Almirall’s 2025 Results




Almirall’s 2025 Results

Almirall meets guidance for 2025, delivering 12.4% net sales growth and further pipeline progress, continuing its sustained growth trajectory with strong dermatology performance and commercial execution in Europe

• Almirall delivered net sales growth in 2025 of 12.4% exceeding €1bn (total of €1,108.1MM), revenue increase of 12.5% (total of €1,114.5 MM), and EBITDA growth of 20.9% (total of €232.9 MM) – in line with its guidance and its sustained growth trajectory.
• This revenue growth further advances Almirall’s leadership in medical dermatology driven by the strong performance of its European dermatology business (+25.6% YoY increase to a total of €608 MM).
• The continued strong performance of the biologics portfolio is the backbone of Almirall’s growth, with Ilumetri® net sales increasing 12.3% YoY (total of €234.4 MM), and Ebglyss® net sales increasing more than 3x YoY to a total of €110.8 MM – reflecting its strong position and growth trajectory across Europe in the second year after launch.
• Continued solid performance of the broad dermatology product portfolio with Wynzora® growing 30.5% YoY to a total of €33.8 MM, and Klisyri® growing 33.9% YoY to a total of €32.8 MM, further enhances Almirall’s position as trusted partner for patients and dermatologists.
• Almirall’s business performance fuels the advancement of a diversified and innovative R&D pipeline addressing skin diseases with high unmet need. Pipeline progress in 2025 included the start of the phase II study of the anti-IL-1RAP mAb in Hidradenitis suppurativa, the start of the phase II study of the IL-2muFc in Alopecia areata, and the approval of Jublia^® in Germany and Seysara^® in China.
• Guidance for 2026: net sales growth of 9%-12% and total EBITDA between €270 MM and €290 MM.

BARCELONA, Spain–(BUSINESS WIRE)–Almirall, S.A. (ALM):

“2025 was another important year for Almirall as we continue to deliver against our sustained growth trajectory and further expand our leadership in medical dermatology. Another year of double-digit growth of both net sales at 12.4% and EBITDA at 21.0%, demonstrates Almirall’s strong business performance and focus on executional excellence. Our broad portfolio of dermatology products is the driver of Almirall’s increasing relevance to patients and the medical community with our advanced biologics Ilumetri^® and Ebglyss^® leading our overall growth.

We are very pleased that our solid business performance enables us to continue to invest around 12.5% of our sales in advancing our exciting R&D pipeline that offers future opportunities to patients, the medical community, and for the long-term growth of Almirall. We are very confident in our strategy, commercial excellence, and our R&D capabilities which are the foundation for the long-term growth trajectory and the increasing impact Almirall has on people living with skin conditions, and the medical community.”

Carlos Gallardo, Almirall Chairman and CEO

Almirall, S.A. (ALM), a global biopharmaceutical company based in Barcelona, today announced its financial results for the year 2025.

Summary of results

• Almirall met its guidance for 2025 delivering net sales of over €1bn (€1,108.1 MM) representing a year-on-year growth of 12.4%. The strong performance of the European Dermatology business and the biologics portfolio continued to be the key growth driver of the company’s sustained performance.
• EBITDA reached €232.9 MM, increasing 20.9% year-on-year (vs. €192.2MM in 2024) in line with the guidance and long-term growth trajectory of the company. The strong sales growth achieved in 2025 continues to exceed investment growth, specifically SG&A.
• Almirall finished 2025 with a 0x net debt to EBITDA ratio, which remains highly favourable following the continued investment in expanding the biologics portfolio.
• Gross margin of 64.4% was in line with expectations and continues to be impacted by the sales growth of in-licensed products, especially Ilumetri®.
• Continued investment in Research & Development of €138.1 MM, at 12.5% of net sales.
• SG&A expenses were in line with expectations (increase of 7.9% to €501.1 MM) following the expansion of national launches of Ebglyss® across Europe to build its growth trajectory.
• Net income was €46.2 MM (vs €10.1 MM in 2024)
• Operating cash flow was €174.5 MM in 2025 in line with the mid to long term expectations for the company.

Advancing leadership in medical dermatology

Almirall continues to deliver its sustained growth trajectory based on a strong sales performance, mainly driven by the dermatology business in Europe which is led by the biologics portfolio as key growth driver. An increase of net sales by 12.4% YoY led to the company surpassing €1bn (net sales of €1,108.1 MM). In 2025 EBITDA delivered was €232.9 MM (increase of 20.9% YoY) with a gross margin of 64.4% confirming Almirall’s trajectory of sustained growth and margin expansion. The strong dermatology sales in Europe increased 25.6% YoY to a total of €608 MM further increasing its relevance to patients and physicians.

Atopic dermatitis and psoriasis are key indications within medical dermatology and will remain highly relevant based on the expected increase of numbers of patients diagnosed, and further opportunities for patients to benefit from advanced treatment options.

Ebglyss^®, for the treatment of moderate to severe atopic dermatitis, generated €110.8 MM of sales during 2025 – demonstrating a solid increase of its market share after successful launches across European markets. The product’s growth trajectory remains in line with the expected peak sales in Europe of above €450 MM.

