{"success":true,"data":{"pressRelease":{"id":"167226","rtpr_id":"nGNXhzxlq-20261013","ticker":"ENTX","exchange":"NASDAQ","all_tickers":["ENTX","5DT"],"title":"Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture and Showcases Phase 3 Design at ASBMR 2026 Annual Meeting ","author":"Globe Newswire","published_at":"2026-10-13T11:00:00.379Z","article_body":"Post-hoc Phase 2 data show greater bone mineral density (BMD) gains and\nanabolic effect with EB613 in postmenopausal women with baseline T-scores of\n≤-2.5 (osteoporosis) versus T-scores of >-2.5 (osteopenia)\n\nThese findings support the potential benefit of EB613 in postmenopausal women\nwith osteoporosis at high risk for fracture - consistent with the study\npopulation to be enrolled in Entera’s Phase 3 study\n\nTEL AVIV, Israel, Oct. 13, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:\nENTX) (“Entera” or the “Company”), a leader in the development of oral\npeptides, today announced data from a Plenary Poster Presentation (abstract\n#7062) and a Late-breaking Poster Presentation (abstract #8726) at the\nAmerican Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting\nwhich was held October 9-12, 2026, in Boston, Massachusetts.\n\n“As we have learned about the importance of treatment sequence, our\ntherapeutic strategies have evolved toward using anabolic therapy first to\noptimize osteoporosis patient management. Multiple studies illustrate the\nsuperiority of anabolic over anti-resorptive drugs at reducing fractures,\nbuilding BMD, and restoring skeletal microarchitecture. Several major\nguidelines support this approach. Nonetheless, daily injections remain a\nbarrier for both patients and prescribers. EB613 is uniquely positioned to be\nthe first oral anabolic tablet for the treatment of osteoporosis. The oral\ntablet will allow us to overcome barriers to implementing the anabolic-first\nstrategy. Our 6 month clinical data with EB613 show rapid stimulation of bone\nformation and robust early BMD accrual, especially in patients who start with\nlower BMD and who need the largest gains. ” said Felicia Cosman, M.D.,\nProfessor of Medicine at Columbia University.\n\n“The evidence package to date has laid the foundation for our Phase 3 plans.\nThe opportunity to evaluate the safety and efficacy of EB613 for product\nregistration has generated excitement among clinical investigators and\npatients. As the first oral anabolic agent in late-stage clinical development,\nEB613 offers the potential to evolve the treatment paradigm to help address\nimportant needs of patients,” said Rachel B Wagman, MD, Chief Clinical\nAdvisor to Entera.\n\nAbstract Title: EB613, Oral PTH(1-34) Tablet, Shows Markedly Enhanced Anabolic\nEffects in Postmenopausal Women with Osteoporosis at High Risk of Fracture:\nInsights from Phase 2 Trial\n\nThe Phase 2 study (Tripto-Shkolnik 2024) randomized 161 postmenopausal women\nwith low bone mass or osteoporosis to placebo or four EB613 dose levels for 6\nmonths. To explore the anabolic effect of EB613 2.5 mg daily, in women with\nosteoporosis (baseline T-score of ≤-2.5), a post-hoc sensitivity analysis\nevaluated the relationship between baseline T-score and effects on BMD and\nbone turnover markers (BTMs) at 6 months.\n\nKey findings included:\n* Greater BMD gains in women with baseline T-scores of ≤-2.5: Mean\nplacebo-adjusted BMD increases at 6 months were 4.23% (n=6) at the total hip\nand 4.22% (n=9) at the lumbar spine in women with baseline T-scores of ≤-2.5\nat each of those measured skeletal sites, compared with 1.02% (n=15) and 1.59%\n(n=12) in women with T-scores of >-2.5. Across all 21 participants treated\nwith EB613 2.5 mg, the pooled increases were 1.84% (TH) and 2.72% (LS).\n* Larger and more persistent bone turnover marker changes: Similarly, changes\nin P1NP (bone formation) and CTX (bone resorption) were also somewhat larger\nand more persistent in women with a T-score of ≤-2.5 at any measured\nskeletal site (n=15) than in women with T-scores of >-2.5 at all sites (n=6).\nThis post-hoc, exploratory analysis produced hypothesis-generating findings\nthat support the potential for EB613 treatment in postmenopausal women with\nosteoporosis at high risk for fracture.