Levicept to Present Key New Data from Phase II Trial of LEVI-04, a Novel Neurotrophin-3 Inhibitor, at ACR Convergence 2025




Levicept to Present Key New Data from Phase II Trial of LEVI-04, a Novel Neurotrophin-3 Inhibitor, at ACR Convergence 2025

• A significant, dose-dependent reduction in bone marrow lesion presence and area was observed for LEVI-04 compared with placebo in patients with osteoarthritis
• Changes in bone marrow lesion area were significantly correlated with changes in patient-reported symptoms including pain
• Further presentations detail LEVI-04 mechanism of action, functional outcomes and imaging screening exclusions
• LEVI-04 is a first-in-class novel biologic under development as non-addictive pain treatment

SANDWICH, UK, Sept. 25, 2025 (GLOBE NEWSWIRE) — Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, will be presenting key new data from its large-scale Phase II trial of LEVI-04 at the American College of Rheumatology’s annual meeting, ACR Convergence 2025, being held from 24 – 29 October in Chicago, Illinois.

The new data are from Levicept’s multiarm, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to osteoarthritis (OA) of the knee (ClinicalTrials.gov ID: NCT05618782). Previously presented data showed the primary efficacy endpoint of the trial was met with significant analgesia across all doses, and a favourable safety and tolerability profile.

Professor Philip Conaghan, MBBS, PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, said, “We look forward to presenting new data from this large, robust study of LEVI-04 at ACR Convergence 2025. For the first time, we will show findings which suggest that LEVI-04 holds promise as a therapy to provide contemporaneous modification of joint structure – bone marrow lesions – and symptoms of OA including pain. We will also present an analysis of LEVI-04’s mechanism of action and further studies which we believe add to the evidence of LEVI-04’s potential to offer a vital new treatment option for millions of patients worldwide in need.”

Presentation details:

LEVI-04 Significantly Reduces Bone Marrow Lesions and Symptoms in Knee Osteoarthritis: Results from a Phase II RCT

Oral plenary presentation (0852) – Monday, 27 October, 08:45 – 09:00 CST

Authors: Simon Westbrook, Ali Guermazi and Philip Conaghan

Pharmacology of LEVI-04, a novel treatment for OA

Poster presentation (1804) Tuesday, 28 October, 10:30 – 12:20 CST

Authors: Simon Westbrook and Kerry af Forselles 

Radiologic surveillance in the Phase II RCT of LEVI-04, a novel neurotrophin-3 inhibitor, in people with knee osteoarthritis: exclusions at screening

Poster presentation (2081) Tuesday, 28 October, 10:30 – 12:30 CST

Authors: Ali Guermazi, Philip Conaghan, C. Michael Perkins, Claire Herholdt, Iwona Bombelka and Simon Westbrook

LEVI-04, a Novel Neurotrophin-3 Inhibitor, Demonstrates Clinically Meaningful Improvements in Pain and Physical Function across a Range of OA Outcomes, Including the Staircase-Evoked Pain Procedure (StEPP)

Poster presentation (2101) Tuesday, 28 October, 10:30 – 12:30 CST

Authors: Philip Conaghan, Nathaniel Katz, Asger Bihlet, Laus W. Wullum, Kerry af Forselles, C. Michael Perkins, Bernadette Hughes, Claire Herholdt and Iwona Bombelka 

Levicept

Eliot Forster, CEO – eliot@levicept.com

Media Enquiries

Charles Consultants

Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585

Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Levicept – www.levicept.com

Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.

Follow us on LinkedIn – https://www.linkedin.com/company/levicept-ltd

Arecor announces Co-development Agreement with US Insulin Pump Device Company for AT278 & Sale of Royalty Rights and Technology Access Fees for AT220 and AT292




Arecor announces Co-development Agreement with US Insulin Pump Device Company for AT278 & Sale of Royalty Rights and Technology Access Fees for AT220 and AT292

This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 (“UK MAR”).

Arecor Therapeutics plc
(“Arecor” or the “Company”)

Co-development Agreement with US Insulin Pump Device Company for AT278
and
Sale of Royalty and Technology Access Fees for up to $11 million

• AT278 (500U/mL) is the only ultra-concentrated and ultra-rapid acting insulin in development designed to enable the next generation of longer-wear and miniaturised automated insulin delivery (AID) systems
• Arecor and Sequel Med Tech, LLC to commit up to $1.3 million each to fund development work in preparation for pivotal Phase 2 trial for AT278-Insulin Pump programme
• Strategic intent is to progress to a broader co-development and commercialisation partnership for Phase 2 trial and beyond
• Non-dilutive funds raised through the monetisation of Arecor’s royalty rights related to AT220 and milestone and technology access fees related to AT292
• Cash runway extended to 1H 2027

Cambridge, UK, 25 September 2025: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company focused on drug development and delivery in diabetes and other cardiometabolic diseases, has signed a co-development agreement with Sequel Med Tech LLC (“Sequel”), a company developing state-of-the-art insulin delivery technologies, to combine AT278 (500U/mL) with Sequel’s twiist™ Automated Insulin Delivery (AID) system powered by Tidepool, and a royalty financing agreement with Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) (“Ligand”) which will raise non-dilutive capital of up to $11 million (£8.2 million).

