PART I [Business](index=5&type=section&id=Item%201.%20Business) BioVie Inc. is a clinical-stage biopharmaceutical company developing treatments for neurological, neurodegenerative, and advanced liver diseases, with key drug candidates bezisterim (NE3107) and BIV201 [Neurodegenerative Disease Program](index=5&type=section&id=Neurodegenerative%20Disease%20Program) This program focuses on bezisterim (NE3107), an orally administered small molecule targeting inflammation-driven insulin resistance for Alzheimer's, Parkinson's, and Long COVID - Bezisterim (NE3107) is an investigational, orally administered small molecule targeting inflammation and insulin resistance for Alzheimer's, Parkinson's, and Long COVID treatment[20](index=20&type=chunk)[21](index=21&type=chunk) - A Phase 3 trial for bezisterim in mild-to-moderate Alzheimer's Disease (NCT04669028) was completed, but data was significantly impacted by protocol violations at **15 study sites**, rendering the trial underpowered for its primary endpoints[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - A Phase 2 study in Parkinson's Disease (NCT05083260) showed significant improvements in motor control, with a new Phase 2b study for new onset PD commencing in April 2025[22](index=22&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The company was awarded a **$13.1 million** grant from the U.S. Department of Defense (DOD) to fund a Phase 2 study (ADDRESS-LC) of bezisterim for neurological symptoms in Long COVID, which began in May 2025[30](index=30&type=chunk)[31](index=31&type=chunk) [Liver Cirrhosis Program](index=7&type=section&id=Liver%20Cirrhosis%20Program) The company is developing BIV201 for ascites in advanced liver cirrhosis, holding FDA Fast Track and Orphan Drug designations, and is finalizing a Phase 3 study protocol - BIV201 is an investigational drug for ascites in advanced liver cirrhosis, granted both FDA Fast Track and Orphan Drug status[35](index=35&type=chunk) - Following a Phase 2 study showing ascites fluid reduction, the company is finalizing a Phase 3 study protocol with a composite primary endpoint for cirrhosis and ascites patients who recovered from acute kidney injury (AKI)[36](index=36&type=chunk)[37](index=37&type=chunk)[40](index=40&type=chunk) - BIV201 features a proprietary, room-temperature stable liquid formulation, with patents granted in the U.S., China, Japan, Chile, and India[36](index=36&type=chunk)[38](index=38&type=chunk) [Intellectual Property](index=9&type=section&id=Intellectual%20Property) BioVie protects its drug candidates, BIV201 and bezisterim (NE3107), through a combination of issued and pending patents in the U.S. and foreign jurisdictions - For BIV201, the company holds Orphan Drug Designations and has been granted patents for its novel liquid formulation in the U.S., India, Chile, China, and Japan[44](index=44&type=chunk) - As of July 31, 2025, the bezisterim (NE3107) portfolio includes **12 issued U.S. patents**, **6 pending U.S. patent applications**, and multiple foreign patents and applications, with some patents expiring as late as 2031[45](index=45&type=chunk)[46](index=46&type=chunk) [Government Regulation](index=10&type=section&id=Government%20Regulation) The company's operations are subject to extensive FDA regulation, involving a lengthy and costly drug approval process with preclinical studies and three phases of clinical trials - The FDA drug approval process involves preclinical tests, an Investigational New Drug (IND) application, and three sequential phases of human clinical trials (Phase 1, 2, and 3)[54](index=54&type=chunk)[61](index=61&type=chunk) - The FDA offers expedited programs like Fast Track, priority review, and accelerated approval for drugs treating serious conditions and unmet medical needs, with BIV201 having Fast Track designation[35](index=35&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk) - Orphan Drug Designation, granted to BIV201 for ascites, can provide **seven years** of market exclusivity in the U.S. if it is the first FDA-approved product for the specified rare disease[65](index=65&type=chunk)[66](index=66&type=chunk) [Risk Factors](index=15&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including reliance on third parties, drug development uncertainty, ongoing litigation, lack of revenue, capital needs, and intellectual property challenges [Risks Relating to Our Business and Industry](index=17&type=section&id=Risks%20Relating%20to%20Our%20Business%20and%20Industry) Operational risks include reliance on third-party CROs, financial instability due to no revenue and capital dependence, and ongoing securities litigation related to trial disclosures - The company's reliance on third parties for clinical trials is a major risk, exemplified by significant protocol and cGCP violations at **15 study sites** in the Phase 3 AD trial for bezisterim, rendering it underpowered[80](index=80&type=chunk) - BioVie is subject to a securities class action lawsuit alleging material misrepresentations regarding its Phase 3 AD study, posing financial and reputational risks[85](index=85&type=chunk)[86](index=86&type=chunk) - The company has no approved products, no revenue, and a limited operating history, raising substantial doubt about its ability to continue as a going concern without significant additional funding[88](index=88&type=chunk)[91](index=91&type=chunk)[100](index=100&type=chunk) [Risks Relating to Our Intellectual Property](index=27&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) Commercial success depends on intellectual