Core Insights - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has reached 75% enrollment, targeting approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer's disease [1][2] - The study is evaluating the efficacy of zervimesine (CT1812) over 18 months, in collaboration with the Alzheimer's Clinical Trials Consortium and funded by the National Institute of Aging [1][4] Study Details - The START Study (NCT05531656) aims to assess the efficacy and tolerability of once-daily oral zervimesine in individuals with MCI or early Alzheimer's disease who have elevated Aβ levels [3] - Participants are randomized to receive either zervimesine or placebo, with cognitive and executive function measured using validated tools such as the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales [3] Funding and Support - The START Study is supported by an $81 million grant from the National Institute of Aging [4] - The study is conducted in collaboration with the Alzheimer's Clinical Trials Consortium, which includes 35 leading academic sites specializing in Alzheimer's clinical trials [4] Previous Studies - The SHINE Study, a Phase 2 trial, enrolled 153 adults with mild-to-moderate Alzheimer's disease and met its primary endpoints of safety and tolerability [5][6] - The SHINE Study demonstrated that zervimesine slows cognitive deterioration in patients with lower levels of p-tau217 [2] Product Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating CNS diseases like Alzheimer's and dementia with Lewy bodies [7] - The drug targets the toxic effects of protein buildup in the brain, potentially slowing disease progression and improving patient quality of life [7]

Summary of Alterity Therapeutics Conference Call Company Overview - **Company**: Alterity Therapeutics (ATHE) - **Focus**: Development of therapies for neurodegenerative disorders, specifically targeting multiple system atrophy (MSA) and other Parkinsonian disorders [10][11] Industry Context - **Biotech Sector**: The conference is part of the Pink Asset Management Monsoon Communications Biotech Showcase 2025, highlighting the growing interest in biotech investments [1][2] - **Market Potential**: There are approximately 175 listed life sciences companies on the ASX, making it the third largest biotech exchange globally [2] Core Points and Arguments - **Therapeutic Development**: Alterity's lead asset, ATH434, is a first-in-class oral therapy for MSA, which has received FDA fast-track designation and EU orphan designation [10][17] - **Clinical Trials**: Positive phase two data was disclosed, showing significant efficacy in slowing disease progression in MSA patients [11][27] - **Mechanism of Action**: ATH434 targets the misfolding of alpha-synuclein and imbalanced iron in the central nervous system, which are critical in the pathology of neurodegenerative diseases [15][16] - **Patient Population**: MSA affects up to 50,000 patients in the U.S., with a median survival of seven to eight years post-symptom onset [17][18] Clinical Trial Results - **201 Study**: A randomized double-blind placebo-controlled study with 75 patients showed that the 50 mg dose declined by 48% less than placebo, while the 75 mg dose declined by 30% less than placebo [23][24] - **Orthostatic Hypotension**: A significant symptom in MSA, the placebo group deteriorated by six points, while both active treatment groups stabilized or improved slightly [24] - **Safety Profile**: ATH434 demonstrated a clean safety profile with no serious adverse events related to the study drug [25][27] Future Plans - **Upcoming Presentations**: Alterity plans to present at the International Congress on Parkinson's Disease and Movement Disorders and target an end-of-phase two meeting with the FDA by the end of the year [28] - **Funding**: The company raised $40 million following the positive phase two data in February [31] Additional Insights - **Investor Engagement**: The event emphasized the importance of networking among biotech investors and companies, highlighting the collaborative nature of the sector [5][6] - **Historical Context**: The narrative included a historical perspective on Australian biotech, referencing early challenges faced by companies like Circadian [2][3] This summary encapsulates the key points discussed during the Alterity Therapeutics conference call, focusing on the company's advancements, clinical trial results, and future directions within the biotech industry.

