Cognition Therapeutics Reports Year End 2025 Financial Results and Provides Clinical Development Update
Rhea-AI Summary
Cognition Therapeutics (Nasdaq: CGTX) reported 2025 results and clinical updates for zervimesine (CT1812). Cash and equivalents were approximately $37.0M with $35.7M in obligated NIH grant funds; company estimates runway through Q2 2027. START (545-patient) enrollment completed; SHIMMER Phase 2 showed therapeutic responses in DLB psychosis. A mid-2026 meeting with the FDA Division of Psychiatry is planned to align on a registrational plan for DLB psychosis. 2025 net loss was $23.5M (basic and diluted $(0.32)).
Positive
- Cash balance of $37.0M at year-end 2025
- Obligated NIH grant funds totaling $35.7M
- Completed enrollment in 545-patient START Phase 2 trial
- SHIMMER Phase 2 showed therapeutic responses in DLB psychosis
Negative
- Estimated cash runway only through Q2 2027
- Company reported a $23.5M net loss in 2025
- Research and development spend declined from $41.7M to $37.2M
News Market Reaction – CGTX
On the day this news was published, CGTX declined 2.70%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.8% during that session. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $105.80M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CGTX was up about 0.91% with elevated volume, while peers showed mixed moves: TRDA +2.73%, PRQR +3.95%, TLSA +2.27%, TNYA -7.29%, VYGR +0.75%. No broad, synchronized sector move is evident.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 23 | Earnings date notice | Positive | +5.6% | Announced timing of Q4 and full-year 2025 results and call. |
| Mar 17 | Clinical data update | Positive | +6.5% | Presented Phase 2 SHIMMER data showing 86% NPI-12 decline slowing in DLB. |
| Mar 02 | DLB program advancement | Positive | -2.8% | Announced plans to advance zervimesine toward registrational DLB psychosis trial. |
| Feb 05 | Expanded access update | Positive | -2.9% | Extended expanded access program for DLB patients on zervimesine. |
| Jan 27 | Regulatory meeting update | Positive | -4.3% | Reported completion of Type C FDA meeting on proposed DLB Phase 2b study. |
Recent DLB-focused regulatory and access updates often saw negative price reactions, while the earnings-date announcement and SHIMMER data presentation drew positive moves.
Over recent months, Cognition has focused on zervimesine in dementia with Lewy bodies (DLB) and Alzheimer’s disease. A Jan 21, 2026 Type C FDA meeting and subsequent expanded access and SHIMMER data updates outlined a path toward a registrational DLB program but drew mixed market reactions. The March 26, 2026 earnings release builds on these steps, combining improved financial metrics and cash runway with confirmation of zervimesine’s clinical and regulatory trajectory in both DLB psychosis and early Alzheimer’s disease.
Regulatory & Risk Context
An effective Form S-3 shelf filed on 2025-12-18 allows Cognition to offer up to $300,000,000 of various securities, including a separate at-the-market facility of up to $75,000,000 through Jefferies. Usage count is 0, indicating no takedowns reported yet under this shelf.
Market Pulse Summary
This announcement combines year-end 2025 financial results with clear clinical milestones for zervimesine. Cognition highlighted cash of $37.0M, remaining grants of $35.7M, and an estimated runway through Q2 2027, alongside lower R&D and G&A expenses and a narrower net loss of $23.5M. Clinically, the fully enrolled 545-patient START trial and planned FDA psychiatry meeting for DLB psychosis frame the next catalysts, making regulatory interactions and 2027 topline data key watchpoints.
Key Terms
expanded access program regulatory
phase 2 medical
mild cognitive impairment medical
registrational trials regulatory
AI-generated analysis. Not financial advice.
-Advancing zervimesine clinical development in DLB psychosis –
- Meeting with FDA Division of Psychiatry expected by mid-2026 -
- Management conference call at 8:30 a.m. ET today -
PURCHASE, N.Y., March 26, 2026 (GLOBE NEWSWIRE) -- 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, 2025. Management will host a live webcast conference call at 8:30 a.m. ET to review these financial results and provide an update on clinical development plans for zervimesine (CT1812) in dementia with Lewy bodies (DLB) and Alzheimer’s disease.
“Our progress in 2025 and early 2026 has culminated in a clinical development plan to advance zervimesine for the treatment of psychosis associated with DLB. This patient population has no approved options today and has demonstrated their support of zervimesine’s advancement to registrational trials,” said Lisa Ricciardi, Cognition’s president and CEO. “We received valuable feedback from regulators on both our DLB and Alzheimer’s programs. Our 545-patient ‘START’ trial in early Alzheimer’s disease has completed enrollment. Upon reviewing the results in 2027, we will determine how to advance zervimesine in Alzheimer’s disease. With our near-term focus on DLB, our next steps are centered on a meeting with the FDA Division of Psychiatry to seek alignment on our registrational plan for zervimesine for the treatment of DLB psychosis.”
