ENTX

U.S. Food and Drug Administration (FDA) Alignment on 12-Month Registrational Phase 3 Study to Support NDA for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis Oversubscribed $275 Million Private Placement Led by BVF Partners L.P. (“BVF”) with Participation from Leading Institutional Healthcare Investors to Fund EB613 through Anticipated Submission of NDA to the FDA EB613 Phase 3 Study Initiation Planned for Late 2026 with Topline Data Anticipated in the Second Half of 2028 IND Enabling Studies Ongoing for EB612 - the First Oral Peptide Replacement Tablet in Development for Patients with Hypoparathyroidism – Intention to File IND in First Half of 2027 TEL AVIV, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended June 30, 2026. “The first half of 2026 marked one of the most consequential periods in Entera’s history. Since 2022, our core team embarked upon a journey of deconstruction and reconstruction to advance our science and optimize our pipeline. Despite scarce resources and particularly turbulent times, today, our N-Tab® platform is developing one of the richest pipelines of clinical and near-clinical first in class oral peptide assets; and we have garnered the trust of global talent, luminaries, and financiers who support our mission and vision. Thank you. Osteoporosis is one of the foremost underserved health issues globally, and associated fracture rates continue to rise despite existing treatments. Our discussions with patients and their caregivers across primary care, gynecology, orthopedic surgery, rheumatology and endocrinology acknowledge the urgent need for new treatments, especially, an oral anabolic therapy. We are developing EB613 to address this treatment gap. Our plan is to do the same with EB612 for patients with hypoparathyroidism, also a women-centric condition. The capital raising transaction we announced on July 27, 2026, led by BVF is transformational for Entera. To our knowledge, the transaction is the largest biotech PIPE and the 9th largest PIPE, inclusive of the high-tech sector, on record in Israel. So, we shattered a few records and moving forward, we intend to continue to shatter more records across all our programs with a cohesive, global team of colleagues who are obsessed with our vision and steadfast in our execution,” said Miranda Toledano, Chief Executive Officer of Entera. Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Positive FDA Feedback on 12-Month Registrational Phase 3 Study Received: In June 2026, Entera announced that 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 bone mineral density (BMD) at Month 12 to support a potential new drug application (“NDA”) submission. 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 randomized patients for 24 months in an open-label extension study under a separate protocol. Entera plans 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. Entera plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028. Single Tablet EB613 Data Presented as Late-Breaking Oral at ENDO 2026: In June 2026, at the annual meeting of the Endocrine Society (ENDO 2026), Entera presented comparative Phase 1 data demonstrating that single-tablet EB613 achieved a pharmacokinetic (PK) and pharmacodynamic (PD) profile comparable to both multi-tablet EB613, which was evaluated in the Company’s Phase 2 study, and Forteo®. Comparable calcemic effects and consistent suppression of endogenous PTH(1-84) were shown for both oral EB613 treatments and Forteo®. These data support advancing single-tablet EB613 into the planned Phase 3 registrational study. Key Opinion Leader (KOL) Webinar on Osteoporosis Treatment Landscape: On April 20, 2026, Entera hosted a virtual KOL roundtable with Dr. Felicia Cosman (Professor of Medicine at Columbia University and a globally recognized authority in osteoporosis and anabolic therapies) and Dr. Steven Goldstein (Professor of Obstetrics and Gynecology at New York University Grossman School of Medicine and former President of both the International Menopause Society and the North American Menopause Society) to gain endocrinology and gynecology insights into the current osteoporosis treatment paradigm. The KOLs highlighted the critical unmet demand for an oral anabolic in this silent, asymptomatic disease and EB613’s potential to transform the treatment paradigm. The full transcript is available here. EB613 Data Selected for Plenary Poster Presentation at ASBMR 2026: In August 2026, Entera announced that new Phase 2 analysis of EB613 in postmenopausal women with osteoporosis at high risk of fracture was selected for a plenary poster presentation at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting, taking place October 9–12, 2026 in Boston, Massachusetts. EB612: First-in-Class Oral Long-Acting PTH(1-34) Replacement Tablet for Hypoparathyroidism Robust Preclinical Data Presented at ENDO 2026: In June 2026, Entera reported preclinical data for EB612, a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera’s N-Tab® oral peptide platform, at ENDO 2026. Across three preclinical models - a thyroparathyroidectomized (TPTx) rat model, a minipig model, and a non-human primate model - single oral doses of EB612 produced robust bioavailability and rapid, sustained increases in serum calcium lasting approximately three days. 