Welcome to our dedicated page for Entera Bio news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio stock.
Company Overview
Entera Bio Ltd is a clinical-stage biopharmaceutical company that focuses on the development of innovative oral peptide and therapeutic protein formulations. Utilizing a disruptive drug delivery technology, the company is dedicated to addressing chronic medical conditions where traditional injection therapies have long been the standard. Among the key terms that define this sector are pharmacokinetics, oral peptide therapy, and advanced drug delivery systems. These keywords underline the company’s commitment to reshaping treatment paradigms in conditions like osteoporosis and hypoparathyroidism.
Innovative Oral Delivery Platform
At the heart of Entera Bio's strategy is a proprietary oral delivery platform designed to improve the absorption and efficacy of macromolecular drugs. By formulating its therapeutics as mini tablets, the company overcomes some of the traditional challenges associated with the oral administration of peptides, such as degradation in the gastrointestinal tract. This platform not only supports improved pharmacokinetic profiles for its products but also offers the convenience of non-invasive administration in contrast to conventional injectable treatments.
Product Pipeline and Therapeutic Focus
Entera Bio is dedicated to the development of novel treatment options that meet critical unmet needs. Its pipeline comprises multiple first-in-class oral peptide programs, including:
- EB613: Designed as an oral formulation of synthetic human PTH (1-34) targeting osteoporosis, this product is developed to offer a bone-anabolic treatment option for post-menopausal women with low bone mineral density. The tablet is engineered with a specific pharmacokinetic profile to promote bone turnover and potentially improve bone health.
- EB612: Focused on hypoparathyroidism, this candidate is intended to serve as an innovative peptide replacement therapy in an oral tablet form. Its development represents a significant shift from conventional treatment methods for managing calcium and parathyroid hormone imbalances.
- Additional programs include the first oral formulations of oxyntomodulin and GLP-2 peptide therapies, which explore areas such as obesity management and rare malabsorption conditions like short bowel syndrome. These candidates highlight the company’s strategic deployment of its drug delivery technology across multiple therapeutic areas.
Clinical Development and Market Positioning
The company’s clinical development efforts have been structured around generating robust pharmacodynamic and biomarker data, with studies meticulously designed to assess both the primary endpoints and secondary benefits of its formulations. Entera Bio’s approach exemplifies a scientific rigor in its dose ranging, placebo-controlled studies, thereby fostering a greater understanding of the interplay between drug absorption and clinical efficacy. By leveraging solid clinical findings, the company aims to secure regulatory qualification for its endpoints, which, in turn, positions its products as viable alternatives to existing therapies.
Business Model and Industry Impact
Entera Bio operates on a model that combines cutting-edge biotechnology innovation with a focused clinical-stage development strategy. The company’s revenue generation is anticipated to be tied to milestone achievements in its clinical trials and eventual partnerships or licensing deals as its product candidates progress through various phases of clinical evaluation. By addressing areas of significant unmet medical need, Entera Bio not only fills a gap in the market but also challenges conventional drug administration paradigms, thereby influencing broader industry trends in chronic disease treatment.
Technological and Scientific Expertise
Entera Bio’s advancements hinge on a deep understanding of pharmacokinetics, bioavailability, and molecular absorption. The company’s scientists and researchers work to optimize the mini tablet formulations to suit specific pharmacological profiles. This commitment to thorough scientific inquiry and data-driven decision-making underscores the company's reputation for expertise and reinforces its standing among biopharmaceutical innovators.
Competitive Landscape
Within the highly competitive field of biopharmaceuticals, Entera Bio distinguishes itself through its innovative approach to oral peptide therapeutics. While traditional competitors often rely on injectable therapies, Entera Bio’s focus on oral formulations offers a non-invasive, patient-friendly alternative that could potentially enhance treatment adherence and overall quality of life. This unique positioning is further bolstered by its diversified pipeline, which spans multiple therapeutic areas with high demand and critical unmet needs.
