Cognition Therapeutics, Inc. (Nasdaq:
CGTX), a clinical-stage neuroscience company
developing drugs that treat neurodegenerative disorders by
regulating cellular damage response pathways (the “Company” or
“Cognition”), today reported financial results for the third
quarter ended September 30, 2023 and provided recent business
updates.
“The third quarter of 2023 was a period of considerable progress
for Cognition, with significant clinical development milestones in
our Alzheimer’s disease pipeline: advancing enrollment in our Phase
2 SHINE trial for people with mild-to-moderate Alzheimer’s disease
and initiation of recruitment in our Phase 2 START trial, for which
we amended the trial protocol to include patients with early
Alzheimer’s disease who are being treated with lecanemab,”
commented Lisa Ricciardi, president and CEO of Cognition
Therapeutics. “We believe these important events, in addition to
the data from our SEQUEL EEG study presented at CTAD 2023, position
Cognition and CT1812 as a leader in the innovative Alzheimer’s
landscape.”
Ms. Ricciardi continued, “Looking ahead, we expect to report
topline results from our Phase 2 SHINE trial in mid-2024. Following
this in 2024, we expect to disclose data from our Phase 2 SHIMMER
trial for patients suffering from dementia with Lewy bodies
(DLB).”
“With two anticipated data readouts from our Alzheimer’s disease
and DLB trials, steady patient enrollment across all programs, and
the expanded combination treatment opportunity in our START trial,
we believe that we are in a strong position to reach our upcoming
milestones and drive the company towards our ultimate goal of
commercializing a novel, once-daily, oral therapeutic that may
enable patients living with neurodegenerative diseases to live
independently longer,” Ms. Ricciardi concluded.
Business and Corporate Highlights
- Initiated clinical sites for CT1812 Phase 2 START Study in
partnership with ACTC
- Unveiled compelling data and insights at CTAD 2023
- Presented full data analyses from exploratory SEQUEL EEG study;
topline results announced in June 2023
- Updated design of Phase 2 START trial allowing approved
monoclonal antibody as background therapy in late-breaking, oral
presentation
- Announced dosing commenced in CT1812 MAGNIFY study for patients
diagnosed with dry age-related macular degeneration (dry AMD)
- Progressed enrollment in 144-patient Phase 2 SHINE Alzheimer’s
disease study; company on track to report topline results in
mid-2024
- Advanced enrollment in 120-patient Phase 2 SHIMMER DLB study;
anticipating data readout in mid-2024
Financial ResultsCash and cash equivalents as
of September 30, 2023, were approximately $33.0 million, and total
grant funds remaining from the NIA were $74.3 million. The Company
estimates that it has sufficient cash to fund operations and
capital expenditures through November of 2024.
Research and development expenses were $11.7 million for
the third quarter ended September 30, 2023, compared to $8.3
million for the same period in 2022. The increase was primarily
related to higher costs associated with Phase 2 trial activities
with contract research organizations, clinical supply manufacturing
and preclinical research.
General and administrative expenses for the third quarter ended
September 30, 2023, were $3.1 million compared to $4.4 million for
the three months ended September 30, 2022. The decrease was
primarily related to lower professional fees, Director &
Officer Liability insurance partially offset by increased
equity-based compensation.
The Company reported a net loss of $6.7 million or $(0.22) per
basic and diluted share for the third quarter ended September 30,
2023, compared to a net loss of $6.6 million or $(0.29) per basic
and diluted share during the same period in 2022.
About Cognition Therapeutics:Cognition
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
engaged in the discovery and development of innovative, small
molecule therapeutics targeting age-related degenerative disorders
of the central nervous system and retina. We are currently
investigating our lead candidate CT1812 in clinical
programs in Alzheimer’s disease, dementia with Lewy bodies
(DLB) and dry age-related macular degeneration (dry AMD). We
believe CT1812 and our pipeline of σ-2 receptor modulators can
regulate pathways that are impaired in these diseases. We believe
that targeting the σ-2 receptor with CT1812 represents a mechanism
functionally distinct from other current approaches in clinical
development for the treatment of degenerative diseases. More about
Cognition Therapeutics and its pipeline can be found
at https://cogrx.com/.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release, other than statements of
historical facts or statements that relate to present facts or
current conditions, including but not limited to, statements
regarding our cash runway, our product candidates, including
CT1812, and any expected or implied benefits or results, including
that initial clinical results observed with respect to CT1812 will
be replicated in later trials and our clinical development plans
and our plans to provide clinical updates or future data from our
clinical studies, are forward-looking statements. These statements,
including statements relating to the timing and expected results of
our clinical trials involve known and unknown risks, uncertainties
and other important factors that may cause our actual results,
performance, or achievements to be materially different from any
future results, performance, or achievements expressed or implied
by the forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “might,” “will,”
“should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “forecast,” “potential” or “continue” or the
negative of these terms or other similar expressions. We have based
these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our business, financial
condition, and results of operations. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions, some
of which cannot be predicted or quantified and some of which are
beyond our control. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: competition; our ability to secure new (and retain existing)
grant funding; our ability to grow and manage growth, maintain
relationships with suppliers and retain our management and key
employees; our ability to successfully advance our current and
future product candidates through development activities,
preclinical studies and clinical trials and costs related thereto;
uncertainties inherent in the results of preliminary data,
pre-clinical studies and earlier-stage clinical trials being
predictive of the results of early or later-stage clinical trials;
the timing, scope and likelihood of regulatory filings and
approvals, including regulatory approval of our product candidates;
changes in applicable laws or regulations; the possibility that the
we may be adversely affected by other economic, business or
competitive factors, including ongoing economic uncertainty; our
estimates of expenses and profitability; the evolution of the
markets in which we compete; our ability to implement our strategic
initiatives and continue to innovate our existing products; our
ability to defend our intellectual property; the impact of the
COVID-19 pandemic on our business, supply chain and labor force;
the impacts of ongoing global and regional conflicts; and the risks
and uncertainties described more fully in the “Risk Factors”
section of our annual and quarterly reports filed with the
Securities Exchange Commission and are available at www.sec.gov.
