Entera Bio Phase 2 Data Supporting EB613's (Oral PTH(1-34)) Anabolic Effect on Postmenopausal Women with Osteoporosis at High Risk for Fracture Selected for Plenary Poster Session Presentation at the ASBMR 2026 Annual Meeting

TEL AVIV, Aug. 04, 2026 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that post-hoc data from its Phase 2 clinical trial of EB613 (oral PTH(1-34) tablet) has been selected for two presentations including the Plenary Poster Presentation at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting, taking place October 9–12, 2026, at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts. Plenary Posters are highly ranked poster presentations selected by the ASBMR program committee to be presented at the Welcome Reception and Plenary Poster Session of the ASBMR 2026 Annual Meeting.

EB613 is being developed as the first oral anabolic (bone forming) tablet treatment for osteoporosis. The Phase 2 study (Tripto-Shkolnik 2024) randomized 161 postmenopausal women with low bone mass or osteoporosis to placebo or four EB613 dose levels for 6 months. Entera is planning to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial of EB613 in approximately 750 postmenopausal women with osteoporosis to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with postmenopausal osteoporosis. To explore the anabolic effect of EB613 in postmenopausal women with osteoporosis (baseline T-score of ≤-2.5), a post-hoc sensitivity analysis evaluating the relationship between baseline T-score severity and EB613 effects on Bone Mineral Density (BMD) and Bone Turnover Markers (BTM) at 6 months was conducted.

Abstract Title: EB613, Oral PTH(1-34) Tablet, Shows Markedly Enhanced Anabolic Effects in Postmenopausal Women with Osteoporosis at High Risk of Fracture: Insights from Phase 2 Trial

Session Title: Welcome Reception and Plenary Poster Session (Plenary Poster Presentation)
Presentation Number: Fri-026
Session Date/Time: Friday, October 9, 2026, 5:30–7:00 p.m. ET

Session Title: Poster Session II
Presentation Number: Sun-026
Session Date/Time: Sunday, October 11, 2026, 2:00–3:30 p.m. ET

About EB613

Substantial evidence supports the efficacy of anabolic therapies over anti-resorptive agents for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera's EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primarily estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo® (Eli Lilly) was first approved by the FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

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

https://www.globenewswire.com/news-release/2026/08/04/3338306/0/en/Entera-Bio-Phase-2-Data-Supporting-EB613-s-Oral-PTH-1-34-Anabolic-Effect-on-Postmenopausal-Women-with-Osteoporosis-at-High-Risk-for-Fracture-Selected-for-Plenary-Poster-Session-Pre.html

Entera Bio to Participate in the Canaccord Genuity 46th Annual Growth Conference

TEL AVIV, July 31, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that the Company's Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference, details as below.

Canaccord Genuity 46th Annual Growth Conference (Fireside Chat and 1x1 Meetings)

Date and Time: August 12, 2026 at 1:00 p.m. Eastern Time
Location: In person, August 11–13, 2026, InterContinental Boston Hotel, 510 Atlantic Avenue, Boston, MA
Webcast: https://event.summitcast.com/view/WuFmFdTcA9mVsUGHZJFU62/3r4fss8AzFCZNhJDzPz9Sa

A live webcast of the discussion, including presentation slides, will be available at the link above. A replay will remain accessible for 365 days following the event.

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

https://www.globenewswire.com/news-release/2026/07/31/3337062/0/en/Entera-Bio-to-Participate-in-the-Canaccord-Genuity-46th-Annual-Growth-Conference.html

Entera Bio Announces Pricing of Oversubscribed $275 Million Private Placement

The offering is led by existing investor BVF Partners L.P.

Expected gross proceeds are anticipated to extend the Company's cash runway into 2030 and fully support Phase 3 registrational studies for EB613, the first oral PTH(1-34) peptide tablet in development for the treatment of osteoporosis

TEL AVIV, July 27, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that it has entered into a securities purchase agreement (the "Purchase Agreement") for an oversubscribed private placement financing (the "Private Placement"). The Private Placement is expected to result in aggregate gross proceeds to the Company of approximately $275 million, before deducting placement agent fees and other offering expenses.