\n\n“Although our Phase 2 data showed positive responses in postmenopausal women\nwith low bone mass (osteopenia) as well as women with osteoporosis by T-score,\nthis analysis further derisks our thesis for the population we intend to\nenroll in our Phase 3 study,” said Miranda Toledano, Chief Executive Officer\nof Entera.\n\nAbstract Title: EB613 [Oral PTH(1-34)]: The First Oral Anabolic Tablet for the\nTreatment of Osteoporosis: Phase 3 Study Design\n\nThe registrational Phase 3 for EB613 is designed as a multinational,\nrandomized, double-blind, placebo-controlled Phase 3 safety and efficacy study\nin postmenopausal women with osteoporosis. The study is designed to evaluate\nthe effectiveness of EB613, based on change in Month 12 BMD at the total hip,\ncompared with placebo. Secondary endpoints include lumbar spine and femoral\nneck BMD at Month 12, and total hip, lumbar spine and femoral neck BMD at\nMonths 3 and 6.\n\nSafety will be evaluated through assessment of adverse events, vital signs,\nphysical examinations, and clinical laboratory tests. The PK of PTH(1-34)\nfollowing oral administration of EB613 will be evaluated in a subset of study\nparticipants through a Population-PK (Pop-PK) sub-study and Full PK sub-study.\n\nApproximately 900 participants will be randomized 2:1 to EB613 (N ~ 600) or\nplacebo (N ~ 300) for a 12-month, double-blind, placebo-controlled study\nperiod. Eligible participants will be postmenopausal women 50-90 years of age\nand ≥5 years from the last menstrual period with osteoporosis diagnosed by\nDXA with BMD T-score ≤-2.50 at either lumbar spine, total hip, or femoral\nneck. Participants completing 12 months will be eligible to enroll in an\nextension study through Month 24. The objective of the extension study is to\nevaluate safety and durability of response of EB613 at 18 months and 24\nmonths.\n\nAbout Entera\nEntera is a clinical stage company focused on developing oral peptide and\nprotein replacement therapies for significant unmet medical needs where an\noral tablet form holds the potential to transform the standard of care. The\nCompany leverages a disruptive and proprietary technology platform (N-Tab®)\nand its pipeline of first-in-class oral peptide programs. The Company’s most\nadvanced product candidate, EB613 (oral PTH(1-34)), is being developed as the\nfirst oral, osteoanabolic (bone building) once-daily tablet for osteoporosis.\nEntera is also developing the first oral acylated PTH(1-34) tablet as a\nreplacement therapy for patients with hypoparathyroidism (EB612); the first\noral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the\ntreatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet\nas an injection-free alternative for patients suffering from rare\nmalabsorption conditions such as short bowel syndrome in collaboration with\nOPKO Health, Inc. For more information on Entera, visit www.enterabio.com or\nfollow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=4pMZixAsuA1ek_Sn3uFL9lxao2josfp-9_r7-MWGJ64oFXKDvwv7DQo6JiFf9V_mUWDCVjNeUjMAD89PKap6jPCGAFKj9cHnLRHbJ6CIFk4=),\nTwitter\n(https://www.globenewswire.com/Tracker?data=QB_JSNEHKIF9IxZG1sjPIHuRfYK7dH0QkG73iA3QfqO5xeIUT5baEbfZvt1FM_p9m3aaxil3XN72MN3Qpjdgaw==),\nand Facebook\n(https://www.globenewswire.com/Tracker?data=gQHvmeUH8mGySYapuI9c7BD1pDLwL1TnC0ODtXPykNoZHDz5pMSlFOSXPDd-YlrgiL2uB-kLAaZE6_FmjH58TL71JgpBpn2dl3PlgqEkStw=).\n\nAbout EB613\nEntera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as\nthe first oral, once-daily anabolic tablet treatment for osteoporosis. Entera\ncompleted a Phase 2, 6-month, 161-patient, placebo-controlled study that met\nall biomarker and BMD endpoints without significant safety concerns in women\nwith postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid\ndose-proportional increases in biochemical markers of bone formation,\nreductions in markers of bone resorption, and increases in lumbar spine, total\nhip, and femoral neck BMD. The effects of EB613 on trabecular and cortical\nbone using 3D-DXA showed increases with EB613 compared to placebo on a variety\nof indices, including integral volumetric BMD and trabecular volumetric BMD,\ncortical thickness, and cortical surface BMD. Mechanistically, the findings\nsuggest that bone strengthening and fracture resistance may occur rapidly with\nEB613. Furthermore, the data are consistent with that of published\nsubcutaneous teriparatide at the 6-month time point.