Cognition Therapeutics CEO Issues Letter to Shareholders
Rhea-AI Summary
Cognition Therapeutics (Nasdaq: CGTX) reported progress advancing zervimesine (CT1812) toward late‑stage development for DLB psychosis and continuing Alzheimer's programs. Key facts: $80 million fully funded Phase 2 START trial of 545 participants; START readout expected in H2 2027. SHIMMER and SHINE Phase 2 data showed strong effects, including a 95% reduction in cognitive decline for participants with low p‑tau217. Company plans FDA discussions for a registrational DLB psychosis path in Q2 2026 and will evaluate next steps after START results.
Positive
- $80 million fully funded Phase 2 START trial
- START trial 545 participants fully enrolled
- SHINE subgroup showed 95% reduction in decline for low p‑tau217
- Planned FDA discussion for DLB registrational path in Q2 2026
Negative
- Primary commercial strategy depends on low p‑tau217 patient subgroup
- Next major data catalyst not expected until H2 2027
Key Figures
Market Reality Check
Peers on Argus
CGTX fell 18.56% while key biotech peers were mixed: TRDA up 4.13%, PRQR up 6.58%, TNYA up 10.4%, TLSA down 5.65%, VYGR down 1.03%. Momentum scanners only flagged VYGR on the upside, reinforcing a stock-specific move rather than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 26 | Earnings & pipeline | Positive | -2.7% | Reported 2025 results, cash runway to Q2 2027, and START enrollment completion. |
| Mar 23 | Earnings date set | Neutral | +5.6% | Announced timing of Q4 and full-year 2025 results and conference call. |
| Mar 17 | Clinical data update | Positive | +6.5% | Presented SHIMMER Phase 2 data showing 86% slowing of NPI-12 decline in DLB. |
| Mar 2 | DLB program plan | Positive | -2.8% | Announced plans for registrational DLB psychosis program after FDA Type C meeting. |
| Feb 5 | Access program | Positive | -2.9% | Extended expanded access program for DLB patients on zervimesine (CT1812). |
Recent DLB/Alzheimer’s updates often produced muted or negative reactions, with several positive clinical and development milestones followed by modest selloffs.
Over recent months, CGTX has repeatedly highlighted progress for zervimesine. On Feb 5, 2026, it extended an expanded access program in DLB, yet shares fell. Subsequent news on advancing zervimesine for DLB psychosis (Mar 2) and strong Phase 2 SHIMMER data (Mar 17) showed mixed price responses, including both gains and pullbacks. The Mar 26 year-end 2025 update emphasized cash of $37.0M plus $35.7M in NIH funds and runway through Q2 2027. Today’s shareholder letter reiterates these clinical and funding themes, but the pre-news setup shows a stock already trading well below its 200-day MA.
Regulatory & Risk Context
An effective S-3 shelf filed on 2025-12-18 allows CGTX to offer up to $300,000,000 in various securities, including up to $75,000,000 via an at-the-market program with Jefferies. Usage_count is 0, indicating no takedowns recorded in the provided data.
Market Pulse Summary
This announcement underscores CGTX’s strategy of advancing zervimesine across DLB psychosis and early Alzheimer’s disease while relying heavily on non‑dilutive funding. The letter highlights a fully enrolled, NIH‑funded $80 million START trial with 545 patients and subgroup data suggesting up to 95% slowing of decline in low p‑tau217 populations. With an effective $300,000,000 shelf and significant grant backing, key aspects to watch include upcoming FDA psychiatry discussions in 2026 and the planned START readout in the second half of 2027.
Key Terms
dementia with Lewy bodies medical
DLB psychosis medical
mild cognitive impairment medical
p-tau217 medical
neuropsychiatric inventory (NPI) medical
Phase 2 medical
expanded access program regulatory
AI-generated analysis. Not financial advice.
Advancing Zervimesine (CT1812) towards late-stage trials for
dementia with Lewy bodies (DLB) psychosis
Fully funded
PURCHASE, N.Y., March 31, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience company developing drugs that treat neurodegenerative disorders, has published CEO Lisa Ricciardi’s Letter to Shareholders. The full text of the letter follows.
A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER
To my fellow Shareholders,
We made significant progress in 2025 towards our goal of developing transformative treatments for neurodegenerative diseases. As discussed on our financial results conference call last week, we are advancing zervimesine (CT1812) in late-stage trials for the treatment of the DLB psychosis. And in parallel we are making good progress in our START trial in mild cognitive impairment (MCI) and early Alzheimer’s disease.
Compelling SHIMMER Results Support Advancing Zervimesine in DLB Psychosis
Last year, we presented strong results from our Phase 2 SHIMMER trial in mild-to-moderate DLB at the International Lewy Body Dementia Conference. In the SHIMMER trial, we assessed the impact of zervimesine using standardized CNS measurements. While zervimesine showed a favorable impact across diverse symptom domains, some of the most compelling results were in the neuropsychiatric inventory (NPI), which assesses behavior and psychosis.
Based on these results, an analysis of the DLB-psychosis market, conversations with advisors and regulators, including a Type C meeting with the FDA, and feedback from individuals in the expanded access program, we announced our decision to advance zervimesine for the treatment of DLB psychosis. In the second quarter of 2026, we expect to meet with the FDA’s Division of Psychiatry to discuss next steps in our registrational plan for DLB psychosis.
Commitment to Alzheimer’s Disease
Our Phase 2 SHINE study in mild-to-moderate Alzheimer’s disease showed a reduction in cognition decline on par with the approved monoclonal antibodies. In addition, it was clear that participants with less disease burden were experiencing a more robust response to zervimesine. These individuals, who had lower levels of the protein p-tau217 in their blood, had a
As reflected in our end-of Phase 2 meeting minutes, the FDA aligned with our Phase 3 program design for six-months studies that screen for low p-tau217 levels to advance zervimesine for the treatment of Alzheimer's disease.
START Study Progressing to Data Readout in the Second Half of 2027
The fully enrolled START study is our Phase 2 study in 545 participants with MCI and early Alzheimer’s disease. Since these participants are earlier in the course of the disease, we expect that the majority will have lower levels of p-tau217. We showed at CTAD 2025 very compelling efficacy results in patients with low p-tau 217 – in fact, up to
Looking Ahead
Thank you for your continued support as we pursue this mission together. With the momentum of 2025’s achievements, I am confident that 2026 will bring zervimesine one step closer to the patients who need safe and effective treatment options.
Sincerely,
Lisa Ricciardi
Chief Executive Officer, Cognition Therapeutics
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 concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the size of the market and the unmet need, 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 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, the timing and expected results of our clinical 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 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.
| 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) announce about the START trial on March 31, 2026?
How did zervimesine perform in Phase 2 SHINE and SHIMMER results for CGTX?
What regulatory steps is Cognition Therapeutics (CGTX) pursuing for DLB psychosis?
How will concomitant use of existing AD agents affect CGTX's START data interpretation?
Does Cognition Therapeutics (CGTX) have funding to complete START through 2027?
What are the near‑term milestones investors should watch for from CGTX in 2026–2027?
