• FDA provides pivotal agreement on EB613 Phase 3 design, confirming Bone Mineral Density (BMD) as primary endpoint and clearing streamlined pathway for first oral anabolic osteoporosis treatment
• Significant regulatory and pipeline advancements achieved including FDA waiver of additional safety studies and next–gen EB613 expected to enter Phase 1 in November 2025
• Strong momentum across OPKO collaboration with obesity program showing promising preclinical data; and EB612 oral PTH directed hypoparathyroidism program candidate validation
• Strong balance sheet provides runway through mid–Q3 2026, including dedicated OPKO collaboration funding

JERUSALEM, Aug. 08, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended June 30, 2025.

“Last week's FDA agreement on using BMD as the primary endpoint for EB613's Phase 3 program represents a pivotal milestone in our journey to bring the first oral anabolic osteoporosis tablet treatment to market,” said Miranda Toledano, Chief Executive Officer of Entera. “This unprecedented regulatory alignment validates both the strength of our clinical data and our strategic vision that began taking shape in July 2022. The concurrence opens the door to addressing a massive unmet need – with less than 25% of the world's 200 million osteoporotic women having access to safe, effective, and affordable treatment options, and no new therapies approved in this space since 2019. Beyond EB613, throughout Q2, we continued building momentum across our entire pipeline, including presenting promising pharmacokinetic data for our oral GLP–1/glucagon dual agonist program with OPKO. With our strengthened cash position of $18.9 million, including dedicated OPKO collaboration funding, we are well–positioned to execute on multiple value–creating milestones across 2025 and beyond.”

Key Recent Highlights

EB613: First Oral PTH(1–34) Anabolic Treatment for Osteoporosis

• FDA Agreement that BMD Primary Endpoint Would Support NDA: In a July Type A meeting, FDA provided written concurrence on our Phase 3 study design – a single multinational, randomized, double–blind, placebo–controlled, 24–month study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. As a 505(b)(2) application, the submission will rely on FDA's previous findings of effectiveness and safety for the Reference Listed Drug Forteo^®, where the correlation between BMD and fracture has been well–established. The study is designed and powered to demonstrate a statistically significant increase in total hip BMD, coupled with a positive trend on vertebral fracture reduction as key secondary endpoint to provide substantial evidence of effectiveness. This FDA decision is independent of the Agency's qualification of the SABRE BMD Initiative which is still expected within 2025.

• Regulatory Burden Significantly Reduced: In May and June, Entera received written agreements from FDA that dedicated oral carcinogenicity studies and comprehensive nonclinical developmental and reproductive toxicity (DART) studies are not warranted given the totality of evidence generated fromForteo^® literature and nonclinical studies conducted with EB613.
• Strong Clinical Data Gains Scientific Recognition: In April, Dr. Rachel B Wagman presented early effects of EB613 on trabecular and cortical bone using 3D–DXA at the 2025 WCO–IOF–ESCEO Congress. Additionally, 3D Shaper Phase 2 data was selected for oral presentation at ASBMR 2025 in September.
• Next–Generation EB613 Advancing: “Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology” was selected for poster presentation at ASBMR 2025. Next Gen EB613 is being developed with a new generation of Entera's N–TAB™ platform and is expected to enter the clinic in a Phase 1 Safety and PK Study in November 2025.
• Strategic Regulatory Engagement: In June, CEO Miranda Toledano participated in the Boston “CEO Forums: An FDA Listening Tour to Engage Pharma and Bio CEOs” and presented a one–minute brief on osteoporosis and potential regulatory reform to spur innovation.

First PTH (1–34) Tablet Protein Replacement Therapy for Hypoparathyroidism

• First pre–clinical PK/PD data from undisclosed collaborative research with long–acting PTH agonist as a once–daily tablet format is expected by end of year.