Sarah Howell, CEO of Arecor Therapeutics said:

“The co-development agreement for AT278 and the non-dilutive fund raising via the monetisation agreement are both major strategic achievements for Arecor. The Sequel agreement marks a key milestone, furthering our ambitions to realise AT278’s significant benefits for people living with diabetes as well as building substantial value for our shareholders. The funding realised through the monetisation of specific royalty rights enables us to accelerate AT278’s clinical development and extends our cash runway to 1H 2027 without diluting our shareholders.”

Co-Development Agreement

To preserve long-term value within Arecor, the Company has pursued a strategic co-development partnership with an insulin pump innovator. Sequel’s advanced AID technology aligns with Arecor’s commitment to transformative drug delivery solutions. Its twiist™ AID System’s iiSure™ technology leverages acoustic sensing to precisely measure each insulin dose, delivering superior dosing accuracy and detecting occlusions up to nine times faster than other automated insulin delivery systems. This high level of precision makes it an ideal complement to AT278’s ultra-concentrated, ultra-rapid insulin product.

Under the terms of the agreement, Arecor and Sequel will co-fund all trial-enabling development activities for the AT278-AID System development programme to achieve Phase 2 trial-ready status. Each company will commit up to $1.3 million to accelerate and fund all Phase 2 clinical trial-enabling development work. This will include regulatory interactions and filings with the US Food and Drug Administration (FDA), clinical trial batch manufacturing and AID System compatibility work. Work will commence immediately and is expected to be completed during 1H 2026, culminating in the filing of an IND (Investigational New Drug). If approved, the programme would be ready to enter a pivotal Phase 2 clinical study during 2H 2026.

Longer term, both companies have confirmed their strategic intent to enter a broader, co-development and commercialisation partnership. This would enable the further development and future commercialisation of AT278 in a next generation AID system, serving a key unmet patient need in a high value market.

Sarah Howell, CEO of Arecor Therapeutics added:

“Sequel has expertise in the development and commercialisation of AID Systems, exemplified by the recent launch of the innovative twiist™ AID System. The pairing of AT278 – the only ultra-concentrated (500U/mL), ultra-rapid insulin in development – with the twiist™ AID system, enables longer wear, even for those people with diabetes (PwD) who require high daily doses of insulin, as well as future miniaturisation opportunities. This combination will unlock powerful benefits for more PwD and provide more choice in how they manage their diabetes.

“We are proud to be bringing devices and therapeutics together in a collaboration which addresses a real unmet need in a high value market, helping people with diabetes better manage their blood glucose whilst significantly lowering the daily burden of disease management.”

Alan Lotvin, CEO of Sequel Med Tech commented:

“We take a comprehensive approach to diabetes management, exploring every opportunity to improve systems that make life easier for people living with diabetes. Our collaboration with Arecor presents a unique opportunity to deliver a truly next-generation solution by integrating our twiist™ AID system – powered by precision iiSure™ technology – with Arecor’s AT278, the only highly concentrated ultra-rapid acting insulin.

iiSure™ technology enables twiist™ to be the first system that directly measures the volume of insulin delivered with each microdose and includes 4 checkpoints along the way to help ensure accurate delivery -something no other AID system can do. This precision is especially critical when working with highly concentrated insulin. Together, this combination has the potential to expand the benefits of AID to all individuals on intensive insulin therapy and provide additional options for PwD, helping them achieve tighter glucose control and improved outcomes.”

Market Opportunity

This partnership, including commercialisation outside the US, presents significant growth potential for Arecor. The Company estimates the total addressable US insulin revenue market opportunity for AT278 is very attractive at c.$2.9 billion with additional upside through commercialisation in Europe and other territories. This is driven by two high unmet-need market segments: 1) People with diabetes who require high daily insulin doses and prefer pumps yet currently lack a suitable pump option and 2) People with diabetes seeking the convenience of an extended-wear device with insulin capacity for 7+ days.

In the Arecor management’s opinion, AT278 has the potential to be the only insulin that can enable and catalyse the next generation of longer wear and miniaturised AID systems, simplifying care, reducing care burden and broadening access to people living with Type 1 or Type 2 diabetes.

