PURCHASE, N.Y., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, has extended the duration of the expanded access program (EAP) for dementia with Lewy bodies (DLB). The program, which was originally expected to provide each participant with twelve months of treatment, will now allow several more months of treatment. “The EAP has been running since June 2025 and is e ...

Core Insights - Cognition Therapeutics, Inc. is advancing its investigational drug zervimesine (CT1812) for treating dementia with Lewy bodies (DLB) and has conducted a Type C meeting with the FDA to discuss the Phase 2b study [1][2] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [4] - The company has completed Phase 2 studies for zervimesine in DLB and mild-to-moderate Alzheimer's disease, with ongoing studies supported by an $81 million grant from the National Institute of Aging [4] Drug Development - Zervimesine is an oral, once-daily pill aimed at treating CNS diseases, specifically targeting the toxic effects of Aβ and ɑ-synuclein proteins that contribute to neurodegeneration [2] - The drug has shown promise in interrupting the toxic effects of these proteins, potentially slowing disease progression and improving patient quality of life [2] Regulatory Engagement - The FDA meeting was described as productive, focusing on clinically meaningful endpoints for the upcoming Phase 2b study [2] - The company anticipates receiving meeting minutes from the FDA later this quarter, indicating ongoing communication to advance clinical development [2]

Core Insights - Cognition Therapeutics, Inc. announced the publication of a Phase 2 study on zervimesine (CT1812) for mild-to-moderate Dementia with Lewy Bodies (DLB) in the journal Alzheimer's & Dementia, highlighting the unmet need for disease-modifying treatments in this area [1][2] Study Results - The Phase 2 SHIMMER study involved 130 adults with mild-to-moderate DLB, confirming zervimesine's safety and tolerability while showing improvements in behavioral, cognitive, functional, and movement domains [2][6] - Zervimesine treatment led to significant improvements in neuropsychiatric symptoms, cognitive fluctuations, and activities of daily living compared to placebo [3][4] - Most treatment-related adverse events were mild or moderate, consistent with previous clinical experiences [3] Future Developments - The U.S. FDA is scheduled to meet with Cognition in January 2026 to discuss the next clinical studies for zervimesine, focusing on clinically meaningful endpoints [4] - The SHIMMER study was supported by a grant from the National Institute on Aging totaling approximately $30 million [7] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for age-related degenerative disorders of the central nervous system, with zervimesine as a lead candidate [8][9]

Summary of Cognition Therapeutics FY Conference Call Company Overview - **Company**: Cognition Therapeutics (NasdaqGM: CGTX) - **Focus**: Development of zervimesine for neurodegenerative diseases, particularly Alzheimer's disease and Lewy body dementia Key Points Zervimesine Mechanism and Clinical Programs - **Mechanism of Action**: Zervimesine is designed to block toxic oligomers by binding to TMEM97 and PGRMC1 proteins on neurons, leading to reduced binding affinity of oligomers and restoration of synaptic health [4][5] - **Clinical Focus**: The drug is being investigated for dementia with Lewy bodies (DLB) and Alzheimer's disease, with overlapping pathologies noted between the two conditions [7][8] - **Current Management of DLB**: There are no approved treatments for DLB, leading to a reliance on off-label medications, which often results in a lengthy and complicated diagnosis process [9][10] Clinical Trial Insights - **SHIMMER Study Outcomes**: The study showed benefits across cognitive, functional, and behavioral domains, with the strongest effects observed in neuropsych symptoms [11][12] - **FDA Engagement**: Cognition Therapeutics is preparing for a Type C meeting with the FDA to discuss endpoints for a potential phase 3 trial, emphasizing the importance of activities of daily living (ADLs) in evaluating efficacy [13][16] - **Alzheimer's SHINE Study**: The study focused on patients with lower p-tau217 burden, showing significant slowing of disease progression, with a 95% reduction in disease progression observed in half of the patients [22][30] Regulatory and Development Strategy - **Regulatory Strategy**: The FDA has encouraged the company to enrich the patient population for those with lower p-tau levels and to use a single dose for trials [35][36] - **Trial Design Considerations**: The company is evaluating whether to conduct one six-month trial or a longer trial to capture the drug's efficacy effectively [37][40] Safety and Tolerability - **Safety Profile**: Zervimesine has shown a favorable safety profile, with serious adverse events lower than in the placebo group. Liver function tests are monitored, but changes are reversible [53][54] Future Directions - **Potential for Other Conditions**: There is interest in exploring zervimesine for other neurodegenerative conditions, including Parkinson's disease and multisystem atrophy [58] Additional Insights - **Patient Experience**: The variability in symptoms and the impact of cognitive decline on daily life were highlighted, emphasizing the need for effective treatments [11][12] - **Market Positioning**: The company aims to position zervimesine as a disease-modifying drug, addressing both cognitive and behavioral symptoms in patients with Alzheimer's and DLB [12][18] This summary encapsulates the critical discussions and insights from the Cognition Therapeutics FY Conference Call, focusing on the company's strategic direction, clinical findings, and regulatory interactions.