OPKO Health Collaboration Programs

• First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity: In June, a poster at ENDO2025 reported PK data from a mini–pig study of oral OPK–88006 (dual GLP–1/glucagon receptor agonist in partnership with OPKO Health, Nasdaq: “OPK”) which showed plasma levels consistent with those reported in humans for the highest subcutaneous dose of Wegovy™ (semaglutide) weekly injection, a standard of care for the treatment of obesity. The reported pharmacological data supports a once–daily tablet regimen of this first–in–class oral dual agonist. A Phase 1 study is being planned and IND filing is expected in H1 2026.
• First GLP–2 Peptide Tablets for Short Bowel Syndrome: In June, Entera in partnership with OPKO's “First–in–Class Oral GLP–2 Analog for Treatment of Short Bowel Syndrome” abstract was selected for poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress.

Financial Results for the Quarter Ended June 30, 2025

Cash and cash equivalents were $18.9 million as of June 30, 2025, including $8.0 million in restricted cash designated to fund the OPKO collaboration through Phase 1 studies of oral GLP–1/glucagon candidate OPK–88006. Cash on hand is expected to support operations through mid–third quarter 2026.

Net loss was $2.7 million, or $0.06 per ordinary share, for the three months ended June 30, 2025, compared to $2.1 million, or $0.06 per ordinary share, for the three months ended June 30, 2024.

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024, an increase of $0.4 million. The increase was primarily due to regulatory activities and Phase 3 planning for EB613.

General and administrative expenses were $1.1 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024.

Total operating expenses were $2.7 million for the three months ended June 30, 2025, compared to $2.2 million for the three months ended June 30, 2024.

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 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 presentation. The information in this presentation is provided only as of the date of this presentation, 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.

GLOBENEWSWIRE (Distribution ID 9509020)

JERUSALEM, May 09, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended March 31, 2025.

“During Q1 2025, Entera continued to generate intrinsic value with progress across our programs while significantly extending our cash runway into late 2026 via direct investment from marquis investors and our strategic partner, OPKO Health Inc. (“OPKO”). EB613 early mechanistic effects on both trabecular and cortical bone compartments data using 3D–Shaper software analysis was selected for oral presentation out of 1,680 abstracts submitted to the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress. Subsequent EB613 abstracts have been submitted to both the 2025 American Society for Bone Mineral Research (ASBMR) and the North American Menopause Society (NAMS) conferences. Pre–IND activities for our Next Gen EB613 tablet candidate are in final stages, with plans to initiate a Phase 1 study in H2 2025. Via the execution of our recent license agreement with OPKO, we are fully funded to co–develop Oral OPK–88006 (the first dual acting GLP1/Glucagon single tablet for metabolic diseases) through SAD/MAD Phase 1 studies while retaining a 40% stake in the economics of this important asset. An abstract for Oral OPK–88006 has been submitted to ENDO2025. Finally, we are judiciously strengthening our core team with important appointments including Ms. Leslie Gautam, as Chief Business Officer and Ms. Cherin Smith as Head of Clinical Operations, both of whom have extensive experience in strategic and operational execution in women–centric conditions,” said Miranda Toledano, Chief Executive Officer of Entera.

