AGC Biologics Strengthens Single-Use Technology Network and Adds 5,000 L Vessels from Thermo Scientific to New Yokohama, Japan Facility




AGC Biologics Strengthens Single-Use Technology Network and Adds 5,000 L Vessels from Thermo Scientific to New Yokohama, Japan Facility

CDMO’s new site introducing the most advanced and large-scale single-use bioreactors in the region

YOKOHAMA, Japan & SEATTLE–(BUSINESS WIRE)–AGC Biologics, your friendly CDMO expert, today announced a strategic decision about the large-scale single-use technology it will use at its new Yokohama, Japan facility. The CDMO is introducing two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.), which makes the site one of the most advanced in Japan for large-scale mammalian-based biologics production, with GMP operations beginning in 2027.

According to 2024 data from BDO Group’s bioTRAK Database, single-use technology represents 51 percent of all mammalian bioreactor technology globally, outpacing the traditional stainless-steel alternative. Attributes driving this trend include fewer cleaning requirements, lower cost barrier to entry and timeline for setup, flexible configurations, scalability to meet changing product demands, and shorter clinical production timelines. AGC Biologics has the second largest global network of single-use manufacturing capacity by volume in the industry, according to bioTRAK. The new bioreactor technology ensures the company stays ahead of industry-wide demand for single-use systems.

“The new Yokohama site is designed to utilize single-use bioreactors to offer large-scale GMP manufacturing. The cutting-edge technology from Thermo Scientific makes this one of the most advanced sites in Japan for large-scale manufacturing and further expands our robust global network of single-use manufacturing sites on three continents,” said Christoph Winterhalter, Chief Business Officer, AGC Biologics. “This location offers the capabilities to meet the commercial needs of customers in Japan and Asia, as well as global customers seeking capacity using the latest technology.”

“Flexibility and the means to scale production cost-effectively is key for any developer of therapies today, and CDMOs need the best technology possible to help them accomplish that. The DynaDrive 5,000 L Single-Use Bioreactor delivers seamless scalability, exceptional flexibility, and superior process intensification capabilities – embodying best-in-class performance. AGC Biologics’ new site in Yokohama will be a premier site in Japan for large-scale single-use technology thanks to our collaboration,” said Daniella Cramp, Senior Vice President and President of Thermo Fisher Scientific’s Bioproduction business.

The new AGC Biologics Yokohama facility will offer support from initial process development work for early-phase projects to late-phase and commercial production. It will support mammalian expression, cell therapy, and messenger RNA (mRNA) drug products.

The Yokohama facility is expected to help maximize operational and supply chain efficiencies across AGC Biologics’ global network by adding another site in the region. The CDMO currently operates one site in Japan, its Chiba facility, offering mammalian expression and microbial fermentation services.

AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company operates over 10 facilities worldwide focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals.

To learn more about AGC Biologics’ global network of services for protein biologics and cell and gene therapies, please visit www.agcbio.com.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

Contacts

Media Contact
Nick McDonald

AGC Biologics

nmcdonald@agcbio.com

AGC Inc. Media Contact
info-pr@agc.com

Quibim Announces New Board of Directors To Promote Growth And Strategic Expansion




Quibim Announces New Board of Directors To Promote Growth And Strategic Expansion

NEW YORK & VALENCIA, Spain & CAMBRIDGE, England–(BUSINESS WIRE)–#AIinHealthcare—Quibim, the global pioneer in imaging biomarkers for precision medicine, is pleased to announce the formation of its new Board of Directors. This strategic move aligns with Quibim’s commitment to innovation and growth in the healthcare sector. It follows the recent FDA 510(k) clearance of its flagship product, QP-Prostate CAD, and the close of a $50M Series A funding round in January. Quibim’s advanced imaging solutions are currently utilized across more than 180 sites worldwide.

The new Board of Directors is composed of six members:

• Dr. Ángel Alberich-Bayarri, CEO & Co-Founder of Quibim
• Tom Tynes, Founder of T2 MedTech (Independent Director)
• Pierre Socha, Partner at Amadeus Capital
• Romain Lavault, General Partner at Partech
• Guillem Masferrer, Partner at Asabys Partners
• José Mesa, Partner at Columbus Venture Partners and Buenavista’s representative on the Board

One of the new appointments to the Board of Directors is Tom Tynes, who joins as an independent director. Tom brings a wealth of experience, having led the formation, profitable growth, and success of several medical device companies over the past 30 years. During his career, Tom has played a pivotal role in developing numerous transformative innovations and technologies in diagnostic imaging and minimally invasive image-guided intervention, resulting in several patented, market-leading solutions that have driven major advances in clinical practice guidelines. While Tom was a pioneer in breast imaging and intervention – most notably through the development of DynaCAD, the industry-leading computer-aided detection (CAD) system for breast MRI – his expertise later expanded to other high-impact clinical areas, including lung and prostate cancer. Tom will play a significant role in advising and guiding Quibim’s expansion into the US market and supporting Quibim’s long-term vision and growth plans.

