National Condom Month: Why Today’s Protection Is About Pleasure, Confidence and Connection, According to Sex & Relationship Expert, Dr. Deb Laino




National Condom Month: Why Today’s Protection Is About Pleasure, Confidence and Connection, According to Sex & Relationship Expert, Dr. Deb Laino

PHILADELPHIA–(BUSINESS WIRE)–In recognition of National Condom Month, sex and relationship therapist Dr. Deb Laino is encouraging young adults to prioritize safer sex practices – not just for protection, but for the emotional and relational benefits that come with feeling secure and aligned with your partner. As conversations around consent and sexual wellness continue to evolve, Dr. Laino emphasizes that condoms are not just about prevention – they help create a shared understanding of responsibility, reduce anxiety around unintended consequences, and allow couples to be more present with one another.

“Being responsible and using condoms should feel seamless, not awkward,” says Dr. Laino. “When you feel confident and comfortable, you can focus on the chemistry, the closeness, and the experience you’re creating together – which is what truly enhances pleasure and connection.”

When used correctly and consistently, condoms remain one of the most effective and accessible methods for helping prevent sexually transmitted infections (STIs) and unintended pregnancy. But beyond protection, they can also increase emotional safety, build mutual trust, and remove distractions or worry that can interfere with intimacy – ultimately allowing partners to feel more relaxed, confident, and connected in the moment.

Among one of the newest sexual health innovations is Trojan G.O.A.T.™ (Greatest of All Trojan) from Trojan Brand Condoms. Made with patent-pending UltraFlex™ Non-Latex material, G.O.A.T. is designed to be soft, flexible, strong, odorless, and colorless – helping partners experience a closer, more natural feel. The material is engineered to enhance body heat transfer and adapt to movement, supporting comfort and a sense of next-level intimacy without compromising reliability.

Trojan also offers a range of condoms to meet different preferences, including Trojan Pleasure Pack, which provides a mix of textures and sensations; Trojan BareSkin Raw, designed for an ultra-thin feel; and Trojan Magnum condoms, created for those who prefer a larger fit for added comfort and security.

Dr. Laino encourages individuals to approach safe sex proactively – having conversations with partners ahead of time, choosing products that feel comfortable, and viewing condom use as a shared responsibility.

For more information on Dr. Deb Laino, please visit the following website.

Contacts

Media Contact

Kaitlin Boyle, kaitlin.boyle@gcw.agency

Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2025




Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2025

OLDSMAR, Fla.–(BUSINESS WIRE)–Cryo-Cell International, Inc. (NYSE American LLC: CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for its fiscal year ended November 30, 2025.

Financial Results

Revenue

Consolidated revenues for fiscal 2025 were $31.6 million compared to $32.0 million for fiscal 2024. The revenues for fiscal 2025 consisted of $31.4 million in processing and storage fee revenue, $54,000 in product revenue and $130,000 in public banking revenue compared to $31.6 million in processing and storage fee revenue, $68,000 in product revenue and $367,000 in public banking revenue for fiscal 2024.

Net (Loss) Income

The Company reported a net loss of $2.4 million in fiscal 2025 or $0.30 per basic and diluted share, compared to net income of $402,000 in fiscal 2024 or $0.05 per basic and diluted share. Due to changes in sales trends and estimated recoverability of cost capitalized into inventory, an impairment charge of $4.4 million was recognized during the fourth quarter of November 30, 2025 to reduce the public inventory from cost to net realizable value.

About Cryo-Cell International, Inc.

Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. ‎More than 500,000 parents from 87 countries have entrusted Cryo-Cell International, Inc. with ‎their baby’s cord blood and cord tissue stem cells. In addition to its private bank, Cryo-Cell ‎International, Inc. has a public banking program in partnership with Duke University. Cryo-Cell’s ‎public bank has provided cord blood for more than 700 transplants and operates a cord ‎blood donation site at one of the country’s most prominent hospitals, Cedars–Sinai Hospital in ‎Los Angeles. Cryo-Cell’s facility is FDA registered, cGMP-/cGTP-‎compliant and licensed in all states requiring licensure. Besides being AABB accredited as a ‎cord blood facility, Cryo-Cell was also the first U.S. (for private use only) cord blood bank to ‎receive FACT accreditation for adhering to the most stringent cord blood quality standards ‎set by any internationally recognized, independent accrediting organization. Cryo-Cell has ‎the exclusive rights ‎to PrepaCyte-CB, the industry’s most advanced cord blood processing ‎technology.‎

Cryo-Cell’s mission is to provide premier cord blood and cord tissue cryopreservation services, to develop, manufacture and administer cellular therapies to significantly improve the lives of patients worldwide and to offer the highest quality and most cost effective biostorage solutions available.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, you can identify forward-looking statements by terminology such as “will,” “may,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “forecasts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Generally, the words “anticipate,” “believe,” “continue,” “expect,” “intend,” “estimate,” “project,” “plan” and similar expressions identify forward-looking statements. In particular, statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance contain forward-looking statements.

