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Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs - Discussed plans to support a pivotal Alzheimer's disease program with FDA at end-of-phase 2

Key Takeaway: Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced its financial results for Q2 2025, highlighting advancements in its clinical programs. Notably, the company has crossed 50% enrollment in its Phase 2 START study of zervimesine for Alzheimer's disease and is preparing for a pivotal meeting with the FDA regarding its registration plans. Additionally, Cognition has initiated an expanded access program for dementia with Lewy bodies. However, the company continues to report financial losses.

Market Sentiment Analysis

POSITIVE FACTORS

  • Cognition Therapeutics reported significant progress in clinical programs, including surpassing 50% enrollment in Phase 2 START study.
  • Company is preparing for a pivotal Alzheimer's disease program submission with the FDA, indicating confidence in zervimesine's potential.
  • The initiation of an expanded access program for dementia with Lewy bodies showcases a proactive approach to patient involvement.

CONCERNS & RISKS

  • Despite its progress, Cognition Therapeutics reported a net loss of $6.7 million for the quarter, indicating ongoing financial challenges.
  • The company faces uncertainties inherent in clinical trial outcomes and the potential for regulatory hurdles with the FDA.

Full Press Release Details

Cognition Therapeutics Reports Financial Results
for the Second Quarter 2025
and Highlights Progress Across Clinical Programs
- Discussed plans to support a pivotal Alzheimer's
disease program with FDA at end-of-phase 2 meeting -
- Initiated expanded access program (EAP) for
people with dementia with Lewy bodies (DLB) -
- Surpassed 50% enrollment in Phase 2 START'
study of zervimesine in early Alzheimer's disease -
Purchase, NY - August 7, 2025 - Cognition Therapeutics,
Inc. (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing drugs that treat
neurodegenerative disorders, today reported financial results for the second quarter ended June 30, 2025, and provided a business update.
"The second quarter of 2025 has been very productive, with milestones
from each of our clinical programs," stated Lisa Ricciardi, Cognition's president and CEO. "These accomplishments
highlight the potential for zervimesine to slow the progression of age-related degenerative diseases such as Alzheimer's disease,
dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). The clinical findings from each program have been
supplemented by the publication of proteomic analyses and in vitro studies that support the mechanism of action of zervimesine
in these patient populations."
Business and Corporate Highlights
"Later this month we anticipate receiving the FDA's minutes
from our end-of-Phase 2 meeting regarding registrational plans for zervimesine in Alzheimer's disease. We expect these will confirm
our understanding of the Agency's expectations for a clinical program in Alzheimer's disease," added Ms. Ricciardi. "In
addition, we expect FDA will have a decision on breakthrough designation for zervimesine in DLB in the third quarter 2025. We expect
these milestones will be valuable to potential partners as we continue to evaluate our options to support development of zervimesine."
Cognition Therapeutics, Inc.
Second Quarter 2025 Financial Results
Cash, cash equivalents, and restricted cash equivalents as of June
30, 2025 were approximately $11.6 million and total obligated grant funds remaining from the National Institute of Aging, a division of
the National Institute of Health were $41.9 million. The Company estimates that it has sufficient cash to fund operations and capital
expenditures into the second quarter of 2026.
Research and development expenses were $11.5 million for the quarter
ended June 30, 2025, compared to $11.6 million for the comparable period in 2024. The change in research and development expenses was
primarily driven by a decrease in professional fees.
General and administrative expenses were $2.5 million for the quarter
ended June 30, 2025, compared to $3.1 million for the comparable period in 2024. The change in general and administrative expenses was
driven primarily by reduced stock-based compensation expenses.
The Company reported a net loss of $6.7 million, or $(0.11) per basic
and diluted share for the quarter ended June 30, 2025, compared to a net loss of $7.0 million, or $(0.18) per basic and diluted share
for the same period in 2024.
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical
company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central
nervous system. We recently completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB),
mild-to-moderate Alzheimer's disease and geographic atrophy secondary to dry AMD. The Phase 2 START study (NCT05531656)
in early Alzheimer's disease is ongoing with $81 million in grant support from the National Institute of Aging (NIA) at the National
Institutes of Health. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the
sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about
Cognition Therapeutics and our pipeline can be found at https://cogrx.com.
Forward-Looking Statements
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 or made during the conference call, other than statements of historical facts or statements that relate
to present facts or current conditions, including but not limited to, statements related to our cash runway, our clinical studies of
zervimesine (CT1812), and any analysis of the results therefrom; any expected or implied benefits or results of zervimesine, including
that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans,
and our plans for regulatory approval, including our expectations regarding the results and timing of the end-of-Phase 2 meeting for
Alzheimer's disease and the FDA's review of breakthrough designation for zervimesine in DLB, 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 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 impacts of global political changes and global economic conditions, supply
chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; 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.
(in thousands, except share and per share data amounts) Three Months Ended June 30, Six Months Ended June 30,
Consolidated Statements of Operations Data: 2025 2024 2025 2024
Operating Expenses:
Research and development $ 11,481 $ 11,577 $ 22,267 $ 22,130
General and administrative 2,497 3,101 5,486 6,650
Total operating expenses 13,978 14,678 27,753 28,780
Loss from operations (13,978 ) (14,678 ) (27,753 ) (28,780 )
Other income (expense):
Grant income 7,106 7,311 12,192 12,223
Other income, net 141 333 355 577
Interest expense (3 ) (7 ) (8 ) (17 )
Loss on currency translation from liquidation of subsidiary - - - (195 )
Total other income, net 7,244 7,637 12,539 12,588
Net loss $ (6,734 ) $ (7,041 ) $ (15,214 ) $ (16,192 )
Foreign currency translation adjustment, including reclassifications - - - 195
Total comprehensive loss $ (6,734 ) $ (7,041 ) $ (15,214 ) $ (15,997 )
Net loss per share:
Basic $ (0.11 ) $ (0.18 ) $ (0.24 ) $ (0.44 )
Diluted $ (0.11 ) $ (0.18 ) $ (0.24 ) $ (0.44 )
Weighted-average common shares outstanding:
Basic 63,690,945 40,062,954 62,169,748 36,899,112
Diluted 63,690,945 40,062,954 62,169,748 36,899,112
As of
(in thousands) June 30, 2025 December 31, 2024
Consolidated Balance Sheet Data:
Cash, cash equivalents, and restricted cash equivalents $ 11,557 $ 25,009
Total assets 19,622 30,234
Total liabilities 12,593 11,484
Accumulated deficit (190,374 ) (175,160 )
Total stockholders' equity 7,029 18,750
Cognition Therapeutics, Inc.

Frequently Asked Questions

What are Cognition Therapeutics' plans for Alzheimer's disease?

Cognition Therapeutics aims to support a pivotal Alzheimer's program, with plans discussed at an end-of-phase 2 meeting with the FDA.

How is Cognition Therapeutics progressing in its clinical studies?

The company has surpassed 50% enrollment in the Phase 2 START study of zervimesine for early Alzheimer's disease.

What is the current financial status of Cognition Therapeutics?

As of June 30, 2025, the company reported approximately $11.6 million in cash and equivalents.

What are Cognition's expenses for the second quarter of 2025?

Research and development expenses were $11.5 million, while general and administrative expenses were $2.5 million.

What is zervimesine's role in Cognition's research?

Zervimesine is being developed to slow the progression of Alzheimer's disease and other neurodegenerative disorders.

Last updated: Aug 7, 2025