Tom Tynes commented on his new role: “I am thrilled to join Quibim’s Board of Directors at such a pivotal time. I look forward to leveraging my experience to help drive Quibim’s expansion into the US market and support its innovative approach to transforming patient care.”

The additions of Guillem Masferrer and José Mesa to the Board represent the new investors from Quibim’s recent Series A funding round of $50M which was announced in January this year. Their extensive experience and contacts in life sciences and biotech will be instrumental in driving Quibim’s strategic initiatives. Pierre Socha and Romain Lavault, represent the long-standing investors and bring a wealth of expertise that will continue to guide Quibim’s advancements in the healthcare space.

Dr. Ángel Alberich-Bayarri, CEO of Quibim, stated: “The formation of our new Board of Directors marks a significant milestone for Quibim. With the combined expertise of our new and existing members, we are well-positioned to accelerate our growth and continue our mission of transforming patient data into patient care. These changes are a natural progression following our Series A funding and are aligned with our strategic priorities to enhance our market presence and technological capabilities. We are confident that the new Board will drive Quibim towards achieving its mission to turn imaging into a catalyst for precision health and revolutionize diagnostics and improve patient outcomes.”

About Quibim

Quibim is a company designing pioneering tools that unlock imaging data to improve patient outcomes. With offices in New York (United States), Cambridge (UK), Valencia, Madrid, and Barcelona (Spain), the company was born from the ambition of turning imaging into a catalyst for precision health. Quibim leads the forefront of imaging biomarkers research in life sciences, pioneering the development of advanced algorithms that transform imaging data into actionable predictions in oncology, immunology, and neurology. The company leverages the capabilities of MRI, CT, and PET imaging to create regulatory-cleared Medical Devices that are seamlessly integrated into the workflows of healthcare providers worldwide. More than 180 sites are using Quibim products globally.

Quibim has developed several products, including:

• QP-Prostate® CAD is the company’s flagship product for identifying prostate cancer. Now includes an industry-leading lesion detection capability.
• QP-Brain®, which provides quantification and visualization of imaging findings. This is useful for identifying patterns of brain atrophy and neurodegenerative diseases like Alzheimer’s, multiple sclerosis, and vascular and frontotemporal dementia at earlier stages and makes reporting more effective. US, UK, and EU regulators recently launched and cleared it.
• QP-Insights®, an all-in-one web platform that manages, stores, and quantitatively analyzes medical images and other clinical data, recently launched and already in use by leading bio-pharmaceutical companies and European research consortiums.
• QP-Liver® improves the diagnosis of diffuse liver diseases by accurately quantifying tissue fat and iron from MRI scans.

Quibim has also announced several high-profile partnerships recently, including Merck KGaA, to develop imaging biomarker models to predict responses of cancer patients to immunotherapy and inform decisions in its global drug development efforts. Additionally, Quibim partnered with Philips, a leader in the health technology industry, to launch AI-based imaging and reporting solutions for MR prostate exams.

Contacts

quibim@camarco.com

ZCG-Backed Unimed Acquires Lagaay Medical Group




ZCG-Backed Unimed Acquires Lagaay Medical Group

Strengthens Global Leadership as the Leading Maritime Health and Compliance Solutions Provider

NEW YORK–(BUSINESS WIRE)–Universal Marine Medical Supply International (“Unimed” or the “Company”), the leading global provider of health and compliance solutions to the maritime industry, today announced its acquisition of Lagaay Medical Group (“Lagaay”), a global distributor of pharmaceutical products and medical devices, from B&S Group S.A. (“B&S”). Unimed is backed by affiliates of ZCG Private Equity, the private equity arm of ZCG, a privately held global firm.

Headquartered in the Netherlands, Lagaay has more than 140 years of experience providing high-quality medical supplies and pharmaceuticals for the marine industry. The company currently offers 10,000 medical SKUs across 100 active countries. This strategic acquisition expands Unimed’s presence in Rotterdam – the largest port in Europe – further enhancing Unimed’s ability to serve global clients with comprehensive healthcare and compliance solutions as part of its long-term growth strategy.

“This transaction marks a significant step in strengthening Unimed’s leadership in the maritime medical industry while deepening our partnerships with clients worldwide,” said Søren Andersen, Chief Executive Officer of Unimed. “We have long respected Lagaay’s business and global reach, particularly its strong presence in Rotterdam. We look forward to welcoming their team to Unimed, expanding our technology-driven subscription model to more clients, and continuing to execute on our growth strategy.”

“Joining forces with Unimed is the right next step for Lagaay, we have always perceived Unimed as a logical partner to capture synergies and strengthen the market position of Lagaay in the maritime medical industry,” said Peter van Mierlo, Chief Executive Officer of B&S. “We are proud of all that we have achieved with Lagaay’s management over the past 4,5 years, growing its client base and solutions, and focusing on operational excellence. We wish the team continued success in this next chapter.”

