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 established a Corporate Advisory Board consisting of seven leaders in various fields to enhance its clinical development and business strategy, particularly focusing on neuroinflammatory disorders like Alzheimer's and Parkinson's [1][2][3] Group 1: Corporate Advisory Board - The Corporate Advisory Board aims to support clinical development, inform business strategy, and enhance stakeholder engagement, with members having personal connections to the neuroinflammatory conditions targeted by BioVie [2] - Board members include experts from diverse sectors such as neuroscience, biotechnology, and finance, bringing decades of experience to the company [1][4][5] Group 2: Drug Candidate Bezisterim - Bezisterim (NE3107) is an investigational drug that modulates inflammation and insulin sensitivity, showing potential in treating Alzheimer's, Parkinson's, and long COVID [6][11] - Clinical trials have demonstrated efficacy, with a Phase 3 study for Alzheimer's and a Phase 2 trial for Parkinson's showing promising results in cognitive and motor function improvements [7][8] Group 3: Clinical Development and Research - BioVie is currently enrolling patients for the Phase 2 SUNRISE-PD trial to evaluate bezisterim's effects on Parkinson's disease, with topline data expected in late 2025 or early 2026 [8] - The company has also initiated the ADDRESS-LC study to assess bezisterim's impact on neurological symptoms associated with long COVID, targeting approximately 200 patients [9][10]

Financial Data and Key Metrics Changes - INmune Bio raised $29.9 million from the sale of common stock and warrants in 2024, issuing a total of 4,145,978 shares and warrants for 3,898,852 shares [37][38] - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023 [40] - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [40] - Cash and cash equivalents at December 31, 2024, were approximately $20.9 million, with an additional $5.4 million raised since year-end [41] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease is expected to announce top-line data in less than 100 days, focusing on neuroinflammation as a primary driver of the disease [8][14] - The INmune platform has pivoted to target solid tumors, with ongoing trials for castrate-resistant metastatic prostate cancer [17][18] - CORDStrom, a new therapeutic platform, is positioned to address systemic disease modification for RDEB, differentiating itself from local wound management therapies [22][24] Market Data and Key Metrics Changes - The ADO2 trial enrolled 208 patients across eight countries, with a focus on those with neuroinflammation driving their Alzheimer's disease [15] - The CaRe PC trial for prostate cancer is progressing, with completion of dosing in the Phase 1 part and ongoing Phase 2 dosing expected to complete by 2025 [18][43] Company Strategy and Development Direction - INmune Bio aims to challenge the amyloid-centric paradigm of Alzheimer's treatment by focusing on neuroinflammation [14][33] - The company is committed to advancing its three therapeutic platforms, with a focus on achieving regulatory milestones and potential commercialization [36][45] - The management emphasizes a precision medicine approach in clinical trials, particularly in the ADO2 trial [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [34][35] - The company believes that addressing neuroinflammation could have broader implications for various CNS diseases [35] - Management highlighted the importance of safety in treating elderly patients with Alzheimer's, noting no significant adverse events reported thus far [31] Other Important Information - The company plans to file a BLA for CORDStrom in the first quarter of 2026, which would mark its first market therapeutic [44][112] - Management is focused on ensuring the quality of regulatory submissions to facilitate successful approvals [113] Q&A Session Summary Question: Is the 12-month open label trial for RDEB required for filing? - Management indicated that they believe the current data is adequate for a BLA submission, but the FDA will ultimately decide [50][51] Question: Will EMACC and CDR results be released at the same time? - Management confirmed that both EMACC and CDR results will be available at the time of data release [56][60] Question: Are there any dropouts in the EXPAREL Phase 2 trial? - Management reported that dropouts are within expected ranges, primarily due to typical issues associated with elderly patients [86] Question: How does the company plan to commercialize CORDStrom? - Management aims to move towards commercialization independently but may seek a partner closer to the launch [93] Question: Will the BLA for CORDStrom be filed in the UK and US? - Management confirmed that they expect to have all necessary data ready for filing in both regions by early 2026 [101][102]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023, indicating a significant increase in losses [41] - Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, compared with approximately $20.3 million for 2023, reflecting a substantial increase in investment in R&D [41] - General and administrative expenses were approximately $9.5 million for the year ended December 31, 2024, compared with approximately $9.6 million for 2023, showing a slight decrease [41] - As of December 31, 2024, the company had cash and cash equivalents of approximately $20.9 million, with an additional $5.4 million raised since year-end through the use of the ATM [42] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease enrolled 208 patients across eight countries, with nearly 800 patients screened, indicating a rigorous patient selection process [15][16] - The CARE-PC trial using IncMUNE for treating metastatic prostate cancer has made steady progress, with completion of dosing in the Phase 1 dose escalation part and ongoing dosing in the Phase 2 part [18] Market Data and Key Metrics Changes - The company has pivoted to solid tumors with the INCMUNE platform, believing that future opportunities are greater in this area compared to hematologic diseases [17] Company Strategy and Development Direction - The company aims to challenge the traditional amyloid-centric paradigm of Alzheimer's disease treatment by focusing on neuroinflammation as a primary driver [14][35] - The addition of Cordstrom has introduced a third therapeutic platform, which is expected to accelerate the timeline to becoming a commercial entity [37] - The company plans to file a Biologics License Application (BLA) for Cordstrom in the first quarter of next year, marking a significant milestone towards revenue generation [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [35][36] - The company is focused on achieving primary clinical objectives while remaining cost-prudent, with expectations of sufficient cash to fund operations through Q3 2025 [42][43] Other Important Information - The company has received orphan drug status and rare pediatric disease designation for Cordstrom, differentiating it from other therapies by providing a systemic disease-modifying approach [22] Q&A Session Summary Question: Is the 12-month open-label trial required for filing? - Management indicated that they have access to all clinical data from the current trial and believe it will be adequate for a BLA submission [51] Question: Will the EMAC and CDR results be staggered? - Both EMAC and CDR results will be released simultaneously when the data becomes public [56][57] Question: Are there any dropouts in the Phase II trial? - Dropouts are less than expected, primarily due to typical elderly-related issues rather than drug efficacy or safety concerns [76] Question: How does the company plan to commercialize Cordstrom? - The company aims to move forward independently but may seek a partner for distribution and marketing as they approach commercialization [82][83] Question: Will the BLA for Cordstrom be filed in the UK and US? - The company expects to have all necessary data ready for filing in the first quarter of 2025, with ongoing preparations for both markets [90][91]

Summary of InMed Pharmaceuticals (INM) Update / Briefing Industry Overview - The discussion centers around the Alzheimer's disease research and development landscape, highlighting the recent advancements in disease-modifying therapies and the challenges faced in clinical trials and drug development [6][7][15]. Key Points and Arguments Advances in Alzheimer's Research - There has been a significant increase in understanding Alzheimer's disease over the past decade, with the first disease-modifying therapies launched in the U.S., Japan, and China [6][7]. - The removal of amyloid from the brains of patients has been achieved, impacting tau levels and disease progression, although the average clinical impact remains limited [15][16][18]. Challenges with Mouse Models - Current mouse models primarily focus on amyloidosis and tauopathy, which do not fully replicate the complexity of Alzheimer's disease [8][9][10]. - The efficacy of treatments is often tested in younger mice, which may not accurately reflect the disease's progression in older adults [10][11]. - Advanced-stage models are necessary to better understand the safety and efficacy of treatments [11][13]. Importance of Biomarkers - The selection of patients for clinical trials has evolved from clinical criteria to biomarker-based criteria, improving the ability to demonstrate clinical efficacy [21][22]. - There is a need for better biomarkers for neuroinflammation, which is still in early development compared to amyloid biomarkers [47][48]. Neuroinflammation as a Target - Chronic neuroinflammation is recognized as a significant factor in Alzheimer's disease, with potential drug targets being explored [32][33][36]. - InMed's compound, INM901, shows promise in modulating neuroinflammation and promoting neurogenesis, with positive results in animal studies [30][51][52]. Diversity in Clinical Trials - Current clinical trials have been criticized for lacking racial and ethnic diversity, which may affect the understanding of drug efficacy across different populations [18][20][60]. Future Directions - The panelists express optimism about the future of Alzheimer's research, emphasizing the need for combination therapies and the potential for repurposing existing drugs [41][65]. - The goal is to transform Alzheimer's from a terminal disease to a chronic condition, improving the quality of life for patients [88][89]. Other Important Content - The discussion highlights the iterative learning process in selecting patients for trials based on biomarkers rather than solely on clinical diagnosis [21][22]. - The role of inflammation in Alzheimer's is complex, with both beneficial and harmful effects depending on the disease stage [40][76]. - The importance of accurate diagnosis and the distinction between Alzheimer's disease and dementia is emphasized [103]. This summary encapsulates the key discussions and insights from the InMed Pharmaceuticals update, focusing on the current state and future directions of Alzheimer's disease research and treatment.