Core Insights - BioVie Inc. is conducting a Phase 2 trial named ADDRESS-LC to evaluate the efficacy of bezisterim for treating Long COVID-related fatigue and cognitive impairment [1][2][10] - Long COVID is recognized as a significant neurological condition affecting approximately 400 million individuals globally, with 6.9% of U.S. adults experiencing it [2] - Bezisterim is an anti-inflammatory agent that targets TLR-driven inflammation, showing promise in treating Long COVID, Alzheimer's disease, and Parkinson's disease [3][8] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and Long COVID [13] - The company’s drug candidate, bezisterim, modulates inflammation and insulin sensitivity, potentially improving clinical outcomes in various neurological conditions [7][13] Trial Design and Funding - The ADDRESS-LC trial is a multicenter, double-blind, randomized, placebo-controlled study, fully funded by a $13.13 million grant from the U.S. Department of Defense [2][12] - The trial incorporates a unique design informed by patient input, aiming to address the unmet needs of Long COVID patients and enhance signal detection for treatment efficacy [4][5] Bezisterim's Mechanism and Clinical Potential - Bezisterim is designed to inhibit TLR4-induced signaling and inflammatory pathways, making it a candidate for reducing neurocognitive symptoms associated with Long COVID [3][10] - The drug has demonstrated a favorable safety and tolerability profile in previous clinical trials for Alzheimer's and Parkinson's diseases [3][9] Key Trial Endpoints - The primary endpoints of the ADDRESS-LC trial include changes in cognitive performance measured by a bespoke Cogstate Cognitive Battery, focusing on symptoms like cognitive impairment and fatigue [5][10]

July 2025 For personal use only Corporate Presentation Forward looking statements This presentation may contain some statements that may be considered "Forward -Looking Statements", within the meaning of the US Securities Laws. Thus, any forward -looking statement relating to financial projections or other statements relating to the Company's plans, objectives, expectations or intentions involve risks and uncertainties that may cause actual results to differ materially. For a discussion of such risks and un ...

Core Insights - ATH434 demonstrated clinical benefits in patients with multiple system atrophy (MSA), showing stabilization of neurological symptoms and a favorable safety profile [1][3][5] Clinical Trial Results - The ATH434-202 Phase 2 trial involved 10 participants with advanced MSA, treated with 75 mg of ATH434 twice daily for 12 months [6] - Over the treatment period, disease progression as measured by the Modified Unified MSA Rating Scale Part I (UMSARS I) was reduced by approximately 50% compared to historical controls [3] - 30% of participants reported stable neurological symptoms, which is notable given the advanced stage of their disease [3][11] Biomarker Outcomes - Neuroimaging results indicated that ATH434 slowed brain atrophy in MSA-affected areas, as measured by the MSA Atrophy Index (MSA-AI) [4][12] - There was a reduction in iron accumulation in the putamen and globus pallidus compared to placebo-treated patients, providing evidence of target engagement [4][12] Safety Profile - ATH434 was well-tolerated, with most adverse events being mild to moderate in severity, and no serious adverse events related to the treatment reported [12][19] Expert Commentary - The CEO of Alterity expressed encouragement regarding the positive results, reinforcing the efficacy observed in previous studies and emphasizing the potential of ATH434 to slow disease progression [5] - The principal investigator noted that the consistent changes in UMSARS and imaging measures support the continued development of ATH434 for MSA treatment [5]