“We are pleased to announce this strategic transaction as Unimed continues to capitalize on both organic and inorganic growth opportunities,” said James Zenni, Founder, President and Chief Executive Officer of ZCG. “With this expansion, Unimed is even more well positioned to lead the maritime industry by delivering the platform of choice to clients globally. We look forward to supporting the combined Unimed and Lagaay leadership and the experienced teams as they integrate two companies.”

The transaction is expected to close in the coming days, subject to the satisfaction of customary closing conditions.

In connection with the acquisition, Unimed will launch a new branding and product suite at the Seatrade Cruise Global conference later this month, marking a new chapter in its evolution as a premier healthcare provider for the maritime sector. Attendees will get a first look at the refreshed identity, reflecting Unimed’s commitment to innovation and excellence.

About Unimed

Unimed is the industry leader in medical supply, equipment and oxygen distribution to global maritime industries, specializing in the delivery of integrated healthcare and compliance solutions to clients worldwide.

Unimed is a portfolio company of ZCG Private Equity, the private equity arm of ZCG (www.zcg.com), a leading privately held global firm comprised of private markets asset management, business consulting services, and technology development and solutions.

For more information, please visit https://universalmarinemedical.com/.

About ZCG

ZCG is a leading, privately held global firm comprised of private markets asset management, business consulting services, and technology development and solutions.

For nearly three decades, ZCG has invested tens of billions of dollars in private equity and credit-related strategies, through multiple economic cycles and across many industries, including consumer products, steel, steel processors, agriculture, consumer food, gaming, hospitality, manufacturing, specialty services, and automotive.

ZCG’s investors include prominent global sovereign wealth funds, endowments, pension funds, insurance companies, foundations, family offices, wealth management firms, and other financial institutions in North America, Europe, Asia, Africa, and the Middle East.

ZCG has a global team comprised of approximately 400 professionals. The company is headquartered in New York, with affiliate offices located in Pune and Mumbai, India, and Riyadh, KSA.

For more information, please visit www.zcg.com.

Contacts

Tim Ragones / Kate Thompson / Madeline Jones

Joele Frank, Wilkinson Brimmer Katcher

212-355-4449

OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma




OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma

• OS Therapies applies for meeting per FDA suggestion received on April 2, 2025
• Based on prior FDA guidance, greater than 200 suitable matched lung metastatic osteosarcoma patient records identified from leading oncology centers in the US, UK and France for inclusion in OST-400, a Retrospective Longitudinal Study of Recurrent Osteosarcoma after Resection in Children and Young Adults

NEW YORK–(BUSINESS WIRE)–OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma. The meeting is expected to occur in the second quarter of 2025, and thereafter the Company intends to initiate a rolling BLA submission with the potential to receive Accelerated Approval as early as year-end 2025. The Company has sufficient cash on hand to operate into mid-2026.

“We are excited to meet with the FDA – and commence market access discussions – the goal of receiving Accelerated Approval for a Biologics License Application of OST-HER2 in the prevention or delay of recurrence lung metastatic osteosarcoma by year-end 2025,” said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. “We believe that we have identified the comparator data necessary to address the comments from FDA regarding our prior BTD request. We expect this data will also be able support our application for Accelerated Approval. Our clinical and regulatory teams are diligently preparing for the meeting and the subsequent BLA submission that is targeted to begin after the public release of additional clinical trial data at MIB Factor in June.”

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $150 million, occurred in February 2025.

“We congratulate the new Acting Director at CBER, Dr. Scott Steele, who comes from a translational medicine background and understands the importance of Comparative Oncology in the development of new cancer immunotherapies and note that President Trump cited deadly rare pediatric cancers as a priority for continued product development for the administration,” said Paul Romness, CEO of OS Therapies. “We believe OST-HER2 will make a significant difference in the treatment of osteosarcoma and welcome the opportunity to engage with FDA to get this investigational treatment to patients as quickly as possible.”

The Company announced positive Phase 2b clinical trial results from its US-based, 21 site, single-arm, open-label clinical study of 39 patients in recurrent, fully resected, lung metastatic osteosarcoma that demonstrated a statistically significant improvement in the proportion of patients that achieved the primary endpoint of 12-month event free survival (EFS) when compared with historical control (33% vs. 20%, p=0.0158), as recommended by FDA prior to the initiation of the study. Due to the aggressive nature of osteosarcoma metastatic to the lung, an aggressive form of rare pediatric bone cancer that requires resections to sequentially remove tumors from the lung given the very poor clinical responses and survival rates to current treatments, placebo-controlled trials are generally disfavored.

