Core Insights - Cognition Therapeutics, Inc. has developed a novel chemical process for manufacturing zervimesine (CT1812), enhancing its stability at room temperature and supporting future clinical studies and potential commercial manufacturing [1][2]. Group 1: Chemical Process and Patent Applications - The new manufacturing process utilizes innovative technologies such as high throughput screening and light-induced, continuous flow processing, which improves the efficiency and safety of zervimesine synthesis [2]. - Provisional patent applications have been filed for the new chemical process and a preferred polymorphic form of zervimesine [1]. Group 2: Zervimesine (CT1812) Overview - Zervimesine (CT1812) is an investigational oral medication aimed at treating central nervous system diseases, including Alzheimer's disease and dementia with Lewy bodies (DLB) [3]. - The drug targets the toxic effects of amyloid beta (Aβ) and ɑ-synuclein proteins, which are associated with neuron damage and cognitive decline in these diseases [3]. Group 3: Company Background - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [4]. - The company is currently investigating zervimesine in clinical programs for DLB and Alzheimer's disease, including the ongoing START study [4].

Core Insights - Cognition Therapeutics, Inc. announced topline results from the SHIMMER study of zervimesine (CT1812) in dementia with Lewy bodies, which will be presented at the International Lewy Body Dementia Conference [1][2] - The study demonstrated significant efficacy signals, with zervimesine-treated participants showing improvements across various symptoms compared to placebo [2][5] Study Overview - The SHIMMER study was a Phase 2 clinical trial involving 130 adults with mild-to-moderate dementia with Lewy bodies, randomized to receive either zervimesine or placebo for six months [8][9] - The study met its primary endpoint of safety and tolerability, with most treatment-related adverse events being mild or moderate [4][5] Efficacy Results - Zervimesine-treated participants scored an average of 86% better on the neuropsychiatric inventory (NPI) A-L compared to placebo [2][5] - Participants on zervimesine preserved 52% more ability in activities of daily living (ADCS-ADL) and showed a 91% reduction in cognitive fluctuations [3][5] - Improvements in motor function were also noted, with zervimesine-treated patients maintaining 62% better motor function than those on placebo [3][5] Implications for Patients - The positive outcomes suggest that zervimesine may allow patients with dementia with Lewy bodies to live at home longer with the support of caregivers, reducing the need for care facility placement [4][5] - The study highlights the potential for zervimesine to alleviate debilitating neuropsychiatric and motor symptoms associated with the disease [2][4] Company Background - Cognition Therapeutics is focused on developing innovative therapeutics for age-related degenerative disorders, with zervimesine being a lead candidate currently investigated in clinical programs for dementia with Lewy bodies and Alzheimer's disease [11]

Core Insights - Cognition Therapeutics, Inc. announced strong therapeutic responses for zervimesine (CT1812) in patients with mild-to-moderate dementia with Lewy bodies (DLB), showing significant improvements across various measures compared to placebo [1][2][3] Study Results - The Phase 2 SHIMMER study involved 130 adults with mild-to-moderate DLB, demonstrating that zervimesine-treated participants scored 86% better on behavioral outcomes, 52% better on activities of daily living, 91% better on cognitive fluctuations, and 62% better on motor symptoms compared to placebo [2][3][6] - Zervimesine treatment resulted in fewer hallucinations, delusions, anxiety, and agitation in patients, which are common debilitating symptoms of DLB [2][4] - The study met its primary endpoint of safety and tolerability, with most treatment-related adverse events being mild or moderate [4][6] Mechanism of Action - Zervimesine is designed to penetrate the blood-brain barrier and selectively bind to the sigma-2 receptor complex, which is involved in regulating cellular processes disrupted by neurodegenerative disease drivers [8] 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 and retina, with zervimesine as its lead candidate [9]

Core Viewpoint - Cognition Therapeutics, Inc. is making significant progress in its clinical programs for neurodegenerative disorders, particularly Alzheimer's disease and dementia with Lewy bodies, and is preparing for key presentations and regulatory meetings in early 2025 [2][3]. Company Developments - CEO Lisa Ricciardi will participate in conferences during the JP Morgan Healthcare Conference week to discuss advancements made in 2024 [1][2]. - The company achieved positive topline results from its Phase 2 SHIMMER study in patients with dementia with Lewy bodies, with findings to be presented at the International Lewy Body Dementia Conference in January 2025 [2]. - Cognition Therapeutics is preparing for an end-of-Phase 2 meeting with the FDA to review results from its SHINE study in mild-to-moderate Alzheimer's disease, marking an important regulatory milestone [2]. - The company received clearance for the generic name of its candidate, CT1812, which will be known as zervimesine [2]. Upcoming Events - Cognition Therapeutics will present at the Longwood Healthcare Leaders Stanford Summit on January 11, 2025, and at the Sachs 8th Annual Neuroscience Innovation Forum on January 12, 2025 [3]. - The panel discussions will focus on accelerating drug development and innovations in Alzheimer's disease and other cognitive disorders [3]. Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina [3]. - The lead candidate, zervimesine, is being investigated in clinical programs for Alzheimer's disease, dementia with Lewy bodies, and dry age-related macular degeneration [3]. - The company believes that zervimesine and its pipeline of Ï-2 receptor modulators can effectively regulate impaired pathways in these diseases, offering a distinct approach compared to other treatments [3].

