LogicMark Launches Predictive Activity Metrics in Freedom Alert Max Device




LogicMark Launches Predictive Activity Metrics in Freedom Alert Max Device

Revolutionary AI-powered technology shifts from reactive emergency response to proactive fall prevention through continuous health monitoring

LOUISVILLE, Ky., Sept. 23, 2025 (GLOBE NEWSWIRE) — LogicMark, Inc. (OTC: LGMK) (the “Company”), a provider of personal emergency response systems (PERS), health communication devices, and technology for the growing care economy, today announced the launch of Activity Metrics in its Freedom Alert Max device. This breakthrough feature introduces activity tracking capabilities powered by predictive AI analytics, fundamentally transforming medical alert technology from reactive emergency response to proactive health crisis prevention.

Activity Metrics enables the Freedom Alert Max medical alert and health communication device to continuously track users’ daily steps and active time, providing caregivers with real-time insights and a complete seven-day activity history through LogicMark’s Care Village app. This data is critical for maintaining senior health and longevity, as regular physical activity directly correlates with vitality and fall prevention in aging adults; decreased activity can often signal underlying issues.

Activity Metrics is one of many services provided as part of LogicMark’s patented Care Processing Technology, which analyzes patterns of aging adults using proprietary AI algorithms. This data establishes a comprehensive, baseline user wellness profile via patent-pending Care Village Digital Twin technology. Through the digital twin, LogicMark is building a back-end mirror image of its users’ physical capabilities and mobility. The technology enables care processing to recognize patterns across individuals and generate the prediction of potential fall risks before actual falls or other emergencies happen. This approach allows for a proactive and preventative approach to caregiving and safer environments for seniors overall.

“We’re transforming medical alert technology by shifting from waiting for an emergency to proactive health monitoring, preventing emergencies and falls before they happen,” said Chia-Lin Simmons, CEO of LogicMark. “Activity Metrics combined with features like our recently launched Medication Reminders, represent our commitment to proactive and preventative senior safety. Now, we can identify potential health issues and fall risks early, giving families and healthcare providers the insights they need to intervene before a crisis occurs.”

LogicMark’s Activity Metrics continues to differentiate the Freedom Alert Max in the medical alert and health communication device market, as the most advanced personal emergency response system available, providing 24/7 monitoring and emergency assistance both at home and on-the-go. The integration of predictive AI analytics with comprehensive activity tracking creates an unmatched health monitoring ecosystem that goes far beyond traditional medical alert devices. The Freedom Alert Max hosts a variety of additional vital features, including Caretaker App, 24/7 US-based monitoring, fall detection, geofencing for memory care alzheimer roaming, emergency caregiver video calling, GPS location services, Medicine reminders, unlimited calling to friends and family, and 988 Suicide and Crisis Lifeline pre-programmed into the device.

LogicMark’s proprietary fall detection technology senses falls and sudden movements and immediately calls for help, even if the person cannot speak or use the device. As falls and movements are detected, the LogicMark algorithm can learn patterns to prevent false positives and use that information to predict when future falls are likely to happen.

Robust GPS location and geofencing capabilities eliminate the concern of aging adults with Alzheimer’s and other forms of dementia wandering off, while still offering independence and the ability to age in place. Geofencing allows caregivers to set a map boundary and receive alert notifications when the device crosses those areas.

Activity Metrics is now available on all Freedom Alert Max devices. The Care Village app can be downloaded for iPhone here and Android here.

About LogicMark, Inc. 
LogicMark, Inc. (OTC: LGMK) is on a mission to enable people of all ages to lead lives with dignity, independence, and the joy of possibility. LogicMark provides PERS, health communications devices, personal safety apps, services, and technologies to create a Connected Care Platform.

LogicMark is dedicated to building a “Care Village” with proprietary technology and innovative solutions for the care economy. A team of leading technologists with a deep understanding of IoT, AI, and machine learning is passionately focused on understanding consumer needs. The Company’s PERS technologies are sold through the United States Veterans Health Administration, dealers and distributors, and directly to consumers. LogicMark has been awarded a contract by the U.S. General Services Administration that enables it to distribute products to federal, state, and local governments. 

To learn more, visit www.investors.logicmark.com and www.logicmark.com.

Media Contact:
logicmark@relativity.ventures

LogicMark Launches Predictive Activity Metrics in Freedom Alert Max Device




LogicMark Launches Predictive Activity Metrics in Freedom Alert Max Device

Revolutionary AI-powered technology shifts from reactive emergency response to proactive fall prevention through continuous health monitoring

LOUISVILLE, Ky., Sept. 23, 2025 (GLOBE NEWSWIRE) — LogicMark, Inc. (OTC: LGMK) (the “Company”), a provider of personal emergency response systems (PERS), health communication devices, and technology for the growing care economy, today announced the launch of Activity Metrics in its Freedom Alert Max device. This breakthrough feature introduces activity tracking capabilities powered by predictive AI analytics, fundamentally transforming medical alert technology from reactive emergency response to proactive health crisis prevention.

Activity Metrics enables the Freedom Alert Max medical alert and health communication device to continuously track users’ daily steps and active time, providing caregivers with real-time insights and a complete seven-day activity history through LogicMark’s Care Village app. This data is critical for maintaining senior health and longevity, as regular physical activity directly correlates with vitality and fall prevention in aging adults; decreased activity can often signal underlying issues.

Activity Metrics is one of many services provided as part of LogicMark’s patented Care Processing Technology, which analyzes patterns of aging adults using proprietary AI algorithms. This data establishes a comprehensive, baseline user wellness profile via patent-pending Care Village Digital Twin technology. Through the digital twin, LogicMark is building a back-end mirror image of its users’ physical capabilities and mobility. The technology enables care processing to recognize patterns across individuals and generate the prediction of potential fall risks before actual falls or other emergencies happen. This approach allows for a proactive and preventative approach to caregiving and safer environments for seniors overall.

“We’re transforming medical alert technology by shifting from waiting for an emergency to proactive health monitoring, preventing emergencies and falls before they happen,” said Chia-Lin Simmons, CEO of LogicMark. “Activity Metrics combined with features like our recently launched Medication Reminders, represent our commitment to proactive and preventative senior safety. Now, we can identify potential health issues and fall risks early, giving families and healthcare providers the insights they need to intervene before a crisis occurs.”

LogicMark’s Activity Metrics continues to differentiate the Freedom Alert Max in the medical alert and health communication device market, as the most advanced personal emergency response system available, providing 24/7 monitoring and emergency assistance both at home and on-the-go. The integration of predictive AI analytics with comprehensive activity tracking creates an unmatched health monitoring ecosystem that goes far beyond traditional medical alert devices. The Freedom Alert Max hosts a variety of additional vital features, including Caretaker App, 24/7 US-based monitoring, fall detection, geofencing for memory care alzheimer roaming, emergency caregiver video calling, GPS location services, Medicine reminders, unlimited calling to friends and family, and 988 Suicide and Crisis Lifeline pre-programmed into the device.

LogicMark’s proprietary fall detection technology senses falls and sudden movements and immediately calls for help, even if the person cannot speak or use the device. As falls and movements are detected, the LogicMark algorithm can learn patterns to prevent false positives and use that information to predict when future falls are likely to happen.

