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]

Financial Performance - The net loss for the three months ended March 31, 2025, was approximately $2.8 million, a decrease of $5.3 million compared to the net loss of $8.1 million for the same period in 2024[128]. - The net loss for the nine months ended March 31, 2025, was approximately $14.1 million, a decrease of $13.1 million compared to the net loss of $27.2 million for the same period in 2024[134]. - Total operating expenses for the three months ended March 31, 2025, were approximately $3.0 million, down from $7.7 million in the same period in 2024, reflecting a decrease of approximately $4.7 million[129]. - Total operating expenses for the nine months ended March 31, 2025, were approximately $14.4 million, down from $27.4 million in 2024, reflecting a decrease of approximately $13.0 million[135]. - Other income increased to approximately $350,000 for the nine months ended March 31, 2025, up from approximately $210,000 in the prior year, driven by a rise in interest income[139]. - The company used net cash in operations totaling approximately $13.4 million, while net cash provided by financing activities was approximately $12.7 million[141]. - The company has not generated any revenue and does not expect to do so in the foreseeable future, relying on ongoing development and commercialization efforts[142]. - There is substantial doubt regarding the company's ability to continue as a going concern due to uncertainties in obtaining sufficient financing[143]. Research and Development - Research and development expenses decreased to approximately $1.3 million for the three months ended March 31, 2025, from $5.7 million in 2024, a reduction of $4.4 million[130]. - Research and development expenses for the nine months ended March 31, 2025, were approximately $8.0 million, a reduction of $13.0 million from $21.0 million in 2024, primarily due to the completion of clinical studies[136]. - Clinical studies expenses decreased by approximately $7.6 million, with current studies costing $4.1 million for the nine months ended March 31, 2025, compared to $69,079 for the same period in 2024[137]. Clinical Trials and Studies - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease completed in December 2022 met its primary and secondary objectives, demonstrating safety and potential enhancement of levodopa activity[121]. - The Company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense to evaluate bezisterim (NE3107) for long COVID treatment, with trials expected to commence in May 2025[123]. - BIV201, an investigational drug for liver disease, is being evaluated for patients with ascites and has a target population generating over $5 billion in annual treatment costs[124]. - A Phase 2 study of BIV201 showed a 53% reduction in ascites fluid for patients who completed treatment, sustained at 43% over three months post-treatment[127]. Financial Position - As of March 31, 2025, the company had working capital of approximately $21.2 million and cash and cash equivalents totaling approximately $23.2 million[140]. Accounting Policies - A new Grant Program accounting policy was added for the nine-month period ended March 31, 2025, with no other significant changes to critical accounting policies[144]. - Recent accounting pronouncements were assessed and determined to have minimal impact on the company's financial statements[146]. Administrative Expenses - Selling, general and administrative expenses remained stable at approximately $6.2 million for the nine months ended March 31, 2025, with notable decreases in directors' and executive teams' compensation[138].

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 clinical trial named SUNRISE-PD set to present findings at the IAPRD 2025 conference in New York City [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses 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 [13]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects, potentially addressing multiple disease indications [8][13]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, evaluating bezisterim's safety and efficacy in patients with early Parkinson's disease [3][4]. - Patients can participate either from home or at clinical sites, with remote supervision by neurologists during assessments [4]. 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 patients' quality of life [5]. - Traditional treatments like levodopa have limitations, including long-term complications such as motor fluctuations and dyskinesia [6]. Mechanism of Action - Bezisterim targets chronic inflammation and insulin resistance, which are linked to the progression of Parkinson's disease, by modulating neuroinflammation and metabolic dysfunctions [7][8]. Expected Outcomes - Topline data from the SUNRISE-PD trial is anticipated in late 2025 or early 2026, with previous studies indicating bezisterim's potential to improve motor control and reduce adverse events when combined with levodopa [9][10].

Core Insights - BioVie Inc. has established a Corporate Advisory Board consisting of seven leaders in various fields to enhance its clinical development and business strategy, particularly focusing on neuroinflammatory disorders like Alzheimer's and Parkinson's [1][2][3] Group 1: Corporate Advisory Board - The Corporate Advisory Board aims to support clinical development, inform business strategy, and enhance stakeholder engagement, with members having personal connections to the neuroinflammatory conditions targeted by BioVie [2] - Board members include experts from diverse sectors such as neuroscience, biotechnology, and finance, bringing decades of experience to the company [1][4][5] Group 2: Drug Candidate Bezisterim - Bezisterim (NE3107) is an investigational drug that modulates inflammation and insulin sensitivity, showing potential in treating Alzheimer's, Parkinson's, and long COVID [6][11] - Clinical trials have demonstrated efficacy, with a Phase 3 study for Alzheimer's and a Phase 2 trial for Parkinson's showing promising results in cognitive and motor function improvements [7][8] Group 3: Clinical Development and Research - BioVie is currently enrolling patients for the Phase 2 SUNRISE-PD trial to evaluate bezisterim's effects on Parkinson's disease, with topline data expected in late 2025 or early 2026 [8] - The company has also initiated the ADDRESS-LC study to assess bezisterim's impact on neurological symptoms associated with long COVID, targeting approximately 200 patients [9][10]