BioVie Inc. (BIVI): History, Ownership, Mission, How It Works & Makes Money

When you look at a clinical-stage biopharmaceutical company like BioVie Inc. (BIVI), the immediate question is always: How does a firm with virtually no product revenue, which reported a net loss of approximately $17.5 million for the fiscal year 2025, sustain its ambitious pipeline? BioVie's strategy hinges on its lead drug candidates, like bezisterim (NE3107) for neurodegenerative disorders, which are backed by a lean $9.3 million in annual R&D expenses and a critical $13.1 million U.S. Department of Defense grant. Are you defintely factoring in the high-stakes, binary outcomes of their Phase 3 trials for Alzheimer's and advanced liver disease, or are you just looking at the $11.2 million market capitalization? Let's break down the history, ownership, and financial engine driving this high-risk, high-reward biotech player.

BioVie Inc. (BIVI) History

You're looking for the bedrock of BioVie Inc., and honestly, understanding where this clinical-stage biopharmaceutical company came from is key to assessing its current risk profile. The company didn't start with its current name or focus; it's a story of strategic pivots and asset acquisitions, which is defintely common in biotech.

Given Company's Founding Timeline

Year established

The company was initially incorporated on April 26, 2013, under the name NanoAntibiotics, Inc.

Original location

The original location of incorporation was Carson City, Nevada.

Founding team members

While formal initial incorporation documents list registered agents, Terren Peizer played a crucial role in the company's early strategic direction, particularly following the pivot that led to the BioVie Inc. name and its focus on clinical development.

Initial capital/funding

Specific initial seed funding details are not readily public. The company's earliest funding came through mechanisms like a reverse merger and subsequent public offerings, rather than traditional venture capital rounds. It went public on May 5, 2014, opening at a split-adjusted price of $6,250.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's trajectory is defined by two major strategic shifts and a critical focus on capital preservation, especially given its development-stage status and lack of revenue. The most transformative decision was the 2021 acquisition that brought bezisterim (NE3107) into the pipeline, making neurodegenerative diseases the core focus.

For the fiscal year ending June 30, 2025, the financial performance shows the direct impact of its clinical focus and capital strategy. The net loss improved significantly to approximately $17.5 million, down from a $32.1 million loss in the prior year. This improvement was largely due to a decrease in research and development (R&D) expenses, which fell to $9.3 million. That's the quick math on managing cash burn while advancing trials.

The capital raises in late 2024 and mid-2025 were also transformative, providing a critical runway. As of June 30, 2025, BioVie Inc. reported cash and cash equivalents totaling $17.5 million, which is the lifeblood of a company in this sector. This capital is being deployed to advance a dual-focus pipeline:

• Accelerate the Phase 2b trial for bezisterim in new-onset Parkinson's disease, targeting topline results by mid-2025.
• Develop a once-daily formulation of bezisterim for a planned Phase 3 Alzheimer's disease trial in late 2025.
• Prepare for a Phase 3 study of BIV201 for refractory ascites, an orphan drug candidate.

What this estimate hides is the inherent risk of a clinical-stage company; success hinges entirely on trial results and securing future financing, still a tight wire act. You can get a better sense of who is betting on these outcomes by Exploring BioVie Inc. (BIVI) Investor Profile: Who's Buying and Why?

BioVie Inc. (BIVI) Ownership Structure

BioVie Inc.'s ownership structure is heavily weighted toward the public float, but the company's strategic direction is still significantly influenced by its core insiders. As of the 2025 fiscal year, the majority of the shares-over 80%-are held by retail and individual investors, which can lead to higher stock price volatility, but the executive team and directors maintain a substantial collective stake.

BioVie Inc.'s Current Status

BioVie Inc. is a publicly traded, clinical-stage biopharmaceutical company. Its common stock is listed on the Nasdaq Capital Market under the ticker symbol BIVI. This public status means the company is subject to the rigorous reporting requirements of the U.S. Securities and Exchange Commission (SEC), providing investors with transparent financial and operational updates, such as the recent November 2025 quarterly earnings report.

The company's market capitalization as of November 2025 stood at approximately $12.14 million. The total shares outstanding for the Class A common stock were approximately 7.54 million. The stock has experienced extreme volatility in the 2025 fiscal year, with its share price around $1.51 in November 2025, representing a steep decline from its price of $33.50 a year earlier.