Core Insights - Cerevance is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases and obesity, with presentations scheduled at the Alzheimer's Association International Conference (AAIC) 2025 [1] Group 1: Upcoming Presentations - Cerevance will present a Phase 1 study on CVN293, an investigational inhibitor targeting NLRP3-mediated neuroinflammation, on July 28, 2025 [2] - Another presentation will focus on the NETSseq platform, revealing insights into astrocyte function in Alzheimer's disease, scheduled for July 30, 2025 [2] Group 2: NETSseq Platform - The NETSseq platform allows for the identification of subtle molecular changes driving disease progression by analyzing brain tissue from over 20,000 donors aged 8 to 104 [3] - This platform aids in identifying low-level expressed targets and rare cell types, enhancing the understanding of neurodegenerative diseases [3] Group 3: CVN293 Overview - CVN293 is a selective oral inhibitor of KCNK13, aimed at reducing neuroinflammation and potentially modifying disease progression in neurodegenerative disorders [4] - The mechanism of CVN293 may also provide therapeutic benefits for obesity, identified through the NETSseq platform [4] Group 4: Company Pipeline - Cerevance's lead investigational treatment, solengepras, is in Phase 3 development for Parkinson's disease, while CVN766 targets binge eating disorder and schizophrenia [5] - CVN293 represents a novel intervention point for both neurodegenerative disorders and obesity [5]

Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease and Parkinson's disease [1][4] - The company will present four scientific posters at the Alzheimer's Association International Conference (AAIC) from July 27–31, 2025, in Toronto, Canada, showcasing advancements in its Alzheimer's clinical program and pharmacokinetic studies of its lead drug candidate, buntanetap [1][2] Presentation Details - Poster 1 will discuss the design of a Phase III study testing the efficacy of buntanetap in early Alzheimer's patients, informed by insights from previous studies, presented by Cheng Fang, Ph.D. [2] - Poster 2 will detail a dual 6-month and 18-month randomized, placebo-controlled, double-blind pivotal clinical trial investigating the efficacy and safety of buntanetap in early Alzheimer's patients, presented by Sarah MacCallum [2] - Poster 3 will cover the comparative pharmacokinetic characterization of the original semi-crystalline and the novel crystalline form of buntanetap in both animals and humans, presented by Alexander Morin, Ph.D. [2] - Poster 4 will focus on the pharmacokinetic characterization of buntanetap in the plasma of patients with early Alzheimer's and Parkinson's diseases, presented by Matthew Peterson, Ph.D. [2] Conference Overview - The AAIC 2025 is recognized as the world's largest meeting dedicated to advancing the science and clinical practice of dementia, bringing together global researchers, clinicians, and professionals to share discoveries and insights aimed at improving the diagnosis, treatment, and care of individuals affected by Alzheimer's disease and other dementias [3]

Core Insights - The study successfully established the safety and tolerability of VTX3232 in patients with early-stage Parkinson's disease, with no drug-related treatment-emergent adverse events reported [1][2] - VTX3232 demonstrated significant reductions in NLRP3-related biomarkers in both cerebrospinal fluid (CSF) and plasma, indicating sustained target engagement [1][3] - The company plans to initiate a placebo-controlled Phase 2 trial for VTX3232 in Parkinson's disease and potentially in other neurodegenerative disorders like Alzheimer's disease [3][6] Study Details - The Phase 2a study evaluated a 40mg oral daily dose of VTX3232 in ten patients over a 28-day treatment period, focusing on safety and tolerability [3][4] - Key secondary objectives included pharmacokinetic profiling and measuring effects on biomarkers of NLRP3 inhibition, with significant reductions observed in IL-1, IL-6, and hsCRP [3][4] - The study showed that VTX3232 maintained plasma and CSF levels above the IC90 for IL-1b for 24 hours [3][9] Biomarker Findings - VTX3232 treatment resulted in reductions of biomarkers such as IL-1β, IL-18, IL-6, and hsCRP, with some approaching the limit of quantitation [9] - Statistically significant improvements were noted in motor and non-motor symptoms of Parkinson's disease, as measured by MDS-UPDRS [9] - No acute changes were observed in exploratory PET imaging, consistent with the short duration of the study [9] Future Development - Ventyx intends to present the complete dataset at a future medical meeting and publish full results in a peer-reviewed journal [5] - The company is also conducting a 12-week Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors, with topline results expected in H2 2025 [1][8] - Planning for a double-blind, placebo-controlled, dose-ranging Phase 2 trial in Parkinson's disease is underway [6]