Robust GPS location and geofencing capabilities eliminate the concern of aging adults with Alzheimer’s and other forms of dementia wandering off, while still offering independence and the ability to age in place. Geofencing allows caregivers to set a map boundary and receive alert notifications when the device crosses those areas.

Activity Metrics is now available on all Freedom Alert Max devices. The Care Village app can be downloaded for iPhone here and Android here.

About LogicMark, Inc. 
LogicMark, Inc. (OTC: LGMK) is on a mission to enable people of all ages to lead lives with dignity, independence, and the joy of possibility. LogicMark provides PERS, health communications devices, personal safety apps, services, and technologies to create a Connected Care Platform.

LogicMark is dedicated to building a “Care Village” with proprietary technology and innovative solutions for the care economy. A team of leading technologists with a deep understanding of IoT, AI, and machine learning is passionately focused on understanding consumer needs. The Company’s PERS technologies are sold through the United States Veterans Health Administration, dealers and distributors, and directly to consumers. LogicMark has been awarded a contract by the U.S. General Services Administration that enables it to distribute products to federal, state, and local governments. 

To learn more, visit www.investors.logicmark.com and www.logicmark.com.

Media Contact:
logicmark@relativity.ventures

X-Chem Launches Chemomics: Applying Omics-Scale Chemistry Data to Yield New Candidate-Quality Molecules




X-Chem Launches Chemomics: Applying Omics-Scale Chemistry Data to Yield New Candidate-Quality Molecules

Intersection of best-in-class DEL, medicinal chemistry and innovative computation sciences launches era of high-throughput insights for drug discovery

WALTHAM, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) — X-Chem, a global leader in data-driven drug discovery, today announced the launch of chemomics: a transformational framework that harnesses the full scale of DNA-encoded library (DEL) technology with computational sciences and AI/ML to extract years’ worth of structure-activity relationship (SAR) insights, generate highly predictive models, and unveil a diversity of starting points. Chemomics uniquely equips discovery programs at their inception with an unprecedented data foundation – empowering teams to reach clinical candidates with transformative speed and confidence.

Chemomics is built on X-Chem’s high signal-to-noise DEL technology, delivering reliable data at true omics scale. Rather than treating DEL as a one-step screen, chemomics establishes a discovery framework that pairs billions of high-quality data points with advanced modeling, design, and analysis – driving predictive insights that fuel actionable, data-grounded decisions earlier.

Chemomics emerged from X-Chem’s drive to unlock the true value of DEL, moving beyond hit lists to reveal the depth of information contained in billions of data points. It addresses the longstanding need for defensible data and clear rationale in decision-making. The approach also has the advantage of transparency – with no “black box” – and hypotheses confirmed through high-throughput synthesis and testing. Chemomics provides actionable insights earlier in discovery, helping teams make confident decisions with speed and clarity.

“The real promise of chemomics is its impact to redefine small molecule drug discovery, enabling unprecedented knowledge building by leveraging billions of data points,” said Karen Lackey, CEO of X-Chem. “Our mission is to be the partner organization of choice, making a difference in bringing life-changing therapies closer to patients.”

Through DEL-ML, pharmacophore modeling, and SAR analysis, chemomics gives discovery teams practical tools to recognize meaningful trends and guide molecule design. Built on years of investment in high signal-to-noise DEL technology, chemomics makes this unprecedented scale of data meaningful. This gives discovery teams confidence in their path forward and marks a new era of discovery powered by DEL’s unprecedented data dimensions.

X-Chem will present chemomics during Discovery on Target this week in Boston. Attendees can visit Booth #303 in the exhibit hall and join the chemomics launch reception on September 24 from 5:00 to 7:00 p.m. at The Fens, Boston Sheraton.

About X-Chem

X-Chem is redefining small molecule drug discovery through a powerful combination of computational sciences, discovery chemistry and data-driven insight. As the pioneer and global leader in DNA-encoded library (DEL) technology, X-Chem provides the foundation for smarter hit identification, accelerated lead progression and greater confidence in early discovery. X-Chem partners globally to turn complex discovery challenges into actionable solutions. Learn more at www.x-chemrx.com.

Media Contact:
Alli Cooke
Alli.Cooke@llyc.global
616.258.5769

AAMI Foundation Awards Grants to Hospital, University Research Teams




AAMI Foundation Awards Grants to Hospital, University Research Teams

Grants will support research at Children’s Hospital of Philadelphia, University of Maryland, University of Massachusetts Amherst

Arlington, Virginia, Sept. 23, 2025 (GLOBE NEWSWIRE) — The AAMI Foundation today announces the recipients of the latest group of Mary K. Logan Research Grants. These three university and hospital projects align with the overall mission of the Association for the Advancement of Medical Instrumentation (AAMI) to promote the safe and effective use of health technology for the purpose of securing optimal patient outcomes. Congratulations to the research teams at the Children’s Hospital of Philadelphia (CHOP), the Elaine Marieb Center for Nursing and Engineering Innovation at the University of Massachusetts Amherst, and the University of Maryland.

CHOP Study on Bag Mask Ventilation of Pediatric Patients

Elizabeth Hyde, MD, MSE, FAAP, Pediatric Critical Care Fellow Physician at the Children’s Hospital of Philadelphia (CHOP), will lead a team of researchers to fill a gap in the literature of an objective, reliable, bag mask valve (BMV) quality in pediatric patients.  

This study is of immense importance, as bag mask valve ventilation is a cornerstone of life-threatening respiratory failure management and a critical step prior to intubation or safe placement of a breathing tube. Further, respiratory failure is the leading cause for admission to pediatric intensive care units (PICUs) and impacts more than 40,000 children in the United States annually. 

The technique for BMV use involves fitting a mask over the patient’s face and manually delivering breaths by squeezing a bag. Failure to provide high-quality BMV ventilation dramatically increases the risk of complications during intubation, ranging in severity from low oxygen levels to cardiac arrest. Building on existing academic literature, this study aims to pioneer a machine-learning-driven BMV assessment tool that can provide an objective measure of BMV quality for pediatric patients. This study is expected to be completed by mid-2026.

University of Massachusetts Amherst Researchers to Study IV Infusion and Smart Pumps 

Researchers at the Elaine Marieb Center for Nursing and Engineering Innovation at the University of Massachusetts Amherst, led by Karen Giuliano, PhD, RN, MBA, will produce novel research to help improve the practice of IV infusion.

Despite the importance of IV infusion and the significant safety issues, minimal research is available to improve this high-risk practice. The Marieb Center already has an IV Smart Pump Laboratory and a long-standing program of IV Smart Pump research focused on usability, safety, and accuracy alongside a national group of research collaborators.  

The study, entitled The Use of Eye-tracking Technology to Measure Cognitive-Behavioral Processes During IV Smart Pump Programming, will support the development of relevant, evidence-based clinical practice recommendations and to inform IV Smart Pump technology innovation. The researchers expect to complete the study by mid-2026.

University of Maryland Study on Medical Device Polymeric Materials Subject to Sterilization

Led by principal investigator Mohamad Al-Sheikhly, Ph.D., of the University of Maryland’s Department of Materials Science and Engineering, this study seeks to assess one promising alternative to ethylene oxide (EO) sterilization.  

Entitled A Comprehensive Investigation into the Compatibility of Medical Device Polymeric Materials Subject to Sterilization Modalities for Update of the TIR17, the study will be conducted in collaboration with industry partners from Abbott Laboratories, Johnson & Johnson, Medtronic, and Noxilizer. 

