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].