New Vizient Survey Finds Drug Shortages Cost Hospitals Nearly $900M Annually in Labor Expenses




New Vizient Survey Finds Drug Shortages Cost Hospitals Nearly $900M Annually in Labor Expenses

IRVING, Texas–(BUSINESS WIRE)–Vizient^® today announced its updated analysis of the financial impact of drug shortages for hospitals to their workforce and budgets. The new survey, “Beyond the Shortage: The Hidden Cost of Drug Supply Chain Disruptions,” revealed that in 2023, hospitals across the U.S. spent roughly 20 million hours managing a range of drug shortages, which translates to nearly $900 million annually in labor costs—more than double the labor costs reported of just under $360 million in the 2019 survey.

“The new survey’s findings illustrate how staffing burdens have surged since 2019, demanding more time and resources—especially in pediatric facilities—to simply navigate drug shortages,” said Nikola Markoski, director, pharmacy sourcing strategic solutions & analytics for Vizient. “If you add in the cost of more expensive alternative therapies, direct purchases outside the hospital’s traditional channels, medication errors and cancelled or delayed medical procedures, the actual total cost of managing drug shortages for hospitals far exceeds the nearly $900 million figure for additional labor.”

Overall, the 132 respondents who participated in the 2024 survey monitored an average of 43 drug shortages and a maximum of 70 over the course of 2023. Pediatric facilities monitored at least 25% more shortages than general facilities due to the high risk and complexity of pediatric populations coupled with treatment often requiring a mix of both adult-approved drugs and pediatric-approved drugs.

Additional findings from the survey include:

• 43% of respondents indicated medication errors that had occurred were related to drug shortages, up from 38% from the 2019 survey.
• 27% of respondents reported that drug shortages caused disruptions in patient care. Outpatient infusion services were most affected with 41% of patient cases omitted, missed or delayed.
• Planned medical procedures were also impacted by shortages, with disruptions reported in 32% of cases, followed by hospital admissions at 22%.

The findings of the updated survey, which focused on the period of January through December 2023, highlight the ongoing direct financial challenges caused by drug shortages, defined as an increase in hospital operating budget or labor expenses associated with drug shortages.

To help providers address the financial pressures related to drug shortages, Vizient offers strategic solutions through its contracting capabilities and pharmacy programs such as the Novaplus Enhanced Supply and Novaplus Enhanced Supply Reserve. Since their inception in 2021, Vizient clients have accessed over 4 million additional units of onshore manufacturer inventory across more than 200 high-impact critical molecules, including many frequently reported in shortage. This expanded access has played a vital role in improving medication availability, maintaining continuity of care and reinforcing resiliency across the supply chain.

In addition to medication access, clients who participate in these programs avoid the financial burden of shortages by mitigating labor costs associated with sourcing and managing alternatives and reducing the need for emergency purchasing. Since 2023, Vizient estimates the programs have generated nearly $300 million in inventory cost avoidance for participating clients.

“While our supply assurance strategies are making a significant difference in practice, the findings of this survey reflect on the work that remains to be done, which is why Vizient continues to expand its strategies for pharmaceuticals and other critical supplies,” said Mittal Sutaria, PharmD, senior vice president, pharmacy contract and program services for Vizient.

Read the full report here.

About Vizient, Inc.

Vizient, Inc., the nation’s largest provider-driven healthcare performance improvement company, serves more than 65% of the nation’s acute care providers, including 97% of the nation’s academic medical centers, and more than 35% of the non-acute market. The Vizient contract portfolio represents $140 billion in annual purchasing volume enabling the delivery of cost-effective, high-value care. With its acquisition of Kaufman Hall in 2024, Vizient expanded its advisory services to help providers achieve financial, strategic, clinical and operational excellence. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.

Contacts

Media contact

Donna Ledbetter

972-830-6321

Donna.ledbetter@vizientinc.com

June Health Launches to Redefine Women’s Health as a Strategic Employer Benefit




June Health Launches to Redefine Women’s Health as a Strategic Employer Benefit

Employers in Canada can now close the care gap for women in the workforce through timely access to expert-led, integrated care and convenient treatment options

TORONTO–(BUSINESS WIRE)–#JuneHealth—June Health, a comprehensive virtual care platform built specifically to serve women’s health needs, today announced its national launch. June Health offers coordinated, clinically rigorous medical and lifestyle-oriented care tailored to perimenopause and midlife health. The multidisciplinary solution, which is the first to provide benefits navigation and include pharmacy and marketplace integrations, is available to individuals and offered as a modern workplace benefit for progressive employers, insurers, and health provider networks.

