheimer’s Association International Conference
(AAIC), which took place from July 29-August 1, 2024 in
Philadelphia. The poster titled, “Novel approach to optimization of
Alzheimer’s vaccine configuration for maximal targeting of toxic
amyloid-beta oligomers,” highlighted data demonstrating that
maximal reactivity was observed with immune IgG against the
monovalent vaccine containing epitope 301, the target of PMN310,
the Company’s clinical-stage monoclonal antibody.
Amyotrophic Lateral Sclerosis Disease Program
(PMN267)
PMN267 is a humanized IgG1 antibody directed against toxic
misfolded TDP-43 as a potential therapeutic target for ALS.
- In August 2024, ProMIS announced the publication of two papers
highlighting the role of toxic misfolded superoxide dismutase-1
(SOD1) aggregates in the pathogenesis of ALS. One paper published
in Acta Neuropathologica is titled, “Seeding activity of human
superoxide dismutase 1 aggregates in familial and sporadic
amyotrophic lateral sclerosis postmortem neural tissues by
real-time quaking-induced conversion,” and the other publication in
the online journal, Open Biology, is titled, “Amyloidogenic regions
in beta-strands II and III modulate the aggregation and toxicity of
SOD1 in living cells.” The Acta Neuropathologica publication can be
accessed here, and the Open Biology publication can be accessed
here.
- In April 2024, the Company announced the publication of
supportive preclinical data for PMN267 as a potential therapeutic
agent for ALS in the Journal of Biological Chemistry in an article
titled, “Tryptophan residues in TDP-43 and SOD1 modulate the
cross-seeding and toxicity of SOD1." The publication can be
accessed here.
Corporate
- In July 2024, ProMIS completed a private investment in public
equity (PIPE) financing that will provide up to $122.7 million in
gross proceeds, which includes an initial upfront funding of $30.3
million and up to $92.4 million tied to exercise of warrants based
on the Company achieving certain milestones, with certain of the
warrants being subject to shareholder approval. The PIPE financing
included participation from new and existing healthcare specialist
investors such as Great Point Partners, LLC, Armistice Capital,
Ally Bridge Group, Sphera Healthcare, and other institutional and
individual accredited investors. Proceeds from the private
placement are expected to be used to advance the clinical
development of PMN310, as well as for working capital and other
general corporate expenses.
Second Quarter 2024 Financial Highlights
- Cash and cash equivalents were $1.0 million as of June 30,
2024, compared to $12.6 million as of December 31, 2023. Following
the close of the quarter, in July 2024, the Company completed a
PIPE financing that provided initial upfront funding of $30.3
million and which has the potential to provide an addition $92.4
million tied to exercise of warrants based on the Company achieving
certain milestones, with certain of the warrants being subject to
shareholder approval.
- Research and development expenses were $1.6 million for the
three-months ended June 30, 2024, compared to $1.0 million for the
same period in 2023, primarily attributable to a $0.9 million
increase in direct research and development expenses related to
PMN310 Phase 1a clinical trial costs, offset by a decrease of $0.2
million in consulting expenses.
- General and administrative expenses decreased to $1.1 million
for the quarter ended June 30, 2024, compared to $1.9 million for
the same period in 2023, which included one-time costs of $0.8
million related to expensing previously deferred financing
costs.
- Net loss was $2.6 million for the quarter ended June 30, 2024,
compared to a net loss of $2.3 million for the same period in
2023.
About ProMIS Neurosciences
Inc.
ProMIS Neurosciences Inc. is a clinical 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 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 Cambridge,
Massachusetts and Toronto, Ontario.
Forward-Looking Statements
Nasdaq has not reviewed and does not accept 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”, “excited about”, “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 the announcement of results of all five
cohorts of the Company’s Phase 1a study, plans to advance PMN310
into a Phase 1b MAD study in AD patients and expectations of such
study results, the potential for such studies to provide the first
proof-of-concept data for PMN310, the potential that PMN310 has the
potential to positively benefit patients with AD, the targeting of
toxic misfolded proteins in neurodegenerative diseases that the
Company believes may directly address fundamental AD pathology
(including the belief and understanding that toxic oligomers of Aβ
are a major driver of AD) and have greater therapeutic potential
due to reduction of off-target activity, a computationally-derived
Aβ vaccine for AD and the Company’s PMN310 antibody and vaccine
candidate, management’s belief that its patented platform
technology has created an antibody candidate specific to toxic
misfolded oligomers known to be present in AD, therapeutic activity
and preferential targeting of toxic soluble aggregates by
Aß-directed antibodies and the potential implications thereof, the
Company’s pipeline, including application of its platform to other
diseases, statements regarding preclinical data, including data
announced regarding ALS, 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, use of
capital expenses, including the use of proceeds from the PIPE
financing, 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 risk that
preclinical results or early results may not be indicative of
future results, 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 Report
on Form 10-K for the year ended December 31, 2023 and in its
subsequent filings filed with the United States 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.