\n\nAbout Osteoporosis\nOsteoporosis is a chronic, progressive disorder in which bone resorption\nexceeds formation, resulting in decreased bone strength and increased\nsusceptibility to fracture. Osteoporosis is a major and growing public health\nissue, responsible for over 2 million fractures annually in the US. After age\n50, one in three women and one in five men will suffer an osteoporosis-related\nfracture in their remaining lifetime. Osteoporotic fractures lead to chronic\npain, decreased quality of life, and increased disability, and contribute to\npremature death. Studies show that up to 20-24% of hip fracture patients die\nwithin one year of the fracture. The total medical cost of osteoporotic\nfractures is projected to increase from $57 billion in 2018 to $95 billion by\n2040, largely related to the aging population. Postmenopausal women are at\nhigher risk of developing osteoporosis-related fractures, particularly in the\nhip, spine, and wrist. The mechanism for low BMD in postmenopausal women is\nprimarily estrogen deficiency, which leads to accelerated bone loss,\nespecially in the first 5-10 years after menopause. Forteo® (Eli Lilly) was\nfirst approved by the FDA in 2002 for the treatment of postmenopausal women\nwith osteoporosis and subsequently for treatment of men with primary or\nhypogonadal osteoporosis at high risk of fracture, and for osteoporosis\nassociated with sustained systemic glucocorticoid therapy.\n\nCautionary Statement Regarding Forward Looking Statements\nVarious statements in this press release are “forward-looking statements”\nwithin the meaning of the Private Securities Litigation Reform Act of 1995.\nAll statements (other than statements of historical facts) in this press\nrelease regarding our prospects, plans, financial position, business strategy,\nclinical development activities, collaboration arrangements and expected\nfinancial and operational results are forward-looking statements. Words such\nas, but not limited to, “anticipate,” “believe,” “can,”\n“could,” “expect,” “estimate,” “design,” “goal,”\n“intend,” “may,” “might,” “objective,” “plan,”\n“predict,” “project,” “target,” “likely,” “should,”\n“will,” and “would,” or the negative of these terms and similar\nexpressions or words, identify forward-looking statements. Forward-looking\nstatements are based upon current expectations that involve risks, changes in\ncircumstances, assumptions and uncertainties. Forward-looking statements\nshould not be read as a guarantee of future performance or results and may not\nbe accurate indications of when such performance or results will be achieved.\nImportant factors that could cause actual results to differ materially from\nthose reflected in Entera’s forward-looking statements include, among\nothers: changes in the interpretation of clinical data; results of our\nclinical trials; the FDA’s interpretation and review of our results from and\nanalysis of our clinical trials; unexpected changes in our ongoing and planned\npreclinical development and clinical trials, the timing of and our ability to\nmake regulatory filings and obtain and maintain regulatory approvals for our\nproduct candidates; the potential disruption and delay of manufacturing supply\nchains; loss of available workforce resources, either by Entera or its\ncollaboration and laboratory partners; impacts to research and development or\nclinical activities that Entera may be contractually obligated to provide;\noverall regulatory timelines; the size and growth of the potential markets for\nour product candidates; the scope, progress and costs of developing Entera’s\nproduct candidates; Entera’s reliance on third parties to conduct its\nclinical trials; Entera’s ability to establish and maintain development and\ncommercialization collaborations; Entera’s operation as a development stage\ncompany