GUERBET : 2025 full-year results.




GUERBET : 2025 full-year results.

2025 full-year results

• Revenue: €786.4 million, down 3.5% at CER¹ and like-for-like², mainly due to the fall in activity in France
• Profitability: restated EBITDA margin³ of 12.0% (at the high end of the adjusted range communicated in December)
• Net Income: loss of €112.7 million, which includes a non-recurring impairment of €86 million
• Free cash flow: in positive territory at €19.2 million
• Indebtedness: net debt/EBITDA ratio of 4.0x, below the ceiling of 4.8x set in December 2025 under the waiver obtained by the Group from its lenders.

2026

• Significant negative impact expected from the situation in Raleigh on revenue, profitability, cash generation and group indebtedness with a probable risk of covenant breach on June 30, 2026
• No dividend distribution in respect of the 2025 fiscal year
• Continuation of the transformation plan and strategic focus on sustainably improving the Group’s sales momentum and competitiveness

Villepinte, March 11, 2026, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its consolidated financial statements for fiscal 2025.

Full-year revenue came to €786.4 million, down 6.5%. After excluding the currency effect (-€22.8 million), mainly due to the depreciation of the US dollar, the Brazilian real and the South Korean won, this decline narrows to 3.8% at constant exchange rates (CER)¹. At CER and on a like-for-like basis², Guerbet’s revenue fell by 3.5% in 2025.

This decline is mainly due to two factors: the contraction in activity in France, without which sales would have been stable in 2025, and the loss of revenue in the fourth quarter linked to the situation at the Raleigh site (North Carolina).

In EMEA, full-year sales were down 2.5% at CER and on a like-for-like basis. However, after stripping out France, the region posted growth of 7.6% for the year. In France, the completion of the adaptation of manufacturing processes in line with the switch in the mix to comply with supply chain reform (from single dose to large vials) led to a return to growth in the fourth quarter of 2025.

In the Americas, full-year revenue was down 3.8% at CER and like-for-like. This decline, concentrated in the fourth quarter of 2025, was due to the delay in the release of batches produced at the Raleigh site because of the work being carried out under the compliance plan following the recommendations of the Food and Drug Administration (FDA).

In Asia, revenue for the year was down 4.8% at CER and like-for-like, due in particular to the loss of a major call for tenders in Vietnam.

By business, full-year revenue in Diagnostic Imaging was down 5.3% at CER and like-for-like, due to:

• In the IRM division (-1.9%), an increase in the Dotarem^® / Elucirem^TM franchise over the first nine months, followed by a decrease in the fourth quarter linked to the situation at the Raleigh site.
• In the X-ray division (-7.2%), the decrease in volumes for Xenetix^® and Optiray^®, mainly in France.

In Interventional Radiology, revenue rose by 9.7% at CER and like-for-like in 2025, still driven by solid momentum in volumes and prices for Lipiodol^®, particularly in vascular embolization.

Net income includes a significant non-recurring impairment, with no impact on cash

In 2025, the Group generated an EBITDA margin rate representing 10.5% of revenue. Excluding non-recurring costs related to the optimization of the operating plan and the change in the sales model which totaled -€12.2 million (vs. -€6.0 million in 2024), the restated margin rate was 12.0%, at the high end of the adjusted range communicated on December 2 (between 10.5% and 12%), compared with 14.9% in 2024.

The fall in profitability is due to the decline in activity and pressure on prices, particularly in the United States where margins were penalized by the unfavorable increase in the weight of distributors in the customer mix. At the same time, the Group maintained good cost discipline, with a decrease in personnel expenses (-7.2%) and external expenses (-6.5%).

The Group made an operating loss for the year of -€88.2 million, after the recognition of €170.4 million in depreciation, amortization and provisions. This includes in particular a non-recurring impairment of €86 million recorded in relation to the current situation at the Raleigh site following the impairment tests carried out during the year, as well as a provision of €10 million relating to the future destruction of certain inventories at the Raleigh site. These two accounting items have no impact on the Group’s cash generation.

After taking into account lower financial expenses (-12.8%) of €19.4 million, and foreign exchange losses (€2.0 million) and tax (€3.1 million), the Group made a net loss of -€112.7 million, compared with a profit of €13.5 million in 2024. On the balance sheet, shareholders’ equity stood at €267 million at December 31, 2025, compared with €394 million a year earlier.

Free cash flow and Indebtedness

Free cash flow (FCF) was positive for the year at €19.2 million (versus -€9.1 million in 2024), driven by a significant improvement in working capital requirements (WCR), thanks in particular to the optimization of the average days sales outstanding (DSO).

Net debt came to €325.7 million (vs. €344.9 million in 2024), i.e. financial leverage⁴ (net debt/EBITDA) of 4.0x (compared with 2.9x in 2024), below the ceiling of 4.8x set in December 2025 under the waiver obtained by the Group for its covenant from its lenders.

