Acute respiratory disease

Pfizer’s RSV vaccine was 90% effective at preventing the most severe outcomes in the first-ever vaccination season, the company said, underscoring its potential benefits as another respiratory virus season kicks off. The new data, presented at IDWeek Thursday, are a clearer look at how Abrysvo fared at preventing severe illness and hospitalizations. The results come from Kaiser Permanente of Southern California, though the trial was paid for by Pfizer and includes Pfizer co-authors. The retrospective study looked at patients 60 and older who were hospitalized or came to the emergency room with severe acute respiratory illness. In that group, the vaccine was 90% effective at preventing the most severe respiratory cases, with only one positive case identified among patients vaccinated with Abrysvo. The confidence interval was wide, stretching from 24% to 99% in the primary analysis. While the results aren’t vastly different from what the company has shown in previous trials, the study was the first time immunocompromised people were reviewed, after those patients weren’t included in the Phase 3 study. Despite the introduction of RSV vaccines for the first time, rates of RSV-associated hospitalization among people 65 and older last fall and winter were the highest recorded in the last seven years. According to data from the CDC , the hospitalization rate in that age group peaked at 9.4 hospitalizations per 100,000 people in the last week of December 2023. The second-highest weekly hospitalization peak in the last seven years was 6.1 per 100,000 people during the 2022-2023 season, as people came out of Covid-19 precautions and the prevalence of other respiratory illnesses surged. Public health officials shifted their RSV vaccination strategy over the summer, moving from advising that anyone 60 and older consult a healthcare professional before getting a shot to outright recommending one for people in the same age group who are at higher risk of severe disease. Advisors to the CDC also specified that anyone 75 and older should get the vaccine. Roughly 1 in 4 people 60 and older got vaccinated in the first season. But because the previous guidance technically included anyone 60 and older, investors and analysts projected that the new guidance may actually shrink the market. Clinicians and pharmacists, however, felt that the new guidance would be easier to implement and that they could more confidently advise who should get the shot. Recent data assessed by Jefferies at the beginning of October found a 40% drop in vaccine prescriptions compared to the same point in 2023. But there were signs of hope, with both GSK and Pfizer notching double-digit gains in prescriptions in the last week of September compared to the week prior. Prescriptions of Moderna’s vaccine, mResvia, were also growing week-to-week, but those gains were “incremental,” according to Jefferies.

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines. Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2 Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effective against medically attended, laboratory-confirmed influenza, with vaccine effectiveness (VE) highest in children six months to three years of age at 88%, compared with unvaccinated participants.3 RWE studies can play a key role in assessing influenza vaccine effectiveness each season. RWE complements randomized controlled trials (RCT), assessing influenza vaccine effectiveness on an ongoing basis and contributing to an ever-growing data set on real-world outcomes. SUMMIT, N.J., Oct. 1, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced data from a range of real-world evidence (RWE) studies, highlighting the important role influenza vaccination plays in protecting public health. The data are being presented in an oral presentation and poster sessions at OPTIONS for the Control of Influenza (OPTIONS XII), being held in Brisbane, Australia from September 29 to October 2, 2024. Given the ever-changing nature of the influenza virus, RWE studies are valuable in assessing influenza vaccine effectiveness season-over-season. RWE is a complement to randomized controlled trial (RCT) research, assessing influenza vaccine effectiveness on an ongoing basis and providing an ever-growing data set on real-world outcomes. "CSL Seqirus remains committed to evaluating vaccine effectiveness through the rigorous generation of real-world evidence," said Gregg Sylvester, Chief Health Officer, CSL Seqirus. "Our studies and presentations at OPTIONS XII reflect our dedication to helping to protect people against influenza and its associated medical complications across all ages, including those as young as six months old. We have chosen to include studies with test confirmed data. This approach may provide more robust evidence." Among others, RWE studies being presented by CSL Seqirus at OPTIONS XII include: Results of a study of the 2022/23 influenza season in the US showed that cell-based quadrivalent (QIVc) vaccines prevented more outpatient test-confirmed influenza for those aged six months to 64 years compared with the egg-based quadrivalent (QIVe) vaccines.1 Results from a study of the 2023/24 influenza season in the