Arecor’s strategic priority has been to pursue high-value R&D opportunities that have the potential to generate significant value for shareholders. Near term, the management anticipates that AT278, the ultra-concentrated, ultra-rapid acting insulin candidate, and the development of a novel oral delivery of peptides platform technology, offer the best opportunities to fulfil this aim. This partnership with Sequel Med Tech is a significant step forward in realising the benefits of AT278 for patients as well building significant value for shareholders.

Monetisation of Royalty and Technology Access Fee Streams

Arecor has sold the global royalty rights related to AT220, an Arestat®-enhanced biosimilar product marketed by a global pharmaceutical company, and all potential milestone and technology access fees related to AT292 (licensed to Inhibrx, now Sanofi’s Efdoralprin alfa) (the “Royalty Financing Agreement”) to Ligand.

Under the terms of the agreement, Ligand will pay Arecor up to $11.0 million (£8.2 million). This includes a $7.0 million upfront cash payment and an additional $4.0 million, which will be payable upon the achievement of certain commercial milestones related to AT220 and AT292, of which $1.0 million is expected to be received during 2026.

As part of the transaction, Ligand will receive warrants over 1,002,739 ordinary shares of 1 pence each in the Company (“Ordinary Shares”) which will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares of the Company. The exercise price for the warrants will be 67.39 pence, being the 30-day volume-weighted average price at the date of the agreement. The warrants are exercisable over 10 years.

Arecor’s strategic priority has been to pursue high-value R&D opportunities that have the potential to generate significant value for shareholders. Near term, the management anticipates that AT278, the ultra-concentrated, ultra-rapid acting insulin candidate, and the development of a novel oral delivery of peptides platform technology, offer the best opportunities to fulfil this aim. The royalty financing agreement provides immediate, non-dilutive capital, allowing the initiation of AT278 Phase 2-enabling activities without delay, and strengthens Arecor’s balance sheet by extending the cash runway to 1H 2027.

Sarah Howell, CEO of Arecor said:

“The royalty financing agreement with Ligand is also an important step forward. This financing extends our cash runway to 1H 2027, strengthening the balance sheet for future potential partnering discussions.”

Todd Davis, CEO of Ligand said:

“We are excited to partner with Arecor on this compelling opportunity to invest in two partnered assets with significant commercial potential. This unique investment exemplifies the types of deals our team aims to pursue, focusing on highly differentiated, de-risked assets that are marketed by strong partners.”

-ENDS-

For more information, please contact:

Notes to Editors

About Arecor

Arecor Therapeutics plc is a clinical stage biopharmaceutical company focused on drug development and delivery in diabetes and other cardiometabolic diseases. The Company is applying its proprietary technology platform, Arestat®, to develop a portfolio of proprietary products, as well as working with leading pharmaceutical and biotechnology companies to deliver enhanced therapeutic products. Its lead product is AT278, the only ultra-concentrated (500U/mL) ultra-rapid acting insulin which is now being co-developed with Sequel Med Tech, a company developing state-of-the art insulin delivery technologies. Arecor is also developing a novel oral delivery platform for peptides (e.g. GLP-1 receptor agonists) targeting the obesity and diabetes markets. The Company is listed on AIM (AIM: AREC) and is based in Cambridge, UK. For further details please see www.arecor.com

About AT278

AT278 is a novel proprietary formulation of an existing insulin, designed to accelerate the absorption of insulin post injection even at very high concentrations (500U/mL). With its best-in-class profile, it has the potential to disrupt the market for insulin treatment as the first concentrated, yet very rapid acting insulin for the growing population of people with diabetes with high daily insulin needs as well as to act as a critical enabler in the development of next-generation, miniaturised longer wear automated insulin delivery (AID) systems.

About Sequel Med Tech

Headquartered in Manchester, New Hampshire, US, Sequel is developing the next generation of transformative drug-delivery advancements. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel was co-founded by visionary Dean Kamen, serial entrepreneur Pablo Legorreta, seasoned medical device executive Bill Doyle and healthcare leader Alan Lotvin, MD. Sequel’s focus is to bring the latest developments in science and technology to the marketplace, helping drive more accessible drug delivery. For more information, please visit www.sequelmedtech.com.

About AT220

Under a license agreement entered into in 2015, Arecor developed a novel and differentiated, Arestat®-enhanced formulation of its global pharmaceutical company partner’s undisclosed product, AT220. The product was first commercialised by Arecor’s partner in November 2023, generating royalties for Arecor under a worldwide license agreement.

About AT292

AT292 is an Arestat®-enhanced, optimised recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency, developed by Arecor under a license agreement entered into by Arecor and Inhibrx in 2020. In 2024 Sanofi acquired Inhibrx’s assets and liabilities associated with AT292, now “SAR447537”. A registration-enabling clinical trial of SAR447537 is underway.

VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001




VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001

VarmX receives Phase 1 waiver from Japanese regulator PMDA
for lead asset VMX-C001

• Japanese regulator, the PMDA, waived the requirement for a Phase 1 trial in Japanese subjects for lead asset VMX-C001, enabling it to go straight to Phase 3 development
• Rare waiver recognizes the global dataset already generated for VMX-C001 and streamlines the path to the important Japanese market
• Japan to be included in global EquilibriX-S Phase 3 trial of VMX-C001 in patients taking FXa DOACs undergoing urgent surgery
• Raises the prospect of faster access for Japanese FXa DOAC patients needing urgent surgery or facing severe bleeding
• Reduces cost and de-risks development of VMX-C001 in Japan

Leiden, The Netherlands, 25 September 2025 – VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting factor Xa (FXa DOACs) and inherited coagulation disorders, announces that the Japanese medicines regulator, the Pharmaceuticals and Medical Devices Agency (PMDA), has waived the requirement for a Japanese Phase 1 trial of lead asset, VMX-C001, a novel bypass agent which restores blood coagulation in patients receiving a FXa DOAC.

The PDMA has recognized the global dataset already generated for VMX-C001 and the unmet need for treatments that can enable urgent surgery in patients on FXa DOACs, and removed the requirement for a Phase 1 (ethnic bridging) study of a drug candidate in the Japanese population before entering further clinical studies in the country. It is very rare for this requirement to be waived entirely and this will enable VarmX to proceed directly to include Japanese patients in its global Phase 3 EquilibriX-S study of VMX-C001. The PMDA has also offered earlier interactions in the development process, potentially leading to an accelerated submission for drug approval in Japan.

This news follows VarmX’s announcement in July 2025, confirming that the FDA had cleared its Investigational New Drug (IND) application for VMX-C001. Also, VarmX announced in August 2025 that the FDA has given VMX-C001 Fast Track Designation. Both events enable the initiation of
EquilibriX-S, a landmark clinical trial evaluating the ability of a FXa DOAC bypassing agent to rapidly and durably restore coagulation in patients taking any FXa DOAC undergoing urgent surgery. VarmX recently entered a partnership with CSL in a strategic collaboration and option agreement to develop this molecule.

By 2030, approximately 30 million patients in the US, Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients will experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge.

John Glasspool, CEO of VarmX, said:

“We are proud that we can include Japan in our global Phase 3 EquilibriX-S study. Being granted a Phase 1 waiver by the Japanese PMDA is a rare example of a drug candidate being allowed to go directly into Phase 3 studies in Japan, enabling a truly global program.

“This recognition highlights both the real unmet need for treatments that  rapidly restore coagulation and enable urgent surgery in patients on Factor Xa direct oral anticoagulants, as well as the robustness of our existing clinical data package. Also, it significantly de-risks our development of VMX-C001 in Japan and potentially allows access for Japanese patients at the same time as Europe and the United States.   

“This is another global milestone in the development of our novel bypass agent, building on the momentum already achieved with US FDA IND approval in July and Fast Track Designation earlier this month.”  

ENDS

Notes to Editors

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter. For more information, please visit www.varmx.com.

About VMX-C001

VMX-C001 is a modified, human, factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade.VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and crucially, no additional thrombotic risk.

For further information, please contact:

Vigo Consulting (media enquiries)
Rozi Morris
+44 20 7390 0230
VarmX@vigoconsulting.com

Attachments

• image1
• Japanese PMDA waiver FINAL2

Basilea awarded BARDA contract for the development of novel oral phase 3-ready antibiotic ceftibuten-ledaborbactam




Basilea awarded BARDA contract for the development of novel oral phase 3-ready antibiotic ceftibuten-ledaborbactam

– Total non-dilutive funding of up to USD 159 million upon completion of predefined milestones, including near-term committed funding of USD 6 million

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, September 25, 2025

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services, has novated a contract from Venatorx Pharmaceuticals, Inc. (Venatorx) to Basilea to support the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. Basilea recently acquired the global rights to ceftibuten-ledaborbactam etzadroxil from Venatorx.

David Veitch, Chief Executive Officer of Basilea, said: “We thank BARDA for their continued collaboration and support for the development of novel anti-infectives to help patients with severe infections. The funding helps us to further advance our newly in-licensed novel antibiotic ceftibuten-ledaborbactam, which we believe holds a strong promise in addressing the critical unmet need for the oral treatment of cUTIs caused by multidrug-resistant Gram-negative bacteria.”