“We continue to optimize and prepare to initiate our proposed pivotal program for EB613, the first and only oral anabolic “bone building” tablet treatment under clinical investigation in postmenopausal women with osteoporosis. The earlier the age at which menopause occurs the greater the risk of long–term impact on bone and heart health. EB613 is specifically intended to provide an oral anabolic treatment in tablet format earlier in an osteoporosis patient’s journey to increase skeletal mass and reduce the risk of fracture. EB613 comprises the first 34 N–terminal amino acid sequence of the human parathyroid hormone, PTH(1–34) or teriparatide, which is a validated standard of care and only available as a daily subcutaneous injection. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. In the U.S., there are over 54 million American women and men with at–risk bone health and osteoporosis. The statistics associated with osteoporosis are staggering: fracture rates are on the rise state by state, severe mortality (20% – 30% die within 12 months of fracture), catastrophic comorbidity (50% of fracture survivors unable to walk independently), a persistent treatment chasm (<25% receive osteoporosis medication) and escalating and preventable pharmacoeconomic burden ($57 billion in Medicare). No new osteoporosis drug has been approved by U.S. Food and Drug Administration (FDA) since 2019 due to the ethical, size and duration challenges imposed by fracture–based studies. At the heart of this significant public health concern is the need for regulatory reform of the fracture endpoint currently required for approval of osteoporosis drugs by the FDA. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is bone mineral density (BMD). The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), initiative has amassed the strongest evidence to date substantiating that gains in total–hip BMD reliably predict fracture–risk reduction as a viable surrogate to fracture. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate to cardiovascular outcomes and HBA1C as a surrogate to diabetes complications. In March 2024 the FDA Biomarker Division indicated to the SABRE group that a decision may be issued within 10 months. Recent presentations by SABRE at medical congresses indicate their continued optimism that a ruling by FDA on the qualification of BMD as a surrogate for fracture is expected in 2025. We strongly endorse the proposed BMD ruling and view it as crucial to reinvigorate much needed innovation and more treatment choices for patients and clinicians in this underserved disease. We will be taking additional steps to ensure the continuity of clinical development for EB613,” said Miranda Toledano, Chief Executive Officer of Entera.

Key Recent Highlights

EB613: First Oral PTH(1–34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

• On April 15, 2025, our Chief Clinical Advisor Dr. Rachel B Wagman presented at the 2025 WCO–IOF–ESCEO Congress “EFFECTS OF EB613 TABLETS [ORAL PTH(1–34)] ON TRABECULAR AND CORTICAL BONE USING 3D–DXA: POST–HOC RESULTS FROM PHASE 2 STUDY.” After 6 months of treatment, the findings showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. The evaluation showed a broad distribution of bone loss in the femur with placebo and a similarly broad distribution of bone gain in the femur with EB613. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6–month time point. During the quarter, further abstracts have been submitted to ASBMR and NAMS 2025 conferences
• Next Gen EB613, which is being developed with new generation of our N–TAB™ platform, is finalizing pre–IND activities with a plan to enter the clinic in H2 2025. We plan to submit an abstract on Next Gen EB613 to a major medical conference in 2025

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

• In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. We expect to file an Investigational New Drug application with the FDA later this year or early in 2026
• During the quarter, we submitted an abstract for Oral OPK–88006 to ENDO2025

First GLP–2 Peptide Tablets for Short Bowel Syndrome

• Given the challenging compliance rates attributed to injectable GLP–2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program. We plan to submit abstracts to a major clinical conference with PK/PD of the single daily tablet of GLP–2 in late 2025

Strong Additions to Entera Core Team

• In March 2025, Cherin Smith joined Entera as EVP, Head of Clinical Operations. Cherin is an accomplished leader with more than 20 years of experience in global clinical operations leadership, project management, and vendor management. With more than a decade of strategic experience in women’s health, Cherin has a broad background in various therapeutic areas, including osteoporosis, metabolic and rare diseases, and cardiovascular and CNS disorders. Cherin led the successful execution of 11 Phase 3 trials with BMD endpoints, including registrational Phase 3 programs for Orilissa®, Myfembree®, and Veozah®, and has contributed to NDA submissions. Cherin holds a Bachelor of Science, Psychobiology degree from the University of California, Los Angeles (UCLA) and is a certified Project Management Professional.
• On May 8^th, 2025, Leslie Gautam joined Entera as Chief Business Officer. Leslie has extensive strategic advisory experience across biopharma, with transaction experience in both clinical and commercial stage companies with a particular focus on women’s health and supportive care. Most recently, Leslie was Co–Founder CEO of an early stage women's health company that provided care delivery and innovation for patients with hyperemesis gravidarum. Prior to this role, Leslie held senior positions in the healthcare investment banking team at Stifel and Houlihan Lokey. Previously, she served as part of the business development teams at Purdue Pharma and Noven Pharmaceuticals and was an Institutional Investor ranked equity research analyst for UBS covering the pharmaceutical sector. Leslie started her career in the healthcare investment banking group of BMO Capital Markets. Leslie holds a B.S. in Psychobiology and Computer Programming from UCLA and an MBA in Finance from Columbia Business School.