Core Insights - Cognition Therapeutics, Inc. reported positive topline results from the Phase 2 COG2201 'MAGNIFY' trial of zervimesine (CT1812) for treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD), showing a 28.6% reduction in GA lesion growth rate and a 28.2% decrease in lesion size at 18 months compared to placebo [1][5][6] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [12] - The company is currently investigating zervimesine in clinical programs for Alzheimer's disease and dementia with Lewy bodies (DLB) [12] Study Details - The MAGNIFY study was a double-masked, placebo-controlled Phase 2 clinical trial designed to enroll 246 adults with GA secondary to dry AMD, but was concluded early with approximately 100 participants enrolled [7][8] - Participants received either a placebo or 200 mg of once-daily oral zervimesine, with assessments for safety, tolerability, and changes in GA lesion size and growth rate [7] Treatment Potential - Zervimesine has shown efficacy signals in three indications, including dry AMD, Alzheimer's disease, and DLB, suggesting its potential as a monotherapy or in combination with existing medications [6][10] - The oral administration of zervimesine could provide a transformative alternative to current treatment options that require regular clinic visits for injections [2][6] Future Plans - Cognition Therapeutics plans to submit complete findings from the MAGNIFY study for presentation at a medical meeting later this year, with additional data on safety, demographics, and visual outcomes still being analyzed [5][6]

Core Insights - Cognition Therapeutics is advancing its Alzheimer's disease and dementia with Lewy bodies (DLB) programs, requesting an end-of-Phase 2 meeting with the FDA to discuss the SHINE study results and plans for a registrational study [2][9] - The company reported a net loss of $8.5 million for Q1 2025, an improvement from a net loss of $9.2 million in Q1 2024, with a loss per share of $(0.14) compared to $(0.27) in the prior year [7][13] - Cash and cash equivalents as of March 31, 2025, were approximately $16.4 million, with total obligated grant funds remaining at $47.0 million, indicating sufficient cash to fund operations into Q4 2025 [4][12] Business and Corporate Highlights - The Phase 2 results in DLB were accepted for oral presentation at the Alzheimer's Association International Congress (AAIC) scheduled for July 27-31, 2025 [9] - Two posters will be presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting, highlighting zervimesine's role in retinal cell health [9] - The company is in the process of securing a commercial investigational new drug (IND) application for zervimesine in DLB to facilitate separate EOP2 meetings for each indication [2] Financial Results - Research and development expenses for Q1 2025 were $10.8 million, slightly up from $10.6 million in Q1 2024, primarily due to increased Phase 2 trial activities [5] - General and administrative expenses decreased to $3.0 million in Q1 2025 from $3.5 million in Q1 2024, attributed to lower stock compensation [6] - Total operating expenses for Q1 2025 were $13.775 million, down from $14.102 million in the same period of 2024 [12]

Core Insights - Cognition Therapeutics, Inc. presented biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for mild-to-moderate Alzheimer's disease at the AD/PD 2025 Conference [1] - The study focused on changes in biomarkers, particularly in a subgroup with lower levels of p-Tau217, which is indicative of Alzheimer's pathology [2] Study Findings - Participants receiving zervimesine for six months showed reductions in plasma biomarkers associated with Alzheimer's compared to placebo [3] - Significant reductions were noted in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL), both linked to neuroinflammation and neurodegeneration, respectively [4] - The low-p-Tau217 subgroup exhibited more pronounced reductions in biomarkers, correlating with cognitive improvements observed in this group [5] Presentation Details - The presentation included multiple studies highlighting the positive impact of CT1812 on plasma biomarkers and cognitive outcomes in Alzheimer's patients [5] - Key authors of the studies presented include Mary Hamby, Ph.D., and others, with presentations scheduled at various locations during the conference [5] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for neurodegenerative disorders, with zervimesine as a lead candidate [6] - The company is exploring zervimesine's mechanism of action through its interaction with the sigma-2 receptor, which is distinct from other treatment approaches [6]

Core Insights - Cognition Therapeutics, Inc. presented biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for mild-to-moderate Alzheimer's disease at the AD/PD 2025 Conference [1][2] Group 1: Study Findings - The study analyzed changes in biomarkers, particularly focusing on participants with lower levels of p-Tau217, a protein indicative of Alzheimer's pathology [2][3] - Participants treated with zervimesine showed reductions in plasma biomarkers associated with Alzheimer's compared to placebo, with the low-p-Tau217 subgroup experiencing more pronounced reductions [3][4] - Significant reductions were noted in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL), both associated with neuroinflammation and neurodegeneration, respectively [4][5] Group 2: Presentation Details - The presentation titled "Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients" was delivered by Dr. Mary Hamby on April 1, 2025 [5] - Additional presentations included analyses of CSF proteomic biomarkers and molecular correlates related to cognitive outcomes in participants of the SHINE study [5] Group 3: Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for age-related neurodegenerative disorders, with zervimesine being the lead candidate [6] - The company is also investigating zervimesine in other clinical programs, including dementia with Lewy bodies [6]