Women over 40 represent the fastest-growing segment of the workforce, yet most health benefit programs still fail to directly address the complex and interconnected health needs of this population. June Health changes this through a convenient digital platform that provides virtual clinical care, on-demand treatment and benefits coordination, AI-powered navigation, a digital pharmacy, expert-vetted health supplements, and women’s mental health support – all in one seamless user experience.

“Untreated perimenopause is a silent productivity and retention crisis that hits companies where it hurts – in absenteeism, burnout, and talent attrition. June is purpose-built to solve this clinically, digitally, and operationally at scale,” said Lori Casselman, founder and CEO of June Health. “The unfortunate reality is that timely access to expert midlife care is out of reach for many women, and employers have a tremendous opportunity to be part of the solution. It’s a necessary evolution of healthcare benefits, which are built to support the health needs of an entire workforce.”

A Platform Designed for Employers. A Model Built for Real Life.

Unlike generic telehealth or symptom-based consumer apps, June Health delivers a full-stack care model centered around managing the common and often debilitating health symptoms associated with perimenopause. The platform combines the convenience of virtual care with the credibility of a multidisciplinary team of health experts, including physicians, nurse practitioners, dietitians, mental health professionals, and naturopaths – trained and credentialed in the science and lived experience of women.

For employers, June offers a ready-to-deploy benefit that complements existing health plans, reduces healthcare costs, and drives measurable workforce ROI. With the Canadian economy losing an estimated $3.5 billion annually due to unaddressed menopause symptoms, June Health helps employers tackle one of the last remaining frontiers in inclusive, high-impact benefits design.

“Perimenopause can last up to 10 years, presents with over 40 common symptoms, and affects everything from cognitive function to cardiovascular health,” said Dr. Romy Nitsch, Medical Director at June Health. “It’s time we stopped treating this as a lifestyle issue and started addressing it as the complex medical phase it truly is. Our team delivers evidence-based care that reflects the whole woman – her biology, her stress load, and her full healthcare needs.”

How June Works: A Tech-Enabled Ecosystem for Women’s Health

June isn’t just virtual care, it’s a connected care ecosystem. The platform’s unique service architecture ensures that women receive timely, personalized, empathetic, proactive, and continuous support throughout their health journey. Key features include:

• Intelligent Triage and Clinical Matching – A proprietary intake system that rapidly assesses symptoms and connects members to the right specialists at the right time.
• Multidisciplinary Clinical Team – Access to a co-ordinated team of certified women’s health experts, including physicians, naturopaths, registered dietitians, mental health professionals, weight management and fitness specialists, and more. Delivered through convenient virtual appointments tailored to busy lives.
• Dedicated Care Coordinators – Personal care advocates help women navigate coverage, treatment options, and provider referrals, taking the friction out of care.
• Integrated Pharmacy and Supplement Marketplace – Curated, clinically-backed products delivered to members’ doors via seamless in-app ordering.
• Community and Education Hub – On-demand programs, peer support, and trusted resources designed for the midlife experience.
• AI-Powered Assistant: Ask June – A 24/7 smart concierge offering real-time guidance, symptom tracking, care navigation, and escalation to human care when needed.

Closing the Gap for Good

More than 10 million women in Canada are navigating midlife health changes, many in silence and without the support of trained clinicians who understand the issues they face. June Health exists to change that, not only by delivering personalized, expert care to women, but by helping forward-looking employers become part of the solution.

A Founding Story Rooted in Lived Experience and Deep Market Insight

June Health was founded by Lori Casselman, an experienced healthcare executive who saw firsthand how the healthcare system and employee benefit models have failed to address the serious health symptoms women navigate through midlife. With leadership experience at Sun Life, Telus Health, and as former Chief Health Officer at League, Lori recognized a pressing opportunity to build a more personalized, clinically rigorous, and scalable solution.

To bring this vision to life, she partnered with Dr. Romy Nitsch, MD, MHSc, Medical Director and Deputy Department Head, Obstetrics & Gynecology, and Associate Professor, Faculty of Medicine, Queen’s University; and Fazlin Bandali, a seasoned operator with a decade of experience at Shopify, following several early-stage tech startup roles. Together, this multidisciplinary team brings expertise across healthcare and insurance, clinical excellence, and digital product innovation to uniquely position June Health to lead this category.

Employers that want to offer June Health as a workplace benefit can contact June Health at support@junewomenshealth.com or www.junehealth.care.

About June Health

June Health is Canada’s first fully integrated virtual care platform dedicated to midlife women’s health. Purpose-built to support employers, health plans, and providers, June offers end-to-end clinical support, AI-powered care navigation, pharmacy integration, and a curated digital health marketplace. June is on a mission to close the midlife care gap and make personalized, expert care accessible for every woman — whenever and wherever she needs it.

