Core Viewpoint - BioVie Inc. has announced a public offering of 6,000,000 units at a price of $2.00 per unit, aiming to raise approximately $12 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - Each unit consists of one share of common stock and one warrant, with pre-funded units available [1]. - The gross proceeds from the offering are expected to be around $12 million before deducting underwriting discounts and commissions [1]. - The warrants will be immediately exercisable at an exercise price of $2.50 per share and will expire five years from issuance [1]. - The underwriter has a 45-day option to purchase up to an additional 900,000 shares or warrants to cover over-allotments [1]. Group 2: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic debilitating conditions, including liver disease and neurological disorders [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in Alzheimer's and Parkinson's diseases [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].

Core Insights - BioVie Inc. presented findings on Bezisterim, indicating its potential to decrease biological age acceleration in Alzheimer's Disease by modulating DNA methylation of over 100 genes related to aging and diseases of aging [1][4]. Group 1: Bezisterim's Mechanism and Effects - Bezisterim modulates TNFα-driven inflammation, helping to reestablish homeostasis and affecting multiple genes simultaneously [4]. - The treatment resulted in significant age deceleration across various biological clocks after 30 weeks, including reductions of -3.16 years for SkinBloodClockAge and -4.12 years for PhenoAge [5]. - Bezisterim demonstrated modulation of inflammatory gene expression, reducing levels of inflammatory cytokines such as TNFα, IL-6, and IL-17 [5]. Group 2: Clinical Trials and Efficacy - BioVie is conducting ongoing studies to explore Bezisterim's potential in improving healthspan in normal aging and its effects on neurodegenerative diseases [4]. - In Alzheimer's Disease, Bezisterim-treated patients showed improved cognition and biomarker levels in a Phase 2 trial, with significant improvements in metabolic and inflammatory biomarkers compared to placebo [10][11]. - The company is also enrolling patients in a Phase 2 trial for Parkinson's Disease, with topline data expected in late 2025 or early 2026 [8]. Group 3: Safety and Tolerability - Bezisterim is not immunosuppressive and has shown favorable safety and tolerability profiles in clinical trials for Alzheimer's Disease and Parkinson's Disease [6][7].

Core Insights - BioVie Inc. has appointed Amy S. Chappell, MD, FAAN, and Kameel D. Farag to its Board of Directors, enhancing its leadership in neuroscience drug development and corporate finance [1][2][3] 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, as well as advanced liver disease [5] - The company's lead drug candidate, bezisterim, targets neuroinflammation and insulin resistance, which are key factors in Alzheimer's and Parkinson's diseases, as well as neurological symptoms of long COVID [5] Leadership Expertise - Dr. Amy S. Chappell has over 25 years of experience in clinical neuroscience, having played a significant role in the development and FDA approval of multiple CNS therapies during her tenure at Eli Lilly & Co. [2] - Kameel D. Farag has a strong background in biotech and global finance, with experience in scaling companies and securing significant financing, including over $150 million at Aspen Neuroscience [3] Clinical Development Progress - BioVie is advancing bezisterim through Phase 2 trials for early Parkinson's disease and long COVID, while also planning further clinical development for Alzheimer's disease and ascites programs [2][4] - The company recently presented promising data on bezisterim's potential to slow or reverse biological aging and neurodegeneration at a major conference [4] Regulatory Status - BioVie’s orphan drug candidate BIV201, which is under FDA Fast Track status, is being evaluated for its effectiveness in reducing further decompensation in patients with liver cirrhosis and ascites [5]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim, which shows promise in treating neurological disorders, particularly Alzheimer's disease, Parkinson's disease, and long COVID, by modulating inflammation and potentially altering biological aging [1][9]. Group 1: Bezisterim's Mechanism and Effects - Bezisterim differs from traditional Alzheimer's treatments by modulating inflammation and affecting multiple genes simultaneously, potentially altering biological age through anti-inflammatory epigenetic modifications [2][3]. - In a Phase 3 study, bezisterim demonstrated significant effects on biological aging, with bezisterim-treated patients showing an average biological age reduction of -3.16 years for SBCAge and -4.12 years for PhenoAge compared to placebo [5]. - Bezisterim has shown improvements in metabolic and inflammatory biomarkers, including a decrease of -8.5 mg/dL in fasting glucose and -15 mg/dL in cholesterol levels compared to placebo [5]. Group 2: Clinical Trials and Studies - The ongoing Phase 2 SUNRISE-PD trial is evaluating bezisterim's safety and efficacy in Parkinson's disease, with topline data expected in late 2025 or early 2026 [5]. - Previous studies indicated that bezisterim improved motor control in Parkinson's patients when combined with levodopa, with no adverse events reported [6]. - The Phase 2 ADDRESS-LC study aims to assess bezisterim's efficacy in reducing neurological symptoms associated with long COVID, targeting cognitive dysfunction and fatigue [7]. Group 3: Company Overview and Future Directions - BioVie Inc. focuses on developing innovative therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance, key factors in Alzheimer's and Parkinson's diseases [9]. - The company is also advancing its orphan drug candidate BIV201 for liver cirrhosis, which has received FDA Fast Track status [9].