Ilumetri®, for the treatment of psoriasis, continued to grow in line with expectations in 2025, with net sales increasing 12.3% YoY, to a total of €234.4 MM. Anti-IL 23 antibodies remain the leading class in advanced psoriasis treatment, and the product is well positioned in this segment remaining on track to meet the expected above €300 MM peak sales target. The 200mg dose option adds flexibility to patients treated with the product, thus reinforcing its competitive profile.

Almirall’s broad dermatology product portfolio is a key factor in further building the company’s high relevance as a specialist and leader in medical dermatology with continued strong sales performance. In 2025 Wynzora® grew 30.5% YoY to a total of €33.8 MM, Klisyri® grew 33.9% YoY to a total of €32.8 MM.

R&D pipeline

Almirall’s continued investment in its leading R&D capabilities, and the medical dermatology pipeline are closely aligned with the company’s long-term view on its contributions and commitment to positively impact patients and society and with further growing its leadership in medical dermatology. In 2025 Almirall continued to invest around 12.5% of net sales in R&D, representing a total of 138.1 MM. Major pipeline achievements in 2025 include the progress of key developmental assets through clinical testing with 3 ongoing proof-of-concept (PoC)/Phase II studies including an anti-IL-1RAP monoclonal antibody (mAb) targeting hidradenitis suppurativa, an IL-2muFc mutant fusion protein targeting alopecia areata, a further inflammatory skin disease, and atopic dermatitis – the latter led by Almirall’s partner Simcere. Furthermore, Efinaconazole was approved in Germany for the treatment of nail fungal infections, and Sarecycline was approved in China for the treatment of acne.

Additional pipeline programs are expected to progress into phase II/PoC studies in the next 12 months including an anti-IL-21 monoclonal antibody targeting hidradenitis suppurativa.

Several ongoing clinical studies supporting Ebglyss^® and Ilumetri^® will increase the body of evidence for these important biologics and are aimed at enabling more patients to get access to the benefits of these advanced treatments. This work includes the recent announcement to start a Phase III study with lebrikizumab in patients with nummular eczema. Nummular eczema is a debilitating condition that is distinct from atopic dermatitis but is thought to involve similar disease mechanisms and therefore makes targeting IL-13 by lebrikizumab a potentially promising therapy optionⁱ.

For tildrakizumab, the 2-year POSITIVE study presented at the 2025 European Academy of Dermatology and Venerology Congress – EADV – underpins the product’s long-term value and real-world impact on patients’ wellbeing.

Partnership with the dermatology community

Almirall’s close collaborations with dermatologists and life-science experts continue to be a key cornerstone for the company’s dedication to and success in medical dermatology. These partnerships expand Almirall’s focus on fostering scientific exchange and to advance the understanding of skin diseases, treatment options, and their impact on patients.

Almirall’s strong presence at the 2025 EADV annual congress in Paris was a demonstration of the company’s leadership in medical dermatology with the presentation of 44 scientific abstracts, two expert-led symposia on atopic dermatitis and psoriasis and with the publication of the two-year data of the POSITIVE study on Ilumetri® demonstrating the positive impact of the treatment on patients and their psychological well-being as well as the holistic approach Almirall takes to addressing patient needs.

Almirall also successfully hosted the SkinAcademy event in Barcelona in March and Almirall’s specialised ImmunoSkin event in Madrid in November 2025. These events are crucial opportunities for exchange on scientific and clinical topics in medical dermatology.

About Almirall

Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.

For more information, please visit https://www.almirall.com/

Legal notice:

This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are “forward-looking statements.” These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly disclaims any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law.

ⁱ Hagenström K, Müller K, Klinger T, Willers C, Eyerich K, Augustin M. Epidemiology of nummular eczema – methodological approaches and outcomes from nationwide claims data analyses. J Dtsch Dermatol Ges. 2025 Nov 16. doi: 10.1111/ddg.15932. Epub ahead of print. PMID: 41243467.

Contacts

Corporate Communications
corporate.communication@almirall.com
Phone: +34 93 291 35 08

Investor Relations
investors@almirall.com
Phone: (+34) 93 291 30 87

Virion Therapeutics Reports Broad and Sustained Anti-HBV Immunity Following a Single VRON-0200 Dose in the Majority of Chronically HBV-Infected Patients From its Phase 1b Study at CROI 2026




Virion Therapeutics Reports Broad and Sustained Anti-HBV Immunity Following a Single VRON-0200 Dose in the Majority of Chronically HBV-Infected Patients From its Phase 1b Study at CROI 2026

PHILADELPHIA–(BUSINESS WIRE)–Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at the 33^rd Conference on Retroviruses and Opportunistic Infections (CROI), in Denver, CO, that a single intramuscular dose of VRON-0200, its novel, first-in-class, immunotherapy for HBV Functional Cure was able to “spark” and re-awaken durable HBV-specific immunity in the majority of chronically HBV-infected patients – with HBsAg declines that were sustained or deepened through Day 360. These data, presented as a late breaker presentation, by Dr. Sue Currie, PhD., Virion Therapeutics, also highlighted VRON-0200’s ongoing favorable safety and tolerability profile, and its rapid and profound synergy when combined with antigen lowering antiviral agents.