Polymeric materials representing nine polymer “classes” relevant to the medical device industry will be subjected to sterilization via hydrogen peroxide. Prior to and upon exposure to the sterilization modalities by the industry partners, the polymeric materials will be characterized at the University of Maryland, College Park using a comprehensive series of quantitative methods.  

The study aims to deliver a comprehensive analysis of the characterization methods, mechanisms of the effects of hydrogen peroxide sterilization to enhance AAMI TIR17: 2024; Compatibility of materials subject of sterilization and contribute to a future strategic plan for sterilization for use by the healthcare manufacturing industry. The study is expected to be completed by mid-2026.  

Join the AAMI Foundation in congratulating the worthy recipients of these Mary K. Logan Research Grants and wishing them well as they commence their efforts to bring new knowledge to the health technology field and support optimal patient outcomes!  

CONTACT: Contact the AAMI media team at dvisnovsky@aami.org

Labviva Kicks Off Smart Lab of the Future Tour




Labviva Kicks Off Smart Lab of the Future Tour

Life sciences procurement leader showcases AI-driven supply chain innovation at global events

BOSTON, Sept. 23, 2025 (GLOBE NEWSWIRE) — Labviva, the leading AI-powered procurement platform for life sciences, today announced the launch of its Smart Lab of the Future tour—a global initiative showcasing how AI-driven procurement is transforming scientific research. Through a series of high-profile events and speaking engagements across North America and Europe, Labviva will spotlight customer innovations and share a roadmap for organizations aspiring to become Smart Labs of the Future.

The tour underscores Labviva’s commitment to driving the adoption of AI in supply chain procurement for global pharmaceutical, biotechnology, and research university labs. Experts will discuss industry priorities, including supply chain resilience, regulatory compliance, cost optimization, and supplier diversity.

“The Smart Lab of the Future tour is more than a series of events—it’s about inspiring global dialogue around how AI can unlock tremendous efficiencies for research laboratories,” said Siamak Baharloo, CEO of Labviva. “We’re highlighting proven customer impact, global accessibility, and the innovations needed to transform procurement into a strategic driver of scientific advancement.”

Smart Lab of the Future Tour Stops

Lab Manager AI & Lab Software Digital Summit
On Sept. 10, Labviva CEO Siamak Baharloo and CTO Nicholas Rioux presented a webinar on Navigating the New Landscape of Laboratory Research at the virtual summit. This session explored how AI-enabled procurement and diversified supplier ecosystems help research teams adapt to economic realities while accelerating scientific innovation.

Procurement & Supply Chain Live – London | Sept. 23-24, 2025
On Sept. 24 (14:15–15:00 GMT+1), Regeneron’s Senior Vice President and Chief Procurement Officer will present the panel discussion titled The Future of Procurement Technology. The panel will explore the future of procurement tools, platforms, and ecosystems. In addition, Labviva customer Regeneron has been shortlisted as a finalist for the Global Procurement and Supply Chain Award’s best Procurement Transformation. Winners will be announced at the award ceremony on Sept. 24.

Next Gen Supply Chain Conference – Nashville, TN | Oct. 22–24, 2025
On Oct. 23 (9:45–10:05 a.m. ET), Regeneron will share a case study detailing its journey of digital transformation across its R&D procurement ecosystem, highlighting the Regeneron Marketplace, which Labviva powers. The platform delivers transparency, efficiency, and measurable savings while advancing supplier diversity.

World Procurement Excellence Summit – Frankfurt, Germany | Oct. 30–31, 2025
Labviva will showcase its global capabilities in Germany at the World Procurement Excellence Summit. On Oct. 30 (14:55–15:15 CEST), Nick Premnath, Labviva’s SVP of Commercial Strategy, will present Neutral Party Strategy: Harnessing AI to Transform Procurement and Supply Chain in Europe. The session will demonstrate how Labviva’s neutral marketplace model supports compliance with EU regulations, unlocks supplier opportunities, and builds resilient and sustainable supply chains. To schedule a meeting or press interview with Labviva at an upcoming conference, please contact Gabrielle Lescarbeau at gabby@penvine.com.

To learn more about Labviva, visit www.labviva.com.

About Labviva
Labviva is the leading AI-driven procurement platform built for life sciences laboratories. By connecting researchers, suppliers, and procurement teams in a transparent marketplace, Labviva delivers cost savings, compliance assurance, and supply chain resilience—while advancing supplier diversity and innovation across the globe. Through its Smart Lab of the Future thought leadership series, Labviva is showcasing the impact of digital transformation on laboratory sourcing and procurement worldwide. To learn more about how Labviva accelerates the science of life, visit us at www.labviva.com.
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Media Contacts:
Gabrielle Lescarbeau
PenVine PR
413-896-1991
gabby@penvine.com

Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update




Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update

Ad hoc announcement pursuant to Art. 53 LR

A conference call will be held on September 23, 2025, at 14:00 CEST / 13:00 BST / 08:00 BST.
Details are at the end of this news release

Pratteln, Switzerland, September 23, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s financial results for the six months ended June 30, 2025, reports on progress with AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) and provides updates on its corporate and financing initiatives.

Highlights

• Total revenue increased 70% to CHF 24 million (H1 2024: CHF 14.1 million) driven by strong sales growth in launched markets in addition to growing royalty and product supply revenues
• Product sales increased 76% to CHF 11.6 million (H1 2024: CHF 6.6 million), led by Germany and Austria with first contributions from the UK following the Q2 launch
• Royalties from licensing partners in the U.S. and China of CHF 5.4 million (H1 2024: CHF 0.9 million), already >25% above full year 2024; further acceleration expected in H2 2025
• Global sales (including partners) of AGAMREE exceed USD 100 million on a four consecutive quarter basis, ahead of expectations, triggering a USD 25 million sales milestone payment due, reflected in cost of sales (COS)
• Operating expenses (excluding non-cash compensation) of CHF 25 million (H1 2024: CHF 24.1 million), in line with full year CHF 50-55 million guidance
• Operating loss of CHF 35.4 million (H1 2024: loss of CHF 17.7 million)
• Global rollout advancing with new distribution agreements (post period-end) across five Gulf Cooperation Council (GCC) countries, India, and Türkiye
• Cash and cash equivalents of CHF 18.4 million at June 30, 2025 (Dec 31, 2024: CHF 40.9 million); strengthened by approximately CHF 20 million of growth capital in September 2025
• Cash-flow break-even guidance maintained for mid-2026
• Full year 2025 revenue is expected to exceed the previous guidance range of CHF 65-70 million

Dario Eklund, CEO of Santhera said: “It has been an exciting period for the business, as the global rollout of AGAMREE has continued at pace. Our partner Catalyst is seeing particularly strong demand in the US, with increasing expectations in China through Sperogenix. Sales in Germany and Austria continue to exceed expectations, and the UK is contributing positively following the Q2 launch. We look forward to the second half of the year, with the publication of our GUARDIAN study on the horizon and the rollout of AGAMREE continuing through direct launches in Europe and via distribution and licensing partners globally. All these efforts are aimed at enabling more patients access to this important treatment around the world.”

