UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to WASHINGTON, D.C. 20549 Commission file number: 001-38556 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ENTERA BIO LTD. (Exact name of Registrant as specified in its charter) For the quarterly period ended March 31, 2025 OR Indicate by check mark whether the registrant is a shell comp ...

Exhibit 99.1 Entera Bio Announces First Quarter 2025 Financial Results and Business Updates JERUSALEM, May 9th 2025 –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 marq ...

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 ...

JERUSALEM, April 15, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, announced highlights from Dr. Rachel B Wagman’s oral presentation at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Congress in Rome entitled “EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY.” EB613 is being developed as t ...

JERUSALEM, April 15, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of oral peptides and proteins replacement therapies, announced highlights from Dr. Rachel B Wagman's oral presentation at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Congress in Rome entitled "EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY."  EB613 is being developed as th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _ to _ . (State or Other Jurisdiction of Incorporation or Organization) Israel 00-0000000 (I.R.S. Employer Identification No.) Kiryat Hadassah Minrav Building - Fift ...

Exhibit 99.1 JERUSALEM, March 28 2025 –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 balan ...

Core Insights - Entera Bio Ltd. reported significant advancements in its oral peptide and protein replacement therapies, particularly in osteoporosis and obesity treatments, during 2024 [2][4][12] - The company aims to address unmet medical needs with its innovative N-Tab™ platform, focusing on oral formulations for conditions like osteoporosis, hypoparathyroidism, and short bowel syndrome [12] Financial Performance - For the year ended December 31, 2024, Entera reported a net loss of $9.5 million, or $0.25 per share, compared to a net loss of $8.9 million, or $0.31 per share, for 2023 [11][21] - As of December 31, 2024, the company had cash and cash equivalents of $8.7 million, which increased to $21 million by March 28, 2025, due to investments from institutional shareholders [9] Key Achievements - Entera advanced its EB613 program, the first oral PTH(1-34) tablet treatment candidate for women with osteoporosis, and is preparing for a pivotal Phase 3 study [3][4] - The company also announced the first GLP-1/glucagon agonist peptide tablet candidate for obesity, with promising pharmacokinetic results [5][10] - Entera's collaboration with OPKO Health has been pivotal in developing its oral peptide therapies, including the oral GLP-2 tablets for short bowel syndrome [10][12] Research and Development - Research and development expenses for 2024 were $4.5 million, consistent with the previous year, reflecting ongoing efforts in clinical trials and preparation for future studies [9][21] - The company is focused on innovative approaches to osteoporosis treatment, with the SABRE project under FDA review to qualify bone mineral density as a surrogate endpoint for fractures [3][6] Market Potential - Entera targets a significant market with an estimated 200 million women suffering from osteoporosis, highlighting the need for new treatment options [3] - The company's oral therapies aim to improve patient compliance and address the limitations of current injectable treatments for conditions like short bowel syndrome and obesity [10][12]

Core Viewpoint - OPKO Health and Entera Bio have entered into a collaboration and license agreement to develop the first oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders, with plans to file an Investigational New Drug application with the FDA later this year [1][2]. Group 1: Collaboration Details - OPKO will hold a 60% ownership interest in the program, while Entera will hold 40%, and they will share development costs accordingly [2]. - OPKO purchased 3,685,226 ordinary shares of Entera at $2.17 per share to fund Entera's share of costs through Phase 1 of the development program [2]. - Entera has the option to continue funding its share post-Phase 1 to maintain its ownership interest; if it opts out, it will retain a 15% interest in the program [2]. Group 2: Product Information - The program combines OPKO's long-acting oxyntomodulin analog (OPK-88006) with Entera's N-Tab™ technology, which has shown favorable pharmacodynamic and pharmacokinetic data [1][5]. - Oxyntomodulin is a naturally occurring peptide hormone that suppresses appetite and induces weight loss, with additional cardioprotective and anti-fibrotic properties [5]. Group 3: Company Backgrounds - Entera Bio focuses on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology, with a pipeline that includes five oral peptide programs [6]. - OPKO Health is a multinational biopharmaceutical and diagnostics company aiming to establish leading positions in rapidly growing markets through its discovery and commercialization expertise [7].

Company Overview - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies in tablet form, addressing significant unmet medical needs [2] - The company utilizes a proprietary technology platform known as N-Tab™ and has a pipeline that includes five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2 [2] Product Development - The most advanced product candidate, EB613, is being developed as the first oral osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [2] - A Phase 2 study of EB613 tablets (n=161) met primary and secondary endpoints related to bone turnover biomarkers and BMD [2] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA's qualification of a quantitative BMD endpoint [2] - The EB612 program is aimed at developing the first oral PTH(1-34) tablet for hypoparathyroidism [2] - The company is also developing the first oral oxyntomodulin for obesity treatment and the first oral GLP-2 peptide tablet for rare malabsorption conditions in collaboration with OPKO Health [2] Upcoming Conferences - Entera Bio will participate in several upcoming conferences, including: - Leerink Partners Global Healthcare Conference on March 12, 2025, in Miami, FL [2] - 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases with an oral presentation on April 11, 2025, and a poster presentation on April 13, 2025, in Rome [2] - 2025 BIO International Convention from June 16-19, 2025, in Boston, MA [2]