OSE Immunotherapeutics Receives Second Positive IDMC Recommendation for Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

OSE Immunotherapeutics Receives Second Positive IDMC Recommendation for Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer




OSE Immunotherapeutics Receives Second Positive IDMC Recommendation for Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

NANTES, France, February 26, 2026 – 6pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi® in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes.

In line with the predefined study oversight plan, the IDMC, composed of independent clinical and statistical experts, conducted a comprehensive assessment of patient safety, trial conduct and key efficacy indicators. Based on this review, the IDMC recommended that the study continue without modifications, confirming the robustness of the trial’s conduct to date.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, commented: “We welcome this new positive assessment from the IDMC. A total of 163 patients had been randomized at the time of the meeting, with 152 included in the analysis reviewed by the IDMC. These figures are fully consistent with our recruitment objectives.”

Initiated in 2024, ARTEMIA compares Tedopi® monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The trial is enrolling across sites in Europe, the UK, the US and Canada and is designed to generate confirmatory data to support potential regulatory filings.

The next IDMC review is scheduled for October 2026. Study enrollment is expected to conclude by year-end 2026. Tedopi® NSCLC Pivotal Phase 3 interim futility analysis is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028.

ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is listed on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn.

Contacts

OSE Immunotherapeutics: investors@ose-immuno.com

FP2Com: Florence Portejoie: fportejoie@fp2com.fr I +33 6 07 768 283

 

Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.  

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

Attachment

Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate Update

Issuer: Immunic AG

/ Key word(s): Annual Results

Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate Update

26.02.2026 / 12:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate Update

– Top-Line Data from Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 – 

– Raised Proceeds of $200 Million in a Private Placement, with Potential for up to an Additional $200 Million – 

– Net Proceeds Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis and Begin of Transition into a Commercial Organization – 

NEW YORK, February 26, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate update.

“The phase 3 ENSURE-1 and ENSURE-2 trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) continue to progress, with top-line data expected to be available by the end of 2026,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “As we continue to advance our multiple sclerosis (MS) program with vidofludimus calcium, we were extremely pleased to have recently announced the successful completion of an oversubscribed private placement of up to $400 million in gross proceeds, with $200 million in upfront gross proceeds. This financing is truly a pivotal milestone for Immunic and positions us to confidently transition into a fully integrated commercial-stage company. The transaction was led by our existing investor BVF Partners L.P. with participation from a group of highly regarded new and other existing investors. This level of commitment reflects growing confidence in our program and reinforces our belief in vidofludimus calcium’s potential to address the underlying drivers of MS progression.”

“The proceeds from the initial closing are expected to fund our operations through the ENSURE top-line data and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027, with a targeted potential regulatory approval date in 2028,” continued Dr. Vitt. “They also support preparations for the potential launch of vidofludimus calcium in RMS, including expansion of our medical and commercial infrastructure. Additionally, based on the totality of the phase 2 CALLIPER trial data in progressive MS, which showed not only substantial and medically relevant reductions for vidofludimus calcium in delaying 24-week confirmed disability progression but also statistically significant 24-week confirmed disability improvement, while confirming the drug’s favorable safety and tolerability profile already observed in previous clinical trials, we plan to initiate a confirmatory phase 3 program in primary progressive multiple sclerosis (PPMS) later this year as well.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “This is an exciting moment for Immunic and for individuals living with MS, as we believe that vidofludimus calcium could represent a potentially transformative approach to disease modification. Current oral therapies for RMS mainly control inflammation and relapses, often have complex safety and tolerability issues and do not adequately address the neurodegenerative processes driving disability progression and long-term disability. In contrast, vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through Nurr1 activation, while reducing new inflammatory damage via selective DHODH inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses. As such, we believe vidofludimus calcium may achieve a best-in-class benefit-risk profile and, therefore, could represent a large commercial opportunity in the global MS market, which is projected to reach over $30 billion by the early 2030s.” 

Fourth Quarter 2025 and Subsequent Highlights 

  • February 2026: Completed an oversubscribed private placement of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026.
    • Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Thor Nagel, Principal at BVF Partners L.P., appointed to the Board. Plans underway for further Board refreshment to support the company’s evolution into a commercial-stage organization.
    • Initiated search for a new Chief Executive Officer with deep commercial expertise in MS to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board.
  • February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive MS at the ACTRIMS Forum 2026. The findings, presented in two poster presentations, provide additional evidence of vidofludimus calcium’s effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce Immunic’s belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.

Anticipated Clinical Milestones

  • Vidofludimus calcium in MS:
  • Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.
  • Initiation of a phase 3 clinical program in PPMS is expected later this year and estimated to take approximately 3.5 to 4 years to complete.
  • IMU-856: The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.

Financial and Operating Results 

  • Research and Development (R&D) Expenses were $82.0 million for the twelve months ended December 31, 2025, as compared to $80.0 million for the twelve months ended December 31, 2024. The $1.9 million increase reflects (i) a $3.9 million increase in external development costs related to the vidofludimus calcium program and (ii) a $1.8 million increase in personnel expenses for R&D. The increase was offset by (i) a $3.0 million decrease in external development costs related to IMU-856 and (ii) a $0.8 million decrease across numerous categories.
  • General and Administrative (G&A) Expenses were $21.2 million for the twelve months ended December 31, 2025, as compared to $18.0 million for the same period ended December 31, 2024. The $3.2 million increase was due to (i) a $1.9 million increase related to personnel expenses, of which $0.3 million was related to non-cash stock compensation, (ii) a $0.8 million increase in legal and consultancy expenses and (iii) a $0.5 million increase related to costs across numerous categories. 
  • Interest Income was $1.0 million for the twelve months ended December 31, 2025, as compared to $3.4 million for the twelve months ended December 31, 2024. The $2.4 million decrease was due to a lower average cash balance.
  • In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the company’s authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the twelve months ended December 31, 2025.
  • Other Income (Expense) was $5.0 million for the twelve months ended December 31, 2025, as compared to ($1.0 million) for the same period ended December 31, 2024. The $6.1 million increase was primarily attributable to (i) $4.8 million of grant income from the German Federal Ministry of Finance, of which $1.0 million was recognized in the first quarter 2025 and $3.8 million was recognized in the fourth quarter 2025, (ii) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.
  • Net Loss for the twelve months ended December 31, 2025, was approximately $97.2 million, or $0.62 per basic and diluted share, based on 155,688,030 weighted average common shares outstanding, compared to a net loss of approximately $100.5 million, or $1.00 per basic and diluted share, based on 100,174,766 weighted average common shares outstanding for the same period ended December 31, 2024.
  • Cash and Cash Equivalents as of December 31, 2025 were approximately $15.5 million. With these funds and the approximately $187.0 million net cash proceeds raised in the February 2026 private placement, Immunic expects to be able to fund its operations into late 2027. 