with limited operating history; Entera’s competitive position with\nrespect to other products on the market or in development for the treatment of\nosteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic\nconditions and other disease categories it pursues; Entera’s ability to\ncontinue as a going concern absent access to sources of liquidity; Entera’s\nability to obtain and maintain regulatory approval for any of its product\ncandidates; Entera’s ability to comply with Nasdaq’s minimum listing\nstandards and other matters related to compliance with the requirements of\nbeing a public company in the United States; Entera’s intellectual property\nposition and its ability to protect its intellectual property; and other\nfactors that are described in the “Cautionary Statement Regarding\nForward-Looking Statements,” “Risk Factors” and “Management’s\nDiscussion and Analysis of Financial Condition and Results of Operations”\nsections of Entera’s most recent Annual Report on Form 10-K filed with the\nSEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q\nand Current Reports on Form 8-K. There can be no assurance that the actual\nresults or developments anticipated by Entera will be realized or, even if\nsubstantially realized, that they will have the expected consequences to, or\neffects on, Entera. Therefore, no assurance can be given that the outcomes\nstated or implied in such forward-looking statements and estimates will be\nachieved. Entera cautions investors not to rely on the forward-looking\nstatements Entera makes in this press release. The information in this press\nrelease is provided only as of the date of this press release, and Entera\nundertakes no obligation to update or revise publicly any forward-looking\nstatements, whether as a result of new information, future events or\notherwise, except to the extent required by law.\n\nCompany Contact:\nIR@enterabio.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/cad5c2b9-1536-4364-aa1b-6b8216d3658f)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXhzxlq-20261013","title":"Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture and Showcases Phase 3 Design at ASBMR 2026 Annual Meeting ","author":"Globe Newswire","ticker":"ENTX","created":"2026-10-13T11:00:00.379Z","tickers":["ENTX","5DT"],"exchange":"NASDAQ","article_body":"Post-hoc Phase 2 data show greater bone mineral density (BMD) gains and\nanabolic effect with EB613 in postmenopausal women with baseline T-scores of\n≤-2.5 (osteoporosis) versus T-scores of >-2.5 (osteopenia)\n\nThese findings support the potential benefit of EB613 in postmenopausal women\nwith osteoporosis at high risk for fracture - consistent with the study\npopulation to be enrolled in Entera’s Phase 3 study\n\nTEL AVIV, Israel, Oct. 13, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:\nENTX) (“Entera” or the “Company”), a leader in the development of oral\npeptides, today announced data from a Plenary Poster Presentation (abstract\n#7062) and a Late-breaking Poster Presentation (abstract #8726) at the\nAmerican Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting\nwhich was held October 9-12, 2026, in Boston, Massachusetts.\n\n“As we have learned about the importance of treatment sequence, our\ntherapeutic strategies have evolved toward using anabolic therapy first to\noptimize osteoporosis patient management. Multiple studies illustrate the\nsuperiority of anabolic over anti-resorptive drugs at reducing fractures,\nbuilding BMD, and restoring skeletal microarchitecture. Several major\nguidelines support this approach. Nonetheless, daily injections remain a\nbarrier for both patients and prescribers. EB613 is uniquely positioned to be\nthe first oral anabolic tablet for the treatment of osteoporosis. The oral\ntablet will allow us to overcome barriers to implementing the anabolic-first\nstrategy. Our 6 month clinical data with EB613 show rapid stimulation of bone\nformation and robust early BMD accrual, especially in patients who start with\nlower BMD and who need the largest gains. ” said Felicia Cosman, M.D.,\nProfessor of Medicine at Columbia University.\n\n“The evidence package to date has laid the foundation for our Phase 3 plans.