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