BioVie Inc.'s Ownership Breakdown

Understanding who owns the shares is crucial, as it clarifies who holds the voting power in key decisions, like the election of directors, which shareholders approved at the November 2025 annual meeting. The ownership is primarily distributed across three categories: institutional investors (like mutual funds and ETFs), insiders (executives and directors), and the public float (retail investors).

The high retail/public float percentage means the stock is heavily influenced by individual investor sentiment and trading activity. Institutional ownership is relatively low at 4.59%, but major holders include Vanguard Group Inc. and Geode Capital Management LLC. Insiders, with nearly 15% of the company, still hold enough sway to defend against most unsolicited takeover attempts, which is defintely important for a small-cap biotech.

BioVie Inc.'s Leadership

The company is steered by an experienced leadership team and a Board of Directors, many of whom have significant tenure in the biopharma and finance sectors. This stability in the management team, which has an average tenure of about 4.5 years, is a key consideration for investors.

The executive team focuses on advancing the company's drug candidates, such as bezisterim (NE3107) for neurological disorders and BIV201 for liver disease.

• Cuong Viet Do: President & Chief Executive Officer (CEO).
• Joanne Kim: Chief Financial Officer (CFO), Treasurer & Corporate Secretary.
• Joseph M. Palumbo, MD: Executive VP of R&D and Chief Medical Officer.
• David Morse, PhD: Chief Regulatory Officer and Senior Vice President.
• Chris Reading, PhD: Senior Vice President, Alzheimer's Disease Program.

The Board of Directors, which includes the CEO, was re-elected in November 2025 and provides oversight on strategy and governance. To learn more about the strategic direction these leaders are setting, you can read the Mission Statement, Vision, & Core Values of BioVie Inc. (BIVI).

BioVie Inc. (BIVI) Mission and Values

BioVie Inc.'s core purpose transcends typical pharmaceutical profit motives; it is fundamentally about developing innovative drug therapies to tackle debilitating neurodegenerative and liver diseases where patient options are defintely limited. This mission is the cultural DNA that drives their significant research and development (R&D) spend, even while operating without revenue.

BioVie Inc.'s Core Purpose

You're looking for the 'why' behind the numbers, and for a clinical-stage company like BioVie Inc., their mission is their business model. They are a pure-play bet on scientific advancement, which is why their focus is so tight on high-unmet-need conditions.

Official mission statement

The company's mission centers on developing innovative drug therapies for neurodegenerative and metabolic disorders, striving to address critical unmet medical needs and improve the quality of life for patients. This is not just a statement; it's the justification for their cash burn, which is why understanding their pipeline is key. For example, their lead drug candidate, bezisterim (NE3107), targets inflammation-driven insulin resistance, a key driver in Alzheimer's disease (AD) and Parkinson's disease (PD).

• Develop novel therapies for diseases like AD, PD, and advanced liver cirrhosis.
• Address medical conditions where current treatments are inadequate or nonexistent.
• Focus resources on rigorous clinical trials and scientific advancement.

Check out Breaking Down BioVie Inc. (BIVI) Financial Health: Key Insights for Investors for a look at how this mission translates into their balance sheet.

Vision statement

BioVie Inc. envisions itself as a leader in innovative therapies for neurological and liver diseases. This isn't just about being first; it's about providing new, effective treatments that genuinely enhance patient outcomes. As of June 30, 2025, the company had working capital of approximately $18.4 million, showing the capital they've secured to pursue this vision through the next stages of clinical development.

• Expand treatment options where few currently exist.
• Improve patient outcomes and quality of life.
• Drive scientific progress in complex disease understanding.

They are betting their $11.2 million market capitalization (as of November 7, 2025) on this long-term vision.

BioVie Inc. slogan/tagline

While a single, formal marketing slogan isn't always typical for a clinical-stage biopharma firm, their stated ambition is to 'unlock the science of longevity and transform the way people live.' This goal captures the transformative nature of their work-moving beyond just treating symptoms to addressing the underlying causes of age-related and chronic debilitating conditions.

Their core values reinforce this drive:

• Innovation: Embrace novel approaches to drug development.
• Patient-Centricity: Keep patient well-being at the forefront of all decisions.
• Integrity: Maintain transparency and high ethical standards.
• Collaboration: Foster partnerships for shared scientific goals.

Here's the quick math: they closed a $12 million public offering in August 2025 to fund these efforts, demonstrating a clear commitment to their mission over short-term revenue generation. That's a huge capital injection for a company with $17.5 million in cash as of mid-year 2025.

