الإمارات العربية المتحدة تعتمد المكمل Longevity+ من BioAro، فاتحة المجال إلى إمكانات تسويقية كبيرة في مجال الصحة الوقائية العالمية

كالجاري، ألبرتا, July 08, 2025 (GLOBE NEWSWIRE) — في خطوة مهمة تربط بين التكنولوجيا الحيوية والصحة الوقائية واتجاهات العافية العالمية، أعلنت شركة التكنولوجيا الحيوية الكندية BioAro عن إطلاق أول منتج غذائي علاجي لها ضمن خط المكملات الجديد: Longevity+™، وهي كبسولة مُنتظر حصولها على براءة اختراع ومُصممة علميًا لدعم الشيخوخة الصحية من خلال التكامل التآزري متعدد الجزيئات. وبعد الحصول على الموافقات اللازمة في دولة الإمارات العربية المتحدة، أصبحت شركة BioAro الآن على أهبة الاستعداد للتوسع في أمريكا الشمالية وأوروبا والمملكة المتحدة وبلدان أخرى.

يأتي إطلاق مكمل Longevity+™ في وقتٍ حيوي، حيث من المتوقع أن يتجاوز سوق إطالة العمر والشيخوخة الصحية العالمي 44 مليار دولار أمريكي بحلول عام 2030، مدفوعًا بالطلب المتزايد على المكملات الغذائية العلاجية المتقدمة التي تتجاوز مفهوم المكملات الأساسية. دخول BioAro إلى هذا المجال ليس بالخبر العادي. فهو يعني الجمع بين أحدث الأبحاث والرؤى السريرية وتقنيات تحليلات البيانات البيولوجية المتعددة – وهي سمات مميزة لأصولها في مجال التكنولوجيا الحيوية – لتقديم منتج قائم على العلم، لا على المبالغة.

بروتوكول متكامل ومبتكر لإطالة العمر

ما يميز Longevity+™ ليس تركيبته فحسب، بل فلسفته أيضًا: حيث تلتقي البساطة بالتآزر. تحتوي كل جرعة يومية (كبسولتان) على مزيج قوي من أحادي نيوكليوتيد النيكوتيناميد (NMN)، والريسفيراترول، والإنزيم المساعد Q10، والكركمين، وفيتامين د، وفيتامين ب12 – وهي جزيئات تدعم كل منها على حدة طاقة الخلايا، وصحة الميتوكوندريا، وتعديل الاستجابة الالتهابية، والنشاط الذهني. ولكن عند تناولها معًا بنسبة مُصممة بدقة، تشير الأبحاث العلمية المبكرة إلى أنها قد تُحدث تأثيرات تآزرية تُعزز فوائدها الفردية، مما قد يُوفر مسارًا متكاملًا لإطالة العمر الصحي.

صرح الدكتور Anmol Kapoor، مؤسس BioAro: “لا نريد أن نكون مجرد شركة مكملات أخرى”. “تركيبتنا إنما هي نتاج سنوات من البحث الصحي الدقيق في علم الجينوم، وعلم الأيض، والطب الشخصي. لقد صممنا Longevity+ من منظور بيولوجيا الأنظمة، مع التركيز على كيفية تفاعل الجزيئات – وليس فقط على كيفية عملها بمفردها.”

من المختبر إلى الحياة: طموح عالمي لشركة كندية في مجال التكنولوجيا الحيوية

استنادًا إلى تاريخ BioAro في التشخيص الدقيق وتقنيات تحيليلات البيانات البيولوجية المتعددة القائمة على الذكاء الاصطناعي، يمثل خط المكملات أول منتج من المكملات الصحية موجه للمستهلك تطلقه الشركة، حيث يحول سنوات من البحث المعقد إلى بروتوكول يومي بسيط.

شركة BioAro بصدد إتمام شراكات توزيع في أمريكا الشمالية وأوروبا والمملكة المتحدة والهند وجنوب شرق آسيا تزامنًا مع الحصول على التصاريح التنظيمية والموافقة على تسويقه في دولة الإمارات العربية المتحدة، إحدى أكثر أسواق العالم تقدمًا في مجال ابتكارات الصحة والعافية. كما تخطط الشركة لدمج Longevity+ في برامجها السريرية لإطالة العمر، بما في ذلك التقييمات الصحية الشخصية وأدوات مراقبة الصحة رقميًا، مما يُشكل منظومة متكاملة للراغبين في إدارة الشيخوخة والحيوية بشكل استباقي.

أهمية وفعالية مكونات المنتج

* NMN (أحادي نيوكليوتيد النيكوتيناميد): من الطلائع الحيوية لإنزيم NAD+، والذي يُعد ضروريًا لصحة الميتوكوندريا وإصلاح الخلايا.

* الريسفيراترول: بوليفينول معروف بقدرته على تنشيط السرتوينات ومحاكاة فوائد تقييد السعرات الحرارية.

* تميم الإنزيم Q10: ضروري لسلامة القلب وأيض الطاقة، وخاصةً لدى كبار السن.

* الكركمين: مركب قوي مضاد للالتهابات ومضاد للأكسدة مستخلص من الكركم.

* فيتامين د وب12: ضروريان لتعديل الاستجابة المناعية والصحة العصبية الذهنية والتوازن الأيضي.

تمثل هذه التركيبة تحولًا نحو التفكير على مستوى أنظمة الجسم في المكملات – حيث لا يتمثل الهدف في تحميل الجسم بعناصر غذائية معزولة، بل استعادة الانسجام على المستوى الجزيئي.

قيد الحصول على براءة اختراع ومعزز بقوة الأداء

يخضع Longevity+™ حاليًا لمراجعة الحصول على براءة اختراع لتركيبته المبتكرة وآلية توصيله، حيث تستفيد BioAro من أبحاثها الخاصة في تحسين امتصاص العناصر الغذائية والتوافر البيولوجي. إن الدراسات السريرية التجريبية هي الآن في مراحل التخطيط في جميع أنحاء كندا والإمارات العربية المتحدة، مع التركيز على تتبع المؤشرات الحيوية للتحقق من صحة النتائج في فئات المستخدمين على أرض الواقع.

إعادة تعريف مستقبل الشيخوخة

مع دخول BioAro في مجال المكملات التي تساعد على إطالة العمر، لا تخطط الشركة لبيع المكملات فقط، بل إنها تعمل على تشكيل تصور جديد حول الشيخوخة، حيث تجتمع الوقاية مع الأداء، وحيث تحل الاستراتيجيات القائمة على أسس علمية محل نصائح العافية المجزأة.

يضيف الدكتور Kapoor قائلًا: “نتطلع إلى مستقبل يتولى فيه الأفراد إدارة الشيخوخة بشكل استباقي، مدعومين بالبيانات والدقة والأسس العلمية المتينة. وLongevity+ هو مجرد البداية.”

نبذة عن BioAro
شركة BioAro Inc. هي شركة كندية متخصصة في مجال التكنولوجيا الحيوية والرعاية الصحية الدقيقة تركز على تقنيات البيانات البيولوجية المتعددة والأدوات التشخيصية المدفوعة بالذكاء الاصطناعي والطب الوقائي. تُعد شركة BioAro رائدة في دمج علم الجينوم وتكنولوجيا الأجهزة القابلة للارتداء والعلاجات المخصصة في حلول الرعاية الصحية اليومية، وتتواجد منتجاتها في جميع أنحاء كندا والولايات المتحدة ودول مجلس التعاون الخليجي وأمريكا الجنوبية والاتحاد الأوروبي والمملكة المتحدة.

عرض حصري!

في إطار التزامنا بتعزيز الصحة الشخصية، تُقدّم BioAro خصمًا حصريًا على مكملاتنا المتميزة لإطالة العمر، وذلك لمستخدمي تطبيق Biongevity على متجري Playstore وApple Store أو لزائري موقعنا الإلكتروني www.biongevity.com. ابدأ رحلتك نحو صحة أفضل اليوم!