In order to support Guerbet Group’s long-term development, the Board of Directors will propose at the General Shareholders’ Meeting of May 22, 2026 that no dividends be distributed to shareholders in respect of the 2025 fiscal year.

Update on the Raleigh site and significant negative impact expected in 2026 on revenue, profitability, cash generation and group indebtedness

At the Raleigh industrial site, the remediation plan initiated in the fourth quarter of 2025 is continuing with a new management team in place and the support of external experts. The corrective actions undertaken, including the modernization of equipment and processes, aim to respond as quickly as possible to the FDA’s requests, and thus allow a return to a normative release rate for batches produced at the plant. The batch release rate has increased compared to the fourth quarter of 2025 and will continue to increase throughout the 2026 fiscal year.

The Raleigh site plans to be ready for a new FDA inspection by the end of fiscal 2026.

It expects to return to a normative release rate by the end of 2026, allowing Guerbet to operate under normal conditions in full-year 2027.

The Group anticipates a significant negative financial impact in 2026 from the situation in Raleigh:

• On activity mainly in North America and Latin America;
• On profitability, due to expenses related to the compliance plan, the increase in unit costs caused by a lower level of production, and inventory destruction costs;
• On cash generation, with free cash flow expected to be negative for the year and net debt expected to increase.

Guerbet draws attention to the probable risk of non-compliance with the net financial debt to EBITDA ratio of x3.5 tested on June 30, 2026 under the terms of the €350 million syndicated credit agreement and the €50 million EuroPP bond issue agreement and €50 million Relance bond issue agreement. If this non-compliance materializes, it would give lenders the right, subject to certain majorities being reached, to declare their debt due and payable in advance from the second half of 2026.

The Board of Directors has approved the Group’s consolidated financial statements today in accordance with the going concern principle. The audit procedures on the consolidated financial statements have been carried out and the auditors’ report, which will mention a significant uncertainty related to the going concern assumption due to the probable risk of non-compliance with the debt ratio mentioned above, is currently being issued.

The going concern assumption is therefore based on the assumption that a waiver will be obtained from the lenders. If this assumption is not met, the going concern assumption used for the financial statements as of December 31, 2025 may not be appropriate.

Guerbet is confident in its ability to find a satisfactory solution within a timeframe that is compatible with its contractual commitments.

Pursuing its transformation plan and strategic priorities

Guerbet’s teams remain fully committed to implementing the transformation plan launched in autumn 2025, aimed at strengthening sales momentum and restoring long-term profitability. This plan is based on three strategic priorities:

• Strengthen operational efficiency in Diagnostic Imaging by improving the competitiveness of the X-ray activity – in particular by streamlining the reference portfolio, promoting multi-dose (large) vials and optimizing industrial processes – while continuing to gain market share in MRI thanks to the Dotarem®/Elucirem™ franchise, with a ramp-up for the latter through geographical expansion and new indications.
• Support the strong momentum in Interventional Radiology (average full-year growth of +16.1% since 2012) by capitalizing on the positioning of Lipiodol® as the reference treatment for HCC (liver cancer), the growth in its use for vascular embolization, and the potential of Lipiojoint in the management of osteoarthritis.
• Improve productivity and cash generation by focusing on the twin aims of reducing fixed costs by implementing a plan to completely overhaul the support functions across the Group’s entire geographical scope, improving commercial and industrial efficiency and strengthening the financial structure through cash generation, based on rigorous management of working capital requirements (control of payment deadlines, optimization of inventories) and strict control of purchases. The full effect of this transformation plan is expected to be visible in fiscal 2027. The implementation of these measures in the French scope will be subject to consultation with the employee representative bodies for projects falling within their remit.

In this environment, the Group will communicate its 2026 targets at the latest when it presents its first-half revenue on July 23, 2026.

Next event:

Q1 2026 revenue
April 23, 2026 after market close

Glossary

Net debt: Net financial debt is defined as the sum of current and non-current borrowings less cash and cash equivalents and marketable securities.

EBITDA: EBITDA is defined as operating income plus net depreciation, amortization, impairment and provisions for risks.

Restated EBITDA: Restated EBITDA is defined as EBITDA minus non-recurring expenses related to reorganizations of the operational model.   

Free cash flow (FCF): Free cash flow is defined as the change in net debt from one year to the next.

Like-for-like basis: Like-for-like basis refers to the scope excluding the urology and Accurate businesses, sold in July 2024 and January 2025 respectively.

At constant exchange rates: At constant exchange rates means the impact of exchange rates is eliminated by recalculating sales for the period based on the exchange rates used for the previous year.

