COGNITION THERAPEUTICS INC Stock Price, News & Analysis

Cognition Therapeutics (NASDAQ: CGTX) announced key regulatory developments for its drug zervimesine (CT1812). The company has scheduled an end-of-Phase 2 meeting with the FDA on July 9, 2025, to discuss results from the SHINE study in mild-to-moderate Alzheimer's disease and plans for Phase 3 trials.

Additionally, following positive Phase 2 SHIMMER study results, CGTX has submitted applications for both breakthrough therapy designation and IND approval for Dementia with Lewy Bodies (DLB). The company is also progressing with an expanded access program (EAP) for DLB patients, with high interest among former SHIMMER study participants.

Cognition Therapeutics (NASDAQ: CGTX) has received an anonymous donation to fund an expanded access program (EAP) for zervimesine (CT1812) in treating dementia with Lewy bodies (DLB). The donation comes from a family whose member was treated in the Phase 2 SHIMMER study. The EAP will initially accommodate about 30 patients who will receive 100 mg daily oral zervimesine for approximately one year. Dr. James Galvin from the University of Miami will lead the multi-center program, with Banner Sun Health Research Institute in Arizona as the first of eight activated sites. The program will be available to eligible SHIMMER study participants and new patients with mild-to-moderate DLB. Dr. David Shprecher will serve as the primary investigator at Banner Sun Health Research Institute.

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) presented promising preclinical data for zervimesine (CT1812) at the Association for Research in Vision and Ophthalmology (ARVO). The data demonstrates the drug's potential to protect retinal cells in dry age-related macular degeneration (dry AMD). Key findings show that zervimesine binds to the TMEM97 receptor, regulating LDL uptake in retinal cells, and may protect against oxidized lipid damage. In a Phase 2 clinical trial with 100 participants, zervimesine showed a 28.6% reduction in GA lesion growth compared to placebo. The drug has also shown promise in Alzheimer's disease and dementia with Lewy bodies studies. Two posters presented at ARVO detailed the drug's mechanism in regulating retinal cell lipid uptake and protecting against cell damage.

Cognition Therapeutics (NASDAQ: CGTX) reported promising topline results from their Phase 2 MAGNIFY trial of zervimesine (CT1812) in treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The study demonstrated that zervimesine-treated patients showed 28.6% slower GA lesion growth and 28.2% smaller lesions at 18 months compared to placebo. The trial included approximately 100 participants, with 2/3 completing 12 months and 1/3 completing 18 months of dosing. As a once-daily oral treatment, zervimesine offers a potential alternative to current intravitreal injections, potentially transforming treatment accessibility. The company plans to present complete findings, including safety data and visual outcomes, at an upcoming medical meeting.

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.