BioVie Inc. (BIVI) Stock Analysis

Why this analysis is different

• A sector-relative MoonshotScore — five pillars (business quality, financial safety, valuation, growth durability, momentum) re-ranked nightly against the full universe of US-listed common stocks.
• An AI Council read across up to eight perspectives — value, macro, quantitative, and momentum lenses — that shows where they disagree instead of averaging the tension away.
• Figures come straight from FMP and Yahoo Finance filings data. The AI writes the narrative around the numbers — it never edits the numbers.

BioVie Inc. (BIVI) Healthcare & Pipeline Overview

BioVie Inc. is a clinical-stage biotechnology firm advancing drug therapies for Alzheimer's, Parkinson's, liver disease, and cancers. With lead candidates in Phase III trials for Alzheimer's, BioVie aims to address unmet medical needs, though it faces typical clinical development and regulatory approval risks in the competitive biotech landscape.

What Is the Investment Thesis for BIVI?

BioVie Inc. presents a high-risk, high-reward investment opportunity typical of clinical-stage biotechnology companies. The primary value driver is NE3107, currently in Phase III trials for Alzheimer's disease. Positive Phase III results and subsequent regulatory approval could significantly increase the company's valuation. However, clinical trial outcomes are inherently uncertain, and failure to meet endpoints or secure regulatory approval would negatively impact the stock. With a market cap of approximately $0.01 billion and a beta of 0.67, BIVI exhibits moderate volatility. Key catalysts include the progression of NE3107 through clinical trials and potential partnerships or acquisitions. Investors should carefully consider the risks associated with clinical-stage biotech companies before investing.

Based on FMP financials and quantitative analysis

BIVI Key Highlights

BIV201 completed Phase IIa clinical trial for ascites due to chronic liver cirrhosis, demonstrating initial safety and efficacy.

• NE3107 is in Phase III clinical trial for mild to moderate Alzheimer's disease, representing a significant potential market opportunity.
• NE3107 is also in Phase I clinical trial for Parkinson's disease, expanding the potential therapeutic applications.
• Pre-clinical development of NE3107 for multiple myeloma and prostate cancer indicates a broad therapeutic potential.
• The company operates with a lean structure of 14 employees, reflecting its focus on research and development.

Who Are BIVI's Competitors?

BIVI is benchmarked below against 8 industry peers on price, market cap, and our AI MoonshotScore.

AI Score by Stock Expert AI · Price data: FMP / Yahoo Finance

What Are BIVI's Key Strengths?

Promising drug candidates in clinical trials.

• Focus on unmet medical needs.
• Experienced management team.
• Proprietary technology platform.

What Are BIVI's Weaknesses?

Limited financial resources.

• High dependence on clinical trial outcomes.
• Small number of employees.
• No currently marketed products.

What Could Drive BIVI Stock Higher?

BIVI catalyst: Phase III clinical trial results for NE3107 in Alzheimer's disease (timeline dependent on trial progress).

• Potential strategic partnerships with larger pharmaceutical companies.
• Initiation of new clinical trials for NE3107 in other indications.
• Continued enrollment and progress in ongoing clinical trials.
• Advancements in pre-clinical development of NE3107 for oncology applications.

What Are the Key Risks for BIVI?

Financial-distress signal — its Altman Z-Score of -38.90 sits in the distress zone (elevated bankruptcy risk).

• Weak fundamentals — a Piotroski F-Score of 2/9 flags soft profitability, leverage or efficiency.
• Failure to achieve positive results in clinical trials.
• Regulatory delays or rejection of drug candidates.
• Competition from other companies developing similar therapies.
• Limited financial resources to support ongoing research and development.
• Dependence on key personnel and management team.

What Are the Growth Opportunities for BIVI?

• Alzheimer's Disease Treatment: NE3107's Phase III trial targeting mild to moderate Alzheimer's disease represents a substantial growth opportunity. Positive trial results could lead to regulatory approval and commercialization, positioning BioVie to capture a significant share of this market. The timeline for potential approval is dependent on trial outcomes and regulatory review, but could be within the next 2-3 years.
• Parkinson's Disease Treatment: The Phase I clinical trial of NE3107 for Parkinson's disease offers another growth avenue. While earlier in development than the Alzheimer's program, successful trials could expand NE3107's therapeutic applications. The Parkinson's disease market is also significant, with increasing prevalence due to aging populations. BioVie's competitive advantage lies in NE3107's unique mechanism of action, potentially offering a novel treatment approach.
• Liver Disease Treatment: BIV201, having completed Phase IIa trials for ascites due to chronic liver cirrhosis, presents a potential growth opportunity in the liver disease market. Further development and clinical trials are needed, but positive results could lead to a valuable treatment option for patients with this condition. The market for liver disease treatments is growing, driven by increasing prevalence of liver diseases.
• Oncology Applications: The pre-clinical development of NE3107 for multiple myeloma and prostate cancer represents a longer-term growth opportunity. While still in early stages, successful pre-clinical studies could lead to clinical trials and potential new cancer therapies. The oncology market is vast and competitive, but innovative treatments are always in demand. BioVie's approach could offer a differentiated therapeutic option.
• Strategic Partnerships: BioVie has the opportunity to pursue strategic partnerships with larger pharmaceutical companies to accelerate the development and commercialization of its drug candidates. Partnerships could provide funding, expertise, and access to larger markets. This could significantly de-risk the company's development programs and enhance its growth prospects. The timeline for potential partnerships is uncertain, but could occur at any stage of clinical development.