\nThe opportunity to evaluate the safety and efficacy of EB613 for product\nregistration has generated excitement among clinical investigators and\npatients. As the first oral anabolic agent in late-stage clinical development,\nEB613 offers the potential to evolve the treatment paradigm to help address\nimportant needs of patients,” said Rachel B Wagman, MD, Chief Clinical\nAdvisor to Entera.\n\nAbstract Title: EB613, Oral PTH(1-34) Tablet, Shows Markedly Enhanced Anabolic\nEffects in Postmenopausal Women with Osteoporosis at High Risk of Fracture:\nInsights from Phase 2 Trial\n\nThe Phase 2 study (Tripto-Shkolnik 2024) randomized 161 postmenopausal women\nwith low bone mass or osteoporosis to placebo or four EB613 dose levels for 6\nmonths. To explore the anabolic effect of EB613 2.5 mg daily, in women with\nosteoporosis (baseline T-score of ≤-2.5), a post-hoc sensitivity analysis\nevaluated the relationship between baseline T-score and effects on BMD and\nbone turnover markers (BTMs) at 6 months.\n\nKey findings included:\n* Greater BMD gains in women with baseline T-scores of ≤-2.5: Mean\nplacebo-adjusted BMD increases at 6 months were 4.23% (n=6) at the total hip\nand 4.22% (n=9) at the lumbar spine in women with baseline T-scores of ≤-2.5\nat each of those measured skeletal sites, compared with 1.02% (n=15) and 1.59%\n(n=12) in women with T-scores of >-2.5. Across all 21 participants treated\nwith EB613 2.5 mg, the pooled increases were 1.84% (TH) and 2.72% (LS).\n* Larger and more persistent bone turnover marker changes: Similarly, changes\nin P1NP (bone formation) and CTX (bone resorption) were also somewhat larger\nand more persistent in women with a T-score of ≤-2.5 at any measured\nskeletal site (n=15) than in women with T-scores of >-2.5 at all sites (n=6).\nThis post-hoc, exploratory analysis produced hypothesis-generating findings\nthat support the potential for EB613 treatment in postmenopausal women with\nosteoporosis at high risk for fracture.\n\n“Although our Phase 2 data showed positive responses in postmenopausal women\nwith low bone mass (osteopenia) as well as women with osteoporosis by T-score,\nthis analysis further derisks our thesis for the population we intend to\nenroll in our Phase 3 study,” said Miranda Toledano, Chief Executive Officer\nof Entera.\n\nAbstract Title: EB613 [Oral PTH(1-34)]: The First Oral Anabolic Tablet for the\nTreatment of Osteoporosis: Phase 3 Study Design\n\nThe registrational Phase 3 for EB613 is designed as a multinational,\nrandomized, double-blind, placebo-controlled Phase 3 safety and efficacy study\nin postmenopausal women with osteoporosis. The study is designed to evaluate\nthe effectiveness of EB613, based on change in Month 12 BMD at the total hip,\ncompared with placebo. Secondary endpoints include lumbar spine and femoral\nneck BMD at Month 12, and total hip, lumbar spine and femoral neck BMD at\nMonths 3 and 6.\n\nSafety will be evaluated through assessment of adverse events, vital signs,\nphysical examinations, and clinical laboratory tests. The PK of PTH(1-34)\nfollowing oral administration of EB613 will be evaluated in a subset of study\nparticipants through a Population-PK (Pop-PK) sub-study and Full PK sub-study.\n\nApproximately 900 participants will be randomized 2:1 to EB613 (N ~ 600) or\nplacebo (N ~ 300) for a 12-month, double-blind, placebo-controlled study\nperiod. Eligible participants will be postmenopausal women 50-90 years of age\nand ≥5 years from the last menstrual period with osteoporosis diagnosed by\nDXA with BMD T-score ≤-2.50 at either lumbar spine, total hip, or femoral\nneck. Participants completing 12 months will be eligible to enroll in an\nextension study through Month 24. The objective of the extension study is to\nevaluate safety and durability of response of EB613 at 18 months and 24\nmonths.\n\nAbout Entera\nEntera is a clinical stage company focused on developing oral peptide and\nprotein replacement therapies for significant unmet medical needs where an\noral tablet form holds the potential to transform the standard of care. The\nCompany leverages a disruptive and proprietary technology platform (N-Tab®)\nand its pipeline of first-in-class oral peptide programs. The Company’s most\nadvanced product candidate, EB613 (oral PTH(1-34)), is being developed as the\nfirst oral, osteoanabolic (bone building) once-daily tablet for osteoporosis.