BUSINESS AND CORPORATE UPDATE
(Including post period events)

• Direct market sales growing strongly with approximately 40% of steroid using DMD patients in Germany now treated with AGAMREE. Austria becomes the first country to have in excess of 50% market share for DMD patients taking corticosteroids

• Pricing and reimbursement discussions advancing in Spain, Italy and the Nordic regions, with launches expected from Q4 2025 into Q1 2026
• US partner Catalyst Pharmaceuticals, Inc. (“Catalyst”) posted strong AGAMREE H1 sales of USD 49.4 million, on track to reach its guidance for FY 2025 sales of USD 100-110 million, which would trigger an additional milestone to Santhera of USD 12.5 million
• Chinese partner Sperogenix Therapeutics Ltd. (“Sperogenix”) commences commercial rollout on a non-reimbursed basis. Forecasted demand in China for 2025 and 2026 has increased
• Continued rollout of AGAMREE worldwide with distribution agreements signed for five Gulf Corporation Council (GCC) countries, India and Türkiye post period end
• Catherine Isted joined Santhera as CFO in February and Dr. Melanie Rolli joined the Santhera Board in May

Successful launches drive own market sales in Europe
Following successful 2024 launches in Germany and Austria, patient numbers continue to grow, with approximately 450-500 patients having initiated AGAMREE and many of these patients having been on the therapy for well over a year. In Germany, use is broadening beyond the initial pediatric cohort as neurologists increasingly (re)start or switch older DMD patients to AGAMREE. Combination therapy with givinostat is also rising in the country. Roughly 40% of corticosteroid-using DMD patients in Germany have been treated to date with AGAMREE. In Austria, strong uptake has continued into 2025, making it the first country where more than half of steroid-using Duchenne patients are being treated with AGAMREE.

In the United Kingdom, after positive final NICE guidance in January 2025, AGAMREE became available nationwide from April. Updated UK guidelines on “Corticosteroids in Duchenne muscular dystrophy” (April 2025) favor daily regimens and recognize AGAMREE as equally effective with fewer side effects than traditional corticosteroids. In mid-Q3, Santhera introduced a home-delivery program to streamline access and reduce administrative burden on centers. Early feedback has been positive and is expected to support ordering momentum into Q4.

Advancing the rollout of AGAMREE across Europe
A key focus of the business is the continued rollout across Europe, and the Company is advancing multiple national reimbursement submissions and pricing negotiations across the continent.

AGAMREE has been available in Spain through a paid, named-patient program since mid-2024, and the Company has been working to secure full approval and reimbursement so all eligible patients can access the medicine. Santhera’s proposal is scheduled for discussion at the upcoming October CIMP meeting. Subject to a positive outcome, the launch into regional and hospital formularies is expected to begin in Q4 2025 and to continue into 2026 as regional rollout progresses. In Portugal, an early access plan is about to start, with pricing and reimbursement discussions running in parallel.

Across the Nordics – Sweden, Denmark, Finland, and Norway – pricing and reimbursement filings are progressing alongside pre-marketing activities conducted by local teams. First sales are anticipated between Q4 2025 and Q1 2026 as country launches commence.

In Italy, following discussions with the Italian Medicines Agency (AIFA), the Company has decided to update the reimbursement dossier with long-term GUARDIAN study data once available. Approval is anticipated in late Q1 2026, assuming good progress with regulators over the coming quarter. In the meantime, an early access program is being rolled out with the aim of covering the majority of Italian expert centers, supported by strong engagement with key opinion leaders and patient advocacy groups.

Reimbursement discussions continue in the Benelux region, with launches expected during 2026. In France, pricing negotiations with CEPS are ongoing. As previously disclosed, Santhera expects to include additional GUARDIAN data and potentially other supportive evidence in the dossier to achieve the appropriate ASMR rating and broader positioning. The Company will update the market on expected launch timing as discussions progress. In Switzerland, pre-marketing activities have begun, with marketing authorization expected in H1 2026, with fully reimbursed launch targeted for the second half of 2026.

Strong US partner sales with Catalyst continues
Santhera’s U.S. licensing partner, Catalyst, continued to report strong growth, delivering AGAMREE sales of USD 49.4 million in the first half of 2025, driven by accelerated physician adoption. This strong and sustained uptake underscores AGAMREE’s positioning as a new standard of care for DMD. Based on current projections, Catalyst has guided USD 100-110 million in 2025 sales. Upon achieving at least USD 100 million, Santhera would receive a USD 12.5 million milestone. The robust U.S. performance is also increasing Santhera’s inventory requirements and contributing to higher supply sales and royalties.

Sperogenix non-reimbursed commercial rollout commences
In China, partner Sperogenix commenced a non-reimbursed commercial rollout of AGAMREE in September 2025, in addition to the earlier started Early Access Program. Uptake has been encouraging, with more than 250 patients treated to date. Priorities for the second half of 2025 are to expand sales in the non-reimbursed market. In anticipation of increased demand in 2025-2026, Santhera is bringing forward inventory plans to provide product to this market.

Geographical expansion continues successfully
Across additional territories, Santhera is broadening access through distribution partnerships. In 2024, the Company signed an agreement with GENESIS Pharma SA covering 20 Central and Eastern European markets and established regional distribution agreements for Israel and Qatar. During 2025, Santhera signed further agreements in five Gulf Cooperation Council countries, Türkiye, and India, and continues to engage in various discussions to expand its global footprint and broaden patient access to AGAMREE.

New AGAMREE data to be presented in early Q4 2025
Santhera continues to generate additional long-term clinical outcomes in DMD patients with up to seven years on AGAMREE and looks forward to reporting long-term effectiveness and safety results from the GUARDIAN study in early Q4 2025. In parallel, real-world evidence abstracts from both younger and older patient cohorts in Germany – where AGAMREE has been available the longest – have been submitted for presentation at the World Muscle Society Congress in Vienna, October 7–11, 2025.

Pipeline development and business development initiatives
As previously guided, Santhera does not plan near-term investment in additional indication expansions for AGAMREE, though it retains the option to leverage partner-run studies at a future date. Resources will remain focused on maximizing the DMD opportunity. In addition, Santhera remains actively engaged in looking to expand its product portfolio and leveraging its infrastructure through licensing, distribution agreements, and potential M&A transactions, with updates expected in 2026.

Executive and Board changes
During the first half of 2025, there were leadership changes at both the executive and Board levels. In February, Catherine Isted joined as Chief Financial Officer, succeeding Andrew Smith. She brings more than 25 years of life-sciences leadership and was formerly CFO of BenevolentAI, a Euronext-listed AI-driven drug discovery Company. In May 2025, shareholders elected Dr. Melanie Rolli to the Board at the AGM, replacing Dr. Otto Schwarz, who did not stand for re-election. She is a seasoned biopharma executive with over 20 years of international experience and is currently CEO of Helsinn Healthcare.

Financing (further detail given in the financials section)
In September 2025, Santhera secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches. The financing comprised USD 13 million from a royalty monetization with R-Bridge, on terms designed to preserve long-term value while providing near-term growth capital. In addition, Highbridge increased its commitment with a CHF 10 million upsizing of its convertible bond, extending maturity and enhancing financial flexibility.