Following feedback from FDA, the Company designed OST-400, a Retrospective Longitudinal Study of Recurrent Osteosarcoma after Resection in Children and Young Adults being conducted with clinicians from leading oncology centers in the United States, the United Kingdom and France to obtain potentially over 200 suitable de-identified patient records from which the appropriate matched, external historic control is being developed. At the invitation of FDA on April 2, 2025, the requested meeting is to get agreement with respect to the methods the Company is using to finish collecting OST-400 so that the appropriate matched, external, historic control is used to complete the statistical analysis that will be used to support BTD and Accelerated Approval.

The Company intends to present the data from the Phase 2b clinical trial of OST-HER2 compared with the matched, external, historic control comparator agreed upon with FDA derived from OST-400 at MIB Factor in June 2025. Thereafter, the Company intends to file a BLA for OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma, with the aim of receiving approval by the end of 2025.

OST-HER2, an immunotherapy for osteosarcoma using a HER2 bioengineered form of the bacteria Listeria monocytogenes to trigger a strong immune response against cancer cells expressing HER2, is being featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. A trailer for the movie is available here. The movie will be aired live nationally on PBS and will available via streaming on PBS’ website in early May 2025.

About OS Therapies

OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.

In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

OS Therapies Contact Information:
Jack Doll

410-297-7793

Irpr@ostherapies.com

https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/

Ethris and Lonza Collaborate to Develop Spray-Dried mRNA Vaccines for Respiratory Disease Prevention




Ethris and Lonza Collaborate to Develop Spray-Dried mRNA Vaccines for Respiratory Disease Prevention

• Formulations to be developed at Lonza’s Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US), in accordance with current Good Manufacturing Practice (cGMP) standards
• Collaboration is part of Ethris’ strategy to develop spray-dried mucosal mRNA vaccines that are stable at room temperature and capable of generating a localized immune response, funded by the Coalition for Epidemic Preparedness Innovations (CEPI), including a first candidate against influenza

MUNICH & BASEL, Switzerland–(BUSINESS WIRE)–Ethris, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, and Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), today announced a collaboration to develop room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates, designed for mucosal delivery that offer a promising approach to combat respiratory diseases.

Room-temperature stability aims to address significant supply chain challenges associated with some mRNA vaccines, including the dependence on ultra-low-temperature storage and complex delivery systems. Overcoming these challenges will simplify production, reduce costs, and support rapid, scalable vaccine development. In addition, spray-dried formulations of mRNA-based vaccine candidates aims to enable needle-free nasal administration, potentially achieving mucosal immunity¹.

The initial focus of the collaboration is to develop a first-in-class mRNA vaccine candidate against influenza delivered nasally. This non-invasive approach is designed to provide localized immune responses with an immune effect comparable to intramuscular vaccines and could reduce virus transmission by generating mucosal immunity at the site of virus entry.

Under the terms of the agreement, Lonza will provide spray-drying and particle engineering for vaccine candidates based on Ethris’ stabilized non-immunogenic mRNA (SNIM^® RNA) and stabilized lipid nanoparticles (SNaP LNP) platform at its Bend (US) site, which specializes in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles. Lonza’s development expertise enables access to ideal properties for delivery to the respiratory tract alongside physical stability, while preserving the activity of the mRNA encapsulated within an LNP.

Dr. Carsten Rudolph, Chief Executive Officer, Ethris, commented: “Lonza’s support and leading expertise is an asset and provides unique support as we progress development of our mRNA vaccine technology under the CEPI grant. Together, I believe we are well positioned to create promising non-invasive mucosal vaccine candidates that could potentially transform how respiratory diseases are prevented globally.”

Jan Vertommen, Vice President, Head of Commercial Development, Advanced Synthesis, Lonza, added: “Spray-drying represents a well-established technique that addresses solubility and other manufacturing and stability challenges. However, its application in the field of DNA and RNA-based products represents a highly innovative approach, with another level of complexity introduced by the presence of LNPs. Combining the expertise of Lonza Bend site’s particle engineering team with the innovative SNIM^® RNA of Ethris, there is great potential to target unmet medical needs in the field of non-invasive vaccine delivery.”

Additional Information

To learn more about Lonza’s particle engineering services, visit Lonza | Particle Engineering Services

About Ethris

Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platforms to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimized formulation and nebulization technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives.

For more information, visit www.ethris.com

Disclaimer

Certain matters discussed in this media advisory may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this media advisory.

All trademarks belong to Lonza and are registered in CH, US and/or EU, or belong to their respective third party owners and are used only for informational purposes.

Privacy Policy link

¹ Lavelle EC, Ward RW. Nat Rev Immunol. 2021, 22, 236

Contacts

Ethris Contact Details
Dr. Philipp Schreppel

+49 89 244 153 042

schreppel@ethris.com

Lonza Contact Details
media@lonza.com

ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch




ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced details about its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company’s business operations, U.S. and global regulatory advances of its clinical-stage products, with fireside chats hosted by Dr. Patrick Soon-Shiong and key opinion leaders involved in the company’s research programs.