We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. These forward-looking statements involve risks and uncertainties and reflect only our current views, expectations and assumptions with respect to future events and our future performance. If risks or uncertainties materialize or assumptions prove incorrect, actual results or events could differ materially from those expressed or implied by such forward-looking statements. Risks that could cause actual results to differ from those expressed or implied by the forward-looking statements we make include, among others, the success of the Company’s global expansion initiatives and product diversification, including its addition of the ExtraVault services, the Company’s actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company’s future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company’s business, the success of the Company’s initiative to expand its core business units to include biopharmaceutical manufacturing and operating clinics, the complexities, uncertainties, required consents and timing related to the potential spinoff of Celle Corp., the uncertainty of profitability from its biopharmaceutical manufacturing and operating clinics, the Company’s ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations and the success and enforceability of the Company’s umbilical cord blood and cord tissue license agreements, together with the associated intellectual property and their ability to provide the Company with royalty fees, along with the Risk Factors set forth in the Company’s Form 10-Q filed on October 15, 2025.

This list of risks and uncertainties, however, is only a summary of some of the most important factors and is not intended to be exhaustive. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. These risks and uncertainties may cause our actual future results to be materially different than those expressed in our forward-looking statements. These forward-looking statements are made only as of the date hereof. Except as otherwise required by applicable law, we do not undertake and expressly disclaim any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments. All subsequent written and oral forward-looking statements attributable to us, or to persons acting on our behalf, are expressly qualified in their entirety by these cautionary statements.

Contacts

Irene Smith

813-749-2102

Ismith@cryo-cell.com

Prothena Announces up to $100 Million Share Repurchase Plan




Prothena Announces up to $100 Million Share Repurchase Plan

DUBLIN–(BUSINESS WIRE)–$PRTA #Prothena–Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that its Board of Directors has authorized a Share Repurchase Plan under which the Company may repurchase up to $100.0 million of the Company’s outstanding ordinary shares, par value $0.01 per share.

Prothena had cash, cash equivalents and restricted cash of $308.4 million and no debt as of December 31, 2025. Excluding any potential purchases under this Share Repurchase Plan, Prothena expects to end the year with approximately $255 million in cash, cash equivalents, and restricted cash. This financial guidance does not include the potential to earn up to $105 million of aggregate clinical milestone payments from strategic partners in 2026 related to the advancement of both coramitug for ATTR amyloidosis with cardiomyopathy by Novo Nordisk and PRX019 for neurodegenerative diseases by Bristol Myers Squibb.

Prothena may repurchase the shares from time to time in open market transactions, which may be structured to occur in accordance with the requirements of Rule 10b-18 of the Securities Exchange Act of 1934, as amended. Prothena may also enter into Rule 10b5-1 plans to facilitate repurchases. The timing, number of shares repurchased, and prices paid for the shares under this program will depend on general business and market conditions as well as corporate and regulatory limitations, prevailing share prices, and other considerations. The Share Repurchase Plan will expire on December 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of ordinary shares. No amount or any amount of outstanding ordinary shares may be acquired by the expiration of the Share Repurchase Plan, at Prothena’s sole discretion.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including Parkinson’s disease, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS) and a number of other neurodegenerative diseases. Prothena is developing and applying its proprietary CYTOPE^® technology to target a broad spectrum of intracellular disease pathways in the brain and periphery. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, our plans and expectations regarding the Share Repurchase Plan, capital allocation, and other objectives and expectations; our anticipated cash burn and projected year end cash, cash equivalents, and restricted cash; and the receipt of clinical milestone payments in 2026. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to uncertainties related to the completion of operational and financial closing procedures, audit adjustments and other developments that may arise that would require adjustments to the preliminary financial results included in this press release, as well as those described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2026, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

Contacts

Mark Johnson, CFA, Vice President, Investor Relations

650-837-8550

IR@prothena.com
Media@prothena.com

AOP Health on Rare Diseases: Information. Collaboration. Innovation.




AOP Health on Rare Diseases: Information. Collaboration. Innovation.

Why closing knowledge gaps matters for patients, healthcare and innovation.

VIENNA–(BUSINESS WIRE)–#AOPHealth—Between 27 and 36 million¹ people in Europe are living with a rare disease, yet only around six percent currently have access to an approved treatment². Progress in diagnosis and treatment is often slowed by knowledge gaps, including the lack of clear, reliable, and patient-friendly information needed to support informed decision-making. Drawing on 30 years of experience in researching and developing therapies for rare diseases, AOP Health underscores the importance of collaboration across the healthcare community. On Rare Disease Day 2026, the company joins healthcare professionals, researchers and patient representatives in highlighting the need for closer cooperation to generate, share and better use scarce data to improve care for people living with rare diseases.

