-- 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$(R)$, 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(R) 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$(TM)$ 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(TM) 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(TM) (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(TM)) 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.

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