The discussions will include clinical and regulatory updates on the company’s bladder cancer program, regenerative medicine advanced therapy (RMAT) designations, including results on non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer trials, as well as lymphopenia rescue data related to these trials (Cancer BioShield).

In addition, updates will be provided on the natural killer (NK) cell therapy program, the Lynch syndrome accrual and fireside chats on virally induced cancers, including discussions on Long-COVID.

The key opinion leaders participating in the fireside chats with ImmunityBio leadership include:

• Dr. Christopher Pieczonka – Chief Executive Officer, Associated Medical Professionals of New York & Corporate Director of Clinical Research of US Urology Partners
• Dr. Steven Finkelstein – National Director of Radiation Oncology, US Urology Partners. Director of the Center of Advanced Radiation Excellence (CARE) and Director Radiation Oncology Research
• Dr. Mark Lanasa – Senior Vice President, Chief Medical Officer, Solid Tumors, BeiGene
• Dr. Jennifer Buell – President & Chief Executive Officer, MiNK Therapeutics
• Dr. Krishnansu Tewari – Gynecologic Oncology, Obstetrics & Gynecology at UC Irvine Health
• Dr. David Kerr – Professor of Cancer Medicine Genetics and Genomics, University of Oxford
• Dr. Timothy Heinrich – Professor, School of Medicine UC San Francisco
• Dr. Carlos Cardo-Cardon – Chairman for the Mount Sinai Health System Dept. of Pathology

Key timelines for catalysts of product candidates will be presented, along with a discussion of ongoing clinical trials.

The program will feature a presentation by ImmunityBio Founder, Executive Chairman and Global Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, outlining the fundamental science underpinning the company’s technology platforms. This technology harnesses the immune system to deliver long-term disease protection and prevention.

This limited space event will be held in person in El Segundo, California. Individuals wishing to attend in person must RSVP in advance via email (investorday2025@immunitybio.com). The event will also be live-streamed.

The live stream can be found at:

https://viavid.webcasts.com/starthere.jsp?ei=1713505&tp_key=40dc7065b5

Participant Listening (Listen Only)

1-844-539-3703 or 1-412-652-1273

About ImmunityBio

ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the anticipated date, time, location, subject matter and other information regarding the key opinion leader and investor meeting described herein, anticipated attendees and presenters at the foregoing, ImmunityBio’s potential growth trajectory and business prospects, ImmunityBio’s beliefs regarding the potential for its approach to revolutionize cancer care, ImmunityBio’s manufacturing and production capabilities, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and its and its collaborators’ investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks, uncertainties and potential changes in circumstances that may impact ImmunityBio’s ability to hold the investor day program as described herein and the anticipated presenters’ ability to attend the same, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (viii) potential delays in product availability and regulatory approvals, (ix) the risks and uncertainties associated with third party collaborations and agreements, (x) ImmunityBio’s ability to retain and hire key personnel, (xi) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Contacts

ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

Epsilogen Announces Acquisition of TigaTx, Inc. to Create World’s Leading Pan-Isotype Cancer Antibody Company




Epsilogen Announces Acquisition of TigaTx, Inc. to Create World’s Leading Pan-Isotype Cancer Antibody Company

Highlights

• The acquisition combines IgA antibody assets and expertise of Boston-based TigaTx with Epsilogen’s assets and expertise in IgE to create the world’s leading pan-isotype cancer antibody company
• Allows selection of the most appropriate antibody isotype for a given cancer, applying the unique mechanisms of action for each:
  • IgA activates neutrophils, a potent and highly abundant immune effector cell
  • IgE activates T cells and macrophages to warm up the tumour microenvironment (TME)
• Facilitates combination of different isotype functions into single antibody molecules with enhanced potency and performance
• Combined clinical-stage company benefits from a strong pipeline:
  • MOv18 IgE, an anti-Folate Receptorα IgE antibody, currently in a Phase Ib Proof of Concept trial in platinum-resistant ovarian cancer. Data from a Phase I trial found it to be safe and well tolerated with early signs of clinical activity
  • EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody with IND-enabling studies underway
  • Further IgE and IgA antibodies targeted to other validated cancer antigens
• In addition to IgE, the combined company has three proprietary antibody platforms:
  • IgEG antibodies which combine IgE and IgG functionality into a single antibody molecule
  • Bispecific IgEs and IgEGs which can bind two different antigens simultaneously
  • IgA 3.0, an engineered derivative of wild type IgA with improved manufacturing profile
• US based TigaTx becomes a wholly owned subsidiary of Epsilogen
  • Sonia Gulati of Global BioAccess Fund has joined Epsilogen’s board of directors
  • Financial terms of the transaction have not been released

LONDON & BOSTON–(BUSINESS WIRE)–Epsilogen, the global leader in the development of immunoglobulin E (IgE) antibody therapeutics, today announces that it has completed the acquisition of TigaTx, Inc., a biotechnology company developing engineered immunoglobulin A (IgA) antibodies, to create the world’s leading pan-isotype cancer antibody company.