\nEntera is also developing the first oral acylated PTH(1-34) tablet as a\nreplacement therapy for patients with hypoparathyroidism (EB612); the first\noral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the\ntreatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet\nas an injection-free alternative for patients suffering from rare\nmalabsorption conditions such as short bowel syndrome in collaboration with\nOPKO Health, Inc. For more information on Entera, visit www.enterabio.com or\nfollow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=4pMZixAsuA1ek_Sn3uFL9lxao2josfp-9_r7-MWGJ64oFXKDvwv7DQo6JiFf9V_mUWDCVjNeUjMAD89PKap6jPCGAFKj9cHnLRHbJ6CIFk4=),\nTwitter\n(https://www.globenewswire.com/Tracker?data=QB_JSNEHKIF9IxZG1sjPIHuRfYK7dH0QkG73iA3QfqO5xeIUT5baEbfZvt1FM_p9m3aaxil3XN72MN3Qpjdgaw==),\nand Facebook\n(https://www.globenewswire.com/Tracker?data=gQHvmeUH8mGySYapuI9c7BD1pDLwL1TnC0ODtXPykNoZHDz5pMSlFOSXPDd-YlrgiL2uB-kLAaZE6_FmjH58TL71JgpBpn2dl3PlgqEkStw=).\n\nAbout EB613\nEntera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as\nthe first oral, once-daily anabolic tablet treatment for osteoporosis. Entera\ncompleted a Phase 2, 6-month, 161-patient, placebo-controlled study that met\nall biomarker and BMD endpoints without significant safety concerns in women\nwith postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid\ndose-proportional increases in biochemical markers of bone formation,\nreductions in markers of bone resorption, and increases in lumbar spine, total\nhip, and femoral neck BMD. The effects of EB613 on trabecular and cortical\nbone using 3D-DXA showed increases with EB613 compared to placebo on a variety\nof indices, including integral volumetric BMD and trabecular volumetric BMD,\ncortical thickness, and cortical surface BMD. Mechanistically, the findings\nsuggest that bone strengthening and fracture resistance may occur rapidly with\nEB613. Furthermore, the data are consistent with that of published\nsubcutaneous teriparatide at the 6-month time point.\n\nAbout Osteoporosis\nOsteoporosis is a chronic, progressive disorder in which bone resorption\nexceeds formation, resulting in decreased bone strength and increased\nsusceptibility to fracture. Osteoporosis is a major and growing public health\nissue, responsible for over 2 million fractures annually in the US. After age\n50, one in three women and one in five men will suffer an osteoporosis-related\nfracture in their remaining lifetime. Osteoporotic fractures lead to chronic\npain, decreased quality of life, and increased disability, and contribute to\npremature death. Studies show that up to 20-24% of hip fracture patients die\nwithin one year of the fracture. The total medical cost of osteoporotic\nfractures is projected to increase from $57 billion in 2018 to $95 billion by\n2040, largely related to the aging population. Postmenopausal women are at\nhigher risk of developing osteoporosis-related fractures, particularly in the\nhip, spine, and wrist. The mechanism for low BMD in postmenopausal women is\nprimarily estrogen deficiency, which leads to accelerated bone loss,\nespecially in the first 5-10 years after menopause. Forteo® (Eli Lilly) was\nfirst approved by the FDA in 2002 for the treatment of postmenopausal women\nwith osteoporosis and subsequently for treatment of men with primary or\nhypogonadal osteoporosis at high risk of fracture, and for osteoporosis\nassociated with sustained systemic glucocorticoid therapy.\n\nCautionary Statement Regarding Forward Looking Statements\nVarious statements in this press release are “forward-looking statements”\nwithin the meaning of the Private Securities Litigation Reform Act of 1995.