PURCHASE, N.Y., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates designed to treat neurodegenerative disorders, announced that the Company’s president and CEO, Lisa Ricciardi will participate in an “unplugged” fireside discussion at the annual Piper Sandler Healthcare Conference. The conference will take place December 2-4, 2025 at The Lotte New York Palace hotel. Details of Cognition’s fireside discussion are as follows: E ...

Core Insights - Anavex Life Sciences Corp. has successfully developed a once-daily oral tablet formulation for the ANAVEX3-71 program, demonstrating safety and tolerability in a Phase 1b clinical trial [1][2][3] Group 1: Product Development - The new modified-release oral tablet of ANAVEX3-71 shows superior pharmacokinetics compared to the immediate-release oral capsule, allowing for once-daily dosing [1][2] - The Phase 1b clinical trial (ANAVEX3-71-002) confirmed the pharmacokinetic profile supportive of once-daily dosing and consistent safety profile with prior studies [2][3] Group 2: Mechanism of Action - ANAVEX3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, which has the potential to treat all symptom domains of schizophrenia without the side effects associated with standard antipsychotics [3][4] - The drug candidate has shown beneficial effects on mitochondrial dysfunction and neuroinflammation in preclinical trials, indicating its potential for treating Alzheimer's disease and other CNS disorders [4]

Core Viewpoint - Cognition Therapeutics, Inc. has successfully closed a registered direct offering of 14,700,000 shares of common stock at a price of $2.05 per share, raising approximately $30 million in gross proceeds to advance its drug zervimesine for neurodegenerative disorders [1][2]. 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 [6]. - The company has completed Phase 2 studies for its lead candidate, zervimesine (CT1812), targeting dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [6]. Product Information - Zervimesine (CT1812) is an investigational oral medication designed for the treatment of CNS diseases, specifically Alzheimer's disease and dementia with Lewy bodies [4]. - The drug aims to interrupt the toxic effects of Aβ and ɑ-synuclein proteins, which are associated with neurodegeneration, potentially slowing disease progression and improving patient quality of life [4]. Financial Details - The offering was facilitated by Titan Partners Group, which acted as the sole placement agent [2]. - The shares were offered under a shelf registration statement previously filed with the U.S. Securities and Exchange Commission, which was declared effective on January 3, 2023 [2].

Core Viewpoint - Cognition Therapeutics, Inc. has announced a registered direct offering of 14,700,000 shares of common stock, expected to generate approximately $30 million in gross proceeds to fund Phase 3 programs of zervimesine for neurodegenerative disorders and for general corporate purposes [1][2]. Group 1: Offering Details - The offering is made to two new fundamental institutional investors, including a prominent global investment manager [2]. - The closing of the offering is anticipated to occur on or about August 29, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the preparation of Phase 3 programs of zervimesine in neurodegenerative disorders, as well as for working capital and general corporate purposes [2]. 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 [5]. - The company has completed Phase 2 studies of zervimesine in conditions such as dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [5]. - The ongoing Phase 2 START study in early Alzheimer's disease is supported by $81 million in grant funding from the National Institute of Aging [5].

Core Points - Cognition Therapeutics, Inc. has regained compliance with Nasdaq's minimum share price requirement under Rule 5550(a)(2) [1][2] - The company achieved a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, with the requirement fulfilled on August 25, 2025 [2] - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [3] Company Overview - Cognition Therapeutics is currently developing zervimesine (CT1812), targeting dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [3] - The Phase 2 START study in early Alzheimer's disease is ongoing, supported by $81 million in grants from the National Institute of Aging [3] - The mechanism of zervimesine involves interaction with the sigma-2 receptor, which is distinct from other treatment approaches for degenerative diseases [3]

Core Insights - Quantum BioPharma Ltd. has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS, which will be used in the upcoming Phase 2 clinical trial for multiple sclerosis (MS) [1][3] - Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound that has shown potential in preclinical models to prevent demyelination, a key characteristic of MS [2] - The company is preparing an Investigational New Drug (IND) application with the FDA as part of its clinical development strategy for Lucid-MS [3] Company Overview - Quantum BioPharma is focused on developing innovative therapies for neurodegenerative disorders and has a portfolio of drug candidates at various stages of development [4] - The company retains a 20.11% ownership stake in Unbuzzd Wellness Inc., which includes a royalty agreement of 7% on sales until total payments reach $250 million, after which the royalty will decrease to 3% [4] - Quantum BioPharma also maintains strategic investments through its subsidiary, FSD Strategic Investments Inc., which involves loans secured by residential or commercial property [4]

Core Insights - Quantum BioPharma Ltd. has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral formulation of Lucid-MS, which will be used in the upcoming Phase 2 clinical trial for multiple sclerosis (MS) [1][3] - Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound that has shown potential in preclinical models to prevent demyelination, a key characteristic of MS [2][4] - The company is preparing an Investigational New Drug (IND) application with the FDA as part of its clinical development strategy for Lucid-MS [3] Company Overview - Quantum BioPharma is focused on developing innovative therapies for neurodegenerative disorders and metabolic disorders, with a portfolio that includes drug candidates at various stages of development [4] - The company retains a 20.11% ownership stake in Unbuzzd Wellness Inc., which is involved in the development of a product called unbuzzd™, and has a royalty agreement that includes 7% of sales until total payments reach $250 million, after which the royalty will drop to 3% [4] - Quantum BioPharma also maintains strategic investments through its subsidiary, FSD Strategic Investments Inc., which includes loans secured by residential or commercial property [4]

Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - The SHIMMER study demonstrated zervimesine's significant impact on neuropsychiatric symptoms, with DLB patients showing an average of 86% improvement compared to placebo [2][3] - Zervimesine's efficacy in Alzheimer's disease was also highlighted in the Phase 2 SHINE study, where it was found to halt cognitive decline in patients with lower plasma p-tau217 levels by 129% and 91% for mild and moderate cases, respectively [4] Study Details - The SHIMMER study enrolled 130 adults with mild-to-moderate DLB, randomized to receive either zervimesine or placebo for six months [6][7] - The SHINE study included 153 adults with mild-to-moderate Alzheimer's disease, also randomized to receive zervimesine or placebo for six months [9][10] - Both studies met their primary endpoint of safety and tolerability, supported by approximately $30 million in grants from the National Institute on Aging [8][10] Biomarker Findings - Plasma p-tau217 levels were identified as a potential biomarker to predict which Alzheimer's patients would benefit most from zervimesine treatment [1][4] - Significant reductions in plasma glial fibrillary acidic protein (GFAP) were observed in SHINE participants with lower p-tau217 levels, indicating a potential impact on neuroinflammation [5][4] - The studies also showed trends towards normalization of neurofilament light (NfL) and amyloid beta species, suggesting zervimesine's influence on Alzheimer's disease biology [5][4] Company Overview - Cognition Therapeutics, Inc. focuses on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as its lead candidate [13] - Zervimesine is an investigational oral medication aimed at treating Alzheimer's disease and DLB, targeting the toxic effects of protein buildup in the brain [11][13] - The company has received FDA Fast Track designation for zervimesine in Alzheimer's disease, indicating its potential significance in addressing unmet medical needs [11]

Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - Zervimesine treatment showed an 86% improvement in neuropsychiatric symptoms compared to placebo after six months [2] - The SHINE study results indicated that lower plasma p-tau217 levels can identify Alzheimer's patients more likely to benefit from zervimesine treatment [3][4] Study Results - The SHIMMER study met its primary endpoint of safety and tolerability, with zervimesine showing a positive impact across various scales [2][6] - DLB patients treated with zervimesine scored significantly better on the neuropsychiatric inventory, particularly in symptoms like hallucinations and anxiety [2][3] - The SHINE study also met its primary endpoint, with zervimesine arresting cognitive deterioration by 129% in mild Alzheimer's and 91% in moderate Alzheimer's patients [4][9] Biomarker Analysis - Plasma p-tau217 levels were used to identify patients likely to benefit from zervimesine, with significant reductions in neuroinflammation markers observed [4][5] - The study found trends towards normalization of neurofilament light (NfL) and amyloid beta species in patients with lower p-tau217 levels [5][4] - Zervimesine's impact on neuroinflammation and neurodegeneration was supported by biomarker evidence presented at the conference [5][4] Company Overview - Cognition Therapeutics is focused on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as a lead candidate [11][13] - The company has received significant funding from the National Institute on Aging, totaling approximately $30 million for both the SHIMMER and SHINE studies [8][10] - Zervimesine has been granted FDA Fast Track designation for Alzheimer's disease, indicating its potential significance in treatment [11]

Financial Data and Key Metrics Changes - The company is focused on executing the clinical development plan for NurOwn and has received FDA clearance to initiate a pivotal Phase 3b trial for ALS [6][10] - Financial constraints have been acknowledged, but the company has made significant strides in trial preparations despite limited resources [13][25] Business Line Data and Key Metrics Changes - The NurOwn technology platform is central to the company's strategy, with ongoing clinical trials aimed at demonstrating its therapeutic benefits [6][12] - The company is actively negotiating clinical trial agreements with approximately 15 leading clinical centers across the U.S. for the Phase 3b trial [10][25] Market Data and Key Metrics Changes - The ALS community's strong interest in NurOwn is highlighted by the engagement of renowned ALS clinicians and researchers [10] - The company participated in the annual ALF Drug Development Summit, indicating its active involvement in the ALS therapeutic development landscape [12] Company Strategy and Development Direction - The company aims to secure strategic funding to support the trial, with a focus on partnerships and non-dilutive grants [14][26] - Expansion of manufacturing capabilities in the U.S. is a key strategic objective, with plans to announce a letter of intent with a U.S.-based facility [30] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency for innovative therapeutic options in ALS and the commitment to executing the trial with scientific rigor [11][12] - The company is optimistic about the potential of NurOwn and is preparing for various funding opportunities to ensure timely trial commencement [14][26] Other Important Information - The trial, named "Endurance," is designed to resonate with the ALS community, reflecting the strength and resilience of ALS patients [27] - The company is encouraged by progress in its exosome program, which shows potential in treating respiratory and inflammatory diseases [34] Q&A Session Summary Question: Can you start the trial without proper funding? - Management stated that while significant progress has been made, proper funding is essential to commence the trial [25][26] Question: What is the meaning of the trial name "Endurance"? - The name was chosen to resonate with the ALS community and reflects the company's commitment to delivering a therapeutic option for ALS [27] Question: Will the company also be producing in the U.S.? - The company confirmed plans to expand its manufacturing footprint in the U.S. and will announce a letter of intent with a U.S.-based facility [30] Question: Can you update on any advances in the exosome program? - Management expressed encouragement regarding the exosome program's progress and is preparing to advance it towards clinical development [34] Question: Have you had any communications with FDA regarding stratification by UNC13A? - Management indicated that while the FDA has not approved any biomarker as a surrogate, they are excited about the genetic discoveries and will explore them further [39][40] Question: Can the mechanism of action be used as part of the data package for the next BLA? - Management confirmed that the protective effect observed in cell cultures could support the data package for future filings [43] Question: How many clinical trial sites are you looking to open? - Management confirmed plans to open approximately 15 clinical trial sites and is finalizing agreements to begin patient enrollment [48][50]