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 100 years, with 2,746 employees worldwide, we continuously innovate and devote 10% of our revenue to Research and Development in four centers in France and the United States. Guerbet (GBT) is listed in Compartment B of Euronext Paris and generated revenue of €786 million in 2025. For more information, please visit www.guerbet.com.

Forward-looking statements

Certain information contained in this press release is not historical data but constitutes forward-looking statements.

These forward-looking statements are based on estimates, forecasts and assumptions including, without limitation, assumptions regarding the Group’s current and future strategy and the economic environment in which the Group
operates. They involve known and unknown risks, uncertainties and other factors, which may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly in these forward-looking statements.

These forward-looking statements are only valid as of the date of this press release and the Group expressly disclaims any obligation or commitment to issue an update or revision of the forward-looking statements contained in this press release to reflect changes in the assumptions, events, conditions or circumstances on which such forward-looking statements are based. Forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and generally beyond the control of the Group.

These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing analyses, decisions by regulatory authorities, such as the Food and Drug Administration or the European Medicines Agency, whether or not to approve, and when, the application for a drug, process or biological product for one of these candidate products, as well as their labeling decisions and other factors that may affect the availability or commercial potential of these candidate products. A detailed description of the risks and uncertainties related to the Group’s activities can be found in chapter 4.8 “Risk factors” of the Group’s Universal Registration Document registered by the AMF under number D.25-0220 on April 3, 2025, available on the Group’s website (www.guerbet.com).

¹ At constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous fiscal year.

² Excluding the urology and Accurate activities (including sales in 2025 of inventories of components and finished products), which were sold in July 2024 and January 2025 respectively.
³ Excluding non-recurring costs related to the optimization of the operational framework and changes to the sales model.
⁴    This covenant applies to the bank debt and bonds negotiated in 2023.

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• 260311 CP GBT RA_Final_EN

Io Therapeutics, Inc. announces publication of studies on the company’s RXR agonist compound IRX4204 for breast cancer prevention




Io Therapeutics, Inc. announces publication of studies on the company’s RXR agonist compound IRX4204 for breast cancer prevention

SPRING, Texas, March 11, 2026 (GLOBE NEWSWIRE) — Io Therapeutics, Inc. in Spring, Texas, announces collaborative publication of data from preclinical studies with scientists at The University of Texas MD Anderson Cancer Center demonstrating effectiveness of the retinoid X receptor (RXR) agonist compound IRX4204 in models of prevention of estrogen receptor-negative and triple-negative breast cancers in three different genetically predisposed mouse models.

The research report titled: “Targeting the RXR Pathway for the Prevention of Triple-Negative Breast Cancer”, was led by MD Anderson researchers Cassandra L. Moyer, Ph.D., former postdoctoral fellow; Abhijit Mazumdar, Ph.D., associate professor of Clinical Cancer Prevention; and Powel H. Brown, M.D., Ph.D., professor Clinical Cancer Prevention. The study was published in the March 1, 2026, issue of Cancer Prevention Research.

The studies demonstrate that RXR agonism mediated by IRX4204 significantly delays the formation of mammary tumors in three estrogen receptor-negative mouse models: MMTV-ErbB2, C3(1)SV40-Tag, and Brca1-deficient, with minimal toxicities. In some cases, IRX4204 completely prevented mammary tumor formation. Biomarker analysis revealed that delayed tumors arising after IRX4204 treatment had decreased Ki-67 expression (a marker of how rapidly cancer cells are dividing) and increased immune infiltration of cytotoxic T cells. This supports that IRX4204 has direct inhibitory effects on breast cancer cell growth and promotes cancer cell killing by immune cells. Both mechanisms may be critical for IRX4204 prevention of triple-negative breast cancer. This preclinical data supports the further evaluation of use of IRX4204 for the prevention of estrogen receptor-negative and triple-negative breast cancers.

Dr. Mazumdar stated: “While prophylactic treatment with selective estrogen receptor (ER) modulators and aromatase inhibitors targeting the nuclear ER can prevent the formation of ER-positive tumors in women at high risk of breast cancer, these agents do not prevent ER-negative and triple-negative breast cancers. A substantial unmet need remains to prevent formation of ER-negative and triple negative breast cancers, which are often highly aggressive and associated with poorer survival. This study opens the door to the future research to evaluate the possibility of using RXR agonists, like IRX4204, to prevent these cancers.”

Martin E. Sanders, M.D., Chief Executive Officer of Io Therapeutics stated “IRX4204 is a clinical stage compound which was invented by Vidyasagar, Ph.D., Chief Science Officer at Io Therapeutics. IRX4204 more potently and more selectively activates RXR than earlier generation RXR agonists. It has demonstrated an excellent safety profile in clinical trials in over 100 patients. IRX4204 has a safety profile that should allow it to be suitable as an agent for chronic treatment to effect prevention of triple negative breast cancers. This outcome would provide major benefit to millions of women now and in the future, who are at risk over the course of their lifetimes for the development of aggressive, poorly treatable estrogen receptor-negative or triple-negative breast cancers.”