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases such as celiac disease, inflammatory bowel disease, and Graft-versus-Host-Disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company’s Nurr1 platform. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

 

 


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ImageneBio to Participate in Leerink Global Healthcare Conference

ImageneBio to Participate in Leerink Global Healthcare Conference




ImageneBio to Participate in Leerink Global Healthcare Conference

SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) — ImageneBio, Inc. (Nasdaq: IMA, “Imagene,” or the “Company”), today announced management will participate in a fireside chat and hold one-on-one meetings at the 2026 Leerink Global Healthcare Conference taking place March 8-11 in Miami, Florida.

Fireside Date: Tuesday, March 10
Time: 3:00pm EST
Webcast: Linked here and archived for 90 days on events page on the Imagene IR website

About ImageneBio, Inc.
Imagene is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immunological, autoimmune and inflammatory diseases with differentiated clinical profiles. The Company’s program, IMG-007, is a receptor targeting, nondepleting anti-OX40 monoclonal antibody with multiple differentiating features. Imagene has completed Phase 1b/2a clinical trials of IMG-007 in both atopic dermatitis and alopecia areata and is currently conducting a Phase 2b clinical trial of IMG-007 in patients with moderate-to-severe atopic dermatitis. For more information, please visit www.imagenebio.com.

Investor and Media Contact:
ir@imagenebio.com

10 Presentations on Day 3 of Bionano Symposium 2026 Showcase OGM’s Utility in Unraveling the Complex Puzzles of Constitutional Genetic Disorders

10 Presentations on Day 3 of Bionano Symposium 2026 Showcase OGM’s Utility in Unraveling the Complex Puzzles of Constitutional Genetic Disorders




10 Presentations on Day 3 of Bionano Symposium 2026 Showcase OGM’s Utility in Unraveling the Complex Puzzles of Constitutional Genetic Disorders

SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today announced highlights from Day 3 of Bionano Symposium 2026, entitled OGM Making its Mark in Constitutional Genetic Disorders. Presentations highlighted how these conditions, which include developmental delay, intellectual disability, neuromuscular disorders, reproductive disorders, birth defects and other so-called rare diseases, present unique challenges to the cytogenetics and molecular pathology teams investigating them. Unlike hematologic malignancies, where established guidelines may better define the search for relevant chromosomal aberrations and genetic variants, the genetic drivers of constitutional disorders are more typically unknown, which makes Bionano’s end-to-end workflow based on the unbiased, genome-wide approach of optical genome mapping (OGM) particularly useful. Attendance at Symposium 2026 has grown to more than 1,200 participants from over 73 countries, with Day 3’s presentations coming from Japan, India, Brazil,
the Netherlands, Turkey, and the United States, while the online poster hall now features 50 posters.

Alka Chaubey, PhD, FACMG, Bionano’s chief medical officer, opened the session by emphasizing the power of OGM to deliver unbiased, comprehensive, genome-wide structural variant (SV) detection. She highlighted how OGM can provide positional context for interpreting complex rearrangements. Dr. Chaubey also noted the rapid growth in OGM publications and demonstrated how VIATM software can facilitate interpretation, turning complex structural variants into insights, helping to standardize workflows and uncover previously hidden genomic information.

Among the key scientific highlights:

Dr. Yassmine Akkari (Nationwide Children’s Hospital) traced the evolution of constitutional genomics and the growing impact of OGM in constitutional disorders. She highlighted how OGM can shift the paradigm for research in rare and unresolved disorders by bridging gaps between cytogenetics and molecular genomics and uncovering variants missed by traditional cytogenetics or sequencing, emphasizing the technology’s transformative role.

Dr. Mehmet Burak Mutlu (Detagen Genetic Diseases Diagnosis and Evaluation Center) demonstrated OGM’s utility in autism spectrum disorder (ASD). In a study, they identified relevant variants to ASD in 24% of 34 cases, including FMR1 repeat expansions and candidate gene SVs missed by exome sequencing. Detailed case studies highlighted OGM’s unique capacity to detect complex translocations, mosaic repeat expansions, and cryptic structural variants, positioning OGM as a potential “all-in-one” analytical tool for neurodevelopmental disorders.

Drs. Li Fu (Yokohama City University) and Debopriya Chakraborty (Dartmouth-Hitchcock Medical Center) explored how OGM can play a role in reproductive genetics, revealing cryptic balanced and unbalanced translocations in recurrent pregnancy loss (RPL), providing insights that conventional karyotyping and microarray often miss and supporting future use of OGM for improved genetic counseling and family planning.

Dr. Walaa Darwiche (CHU Amiens – Picardie), Dr. Laila El Khattabi (Sorbonne University APHP Hospitals and Paris Brain Institute), & Dr. Bruna Burssed (Universidade Federal de São Paulo and Radboud University Medical Center) presented studies highlighting OGM’s ability to resolve rare constitutional rearrangements, including complex copy number variations and mosaicism. Their collective findings underscored OGM’s role in identifying previously undetectable relevant events across diverse populations, improving the understanding in unresolved cases.

Dr. Karthik Bharadwaj Tallapaka (Centre for Cellular and Molecular Biology) demonstrated the power of OGM to detect structural variants associated with fascioscapulohumeral muscular dystrophy (FSHD), infertility and reproductive disorders in research cases in India, showing how genome-wide mapping can uncover subtle yet relevant alterations missed by conventional cytogenetics, and provides new opportunities to understand genetic contributions to reproductive challenges. Dr Bharadwaj emphasized the need for population specific OGM databases to strengthen the discovery in constitutional and undiagnosed diseases in India.

Dr. Nikhil Sahajpal (Greenwood Genetic Center) demonstrated how OGM can strengthen existing constitutional genomic workflows by providing positional and structural insights that extend beyond microarray and sequencing alone. His cases showed important value in characterizing balanced translocations, clarifying complex cases and resolving cytogenetic and sequencing-negative cases. He also illustrated OGM and VIA’s role as powerful research tools for investigating genetic contributors to rare disorders, enabling scientists to gain deeper insights into cases that remain unresolved with standard methods. Among Dr. Sahajpal’s key statistical results was the success rate in detecting pathogenetic variants. He showed that in a cohort of 133 subjects with rare diseases, OGM identified pathogenic or likely pathogenic variants in 20% of subjects. Perhaps even more striking were his findings that in a cohort of 65 subjects that previously tested negative by chromosomal microarray analysis (CMA) and whole exome sequencing (WES), OGM identified pathogenic or likely pathogenic variants in 12% of subjects, while the success rate was 5% in subjects that previously tested negative with whole genome sequencing (WGS).

The session concluded with a live panel discussion and Q&A session with speakers and moderated by Bionano’s Dr. Chaubey, Dr. Andy O’Shaughnessy, Dr. Dana Jaber, and Cami Asher. Panelists discussed best practices for OGM implementation, strategies for resolving complex constitutional disorders, complementing OGM with sequencing techniques, and future research directions in rare and developmental conditions.

“Day 3 of Symposium 2026 demonstrated how OGM is expanding the frontiers of constitutional genomics by enabling resolution of complex structural variants previously inaccessible using conventional methods,” said Dr. Chaubey. “From autism spectrum disorders and recurrent pregnancy loss to rare diseases, OGM is driving discovery and insights across diverse genomic research applications that are very challenging to investigate with classical cytogenetics and molecular pathology methods.”

Erik Holmlin, president and chief executive officer of Bionano, added, “Today’s presentations took us into the world of genetic conditions, including rare genetic disorders. To call these conditions rare is a misnomer – they are collectively quite common, with millions of samples analyzed every year as researchers search for the genetic drivers of these diseases. Day 3 illustrated nicely how OGM can help break down the barriers in our understanding of constitutional disorders and is doing so with impressive geographic breadth. Our mission to transform the way the world sees the genome is a global initiative and Symposium 2026 shows this aspect nicely.”

Session recordings will be available on-demand via the Bionano YouTube channel. The live panel discussion and Q&A session will not be available on-demand.

Bionano Symposium 2026 continues with Day 4: Genome Landscape Analysis with Bionano Products: Ionic, Saphyr, Stratys, and VIA on February 26, 2026, from 7:00-10:00 AM PT, featuring impactful presentations and the announcement of the scientific poster competition! Attendees may also explore scientific posters available throughout the event on the virtual platform at the link below.

Symposium registration is free and open to all. To register, visit: www.bionano.com/symposium-2026

About Bionano Genomics

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services.

For more information, visit www.bionano.com or www.bionanolaboratories.com.

Bionano’s products are for research use only and not for use in diagnostic procedures.

Forward-Looking Statements of Bionano Genomics

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. Words such as “ability,” “anticipate,” “believe,” “can,” “capacity,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to provide positional context for interpreting complex rearrangements; the ability and utility of VIA to facilitate interpretation of complex structural variants; the ability and utility of OGM to shift the paradigm for research in rare and unresolved disorders by bridging gaps between cytogenetics and molecular genomics and uncovering variants missed by traditional cytogenetics or sequencing; the ability and utility of OGM to be useful in the analysis of ASD samples and for OGM to be an “all-in-one” analytical tool for neurodevelopmental disorders; the ability and utility of OGM to play a role in reproductive health and provide insights missed by conventional cytogenetics; the ability and utility of OGM to improve genetic counseling and family planning; the ability and utility of OGM to resolve rare constitutional rearrangements; the ability and utility of OGM to uncover subtle alterations missed by conventional cytogenetics and associated with infertility and reproductive disorders; the ability and utility of OGM to strengthen existing constitutional genomic workflows by providing positional and structural insights that extend beyond microarray and sequencing alone; the ability and utility of OGM to expand the frontiers of constitutional genomics and enable resolution of complex structural variants previously inaccessible using conventional methods; the ability and utility of OGM to break down the barriers in our understanding of constitutional disorders; continued research, presentations and publications involving OGM, its utility compared to traditional cytogenetics and our technologies; and our ability to drive adoption of OGM and our technology solutions and any other statements that are not of historical fact. Each of these forward-looking statements involves risks and uncertainties. Accordingly, investors and prospective investors are cautioned not to place undue reliance on these forward-looking statements as they involve inherent risk and uncertainty (both general and specific) and should note that they are provided as a general guide only and should not be relied on as an indication or guarantee of future performance. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the failure of OGM to provide positional context for interpreting complex rearrangements; the failure of VIA to facilitate interpretation of complex structural variants; the failure of OGM to shift the paradigm for research in rare and unresolved disorders by bridging gaps between cytogenetics and molecular genomics and uncovering variants missed by traditional cytogenetics or sequencing; the failure of OGM to be useful in the analysis of ASD samples and for OGM to be an “all-in-one” analytical tool for neurodevelopmental disorders; the failure of OGM to play a role in reproductive health and provide insights missed by conventional cytogenetics; the failure of OGM to improve genetic counseling and family planning; the failure of OGM to resolve rare constitutional rearrangements; the failure of OGM to uncover subtle alterations missed by conventional cytogenetics and associated with infertility and reproductive disorders; the failure of OGM to strengthen existing constitutional genomic workflows by providing positional and structural insights that extend beyond microarray and sequencing alone; the failure of OGM to expand the frontiers of constitutional genomics and enable resolution of complex structural variants previously inaccessible using conventional methods; the failure of OGM to break down the barriers in our understanding of constitutional disorders; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a “going concern,” which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; the impact of adverse geopolitical and macroeconomic events and uncertain market conditions, including inflation, tariffs, and supply chain disruptions, on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; study results that differ or contradict the results mentioned in this press release and at Day 3 of Symposium 2026; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties including those described in our filings with the Securities and Exchange Commission (“SEC”), including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Reports on Form 10-Q and in other filings subsequently made by us with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as may be required by law.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
IR@bionano.com

