BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson’s Disease

Rhea-AI Summary

BioVie (NASDAQ: BIVI) completed enrollment of 60 patients in its Phase 2 SUNRISE-PD trial testing bezisterim (NE3107) in early Parkinson’s disease patients not previously treated with carbidopa/levodopa. SUNRISE-PD uses a hybrid, decentralized design to improve access and flexibility for participants ages 41–80 diagnosed within the past four years. BioVie expects to analyze data and report topline results in 1H 2026. The company noted prior PD studies of bezisterim with levodopa/carbidopa showed symptom improvements and a favorable safety profile.

Positive

• Completed enrollment of 60 patients in Phase 2 SUNRISE-PD
• Topline results expected in 1H 2026
• Hybrid decentralized design improved access and trial feasibility

Negative

• No topline efficacy or safety readout yet; results pending in 1H 2026

Key Figures

SUNRISE-PD enrollment 60 patients Phase 2 SUNRISE-PD trial in early Parkinson’s disease

Participant age range 41 to 80 years Inclusion criteria for SUNRISE-PD trial

Diagnosis window Within past four years Early Parkinson’s disease patients in SUNRISE-PD

Topline timing 1H 2026 Expected topline results from SUNRISE-PD

Double-blind duration 12 weeks Double-blind phase in SUNRISE-PD Phase 2b design

Bezisterim dose 20 mg twice daily Dosing regimen in Phase 2b SUNRISE-PD design

Public offering size $12 million August 2025 public unit offering

Quarterly net loss $5.1 million Net loss for quarter ended September 30, 2025

Market Reality Check

$1.30 Last Close

Volume Volume 112,358 is slightly below 20-day average of 124,348 (relative volume 0.9). normal

Technical Shares at $1.35 are well below the 200-day MA of $5.22 and closer to the 52-week low of $1.10 than the high of $25.764.

Peers on Argus

BIVI was down 2.88% while peers were mixed: NERV +10.82%, NXTC +6.15%, MTVA +4.65%, IMNN -1.26%, BCTX -0.97%. Moves do not indicate a broad sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 19	Investor webinar	Neutral	-4.2%	Announced December 9, 2025 live investor webinar and Q&A session.
Sep 26	Investor webinar	Positive	+3.3%	Planned October 8, 2025 webinar with pipeline and partnership updates.
Aug 13	Clinical trial design	Positive	-2.4%	Highlighted DOD‑funded ADDRESS-LC Phase 2 Long COVID trial design.
Aug 13	Equity offering close	Negative	-6.7%	Closed <b>$12 million</b> public offering of units and warrants.
Aug 07	Equity offering pricing	Negative	-42.6%	Priced <b>$12 million</b> public offering with tradable warrants.

Pattern Detected

Recent positive or neutral catalysts, including clinical and investor updates, often saw flat-to-negative reactions, while equity offerings aligned with sharp declines.

Recent Company History

Over the past six months, BioVie announced investor webinars highlighting bezisterim and BIV201, advanced clinical trial designs such as the ADDRESS-LC Phase 2 Long COVID study, and executed a $12 million public offering with units and warrants. The offering and its pricing coincided with notable share price declines. Regulatory filings detailed growing equity incentive capacity and ongoing losses with going-concern language. Today’s SUNRISE-PD enrollment completion follows earlier initiation of this trial, extending the company’s execution track in neurology programs.

Market Pulse Summary

This announcement confirms completion of enrollment of 60 early Parkinson’s patients into the Phase 2 SUNRISE-PD trial of bezisterim, moving the study firmly into its data‑collection phase ahead of expected topline results in 1H 2026. Historical updates show BioVie steadily advancing neurology and Long COVID programs amid ongoing losses and prior equity raises. Investors may watch for future clinical readouts, additional financing steps, and how the company manages its development pipeline against disclosed going‑concern risks.

Key Terms

phase 2 medical

"its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

parkinson’s disease medical

"individuals with early-stage Parkinson’s disease (PD) who have not been treated"

A progressive brain disorder that gradually impairs movement, balance and certain mental functions by reducing the brain’s ability to produce a chemical important for controlling motion. Investors care because it creates a large, growing market for treatments, devices and care services; success or failure of drugs and clinical trials, regulatory approvals, and long-term care costs can materially affect pharmaceutical and medical-device company valuations.

carbidopa/levodopa medical

"who have not been treated with carbidopa/levodopa."

A combination medication used to treat symptoms of Parkinson’s disease by supplying a dopamine precursor (levodopa) and a companion drug (carbidopa) that keeps more of that medicine available in the brain. Think of levodopa as the fuel the brain needs and carbidopa as the protective cap that prevents most of the fuel from leaking away before it reaches the engine. Investors watch this drug because regulatory approvals, new formulations, patent status and competition from generics directly affect sales, treatment adoption and the value of companies developing or selling Parkinson’s therapies.

decentralized technical

"The trial uses a hybrid, decentralized Phase 2 trial designed to reduce"

Decentralized describes a system where control and decision-making are spread across many participants instead of held by a single central authority. Like a group of neighbors sharing responsibility for a community garden rather than one owner, decentralization can reduce single points of failure, change how profits and risks are allocated, and affect transparency and governance—key factors investors evaluate for stability, control, and regulatory exposure.

alzheimer’s disease medical

"including Alzheimer’s disease (AD) and Long COVID (LC), all conditions"