About Io Therapeutics: Io Therapeutics, Inc. is a privately held company headquartered in Spring, Texas. More information on Io Therapeutics and its product development programs is available on the company’s web site: www.io-therapeutics.com

Forward Looking Statements: This new release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995.

Contact: info@io-therapeutics.com

Philips expands digital pathology portfolio with cloud-enabled Philips IntelliSite Pathology Solution on HealthSuite




Philips expands digital pathology portfolio with cloud-enabled Philips IntelliSite Pathology Solution on HealthSuite

March 11, 2026

Fully cloud‑enabled solution designed to help healthcare organizations scale digital pathology adoption and workflows

Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the expansion of its digital pathology portfolio with new cloud-enabled capabilities designed to help healthcare organizations scale digital diagnostics, improve productivity, and advance their transformation to fully digital workflows.

Philips IntelliSite Pathology Solution on HealthSuite¹, powered by Amazon Web Services (AWS) is a fully cloud-enabled digital pathology solution that helps pathology laboratories adopt and scale digital workflows without the complexity of on-premise infrastructure. The platform helps to securely store, manage, and enable analysis of large volumes of high-resolution pathology images while allowing pathologists to access, review, and collaborate on cases from virtually anywhere.² By simplifying IT management and operations and supporting scalable data management and collaboration, the solution helps laboratories improve workflow efficiency and advance routine clinical use of digital pathology.

The cloud-enabled offering combines Philips’ leadership in digital pathology with AWS’ leading healthcare cloud infrastructure. In January 2026, Frost & Sullivan recognized Philips with the 2025 Global Enabling Technology Leadership Award in Digital Pathology, while AWS was named 2026 Best in KLAS for Public Cloud Infrastructure.

Advancing digital pathology toward routine clinical practice
Healthcare organizations are under growing pressure to manage rising image volumes, address workforce shortages, and prepare for AI-enabled diagnostics. According to the Signify Research Digital Pathology – World 2025 report, many pathology departments have yet to adopt digital pathology for routine clinical diagnosis and continue to operate hybrid environments where microscopes remain central to primary diagnosis.

Fully digital workflows can improve efficiency, enable collaboration and case review, enhance diagnostic consistency, and create structured data foundations that support quality improvement and scalable AI interoperability³. Philips’ cloud‑enabled digital pathology offering supports secure, remote access to images, simplifies data management at scale², while supporting enterprise integration⁴ and AI‑enabled applications across health systems.

“As early adopters of digital pathology, we have already experienced the operational and clinical value of working in a fully digital environment,” said Dr. Cordon-Cardo, Chair of the Department of Pathology, Molecular and Cell-Based Medicine at Mount Sinai Health System. “As our program matures, the ability to scale efficiently across sites and manage the growing volume of pathology data becomes increasingly important. A cloud‑enabled deployment reduces reliance on on‑premise infrastructure while providing the flexibility, performance, and scalability required for enterprise collaboration and AI integration. This represents an important next step in advancing our digital pathology strategy.”

A proven foundation for digital pathology
Philips’ digital pathology portfolio includes FDA‑cleared whole‑slide scanners, an image management system, archive services, and implementation and support services that help laboratories transition from analog to digital pathology workflows. With thousands of digital pathology users worldwide and a growing number of clinical sites going fully digital, Philips has built one of the largest installed bases.

“By combining scalable cloud innovation with deep domain expertise and end-to-end services, we partner with our customers throughout their transformation journey – from the first digital slide to fully connected ecosystems that help turn data into actionable insight for precision care,” said Martijn Hartjes, Business Leader Clinical Informatics at Philips. “Successful digital pathology adoption is not about technology alone, it’s about reimagining how care teams access clinical data and collaborate across a health system.”

Expanding the Philips HealthSuite Integrated Diagnostics portfolio
Philips IntelliSite Pathology on HealthSuite is the newest addition to the Philips HealthSuite Integrated Diagnostics portfolio – a rich suite of cloud-based diagnostic solutions, powered by AWS, and designed to connect data, integrate workflows, and embed AI across the diagnostic enterprise.⁴

The portfolio brings together Philips’ latest cloud innovations, architected to operate independently or connect across diagnostic domains.² Other key solutions include Image Management on HealthSuite featuring Web Diagnostic Viewer, Cardiovascular Workspace on HealthSuite, and advanced visualization and AI management capabilities. Together, these solutions help health systems enable data interoperability ⁴, across radiology, cardiology, and pathology, streamline diagnostic workflows, and support more coordinated, data-driven care.

