Terlipressin Acetate

– Three posters highlight research on outcomes of TERLIVAZ treatment in key subpopulations of adults with HRS with rapid reduction in kidney function1 – DUBLIN, June 5, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of three posters on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at the 2024 European Association for the Study of the Liver (EASL) Congress taking place in Milan, Italy from June 5-8, 2024. The posters include a retrospective chart review that examined the potential relationship of serum creatinine (SCr) levels and treatment outcomes in support of earlier diagnosis;2 data analyzing clinical response to TERLIVAZ in HRS patients with a mean arterial pressure (MAP) of <65 mm Hg;3 and the effect of TERLIVAZ on renal function among patients with alcohol-associated hepatitis (AAH) and hepatorenal syndrome-acute kidney injury (HRS-AKI) who had acute-on-chronic liver failure (ACLF) grades 0–2.4 TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.5 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually and rates of hospitalizations are increasing.6 Currently, TERLIVAZ is only approved in the U.S. Please see Limitation of Use and Important Safety Information, including Boxed Warning, below. "The posters being shared at EASL showcase the potential benefits of treatment with TERLIVAZ in several patient subpopulations where there is a significant need. We remain steadfast in our dedication to furthering our knowledge on the clinical outcomes for those affected by HRS and the role TERLIVAZ treatment can play for appropriate patients," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. Poster #SAT-320: Early diagnosis and treatment with terlipressin for adults with hepatorenal syndrome improves clinical outcomes and reduces healthcare resource utilization2 Presenter: Dr. Juan F. Gallegos-Orozco Session Type: Poster Presentation Session Title: Acute Liver Failure and Drug-Induced Liver Injury Session Date and Time: Saturday, June 8, 2024; 10:00 – 10:08 a.m. CEST This analysis used a decision-analytic model leveraging data from the CONFIRM trial and a medical chart review study from the United Kingdom to assess HRS patients across SCr groups at the time of HRS diagnosis to evaluate the potential impact of earlier HRS diagnosis and TERLIVAZ treatment.2 The model assessed on-label treatment (SCr levels <3 mg/dL or ≥3 to <5 mg/dL) with TERLIVAZ, and excluded those with SCr levels ≥5 mg/dL or those with grade 3 ACLF.2 In this analysis, earlier HRS diagnosis and treatment with TERLIVAZ was associated with a 3,040 greater HRS reversals, 960 fewer patients with renal replacement therapy (RRT) rate during hospitalization, fewer intensive care unit days, and a shorter overall length of hospitalization when compared to current clinical practice.2 The analysis further showed that a reduction in hospitalization could generate $11,504 savings/cost offset per person and a total annual national savings of $460.2 million in the U.S. (based on 2023 U.S. dollars).2 Poster #SAT-076: Patients with hepatorenal syndrome and lower baseline mean arterial pressure derive significant survival benefit from treatment with terlipressin3 Presenter: Dr. Paul Yien Kwo Session Type: Poster Presentation Session Title: Cirrhosis and its complications: Portal Hypertension Session Date and Time: Saturday, June 8, 2024; 8:30 a.m. CEST This analysis included pooled data from three Phase III, placebo-controlled studies of TERLIVAZ in patients with HRS with rapid reduction in kidney function and examined the clinical response from patients with a baseline MAP of <65 mm Hg (n=608).3 The rate of HRS reversal was 22.4% [11/49] in the TERLIVAZ group and 5.9% [2/34] in the placebo group (p=.041).3 The proportion of patients requiring RTT at Day 30 was 28.6% [14/49] in the TERLIVAZ group and 47.1% [16/34] in the placebo group (p=.085); at Day 60 was 30.6% [15/49] in the TERLIVAZ group and 47.1% [16/34] in the placebo group (p=.128); and at Day 90 was 34.7% [17/49] in the TERLIVAZ group and 47.1% [16/34] in the placebo group (p=.258).3 Poster #THU-074: Effect of terlipressin on patients with hepatorenal syndrome, alcohol-associated hepatitis, and acute-on-chronic liver failure grade 0–24 Session Type: Poster Session Session Title: Cirrhosis and its complications: ACLF and Critical illness Session Date: Thursday, June 6, 2024 This analysis included pooled data from three Phase III studies of TERLIVAZ to assess the effect of treatment on renal function among the subpopulation of patients with AAH, HRS-AKI, and ACLF grades 0–2 (n=141).4 Change in renal function, measured as least squares (LS) mean changes in SCr from baseline to end of treatment (EOT) with and without interaction between treatment and day were –0.98 mg/dL and –1.02 mg/dL for the TERLIVAZ arms, and –0.35 mg/dL and –0.26 mg/dL for the placebo arms, respectively.4 The difference in LS mean change in SCr between the TERLIVAZ and placebo arms was –0.64 mg/dL without interaction, and –0.76 mg/dL with interaction between treatment and day (both p<.001).4 In the TERLIVAZ (n=84) and placebo (n=60) arms, the incidence of HRS reversal (defined as at least 1 SCr value of ≤1.5 mg/dL while on treatment by Day 14 or discharge) was 44.0% and 11.7% (p<.001), respectively.4 Incidence of RRT