Dr. Currie commented: “We are now at a pivotal point in the development of potential functional cures for chronic HBV, with exciting progress being made, with different classes of HBV treatments. These treatments, however, are limited by their inability to restore a patient’s own immune responses against the virus. As a result, once treatment is discontinued, viral rebound typically occurs in a large proportion of patients. The field now believes that immune modulators are necessary to mitigate this virological rebound. VRON-0200 is the first new HBV immune modulator since pegylated interferon to show durable clinical activity with sustained and/or improving anti-HBV responses up to one year (360 days) following a single dose – which has the potential to prevent the need for rescue medications after HBV treatment discontinuation, and improve overall functional cure rates.” Currie added, “Additionally, the rapid HBsAg declines seen when combined with investigational antivirals, the “fan” to the VRON-0200 “spark”, has the added future potential of shortening combination treatment regimens, and also expansion to other populations such as those with higher baseline HBsAg levels (e.g., >3,000 IU/mL) and co-infected patients (e.g., HIV/HBV, HDV/HBV). This “Spark and Fan” model, where an upfront VRON-0200 “spark” dose “primes” one’s own anti-HBV immune response, then is “fanned” (boosted) by an antiviral regimen(s) that removes the virus (e.g., HBsAg), could make VRON-0200 a foundational backbone agent to a wide range of future Functional Cure strategies.”

“Locally acting checkpoint modifiers (CPM) enhance, broaden, and prolong immune responses to chronic infections and cancer, and by mechanism, minimize the risks for serious “off target” adverse events,” said Dr. Andrew Luber, Pharm.D., CEO of Virion. Luber added, “VRON-0200, Virion’s first CPM-containing immunotherapy, with its favorable safety and tolerability profile, documented durable clinical activity, and convenient single i.m. administration, along with its potential for increased accessibility due to its ease of scalabilty and distribution, make it ideal for global public health initiatives. A Phase 2b SPARK-B trial for HBV Functional Cure is in development and will use the “Spark and Fan” approach to evaluate VRON-0200 in combination with investigational antivirals. The benefits of CPM for other chronic viral diseases such as HDV/HBV, HIV/HBV, HIV Cure, HSV-2, EBV, are being considered, and the lessons learned from the VRON-0200 program are being applied to our VRON-0300 program for advanced solid tumors. We look forward to sharing more data from the current Phase 1b VRON-0200 trial at future meetings.”

The presentation is available for download at www.VirionTx.com and more details of this study can be found at ClinicalTrials.gov (Identifier: NCT06070051).

About Chronic Hepatitis B

Despite a preventative vaccine, cases of chronic hepatitis B (CHB) continue to rise, with an estimated 254 million persons infected worldwide and 1.1 million deaths per year from HBV-related liver complications. Chronic HBV remains a global health issue with a high unmet medical need since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus. Current and investigational HBV Functional Cure treatments have been limited by their inability to restore a patient’s own immune responses against the virus. As a result, once treatment is discontinued, and the antiviral agents are no longer present, viral rebound typically occurs. As a result, immune modulators are now considered necessary for future cure treatment strategies.

About VRON-0200

VRON-0200 is an investigational therapeutic immunotherapy designed with the goal of providing a functional cure for chronic HBV infection. Clinical data from an ongoing Phase 1b trial have shown VRON-0200 to be safe and well tolerated, and, when given as a single intramuscular dose, was immunogenic, and able to “Spark” anti-HBV activity in chronically HBV-infected patients on nucleos(t)ide therapy alone, and, also, when given with combination antiviral therapies. These results suggest the potential of VRON-0200 to be the key backbone immune modulator for HBV functional cure treatments.

About Virion Therapeutics (Virion)

Virion Therapeutics, LLC is a clinical-stage company developing novel immunotherapies that utilize proprietary checkpoint modifiers to enhance/restore, broaden, and elicit sustained immune responses, with the goal to cure cancer and chronic infectious diseases. Virion’s pipeline now includes its lead VRON-0200 clinical program, and several additional IND-enabling programs, such as its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies.

To learn more, visit www.VirionTx.com

Contacts

Virion Therapeutics, LLC, Dr. Sue Currie, Chief Operating Officer

scurrie@viriontx.com
1-800-841-9303

Nuclera and leadXpro Partner to Accelerate Structure-Based Drug Design for Complex Membrane Proteins




Nuclera and leadXpro Partner to Accelerate Structure-Based Drug Design for Complex Membrane Proteins

• Partnership will deliver AI-guided end-to-end workflow to access challenging membrane protein targets
• To de-risk and shorten path to critical structural and biophysical insights that inform structure-based drug design

CAMBRIDGE, England & BOSTON & VILLIGEN, Switzerland–(BUSINESS WIRE)–Nuclera, the biotechnology company enabling rapid access to high-quality proteins and leadXpro, a specialist in structure-based drug discovery for membrane proteins, today announced a scientific partnership. The collaboration brings together eProtein Discovery’s^™ rapid multiplex membrane protein screening with leadXpro’s AI/ML-driven construct design and membrane protein expertise to advance structural studies and therapeutic development.

Membrane proteins remain among the most valuable yet difficult to obtain drug targets. These proteins are notoriously challenging to express and purify in sufficient quantity and quality for structural biology and biophysical studies, limiting drug discovery programs even when promising biology is well understood.

