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BioVie Inc. (BIVI): Business Model Canvas [Dec-2025 Updated] |
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BioVie Inc. (BIVI) Bundle
You're assessing a classic clinical-stage biopharma play, and for BioVie Inc., the entire business model is a focused sprint to commercialization for its two lead candidates, NE3107 and BIV201. Honestly, the near-term reality is stark: as of June 30, 2025, the company held about $17.5 million in cash to fund its pipeline, which saw R&D expenses hit roughly $9.3 million for FY 2025 while product revenue remained at $0.00. This Canvas maps out the high-stakes dependencies-from CROs and the FDA to the $12 million gross proceeds from its August 2025 equity raise-that underpin their pursuit of markets like Parkinson's Disease and Orphan Drug refractory ascites; check below to see the precise structure of this venture.
BioVie Inc. (BIVI) - Canvas Business Model: Key Partnerships
The Key Partnerships block for BioVie Inc. centers on external entities critical for clinical development, regulatory navigation, and future commercialization efforts for its drug candidates, bezisterim (NE3107) and BIV201.
For the bezisterim Long COVID program, the U.S. Department of Defense (DOD) is a primary financial partner. BioVie Inc. secured an award of up to $13.1 million in non-dilutive funding through the DOD's Peer Reviewed Medical Research Program (PRMRP) to support the Phase 2b clinical trial of bezisterim for neurological symptoms associated with Long COVID. This funding included an initial allocation of $499,200 for the planning phase, with the option to access the remaining $12.6 million upon completion of planning milestones. The trial, anticipated to commence by early 2025, is designed as a multicenter study involving approximately 200 patients.
Clinical trial execution relies on established networks. While specific Clinical Research Organizations (CROs) are not detailed in recent disclosures, the BIV201 trial for refractory ascites involved ten prestigious research centers across the U.S. Academic involvement is also evident; Dr. Michael Peluso, who leads a Long COVID clinical trials program at the University of California, San Francisco, has been associated with the bezisterim Long COVID trial. Furthermore, BioVie Inc. has engaged with Key Opinion Leaders from institutions like Brown University Warren Alpert Medical School and the Medical University of So. for program discussions.
In terms of disease-specific foundations, BioVie Inc. previously announced a partnership with the American Liver Foundation (ALF) to conduct an educational campaign regarding chronic liver cirrhosis and its complications, supporting awareness for the BIV201 program. There are no specific reports detailing a partnership with the Michael J. Fox Foundation as of late 2025.
For BIV201 commercialization, BioVie Inc. is actively pursuing external collaboration. The Phase 3 trial for BIV201, which focuses on cirrhotic patients with ascites who have experienced an acute kidney injury, is delayed pending partnership funding. The active agent in BIV201, terlipressin, is already approved in about 40 countries for related complications of advanced liver cirrhosis, which provides a foundation for potential large pharmaceutical partners interested in U.S. and Japan market entry.
Here's a look at the quantified partnership elements:
| Partner Type | Partner/Program | Financial/Statistical Metric | Value/Count |
|---|---|---|---|
| Government Funding | U.S. Department of Defense (DOD) - Long COVID Trial | Total Potential Grant Funding | $13.1 million |
| Government Funding | U.S. Department of Defense (DOD) - Long COVID Trial | Initial Planning Phase Funding | $499,200 |
| Clinical Sites | BIV201 Phase 2b Trial Sites | Number of Research Centers | Ten |
| Disease Foundation | American Liver Foundation (ALF) | Partnership Focus | Educational Campaign/Awareness |
| Commercialization Target | BIV201 Active Agent Approval | Number of Countries Approved Outside US/Japan | About 40 |
| Clinical Trial Scope | Bezisterim Long COVID Phase 2b Trial Size | Approximate Number of Patients | 200 |
The reliance on non-dilutive government funding for the Long COVID trial de-risks that specific development path near-term.
- DOD grant expected to fund trial execution starting early 2025.
- BIV201 Phase 3 trial design finalized following FDA feedback.
- Partnering discussions ongoing for BIV201 geographic rights.