للاستفسارات الإعلامية أو شراكات التوزيع أو لطلب عينات المنتجات، يُرجى الاتصال بـ:
جهة الاتصال الإعلامية:
Mohini
البريد الإلكتروني: [email protected]
رقم الهاتف: 2221–250–403–1+

لمزيد من المعلومات، يُرجى زيارة: www.BioAro.com | www.biongevity.com


Longevity+™ هي علامة تجارية مملوكة لشركة BioAro Inc. قيد الحصول على براءة اختراع. ولم يتم تقييم هذه البيانات من جانب الهيئات التنظيمية في جميع الولايات القضائية. لا يهدف هذا المنتج إلى تشخيص أو علاج أو شفاء أو منع أي مرض.

الصور المصاحبة لهذا الإعلان متاحة على:

https://www.globenewswire.com/NewsRoom/AttachmentNg/b696ab44–9f1f–4fa0–89dc–e221bc2010d2

https://www.globenewswire.com/NewsRoom/AttachmentNg/ca4969a1–f8b7–404a–a505–674b3eb975a3

https://www.globenewswire.com/NewsRoom/AttachmentNg/86acd16a–ca50–48c9–b51c–237d91e36d51


GLOBENEWSWIRE (Distribution ID 9489295)

Les Émirats arabes unis approuvent le complément Longevity+ de BioAro, ouvrant la voie à un fort potentiel sur le marché mondial de la santé préventive

CALGARY, Alberta, 08 juill. 2025 (GLOBE NEWSWIRE) — Dans une avancée majeure à l’intersection de la biotechnologie, de la santé préventive et des tendances commerciales en matière de bien–être, la société canadienne de biotechnologie BioAro annonce le lancement de son tout premier produit nutraceutique, issu de sa nouvelle gamme de suppléments : Longevity+™. Cette capsule, en instance de brevet et scientifiquement formulée, vise à favoriser un vieillissement en bonne santé grâce à l'intégration synergique de plusieurs molécules. Déjà approuvé aux Émirats arabes unis (EAU), BioAro se prépare désormais à étendre sa présence en Amérique du Nord, en Europe, au Royaume–Uni, et au–delà.

Le lancement de Longevity+™ intervient à un moment clé, alors que le marché mondial de la longévité et du vieillissement en bonne santé devrait dépasser les 44 milliards de dollars d’ici 2030, porté par une demande croissante en nutraceutiques avancés allant au–delà de la supplémentation traditionnelle. L’arrivée de BioAro sur ce marché s’inscrit dans une démarche résolument innovante. Le produit allie recherche de pointe, expertise clinique et approche multi–omique, héritées directement de l’expertise biotechnologique de BioAro, pour offrir une solution fondée sur la science, loin du simple effet de mode.

Un protocole de longévité révolutionnaire et tout–en–un

Ce qui distingue Longevity+™, c'est autant sa formulation que sa philosophie : la simplicité au service de la synergie. Chaque dose quotidienne (deux gélules) renferme une synergie puissante de nicotinamide mononucléotide (NMN), resvératrol, coenzyme Q10, curcumine, vitamine D, et vitamine B12, des molécules reconnues pour leur action ciblée sur l’énergie cellulaire, la santé mitochondriale, la modulation de l’inflammation et la clarté cognitive. Pris ensemble dans un ratio précisément défini, ces composés pourraient, selon les premières recherches scientifiques, générer des effets synergiques qui renforcent leurs bienfaits respectifs, ouvrant la voie à une approche intégrée pour prolonger la santé au fil du temps.

« Nous ne voulions pas être une énième entreprise de compléments alimentaires » déclare le Dr Anmol Kapoor, fondateur de BioAro. « Cette formulation est l’aboutissement d’années de recherche avancée en santé de précision, croisant génomique, métabolomique et médecine personnalisée. Nous avons conçu Longevity+ selon une approche de biologie systémique, en nous concentrant sur les interactions entre les molécules, et non uniquement sur leurs effets isolés. »

Du laboratoire à la vie : l’ambition mondiale d’une biotech canadienne

Ancré dans l’héritage de BioAro en diagnostics de précision et analyses multi–omiques pilotées par IA, cette gamme de compléments est le premier produit de santé grand public de l’entreprise, fruit de nombreuses années de recherche transformées en un protocole quotidien facile à suivre.

Avec l’autorisation réglementaire et l’approbation pour la mise sur le marché aux Émirats arabes unis, l’un des marchés les plus avancés au monde en matière d’innovation santé et bien–être, BioAro finalise ses partenariats de distribution en Amérique du Nord, en Europe, au Royaume–Uni, en Inde et en Asie du Sud–Est. L’entreprise prévoit également d’intégrer Longevity+ dans ses programmes cliniques dédiés à la longévité, incluant des bilans de santé personnalisés et un suivi numérique du bien–être, afin de proposer un écosystème complet pour accompagner ceux qui souhaitent gérer de manière proactive leur vieillissement et leur vitalité.

Une composition qui fait toute la différence

  • NMN (nicotinamide mononucléotide) : un précurseur puissant de NAD+, essentiel pour la santé mitochondriale et la réparation cellulaire.
  • Resvératrol : un polyphénol reconnu pour activer les sirtuines et reproduire les bienfaits de la restriction calorique.
  • Coenzyme Q10 : indispensable au métabolisme cardiaque et énergétique, particulièrement chez les personnes âgées.
  • Curcumine : un puissant composé anti–inflammatoire et antioxydant extrait du curcuma.
  • Vitamines D et B12 : essentielles pour la modulation du système immunitaire, la santé neurocognitive et l’équilibre métabolique.

Cette formulation incarne une évolution vers une approche globale de la supplémentation, où l’objectif n’est pas de surcharger l’organisme en nutriments isolés, mais de rétablir l’harmonie au niveau moléculaire.

Brevet en instance, axé sur la performance

Longevity+™ fait actuellement l’objet d’un examen de brevet pour sa combinaison innovante et son mécanisme de délivrance, BioAro s’appuyant sur sa recherche propriétaire pour optimiser l’absorption des nutriments et leur biodisponibilité. Des études pilotes cliniques sont en cours de planification au Canada et aux Émirats arabes unis, mettant l’accent sur le suivi des biomarqueurs afin de valider les résultats chez des populations réelles.

Redéfinir l’avenir du vieillissement

Avec son entrée sur le marché des compléments pour la longévité, BioAro ne se contente pas de commercialiser des produits, mais façonne une nouvelle vision du vieillissement, centrée sur la prévention et l’optimisation des performances, et où des approches rigoureusement fondées sur la science supplantent les recommandations fragmentaires en matière de bien–être.

« Nous envisageons un avenir où chacun pourra gérer son vieillissement de manière proactive, grâce à des données précises, une médecine personnalisée et une science avancée », ajoute le Dr Kapoor. « Longevity+ n’est que le début. »

À propos de BioAro
BioAro Inc. est une entreprise canadienne de biotechnologie et santé de précision, spécialisée dans la multi–omique, les diagnostics pilotés par IA et la médecine préventive. Avec une présence au Canada, aux États–Unis, dans le Golfe (GCC), en Amérique du Sud, en Europe et au Royaume–Uni, BioAro se positionne en leader dans l’intégration de la génomique, des technologies portables et des thérapies personnalisées au service de la santé au quotidien.

Offre exclusive !

Dans le cadre de notre engagement pour le bien–être personnalisé, BioAro propose une remise exclusive sur ses compléments premium pour la longévité, réservée aux utilisateurs téléchargeant l’application Biongevity sur le Playstore ou l’Apple Store, ou visitant notre site web www.biongevity.com. Prenez votre santé en main dès aujourd’hui !

Pour toute demande média, partenariat de distribution ou échantillon produit, veuillez contacter :
Contact presse :
Mohini
E–mail : [email protected]
Téléphone : +1–403–250–2221

Pour en savoir plus, rendez–vous sur : www.BioAro.com | www.biongevity.com


Longevity+™ est une marque déposée de BioAro Inc. Brevet en cours d’homologation. Ces déclarations n’ont pas été évaluées par les autorités réglementaires dans toutes les juridictions. Ce produit n’entend pas diagnostiquer, traiter, guérir ni prévenir quelconque maladie.