property protection, facing risks of patent challenges, invalidation, circumvention, limited global protection, and costly litigation - The company's ability to compete relies on maintaining proprietary technologies, but patents can be challenged, invalidated, or circumvented, and pending applications may not result in issued patents[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - Patent lifespans are limited and may expire before or shortly after product commercialization, exposing the company to generic competition[157](index=157&type=chunk) - The company may face expensive, time-consuming, and unsuccessful lawsuits to protect its patents or defend against third-party infringement claims[165](index=165&type=chunk)[174](index=174&type=chunk) [Risks Relating to Our Common Stock](index=38&type=section&id=Risks%20Relating%20to%20Our%20Common%20Stock) Common stock investors face significant price volatility, future dilution from equity offerings and warrant exercises, and potential negative impacts from a 1-for-10 reverse stock split - The company's stock price is highly volatile and may fluctuate significantly based on clinical results, analyst recommendations, and market conditions[183](index=183&type=chunk) - Stockholders may experience significant future dilution from potential equity offerings, the exercise of outstanding warrants and options, and share issuances upon achieving clinical and regulatory milestones[185](index=185&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk) - The company effected a **1-for-10 reverse stock split** on July 7, 2025, which has caused and could further cause stock price decline and reduced common stock liquidity[189](index=189&type=chunk) [Cybersecurity](index=42&type=section&id=Item%201C.%20Cybersecurity) BioVie's cybersecurity program, managed by an external vendor and overseen by the Audit Committee, protects information systems, with no material threats identified in the last fiscal year - The company's cybersecurity program is managed by an outside vendor, supervised by the CFO, and overseen by the Board's Audit Committee[205](index=205&type=chunk)[206](index=206&type=chunk) - No risks from known cybersecurity threats have materially affected the company in the last fiscal year[206](index=206&type=chunk) [Properties](index=42&type=section&id=Item%202.%20Properties) The company leases its corporate headquarters in Carson City, Nevada, and an additional office in San Diego, California, under separate agreements Properties Leased | Location | Lease Details | | :--- | :--- | | Carson City, NV (HQ) | Annual rent of **$2,200**, one-year term commenced Oct 2022, renewed annually | | San Diego, CA | 60-month term commenced Feb 2024, current monthly rent of **$10,024** with **4% annual increase** | [Legal Proceedings](index=43&type=section&id=Item%203.%20Legal%20Proceedings) BioVie is defending against a consolidated shareholder class action and two derivative lawsuits alleging material misrepresentations regarding its Phase 3 Alzheimer's trial - A consolidated shareholder class action lawsuit alleges material misrepresentations related to the Phase 3 AD trial of bezisterim for securities purchased between December 7, 2022, and November 28, 2023, with the court denying the company's motion to dismiss[210](index=210&type=chunk) - Two shareholder derivative lawsuits making similar allegations have been filed, with one stayed pending the class action suit's motion to dismiss resolution[211](index=211&type=chunk)[212](index=212&type=chunk) PART II [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For FY2025, BioVie reported a net loss of **$17.5 million**, a significant reduction from **$32.1 million** in FY2024, primarily due to decreased R&D expenses, but faces going concern doubts [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Net loss decreased by **$14.6 million** year-over-year to **$17.5 million** in FY2025, driven by a **$13.8 million** reduction in R&D expenses as clinical trials concluded Selected Statement of Operations Data | Metric | Year Ended June 30, 2025 | Year Ended June 30, 2024 | | :--- | :--- | :--- | | **Net Loss** | **$17.5 million** | **$32.1 million** | | Research & Development Expenses | **$9.3 million** | **$23.1 million** | | Selling, General & Administrative Expenses | **$8.6 million** | **$8.8 million** | - The **$13.8 million** decrease in R&D expenses was primarily due to clinical study completion in the prior fiscal year, leading to a net decrease in clinical trial expenses of approximately **$10.8 million**[236](index=236&type=chunk)[237](index=237&type=chunk) [Capital Resources and Liquidity](index=49&type=section&id=Capital%20Resources%20and%20Liquidity) As of June 30, 2025, the company held **$17.5 million** in cash, but recurring losses and negative operating cash flow of **$19.0 million** raise substantial doubt about its going concern ability Selected Financial Position and Cash Flow Data | Metric | As of June 30, 2025 | | :--- | :--- | | Cash and cash equivalents | **$17.5 million** | | Working capital | **$18.4 million** | | Accumulated deficit | **$352.1 million** | | Net cash used in operating activities (FY2025) | **$19.0 million** | - The company's financial condition raises substantial doubt about its ability to continue as a going concern, with future operations dependent on securing additional financing[241](index=241&type=chunk)[243](index=243&type=chunk) - The company raised capital through a **$3.0 million** public offering in September 2024 and **$15.9 million** from three