To learn more, visit junehealth.care. Follow us on LinkedIn.

Contacts

Media Contact:
Jodi Echakowitz

Boulevard Public Relations

jodi@boulevardpr.com

Arialys Therapeutics Publishes Preclinical Data in Nature Communications Supporting ART5803 as a First-in-Class Precision Therapeutic for Anti-NMDA Receptor Autoimmune Neuropsychiatric Disease




Arialys Therapeutics Publishes Preclinical Data in Nature Communications Supporting ART5803 as a First-in-Class Precision Therapeutic for Anti-NMDA Receptor Autoimmune Neuropsychiatric Disease

Study highlights novel monovalent therapeutic antibody’s ability to block NMDA receptor internalization and reverse disease phenotypes in primate models

LA JOLLA, Calif.–(BUSINESS WIRE)–#ANRE—Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatric diseases, today announced the publication of preclinical data in Nature Communications demonstrating that its lead drug candidate, ART5803, effectively blocks the underlying disease mechanism in anti-NMDA receptor encephalitis (ANRE) and rapidly reverses behavioral symptoms in a non-human primate model. The findings support the continued clinical development of ART5803 as a first-in-class, targeted therapeutic. The company is currently completing Phase 1 safety studies for ART5803 and plans Phase 2 evaluation in anti-NMDA receptor encephalitis (ANRE) and autoimmune psychosis patients in the second half of 2025.

“This study underscores the promise of ART5803 to directly address neuropsychiatric disease caused by anti-NMDA receptor-targeting pathogenic antibodies,” said Peter Flynn, Ph.D. President and CEO of Arialys Therapeutics. “Despite our understanding of the disease mechanism and its severity, ANRE lacks an approved therapy. Further, there is a growing body of data identifying significant levels of anti-NMDA receptor autoantibodies in subpopulations of patients diagnosed with diseases that result in psychosis and dementia.”

“These data provide compelling evidence that ART5803 can directly block the pathogenic effect of autoantibodies that target the NMDA receptor, resulting in a rapid resolution of symptoms,” said Mitsuyuki (Mickey) Matsumoto, Ph.D., Chief Scientific Officer of Arialys Therapeutics and senior author of the paper. “Our detailed structural and functional analyses confirm that ART5803 precisely inhibits NMDA receptor internalization induced by the pathogenic autoantibodies, while preserving normal receptor function. In addition, our discovery of a potential molecular mimicry mechanism for anti-NMDA receptor autoantibody generation broadens the understanding of disease initiation and may inform future indication expansion for ART5803.”

Anti-NMDA receptor encephalitis (ANRE) is a rare, potentially lethal, poorly managed, and often misdiagnosed neurological disease. ANRE is caused by pathogenic autoantibodies that bind to and crosslink NMDA receptors in the brain, leading to receptor internalization and synaptic dysfunction. The result is a range of debilitating neuropsychiatric symptoms including psychiatric and behavioral alterations, cognitive decline, seizures, coma, and diminished autonomic function. A significant percentage of ANRE patients are pediatric, where NMDA receptor-specific autoantibodies can also result in neurological development deficits. There are no approved therapies for this disease, and current treatments rely on broadly immunosuppressive therapies, which are associated with delayed efficacy and significant side effects.

Recent findings have also identified anti-NMDA receptor autoantibodies in other neurological and psychiatric diseases such as schizophrenia, depression, bipolar disorder, and dementia. Arialys is planning clinical assessment of ART5803 in anti-NMDA receptor autoantibody-positive psychosis patients. The company is also currently testing patient samples using a proprietary high-throughput screen for autoantibodies to identify enriched disease indications and subpopulations for future clinical development.

ART5803 is a humanized, monovalent IgG1 antibody engineered to selectively bind the GluN1 subunit of the NMDA receptor without disrupting receptor function or causing internalization. In this study, ART5803 demonstrated the ability to potently block NMDA receptor internalization in cellular and neuronal models and reversed both molecular and behavioral hallmarks of disease in a novel marmoset model of ANRE. Notably, ART5803 exhibited rapid onset of action and was well tolerated in vivo. The publication also includes a detailed characterization of ART5803’s binding epitope, its mechanism of action, and population pharmacokinetic modeling supporting the feasibility of systemic administration in patients.

In addition to demonstrating the therapeutic potential of ART5803, the paper revealed a potential link between infections—specifically Toxoplasma gondii and certain bacterial pathogens—and the generation of pathogenic anti-NMDA receptor autoantibodies. Epitope mapping analysis identified regions of potential molecular mimicry between microbial proteins and the GluN1 subunit of the NMDA receptor, suggesting that infections could serve as environmental triggers for disease initiation. Notably, toxoplasmosis and bacterial infections are well-established risk factors for a range of neuropsychiatric conditions. These findings not only suggest a basis for disease pathogenesis but also support broader therapeutic opportunities for ART5803 across autoimmune neuropsychiatric disorders.

