Triolex (bezisterim) / Harbor Biosci, BioVie - LARVOL DELTA

DEMOGRAPHICS AND BASELINE CHARACTERISTICS OF PARTICIPANTS IN A STUDY OF BEZISTERIM (NE3107) IN EARLY PARKINSON'S DISEASE (SUNRISE-PD) (ADPD 2026) - P2 | "Baseline demographics and disease characteristics of PD patient populations are essential for interpreting later results, a critical step in developing new treatments for PD. SUNRISE-PD is expected to provide important data on the benefits of bezisterim in patients with early PD and lay the foundation for a study of potential disease-modifying activity."

CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder • TNFA

BioVie Announces Abstract Accepted for Presentation at AD/PD 2026 (The Manila Times) - "The abstract....summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster. Topline results from the SUNRISE-PD study are expected in mid‑2026....The AD/PD Alzheimer’s Disease and Parkinson’s Disease Conference will present all the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development, and clinical trials in Alzheimer’s, Parkinson’s, and other related neurological disorders."

Clinical • P2b data • Alzheimer's Disease • Parkinson's Disease

A Study of NE3107 (Bezisterim) in Early Parkinson's Disease (SUNRISE-PD): Baseline Demographics and Characteristics (AAN 2026) - P2 | "A critical step in developing new treatments for PD is analyzing trends in demographics and disease characteristics among various patient populations, which is the aim of this descriptive study on the currently enrolled SUNRISE-PD patients. Upon study completion, SUNRISE-PD is expected to provide important data on the benefits of bezisterim in patients with early PD, laying the foundation for a study of potential disease-modifying activity."

CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder • TNFA

Join Biovie’s Exclusive Live Investor Webinar and Q&A Session on March 4 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, President and CEO of BioVie, who will discuss BioVie’s investigational drug candidate bezisterim (NE3107), a first-in-class, orally available small molecule that targets inflammation and insulin resistance, two key drivers of Alzheimer’s, Parkinson’s, and Long COVID, where it has shown encouraging signals of improved cognition, motor function, and reduced neuroinflammation across clinical studies....He will also outline progress with BIV201, BioVie’s orphan drug candidate for patients suffering from cirrhosis and ascites, who are subject to life-threatening complications with no FDA-approved therapies."

Clinical • Alzheimer's Disease • Gastrointestinal Disorder • Novel Coronavirus Disease • Parkinson's Disease

BioVie Inc...announced the acceptance of two abstracts from studies on its lead candidate bezisterim (NE3107), in the treatment of Alzheimer’s Disease and Long COVID at the 2026 American College of Psychiatrists (ACP) annual meeting, to be held February 18-22, in Bonita Springs, FL. (GlobeNewswire)

Clinical data • Alzheimer's Disease • Novel Coronavirus Disease

BioVie could offer first new Parkinson’s therapy in decades (Proactiveinvestors) - "Topline data from SUNRISE-PD are expected in April or May 2026, placing the company firmly in a catalyst window that many biotech investors look for."

P2b data • Parkinson's Disease

ADdRESs-LC: NE3107 in Adults With Neurological Symptoms of Long COVID (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: BioVie Inc. | Trial completion date: Jan 2026 ➔ Aug 2026 | Trial primary completion date: Nov 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Novel Coronavirus Disease

BioVie Inc...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. (BioVie Press Release) - "Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results first half of 2026."

Enrollment closed • P2b data • Parkinson's Disease

BioVie advances Parkinson’s...programs ahead of 2026 (Proactiveinvestors) - "...BioVie has launched a new clinical trial enrolling 60 patients with earlier-stage Parkinson’s disease to evaluate Bezisterim as a standalone therapy. The goal of the study is to assess the drug’s potential disease-modifying effects when administered earlier in the disease course. Topline data from this trial are expected in April or May of 2026."

