Core Viewpoint - Long COVID is increasingly recognized as a serious condition affecting millions, with no approved treatment options currently available, highlighting the urgent need for effective therapies [1][2][4] Group 1: Long COVID Overview - Long COVID impacts approximately 20 million adults in the U.S. and millions more globally, with 10-30% of COVID-19 patients experiencing lingering symptoms such as fatigue and cognitive impairment [2][5] - The economic impact of long COVID is significant, estimated at $3.7 trillion due to loss in quality of life, earnings, and increased medical costs [5] Group 2: Bezisterim Development - BioVie Inc. has initiated the Phase 2 ADDRESS-LC clinical trial to evaluate bezisterim (NE3107) for treating neurological symptoms associated with long COVID, with topline data expected in the first half of 2026 [1][3] - Bezisterim targets neuroinflammation, which is believed to play a central role in long COVID symptoms, and has shown potential in reducing chronic symptoms in trials for Alzheimer's and Parkinson's diseases [1][3][6] Group 3: Clinical Trial Details - The ADDRESS-LC study is a randomized, placebo-controlled trial involving approximately 200 patients with long COVID experiencing cognitive impairment and fatigue [3][8] - The trial is fully funded by a $13.13 million grant from the U.S. Department of Defense [10] Group 4: Mechanism of Action - Bezisterim is an orally bioavailable, blood-brain barrier-permeable compound that modulates inflammatory pathways implicated in chronic inflammation, potentially improving symptoms in long COVID patients [6][8] - The drug is designed to reduce neuroinflammation and address metabolic dysfunction, which may help restore normal function and improve quality of life for affected individuals [3][4] Group 5: Broader Implications - The persistent presence of SARS-CoV-2 proteins and the resulting inflammatory pathways are linked to prolonged neuroinflammation and symptoms in long COVID patients, indicating a need for targeted interventions [4][8] - BioVie is also conducting trials for bezisterim in Parkinson's and Alzheimer's diseases, demonstrating its broader therapeutic potential [7][9]

Core Insights - Masitinib demonstrates neuroprotective effects by lowering serum neurofilament light chain (NfL), a key biomarker for neurodegenerative disorders such as multiple sclerosis, amyotrophic lateral sclerosis, and Alzheimer's disease [1][4][6] Group 1: Research Findings - The study published in PLOS One shows that masitinib can significantly reduce serum NfL levels, indicating its potential neuroprotective effects [1][3] - At Day 8, masitinib treatment reduced NfL levels by 43% at a dosage of 50 mg/kg/day and by 60% at 100 mg/kg/day, demonstrating a dose-dependent response [5][11] - Absolute serum NfL concentrations were approximately 25% lower in both masitinib treatment groups compared to the EAE control group at Day 8, with further reductions observed at Day 15 [5][6] Group 2: Mechanism of Action - Masitinib targets the innate neuroimmune system, specifically mast cells and microglia, which are implicated in the pathophysiology of neurodegenerative diseases [4][7] - The drug has shown clinical benefits in previous trials for progressive multiple sclerosis, ALS, and mild-to-moderate Alzheimer's disease, reinforcing its therapeutic promise [4][6] Group 3: Functional Performance - Masitinib treatment improved grip strength in EAE mouse models, with treated mice recovering to baseline levels by Day 15, indicating a protective effect on motor function [11] - Both treatment groups exhibited significantly less relative deterioration in grip strength compared to the EAE control group (p < 0.001) [11]

This presentation by Contineum Therapeutics, Inc. ("Contineum", "We" or "Our) contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including without limitation statements regarding our future results of operations and financial position, future revenue, timing, progress and expected results of our clinical trials and our product development efforts, business strategy, prospects, research and development costs, timing and likelihood of ...

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Core Insights - Nyxoah is on track for anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements and currently undergoing final site inspection [2][4][17] - The company reported a revenue of €1.1 million for Q1 2025, a decrease from €1.2 million in Q1 2024, with a gross profit margin of 61.8% [5][10][11] - Significant increases in research and development expenses (€9.0 million) and selling, general and administrative expenses (€12.4 million) were noted, contributing to an operating loss of €20.6 million for Q1 2025 [12][13][14] Financial Performance - Revenue for Q1 2025 was €1.1 million, down from €1.2 million in Q1 2024 [10] - Cost of goods sold was €406,000, resulting in a gross profit of €658,000 [11] - Research and development expenses rose to €9.0 million from €7.2 million year-over-year [12] - Selling, general and administrative expenses increased to €12.4 million from €6.0 million year-over-year [13] - The operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024 [14] Cash Position - As of March 31, 2025, cash, cash equivalents, and financial assets totaled €63.0 million, down from €85.6 million at the end of 2024 [15] Regulatory Progress - The FDA issued an Approvable Letter for Nyxoah's PMA application for the Genio® system, indicating that the application meets the necessary requirements [6][17] - The final step before full PMA approval is an on-site inspection of the U.S. manufacturing site, which has already passed a previous inspection with no deficiencies [4][18] Company Overview - Nyxoah focuses on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, a hypoglossal neurostimulation therapy [21] - The company received its European CE Mark for the Genio® system in 2019 and has conducted successful IPOs on Euronext Brussels and NASDAQ [22]

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].

This presentation may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking s ...