ART5803 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers. In February 2025, Arialys announced completion of all single ascending dose (SAD) cohorts and initiation of multiple ascending dose (MAD) cohorts. The company expects to share initial clinical data in the second half of 2025 and initiate Phase 2 proof-of-concept studies.

The publication was completed in collaboration with researchers from Astellas Pharma Inc., University of California, Davis, Kitasato University School of Medicine, and Vanadro LLC.

About Arialys Therapeutics

Arialys was founded by investors Avalon Bioventures, Catalys Pacific and MPM to meaningfully expand the treatment possibilities for neuropsychiatric disorders driven by autoimmune disease. Using a combination of highly sensitive autoantibody detection, patient sampling and receptor structural biology, Arialys has developed a first-in-class precision therapy to specifically block pathogenic autoantibodies in the brain. Arialys is headquartered in La Jolla, California. For more information, visit www.arialysrx.com.

Contacts

Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com

Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)




Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)

BARCELONA, Spain–(BUSINESS WIRE)–Ferrer, a B Corp-certified international pharmaceutical company, has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development of progressive supranuclear palsy (PSP), has received Fast Track designation from the US Food & Drug Administration (FDA). FNP-223, a new molecular entity in active development for PSP, is in an ongoing Phase 2 study to evaluate its safety, efficacy, and pharmacokinetics in adult patients with possible or probable PSP-Richardson syndrome (PSP-RS), the most common clinical variant of this neurodegenerative disease¹.

“We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible,” said Mario Rovirosa, Chief Executive Officer of Ferrer.

Fast Track designation is a significant milestone in the drug development process. It is a program that offers the possibility of having more frequent meetings with the FDA to discuss the drug’s development, eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

“This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease,” said Marta Parmar, Ferrer’s Chief Quality, Regulatory and Pharmacovigilance Officer.

Progressive supranuclear palsy manifests in patients with symptoms such as difficulty speaking, imbalance, changes in gait, cognitive problems^2-4. PSP has a prevalence of approximately 5 cases per 100,000 people and primarily affects individuals over the age of 60³. The disease’s etiology is believed to be related to the abnormal accumulation of tau proteins in certain areas of the brain, leading to neurodegeneration^3,4. Preclinical models have demonstrated that FNP-223 can prevent the abnormal accumulation of tau proteins in neurons⁵. Ferrer now aims to show that this molecule is safe and effective in patients with PSP.

Oscar Pérez, Chief Scientific Officer of Ferrer, also expressed his enthusiasm: “Receiving Fast Track designation is a significant milestone in our journey to provide a transformative treatment for PSP. We are excited to advance our research and hopefully offer a new therapeutic option earlier for patients living with this challenging condition.”

About FNP-223

FNP-223 is a new orally administered chemical compound that functions as a reversible and substrate-competitive inhibitor of the O-GlcNAcase (OGA) enzyme⁵. Mechanistically, FNP-223 binds to the active site of OGA enzyme. As a result, the inhibitor prevents the substrate from accessing the catalytic pocket, thereby impeding the removal of O-GlcNAc modifications from natural client proteins such as the tau protein. Inhibiting O-GlcNAcase is expected to cause a rapid increase of O-GlcNAcylated (glycosylated) tau proteins, ultimately leading to a reduction in abnormal aggregated tau as neurofibrillary tangles (NFT) over a certain period⁵.

Bibliography:

1. ClinicalTrials.gov A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). ClinicalTrials.gov [Internet]. Available from: https://www.clinicaltrials.gov/study/NCT06355531.

2. Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/j.parkreldis.2020.04.014. Epub 2020 May 25.

3. Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526098/.

4. Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021;21(5):376-383. doi: 10.1136/practneurol-2020-002794.

5. Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20;13(8):1296-1314. doi: 10.1021/acschemneuro.2c00057.

Contacts

gortizdez@ferrer.com
+34 936003779

Astoriom Appoints Brittany Jackson as CFO




Astoriom Appoints Brittany Jackson as CFO

Key appointment to lead the company’s financial strategy and support continued global growth in sample stability and biorepository storage solutions

ROCHDALE, England–(BUSINESS WIRE)–#Astoriom–Astoriom, a global leader in the R&D sample stability and biorepository storage industry, has appointed Brittany Jackson, FCCA as Chief Financial Officer (CFO). Brittany will work alongside the team to support the company’s financial and strategic initiatives and continue strengthening the organization’s growth in key global markets. Her appointment will also help to ensure sustainable success across its portfolio of sample stability storage, biorepository storage, disaster protection and recovery, as well as sample storage equipment and validation services.