on Days 30, 60, and 90 were 24% and 25%, 26% and 27%, and 26% and 27% (p>.800 for all), respectively.4 Key Study Limitations The safety and efficacy of TERLIVAZ within the study subgroups assessed in SAT-320, THU-074, and SAT-076 have not been evaluated by the FDA. The limitations of these studies include but are not limited to small sample sizes, variables in methodology and possible errors and omissions within the data sets. These analyses were sponsored by Mallinckrodt Pharmaceuticals. INDICATION AND LIMITATION OF USE TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%. Contraindications TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. In patients with ongoing coronary, peripheral, or mesenteric ischemia. Warnings and Precautions Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure. Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks. Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions. Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. Adverse Reactions The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Please click here to see full Prescribing Information, including Boxed Warning. ABOUT HEPATORENAL SYNDROME (HRS) Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.5 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.5 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually and rates of HRS hospitalizations are increasing.6 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of less than two weeks and greater than 80 percent mortality within three months.7 ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400450 06/24 References 1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023. 2 Gallegos-Orozco JF, et al. Early Diagnosis and Treatment with Terlipressin for Adults with Hepatorenal Syndrome Improves Clinical Outcomes and Reduces Healthcare Resource Utilization. Poster presentation to be shared at the 2024 European Association for the Study of the Liver (EASL) Conference. June 2024. 3 Kwo P, et al. Patients with hepatorenal syndrome and lower baseline mean arterial pressure derive significant survival benefit from treatment with terlipressin. Poster presentation to be shared at the 2024 European Association for the Study of the Liver (EASL) Conference. June 2024. 4 Moore K, et al. Effect of terlipressin on patients with hepatorenal syndrome, alcohol-associated hepatitis, and acute-on-chronic liver failure grade 0–2. Poster presentation to be shared at the 2024 European Association for the Study of the Liver (EASL) Conference. June 2024. 5 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: . Accessed June 2024. 6 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin K, Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890. 7 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. . SOURCE Mallinckrodt plc

CARSON CITY, Nev., June 04, 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 the formation of a long COVID Advisory Board that will provide the Company with strategic guidance on the design and execution of a Phase 2b trial in patients with long COVID, with funding from the U.S. Department of Defense. 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, which include cognitive dysfunction and fatigue, are debilitating and to date there are no therapies proven effective for treatment. The Advisory Board includes four of the leading experts in long COVID (Michael Peluso, MD, MHS and Steven Deeks, MD from the University of California, San Francisco; Sherry Chou, MD and Igor Koralnik, MD from Northwestern Feinberg School of Medicine in Chicago) and two industry experts in outcomes and neuropsychiatric clinical development (Cynthia Girman, Dr. PH, Founder and President of CERobs Consulting, Dr. Douglas Feltner, former Chief Medical Officer at Kisbee Therapeutics and Exicure Inc). Joseph Palumbo, MD, LFAPA, MACPsych, BioVie’s Chief Medical Officer and Head of Research and Development will chair the Advisory Board. “We are gratified to have been selected and to have received funding from the DoD to evaluate our novel therapeutic bezisterim in patients with Long COVID,” said Dr. Palumbo. “Bezisterim is an anti-inflammatory and insulin-sensitizer that permeates the blood-brain barrier and could represent a novel oral treatment targeting an underlying cause of long COVID symptoms. Our Scientific Advisory Board will play a pivotal role in guiding and accelerating our program in the currently funded planning phase. We are pleased to have this esteemed group of scientists as collaborators to set science in motion." Advisory Board Michael Peluso, MD, MHS and Steven Deeks, MD are infectious disease clinical researchers at University of California, San Francisco. When the SARS-CoV-2 pandemic emerged, they led the efforts to implement the Long-term Impact of Infection with Novel Coronavirus (LIINC) study examining COVID’s long-term effects on health. LIINC became one of the first studies focused on understanding the biological mechanisms that drive long COVID and has supported over 50 scientific collaborations. Dr. Peluso, Assistant Professor of Medicine, leads a long COVID clinical trial program within LIINC and also oversees the implementation of the NIH’s RECOVER long COVID initiative at UCSF. Dr. Deeks, Professor of Medicine, was a co-organizer of the 2023 Keystone Symposia