As a result of the combination of these two privately held companies, US-based TigaTx becomes a wholly owned subsidiary of Epsilogen. Financial terms of the transaction have not been disclosed. Additionally, Dr Sonia Gulati, a Principal at Global BioAccess Fund has joined the Epsilogen Board of Directors.

Commenting on the acquisition, Epsilogen CEO Tim Wilson said: “We are excited to create the world’s leading pan-isotype antibody company with the goal of bringing improved therapeutics to cancer patients. Combining the capabilities of Epsilogen with those of TigaTx gives us the ability to choose the most relevant isotype for a given cancer, whether a cold tumour environment we want to drive multiple immune effector cells into or leverage neutrophils. The transaction also facilitates the combination of different isotype functions into a single antibody molecule. We are looking forward to working with our new colleagues in Boston and creating additional opportunities in our pipeline.”

Sonia Gulati PhD, a Principal at the Global BioAccess Fund said: “We are thrilled about the merger with Epsilogen and believe deeply in the potential of IgA and IgE-based therapies to transform cancer treatment. Together, we are advancing a new frontier in immunotherapy to bring innovative solutions to patients in need.”

Pete Finan, Epsilogen’s Non-Executive Chairman and a General Partner at Epidarex Capital commented: “Nature has evolved five different antibody isotypes to perform specific biologic functions. Following the acquisition, Epsilogen is in a unique position with in-house deep expertise in three of these, IgE, IgA and IgG. We very much look forward to the company turning this potential into innovative new medicines for cancer patients.”

Rationale: Creating the world’s leading pan-isotype cancer antibody company

The primary purpose of this transaction is to create the world’s leading pan-isotype antibody company with the goal of pioneering radically new antibody therapeutics in oncology. The acquisition not only gives Epsilogen the capability of selecting the appropriate antibody isotype for a given cancer, given the differentiated therapeutic mechanisms of each, but also allows it to mix and match IgE, IgA and IgG functionality into a single antibody molecule. Such hybrid antibodies have the potential to activate multiple compartments of the immune system as well as possessing improved PK/PD profiles. This is especially powerful in the light of the importance of the epitope in determining the clinical performance of antibodies.

The human immune system has evolved five main antibody isotypes (IgG, IgM, IgE, IgA and IgD) which it can call upon depending upon the challenge faced. All cancer antibodies and antibody derivatives to date, and virtually all in clinical development, are based on the IgG isotype. IgG utilises the gamma chain constant region whereas antibodies of the IgE and IgA isotypes use the epsilon and alpha chain constant regions respectively; the variable regions of all wild type antibodies are structurally the same.

IgE and IgA antibodies have distinct and potent immunological effector functions predominantly working through myeloid cells and neutrophils respectively. Each of these broad classes can bring about solid tumour destruction in a variety of preclinical models.

The acquisition bolsters Epsilogen’s pipeline by adding EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody, scheduled to enter the clinic in 2026. MOv18 IgE is currently in a Phase Ib trial for treatment of platinum-resistant ovarian cancer (PROC). Phase I trial data previously showed the antibody to be safe and well tolerated with preliminary signs of anti-cancer activity. Epsilogen’s earlier stage pipeline also features a number of other IgE antibody candidates targeting a variety of tumour antigens.

About TigaTx

TigaTx is a biotechnology company developing engineered monomeric IgA neutrophil engagers to unleash the tumour killing power of neutrophils for cancer. The company’s cutting-edge approach in engineered therapeutic IgA is based on pioneering work by Professor Jeanette Leusen conducted at the Utrecht Medical Center (Utrecht, The Netherlands). Based in Boston, MA, TigaTx is developing a pipeline of therapies to treat different cancer types.

About Epsilogen Ltd

Epsilogen is the world’s leading pan-isotype antibody therapeutic company for the treatment of cancer. It has unique and proprietary expertise in the discovery and development of IgE, IgA and IgG-based therapeutics with each isotype possessing differentiated immune effector function. IgE has significant activity against various tumour types by activating myeloid cells and T cells thereby warming up the tumour micro-environment (TME). IgA’s anti-cancer potential is mediated by the activation of neutrophils, highly abundant effector cells which drive innate and adaptive immunity. The distinct activity profiles of each isotype allow Epsilogen to select the most appropriate isotype for a given cancer. The company has also combined different isotypes into a single antibody molecule with enhanced functionality.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial found it to be safe and well tolerated with early signs of clinical activity. Epsilogen has initiated a Phase Ib trial in platinum-resistant ovarian cancer patients. Find out more at Epsilogen.com.