registered direct offerings in October 2024[244](index=244&type=chunk)[245](index=245&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of June 30, 2025, management concluded that both disclosure controls and internal control over financial reporting were effective, with no material changes identified - Management concluded that disclosure controls and procedures were effective as of June 30, 2025[252](index=252&type=chunk) - Management concluded that internal control over financial reporting was effective as of June 30, 2025[253](index=253&type=chunk) PART III [Directors, Executive Compensation, Security Ownership, and Other Matters](index=52&type=section&id=Items%2010-14) Information for Items 10 through 14, covering directors, executive compensation, security ownership, related transactions, and accountant fees, is incorporated by reference from the 2025 proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's 2025 Proxy Statement[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=53&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all financial statements and exhibits filed with the Form 10-K report, including corporate governance documents, material contracts, and certifications - This item lists the financial statements and exhibits filed with the report, including agreements, bylaws, and certifications[265](index=265&type=chunk)[266](index=266&type=chunk) Financial Statements and Notes [Report of Independent Registered Public Accounting Firm](index=58&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor's report includes a 'Going Concern' paragraph due to recurring losses and negative cash flows, and identifies 'Research and development expenses and related accruals' as a Critical Audit Matter - The auditor's report contains a 'Going Concern' paragraph, citing recurring losses and negative cash flows from operations as raising substantial doubt about the company's ability to continue[281](index=281&type=chunk) - The audit identified 'Research and development expenses and related accruals' as a Critical Audit Matter due to the high degree of management judgment and subjectivity required[286](index=286&type=chunk)[287](index=287&type=chunk) [Financial Statements](index=60&type=section&id=Financial%20Statements) Financial statements show cash and cash equivalents decreased to **$17.5 million** in FY2025, with net loss improving to **$17.5 million** from **$32.1 million** in FY2024 Selected Balance Sheet Data | Selected Balance Sheet Data (As of June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | **$17,544,547** | **$23,843,798** | | Total Assets | **$21,562,199** | **$25,208,345** | | Total Liabilities | **$2,550,214** | **$9,702,130** | | Total Stockholders' Equity | **$19,011,985** | **$15,506,215** | Selected Statement of Operations Data | Selected Statement of Operations Data (Year Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Loss from Operations | **$(18,066,200)** | **$(32,179,585)** | | Net Loss | **$(17,542,120)** | **$(32,120,533)** | | Net Loss Per Share (Basic & Diluted)** | **$(12.12)** | **$(73.05)** | Selected Cash Flow Data | Selected Cash Flow Data (Year Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | **$(19,025,205)** | **$(27,945,024)** | | Net cash provided by financing activities | **$12,725,954** | **$17,802,939** | [Notes to Financial Statements](index=65&type=section&id=Notes%20to%20Financial%20Statements) Notes detail accounting policies, clinical programs, and financial items, including 'Going Concern' uncertainty, related party transactions, equity financings, litigation, and subsequent events - Note 2 reiterates that recurring losses and the need for additional capital raise substantial doubt about the Company's ability to continue as a going concern[316](index=316&type=chunk)[318](index=318&type=chunk) - Note 5 discloses that capital raises triggered down-round features in warrants held by Acuitas, resulting in deemed dividends of **$369,465** in FY2025 and **$886,423** in FY2024[349](index=349&type=chunk) - Note 8 details several equity offerings, including a September 2024 offering that raised approximately **$3.0 million** gross and three October 2024 offerings that raised approximately **$15.9 million** gross[367](index=367&type=chunk)[368](index=368&type=chunk) - Note 14 discloses a subsequent event: on August 11, 2025, the company closed an underwritten public offering, raising net proceeds of approximately **$10.4 million**[407](index=407&type=chunk)

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]

Core Viewpoint - BioVie Inc. has successfully closed a public offering of 6,000,000 units, raising approximately $12 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - Each unit in the offering consisted of one share of common stock and one warrant, priced at $2.00 per unit [1]. - The underwriter exercised an option to purchase an additional 667,300 warrants, increasing the total offering size [1]. - The warrants are immediately exercisable at an exercise price of $2.50 per share and expire five years from issuance [1]. Group 2: Use of Proceeds - The proceeds from the offering will be utilized 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 debilitating conditions, including neurological disorders like Alzheimer's and Parkinson's diseases, as well as liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in neurodegenerative diseases [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].

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 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.