Meeting focused on long COVID pathogenesis and treatment. Sherry Chou, MD and Igor Koralnik, MD from Northwestern Feinberg School of Medicine in Chicago are experts in the neurological sequalae of COVID infection and were the first to characterize the neurological complications in hospitalized COVID-19 patients in the U.S. Dr. Chou, who is the Chief of Neurocritical Care and Associate Professor of Neurology at Northwestern Feinberg School of Medicine, founded and leads the large Global Consortium Study on Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID) and serves as an invited member to the World Health Organization forum on neurological impacts of COVID-19. Dr Koralnik, who is Chief of Neuro-infectious Disease and Global Neurology in the Department of Neurology at Northwestern Feinberg School of Medicine, created one of the first Neuro COVID-19 clinics in the country where he and his team investigate, diagnose and manage neurological symptoms of long COVID. “Through the Northwestern Medicine Comprehensive COVID-19 Center, we have evaluated over 4,000 individuals with Long COVID and more than 2,500 at the NEURO-COVID-19 clinic and have documented the neurocognitive and other significant health challenges that remain without effective treatments” stated Dr. Koralnik. “I am excited to join my fellow colleagues to provide guidance to BioVie in the development of this important trial to assess the potential impact of bezisterim in the treatment of long COVID.” Cynthia Girman, Dr. PH, Founder and President of CERobs Consulting, has forty years of epidemiology and biostatistical experience in the pharmaceutical industry. She is an expert in study design and methodology for real world evidence, observational non-interventional studies as well as external control arms for clinical trials. Dr. Girman also provides expertise for endpoint strategies for clinical trials, including clinical outcome assessments and patient reported outcomes, and their justification to regulatory bodies. Previously, Dr. Girman served as Executive Director and Head of Data Analytics & Observational Methods in the Center for Observational & Real-World Evidence at Merck Research Laboratories, where she founded the Center of Excellence for Comparative & Outcomes Evidence and one for the Development, Validation, Standardization and Implementation of Endpoints (DEVISE) for clinical trials. She is currently a member of the Methodology Committee for the Patient Centered Outcome Research Institute. Dr. Douglas Feltner is a physician-scientist, with over 25 years of experience in clinical drug development and in translational medicine, primarily focused on neurology, psychiatry and neuroscience. Prior to recent positions as Chief Medical Officer at Kisbee Therapeutics and Exicure Inc., Dr. Feltner served as Vice President, Neuroscience Development, for AbbVie, Inc. and Vice President, Global Head of Translational Medicine for Pfizer, Inc. Dr. Feltner earned his M.D., with distinction in research, from the University of Michigan Medical School, did his residency in psychiatry at George Washington University, and was a postdoctoral fellow in the Lab of Mammalian Genes and Development at The National Institute of Child Health and Human Development. "I am so delighted for our team to be working with and learning from our selected experts," said BioVie CEO Cuong Do. "The Advisory Board brings expertise to help us design the exploratory Phase 2b trial to assess how bezisterim may address the cognitive and fatigue symptoms of long Covid. Finalization of the protocol and obtaining the necessary regulatory approvals will trigger a milestone meeting with the PRMP programmatic panel that is required to allow us to exercise the award option of $12.6 million in the approved budget to conduct the clinical trial.” 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. The preliminary plan is to conduct a Phase 2b, randomized (1:1), placebo-controlled, multicenter trial to evaluate the safety and tolerability of 3 months of treatment with bezisterim and assess the ability of this treatment to reduce the neurocognitive symptoms that are associated with long COVID, in approximately 200 patients. Terms of the Department of Defense Award The 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 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 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. 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 Bezisterim Bezisterim (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-to-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 NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNγ). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is 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 NFκB (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 U.S. Food and Drug Administration (“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 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" 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. References 1 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: . 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 Mackle Managing Director, LifeSci Advisors, LLC bmackle@lifesciadvisors.com For Media Relations Inquiries: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com