Core Insights - Cognition Therapeutics, Inc. has successfully completed enrollment in its expanded access program for zervimesine, with participants receiving 100 mg daily for up to one year [1][2] - The company has scheduled a Type C meeting with the U.S. FDA for the second half of January to discuss the proposed design of a Phase 3 program for zervimesine in dementia with Lewy bodies (DLB) [2][3] Expanded Access Program - The COG1202 expanded access program is open-label and includes eligible participants from the Phase 2 SHIMMER study and additional patients diagnosed with mild-to-moderate DLB [3] - Dr. James E. Galvin is the lead investigator for this multi-center program [3] Zervimesine (CT1812) - Zervimesine is an investigational oral medication aimed at treating CNS diseases, specifically Alzheimer's disease and DLB, by interrupting the toxic effects of Aβ and ɑ-synuclein [4] - The drug has shown a good safety profile in clinical studies to date [4][5] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in DLB and mild-to-moderate Alzheimer's disease, with ongoing studies in early Alzheimer's disease [6]

Core Insights - Cognition Therapeutics is advancing its registrational program for zervimesine in mild-to-moderate Alzheimer's disease, having discussed the program design with the FDA during an end-of-Phase 2 meeting [1][2] - The Phase 3 program will focus on adults with mild-to-moderate Alzheimer's disease and lower plasma p-tau217 levels, which is expected to enrich the study population for zervimesine treatment [2][3] - The SHINE study demonstrated a 95% slowing of cognitive decline in participants with lower p-tau217 levels treated with zervimesine compared to placebo [3] - Cognition Therapeutics plans to align its global Alzheimer's disease registrational plans with the European Medicines Agency (EMA) [4] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [9] - Zervimesine (CT1812) is an investigational oral medication aimed at treating Alzheimer's disease and dementia with Lewy bodies, targeting the toxic effects of Aβ and ɑ-synuclein [5][9] - The company has received significant grant support, including approximately $30 million for the SHINE study from the National Institute on Aging [8] Clinical Study Details - The SHINE study was a double-blind, placebo-controlled Phase 2 trial involving 153 adults, which met its primary endpoints of safety and tolerability [7][8] - Participants were randomized to receive either placebo or zervimesine at doses of 100 mg or 300 mg daily for six months [8] - The Phase 3 studies may consist of two six-month trials with a 1:1 randomization to zervimesine or placebo, with efficacy measured using validated cognitive and functional scales [3] Future Plans - Cognition Therapeutics is actively evaluating its resources across dementia with Lewy bodies and Alzheimer's disease [4] - The company aims to conduct a scientific advice meeting with the EMA to ensure alignment on registrational plans [4]

Core Insights - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative disorders [3] - The company will participate in the 37th Annual Piper Sandler Healthcare Conference, with a discussion scheduled for December 3, 2025 [1][2] Company Overview - Cognition Therapeutics specializes in small molecule therapeutics targeting age-related degenerative disorders of the central nervous system [3] - The company has completed Phase 2 studies for its lead candidate, zervimesine (CT1812), in conditions such as dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [3] - An ongoing Phase 2 START Study (NCT05531656) is focused on early Alzheimer's disease [3] - Zervimesine is believed to interact with the sigma-2 receptor, offering a distinct mechanism compared to other treatments for degenerative diseases [3]

Core Insights - Cognition Therapeutics, Inc. has achieved target enrollment of 540 participants in the Phase 2 'START' Study, which evaluates the safety and efficacy of zervimesine (CT1812) in patients with mild cognitive impairment or early Alzheimer's disease [1][2] - The study is supported by an $81 million grant from the National Institute of Aging and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium [5] Enrollment and Study Design - The START study has seen strong enrollment, with approximately 50% of participants enrolled in the last six months, driven by interest from patients and investigators [2] - The study involves a randomized, placebo-controlled design, assessing once-daily oral zervimesine over 18 months, measuring cognition and executive function using validated tools [4] Drug Mechanism and Potential - Zervimesine is an investigational oral drug targeting neurodegenerative disorders, with a unique mechanism distinct from currently approved therapies, potentially benefiting a broader range of Alzheimer's patients [3][6] - The drug aims to interrupt the toxic effects of protein buildup in the brain, which is associated with Alzheimer's and dementia with Lewy bodies, potentially slowing disease progression [7] Clinical Context - The START study was initiated following the accelerated approval of Leqembi in the US, allowing participants on stable background therapy with approved monoclonal antibodies to enroll [2] - Approximately 15% of participants in the START study are also receiving infusions of Leqembi or Kisunla [2] Company Overview - Cognition Therapeutics is focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system, with ongoing Phase 2 studies for zervimesine in various conditions [8]