Integrating eProtein Discovery’s Cell Free Protein Synthesis multiplex screening technology with leadXpro’s AI/ML and biophysical and structural characterization expertise, the partnership will establish an AI-guided, iterative, end-to-end workflow. The workflow will link in silico construct design with rapid, experimental multiplex screening to accelerate and de-risk challenging membrane protein programs, shortening the path to structural and biophysical insights for structure-based drug discovery.

Membrane protein constructs will be screened using Nuclera’s eProtein Discovery system with the most promising variants undergoing detailed biophysical characterization and high-resolution cryo-EM structure determination led by leadXpro. Insights from these studies will be integrated into AI/ML models for construct design and stability predictions, improving yields, functionality, and success rates. The partnership will also inform future integration of AI/ML capabilities into Nuclera’s product portfolio to embed predictive design into the eProtein Discovery System, and strengthen leadXpro’s platform in rapidly producing and characterizing difficult membrane protein targets.

Dr Michael Chen, CEO and co-founder, Nuclera, said: “Scientists are under pressure to progress increasingly complex membrane protein programs faster. By partnering with leadXpro, we can pair AI/ML-driven construct design with our rapid multiplex membrane protein screening to provide a truly ‘lab-in-loop’ workflow. This collaboration is an important step towards embedding AI/ML into Nuclera’s system so that researchers can go from sequence to high-value structural and functional insights in a fraction of the time currently required.”

Dr Michael Hennig, CEO, leadXpro, commented: “Access to well-optimized membrane protein constructs is critical for producing high-quality proteins that enable biophysical and structural biology studies. Nuclera’s eProtein Discovery platform provides a robust, rapid, and reproducible approach to exploring construct space. Combined with our established AI/ML and structural biology expertise, this integration allows us to support better design decisions earlier and accelerate the progression of promising drug candidates.”

For more information about Nuclera’s eProtein Discovery system, please visit: https://www.nuclera.com/system/

For more information on leadXpro’s Technology Platform, please visit: https://leadxpro.com/technology-platform/

Contacts

Media contact:
Dr Ben Rutter

Zyme Communications

Tel: +44(0)7920 770 935

Email: ben.rutter@zymecommunications.com

Sensorion Announces Leadership Changes




Sensorion Announces Leadership Changes

• Nawal Ouzren Chief Executive Officer to step down for personal reasons
• Amit Munshi, Chairman of Sensorion to assume role of Interim CEO

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced that Nawal Ouzren, Sensorion’s Chief Executive Officer and a Director on the Company’s Board, is stepping down from both posts due to a personal matter incompatible with serving as Chief Executive Officer. Amit Munshi, who serves as the Chairman of Sensorion will assume the role of Interim Chief Executive Officer and Ms. Ouzren will remain temporarily as a consultant to the Company to ensure an effective transition. This leadership change is effective immediately and the Board has commenced its search for a permanent Chief Executive Officer.

“Since taking on the role of Chief Executive Officer back in 2017, it’s been an absolute pleasure to work with the entire Sensorion team as we embarked on an ambitious journey to provide best-in-class restoration therapeutics and preventive treatments for hearing loss disorders that impact millions of patients across the globe,” commented Nawal Ouzren. “While unexpected, my departure comes at a time when the Company is well positioned to execute on its clinical and corporate development plan having recently completed an important financing milestone anchored by strategic investor Sanofi which enables the advancement of key pipeline assets to significant value inflection points while strengthening the balance sheet. I leave the Company with a strong management team in place and will work with Amit to facilitate a smooth transition. Moving forward, I wish the Sensorion team best wishes as it continues its critical mission to help patients suffering from a variety of hearing loss conditions.”

“On behalf of the Board, I wish to thank Nawal for her exceptional leadership during her tenure as Chief Executive Officer“ commented Amit Munshi, Sensorion’s Chairman of the Board and Interim CEO. “I look forward to working with my fellow Board members and the management team to maintain our clinical development timelines and corporate growth objectives.”

The Company recently announced (January 26^th, 2026) a €60 million placement reserved to specific categories of investors and led by Sanofi with participation from top tier healthcare dedicated institutional investors. This transaction is an important milestone for Sensorion’s evolution. Its proceeds will mostly be allocated to advancing the Company’s pipeline of next generation gene therapy candidates while providing sufficient cash runway through the end of H1 2027. The programs that are being prioritized include SENS-601 (GJB2-GT) targeting hearing loss associated with GJB2 mutations which are responsible for the most frequent type of congenital deafness, accounting for approximately 50% of autosomal recessive non-syndromic congenital hearing loss and also implicated in early-onset forms of severe presbycusis in adults. The Company is on track to submit SENS-601’s clinical trial application submission in Q1 2026. Other clinical development milestones in Q1 2026 include cohort two 6 months follow-up data reporting of the Phase 1/2 Audiogene trial for SENS-501 which targets hearing loss related to mutations in the GJB2 gene.

About Sensorion

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates.

It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.