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. Following the previously announced expansion of the Company’s collaboration with OPKO Health (“OPKO”) in February 2026, Entera and OPKO intend to file an Investigational New Drug (IND) application for EB612 in the first half of 2027. EB618: First-in-Class Oral Dual GLP-1/Glucagon (Oxyntomodulin) Tablet for Obesity and Metabolic Disorders Non-Human Primate PK/PD Data Presented at ENDO 2026: In June 2026, Entera reported single-dose PK/PD results in non-human primates for EB618, a proprietary long-acting oxyntomodulin analog formulated with Entera’s N-Tab® platform, at ENDO 2026. EB618 exhibited robust bioavailability with dose-proportional systemic exposure across three tested tablet strengths and low variability and produced a dose-proportional pharmacologic effect on postprandial blood glucose levels. EB618 was well tolerated 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. As previously disclosed, Entera expects to evaluate the initiation of EB618 clinical development pursuant to analysis of the Phase 1 SAD/MAD studies of subcutaneous injectable OXM being conducted by OPKO. Corporate Highlights Oversubscribed $275 Million Private Placement: Subsequent to quarter end, in July 2026, Entera announced the oversubscribed private placement which provided gross proceeds of approximately $275.0 million before deducting placement agent fees and offering expenses. The Private Placement was led by existing investor 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. Upon closing of the Private Placement, BVF was granted the right to designate two directors to the Company’s board of directors. The net proceeds are anticipated to fully support the Phase 3 registrational program of EB613 through the anticipated submission of NDA to the FDA, advance EB612 into the clinic in collaboration with OPKO and extend the Company’s cash runway into 2030. Direct Investment Led by BVF: In April 2026, Entera announced a private placement led by BVF for approximately $10.0 million in gross proceeds, with the potential for up to $24.5 million in total proceeds upon full exercise of accompanying five-year warrants. Financial Results for the Three Months Ended June 30, 2026 Cash and cash equivalents were $11.3 million as of June 30, 2026, and restricted cash was $7.1 million, primarily designated to fund the OPKO collaboration. On a pro forma basis, following the closing of the July 2026 private placement in which the Company received aggregate gross proceeds of approximately $275.0 million, the Company’s cash resources are expected to be sufficient to fully fund the planned Phase 3 registrational program of EB613 through topline results and the anticipated submission of an NDA to the FDA and to support the Company’s operations into 2030. Research and development expenses for the three months ended June 30, 2026 were $3.2 million, as compared to $1.5 million for the three months ended June 30, 2025. The increase of $1.7 million was primarily attributable to increased materials, production and other costs related to the preparation of the EB613 Phase 3 program and to activities under the OPKO collaboration. General and administrative expenses for the three months ended June 30, 2026 were $1.4 million, as compared to $1.1 million for the three months ended June 30, 2025. Net loss was $7.3 million, or $0.14 per ordinary share (basic and diluted), for the three months ended June 30, 2026, as compared to $2.7 million, or $0.06 per ordinary share (basic and diluted), for the three months ended June 30, 2025. The increase was primarily driven by a $2.7 million non-cash fair value remeasurement of the pre-funded warrants issued in our April 2026 private placement, which are classified as a financial liability. About EnteraEntera 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 GLP-1/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 StatementsVarious 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 anticipated use of proceeds from the July 2026 private placement; the timing, design, and results of the planned Phase 3 registrational study of EB613; the FDA’s ongoing review of the EB613 program, including the terms and interpretation of the FDA’s feedback on our Clinical Amendment; the timing of the anticipated IND filings for EB612 and EB618 in collaboration with OPKO Health; the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; 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 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:[email protected] ENTERA BIO LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands) ENTERA BIO LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share data)(Unaudited)

