Announcement • Aug 06
BioVie Reports Topline Results Of Phase 2 SUNRISE-PD Trial Of Bezisterim In Early Parkinson’s Disease BioVie Inc. announced results from the Company’s Phase 2 SUNRISE-PD trial evaluating its drug candidate bezisterim in early-stage Parkinson’s disease (PD). The SUNRISE-PD trial was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial designed to establish proof-of-mechanism and proof-of-concept in patients with early-stage PD that had not previously been treated with carbidopa/levodopa. Under the statistical analysis plan submitted to the U.S. Food and Drug Administration (FDA), the study’s primary pharmacodynamic assessment focused on changes in a predefined panel of blood-based inflammatory markers of disease. The study also evaluated motor and non-motor endpoints, clinician-rated outcomes, quality-of-life, and safety and tolerability measures to assess bezisterim’s activity and clinical profile in early PD, with the goal of informing the design of a potentially pivotal Phase 3 trial. The trial successfully met prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage. Participants treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of daily living, motor symptoms, and non-motor symptoms. The majority of patients treated with bezisterim showed improvement on EPNIC-15, a composite endpoint encompassing 15 clinically relevant motor and non-motor measures of PD. In contrast, patients receiving placebo showed a change in the opposite direction (bezisterim = -0.04, placebo = +0.18, Cohen’s d = -0.94, p=0.0006). EPNIC-15 aligns clinical outcome measurements from UPDRS Parts I (non-motor symptoms), II (activities of daily living), and III (motor symptoms), as well as PDSS-2 (sleep) with bezisterim’s proposed mechanism of action, providing a sensitive tool to evaluate anti-inflammatory treatment effects in early PD. Bezisterim treatment appeared to have a beneficial impact on plasma biomarkers of neurodegeneration and reduced biomarkers of both neuro- and systemic-inflammation. New Risk • Jul 22
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.73m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (307% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.73m market cap). Minor Risk Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Jul 18
BioVie Inc. has filed a Follow-on Equity Offering in the amount of $50 million. BioVie Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Class A Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant 