Clinical and Operational Highlights:
DLB psychosis
- Published results from Phase 2 ‘SHIMMER’ COG1201 study in DLB, which were also presented at the International Lewy Body Dementia Conference. Results show strong therapeutic responses across behavioral domains and particularly psychosis, as well as functional, cognitive, and movement domains
- Launched expanded access program (NCT06961760) for DLB patients following philanthropic donation
- Planned mid-year meeting with FDA Division of Psychiatry to discuss DLB psychosis and path forward
- Appointed Dr. David Weinstein, VP of clinical development
Alzheimer’s disease
- Completed enrollment in December 2025 in Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease; topline results expected in 2027
- Conducted end-of-Phase 2 meeting with FDA and aligned with Agency on development plan for zervimesine in Alzheimer's disease
- Held scientific advice interaction with European Medicines Agency to discuss the Alzheimer’s disease program
- Decision expected on registrational program in Alzheimer’s disease to follow results from START study
2025 Financial Results
Cash, cash equivalents, and restricted cash equivalents as of December 31, 2025 were approximately
Research and development expenses were
General and administrative expenses were
The Company reported a net loss of
Conference Call Information
Management will host a conference call and live webcast to discuss Cognition’s financial results today at 8:30 a.m. ET. To participate in the conference call, dial (800) 445-7795 (U.S.) or (785) 424-1699 (international) and provide conference ID number CGTXQ4. The audio webcast with live Q&A will be accessible at https://viavid.webcasts.com/starthere.jsp?ei=1756394&tp_key=3ba1f3315f or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available for 90 days beginning at approximately 10:30 a.m. ET on March 26, 2026.
About Cognition Therapeutics:
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly
About Zervimesine (CT1812)
Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have been completed in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date.
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
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, 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 runway, our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory 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 ongoing global and regional conflicts on our business, 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. Unaudited Selected Financial Data | |||||||
| (in thousands, except share and per share data amounts) | For the Year Ended December 31, | ||||||
| Consolidated Statements of Operations Data: | 2025 | 2024 | |||||
| Operating Expenses: | |||||||
| Research and development | $ | 37,187 | $ | 41,676 | |||
| General and administrative | 10,612 | 12,290 | |||||
| Total operating expenses | 47,799 | 53,966 | |||||
| Loss from operations | (47,799 | ) | (53,966 | ) | |||
| Other income (expense): | |||||||
| Grant income | 23,406 | 19,549 | |||||
| Other income, net | 919 | 666 | |||||
| Interest expense | (13 | ) | (25 | ) | |||
| Loss on currency translation from liquidation of subsidiary | — | (195 | ) | ||||
| Total other income, net | 24,312 | 19,995 | |||||
| Net loss | $ | (23,487 | ) | $ | (33,971 | ) | |
| Foreign currency translation adjustment, including reclassifications | — | 195 | |||||
| Total comprehensive loss | $ | (23,487 | ) | $ | (33,776 | ) | |
| Net loss per share: | |||||||
| Basic | $ | (0.32 | ) | $ | (0.86 | ) | |
| Diluted | $ | (0.32 | ) | $ | (0.86 | ) | |
| Weighted-average common shares outstanding: | |||||||
| Basic | 72,766,983 | 39,730,148 | |||||
| Diluted | 72,766,983 | 39,730,148 | |||||
| As of | |||||||
| (in thousands) | December 31, 2025 | December 31, 2024 | |||||
| Consolidated Balance Sheet Data: | |||||||
| Cash, cash equivalents, and restricted cash equivalents | $ | 37,000 | $ | 25,009 | |||
| Total assets | 48,390 | 30,234 | |||||
| Total liabilities | 14,119 | 11,484 | |||||
| Accumulated deficit | (198,647 | ) | (175,160 | ) | |||
| Total stockholders’ equity | 34,271 | 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 did Cognition Therapeutics (CGTX) report for cash and runway on March 26, 2026?
What is the status of zervimesine (CT1812) development for DLB psychosis for CGTX?
Has Cognition Therapeutics (CGTX) completed enrollment in its Alzheimer’s START trial?
How did Cognition Therapeutics (CGTX) perform financially in 2025 compared to 2024?
What upcoming regulatory interaction is planned for CGTX’s DLB program?
Does Cognition Therapeutics (CGTX) have additional funding sources disclosed on March 26, 2026?