P2 data • Trial status • Parkinson's Disease

Join Biovie’s Exclusive Live Investor Webinar and Q&A Session on December 9 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, President and CEO of BioVie, who will discuss bezisterim (NE3107), BioVie’s first-in-class, orally available small molecule that targets inflammation and insulin resistance, two key drivers of Alzheimer’s, Parkinson’s, and Long COVID, where it has shown encouraging signals of improved cognition, motor function, and reduced neuroinflammation across clinical studies. He will also outline progress with BIV201, BioVie’s late-stage orphan drug candidate for refractory ascites, a life-threatening complication of liver cirrhosis with no FDA-approved therapies."

Clinical • Alzheimer's Disease • Gastrointestinal Disorder • Novel Coronavirus Disease • Parkinson's Disease

BioVie to Host Live Investor Webinar and Q&A on Oct. 8 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, president and CEO of BioVie, who will discuss bezisterim (NE3107), the company’s first-in-class, orally available small molecule that targets inflammation and insulin resistance, two key drivers of Alzheimer’s, Parkinson’s, and long COVID....Do will also outline progress with BIV201, BioVie’s late-stage orphan drug candidate for refractory ascites, a life-threatening complication of liver cirrhosis that currently has no FDA-approved therapies."

Clinical • Alzheimer's Disease • Liver Cirrhosis • Novel Coronavirus Disease • Parkinson's Disease

Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Neurological Associates of West Los Angeles | The participant's caregiver requested for the participant to be withdrawn from the study. The investigator has decided to close out.

Trial primary completion date • Trial termination • CNS Disorders • Fatigue • Vascular Neurology

BioVie Presented Data Highlighting that Patients Treated with Bezisterim Potentially Experienced an Age Deceleration Advantage Compared to Placebo on 10 Different Biological Clocks at the 2nd World Conference on Aging and Gerontology (BioVie Press Release) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "An analysis of the Company’s Phase 3 NM101 study (NCT04669028) evaluating bezisterim in patients with mild-to-moderate probable Alzheimer’s Disease (AD) assessed 33 blood samples of patients treated with bezisterim (n = 17) and placebo (n = 16) revealed: Biological aging. After 30 weeks of treatment, bezisterim-treated patients experienced significant age deceleration compared to placebo-treated patients on all biological clocks assessed, including −3.16 years for SkinBloodClockAge (p = 0.036), −4.12 years for PhenoAge (p = 0.048), −1.38 years for GrimAge (p = 0.148), −4.24 years for Hannum clock (p = 0.015), and −3.77 years for InflammAge (p = 0.050); Inflammatory gene expression. Bezisterim appeared to modulate gene expression of dozens of genes in the inflammatory cascade (e.g., NFkB, MAP, JNK), resulting in reduced expression of inflammatory..."

P3 data • Alzheimer's Disease

BioVie Announces Data Highlighting Bezisterim’s Potential to Slow or Reverse Biological Aging and Neurodegeneration Featured as a Keynote Talk at the 7th World Aging and Rejuvenation Conference (Businesswire) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "An analysis of the Company’s Phase 3 NM101 study (NCT04669028) evaluating bezisterim in patients with mild-to-moderate probable AD assessed 33 blood samples of patients treated with bezisterim (n = 17) and placebo (n = 16) using five validated epigenetic 'biological' clocks that analyze genes linked to aging, as well as age-related inflammatory markers. In this analysis, treatment with bezisterim demonstrated: Biological Aging Effects. After 30 weeks of treatment, the average difference between the placebo and bezisterim groups was −3.16 years for SBCAge (p = 0.036), −4.12 years for PhenoAge (p = 0.048), −1.38 years for GrimAge (p = 0.148), −4.24 years for Hannum clock (p = 0.015), and −3.77 years for InflammAge (p = 0.050). The various 'biological clocks' measure the extent of age deceleration advantage bezisterim-treated patients have compared to those treated with placebo."

