BioVie (NASDAQ:BIVI) Issues Earnings Results

BioVie (NASDAQ:BIVI) announced its quarterly earnings data on Wednesday. The company reported ($0.70) earnings per share for the quarter, FiscalAI reports.

Here are the key takeaways from BioVie’s conference call:

• BioVie reported favorable Phase II SUNRISE-PD results for bezisterim in early Parkinson’s disease, including statistically significant improvements in motor and non-motor measures among patients with higher baseline inflammation.
• Biomarker analyses showed broad changes in proteins linked to inflammation and neurodegeneration, including declines in neurofilament light and GFAP after an initial increase; management said these findings may support a disease-modifying effect.
• Bezisterim was described as well tolerated, with a safety profile similar to placebo, no serious or severe adverse events, and no deaths reported in the 57-patient trial.
• BioVie plans to seek an FDA end-of-Phase II meeting and propose a Phase III study with a six-month symptomatic endpoint, likely focused on UPDRS Part III, followed by an additional 12 months to assess disease progression. However, the Phase II study was small and only three months long, and claims of disease modification remain unproven until a registrational trial is completed.
• The company expects long-COVID Phase II data within 30–60 days and plans to reactivate partnering discussions now that Parkinson’s data are available, while acknowledging that any accelerated approval or partnership outcome remains uncertain.

BioVie Stock Performance

Shares of NASDAQ BIVI traded up $0.01 during mid-day trading on Thursday, reaching $1.57. 4,452,924 shares of the company’s stock were exchanged, compared to its average volume of 1,075,386. The company’s 50-day moving average is $1.70 and its 200-day moving average is $1.49. BioVie has a 52-week low of $0.82 and a 52-week high of $3.79. The firm has a market capitalization of $11.84 million, a price-to-earnings ratio of -0.64 and a beta of 0.60.

Hedge Funds Weigh In On BioVie

Several large investors have recently made changes to their positions in the stock. DRW Securities LLC acquired a new stake in BioVie in the 4th quarter valued at approximately $149,000. Prosperity Wealth Management Inc. purchased a new position in BioVie during the 3rd quarter valued at about $273,000. Prelude Capital Management LLC acquired a new position in BioVie in the 3rd quarter valued at about $275,000. Citadel Advisors LLC purchased a new stake in BioVie during the third quarter worth about $199,000. Finally, Squarepoint Ops LLC acquired a new stake in shares of BioVie during the third quarter worth about $63,000. 4.59% of the stock is currently owned by institutional investors and hedge funds.

Wall Street Analysts Forecast Growth

BIVI has been the topic of several research reports. Wall Street Zen upgraded BioVie to a “sell” rating in a research report on Saturday, July 18th. Weiss Ratings reaffirmed a “sell (e+)” rating on shares of BioVie in a report on Friday, July 17th. One analyst has rated the stock with a Sell rating, Based on data from MarketBeat.com, BioVie currently has a consensus rating of “Sell”.

BioVie Company Profile

BioVie Inc is a clinical‐stage biopharmaceutical company focused on developing novel therapies for chronic liver diseases and associated neurological complications. The company’s research and development efforts center on candidates designed to address serious unmet medical needs in hepatic encephalopathy and other liver‐related disorders. BioVie advances its pipeline through controlled clinical trials and regulatory interactions in North America.

The company’s lead product candidate, BIV201, is undergoing Phase 2 clinical evaluation for the treatment of hepatic encephalopathy, a life‐threatening condition marked by elevated neurotoxins in patients with advanced liver disease.