Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX), a developer of oral peptides and proteins replacement therapies, will present data from three key programs at major conferences in September 2025. The presentations include clinical data for EB613, their oral PTH(1-34) tablet for osteoporosis treatment, at ASBMR 2025, featuring results from a Phase 2 study of 161 post-menopausal women.

The company will also present data on their Next-Gen EB613 tablet and a novel oral GLP-2 analog for Short Bowel Syndrome at ESPEN Congress. Additionally, CEO Miranda Toledano will deliver a corporate overview at the H.C. Wainwright Global Investment Conference.

• Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1-34) tablet treatment, EB613 on trabecular and cortical bone, and Next-Gen EB613 PK/PD data slated for oral and poster presentations at ASBMR
• Short Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP-2 tablet candidate poster presentation at ESPEN
• Corporate Overview at H.C. Wainwright Investor Conference
  

JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today announced that the Company will present data across three key programs during September 2025. Details on the presentations are available below:

American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting:
Oral Presentation – Dr. Rachel B. Wagman

• Title: Effects of EB613 Tablets [Oral PTH(1-34)] on Trabecular and Cortical Bone Using 3D-DXA: Results from Phase 2 Study (1014)
• Time: Friday, September 5, 2025, 11:45 AM
• Location: General Session Room, 6BC (6th Floor, Seattle Convention Center)
  

EB613 is being developed as the first, once-daily oral anabolic (bone forming) tablet treatment for postmenopausal women with osteoporosis. A placebo-controlled Phase 2 study in 161 post-menopausal women produced a rapid onset of action with increases in BMD at both cortical bone (femoral neck and hip region) and cancellous bone (spine). Based on a July 2025 alignment with FDA, Entera is planning a global Phase 3 registration study of EB613 in women with osteoporosis.

Poster Presentation – Next-Gen EB613

• Title: Advancing Oral Anabolic Treatments for Osteoporosis: Pre-Clinical Data for Next-Gen EB613 Tablet Utilizing N-Tab™ Proprietary Technology (581)
• Time: Sunday, September 7, 2025, 2:00 PM - 3:30 PM
• Location: Discovery Hall, Hall 4B (4th Floor, Seattle Convention Center)
  

47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress

Poster Presentation - GLP-2 Short Bowel Syndrome:

• Title: A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome
• Time: Saturday, September 13, 2025, 3:30 PM - 4:00 PM
• Location: Forum Hall Foyer 3, Prague, Czech Republic
  

The oral GLP-2 tablet program combines a proprietary long acting GLP-2 agonist developed by OPKO Health with Entera's proprietary N-Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist requires daily subcutaneous injections.

H.C. Wainwright Conference

Entera’s Chief Executive Officer Miranda Toledano will present at the H.C. Wainwright 27th Annual Global Investment Conference. The virtual presentation will be available on Friday, September 5, 2025 at 7:00 AM ET at:

https://journey.ct.events/view/0f59c59b-da4e-4dc2-a865-4f1883eca26f

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 a 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)teriparatide), 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 with alignment from FDA on the use of BMD as its primary 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 and OPKO’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, whether by Entera, OPKO or their respective collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO 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 our product candidates; the parties’ reliance on third parties to conduct clinical trials; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt-out, and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; 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 and OPKO’s intellectual property positions and their ability to protect their respective intellectual property; 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.

Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com

FAQ

What are the key findings from Entera Bio's (ENTX) Phase 2 study of EB613?

The Phase 2 study of EB613 in 161 post-menopausal women demonstrated rapid onset of action with increases in BMD at both cortical bone (femoral neck and hip region) and cancellous bone (spine).

When will Entera Bio (ENTX) present at the ASBMR 2025 Annual Meeting?

Dr. Rachel B. Wagman will present on Friday, September 5, 2025, at 11:45 AM in the General Session Room at the Seattle Convention Center.

What is the significance of Entera Bio's oral GLP-2 program?

Entera Bio's oral GLP-2 program aims to develop the first oral alternative to currently approved GLP-2 agonists, which require daily subcutaneous injections for Short Bowel Syndrome treatment.

What are Entera Bio's (ENTX) plans for EB613 following FDA alignment?

Following July 2025 FDA alignment, Entera Bio is planning a global Phase 3 registration study of EB613 in women with osteoporosis.

When is Entera Bio's (ENTX) presentation at the H.C. Wainwright Conference?

CEO Miranda Toledano's virtual presentation will be available on Friday, September 5, 2025, at 7:00 AM ET.