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 second quarter ended June 30, 2023 and provided
recent business updates.
“The first half of 2023 saw positive news from
Eisai and Lilly culminating in an approval for lecanemab and BLA
filing for donanemab. These developments are exciting and speak to
the advances being made in understanding disease drivers, such as
amyloid-β oligomers. Cognition Therapeutics also made progress
against this target in our own R&D effort during the first half
of 2023, further demonstrating the potential of our lead oral drug
candidate, CT1812 to treat degenerative diseases of the central
nervous system and retina, which remain critically underserved,”
commented Lisa Ricciardi, president and CEO of Cognition
Therapeutics. “We were encouraged by the positive topline results
from our SEQUEL study. In this trial, we demonstrated the impact of
CT1812 on neurophysiological endpoints such as synapse activity and
connectivity as measured by quantitative electroencephalogram
(qEEG). We anticipate full study results to be available in the
fourth quarter of 2023. The cornerstone of our work at Cognition is
solid science and robust data, and we continue to augment our
growing body of clinical evidence with compelling insights that we
believe support our further development of CT1812.
Ms. Ricciardi added, “In building the scientific
case for CT1812, our team and leading collaborators published a
major review article in the International Journal of Molecular
Science Review, which presented the mechanistic rationale
for sigma-2 (σ-2) receptor modulation as a differentiated and
targeted approach to protecting key cells from damage and death in
the progression of Alzheimer’s disease, dementia with Lewy bodies
(DLB) and dry age-related macular degeneration (dry AMD).
Additionally, we also announced the publication of complete results
from our Phase 1 SNAP study, which indicated that CT1812
selectively engages its primary target, the σ-2 receptor, and
achieves rapid displacement of amyloid-β oligomers from synapses
after just a single oral dose. Beyond CT1812’s target engagement,
we have built a library of data that supports CT1812’s ability to
mitigate brain volume atrophy in our SPARC trial and early signals
of cognitive benefit observed in our SHINE trial.
“We continue to advance our ongoing trials for
Alzheimer’s disease (SHINE and START), dementia with Lewy bodies
(SHIMMER), and our MAGNIFY trial in people with geographic atrophy
caused by dry AMD. We believe our current equity capital and grant
funding will provide the necessary resources to reach key
inflection points and clinical milestones into the third quarter of
2024,” Ms. Ricciardi concluded.
Business and Corporate
Highlights
- Reported positive topline results from SEQUEL qEEG study
- Activated the first site in the National Institute on
Aging-funded 540-patient Phase 2 START study for early Alzheimer’s
disease
- Initiated dosing in patients with CT1812 in the MAGNIFY dry AMD
study
- Advanced enrollment in the 144-patient SHINE study and
120-patient SHIMMER trial
- Published confirmatory evidence from the SNAP Study in
Translational Neurodegeneration showing that CT1812
selectively engages the σ-2 receptor supporting its unique and
neuroprotective mechanism of action
- Presented evidence supporting CT1812 impact on pathways
associated with degenerative diseases at the Association for
Research in Vision and Ophthalmology and Alzheimer's Association
International Conference
- Appointed John Doyle (CFO) and Steven Weissman, Ph.D. (CMC),
whose combined experience will be crucial as the company advances
through its ongoing Phase 2 studies and plans for future
programs
Financial Results
Cash and cash equivalents as of June 30, 2023,
were approximately $37.2 million, and total grants funds remaining
from the NIA were $81.8 million. The Company estimates that it has
sufficient cash to fund operations and capital expenditures through
the third quarter of 2024.
Research and development expenses were $8.5
million for the second quarter ended June 30, 2023, compared
to $9.1 million for the same period in 2022. The decrease was
primarily related to non-recurring start-up activities from the
Phase 2 SHINE and SHIMMER trials.
General and administrative expenses for the
second quarter ended June 30, 2023, were $3.3 million compared to
$3.1 million for the three months ended June 30, 2022. The increase
was primarily due to an increase in professional fees, partially
offset by lower Director & Officer Liability insurance and
other expenses.
