Core Viewpoint - BioVie Inc is advancing a new hypothesis regarding Parkinson's disease, suggesting that inflammation and insulin resistance in the brain may play a significant role alongside dopamine loss, which has traditionally been the focus of treatment [2][3][4]. Group 1: Disease Understanding - Parkinson's disease affects approximately one million people in the U.S., with prevalence expected to rise due to aging populations [3]. - The traditional treatment approach has remained largely unchanged for over 50 years, primarily focusing on dopamine replacement [3]. - BioVie proposes that insulin resistance may be central to neurodegeneration and neuronal dysfunction, impacting glucose metabolism and dopamine production [4][5][6]. Group 2: Limitations of Current Treatments - Levodopa, while effective in restoring muscle control, has significant limitations including a short half-life requiring multiple daily doses, leading to "off" periods where symptoms return [7][8]. - Over time, the effectiveness of levodopa diminishes, necessitating higher doses that can result in levodopa-induced dyskinesia, causing involuntary movements [8][9]. Group 3: New Drug Candidate - Bezisterim - Bezisterim is an oral small molecule designed to cross the blood-brain barrier, targeting inflammation and improving insulin sensitivity without immune suppression [10][11]. - Early Phase 2 studies indicated that bezisterim, when combined with levodopa, improved motor control and "morning on" function compared to levodopa alone [11][12]. Group 4: Clinical Trials and Future Directions - BioVie has completed enrollment in the 60-patient Phase 2 SUNRISE-PD trial, focusing on patients diagnosed within the past four years who have not yet started levodopa treatment [13][14]. - The trial aims to assess both motor and non-motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS) and incorporates biomarker analysis for future development [13][15]. - Topline results from the SUNRISE-PD trial are expected in the first half of 2026, which could significantly impact Parkinson's treatment if successful [16][17]. Group 5: Long-term Vision - If successful, bezisterim could be the first drug to demonstrate the ability to delay the progression of Parkinson's disease, potentially becoming a first-line therapy introduced early in treatment [18][19]. - The drug's administration as an oral capsule taken twice daily, or potentially once daily, could simplify treatment regimens compared to the frequent dosing required for levodopa [20].

Core Insights - BioVie Inc. announced the acceptance of an abstract for its SUNRISE-PD study on bezisterim (NE3107) for treating Parkinson's Disease at the AD/PD 2026 conference [1][2] Group 1: Study and Results - The abstract titled "Demographics and Baseline Characteristics of Participants in a Study of Bezisterim (NE3107) in Early Parkinson's Disease (SUNRISE-PD)" summarizes initial data from the study, which will be presented as a poster [2] - Topline results from the SUNRISE-PD study are expected in mid-2026, following the enrollment of 60 patients to evaluate bezisterim's efficacy in improving motor and non-motor symptoms in untreated Parkinson's patients [4] Group 2: Drug Mechanism and Applications - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression, showing potential for various neurological conditions including Parkinson's, Long COVID, and Alzheimer's [3][7] - In previous Phase 2 studies for Parkinson's, patients taking bezisterim with levodopa exhibited better motor control and fewer symptoms compared to those on levodopa alone, with minimal side effects reported [4] Group 3: Other Clinical Trials - The ADDRESS-LC trial is currently enrolling about 200 patients to assess bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data also expected in mid-2026 [5] - BioVie has conducted Phase 2 and Phase 3 trials for Alzheimer's disease, with early results indicating improvements in cognition and biomarkers, warranting further investigation [6] Group 4: Company Overview - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7] - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for patients with cirrhosis and ascites [8]

Core Insights - BioVie Inc. is hosting a webinar on March 4, 2026, to discuss its investigational drug candidate bezisterim (NE3107) and its orphan drug candidate BIV201 [1][2][3] Group 1: Drug Development - Bezisterim (NE3107) is a first-in-class, orally available small molecule targeting inflammation and insulin resistance, which are key drivers of Alzheimer's, Parkinson's, and Long COVID, showing promising results in improving cognition, motor function, and reducing neuroinflammation [2][6] - BIV201 is a continuous infusion treatment of terlipressin for patients with cirrhosis and ascites, which has received FDA Orphan and Fast Track designations, and is set to enter a Phase 3 trial [3][7] Group 2: Market Potential - BioVie is positioned to create significant value with multiple clinical programs advancing into late-stage development, supported by strong safety data and multi-billion-dollar market opportunities [3] - The company aims to address life-threatening complications in liver disease with no FDA-approved therapies currently available [3][7]

Core Viewpoint - BioVie Inc. announced the acceptance of two abstracts for its lead candidate bezisterim (NE3107) at the 2026 American College of Psychiatrists annual meeting, focusing on Alzheimer's Disease and Long COVID [1][2]. Group 1: Bezisterim Overview - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression and with low drug-drug interaction risk [3]. - The drug targets neuroinflammation pathways (ERK, NFκB, TNF-α) and has potential applications in Parkinson's disease, Long COVID, and Alzheimer's disease [3]. Group 2: Clinical Trials and Results - In Parkinson's disease, a completed Phase 2 study indicated that patients taking bezisterim with levodopa experienced better motor control and fewer morning symptoms compared to those on levodopa alone, with minimal side effects [4]. - The SUNRISE-PD trial is currently enrolling 60 patients to assess bezisterim's efficacy in improving symptoms for untreated Parkinson's patients, with topline results expected in mid-2026 [4]. - The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data anticipated in mid-2026 [5]. - In Alzheimer's disease, both Phase 2 and Phase 3 trials have been conducted, showing early results that suggest cognitive improvements and biomarker support for further trials [6]. Group 3: Company Background - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7]. - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for its efficacy in patients with cirrhosis and ascites [8].

