Teduglutide Recombinant

MIAMI, FL, USA and JERUSALEM, Israel I July 08, 2025 I OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47 th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic. Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome Poster Viewing Date & Time: September 13, 2025, 3:30 – 4:00 p.m. local time & Welcome Reception Poster Topic: Poster Session 1 – Liver and gastrointestinal tract Location of Display: Forum Hall Foyer 3 The oral GLP-2 tablet program 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. Currently, the only approved GLP-2 agonist, which is marketed under the brand GATTEX ® (teduglutide), requires daily subcutaneous injections. “Given the heterogeneity of patients with SBS and challenging compliance rates attributed to injectable GLP-2 therapy, we believe a daily tablet format may enable more personalized care of this peptide and individualize titration,” said Miranda Toledano, Entera Chief Executive Officer. About Short Bowel Syndrome Short bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the US and EU are living with SBS, and current annual sales of GATTEX ® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals 1 . SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children. 2 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 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 the 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 . About OPKO Health OPKO Health 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 its novel and proprietary technologies. For more information, visit www.opko.com . SOURCE: OPKO Health

MIAMI and JERUSALEM, July 08, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic. Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome Poster Viewing Date & Time: September 13, 2025, 3:30 - 4:00 p.m. local time & Welcome Reception Poster Topic: Poster Session 1 - Liver and gastrointestinal tract Location of Display: Forum Hall Foyer 3 The oral GLP-2 tablet program 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. Currently, the only approved GLP-2 agonist, which is marketed under the brand GATTEX® (teduglutide), requires daily subcutaneous injections. “Given the heterogeneity of patients with SBS and challenging compliance rates attributed to injectable GLP-2 therapy, we believe a daily tablet format may enable more personalized care of this peptide and individualize titration,” said Miranda Toledano, Entera Chief Executive Officer. About Short Bowel Syndrome Short bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the US and EU are living with SBS, and current annual sales of GATTEX® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals1. SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children.2 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 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 the 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. About OPKO Health OPKO Health 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 its novel and proprietary technologies. For more information, visit www.opko.com. 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 and OPKO’s forward-looking statements include, among others: results of our clinical trials; the anticipated benefits of an oral tablet for the treatment of SBS; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10-K filed with the SEC, as well as the companies’ respective 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward-looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any 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. 1 https://rarediseases.org/rare-diseases/short-bowel-syndrome/ 2 Zhu C, Li Y. An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults. J Int Med Res. 2022 Mar;50(3):3000605221086145. doi: 10.1177/03000605221086145. PMID: 35343263; PMCID: PMC8966062. Released July 8, 2025