P3 data • Alzheimer's Disease

BioVie Highlights Patient-Centric Design of SUNRISE-PD Trial at Advanced Therapeutics in Movement & Related Disorders Congress (ATMRD) (GlobeNewswire) - "ioVie Inc...announced that a poster highlighting the patient-centric design and accessibility of its ongoing SUNRISE-PD Phase 2 clinical trial will be presented at the Advanced Therapeutics in Movement & Related Disorders Congress, to be held at National Harbor, MD, from June 27-30, 2025...SUNRISE-PD is a Phase 2 trial evaluating bezisterim (NE3107) in individuals with early-stage PD that aims to address these challenges through a hybrid, decentralized design....The study’s flexible design includes in-home visits conducted by study nurses with neurologist oversight via video conferencing and remote assessment of motor symptoms using a modified MDS-UPDRS Part III scale evaluated by a centralized rating committee. All data collection is supported by digital tools and virtual documentation to ensure consistency, quality, and ease of use for participants."

Clinical protocol • Trial status • Parkinson's Disease

BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders Congress (GlobeNewswire) - "BioVie...announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson’s disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025....SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design that will last 20 weeks from the initial screening phase to the safety follow up."

P2b data • Parkinson's Disease

BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease on May 28, 2025 (GlobeNewswire) - "The event will provide an update on BioVie's Phase 2 trial (SUNRISE-PD; sunrisepd.com) evaluating bezisterim (NE3107) for the treatment of Parkinson's disease."

P2b data • Parkinson's Disease

BioVie to Present Rationale and Design of Phase 2 SUNRISE-PD Clinical Trial at the 30th World Congress on Parkinson’s Disease and Related Disorders (IAPRD 2025) (GlobeNewswire) - "BioVie Inc...today announced that a poster on the rationale and design of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson’s disease will be presented in a Guided Poster Tour session at the 30th World Congress on Parkinson’s Disease and Related Disorders (IAPRD 2025), being held May 7-10, 2025, in New York City."

P2b data • Parkinson's Disease

ADdRESs-LC: NE3107 in Adults With Long COVID (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: BioVie Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Novel Coronavirus Disease

BioVie Initiates SUNRISE-PD Clinical Trial Assessing Bezisterim in Early Parkinson’s Disease with First Patient Enrolled (GlobeNewswire) - "BioVie Inc...announced that patient enrollment is now open for the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in patients with Parkinson’s disease (PD) who haven’t been treated with carbidopa/levodopa. The first patient in the trial has been enrolled, and the Company anticipates topline data to be available in late 2024 or early 2025."

Enrollment open • P2 data • Parkinson's Disease

BioVie to Host KOL Investor Webcast to Discuss the Long COVID Treatment Landscape and its ADDRESS-LC Trial on April 10, 2025 (GlobeNewswire) - "BioVie Inc...announced that it will host a virtual investor event featuring key opinion leader (KOL) Lindsay McAlpine, MD, BSc (Yale University), who will join company management to discuss the unmet need and current treatment landscape for long COVID on Thursday, April 10, 2025 at 10:00 AM ET....The event will provide an update on BioVie's ADDRESS-LC trial evaluating bezisterim (NE3107) for the treatment of long COVID. Bezisterim is a novel, oral, blood-brain barrier–permeable, anti-inflammatory, insulin-sensitizing agent that has shown to selectively inhibit inflammation-driven ERK- and NF-κB-stimulated inflammatory mediators, without inhibiting their homeostatic functions."

Trial status • Novel Coronavirus Disease

ADdRESs-LC: NE3107 in Adults with Long COVID (clinicaltrials.gov) - P2 | N=208 | Not yet recruiting | Sponsor: BioVie Inc.

New P2 trial • Novel Coronavirus Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: BioVie Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: BioVie Inc.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

BioVie’s Upcoming Parkinson’s Disease Clinical Trial is Fully Funded (GlobeNewswire) - "BioVie Inc...is pleased to announce that the upcoming PD-202 A Double-Blind, Randomized, Placebo-controlled, Study of Bezisterim in Subjects with Early Parkinson’s Disease is now fully funded. Favorable capital market conditions last week enabled the company to raise over $15 million from secondary offerings, and the proceeds allow the Company to fund fully the costs of this upcoming clinical trial. The trial is expected to start in early 2025, and topline results are expected by late 2025...The Company's strategic priorities include launching a Phase 2 trial for PD in early 2025...and initiating a Phase 3 trial for AD in late 2025 with a new once-daily formulation of bezisterim."

Financing • New P2 trial • New P3 trial • New trial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease