אנטרה ביו מודיעה על תוצאותיה הכספיות לשנת 2024 כולה ומספקת עדכונים עסקיים

ירושלים, 28 במרץ 2025, (GLOBE NEWSWIRE) –

אנטרה ביו Entera Bio Ltd.(נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לשנה שהסתיימה ביום 31 בדצמבר 2024.

Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates

JERUSALEM, March 28, 2025 (GLOBE NEWSWIRE) –

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 balance sheet. To our core team with whom I started this journey in late 2022 as a board member, and to our rapidly expanding ecosystem of premier global advisors, I thank you for your commitment and dedication. To our existing and new shareholders, we are grateful for your belief and support of our thesis. To our collaborators, especially, the formidable team at OPKO Health, Inc., we are grateful for your partnership and the opportunity to expand our N-Tab™ platform to additional high value peptides," said Miranda Toledano, Chief Executive Officer of Entera.

"To our potential patient base for whom we are developing EB613: the majority of the estimated 200 million women with osteoporosis who wish to preserve their bone health, who remain underserved with current treatments and who have not been able to access a new therapy since 2019, our dedication to you is firm and unwavering. Osteoporosis is one of the foremost underserved health issues globally which disproportionally afflicts women. Most women experience menopause between the ages of 45 and 55 years. One in three women over age 50 will develop osteoporosis, and one in two of those women will develop an osteoporosis-related fracture. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. Nevertheless, most patients remain untreated. Furthermore, existing regulatory guidelines requiring fracture outcomes have curtailed innovation in this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), based on a statistical meta-analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip BMD to fracture outcomes, is undergoing review at FDA. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate marker for CV outcomes and HBA1C as a surrogate for the risk of future diabetes complications, both of which enabled the advancement of many important new therapies for those conditions. We look forward to potential updates from FDA and SABRE on this important ruling and to potentially initiating our pivotal Phase 3 study of EB613 promptly thereafter. Our EB613, the first oral PTH(1-34) peptide treatment candidate is being developed to close the treatment gap in osteoporosis with a validated anabolic mechanism of action in tablet form. We plan to continue our mission to add value to Entera in 2025, with humility and a focus on execution," said Miranda Toledano, Chief Executive Officer of Entera.

2024 Key Achievements:

EB613: First Oral PTH(1-34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

• In March 2024, theASBMR announced that the FDA had communicated to the SABRE project teamthat a ruling to qualify the treatment-related change in bone mineraldensity (BMD) as a surrogate endpoint for fractures in future trials ofnew anti-osteoporosis drugs would be provided within 10 months

• In April 2024,Entera announced that the Journal of Bone and Mineral Research (JBMR)published EB613 placebo controlled Phase 2 Trial results, highlighting itsdual mechanism of action and rapid increases in BMD at trabecular andcortical skeletal sites

• In June 2024, anindependent editorial was published by the JBMR "A Novel Oral PTH(1-34)[EB613] Unveils the Promise of Modeling-Based Anabolism with No Increasein Bone Remodeling"

• In September 2024,Entera presented new comparative pharmacological data for EB613 vs.Forteo® at the ASBMR September 2024 Annual Meeting in Toronto. Theabstract was previewed by Dr. Serge Ferrari of Geneva University Hospitalin Switzerland in his sneak-peak highlights of cutting-edge clinicalabstracts on osteoporosis therapy at ASBMR2024

First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

• In September 2024,Entera and OPKO Health jointly announced toplinepharmacokinetic/pharmacodynamic (PK/PD) results for the oral oxyntomodulin(OXM) tablet program

• The program isfocused on developing the first oral dual agonist GLP-1/glucagon peptideas a potential once-daily treatment for patients with obesity andmetabolic disorders combining OPKO’s proprietary long-acting oxyntomodulinanalog (OPK-88006) and Entera’s proprietary N-Tab™ platform

• Oral OXM exhibitedsignificant systemic exposure across two in vivo models,a favorable PK profile and bioavailability. The high plasma concentrationswith prolonged systemic exposure were consistent with the reportedhalf-life for semaglutide (Rybelsus®), the only approved oral GLP-1analog. Oral OXM showed a statistically significant reduction in plasmaglucose levels compared with placebo

• In March 2025, weentered into a collaboration and license agreement with OPKO relating tothe preclinical and clinical development of the Oral OXM program. Underthe terms of the agreement, OPKO and Entera will hold 60% and 40% pro-rataownership interests, respectively, in the program and be responsible for60% and 40% of the program’s development costs, respectively. Thecompanies expect to file an Investigational New Drug application with theU.S. Food and Drug Administration (FDA) later this year

First GLP-2 Peptide Tablets for Short Bowel Syndrome

• During 2024,Entera and OPKO completed a proof of concept (PoC) single dosepharmacokinetic study in rodents. Oral GLP-2 tablets exhibited significantsystemic exposure. Furthermore, plasma levels achieved with the oraltablet form of the GLP-2 analogue were about 10-fold higher thantherapeutic plasma concentrations reported for subcutaneously administeredteduglutide (Gattex®)

• Thepharmacokinetic analysis of the data obtained following the IV injectionsof the GLP-2 peptide showed the plasma half-life in rats to be about sixtimes longer than the half-life reported for teduglutide in the sameanimal model. This data is consistent with previously reported PK datarelating to OPKO’s GLP-2 peptide’s long-acting profile, which hadinitially been developed as a weekly subcutaneous injection

• Given thechallenging compliance rates attributed to injectable GLP-2 therapy andheterogeneity of short bowel syndrome (SBS) patients, we believe a dailytablet format may address a significant unmet need in treating andtitrating SBS patients more effectively than injectable alternatives. OPKOand Entera are determining next steps for this program

EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets Candidate for Hypoparathyroidism

• In June 2024,Entera presented Phase 1 clinical data for EB612, which is being developedas the first oral PTH(1-34) tablet peptide replacement therapy for patientswith hypoparathyroidism, at the Endocrine Society ENDO 2024 AnnualMeeting. This Phase 1 data supports potentially moving the BID tablet doseto Phase 2 development in patients with hypoparathyroidism

• Entera continuesto collaborate productively with a third party on the oral tabletdevelopment of another PTH replacement treatment for hypoparathyroidism

Financial Results for the Year Ended December 31, 2024

As of December 31, 2024, Entera had cash and cash equivalents of $8.7 million. As of March 28, 2025, Entera had cash and cash equivalents of $21 million, largely attributable to at-market direct investments from existing and new institutional shareholders and our partner, OPKO. The cash is expected to be sufficient to fund our operations into the third quarter of 2026, including ongoing work related to the planned EB613 phase 3 study, regulatory expenses, research and development, patent prosecution, the completion of an additional Phase 1 PK study related to our new generation platform and our share of projected oral GLP1/Glucagon tablet Phase 1 study expenses in collaboration with OPKO.

• Research anddevelopment expenses for the years ended December 31, 2024 and December31, 2023 were each $4.5 million. There was a decrease of $0.8 millionrelated to the completion of the first cohorts of a Phase 1 PK study,which occurred in 2023. The decrease was offset by an increase of $0.8million in 2024 related to optimization related to the preparation of theEB613 phase 3 study

• General andadministrative expenses for the year ended December 31, 2024 were $5.1million, compared to $4.4 million for the year ended December 31, 2023.The increase of $0.7 million was mainly attributable to expanding ourintellectual property position and advisor compensation. The increase waspartially offset by a decrease of $0.2 million in D&O insurance costsand other costs

• Operating expensesfor the year ended December 31, 2024 were $9.6 million, as compared to$8.9 million for the year ended December 31, 2023

Net loss was $9.5 million, or $0.25 per ordinary share (basic and diluted), for the year ended December 31, 2024, as compared to 8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023.

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™) and its pipeline includes five differentiated, 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 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.

Contact:

Entera Bio:

Ms. Miranda Toledano

Chief Executive Officer

Entera Bio

Email: [email protected]

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