Cognition Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
November 14 2022 - 8:00AM
Cognition Therapeutics, Inc. (Nasdaq: CGTX), (the
“Company” or “Cognition”) today reported financial results for the
third quarter ended September 30, 2022 and provided an update on
the company’s business and clinical development progress.
“We continue to advance three Phase 2 clinical trials
investigating CT1812 and are highly motivated by the encouraging
data from our clinical programs as well as favorable results from
complementary approaches being pursued by peers in the industry,”
said Lisa Ricciardi, president and CEO of Cognition
Therapeutics. “With the prospect of near-term completion of
enrollment in SEQUEL, expanded enrollment in the SHINE Alzheimer’s
study, and continued progress in the SHIMMER DLB study, we believe
we are entering a period of significant clinical progress.”
Cognition’s lead candidate, CT1812, is in development for
age-related degenerative diseases and is designed to prevent the
binding of toxic oligomers to neurons, thus protecting these
sensitive brain cells. Supplemental grant awards from the
National Institute of Aging (NIA) are supporting the completion of
enrollment in the SEQUEL study and the continuation and completion
of the SHINE trial. The company is now expanding enrollment for the
ongoing Phase 2 SHINE study into Spain, The Netherlands and the
Czech Republic.
Business and Clinical
Updates:
- 18 new sites open in the SHIMMER study in DLB with more to be
added; all sites expected to be activated by year-end.
- SHIMMER principal investigator, James E. Galvin, MD, to present
Cognition’s DLB study design at Clinical Trials in Alzheimer’s
Disease (CTAD) conference in San Francisco in November
- Presented proteomic data at AAIC 2022 held in August
demonstrating a downward shift in disease-relevant biomarkers
including YKL-40, a biomarker of inflammation, which is upregulated
in Alzheimer’s disease, towards levels observed in healthy,
non-demented individuals, supporting a positive impact of CT1812 on
disease biology.
- Cash runway extended into the first half of 2024, inclusive of
a $2.14M additional NIA grant awarded for the SEQUEL study
Q3 2022 Financial
Results:
- Research and development expenses for the third quarter ended
September 30, 2022 were $8.3 million compared to $3.7 million in
2021. The increase for 2022 was primarily attributable to an
increased phase 2 trial activity, personnel costs, and preclinical
program expenses.
- General and administrative expenses for the third quarter ended
September 30, 2022 were $4.4 million compared to $1.6 million in
2021. The increase for 2022 was primarily attributable to an
increase in Director & Officer liability insurance,
compensation and benefits expenses, professional fees driven by
increased audit, tax, and legal services, and stock-based
compensation expense.
- Net loss attributable to common stockholders for the third
quarter ended September 30, 2022, was $6.6 million or $0.29 per
share. The net loss attributable to common stockholders for the
third quarter ended September 30, 2021 was $4.9 million, or $8.12
per share.
- Grant income for the third quarter ended September 30, 2022
totaled $5.9 million.
- Cash and cash equivalents at September 30, 2022 were
approximately $46.6 million.
- As of September 30, 2022, a total of $93.6 million of awarded
grants remained available to fund our pipeline programs.
About Cognition TherapeuticsCognition
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 and financial resources and our clinical
development plans, are forward-looking statements. These statements
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;
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; 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; and the risks and uncertainties described in the
“Risk Factors” section of our annual and quarterly reports filed
the Securities Exchange Commission. 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
TherapeuticsUnaudited Selected Financial
Data
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(in thousands, except share and per share
data) |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Consolidated
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,268 |
|
|
$ |
3,675 |
|
|
$ |
23,884 |
|
|
$ |
12,999 |
|
General and administrative |
|
|
4,357 |
|
|
|
1,548 |
|
|
|
10,367 |
|
|
|
3,791 |
|
Total operating expenses |
|
|
12,625 |
|
|
|
5,223 |
|
|
|
34,251 |
|
|
|
16,790 |
|
Loss from operations |
|
|
(12,625 |
) |
|
|
(5,223 |
) |
|
|
(34,251 |
) |
|
|
(16,790 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
5,947 |
|
|
|
3,037 |
|
|
|
18,236 |
|
|
|
12,375 |
|
Change in the fair value of the derivative liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,209 |
|
Change in the fair value of the Simple Agreements for Future
Equity |
|
|
— |
|
|
|
(932 |
) |
|
|
— |
|
|
|
(1,976 |
) |
Other (expense) income, net |
|
|
55 |
|
|
|
8 |
|
|
|
(182 |
) |
|
|
256 |
|
Gain on debt extinguishment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
443 |
|
Interest expense, net |
|
|
(2 |
) |
|
|
— |
|
|
|
(18 |
) |
|
|
(894 |
) |
Total other income (expense), net |
|
|
6,000 |
|
|
|
2,113 |
|
|
|
18,036 |
|
|
|
12,413 |
|
Net loss |
|
|
(6,625 |
) |
|
|
(3,110 |
) |
|
|
(16,215 |
) |
|
|
(4,377 |
) |
Cumulative preferred stock dividends |
|
|
— |
|
|
|
(1,859 |
) |
|
|
— |
|
|
|
(4,326 |
) |
Net loss attributable to common stockholders |
|
$ |
(6,625 |
) |
|
$ |
(4,969 |
) |
|
$ |
(16,215 |
) |
|
$ |
(8,703 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.29 |
) |
|
$ |
(8.12 |
) |
|
$ |
(0.71 |
) |
|
$ |
(14.87 |
) |
Weighted-average common shares outstanding, basic and
diluted(1) |
|
|
23,024,026 |
|
|
|
611,680 |
|
|
|
22,684,309 |
|
|
|
585,320 |
|
|
|
As of |
(in
thousands) |
|
September 30, 2022 |
|
December 31, 2021 |
Consolidated Balance Sheet Data |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,610 |
|
|
$ |
54,721 |
|
Total assets |
|
|
53,557 |
|
|
|
59,137 |
|
Total liabilities |
|
|
14,237 |
|
|
|
7,864 |
|
Accumulated deficit |
|
|
(110,219 |
) |
|
|
(94,004 |
) |
Total stockholders’
equity |
|
|
39,320 |
|
|
|
51,273 |
|
Contact Information: Cognition
Therapeutics, Inc. info@cogrx.com
Aline Sherwood (media) Scienta
Communications asherwood@scientapr.com
Daniel Kontoh-Boateng / Rosalyn Christian
(investors) Tiberend Strategic Advisors,
Inc. dboateng@tiberend.com / rchristian@tiberend.com
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