Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs

Rhea-AI Summary

Cognition Therapeutics (NASDAQ: CGTX) reported significant progress in its clinical programs for Q2 2025, particularly with its lead drug candidate zervimesine. The company achieved key milestones including surpassing 50% enrollment in Phase 2 'START' study for early Alzheimer's disease, reporting positive topline results in dry AMD with 28.6% reduction in GA lesion growth, and initiating an expanded access program for DLB patients.

Financial results showed cash position of $11.6 million with additional $41.9 million in NIA grant funds. Q2 2025 net loss was $6.7 million ($0.11 per share), improved from $7.0 million loss in Q2 2024. The company expects sufficient funding into Q2 2026.

Positive

• Positive Phase 2 dry AMD results showing 28.6% reduction in GA lesion growth
• Secured $41.9 million in remaining grant funds from National Institute of Aging
• Improved net loss per share to $0.11 from $0.18 year-over-year
• Reduced G&A expenses by 19.4% year-over-year to $2.5 million
• Successfully conducted end-of-phase 2 meeting with FDA for Alzheimer's program

Negative

• Limited cash runway extending only into Q2 2026
• Relatively low cash position of $11.6 million for clinical-stage company
• Still seeking potential partners for zervimesine development

Insights

Biotech Investment Analyst

Cognition's pipeline shows clinical momentum in neurodegenerative diseases despite cash runway concerns extending only into Q2 2026.

Cognition Therapeutics continues to advance its lead candidate zervimesine across multiple neurodegenerative indications, with several positive developments in Q2 2025. The company has completed an end-of-phase 2 FDA meeting for its Alzheimer's program, reached 50% enrollment in its Phase 2 START study, and reported promising data in dry AMD showing a 28.6% reduction in geographic atrophy lesion growth compared to placebo.

Particularly encouraging is the progress in dementia with Lewy bodies (DLB), where Cognition has initiated an expanded access program and applied for FDA breakthrough designation. These developments position zervimesine as a potential therapeutic across multiple high-value indications.

However, the financial situation warrants close attention. With $11.6 million in cash and equivalents, Cognition has a runway only into Q2 2026. While they have $41.9 million in obligated grant funds from the National Institute of Aging, the company's quarterly net loss of $6.7 million (improved from $7.0 million in Q2 2024) suggests they will need additional funding or partnerships to advance their programs through completion.

CEO Lisa Ricciardi's comments about evaluating "options to support development" indicate the company is actively seeking partnerships, which may be critical for their long-term clinical development strategy. The upcoming FDA feedback on their Alzheimer's registrational pathway and potential breakthrough designation in DLB could significantly impact partnership discussions and the company's strategic direction.

- 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, N.Y., Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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

• Conducted productive EOP2 meeting with FDA to review results from the Phase 2 ‘SHINE’ study of zervimesine (CT1812) in Alzheimer’s disease;
• Surpassed 50% enrollment in the Phase 2 study of zervimesine in early Alzheimer’s disease, which is being conducting in partnership with colleagues at the Alzheimer’s Clinical Trials Consortium (ACTC);
• Reported positive topline results from Phase 2 dry AMD study showing 28.6% reduction of geographic atrophy (GA) lesion growth at 18 months with once-daily oral zervimesine treatment compared to placebo;
• Received philanthropic donation to support EAP for former Phase 2 ‘SHIMMER’ participants and other patients with DLB; onboarded three clinical sites;
• Presented results from Phase 2 ‘SHIMMER’ study of zervimesine in DLB at the Alzheimer’s Association International Congress (AAIC) on July 29th in Toronto, Canada;
• Applied to FDA for breakthrough designation for zervimesine in DLB;
• Submitted comprehensive manuscript describing proposed mechanism of action of zervimesine in the treatment of dry AMD / GA to peer-reviewed journal;
• Published proteomics analysis from the Phase 2 ‘SEQUEL’ COG0202 study showing the impact of zervimesine on key cellular functions in Alzheimer’s disease.

“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.”

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 
This 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.

(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

Contact Information:    Cognition Therapeutics, Inc.     info@cogrx.com	Mike Moyer (investors)  LifeSci Advisors  mmoyer@lifesciadvisors.com

This press release was published by a CLEAR® Verified individual.

FAQ

What were the key clinical trial results for Cognition Therapeutics (CGTX) in Q2 2025?

In Q2 2025, CGTX reported positive Phase 2 dry AMD results with 28.6% reduction in GA lesion growth at 18 months with zervimesine. The company also surpassed 50% enrollment in Phase 2 'START' study for early Alzheimer's disease.

What is CGTX's current financial position as of Q2 2025?

CGTX reported $11.6 million in cash and equivalents, plus $41.9 million in NIA grant funds, with runway into Q2 2026. Q2 net loss was $6.7 million ($0.11 per share).

What is zervimesine and what conditions is CGTX developing it for?

Zervimesine (CT1812) is CGTX's lead drug candidate being developed for Alzheimer's disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD).

What are the next major catalysts for Cognition Therapeutics (CGTX)?

CGTX expects FDA minutes from end-of-Phase 2 meeting for Alzheimer's program and FDA decision on breakthrough designation for zervimesine in DLB in Q3 2025.

How did CGTX's operating expenses change in Q2 2025?

R&D expenses slightly decreased to $11.5 million from $11.6 million, while G&A expenses decreased to $2.5 million from $3.1 million year-over-year.