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]

Group 1 - Option Therapeutics, a biotechnology company focused on liver diseases, plans to raise up to $25 million through an IPO, offering 2.3 million shares at a price range of $10 to $12 per share [1][2] - The company is a spin-off from BioVie, which has shifted its strategic focus towards neurodegenerative diseases, particularly Alzheimer's and Parkinson's [2] - Option Therapeutics' core product, BIV201, is under evaluation for treating complications related to advanced liver cirrhosis and is currently in patent-pending status in multiple countries [1] Group 2 - The funds raised from the IPO will primarily support the critical Phase 3 clinical trials for BIV201, which has received Fast Track Designation from the FDA [1] - After the IPO, BioVie will retain majority voting power and control over Option Therapeutics, ensuring strategic alignment while allowing independent operations [2] - Option Therapeutics was established in 2025 and plans to list on the NYSE American under the ticker symbol OPTN, with ThinkEquity serving as the sole bookrunner for the transaction [2]

As filed with the Securities and Exchange Commission on January 23, 2026. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 OPTION THERAPEUTICS INC. (Exact name of registrant as specified in its charter) | | | (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 680 W Nye Lane, Suite 201 Carson ...

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 is hosting a webinar on December 9, 2025, featuring CEO Cuong Do, who will discuss the drug bezisterim (NE3107) and its potential benefits [2][3] - BioVie is advancing multiple late-stage clinical programs, including BIV201, an orphan drug candidate for refractory ascites, with significant market opportunities [2] Company Overview - BioVie Inc. is engaged in developing therapies targeting neuroinflammation and insulin resistance, which are critical factors in Alzheimer's and Parkinson's diseases [4] - Bezisterim is a first-in-class, orally available small molecule that has shown promising results in improving cognition and motor function in clinical studies [2][4] - BIV201, the company's late-stage candidate, is under FDA Fast Track status and aims to address complications of liver cirrhosis, with guidance from the FDA for Phase 3 clinical testing [4] Market Potential - The company is positioned to create significant value with its late-stage programs and strong safety data, targeting multi-billion-dollar market opportunities [2] - The ongoing clinical studies and potential partnerships are expected to enhance BioVie's market presence and financial performance [2]

BioVie (NasdaqCM:BIVI) Update Summary Company Overview - **Company**: BioVie Inc. (Ticker: BIVI) - **Industry**: Biotechnology - **Focus**: Development of therapeutics for neurodegenerative diseases and conditions related to inflammation Key Points and Arguments Clinical Trials and Drug Development - **Parkinson's Disease Trial**: - Currently in Phase II, with enrollment expected to be completed by 2025 - Top-line data readout projected for April-May 2026 [5][7] - Drug candidate bezisterone shows promise in improving muscle control and reducing inflammation [8][15] - **Long COVID Trial**: - Phase II trial underway, with good enrollment progress - Expected to provide guidance on full enrollment within a month [6][24] - A $13 million grant received to test therapeutic effects on CNS symptoms of long COVID [28] - **Ascites Treatment**: - Phase III protocol submitted to the FDA, awaiting feedback [6][34] - Drug candidate BIV201 shows a 50% reduction in dermatitis volume in Phase 2a trial [33] - Expected annual sales for BIV201 estimated between $1.6 billion and $2 billion in the U.S. [37][40] Mechanism of Action - **Bezisterone**: - Modulates TNF alpha production, a key regulator of inflammation [8][9] - Demonstrated neuroprotective properties in preclinical studies [16][18] - Potential to address both Parkinson's and Alzheimer's diseases by reducing inflammation and improving neuronal health [71] Market Potential - **Parkinson's Market**: - Approximately 1 million patients in the U.S. - Estimated annual sales potential of $3 billion to $5 billion with 10% market penetration [36][37] - **Ascites Market**: - Significant unmet need with no current approved therapies - Estimated annual sales potential of $1.6 billion to $2 billion in the U.S. [37][40] Financial Position - **Cash Runway**: - Sufficient cash to fund operations through 2026, covering the timelines for ongoing trials [7][38] - Actively seeking to raise $25 million to fund Phase III trials for ascites [35] Regulatory and Legal Considerations - **FDA Interaction**: - Anticipated to receive no comments on the Phase III protocol for ascites, allowing progression to the next trial phase [40] - **Class Action Lawsuit**: - Currently in the discovery phase, not seen as a significant drain on resources [60][61] Strategic Partnerships - **Pharmaceutical Partnerships**: - Ongoing discussions with major pharmaceutical companies, with interest in the novel mechanism of action [56] - Expectation to out-license or be acquired upon demonstrating positive trial data [56] Additional Insights - **Long COVID Awareness**: - Significant number of Americans suffering from long COVID, with no effective treatments currently available [24][25] - **Market Dynamics**: - The biotechnology sector has faced challenges in capital raising, but there are signs of improvement [46][47] - **Future Development**: - Plans to develop a once-daily formulation of bezisterone post-trial completion [48][49] This summary encapsulates the critical developments and strategic outlook for BioVie, highlighting its innovative approaches to treating significant health conditions and the potential market opportunities that lie ahead.

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]

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 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].