US showed that cell culture-based inactivated influenza vaccine (ccIIV4) generated real-world effectiveness against medically attended, laboratory-confirmed influenza, compared with unvaccinated participants. Vaccine effectiveness was highest in children six months to three years of age at 88%.3 Results from a review of the 2017 to 2020 influenza seasons revealed a higher relative effectiveness of QIVc over QIVe/egg-based trivalent (TIVe) vaccines across the three influenza seasons for both test-confirmed influenza and clinically diagnosed influenza.2 Results from a study of the 2022/23 influenza season in the US showed comparability between MF59® adjuvanted quadrivalent inactivated influenza vaccine (aQIV) and high-dose quadrivalent inactivated influenza vaccine (HD-QIV) in preventing test-confirmed influenza-related emergency department visits and/or inpatient admissions settings among adults aged 65 and over.4 "The results from these studies are a continued demonstration of the value of RWE in generating valuable insights into influenza vaccine effectiveness," said Mendel Haag, Senior Director, Center of Outcomes Research & Epidemiology, CSL Seqirus. "These studies have collected and analyzed data over several recent influenza seasons. They highlight the effectiveness of cell-based influenza vaccines in protecting people six months to 64 years old against test-confirmed influenza compared to standard egg-based vaccines, particularly in our more vulnerable populations, as well as the comparability between MF59® adjuvanted vaccines and high-dose vaccines in preventing flu-related ER and hospital admissions." CSL Seqirus is at the forefront of influenza research and is proud to present a series of compelling data that spans across various aspects of influenza prevention and ages. The research emphasizes the company's commitment to advancing public health through RWE and innovative vaccine technology. ABOUT THE STUDIES PRESENTED AT OPTIONS XII Relative vaccine effectiveness of cell-based versus egg-based quadrivalent influenza vaccines against test-confirmed influenza in the United States 2022-23 influenza season 1 Researchers applied a retrospective test-negative design among individuals aged 6 months to 64 years vaccinated with either QIVc or QIVe in 2022-23 and who had an influenza test obtained in routine outpatient care within +/- 7 days of a documented acute respiratory or febrile illness. Exposure, outcome, and covariate data were obtained from outpatient electronic health records linked to pharmacy and medical claims. rVE was calculated by comparing the odds of testing positive for influenza among QIVc recipients with the odds among QIVe recipients, using a doubly robust analysis that combined inverse probability of treatment weighting with multivariable adjustment. The study included 43,086 tested patients, of whom 18.6% received QIVc and 81.4% received QIVe. QIVc was generally more effective than QIVe in preventing test-confirmed influenza in the outpatient care setting, with an estimated rVE of 7.7% (95% CI: 0.9% – 13.9%). This study showed increased relative effectiveness of QIVc compared to QIVe in preventing outpatient test-confirmed influenza in the population aged 6 months to 64 years during the 2022-23 season in the United States. These findings add to the body of evidence supporting improved effectiveness of cell-based versus egg-based vaccines. Relative effectiveness of cell-based influenza vaccines versus egg-based influenza vaccines: A review of test-confirmed and clinical diagnosis-based influenza outcomes 2 Researchers identified 10 studies reporting on the rVE of QIVc vs QIVe/TIVe among persons aged 4–64 years from a prior systematic literature review (PROSPERO CRD42020160851) that included studies published between 01-January-2016 and 25-February-2022. Additionally, a scoping review was conducted to identify additional studies published between 25-February-2022 and 01-March-2024. A DerSimonian and Laird random effects model was applied for the meta-analyses of these data. Among persons aged 4–64 years, the pooled rVE showed a consistent benefit of QIVc for both outcome types, with estimates of 11.9% (95% CI, 3.0%–20%; n studies=3) for 2017–2018, 11.8% (3.5%–19.4%; n=2) for 2018–2019, and 10.0% (2.7%–16.7%; n=1) for 2019–2020 in preventing test-confirmed influenza and 18.7% (8.7%–27.6%; n=2) for 2017–2018, 5.9% (4.3%–7.5%; n=2) for 2018–2019, and 10.1% (6.1%–14.0%; n=2) for 2019–2020 in preventing clinically diagnosed influenza. Researchers found that for persons aged 4–64 years, QIVc showed increased effectiveness over QIVe/TIVe across the three influenza seasons for both test-confirmed influenza and clinically diagnosed influenza. The results do not suggest systematic over or underestimation of rVE for prevention of clinically diagnosed compared to test-confirmed influenza. Effectiveness of cell culture-based inactivated influenza vaccine against medically-attended, laboratory-confirmed influenza in Wisconsin, US, 2023-2024 3 Researchers actively recruited patients aged 6 months to 64 years with acute respiratory illness at Marshfield Clinic Health System outpatient facilities between October 2023 and May 2024. Respiratory