Brittany brings extensive experience across biotech, manufacturing, education, hospitality and professional services, having previously held positions at companies including Protocol, Champion Accountants and The Manchester Metropolitan University. She is a Fellow of the Association of Chartered Certified Accountants (ACCA) and a commercially focused and results-driven leader, she has guided organizations through high-growth phases, operational transformation, and ownership transitions. Beyond finance, Brittany has also overseen IT, HR, legal, software, payroll, and quality functions, providing her with broad and strategic views of business management. By aligning these functions with Astoriom’s long-term goals, Brittany will help to ensure that operational efficiencies are maximized.

Lori A. Ball, CEO, Astoriom, said: “Brittany is a forward-thinking, purposeful leader. Her energy and expertise are invaluable and will be a great fit for our team. We are committed to ensuring sample assets are protected and preserved to support scientific R&D advancements, product safety and compliance, and innovation. With Brittany on board to help deliver Astoriom’s vision, I am confident we will continue to drive excellence across all aspects of the business and achieve impactful results for our customers worldwide.”

Brittany Jackson, CFO, Astoriom, said: “I’m enthusiastic about embedding finance as a true strategic partner to all stakeholders, innovating operational processes and building strong, empowered teams. With Astoriom’s mission to deliver industry-leading stability storage and biorepository services that create meaningful value for R&D companies worldwide, I’m excited to join the team at this pivotal moment of global expansion. I’m looking forward to supporting the company’s commercial growth while shaping operational maturity to ensure we continue to achieve organizational excellence.”

For more information about Astoriom’s team, please visit: https://www.astoriom.com/about/

ENDS

Contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

+447789053885

michelle.ricketts@codoncommunications.com

Mursla Bio Introduces AI Precision Medicine Platform Built on Organ-Specific EV Isolation from Blood




Mursla Bio Introduces AI Precision Medicine Platform Built on Organ-Specific EV Isolation from Blood

• Platform is built on biologically labelled, organ-specific multi-omics data carried by extracellular vesicles isolated from 2ml plasma samples
• Enables differentiated AI-powered biomarker discovery and IVD translation for patient stratification, therapeutic monitoring, surrogate markers and other diagnostic development programs
• Publication of pre-print data, with support from Evotec International GmbH and University College London demonstrates validation of Platform’s capability for liver diseases

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to advance precision diagnostics and significantly improve cancer outcomes for at-risk patients, today announced the commercial launch of its AI Precision Medicine Platform, alongside a pre-print¹ reporting the first validated method for isolating hepatocyte EVs from plasma for organ-specific proteomic and miRNA profiling. Mursla Bio is engaging with potential partners to apply its Platform to additional disease areas, biomarker discovery and IVD translation programs.

The Platform addresses a major gap in liquid biopsy and precision medicine: enabling non-invasive access to organ-specific molecular information from blood with high spatial and biological resolution. Mursla Bio’s Platform is built on its ability to isolate and analyze EVs which are secreted by specific organs into the bloodstream. The Platform reduces non-target background by up to five orders of magnitude compared to standard bulk EV isolation and significantly improves data structure, enhancing prediction model generalization.

The pre-print presents the first multi-layered validation of hepatocyte EV isolation in humans, confirming liver origin through proteomic and nucleic acid markers. Key supporting proteomics data was generated in collaboration with Evotec International GmbH. Patient samples were provided by University College London, with Professor Brian Davidson, a global leader in liver disease surgery and clinical research, contributing as a co-author. The study shows that Mursla Bio’s method yields robust, organ-specific multi-omics data using minimal blood volume, offering a novel scalable approach for biomarker and AI development.

Mursla Bio’s Platform incorporates optimized multi-omics workflows, embedded AI pipelines, and IVD translation processes to convert complex biological signals into practical, regulatory-grade assays. These assays are deployable on standard commercial instruments using patented, PCR and ELISA-like steps designed for clinical adoption. The Platform also underpins the development of EvoLiver™, the Company’s lead clinical program for liver cancer surveillance in cirrhotic patients. Built on multi-omics data from over 300 patients, EvoLiver achieved 86% sensitivity and 88% specificity on a locked, IVD-compatible assay for early-stage hepatocellular carcinoma detection², and has received Breakthrough Device Designation from the FDA³.

Pierre Arsène, Founder and CEO of Mursla Bio, said: “EVs are nature’s native signal enrichment system for long-distance communication between cells and organs. Our platform harnesses this biology to non-invasively access organ-specific, multi-omics data from just a small blood sample. It produces structured, biologically labeled datasets that are optimized for AI and ready to support diagnostic translation. EvoLiver is our first proof point of real-world clinical impact, and we are now expanding access to the platform to advance our pipeline and enable partnerships across other disease areas.”