The existing funding agreement between BARDA and Venatorx was novated, with Basilea replacing Venatorx as a contracting party. Under the terms of the contract, Basilea will be reimbursed for a portion of the development costs required to bring ceftibuten-ledaborbactam etzadroxil to market, including the planned Phase 3 clinical studies. The non-dilutive funding comprises an initial amount of approximately USD 6 million and options to provide up to USD 153 million of additional non-dilutive funding upon completion of predefined milestones.

About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations

Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens.

About ceftibuten-ledaborbactam etzadroxil

Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales.^[1] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use.

About complicated urinary tract infections (cUTI)

Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings.

Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options.^[2] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48).

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

For further information, please contact:

This ad hoc announcement can be downloaded from www.basilea.com. 

References

1. J. A. Karlowsky, M. G. Wise, M. A. Hackel et al. Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018–2020 Global Surveillance Collection. Antimicrobial Agents and Chemotherapy 2022, Nov 15;66(11):e0093422
2. T. P. Lodise, T. Chopra, B. H. Nathanson et al. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infectious Diseases 2022, Jun 24;9(7):ofac315.

Attachment

• Press release (PDF)

Fagron announces the acquisition of UCP in North America and FDA inspection update




Fagron announces the acquisition of UCP in North America and FDA inspection update

Regulated information – inside information
Nazareth (Belgium)/Rotterdam (The Netherlands), 25 September 2025 – 7:00 AM CET

Fagron announces the acquisition of UCP in North America and FDA inspection update

Fagron, the leading global player in pharmaceutical compounding, is pleased to announce a strategic acquisition that will significantly reinforce its presence in North America. The company has signed the acquisition of University Compounding Pharmacy (UCP), a 503A pharmaceutical compounder specializing in the health and wellness segment in California, whilst adhering to a disciplined acquisition strategy.

The company has also been inspected by the FDA at its Wichita and Las Vegas facilities, with none of the observations from the 2024 inspection in Wichita being now repeated, which validates our remediation has addressed the Agency’s prior concerns.

UCP

UCP, based in San Diego, the U.S., is a 503A pharmaceutical compounder specializing in the health and wellness segment, with strong positions in hormones and urology and a solid compliance record, making it highly complementary to Anazao and enabling a differential coast-to-coast offering. This underpins Fagron’s strategy to build a nationwide compounding platform in the U.S., spanning both 503A (patient-specific) and 503B (outsourcing) services.

The acquisition deepens Fagron’s presence in North America’s prevention and lifestyle segment and strengthens our position in California, one of the largest and most tightly regulated healthcare markets in the U.S., where licences are difficult to obtain.

The enterprise value of this acquisition is c.$41.5 million. It will be fully financed through Fagron’s own resources and remains subject to customary clearance. This business generates around twenty five million dollars in annual revenue and an EBITDA margin below Fagron’s existing group margin. We expect to realise synergies over the next 18–24 months as the business is integrated into Fagron’s operations.

Quality Update

The Food and Drug Administration (FDA) has conducted an inspection at Fagron Sterile Services (“FSS”) in Wichita, Kansas to verify the corrective and preventive actions taken following the routine inspection in June 2024 and the Warning Letter issued in December 2024. In March 2025, the Agency acknowledged our CAPA submission and stated it adequately addressed their concerns, pending an on-site verification. During the 2025 visit none of the observations from the 2024 inspection were repeated, which validates our remediation has addressed the Agency’s prior concerns.

Separately, following this new routine inspection, the FDA issued a Form 483 with six observations. In addition, the FDA also conducted a routine inspection of the 503B Anazao Health facility in Las Vegas with four observations.

Fagron remains committed to working collaboratively with the FDA to address its inspectional observations and is already implementing new corrective actions to further improve its protocols. Our top priority is providing safe and effective sterile drug products to our customers and their patients and we remain confident in our robust systems and the quality and safety of the products we produce. 

Financial calendar 2025
9 October 2025                Trading update third quarter 2025

Results and trading updates are published at 7.00 AM CET.

Further information
Ignacio Artola
Global Investor Relations Leader
Tel. +34 670385795
ignacio.artola@fagron.com

About Fagron

Fagron is the leading global company active in pharmaceutical compounding, focusing on delivering personalized medicine to hospitals, pharmacies, clinics, and patients in more than 35 countries around the world.

The Belgian company Fagron NV is based on Venecoweg 20A in Nazareth and is listed on Euronext Brussels and Euronext Amsterdam under the ticker symbol ‘FAGR’. Fagron’s operational activities are managed through the Dutch company Fagron BV. Fagron BV’s head office is located in Rotterdam.