Des photos accompagnant ce communiqué sont disponibles au :

https://www.globenewswire.com/NewsRoom/AttachmentNg/b696ab44–9f1f–4fa0–89dc–e221bc2010d2

https://www.globenewswire.com/NewsRoom/AttachmentNg/ca4969a1–f8b7–404a–a505–674b3eb975a3

https://www.globenewswire.com/NewsRoom/AttachmentNg/86acd16a–ca50–48c9–b51c–237d91e36d51


GLOBENEWSWIRE (Distribution ID 9489295)

UAE Approves BioAro’s Longevity+ Supplement, Signaling Major Market Potential in Global Preventive Health

CALGARY, Alberta, July 08, 2025 (GLOBE NEWSWIRE) — In a significant move that bridges biotechnology, preventive health, and global wellness trends, Canadian biotech company BioAro has announced the launch of its first nutraceutical product under its new supplement line: Longevity+™, a patent–pending, scientifically formulated capsule designed to support healthy aging through synergistic multi–molecule integration. With approvals already secured in the United Arab Emirates (UAE), BioAro is now poised for expansion into North America, Europe, the UK, and beyond.

The launch of Longevity+™ comes at a pivotal time, as the global longevity and healthy aging market is projected to surpass $44 billion by 2030, driven by growing demand for advanced nutraceuticals that go beyond basic supplementation. BioAro’s entry into this space is far from ordinary. It brings together cutting–edge research, clinical insight, and multi–omics intelligence—hallmarks of its biotech origins—to deliver a product rooted in science, not hype.

A Breakthrough, All–in–One Longevity Protocol

What sets Longevity+™ apart is not just its formulation, but its philosophy: simplicity meets synergy. Each daily dose (two capsules) contains a potent blend of Nicotinamide Mononucleotide (NMN)ResveratrolCoenzyme Q10CurcuminVitamin D, and Vitamin B12—molecules that individually support cellular energy, mitochondrial health, inflammation modulation, and cognitive clarity. But when taken together in a precisely engineered ratio, early scientific research suggest they may create synergistic effects that amplify their individual benefits—potentially offering an integrated path to extending healthspan.

“We didn't want to be just another supplement company,” says Dr. Anmol Kapoor, Founder of BioAro. “Our formulation was born from years of precision health research in genomics, metabolomics, and personalized medicine. We’ve built Longevity+ from a systems biology perspective, focusing on how molecules interact—not just how they function alone.”

From Lab to Life: A Canadian Biotech’s Global Ambition

Rooted in BioAro’s legacy of precision diagnostics and AI–driven multi–omics, the supplement line represents the company’s first consumer–facing health supplement product, translating years of complex research into a simple, daily protocol.

With regulatory clearance and market entry approval in the UAE, one of the world’s most progressive markets for health and wellness innovation, BioAro is finalizing distribution partnerships across North America, Europe, the UK, India, and Southeast Asia. The company also plans to integrate Longevity+ into its clinical longevity programs, including personalized health assessments and digital wellness tracking, forming an end–to–end ecosystem for those seeking to proactively manage aging and vitality.

What’s Inside Matters

  • NMN (Nicotinamide Mononucleotide): A powerful NAD+ precursor, vital for mitochondrial health and cellular repair.
  • Resveratrol: A polyphenol known to activate sirtuins and mimic caloric restriction benefits.
  • Coenzyme Q10: Essential for heart and energy metabolism, particularly in aging populations.
  • Curcumin: A potent anti–inflammatory and antioxidant compound from turmeric.
  • Vitamin D & B12: Crucial for immune modulation, neurocognitive health, and metabolic balance.

This formulation represents a shift toward systems–level thinking in supplementation—where the goal is not to overload the body with isolated nutrients, but to restore harmony at the molecular level.

Patent–Pending, Performance–Driven

Longevity+™ is currently under patent review for its novel combination and delivery mechanism, with BioAro leveraging its proprietary research in nutrient absorption optimization and bioavailability. Clinical pilot studies are in planning phases across Canada and the UAE, with an emphasis on biomarker tracking to validate outcomes in real–world populations.

Redefining the Future of Aging

With its entrance into the longevity supplement space, BioAro is not planning to just sell supplements, it is shaping a new narrative around aging, one where prevention and performance intersect, and where scientifically grounded strategies replace fragmented wellness advice.

“We envision a future where individuals manage aging proactively, backed by data, precision, and powerful science,” adds Dr. Kapoor. “Longevity+ is just the beginning.”

About BioAro
BioAro Inc. is a Canadian biotechnology and precision health company focused on multi–omics, AI–driven diagnostics, and preventive medicine. With a presence across Canada, USA, GCC, South America, EU, and UK, BioAro is a pioneer in integrating genomics, wearable technology, and personalized therapeutics into everyday healthcare solutions.

Exclusive Offer!

As part of our commitment to advancing personalized wellness, BioAro is offering an exclusive discount on our premium longevity supplements for users who download the app Biongevity Playstore and Apple store or visit our website at www.biongevity.com. Start your journey to better health today!

For media inquiries, distribution partnerships, or product samples, contact:
Media Contact:
Mohini
Email: [email protected]
Phone: +1–403–250–2221

For more info, please visit: www.BioAro.com | www.biongevity.com


Longevity+™ is a trademark of BioAro Inc. Patent pending. These statements have not been evaluated by regulatory bodies in all jurisdictions. This product is not intended to diagnose, treat, cure, or prevent any disease.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/b696ab44–9f1f–4fa0–89dc–e221bc2010d2

https://www.globenewswire.com/NewsRoom/AttachmentNg/ca4969a1–f8b7–404a–a505–674b3eb975a3

https://www.globenewswire.com/NewsRoom/AttachmentNg/86acd16a–ca50–48c9–b51c–237d91e36d51


GLOBENEWSWIRE (Distribution ID 9488723)

OPKO Health and Entera Bio Abstract for First-in-Class Dual GLP-1/Glucagon Tablet Candidate for Patients with Obesity and Metabolic Disorders Selected for Presentation at the ENDO 2025 Annual Meeting

MIAMI and JERUSALEM, June 25, 2025 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK–88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12–15, 2025 in San Francisco, CA, USA.

Oral OPK–88006 is being developed pursuant to a collaboration and license agreement between OPKO and Entera whereby the companies are advancing a proprietary novel dual agonist GLP–1/glucagon peptide as a once–daily tablet treatment and as a weekly subcutaneous injection for patients with obesity, metabolic and fibrotic disorders. The oral program combines OPKO’s proprietary long–acting oxyntomodulin analog (OPK–88006) and Entera’s proprietary N–Tab™ technology.

“Oral peptides remain rare in metabolic therapy, and having both tablet and injectable formats with our partner OPKO should allow us to tailor induction and maintenance regimens to each patient to optimize outcomes,” said Miranda Toledano, Chief Executive Officer of Entera. “Our once–daily tablet may be simpler to titrate and offer tolerability benefits. Our joint program prioritizes durable, sustainable weight loss to help prevent or mitigate comorbidities such as severe fatty liver, sleep apnea, and other metabolic disorders.”

OPKO and Entera expect to file an Investigational New Drug application with the U.S. Food and Drug Administration later this year for both oral OPK–88006 tablet and a weekly injectable variant of the same molecule, which OPKO intends to develop independently. Phase 1 clinical studies are being planned.

Abstract Title: First–in–Class Oral Dual GLP–1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders: In Vivo Pharmacokinetic and Pharmacodynamic Results
Presentation Number:  SUN–680
Session Date/Time: Sunday, July 13, 2025, 12:00 – 01:30 PM Pacific time

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry–leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward–looking statements include, among others: results of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the anticipated benefits of both the daily tablet and an injectable form; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt–out, and strategic collaborations; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10–K filed with the SEC, as well as the companies’ respective subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9484203)

Fortrea und Emery Pharma kündigen strategische Zusammenarbeit zur Durchführung FDA-konformer Arzneimittelwechselwirkungsstudien mit Rifampin an

Durham, North Carolina, June 24, 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (das „Unternehmen“), ein führendes globales Auftragsforschungsinstitut (Contract Research Organization CRO), hat heute eine strategische Zusammenarbeit mit Emery Pharma bekanntgegeben. Emery Pharma ist ein führendes analytisches und bioanalytisches CRO, das Prüfdienstleistungen unter der aktuellen Guten Herstellungspraxis (cGMP) und der Guten Laborpraxis (GLP) anbietet. Ziel ist es, eine schnelle Los–für–Los–Prüfung von 1–Methyl–4–Nitrosopiperazin (MNP) von Rifampin, dem bevorzugten Medikament für Arzneimittelwechselwirkungsstudien (Drug–Drug Interaction, DDI), bereitzustellen. Damit soll bescheinigt werden, dass die Verunreinigungen unter dem von der U.S. Food and Drug Administration (FDA) festgelegten Acceptable Intake (AI)–Limit liegen.

