BioVie (NASDAQ:BIVI) Posts Earnings Results

BioVie (NASDAQ:BIVI) announced its quarterly earnings results on Wednesday. The company reported ($0.70) EPS 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 trading on Thursday, reaching $1.57. The company had a trading volume of 4,519,429 shares, compared to its average volume of 1,075,775. BioVie has a 52 week low of $0.82 and a 52 week high of $3.79. The business’s 50 day moving average price is $1.70 and its 200-day moving average price is $1.49. The stock has a market cap of $11.81 million, a PE ratio of -0.64 and a beta of 0.60.

Institutional Inflows and Outflows

Institutional investors have recently bought and sold shares of the stock. DRW Securities LLC acquired a new position in BioVie during the 4th quarter worth $149,000. Prosperity Wealth Management Inc. bought a new stake in shares of BioVie during the third quarter worth $273,000. Prelude Capital Management LLC acquired a new position in shares of BioVie during the third quarter valued at $275,000. Citadel Advisors LLC bought a new position in BioVie in the third quarter valued at about $199,000. Finally, Squarepoint Ops LLC acquired a new stake in BioVie in the third quarter worth about $63,000. Institutional investors own 4.59% of the company’s stock.

Analyst Ratings Changes

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

About BioVie

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.