Philips will showcase its expanded digital pathology portfolio at HIMSS 2026 (Las Vegas, March 9–12) and at USCAP 2026 (San Antonio, March 21–26).

¹ PIPS on HealthSuite is work in progress and not available in the USA or any other jurisdiction. Future availability cannot be ensured.
² Third party claims from AWS, which may not apply in all markets and may be updated from time to time. The functionalities and benefits of the solution depend on customer-specific configuration and use. Please contact your local Philips representative for (market) availability.
³ AI interoperability with PIPS on HealthSuite is a work in progress, is not available in the United States or any other jurisdiction, and will initially be available only with Ibex AI. Future availability cannot be guaranteed. Ibex AI and the contextual launch of Ibex AI within PIPS are Research Use Only (RUO) in the United States.
⁴ Not intended for diagnostic, monitoring or therapeutic purposes or in any other manner for regular medical practice.

For further information, please contact:

Anna Hogrebe
Philips Global External Relations
Tel.: +1 416 270 6757
E-mail: anna.hogrebe@philips.com  

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2025 sales of EUR 18 billion and employs approximately 64,800 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachment

• Clinician reviewing digital pathology slide

KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize




KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize

Collaboration brings non-viral, site-specific DNA insertion to crop trait development, intended to accelerate the path to more resilient and sustainable agriculture

CAMBRIDGE, Mass., March 11, 2026 (GLOBE NEWSWIRE) — KOMO Biosciences, a developer of non-viral targeted insertion technologies, today announced that it has granted Syngenta, a world leader in agricultural innovation, a Research Evaluation License to assess aspects of KOMO’s proprietary KOMbine™ platform that is designed for precision genome modification in Zea mays (maize).

Under the agreement, Syngenta will evaluate KOMO’s non-viral, integrase-based genome engineering technology for research applications focused on the controlled and predictable introduction of genetic programs into maize genomes. The evaluation will support early-stage studies exploring how precise genomic integration can enable more advanced crop trait development.

KOMO’s platform addresses a core limitation of existing genetic engineering approaches: the inability to reliably and efficiently introduce large or complex genetic payloads into defined genomic locations without relying on viral delivery or nuclease-induced DNA breaks. This challenge is well recognized in therapeutic development and is increasingly important in agriculture as modern traits require coordinated expression of multiple genes with long-term stability.

Maize remains one of the world’s most critical crops, yet improving traits such as stress tolerance, yield stability, and resource efficiency increasingly depend on precise genomic control rather than single-gene edits. KOMO’s integrase-based approach is designed to enable site-specific, programmable genome modification, supporting predictable expression and durable performance across generations.

“This evaluation reflects a broader shift in how genome engineering is evolving,” said Jennifer Manning, Founder and CEO of KOMO Biosciences. “As biological systems become more complex, the question is no longer just whether a gene can be edited, but whether genetic programs can be reliably installed and controlled. KOMO was built to enable that next layer of genome engineering, and we’re excited to see this capability explored in maize and other agricultural systems.”

“At Syngenta, we’re energized by our collaboration with KOMO Biosciences. By combining our deep expertise in plant genetics and trait introgression with KOMO’s cutting-edge technology, we can accelerate our commitment to bring more precise solutions to farmers around the world.” stated Trevor Hohls, Global Head of R&D, Syngenta Seeds.

About KOMO Biosciences
KOMO Biosciences is a next‑generation precision genome engineering company developing non-viral, large serine integrase-based platforms for precise and scalable genome modification. Its technologies, including its KOMbine™ and KOMbineX™ platforms, are designed to enable the controlled insertion of large genetic payloads into defined genomic loci, supporting applications across therapeutics, biomanufacturing, agriculture, and synthetic biology. KOMO’s platforms are designed to overcome key limitations of existing gene editing approaches, including constraints on payload size, predictability, and durability.

Learn more at www.komobiosciences.com.

About Syngenta
Syngenta is a global leader in agricultural innovation with a presence in more than 90 countries. Syngenta is focused on developing technologies and farming practices that empower farmers, so they can make the transformation required to feed the world’s population while preserving our planet. Its bold scientific discoveries deliver better benefits for farmers and society on a bigger scale than ever before. Guided by its Sustainability Priorities, Syngenta is developing new technologies and solutions that support farmers to grow healthier plants in healthier soil with a higher yield. Syngenta Crop Protection is headquartered in Basel, Switzerland; Syngenta Seeds is headquartered in the United States. Read our stories and follow us on LinkedIn, Instagram & X.

Media Contacts
KOMO Biosciences
Keith Bowermaster, APR, CCMP
keith.bowermaster@genesisbiocapital.com

Syngenta Media Relations
media@syngentagroup.com

This press release contains forward-looking statements regarding potential applications of KOMO’s technologies and the anticipated benefits of the collaboration. Actual results may differ materially from those expressed or implied due to a variety of factors, including scientific, regulatory, and commercial uncertainties.

KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize




KOMO Biosciences Grants Research Evaluation License to Syngenta to Explore Precision Genome Modification in Maize

Collaboration brings non-viral, site-specific DNA insertion to crop trait development, intended to accelerate the path to more resilient and sustainable agriculture

CAMBRIDGE, Mass., March 11, 2026 (GLOBE NEWSWIRE) — KOMO Biosciences, a developer of non-viral targeted insertion technologies, today announced that it has granted Syngenta, a world leader in agricultural innovation, a Research Evaluation License to assess aspects of KOMO’s proprietary KOMbine™ platform that is designed for precision genome modification in Zea mays (maize).

Under the agreement, Syngenta will evaluate KOMO’s non-viral, integrase-based genome engineering technology for research applications focused on the controlled and predictable introduction of genetic programs into maize genomes. The evaluation will support early-stage studies exploring how precise genomic integration can enable more advanced crop trait development.

KOMO’s platform addresses a core limitation of existing genetic engineering approaches: the inability to reliably and efficiently introduce large or complex genetic payloads into defined genomic locations without relying on viral delivery or nuclease-induced DNA breaks. This challenge is well recognized in therapeutic development and is increasingly important in agriculture as modern traits require coordinated expression of multiple genes with long-term stability.

Maize remains one of the world’s most critical crops, yet improving traits such as stress tolerance, yield stability, and resource efficiency increasingly depend on precise genomic control rather than single-gene edits. KOMO’s integrase-based approach is designed to enable site-specific, programmable genome modification, supporting predictable expression and durable performance across generations.

“This evaluation reflects a broader shift in how genome engineering is evolving,” said Jennifer Manning, Founder and CEO of KOMO Biosciences. “As biological systems become more complex, the question is no longer just whether a gene can be edited, but whether genetic programs can be reliably installed and controlled. KOMO was built to enable that next layer of genome engineering, and we’re excited to see this capability explored in maize and other agricultural systems.”

“At Syngenta, we’re energized by our collaboration with KOMO Biosciences. By combining our deep expertise in plant genetics and trait introgression with KOMO’s cutting-edge technology, we can accelerate our commitment to bring more precise solutions to farmers around the world.” stated Trevor Hohls, Global Head of R&D, Syngenta Seeds.

About KOMO Biosciences
KOMO Biosciences is a next‑generation precision genome engineering company developing non-viral, large serine integrase-based platforms for precise and scalable genome modification. Its technologies, including its KOMbine™ and KOMbineX™ platforms, are designed to enable the controlled insertion of large genetic payloads into defined genomic loci, supporting applications across therapeutics, biomanufacturing, agriculture, and synthetic biology. KOMO’s platforms are designed to overcome key limitations of existing gene editing approaches, including constraints on payload size, predictability, and durability.

Learn more at www.komobiosciences.com.

About Syngenta
Syngenta is a global leader in agricultural innovation with a presence in more than 90 countries. Syngenta is focused on developing technologies and farming practices that empower farmers, so they can make the transformation required to feed the world’s population while preserving our planet. Its bold scientific discoveries deliver better benefits for farmers and society on a bigger scale than ever before. Guided by its Sustainability Priorities, Syngenta is developing new technologies and solutions that support farmers to grow healthier plants in healthier soil with a higher yield. Syngenta Crop Protection is headquartered in Basel, Switzerland; Syngenta Seeds is headquartered in the United States. Read our stories and follow us on LinkedIn, Instagram & X.

Media Contacts
KOMO Biosciences
Keith Bowermaster, APR, CCMP
keith.bowermaster@genesisbiocapital.com

Syngenta Media Relations
media@syngentagroup.com

This press release contains forward-looking statements regarding potential applications of KOMO’s technologies and the anticipated benefits of the collaboration. Actual results may differ materially from those expressed or implied due to a variety of factors, including scientific, regulatory, and commercial uncertainties.

Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study




Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study

Access the Moleculin CEO Corner here

HOUSTON, March 11, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. The CEO Corner is designed to provide investors and stakeholders with enhanced insight into the Company’s corporate developments, clinical progress and strategic initiatives.

As part of the segment, Mr. Klemp discussed progress on the Company’s pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine (AnnAraC) for patients with relapsed or refractory Acute Myeloid Leukemia. Mr. Klemp explained that the adaptive Phase 3 trial was designed with input from the U.S. Food and Drug Administration and includes an initial cohort of 45 patients. After treatment of these patients is completed, the study will undergo an interim unblinding to evaluate safety and efficacy and help inform the most efficient regulatory path forward. Enrollment and dosing across clinical sites are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The study builds on encouraging results from the Company’s earlier MB-106 Study, in which AnnAraC demonstrated overall survival outcomes that exceeded historical benchmarks in this difficult-to-treat patient population.

