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Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update Positive Results with Zervimesine (CT1812) in Phase 2 SHIMMER Dementia with Lewy Bodies (DLB) Phase 2 SHINE Data Show Dramatic S

Key Takeaway: Cognition Therapeutics, Inc. reported positive financial results for the year ended December 31, 2024, highlighting successful Phase 2 clinical trials for Zervimesine in treating Alzheimer's disease and dementia with Lewy bodies. The company aims to transition Zervimesine into late-stage trials and is pursuing regulatory meetings with the FDA to solidify clinical protocols for both indications. As part of a strategic reshuffling, Cognition is focusing its resources on these key areas while maintaining a strong cash position into 2025.

Market Sentiment Analysis

POSITIVE FACTORS

  • Zervimesine shows promising results in Phase 2 studies for Alzheimer's and DLB.
  • Planned advancement to late-stage trials indicates strong product pipeline.
  • Strategic decision to focus on key indications expected to improve cash flow.

Full Press Release Details

Cognition Therapeutics Reports Year End 2024
Financial Results and Provides Business Update
Positive Results with Zervimesine (CT1812) in
Phase 2 SHIMMER Dementia with Lewy Bodies (DLB)
Phase 2 SHINE Data Show Dramatic Slowing of
Cognitive Decline with Zervimesine in a Key Pre-specified Alzheimer's Disease Subgroup
2025 Objective: Advance Zervimesine into Late-stage
Trials for DLB and Alzheimer's Disease
Management will Review Results at 8:00 a.m. ET
on Live Webcast and Conference Call
NY - March 20, 2025 - Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing
product candidates that treat neurodegenerative disorders, (the "Company" or "Cognition"), today reported financial
results for the fourth quarter and full year ended December 31, 2024, and provided a business update.
Data readouts in 2024 from the Company's Phase 2 studies in mild-to-moderate
Alzheimer's disease and dementia with Lewy bodies (DLB) support the potential of zervimesine (also CT1812) in these patient populations.
The Company reprioritized its clinical focus in 2025, concluding enrollment in the Phase 2 dry AMD clinical study in order to devote resources
to support the planned registrational programs for Alzheimer's and DLB, and extend the cash runway into the fourth quarter of 2025.
Next steps for zervimesine include end-of-Phase 2 meetings with the
U.S. Food and Drug Administration (FDA) to align on plans for Phase 3 clinical protocols for both indications. The company plans to request
separate end-of-Phase 2 meetings for Alzheimer's disease and DLB. That process is expected to start in early second quarter of 2025.
The FDA typically responds to a request within two weeks.
Lisa Ricciardi, Cognition's president and CEO, added, "Zervimesine
delivered positive clinical data during 2024 from two key Phase 2 studies: the SHIMMER study in DLB and the SHINE study
in Alzheimer's disease. These results show the value that zervimesine holds as we advance towards Phase 3 clinical trials. Looking
ahead, we will meet with the FDA on plans to start Phase 3 studies in Alzheimer's disease and DLB. In parallel, we are actively
evaluating options to fund our clinical trials, including potential partnering opportunities with pharmaceutical companies."
2024 Corporate and Clinical Highlights:
In January 2025, we made the strategic decision to voluntarily
conclude the Phase 2 MAGNIFY (COG2201) study to focus resources on our ongoing programs in Alzheimer's and DLB. The early conclusion
of MAGNIFY was not the result of any safety concerns. This pipeline prioritization has resulted in cost savings that are expected to extend
the company's cash runway.
2024 Financial Results
Cash and cash equivalents as of December 31, 2024, were approximately
$25.0 million, and total obligated grant funds remaining from the NIA were $50.0 million.
Research and development expenses were $41.7 million for the year ended
December 31, 2024, compared to $37.2 million for 2023. The increase was primarily related to higher costs associated with activities
underway to complete two Phase 2 trials.
General and administrative expenses were $12.3 million for the year
ended December 31, 2024, compared to $13.5 million for 2023. The decrease was primarily related to lower equity-based compensation
and professional fees, partially offset by higher employee compensation and benefits.
The Company reported a net loss of $34.0 million, or $(0.86) per basic
and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million, or $(0.86) per basic and diluted
Conference Call Information
will host a conference call and live webcast to discuss Cognition's financial results today at 8:00 a.m. ET. To participate
in the conference call, dial (877) 704-4453 (U.S.) or (201) 389-0920 (international) and provide conference ID number 13751938. Alternatively,
you may connect to the live webcast via this link: https://viavid.webcasts.com/starthere.jsp?ei=1709298&tp_key=d22af20c47 or
by visiting the Investor Relations page of the Cognition website at www.cogrx.com. An archived webcast recording will be available
approximately one hour after the conclusion of the live call.
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 and retina. We currently are investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with
Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We
believe zervimesine and our pipeline of -2 receptor modulators can regulate pathways that are impaired in these diseases that are
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 analyses of the results therefrom; any expected or implied clinical benefits of zervimesine; the expectation that initial
clinical results observed with zervimesine will be replicated in later trials; and our clinical development plans, 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 our listing 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.
Unaudited Selected Financial Data
(in thousands, except share and per share data amounts) For the Year Ended December 31,
Consolidated Statements of O perations Data: 2024 2023
Operating Expenses:
Research and development $ 41,676 $ 37,196
General and administrative 12,290 13,528
Total operating expenses 53,966 50,724
Loss from operations (53,966 ) (50,724 )
Other income (expense):
Grant income 19,549 24,805
Other income, net 666 158
Interest expense (25 ) (27 )
Loss on currency translation from liquidation of subsidiary (195 ) -
Total other income, net 19,995 24,936
Net loss $ (33,971 ) $ (25,788 )
Foreign currency translation adjustment, including reclassifications 195 4
Total comprehensive loss $ (33,776 ) $ (25,784 )
Net loss per share:
Basic $ (0.86 ) $ (0.86 )
Diluted $ (0.86 ) $ (0.86 )
Weighted-average common shares outstanding:
Basic 39,730,148 30,029,087
Diluted 39,730,148 30,029,087
As of
(in thousands) December 31, 2024 December 31, 2023
Consolidated Balance Sheet Data:
Cash and cash equivalents $ 25,009 $ 29,922
Total assets 30,234 35,163
Total liabilities 11,484 10,689
Accumulated deficit (175,160 ) (141,189 )
Total stockholders' equity 18,750 24,474

Frequently Asked Questions

What is Zervimesine (CT1812)?

Zervimesine is a candidate therapeutic developed by Cognition for treating neurodegenerative disorders.

What was the outcome of the Phase 2 studies for Zervimesine?

The Phase 2 studies showed promising results, indicating potential benefits in Alzheimer’s and DLB.

When does Cognition plan to advance Zervimesine to late-stage trials?

Cognition aims to advance Zervimesine into late-stage trials for Alzheimer's and DLB in 2025.

What are Cognition's financial highlights for 2024?

Cognition reported approximately $25 million in cash with a net loss of $34 million.

How can I join Cognition's conference call?

You can join by calling (877) 704-4453 or via the live webcast on Cognition's website.

Last updated: Mar 20, 2025