\nAll statements (other than statements of historical facts) in this press\nrelease regarding our prospects, plans, financial position, business strategy,\nclinical development activities, collaboration arrangements and expected\nfinancial and operational results are forward-looking statements. Words such\nas, but not limited to, “anticipate,” “believe,” “can,”\n“could,” “expect,” “estimate,” “design,” “goal,”\n“intend,” “may,” “might,” “objective,” “plan,”\n“predict,” “project,” “target,” “likely,” “should,”\n“will,” and “would,” or the negative of these terms and similar\nexpressions or words, identify forward-looking statements. Forward-looking\nstatements are based upon current expectations that involve risks, changes in\ncircumstances, assumptions and uncertainties. Forward-looking statements\nshould not be read as a guarantee of future performance or results and may not\nbe accurate indications of when such performance or results will be achieved.\nImportant factors that could cause actual results to differ materially from\nthose reflected in Entera’s forward-looking statements include, among\nothers: changes in the interpretation of clinical data; results of our\nclinical trials; the FDA’s interpretation and review of our results from and\nanalysis of our clinical trials; unexpected changes in our ongoing and planned\npreclinical development and clinical trials, the timing of and our ability to\nmake regulatory filings and obtain and maintain regulatory approvals for our\nproduct candidates; the potential disruption and delay of manufacturing supply\nchains; loss of available workforce resources, either by Entera or its\ncollaboration and laboratory partners; impacts to research and development or\nclinical activities that Entera may be contractually obligated to provide;\noverall regulatory timelines; the size and growth of the potential markets for\nour product candidates; the scope, progress and costs of developing Entera’s\nproduct candidates; Entera’s reliance on third parties to conduct its\nclinical trials; Entera’s ability to establish and maintain development and\ncommercialization collaborations; Entera’s operation as a development stage\ncompany with limited operating history; Entera’s competitive position with\nrespect to other products on the market or in development for the treatment of\nosteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic\nconditions and other disease categories it pursues; Entera’s ability to\ncontinue as a going concern absent access to sources of liquidity; Entera’s\nability to obtain and maintain regulatory approval for any of its product\ncandidates; Entera’s ability to comply with Nasdaq’s minimum listing\nstandards and other matters related to compliance with the requirements of\nbeing a public company in the United States; Entera’s intellectual property\nposition and its ability to protect its intellectual property; and other\nfactors that are described in the “Cautionary Statement Regarding\nForward-Looking Statements,” “Risk Factors” and “Management’s\nDiscussion and Analysis of Financial Condition and Results of Operations”\nsections of Entera’s most recent Annual Report on Form 10-K filed with the\nSEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q\nand Current Reports on Form 8-K. There can be no assurance that the actual\nresults or developments anticipated by Entera will be realized or, even if\nsubstantially realized, that they will have the expected consequences to, or\neffects on, Entera. Therefore, no assurance can be given that the outcomes\nstated or implied in such forward-looking statements and estimates will be\nachieved. Entera cautions investors not to rely on the forward-looking\nstatements Entera makes in this press release. The information in this press\nrelease is provided only as of the date of this press release, and Entera\nundertakes no obligation to update or revise publicly any forward-looking\nstatements, whether as a result of new information, future events or\notherwise, except to the extent required by law.\n\nCompany Contact:\nIR@enterabio.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/cad5c2b9-1536-4364-aa1b-6b8216d3658f)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-13T11:00:00.504191155Z","server_sent_at_ms":1791889200504},"received_at":"2026-10-13T11:00:00.719Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}