Core Insights - Cognition Therapeutics, Inc. reported positive results from the exploratory Phase 2 SHIMMER study, indicating that CT1812 showed strong therapeutic responses in patients with dementia with Lewy bodies (DLB) across various measures [1][2] Study Results - The SHIMMER Phase 2 study involved 130 patients with mild-to-moderate DLB, who were randomized to receive either CT1812 or placebo for six months [1] - The study met its primary endpoint of safety and tolerability, with DLB patients treated with CT1812 showing significant improvements in behavioral, functional, cognitive, and movement measures compared to placebo [2] - There was an 82% slowing in the total neuropsychiatric inventory (NPI), with notable reductions in anxiety, hallucinations, and delusions among CT1812 treated patients [2] - Caregiver distress also saw a marked reduction, indicating a positive impact on the daily lives of patients receiving the drug [3] - Participants treated with CT1812 experienced a 91% decline in fluctuations in attention, demonstrating a slowing decline across all three cognitive measures compared to placebo [3] Financial Position - As of September 30, 2024, Cognition Therapeutics reported cash and cash equivalents of approximately $22.0 million, with total grant funds remaining from the NIA at $53.6 million [5] - The company estimates it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025 [5] Stock Performance - Following the positive study results, CGTX stock increased by 93.45%, reaching $0.88 [6]

Clinical Trial Results - CT1812 demonstrated strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB) in the exploratory Phase 2 SHIMMER study [1] - The study met its primary endpoint of safety and tolerability, with CT1812-treated patients showing improvement in behavioral, functional, cognitive, and movement measures compared to placebo [2] - There was an 82% slowing in the total neuropsychiatric inventory (NPI), with significant reductions in anxiety, hallucinations, and delusions in the CT1812-treated arms [2] - Participants treated with CT1812 experienced a 91% slowing in the decline of attention fluctuations compared to placebo [2] Study Design and Details - The SHIMMER Phase 2 study enrolled 130 patients with mild-to-moderate DLB, randomized to receive one of two oral doses of CT1812 or placebo daily for six months [2] - The study is supported by a $30 million grant from the National Institute on Aging of the National Institutes of Health (NIH) [8] - The study is being conducted at over 30 sites in the United States, many of which are Lewy Body Dementia Association (LBDA) centers of excellence [8] Future Plans and Expectations - Cognition Therapeutics plans to advance CT1812 into late-stage trials based on the positive results from the SHIMMER study [1] - The company will present detailed data at the International Lewy Body Dementia Conference (ILBDC) in January 2025 [2] - Cognition Therapeutics will review the topline efficacy and safety findings with the FDA in an end-of-Phase 2 meeting [3] About CT1812 - CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex [10] - CT1812 is currently being investigated in clinical programs for Alzheimer’s disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD) [12] About Dementia with Lewy Bodies (DLB) - DLB is the second most common cause of dementia, affecting an estimated 1.4 million Americans [6] - The disease is caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies within brain neurons [6] - DLB disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems, leading to symptoms such as hallucinations, delusions, and movement disorders [6]

Core Viewpoint - Cognition Therapeutics, Inc. (CGTX) has experienced a bearish price trend recently, losing 9.6% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a potential bottom in the stock price, suggesting that selling pressure may be exhausting and that bulls could be gaining control [2][4]. - A hammer pattern forms when there is a small candle body with a long lower wick, typically occurring during a downtrend, signaling a possible reversal if it appears at the bottom of the trend [3][4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for CGTX, which is a bullish indicator that could lead to price appreciation in the near term [6]. - The consensus EPS estimate for CGTX has increased by 14.1% over the last 30 days, indicating that analysts expect better earnings than previously predicted [7]. - CGTX holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [8].

– Topline results in second dementia indication expected to be reported in December 2024 – PURCHASE, N.Y., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB). The Company anticipates that topline results will be available in ...

Core Insights - Cognition Therapeutics, Inc. reported a 95% reduction in cognitive decline in patients treated with CT1812 who had lower plasma p-tau217 levels, indicating the drug's potential to modify the disease progression of Alzheimer's [1][2][3] Group 1: Study Findings - The Phase 2 'SHINE' study involved 153 adults with mild-to-moderate Alzheimer's disease, focusing on safety, tolerability, and cognitive function [4] - Participants with lower plasma p-tau217 levels experienced a 2.7-point improvement on the ADAS-Cog11 scale compared to placebo over six months [2][4] - Key biomarkers reflecting Alzheimer's disease pathology showed normalization in CT1812-treated participants, including reductions in GFAP, NfL, Aβ42, and Aβ40 [3][4] Group 2: Future Plans - The company plans to present comprehensive biomarker results at scientific conferences in 2025 and intends to meet with the FDA to discuss the findings and Phase 3 program design [3][4] - Ongoing recruitment for the START study and completed enrollment in the SHIMMER study indicate the company's commitment to advancing CT1812's clinical development [9][10] Group 3: About CT1812 - CT1812 is an experimental small molecule that targets the sigma-2 receptor complex, aiming to displace toxic Aβ oligomers and regulate cellular processes affected by Alzheimer's disease [8] - The median baseline level of plasma p-tau217 in the SHINE study was found to be 1.0 pg/mL, with participants categorized based on levels above or below this median [6][7]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40886 Cognition Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 13-436 ...