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Cognition Therapeutics, Inc. (NASDAQ: CGTX) is a clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related degenerative disorders of the central nervous system. Its news flow centers on the clinical and regulatory progress of its lead candidate, zervimesine (CT1812), an investigational oral pill in development for Alzheimer’s disease, dementia with Lewy bodies (DLB) and related conditions.
News updates from Cognition Therapeutics frequently cover milestones in its Phase 2 clinical programs. These include results and analyses from the SHINE study in mild-to-moderate Alzheimer’s disease, the SHIMMER study in mild-to-moderate DLB, and the START study in early Alzheimer’s disease. Articles describe safety and tolerability outcomes, changes in cognition and function measured by validated scales, and exploratory findings in behavioral, movement and neuropsychiatric domains.
Investors following CGTX news also see announcements about expanded access programs for zervimesine in DLB, collaborations with organizations such as the Alzheimer’s Clinical Trials Consortium, and substantial grant support from the National Institute on Aging of the National Institutes of Health. Regulatory and scientific updates, such as end-of-Phase 2 discussions with the U.S. Food and Drug Administration, Type C meeting plans, and presentations at major Alzheimer’s disease conferences, are regular features of the company’s news cycle.
In addition, Cognition Therapeutics issues press releases on financing transactions, including registered direct offerings of common stock and at-the-market equity programs, which provide context on how it funds ongoing and planned studies. For readers tracking CGTX, this news page consolidates clinical, regulatory, scientific and capital markets developments related to zervimesine and the company’s broader neurodegenerative disease pipeline.
Cognition Therapeutics (NASDAQ: CGTX) has released its tenth episode of the "Conversations" video podcast series focused on Dementia with Lewy Bodies (DLB). The two-part episode features caregivers Carla Preyer and Linda Szypula Ed.D., who were previously featured in the documentary "Facing the Wind," alongside medical experts Dr. Brendan Kelley from UT Southwestern Medical Center and Dr. Samantha K. Holden from the University of Colorado School of Medicine.
Part 1 explores caregiver challenges and distress in managing DLB patients, while Part 2 discusses the disease's fluctuating symptoms and measurement tools. The episode also provides insights into meaningful symptoms for patients and families, and how this information guides DLB clinical trial design.
Cognition Therapeutics (NASDAQ: CGTX) reported its Q1 2025 financial results and provided key business updates. The company has requested an end-of-Phase 2 meeting with the FDA to review results from the SHINE study in Alzheimer's disease. Their Phase 2 'SHIMMER' study results in dementia with Lewy bodies (DLB) were accepted for presentation at AAIC 2025.
Financial highlights include: cash position of $16.4 million as of March 31, 2025, with $47.0 million in remaining NIH grant funds. Q1 2025 saw R&D expenses of $10.8 million and G&A expenses of $3.0 million. Net loss was $8.5 million ($0.14 per share), improved from $9.2 million ($0.27 per share) in Q1 2024. The company expects current cash to fund operations into Q4 2025.
Cognition Therapeutics (NASDAQ: CGTX) presented biomarker results from their Phase 2 SHINE study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Conference. The study revealed that patients treated with zervimesine for six months showed reductions in key plasma biomarkers associated with Alzheimer's disease processes compared to placebo.
Notably, a prespecified subgroup of patients with lower initial p-Tau217 levels demonstrated more pronounced reductions in important biomarkers, including:
- Significant decreases in glial fibrillary acidic protein (GFAP), linked to neuroinflammation
- Reduced levels of neurofilament light (NfL), associated with neurodegeneration
- Lower amounts of amyloid beta (Aβ) and tau species (p-Tau217)
The findings align with the cognitive benefits observed in the study population, particularly in the low-p-Tau217 subgroup, supporting zervimesine's mechanism of action in impacting disease progression.
Cognition Therapeutics (NASDAQ: CGTX) will present biomarker results from their Phase 2 SHINE study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Conference in Vienna. The presentation, scheduled for April 1-5, 2025, will focus on analyzing key blood sample biomarkers including neurofilament light chain, glial fibrillary acidic protein, amyloid beta, and tau species.
Dr. Mary Hamby, VP of research, will deliver a podium presentation examining the drug's impact on disease biology by comparing biomarker changes between zervimesine and placebo groups. The presentation will complement previously reported positive cognitive and functional findings to provide a comprehensive understanding of the drug's effectiveness.
Additional poster presentations will cover CSF proteomic biomarker analysis, correlation of CSF proteins with cognitive outcomes, and molecular correlates with CT1812 treatment-related changes in NfL CSF levels.
Cognition Therapeutics (NASDAQ: CGTX) has reported its financial results for Q4 and full-year 2024, highlighting significant progress in its neurodegenerative disorder treatments. The company's lead candidate, zervimesine (CT1812), showed promising results in two Phase 2 studies:
The SHIMMER study in Dementia with Lewy Bodies (DLB) demonstrated up to 91% slowing compared to placebo across behavioral, functional, cognitive, and movement measures. The SHINE study in Alzheimer's disease revealed near-total preservation of cognition in patients with lower p-tau217 levels.
Financial highlights include:
- Cash position of $25.0 million as of December 31, 2024
- $50.0 million in remaining NIA grant funds
- R&D expenses increased to $41.7 million from $37.2 million in 2023
- Net loss of $34.0 million ($0.86 per share)
The company plans to advance zervimesine into Phase 3 trials for both DLB and Alzheimer's, with FDA meetings expected in early Q2 2025. Cash runway extends into Q4 2025.
Cognition Therapeutics (Nasdaq: CGTX), a clinical stage company focused on neurodegenerative disorders treatment, has announced it will release its Q4 and full-year 2024 financial results on Thursday, March 20, 2025, before market open. The company will host a conference call at 8:00 a.m. ET on the same day, during which management will review financial and operating results and provide a business update.
Cognition Therapeutics (CGTX) has received a notification from Nasdaq regarding its transfer from The Nasdaq Global Market to The Nasdaq Capital Market, effective March 14, 2025. This follows the company's failure to maintain a minimum bid price of $1.00 per share over 30 consecutive business days, as initially notified on September 12, 2024.
The company has been granted an additional 180 calendar days until September 8, 2025, to regain compliance by achieving a closing bid price of at least $1.00 per share for 10 consecutive business days. If compliance is not achieved naturally, CGTX may seek stockholder approval for a reverse stock split, which would need to be implemented at least 10 business days before the compliance period ends.
Cognition Therapeutics (NASDAQ: CGTX), a clinical stage company focused on neurodegenerative disorders, has announced that President and CEO Lisa Ricciardi will deliver a live presentation at the Life Sciences Virtual Investor Conference on March 13, 2025, at 9:30 a.m. ET.
The presentation will outline the company's 2025 plans for advancing zervimesine (CT1812) in Alzheimer's disease and dementia with Lewy bodies, following positive Phase 2 data readouts. The interactive online event will feature real-time Q&A with the management team.
Investors unable to attend the live event can access an archived webcast through Cognition's Investor Relations webpage. Pre-registration is recommended for interested participants at www.virtualinvestorconferences.com.
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