specimens were tested using multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) to identify influenza cases; controls were influenza-negative. Analyses were restricted to ccIIV4 recipients and unvaccinated participants. Among 1,850 participants, 228 were aged 6 months to 3 years, 230 aged 4 to 8 years, 363 aged 9 to 17 years, and 1,029 aged 18 to 64 years. Adjusted VE of ccIIV4 against any influenza was 60% (95% CI, 47%−70%) in persons 6 months to 64 years. Adjusted VE was 88% (95% CI, 64%-97%) among children aged 6 months to 3 years, 63% (95% CI, 39%−78%) among children aged 4 to 17 years, and 50% (95% CI, 29%−65%) among adults 18 to 64 years. Adjusted VE against influenza B was 72% (95% CI, 49%–86%) overall. Analysis revealed that ccIIV4 was effective against medically attended, laboratory-confirmed influenza in 2023-24. ccIIV4 effectiveness was highest in children 6 months to 3 years of age and for influenza B in persons 6 months to 64 years. Relative vaccine effectiveness of adjuvanted quadrivalent inactivated influenza vaccine (aQIV) vs high-dose quadrivalent inactivated influenza vaccine (HD-QIV) for prevention of test-confirmed influenza during the 2022-2023 influenza season 4 This retrospective test negative design (TND) study included US adults age ≥65 years vaccinated with aQIV or HD-QIV who presented with acute respiratory or febrile illness during the 2022-2023 influenza season in any emergency department and/or inpatient admissions settings. Test-positive cases and test-negative controls were grouped by vaccine received. The rVE was evaluated using a doubly robust approach, combining inverse probability of treatment weighting (IPTW) and logistic regression to adjust for potential confounders. After applying eligibility criteria, 30,911 tested vaccinated patients were included (2,361 positive cases and 28,550 negative controls). No significant differences were found in the rVE of aQIV vs. HD-QIV in preventing test-confirmed influenza in any setting (-2.5% (95% CI: [-13.4 to 7.4]) or in ED/IP settings (0.0% [-15.9 to 13.7]). Researchers found that, consistent with prior evidence, these results show comparability between aQIV and HD-QIV for preventing test-confirmed influenza in any setting and in ED/IP settings among US adults ≥65 years during the 2022-2023 season. Study Limitations The above studies featuring RWE were subject to the typical limitations associated with retrospective analyses. Unmeasured and residual confounding remain a potential source of bias as in all observational research. The amount and quality of data available on individuals may vary and clinical and claims data do not include all data that could inform and adjust for health seeking behavior, such as individual or contextual socioeconomic data. Studies included outcomes which were obtained as part of routine care and not performed according to pre-set screening criteria, including test confirmed influenza in the retrospective test-negative designs. Vaccination in these observational studies was not randomly assigned. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.5 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.5 Because transmission of influenza viruses to others may occur before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others.5 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.6 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.6 The CDC recommends that for most people who need only one dose of flu vaccine, vaccination should ideally happen in September or October.6 About CSL Seqirus CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus offers a broad portfolio of innovative, differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit . About CSL CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/we-are-csl/vita-original-stories and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. FLUCELVAX® (Influenza Vaccine) IMPORTANT SAFETY INFORMATION What is FLUCELVAX® (Influenza Vaccine)? FLUCELVAX is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX may not protect all people who receive the vaccine. Who should not receive FLUCELVAX? You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. Before receiving FLUCELVAX, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUCELVAX should be made by your healthcare provider, based on careful consideration of the potential benefits and risks. have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are the most common side effects of FLUCELVAX? pain and/or redness where the vaccine was given headache extreme tiredness muscle aches Additional side effects seen in children include: tenderness, bruising and/or a raised hardened area where the vaccine was given sleepiness irritability diarrhea changes in eating habits feeling unwell (malaise) These are not all of the possible side effects of FLUCELVAX. