EB612, a first-in-class long-acting PTH(1-34) oral peptide for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026

EB618, a first-in-class dual GLP-1/glucagon oral receptor agonist (oxyntomodulin) for obesity and metabolic disorders, showed dose-proportional pharmacokinetics and a robust effect on blood glucose in non-human primates

TEL AVIV, June 16, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera"), a leader in the development of oral peptides, reported preclinical data at ENDO 2026, the annual meeting of the Endocrine Society, for its EB612 and EB618 pipeline programs. Both EB612 and EB618 programs are being co-developed with OPKO Health Inc. (NASDAQ:OPK).

"The strength of these results underscores the consistency of our N-Tab^® platform to develop proprietary oral peptides across a myriad of targets and indications," said Miranda Toledano, Chief Executive Officer of Entera.

EB612: First-in-Class Oral Long-Acting PTH(1-34) Peptide Tablet for Hypoparathyroidism

EB612 is a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera's N-Tab^® oral peptide platform. As the first oral peptide replacement therapy, EB612 aims to provide patients with an oral alternative to currently approved or development-stage peptides that require injections.

In a poster presentation entitled "Pre-Clinical Results for EB612: First-in-Class Oral Long-Acting PTH(1-34) Analog as Hormone Replacement Tablet for Patients with Hypoparathyroidism," Entera highlighted the following data for EB612:

In the thyroparathyroidectomized (TPTx) rat model, the established and widely used preclinical model of hypoparathyroidism, the long-acting PTH(1-34) analog, dosed daily for 7 days, restored serum calcium and reduced phosphate to levels comparable to sham control animals.
In a minipig model, a single oral dose of EB612 reached maximal plasma levels 2 to 3 hours post-dose, with drug remaining detectable in plasma for more than three days. This sustained pharmacokinetic exposure was associated with a rapid and long-lasting increase in serum Ca in all study animals. The calcemic effect lasted for approximately three days.
In a non-human primate model, a single oral dose of EB612 produced a robust and sustained increase in serum calcium for approximately three days, accompanied by a correlating suppression of endogenous PTH levels.

EB612 was well tolerated, with no safety concerns identified, and the calcemic effects were consistent with those reported for clinically validated injectable PTH-replacement therapies for hypoparathyroidism.

Ongoing studies are advancing EB612 toward first-in-human clinical evaluation. As announced in February 2026, Entera and OPKO expanded their collaboration to advance EB612 on a 50/50 basis, with an intention to file an investigational new drug (IND) application in late 2026.

EB618: First-in-Class Oral Dual GLP-1/Glucagon receptor agonist (Oxyntomodulin) Tablet for Obesity and Metabolic Disorders

Oxyntomodulin (OXM) is a naturally occurring dual GLP-1/glucagon receptor agonist hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life.

The EB618 tablet is a proprietary long-acting OXM analog formulated with Entera's N-Tab^® platform.

In a poster presentation at ENDO 2026 entitled "EB618, First-In-Class Oral Tablet of Dual GLP-1/Glucagon Receptor Agonist for Patients with Obesity and Metabolic Disorders: Results from PK-PD Study in Non-Human Primates," Entera reported a single dose pharmacokinetic-pharmacodynamic study in non-human primates:

EB618 exhibited robust bioavailability, with dose-proportional systemic exposure across three tested tablet strengths and low variability.
A dose-proportional pharmacologic effect on postprandial blood glucose levels was observed.
EB618 was well tolerated, with no safety concerns identified, at doses exceeding the anticipated clinical dose range by more than tenfold.

These data support the continued clinical development of EB618 as a potential first-in-class oral once-daily GLP-1/glucagon receptor agonist for the treatment of obesity and metabolic disorders.

About Entera

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 a disruptive and proprietary technology platform (N-Tab^®) and its pipeline of first-in-class oral peptide programs. 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 for 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 also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release 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 press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are 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 press release. The information in this press release is provided only as of the date of this press release, 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.

Company Contact:

IR@enterabio.com

Entera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026