COGNITION THERAPEUTICS (CGTX) Company Report

Cognition Therapeutics' zervimesine (CT1812) demonstrated strong efficacy in the SHINE study for mild to moderate Alzheimer's disease, achieving a 95% reduction in disease progression over six months and 60%-70% slowing of ADL deterioration in patients with lower p-tau217 burden.
The company received positive feedback from the FDA during its End-of-Phase 2 meeting for Alzheimer's, with the agency agreeing to enrich the patient population for lower p-tau, use a single 100mg dose, and suggesting a six-month trial duration may be sufficient for a pivotal study.
For its dementia with Lewy bodies (DLB) program, zervimesine demonstrated benefits across neuropsych, cognitive, and movement symptoms in the SHIMMER study, and Cognition Therapeutics is scheduled for a Type C meeting with the FDA in the second half of January to discuss the Phase 3 design.
Zervimesine is an oral, generally well-tolerated drug that acts by blocking toxic oligomer binding to neuron surface proteins, offering a distinct mechanism of action compared to antibody-based therapies.

4 days ago

Cognition Therapeutics Discusses Zervimesine Clinical Progress and Regulatory Strategy

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New Projects/Investments

Guidance Update

Cognition Therapeutics' Zervimesine (CT1812) works by binding to TMEM97 and PGRMC1 proteins on neuron surfaces, which reduces the binding of toxic oligomers and helps restore synapse health.
In the SHINE study for Alzheimer's disease, patients with lower p-tau217 burden (a blood-based biomarker) demonstrated a 95% reduction in disease progression over six months across cognitive and functional measures.
The company has a Type C meeting with the FDA in the second half of January 2025 regarding its Zervimesine clinical program for dementia with Lewy bodies (DLB), an indication with no currently approved treatments.
Following an end-of-phase two meeting for Alzheimer's, the FDA provided guidance allowing for a six-month trial duration, enrichment of patients with lower p-tau, and flexibility on endpoints for future studies.

4 days ago

Cognition Therapeutics Completes Enrollment in Phase 2 START Study

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New Projects/Investments

Cognition Therapeutics, Inc. (CGTX) has reached target enrollment of 540 participants in its randomized, placebo-controlled Phase 2 ‘START’ Study.
The START Study is designed to assess the safety and activity of zervimesine (CT1812) in individuals with mild cognitive impairment (MCI) or early Alzheimer’s disease.
Topline results from the study are expected after all participants have completed 18 months of treatment.
The study is supported by an $81 million grant from the National Institute of Aging (NIA).

Nov 13, 2025, 12:36 PM

Cognition Therapeutics Reports Q3 2025 Financial Results and Clinical Progress

CGTX

Earnings

New Projects/Investments

Guidance Update

Cognition Therapeutics reported a net loss of $4.9 million, or $(0.06) per basic and diluted share, for the third quarter ended September 30, 2025, an improvement from the $9.9 million net loss in the comparable 2024 period.
Research and development expenses decreased to $3.8 million for Q3 2025, down from $11.4 million in Q3 2024, primarily due to the completion of SHINE and SHIMMER clinical trials.
The company strengthened its financial position by completing a $30 million registered direct offering and reported $39.8 million in cash, cash equivalents, and restricted cash equivalents as of September 30, 2025, providing an estimated cash runway into the second quarter of 2027.
Cognition Therapeutics achieved alignment with the U.S. FDA on a registrational path for zervimesine in Alzheimer’s disease and has surpassed 75% enrollment in the Phase 2 'START' study.

Nov 6, 2025, 12:34 PM

Cognition Therapeutics Provides Update on Zervimesine Clinical Programs and Financial Position

CGTX

New Projects/Investments

Zervimesine (CT1812) is advancing towards Phase 3, with the FDA aligning on the Phase 3 design for mild-to-moderate Alzheimer's disease, targeting patients with p-tau217 at screening ≤ 1.0 pg/mL.
Phase 2 studies demonstrated consistent efficacy signals for zervimesine in Alzheimer's disease (SHINE study), Dementia with Lewy Bodies (SHIMMER study), and dry age-related macular degeneration (MAGNIFY study).
The company reported a favorable safety and tolerability profile for zervimesine across all studies, with over 450 people treated to date.
Cognition Therapeutics closed a $30 million equity raise in August 2025.
As of June 30, 2025, the company's financial position was: | Metric | Q2 2025 | |---|---| | Cash and cash equivalents ($USD Millions) | $11.6 | | Remaining grant funding ($USD Millions) | $42 |

Sep 15, 2025, 11:00 AM

Cognition Therapeutics Closes Registered Direct Offering

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New Projects/Investments

Cognition Therapeutics (CGTX) closed a registered direct offering on September 2, 2025.
The offering generated approximately $30 million in gross proceeds from the sale of 14,700,000 shares of common stock at a purchase price of $2.05 per share.
The company intends to use the additional capital to advance zervimesine for the treatment of serious neurodegenerative disorders.