Important information regarding forward-looking statements
Certain statements in this press release may be deemed to be forward-looking. Such forward-looking statements are based on current expectations and are influenced by various risks and uncertainties. Consequently, Fagron cannot provide any guarantee that such forward-looking statements will, in fact, materialize and cannot accept any obligation to update or revise any forward-looking statement as a result of new information, future events or for any other reason.

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

Attachment

• Fagron announces the acquisition of UCP in North America and FDA inspection update

H1 25 Results Confirm the Relevance of Roquette’s Strategy




H1 25 Results Confirm the Relevance of Roquette’s Strategy

H1 25 Results Confirm the Relevance of Roquette’s Strategy

• Roquette outperforms its key markets, delivering solid H1 results in current complex market conditions.
• Successful completion of the acquisition of IFF Pharma Solutions¹and implementation of a new organization with two complementary Business Groups².
• +4% turnover growth to €2,371 million (-3% Like-For-Like basis, LFL³) and +18% EBITDA increase to €294 million (-1% LFL), supported by a favorable mix effect and the consolidation of two months of IFF Pharma Solutions.
• +150 bps increase in EBITDA margin to 12.4% (11.2% LFL), driven by IFF Pharma Solutions and the food and nutrition segments, a consistent pricing strategy, and disciplined cost management supported by the Group’s competitiveness program.
• Reflecting the usual seasonality of Working Capital Requirement and excluding the cash impact of the acquisition, Free Cash-Flow landed at -€150 million.

Lille – September 25^th, 2025 – Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, today announced its 2025 H1 results, following the approval of its financial statements by the Board of Directors.

Thierry Fournier, CEO of Roquette, commented on the period: “The successful acquisition of IFF Pharma Solutions was a key milestone for the Group, leading to the evolution of our integrated operating model. With our two Business Groups, operating under the strong Roquette brand, we are already seeing positive signs of their complementarity in the H1 results.”

In the first half of the year, the Group outperformed its key markets:

• The Health & Pharma Solutions Business Group achieved strong results, driven by the contributions from the recently acquired IFF Pharma Solutions and the starch-based excipient business, which partially offset performance in the capsule segment. “The overall commercial results of the Business Group benefitted from the positive impact of IFF Pharma Solutions, which exceeded the Group’s forecasts. This outcome confirms the strength of Roquette’s strategy to offer a more diversified portfolio covering all drug delivery technologies, along with an expanded geographical footprint. I would add that the integration project is on track to unlock the potential of this combination as expected.”
  • The Nutrition & Bioindustry Business Group’s performance was fueled by sustained demand for Roquette’s specialty products, leading to a favorable mix effect, with market share growth in some specific markets. The Business Group’s consistent pricing strategy and effective cost management led to a significant improvement in its EBITDA margin. “The Nutrition & Bioindustry Business Group has increased margins, underscoring the effectiveness of its disciplined commercial strategy. This approach has highlighted the Business Group’s ability to navigate challenging markets and contribute to overall robust results.”

In a volatile macroeconomic environment, Roquette remains focused on the seamless execution of its strategy, its competitiveness and its deleveraging. “To effectively execute our strategy, we will focus on three key levers: operational excellence, innovation, and the implementation of our new operating model, all while continuing the successful integration of IFF Pharma Solutions in the short term. This approach is designed to enhance profitability and create value for all our stakeholders going forward,” concluded Thierry Fournier.

HALF YEAR 2025 CONSOLIDATED KEY FIGURES⁴

^{(a) Excluding non-recurring items amounting to €164 million (€28 million in H1 24) and associated taxes.
(b) IFF Pharma Solutions acquired on May 1st, 2025
(c) Combined EBITDA includes IFF Pharma Solutions estimated EBITDA over the last twelve months.}

FINANCIAL PERFORMANCE

SOLID H1 25 RESULTS IN COMPLEX MARKET CONDITIONS

Roquette’s operational performance in H1 2025 showed positive momentum, with turnover and EBITDA up 4% and 18%, respectively (down 3% and 1% on a Like-For-Like basis). This growth was primarily driven by the consolidation of IFF Pharma Solutions since May 1^st, 2025, which has shown promising results, and a positive product mix.

In a complex economic environment, the Group maintained operational resilience and focused on its strategic execution, resulting in volume growth of 2% and market share gains in some key markets.

The EBITDA margin expanded to 12.4% (11.2% LFL), up from 10.9% at end of June 2024. This improvement reflects the strong contribution of the higher value-added products from IFF Pharma Solutions and the food and nutrition segment. A more favorable cost environment along with rigorous cost management further reinforced profitability.

Cost management efforts are driven by the Group’s ambitious competitiveness program, initiated in 2023, which has constantly exceeded expectations. Building on its success, the program has been extended from 2026 to 2028 with even more ambitious targets, ensuring continued structural efficiency improvement and sustainable value creation.

