CGTX

Meeting with FDA Division of Psychiatry scheduled for May 2026 expected to inform registrational plans for zervimesine in DLB psychosis PURCHASE, N.Y., May 07, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We filed a request to meet with the Food and Drug Administration’s Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy body (DLB) psychosis,” stated Lisa Ricciardi, Cognition’s president and CEO. “We recently received our meeting invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in this important indication. “Looking ahead, we remain committed to developing zervimesine for the treatment of Alzheimer’s disease. Topline results from the 545-participant Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease are anticipated in 2027. We expect these findings will inform our clinical development plans for Alzheimer’s disease.” Business and Corporate Highlights Requested a meeting with FDA Division of Psychiatry, which is expected to be conducted on May 20 with receipt of meeting minutes anticipated in June. Presented two posters at the AD/PD™ 2026 Alzheimer’s & Parkinson’s Diseases Conference: an analysis of zervimesine’s effect on the components of the neuropsychiatric index, which was used in the Phase 2 COG1201 SHIMMER study (NCT05225415) in participants with DLB; and a proposed composite endpoint containing measures of memory, motor, fluctuations, behavior and psychosis, which may be an effective method of capturing the complexity of DLB symptoms in future clinical trials. First Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of March 31, 2026 were approximately $31.2 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $25.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Research and development expen...

This article first appeared on GuruFocus. Cash and Cash Equivalents: Approximately $37 million as of December 31, 2025. Total Grant Funds Remaining: $35.7 million from the NIA. Research and Development Expenses: $37.2 million for the year ended December 31, 2025, down from $41.7 million in 2024. General and Administrative Expenses: $10.6 million for the year ended December 31, 2025, down from $12.3 million in 2024. Net Loss: $23.5 million or $0.32 per basic and diluted share for the year ended December 31, 2025, compared to $34 million or $0.86 per basic and diluted share for 2024. Warning! GuruFocus has detected 1 Warning Sign with CGTX. Is CGTX fairly valued? Test your thesis with our free DCF calculator. Release Date: March 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cognition Therapeutics Inc (NASDAQ:CGTX) has prioritized the development of zervimesine for the treatment of DLB psychosis, based on promising Phase 2 study results. The company reported an 86% slowing of progression in neuropsychiatric symptoms, particularly psychosis, in DLB patients treated with zervimesine. Cognition Therapeutics Inc (NASDAQ:CGTX) has sufficient cash to fund operations through the second quarter of 2027, providing financial stability for ongoing research and development. The Expanded Access Program for zervimesine has received strong interest from DLB patients and their families, indicating potential demand for the treatment. The company is exploring the potential for zervimesine to be a first-in-class treatment for DLB psychosis, an area with no currently approved medications. Cognition Therapeutics Inc (NASDAQ:CGTX) reported a net loss of $23.5 million for the year ended December 31, 2025, indicating ongoing financial challenges. The company has not yet completed FDA meetings to finalize the regulatory path for zervimesine in DLB psychosis, which could delay progress. There is uncertainty regarding the trial design and endpoints for the upcoming DLB psychosis study, pending regulatory feedback. The company has not announced plans for exploring zervimesine in ocular conditions, limiting its current focus to DLB and Alzheimer's disease. The transition from capsule to tablet form for zervimesine is still underway, which may impact the timeline for clinical trials and eventual commercialization. Q: Do you pla...

-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-Ph...