- BIV201 active agent has FDA Fast Track status for ascites.
BioVie Inc. (BIVI) - Canvas Business Model: Key Activities
You're looking at the core engine of BioVie Inc. (BIVI), which is entirely focused on advancing its pipeline through the clinic. For a pre-revenue biotech like BioVie Inc., the Key Activities are where every dollar goes and where every milestone is won or lost.
Drug Research and Development (R&D) for bezisterim (NE3107) and BIV201
The R&D activity centers on optimizing bezisterim (NE3107) for multiple indications and preparing BIV201 for its next major trial phase. This activity is reflected directly in the operating expenses. For the fiscal year ending June 30, 2025, BioVie Inc. reported Research and Development (R&D) expenses of approximately $9.3 million, which was a significant reduction from the $23.1 million spent in the prior fiscal year. This scaling down suggests a shift from early-stage work to focused trial execution. Looking at the third quarter of fiscal year 2025, which ended March 31, 2025, R&D expenses were down to $1.3 million from $5.7 million year-over-year. The company reported $0.00 in product revenue for Q3 2025, consistent with its clinical-stage status.
Execution of Phase 2/3 clinical trials (PD, Long COVID, AD)
Executing the clinical program is the most critical activity, consuming the majority of the R&D budget. BioVie Inc. is running concurrent trials for bezisterim across three major indications. The company's ability to manage these trials is paramount to its valuation. Here's a breakdown of the expected timelines as of late 2025:
| Indication | Trial Phase/Status | Key Data Expectation Timeline |
| Parkinson's Disease (PD) | Phase 2 SUNRISE-PD trial enrolling patients | Topline data expected in late 2025 or early 2026 |
| Long COVID | Phase 2 ADDRESS-LC trial, first patient enrolled in May 2025 | Topline data anticipated in the first half of 2026 |
| Alzheimer's Disease (AD) | Initiating Phase 3 trial with a new once-daily formulation | Phase 3 initiation planned for late 2025 |
The Long COVID trial received a substantial, non-dilutive funding source: a grant from the U.S. Department of Defense (DOD) of up to $13.1 million.
For BIV201, the activity involves finalizing the Phase 3 design for ascites related to liver cirrhosis, with commencement contingent on securing a suitable partner.
Regulatory strategy and interaction with the FDA
Interaction with the Food and Drug Administration (FDA) is a constant key activity, especially for advancing BIV201 and bezisterim. BIV201 already holds two key designations which streamline regulatory interaction:
- FDA Fast Track status for BIV201.
- Orphan Drug designation for BIV201.
The company has received guidance from the FDA specifically regarding the design of the Phase 3 clinical testing for BIV201. For bezisterim, the company is executing trials based on prior FDA protocol submissions, such as the one for the new-onset PD study submitted in July 2024.
Intellectual Property (IP) protection and maintenance
While specific maintenance costs aren't itemized separately from SG&A, the activity involves securing and defending the composition of matter and method of use patents for bezisterim and BIV201. The focus here is maintaining the exclusivity that justifies the R&D spend. The company's strategy is built around bezisterim's unique mechanism-binding to ERK and selectively modulating NFκB activation-which is the core IP asset being tested across its indications.
Continuous capital raising and investor relations (IR)
As a clinical-stage company with no product revenue, continuous capital raising is a necessary, high-frequency activity. The financial results for the fiscal year ending June 30, 2025, show a net loss of approximately $17.5 million, an improvement from the $32.1 million loss the prior year. This reduced burn rate is critical for runway, but financing remains essential. As of June 30, 2025, BioVie Inc. held $17.5 million in cash and cash equivalents. The company executed a significant financing event in August 2025, closing a public offering that raised approximately $12 million in gross proceeds. This followed earlier financing in the first nine months of 2025, which brought in net proceeds of $15.7 million from equity offerings plus $2.9 million from warrant exercises. Management noted substantial doubt about continuing as a going concern without additional financing as of March 31, 2025. The working capital position improved to approximately $24.4 million by September 30, 2025.