Fortrea hat sich für Emery Pharma entschieden, da das Unternehmen über starke Kompetenzen im Bereich analytischer und bioanalytischer Tests zur Unterstützung der globalen klinischen Programme von Fortrea verfügt. Das Fachwissen von Emery Pharma in diesem Bereich erweitert die Möglichkeiten von Fortrea, Rifampin als Mittel zur Induktion des CYP3A4–Isoenzyms in DDI–Studien einzusetzen. Die heute bekanntgegebene Zusammenarbeit ermöglicht es Sponsoren, DDI–Bewertungen mit Rifampin durchzuführen. Aufgrund seines Sicherheits– und Verträglichkeitsprofils wird Rifampin in diesen Studien häufig als bevorzugter Wirkstoff genannt.

„Diese Zusammenarbeit spiegelt unser gemeinsames Engagement für ein intelligenteres Studiendesign und mehr Sicherheit für die Teilnehmer wider“, so Dr. Oren Cohen, Chief Medical Officer und President of Clinical Pharmacology Services bei Fortrea. „Durch die Kooperation mit Emery Pharma ermöglichen wir die Verwendung von Rifampin. Damit unterstützen wir Sponsoren dabei, das Risiko von Studien in der frühen Phase zu minimieren, die Durchführung zu beschleunigen und die Datenqualität zu optimieren. Die fundierten Fachkenntnisse von Emery Pharma in den bioanalytischen Wissenschaften, gepaart mit Guter Laborpraxis (GLP) und Guter Herstellungspraxis (GMP), in Verbindung mit den branchenführenden Fähigkeiten von Fortrea im Bereich der klinischen Durchführung, machen diese Zusammenarbeit zur idealen Lösung für die Prüfung von Rifampin in unseren DDI–Studien. Durch die Zusammenarbeit sind wir in der Lage, qualitativ hochwertige Daten zu generieren, von denen Patienten weltweit profitieren werden.“

Dr. Ron Najafi, CEO von Emery Pharma, fügte hinzu: „Wir freuen uns darauf, mit Fortrea zusammenzuarbeiten, um wichtige Frühphasenstudien voranzutreiben. Die Stärke unseres Teams liegt in der Lösung komplexer analytischer Herausforderungen sowie in der Gewährleistung, dass die Studien den höchsten gesetzlichen und wissenschaftlichen Standards entsprechen. Wir freuen uns darauf, einen Beitrag zu einer sichereren, schnelleren und wirksameren Entwicklung von Arzneimitteln zu leisten.“

DDI–Studien sind ein wichtiger Eckpfeiler bei der Entwicklung neuer Therapeutika. Rifampin ist ein weit verbreitetes Antibiotikum und war traditionell ein Schlüsselinstrument in DDI–Studien. Aufgrund der Entdeckung von MNP (eine Nitrosamin–Verunreinigung) wurde es jedoch kritisch beäugt. Im Jahr 2021 stellte die FDA fest, dass alle getesteten Rifampin–Chargen MNP–Gehalte aufwiesen, die über den bisher akzeptierten Grenzwerten lagen. Dies veranlasste die Forscher, nach alternativen Medikamenten zu suchen. Mit diesen Ersatzstoffen sind jedoch Sicherheitsbedenken und langsamere Aktivierungszeiten verbunden. Im Jahr 2023 hat die FDA ihre Leitlinien aktualisiert und den zulässigen MNP–Grenzwert für Rifampin erhöht.

Kunden von Fortrea, die klinische Pharmakologiestudien mit flexiblen Studiendesigns durchführen, die den Anforderungen der FDA entsprechen, können nun diesen innovativen Ansatz zur Prüfung des Rifampin–Verunreinigungsgrads nutzen.

Über Fortrea

Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Life–Sciences–Branche. Um Innovationen im Gesundheitswesen voranzutreiben und das Angebot lebensverändernder Therapien für Patienten zu beschleunigen, arbeiten wir mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen. Fortrea bietet das Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie sowie Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielfältiges Team, das in etwa 100 Ländern tätig ist, ist darauf ausgelegt, Kunden weltweit fokussierte und flexible Lösungen zu bieten. Erfahren Sie mehr darüber, wie Fortrea zu einer transformativen Kraft von der Pipeline bis zum Patienten wird. Besuchen Sie dazu unsere Website unter Fortrea.com und folgen Sie uns auf LinkedIn und X (ehemals Twitter).

Über Emery Pharma

Emery Pharma ist ein führendes Auftragsforschungsunternehmen für analytische und bioanalytische Dienstleistungen mit Sitz in Alameda, Kalifornien. Das Unternehmen ist bekannt für seine wissenschaftliche Führungsrolle bei der Analyse von Verunreinigungen und der Einhaltung von Vorschriften. Das Unternehmen ist auf analytische Tests spezialisiert, die den Richtlinien der Guten Laborpraxis (GLP) und der aktuellen Guten Herstellungspraxis (cGMP) entsprechen, und bietet eine umfassende Palette von Dienstleistungen an, die jede Phase der Arzneimittelentwicklung unterstützen – von der frühen Entdeckung bis hin zu klinischen Studien und der Vermarktung.

Als Pionier in der Entwicklung und Validierung empfindlicher und spezifischer Tests zum Nachweis von Nitrosaminen spielte Emery Pharma eine Schlüsselrolle bei der Unterstützung von Pharmaunternehmen im Umgang mit den sich entwickelnden FDA– und ICH–Richtlinien. Dank der hochmodernen Fähigkeiten des Unternehmens in den Bereichen Flüssigchromatographie–Massenspektrometrie (LC–MS/MS) und hochauflösende Massenspektrometrie (HRMS) ist eine präzise Quantifizierung von Nitrosamin–Verunreinigungen im Spurenbereich möglich. Dazu zählen NDSRIs, NDMA und MNP in komplexen Matrizen.

Emery Pharma bietet außerdem ein Antibiotika–Screening, robuste Stabilitätsprüfungsprogramme für Produkte in der Forschungsphase und für kommerzielle Produkte sowie fortschrittliche Analyseplattformen wie Kernspinresonanz (NMR) und Gaschromatographie–Massenspektrometrie (GC–MS). Das Team aus interdisziplinären Wissenschaftlern bietet Problemlösungen, Methodenentwicklung und Prüfdienstleistungen, wobei der Fokus stark auf regulatorischer Bereitschaft und Datenintegrität liegt.

Angespornt durch sein Engagement für wissenschaftliche Spitzenleistungen und die öffentliche Gesundheit treibt Emery Pharma die Erstellung von Verunreinigungsprofilen weiter voran. Dadurch werden Arzneimittel sicherer und die Branche kann die mit Nitrosaminen und anderen genotoxischen Verunreinigungen verbundenen Risiken besser mindern.

Für weitere Informationen besuchen Sie uns aufemerypharma.comund folgen Sie uns auf LinkedIn.