Contacts

For more information please contact:

Communications advisor to Epsilogen Ltd:

Simon Conway/Tim Stamper/Amy Byrne

FTI Consulting

epsilogen@fticonsulting.com
+44 (0)20 3727 1000

MaaT Pharma Announces Initiation of Coverage of its Stock by H.C. Wainwright & Co




MaaT Pharma Announces Initiation of Coverage of its Stock by H.C. Wainwright & Co

LYON, France–(BUSINESS WIRE)–$MAAT #Analysts–Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announces the initiation of coverage of its stock by H.C. Wainwright & Co.

With a research report named “In With the Gut and Out With the Bad in GvHD; Initiating at Buy With a €21 PT”, H.C. Wainwright & Co initiated coverage of MaaT Pharma on April 4th, 2025 with a Buy recommendation and a Target Price of €21.

H.C. Wainwright & Co, a leading full-service U.S. investment bank, provides corporate finance, strategic advisory, and related services to public and private companies across a wide range of sectors and geographies. Their initiation of coverage underscores the strong global potential of MaaT Pharma and its therapies and marks an important step toward expanding its presence in the U.S. market.

This new coverage complements the continued support from existing European brokerage partners—Gilbert Dupont / Groupe Société Générale, Kepler Cheuvreux, KBC Securities, Kempen, and Portzamparc / Groupe BNP Paribas—further reinforcing the growing interest in MaaT Pharma across both sides of the Atlantic.

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Contacts

MaaT Pharma – Investor Relations
Guilhaume DEBROAS, Ph.D.

Head of Investor Relations

+33 6 16 48 92 50

invest@maat-pharma.com

Rx Communications Group – U.S. Investor Relations
Michael Miller

Managing Director

+1-917-633-6086

mmiller@rxir.com

MaaT Pharma – Media Relations
Pauline RICHAUD

Senior PR & Corporate Communications Manager

+33 6 14 06 45 92

media@maat-pharma.com

Catalytic Agency – U.S. Media Relations
Heather Shea

Media relations for MaaT Pharma

+1 617-286-2013

heather.shea@catalyticagency.com

Oasis Files Shareholder Derivative Lawsuit Against Kobayashi Pharmaceutical Directors




Oasis Files Shareholder Derivative Lawsuit Against Kobayashi Pharmaceutical Directors

(Securities Code: 4967 JT)

*On April 3, 2025, Oasis filed a shareholder derivative lawsuit with the Osaka District Court against the Directors of Kobayashi Pharmaceutical

*The lawsuit is related to the Directors’ handling of the Beni Koji red-yeast scandal and is part of Oasis’s continued efforts to improve corporate governance at Kobayashi Pharmaceutical

More information available at www.KobayashiCorpGov.com

HONG KONG–(BUSINESS WIRE)–Oasis Management Company Ltd. (“Oasis”) is the manager to funds that beneficially own over 10.1% of Japanese pharmaceuticals and food products manufacturer Kobayashi Pharmaceutical Co., Ltd. (4967 JT) (“Kobayashi Pharma” or the “Company”).

As Kobayashi Pharma’s second largest shareholder and the largest institutional shareholder, Oasis has accelerated its effort to rebuild the Company’s governance to secure appropriate reparations for the victims of the Beni Koji scandal, ensure improved product safety going forward, and ensure accountability by directors. As part of the effort, Oasis requested an Extraordinary General Meeting (“EGM”), submitted proposals for that EGM, and also submitted an advisory resolution at the Company’s 2025 Annual General Meeting (“AGM”), all with the aim to improve Kobayashi Pharma’s corporate governance and launch a truly independent third-party investigation to determine the cause of the Beni Koji scandal and ensure such an event never happens again.

Pursuant to our continued efforts to improve Kobayashi Pharma, in November 2024, Oasis submitted a request to Kobayashi Pharma’s auditors to initiate the filing of an action to hold the Company’s Directors accountable for their failures. The Company’s auditors declined to take any action. As a result, on January 28, 2025, Oasis announced that it was preparing to file a shareholder derivative lawsuit against the Directors, and on April 3, 2025, Oasis formally filed that shareholder derivative lawsuit. Filed in the Osaka District Court on behalf of the Company, the lawsuit is against the Kobayashi Pharma Directors and intends to recover approximately JPY 13.5 billion in damages for the Company and its shareholders.

Directors named as defendants:

• Director of the Company (at the relevant time), Mr. Satoshi Yamane
• Representative Director of the Company (at the relevant time), Mr. Akihiro Kobayashi
• Representative Director of the Company (at the relevant time), Mr. Kazumasa Kobayashi
• Outside Director of the Company (at the relevant time), Mr. Kunio Ito
• Outside Director of the Company (at the relevant time), Ms. Kaori Sasaki
• Outside Director of the Company (at the relevant time), Ms. Chiaki Ariizumi
• Outside Director of the Company, Mr. Yoshiro Katae

From the results of the AGM, it is apparent that the founding family continues to have enormous influence over the Company. It is clear that the founding family remains a hurdle to installing effective corporate governance. Oasis will continue our important efforts to improve Kobayashi Pharma’s corporate governance.

