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]

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 initiated patient enrollment for the Phase 2 SUNRISE-PD clinical trial, which evaluates the safety and efficacy of bezisterim in patients with Parkinson's disease who have not been treated with carbidopa/levodopa, with topline data expected in late 2024 or early 2025 [2][4][7] 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 [14][15] - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer and anti-inflammatory drug candidate that may provide clinical improvements in various disease indications [11][14] Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study designed to last 20 weeks, with approximately 60 patients randomized to receive either 20 mg of bezisterim or placebo twice daily [4][5] - The trial incorporates a decentralized approach, allowing patients to participate remotely, which broadens access for individuals with Parkinson's disease [4][6][7] Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms, with current treatments primarily providing symptomatic relief without modifying disease progression [3][8][9] - Emerging research indicates that chronic inflammation and insulin resistance play critical roles in the onset and progression of Parkinson's disease, suggesting that targeting these mechanisms may offer new therapeutic avenues [10][12] Support and Collaboration - Patient enrollment for the SUNRISE-PD trial is supported by prominent advocacy groups, including The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson's Foundation, emphasizing the importance of increased patient access to clinical trials [2][7][6]

Core Viewpoint - BioVie Inc. is hosting a virtual investor event to discuss the unmet needs and treatment landscape for long COVID, featuring KOL Lindsay McAlpine, MD, on April 10, 2025 [1] Group 1: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including long COVID, Alzheimer's disease, and Parkinson's disease [6] - The company's drug candidate, bezisterim (NE3107), is an oral, blood-brain barrier-permeable, anti-inflammatory agent that selectively inhibits inflammation-driven mediators without affecting their homeostatic functions [2][6] - BioVie is also developing BIV201, an orphan drug candidate for advanced liver disease, which has received FDA Fast Track status [6] Group 2: Long COVID Insights - Long COVID is characterized by persistent symptoms of COVID-19 lasting three months or more, affecting over 17 million adults in the U.S., with a potential prevalence of up to 22% [5] - The economic impact of long COVID is estimated at $3.7 trillion, highlighting the significant loss in quality of life and increased medical costs [5] - Currently, there are no proven effective therapies for the treatment of long COVID, indicating a substantial unmet medical need [5] Group 3: Research and Development - The ADDRESS-LC trial is evaluating bezisterim for long COVID, with a focus on chronic neuroinflammation potentially driven by the viral spike protein [2] - The event will include a live Q&A session to engage with participants and address inquiries regarding the trial and treatment options [3]

Financial Performance - The net loss for the three months ended December 31, 2024, was approximately $7.1 million, a decrease from the net loss of $8.4 million for the same period in 2023, reflecting a $1.3 million improvement [133]. - The net loss for the six months ended December 31, 2024, was approximately $11.3 million, significantly reduced from $19.1 million for the same period in 2023, a decrease of $7.8 million [139]. - Other income decreased by approximately $395,000, from $545,000 in 2023 to $150,000 in 2024, mainly due to a change in fair value of derivative liabilities and reduced interest income [146]. - The accumulated deficit as of December 31, 2024, was approximately $345.9 million [148]. Operating Expenses - Total operating expenses for the three months ended December 31, 2024, were approximately $7.3 million, down from $8.8 million in 2023, indicating a net decrease of approximately $1.5 million [134]. - Total operating expenses for the six months ended December 31, 2024, were approximately $11.4 million, down from $19.7 million in 2023, reflecting a decrease of approximately $8.3 million [140]. - Selling, general and administrative expenses increased by approximately $409,000, from $4.2 million in 2023 to $4.6 million in 2024, driven by higher consultancy and legal fees [145]. Research and Development - Research and development expenses decreased to approximately $4.7 million for the three months ended December 31, 2024, from $6.5 million in 2023, a decline of $1.8 million [135]. - Research and development expenses decreased by approximately $8.7 million, from $15.3 million in 2023 to $6.7 million in 2024, primarily due to the completion of clinical studies [141]. - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease was completed in December 2022, meeting both primary and secondary objectives [124]. - The Company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense for evaluating bezisterim (NE3107) for long COVID treatment [126]. - BIV201, an investigational drug for liver disease, has received FDA Fast Track and Orphan Drug status, with ongoing discussions regarding Phase 3 clinical testing [127]. - In March 2023, data from the first 15 patients treated with BIV201 indicated at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the pre-treatment period [129]. - Bezisterim (NE3107) has been patented in the United States, Australia, Canada, Europe, and South Korea, indicating the Company's commitment to protecting its intellectual property [122]. Cash Flow and Financing - As of December 31, 2024, the company had working capital of approximately $23.2 million and cash and cash equivalents totaling approximately $24.4 million [148]. - The company used net cash in operations totaling approximately $12.2 million, while net cash provided by financing activities was approximately $12.7 million [149]. - 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 [150]. - The company raised approximately $15.9 million from October offerings, with gross proceeds before fees and expenses [154]. - The company completed a public offering in September 2024, raising approximately $3.0 million before deducting fees and expenses [153]. - The company has raised funds through various equity offerings, including a Controlled Equity Offering that generated approximately $6,400 in net proceeds [152].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against BioVie Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors [1] Summary by Relevant Sections Allegations - The class action complaint alleges that during the Class Period from August 5, 2021, to November 29, 2023, BioVie made materially false and misleading statements and failed to disclose adverse facts about its business and operations [2] - Specific allegations include: - Lack of proper oversight of the Phase 3 clinical trial [2] - Negative impact of the COVID-19 pandemic on the trial's oversight [2] - Increased risk of unreliable data due to reliance on contract research organizations, leading to significant patient exclusions from the trial [2] - Failure of the Phase 3 clinical trial to meet its primary endpoints due to these exclusions [2] - Misleading statements regarding BioVie's business, operations, and compliance with current good clinical practices [2] Contact Information - Long-term stockholders of BioVie are encouraged to reach out for more information regarding the claims or their rights [3] - Contact can be made via email or telephone, with no cost or obligation to the stockholders [3] About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents investors in various complex litigations across state and federal courts [4]