BioVie Inc. (BIVI) How It Works

BioVie Inc. is a clinical-stage biopharmaceutical company that creates value by developing novel, small-molecule drug therapies for chronic, debilitating conditions, primarily focusing on neurodegenerative disorders and advanced liver diseases. The company's entire operational model centers on advancing its two lead drug candidates, bezisterim and BIV201, through rigorous clinical trials to secure eventual regulatory approval and commercialization, as it currently generates no revenue from product sales.

You're looking at a company where success is all about clinical milestones, not current sales. It's a binary bet: either the trials succeed and the drug gets approved, or the substantial R&D investment is lost.

BioVie Inc.'s Product/Service Portfolio

The company's value proposition in November 2025 rests entirely on its pipeline of investigational drug candidates, which target conditions with high unmet medical needs.

BioVie Inc.'s Operational Framework

As a clinical-stage company, BioVie's operational framework is streamlined to support research and development (R&D) and regulatory affairs, minimizing commercial overhead. For the fiscal year 2025 (ending June 30, 2025), the company reported total operating expenses of approximately $18.1 million, with R&D expenses accounting for $9.3 million of that total.

• Capital-Driven Funding: Operations are financed through equity offerings and non-dilutive grants, not product sales. In August 2025, the company closed a public offering that grossed approximately $12 million.
• Clinical Trial Management: The core process is managing multi-site clinical trials, such as the Phase 2 SUNRISE-PD trial for Bezisterim, which started in April 2025.
• Strategic Partnerships: BioVie secured a $13.1 million clinical trial grant from the U.S. Department of Defense (DoD) in April 2024 to evaluate Bezisterim for neurological symptoms associated with Long COVID, with trials starting in May 2025. This non-dilutive funding is crucial.
• Lean Structure: The company maintains a small operational footprint, focusing on outsourcing clinical research and manufacturing, which keeps selling, general, and administrative (SG&A) expenses relatively stable at around $8.6 million for FY 2025.

Here's the quick math: with a net loss of about $17.5 million in FY 2025, the company's cash position of $17.5 million as of June 30, 2025, means capital raises are defintely a continuous necessity to fund the pipeline.

BioVie Inc.'s Strategic Advantages

BioVie's competitive edge comes from its intellectual property and the regulatory status of its lead candidates, which create significant barriers to entry for competitors. You can learn more about the institutional interest in this model by Exploring BioVie Inc. (BIVI) Investor Profile: Who's Buying and Why?

• Novel Mechanism of Action: Bezisterim's specific and selective inhibition of inflammatory ERK/NF-κB pathways is a first-in-class approach, potentially offering a differentiated treatment profile compared to existing or emerging therapies for neurodegenerative diseases.
• Orphan Drug Designation: BIV201's Orphan Drug designation for refractory ascites provides seven years of market exclusivity in the U.S. post-approval, plus tax credits and protocol assistance, significantly de-risking the commercial path for that candidate.
• Non-Dilutive Government Funding: The substantial DoD grant for the Long COVID trial provides a capital runway for a new indication without further equity dilution, validating the drug's potential in an emerging, high-need market.
• Multiple Indications: The lead candidate, Bezisterim, is being tested across three major indications-Parkinson's, Alzheimer's, and Long COVID-which diversifies the clinical risk and expands the potential total addressable market.

BioVie Inc. (BIVI) How It Makes Money

BioVie Inc. is a clinical-stage biopharmaceutical company, meaning it currently generates $0 in revenue from product sales, as its drug candidates are not yet approved or commercialized. The company's economic engine is driven entirely by capital raises, such as equity offerings, and non-dilutive funding like government grants and reimbursements, which finance its extensive research and development (R&D) operations.

You're looking at a classic biotech model: the company makes money by advancing its drug pipeline-bezisterim (NE3107) for neurological disorders and BIV201 for liver disease-through clinical trials, which increases the company's valuation and allows it to secure more funding. That's how the business sustains itself right now.

BioVie Inc.'s Revenue Breakdown

Because BioVie Inc. is a pre-commercial company, its traditional revenue from product sales is 0% of its total income. The figures below reflect the sources of operational cash flow that fund the business, which is the closest proxy to revenue for a company in this stage.

The company's primary source of non-dilutive operational cash flow in the near-term comes from clinical trial funding. For example, BioVie Inc. received a $2.5 million reimbursement from the Department of Defense (DoD) for its Long COVID program during the third quarter of fiscal year 2025, which is a key operational inflow. This is not product revenue, but it offsets R&D costs, which is just as important right now.