Investor Relations is focused on communicating the execution risk and pipeline milestones to justify these capital needs. The company reported its Q3 2025 earnings on November 10, 2025, posting a GAAP EPS of -$0.98.
Finance: draft 13-week cash view by Friday.
BioVie Inc. (BIVI) - Canvas Business Model: Key Resources
You're looking at the core assets that power BioVie Inc.'s strategy right now, which is heavily weighted toward clinical development and intellectual property protection. Here's the quick math on what they are holding onto as of late 2025.
The primary tangible financial resource is the capital base. As of the end of the fiscal year on June 30, 2025, BioVie Inc. reported its cash and cash equivalents stood at $17.54 million. This figure is a key input for funding near-term clinical milestones, especially given the negative operating cash flow of approximately $-18.47 million for the trailing twelve months (TTM).
The intangible resources, the drug candidates, are the real value drivers. BioVie Inc. centers its pipeline on two lead assets:
- Lead drug candidates: bezisterim (NE3107) and BIV201 (continuous infusion terlipressin)
For BIV201, the continuous infusion terlipressin formulation, the key resource is the regulatory positioning for refractory ascites. The drug has received FDA Fast Track designation for refractory ascites. The clinical data from the terminated Phase 2b trial showed encouraging efficacy; specifically, patients who completed treatment experienced a 53% reduction in ascites fluid buildup compared to no change in the standard-of-care only group (p<0.001). Furthermore, an earlier look at 15 patients showed a 34% reduction in fluid versus a 3.1% increase in the control group (p=0.0046). BioVie Inc. is now working with the FDA to finalize the Phase 3 protocol, which will focus on reducing subsequent complications after acute kidney injury in cirrhotic patients with ascites.
For bezisterim (NE3107), the focus is on neurological indications, leveraging its mechanism as an anti-inflammatory and insulin-sensitizer that crosses the blood-brain barrier.
The clinical data supporting these assets are critical resources, as they de-risk future development:
| Trial/Indication | Drug Candidate | Status/Key Data Point |
|---|---|---|
| SUNRISE-PD (Parkinson's Disease) | Bezisterim | Phase 2 enrolling; topline data expected in late 2025 or early 2026 |
| ADDRESS-LC (Long COVID) | Bezisterim | Phase 2 enrolling; fully funded by a U.S. Department of Defense (DOD) grant |
| Alzheimer's Disease (AD) | Bezisterim | Planning to initiate Phase 3 trial in late 2025 using a new once-daily formulation |
| Refractory Ascites | BIV201 | Phase 2b showed 53% reduction in fluid for completers vs. no change for SOC only (p<0.001) |
Intellectual property forms a strong protective layer around the novel mechanisms. BioVie Inc. has patent protection for BIV201, with a specific method of use patent expected to provide U.S. protection until 2036. They are also pursuing overseas issuances and have other undisclosed patent applications.
The regulatory advantages translate directly into market exclusivity potential:
- FDA Fast Track designation for BIV201 in refractory ascites
- Orphan Drug designation secured for BIV201 for both ascites and hepatorenal syndrome (HRS)
- Orphan therapies typically receive 7 years of market exclusivity upon first FDA marketing approval for the designated rare disease
Finance: draft 13-week cash view by Friday.
BioVie Inc. (BIVI) - Canvas Business Model: Value Propositions
You're looking at the core value BioVie Inc. is trying to deliver across its pipeline, which is heavily focused on targeting neuroinflammation and related mechanisms. This is where the potential for significant patient impact-and financial upside-resides.
The lead asset, bezisterim (formerly NE3107), is positioned as a novel, orally available small molecule. Its mechanism involves binding to ERK and selectively modulating NFκB activation and TNF-α production. It is described as an oral, blood-brain barrier-permeable, anti-inflammatory, insulin-sensitizing agent.
For Parkinson's Disease (PD), the value proposition centers on offering a potential disease-modifying therapy, aiming to be the first new treatment in over five decades. The Phase 2 SUNRISE-PD trial is evaluating bezisterim as a monotherapy for early PD patients who have not yet been treated with carbidopa/levodopa. Topline data from this trial is anticipated by late 2025 or early 2026. Previous Phase 2a data in PD showed a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS), contrasted with a worsening of +1 point for placebo-treated patients.
