New Risk • May 13
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$21m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Shareholders have been substantially diluted in the past year (307% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.95m market cap). Announcement • Apr 29
Biovie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease Ahead of Topline Data in 2Q26 BioVie Inc. announced that it will host a virtual key opinion leader (KOL) event on Thursday, May 7, 2026 at 2:00 PM ET featuring Suzanne de la Monte, MD, MPH (Brown University Warren Alpert Medical School, Providence VA Medical Center), who will join company management to discuss how bezisterim’s mechanism of action could potentially address the pathology and progression of neurodegenerative diseases, including Parkinson’s disease. Bezisterim (NE3107) is an investigational 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, NF?B, TNF-a), 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 completed a Phase 2 study in which patients with moderate- to severe stage Parkinson’s disease taking bezisterim with levodopa had better motor control and reported fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD is evaluating whether bezisterim alone can help improve motor and non-motor symptoms in 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 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long COVID. The hypotheses being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NF?B 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. Preliminary data from these trials 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. Announcement • Apr 14
BioVie Inc Announces Abstract Acceptance For Sunrise-Pd Study On Bezisterim In Parkinson's Disease BioVie Inc. announced the acceptance of an abstract from its SUNRISE-PD study on lead candidate bezisterim (NE3107) in the treatment of patients with Parkinson’s Disease at the upcoming American Academy of Neurology Annual Meeting (AAN), to be held in Chicago, IL from April 18–22, 2026. The abstract, titled A Study of NE3107 (Bezisterim) in Early Parkinson's Disease (SUNRISE-PD): Baseline Demographics and Characteristic (J. Palumbo1, C Ahlem1, C.L. Reading1, S. O’Quinn2, J. Zhang3, M. Stacy4), summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster during the Movement Disorders Session on Parkinson's Disease Emerging Therapeutics, on Monday, April 20, from 5:00 PM–6:00 PM CT. Topline results from the SUNRISE-PD study are expected in mid-2026. 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, NF?B, TNF-a), 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 NF?B 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. 