Research and Collaborative Endeavors
Entera Bio actively pursues collaborations with industry research institutions and clinical organizations to validate its oral delivery platform and advance its product candidates through rigorous clinical trials. This collaborative approach not only strengthens the company’s intellectual foundation but also opens pathways for integrating new scientific insights, ultimately propelling its mission to transform standard treatment protocols.
Conclusion
In summary, Entera Bio Ltd stands as a pioneering force in the realm of oral peptide therapeutics. With a strong foundation in scientific research, a robust clinical pipeline, and a clear commitment to addressing chronic diseases with unmet needs, the company offers a comprehensive approach to revolutionizing drug delivery. Investors and industry observers can appreciate the depth of innovation and the commitment to advancing treatment paradigms that defines Entera Bio's strategic positioning in the biopharmaceutical landscape.
Entera Bio (NASDAQ: ENTX) reported its financial results for 2024, marking a transformational year in developing oral peptide therapies. The company's flagship product, EB613, the first oral PTH(1-34) tablet for osteoporosis, made significant progress with published Phase 2 trial results in JBMR.
Key developments include successful results in their GLP-1/Glucagon program with OPKO Health, showing significant systemic exposure and glucose reduction. The company also advanced their GLP-2 peptide tablets program for Short Bowel Syndrome, demonstrating 10-fold higher plasma levels compared to existing treatments.
Financial highlights: Cash position of $21 million as of March 2025, sufficient until Q3 2026. R&D expenses remained stable at $4.5 million, while G&A expenses increased to $5.1 million. Net loss for 2024 was $9.5 million ($0.25 per share) compared to $8.9 million ($0.31 per share) in 2023.
OPKO Health (NASDAQ: OPK) and Entera Bio (NASDAQ: ENTX) have formed a collaboration agreement to develop the first oral dual agonist GLP-1/glucagon peptide tablet for treating obesity and metabolic disorders. The program combines OPKO's OPK-88006 with Entera's N-Tab™ technology, following favorable data reported in September 2024.
The partnership structure gives OPKO a 60% ownership stake and Entera a 40% stake, with corresponding cost-sharing responsibilities. OPKO has purchased 3,685,226 Entera shares at $2.17 per share, with proceeds funding Entera's Phase 1 development costs. Post-Phase 1, Entera can maintain its 40% stake by continuing funding, or opt-out to retain 15% ownership while OPKO increases to 85%.
The companies plan to file an Investigational New Drug application with the FDA later this year. The treatment utilizes oxyntomodulin, a natural hormone that suppresses appetite, induces weight loss, and offers cardioprotective and anti-fibrotic benefits. Currently, no approved dual GLP-1/Glucagon agonists exist in the market.
Entera Bio (NASDAQ: ENTX), a pioneer in developing oral peptide and protein replacement therapies in tablet form, has announced its participation in three major upcoming events in 2025.
The company will attend the Leerink Partners Global Healthcare Conference on March 12 in Miami, FL, where they will conduct in-person one-on-one meetings. At the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), Entera will deliver an oral presentation on April 11 at 10:00 GMT in the Roma Convention Center's Auditorium A, followed by a poster presentation (Poster #P1265) on April 13 from 8:30-13:00. Additionally, the company will participate in the BIO International Convention scheduled for June 16-19 at the Boston Convention & Exhibition Center.
Entera Bio (NASDAQ: ENTX) announced that two abstracts related to EB613, their oral PTH(1-34) tablet treatment for post-menopausal osteoporosis, have been accepted for presentation at the WCO-IOF-ESCEO congress in Rome (April 10-13, 2025). The presentations will focus on the effects of EB613 on trabecular and cortical bone using 3D-DXA, and its impact on bone modeling versus remodeling.
In a Phase 2 placebo-controlled study, EB613 demonstrated rapid onset and significant BMD increases across all skeletal sites over 6 months, along with increased bone formation (P1NP) and reduced bone resorption (CTX). The treatment is being developed as the first once-daily oral anabolic therapy for high-risk post-menopausal women with osteoporosis, targeting a condition that affects an estimated 200 million women globally.
