Entera Announces First Quarter 2026 Financial Results and Updates Across its Oral Peptide Programs

 

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – Phase 3 protocol submitted with FDA feedback expected imminently; incremental data submitted to ENDO2026 and ASBMR

 

EB612, the first oral long-acting PTH peptide replacement tablet for hypoparathyroidism – Expanded 50/50 partnership with OPKO; intention to file IND in late 2026; data submitted to ENDO2026

 

EB618, the first oral OXM (dual GLP-1/Glucagon) tablet for metabolic and fibrotic conditions – data submitted to ENDO2026

 

Direct Investment led by BVF Partners L.P. to support EB613 pivotal study acceleration and working capital

 

TEL AVIV, May 8, 2026 -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended March 31, 2026.

 

“The first quarter of 2026 solidified Entera’s position as the leading oral peptide therapeutics company. Our N-Tab® platform is developing arguably the richest pipeline of clinical and near-clinical first in class assets, and we are driven by our mission to develop transformative medicines and invest in therapeutic spaces that have been ignored and require urgent attention,” said Miranda Toledano, CEO of Entera.

 

“This begins with our EB613 journey to develop the first oral anabolic to potentially help millions of women preserve their bone health while advocating for much needed innovation in a therapeutic space which disproportionately affects the health of women. In March 2026, we submitted documents to FDA related to EB613’s potential registrational package. This quarter, we also completed a critical Phase 1 bridging study for the single, final tablet formulation of EB613. Additionally, we submitted PK and TPTX proof of concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions to ENDO2026 and ASBMR. Each of these milestones has been executed with a strong focus on capital efficiency by a core team that has a unifying commitment to succeed in developing therapeutics that matter,” said Miranda Toledano, Chief Executive Officer of Entera.

 

 

EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis

 

 

 

 

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

 

 

EB618: First-in-Class Oral Dual GLP-1/Glucagon (OXM) Tablet for Obesity and Metabolic Disease

 

 

Corporate Highlights

 

 

 

 

Cash and cash equivalents as of March 31, 2026, were $11.9 million.  As of May 8, 2026, cash and cash equivalents were $20.4 million, inclusive of the proceeds from the private placement led by BVF Partners L.P. in April 2026 and the $7.8 million restricted cash which is designated to fund the OPKO collaboration including EB612 and EB618. The Company’s available funds are expected to support operations through the first quarter of 2027, including activities related to the preparation of the planned Phase 3 registrational study of EB613.

 

 

 

 

Net loss was $3.5 million, or $0.07 per ordinary share (basic and diluted), for the three months ended March 31, 2026, as compared to $2.6 million, or $0.06 per ordinary share (basic and diluted), for the three months ended March 31, 2025.

 

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.

 

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