These risks are not exhaustive and we face both known and unknown
risks. You should not rely on these forward-looking statements as
predictions of future events. The events and circumstances
reflected in our forward-looking statements may not be achieved or
occur, and actual results could differ materially from those
projected in the forward-looking statements. Moreover, we operate
in a dynamic industry and economy. New risk factors and
uncertainties may emerge from time to time, and it is not possible
for management to predict all risk factors and uncertainties that
we may face. Except as required by applicable law, we do not plan
to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Cognition Therapeutics, Inc.Unaudited
Selected Financial Data |
|
|
|
|
|
(in thousands,
except share and per share data) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
Consolidated Statements of Operations Data: |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,669 |
|
|
$ |
8,268 |
|
|
$ |
25,596 |
|
|
$ |
23,884 |
|
General and administrative |
|
|
3,076 |
|
|
|
4,357 |
|
|
|
9,939 |
|
|
|
10,367 |
|
Total operating expenses |
|
|
14,745 |
|
|
|
12,625 |
|
|
|
35,535 |
|
|
|
34,251 |
|
Loss
from operations |
|
|
(14,745 |
) |
|
|
(12,625 |
) |
|
|
(35,535 |
) |
|
|
(34,251 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
7,684 |
|
|
|
5,947 |
|
|
|
18,035 |
|
|
|
18,236 |
|
Other income (expense), net |
|
|
314 |
|
|
|
55 |
|
|
|
(129 |
) |
|
|
(182 |
) |
Interest expense |
|
|
(2 |
) |
|
|
(2 |
) |
|
|
(18 |
) |
|
|
(18 |
) |
Total other income, net |
|
|
7,996 |
|
|
|
6,000 |
|
|
|
17,888 |
|
|
|
18,036 |
|
Net loss |
|
$ |
(6,749 |
) |
|
$ |
(6,625 |
) |
|
$ |
(17,647 |
) |
|
$ |
(16,215 |
) |
Unrealized gain (loss) on foreign currency translation |
|
|
— |
|
|
|
(1 |
) |
|
|
3 |
|
|
|
(3 |
) |
Total comprehensive loss |
|
$ |
(6,749 |
) |
|
$ |
(6,626 |
) |
|
$ |
(17,644 |
) |
|
$ |
(16,218 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.22 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.71 |
) |
Diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.71 |
) |
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
30,365,506 |
|
|
|
23,024,026 |
|
|
|
29,696,296 |
|
|
|
22,684,309 |
|
Diluted |
|
|
30,365,506 |
|
|
|
23,024,026 |
|
|
|
29,696,296 |
|
|
|
22,684,309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
(in thousands) |
|
|
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
|
$ |
32,969 |
|
|
$ |
41,562 |
|
Total
assets |
|
|
|
|
|
|
|
|
38,772 |
|
|
|
50,425 |
|
Total
liabilities |
|
|
|
|
|
|
|
|
9,846 |
|
|
|
10,176 |
|
Accumulated deficit |
|
|
|
|
|
|
|
|
(133,048 |
) |
|
|
(115,401 |
) |
Total
stockholders’ equity |
|
|
|
|
|
|
|
|
28,926 |
|
|
|
40,249 |
|
Contact Information: Cognition Therapeutics,
Inc. info@cogrx.com |
Casey McDonald (media) Tiberend Strategic Advisors, Inc.
cmcdonald@tiberend.com |
Daniel Kontoh-Boateng (investors) Tiberend Strategic Advisors,
Inc. dboateng@tiberend.com |
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