Entera Bio Ltd Stock Price, News & Analysis

Entera Bio (NASDAQ: ENTX) presented promising Phase 2 study results for EB613, their innovative once-daily oral PTH(1-34) tablet for postmenopausal osteoporosis treatment, at the 2025 WCO-IOF-ESCEO Congress in Rome.

The study involving 161 postmenopausal women demonstrated that after 6 months of treatment, EB613 showed significant improvements in bone mineral density (BMD) compared to placebo. The 3D-DXA analysis revealed increases in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD.

The results indicate early beneficial effects on both trabecular and cortical bone of the proximal femur, suggesting potential rapid bone strengthening and fracture resistance. This development is particularly significant as postmenopausal osteoporosis affects an estimated 200 million women globally, with 50% of women over 50 at risk of fragility fractures.

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.