What Threats Does BIVI Face?

• Clinical trial failures.
• Competition from other pharmaceutical companies.
• Regulatory hurdles.
• Patent expiration.

What Are BIVI's Competitive Advantages?

• Patent protection for its drug candidates, providing exclusivity.
• Proprietary formulations and drug delivery technologies.
• Clinical data demonstrating efficacy and safety, creating a barrier to entry.
• Expertise in drug development and regulatory affairs.

What Does BIVI Do?

BioVie Inc., founded in 2013 and based in Carson City, Nevada, is a clinical-stage biotechnology company dedicated to discovering, developing, and commercializing novel drug therapies. Originally incorporated as NanoAntibiotics, Inc., the company rebranded to BioVie Inc. in July 2016 to reflect its broader therapeutic focus. BioVie's pipeline features two primary drug candidates: BIV201 and NE3107. BIV201 has completed a Phase IIa clinical trial for treating ascites resulting from chronic liver cirrhosis. NE3107 is currently in a Phase III clinical trial for patients with mild to moderate Alzheimer's disease and a Phase I clinical trial for Parkinson's disease. Additionally, NE3107 is in the pre-clinical stage for treating multiple myeloma and prostate cancer, highlighting BioVie's commitment to addressing a range of unmet medical needs. The company operates primarily in the United States, focusing on innovative therapies for debilitating conditions.

What Products and Services Does BIVI Offer?

• Develops drug therapies for neurological and liver diseases.
• Focuses on clinical-stage drug development.
• Conducts clinical trials to evaluate drug efficacy and safety.
• Seeks regulatory approval for its drug candidates.
• Aims to commercialize approved therapies.
• Engages in pre-clinical research for new drug applications.
• Specializes in innovative therapies for unmet medical needs.

How Does BIVI Make Money?

• Develops and patents novel drug therapies.
• Conducts clinical trials to demonstrate efficacy and safety.
• Seeks regulatory approval from agencies like the FDA.
• Out-licenses or commercializes approved therapies, generating revenue through sales or royalties.

What Industry Does BIVI Operate In?

BioVie Inc. operates within the competitive biotechnology industry, characterized by high R&D costs, lengthy development timelines, and significant regulatory hurdles. The Alzheimer's disease market, where NE3107 is being developed, is projected to grow substantially due to the aging global population. Competition includes established pharmaceutical companies and other biotech firms developing Alzheimer's treatments. BioVie's success depends on demonstrating the efficacy and safety of its drug candidates and navigating the complex regulatory landscape. The company's focus on NE3107 positions it to potentially capitalize on the growing demand for effective Alzheimer's therapies.

Who Are BIVI's Key Customers?

• Patients suffering from Alzheimer's disease.
• Patients suffering from Parkinson's disease.
• Patients suffering from liver cirrhosis and ascites.
• Patients with multiple myeloma and prostate cancer (potential future customers).

Over the past six months, BioVie Inc. insiders filed 4 SEC Form 4 transactions — 0 sales and 4 purchases. On net that is roughly 23K shares acquired (about $49K) — insiders putting money in tends to read as conviction.

BioVie Inc. has beaten Wall Street's EPS estimate in 5 of its last 8 reported quarters — more hits than misses. Reported results have landed about 16.4% above estimates on average.

BioVie Inc.'s Piotroski F-Score is 2/9, a 9-point checklist of profitability, leverage and efficiency — flagging fundamental weakness worth scrutiny. Its Altman Z-Score of -38.90 places it in the distress zone, a signal of elevated financial risk.

Key Financial Metrics

A current ratio of 9.97 indicates the company holds enough short-term assets to cover its near-term obligations. Its earnings yield is -136.1%, the inverse of the P/E and a quick read on earnings relative to price.

BioVie Inc. (BIVI) Valuation Context

Valued at $14.9M, BIVI is classified as a micro-cap stock. Relative to its peer group, BIVI's quantitative score of 28/100 is below the peer average of 75/100.

BIVI Revenue & Earnings Trend

In Q4 FY2026, BIVI generated $0 in top-line revenue. The company recorded a net loss of $5.6M, with diluted EPS of $-0.75. Quarter-over-quarter revenue has been mixed, typical for a micro-cap company operating in Healthcare. Across the four most recent quarters, BIVI averaged $-0.80 in diluted EPS.

Company Profile

BioVie Inc. operates in the Biotechnology industry within the Healthcare sector. It is headquartered in Carson City, US. The company is led by CEO Cuong Viet Do. BIVI has traded publicly since 2020.

BIVI Financials

BIVI Latest News

BIVI Analyst Consensus

BIVI MoonshotScore

BIVI Healthcare Stock FAQ

Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.

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