A progressive brain disorder that gradually erodes memory, thinking and the ability to perform everyday tasks, similar to a computer slowly losing files and processing speed. It matters to investors because its large and growing patient population drives demand for treatments, long-term care, diagnostics and related services, making clinical trial results, regulatory decisions and patent exclusivity major value drivers for healthcare and biotech companies.

long covid medical

"including Alzheimer’s disease (AD) and Long COVID (LC), all conditions"

A condition where symptoms from a viral infection persist or recur for weeks or months after the initial illness has cleared, often affecting energy, breathing, cognition or other body systems. It matters to investors because prolonged illness can change workforce availability, raise healthcare and insurance costs, shift demand for medical treatments and services, and influence regulatory and policy decisions—think of it as a lingering drag on productivity and expenses that can alter company performance.

anti-inflammatory medical

"Bezisterim is an anti-inflammatory and insulin-sensitizing agent being developed"

A substance or treatment that reduces swelling, redness, pain, or immune overreaction in the body. Investors care because anti-inflammatory products represent a large and steady part of healthcare spending—new or improved treatments can expand markets, change prescribing patterns, lower complication rates, or affect reimbursement and regulatory review, much like a more efficient tool replacing an older one in a toolbox.

insulin-sensitizing medical

"Bezisterim is an anti-inflammatory and insulin-sensitizing agent being developed"

Improving the body's response to insulin so cells take up sugar from the blood more effectively; think of it as tuning a lock so the insulin 'key' works more easily. For investors, insulin-sensitizing therapies can change the size and profitability of markets for diabetes and metabolic disease treatments, affect clinical outcomes and healthcare costs, and influence regulatory and reimbursement prospects for related drugs.

AI-generated analysis. Not financial advice.

- Patient-centric trial aiming to evaluate whether bezisterim can help delay disease progression reaches enrollment milestone -

- Topline Results from the SUNRISE-PD Trial Expected in 1H 2026 -

CARSON CITY, Nev., Jan. 08, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that it has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in individuals with early-stage Parkinson’s disease (PD) who have not been treated with carbidopa/levodopa.

SUNRISE-PD explores whether bezisterim can affect the progression of Parkinson’s symptoms in patients diagnosed with PD within the past four years who need treatment for their symptoms. The trial uses a hybrid, decentralized Phase 2 trial designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care. The study’s flexible design allows participants to complete their study visits either at home or in a clinic, improving access and flexibility while maintaining rigorous data quality and centralized oversight. Completion of enrollment for SUNRISE-PD reflects strong engagement from the PD community and highlights the feasibility of patient-centric trial designs in PD research.

“We are looking to see how bezisterim treatment may affect symptomatic progression for Parkinson’s disease patients needing treatment for the first time,” said Cuong Do, President and CEO of BioVie Inc. “Completing enrollment in SUNRISE-PD is an important milestone for BioVie and a testament to the need for more accessible and inclusive clinical trials for people with Parkinson’s disease This milestone benefited from the strong engagement of the Parkinson’s disease community, and we look forward to advancing SUNRISE-PD toward topline data and continuing our mission to develop a potentially disease-modifying treatment for people living with Parkinson’s disease.”

Bezisterim is an anti-inflammatory and insulin-sensitizing agent being developed for PD and other neurodegenerative diseases including Alzheimer’s disease (AD) and Long COVID (LC), all conditions where inflammation contributes to neurological damage. In previous clinical trials of PD, bezisterim was administered in combination with levodopa/carbidopa and demonstrated improvements in both motor and non-motor symptoms with a favorable safety profile. It is designed to target key biological processes believed to contribute to the progression of PD, with the goal of modifying the course of the condition over time.

SUNRISE-PD enrolled individuals ages 41 to 80 who were diagnosed with PD within the past four years and had not been treated with carbidopa/levodopa. BioVie supported enrollment through outreach and awareness efforts with the support of leading advocacy organizations in the PD field, including The Michael J. Fox Foundation, Davis Phinney Foundation, and the Parkinson’s Foundation.

Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results first half of 2026.

About Bezisterim

Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease.

In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate- to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026.

For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026.

In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s.

About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue.

In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit www.bioviepharma.com.

For Investor Relations Inquiries:	For Media Inquiries:
Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com	Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com

FAQ

What milestone did BioVie (BIVI) announce on January 8, 2026 about SUNRISE-PD?

BioVie announced completion of enrollment of 60 patients in the Phase 2 SUNRISE-PD trial.

When does BioVie expect to report topline results for SUNRISE-PD (BIVI)?

The company anticipates analyzing data and reporting topline results in 1H 2026.

Who was eligible for the SUNRISE-PD trial (BIVI) and what age range was enrolled?

SUNRISE-PD enrolled individuals aged 41–80 diagnosed with Parkinson’s within the past four years and not treated with carbidopa/levodopa.

What is bezisterim (NE3107) being studied for in BioVie’s SUNRISE-PD trial (BIVI)?

Bezisterim is being evaluated for effects on motor and non-motor symptoms and potential disease progression in early Parkinson’s disease.

How did SUNRISE-PD’s design aim to improve participant access in the BioVie (BIVI) trial?

The trial used a hybrid, decentralized design allowing participants to complete visits at home or in clinic to reduce mobility and geographic barriers.