The cost of net financial debt amounted to €32 million, up from €25 million at end of June 2024. This increase was expected as it reflected the higher debt volume following the acquisition in May 2025. This was partially offset by lower interest rates as well as by the interest income collected on the €1.2 billion deposit initiated after the inaugural bond issuance in November 2024 until the acquisition.        

The other financial charges amounted to €25 million, up from €6 million at end of June 2024, mainly due to the strengthening of the euro against the US dollar affecting the revaluation of some monetary balance sheet items.

The reported net result for the period was -€115 million, compared to €26 million at end of June 2024. This decline mainly reflects:

• non-cash impairment charges of €55 million (Roquette India) and €67 million (Roquette America);
• the anticipated IFF Pharma Solutions and Qualicaps acquisition and integration costs representing €52 million.

Excluding these non-recurring items and the associated taxes, the adjusted net result amounted to €42 million compared to €46 million at end of June 2024.

The Group successfully navigated challenging market conditions in the first semester 2025, including the tariff measures implemented by the U.S. administration. The Group actively monitors the situation, and a dedicated global task force has been put in place to collect data on exposures and impacts. To date, the flows to and from the US affected by the tariffs would represent less than 5% of total turnover (based on contract value in 2025). The Group has a globally diversified footprint that allows to adapt flexibly to changing business conditions, and continuously and proactively adjust strategies to minimize any potential impact. Moreover, regular and constructive dialogue is maintained with customers and partners to ensure supply chain resilience and mitigate potential disruptions.

FREE CASH-FLOW GENERATION

In H1 2025, Free Cash-Flow stood at -€150 million, from -€9 million at end of June 2024, excluding the cash-impact linked to the acquisition of IFF Pharma Solutions. Several factors underpin this performance:

• Working Capital Requirement reflected normal mid-year seasonality, with increases in inventories and receivables, compared to prior year which was unusually low due to record inflation;
• Operating Cash-Flow increased to €186 million from €176 million, in line with strong EBITDA growth;
• Capital expenditures remained stable.

PERFORMANCE BY BUSINESS GROUP

HEALTH & PHARMA SOLUTIONS – BOOSTED BY IFF PHARMA SOLUTIONS ACQUISITION

Sales amounted to €546 million, up 33% from end of June 2024, boosted by the two months consolidation of the IFF Pharma Solutions acquisition. EBITDA came in at €145 million, representing a margin of 26.5%.
IFF Pharma Solutions delivered results above expectations, driven by strong performance across its portfolio. The starch excipient business demonstrated sustained performance, partially offsetting softer volumes in the capsules category. Excluding IFF Pharma Solutions and the exchange rate impact, sales and EBITDA declined 8% and 16%, respectively.

This resilience underlines the relevance of the Group’s strategic orientation toward diversification to strengthen its ability to navigate fluctuations in specific product lines while maintaining overall profitability.

NUTRITION AND BIOINDUSTRY – STRONG EBITDA GROWTH

Sales amounted to €1,923 million, down 2% from end-June 2024 and EBITDA stood at €149 million, with margin improvement to 7.8% (+110bps) due to a positive mix effect.

Demand remained soft overall for commodities due to economic uncertainties, prices declined in line with the raw material price decrease and pressure remained due to lower sugar price in Europe.
Nevertheless, volume grew in Europe, accompanied by a market share gain of over 1 point in some key markets. In contrast, complex conditions are observed in the Americas and competition intensified in India.

The food and nutrition segment continued to deliver strong results, with European volumes growth, driving EBITDA margin enhancement.

This performance demonstrates the Group’s ability to capture value in high-demand categories in challenging market conditions.

BALANCE SHEET

^{(a) Combined EBITDA includes IFF Pharma Solutions estimated EBITDA over the last twelve months.}

Strong liquidity and balanced maturity profile

The debt maturity profile is also well-balanced, with no major repayments in the next 3 years – excluding the bridge refinancing in 2026 – and an average debt maturity of 3.7y. In terms of liquidity, as of June 2025, Roquette maintained a strong liquidity position, with over 1.3 billion euros in available liquidity (€0.7bn undrawn credit lines, €0.2bn undrawn commercial papers and cash available). 

At end of June 2025, the Group’s net financial debt rose to €2,854 million, compared with €237 million at end-December 2024. This level reflects the anticipated impact of the IFF Pharma Solutions acquisition completed in May 2025.

Consequently, the restated IFRS leverage ratio reached 3.75x considering a conservative calculation for the estimated last twelve-month combined EBITDA, leaving headroom under covenants and allowing the Group to comply with its financial covenants at end of June 2025.