Guidance and outlook
Based on continued strong growth in both direct and partner markets, FY 2025 revenue is now expected to exceed the previous guidance range of CHF 65-70 million. At the same time the Company has maintained disciplined cost control, with operating expenses (excluding non-cash share-based compensation) for 2025, and on a constant-portfolio basis going forward, expected to remain within the previously guided range of CHF 50-55 million. Santhera reiterates its 2028 revenue guidance of EUR 150 million (including royalties but excluding milestones) and maintains its 2030 guidance of more than EUR 150 million in direct market sales alone (excluding all distributor and licensing market royalties and milestones).

FINANCIAL PERFORMANCE

Financial highlights (including post period events)

• Total revenue increased 70% to CHF 24.0 million (H1 2024: CHF 14.1 million)
• Product sales increased 76% to CHF 11.6 million (H1 2024: CHF 6.6 million)
• Santhera recognized CHF 12.4 million (H1 2024: CHF 7.6 million) from partners in China and North America, reflecting a 63% increase in royalties, milestones and product supply
• Global sales (including partners) of AGAMREE exceed USD 100 million on a four consecutive quarter basis, triggering a USD 25 million sales milestone payment reflected in COS
• Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7million)
• Operating loss of CHF -35.4 million (H1 2024: loss of CHF -17.7 million). Excluding the USD 25 million (CHF 20.3 million) milestone, operating loss was reduced by CHF 2.6 million
• Cash and cash equivalents at June 30, 2025 of CHF 18.4 million (December 31, 2024: CHF 40.9 million)
• In September, the Company secured CHF 20 million in royalty and convertible bond financing
• Cash-flow break-even guidance maintained for mid-2026

Net Revenue
In the first half year 2025, Santhera reported revenue from contracts with customers of CHF 24.0 million (H1 2024: CHF 14.1 million) driven by strong sales growth in launched markets in addition to growing royalty and product supply revenue. Net sales amounted to CHF 11.6 million following the continued success of AGAMREE in Germany and Austria with first contributions from the UK following the Q2 launch (H1 2024: CHF 6.6 million). Royalties and net sales to licensing partners increased substantially to CHF 5.4 million and CHF 5.7 million (H1 2024: CHF 0.9 million and CHF 1.2 million), driven by U.S. growth. Milestones in the period reached CHF 0.9 million compared to CHF 5.4 million in H1 2024, reflecting a Chinese milestone received in the prior year.

Cost of sales
Cost of sales increased to CHF 32.1 million (H1 2024: CHF 5.2 million). In addition to increased direct and indirect costs due to growing sales, this figure also reflects the milestone payment of USD 25 million (CHF 20.3 million) to ReveraGen and R-Bridge for the achievement of an AGAMREE sales milestone, which is agreed to be paid in line with cash flow generation. Cost of sales for the six months also included non-cash intangible amortization of CHF 2.5 million (H1 2024: CHF 2.5 million) and royalties payable of CHF 3.7 million (H1 2024: CHF 1.0 million).

Operating expenses and result
Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7 million) were consistent year-over-year. These relate to employee expenses as the Company expands activities to support the commercialization of AGAMREE, offset by decreases in development expenses due to non-recurring longer-term study expenses closing in the prior year.

Development expenses amounted to CHF 11.7 million (H1 2024: CHF 13.8 million). The decrease of -15% was driven by the completion of longer-term studies and CMC (chemistry, manufacturing, and controls) development activities coming to a close in the prior year.

Marketing and sales expenses were CHF 6.8 million (H1 2024: CHF 4.7 million). The increase of 45% was driven by the Company’s expansion to support the commercialization of AGAMREE in Europe.
General and administrative expenses amounted to CHF 8.8 million (H1 2024: CHF 8.3 million), with additional activities focused on supporting commercial growth.

The operating result amounted to a CHF -35.4 million loss (H1 2024: CHF -17.7 million loss).

Financial income and expenses
Financial income amounted to CHF 8.1 million (H1 2024: CHF 8.6 million). The decrease was predominantly related to a lower gain in fair value of financial instruments and a decrease in interest receivable.

Financial expenses were CHF 11.4 million (H1 2024: CHF 6.0 million), primarily due to an increase in realized and unrealized foreign exchange losses.

In summary, this resulted in a net financial expense of CHF -3.3 million, compared with a net income of CHF 2.6 million for H1 2024.

Net result
The net result in H1 2025 was a CHF -38.8 million loss, compared to a loss of CHF -15.3 million in H1 2024 mainly driven by the one-time USD 25 million (CHF 20.3 million) milestone payable and the financial expenses.

Cash balance and cash flows
As of June 30, 2025, the Company had cash and cash equivalents of CHF 18.4 million compared to CHF 40.9 million as of December 31, 2024. This represents a decrease of CHF -22.5 million (H1 2024: decrease of CHF -13.9 million).

Net cash flow used in operating activities amounted to CHF -20.6 million (H1 2024: net cash outflow of CHF -15.3 million).

Net cash flow used in financing activities was CHF -1.6 million (H1 2024: CHF -0.4 million).

Assets and liabilities
Intangible assets decreased by CHF -2.5 million to CHF 66.4 million, reflecting amortization in the period.
Total assets decreased by CHF -21.7 million to CHF 130.8 million. This is a result of a CHF -22.5 million reduction in cash and decrease of trade receivables, offset by an increase in inventory to support sales growth following product commercialization.

Total liabilities increased by CHF 8.5 million to CHF 133.3 million driven by the 20.3 million milestone payment owed to ReveraGen and R-Bridge for achievement of sales milestones of AGAMREE, offset by a decrease in the fair value of financial liabilities.

Shareholders’ equity
Total consolidated equity as of June 30, 2025, was CHF -2.6 million compared to CHF 27.7 million as of December 31, 2024.

Financing activities
This morning Santhera announced that it has secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches.

R-Bridge royalty monetization agreement (USD 13 million)

Santhera has secured a royalty monetization with existing investor R-Bridge. Under the terms of the agreement, R-Bridge will receive 25% of net royalties on AGAMREE from Catalyst (North America) and Sperogenix (China). Upon closing, R-Bridge will pay Santhera USD 13 million (CHF 10.3 million), net of certain fees, upfront.

This is in addition to an existing agreement under which R-Bridge is entitled to 75% of future royalty income from these licenses. As with the prior arrangement, payments to R-Bridge are capped; once the agreed ceiling or duration is met, North American & China royalties revert to Santhera. Santhera retains buy-back rights over the royalty stream.

Highbridge convertible bond extension (CHF 10 million)

Under the agreement, Highbridge will provide an additional CHF 10 million via a new convertible note. The instrument will also exchange, at parity, the existing CHF 7 million convertible bond that was previously scheduled to mature on 30 September. The new convertible bond will have a three-year maturity, with a conversion price set at a 10% premium to the closing share price on the date of this announcement. In addition, the company will issue Highbridge approximately 110,000 shares as consideration for Highbridge agreeing to increased flexibility in relation to the CHF 35 million 4-year term loan signed in August 2024.

Half Year Report
The Santhera Half Year Report 2025 (English only) is available for download on the Company’s website at www.santhera.com/financial-reports.

Analyst Briefing
Santhera’s management team will be hosting a briefing for analysts and investors via a webcast at 14:00 CEST (08:00 ET) on 23 September 2025.

Register here: https://www.investormeetcompany.com/santhera-pharmaceuticals-holding-ag/register-investor

A recording of the webcast and the results presentation will be made available on the website following the event.

For further information please contact:

Catherine Isted, Chief Financial Officer:                                                                                            IR@santhera.com

ICR Healthcare:                                                                                                           Santhera@icrhealthcare.com

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.

