Small Cap Annovis Bio Inc. (NYSE:ANVS) stock is trading higher on Monday, with a session volume of 12.29 million compared to the average volume of 615.12 thousand as per data from Benzinga Pro.A late-stage clinical drug platform company focused on neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease, revealed new data demonstrating the impact of amyloid co-pathology on cognitive outcomes in Parkinson’s patients and the therapeutic efficacy of buntanetap.In the Phase 3 study in earl ...

Core Insights - Alector, Inc. is advancing its innovative drug candidates targeting neurodegenerative diseases, focusing on its Alector Brain Carrier (ABC) platform for enhanced delivery of therapeutics to the brain [2][3] Financial Overview - As of September 30, 2025, Alector reported cash, cash equivalents, and investments totaling $291.1 million, which is expected to fund operations through 2027 [15] - Collaboration revenue for Q3 2025 was $3.3 million, a significant decrease from $15.3 million in Q3 2024, primarily due to the completion of performance obligations related to previous programs [9] - Total research and development expenses for Q3 2025 were $29.4 million, down from $48.0 million in Q3 2024, attributed to reduced spending on specific programs and workforce reductions [10] - General and administrative expenses for Q3 2025 were $11.5 million, compared to $15.8 million in Q3 2024, reflecting cost-saving measures [13] - A net loss of $34.7 million was reported for Q3 2025, an improvement from a net loss of $42.2 million in Q3 2024 [14] Drug Development Pipeline - Alector has selected AL137 as the lead candidate for its ABC-enabled anti-amyloid beta antibody in Alzheimer's disease, with an IND filing targeted for 2026 [4] - The company is also advancing AL050, an ABC-enabled GCase enzyme replacement therapy for Parkinson's disease, with an IND submission planned for 2027 [11] - The ABC platform is designed to facilitate the delivery of antibodies, enzymes, and siRNA to the brain, demonstrating robust brain penetration and favorable safety profiles [2][3] Clinical Trials and Collaborations - The PROGRESS-AD Phase 2 clinical trial for nivisnebart (AL101) in early Alzheimer's disease is ongoing, with an independent interim analysis planned for the first half of 2026 [12] - Alector and GSK are collaborating on the development of nivisnebart, which aims to elevate progranulin concentrations in the brain [12][6] - The INFRONT-3 Phase 3 trial for latozinemab did not show clinical benefit, leading to the discontinuation of further studies for this candidate [7] Strategic Focus - Alector has implemented a workforce reduction of approximately 47% to concentrate resources on high-priority programs and extend its cash runway [8] - The company continues to anticipate collaboration revenue between $13 million and $18 million for the year, with total R&D expenses projected between $130 million and $140 million [16]

All 84 clinical sites across the U.S. are fully activated, enrolling, and treating patients The first group of participants reached the 6-month treatment milestone The study is now 25% complete, keeping Annovis on track for data readout MALVERN, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's diseas ...

Core Insights - Alector, Inc. announced that its Phase 3 INFRONT-3 clinical trial of latozinemab (AL001) for frontotemporal dementia due to a progranulin gene mutation did not meet its primary clinical endpoint, although it showed a significant effect on plasma progranulin biomarker levels [2][3][14] Company Updates - The INFRONT-3 trial was a 96-week, double-blind study that failed to demonstrate clinical benefits in slowing disease progression, leading to the discontinuation of the open-label extension and continuation study for latozinemab [2][3] - Alector's pipeline includes ongoing collaboration with GSK on nivisnebart (AL101/GSK4527226) in a Phase 2 trial for early Alzheimer's disease, with completion expected in 2026 [6] - Alector is advancing multiple preclinical programs, including AL137 for anti-amyloid beta therapy and AL050 for enzyme replacement therapy in Parkinson's disease, with IND submissions targeted for 2026 and 2027 respectively [8][9] - The company is also developing a proprietary blood-brain barrier technology platform, Alector Brain Carrier (ABC), aimed at enhancing therapeutic delivery to the brain [7][17] Leadership and Workforce Changes - Alector is reducing its workforce by approximately 49% to focus resources on high-priority programs [10][11] - Sara Kenkare-Mitra, President and Head of R&D, will resign effective December 22, 2025, after contributing significantly to the company's R&D efforts [12][13] Financial Position - As of September 30, 2025, Alector reported approximately $291.1 million in cash and equivalents, expected to fund operations through 2027 [13]