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – Phase 3 protocol submitted with FDA feedback expected imminently; incremental data submitted to ENDO2026 and ASBMR EB612, the first oral long-acting PTH peptide replacement tablet for hypoparathyroidism – Expanded 50/50 partnership with OPKO; intention to file IND in late 2026; data submitted to ENDO2026 EB618, the first oral OXM (dual GLP-1/Glucagon) tablet for metabolic and fibrotic conditions – data submitted to ENDO2026 Direct Investment led by BVF Partners L.P. to support EB613 pivotal study acceleration and working capital TEL AVIV, May 08, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended March 31, 2026. “The first quarter of 2026 solidified Entera’s position as the leading oral peptide therapeutics company. Our N-Tab® platform is developing arguably the richest pipeline of clinical and near-clinical first in class assets, and we are driven by our mission to develop transformative medicines and invest in therapeutic spaces that have been ignored and require urgent attention,” said Miranda Toledano, CEO of Entera. “This begins with our EB613 journey to develop the first oral anabolic to potentially help millions of women preserve their bone health while advocating for much needed innovation in a therapeutic space which disproportionately affects the health of women. In March 2026, we submitted documents to FDA related to EB613’s potential registrational package. This quarter, we also completed a critical Phase 1 bridging study for the single, final tablet formulation of EB613. Additionally, we submitted PK and TPTX proof of concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions to ENDO2026 and ASBMR. Each of these milestones has been executed with a strong focus on capital efficiency by a core team that has a unifying commitment to succeed in developing therapeutics that matter,” said Miranda Toledano, Chief Executive Officer of Entera. Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera announced it had submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan, and extension synopsis under its IND 505(b)(2) for EB613. The planned Phase 3 trial is designed as a multinational, randomized, double-blind, placebo-controlled safety and efficacy study in 750 postmenopausal women with osteoporosis, with percentage change in total hip bone mineral density (BMD) from baseline to month 12 as the primary outcome measure. Entera also submitted a protocol synopsis to conduct an extension study which is designed to evaluate 24 months of EB613 monotherapy treatment or 12 months of EB613 followed by 12 months of treatment with a standard anti-resorptive drug. Next-Gen EB613 Single Tablet Advanced as Phase 3 Candidate: In January 2026, Entera completed a Phase 1 PK and safety bridging study comparing the single-tablet to the multi-tablet formulation of EB613 and Forteo® (teriparatide SC injection, Eli Lilly). Entera plans to advance the single tablet of EB613 into Phase 3. Data has been submitted as an abstract to ENDO2026. Key Opinion Leader (KOL) Webinar on Osteoporosis Treatment Landscape: On April 20, 2026, Entera hosted a virtual KOL roundtable with Dr. Felicia Cosman (Professor of Medicine at Columbia University) and Dr. Steven Goldstein (Professor of Obstetrics and Gynecology at NYU Grossman School of Medicine and former President of both the International Menopause Society and the North American Menopause Society) to gain endocrinology and gynecology insights into how the clinician ecosystem treats osteoporosis today. The KOLs highlighted the critical unmet demand for an oral anabolic in this silent, asymptomatic disease and EB613’s potential to transform the paradigm. A replay of the video is available at the following link: https://www.youtube.com/watch?v=2z6oOgwAWmg EB612: First-in-Class Oral Long-Acting PTH(1-34) Replacement Tablet for Hypoparathyroidism Expanded OPKO 50/50 Partnership Accelerates Path to Clinic, Funded Through Phase 1: In February 2026, Entera and OPKO amended and restated their 2025 Collaboration Agreement to advance the first oral long-acting PTH (LA-PTH) analog as a once-daily tablet for patients with hypoparathyroidism. The EB612 program has been prioritized, with an expectation to file an IND application in late 2026. TPTX and PK study data completed during the quarter have been submitted as abstracts to ENDO2026. EB618: First-in-Class Oral Dual GLP-1/Glucagon (OXM) Tablet for Obesity and Metabolic Disease In March 2025, Entera and OPKO announced that the potential initiation of EB618 would occur pursuant to analysis of the Phase 1 SAD/MAD studies that OPKO plans to initiate with subcutaneous once weekly injectable OXM. Pharmacokinetic data for the oral OXM tablet developed by Entera in NHP has been submitted to ENDO2026. Corporate Highlights Geno J. Germano Appointed Chairman of the Board: In February 2026, Mr. Germano, formerly Group President of Pfizer’s Global Innovative Pharmaceutical Business, succeeded Gerald Lieberman as Chairman. Mr. Germano brings more than three decades of leadership experience across development, commercialization, and global operations at Pfizer, Wyeth, and other leading biopharmaceutical companies, and has served on the board of directors of Sage Therapeutics, Bioverativ Inc., and The Medicines Company, among others. Steve Rubin Joined Board of Directors: In February 2026, Steve Rubin, Executive Vice President of Administration and director at OPKO, joined Entera’s Board of Directors. Mr. Rubin brings three decades of experience in corporate governance and strategic oversight of drug development across multiple public biotechnology companies. Financial Results for the Quarter Ended March 31, 2026 Cash and cash equivalents as of March 31, 2026, were $11.9 million. As of May 8, 2026, cash and cash equivalents were $20.4 million, inclusive of the proceeds from the private placement led by BVF Partners L.P. in April 2026 and the $7.8 million restricted