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Entera Exhibit 99.1 Entera Announces Second Quarter 2026 Financial Results and Business Updates 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 , August 7 , 2026 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 .