***

Oasis Management Company Ltd. manages private investment funds focused on opportunities in a wide array of asset classes across countries and sectors. Oasis was founded in 2002 by Seth H. Fischer, who leads the firm as its Chief Investment Officer. More information about Oasis is available at https://oasiscm.com. Oasis has adopted the Japan FSA’s “Principles of Responsible Institutional Investors” (a/k/a the Japan Stewardship Code) and, in line with those principles, Oasis monitors and engages with our investee companies.

The information and opinion contained in this press release (referred to as the “Document”) is provided by Oasis Management Company (“Oasis”) for informational purposes only or for reference purposes only. The Document is not intended to solicit or seek shareholders to, jointly with Oasis, acquire or transfer, or exercise any voting rights or other shareholder’s rights with respect to any shares or other securities of a specific company which are subject to the disclosure requirements under the large shareholding disclosure rules under the Financial Instrument and Exchange Act. Shareholders that have an agreement to jointly exercise their voting rights are regarded as Joint Holders under the Japanese large shareholding disclosure rules and they must file notification of their aggregate shareholding with the relevant Japanese authority for public disclosure under the Financial Instruments and Exchange Act. Except for the case where Oasis expressly enters into the agreement as a joint holder requiring such disclosure, Oasis does not intend to take any action triggering reporting obligations as a Joint Holder. The Document exclusively represents the opinions, interpretations, and estimates of Oasis.

Contacts

Media Contact
For all inquiries, please contact:

Taylor Hall

media@oasiscm.com

QIAGEN Delivers Strong Preliminary Q1 2025 Results Exceeding Outlook and Raises Full-Year 2025 Adjusted EPS Outlook




QIAGEN Delivers Strong Preliminary Q1 2025 Results Exceeding Outlook and Raises Full-Year 2025 Adjusted EPS Outlook

• Q1 2025 preliminary net sales rise 7% CER and adjusted diluted EPS results of at least $0.55 CER both above outlook despite challenging macro environment

• Full-year 2025 adjusted diluted EPS outlook raised to about $2.35 CER (prior outlook about $2.28 CER)

• On track to exceed 31% CER adjusted operating income margin ahead of 2028 mid-term target

VENLO, Netherlands–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced preliminary Q1 2025 results that exceeded its outlook for both net sales and adjusted earnings per share (EPS), reflecting strong performances across many growth drivers.

Net sales grew approximately 5% (+7% at constant exchange rates, CER) to about $483 million in Q1 2025, surpassing the previously communicated outlook for about 3% CER growth (4% CER core business excluding discontinued products such as NeuMoDx and Dialunox). Adjusted diluted EPS are expected to be at least $0.55 CER compared to the previously communicated outlook for about $0.50 CER.

Sales of the QuantiFERON latent TB test grew about 15% CER as global adoption continues to shift from the skin test to this proven, modern blood-based test. The QIAstat-Dx syndromic testing system advanced above 35% CER on continued demand for respiratory panels along with growth in gastrointestinal and meningitis testing. The QIAcuity digital PCR system and QIAGEN Digital Insights bioinformatics business both delivered high-single-digit CER gains, reflecting solid adoption across research and clinical applications. Additional growth contributions also came from higher sales of PCR consumables and from OEM products. Sample technologies sales declined 1% CER, reflecting the cautious instrument spending environment among some Life Sciences customers.

Given the positive start to 2025, QIAGEN is raising its adjusted diluted EPS outlook for full-year 2025 in light of the strong sales growth in Q1 and the overall current business trends, which includes expected headwinds from the recently announced U.S. import tariffs and a better-than-expected tax environment.

Full-year 2025, adjusted diluted EPS are now expected to be about $2.35 CER, up from the prior full-year outlook for about $2.28 CER, while reaffirming the goal to improve the adjusted operating income margin to above 30% for the year.

QIAGEN will provide additional perspectives on the outlook for full-year 2025 with the publication of full Q1 2025 results on May 7, 2025.

Additionally, QIAGEN now expects to reach the mid-term adjusted operating income margin goal of at least 31% well ahead of the original 2028 timeline, reflecting the stronger-than-anticipated improvements delivered during 2024 and 2025.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s financial and operational outlook, including its expected Q1 25 and full year net sales, adjusted diluted EPS and adjusted operating income margin, products, development timelines, marketing and / or regulatory approvals, growth strategies, collaborations and operating results are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, tariffs, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN’s products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other “force majeure” events. There is also no guarantee that anticipated financial and operational results will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN

Category: Corporate

Contacts

Contacts QIAGEN:
Investor Relations
John Gilardi, +49 2103 29 11711

Domenica Martorana, +49 2103 29 11244

e-mail: ir@QIAGEN.com

Public Relations
Thomas Theuringer, +49 2103 29 11826

e-mail: pr@QIAGEN.com