Company Overview - Vigil Neuroscience, Inc. is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases by restoring the function of microglia, the immune cells of the brain [11] - The company is developing VG-3927, a novel small molecule TREM2 agonist aimed at treating Alzheimer's disease [11] Acquisition Details - Sanofi has entered into a definitive merger agreement to acquire Vigil for an upfront payment of $8.00 per share in cash, with a potential additional $2.00 per share contingent value right (CVR) based on the first commercial sale of VG-3927 [2][6] - The total equity value of the transaction, including the potential CVR payment, is approximately $600 million on a fully diluted basis [2] - The acquisition is expected to close in the third quarter of 2025, subject to customary conditions including shareholder approval [8] Strategic Implications - The acquisition is expected to strengthen Sanofi's development capabilities in neurology, particularly in advancing therapies for Alzheimer's disease [5][3] - Activating TREM2 is anticipated to enhance the neuroprotective function of microglia, addressing the dysregulation seen in neurodegenerative diseases [3] - There is a critical need for more effective and safer treatment options for Alzheimer's disease, as current therapies do not stop or reverse disease progression [4] Financial Aspects - Vigil shareholders will receive a total of up to $10.00 per share, consisting of $8.00 at closing and a potential $2.00 CVR [1][2] - The equity value of the transaction represents approximately $470 million based on the upfront cash payment [6] Additional Information - Iluzanebart, Vigil's monoclonal antibody program, will not be part of the acquisition and will return to Amgen prior to the transaction closing [7] - The transaction is supported by voting and support agreements representing approximately 16% of Vigil's total common shares outstanding [7]

Core Viewpoint - Annovis Bio Inc. is advancing its pivotal Phase 3 clinical trial for Alzheimer's disease, with a focus on the drug buntanetap, while also reporting significant financial updates for the first quarter of 2025 [1][2][3]. Corporate Updates - The pivotal Phase 3 clinical trial for early Alzheimer's disease began on February 5, 2025, aiming to enroll approximately 760 participants to evaluate the drug's symptomatic benefits and potential disease-modifying effects [2]. - Annovis management has actively participated in several key scientific conferences, presenting findings related to neurodegenerative diseases and engaging with the healthcare community [8]. Financial Results - As of March 31, 2025, Annovis reported cash and cash equivalents of $22.2 million, an increase from $10.6 million a year earlier [8]. - Research and development expenses for Q1 2025 were $5.0 million, down from $6.5 million in Q1 2024, while general and administrative expenses remained stable at $1.3 million [8]. - The company reported a net loss of $5.5 million for Q1 2025, with a basic and diluted net loss per share of $0.32, compared to a net loss of $1.1 million and a diluted net loss per share of $0.72 in the same period last year [8][13].

Letter outlines Phase 3 timeline for PrimeC in ALS, provides update on Canadian regulatory pathway and strategic partnership discussions; Company optimistic about ongoing partnership discussions with global pharmaceutical companyCAMBRIDGE, Mass., April 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today issued a shareholder letter from Chief Executive Officer ...

Core Viewpoint - Anavex Life Sciences Corp. is set to present at the 24th Annual Needham Virtual Healthcare Conference, highlighting its focus on developing innovative treatments for various CNS disorders, including Alzheimer's and Parkinson's diseases [1]. Company Overview - Anavex Life Sciences Corp. (NASDAQ:AVXL) is a publicly traded biopharmaceutical company dedicated to developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders [3]. - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating Parkinson's disease dementia and Rett syndrome [3]. - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease progression [3]. - The company is also developing ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, demonstrating disease-modifying activity against Alzheimer's disease in preclinical trials [3]. Upcoming Events - Christopher U Missling, PhD, President & CEO of Anavex, will present at the Needham Virtual Healthcare Conference on April 7, 2025, at 3:45 PM (ET) [1]. - A live audio webcast of the presentation will be available on the company's website, with an archived version accessible later that day [2].