Progranulin (PGRN)-Elevating Franchise - Alector's pivotal Phase 3 data readout for Latozinemab (AL001) in FTD-GRN is expected by mid-Q4 2025[13, 65] - The Phase 2 clinical trial for Nivisnebart (AL101/GSK4527226) in Alzheimer's Disease completed enrollment in April 2025[13, 68] - Latozinemab and nivisnebart have demonstrated a 2- to 3-fold increase in PGRN levels in clinical trials[50] - In the INFRONT-2 trial, Latozinemab treatment showed an estimated ~48% slowing of annual disease progression in FTD-GRN participants compared to historical controls, representing a 31-point change[61] Alector Brain Carrier (ABC) Platform - Alector expects to initiate a first-in-human clinical trial with its Alector Brain Carrier in 2026[13, 120] - AL037, an ABC-enabled anti-Aβ antibody, at 3mg/kg reached 38 nM in vessel-containing frontal cortex in NHP, showing an 18x increase compared to the naked antibody[114] - AL137, a second anti-Aβ antibody lead, at 3mg/kg reached 84 nM in vessel-containing frontal cortex in NHP, showing a 32x increase compared to the naked antibody[117] - AL050, an ABC-enabled GCase ERT, demonstrated a 5- to 19-fold enhancement in brain delivery in NHPs[149] - Peripheral delivery of SOD1 siRNA-ABC resulted in 50-80% knockdown across multiple brain structures in mice[171] Financial Resources - Alector has over $300 million in cash, providing a runway into the second half of 2027[13]

Summary of Coya Therapeutics FY Conference Call Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of transformative therapies for patients suffering from neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's, and Parkinson's [2][3] Core Points and Arguments - **Vision and Mission**: Coya aims to make neurodegenerative diseases manageable, shifting the narrative from the disease to the patients' lives [3] - **Scientific Approach**: The company believes that neurodegenerative diseases are primarily neuroinflammatory and that addressing neuroinflammation can halt disease progression [5][6] - **Lead Program**: COIA-302, a combination of low-dose interleukin-2 and CTLA-4, is set to enter a pivotal Phase 2b study involving 120 ALS patients, with the first patient expected to be dosed in Q4 2025 [8][24] - **Clinical Trial Support**: Coya has partnered with the NILS Foundation, the largest ALS consortium, to facilitate faster recruitment for the trial [9] Clinical Data and Outcomes - **Current ALS Treatment Landscape**: Existing therapies show minimal efficacy, with patients declining by approximately 6 points in 6 months on the ALSFRS scale [14] - **Initial Study Results**: In a small investigator-initiated study, Coya observed stabilization or improvement in ALSFRS scores, contrasting with expected declines [16][17] - **Mechanistic Insights**: The combination therapy has shown to maintain Treg function and numbers, which are crucial for managing neuroinflammation [12][18] Future Plans and Partnerships - **Regulatory Pathway**: The primary endpoint for the Phase 2b trial is set for 6 months, with plans to approach the FDA for a BLA filing based on the data [23] - **Commercialization Partnership**: Coya has partnered with Dr. Reddy's Laboratories for the commercialization of COIA-302, which will alleviate some financial burdens associated with bringing the product to market [24][26] - **Funding and Cash Flow**: A $700 million partnership with Dr. Reddy's provides non-dilutive cash flow, enhancing Coya's financial position [26] Additional Indications - **Frontotemporal Dementia (FTD)**: Coya plans to file an IND for FTD this year, with a small randomized study expected to start in 2026, supported by a $5 million investment from the Alzheimer's Drug Discovery Foundation [29] - **COIA-303 Development**: A new product combining COIA-301 with GLP-1 weight loss drugs shows promise in reducing neuroinflammatory markers, with potential applications in Alzheimer's disease [30][31] Key Metrics and Milestones - **Upcoming Milestones**: - Dosing of the first ALS patient in 2025, triggering a $4.2 million payment from Dr. Reddy's [33] - Filing for FTD IND and additional data from ongoing trials expected by the end of 2025 [33] Conclusion - Coya Therapeutics is positioned to make significant advancements in the treatment of neurodegenerative diseases, with a strong scientific foundation, promising early clinical data, and strategic partnerships that enhance its operational and financial capabilities [34]