Kontakt zu Fortrea:

Galen Wilson (Medien) – 703–298–0802, [email protected]
Kate Dillon (Medien) – 646–818–9115, [email protected]
Hima Inguva (Anleger) – 877–495–0816, [email protected]

Kontakt zu Emery Pharma

Chris Purcell (Business Development) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea et Emery Pharma annoncent une collaboration stratégique visant à mener des études sur les interactions médicamenteuses répondant aux normes de la FDA en utilisant la rifampicine

DURHAM, Caroline du Nord, 24 juin 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE) (la « Société »), une société de recherche contractuelle d’envergure mondiale (CRO) de premier plan, a annoncé aujourd’hui une collaboration stratégique avec Emery Pharma, une CRO analytique et bioanalytique de pointe, fournissant des services d’analyse conformes aux Bonnes Pratiques de Fabrication actuelles (BPF) et aux Bonnes Pratiques de Laboratoire (BPL). Cette collaboration vise à proposer un test rapide, lot par lot, de la 1–méthyl–4–nitrosopipérazine (MNP) de la rifampicine, le médicament de référence pour les études d’interactions médicamenteuses (IM), afin de certifier que les impuretés sont inférieures à la limite d’ingestion acceptable (IA) définie par les directives de la Food and Drug Administration (FDA) des États–Unis.

Fortrea a choisi Emery Pharma en raison de ses solides compétences en matière de tests analytiques et bioanalytiques, soutenant ainsi les programmes cliniques mondiaux de Fortrea. L’expertise d’Emery Pharma dans ce domaine permet à Fortrea de proposer la rifampicine comme agent inducteur de l’isoenzyme CYP3A4 dans les études d’IM. La collaboration annoncée aujourd’hui permet aux commanditaires de réaliser des évaluations d’IM en utilisant la rifampicine, fréquemment citée comme l’agent de référence dans ces études en raison de son profil d’innocuité et de tolérance.

« Cette collaboration reflète notre engagement commun en faveur d’une conception plus intelligente des études et d’une sécurité renforcée pour les participants » a indiqué Oren Cohen, M.D., Directeur médical et Président des services de pharmacologie clinique chez Fortrea. Et d’ajouter en ces termes « En permettant l’utilisation de la rifampicine grâce à notre collaboration avec Emery Pharma, nous aidons les promoteurs à réduire les risques des essais en phase précoce, à accélérer les délais et à améliorer la qualité des essais. L’expertise approfondie d’Emery Pharma dans les sciences bioanalytiques, associée à ses capacités de conformité au regard des BPL et des BPF, constitue un atout majeur. Combinée aux compétences de Fortrea pour conduire des études cliniques d’envergure internationale, cette collaboration représente une alliance idéale. Elle permettra de tester la rifampicine dans le cadre de nos études d’interactions médicamenteuse. Ainsi cette collaboration renforce notre capacité à produire des données de haute qualité qui bénéficieront aux patients du monde entier ».

De son côté, Ron Najafi, Ph.D., directeur général d’Emery Pharma, a ajouté « C’est un honneur pour nous de collaborer avec Fortrea pour faire progresser les études critiques en phase précoce. La force de notre équipe réside dans sa capacité à résoudre des défis analytiques complexes et à garantir que les études respectent les normes réglementaires et scientifiques les plus strictes. Nous sommes enthousiastes à l’idée de contribuer au développement de médicaments plus sûrs, plus rapides et plus efficaces ».

Les études d’IM constituent la pierre angulaire dans le développement de nouveaux traitements. La rifampicine, un antibiotique largement utilisé et traditionnellement inclus comme un outil clé dans les études d’IM, a fait l’objet d’une attention particulière en raison de la découverte de la MNP, une impureté de nitrosamine. En 2021, la FDA a constaté que tous les lots de rifampicine présentaient des niveaux de MNP qui dépassaient les limites précédemment acceptées, ce qui a incité les chercheurs à explorer des médicaments alternatifs. Toutefois, ces substituts posent des problèmes de sécurité et présentent des temps d’activation plus lents. En 2023, la FDA a mis à jour ses directives, augmentant la limite acceptable de MNP pour la rifampicine.

Cette approche innovante de tests des niveaux d’impureté de la rifampicine est désormais disponible pour les clients de Fortrea qui mènent des essais de pharmacologie clinique, avec des protocoles d’études flexibles répondant aux exigences de la FDA.

À propos de Fortrea

Fortrea (Nasdaq : FTRE) est un fournisseur mondial de premier plan de solutions de développement clinique pour le secteur des sciences de la vie. Fortrea s’associe à des sociétés établies et émergentes du domaine biopharmaceutique, de la biotechnologie, des dispositifs médicaux et des diagnostics pour stimuler l’innovation en matière de santé, et accélérer la mise au point de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. Nos solutions s’appuient sur 30 ans d’expérience dans 20 disciplines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée, qui travaille dans près de 100 pays, est dimensionnée pour fournir des solutions ciblées et flexibles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

À propos d’Emery Pharma

Emery Pharma est une société de recherche contractuelle de premier plan spécialisée en analyses analytiques et bioanalytiques basée à Alameda en Californie, reconnue pour son expertise scientifique en matière d’analyse des impuretés et de conformité réglementaire. Spécialisée dans les tests analytiques conformes aux normes BPL et BPF, l’entreprise propose une gamme complète de services qui soutiennent chaque étape du développement des médicaments, de la découverte initiale aux essais cliniques, jusqu’à la commercialisation.

Société pionnière dans le développement et la validation de tests sensibles et spécifiques pour la détection des nitrosamines, Emery Pharma a joué un rôle clé en aidant les promoteurs et les fabricants de produits pharmaceutiques à s’adapter à l’évolution des directives de la FDA et de l’ICH. Les capacités de pointe de l’entreprise en matière de chromatographie liquide couplée à la spectrométrie de masse (LC–MS/MS) et de spectrométrie de masse à haute résolution (HRMS) permettent la quantification précises des impuretés nitrosamines à l’état de traces, y compris les NDSRI, NDMA et MNP, dans des matrices complexes.

Emery Pharma propose également un criblage des antibiotiques, des programmes robustes de tests de stabilité pour les produits en phase de recherche et les produits commercialisés, ainsi que des plateformes analytiques avancées telles que la résonance magnétique nucléaire (RMN) et la chromatographie gazeuse couplée à la spectrométrie de masse (GC–MS). Son équipe de scientifiques interdisciplinaires fournit des services de résolution de problèmes, de développement de méthodes et d’investigation, avec un fort accent porté sur la conformité réglementaire et l’intégrité des données.

Animée par un engagement en faveur de l’excellence scientifique et de la santé publique, Emery Pharma continue de faire progresser le domaine du profilage des impuretés, garantissant des médicaments plus sûrs et contribuant aux efforts déployés à l’échelle du secteur pour réduire les risques liés aux nitrosamines et autres contaminants génotoxiques.

Pour en savoir plus, consultez le site www.emerypharma.com et suivez–nous sur LinkedIn.

Contacts Fortrea :

Galen Wilson (Médias) – 703–298–0802, [email protected]
Kate Dillon (Médias) – 646–818–9115, [email protected]
Hima Inguva (Investisseurs) – 877–495–0816, [email protected]

Contacts pour Emery Pharma :

Chris Purcell (Développement commercial) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea & Emery Pharma Anunciam Colaboração Estratégica para Fornecer Estudos de Interação Medicamentosa Usando Rifampicina em Conformidade com o FDA

DURHAM, N.C., June 24, 2025 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE) (a “Empresa”), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje uma colaboração estratégica com a Emery Pharma, uma CRO analítica e bioanalítica líder que fornece serviços de teste sob as atuais Boas Práticas de Fabricação (cGMP) e Boas Práticas de Laboratório (GLP), para teste rápido lote a lote, 1–metil–4–nitrosopiperazina (MNP) de rifampicina, o medicamento preferido para estudos de interação medicamentosa (DDI), para certificar que as impurezas estão abaixo do Limite de Ingestão Aceitável (AI) estabelecido pelas diretrizes do Food and Drug Administration (FDA) dos EUA.

A Fortrea selecionou a Emery Pharma devido à sua profunda capacidade de testes analíticos e bioanalíticos, em apoio aos programas clínicos globais da Fortrea. A experiência da Emery Pharma nesta área complementa a capacidade da Fortrea de oferecer rifampicina como agente para induzir a isoenzima CYP3A4 em estudos de DDI. A colaboração anunciada hoje viabiliza que os patrocinadores realizem avaliações de DDI usando rifampicina, o agente preferido nesses estudos devido ao seu perfil de segurança e tolerabilidade.