The Company reported a net loss of $4.7 million
or $(0.16) per basic and diluted share for the second quarter ended
June 30, 2023, compared to a net loss of $5.8 million or $(0.25)
per basic and diluted share during the same period in 2022.
Conference CallCognition will
host a conference call and webcast on Tuesday, August 8, 2023, at
8:00 a.m. ET, to discuss the second quarter corporate and financial
update. To access the call, dial (800) 715-9871 or (646) 307-1963
for international callers and provide conference call ID number
8093818. A live webcast can be accessed here:
https://edge.media-server.com/mmc/p/uk2ydsta or on the Investors
section of the company website under News & Events. Shortly
following completion of the call, an archive will be made available
and will be saved for 90 days.
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, are forward-looking statements. These
statements, including statements relating to the timing and
expected results of our clinical trials, and cash
runway, 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 and
pre-clinical studies being predictive of the results of 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
ongoing 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. 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 June 30, |
|
Six Months Ended June 30, |
Consolidated
Statements of Operations Data: |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,497 |
|
|
$ |
9,098 |
|
|
$ |
13,927 |
|
|
$ |
15,616 |
|
General and administrative |
|
|
3,320 |
|
|
|
3,115 |
|
|
|
6,863 |
|
|
|
6,010 |
|
Total operating expenses |
|
|
11,817 |
|
|
|
12,213 |
|
|
|
20,790 |
|
|
|
21,626 |
|
Loss from operations |
|
|
(11,817 |
) |
|
|
(12,213 |
) |
|
|
(20,790 |
) |
|
|
(21,626 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
6,925 |
|
|
|
6,385 |
|
|
|
10,351 |
|
|
|
12,289 |
|
Other expense, net |
|
|
172 |
|
|
|
(42 |
) |
|
|
(443 |
) |
|
|
(237 |
) |
Interest expense |
|
|
(6 |
) |
|
|
(7 |
) |
|
|
(16 |
) |
|
|
(16 |
) |
Total other income, net |
|
|
7,091 |
|
|
|
6,336 |
|
|
|
9,892 |
|
|
|
12,036 |
|
Loss before income tax |
|
|
(4,726 |
) |
|
|
(5,877 |
) |
|
|
(10,898 |
) |
|
|
(9,590 |
) |
Income tax benefit |
|
|
— |
|
|
|
125 |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(4,726 |
) |
|
$ |
(5,752 |
) |
|
$ |
(10,898 |
) |
|
$ |
(9,590 |
) |
Unrealized (loss) gain on foreign currency translation |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
3 |
|
|
|
(2 |
) |
Total comprehensive loss |
|
$ |
(4,727 |
) |
|
$ |
(5,755 |
) |
|
$ |
(10,895 |
) |
|
$ |
(9,592 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.16 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.43 |
) |
Diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.43 |
) |
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
29,614,822 |
|
|
|
22,595,359 |
|
|
|
29,356,144 |
|
|
|
22,511,636 |
|
Diluted |
|
|
29,614,822 |
|
|
|
22,595,359 |
|
|
|
29,356,144 |
|
|
|
22,511,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
(in thousands) |
|
|
|
|
|
|
June 30, 2023 |
|
December
31, 2022 |
Consolidated Balance
Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
|
|
$ |
37,190 |
|
|
$ |
41,562 |
|
Total assets |
|
|
|
|
|
|
|
|
|
43,960 |
|
|
|
50,425 |
|
Total liabilities |
|
|
|
|
|
|
|
|
|
9,574 |
|
|
|
10,176 |
|
Accumulated deficit |
|
|
|
|
|
|
|
|
|
(126,299 |
) |
|
|
(115,401 |
) |
Total stockholders’
equity |
|
|
|
|
|
|
|
|
|
34,386 |
|
|
|
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
Cognition Therapeutics (NASDAQ:CGTX)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Cognition Therapeutics (NASDAQ:CGTX)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024