Financial Performance - The net loss for the three months ended September 30, 2024, was approximately $4.2 million, a decrease of $6.5 million compared to a net loss of $10.7 million for the same period in 2023[123]. - Total operating expenses for the three months ended September 30, 2024, were approximately $4.1 million, down from $10.9 million in the same period in 2023, reflecting a decrease of approximately $6.8 million[124]. - Research and development expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline of approximately $6.9 million from $8.9 million for the same period in 2023[125]. - As of September 30, 2024, the Company had working capital of approximately $13.3 million and cash and cash equivalents totaling approximately $20.0 million[131]. - The Company has not generated any revenue and does not expect to do so in the foreseeable future, relying on ongoing development and financing efforts[133]. Clinical Trials and Drug Development - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease was completed in December 2022, with both primary and secondary objectives met[114]. - 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, with trials expected to commence by early 2025[116]. - BIV201, an investigational drug for liver disease, showed a 53% reduction in ascites fluid for patients who completed treatment, sustained at a 43% reduction over three months post-treatment[119]. - The FDA has granted Fast Track and Orphan Drug status to BIV201, which is being evaluated for the treatment of ascites due to chronic liver cirrhosis[117]. - The Company anticipates finalizing protocol designs for the Phase 3 study of BIV201 following guidance from the FDA regarding clinical testing[120]. Capital Raising Activities - During the three months ended September 30, 2024, the Company sold approximately 2,143 shares of Common Stock for total net proceeds of approximately $6,400 after commissions and offering costs[135]. - The Company closed a public offering on September 25, 2024, of 1,360,800 shares at a combined public offering price of $1.53 per share, generating gross proceeds of approximately $3.0 million before expenses[136]. - In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares, with gross proceeds of approximately $15.9 million before expenses[137]. - The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following issuance[137]. - The Company issued placement agent warrants in the October Offerings to purchase 412,800 shares of Common Stock at prices ranging from $1.88 to $3.54 per share[137]. - The September Common Warrants have an exercise price of $1.53 per share and are immediately exercisable upon issuance[136]. - The Company incurred offering expenses of approximately $747,000 for the September 2024 Offering and approximately $2.8 million for the October Offerings[136][137]. - The September Placement Agent's Warrants are exercisable at a price of $1.91 per share, equal to 125% of the public offering price[136]. Accounting Policies - The Company added a Grant Program accounting policy for the three-month period ended September 30, 2024, with no other significant changes to critical accounting policies[138]. - The Company determined that recent accounting pronouncements are either not applicable or expected to have minimal impact on financial statements[139].

Core Viewpoint - BioVie Inc. has announced a registered direct offering of 1,146,000 shares of its common stock at a price of $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on or about October 29, 2024, pending customary closing conditions [2]. - ThinkEquity is acting as the sole placement agent for this offering [2]. - The shares are being offered under a shelf registration statement filed with the SEC, which became effective on August 28, 2023 [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for working capital and general corporate purposes [2]. Group 3: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic conditions, including neurological disorders and liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in Alzheimer's disease and Parkinson's disease [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].