Sensorion’s portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion’s small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, has completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.

www.sensorion.com

Disclaimer

This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Contacts

Investor Relations
Sensorion

Nicolas Bogler, Investor Relations and Communication

ir.contact@sensorion-pharma.com

Press Relations
Maarc Communication

Bruno Arabian / 00 33(0)6 87 88 47 26

bruno.arabian@maarc.fr
Nicolas Entz / 00 33 (0)6 33 67 31 54

nicolas.entz@maarc.fr

Poxel Reports its 2025 Revenue and Provides an Update on its Financial Position




Poxel Reports its 2025 Revenue and Provides an Update on its Financial Position

• Gross sales of TWYMEEG^® in Japan continued to accelerate, increasing by 15.0% in the fourth quarter of 2025 (October–December) compared with the previous quarter, and by 40% compared with the fourth quarter of 2024.
• Poxel generated revenue of €5.0 million for the year ended 31 December 2025 corresponding to 10% royalties on TWYMEEG net sales
• As at 31 December 2025, cash and cash equivalents amounted to €0.9 million.

LYON, France–(BUSINESS WIRE)–Regulatory News:

POXEL SA (Euronext: POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, reports today its annual revenue for the fiscal year ended December 31, 2025, and provides an update on its financial position.

Consolidated Revenue

Poxel generated consolidated revenue of €5 millions¹ for the year ended 31 December 2025, compared with €6.6 million in the corresponding period in 2024, which included a milestone payment of ¥500 million (€3.1 million) from Sumitomo following the achievement of a contractual sales threshold for TWYMEEG^®.

Consolidated revenue for fiscal year 2025 fully reflects the ¥873 million in royalties received from Sumitomo Pharma, namely:

• 10% of TWYMEEG® net sales in Japan in the first and fourth quarters of 2025, as the ¥5 billion net sales threshold was exceeded in the last quarter of Sumitomo’s 2024–2025 fiscal year, which corresponds to Poxel’s first quarter of 2025, and in the third quarter of Sumitomo’s 2025–2026 fiscal year, which corresponds to Poxel’s fourth quarter of 2025.
• 8% of TWYMEEG® net sales in Japan for Poxel’s second and third quarters of 2025.
• However, the ¥5 billion threshold was reached during the fourth quarter of 2025, resulting in the retroactive application of the 10% royalty rate to the second and third quarters. Poxel will therefore receive an additional amount of ¥88 million in respect of the second and third quarters.

Under the license agreement with Merck Serono, Poxel will pay Merck Serono a fixed royalty of 8% calculated on net sales of Imeglimine, regardless of the level of sales. In accordance with the royalty monetization agreement with OrbiMed, net positive royalties will be allocated largely to the redemption of the bonds.

TWYMEEG^® (Imeglimin)

• For the quarter ended December 2025, gross sales of TWYMEEG® in Japan increased by 15% to ¥2.9 billion (€1.4 million¹), compared with sales of ¥2.5 billion in the previous quarter, as reported by Sumitomo Pharma.
• Poxel continues to implement its recovery plan and expects to receive double-digit royalty growth on TWYMEEG® sales in 2026.

Consolidated cash and cash equivalents

As at 31 December 2025, total consolidated cash and cash equivalents amounted to €0.9 million, compared with €0.6 million as at 30 September 2025.

Post-closing events

Approval of the continuation plan and conclusion of the judicial reorganisation proceedings

The continuation plan of Poxel was approved by the Lyon Commercial Court on 22 January 2026. This decision brings to an end the observation period opened on 5 August 2025 and confirms Poxel SA’s exit from judicial reorganisation proceedings. It enables the Company to implement the continuation plan presented to shareholders in several communications in November and December 2025, including the capital increases approved by the General Meeting of 11 December 2025, which will be the subject of specific press releases.

About Poxel SA

Poxel is a clinical stage biopharmaceutical Company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilised Rpioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG^® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and 5 sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release concerning future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, but are not limited to, any statements preceded by, followed by, or including words such as ‘objective,’ ‘believe,’ ‘expect,’ ‘aim,’ ‘intend,’ ‘may,’ ‘anticipate,’ ‘estimate,’ ‘plan,’ ‘project,’ ‘will,’ ‘could,’ ‘likely,’ ‘should,’ and other words and terms of similar meaning, or the negative form of these words and terms. 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 differ materially from the results or performance expected, expressed or implied in such forward-looking statements. Actual events or results may differ from those described in this document due to a number of risks or uncertainties described in the Company’s 2024 Universal Registration Document available on the Company’s website and that of the AMF (https://www.amf-france.org/fr). The Company does not endorse and is not responsible for the content of external hyperlinks mentioned in this press release.

Glossary

For the sake of clarity and transparency, please find below a list of words and/or expressions used in this press release or in other communications from Poxel:

• Sumitomo Pharma’s financial year runs from April to March. By way of example, fiscal year 2025 runs from April 1, 2025 to March 31, 2025.
• TWYMEEG royalties: In accordance with the agreement with Sumitomo Pharma, Poxel is eligible to receive royalties on sales of TWYMEEG (Imeglimin) in Japan.
  • Sumitomo Pharma reports the number of gross sales of TWYMEEG, while royalties on TWYMEEG sales are calculated based on net sales;
  • Net sales represent gross sales fewer potential rebates, allowances and costs such as prepaid freight, shipping and handling charges, customs duties and insurance costs;
  • Poxel is eligible for tiered royalties ranging from 8% to 18% on Sumitomo Pharma’s net sales of TWYMEEG.
• Positive net royalties: In accordance with the license agreement with Merck Serono, Poxel will pay Merck a fixed percentage of 8% of net sales of TWYMEEG, regardless of the level of sales. Royalties on TWYMEEG net sales received by Poxel above this 8% threshold are referred to as positive net royalties. Accordingly, net royalties will be positive for Poxel when TWYMEEG net sales exceed ¥5 billion during a fiscal year, and the royalty rate reaches 10% or more.
• Poxel refers to the Poxel Group, including its subsidiaries (Poxel Inc. and Poxel KK), as well as the three secured trusts established as part of the royalty monetization and debt restructuring transactions announced on September 30, 2025.