Pharming Group to report fourth quarter and full year 2025 financial results and provide business update on March 12

Pharming Group to report fourth quarter and full year 2025 financial results and provide business update on March 12




Pharming Group to report fourth quarter and full year 2025 financial results and provide business update on March 12

Leiden, the Netherlands, February 26, 2026: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/Nasdaq: PHAR) confirms that it will report its preliminary (unaudited) financial results for the fourth quarter and full year 2025 and provide a business update on Thursday, March 12, 2026.

Management will host a conference call and webcast for analysts and investors on the same day at 13:30 CET/08:30 am EDT.

To participate in the conference call or to watch the live webcast, please register in advance using the links below.

Conference call registration:
https://register-conf.media-server.com/register/BIb3649a77439d4a2d8e5e002bac980cd1

Once registered, dial-in information and a unique PIN will be provided, allowing access to the call.

Please note, the Company will only take questions from dial-in attendees.

Webcast registration:
https://edge.media-server.com/mmc/p/ddxigjqm

The webcast will also be accessible on the Pharming website at Investors/Financial Documents, and a replay will be available shortly after the event.

About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the U.S.

For more information, visit www.pharming.com and find us on LinkedIn.

For further public information, contact:
Investor Relations
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com

Media Relations
Global: Saskia Mehring, Corporate Communications Manager
T: +31 6 28 32 60 41
E: media.relations@pharming.com

U.S.: Ethan Metelenis (Precision AQ on behalf of Pharming)
T: +1 (917) 882-9038

Netherlands: Leon Melens (LifeSpring Life Sciences Communication on behalf of Pharming)
T: +31 6 53 81 64 27

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Asahi Kasei to Acquire Aicuris to Accelerate Growth in Severe Infectious Diseases

Asahi Kasei to Acquire Aicuris to Accelerate Growth in Severe Infectious Diseases




Asahi Kasei to Acquire Aicuris to Accelerate Growth in Severe Infectious Diseases

Wuppertal, Germany, February 26, 2026 – Aicuris Anti-infective Cures AG (“Aicuris”) today announced that it has entered into a definitive agreement under which Asahi Kasei, through its wholly owned U.S. subsidiary Veloxis Pharmaceuticals, Inc., will acquire all shares of Aicuris for a total of €780 million (~$920 million*). The acquisition will enable Asahi Kasei to strategically expand its portfolio of therapies designed to treat severe viral infections, addressing critical infectious complications faced by patients undergoing hematopoietic stem cell transplant, solid organ transplants and other immunologically driven conditions.

Aicuris has established a strong track record in developing antiviral therapies for people with weakened immune systems, for whom otherwise manageable infections can become life-threatening. Building on its flagship product PREVYMIS® (marketed by MSD) for cytomegalovirus infection prevention in a defined group of transplant recipients, Aicuris’ wholly owned late-stage candidate pritelivir met the primary endpoint in a global Phase 3 trial in refractory herpes simplex virus infection and demonstrated statistical superiority versus investigator’s choice in immunocompromised patients. The company’s pipeline also includes AIC468, a Phase 2-ready therapeutic candidate designed to specifically treat and protect kidney transplant recipients from potentially severe consequence of BK virus (BKV) reactivation.

“Asahi Kasei’s goal to address serious unmet needs in infectious diseases aligns with our mission to provide innovative antiviral therapies for immunocompromised patients,” said Larry Edwards, CEO of Aicuris. “This transaction recognizes the strength of our R&D engine and the strategic progress our team has achieved with PREVYMIS®, pritelivir and AIC468. Becoming part of Asahi Kasei will accelerate our research and development, strengthen launch readiness in the US, and bring our programs to more patients worldwide. I am deeply grateful to our employees, partners and investors, and the patients who gave us their trust, leading to this successful outcome.”

By leveraging its U.S.-based transplant‑center channel and renal‑disease network, Asahi Kasei aims to accelerate the commercialization of products currently in the development pipeline. Furthermore, Asahi Kasei seeks to maximize the value of Aicuris’ development pipeline by harnessing the synergies derived from the companies’ combined research and development strengths in the field of infectious diseases, together with Asahi Kasei’s extensive intellectual property expertise. The acquisition aligns with Asahi Kasei’s objective for a “One AK Pharma” operating model that integrates research, clinical development, and commercial functions across a tri-regional footprint spanning Japan, the U.S., and Europe.

Ken Shinomiya, Head of Asahi Kasei’s Healthcare Sector, commented: “This acquisition strategically enhances and further integrates the value chain across our priority focus areas of autoimmunity, renal-related diseases, transplantation, and severe infectious diseases. It supports the thoughtful, stepwise expansion of our pipeline while reinforcing our strong and sustainable growth trajectory toward becoming a leading global specialty pharma company.”

“Aicuris is an outstanding example of the strength of Germany’s biotech ecosystem which translates pioneering research into meaningful clinical impact,” said Christian Foerster Managing Director at ATHOS, Aicuris’ founding investor. “As one of the first investments of ATHOS, we are proud of the team’s achievements in bringing novel therapeutic options to disease areas that have not seen innovation in decades. By uniting Aicuris’ pipeline with Asahi Kasei’s global commercial expertise and reach, these important therapeutics will made available to the patients who urgently need them.”