“Essa colaboração é um exemplo do nosso compromisso compartilhado em um projeto de estudo mais inteligente e maior segurança dos participantes”, disse Oren Cohen, M.D., diretor médico e presidente dos Serviços de Farmacologia Clínica da Fortrea. “Ao viabilizar o uso da rifampicina por meio da nossa colaboração com a Emery Pharma, ajudamos os patrocinadores a reduzir o risco dos testes em fase inicial, acelerar cronogramas e aumentar a qualidade dos dados. A profunda experiência da Emery Pharma em ciências bioanalíticas, juntamente com suas capacidades de GLP e GMP, combinadas com a capacidade de conduta clínica líder da indústria da Fortrea, tornam esta colaboração ideal para o teste de rifampicina para uso em nossos estudos de DDI. A colaboração aprofunda nossa capacidade de gerar dados de alta qualidade que beneficiarão pacientes em todo o mundo.”

Ron Najafi, Ph.D., diretor executivo da Emery Pharma, acrescentou: “Estamos honrados com a parceria com a Fortrea no avanço de estudos críticos em fase inicial. A força da nossa equipe está em resolver desafios analíticos complexos e garantir que os estudos atendam aos mais altos padrões regulatórios e científicos. Estamos empolgados em contribuir para um desenvolvimento de medicamentos mais seguro, rápido e eficaz.”

Os estudos de DDI são essenciais para o desenvolvimento de novas terapêuticas. A rifampicina, um antibiótico amplamente utilizado e tradicionalmente uma ferramenta essencial para os estudos de DDI, tem enfrentado escrutínio devido à descoberta de MNP, uma impureza de nitrosamina. Em 2021, o FDA descobriu que todos os lotes de rifampicina testados continham níveis de MNP que excediam os limites aceitos anteriormente, levando os pesquisadores a explorar medicamentos alternativos. No entanto, esses substitutos trazem preocupações de segurança e tempos de ativação mais lentos. Em 2023, o FDA atualizou sua orientação, elevando o limite aceitável de MNP na rifampicina.

Esta abordagem inovadora aos testes de níveis de impurezas da rifampicina agora está disponível para os clientes da Fortrea que realizam ensaios de farmacologia clínica, com projetos de estudo flexíveis que atendem aos requisitos do FDA.

Sobre a Fortrea

A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I–IV, farmacologia clínica e serviços de consultoria. As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em cerca de 100 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo. Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para pacientes em Fortrea.com e siga–nos em LinkedIn e X (ex–Twitter).

Sobre a Emery Pharma

A Emery Pharma é uma organização líder em pesquisa de contratos analíticos e bioanalíticos com sede em Alameda, Califórnia, reconhecida por sua liderança científica em análise de impurezas e conformidade regulatória. Especializada em testes analíticos compatíveis com GLP e cGMP, a empresa fornece um conjunto abrangente de serviços que apoiam todas as etapas do desenvolvimento de medicamentos – desde a descoberta precoce até ensaios clínicos e comercialização.

Pioneira no desenvolvimento e validação de ensaios sensíveis e específicos para detecção de nitrosaminas, a Emery Pharma tem tido um papel fundamental em ajudar patrocinadores e fabricantes farmacêuticos a navegar pelas diretrizes em evolução do FDA e da ICH. A capacidade de ponta da empresa em cromatografia líquida–espectrometria de massa (LC–MS/MS) e espectrometria de massa de alta resolução (HRMS) permitem a quantificação precisa de impurezas da nitrosamina a nível de traço, incluindo NDSRIs, NDMA e MNP, em matrizes complexas.

A Emery Pharma também oferece triagem de antibióticos, programas robustos de teste de estabilidade de produtos em estágio de pesquisa e comerciais, juntamente com plataformas analíticas avançadas, como ressonância magnética nuclear (NMR) e cromatografia gasosa–espectrometria de massa (GC–MS). Sua equipe de cientistas interdisciplinares oferece serviços de solução de problemas, desenvolvimento de métodos e investigação com um forte foco no preparo regulatório e na integridade dos dados.

Impulsionada pelo compromisso com a excelência científica e a saúde pública, a Emery Pharma continua a avançar no campo da definição de perfis de impurezas – garantindo medicamentos mais seguros e contribuindo para os esforços de toda a indústria para mitigar os riscos associados às nitrosaminas e outros contaminantes genotóxicos.

Para mais informações, visite emerypharma.com e siga–nos no LinkedIn.

Contatos da Fortrea:

Galen Wilson (Mídia) – 703–298–0802, [email protected]
Kate Dillon (Mídia) – 646–818–9115, [email protected]
Hima Inguva (Investidores) – 877–495–0816, [email protected]

Contato da Emery Pharma:

Chris Purcell (Desenvolvimento de Negócios) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea & Emery Pharma Announce Strategic Collaboration to Deliver FDA Compliant Drug-Drug-Interaction Studies Using Rifampin

DURHAM, N.C., June 24, 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced a strategic collaboration with Emery Pharma, a leading analytical and bioanalytical CRO providing testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), to provide rapid lot–by–lot, 1–methyl–4–nitrosopiperazine (MNP) testing of rifampin, the preferred drug for drug–drug interaction (DDI) studies, to certify impurities are below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines.

Fortrea has selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing in support of Fortrea’s global clinical programs. Emery Pharma’s expertise in this area supports Fortrea’s ability to offer rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies. The collaboration announced today allows sponsors to conduct DDI assessments using rifampin, which is frequently named as the preferred agent in these studies, due to its safety and tolerability profile.

“This collaboration reflects our shared commitment to smarter study design and greater participant safety,” said Oren Cohen, M.D., chief medical officer and president of Clinical Pharmacology Services at Fortrea. “By enabling use of rifampin through our collaboration with Emery Pharma, we’re helping sponsors de–risk early–phase trials, accelerate timelines and enhance data quality. Emery Pharma’s deep expertise in bioanalytical sciences, coupled with their GLP and GMP capabilities, combined with Fortrea’s industry–leading clinical conduct capabilities makes this an ideal collaboration for the testing of rifampin for use in our DDI studies. The collaboration strengthens our ability to generate high–quality data that will benefit patients worldwide.”

Ron Najafi, Ph.D., chief executive officer of Emery Pharma, added, “We’re honored to partner with Fortrea in advancing critical early–phase studies. Our team’s strength lies in solving complex analytical challenges and ensuring studies meet the highest regulatory and scientific standards. We’re excited to contribute to safer, faster and more effective drug development.”

DDI studies are a cornerstone in the development of new therapeutics. Rifampin, a widely used antibiotic and traditionally a key tool in DDI studies, has faced scrutiny due to the discovery of MNP, a nitrosamine impurity. In 2021, the FDA found that all tested rifampin batches contained MNP levels exceeding previously accepted limits, prompting researchers to explore alternative drugs. However, these substitutes come with safety concerns and slower activation times. In 2023, the FDA updated its guidance, raising the acceptable MNP limit for rifampin.

This innovative approach of testing rifampin impurity levels is now available to Fortrea customers conducting clinical pharmacology trials, with flexible study designs that meet FDA requirements.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

About Emery Pharma

Emery Pharma is a leading analytical and bioanalytical contract research organization based in Alameda, California, recognized for its scientific leadership in impurity analysis and regulatory compliance. Specializing in GLP– and cGMP–compliant analytical testing, the company provides a comprehensive suite of services that support every stage of drug development—from early discovery through clinical trials and commercialization.

A pioneer in the development and validation of sensitive and specific assays for nitrosamine detection, Emery Pharma has played a key role in helping pharmaceutical sponsors and manufacturers navigate evolving FDA and ICH guidelines. The company’s cutting–edge capabilities in liquid chromatography–mass spectrometry (LC–MS/MS) and high–resolution mass spectrometry (HRMS) enable the precise quantification of trace–level nitrosamine impurities, including NDSRIs, NDMA and MNP, in complex matrices.