¹ Converted at the exchange rate as at 31 December 2025

Contacts

Investor relations / Media

NewCap

Théo Martin / Paul Boivin

investors@poxelpharma.com
+33 1 44 71 94 94

Newron Secures Up to EUR 38 Million to Advance Phase III Evenamide Program




Newron Secures Up to EUR 38 Million to Advance Phase III Evenamide Program

Ad hoc announcement pursuant to Art. 53 LR 

Proceeds expected to fund global ENIGMA-TRS studies and extend cash runway beyond pivotal 12-week results, supporting development of evenamide as the potential first add-on therapy for treatment-resistant schizophrenia

MILAN, Italy & MORRISTOWN, N.J.–(BUSINESS WIRE)–$NWRN #schizophrenia–Newron Pharmaceuticals S.p.A. (“Newron”, or the “Company”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it has entered into an agreement for the subscription of newly issued shares for proceeds of up to EUR 38 million with a group of existing and new shareholders from Europe and Asia, strengthening the Company’s financial position as it advances the ENIGMA-TRS Phase III program.

Under the agreement, the investor group will initially subscribe to up to 779,624 newly issued shares at a subscription price of EUR 19.24 per share, which corresponds to gross proceeds of up to EUR 15 million. Alongside the progress of the ENIGMA-TRS 1 and 2 pivotal studies towards the 12-week results, expected in Q4 of this year, and no later than November 30, 2026, the group will subscribe to an additional number of newly issued shares for total proceeds of EUR 11 million, at a subscription price to be calculated pursuant to an agreed formula. Finally, the group will subscribe to an additional number of newly issued shares for total proceeds of EUR 12 million upon disclosure of results from the ENIGMA-TRS pivotal studies, conditional to such results being positive, and at a subscription price to be calculated pursuant to the agreed formula*. The share subscriptions are governed by the capital increase authorized by Newron’s shareholders in 2018 and approved and empowered by the Company’s board of directors in 2025.

“The investment by this group of existing and new shareholders is further validation of our development strategy for evenamide as the potential first add-on therapy in schizophrenia and as a new treatment option for the vast majority of patients who are poorly responding or resistant to available treatment options,” said Roberto Galli, CFO of Newron. “Importantly, this financing is expected to extend our operational runway well beyond the upcoming 12-week results from the ENIGMA-TRS 1 and 2 pivotal studies and support continued execution of our Phase III development program.”

The initial up to 779,624 newly issued shares are expected to be listed and traded on the SIX Swiss Exchange under the same ISIN as the Company’s existing shares (ISIN: IT0004147952) in the next few days, upon payment and settlement. Furthermore, the new shares are expected to be listed and traded on the Primärmarkt of the Düsseldorf Stock Exchange, as well as traded on the Quotation Board of the Frankfurt Stock Exchange (Xetra).

About ENIGMA-TRS

The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in August 2025, is an international, one-year, double-blind, placebo-controlled study in at least 600 patients to evaluate the efficacy, tolerability, and safety of evenamide 15 mg and 30 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo. ENIGMA-TRS 2, initiated in December 2025, is a Phase III, international, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo, in patients suffering from TRS. ENIGMA-TRS 2 will enroll at least 400 patients.

About evenamide

Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.

About treatment-resistant schizophrenia (TRS)

A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Contacts

For more information, please contact:


Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com

VB Spine Announces Intent to Acquire Exclusive Rights to Augmedics’ Spine Platform




VB Spine Announces Intent to Acquire Exclusive Rights to Augmedics’ Spine Platform

Transaction will expand VB Spine’s enhanced visualization portfolio to include augmented reality navigation with the Augmedics xvision Spine System®

NEW YORK & CHICAGO–(BUSINESS WIRE)–VB Spine LLC (“VB Spine”), the largest privately held spine company, today announced it has entered into a definitive agreement to acquire exclusive rights to the xvision Spine System® (xvision) from Augmedics, adding augmented reality (AR) navigation to VB Spine’s growing enhanced visualization portfolio. Augmedics is the first company to offer an FDA-cleared AR navigation platform in spine surgery, positioning VB Spine to become a world leader in AR-enabled spine solutions. The transaction is subject to approval and customary closing conditions and is expected to close in the coming weeks.

The xvision Spine System is designed to combine the benefits of navigation with the ease and utility of open surgery: visualization while looking directly at the patient, accuracy and precision, workflow efficiency, and radiation reduction. With nearly 13,000 patients treated with xvision, the transaction brings together two complementary portfolios focused on redefining spine care.