Access the CEO Corner on the Company’s website here.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study




Moleculin Releases Next CEO Corner Segment Highlighting MIRACLE Study

Access the Moleculin CEO Corner here

HOUSTON, March 11, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. The CEO Corner is designed to provide investors and stakeholders with enhanced insight into the Company’s corporate developments, clinical progress and strategic initiatives.

As part of the segment, Mr. Klemp discussed progress on the Company’s pivotal MIRACLE Study evaluating Annamycin in combination with cytarabine (AnnAraC) for patients with relapsed or refractory Acute Myeloid Leukemia. Mr. Klemp explained that the adaptive Phase 3 trial was designed with input from the U.S. Food and Drug Administration and includes an initial cohort of 45 patients. After treatment of these patients is completed, the study will undergo an interim unblinding to evaluate safety and efficacy and help inform the most efficient regulatory path forward. Enrollment and dosing across clinical sites are progressing as planned, with completion of treatment for the first 45 patients expected in the near term. The study builds on encouraging results from the Company’s earlier MB-106 Study, in which AnnAraC demonstrated overall survival outcomes that exceeded historical benchmarks in this difficult-to-treat patient population.

Access the CEO Corner on the Company’s website here.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder




New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder

• Patients adherent to SUBLOCADE^® for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUD
• Patients adherent to SUBLOCADE had the lowest inpatient, emergency department, and detoxification utilization across all treatment groups

RICHMOND, Va., March 11, 2026 (GLOBE NEWSWIRE) — Indivior Pharmaceuticals (Nasdaq: INDV) today announced findings from a new real-world evidence, retrospective observational study published in Frontiers in Public Health showing that adherence to SUBLOCADE^® (extended-release buprenorphine), a monthly injectable, is associated with meaningfully lower healthcare utilization and medical costs among commercially insured patients with opioid use disorder (OUD). These outcomes were more favorable compared to both patients adherent to other medications for OUD (MOUD) and to those who were nonadherent to MOUD.

These findings add to growing evidence that long-acting injectable buprenorphine treatment supports sustained engagement in care and reduces costly acute healthcare use.

To evaluate the relationship between treatment adherence, medication type, healthcare utilization, and costs, patients were grouped based on adherence level and primary MOUD received during follow-up including: those adherent to SUBLOCADE, those not adherent to SUBLOCADE but adherent to other MOUD (e.g., transmucosal buprenorphine), and those who were not adherent to any MOUD.

Patients who were adherent to SUBLOCADE across the 12-month follow-up experienced the lowest rates of inpatient admissions, emergency department visits, and detoxification services across all other groups.

Key findings:

• $15,017 (42%) lower annual non-MOUD medical costs per patient for SUBLOCADE-adherent patients vs other MOUD ($35,761 vs. $50,778).
• Lower adjusted costs observed among MOUD nonadherent patients likely reflect disengagement from routine outpatient care, and greater reliance on acute services.

“These data highlight the potential of long-acting injectable buprenorphine treatment to improve care continuity for people living with OUD and reduce the need for acute, high-cost healthcare services,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior.

Across treatment groups, consistent use of a monthly injectable buprenorphine was associated with lower overall healthcare expenditures compared with adherence to other MOUD. Consistent with other research, this study found that adherence to MOUD remains low overall, underscoring the broader challenges of treatment continuity in OUD care.

“These findings reinforce the importance of evaluating OUD treatment based on total healthcare cost,” said Patrick Barry, Chief Commercial Officer at Indivior. “Sustained engagement with long-acting therapy can reduce costly acute care use, generating meaningful system-wide savings while supporting treatment continuity for patients.”

Study limitations include the retrospective observational design and reliance on administrative claims data, which may be subject to coding inaccuracies and unmeasured confounding. Portions of the study period overlapped with the COVID-19 pandemic, where disruptions in care may have influenced healthcare utilization patterns. At the time the study was conducted, SUBLOCADE was the only extended-release buprenorphine product available in the U.S. market.

The study is available online: Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder

About SUBLOCADE®

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

INDICATION

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.

CONTRAINDICATIONS

Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.

Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. 