cash which is designated to fund the OPKO collaboration including EB612 and EB618. The Company’s available funds are expected to support operations through the first quarter of 2027, including activities related to the preparation of the planned Phase 3 registrational study of EB613. Research and development expenses for the three months ended March 31, 2026 were $2.3 million, as compared to $1.1 million for the three months ended March 31, 2025. General and administrative expenses for the three months ended March 31, 2026 were $1.3 million, as compared to $1.4 million for the three months ended March 31, 2025. Total operating expenses for the three months ended March 31, 2026 were $3.5 million, as compared to $2.6 million for the three months ended March 31, 2025. Net loss was $3.5 million, or $0.07 per ordinary share (basic and diluted), for the three months ended March 31, 2026, as compared to $2.6 million, or $0.06 per ordinary share (basic and diluted), for the three months ended March 31, 2025. About Entera Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Company Contact: [email protected] ENTERA BIO LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) ENTERA BIO LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited)

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – FDA Type A endpoint alignment in July 2025, Phase 3 protocol submitted to the FDA with comments expected in early Q2 2026 EB612, the first long-acting oral PTH peptide replacement tablet for patients with hypoparathyroidism - final variants selected, pre-IND initiatives underway with intention to file IND in late 2026 in partnership with OPKO EB618, the first Oral OXM (GLP-1/Glucagon) peptide tablet for patients with metabolic syndromes – PK/PD validation complete, intention to file IND pursuant to OPKO Phase 1 SAD/MAD SC injection data TEL AVIV, March 27, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the year ended December 31, 2025. "2025 was a landmark year for Entera, our EB613 program and for the osteoporosis community as a whole. We are eager to initiate our important phase 3 study for EB613 and thank the investigator and patient community for their enthusiasm to take part in this mission. While current injectable anabolic or bone forming agents are accepted or accessed by a minority of osteoporosis patients in whom they should be used, our mission with EB613 is to democratize anabolic treatment. EB613 is being developed as the first oral bone building tablet so potentially, every woman and man can have the opportunity to protect their bones whether they are being treated with a primary care practitioner or a specialist,” said Miranda Toledano, Chief Executive Officer of Entera. “Throughout 2025, we also met every milestone relating to our pipeline and advanced each program with the utmost capital efficiency. Our N-Tab® oral peptide platform delivered differentiated preclinical data on LA-PTH, GLP-1/Glucagon and GLP-2 targets in partnership with OPKO Health, Inc. (“OPKO”). We believe these assets will further drive value for patients with hypoparathyroidism, metabolic syndromes and rare gastrointestinal chronic conditions.” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan, and open-label extension synopsis under its IND 505(b)(2) for EB613. The planned Phase 3 trial is a multinational, randomized, double-blind, placebo-controlled safety and efficacy study in 750 postmenopausal women with osteoporosis, with percentage change in total hip bone mineral density (BMD) from baseline to month 12 (rather than month 24) as the primary outcome measure, significantly reducing enrollment requirements and accelerating the potential path to approval. The final single-tablet formulation (Next-Gen EB613) is intended to advance directly into Phase 3, replacing the previous multi-tablet candidate. The Company is still preparing to initiate the study in late 2026, which could translate into topline results in the second half of 2028, approximately one year earlier than previously expected. Entera also submitted a synopsis for a 12-month open-label extension study expected to run in parallel with the NDA review which will provide 12-month, 24-month and sequence data for EB613. FDA feedback is anticipated in late April 2026. FDA Alignment on BMD as Primary Endpoint: In July 2025, in a written response to a Type A meeting, the FDA agreed with Entera's proposal that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures as the key secondary endpoint, would support an NDA marketing application for EB613, making Entera the first company to receive such independent alignment. Following this milestone, in December 2025, the FDA issued a broad qualification of BMD with a suggested context of use that the percentage change from baseline at 24 months in total hip BMD could serve as a validated surrogate efficacy endpoint for novel osteoporosis drug development. Next-Gen EB613: Preclinical PK data presented at ASBMR 2026 showed comparable pharmacokinetic exposure of the single tablet to the multitablet EB613 formulation. In late 2025, Entera conducted a Phase 1 safety and PK bridging study of the single tablet versus the multitablet and versus Forteo®. In early 2026, Entera made the determination to advance the single tablet (the final commercial formulation) to Phase 3 based on its comparability to the multitablet and Forteo®. Strong Phase 2 Data Reinforce Early Onset of EB613 Mechanism of Action to Increase Bone Formation and Decrease Bone Loss: At both IOF and ASBMR 2025 Annual Meetings, EB613 post-hoc 3D-DXA data were selected for oral presentation. The analysis demonstrated significant increases in both trabecular and cortical bone indices after just six months of EB613 treatment, comparable to those reported for injectable teriparatide and abaloparatide. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Expanded Evidence in Early Postmenopausal Women: At the NAMS 2025 Meeting, new post-hoc Phase 2 analysis showed EB613’s ability to drive significant and consistent gains in BMD at the spine, femoral neck and hip in younger women within 10 years of their last menstrual period and after more than 10 years post-last menstrual period. For younger high-risk women without a prior fracture, BMD is the single most important predictor of osteoporotic fractures. EB612: First-in-Class Oral Long-Acting PTH(1-34) Replacement Tablet for Hypoparathyroidism Positive Preclinical Data Validates Long-Acting PTH Tablet Candidate: In December 2025, Entera announced positive in vivo pharmacokinetic and pharmacodynamic data for proprietary long-acting PTH (LA-PTH) analogs developed by OPKO and formulated with Entera’s N-Tab® platform. In these studies, a single oral tablet achieved a markedly longer plasma half-life compared to unmodified PTH(1-34) controls, with sustained serum calcium elevation for over three days. Expanded OPKO Collaboration Accelerates Path to Clinic, Fully Funded Through Phase 1: In February 2026, Entera and OPKO expanded their 2025 collaboration agreement to co-develop the oral LA-PTH tablet for hypoparathyroidism as a priority program, with each party holding a 50% pro-rata ownership interest and sharing development costs equally. The companies have jointly decided to accelerate the program and expect to file an IND application in late 2026. Importantly, Entera’s expenses related to development of the LA-PTH program into Phase 1 are expected to be funded with existing cash on the balance sheet. EB618: First-in-Class Oral Dual GLP-1/Glucagon (OXM) Tablet for Obesity and Metabolic Disease Oral OXM PK/PD Validation Completed; Phase 1 Sequencing Established: Following successful completion of in vivo PK/PD validation for both the subcutaneous and oral formulations of OPK-88006 in 2025, preclinical data presented at ENDO 2025 demonstrated plasma levels consistent with those reported in humans for the highest approved dose of Wegovy® (semaglutide). Entera and OPKO have jointly determined that Phase 1 data from the injectable formulation, expected by year-end 2026, will catalyse the initiation of the oral OXM tablet to Phase 1. GLP-2 Program for Short Bowel Syndrome PK data presented at ESPEN 2025: The joint Entera-OPKO abstract highlighted a plasma half-life of approximately 15 hours, representing an 18-fold improvement over teduglutide (Gattex®), the only approved GLP-2 therapy for the treatment of short bowel syndrome, which requires a daily injection. The daily GLP-2 tablet candidate could fundamentally change how SBS patients are treated, offering a less-invasive administration that can be titrated to enable personalized dosing in this rare and heterogeneous condition. Financial Results for the Year Ended December 31, 2025 Cash and cash equivalents were $14.9 million as of December 31, 2025, including $7.8 million in restricted cash designated to fund the OPKO collaboration, inclusive of LA-PTH for hypoparathyroidism (EB612). Cash on hand (not including restricted cash) is expected to support operations through the middle of the third quarter of 2026. Net loss was $11.4 million, or $0.25 per ordinary share, for the year ended December 31, 2025, compared to $9.5 million, or $0.25 per ordinary share, for the year ended December 31, 2024. Research and development expenses were $6.0 million for the year ended December 31, 2025, compared to $4.5 million for the same period in 2024, an increase of $1.5 million, primarily reflecting continued regulatory and Phase 3 preparation activities for EB613 and costs related to our internal programs and collaboration programs. General and administrative expenses for the year December 31, 2025 were $5.5 million as compared to $5.1 million for year ended December 31, 2024, an increase of $0.4 million, primarily due to increase in consultants’ fees and compensation. Total operating expenses were $11.5 million for the year ended December 31, 2025, compared to $9.6 million for the year ended December 31, 2024. Net Cash used in operating activities for the year ended December 31, 2025 was $7.4 million. 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 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 Bio, 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: [email protected] ENTERA BIO LTD. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data)

FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study EB613 Phase 2 Data Demonstrating Consistent Efficacy across Younger Post-Menopausal Women with Osteoporosis and its Impact on Trabecular and Cortical Bone Indices, Highlighted at NAMS and ASBMR Next-Generation EB613 Remains on Track for Phase 1 Initiation in Late 2025 Pre-Clinical Data for Oral OXM in Obesity and Oral GLP-2 in Short Bowel Syndrome in Collaboration with OPKO Presented at ENDO2025 and ESPEN JERUSALEM, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended September 30, 2025. “Our achievements this quarter are testament to Entera’s leadership position in oral peptide innovation and our team’s unrelenting mission to deliver transformative treatments to patients, starting with post-menopausal women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. “Our FDA agreement for EB613 this July is unprecedented and underscores the strength of our data and the promise for EB613 to close the treatment chasm in osteoporosis, a disease which disproportionately afflicts women and remains grossly undertreated globally. EB613 data continues to be highlighted across major medical conferences focused on advancing novel treatments in bone metabolism, endrocrine and women’s health, while our N-Tab™ platform consistently delivered across pipeline programs, including our oral GLP-2 program for short bowel syndrome and our oral OXM program in metabolic diseases in partnership with OPKO Health (“OPKO”).” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Osteoporosis FDA Agreement on BMD as Primary Endpoint: In a written response to a Type A meeting, the FDA agreed with Entera’s proposal that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures as the key secondary endpoint, would support an NDA marketing application for EB613. Strong Phase 2 Data Reinforce Early Onset of EB613 Anabolism: At the ASBMR 2025 Annual Meeting, Entera presented post-hoc 3D-DXA results showing significant increases in both trabecular and cortical bone indices after just six months of EB613 treatment, comparable to injectable teriparatide and abaloparatide. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Expanded Evidence in Early Postmenopausal Women: At the NAMS 2025 Meeting, new Phase 2 analysis demonstrated EB613 ability to drive significant and consistent gains in BMD at the spine, femoral neck and hip in younger women within 10 years of menopause, with improvements comparable to those observed in women more than 10 years post-menopause. For younger high-risk women without a prior fracture, BMD is the single most important predictor of osteoporotic fractures. Today, it is estimated that less than 15% of women are willing to take or have access to currently approved anabolics, which require daily or monthly injections. Next-Gen EB613: Preclinical PK data presented at ASBMR showed comparable pharmacokinetic exposure to the current formulation using a single fixed dose regimen, validating the N-Tab™ platform and potential franchise expansion. A Phase 1 trial of Next-Gen EB613 currently remains on track to initiate in late 2025. GLP-2 Program for Short Bowel Syndrome (in collaboration with OPKO) Positive PK data presented at ESPEN 2025: The joint Entera-OPKO abstract highlighted a plasma half-life of approximately 15 hours, representing an 18-fold improvement over teduglutide (Gattex®), the only approved GLP-2 therapy, which requires a daily injection. The daily GLP-2 tablet candidate could fundamentally change how SBS patients are treated, offering a less-invasive administration that can be titrated to enable personalized dosing in this rare and heterogeneous condition. Dual GLP-1/Glucagon OXM Tablet Program (in collaboration with OPKO) Encouraging preclinical data presented at the Endocrine Society (ENDO) 2025 annual meeting: In the abstract titled “First-in-Class Oral Dual GLP-1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders” PK data reported from a minipig study show plasma levels of OPK-88006 consistent with those reported in humans for the highest, 2.4 mg subcutaneous dose of Wegovy (semaglutide) weekly injection, a standard of care for the treatment of obesity. An IND for oral OXM is planned for H1 2026. EB612: Oral PTH(1-34) Peptide Replacement Therapy for Hypoparathyroidism Collaborative studies evaluating a novel, long-acting PTH analog remain on track to deliver first PK/PD pre-clinical data for a single tablet candidate by year-end 2025. Financial Results for the Quarter Ended September 30, 2025 Cash and cash equivalents were $16.6 million as of September 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 the middle of the third quarter of 2026. Net loss was $3.2 million, or $0.07 per ordinary share, for the three months ended September 30, 2025, compared to $3.0 million, or $0.08 per ordinary share, for the three months ended September 30, 2024. Research and development expenses were $1.6 million for the three months ended September 30, 2025, compared to $1.5 million for the same period in 2024, an increase of $0.1 million, primarily reflecting continued regulatory and Phase 3 preparation activities for EB613. General and administrative expenses were $1.6 million for the three months ended September 30, 2025, compared to $1.5 million for the prior-year quarter. Total operating expenses were $3.3 million for the three months ended September 30, 2025, compared to $3.0 million for the three months ended September 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 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). 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 metabolic syndromes; and first oral GLP-2 peptide 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, 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 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 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: Entera Bio: Ms. Miranda Toledano Chief Executive Officer, Entera Bio Email: [email protected] ENTERA BIO LTD. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited)