About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4].

In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [1, 4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity.

Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6].

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:
[1]        Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
[2]         Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.

[3]         Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293
[4]         Heier CR et al (2019). Life Science Alliance DOI: 10.26508
[5]         Ward et al., WMS 2022, FP.27 – Poster 71. Link.
[6]        Hasham et al., MDA 2022 Poster presentation. Link.

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.

# # #

Interim Consolidated Balance Sheet

Interim Consolidated Income Statement

Interim Consolidated Statement of Cash Flows

Attachment

• 250923 Santhera H1 Interim results_Final_10pm

Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update




Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update

Ad hoc announcement pursuant to Art. 53 LR

A conference call will be held on September 23, 2025, at 14:00 CEST / 13:00 BST / 08:00 BST.
Details are at the end of this news release

Pratteln, Switzerland, September 23, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s financial results for the six months ended June 30, 2025, reports on progress with AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) and provides updates on its corporate and financing initiatives.

Highlights

• Total revenue increased 70% to CHF 24 million (H1 2024: CHF 14.1 million) driven by strong sales growth in launched markets in addition to growing royalty and product supply revenues
• Product sales increased 76% to CHF 11.6 million (H1 2024: CHF 6.6 million), led by Germany and Austria with first contributions from the UK following the Q2 launch
• Royalties from licensing partners in the U.S. and China of CHF 5.4 million (H1 2024: CHF 0.9 million), already >25% above full year 2024; further acceleration expected in H2 2025
• Global sales (including partners) of AGAMREE exceed USD 100 million on a four consecutive quarter basis, ahead of expectations, triggering a USD 25 million sales milestone payment due, reflected in cost of sales (COS)
• Operating expenses (excluding non-cash compensation) of CHF 25 million (H1 2024: CHF 24.1 million), in line with full year CHF 50-55 million guidance
• Operating loss of CHF 35.4 million (H1 2024: loss of CHF 17.7 million)
• Global rollout advancing with new distribution agreements (post period-end) across five Gulf Cooperation Council (GCC) countries, India, and Türkiye
• Cash and cash equivalents of CHF 18.4 million at June 30, 2025 (Dec 31, 2024: CHF 40.9 million); strengthened by approximately CHF 20 million of growth capital in September 2025
• Cash-flow break-even guidance maintained for mid-2026
• Full year 2025 revenue is expected to exceed the previous guidance range of CHF 65-70 million

Dario Eklund, CEO of Santhera said: “It has been an exciting period for the business, as the global rollout of AGAMREE has continued at pace. Our partner Catalyst is seeing particularly strong demand in the US, with increasing expectations in China through Sperogenix. Sales in Germany and Austria continue to exceed expectations, and the UK is contributing positively following the Q2 launch. We look forward to the second half of the year, with the publication of our GUARDIAN study on the horizon and the rollout of AGAMREE continuing through direct launches in Europe and via distribution and licensing partners globally. All these efforts are aimed at enabling more patients access to this important treatment around the world.”

BUSINESS AND CORPORATE UPDATE
(Including post period events)

• Direct market sales growing strongly with approximately 40% of steroid using DMD patients in Germany now treated with AGAMREE. Austria becomes the first country to have in excess of 50% market share for DMD patients taking corticosteroids

• Pricing and reimbursement discussions advancing in Spain, Italy and the Nordic regions, with launches expected from Q4 2025 into Q1 2026
• US partner Catalyst Pharmaceuticals, Inc. (“Catalyst”) posted strong AGAMREE H1 sales of USD 49.4 million, on track to reach its guidance for FY 2025 sales of USD 100-110 million, which would trigger an additional milestone to Santhera of USD 12.5 million
• Chinese partner Sperogenix Therapeutics Ltd. (“Sperogenix”) commences commercial rollout on a non-reimbursed basis. Forecasted demand in China for 2025 and 2026 has increased
• Continued rollout of AGAMREE worldwide with distribution agreements signed for five Gulf Corporation Council (GCC) countries, India and Türkiye post period end
• Catherine Isted joined Santhera as CFO in February and Dr. Melanie Rolli joined the Santhera Board in May

Successful launches drive own market sales in Europe
Following successful 2024 launches in Germany and Austria, patient numbers continue to grow, with approximately 450-500 patients having initiated AGAMREE and many of these patients having been on the therapy for well over a year. In Germany, use is broadening beyond the initial pediatric cohort as neurologists increasingly (re)start or switch older DMD patients to AGAMREE. Combination therapy with givinostat is also rising in the country. Roughly 40% of corticosteroid-using DMD patients in Germany have been treated to date with AGAMREE. In Austria, strong uptake has continued into 2025, making it the first country where more than half of steroid-using Duchenne patients are being treated with AGAMREE.

In the United Kingdom, after positive final NICE guidance in January 2025, AGAMREE became available nationwide from April. Updated UK guidelines on “Corticosteroids in Duchenne muscular dystrophy” (April 2025) favor daily regimens and recognize AGAMREE as equally effective with fewer side effects than traditional corticosteroids. In mid-Q3, Santhera introduced a home-delivery program to streamline access and reduce administrative burden on centers. Early feedback has been positive and is expected to support ordering momentum into Q4.

Advancing the rollout of AGAMREE across Europe
A key focus of the business is the continued rollout across Europe, and the Company is advancing multiple national reimbursement submissions and pricing negotiations across the continent.

AGAMREE has been available in Spain through a paid, named-patient program since mid-2024, and the Company has been working to secure full approval and reimbursement so all eligible patients can access the medicine. Santhera’s proposal is scheduled for discussion at the upcoming October CIMP meeting. Subject to a positive outcome, the launch into regional and hospital formularies is expected to begin in Q4 2025 and to continue into 2026 as regional rollout progresses. In Portugal, an early access plan is about to start, with pricing and reimbursement discussions running in parallel.

Across the Nordics – Sweden, Denmark, Finland, and Norway – pricing and reimbursement filings are progressing alongside pre-marketing activities conducted by local teams. First sales are anticipated between Q4 2025 and Q1 2026 as country launches commence.

In Italy, following discussions with the Italian Medicines Agency (AIFA), the Company has decided to update the reimbursement dossier with long-term GUARDIAN study data once available. Approval is anticipated in late Q1 2026, assuming good progress with regulators over the coming quarter. In the meantime, an early access program is being rolled out with the aim of covering the majority of Italian expert centers, supported by strong engagement with key opinion leaders and patient advocacy groups.

Reimbursement discussions continue in the Benelux region, with launches expected during 2026. In France, pricing negotiations with CEPS are ongoing. As previously disclosed, Santhera expects to include additional GUARDIAN data and potentially other supportive evidence in the dossier to achieve the appropriate ASMR rating and broader positioning. The Company will update the market on expected launch timing as discussions progress. In Switzerland, pre-marketing activities have begun, with marketing authorization expected in H1 2026, with fully reimbursed launch targeted for the second half of 2026.

Strong US partner sales with Catalyst continues
Santhera’s U.S. licensing partner, Catalyst, continued to report strong growth, delivering AGAMREE sales of USD 49.4 million in the first half of 2025, driven by accelerated physician adoption. This strong and sustained uptake underscores AGAMREE’s positioning as a new standard of care for DMD. Based on current projections, Catalyst has guided USD 100-110 million in 2025 sales. Upon achieving at least USD 100 million, Santhera would receive a USD 12.5 million milestone. The robust U.S. performance is also increasing Santhera’s inventory requirements and contributing to higher supply sales and royalties.