About Opioid Use Disorder (OUD) 
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior 
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

For Further Information 
Investors: 
Jason Thompson 
Indivior Pharmaceuticals 
Tel: 804-402-7123 
E-mail: jason.thompson@indivior.com 

Media: 
Cassie France-Kelly 
Indivior Pharmaceuticals 
Tel: 804-594-0836 
E-mail: Indiviormediacontacts@indivior.com

New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder




New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder

• Patients adherent to SUBLOCADE^® for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUD
• Patients adherent to SUBLOCADE had the lowest inpatient, emergency department, and detoxification utilization across all treatment groups

RICHMOND, Va., March 11, 2026 (GLOBE NEWSWIRE) — Indivior Pharmaceuticals (Nasdaq: INDV) today announced findings from a new real-world evidence, retrospective observational study published in Frontiers in Public Health showing that adherence to SUBLOCADE^® (extended-release buprenorphine), a monthly injectable, is associated with meaningfully lower healthcare utilization and medical costs among commercially insured patients with opioid use disorder (OUD). These outcomes were more favorable compared to both patients adherent to other medications for OUD (MOUD) and to those who were nonadherent to MOUD.

These findings add to growing evidence that long-acting injectable buprenorphine treatment supports sustained engagement in care and reduces costly acute healthcare use.

To evaluate the relationship between treatment adherence, medication type, healthcare utilization, and costs, patients were grouped based on adherence level and primary MOUD received during follow-up including: those adherent to SUBLOCADE, those not adherent to SUBLOCADE but adherent to other MOUD (e.g., transmucosal buprenorphine), and those who were not adherent to any MOUD.

Patients who were adherent to SUBLOCADE across the 12-month follow-up experienced the lowest rates of inpatient admissions, emergency department visits, and detoxification services across all other groups.

Key findings:

• $15,017 (42%) lower annual non-MOUD medical costs per patient for SUBLOCADE-adherent patients vs other MOUD ($35,761 vs. $50,778).
• Lower adjusted costs observed among MOUD nonadherent patients likely reflect disengagement from routine outpatient care, and greater reliance on acute services.

“These data highlight the potential of long-acting injectable buprenorphine treatment to improve care continuity for people living with OUD and reduce the need for acute, high-cost healthcare services,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior.

Across treatment groups, consistent use of a monthly injectable buprenorphine was associated with lower overall healthcare expenditures compared with adherence to other MOUD. Consistent with other research, this study found that adherence to MOUD remains low overall, underscoring the broader challenges of treatment continuity in OUD care.

“These findings reinforce the importance of evaluating OUD treatment based on total healthcare cost,” said Patrick Barry, Chief Commercial Officer at Indivior. “Sustained engagement with long-acting therapy can reduce costly acute care use, generating meaningful system-wide savings while supporting treatment continuity for patients.”

Study limitations include the retrospective observational design and reliance on administrative claims data, which may be subject to coding inaccuracies and unmeasured confounding. Portions of the study period overlapped with the COVID-19 pandemic, where disruptions in care may have influenced healthcare utilization patterns. At the time the study was conducted, SUBLOCADE was the only extended-release buprenorphine product available in the U.S. market.

The study is available online: Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder

About SUBLOCADE®

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

INDICATION

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.

CONTRAINDICATIONS

Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.

Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. 

About Opioid Use Disorder (OUD) 
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior 
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

For Further Information 
Investors: 
Jason Thompson 
Indivior Pharmaceuticals 
Tel: 804-402-7123 
E-mail: jason.thompson@indivior.com 

Media: 
Cassie France-Kelly 
Indivior Pharmaceuticals 
Tel: 804-594-0836 
E-mail: Indiviormediacontacts@indivior.com

Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program




Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations Following Strong Progress in CGM Program

– Company accelerating partner engagement ahead of pivotal clinical trial to be initiated in 2026

DUBLIN and WILSONVILLE, Ore., March 11, 2026 (GLOBE NEWSWIRE) — Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that senior members of its executive leadership team will attend the ATTD 2026 (Advanced Technologies & Treatments for Diabetes) conference in Barcelona this week to progress strategic collaborations and commercialization plans for the Company’s next‑generation Continuous Glucose Monitoring (“CGM”) platform, CGM+.

The Company’s presence at ATTD follows compelling clinical performance data from its latest CGM technology developments, which formed the basis for Trinity Biotech’s decision to advance the program into a pivotal clinical trial in 2026. These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs. Ahead of this major development milestone, ATTD 2026 provides an important platform for the Company to accelerate partner engagement and prepare for the next phase of development and commercial readiness.

“Our CGM program has reached a meaningful inflection point, and ATTD is an ideal forum to deepen the partnerships necessary to bring this important innovation to market,” said John Gillard, Trinity Biotech President & Chief Executive Officer. “With pivotal clinical trial preparations underway, our team will be engaging with prospective collaborators across clinical research, technology integration, and commercial distribution as we build momentum with this exciting platform.”

Trinity Biotech’s CGM+ platform is being developed as part of the Company’s broader strategy to create integrated, AI-native healthcare analytics that support data-driven health solutions to enhance the management of diabetes and metabolic health worldwide.

For more information on CGM+ please visit our dedicated website https://cgm.trinitybiotech.com/

Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company’s website: www.trinitybiotech.com.