Option Therapeutics成立于2025年，计划在纽约证券交易所美国板(NYSE American)上市，股票代码为 OPTN。ThinkEquity担任该交易的独家账簿管理人。 该公司专注于开发治疗严重及危及生命的肝脏疾病的候选药物。其主导产品BIV201目前正被评估用于 治疗与晚期肝硬化相关的并发症，并已在美国、中国、日本、智利和印度提交专利申请。Option Therapeutics目前尚未产生收入。 周一，从BioVie分拆出来的临床二期肝病生物技术公司Option Therapeutics(OPTN.US)缩减了其即将进行 的IPO的规模。这家总部位于内华达州卡森城的公司现计划通过发行180万股、定价区间为10至12美元 的方式募资2000万美元。该公司此前曾申请以相同区间发行230万股。以发行价区间中值计算，Option Therapeutics的募资额将比此前预期减少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]

Summary of BioVie Conference Call Company Overview - **Company**: BioVie Inc. (Ticker: BIVI) - **Focus**: Development of drug candidates for neurological and liver diseases, specifically targeting Parkinson's disease, long COVID, and ascites Key Drug Candidates Bezisterim (formerly NE3107) - **Mechanism**: Modulates inflammation by blocking TNF-alpha production, which is linked to various diseases including Parkinson's and Alzheimer's [3][6] - **Clinical Trials**: - **Parkinson's Trial**: Fully enrolled, top-line data expected in Q2 2026 [4][5] - **Long COVID Trial**: Rapid enrollment, top-line data expected by August 2026 [5][21] - **Clinical Findings**: - In Parkinson's patients, bezisterim showed improvements in muscle control and reduced insulin resistance [11][15] - Combination with Levodopa demonstrated a synergistic effect, improving motor control and reducing dyskinesia [16][18] - Neuroprotective properties observed, with treated subjects retaining more neurons [17] - **Market Potential**: Estimated annual sales opportunity of $3 billion to $5 billion in the U.S. for Parkinson's treatment [31] BIV201 - **Indication**: Treatment for ascites, a severe liver disease with over 50% mortality within a year [22][24] - **Clinical Trials**: - Phase 2 trials showed over 50% reduction in ascites fluid buildup [26] - Fast track and orphan designation received from the FDA, with plans for a Phase 3 trial [27][28] - **Market Potential**: Estimated annual sales of $2 billion in the U.S. [55] Industry Context - **Long COVID**: Affects approximately 17 million Americans, with no approved treatments available [20][32] - **Market Need**: Significant unmet medical need for both long COVID and ascites, highlighting the potential for bezisterim and BIV201 to fill these gaps [20][24] Financial and Strategic Considerations - **Funding Challenges**: Difficulty in raising necessary funds for trials, with discussions ongoing for potential partnerships [33][34] - **Regulatory Path**: Plans to seek accelerated approval or emergency use authorization for long COVID treatment based on trial results [31][48] - **Investor Sentiment**: Current market conditions have led to a depressed stock price, with hopes that positive trial results will improve investor interest [36][37] Conclusion - BioVie is positioned with two promising drug candidates, bezisterim and BIV201, targeting significant health issues with substantial market potential. Upcoming clinical trial results are critical for the company's future and investor confidence.

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]

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]