BioVie (NASDAQ:BIVI) President and CEO Cuong Do outlined near-term clinical milestones and the company’s development priorities during a RedChip Companies webinar, emphasizing upcoming top-line data readouts for its lead inflammation-modulating candidate bezisterim and providing an update on its ascites program, BIV201.
Two near-term data catalysts: Parkinson’s in Q2 2026 and long COVID by late summer 2026
Do said BioVie has two near-term clinical catalysts. The company’s Phase II Parkinson’s trial is fully enrolled, with the last patient’s final visit expected at the end of April. BioVie expects a top-line readout in Q2 2026, which Do said could arrive in May or June.
Bezisterim: inflammation mechanism and development focus
Do described bezisterim (formerly NE3107) as an inflammation modulator that blocks production of TNF-alpha, which he characterized as a “master regulator” of inflammation. He said bezisterim acts by blocking activation of inflammatory ERK and NF-κB signaling, with the goal of interrupting what he described as a self-reinforcing inflammatory cycle.
He linked the mechanism to multiple conditions the company is pursuing or has studied, including Parkinson’s disease, Alzheimer’s disease, and long COVID. He also referenced observations from prior trials, stating that patients treated with bezisterim in various studies experienced reduced inflammation and associated insulin resistance, and that patients in the company’s Parkinson’s and Alzheimer’s trials had shown improvements in motor control and cognition/function, respectively. Do also said patients experienced lowered levels of DNA methylation, which he described as modulation of biological aging.
Asked about strategic priorities, Do said Parkinson’s is the company’s top priority and long COVID is second, with a caveat: if long COVID data are “very strong” and FDA feedback supports a faster path such as accelerated approval or emergency use authorization, long COVID could become the top priority.
Parkinson’s rationale and prior clinical results discussed
Do said BioVie’s Parkinson’s strategy is rooted in the view that symptoms are associated with both low dopamine and inflammation/insulin resistance, arguing that reversing insulin resistance may help the brain use available dopamine. He contrasted the current standard approach—levodopa—with what he presented as potential benefits of bezisterim.
He described limitations of levodopa including its short half-life, “off” periods overnight and in the morning, and the development of levodopa-induced dyskinesia at higher doses over time.
Do reviewed preclinical work in rodents and non-human primates, stating that bezisterim alone was “equally effective as levodopa” in restoring motor control and that combination dosing produced a synergistic effect with reduced dyskinesia. He also said animals treated with bezisterim retained twice as many neurons in brain analysis at the end of the study, which he said suggested neuroprotective properties.
He then discussed a 40-patient clinical study that evaluated bezisterim plus levodopa versus placebo plus levodopa over 28 days. Do said the combination arm showed an advantage of “about a 3-plus point” improvement on the Unified Parkinson’s Disease Rating Scale Part III motor score versus levodopa alone, and that in patients younger than 70 years old, the difference was “over four points.” He also highlighted an overnight/morning effect, stating that none of the levodopa-only patients had motor control at “time zero” in the morning, while roughly a third of patients receiving bezisterim plus levodopa did.
Do said the ongoing, fully enrolled Phase II Parkinson’s trial includes 60 earlier-stage patients who are going on therapy for the first time, with half receiving placebo and half receiving bezisterim. He framed the goal as demonstrating delayed progression, noting that a longer Phase III program would be required to establish disease-modifying effects. He added that after Phase II data, initiating a Phase III trial could take six to nine months due to planning, site activation, and fundraising.
Long COVID trial: rationale, funding, and potential regulatory discussion
Do described long COVID as persistent symptoms following infection, citing brain fog, fatigue, and malaise. He said there are at least 17 million Americans with long COVID and that more than 3 million have quit or changed jobs due to severe symptoms. He emphasized that there are no approved treatments, and he characterized existing care at long COVID centers as largely palliative.
BioVie’s Phase II long COVID trial is supported by a $13 million grant, which Do said fully funds a 200-patient study (placebo-controlled) with roughly four months of follow-up. He said the company believes long COVID symptoms are driven by circulating viral protein fragments that sustain immune activation and inflammation, and he argued bezisterim may help by blocking ERK and NF-κB activation. In Q&A, Do said bezisterim would not eliminate circulating fragments, but the company hopes it could provide symptomatic relief.
Do said that if the long COVID results are significant, BioVie plans to meet with the FDA in the fall to discuss what might be required for accelerated approval or potentially emergency use authorization, depending on the data and the agency’s reaction.
BIV201 for ascites: Phase II results, FDA feedback, and funding options
Do also reviewed BioVie’s second asset, BIV201, a novel formulation of terlipressin being developed for ascites associated with end-stage liver disease. He said ascites has greater than 50% mortality within a year and that there are no approved therapies, with paracentesis used to repeatedly remove accumulated abdominal fluid.
Do said terlipressin is a potent vasoconstrictor with a difficult side-effect profile when administered as bolus injections. BioVie’s approach is to deliver terlipressin via a saline bag connected to a portable infusion pump, slowly infusing over 24 hours to avoid high peak concentrations.
He summarized a Phase 2A study in which the company maintained a constant therapeutic dose and reported no drug-related serious adverse events. He then described a Phase 2B trial designed to enroll 30 patients to measure reduction of ascites fluid buildup, which BioVie stopped early after enrolling 15 patients. Do said those completing treatment saw a 50%+ reduction in ascites fluid buildup, while standard-of-care patients saw “really no change.” BioVie opted to stop early and engage the FDA about advancing to Phase III and registration.
Do said BIV201 already has fast track and orphan designation, and that the FDA has provided the feedback needed to initiate a single Phase III trial for registration. He said the Phase III trial would be about 200 patients, but BioVie is exploring funding options to initiate it. In response to a question about delays and partnering, Do said potential partners have faced similar small-cap financing challenges in raising approximately $25 million to run the registration trial. He also said the company is considering taking the ascites program public in a separate company to raise the needed funds, and he expressed hope to have the drug “in the clinic this year.”
Other discussion topics: reverse split, partnering, and Florida testing sites
Do addressed a question about BioVie’s prior reverse split, calling it “a terrible thing to have to do” but necessary to meet Nasdaq’s $1 minimum bid requirement. He said small-cap biotech has been depressed with diminished trading volume and expressed frustration with BioVie’s share price, adding that he hopes positive clinical results will increase awareness and interest.
On partnerships, Do said BioVie has discussed a range of structures over the years, from licensing arrangements to a full buyout, and that “everything is on the table.” He said larger pharmaceutical companies tend to be risk-averse and often prefer to wait for statistically significant, later-stage results before doing deals.
Do also provided an update regarding alleged malfeasance at certain Florida testing centers that he said contributed to results that did not achieve statistical significance in an earlier context. He said BioVie has been cooperating with the FDA and Department of Justice for roughly two years and is aware of FDA inspections and Form 483 citations at some sites. He said BioVie is waiting to see whether regulators initiate criminal prosecution, and if not, the company may initiate litigation itself.
About BioVie (NASDAQ:BIVI)
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.