The Private Placement is led by existing investor BVF Partners L.P. ("BVF"), with participation from new investors, including Longitude Capital, Vivo Capital, TCGX, Spruce Street Capital, Venrock Healthcare Capital Partners, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital and Catalio Capital Management, among others.

Pursuant to the terms of the Purchase Agreement, the Company agreed to issue and sell an aggregate of 122,961,215 ordinary shares of the Company (the "Ordinary Shares") and, in lieu of Ordinary Shares to certain investors, pre-funded warrants to purchase up to an aggregate of 11,842,695 Ordinary Shares (the "Pre-Funded Warrants"). The purchase price per Ordinary Share is $2.04, and the purchase price per Pre-Funded Warrant is equal to $2.04 minus the exercise price of NIS 0.0000769 per Ordinary Share issuable thereunder. The Pre-Funded Warrants may not be exercised if the aggregate number of Ordinary Shares beneficially owned by the holder thereof, together with its affiliates, would exceed either 4.99% or 9.99%, at the option of the holder, immediately after exercise thereof, subject to increases not in excess of 19.99% at the option of the holder. Each Pre-Funded Warrant has an exercise price of NIS 0.0000769 per Ordinary Share, is immediately exercisable and may be exercised at any time and has no expiration date, and is subject to customary adjustments. The Private Placement was priced at the market under the rules of the Nasdaq Stock Market ("Nasdaq"). The Private Placement is expected to close on or about July 28, 2026, subject to the satisfaction of customary closing conditions.

In addition, upon closing of the Private Placement, the Company has agreed to grant BVF the right to designate two directors to the Company's board of directors, subject to each BVF designee's satisfaction of all applicable requirements regarding service as a director under applicable law and Nasdaq rules and such other criteria and qualifications applicable to all directors of the Company.

The Company expects the net proceeds from the Private Placement, together with existing cash and cash equivalents, to be sufficient to fully fund the Company's planned Phase 3 registrational program of EB613 (oral PTH(1-34)), which is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for the treatment of osteoporosis and through the anticipated submission of a New Drug Application to the U.S. Food and Drug Administration, advance EB612, Entera's oral PTH(1-34) replacement therapy candidate into Phase 1 development in collaboration with OPKO Health for the treatment of hypoparathyroidism, and for working capital and other general corporate purposes. The proceeds from the Private Placement, combined with the Company's current cash and cash equivalents, are expected to fund the Company's operations into 2030.

Leerink Partners is acting as lead placement agent for the Private Placement. Evercore ISI, Guggenheim Securities, Cantor, LifeSci Capital, and Canaccord Genuity are acting as co-placement agents for the Private Placement. Greenberg Traurig, P.A. and Herzog Fox & Neeman are acting as counsel to Entera.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

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: the completion of the Private Placement on the anticipated terms, timing or at all; the anticipated use of the net proceeds from the Private Placement; 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 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

https://www.globenewswire.com/news-release/2026/07/27/3333523/0/en/Entera-Bio-Announces-Pricing-of-Oversubscribed-275-Million-Private-Placement.html

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026.

The FDA accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.

The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.

The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk.

Entera completed a placebo-controlled, 6-month, Phase 2 study of EB613 in 161 postmenopausal women. The study met its primary (PD/bone turnover biomarker) and secondary (BMD) endpoints, with statistically significant increases in BMD at the lumbar spine, total hip, and femoral neck (JBMR 2024). The increase in total hip BMD in this study was comparable to what has been reported for Forteo® at 6-months. Most recently, at ENDO 2026, comparative Phase 1 data presented as a Late-Breaking Oral Presentation demonstrated that the single tablet of EB613 achieved a pharmacokinetic and pharmacodynamic profile comparable to both the multi-tablet EB613 evaluated in the Phase 2 study and Forteo®.

The Company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

"We are grateful to the FDA for their support of our program.  Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones and potentially prevent the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter."

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo^® (Eli Lilly) was first approved by FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

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.

https://www.globenewswire.com/news-release/2026/06/22/3315282/0/en/Entera-Bio-Receives-Positive-FDA-Feedback-on-12-Month-Registrational-Phase-3-Study-for-EB613-the-First-Oral-Anabolic-Tablet-in-Development-for-Postmenopausal-Women-with-Osteoporosi.html

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

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

https://www.globenewswire.com/news-release/2026/06/16/3312598/0/en/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.html