For further information:
Visit us at www.promisneurosciences.com
Please submit media inquiries to
info@promisneurosciences.com
For Investor Relations, please
contact: Precision AQAnne Marie Fields, Managing
Directorannemarie.fields@precisionaq.comTel. 212-362-1200
PROMIS
NEUROSCIENCES INC.
Condensed Consolidated Balance
Sheets
(expressed in US dollars, except share
amounts)(Unaudited)
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
|
$ |
992,463 |
|
|
$ |
12,598,146 |
|
|
Short-term investments |
|
|
32,358 |
|
|
|
32,358 |
|
|
Prepaid expenses and other current assets |
|
|
384,776 |
|
|
|
988,641 |
|
|
Total current assets |
|
|
1,409,597 |
|
|
|
13,619,145 |
|
|
Total assets |
|
$ |
1,409,597 |
|
|
$ |
13,619,145 |
|
|
Liabilities and
Shareholders' (Deficit) Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,015,167 |
|
|
$ |
7,843,136 |
|
|
Accrued liabilities |
|
|
1,156,789 |
|
|
|
1,506,526 |
|
|
Total current liabilities |
|
|
3,171,956 |
|
|
|
9,349,662 |
|
|
Share-based compensation
liability |
|
|
465,488 |
|
|
|
422,002 |
|
|
Warrant liability |
|
|
49,231 |
|
|
|
94,185 |
|
|
Total liabilities |
|
|
3,686,675 |
|
|
|
9,865,849 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Shareholders' (deficit)
equity: |
|
|
|
|
|
|
|
Series 2 Convertible Preferred Shares, no par value, unlimited
shares authorized, 1,166,667 shares issued and outstanding as of
June 30, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
|
|
Common shares, no par value, unlimited shares authorized,
18,961,116 and 18,885,254 shares issued and outstanding as of
June 30, 2024 and December 31, 2023,
respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
97,818,797 |
|
|
|
97,590,426 |
|
|
Accumulated other comprehensive loss |
|
|
(371,184 |
) |
|
|
(371,184 |
) |
|
Accumulated deficit |
|
|
(99,724,691 |
) |
|
|
(93,465,946 |
) |
|
Total shareholders' (deficit)
equity |
|
|
(2,277,078 |
) |
|
|
3,753,296 |
|
|
Total liabilities and
shareholders' (deficit) equity |
|
$ |
1,409,597 |
|
|
$ |
13,619,145 |
|
|
PROMIS
NEUROSCIENCES INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(expressed in US dollars, except share
amounts)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the |
|
For the |
|
For the |
|
For the |
|
|
|
Three Months Ended |
|
Three Months Ended |
|
Six Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,625,821 |
|
|
$ |
1,005,715 |
|
|
$ |
3,749,599 |
|
|
$ |
4,515,967 |
|
|
General and administrative |
|
|
1,087,885 |
|
|
|
1,894,169 |
|
|
|
2,640,758 |
|
|
|
3,354,588 |
|
|
Total operating expenses |
|
|
2,713,706 |
|
|
|
2,899,884 |
|
|
|
6,390,357 |
|
|
|
7,870,555 |
|
|
Loss from operations |
|
|
(2,713,706 |
) |
|
|
(2,899,884 |
) |
|
|
(6,390,357 |
) |
|
|
(7,870,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of financial instruments |
|
|
59,087 |
|
|
|
606,214 |
|
|
|
44,954 |
|
|
|
564,549 |
|
|
Interest expense |
|
|
— |
|
|
|
(49,182 |
) |
|
|
(76,774 |
) |
|
|
(49,182 |
) |
|
Other income |
|
|
30,962 |
|
|
|
30,878 |
|
|
|
163,432 |
|
|
|
83,783 |
|
|
Total other income (expense), net |
|
|
90,049 |
|
|
|
587,910 |
|
|
|
131,612 |
|
|
|
599,150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(2,623,657 |
) |
|
|
(2,311,974 |
) |
|
|
(6,258,745 |
) |
|
|
(7,271,405 |
) |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
(171,462 |
) |
|
|
— |
|
|
|
(175,816 |
) |
|
Comprehensive loss |
|
$ |
(2,623,657 |
) |
|
$ |
(2,483,436 |
) |
|
$ |
(6,258,745 |
) |
|
$ |
(7,447,221 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding of common shares, basic and diluted |
|
|
19,770,739 |
|
|
|
8,579,284 |
|
|
|
19,544,908 |
|
|
|
8,579,284 |
|
|
ProMIS Neurosciences (TSX:PMN)
過去 株価チャート
から 11 2024 まで 12 2024
ProMIS Neurosciences (TSX:PMN)
過去 株価チャート
から 12 2023 まで 12 2024