Mursla Bio is expanding its pipeline and collaborations, with additional organ programs underway in cardiometabolic, lung, and neurological indications. The Platform will support pharma development through dynamic patient stratification, therapeutic response monitoring, surrogate markers and molecular phenotyping across complex disease biology.

For further information on Mursla Bio’s AI Precision Medicine Platform, please visit https://mursla.com/ai-precision-platform/.

1. “Organ-specific isolation of hepatocyte extracellular vesicles from human plasma enables tissue-resolved proteomic and miRNA profiling”
2. Mursla Bio’s EvoLiver surpasses current standards in liver cancer surveillance
3. Mursla Bio receives FDA Breakthrough Device Designation for EvoLiver™ test

Contacts

Ben Rutter: ben.rutter@zymecommunications.com

Innate Pharma Announces Its Participation in H.C. Wainwright and Wolfe Research Healthcare Conferences




Innate Pharma Announces Its Participation in H.C. Wainwright and Wolfe Research Healthcare Conferences

MARSEILLE, France–(BUSINESS WIRE)–#InvestorRelations–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that members of its executive team will participate in the upcoming investor conferences, detailed below.

• H.C. Wainwright 3^rd Annual Immune Cell Engager Virtual Conference
  
  Dates: June 24, 2025 | Virtual

• Wolfe Research Virtual Biotech Day
  
  Dates: June 26, 2025 | Virtual

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET^® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Investors
Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations

NewCap
Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

D&D Pharmatech Announces Positive Phase 2 Results for DD01 in MASH with Robust Reductions in Liver Fat Accompanied by Improvements in Liver and Metabolic Health




D&D Pharmatech Announces Positive Phase 2 Results for DD01 in MASH with Robust Reductions in Liver Fat Accompanied by Improvements in Liver and Metabolic Health

• After 12 weeks of treatment, the trial primary endpoint was met: 75.8% of DD01-treated subjects achieved at least a 30% reduction in liver fat, 72.7% achieved >50% reduction, and 48.5% achieved normalization of liver fat levels (<5%)
• Treatment with DD01 was associated with a 62.3% relative reduction in liver fat compared to 8% with placebo
• Statistically significant improvements in proC3 levels and liver stiffness (MRE), two non-invasive measures of MASH were observed at 12 weeks
• DD01 was well tolerated; GI side effects were most common, generally mild to moderate, transient, and manageable with limited number of discontinuations
• DD01 treatment resulted in significant reductions in HbA1c and body weight

GYEONGGI-DO, South Korea & GAITHERSBURG, Md.–(BUSINESS WIRE)–D&D Pharmatech, Inc. (D&D) (KOSDAQ: 347850), a clinical-stage biotechnology company developing breakthrough treatments for liver and metabolic diseases, today announced positive results from DD01-DN-02 study, an ongoing 48-week Phase 2 trial designed to evaluate the efficacy and safety of DD01 (a once-weekly dual GLP1/glucagon receptor agonist) in 67 overweight/obese subjects with MASH. DD01 treatment was initiated with two weeks of dosing at 20 mg, followed by the 40mg once-weekly maintenance dose.

Results of a planned 12-week assessment of safety and efficacy revealed DD01 was well tolerated, and the study’s primary endpoint was met. Following a 1:1 randomization of 40mg DD01 and placebo, 75.8% of subjects treated with DD01 achieved at least a 30% reduction in liver fat, 72.7% of subjects achieved greater than 50% reduction in liver fat, and 57.6% of subjects achieved greater than 70% liver fat reduction (in each case, with p < 0.0001). DD01 achieved a mean reduction of liver fat content of 62.3% vs 8.3% for placebo at 12 weeks of treatment, and 48.5% of DD01 subjects achieved normalization of liver fat fraction (defined as liver fat fraction of 5% or less by MRI-PDFF). No placebo subject achieved normalization.

Treatment related reductions in Non-invasive markers of MASH progression were used to evaluate subjects at baseline and after 12 weeks of treatment. DD01 treatment was associated with statistically significant improvements in liver stiffness (MRE), pro-C3 levels, and ELF score.

Additional Endpoints

Twelve-week weight loss data were encouraging. While placebo-treated subjects had no significant weight loss, 42.4% of DD01-treated subjects achieving a greater than 5% reduction in weight. Also encouraging were the results of HbA1c testing. While the study population was not selected to be diabetic, following 12 weeks of DD01 treatment, HbA1c reduction was statistically significant compared to placebo.