The BIV201 program targets refractory ascites, a condition with a life-threatening 50% mortality rate within 12 months, for which there is currently no approved drug. BIV201, a continuous infusion formulation of terlipressin, has Orphan Drug designation (granted in 2016) and Fast Track status. Data from a Phase 2b trial, though limited by small size ($\text{n}=10$ for BIV201+SOC vs $\text{n}=5$ for SOC alone), indicated potential benefit. Patients completing treatment with BIV201+SOC experienced a reduction in ascites fluid buildup of 53% versus no change for Standard of Care (SOC) alone ($\text{p}<0.001$).
Here's a quick look at the BIV201 Phase 2b comparative efficacy endpoints:
| Metric | BIV201+SOC (Completers) | SOC Alone |
|---|---|---|
| Liver Complications (Mean) | 2.87 (90% CI: 1.51; 5.46) | 2.38 (90% CI: 1.20; 4.73) |
| Change in Cumulative Ascites (Mean) | -10.76 (90% CI: -26.51; 5.00) | -4.99 (90% CI: -21.95; 11.97) |
For Long COVID, the value is addressing debilitating neurological symptoms like fatigue and brain fog, which are believed to stem from chronic neuroinflammation. The Phase 2 ADDRESS-LC trial, which is fully funded by a U.S. Department of Defense grant up to $13.1 million, is currently enrolling approximately 200 patients, with topline data expected in the first half of 2026. This condition affects an estimated 20 million adults in the US, with an economic impact estimated at $3.7 trillion.
The safety profile is a key differentiator across the pipeline, particularly for bezisterim. The company states it is not immunosuppressive and carries a low risk of drug-drug interaction. For BIV201, the continuous infusion approach is highlighted as reducing the incidence of severe adverse events compared to the bolus administration used for other indications of terlipressin. However, the Phase 2b trial did note a high rate of hyponatremia in 4/10 patients in the BIV201+SOC group.
The core therapeutic mechanisms BioVie Inc. is targeting with bezisterim include:
- Targeting key mechanisms of neuroinflammation.
- Addressing potential metabolic dysfunction in the CNS.
- Modulating TNF-α production.
- Reducing insulin resistance in the brain.
Financially, BioVie Inc. remains pre-revenue, with zero reported revenue in Q3 FY2025, consistent with its clinical-stage operations. The net loss for Q3 FY2025 was $2.8 million, an improvement from the $8.1 million loss in Q3 FY2024, driven by lower R&D expenses of $1.3 million in Q3 FY2025 (down from $5.7 million year-over-year). As of March 31, 2025, the company maintained $23.2 million in cash and cash equivalents.
Finance: review the cash runway based on the $23.2 million cash balance against the Q3 FY2025 operating expense run rate of approximately $3.0 million per quarter.
BioVie Inc. (BIVI) - Canvas Business Model: Customer Relationships
You're managing a clinical-stage biotech, so your customer relationships aren't about selling widgets; they're about building trust with the scientific community, regulators, and the capital markets to fund multi-year drug development. Here's how BioVie Inc. (BIVI) structures those critical interactions as of late 2025.
High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators
BioVie Inc. (BIVI) focuses on direct scientific engagement to validate its pipeline, particularly bezisterim. This involves hosting specialized events where top medical minds discuss the data. For instance, the company hosted a virtual KOL event on May 28, 2025, specifically to discuss the Phase 2 SUNRISE-PD study for Parkinson's disease, featuring experts like Suzanne de la Monte, MD, MPH, and Mark Stacy, MD. KOLs (Key Opinion Leaders) are central to building credibility for novel mechanisms like bezisterim's selective inhibition of inflammation-driven ERK and NFκB activation.
The company also used KOLs to frame the market need for its other candidates. A KOL Webcast featuring Lindsay McAlpine, MD, BSc (Yale University), was held on April 10, 2025, to discuss the Long COVID treatment landscape and the ADDRESS-LC trial.