“Working in rare diseases since 1996 has shown us that innovation is never a solo effort,” emphasized Melissa Fellner, Vice President Global Therapeutic Areas at AOP Health. “It requires continuous investment in data, open collaboration and information that reaches patients in a form they can use.”

Consistent with this approach, AOP Health is conducting five clinical studies in the field of rare diseases. The company collaborates with researchers at numerous renowned international universities, as well as 58 patient organizations, most of which focus on rare diseases. These partnerships aim to leverage synergies and to strengthen the evidence base.

Collaboration is key

Prof. Dr. med. Haifa Kathrin Al-Ali, a professor of internal medicine at Halle (Saale) University Hospital and Director of the Krukenberg Cancer Center Halle, shares AOP Health’s perspectives. ” Without informed patients, it is difficult to generate evidence that truly represents daily clinical reality,” she said. “Close collaboration and an exchange on equal footing are therefore essential, especially in rare diseases.”

Thus, cooperation between physicians, patients and the pharmaceutical industry plays a crucial role in advancing research.

New EU regulations require informed patients

Furthermore, patient involvement is becoming increasingly central to European evaluation and decision-making processes. New frameworks, such as joint clinical assessments (JCAs), and structured evaluation approaches, such as PICO (which defines populations, comparators, and patient-relevant outcomes), explicitly rely on evidence that reflects real-world needs and experiences. Therefore, robust, patient-relevant data and informed patient perspectives are becoming increasingly critical.

However, meaningful patient participation in these processes requires access to appropriate knowledge and competencies. Eva Otter, Vice President of PHA Europe, a patient advocacy group representing people living with pulmonary hypertension globally emphasizes, “To meet European requirements and participate effectively in evaluation processes, we need access to reliable, evidence-based information presented in a language we can understand. Patient-friendly expert information is therefore not an add-on, but a prerequisite for informed participation and credible assessments.”

Rare Disease Day 2026: Extending access to patient-centred information

To coincide with Rare Disease Day 2026, AOP Health is releasing a new episode of its German-language patient podcast to support patients in processing their diagnosis. This episode focuses on health literacy and addresses a central question: How can patients become well-informed and actively engaged in their care?

Links

Take a look at aop-health.com from 26.2.-2.3.2026 for a Rare Disease Day special and listen to the podcast „Ab jetzt ist alles anders? Leben nach und mit einer schwerwiegenden Diagnose“. (“Everything’s Different Now? Life After and With a Serious Diagnosis”) here.

About AOP Health

AOP Health is a global enterprise group with roots in Austria, where the headquarters of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) is located. Since 1996, the AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the fields of rare diseases and intensive care medicine. The group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners. With the claim “Needs. Science. Trust.” the AOP Health Group emphasizes its commitment to research and development, as well as the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of the company’s actions. (aop-health.com)

¹ https://health.ec.europa.eu/european-reference-networks/rare-diseases_en
² https://www.eurordis.org/rare-disease-policy/european-policy/

Contacts

Further inquiry
DI Isolde Fally

Isolde.Fally@aop-health.com
https://www.aop-health.com

Almirall’s 2025 Results




Almirall’s 2025 Results

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

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

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

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

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

Carlos Gallardo, Almirall Chairman and CEO

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

Summary of results

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

Advancing leadership in medical dermatology

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

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

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

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

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

R&D pipeline

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

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

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

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

Partnership with the dermatology community

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

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

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

About Almirall

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

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

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

Legal notice:

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

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

Contacts

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

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

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




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

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

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

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

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

About Chronic Hepatitis B

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

About VRON-0200

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

About Virion Therapeutics (Virion)

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

To learn more, visit www.VirionTx.com

Contacts

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

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

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




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

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

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

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

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

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

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

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

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

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

Contacts

Media contact:
Dr Ben Rutter

Zyme Communications

Tel: +44(0)7920 770 935

Email: ben.rutter@zymecommunications.com

Sensorion Announces Leadership Changes




Sensorion Announces Leadership Changes

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

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

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

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

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

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

About Sensorion

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

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

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

www.sensorion.com

Disclaimer

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

Contacts

Investor Relations
Sensorion

Nicolas Bogler, Investor Relations and Communication

ir.contact@sensorion-pharma.com

Press Relations
Maarc Communication

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

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

nicolas.entz@maarc.fr

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




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

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

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

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

Consolidated Revenue

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

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

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

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

TWYMEEG^® (Imeglimin)

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

Consolidated cash and cash equivalents

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

Post-closing events

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

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

About Poxel SA

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

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

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

Glossary

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

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

¹ Converted at the exchange rate as at 31 December 2025

Contacts

Investor relations / Media

NewCap

Théo Martin / Paul Boivin

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

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




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

Ad hoc announcement pursuant to Art. 53 LR 

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

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

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

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

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

About ENIGMA-TRS

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

About evenamide

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

About treatment-resistant schizophrenia (TRS)

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

About Newron Pharmaceuticals

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

Important Notices

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

Contacts

For more information, please contact:


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

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

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

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

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