Entera Bio (NASDAQ: ENTX), a pioneer in oral peptide and therapeutic protein delivery, has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The virtual event is scheduled for February 11-12, 2025.
The company's CEO, Miranda Toledano, will deliver a business overview and update presentation on Tuesday, February 11th from 12:40-1:10 PM ET in Track 1. The company will also be available for investor meetings throughout the conference.
Entera Bio reported Q3 2024 financial results and updates on its oral peptide development programs. The company's lead asset, EB613, is advancing as the first oral PTH(1-34) tablet for post-menopausal women with high-risk osteoporosis. Key developments include positive pharmacokinetic results for their GLP-1/Glucagon program with OPKO Health and ongoing development of oral GLP-2 tablets. Financial highlights show cash position of $6.9 million, R&D expenses of $1.5 million, and a net loss of $3.0 million ($0.08 per share). The company expects current cash to fund operations into Q3 2025.
Entera Bio (NASDAQ: ENTX) and OPKO Health, Inc. (NASDAQ: OPK) have announced positive results from their collaborative research on an oral oxyntomodulin (OXM) peptide tablet for obesity and metabolic disorders. The study, combining OPKO's proprietary long-acting OXM analog with Entera's N-Tab™ technology, aims to develop the first oral dual agonist GLP-1/glucagon peptide for once-daily treatment.
Key findings from the in vivo proof-of-concept PK/PD studies in rodent and pig models include:
- Significant systemic exposure following a single dose
- Favorable PK profile and bioavailability
- High plasma concentrations with prolonged systemic exposure in pigs
- Statistically significant reduction in plasma glucose levels in rats
The companies plan to present these data at an upcoming clinical conference and move towards IND-enabling efforts for the program.
Entera Bio (NASDAQ: ENTX), a leader in developing orally delivered peptides and small therapeutic proteins, has announced its participation in three upcoming conferences:
1. H.C. Wainwright 26th Annual Global Investment Conference: Virtual presentation on September 9, 2024, at 7am ET.
2. American Society for Bone and Mineral Research 2024 Annual Meeting: In-person poster presentation on September 28, 2024, from 2:15 – 3:45PM in Toronto, Canada.
3. 7th Annual Evercore ISI HealthCONx Conference: In-person fireside chat on December 4, 2024, from 3:25-3:45PM in Coral Gables, Florida.
These conferences provide Entera Bio with opportunities to showcase its developments and engage with investors and scientific communities.
Entera Bio (NASDAQ: ENTX) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Advancing EB613, the first oral PTH(1-34) daily osteoanabolic tablets for osteoporosis, with new comparative data vs. Forteo® to be presented at ASBMR 2024.
2. Progress on EB612, the first oral PTH(1-34) peptide replacement therapy for hypoparathyroidism, with Phase 1 data supporting potential Phase 2 development.
3. Positive in vivo PK results for GLP-2 peptide tablets for short bowel syndrome, with pharmacology data expected in H2 2024.
4. Ongoing development of GLP-1/Glucagon agonist tablets for obesity, with PK data expected in H2 2024.
5. Financial results: $9.1M cash on hand, sufficient until Q3 2025. Q2 2024 net loss of $2.1M ($0.06 per share) compared to $2.3M ($0.08 per share) in Q2 2023.
Entera Bio (NASDAQ: ENTX) announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® will be presented at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic PTH(1-34) mini tablet therapy for post-menopausal women with high-risk osteoporosis.
The company aims to address the treatment gap in current osteoporosis care, targeting the estimated 200 million women globally affected by post-menopausal osteoporosis. Entera also anticipates a key update from the SABRE (Study to Advance BMD as a Regulatory Endpoint) project at the meeting, following the FDA's communication about qualifying bone mineral density (BMD) as a surrogate endpoint for fractures in future osteoporosis drug trials.
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