The Group reaffirms the IFRS leverage ratio target of 2.3x to 2.7x by 2027, remaining fully committed to maintaining a strong Investment Grade rating.

Status of the accounts:
The limited review procedures on the HY 2025 consolidated financial statements have been completed and the limited review report will be issued on the 25^th of September 2025. It will include a qualification as the Group completed the acquisition of the IFF Pharma Solutions in May 2025, following significant legal reorganizations (including carve-out transactions), and while Management is working to stabilize the impact of these changes, it was challenging to fully substantiate certain balance sheet items at the acquisition date and at June 30, 2025. However, the reported figures are consistent with expectations and the IFF Pharma Solutions audited combined financial statements on December 31, 2024. Integration efforts are expected to clarify the balance sheet and support the contribution of the acquired entities to the Group’s results for the 2025 year-end closing.

About Roquette

Roquette is a leading provider of plant-based ingredients, excipients and pharmaceutical solutions dedicated to enhancing the quality and convenience of essential products for consumers and patients worldwide.  
Roquette employs more than 11,000 people globally, operating in more than 150 countries through more than 40 manufacturing sites and 20 R&D and innovation centers. The company achieved a turnover of €4.5 billion in 2024. 

Harnessing natural resources like wheat, corn and cellulose, Roquette crafts high-performance ingredients and solutions used in everyday foods, oral medications, advanced biopharmaceuticals, and bio-based products.   

Roquette is a family-owned company driven by a long-term vision and a constant commitment to innovation. For almost a century, Roquette has been empowering better living and building a sustainable future by offering the best of nature. 

Discover more about Roquette here 

Press contacts:
Brunswick
Antoine Parison
+33 (0) 7 88 72 28 95
aparison@brunswickgroup.com

Roquette
Corporate Communications
Susannah Duquesne
Susannah.duquesne@roquette.com

Financial Communications
Eloïse de la Chaux
eloise.de-la-chaux@roquette.com

DISCLAIMER – Certain statements contained in this press release may contain forecasts that specifically relate to future events, trends, plans or objectives. By nature, these forecasts involve identified and unidentified risks and uncertainties and may be affected by many factors likely to give rise to a significant discrepancy between the actual results and those indicated in these statements. The group does not undertake to publish an update or revision of these forecasts, or to communicate on new information, future events or any other special circumstance. The amounts presented in this presentation have been rounded to the nearest hundred/unit, which may result in slight discrepancies in totals. Thus, the financial data is provided for informational purposes only and may not exactly match the figures in the consolidated financial statements.

FINANCIAL INFORMATION – This press release and Roquette’s full regulated information are available on the Group’s website: Roquette website

GLOSSARY

To measure its performance, the Group uses certain financial indicators that are not defined by IFRS standards. These indicators are used in the operational monitoring of the Group’s activities and its financial communication (press releases, financial presentations, etc.).

APPENDIX 1 – INCOME STATEMENT

APPENDIX 2 – COMPREHENSIVE INCOME STATEMENT

APPENDIX 3 – BALANCE SHEET

APPENDIX 4 – CASH-FLOW STATEMENT

APPENDIX 5 – GROSS DEBT TOWARDS FINANCIAL INSTITUTIONS

¹ Completion of Roquette’s acquisition of IFF Pharma Solutions
² New Organization following the Acquisition of IFF Pharma Solutions
³ Like-For-Like basis excludes exchange rates impact and perimeter variation.
⁴ The definition of the alternative performance indicators is provided in the appendices of this press release.

Santhera Provides Update on Convertible Bond Issued on 23 September 2025




Santhera Provides Update on Convertible Bond Issued on 23 September 2025

Ad hoc announcement pursuant to Art. 53 LR

Pratteln, Switzerland, September 25, 2025 – Santhera Pharmaceuticals (SIX: SANN) today provides the following update regarding its convertible bond announced on 23 September 2025:

Details:

• The conversion price has been set at CHF 13.5446, representing a 10% premium to the volume-weighted average price (VWAP) of Santhera’s shares on 23 September 2025.
• The coupon is 7%, reflecting a reduction compared with the previous bond.
• The aggregate principal amount of the convertible bond, including the exchange at parity of the prior bond, is CHF 20.132 million.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in China by the National Medical Products Administration (NMPA) and Hong Kong by the Department of Health (DoH). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China and certain countries in Southeast Asia to Sperogenix Therapeutics. For further information, please visit www.santhera.com.

AGAMREE® is a trademark of Santhera Pharmaceuticals.

For further information please contact:

Santhera
Catherine Isted, Chief Financial Officer:

IR@santhera.com

ICR Healthcare

Santhera@icrhealthcare.com

Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

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Attachment

• 250925 Update on convertible bond_Final