Emery Pharma also offers antibiotic screening, robust stability testing programs for both research–stage and commercial products, along with advanced analytical platforms such as nuclear magnetic resonance (NMR) and gas chromatography–mass spectrometry (GC–MS). Its team of interdisciplinary scientists delivers problem–solving, method development and investigational services with a strong focus on regulatory readiness and data integrity.

Driven by a commitment to scientific excellence and public health, Emery Pharma continues to advance the field of impurity profiling—ensuring safer medicines and contributing to industry–wide efforts to mitigate the risks associated with nitrosamines and other genotoxic contaminants.

For more information, visit us at emerypharma.com and follow us on LinkedIn.

Fortrea Contacts:

Galen Wilson (Media) – 703–298–0802, [email protected]
Kate Dillon (Media) – 646–818–9115, [email protected]
Hima Inguva (Investors) – 877–495–0816, [email protected]

Emery Pharma Contacts:

Chris Purcell (Business Development) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9482882)

Noted Vaccine Researcher and Leader Kate O’Brien Awarded Sabin’s Gold Medal; Physician Livancliff Mbianke of Cameroon Receives Rising Star Award

WASHINGTON, May 13, 2025 (GLOBE NEWSWIRE) — The Sabin Vaccine Institute today awarded the Albert B. Sabin Gold Medal to pediatrician Katherine O’Brien, MD, MPH, for her research on the pneumococcal vaccine and leadership in global vaccine research and access, and its Rising Star Award to dedicated physician and public health specialist Livancliff Mbianke, MD, MPH, of Cameroon. The awards were presented at a ceremony in the National Academy of Sciences building in Washington D.C.

O’Brien is a pioneering global health leader whose innovative work in vaccine access and policy has transformed immunization programs worldwide.

“I am honored to award the Sabin Gold Medal to Dr. O’Brien for her extensive scientific and humanitarian work, which has significantly contributed to the development, licensure, and global distribution of critical immunizations,” says Amy Finan, Sabin’s chief executive officer. “The breadth and scope of her work — in addition to her leadership in advancing the availability of vaccines for everyone, everywhere — has saved millions of lives around the world.”

O’Brien’s interest in vaccines and preventable illness began during her early career as a research pediatrician in Port–au–Prince, Haiti, where almost a third of children admitted to the hospital she worked at died, often from vaccine–preventable diseases. Returning to the U.S. to pursue her infectious disease fellowship, Master of Public Health, and training as an epidemiologist, she then worked for the Johns Hopkins Center for American Indian Health and led groundbreaking clinical trials on the pneumococcal vaccine to establish the vaccine’s performance and impact on both disease and on colonization to achieve both individual and population–level protection. O’Brien was appointed Director of Infectious Disease at the Center and led research on vaccine development and implementation for vaccine–preventable diseases disproportionately affecting Indigenous populations. Her work in large–scale vaccine impact studies and clinical trials has been instrumental in the licensure, introduction and global use of vaccines against pneumococcal disease, rotavirus, influenza, and respiratory syncytial virus (RSV).
.
O’Brien continued her leadership in vaccine development, access, and research in her position as the Executive Director of the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health. She has served on WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and on the board of Gavi, the Vaccine Alliance, where she has influenced vaccine financing, policy development, and global immunization strategies.

In her current role as Director, Immunization, Vaccines and Biologicals for the World Health Organization (WHO), O’Brien leads the global vaccine and immunization strategy. She oversees WHO’s work across the vaccine continuum by accelerating new vaccine research and development, advancing vaccine access and equity, introducing new vaccines into country programs, identifying and responding to outbreaks including as WHO’s vaccine technical lead during the COVID–19 pandemic, and strengthening immunization program reach in order to maximize the impact of vaccines, even in the most fragile and vulnerable settings.

O’Brien earned her medical degree from McGill University and a Master of Public Health from Johns Hopkins University. She completed her pediatric and infectious disease training at Johns Hopkins Medical Institutions and served as an Epidemic Intelligence Service officer at the U.S. Centers for Disease Control and Prevention (CDC).

“I am deeply grateful for a career working with incredible people around the world, and through them to have life–saving impact,” says O’Brien. “Vaccines are truly one of science’s greatest achievements. It is immensely fulfilling to work on vaccines all the way from development through licensure and dissemination, and to then see them protect the lives and well–being of families. This award is a huge honor, and a tribute to those who have taught me the value of evidence–based courage.”

Sabin’s Rising Star Award is intended to encourage and recognize the next generation of vaccine and immunization leaders. Mbianke is a dedicated physician and public health specialist whose work in vaccine access and strengthening health systems has made a profound impact on underserved communities. With expertise in immunization, maternal and child health, and community engagement, Mbianke has played a pivotal role in expanding vaccine coverage and improving health outcomes in Cameroon.

“With his recognized achievements in reducing maternal and child mortality by 50% in remote areas and increasing accessibility of vaccines, Dr. Mbianke is leading innovations around immunization in fragile settings,” says Finan. “Whether he is delivering vaccines to displaced populations or creating health clinics out of village councils, his creative solutions serve as a model for those working in challenging settings and makes him a Rising Star in global health.”

As Program Country Manager for the COMBAT Project (Community–Based Tracking for Immunization) at the International Vaccine Access Center (IVAC), Mbianke leads efforts to enhance immunization delivery by improving community–based monitoring, engagement, and service delivery strategies. He also serves as Technical Advisor for the World Health Organization’s “Big Catch–Up,” a global initiative aimed at restoring vaccine coverage following pandemic–related disruptions.

Beyond his advisory roles, Mbianke is the CEO of Empower Women Foundation, where he champions maternal and child health initiatives in Cameroon, advocating for sustainable and locally driven health care solutions. His leadership extends to past roles with WHO, Gavi, USAID, and other global health organizations, where he has contributed to immunization policy formulation and innovative strategies to reach zero–dose and under–immunized children.

A graduate of Université de la Montagne Bagante (MD) and Mountain University for Sustainable Studies (MPH), Mbianke combines medical expertise with public health leadership to promote vaccine confidence and equitable access.

“This award is so meaningful,” says Mbianke. “When you work in settings with such a high burden, sometimes you feel you are not doing enough because you want to improve as many lives as possible. But recognition like the Rising Star award really motivates you. It says you are creating an impact. You are creating a change.”

Awarded annually since 1993 and 2020 respectively, the Albert B. Sabin Gold Medal and Rising Star Award honor individuals who have made extraordinary contributions to immunization and global health. These awards commemorate the legacy of the late Dr. Albert B. Sabin, who discovered the oral polio vaccine and dedicated his life to ensuring everyone in the world had access to vaccines.

Watch the 2025 Albert B. Sabin Gold Medal and Rising Star ceremony on Sabin’s YouTube channel.

About the Sabin Vaccine Institute 
  
The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X @SabinVaccine. 

Media Contact:
Monika Guttman
Senior Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 621–1691
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c995d1e5–eae3–4d74–b2fa–6e7914d38549


GLOBENEWSWIRE (Distribution ID 9451069)

Entera Bio Announces First Quarter 2025 Financial Results and Business Updates

JERUSALEM, May 09, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended March 31, 2025.

“During Q1 2025, Entera continued to generate intrinsic value with progress across our programs while significantly extending our cash runway into late 2026 via direct investment from marquis investors and our strategic partner, OPKO Health Inc. (“OPKO”). EB613 early mechanistic effects on both trabecular and cortical bone compartments data using 3D–Shaper software analysis was selected for oral presentation out of 1,680 abstracts submitted to the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress. Subsequent EB613 abstracts have been submitted to both the 2025 American Society for Bone Mineral Research (ASBMR) and the North American Menopause Society (NAMS) conferences. Pre–IND activities for our Next Gen EB613 tablet candidate are in final stages, with plans to initiate a Phase 1 study in H2 2025. Via the execution of our recent license agreement with OPKO, we are fully funded to co–develop Oral OPK–88006 (the first dual acting GLP1/Glucagon single tablet for metabolic diseases) through SAD/MAD Phase 1 studies while retaining a 40% stake in the economics of this important asset. An abstract for Oral OPK–88006 has been submitted to ENDO2025. Finally, we are judiciously strengthening our core team with important appointments including Ms. Leslie Gautam, as Chief Business Officer and Ms. Cherin Smith as Head of Clinical Operations, both of whom have extensive experience in strategic and operational execution in women–centric conditions,” said Miranda Toledano, Chief Executive Officer of Entera.