Sperogenix non-reimbursed commercial rollout commences
In China, partner Sperogenix commenced a non-reimbursed commercial rollout of AGAMREE in September 2025, in addition to the earlier started Early Access Program. Uptake has been encouraging, with more than 250 patients treated to date. Priorities for the second half of 2025 are to expand sales in the non-reimbursed market. In anticipation of increased demand in 2025-2026, Santhera is bringing forward inventory plans to provide product to this market.

Geographical expansion continues successfully
Across additional territories, Santhera is broadening access through distribution partnerships. In 2024, the Company signed an agreement with GENESIS Pharma SA covering 20 Central and Eastern European markets and established regional distribution agreements for Israel and Qatar. During 2025, Santhera signed further agreements in five Gulf Cooperation Council countries, Türkiye, and India, and continues to engage in various discussions to expand its global footprint and broaden patient access to AGAMREE.

New AGAMREE data to be presented in early Q4 2025
Santhera continues to generate additional long-term clinical outcomes in DMD patients with up to seven years on AGAMREE and looks forward to reporting long-term effectiveness and safety results from the GUARDIAN study in early Q4 2025. In parallel, real-world evidence abstracts from both younger and older patient cohorts in Germany – where AGAMREE has been available the longest – have been submitted for presentation at the World Muscle Society Congress in Vienna, October 7–11, 2025.

Pipeline development and business development initiatives
As previously guided, Santhera does not plan near-term investment in additional indication expansions for AGAMREE, though it retains the option to leverage partner-run studies at a future date. Resources will remain focused on maximizing the DMD opportunity. In addition, Santhera remains actively engaged in looking to expand its product portfolio and leveraging its infrastructure through licensing, distribution agreements, and potential M&A transactions, with updates expected in 2026.

Executive and Board changes
During the first half of 2025, there were leadership changes at both the executive and Board levels. In February, Catherine Isted joined as Chief Financial Officer, succeeding Andrew Smith. She brings more than 25 years of life-sciences leadership and was formerly CFO of BenevolentAI, a Euronext-listed AI-driven drug discovery Company. In May 2025, shareholders elected Dr. Melanie Rolli to the Board at the AGM, replacing Dr. Otto Schwarz, who did not stand for re-election. She is a seasoned biopharma executive with over 20 years of international experience and is currently CEO of Helsinn Healthcare.

Financing (further detail given in the financials section)
In September 2025, Santhera secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches. The financing comprised USD 13 million from a royalty monetization with R-Bridge, on terms designed to preserve long-term value while providing near-term growth capital. In addition, Highbridge increased its commitment with a CHF 10 million upsizing of its convertible bond, extending maturity and enhancing financial flexibility.

Guidance and outlook
Based on continued strong growth in both direct and partner markets, FY 2025 revenue is now expected to exceed the previous guidance range of CHF 65-70 million. At the same time the Company has maintained disciplined cost control, with operating expenses (excluding non-cash share-based compensation) for 2025, and on a constant-portfolio basis going forward, expected to remain within the previously guided range of CHF 50-55 million. Santhera reiterates its 2028 revenue guidance of EUR 150 million (including royalties but excluding milestones) and maintains its 2030 guidance of more than EUR 150 million in direct market sales alone (excluding all distributor and licensing market royalties and milestones).

FINANCIAL PERFORMANCE

Financial highlights (including post period events)

• Total revenue increased 70% to CHF 24.0 million (H1 2024: CHF 14.1 million)
• Product sales increased 76% to CHF 11.6 million (H1 2024: CHF 6.6 million)
• Santhera recognized CHF 12.4 million (H1 2024: CHF 7.6 million) from partners in China and North America, reflecting a 63% increase in royalties, milestones and product supply
• Global sales (including partners) of AGAMREE exceed USD 100 million on a four consecutive quarter basis, triggering a USD 25 million sales milestone payment reflected in COS
• Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7million)
• Operating loss of CHF -35.4 million (H1 2024: loss of CHF -17.7 million). Excluding the USD 25 million (CHF 20.3 million) milestone, operating loss was reduced by CHF 2.6 million
• Cash and cash equivalents at June 30, 2025 of CHF 18.4 million (December 31, 2024: CHF 40.9 million)
• In September, the Company secured CHF 20 million in royalty and convertible bond financing
• Cash-flow break-even guidance maintained for mid-2026

Net Revenue
In the first half year 2025, Santhera reported revenue from contracts with customers of CHF 24.0 million (H1 2024: CHF 14.1 million) driven by strong sales growth in launched markets in addition to growing royalty and product supply revenue. Net sales amounted to CHF 11.6 million following the continued success of AGAMREE in Germany and Austria with first contributions from the UK following the Q2 launch (H1 2024: CHF 6.6 million). Royalties and net sales to licensing partners increased substantially to CHF 5.4 million and CHF 5.7 million (H1 2024: CHF 0.9 million and CHF 1.2 million), driven by U.S. growth. Milestones in the period reached CHF 0.9 million compared to CHF 5.4 million in H1 2024, reflecting a Chinese milestone received in the prior year.

Cost of sales
Cost of sales increased to CHF 32.1 million (H1 2024: CHF 5.2 million). In addition to increased direct and indirect costs due to growing sales, this figure also reflects the milestone payment of USD 25 million (CHF 20.3 million) to ReveraGen and R-Bridge for the achievement of an AGAMREE sales milestone, which is agreed to be paid in line with cash flow generation. Cost of sales for the six months also included non-cash intangible amortization of CHF 2.5 million (H1 2024: CHF 2.5 million) and royalties payable of CHF 3.7 million (H1 2024: CHF 1.0 million).

Operating expenses and result
Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7 million) were consistent year-over-year. These relate to employee expenses as the Company expands activities to support the commercialization of AGAMREE, offset by decreases in development expenses due to non-recurring longer-term study expenses closing in the prior year.

Development expenses amounted to CHF 11.7 million (H1 2024: CHF 13.8 million). The decrease of -15% was driven by the completion of longer-term studies and CMC (chemistry, manufacturing, and controls) development activities coming to a close in the prior year.

Marketing and sales expenses were CHF 6.8 million (H1 2024: CHF 4.7 million). The increase of 45% was driven by the Company’s expansion to support the commercialization of AGAMREE in Europe.
General and administrative expenses amounted to CHF 8.8 million (H1 2024: CHF 8.3 million), with additional activities focused on supporting commercial growth.

The operating result amounted to a CHF -35.4 million loss (H1 2024: CHF -17.7 million loss).

Financial income and expenses
Financial income amounted to CHF 8.1 million (H1 2024: CHF 8.6 million). The decrease was predominantly related to a lower gain in fair value of financial instruments and a decrease in interest receivable.

Financial expenses were CHF 11.4 million (H1 2024: CHF 6.0 million), primarily due to an increase in realized and unrealized foreign exchange losses.

In summary, this resulted in a net financial expense of CHF -3.3 million, compared with a net income of CHF 2.6 million for H1 2024.

Net result
The net result in H1 2025 was a CHF -38.8 million loss, compared to a loss of CHF -15.3 million in H1 2024 mainly driven by the one-time USD 25 million (CHF 20.3 million) milestone payable and the financial expenses.

Cash balance and cash flows
As of June 30, 2025, the Company had cash and cash equivalents of CHF 18.4 million compared to CHF 40.9 million as of December 31, 2024. This represents a decrease of CHF -22.5 million (H1 2024: decrease of CHF -13.9 million).

Net cash flow used in operating activities amounted to CHF -20.6 million (H1 2024: net cash outflow of CHF -15.3 million).

Net cash flow used in financing activities was CHF -1.6 million (H1 2024: CHF -0.4 million).

Assets and liabilities
Intangible assets decreased by CHF -2.5 million to CHF 66.4 million, reflecting amortization in the period.
Total assets decreased by CHF -21.7 million to CHF 130.8 million. This is a result of a CHF -22.5 million reduction in cash and decrease of trade receivables, offset by an increase in inventory to support sales growth following product commercialization.

Total liabilities increased by CHF 8.5 million to CHF 133.3 million driven by the 20.3 million milestone payment owed to ReveraGen and R-Bridge for achievement of sales milestones of AGAMREE, offset by a decrease in the fair value of financial liabilities.

Shareholders’ equity
Total consolidated equity as of June 30, 2025, was CHF -2.6 million compared to CHF 27.7 million as of December 31, 2024.

Financing activities
This morning Santhera announced that it has secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches.

R-Bridge royalty monetization agreement (USD 13 million)

Santhera has secured a royalty monetization with existing investor R-Bridge. Under the terms of the agreement, R-Bridge will receive 25% of net royalties on AGAMREE from Catalyst (North America) and Sperogenix (China). Upon closing, R-Bridge will pay Santhera USD 13 million (CHF 10.3 million), net of certain fees, upfront.

This is in addition to an existing agreement under which R-Bridge is entitled to 75% of future royalty income from these licenses. As with the prior arrangement, payments to R-Bridge are capped; once the agreed ceiling or duration is met, North American & China royalties revert to Santhera. Santhera retains buy-back rights over the royalty stream.

Highbridge convertible bond extension (CHF 10 million)

Under the agreement, Highbridge will provide an additional CHF 10 million via a new convertible note. The instrument will also exchange, at parity, the existing CHF 7 million convertible bond that was previously scheduled to mature on 30 September. The new convertible bond will have a three-year maturity, with a conversion price set at a 10% premium to the closing share price on the date of this announcement. In addition, the company will issue Highbridge approximately 110,000 shares as consideration for Highbridge agreeing to increased flexibility in relation to the CHF 35 million 4-year term loan signed in August 2024.

Half Year Report
The Santhera Half Year Report 2025 (English only) is available for download on the Company’s website at www.santhera.com/financial-reports.

Analyst Briefing
Santhera’s management team will be hosting a briefing for analysts and investors via a webcast at 14:00 CEST (08:00 ET) on 23 September 2025.

Register here: https://www.investormeetcompany.com/santhera-pharmaceuticals-holding-ag/register-investor

A recording of the webcast and the results presentation will be made available on the website following the event.

For further information please contact:

Catherine Isted, Chief Financial Officer:                                                                                            IR@santhera.com

ICR Healthcare:                                                                                                           Santhera@icrhealthcare.com

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.

About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4].

In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [1, 4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity.

Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6].

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:
[1]        Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
[2]         Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.

[3]         Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293
[4]         Heier CR et al (2019). Life Science Alliance DOI: 10.26508
[5]         Ward et al., WMS 2022, FP.27 – Poster 71. Link.
[6]        Hasham et al., MDA 2022 Poster presentation. Link.

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.

# # #

Interim Consolidated Balance Sheet

Interim Consolidated Income Statement

Interim Consolidated Statement of Cash Flows

Attachment

• 250923 Santhera H1 Interim results_Final_10pm

Addex Appoints Bank of New York Mellon as Depositary Bank




Addex Appoints Bank of New York Mellon as Depositary Bank

Ad Hoc Announcement Pursuant to Art. 53 LR

Geneva, Switzerland, September 23, 2025 – Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced the appointment the Bank of New-York Mellon (BNY) as its new ADS depositary agent. This change is expected to become effective on October 6, 2025. 

The appointment of BNY has no impact on the fees paid by ADS holders. At the effective date, no action will be required by the ADS holders.

About Addex Therapeutics

Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex’s partner, Indivior, has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out company, Neurosterix LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, mGlu7 NAM for mood disorders and mGlu2 NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com
  
Contacts: 

Addex Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F, prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

Addex Appoints Bank of New York Mellon as Depositary Bank




Addex Appoints Bank of New York Mellon as Depositary Bank

Ad Hoc Announcement Pursuant to Art. 53 LR

Geneva, Switzerland, September 23, 2025 – Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced the appointment the Bank of New-York Mellon (BNY) as its new ADS depositary agent. This change is expected to become effective on October 6, 2025. 

The appointment of BNY has no impact on the fees paid by ADS holders. At the effective date, no action will be required by the ADS holders.

About Addex Therapeutics

Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex’s partner, Indivior, has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out company, Neurosterix LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, mGlu7 NAM for mood disorders and mGlu2 NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com
  
Contacts: 

Addex Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F, prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

Press Release: Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1




Press Release: Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1

Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1

• Designation earned for one-time AAV gene therapy SAR446268, designed to silence DMPK expression
• Myotonic dystrophy type 1 (DM1) is a rare, genetic disorder that causes progressive muscle weakness and wasting, with no currently approved medicines

Paris, September 23, 2025. The US Food and Drug Administration (FDA) has granted fast track designation to SAR446268, Sanofi’s one-time AAV gene therapy for the treatment of non-congenital (juvenile and adult onset) DM1 myotonic dystrophy type 1 (DM1). This designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. The FDA created this process to help deliver important new medicine to patients earlier and it covers a broad range of serious illnesses.

SAR446268 employs a vectorized RNA interference (RNAi) approach to silence DMPK expression through a single administration. By reducing DMPK transcripts, the gene therapy aims to eliminate the abnormal and toxic RNA foci responsible for splicing defects in muscle tissue, thereby restoring normal splicing and improving muscular function. This approach has the potential to address key symptoms of the disease, including progressive muscle weakness, difficulty relaxing muscles (myotonia), and effects on multiple body systems including heart, lungs, and endocrine functions. SAR446268 is the only investigational therapy in clinical development for this disease, and there are no currently approved therapies for DM1.

SAR446268 is currently under investigation in a first-in-human, phase 1-2 study to evaluate the safety, tolerability, and efficacy (clinical study identifier: NCT06844214). The first patient is planned for enrolment in late 2025. Sanofi has already been granted orphan designations for SAR446268 in both the US (July 2024) and EU (October 2024).

About myotonic dystrophy type 1
Myotonic dystrophy type 1, also known as Steinert’s disease, is an inherited, progressive, rare disorder affecting approximately 1 in 2,300 people worldwide. The condition is caused by mutations in the DMPK gene and is characterized by progressive muscle weakness, difficulty relaxing muscles (myotonia), and effects on multiple body systems including heart, lungs, and endocrine functions. DM1 can manifest at any age with varying severity, from mild adult cases to severe congenital forms, and has a profound impact on quality of life, affecting patients’ ability to perform daily activities, maintain independence, and in severe cases, sustain vital functions. There are no currently approved treatments for DM1.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

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