Company pivots to DLB psychosis: Management will prioritize registering zervimesine (CT-1812) for dementia with Lewy bodies psychosis after Phase II SHIMMER data showed benefits across DLB domains — including an 86% slowing on the NPI-12 neuropsychiatric measure — and the FDA told the company the psychosis signal was compelling, directing them to the Division of Psychiatry. Alzheimer's programs remain active: SHINE Phase II reported a 38% reduction in cognitive decline versus placebo (95% reduction in participants with lower p‑tau217), the FDA agreed to p‑tau217 enrichment, and the START trial completed enrollment at 545 participants with top-line results expected in 2027. Cash runway into mid‑2027: The company had about $37M in cash plus $35.7M of NIA grant funds and estimates funding operations through Q2 2027, while 2025 net loss narrowed to $23.5M and R&D and G&A expenses declined year‑over‑year. Interested in Cognition Therapeutics, Inc.? Here are five stocks we like better. November’s Small-Cap Treasures: 3 Stocks Poised for Growth Cognition Therapeutics (NASDAQ:CGTX) used its fourth-quarter and full-year 2025 earnings call to outline a shift in development priorities for its lead candidate, zervimesine (CT-1812), with management saying it will now focus on pursuing a registration path in dementia with Lewy bodies (DLB) psychosis. Chief Executive Officer Lisa Ricciardi said the company has spent the past 18 months reporting Phase II results in DLB (the SHIMMER study) and mild to moderate Alzheimer’s disease (the SHINE study), and has also completed enrollment in the 18-month START trial in early Alzheimer’s disease. She added that the company has held meetings with U.S. and European regulators and, “with data in hand and feedback from regulators,” decided to prioritize zervimesine’s development for DLB psychosis. → ASML’s $8B Deal: More Than a Purchase, It's a Prophecy Chief Medical Officer Dr. Tony Caggiano described the rationale for the pivot, pointing to published SHIMMER results that, he said, showed zervimesine had a “meaningful impact across DLB symptom domains,” including movement, cognition, function, and behavior. He highlighted neuropsychiatric outcomes measured using the NPI-12 (a 12-item index of neuropsychiatric symptoms), stating zervimesine showed “an 86% slowing of progression relative to placebo” on neuropsychiatric symptoms. Within b...

Conference Call and Live Webcast Scheduled for March 26, 2026 PURCHASE, N.Y., March 23, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), plans to release financial results for the fourth quarter and full year ended December 31, 2025 on Thursday, March 26, 2026 before the market open. Management will host a conference call at 8:30 a.m. ET on the same day to review the financial and operating results and provide a business update. Conference Call Information To participate in the conference call, dial (800) 445-7795 (U.S.) or (785) 424-1699 (international) and provide conference ID number CGTXQ4. The 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 $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at 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 thi...

- Zervimesine exhibited meaningful improvement in behavioral, functional, cognitive, and movement measures compared to placebo - PURCHASE, N.Y., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), today announced that a manuscript entitled, “Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)” (doi: 10.1002/alz.71004) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer’s Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam. “The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine’s safety and tolerability,” explained Anthony O. Caggiano, Cognition’s chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies.” The Phase 2 SHIMMER study randomized 130 adults with mild-to-moderate DLB who took a daily oral dose of zervimesine or placebo for six months. The study met its primary endpoint of safety and tolerability. In addition, after six months of treatment, zervimesine-treated participants’ neuropsychiatric symptoms improved relative to placebo as measured by the neuropsychiatric inventory (NPI). The NPI assesses the frequency and severity of 12 separate behavioral symptoms, including hallucinations, delusions, anxiety and agitation. These symptoms are hallmarks of DLB and can be especially debilitating for patients. Zervimesine treatment also resulted in an improvement in fluctuations, which are described as unpredictable lapses in attention or consciousness that can last for minutes, hours or days. After six months on zervimesine, participants experienced fewer and/or shorter cognitive fluctuations, compared to placebo-treated participants. Activities of daily living such as dressing, bathing, and writing, were also improved relative to placebo after six months of zervimesine treatment. Most treatment-related adverse events were mild or moderate, consistent with previous clinical experience. “DLB has a number of complex symptoms, which can make it difficult to care for...

- $30 Million Registered Direct Offering Support Next Stage of Development for Zervimesine (CT1812) - - Aligned with U.S. FDA on Registrational Path for Zervimesine - - Expanded Access Program for Dementia with Lewy Bodies Ongoing - PURCHASE, N.Y., Nov. 06, 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 third quarter ended September 30, 2025, and provided a business update. “The $30 million registered direct offering enables us to begin preparations for the next stage of development for zervimesine (CT1812),” stated Lisa Ricciardi, Cognition’s president and CEO. “The alignment we achieved with the FDA on a registrational path in Alzheimer’s disease was an important accomplishment. We were encouraged by the agency’s receptivity to study designs and recruitment strategies that support faster, more cost-effective studies. Looking ahead, we believe the clinical pharmacology and bioavailability studies we are conducting will support all planned registrational programs for zervimesine.” Business and Corporate Highlights Achieved alignment with the FDA on a registration path for zervimesine in Alzheimer’s disease following a productive end-of-Phase 2 meeting; Completed a $30 million registered direct offering of 14,700,000 shares of common stock to institutional investors; Expanded access program of zervimesine in DLB is ongoing; Surpassed 75% enrollment in the Phase 2 ‘START’ study of zervimesine in early Alzheimer’s disease being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC); Executing required clinical pharmacology and bioavailability studies to prepare zervimesine for the next stage of development across indications; and Proposed registrational Alzheimer’s disease study design accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) Conference, being held December 1-4, 2025. Third Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of September 30, 2025 were approximately $39.8 million and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $36.3 million. The Company estimates that it has sufficient cash to fund operations...