Core Insights - Athira Pharma, Inc. presented results from its Phase 1 clinical trial of ATH-1105 at the ALS Nexus 2025 conference, focusing on developing treatments for neurodegenerative diseases like ALS [1][3] - ATH-1105 is a novel, orally available small molecule designed to modulate the neurotrophic HGF system, potentially offering new treatment options for ALS [2][3] Group 1: Clinical Trial Results - The Phase 1 trial of ATH-1105 involved 80 healthy volunteers and evaluated the safety, tolerability, and pharmacokinetics of the drug, showing a favorable safety profile and good tolerability [5] - Results indicated dose-proportional pharmacokinetics and CNS penetration, supporting the continued development of ATH-1105 [3][5] Group 2: Company Overview - Athira Pharma is a clinical-stage biopharmaceutical company based in the Seattle area, focused on developing small molecules to restore neuronal health and slow neurodegeneration [6] - The company aims to alter the course of neurological diseases through its pipeline of drug candidates targeting the neurotrophic HGF system [6]

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]

Core Insights - Alector is on track to report topline data from the INFRONT-3 Phase 3 clinical trial of latozinemab for FTD-GRN by mid-Q4 2025, which is a significant milestone for both the company and the frontotemporal dementia (FTD) community [1][2][3] - The ongoing Phase 2 PROGRESS-AD trial of AL101 in early Alzheimer's disease is expected to complete in 2026, indicating Alector's commitment to advancing treatments for neurodegenerative diseases [1][2] - Alector has a strong cash position of $307.3 million as of June 30, 2025, which is projected to fund operations into the second half of 2027 [1][11] Clinical Development - Latozinemab is being developed in collaboration with GSK and aims to restore progranulin levels in the brain, addressing a genetic cause of FTD [2][3][6] - The INFRONT-3 trial is a 96-week, randomized, double-blind, placebo-controlled study, with potential BLA and MAA submissions planned for 2026, depending on trial outcomes [3][6] - AL101, another investigational therapy, is designed similarly to latozinemab and is currently in a Phase 2 trial for early Alzheimer's disease, with enrollment completed in April 2025 [6][8] Financial Performance - Collaboration revenue for Q2 2025 was $7.9 million, a decrease from $15.1 million in Q2 2024, primarily due to the completion of performance obligations related to previous programs [8] - Total R&D expenses for Q2 2025 were $27.6 million, down from $46.3 million in the same quarter of 2024, reflecting reduced spending on certain programs [9] - Alector reported a net loss of $30.5 million for Q2 2025, an improvement from a net loss of $38.7 million in Q2 2024, indicating a positive trend in financial management [10] Research and Development Pipeline - Alector is advancing its preclinical and research pipeline, including brain-penetrant candidates enabled by its proprietary Alector Brain Carrier platform, which aims to enhance therapeutic delivery across the blood-brain barrier [5][6] - The company is progressing several candidates, including an anti-amyloid beta antibody and anti-tau siRNA for Alzheimer's disease, as well as an engineered GCase enzyme replacement therapy for Parkinson's disease [5][6] - The statistical analysis plan for the INFRONT-3 trial has been amended to include plasma progranulin as a co-primary endpoint, highlighting the focus on relevant biomarkers in clinical trials [6]

Core Insights - Alector, Inc. is a late-stage clinical biotechnology company focused on developing therapies for neurodegenerative diseases, with a conference call scheduled for August 7, 2025, to discuss Q2 results and provide a mid-year business update [1][2]. Company Overview - Alector is dedicated to counteracting the progression of neurodegenerative diseases by leveraging genetics, immunology, and neuroscience [3]. - The company is advancing a portfolio of genetically validated programs aimed at removing toxic proteins, replacing missing proteins, and restoring immune and nerve cell function [3]. - Alector's product candidates target various indications, including frontotemporal dementia, Alzheimer's disease, and Parkinson's disease [3]. - The company is developing the Alector Brain Carrier (ABC), a proprietary platform designed to enhance therapeutic delivery across the blood-brain barrier, aiming for improved efficacy and reduced costs [3].