Core Insights - BioVie Inc is focusing on addressing the root causes of neurodegeneration, particularly in Parkinson's disease, rather than just treating symptoms [1][4][12] Company Overview - BioVie Inc is a clinical-stage biopharmaceutical company with a market capitalization in the tens of millions [1] - The company is advancing bezisterim (NE3107), an oral small-molecule drug aimed at blocking TNF alpha mediated inflammation and reversing insulin resistance [2] Parkinson's Disease Focus - Parkinson's disease affects approximately one million people in the U.S., with prevalence expected to rise as the population ages [3] - Current treatments, primarily Levodopa, do not slow neurodegeneration and can lead to involuntary movements [3] - BioVie posits that Parkinson's symptoms arise from low dopamine levels and chronic inflammation due to insulin resistance [4] Clinical Trials and Data - BioVie has completed enrollment in the SUNRISE-PD trial, evaluating bezisterim in 60 early-stage Parkinson's patients not yet on levodopa therapy [6] - The trial aims to determine if bezisterim can delay motor decline, differentiating it from existing treatments [6] - Topline data from the SUNRISE-PD trial is expected in April or May 2026, marking a significant catalyst for the company [7] Broader Implications of Bezisterim - Beyond Parkinson's, bezisterim is also being studied for long COVID and Alzheimer's disease, where chronic inflammation plays a role [8] - A 200-patient trial for long COVID is underway, supported by a $13 million non-dilutive grant [8] Additional Clinical Asset - BioVie is also advancing BIV201, targeting ascites associated with late-stage liver disease, with a Phase 2 trial showing over 50% reduction in fluid buildup [9] - The program has received FDA clearance to proceed directly into a Phase 3 study under orphan and fast-track designations [9] Market Position and Investment Outlook - Despite a broad clinical portfolio, BioVie’s valuation remains modest, attributed to market skepticism towards early-stage biotech [10] - The company presents a high-risk, high-reward investment opportunity with multiple catalysts expected in the next 12 to 18 months [11] - 2026 is anticipated to be a significant year for the company, with potential for substantial market impact if clinical data supports its hypotheses [11][12]

Core Viewpoint - BioVie Inc. has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial, which aims to evaluate the efficacy of bezisterim in delaying disease progression in early-stage Parkinson's disease patients [2][5]. Group 1: Clinical Trial Details - The SUNRISE-PD trial is designed to assess the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients diagnosed with Parkinson's disease within the past four years [3][7]. - The trial employs a hybrid, decentralized design to enhance participation by addressing barriers such as delayed diagnosis and geographic constraints, allowing participants to complete visits at home or in a clinic [3][4]. - Topline results from the SUNRISE-PD trial are expected in the first half of 2026 [1][5]. Group 2: Drug Profile and Mechanism - Bezisterim (NE3107) is an oral drug that targets neuroinflammation and insulin resistance, which are believed to contribute to the progression of Parkinson's disease and other neurodegenerative conditions [6][10]. - Previous clinical trials indicated that bezisterim, when combined with levodopa/carbidopa, improved motor control and reduced symptoms in Parkinson's patients, with a favorable safety profile [4][7]. Group 3: Broader Implications and Future Trials - BioVie is also exploring bezisterim for other conditions, including Long COVID and Alzheimer's disease, with ongoing trials expected to yield results in mid-2026 [8][9]. - The company emphasizes the importance of accessible clinical trials for Parkinson's disease, reflecting strong engagement from the patient community and advocacy organizations [4][5].

Core Insights - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative diseases, including Alzheimer's, Parkinson's, and long COVID [4] - The company will host an investor webinar on October 8, 2025, featuring CEO Cuong Do discussing their drug candidate bezisterim (NE3107) and the late-stage orphan drug BIV201 [2][3] Company Overview - BioVie Inc. is developing bezisterim, an orally available small molecule targeting inflammation and insulin resistance, which are key drivers of Alzheimer's, Parkinson's, and long COVID [2][4] - BIV201 is a late-stage orphan drug candidate for refractory ascites, a complication of liver cirrhosis, currently with no FDA-approved therapies [2][4] - The company has received FDA Fast Track status for BIV201 and is in discussions regarding the design of Phase 3 clinical testing [4] Clinical Development - Clinical studies for bezisterim have shown promising results in improving cognition, motor function, and reducing neuroinflammation [2] - BioVie is advancing several late-stage clinical programs and evaluating potential partnerships in markets with significant commercial potential [3]

As filed with the Securities and Exchange Commission on August 4, 2025. Registration Statement No. 333-288525 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BioVie Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Nevada 2834 46-2510769 (I.R.S. Employer Identification Number) ...

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].