Direct-to-patient outreach for clinical trial enrollment
Enrollment velocity is lifeblood for a clinical-stage company, especially with multiple active trials. BioVie Inc. (BIVI) is actively managing enrollment across its key programs, using trial design features like decentralization to broaden access. The goal for the Parkinson's Phase 2 SUNRISE-PD trial is to be fully enrolled by the end of 2025. The Long COVID Phase 2 ADDRESS-LC trial is designed to enroll approximately 200 patients and received FDA authorization for its IND application in July 2025, with a three-month treatment period planned.
The company has a clear near-term milestone for data readout from the Parkinson's trial, projecting topline data in the April/May time frame of 2026. The Alzheimer's Phase 3 trial initiation was targeted for late 2025.
Here's a snapshot of the active patient engagement and data timelines:
| Program | Trial Phase | Target Enrollment (Approx.) | Key Enrollment/Data Milestone |
|---|---|---|---|
| Bezisterim (Parkinson's) | Phase 2 (SUNRISE-PD) | Not specified, but enrollment picked up quickly | Projected full enrollment by end of 2025; Topline data by April/May 2026 |
| Bezisterim (Long COVID) | Phase 2 (ADDRESS-LC) | Approximately 200 patients | IND authorized by FDA in July 2025; 3-month treatment period |
| Bezisterim (Alzheimer's) | Phase 3 | Not specified | Initiation planned for late 2025 |
Investor relations via webinars and public disclosures (e.g., December 2025 webinar)
Investor communication is frequent and structured, often through third-party hosts like RedChip Companies. BioVie Inc. (BIVI) scheduled an exclusive live Investor Webinar and Q&A Session for December 9, 2025, following a previous one on October 8, 2025. These events are used to update the market on progress, such as the advancement of bezisterim and BIV201. The company also executed public financing, closing a $12 Million public offering on August 11, 2025. Importantly, management stated that the company has sufficient cash runway to last through the end of 2026.
The cadence of these interactions is high:
- Webinar on December 9, 2025 (Scheduled).
- Webinar on October 8, 2025 (Recent).
- KOL Webcast on May 28, 2025.
- KOL Webcast on April 10, 2025.
Close regulatory relationship with the FDA for development path guidance
The relationship with the U.S. Food and Drug Administration (FDA) is crucial for charting the path for both bezisterim and BIV201. For BIV201, which treats refractory ascites-a condition with a 50% mortality rate within 12 months and no FDA-approved therapies-the company has FDA Fast Track status. As of the November 2025 timeframe, the protocol for the BIV201 Phase 3 clinical trial had been submitted to the FDA about three weeks prior, with an expectation to hear back within 30 days. This close interaction is necessary to finalize the development path for a first-in-class therapy. Furthermore, the FDA authorized the IND application for bezisterim in Long COVID in July 2025, directly enabling that Phase 2 trial to commence.
Finance: draft 13-week cash view by Friday.
BioVie Inc. (BIVI) - Canvas Business Model: Channels
Clinical trial sites are the primary physical channel for BioVie Inc. (BIVI) drug delivery and testing as of late 2025. The Phase 2 SUNRISE-PD trial for bezisterim in Parkinson's Disease is enrolling patients, with topline data anticipated in late 2025 or early 2026. This trial utilizes a decentralized design, allowing for remote participation alongside visits to a clinical site. The Phase 2 ADDRESS-LC trial for Long COVID, which commenced patient enrollment on May 15, 2025, involves approximately 200 patients. BioVie Inc. advances its pipeline through clinical research organizations across the United States and Canada.
Data dissemination channels rely heavily on scientific forums and regulatory disclosures. A poster detailing the SUNRISE-PD trial was presented at the Advanced Therapeutics in Movement & Related Disorders® Congress in National Harbor, MD, between June 27 and June 30, 2025. Furthermore, BioVie Inc. presented 'Bezisterim Epigenetic Effects on Aging and Neurodegeneration' at the 7th World Aging and Rejuvenation Conference (ARC-2025) in Vienna, Austria, on July 9th - 10th, 2025. The company's revenue remained at $0.0 for the trailing twelve months ending September 30, 2025, consistent with its clinical-stage focus.