Under the terms of the agreement, Asahi Kasei will pay approximately €780 million (~$920 million*) in an all-cash transaction to acquire the issued shares of Aicuris. Following the completion of required legal procedures, the transaction is expected to close in the first half of 2026.

Bank of America Europe DAC is acting as financial advisor and Gibson Dunn as legal advisor to Aicuris in the transaction.

* At exchange rate of $1/€0.85 as of February 25, 2026

About Aicuris
Aicuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS®, marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate, pritelivir, aims to address refractory HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. Aicuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Contact:
Aicuris Anti-infective Cures AG
info@aicuris.com

Trophic Communications
Dr. Stephanie May and Anja Heuer
Phone: +49 171 1855 682
Email: aicuris@trophic.eu

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Pulselight to host senior health leaders for panel on ‘efficiency drive’ to reduce NHS waste and duplication

Pulselight to host senior health leaders for panel on ‘efficiency drive’ to reduce NHS waste and duplication




Pulselight to host senior health leaders for panel on ‘efficiency drive’ to reduce NHS waste and duplication

Former UK Health Minister Lord Bethell and former Deputy Chief Medical Officer Professor Sir Jonathan Van-Tam, join Pulselight for panel on unlocking NHS efficiency

LONDON, Feb. 26, 2026 (GLOBE NEWSWIRE) — Pulselight, a leading healthcare data analytics provider, will host a senior panel at the Counter Fraud Conference today in the QEII Centre, London. During the live session, Lord James Bethell and Professor Sir Jonathan Van-Tam* will examine how advanced analytics can reduce NHS waste, inefficiency and duplication, releasing resources back to frontline care.

Titled “The Efficiency Drive: How Technology Can Detect and Prevent Systemic Waste in the NHS,” the session will explore how waste, duplication, and inefficiency across NHS systems create avoidable costs and operational drag on day-to-day services. Panellists will discuss how AI-powered analytics can surface waste patterns in seconds rather than weeks, enabling teams to shift from retrospective manual review to real-time detection and prevention that directs resources where they matter most.

Chaired by Irene Manautou, Founder and CEO of Pulselight, the discussion will draw on the speakers’ experience of large-scale public health delivery and national health system leadership. It will focus on what can be done now, using the data the NHS already holds, to improve oversight, improve patient experience and care, and protect public value.

Irene Manautou, Founder and CEO at Pulselight, said: “The NHS loses £20 billion annually to waste, duplication, and inefficiency. Recovering even a fraction would make a meaningful difference to the 7.29 million patients on waiting lists and frontline capacity under pressure.

“This panel is about practical solutions. The NHS already holds vast amounts of data. Our technology can turn that data into real-time actionable insight that strengthens patient care and protects every pound spent.”

Lord James Bethell, former Health Minister, said: “The NHS has grown more complex over time, and complexity creates duplication even when everyone is acting in good faith. Technology now gives us the opportunity to improve oversight, reduce unnecessary process and ensure that taxpayer funding delivers measurable value for patients.”

Professor Sir Jonathan Van-Tam, former Deputy Chief Medical Officer said: “Digitising records has been only the beginning. The real challenge today is joining data across organisations and turning it into insight that teams can act on quickly. If we can identify patterns of waste, duplication and irregularity earlier, we can strengthen workflows and release resources back into patient care.”

If you would like to attend the panel, “The Efficiency Drive: How Technology Can Detect and Prevent Systemic Waste in the NHS,” at the Counter Fraud Conference, it will be in Wesley, Level 4, from 11:55 AM to 12:40 PM. Full details can be found here. Alternatively, please come and find us at Stand 29 if you would like to hear more about us.

*Sir Jonathan Van-Tam is a Board Adviser to Pulselight

For further information, please contact:
Pulselight (Team@Pulselight.com)
Irene Manautou, CEO

For Media Enquiries:
5654 & Company (Pulselight@5654.co.uk)
Matthew Neal (07917 800 011)
Charlotte Dawson (07810 406 284)

Notes to editors

About Pulselight

Pulselight is a data analytics company that detects waste, duplication, and inefficiency across healthcare systems.

Already delivering results in the US, clients have identified over £210 million in waste and recovered £130 million. Pulselight’s AI-powered platform is able to equip NHS leaders with real-time insights to tackle the £20 billion lost annually, strengthen prevention programmes, address health inequalities, and support the safe shift to community-based care.

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

Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day

Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day




Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day

STÄFA, Switzerland, Feb. 26, 2026 (GLOBE NEWSWIRE) —  Phonak, a global leader in innovative hearing solutions, will mark World Hearing Day on March 3 with a global campaign across three continents, putting youth hearing health at the center of the conversation. Together, with its three international ambassadors, Phonak inspires children and teens to protect their hearing, understand the risks of hearing loss, and feel confident to dream big with the support of modern hearing technology.

According to the World Health Organization, around 90 million children aged 5–19 live with hearing loss worldwide. Many cases remain undiagnosed or preventable, with lasting impact on speech and language development, learning, confidence, and social inclusion. This year’s World Hearing Day focuses specifically on the youth and the importance of early action.

Phonak ambassadors are using their voices and platforms to reach the next generation, encouraging them to protect what is precious: their hearing — and reminding young individuals with hearing loss that technology enables them to fully participate in life and pursue their goals without barriers. On World Hearing Day, large-scale digital displays and installations will spotlight the importance of hearing care in iconic public spaces including Antwerp Central Station, Belgium; Shibuya Crossing, Japan; and Times Square, United Sates making their messages visible to millions of people.

Phonak ambassador Emma Meesseman WHD26

Professional basketball player and EuroLeague champion Emma Meesseman will kick off Phonak’s World Hearing Day campaign in Belgium on February 26, encouraging young people to take ownership of their health and build lifelong habits that protect their hearing. “I’m passionate about empowering kids to be their own health advocates,” said Emma.

“They can make smart choices early, especially when it comes to their hearing. I’m proud to use my platform to raise awareness about hearing loss and reduce the stigma around it.”