Business Economics

The core economic fundamental of BioVie Inc. is its ability to secure capital and manage its burn rate (the speed at which it spends cash). The entire business model is a high-risk, high-reward bet on the clinical success of its lead drug candidates.

• Pricing Strategy: Not applicable yet, but the future pricing of bezisterim and BIV201 will be a specialty pharmaceutical model, targeting high prices due to their potential to treat serious conditions like Parkinson's disease, Alzheimer's disease, and advanced liver disease with unmet medical needs.
• Cost Structure: Overwhelmingly dominated by Research and Development (R&D) expenses. For the fiscal year ended June 30, 2025, R&D expenses were approximately $9.3 million, which is more than half of its total operating expenses.
• Key Value Driver: The value of BioVie Inc. is tied to clinical milestones, not sales. A positive Phase 3 trial result for BIV201 or a successful Phase 2 for bezisterim in Parkinson's disease would instantly create billions in potential market capitalization, dwarfing any near-term grant income.
• Capital Reliance: The company relies heavily on equity offerings to fund operations. During the nine months ended March 31, 2025, BioVie Inc. raised net proceeds of $15.7 million from equity offerings, plus an additional $2.9 million from warrant exercises. This is the lifeblood of the company.

The economic reality is stark: without successful clinical trials, the company has no product, and without continuous financing, it has no runway. You can read more about the long-term vision here: Mission Statement, Vision, & Core Values of BioVie Inc. (BIVI).

BioVie Inc.'s Financial Performance

As a clinical-stage biotech, financial health is measured by cash position, burn rate, and the ability to reduce losses while advancing the pipeline. BioVie Inc. has made progress in expense management for the fiscal year 2025.

• Net Loss: For the full fiscal year ended June 30, 2025, BioVie Inc. reported a net loss of approximately $17.54 million. This is a significant improvement from the $32.12 million loss reported in the prior fiscal year, a reduction of nearly 45%.
• Operating Expenses: Total operating expenses for FY 2025 decreased to approximately $18.1 million, down from $32.2 million in the previous year. This reduction is defintely a key sign of tighter cost control, mainly from lower R&D spending after completing certain trials.
• Cash Position: As of June 30, 2025, the company held $17.5 million in cash and cash equivalents, with working capital of approximately $18.4 million. This cash is crucial, but management has explicitly noted substantial doubt about continuing as a going concern without securing additional financing.
• Loss Per Share (LPS): The diluted loss per share from continuing operations for the full year ended June 30, 2025, was $12.12. Here's the quick math: managing that LPS is the primary goal until a drug is approved.

BioVie Inc. (BIVI) Market Position & Future Outlook

BioVie Inc. is positioned as a high-risk, high-reward clinical-stage biopharmaceutical company, with its future trajectory hinging entirely on its lead drug candidate, bezisterim (NE3107), successfully advancing through late-stage trials in neurodegenerative diseases. The company's financial position as of the fiscal year ending June 30, 2025, showed a net loss of approximately $17.5 million, underscoring its pre-revenue status and reliance on capital raises to fund its ambitious pipeline. Exploring BioVie Inc. (BIVI) Investor Profile: Who's Buying and Why?

Competitive Landscape

In the competitive biotech space, particularly for neurodegenerative diseases, BioVie Inc. competes against companies with larger pipelines and market valuations. Since BioVie Inc. is pre-revenue, we use a peer-group market capitalization percentage as a proxy for relative market presence in this table.

Opportunities & Challenges

You need to look at the clinical pipeline for the real opportunities, but honestly, the financial risks are what will drive the stock in the near term. The company's cash and cash equivalents stood at approximately $17.5 million as of June 30, 2025.

Industry Position

BioVie Inc. operates as a micro-cap, clinical-stage entity, ranking low in the broader medical sector. MarketBeat's MarketRank™ scored BioVie Inc. higher than only 14% of companies evaluated, placing it 886th out of 934 stocks in the medical sector [cite: 20 (from step 1)]. The current ratio of 15.83x as of November 2025 does indicate strong short-term liquidity, but this is typical for a pre-revenue biotech that recently raised capital and has minimal liabilities. The low institutional ownership, at just 2.47%, reflects the high-risk nature of its all-or-nothing pipeline. The company's focus on neuroinflammation as a target for AD and PD is a defintely smart, differentiated approach, but it needs a major partnership or a successful late-stage data readout to move beyond its current valuation of approximately $11.2 million.