Capital access is channeled through public markets and regulatory filings. BioVie Inc. trades on NASDAQ under the ticker BIVI. In August 2025, the company closed an underwritten public offering of 6,000,000 units at $2.00 per unit, generating gross proceeds of approximately $12 million. The warrants issued in this offering are exercisable at $2.50 per share. As of the September 30, 2025, SEC filing, cash and cash equivalents stood at $25.0 million, following net proceeds of $15.7 million from equity offerings and $2.9 million from warrant exercises in the nine months prior to March 31, 2025. The company also secured a $13.1 million grant from the U.S. Department of Defense for the Long COVID program.
Future distribution channels are currently being established through partnership discussions, particularly for the BIV201 program for ascites. The BIV201 Phase 3 study is in final preparations, contingent upon identifying a suitable partner. BioVie Inc. is also continuing geographic partnering discussions for bezisterim. The company reported operating expenses for Q3 2025 of $5.3 million (R&D $2.9 million; G&A $2.3 million), with a net loss of $5.1 million for that quarter.
The following table summarizes key financial and operational metrics relevant to channel funding and activity as of late 2025:
| Metric Category | Channel Relevance | Value as of Late 2025 | Reporting Period/Date |
| Capital Raised (Aug 2025 Offering) | Investor Relations/Capital Access | $12 million Gross Proceeds | August 11, 2025 |
| Cash & Equivalents | Clinical Trial Funding Runway | $25.0 million | September 30, 2025 |
| Long COVID Trial Funding Source | Clinical Trial Sites/Testing | $13.1 million DoD Grant | Secured prior to May 2025 |
| PD Trial Funding Source | Clinical Trial Sites/Testing | Over $15 million | Secured prior to November 2024 |
| Long COVID Trial Patient Count | Clinical Trial Sites/Testing | Approximately 200 Patients | Phase 2 ADDRESS-LC |
| Scientific Conference Presentation | Data Dissemination | Advanced Therapeutics in Movement & Related Disorders® Congress | June 27-30, 2025 |
| SEC Form Filed for Offering | Investor Relations/Capital Access | Form S-1 (File No. 333-288525) | August 7, 2025 |
| Warrant Exercise Price | Investor Relations/Capital Access | $2.50 per share | August 2025 Offering |
The company's equity incentive plan was amended to authorize 3,100,000 shares for issuance as of November 10, 2025, supporting compensation for key personnel involved in channel execution.
BioVie Inc. (BIVI) - Canvas Business Model: Customer Segments
You're looking at the patient populations and capital providers that form the foundation of BioVie Inc.'s commercial focus as of late 2025. It's a high-stakes environment, where clinical trial milestones directly translate to investor sentiment.
Patients with newly diagnosed Parkinson's Disease (PD)
This segment is being targeted with bezisterim in the Phase 2 SUNRISE-PD clinical trial, which is designed to evaluate the drug's effect on motor and non-motor symptoms in patients who have not yet started carbidopa/levodopa treatment. Enrollment for this trial, which involves approximately 60 patients, was anticipated to begin in early 2025, with topline data expected by the end of 2025.
Patients with mild-to-moderate Alzheimer's Disease (AD)
BioVie Inc. is focused on the estimated six million Americans suffering from Alzheimer's disease. The company is preparing to initiate a Phase 3 trial for bezisterim in this population in late 2025, utilizing a new once-daily formulation. Data presented in July 2025 from the prior Phase 3 study analysis showed treated patients experienced biological age deceleration of up to 4.24 years across various biological clocks after 30 weeks of treatment compared to placebo.
Individuals with neurological symptoms of Long COVID
This segment is being addressed via the Phase 2 ADDRESS-LC study, which is evaluating bezisterim's efficacy in reducing symptoms like 'brain fog' and fatigue in approximately 200 patients. This trial is fully funded by a U.S. Department of Defense grant totaling $13.1 million, with enrollment expected to start in early 2025 and top-line results anticipated by early 2026. The condition itself is believed to affect over 17 million Americans.
