Core Viewpoint - Invivyd, Inc. announced that the SPEAR Study Group has issued a consensus recommendation for a clinical study design to evaluate monoclonal antibody therapy for Long COVID, which will be presented to the NIH initiative RECOVER-TLC [1][2]. Group 1: Study Design and Objectives - The SPEAR Study Group aims to explore the role of persistent viral reservoirs and circulating spike protein in Long COVID through a proposed clinical study focusing on broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibodies, including VYD2311 [2][5]. - Key elements of the proposed clinical study include deploying high levels of neutralizing monoclonal antibodies over the long term, a randomized placebo-controlled design with over 100 patients per arm, and measuring reduction in detectable spike antigen as a critical endpoint [6][5]. - The study will also explore potential symptom improvement using standardized instruments to correlate the modification of underlying chronic infection with clinical benefits [6][5]. Group 2: Presentation and Workshop - Drs. Amy Proal and David Putrino will present the proposed study design at the Second Annual RECOVER-TLC Workshop on September 9-10, 2025, in Bethesda, Maryland [3]. - Dr. David Putrino will present the study design for funding consideration on September 10, 2025, at 9:25 a.m. ET, while Dr. Amy Proal will discuss the antiviral landscape and implications for Long COVID research later that day at 1:00 p.m. ET [3]. Group 3: VYD2311 Overview - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, with a pharmacokinetic profile that may allow for patient-friendly administration [7][8]. - The antibody was engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages, leveraging the same backbone as other investigational mAbs with emergency use authorization [8][9].

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]

Financial Data and Key Metrics Changes - The company reported a record revenue of $31.1 million for Q2 2025, representing a 37% increase year over year, and a net income of $3.6 million compared to virtually breakeven a year ago [7][20]. - The cash position at the end of the quarter was $60.5 million with no debt [24]. - Gross margin improved to 65%, up from 60.2% a year ago, driven by lower cost inventory and higher e-commerce sales [22]. Business Line Data and Key Metrics Changes - E-commerce business generated $18.1 million in net sales, a 39% increase year over year [7][21]. - The food grade and pharmaceutical grade Niagen ingredient business grew 135% year over year, with revenue of $7.4 million [8][21]. - TRU NIAGEN revenue increased by 22% to $22.7 million, primarily driven by e-commerce revenues [21]. Market Data and Key Metrics Changes - The company is expanding its presence in wellness clinics, onboarding over 800 clinics nationwide to offer the Niagen Plus product line [8]. - The partnership with Watsons in Hong Kong is contributing to steady revenues, with plans for joint marketing efforts to grow brand presence [22]. Company Strategy and Development Direction - The company is focusing on expanding its Niagen Plus product line and exploring telehealth functionality on its website [9][8]. - A worldwide exclusive license agreement was signed with Haukeland University Hospital for the development of nicotinamide riboside as a potential therapy for Parkinson's disease [17]. - The company aims to maintain its position as the gold standard in NAD science and is committed to scientific innovation in the dietary supplement industry [14][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory and strategic goals, highlighting the strong demand for NAD products [19][20]. - The company raised its revenue growth expectation for the full year from 20%-25% to a range of 22%-27% year over year [27]. - Management noted ongoing scrutiny from California regarding outsourcing facility practices but remains optimistic about the partnership with Wells Pharmacy Network [9][10]. Other Important Information - The company has been featured in major media outlets and events, increasing awareness of its products [10][12]. - There is ongoing research into the effects of NAD supplementation on long COVID and fertility, with studies expected to be published soon [15][16][51]. Q&A Session Summary Question: Regarding the initiative for Parkinson's disease - Management indicated that if the NOPARC trial results are positive, they may pivot to nicotinamide riboside triacetate for FDA approval in the U.S. [30][32]. Question: Volume and pricing for NIAGEN IV in clinics - Management noted that while clinics are currently charging high prices for IV experiences, they believe prices need to come down to increase accessibility and volume [36][39]. Question: Steps for treating long COVID - The key milestone to watch is the publication of the Harvard study on NAD supplementation for long COVID, which could lead to a marketing campaign if results are positive [49][54].

Core Insights - BioVie Inc. is hosting a virtual key opinion leader event to discuss the unmet needs and treatment landscape for Parkinson's disease on May 28, 2025 [1] - The event will provide updates on BioVie's Phase 2 trial (SUNRISE-PD) evaluating bezisterim (NE3107) for Parkinson's disease treatment [2] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and Long COVID [12] - The company's drug candidate, bezisterim, is designed to inhibit inflammatory activation and insulin resistance, which are key drivers of neurodegenerative diseases [12] Clinical Trials and Research - BioVie is currently enrolling patients for the Phase 2 SUNRISE-PD trial, which aims to evaluate bezisterim's safety and efficacy in patients recently diagnosed with Parkinson's disease [9] - Previous Phase 2 studies indicated significant improvements in motor control and "morning on" symptoms when bezisterim was combined with levodopa, with no drug-related adverse events reported [9] Key Opinion Leaders - The event will feature Dr. Suzanne de la Monte and Dr. Mark Stacy, both of whom have extensive backgrounds in neurology and Parkinson's disease research [4][5] - Dr. de la Monte has published over 300 peer-reviewed articles and is known for her research on brain insulin resistance and neurodegenerative disorders [4] - Dr. Stacy has also published extensively on Parkinson's disease and has held various leadership roles in related research centers [5] Parkinson's Disease Insights - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact patients' quality of life [6] - Chronic inflammation and insulin resistance are emerging as critical factors in the onset and progression of Parkinson's disease, highlighting the potential for anti-inflammatory and insulin-sensitizing therapies [7] Bezisterim Overview - Bezisterim is an orally bioavailable modulator that can cross the blood-brain barrier, targeting inflammation and insulin resistance without immunosuppression [8] - The drug has shown promise in treating not only Parkinson's disease but also Alzheimer's disease and neurological symptoms associated with Long COVID [8][10]