- 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 show...

Cognition Therapeutics (CGTX) said Thursday that it met with the US Food and Drug Administration to

Zervimesine treatment slowed the rate of GA lesion growth by 28.6% compared to placebo Observed GA lesion area was reduced by 28.2% at 18 months compared to placebo Dry AMD results validate zervimesine’s potential across degenerative disease indications PURCHASE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The results show zervimesine-treated participants had 28.6% slower GA lesion growth on average and at 18 months, their lesions were 28.2% smaller compared to placebo. The MAGNIFY study (NCT05893537) was concluded, after approximately 100 of the planned 246 participants were enrolled. “To date, we have observed evidence of robust slowing of disease progression with zervimesine treatment in Phase 2 studies in Alzheimer’s disease and dementia with Lewy bodies,” explained Anthony O. Caggiano, MD, PhD, Cognition Therapeutics’ chief medical officer and head of R&D. “These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill. Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.” GA is characterized by the formation of lesions composed of dead retinal cells and undegraded waste proteins, creating blind spots in central vision. The change in GA lesions was measured using two methods: growth rate and size. Growth rate: in MAGNIFY, a slope analysis showed that the trajectory of GA had slowed by 28.6% in participants treated with zervimesine. Size: at 18 months, the mean lesion size for zervimesine-treated participants was 28.2% smaller than placebo-treated. See Figure 1. We believe these topline results compare favorably to published data from approved injectable complement inhibitors. Approximately 2/3 of patients completed 12 months of dosing and 1/3 completed 18 months of dosing. Additional data, including safety, demographics, and visual and anatomic outcomes are still being analyzed and will be reported at a later da...

- End-of-Phase 2 meeting with FDA requested for Alzheimer’s disease - - Phase 2 results in dementia with Lewy bodies accepted for oral presentation at AAIC - - Two posters at ARVO describe zervimesine's role supporting retinal cell health - PURCHASE, N.Y., May 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 first quarter ended March 31, 2025, and provided a business update. “During our first quarter of 2025 and in recent weeks, we continued to advance our Alzheimer’s disease and dementia with Lewy bodies (DLB) programs,” stated Lisa Ricciardi, Cognition’s president and CEO. “A request was made with the U.S. Food and Drug Administration to schedule an end-of-Phase 2 (EOP2) meeting to review the results from the SHINE study in Alzheimer’s disease and discuss plans for a registrational study. In order to request separate EOP2 meetings for each indication, both need to have a unique FDA program number. For that reason, we recently initiated the process of securing a commercial investigational new drug (IND) application for zervimesine (CT1812) in DLB. Once that process is complete, we will request an EOP2 for DLB.” Business and Corporate Highlights Requested an EOP2 meeting with FDA to review the results from the SHINE study in Alzheimer’s disease. Phase 2 ‘SHIMMER’ study results in DLB were accepted for a podium presentation at the Alzheimer’s Association International Congress (AAIC), to be held July 27-31, 2025 in Toronto, Canada. Presenting two posters at the Association for Research in Vision and Ophthalmology (ARVO) meeting describing zervimesine's role in regulating lipid metabolism and its ability to protect retinal cells from oxidized lipids, a component of drusen. In January 2025 results from the Company’s Phase 2 ‘SHIMMER’ study were presented at the International Lewy Body Dementia Conference (ILBDC) by James E. Galvin, MD, MPH. (Director, Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine; study director and principal investigator on the SHIMMER study grant from the National Institute of Aging). First Quarter 2025 Financial Results Cash and cash equivalents as of March 31, 2025 were approximately $16.4 million and total obligated gra...