Patients with liver cirrhosis and refractory ascites (Orphan Drug market)
The investigational drug BIV201 targets this serious unmet need and has secured both Orphan Drug and Fast Track designations from the FDA. The company is finalizing the protocol for a Phase 3 study, pending identification of a suitable partner. The broader Global Ascites Market was valued at USD 23,556 million in 2025. The Global Orphan Drugs Market overall is predicted to reach USD 669.5 Billion by 2034 from a 2024 valuation of USD 213.6 Billion.
The specific patient population for BIV201 is a niche within the larger ascites market, which is driven by the rising geriatric population, where the U.S. population aged 65 and older was 19.2% in 2024.
| Indication Segment | Key Trial/Designation Status (Late 2025) | Patient/Market Size Data Point |
| Parkinson's Disease (Early) | Phase 2 SUNRISE-PD enrolling; Topline data by end of 2025 | Trial size of approximately 60 patients |
| Mild-to-Moderate Alzheimer's Disease | Phase 3 trial protocol finalizing for late 2025 initiation | Estimated six million Americans affected |
| Long COVID Neurological Symptoms | Phase 2 ADDRESS-LC enrolling (funded by $13.1 million DoD grant) | Condition affects over 17 million Americans |
| Liver Cirrhosis/Refractory Ascites | BIV201 has Orphan Drug designation; Phase 3 finalizing | Global Ascites Market valued at USD 23,556 million in 2025 |
Institutional and retail investors funding the pipeline
You are looking at a company with zero revenue, so the investor base is funding the pipeline based on clinical milestones. As of November 7, 2025, the stock price was $1.48, resulting in a Market Capitalization of $11.2M, or $11.35M as of December 2, 2025, on 7.54M shares outstanding. For the fiscal year ending June 30, 2025, BioVie Inc. reported a net loss of approximately $17.5 million, which was an improvement from the $32.1 million loss in FY2024, largely due to R&D expenses falling to $9.3 million from $23.1 million the prior year. The company held $17.5 million in cash and cash equivalents as of June 30, 2025, and raised approximately $18.9 million through equity offerings during FY2025. The trailing twelve-month Earnings Per Share (EPS) as of September 30, 2025, was -$12.12. Wall Street analysts currently assign a Moderate Buy consensus rating with an average one-year price target of approximately $6.33.
- Trailing 12-Month Revenue (as of 30-Sep-2025): null
- FY 2025 Total Operating Expenses: $18.1 million
- Total Assets (as of 30-Sep-2025): $21.56 million
- Debt-to-Equity Ratio (MRQ 2025): Approximately 0.01
- Current Ratio (as of 30-Sep-2025): 15.83x
The clear action here is to treat BioVie Inc. as a high-risk, high-reward biotech stock. Finance: draft 13-week cash view by Friday.
BioVie Inc. (BIVI) - Canvas Business Model: Cost Structure
You're looking at the core cash outflows for BioVie Inc. as of late 2025, driven almost entirely by clinical development and corporate upkeep since the company remains pre-revenue. The total operating expenses for the fiscal year ending June 30, 2025, were approximately $18.1 million.
The largest single component of the cost base is Research and Development (R&D). For the fiscal year 2025, BioVie Inc. reported Research and Development (R&D) expenses of approximately $9.3 million. This figure represented a significant reduction from the $23.1 million reported the prior year, reflecting completed clinical trials and workforce adjustments.
Here's a breakdown of the major annual cost line items based on the full-year 2025 report:
| Cost Category | FY 2025 Amount (Approximate) |
| Research and Development (R&D) Expenses | $9.3 million |
| Selling, General, and Administrative (G&A) Expenses | $8.6 million |
| Total Operating Expenses | $18.1 million |
Clinical trial operations and site management costs are embedded within the R&D expenses, but specific standalone figures aren't broken out in the high-level summaries. Still, the R&D spend reflects the costs of advancing bezisterim (NE3107) for Parkinson's disease and Long COVID indications, plus preparations for the BIV201 Phase 3 study in liver disease.