Safety Results

DD01 was well tolerated. Gastrointestinal (GI) side effects were most common, generally mild to moderate, but transient and manageable. To date, only 3 subjects have discontinued treatment due to GI-related adverse events.

Implications

Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech, stated, “We have remarkably positive results for DD01 after only 12 weeks of treatment in MASH. The magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH.”

“Considering the combination of liver and metabolic benefits and the favorable tolerability profile, DD01 has the potential to provide patients and physicians with a MASH treatment that is easy to manage, encourages weight loss and is diabetes friendly.”

Mazen Noureddin, MD, MHSc, Professor of Medicine at Houston Methodist Hospital; Co-Chairman of the Board, Summit & Pinnacle Clinical Research; Director, Houston Research Institutes, commented, “The degree of liver fat reduction with DD01 is striking, with nearly three-quarters of patients achieving at least a 30% reduction and almost half reaching normalization within just 12 weeks. The observed improvement in liver stiffness by MRE, though early, adds further support to the biological activity of this dual GLP-1/glucagon approach, which is designed to act directly on the liver.”

“These consistent MRI-PDFF results provide strong confidence that DD01 has the potential to meet both key regulatory endpoints – MASH resolution and fibrosis improvement – as the program advances. Coupled with favorable metabolic effects and a very low treatment discontinuation rate, DD01 is emerging as a well-differentiated and promising therapy, both within its class and compared to other potent agents in development.”

Additional data will be presented at upcoming medical meetings.

About DD01

DD01 is a once-weekly dual GLP1/glucagon receptor agonist with a half-life of 7-8 days in obese/overweight patients with T2D and MASLD. Following a Phase 1 study that showed DD01 rapidly reduced liver steatosis, improved glucose tolerance, and encouraged weight loss in obese subjects with MASLD and type 2 diabetes, FDA granted DD01 Fast Track Designation for the treatment of MASH. Current Phase 2 results confirm and extend these findings revealing additional benefits in patients with MASH. The effect of DD01 is consistent with its dual-agonist pharmacology. Clinical results show the effects of DD01 are remarkably rapid. DD01 achieves robust results rapidly and with tolerability comparable to other validated MASH treatments.

The GLP1:glucagon potency ratio for DD01 is 11:1. GLP-1R potency is likely an important driver in glucose management for diabetic patients and in weight loss. Importantly, with this ratio, DD01 is clearly also a potent glucagon receptor agonist. Substantial liver fat reduction was observed after only 4 weeks in obese subjects with MASLD (Phase 1). Liver fat reduction by DD01 is clearly not secondary to weight loss at these early timepoints, differentiating it mechanistically from the pure incretin approach. In terms of the balance between efficacy and tolerability, the pharmacokinetics of DD01 are also unique. Good tolerability at clinically active doses is likely aided by very slow absorption (tmax = 6 days) and a long half-life (7-8 days), features which make the onset and rise in DD01 exposure gradual. Peaks associated with poor tolerability and troughs associated with diminished efficacy are avoided. As a result, the need for a lengthy titration period is eliminated and therapeutic levels are reached rapidly. A key differentiator for DD01 is the balanced constellation of clinical benefits afforded by a unique pharmacologic and pharmacodynamic signature. Current data suggest DD01 has the necessary attributes to offer patients and physicians a treatment that is easy to use, supports both liver and metabolic health.

About the DD01-DN-02 Trial

With the support of staff at Summit Clinical Research, the study investigators, and the study participants, the DD01-DN-02 study is fully enrolled and currently ongoing at 12 centers in the U.S. Baseline characteristics were well balanced between both treatment groups with nearly identical mean liver fat fractions (overall mean of 20.7%) and similar body weight (overall mean 99.4 kg) at baseline. Treatment is ongoing and the study includes non-invasive and histologic assessments of MASH resolution and change in fibrosis at 48 weeks. More information about the study is available at www.clinicaltrials.gov under the identifier NCT06410924.

About D&D Pharmatech

D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with a number of metabolic, fibrotic, and neurodegenerative diseases. DD01 and TLY012 are in development for fibrotic liver disease (MASH and cirrhosis). TLY012 has completed IND-enabling studies and has been shown to slow and even reverse established fibrosis in models of liver cirrhosis, chronic pancreatitis, and systemic scleroderma. Two products are in development for neurodegenerative diseases. NLY02 is a small molecule BBB penetrating kinase inhibitor targeting glial activation. It is a potent inhibitor of neurodegeneration. NLY01 is also a potent inhibitor of glial activation. It acts through the incretin pathway to reduce neuronal loss and slow functional decline in models of Parkinson’s, Alzheimer’s, and multiple sclerosis. In a recently completed Phase 2 study conducted in >250 Parkinson’s patients, 36-week of treatment with NLY01 resulted in a significant reduction in motor function decline (UPDRS III) in ~1/3 of trial subjects. NLY01 appeared to slow the progressive decline in motor function in newly diagnosed patients who were young (<60) and treatment naïve.