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider. To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus a t 1-855-358-8966 or VAERS at 1 ‐ 800 ‐ 822 ‐ 7967 or . Before receiving this vaccine, please see the full US Prescribing Information for FLUCELVAX. You can ask your healthcare provider or pharmacist for information about FLUCELVAX that is written for healthcare professionals. FLUAD ® (Influenza Vaccine, Adjuvanted) IMPORTANT SAFETY INFORMATION What is FLUAD® (Influenza Vaccine, Adjuvanted)? FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. Vaccination with FLUAD may not protect all people who receive the vaccine. Who should not receive FLUAD? You should not receive FLUAD if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. Before receiving FLUAD, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUAD should be made by your healthcare provider, based on careful consideration of the potential benefits and risks have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are the most common side effects of FLUAD? Pain and tenderness where vaccine was given Muscle ache Tiredness Headache These are not all of the possible side effects of FLUAD. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider . To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and . Before receiving this vaccine, please see the full US Prescribing Information for FLUAD. You can ask your healthcare provider or pharmacist for information about FLUAD that is written for healthcare professionals. ### USA-CRP-24-0029 MEDIA CONTACT Em Dekonor +44 (0)7920500496 [email protected] REFERENCES 1 Stein, A. et al (2024). Relative vaccine effectiveness of cell-based versus egg-based quadrivalent influenza vaccines against test-confirmed influenza in the United States 2022-23 influenza season. 2 Imran, M. et al (2024). Relative effectiveness of cell-based influenza vaccines versus egg-based influenza vaccines: A review of test-confirmed and clinical diagnosis-based influenza outcomes. 3 Huong Q Nguyen et al. (2024) Effectiveness of cell culture-based inactivated influenza vaccine against medically-attended, laboratory-confirmed influenza in Wisconsin, US, 2023-2024. 4 Imran, M. et al (2024). Relative vaccine effectiveness of adjuvanted quadrivalent inactivated influenza vaccine (aQIV) vs high-dose quadrivalent inactivated influenza vaccine (HD-QIV) for prevention of test-confirmed influenza during the 2022-2023 influenza season. 5 CDC. (2024). Key Facts About Influenza (Flu). Retrieved from: . Accessed September 2024. 6 CDC. (2024). Who Needs a Flu Vaccine and When. Retrieved from: . Accessed September 2024. SOURCE CSL Seqirus WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to receivebulk of $13.1 million grant funding Company anticipates Phase 2 trial to commence by early 2025 CARSON CITY, Nev., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the U.S. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. FDA had previously reviewed and approved the study as Safe to Proceed in August 2024. Approval from OHRO is the last scientific review milestone needed for the Company to receive the additional $12.6 million in grant funding from the U.S. Department of Defense (DOD) and initiate Phase 2 testing in long COVID. The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that more than 17 million adults in the United States currently or previously had long COVID.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms. Terms of the Department of Defense AwardThe work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with the option, if approved, to receive an additional $12.6 million, to initiate a clinical trial once the planning phase has concluded and milestones have been met, through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. About Long COVIDLong COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, hearing loss, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously have long COVID.1 The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.2 To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 The expression of proteins associated with inflammation (LGALS9, CCL21, CCL22, TNF, CXCL10 and CD48) and immune regulation (IL1RN and CD22) have been shown to be elevated in individuals with long COVID versus full-recovered individuals.4 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Thus, drugs modulating inflammation, and that work to regulate the BBB integrity, could represent potential therapeutic mechanisms for treating neurological symptoms of long COVID. About BezisterimBezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is also being investigated for Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. Forward-Looking StatementsThis 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” or words of similar meaning. 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 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, 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. References1 Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136. DOI: http://dx.doi.org/10.15585/mmwr.mm7306a4. 2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu) 3 Evans RA, Leavy OC, Richardson M, et al. Clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK: a prospective observational study. The Lancet Respiratory Medicine. 2022;10(8):761-775. 4 Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to SARS-CoV-2. Nature Immunology. 2024;25:218-225. 5 Greene C, Connoly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment. Nature Neuroscience. 2024;27:421-432. For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com