General and Administrative (G&A) expenses, covering executive salaries and corporate overhead, were reported around $8.6 million for the full year 2025. For context, the Selling, General, and Administrative expenses for the third quarter of FY2025 alone were $1.6 million.
Intellectual property maintenance and legal fees fall under the G&A structure, but specific amounts for these items aren't itemized separately in the available annual summaries. These costs are necessary to maintain the patent estate for bezisterim and BIV201.
Costs associated with capital raising are a recurring, non-operational cash outflow. You saw a significant financing event in August 2025:
- Gross proceeds expected from the August 2025 underwritten public offering were approximately $12 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
- For the nine months ending March 31, 2025, the company raised net proceeds of $15.7 million from equity offerings.
- During that same nine-month period, proceeds from warrant exercises totaled $2.9 million.
- The company also fully repaid its $5 million notes payable during the nine months ending March 31, 2025.
The company's cash position as of June 30, 2025, was $17.5 million in cash and cash equivalents, with a net change in cash for the year of negative $6.29 million.
Finance: draft 13-week cash view by Friday.
BioVie Inc. (BIVI) - Canvas Business Model: Revenue Streams
You're looking at the current financial lifeblood of BioVie Inc. (BIVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage company deep in development: revenue streams are almost entirely non-operational right now. The core business isn't selling products yet; it's securing funding to push its pipeline forward.
For the fiscal year ending June 30, 2025, product revenue was $0.00. That's the reality when you're pre-commercialization. This means the company is entirely reliant on external capital to fund its research and development (R&D) expenses, which were significant, with a net loss of approximately $17.54 million for that same fiscal year.
The most recent, concrete cash infusion came from equity financing. In August 2025, BioVie Inc. closed a public offering, raising approximately $12 million in gross proceeds. This involved selling units comprised of common stock and warrants, a move that clearly signals a trade-off: reducing immediate credit risk but increasing shareholder dilution. To be fair, the net proceeds after deducting underwriting discounts and commissions were closer to $10.5 million.
A critical, non-dilutive source of funding is the grant money tied to clinical progress. BioVie Inc. was awarded up to $13.1 million in non-dilutive funding from the U.S. Department of Defense (DOD) to evaluate bezisterim for neurological symptoms associated with Long COVID. This total award is structured, with an initial $499,200 provided for the planning phase, and the remaining $12.6 million contingent upon successfully executing the Phase 2b clinical trial. This is defintely a key non-equity source that helps extend the cash runway.
Here's a quick look at the concrete financial inflows that make up the current revenue stream profile:
| Revenue Stream Category | Specific Item | Reported Amount (USD) | Status/Notes |
|---|---|---|---|
| Product Sales | FY Ended June 30, 2025 Product Revenue | $0.00 | Zero revenue from commercial product sales. |
| Equity Financing | Gross Proceeds from August 2025 Public Offering | Approximately $12 million | Raised by selling units of stock and warrants. |
| Equity Financing | Net Proceeds from August 2025 Public Offering | Approximately $10.5 million | Actual cash received after fees. |
| Non-Dilutive Grant Funding | Total Potential U.S. DOD Grant (Long COVID) | Up to $13.1 million | Contingent on trial milestones. |
| Non-Dilutive Grant Funding | Initial DOD Planning Phase Funding | $499,200 | Initial tranche received. |
| Non-Dilutive Grant Funding | DOD Clinical Trial Portion (Option) | $12.6 million | Contingent upon trial progress. |
Looking ahead, the model anticipates two major, currently unrealized revenue streams, both contingent on clinical success and partnership activity. These are:
- Future milestone payments derived from any in-licensing agreements that BioVie Inc. might secure post-data readout for its drug candidates.
- Future royalties and product sales revenue, which only materialize if a drug candidate achieves full regulatory approval and subsequent commercial launch.
Finance: draft 13-week cash view by Friday.
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