D&D Pharmatech’s ORALINK technology allows efficient oral uptake of therapeutic peptides. In partnership with Metsera, the company is developing orally active incretin-based peptide drugs for obesity.

Contacts

Neuraly Inc.

Ben Gibson

240-937-5876

bgibson@neuralymed.com

Genentech to Advance Prasinezumab Into Phase III Development for Early-Stage Parkinson’s Disease




Genentech to Advance Prasinezumab Into Phase III Development for Early-Stage Parkinson’s Disease

– Results from Phase IIb PADOVA and longer term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease –

– Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression –

– Parkinson’s disease affects over 10 million people globally and significant unmet need remains –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today its decision to proceed with Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson’s disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLEs) of PADOVA and Phase II PASADENA studies.

“We are encouraged by the efficacy signals observed across the two Phase II trials and their open-label extensions, combined with the favorable safety and tolerability profile of prasinezumab,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We also recognize the substantial need for new treatment options, and the totality of data suggest that prasinezumab may have the potential to become the first disease-modifying treatment for people with Parkinson’s disease.”

Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology.

The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson’s disease, are ongoing.

About prasinezumab

Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease.

Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson’s disease. PADOVA investigated prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance (p=0.0657). In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99], p=0.0431 (nominal). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations.

Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The safety database for prasinezumab consists of data from more than 900 Parkinson’s disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years.

Roche/Genentech entered into a Licensing, Development, and Commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting aggregated alpha-synuclein, such as prasinezumab, for the treatment of Parkinson’s disease.

About Parkinson’s disease

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Today, Parkinson’s disease affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available today, having a significant impact on people’s quality of life; however, no available symptomatic therapies slow down or stop the clinical progression of Parkinson’s disease and the effects wear off over time as the disease progresses.

Genentech and Roche are evaluating multiple approaches to slow down disease progression and potentially prevent Parkinson’s disease that involve targeting underlying disease processes such as aggregated α-syn production, lysosomal dysfunction and neuroinflammation.

About Genentech in Neuroscience

Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Meghan Hindman (650) 467-6800

Advocacy Contact:

Jenee Williams (650) 303-2958

Investor Contacts:

Loren Kalm (650) 225-3217

Bruno Eschli +41 61 687 5284

Prothena’s Partner Roche to Advance Prasinezumab into Phase III Development for Early-Stage Parkinson’s Disease




Prothena’s Partner Roche to Advance Prasinezumab into Phase III Development for Early-Stage Parkinson’s Disease

• Data from Phase IIb PADOVA study and longer term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease
• Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression
• Parkinson’s disease affects over 10 million people globally and significant unmet need remains

DUBLIN–(BUSINESS WIRE)–$PRTA #prothena–Prothena Corporation plc (NASDAQ:PRTA) today announced partner Roche will advance prasinezumab, an investigational anti-alpha-synuclein antibody, into Phase III development in early-stage Parkinson’s disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLE) from both PADOVA and the Phase II PASADENA study.

“As pioneers in developing the first anti-alpha-synuclein targeting antibody, we are excited to see Roche advancing prasinezumab into Phase III development, with the potential to deliver the first disease-modifying treatment option to the millions of individuals living with Parkinson’s disease and their families,” stated Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena.

Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology.

The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson’s disease, are ongoing.

About Prasinezumab

Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease.

Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson’s disease. PADOVA investigated prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance (p=0.0657). In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99], p=0.0431 (nominal). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations.

Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The safety database for prasinezumab consists of data from more than 900 Parkinson’s disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years.

In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit teen royalties on net sales. To date, Prothena has earned $135 million with up to $620 million in additional milestone payments that include regulatory and sales milestones. In addition, Prothena has an option to co-promote prasinezumab in the U.S.

About Parkinson’s disease

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells. Today, Parkinson’s disease affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available. However, no therapies slow down or stop the clinical progression of Parkinson’s disease.

About Prothena

Prothena Corporation plc is a clinical-stage biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design, and proposed mechanism of action prasinezumab; plans for ongoing and future clinical trials of prasinezumab; and amounts we might receive under our collaboration with Roche. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

Contacts

Media

Michael Bachner, Senior Director, Corporate Communications

609-664-7308, michael.bachner@prothena.com

Investors

Mark Johnson, CFA, Vice President, Investor Relations

650-417-1974, mark.johnson@prothena.com