Clinical Study Results - The company reported top-line results from the Phase 2 COG0201 SHINE study, which enrolled 153 adults with mild-to-moderate Alzheimer's disease, demonstrating a 95% reduction in cognitive decline for participants with plasma p-tau217 levels below 1.0 pg/mL[106]. - Zervimesine-treated participants in the SHINE study experienced a mean 38% slowing of cognitive decline at six months compared to placebo, although this difference did not achieve statistical significance[107]. - In the Phase 2 COG1201 SHIMMER study for dementia with Lewy bodies, zervimesine-treated patients scored an average of 86% better than placebo on the neuropsychiatric inventory, indicating significant behavioral improvements[112]. - The MAGNIFY study showed zervimesine-treated participants had 29% slower geographic atrophy lesion growth compared to placebo, with lesions being 28% smaller at 18 months[114]. - The Phase 2 studies of zervimesine were generally well tolerated, with 9.6% of participants experiencing transient treatment-emergent elevations in liver function tests greater than 3xULN[116]. - The company is currently enrolling up to 540 participants in the ongoing Phase 2 study COG0203 (START) for mild cognitive impairment or early Alzheimer's disease[118]. - The company has established an expanded access program for individuals with dementia with Lewy bodies, providing zervimesine to eligible participants for approximately one year[113]. Financial Performance - The company has received approximately $176.7 million in net proceeds from various funding sources since inception, including grants and public offerings[118]. - As of September 30, 2025, the company had cash and cash equivalents of $39.8 million and approximately $36.3 million available from obligated NIA funds for future expenses[118]. - The company completed a follow-on public offering in March 2024, issuing 6,571,428 shares at a price of $1.75 per share, resulting in net proceeds of approximately $11.9 million[122]. - Research and development expenses for Q3 2025 were $3.8 million, a decrease of approximately $7.6 million from $11.4 million in Q3 2024[140]. - General and administrative expenses for Q3 2025 were $2.6 million, down from $3.1 million in Q3 2024, primarily due to a decrease in equity-based compensation[140]. - Grant income for Q3 2025 was $1.2 million, compared to $4.3 million in Q3 2024, reflecting a decrease in eligible reimbursable costs related to clinical trials[141]. - For the nine months ended September 30, 2025, total operating expenses were $34.1 million, down from $43.2 million in the same period of 2024, a reduction of $9.1 million[146]. - Net loss for the nine months ended September 30, 2025, was $20.1 million, compared to a net loss of $26.1 million for the same period in 2024, an improvement of $6 million[146]. - Other income, net was $0.6 million for the nine months ended September 30, 2025, compared to $0.8 million for the same period in 2024, indicating an insignificant change[151]. - Interest expense remained less than $0.1 million for both the nine months ended September 30, 2025, and 2024, showing no significant variation[152]. - Net cash used in operating activities was $21.2 million for the nine months ended September 30, 2025, compared to $20.1 million for the same period in 2024, reflecting a $1.1 million increase in cash used[162]. - Net cash provided by financing activities was $36.0 million for the nine months ended September 30, 2025, significantly higher than $12.2 million for the same period in 2024, primarily due to proceeds from stock offerings[164]. - The company anticipates needing to raise additional funding in the future to support ongoing product development and commercialization efforts[156]. - As of September 30, 2025, the company had $34.8 million available to draw under the Lincoln Park Purchase Agreement[155]. - The total cash flows used in investing activities for the nine months ended September 30, 2025, was zero, compared to less than $0.1 million in 2024[163]. - Contractual obligations as of September 30, 2025, totaled $424,000, with operating lease obligations of $424,000 due over various terms[165]. Future Outlook - The company expects to incur significant and increasing expenses and net losses as it advances product candidates through clinical development and seeks regulatory approval[124]. - The company relies on third parties for the manufacture of zervimesine, which allows it to maintain a more efficient infrastructure[127][128]. - The company will remain an emerging growth company until it achieves at least $1.235 billion in annual revenue[175]. - The company will also be classified as a "large accelerated filer" if the market value of its common stock held by non-affiliates exceeds $700.0 million[175]. - The company must issue more than $1.0 billion in non-convertible debt securities within a three-year period to change its status[175].

Financial Performance - Cash, cash equivalents, and restricted cash equivalents as of September 30, 2025, were approximately $39.8 million, with total obligated grant funds remaining at $36.3 million[4] - The net loss for Q3 2025 was $4.9 million, or $(0.06) per basic and diluted share, compared to a net loss of $9.9 million, or $(0.25) per share in Q3 2024[7] - Total operating expenses for Q3 2025 were $6.4 million, down from $14.5 million in Q3 2024[10] - The accumulated deficit as of September 30, 2025, was $195.3 million, compared to $175.2 million at the end of 2024[10] Research and Development - 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 clinical trials[5] - The company achieved over 75% enrollment in the Phase 2 'START' study of zervimesine in early Alzheimer's disease[6] - The proposed registrational Alzheimer's disease study design was accepted for presentation at the Clinical Trials in Alzheimer's Disease (CTAD) Conference scheduled for December 1-4, 2025[6] Funding and Capital - Cognition Therapeutics completed a $30 million registered direct offering of 14,700,000 shares of common stock to institutional investors[6] - Cognition Therapeutics has sufficient cash to fund operations and capital expenditures into the second quarter of 2027[4] Administrative Expenses - General and administrative expenses were $2.6 million for Q3 2025, compared to $3.1 million for the same period in 2024, driven by reduced stock-based compensation[7]