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. CONTACT: Contact: Corporate Contact: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: [email protected]

Conference call begins at 4:30 p.m. Eastern time today MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2025. Highlights from the second quarter of 2025 and recent weeks include the following: Merck advanced Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck and evaluates safety and tolerability in up to 200 healthy adults. Based on analysis of these results, Merck will determine whether and how to proceed with Phase 2 studies. ModeX continued to advance its immuno-oncology and immunology portfolio with four potential clinical candidates progressing. The MDX2001 CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in selected solid tumors expected in 2026. MDX2004, a multispecific immune rejuvenator, is expected to enter the clinic later this year. Human clinical trials with the MDX2003 tetraspecific antibody for lymphoma/leukemia are expected to begin in early 2026. Development of multispecific antibodies for immune impaired patients at risk for COVID and influenza continued to progress with support from the Biomedical Advanced Research and Development Authority (BARDA). Presented preclinical data on OPK-88006, OPKO’s novel long-acting glucagon-like peptide-1 receptor/glucagon receptor dual agonist in a poster presentation at the American Diabetes Association 85th Scientific Sessions in June. Clinical pharmacology assessments of OPK-88006 in disease models of obesity and energy expenditure activities were encouraging. The presented data compared the 12-week daily treatment outcomes of OPK-88006, semaglutide and survodutide in a GAN diet induced obese and biopsy confirmed mouse model of metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis. In this study, the therapeutic benefits of OPK-88006 on quantitative biological hallmarks of MASH were superior to semaglutide and survodutide, suggesting that OPK-88006 is a promising GLP-1/glucagon receptor dual agonist for the treatment of MASH. Abstract for first-in-class dual GLP-1/glucagon tablet candidate for patients with obesity and metabolic disorders selected for presentation at the ENDO 2025 annual meeting. New pharmacologic and pharmacokinetic in vivo data for the investigational oral OPK-88006 tablet formulation was selected for presentation at ENDO 2025, the annual meeting of the Endocrine Society. Oral OPK-88006 is being developed pursuant to a collaboration and license agreement between OPKO and Entera whereby the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment with OPK-88006 and Entera’s proprietary N-Tab™ technology. Abstract on pharmacokinetics/pharmacodynamics of oral GLP-2 tablet for the treatment of short bowel syndrome selected for 2025 ESPEN Congress. The abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” submitted jointly by OPKO and Entera Bio was selected for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress, taking place September 13–16, 2025, in Prague. Pursuant to a research collaboration agreement with Entera Bio, the companies are developing an oral GLP-2 tablet, which combines a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology, for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. FDA approved the supplemental application for the 4KScore® Test regarding the availability of digital rectal examination information. The U.S. Food and Drug Administration (FDA) approved OPKO’s supplemental application enabling the performance of the 4Kscore® Test without digital rectal examination (DRE) information. The 4Kscore® Test is indicated for the assessment of the likelihood of aggressive prostate cancer in men 45 years old and above and reported to have age-specific elevated/abnormal screening PSA results. Two prospective controlled clinical studies (n=937) conclude that the 4Kscore® Test is a reliable (greater than 96% sensitivity and accuracy) blood test to assess the probability of aggressive prostate cancer, before biopsy decisions. In the U.S., over 90% of PSA screening tests are performed by primary care providers, potential users of the 4Kscore® Test, who don’t routinely perform a DRE. OPKO’s Board of Directors authorized an additional $100 million for its common stock repurchase program, bringing total capacity to $200 million. As of June 30, 2025, approximately $58.5 million of OPKO’s common stock has been repurchased under the program since its authorization in July 2024. This increased authorization, along with the prior authorization, represents approximately 14% of OPKO’s common shares outstanding at the current stock price. Second Quarter Financial Results Consolidated: Consolidated total revenues for the second quarter of 2025 were $156.8 million compared with $182.2 million for the comparable period of 2024. Operating loss for the second quarter of 2025 was $60.0 million compared with $61.7 million for the 2024 quarter. Net loss during the second quarter of 2025 included $91.7 million of non-recurring expense related to the convertible note exchange that closed on April 1, 2025, including unamortized debt discount, debt issuance costs and inducement expense. The prior-year period included $60.5 million of unrealized gain in the fair value of GeneDx Holdings Corp. Net loss for the second quarter of 2025 was $148.4 million, or $0.19 per share, compared with net loss of $10.3 million, or $0.01 per share, for the 2024 quarter. Pharmaceuticals: Revenue from products in the second quarter of 2025 was $40.7 million compared with $40.5 million in the second quarter of 2024, reflecting higher sales volumes in certain international operations partially offset by reduced sales in our Chilean subsidiary due to the impact of foreign currency and a mild winter cold and flu season. Revenue from sales of Rayaldee was $7.2 million for both the current and comparable period. Revenue from the transfer of intellectual property and other was $15.0 million in the second quarter of 2025 compared with $12.3 million in the 2024 period. The increase was driven by higher revenue from the BARDA contract and contract manufacturers’ commercial milestones, partially offset by slightly lower gross profit share payments for NGENLA, which totaled $6.1 million in the 2025 period compared with $6.3 million in the 2024 period. Total costs and expenses increased to $84.4 million in the second quarter of 2025 from $77.6 million in the prior-year period, primarily due to higher research and development expenses driven by growth in our BARDA collaborations and early-stage programs as we prepare for several investigational new drug application filings later this year. Operating loss was $28.7 million in the second quarter of 2025, which included $18.1 million of depreciation and amortization expense, compared with $24.8 million in the second quarter of 2024, which included $17.9 million of depreciation and amortization expense. Diagnostics: Revenue from services in the second quarter of 2025 was $101.1 million compared with $129.4 million in the prior-year period, with the decrease primarily due to lower clinical test volume principally as a result of the sale of certain BioReference assets, partially offset by higher clinical test reimbursement rates. Total costs and expenses were $119.3 million in the second quarter of 2025 compared with $156.0 million in the second quarter of 2024. The decrease was primarily attributable to the assets sold and continued cost-reduction initiatives at BioReference. Operating loss was $18.2 million in the second quarter of 2025, which included $4.9 million of depreciation and amortization expense, compared with $26.6 million in the 2024 period, which included $6.2 million of depreciation and amortization expense. The second quarter of 2025 included revenue of $24.9 million and costs and expenses of $29.4 million from the oncology assets that are pending sale to Labcorp. Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents and restricted cash were $285.4 million as of June 30, 2025. In the second quarter of 2025, OPKO completed an exchange agreement with certain institutional holders to purchase $159.2 million of the Company’s outstanding convertible notes, including accrued and unpaid interest, for 121.4 million shares of common stock and approximately $63.5 million in cash. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until August 7, 2025, by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 3096711. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, whether the anticipated sale of assets to Labcorp will close and the remaining BioReference business will be successful, whether we will be able to submit Investigational New Drug applications for the oral and subcutaneous forms of GLP-1/glucagon and the timing of those submissions, whether we will have a successful collaboration with Entera Bio, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including the timing for when clinical trials for MDX2003 and MDX 2004 will commence and whether they will be successful, whether preclinical data will be indicative of clinical data should any of our preclinical programs progress into clinical development, whether the trial for MDX2001 will continue to progress and whether the data will be positive for all trials, including the EBV Vaccine trial, whether we will receive additional funding from BARDA, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, whether our partner will be able to continue to successfully commercialize NGENLA and the NGENLA profits will provide adequate upside, whether we will continue to repurchase shares under a buyback program, our ability to market and sell any of our products in development, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts: Alliance Advisors IR Yvonne Briggs, 310-691-7100 [email protected] or Bruce Voss, 310-691-7100 [email protected] —Tables to Follow—

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 8th, 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) CONTACT: Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: [email protected]

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. CONTACT: Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: [email protected]