“We continue to optimize and prepare to initiate our proposed pivotal program for EB613, the first and only oral anabolic “bone building” tablet treatment under clinical investigation in postmenopausal women with osteoporosis. The earlier the age at which menopause occurs the greater the risk of long–term impact on bone and heart health. EB613 is specifically intended to provide an oral anabolic treatment in tablet format earlier in an osteoporosis patient’s journey to increase skeletal mass and reduce the risk of fracture. EB613 comprises the first 34 N–terminal amino acid sequence of the human parathyroid hormone, PTH(1–34) or teriparatide, which is a validated standard of care and only available as a daily subcutaneous injection. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. In the U.S., there are over 54 million American women and men with at–risk bone health and osteoporosis. The statistics associated with osteoporosis are staggering: fracture rates are on the rise state by state, severe mortality (20% – 30% die within 12 months of fracture), catastrophic comorbidity (50% of fracture survivors unable to walk independently), a persistent treatment chasm (<25% receive osteoporosis medication) and escalating and preventable pharmacoeconomic burden ($57 billion in Medicare). No new osteoporosis drug has been approved by U.S. Food and Drug Administration (FDA) since 2019 due to the ethical, size and duration challenges imposed by fracture–based studies. At the heart of this significant public health concern is the need for regulatory reform of the fracture endpoint currently required for approval of osteoporosis drugs by the FDA. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is bone mineral density (BMD). The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), initiative has amassed the strongest evidence to date substantiating that gains in total–hip BMD reliably predict fracture–risk reduction as a viable surrogate to fracture. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate to cardiovascular outcomes and HBA1C as a surrogate to diabetes complications. In March 2024 the FDA Biomarker Division indicated to the SABRE group that a decision may be issued within 10 months. Recent presentations by SABRE at medical congresses indicate their continued optimism that a ruling by FDA on the qualification of BMD as a surrogate for fracture is expected in 2025. We strongly endorse the proposed BMD ruling and view it as crucial to reinvigorate much needed innovation and more treatment choices for patients and clinicians in this underserved disease. We will be taking additional steps to ensure the continuity of clinical development for EB613,” said Miranda Toledano, Chief Executive Officer of Entera.

Key Recent Highlights

EB613: First Oral PTH(1–34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

  • On April 15, 2025, our Chief Clinical Advisor Dr. Rachel B Wagman presented at the 2025 WCO–IOF–ESCEO Congress “EFFECTS OF EB613 TABLETS [ORAL PTH(1–34)] ON TRABECULAR AND CORTICAL BONE USING 3D–DXA: POST–HOC RESULTS FROM PHASE 2 STUDY.” After 6 months of treatment, the findings showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. The evaluation showed a broad distribution of bone loss in the femur with placebo and a similarly broad distribution of bone gain in the femur with EB613. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6–month time point. During the quarter, further abstracts have been submitted to ASBMR and NAMS 2025 conferences
  • Next Gen EB613, which is being developed with new generation of our N–TAB™ platform, is finalizing pre–IND activities with a plan to enter the clinic in H2 2025. We plan to submit an abstract on Next Gen EB613 to a major medical conference in 2025

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

  • In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. We expect to file an Investigational New Drug application with the FDA later this year or early in 2026
  • During the quarter, we submitted an abstract for Oral OPK–88006 to ENDO2025

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • Given the challenging compliance rates attributed to injectable GLP–2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program. We plan to submit abstracts to a major clinical conference with PK/PD of the single daily tablet of GLP–2 in late 2025

Strong Additions to Entera Core Team

  • In March 2025, Cherin Smith joined Entera as EVP, Head of Clinical Operations. Cherin is an accomplished leader with more than 20 years of experience in global clinical operations leadership, project management, and vendor management. With more than a decade of strategic experience in women’s health, Cherin has a broad background in various therapeutic areas, including osteoporosis, metabolic and rare diseases, and cardiovascular and CNS disorders. Cherin led the successful execution of 11 Phase 3 trials with BMD endpoints, including registrational Phase 3 programs for Orilissa®, Myfembree®, and Veozah®, and has contributed to NDA submissions. Cherin holds a Bachelor of Science, Psychobiology degree from the University of California, Los Angeles (UCLA) and is a certified Project Management Professional.
  • On May 8th, 2025, Leslie Gautam joined Entera as Chief Business Officer. Leslie has extensive strategic advisory experience across biopharma, with transaction experience in both clinical and commercial stage companies with a particular focus on women’s health and supportive care. Most recently, Leslie was Co–Founder CEO of an early stage women's health company that provided care delivery and innovation for patients with hyperemesis gravidarum. Prior to this role, Leslie held senior positions in the healthcare investment banking team at Stifel and Houlihan Lokey. Previously, she served as part of the business development teams at Purdue Pharma and Noven Pharmaceuticals and was an Institutional Investor ranked equity research analyst for UBS covering the pharmaceutical sector. Leslie started her career in the healthcare investment banking group of BMO Capital Markets. Leslie holds a B.S. in Psychobiology and Computer Programming from UCLA and an MBA in Finance from Columbia Business School.

“I’m honored to join Entera at such a pivotal moment for women’s health. With an outstanding team and a pipeline designed to address long–overlooked conditions, we have an opportunity to turn scientific breakthroughs into meaningful, everyday impact for millions of patients. I’m excited to help accelerate that mission,” said Leslie Gautam, Chief Business Officer of Entera.

Financial Results for the Quarter Ended March 31, 2025

As of March 31, 2025, Entera had cash and cash equivalents and restricted cash of $20.6 million, of which $8 million has been designated to fund the collaboration activity with OPKO. The cash is expected to be sufficient to support the Company’s operations through the middle of the third quarter of 2026.

  • Research and development expenses for the three months ended March 31, 2025 were $1.1 million, as compared to $0.7 million for the three months ended March 31, 2024. The increase of $0.4 million was primarily due to an increase of $0.2 million in other consulting fees, including regulatory required in connection with the optimization processes related to the preparation of the EB613 phase 3 program, $0.1 million in connection with our internal programs and collaboration with OPKO and $0.1 million in share–based compensation.
  • General and administrative expenses for the three months ended March 31, 2025 were $1.4 million, as compared to $1.3 million for the three months ended March 31, 2024. The increase of $0.1 million was mainly attributable to an increase in IP costs and legal fees related to the execution of our collaboration agreement with OPKO and other potential strategic agreements.
  • Operating expenses for the three Months ended March 31, 2025 were $2.6 million, as compared to $2.1 million for the three Months ended March 31, 2024.

Net loss was $2.6 million, or $0.06 per ordinary share (basic and diluted), for the three months ended March 31, 2025, as compared to 2.0 million, or $0.05 per ordinary share (basic and diluted), for the three months ended March 31, 2024.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  March 31,   December 31,
  2025   2024
  (Unaudited)   (Audited)
   
Cash and cash equivalents 12,573   8,660
Accounts receivable and other current assets 645   312
Restricted cash 8,000  
Property and equipment, net 57   57
Other assets 325   361
Total assets 21,600   9,390
       
       
Accounts payable and other current liabilities 1,623   1,176
Total non–current liabilities 598   134
Total liabilities 2,221   1,310
Total shareholders' equity 19,379   8,080
       
Total liabilities and shareholders' equity 21,600   9,390
 

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)

  Three Months Ended
March 31,
  2025   2024  
REVENUES 42    
COST OF REVENUES 42    
GROSS PROFIT    
OPERATING EXPENSES:    
Research and development 1,123   735  
General and administrative 1,440   1,327  
TOTAL OPERATING EXPENSES 2,563   2,062  
OPERATING LOSS 2,563   2,062  
FINANCIAL INCOME, NET 4   (45)  
NET LOSS 2,567   2,017  
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.05  
         
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 43,377,391  

36,735,429

 
     


GLOBENEWSWIRE (Distribution ID 9448396)