Cognition Therapeutics Receives Second Philanthropic Donation to Extend Ongoing Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) received a second philanthropic donation supporting its expanded access program (EAP) for zervimesine (CT1812) in dementia with Lewy bodies (DLB). The gift from Mr. Jeffrey Pechter extends EAP treatment to two years for 32 participants receiving 100 mg once-daily oral zervimesine.
The open-label EAP (COG1202), launched in 2025 after a prior donation, follows positive findings from the Phase 2 SHIMMER study. Cognition plans a second-quarter 2026 meeting with the FDA Division of Psychiatry to discuss a registrational program in DLB psychosis.
AI-generated analysis. Not financial advice.
Positive
- Second donation extends EAP treatment duration to two years
- EAP has enrolled 32 individuals with DLB on 100 mg daily zervimesine
- Program builds on positive findings from Phase 2 SHIMMER study
- FDA Division of Psychiatry meeting on registrational program expected in Q2 2026
Negative
- Zervimesine remains an investigational therapy without current approval
- EAP access is limited to 32 enrolled individuals
- Future trial plans depend on upcoming FDA discussions and meeting minutes
News Market Reaction – CGTX
On the day this news was published, CGTX declined NaN%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CGTX gained 1.69% pre-news, while momentum-screened peers like TLSA and VYGR were up 3.70% and 8.43% respectively. With the sector-move flag at false and mixed moves across broader peers, this reads as a company-specific catalyst tied to its DLB program.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 07 | Q1 earnings update | Positive | +4.3% | Reported Q1 2026 results and cash runway tied to zervimesine programs. |
| Apr 07 | Conference presentation | Positive | -2.4% | Announced Needham conference presentation with Alzheimer’s and DLB updates. |
| Mar 31 | Shareholder letter | Positive | +17.4% | Outlined progress toward late‑stage DLB psychosis development and START trial. |
| Mar 26 | Year-end earnings | Positive | -2.7% | Reported 2025 results, funding runway, and DLB registrational planning. |
| Mar 23 | Earnings date notice | Neutral | +5.6% | Announced timing of Q4 and 2025 results call and presentation access. |
Recent CGTX news—particularly pipeline and strategy updates—has more often been followed by positive price reactions, though conference and broad earnings updates have occasionally seen short-term pullbacks.
Over the last few months, Cognition has repeatedly focused investors on zervimesine. On Mar 23 and Mar 26, it highlighted strong Phase 2 data and an FDA meeting plan, with mixed stock reactions. The Mar 31 shareholder letter emphasizing late-stage development saw a 17.37% gain. Q1 2026 results on May 7 paired strengthened cash runway with a 4.31% rise. Today’s EAP donation and DLB focus fit this ongoing registrational-path narrative.
Regulatory & Risk Context
An effective S-3 shelf dated Dec 18, 2025 allows Cognition to offer up to $300,000,000 in various securities, including an at-the-market facility of up to $75,000,000 with Jefferies LLC. Usage count is 0, so this capacity remained unused before this news, but it provides flexibility to fund ongoing and future zervimesine studies and expanded access efforts.
Market Pulse Summary
This announcement underscores growing support for zervimesine, with a second philanthropic donation extending the EAP to two years for 32 DLB patients on a 100 mg once-daily regimen. It also reiterates plans to meet the FDA Division of Psychiatry in Q2 2026 to shape a registrational program in DLB psychosis. Against a backdrop of prior positive Phase 2 SHIMMER findings, investors may watch upcoming FDA feedback and longer-term EAP experience as key milestones.
Key Terms
expanded access program regulatory
dementia with Lewy bodies medical
dlb medical
open-label medical
phase 2 medical
registrational program regulatory
fda regulatory
psychosis medical
AI-generated analysis. Not financial advice.
PURCHASE, N.Y., May 14, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that a second philanthropic donation has been received from a participant in the ongoing expanded access program (EAP) for people with dementia with Lewy bodies (DLB). The ongoing EAP has been extended to provide two years of treatment for participants, thanks to a generous new donation from Mr. Jeffrey Pechter, founding partner of Mindful Capital in Delray Beach, FL.
The open-label EAP (COG1202) was launched in 2025 with funding by a generous donation from the family of a DLB patient who was treated in the Phase 2 SHIMMER study. The EAP has since enrolled 32 individuals who are receiving 100 mg of once-daily oral zervimesine, a small molecule investigational therapy designed to protect synaptic function in patients with neurodegenerative diseases.
“We continue to be inspired by the high degree of interest in zervimesine from DLB patients and the commitment from people participating in the EAP,” said Lisa Ricciardi, president and CEO of Cognition Therapeutics. “The lack of approved treatments for DLB and the limited availability of clinical research leaves people living with DLB with few options. Due to the overwhelming generosity of our two philanthropic donors, we are able to offer expanded access to zervimesine to the 32 people in our EAP.”
James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, and lead investigator for the EAP, added. “The EAP is a unique opportunity for former participants from the Phase 2 SHIMMER study as well as others who met the EAP’s eligibility criteria to have access to an experimental medication like zervimesine. I’m looking forward to continuing to work with the Cognition team as we learn more about zervimesine’s long-term impact and make plans for a registrational program.”
Following positive findings from the completed Phase 2 SHIMMER study, Cognition is scheduled to meet with the FDA Division of Psychiatry to discuss next steps for a registrational program evaluating zervimesine in DLB psychosis. The Company’s plans for the next trial(s) will be further informed by this meeting with the FDA and subsequent meeting minutes, both of which are expected in the second quarter of 2026.
About the Expanded Access Program (EAP)
The COG1202 expanded access program (EAP) is an open-label program for eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who met the enrollment criteria. Dr. James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine is acting as lead investigator for the EAP. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. More information is available on clinicaltrials.gov under study identifier NCT06961760.
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 and our clinical development plans, including statements regarding our planned FDA interactions and registrational program for zervimesine, the EAP, and any analyses of the results therefrom, 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 the 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 Global 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.