This transaction marks a foundational element in a broader enhanced visualization technology strategy for the company, building on the recent acquisition of the SpineHawk™ intraoperative spinal visualization platform from Robotron Surgical Technologies.

“We have long admired the xvision technology and potential of the platform,” said Marc Viscogliosi, co-CEO of VB Spine. “We believe with our implant integration and scale, we have the ability to harness the true potential of AR navigation. Combined with the SpineHawk platform, this will expand our existing spine solutions and supports our long-term roadmap to redefine spine care with differentiated technologies.”

“We are proud of the clinical impact xvision has made in spine surgery and VB Spine’s commitment to our world-class portfolio,” said Paul Ziegler, President and CEO of Augmedics. “This agreement will strengthen our competitive advantage as an augmented reality innovation engine as we turn our focus to expanding our reach into adjacent surgical indications.”

Subject to approval and closing, VB Spine and Augmedics intend to work together to support an orderly transition for customers.

Regulatory and Availability

The xvision Spine System® with xvision Spine System Software is FDA-cleared in the US. It is intended as an aid for precisely locating anatomical structures in either open, minimally invasive, or percutaneous spine procedures.

Forward-Looking Statements

Certain statements in this release are forward-looking and are based on current expectations, forecasts, and assumptions. Actual results may differ materially due to regulatory, commercial, and operational risks. VB Spine disclaims any obligation to update forward-looking statements except as required by law.

About VB Spine

VB Spine LLC is the largest privately held spine company and among the largest family-owned medical technology companies in the world. With a comprehensive portfolio and a large and growing global distribution network, VB Spine delivers specialized solutions that address critical needs in spine surgery and enhance patient outcomes. Focused on people, partnerships, and operational excellence, VB Spine ensures healthcare professionals have access to the tools and resources needed to provide the highest standard of care. VB Spine is owned and led by the Viscogliosi Brothers. For more information on VB Spine, please visit www.vbspineco.com.

About Augmedics

Augmedics pioneers cutting-edge augmented reality technologies to improve surgical outcomes. Its revolutionary xvision Spine System® enables surgeons to visualize a patient’s anatomy as though they have “x-ray vision,” allowing for precise navigation of instruments and implants during procedures. The first-of-its-kind, FDA-cleared xvision has been used in nearly 13,000 spinal procedures, redefining surgical visualization for spine surgery. Augmedics remains committed to transforming surgery through breakthrough innovation and advancing AR navigation into adjacent specialties. To learn more, visit augmedics.com.

Contacts

For media inquiries only:
spinecommunications@vbspineco.com and info@augmedics.com

Europe Oncology Genomics Tracker Captures Oncologist Perspectives Across Major European Markets – Data Report by DeciBio Consulting LLC




Europe Oncology Genomics Tracker Captures Oncologist Perspectives Across Major European Markets – Data Report by DeciBio Consulting LLC

LOS ANGELES–(BUSINESS WIRE)–#MRD–A new survey-based Genomics Tracker focused on the EU-5 (France, Germany, Italy, Spain, and the United Kingdom) by DeciBio Consulting LLC provides updated insight into how genomics technologies are being evaluated, adopted, and used across Europe’s solid tumor oncology markets. The study is based on responses from 100+ medical oncologists and offers a cross-market view of current priorities, barriers, and areas of momentum.

The Europe Oncology Genomics Tracker characterizes the current clinical use of genomic testing across a patient’s treatment journey (e.g., genomic profiling, MRD / recurrence monitoring, treatment response monitoring) and tracks how use changes over time. Oncology respondents were asked about their use of genomic testing in routine clinical practice within the past three months, as well as their familiarity with various vendors in the ecosystem.

The survey was distributed randomly to oncologists practicing in the UK, France, Germany, Italy, or Spain. Respondents were selected to complete the survey if they were actively practicing medical oncologists or hematologist-oncologists and had seen at least 25 patients in the past three months. Respondents were not excluded from the survey if they were not currently using, or had not previously used, genomics for biomarker testing.

DeciBio Partner and leading author of the tracker, Andrew Aijian, notes the value of integrating the EU tracker into a broader suite of genomics trackers, “Adoption of precision medicine is growing steadily across Europe, though each market presents unique drivers and moderators. The country-specific healthcare frameworks and infrastructure in Europe require different strategies for precision oncology than what we see in the U.S. Having visibility into genomics testing practices in these regions is critical for any precision oncology stakeholder to identify opportunities and risks, and develop locally-optimized strategies.”

Based on recent clinician survey data, the tracker quantifies real-world adoption of testing for treatment selection, detailing tissue versus liquid biopsy use, panel size mix, provider awareness and perception, and the competitive dynamics shaping ordering behavior. It extends beyond profiling to capture emerging use of ctDNA for MRD, recurrence, and treatment response monitoring, highlighting utilization by care setting, confidence in clinical utility, vendor share shifts, pain points, and sales and marketing visibility. Together, these insights enable biopharma, diagnostics, and investors to benchmark performance, identify inflection points in adoption, and prioritize commercial and evidence-generation strategies grounded in current EU clinical practice.