Phonak ambassador Paul Gilbert WHD26

Legendary guitarist and co-founder of the rock band Mr. Big Paul Gilbert brings the message to Japan on February 28, highlighting how musicians and music fans alike must protect their hearing to continue doing what they love.

Through high-impact displays in Shibuya, Paul encourages kids and teens to understand the risks of noise exposure and adopt healthy listening habits, proving that protecting hearing today safeguards tomorrow’s passions.

Phonak ambassador Sara Mearns WHD26

Photo Credit: Mark Mann

Principal dancer at the New York City Ballet Sara Mearns will star in the campaign in New York City’s Times Square on March 2, sharing a message of confidence. She emphasizes that hearing challenges should never limit ambition and that today’s hearing technology enables people to stay connected, confident, and fully engaged in life.

“At Phonak, we are proud that Emma, Paul, and Sara are using their visibility and influence to bring hearing health into everyday conversations worldwide,” said Oliver Frank, Vice President of Phonak Marketing. “By placing this message in global landmarks, we want as many people as possible to recognize that hearing care is not optional, it is a public health priority, especially for our next generation.”

Together, Phonak and its ambassadors share one message:

Never stop dreaming. Care for your hearing.

To learn more about Phonak’s World Hearing Day campaign and meet Phonak ambassadors, visit https://www.phonak.com/en-int/meet-our-ambassadors

Follow the ambassadors on Instagram: @emma_meesseman @paulgilbert_official @saramearns

Phonak Media relations contact:

Global
Florence Camenzind
Phone +41 79 538 7131
Email Florence.camenzind@sonova.com
 
Moon Vitiello
Phone +1 331 219 2535
Email moon.vitiello@sonova.com

To access the media kit, visit this page.
Accompanying billboard videos will be available on the same page beginning February 26.

About Phonak
life is on. Since 1947, Phonak has been dedicated to improving the quality of life for people with hearing loss. Seventy-five years later, our passion for creating life-changing hearing solutions that help people thrive physically, socially, and emotionally remains. By offering the industry’s broadest portfolio of hearing solutions, we’re committed to creating a world where “life is on” for everyone.

At Phonak, innovation is not limited to products. We work to change the conversations surrounding people with hearing loss. We do this by fighting the stigma of hearing aids and creating an understanding of how hearing is connected to the broader context of healthy living.

About Sonova
Sonova is a global leader in innovative hearing care solutions: from personal audio devices and wireless communication systems to audiological care services, hearing aids and cochlear implants. The Group was founded in 1947 and is headquartered in Stäfa, Switzerland. Sonova operates through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser (under license) and Advanced Bionics as well as recognized regional brands. The Group’s globally diversified sales and distribution channels serve an ever-growing consumer base in more than 100 countries. In the 2024/25 financial year, the Group generated sales of CHF 3.9 billion, with a net profit of CHF 547 million. Around 18,000 employees are working on achieving Sonova’s vision of a world where everyone enjoys the delight of hearing.

Sonova has a long-standing commitment to innovation and was ranked no. 12 among the most innovative companies in Europe in 2025 by Fortune magazine, selected from 300 companies across 21 countries and 16 industries. For more information, please visit www.sonova.com

About World Health Organization

Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.
WHO leads global efforts to expand universal health coverage. We direct and coordinate the world’s response to health emergencies. And we promote healthier lives – from pregnancy care through old age. Our Triple Billion targets outline an ambitious plan for the world to achieve good health for all using science-based policies and programmes.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/60984c91-b7c5-4069-b815-a055cb1b0572

https://www.globenewswire.com/NewsRoom/AttachmentNg/9ca69955-5299-41b0-8d5d-a6b43fd374ac

https://www.globenewswire.com/NewsRoom/AttachmentNg/e9324058-2ad1-4ad6-9f48-63fb33fefa32

Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day

Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day




Phonak ambassadors spotlight hearing health for the next generation on World Hearing Day

STÄFA, Switzerland, Feb. 26, 2026 (GLOBE NEWSWIRE) —  Phonak, a global leader in innovative hearing solutions, will mark World Hearing Day on March 3 with a global campaign across three continents, putting youth hearing health at the center of the conversation. Together, with its three international ambassadors, Phonak inspires children and teens to protect their hearing, understand the risks of hearing loss, and feel confident to dream big with the support of modern hearing technology.

According to the World Health Organization, around 90 million children aged 5–19 live with hearing loss worldwide. Many cases remain undiagnosed or preventable, with lasting impact on speech and language development, learning, confidence, and social inclusion. This year’s World Hearing Day focuses specifically on the youth and the importance of early action.

Phonak ambassadors are using their voices and platforms to reach the next generation, encouraging them to protect what is precious: their hearing — and reminding young individuals with hearing loss that technology enables them to fully participate in life and pursue their goals without barriers. On World Hearing Day, large-scale digital displays and installations will spotlight the importance of hearing care in iconic public spaces including Antwerp Central Station, Belgium; Shibuya Crossing, Japan; and Times Square, United Sates making their messages visible to millions of people.

Phonak ambassador Emma Meesseman WHD26

Professional basketball player and EuroLeague champion Emma Meesseman will kick off Phonak’s World Hearing Day campaign in Belgium on February 26, encouraging young people to take ownership of their health and build lifelong habits that protect their hearing. “I’m passionate about empowering kids to be their own health advocates,” said Emma.

“They can make smart choices early, especially when it comes to their hearing. I’m proud to use my platform to raise awareness about hearing loss and reduce the stigma around it.”

Phonak ambassador Paul Gilbert WHD26

Legendary guitarist and co-founder of the rock band Mr. Big Paul Gilbert brings the message to Japan on February 28, highlighting how musicians and music fans alike must protect their hearing to continue doing what they love.

Through high-impact displays in Shibuya, Paul encourages kids and teens to understand the risks of noise exposure and adopt healthy listening habits, proving that protecting hearing today safeguards tomorrow’s passions.