Core Insights - BioVie Inc. is conducting a hybrid, decentralized Phase 2 clinical trial named SUNRISE-PD to evaluate bezisterim (NE3107) in early-stage Parkinson's disease, focusing on patient access and participation [1][2][3] Group 1: Clinical Trial Design - The SUNRISE-PD trial addresses barriers to participation in clinical trials for Parkinson's disease, such as delayed diagnosis and limited mobility, by allowing home or clinic visits [2][3] - The trial is designed to be flexible, utilizing in-home visits by study nurses and remote assessments via video conferencing, ensuring high-quality data collection through digital tools [4] Group 2: Drug Profile - Bezisterim is an orally available, blood-brain barrier-permeable compound that targets inflammation and insulin resistance, showing promise in improving both motor and non-motor symptoms of Parkinson's disease [5][9] - Previous trials indicated that bezisterim has a favorable safety profile and may modify the progression of Parkinson's disease, particularly in early-stage patients [5][10] Group 3: Enrollment and Partnerships - The trial is enrolling participants aged 41 to 80 diagnosed within the last four years who have not yet started treatment with carbidopa/levodopa or other dopamine receptor agonists [3] - BioVie is collaborating with organizations like The Michael J. Fox Foundation to enhance awareness and facilitate participant enrollment across the U.S. [3] Group 4: Presentation Details - A poster detailing the SUNRISE-PD trial will be presented at the Advanced Therapeutics in Movement & Related Disorders Congress from June 27-30, 2025, highlighting the trial's patient-centric approach [1][6]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of early Parkinson's disease, with a Phase 2 SUNRISE-PD trial set to present findings at an upcoming congress [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses on developing innovative therapies for neurological disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as advanced liver disease [12]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects [7][12]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, allowing patients to participate either from home or at clinical sites [2][3]. - The trial aims to evaluate the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients not previously treated with carbidopa/levodopa, with topline data expected in late 2025 or early 2026 [8]. Parkinson's Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact quality of life [4]. - Traditional treatment with levodopa has limitations, including motor fluctuations and dyskinesia, highlighting the need for new therapeutic approaches [5]. Mechanism of Action - Bezisterim targets neuroinflammation and insulin resistance, which are implicated in the progression of Parkinson's disease, potentially offering a new treatment avenue [6][7]. Previous Research Findings - A prior Phase 2 study of bezisterim showed significant improvements in motor control and "morning on" symptoms when combined with levodopa, with no drug-related adverse events reported [9].

Financial Data and Key Metrics Changes - The company reported a total of 18,570,726 shares of common stock issued and outstanding as of the record date [5][6] - Approximately 79.7% of the shares voted in favor of the reverse stock split proposal, while 81.2% voted in favor of the adjournment of the special meeting proposal [19] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were provided in the meeting records Market Data and Key Metrics Changes - No specific market data or key metrics were provided in the meeting records Company Strategy and Development Direction and Industry Competition - The board of directors was granted authority to effect a reverse stock split of the outstanding shares at a ratio between one for five and one for ten, indicating a strategic move to potentially enhance the stock price and attract institutional investors [11] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The special meeting was held to discuss and vote on the reverse stock split proposal and the adjournment of the meeting [11][14] - The meeting concluded with the approval of both proposals, indicating a consensus among shareholders [20] Summary of Q&A Session - There were no questions raised during the meeting, as it primarily focused on voting for the proposals presented [17]

Summary of BioV Virtual KOL Event Company and Industry - **Company**: BioV - **Industry**: Neurodegenerative diseases, specifically focusing on Parkinson's disease and Alzheimer's disease Core Points and Arguments 1. **Introduction of Bezesterone**: Bezesterone is a novel orally bioavailable anti-inflammatory agent that targets inflammation and oxidative stress in neurodegenerative diseases, particularly Parkinson's disease [27][28][29] 2. **Mechanism of Action**: Bezesterone acts on the ERK signaling pathway, reducing tumor necrosis factor expression and activity, and is designed to improve insulin signaling without interfering with homeostasis [30][31][32] 3. **Neuroinflammation's Role**: Neuroinflammation is a significant factor in Parkinson's disease, driving both symptoms and disease progression. Bezesterone aims to reduce this inflammation, potentially improving both motor and non-motor symptoms [35][38] 4. **Clinical Study - Sunrise PD**: The Sunrise PD study is a phase two double-blind randomized controlled trial designed to evaluate the efficacy of bezesterone in early-stage Parkinson's patients who have not been exposed to dopaminergic therapy [52][81] 5. **Endpoints and Measurements**: The primary endpoint is the change in the modified MDS UPDRS rating scale, focusing on motor symptoms, while secondary endpoints include various non-motor symptoms and exploratory biomarkers [53][54] 6. **Comparison with Exenatide**: The panel discussed the limitations of exenatide in Parkinson's treatment and expressed confidence that bezesterone's dual action on inflammation and insulin signaling could yield better results [68][72] 7. **Home-Based Trial Design**: The trial allows for home assessments, where trained nurses conduct evaluations, ensuring patient comfort and potentially increasing participation rates [87][88] 8. **Potential for Disease Modification**: Preclinical data suggest that bezesterone has neuroprotective effects and may modify disease progression, with evidence from various CNS models showing reduced neuronal death [85][86] 9. **Future Plans for Alzheimer's Program**: BioV is also interested in pursuing Alzheimer's research, pending funding availability, with a focus on the adverse event profile observed in previous studies [92] Other Important Content 1. **Expert Presentations**: The event featured presentations from leading experts in neurology, discussing the pathophysiology of Parkinson's disease and the importance of addressing neuroinflammation and oxidative stress [4][5][7] 2. **Patient-Centric Approach**: The trial design emphasizes patient convenience and aims to standardize assessments across remote and traditional sites, potentially improving the quality of data collected [49][62] 3. **Discussion on Non-Motor Symptoms**: The panel acknowledged the significance of non-motor symptoms in Parkinson's disease and their role in diagnosis and treatment [82] 4. **Adverse Event Profile**: Bezesterone has shown a favorable safety profile in previous studies, with adverse effects similar to placebo, which is crucial for patient acceptance [38][60] This summary encapsulates the key points discussed during the BioV virtual KOL event, highlighting the company's focus on innovative treatments for neurodegenerative diseases and the ongoing clinical research efforts.

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 - 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]