Learn more about DeciBio’s Europe Oncology Genomics Tracker: https://www.decibio.com/product/europe-oncology-genomics-tracker

While this tracker is inaugural for the European oncology market, it complements DeciBio’s U.S. Oncology Genomics Tracker. This tool is also distributed on a quarterly basis and similarly aims to characterize current clinical use of genomic testing across genomic profiling, MRD / recurrence monitoring, and treatment response monitoring, as well as track changes over time in the United States.

Learn more about DeciBio’s U.S Oncology Genomics Tracker: https://www.decibio.com/product/u-s-oncology-genomics-tracker

About DeciBio:

DeciBio Consulting (www.decibio.com) is the leading strategy consulting, market intelligence, and SaaS firm dedicated to accelerating innovation in precision medicine.

Headquartered in Los Angeles, California, DeciBio serves a global base of clients and customers, ranging from startups to Fortune 500 healthcare corporations. DeciBio offers advisory services for growth planning, market and opportunity assessment, product and portfolio strategy, voice-of-customer feedback, technology assessment, and commercial due diligence.

Contacts

Hannah Glazier

glazier@decibio.com

Worldwide Clinical Trials Completes Acquisition of Catalyst Clinical Research




Worldwide Clinical Trials Completes Acquisition of Catalyst Clinical Research

CRO expands oncology, adds functional service provider capabilities, strengthens global reach, and accelerates technology to enhance customer value

RESEARCH TRIANGLE PARK, N.C. & NOTTINGHAM, England–(BUSINESS WIRE)–#CROleader—Worldwide Clinical Trials (“Worldwide” or the “Company”), a global contract research organization (CRO), has completed its acquisition of Catalyst Clinical Research, LCC (“Catalyst”) – a specialized oncology CRO and scalable functional service provider (FSP). This strategic transaction creates a combined organization with highly complementary strengths in oncology, biometrics, and FSP capabilities, substantially enhancing Worldwide’s offerings to biopharma customers globally and expanding its employee base to approximately 4,400 across more than 70 countries.

The addition of Catalyst’s deep expertise in early phase oncology, along with its robust FSP model, significantly augments Worldwide’s scientific depth, operational agility, and therapeutic strengths across neuroscience, oncology, rare disease, and internal medicine. Customers now have access to an expanded suite of services, innovative technology platforms, and a broader global site network – supporting efficient, transparent, and flexible development across the clinical trial lifecycle.

“The acquisition of Catalyst strengthens Worldwide’s capabilities in a very deliberate way, building a stronger, more capable CRO partner for our customers,” said Alistair Macdonald, Chief Executive Officer of Worldwide. “It expands our reach into earlier phase oncology, adds targeted FSP and biometrics capabilities, and accelerates our technology platforms, allowing us to better support customers across the full development lifecycle with greater speed, flexibility, and transparency.”

“The completion of the Catalyst acquisition deepens Worldwide’s oncology offering and global reach,” said Matt Jennings, Executive Chairman of Worldwide and Senior Operating Partner of Kohlberg, the majority owner of the Company. “Catalyst’s expertise, technology, and strong biotech relationships are a natural fit for Worldwide and reinforce our strategy to build a differentiated, technology-enabled CRO.”

“Joining the Worldwide team is an exciting next chapter for Catalyst,” said Nik Morton, former President and CEO of Catalyst, who joins Worldwide as EVP, Chief Strategy & Transformation Officer. “We are energized by the cultural alignment between our teams and share a deep commitment to scientific excellence, operational integrity, and a people-first approach. Together, we are well positioned to deliver even greater value to customers worldwide.”

In addition to Morton, Catalyst’s Chairman of the Board, Nick Dyer, joins Worldwide’s Board of Directors. An integration team has been established, with a comprehensive plan underway to ensure a smooth and effective transition for employees, customers, and partners. The Company will leverage its best strengths and practices to unlock new growth and innovation opportunities for customers.

Worldwide acquired Catalyst for an undisclosed amount.

Worldwide is a portfolio company of Kohlberg. Based in Mount Kisco, N.Y., Kohlberg invests in healthcare and services companies. Prior to the deal closing, Catalyst was a portfolio company of QHP Capital, L.P. (“QHP Capital”). QHP Capital is based in Research Triangle Park, N.C., and invests in life sciences and pharma services companies.

BofA Securities served as exclusive advisor and Smith Anderson served as legal counsel to Catalyst. Greenberg Traurig, LLP served as legal counsel to Worldwide.

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials.

The company’s flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people-first, partnership-driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research. Learn more at www.worldwide.com.

Contacts

Media Contact:
Jill Shahravar

Jill.Shahravar@worldwide.com
919-389-9253

Compass Pathways to Announce New Clinical Data from Two Ongoing Phase 3 Trials




Compass Pathways to Announce New Clinical Data from Two Ongoing Phase 3 Trials

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced that tomorrow it will report new clinical data from two ongoing Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The company will be disclosing new clinical data from Part A and Part B from COMP005 and Part A from COMP006. The results are scheduled for release on February 17th at 6:30 am ET, followed by a webinar hosted by Compass management at 8:00 am ET.

Live Webcast

Compass management will host a live audio webcast on February 17th at 8:00 am ET. The webcast will be accessible at this link: https://lifescievents.com/event/hz02j0rpw/

A replay of the webcast will be accessible for 30 days following the event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries

Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324