“I’m honored to join Entera at such a pivotal moment for women’s health. With an outstanding team and a pipeline designed to address long–overlooked conditions, we have an opportunity to turn scientific breakthroughs into meaningful, everyday impact for millions of patients. I’m excited to help accelerate that mission,” said Leslie Gautam, Chief Business Officer of Entera.

Financial Results for the Quarter Ended March 31, 2025

As of March 31, 2025, Entera had cash and cash equivalents and restricted cash of $20.6 million, of which $8 million has been designated to fund the collaboration activity with OPKO. The cash is expected to be sufficient to support the Company’s operations through the middle of the third quarter of 2026.

• Research and development expenses for the three months ended March 31, 2025 were $1.1 million, as compared to $0.7 million for the three months ended March 31, 2024. The increase of $0.4 million was primarily due to an increase of $0.2 million in other consulting fees, including regulatory required in connection with the optimization processes related to the preparation of the EB613 phase 3 program, $0.1 million in connection with our internal programs and collaboration with OPKO and $0.1 million in share–based compensation.

• General and administrative expenses for the three months ended March 31, 2025 were $1.4 million, as compared to $1.3 million for the three months ended March 31, 2024. The increase of $0.1 million was mainly attributable to an increase in IP costs and legal fees related to the execution of our collaboration agreement with OPKO and other potential strategic agreements.

• Operating expenses for the three Months ended March 31, 2025 were $2.6 million, as compared to $2.1 million for the three Months ended March 31, 2024.

Net loss was $2.6 million, or $0.06 per ordinary share (basic and diluted), for the three months ended March 31, 2025, as compared to 2.0 million, or $0.05 per ordinary share (basic and diluted), for the three months ended March 31, 2024.

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 its 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)), 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 pursuant to the FDA’s qualification of a quantitative BMD 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 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 presentation. The information in this presentation is provided only as of the date of this presentation, 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.

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)

GLOBENEWSWIRE (Distribution ID 9448396)

JERUSALEM, March 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today reported financial results and key business achievements for the year ended December 31, 2024.

 “2024 was a truly transformational year for Entera. We delivered key data read–outs and advanced each of our oral peptide PTH(1–34), GLP1/Glucagon and GLP2 tablet programs, significantly increased our stockholder value, and efficiently strengthened our balance sheet. To our core team with whom I started this journey in late 2022 as a board member, and to our rapidly expanding ecosystem of premier global advisors, I thank you for your commitment and dedication. To our existing and new shareholders, we are grateful for your belief and support of our thesis. To our collaborators, especially, the formidable team at OPKO Health, Inc., we are grateful for your partnership and the opportunity to expand our N–Tab™ platform to additional high value peptides,” said Miranda Toledano, Chief Executive Officer of Entera.

 “To our potential patient base for whom we are developing EB613: the majority of the estimated 200 million women with osteoporosis who wish to preserve their bone health, who remain underserved with current treatments and who have not been able to access a new therapy since 2019, our dedication to you is firm and unwavering. Osteoporosis is one of the foremost underserved health issues globally which disproportionally afflicts women. Most women experience menopause between the ages of 45 and 55 years. One in three women over age 50 will develop osteoporosis, and one in two of those women will develop an osteoporosis–related fracture. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. Nevertheless, most patients remain untreated. Furthermore, existing regulatory guidelines requiring fracture outcomes have curtailed innovation in this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), based on a statistical meta–analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip BMD to fracture outcomes, is undergoing review at FDA. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate marker for CV outcomes and HBA1C as a surrogate for the risk of future diabetes complications, both of which enabled the advancement of many important new therapies for those conditions. We look forward to potential updates from FDA and SABRE on this important ruling and to potentially initiating our pivotal Phase 3 study of EB613 promptly thereafter. Our EB613, the first oral PTH(1–34) peptide treatment candidate is being developed to close the treatment gap in osteoporosis with a validated anabolic mechanism of action in tablet form. We plan to continue our mission to add value to Entera in 2025, with humility and a focus on execution,” said Miranda Toledano, Chief Executive Officer of Entera.

