BioVie's High-Stakes Gamble on Alzheimer's and Liver Disease

CARSON CITY, Nev. – February 23, 2026 – Clinical-stage biopharmaceutical company BioVie Inc. is preparing to face investors in a high-stakes webinar on March 4, where it will outline the path forward for a pipeline of ambitious drugs targeting some of medicine’s most intractable diseases. The event comes as the company navigates a complex landscape of promising but challenging clinical data, strategic pivots, and significant financial headwinds, placing CEO Cuong Do in the hot seat to articulate a compelling vision for value creation.

BioVie (NASDAQ: BIVI) is developing two lead candidates aimed at multi-billion-dollar markets with dire unmet needs: bezisterim (NE3107) for neurodegenerative diseases like Alzheimer's and Parkinson's, and BIV201 for a life-threatening complication of advanced liver disease. In the upcoming webinar, hosted by RedChip Companies, management is expected to highlight the potential of these therapies while addressing investor questions about recent clinical trial results and the company's long-term viability.

A Tale of Two Trials: Promise and Peril

The story of BioVie's lead asset, bezisterim, is a case study in the volatile world of biotech. The first-in-class oral drug is designed to cross the blood-brain barrier to target neuroinflammation and insulin resistance, key drivers of Alzheimer’s and Parkinson’s disease. This mechanism offers a potential alternative to amyloid-targeting antibodies like Leqembi, which have shown moderate efficacy but carry risks of brain swelling and bleeding (ARIA).

However, the company’s pivotal Phase 3 trial in Alzheimer’s (NCT04669028) delivered a mix of hope and frustration. In November 2023, BioVie announced the trial had failed to meet its primary endpoints. The failure was not attributed to the drug itself, but to significant operational issues; data from nearly half of the 39 study sites were excluded due to major protocol violations and what the company described as suspected data falsification. The news sent the company's stock plummeting over 60%.

Despite the trial's formal failure, BioVie has focused on a subset of 57 patients from the remaining, compliant sites. According to the company's analysis of this per-protocol group, patients treated with bezisterim showed a 68% improvement on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale compared to placebo. BioVie has argued these results demonstrate the drug’s potential efficacy and favorable safety profile, with no drug-related serious adverse events. The company now plans to launch a new, more tightly controlled Phase 3 trial in 2025, using a once-daily formulation to improve patient adherence.

While the Alzheimer’s program re-tools, bezisterim has shown more straightforwardly positive signals in Parkinson's disease. A Phase 2a study showed that adding bezisterim to standard levodopa therapy provided a 2.8-point advantage on a key motor skills assessment (MDS-UPDRS Part III) and improved non-motor symptoms like sleep and fatigue. Building on this, BioVie has completed enrollment for its Phase 2b SUNRISE-PD trial, with topline data expected in the first half of this year. The company is also exploring the drug for Long COVID, backed by a grant from the U.S. Department of Defense.

A Strategic Pivot for a 'De-Risked' Asset

BioVie's second major program, BIV201, targets refractory ascites, a condition where fluid builds up in the abdomen of patients with advanced liver cirrhosis. It is a grim complication with a 50% mortality rate within a year and no FDA-approved therapies. BIV201 is a novel, continuous infusion of terlipressin—a drug approved in over 40 countries for related conditions—administered via a portable pump for outpatient use. The therapy has already received Orphan Drug and Fast Track designations from the FDA.

Data from a Phase 2b trial showed that patients treated with BIV201 experienced a 53% reduction in ascites fluid buildup compared to standard care. Despite these encouraging results and the company calling it its "most de-risked program," BioVie announced in March 2024 that it was terminating the trial after enrolling only half its intended patients. The stated rationale was that completing the study would take another two years.

This decision highlights the financial realities facing the company. Instead of funding the lengthy trial itself, BioVie is now actively seeking a partner to advance BIV201 into a pivotal Phase 3 study. The move conserves cash for the bezisterim program but leaves the promising liver drug's future dependent on securing a collaboration.

The Financial Tightrope of Biotech

The clinical challenges and strategic shifts are underscored by BioVie's precarious financial position. In its recent SEC filings, the company included a "going concern" warning, acknowledging substantial doubt about its ability to continue operations without securing additional funding. As of December 31, 2025, BioVie had $20.5 million in cash and an accumulated deficit of approximately $363.3 million.

Management has been actively raising capital to stay afloat, securing $21 million in an equity raise in March 2024 and another $12 million in a public offering in August 2025. This constant need for cash is typical for clinical-stage biotechs but adds a layer of urgency to every clinical and strategic decision. The success of the upcoming webinar in boosting investor confidence could be critical for the company's ability to fund its ambitious plans through to completion.

Spotlight on the March 4th Webinar

Against this backdrop, the March 4th investor event becomes more than a standard corporate update. It is a crucial test for BioVie's leadership to restore confidence and lay out a clear, fundable path forward. Investors will be listening intently for details on the redesigned Alzheimer's Phase 3 trial, any progress on finding a partner for the BIV201 liver program, and a concrete strategy for managing its cash runway through upcoming pivotal milestones.

The session represents a critical opportunity for the company to reframe its narrative, moving beyond past setbacks to focus on the scientific promise of its pipeline. For BioVie, its investors, and the millions of patients suffering from these devastating diseases, the stakes could not be higher.