Phonak ambassador Sara Mearns WHD26

Photo Credit: Mark Mann

Principal dancer at the New York City Ballet Sara Mearns will star in the campaign in New York City’s Times Square on March 2, sharing a message of confidence. She emphasizes that hearing challenges should never limit ambition and that today’s hearing technology enables people to stay connected, confident, and fully engaged in life.

“At Phonak, we are proud that Emma, Paul, and Sara are using their visibility and influence to bring hearing health into everyday conversations worldwide,” said Oliver Frank, Vice President of Phonak Marketing. “By placing this message in global landmarks, we want as many people as possible to recognize that hearing care is not optional, it is a public health priority, especially for our next generation.”

Together, Phonak and its ambassadors share one message:

Never stop dreaming. Care for your hearing.

To learn more about Phonak’s World Hearing Day campaign and meet Phonak ambassadors, visit https://www.phonak.com/en-int/meet-our-ambassadors

Follow the ambassadors on Instagram: @emma_meesseman @paulgilbert_official @saramearns

Phonak Media relations contact:

Global
Florence Camenzind
Phone +41 79 538 7131
Email Florence.camenzind@sonova.com
 
Moon Vitiello
Phone +1 331 219 2535
Email moon.vitiello@sonova.com

To access the media kit, visit this page.
Accompanying billboard videos will be available on the same page beginning February 26.

About Phonak
life is on. Since 1947, Phonak has been dedicated to improving the quality of life for people with hearing loss. Seventy-five years later, our passion for creating life-changing hearing solutions that help people thrive physically, socially, and emotionally remains. By offering the industry’s broadest portfolio of hearing solutions, we’re committed to creating a world where “life is on” for everyone.

At Phonak, innovation is not limited to products. We work to change the conversations surrounding people with hearing loss. We do this by fighting the stigma of hearing aids and creating an understanding of how hearing is connected to the broader context of healthy living.

About Sonova
Sonova is a global leader in innovative hearing care solutions: from personal audio devices and wireless communication systems to audiological care services, hearing aids and cochlear implants. The Group was founded in 1947 and is headquartered in Stäfa, Switzerland. Sonova operates through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser (under license) and Advanced Bionics as well as recognized regional brands. The Group’s globally diversified sales and distribution channels serve an ever-growing consumer base in more than 100 countries. In the 2024/25 financial year, the Group generated sales of CHF 3.9 billion, with a net profit of CHF 547 million. Around 18,000 employees are working on achieving Sonova’s vision of a world where everyone enjoys the delight of hearing.

Sonova has a long-standing commitment to innovation and was ranked no. 12 among the most innovative companies in Europe in 2025 by Fortune magazine, selected from 300 companies across 21 countries and 16 industries. For more information, please visit www.sonova.com

About World Health Organization

Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.
WHO leads global efforts to expand universal health coverage. We direct and coordinate the world’s response to health emergencies. And we promote healthier lives – from pregnancy care through old age. Our Triple Billion targets outline an ambitious plan for the world to achieve good health for all using science-based policies and programmes.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/60984c91-b7c5-4069-b815-a055cb1b0572

https://www.globenewswire.com/NewsRoom/AttachmentNg/9ca69955-5299-41b0-8d5d-a6b43fd374ac

https://www.globenewswire.com/NewsRoom/AttachmentNg/e9324058-2ad1-4ad6-9f48-63fb33fefa32

Idorsia reports strong 2025 results with QUVIVIQ sales more than doubling – further sales growth ahead with multiple pipeline catalysts in 2026

Idorsia reports strong 2025 results with QUVIVIQ sales more than doubling – further sales growth ahead with multiple pipeline catalysts in 2026




Idorsia reports strong 2025 results with QUVIVIQ sales more than doubling – further sales growth ahead with multiple pipeline catalysts in 2026

Ad hoc announcement pursuant to Art. 53 LR

  • Idorsia delivers on its upgraded 2025 guidance, with strong QUVIVIQ sales growth, disciplined investment, and a significantly improved bottom line.
  • Focused investment in Idorsia’s pipeline of first-in-class medicines to drive future growth, with key readout for daridorexant in pediatric insomnia imminent and Lucerastat registration study advancing in Fabry’s disease.

Allschwil, Switzerland – February 26, 2026
Idorsia Ltd (SIX: IDIA) announces strong financial and operational results for the full year 2025, setting a new base for further growth ahead and a catalyst rich 2026.

Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: “2025 marked a year of disciplined execution and renewed momentum for Idorsia. We delivered on our upgraded guidance, more than doubled QUVIVIQ sales, and significantly strengthened our financial position – demonstrating that focused investment and commercial excellence can go hand in hand. At the same time, we continued the next phase of growth: positioning TRYVIO/JERAYGO as the first treatment to target a new pathway in hypertension in decades and progressing our pipeline, including the upcoming readout of the pediatric insomnia study and the registrational program for lucerastat in Fabry disease. With multiple catalysts ahead, we enter 2026 with clarity, confidence, and a clear path toward sustainable growth.”

QUVIVIQ® (daridorexant)

  • Global 2025 net sales grow to CHF 134 million, reflecting outstanding year-over-year momentum – with continued strong growth ahead.
  • QUVIVIQ continues to reshape the insomnia treatment landscape, and we are investing to accelerate its trajectory toward blockbuster status. Growth will be driven by expanded global reach through partnerships targeting general practitioners, strategic commercial alliances, additional public reimbursement wins, potential U.S. descheduling, adoption of innovative digital and distribution models, and the initiation of a U.S. label-enhancing study focused on daytime functioning.
  • New opportunity to transform the treatment paradigm in pediatric insomnia with results expected in Q2 2026 from the Phase 2 study for daridorexant – the only dual orexin receptor antagonist in development for this population with high unmet need.

TRYVIO™ / JERAYGO™ (aprocitentan)

  • TRYVIO is available in the US and used in the top 25 hypertension centers.
  • Robust on-market experience among leading experts indicates “PRECISION-like” double-digit blood pressure reductions and confirms the tolerability profile across diverse patient groups.
  • Regulatory success in 2025 – JERAYGO is approved in EU, UK, Switzerland, and Canada.
  • Partnering discussions to maximize the global value of TRYVIO/JERAYGO are progressing.