2024 Key Achievements:

EB613: First Oral PTH(1–34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

• In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months 

• In April 2024, Entera announced that the Journal of Bone and Mineral Research (JBMR) published EB613 placebo controlled Phase 2 Trial results, highlighting its dual mechanism of action and rapid increases in BMD at trabecular and cortical skeletal sites

• In June 2024, an independent editorial was published by the JBMR “A Novel Oral PTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”

• In September 2024, Entera presented new comparative pharmacological data for EB613 vs. Forteo® at the ASBMR September 2024 Annual Meeting in Toronto. The abstract was previewed by Dr. Serge Ferrari of Geneva University Hospital in Switzerland in his sneak–peak highlights of cutting–edge clinical abstracts on osteoporosis therapy at ASBMR2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

• In September 2024, Entera and OPKO Health jointly announced topline pharmacokinetic/pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program

• The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity and metabolic disorders combining OPKO’s proprietary long–acting oxyntomodulin analog (OPK–88006) and Entera’s proprietary N–Tab™ platform

• Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo

• In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year

First GLP–2 Peptide Tablets for Short Bowel Syndrome

• During 2024, Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents. Oral GLP–2 tablets exhibited significant systemic exposure. Furthermore, plasma levels achieved with the oral tablet form of the GLP–2 analogue were about 10–fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex®)

• The pharmacokinetic analysis of the data obtained following the IV injections of the GLP–2 peptide showed the plasma half–life in rats to be about six times longer than the half–life reported for teduglutide in the same animal model. This data is consistent with previously reported PK data relating to OPKO’s GLP–2 peptide’s long–acting profile, which had initially been developed as a weekly subcutaneous injection

• Given the challenging compliance rates attributed to injectable GLP–2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets Candidate for Hypoparathyroidism

• In June 2024, Entera presented Phase 1 clinical data for EB612, which is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for patients with hypoparathyroidism, at the Endocrine Society ENDO 2024 Annual Meeting. This Phase 1 data supports potentially moving the BID tablet dose to Phase 2 development in patients with hypoparathyroidism

• Entera continues to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism

Financial Results for the Year Ended December 31, 2024

As of December 31, 2024, Entera had cash and cash equivalents of $8.7 million. As of March 28, 2025, Entera had cash and cash equivalents of $21 million, largely attributable to at–market direct investments from existing and new institutional shareholders and our partner, OPKO. The cash is expected to be sufficient to fund our operations into the third quarter of 2026, including ongoing work related to the planned EB613 phase 3 study, regulatory expenses, research and development, patent prosecution, the completion of an additional Phase 1 PK study related to our new generation platform and our share of projected oral GLP1/Glucagon tablet Phase 1 study expenses in collaboration with OPKO.

• Research and development expenses for the years ended December 31, 2024 and December 31, 2023 were each $4.5 million. There was a decrease of $0.8 million related to the completion of the first cohorts of a Phase 1 PK study, which occurred in 2023. The decrease was offset by an increase of $0.8 million in 2024 related to optimization related to the preparation of the EB613 phase 3 study

• General and administrative expenses for the year ended December 31, 2024 were $5.1 million, compared to $4.4 million for the year ended December 31, 2023. The increase of $0.7 million was mainly attributable to expanding our intellectual property position and advisor compensation. The increase was partially offset by a decrease of $0.2 million in D&O insurance costs and other costs

• Operating expenses for the year ended December 31, 2024 were $9.6 million, as compared to $8.9 million for the year ended December 31, 2023

Net loss was $9.5 million, or $0.25 per ordinary share (basic and diluted), for the year ended December 31, 2024, as compared to 8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023.

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 its pipeline includes five differentiated, 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)), 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 pursuant to the FDA’s qualification of a quantitative BMD 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 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 presentation. The information in this presentation is provided only as of the date of this presentation, 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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