BioVie Selected for Late-Breaking Oral Presentation of Bezisterim Long COVID Data at the 4th Long COVID International Conference 2026
Exploratory subgroup analyses found statistically significant improvements on multiple measures in patients with greater baseline symptom burden.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
BioVie (NASDAQ: BIVI) will present bezisterim Long COVID data at a late-breaking oral session on November 13, 2026, in Nice, France. The presentation at the 4th Long COVID International Conference will include previously unshared biomarker data from the Phase 2 ADDRESS-LC trial.
The randomized, placebo-controlled exploratory study showed a trend toward improvement across most efficacy measures. Prespecified exploratory analyses found statistically significant improvements on multiple measures in patients with greater baseline symptom burden. Approximately 78% of participants had more severe fatigue, post-exertional malaise or objective cognitive impairment in at least one domain. A $13.13 million U.S. Department of War award fully funds the study.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointA $13.13 million U.S. Department of War award fully funds the Long COVID study. 1.1× market cap
- Minor pointADDRESS-LC showed a trend toward improvement across most patient-reported and objective efficacy measures versus placebo.
- Minor pointPrespecified exploratory high-symptom-burden subgroups showed statistically significant improvements in multiple measures corresponding to their most pronounced symptoms.
Negative
- Minor pointADDRESS-LC evaluated 22 clinical outcome measures, with no single endpoint prespecified as the primary determinant of success.
Key Figures
- Participants with at least one high-burden symptom domain
- Approximately 78%
- ADDRESS-LC participants; fatigue, post-exertional malaise or cognitive impairment
Key Terms
biomarker medical
post-exertional malaise medical
placebo-controlled medical
blood-brain barrier medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
CARSON CITY, Nev., Nov. 02, 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 the Company has been invited to present a late-breaking oral presentation at the 4th Long COVID International Conference 2026 to be held in Nice, France from November 12-13, 2026.
Dr. Penelope Markham, BioVie’s Senior Vice President and Program Lead for Long COVID, will share the presentation titled “Bezisterim Improves Fatigue, Post-Exertional Malaise, and Cognition in Prespecified High-Symptom-Burden Subgroups of the Phase 2 Randomized ADDRESS-LC Trial in Long COVID” during the “Session 8: Clinical Trials” session, starting 3:30 p.m. on Friday, November 13. The presentation will include new biomarker data that has not been shared previously.
The ADDRESS-LC trial, a randomized, placebo-controlled signal seeking, exploratory study, showed treatment with bezisterim showed a consistent trend toward improvement across most patient-reported and objective efficacy measures compared with placebo. In pre-specified, exploratory analyses, patients with more severe baseline fatigue, post-exertional malaise (PEM), or objective cognitive impairment – symptoms affecting approximately
“We look forward to presenting initial biomarker data at the upcoming Long COVID conference that are consistent with the clinical findings observed in ADDRESS-LC,” said Penelope Markham, BioVie’s Senior Vice President and Program Lead for Long COVID. “The biomarkers provide further biological support for the potential of bezisterim in treating Long COVID. Our Trial observed a consistent and clinically coherent pattern of improvement across measures of fatigue, post-exertional malaise, clinician- and patient-reported outcomes, and objective measures of cognition function among patients with greater baseline symptom burden.”
About Long COVID
An estimated 17-20 million U.S. adults reported to be living with Long COVID,1 with 3.8 million experiencing significant limitation to their daily lives.2 Almost 50 percent of those with Long COVID develop persistent or intermittent symptoms.3 The neurological and neuropsychiatric symptoms are among the most common and disabling manifestations of the condition and include fatigue, PEM, sleep disturbance, and persistent sense of difficulty with thinking and memory.4 Chronic innate inflammation accompanied by ongoing immune dysregulation is among the leading hypotheses proposed to explain the symptoms in Long COVID, with numerous investigators describing findings in Long COVID that appear to be supportive of the intended biological targets of bezisterim. Currently, there are no FDA-approved treatment options for Long-COVID.
About the ADDRESS-LC trial
The Phase 2 ADDRESS-LC study (NCT06847191), which is fully funded by a grant from the U.S. Department of War (DoW), is a randomized (1:1), placebo-controlled, signal-finding proof-of-concept, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with Long COVID who have cognitive impairment sequelae and fatigue. The study compared bezisterim, administered as a 20 mg oral capsule twice daily, with a matching placebo to assess its effects on neurocognitive and fatigue-related symptoms. The trial evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of study success. Endpoints include assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, Quality of Life and PEM. As a signal-finding study, the trial was designed to identify efficacy signals, measure treatment effect magnitude, and identify patient subgroups most likely to benefit, to inform the design of future Phase 3 trials
About Bezisterim
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, NFκB, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD).
In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms.
For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with LC. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate).
In AD, BioVie has conducted 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 AD.
Terms of the U.S. Department of War (DoW) Award
The Long COVID study is supported by the Assistant Secretary of War for Health Affairs and endorsed by the DoW by a fully funded award in the amount of
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 investigational drug 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.
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as “expect,” “look forward to,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “will," “project,” “potential,” “may,” or words of similar meaning. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. The Phase 2 ADDRESS-LC trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
For Investor Relations Inquiries:
Contact:
Chuck Padala
Managing Director, LifeSci Advisors, LLC
chuck@lifesciadvisors.com
For Media Inquiries:
Contact:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
_____________________________
1 U.S. Department of Health and Human Services (https://www.hhs.gov/longcovid/index.html)
2 Bonuck et al. Commun Med. 2026;6:177. doi:10.1038/s43856-026-01516-7.
3 Thaweethai et al. Nat Commun. 2025;16(1):9557. doi:10.1038/s41467-025-65239-4.
4 Geng et al. JAMA. 2025 Feb 25;333(8):694-700. doi: 10.1001/jama.2024.24184.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When will BioVie present its bezisterim Long COVID data?
BioVie will present on November 13, 2026, during the Clinical Trials session starting at 3:30 p.m. at the 4th Long COVID International Conference in Nice, France. The presentation will include previously unshared biomarker data from ADDRESS-LC.
How was BioVie's ADDRESS-LC trial designed?
ADDRESS-LC was a Phase 2 randomized, placebo-controlled exploratory trial comparing bezisterim 20 mg twice daily with matching placebo. It enrolled approximately 200 adults with Long COVID and evaluated 22 clinical outcome measures, without a single endpoint prespecified as the primary determinant of success. The study was designed to identify signals and patient subgroups to inform future Phase 3 trials.