Research & Development

  • Alignment with the FDA on the registrational program for lucerastat, positioning Idorsia to advance the first oral therapy intended for all patients with Fabry disease.
  • Advancing Idorsia’s immunology portfolio of first-in-class compounds – starting with Idorsia’s CCR6 antagonist proof-of-concept in psoriasis (proof-of-mechanism for other CCR6- and Th17-associated autoimmune diseases).
  • Clinical validation for Idorsia’s revolutionary drug-like synthetic glycan vaccine technology.

Financial highlights for full year 2025

  • QUVIVIQ sales: CHF 134 million
  • Contract revenue (one-off): CHF 72 million contract revenue
  • Non-GAAP operating expenses: CHF 328 million
  • Non-GAAP operating loss: CHF 100 million including one-off contract revenue of CHF 72 million (US GAAP operating loss: CHF 33 million including CHF 90 million one-off income from Viatris agreement)
  • Strengthened balance sheet through successful debt restructuring and new financing.

Financial Guidance for 2026

  • QUVIVIQ sales: CHF 200 million
  • Non-GAAP operating expenses: approx. CHF 330 million
  • Non-GAAP operating loss: CHF 120 million (US GAAP operating loss: approx. CHF 160 million)
  • Positive commercial contribution and focused investment in value-driving pipeline assets results in continued improvement of underlying business performance.

2026 guidance reflects continued growth of QUVIVIQ (approximately 50% increase in Idorsia-led sales), investment in the lucerastat registration program, and development of the company’s immunology portfolio. TRYVIO/JERAYGO revenues and investments are not included, as these will be considered in any potential partnership agreement. All amounts exclude unforeseen events and any potential upsides from new direct-to-patient distribution models currently being implemented in several geographies and revenue related to additional business development activities.

Financial results

US GAAP results Full Year Fourth Quarter
in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024
Net revenue 221 113 48 60
Operating expenses (268) (351) (106) (140)
Operating income (loss) (33) (232) (56) (78)
Net income (loss) (112) (264) (78) (84)
Basic & diluted EPS (0.52) (1.45) (0.31) (0.45)
Basic & diluted weighted average number of shares 214.7 182.4 248.3 188.3

Net revenue of CHF 221 million in 2025 resulted from product sales (CHF 134 million), product sales to partners (CHF 7 million), and contract revenues (CHF 79 million). This compares to net revenue of CHF 113 million in 2024 as a result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenue (CHF 5 million).

US GAAP operating expenses of CHF 268 million in 2025 and CHF 351 million in 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses for 2025 decreased by CHF 83 million, mainly driven by R&D expenses of CHF 102 million decreasing by CHF 42 million compared to 2024 (CHF 144 million), and SG&A expenses of CHF 221 million decreasing by CHF 52 million compared to 2024 (CHF 273 million).

US GAAP net loss in 2025 amounted to CHF 112 million compared to CHF 264 million (net loss) in 2024. The reduced net loss in 2025 was primarily driven by revenue growth and lower operating expenses as a result of an operational restructuring initiated in Q4 2024.

The US GAAP net loss resulted in a net loss per share of CHF 0.52 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.45 (basic and diluted) in 2024.

Non-GAAP* measures Full Year Fourth Quarter
in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024
Net revenue 214 113 47 60
Operating expenses (328) (427) (96) (121)
Operating income (loss) (100) (308) (47) (60)
Net income (loss) (118) (330) (54) (73)
Basic and diluted EPS (0.55) (1.81) (0.22) (0.39)
Basic and diluted weighted average number of shares 214.7 182.4 248.3 188.3

* Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance.

Non-GAAP net loss in 2025 amounted to CHF 118 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris deal (CHF 90 million), depreciation and amortization (CHF 17 million) , share-based compensation (CHF 6 m), impairment charges (CHF 3 m), restructuring charges (CHF 3 m), accretion and issuance cost amortization (CHF 16 m) and a debt extinguishment loss related to the debt restructuring (CHF 37 million).

The non-GAAP net loss resulted in a net loss per share of CHF 0.55 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.81 (basic and diluted) in 2024.

Liquidity and indebtedness
Liquidity on December 31, 2025, amounted to CHF 89 million. This amount does not include the remaining CHF 80 million available under the new money facility (term loan).

(in CHF millions) Dec 31, 2025 Sep 30, 2025 Dec 31, 2024
Liquidity      
Cash and cash equivalents 89 64 106
Total liquidity* 89 64 106
       
Indebtedness      
Convertible loan 335 335 335
Convertible bonds 49 49 797
Debt notes** 753 753 –
Term loan 18 13 –
Other financial debt 187 186 189
Total indebtedness 1,342 1,336 1,321

*rounding differences may occur

** The debt notes issued by Idorsia Investments SARL in exchange for convertible bonds are senior secured with the shares in Idorsia Investments SARL. The A Notes only benefit from a limited and subordinated Swiss-law governed guarantee by Idorsia Ltd.

Human Resources
Idorsia reduced more than 200 positions worldwide in 2025, bringing the total number of permanent employees to 487 (2024: 689).

Annual Report
Idorsia’s Annual Report 2025 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report, is available at www.idorsia.com/annual-report.

Note to Shareholders
The Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2025, will be held on Wednesday, May 6, 2026.

Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company, being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Idorsia Ltd, attention Corporate Secretary, Hegenheimermattweg 91, CH-4123 Allschwil, to arrive no later than March 22, 2026. Any proposal received after the deadline will be disregarded.

In order to vote at the Annual General Meeting, shareholders must be registered in the company’s shareholder register by April 27, 2026, 17:00 CEST, at the latest.

Results Day Center
Investor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center.

Events

  • First Quarter 2026 Financial Results reporting on April 28, 2026
  • Annual General Meeting of Shareholders on May 6, 2026
  • Half-Year 2026 Financial Results reporting on July 30, 2026

Notes to the editor

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact
George Thampy
Senior Vice President, Head of Investor Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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