Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates
Entera Bio (NASDAQ:ENTX) reported significant progress in Q2 2025, highlighted by FDA's agreement on using Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 program - a potential first oral anabolic osteoporosis treatment. The FDA also waived requirements for additional safety studies, streamlining the regulatory pathway.
The company maintains a strong financial position with $18.9 million in cash, including $8.0 million restricted for OPKO collaboration, providing runway through mid-Q3 2026. Q2 resulted in a net loss of $2.7 million ($0.06 per share), compared to $2.1 million in Q2 2024.
Pipeline developments include promising preclinical data for their obesity program with OPKO, featuring oral GLP-1/glucagon dual agonist showing comparable plasma levels to Wegovy™. Additionally, their next-generation EB613 is expected to enter Phase 1 trials in November 2025.
Entera Bio (NASDAQ:ENTX) ha registrato progressi significativi nel secondo trimestre 2025, con l'accordo della FDA sull'utilizzo della densità minerale ossea (BMD) come endpoint primario per il programma di fase 3 di EB613 — possibile primo trattamento anabolico orale per l'osteoporosi. La FDA ha inoltre rinunciato alla richiesta di studi di sicurezza aggiuntivi, semplificando il percorso regolatorio.
L'azienda mantiene una solida posizione finanziaria con $18,9 milioni in cassa, di cui $8,0 milioni vincolati per la collaborazione con OPKO, garantendo liquidità fino alla metà del terzo trimestre 2026. Nel secondo trimestre si è chiuso con un perdita netta di $2,7 milioni ($0,06 per azione), rispetto a $2,1 milioni nel secondo trimestre 2024.
Lo sviluppo della pipeline include dati preclinici promettenti per il programma sull'obesità con OPKO, che mostrano un agonista duale GLP‑1/glucagone orale con livelli plasmatici comparabili a Wegovy™. Inoltre, la versione di nuova generazione di EB613 dovrebbe entrare in sperimentazione di fase 1 nel novembre 2025.
Entera Bio (NASDAQ:ENTX) informó avances significativos en el 2T de 2025, destacando el acuerdo de la FDA para usar la densidad mineral ósea (BMD) como endpoint primario del programa de fase 3 de EB613 — un posible primer tratamiento oral anabólico para la osteoporosis. La FDA también eximió la necesidad de estudios de seguridad adicionales, agilizando la vía regulatoria.
La compañía mantiene una sólida posición financiera con $18,9 millones en efectivo, incluidos $8,0 millones restringidos para la colaboración con OPKO, lo que ofrece pista de financiación hasta mediados del 3T de 2026. El 2T arrojó una pérdida neta de $2,7 millones ($0,06 por acción), frente a $2,1 millones en el 2T de 2024.
La cartera incluye datos preclínicos prometedores para su programa contra la obesidad con OPKO, con un agonista dual oral GLP‑1/glucagón que muestra niveles plasmáticos comparables a Wegovy™. Además, la versión de nueva generación de EB613 debería entrar en fase 1 en noviembre de 2025.
Entera Bio (NASDAQ:ENTX)는 2025년 2분기에 중요한 진전을 보고했습니다. FDA가 EB613의 3상에서 골밀도(BMD)를 주요 평가변수로 사용하는 데 동의했으며—이는 잠재적인 최초의 경구형 동화작용 골다공증 치료제입니다. FDA는 추가 안전성 연구 요구도 면제해 규제 절차가 간소화되었습니다.
회사는 $18.9 million의 현금을 보유한 견실한 재무 상태를 유지하고 있으며, 이 중 $8.0 million은 OPKO와의 협력에 묶여 있어 2026년 3분기 중반까지 운영 자금을 확보하고 있습니다. 2분기 순손실은 $2.7 million(주당 $0.06)로, 2024년 2분기의 $2.1 million보다 늘었습니다.
파이프라인 관련해서는 OPKO와 진행 중인 비만 프로그램에서 유망한 전임상 데이터가 보고되었으며, 경구형 GLP‑1/글루카곤 이중 작용제가 Wegovy™와 유사한 혈장 수준을 보였습니다. 또한 차세대 EB613은 2025년 11월에 1상 진입이 예상됩니다.
Entera Bio (NASDAQ:ENTX) a annoncé des progrès significatifs au 2e trimestre 2025, marqués par l'accord de la FDA pour utiliser la densité minérale osseuse (BMD) comme critère principal du programme de phase 3 d'EB613 — un potentiel premier traitement anabolisant oral contre l'ostéoporose. La FDA a également renoncé aux exigences d'études de sécurité supplémentaires, simplifiant la voie réglementaire.
La société conserve une situation financière solide avec 18,9 M$ de trésorerie, dont 8,0 M$ réservés pour la collaboration avec OPKO, assurant une visibilité financière jusqu'au milieu du 3e trimestre 2026. Le 2e trimestre s'est soldé par une perte nette de 2,7 M$ (0,06 $ par action), contre 2,1 M$ au 2e trimestre 2024.
Les développements de la pipeline incluent des données précliniques prometteuses pour leur programme anti‑obésité avec OPKO, un agoniste oral dual GLP‑1/glucagon montrant des concentrations plasmatiques comparables à Wegovy™. Par ailleurs, la génération suivante d'EB613 devrait entrer en phase 1 en novembre 2025.
Entera Bio (NASDAQ:ENTX) meldete im 2. Quartal 2025 bedeutende Fortschritte: Die FDA stimmte der Verwendung der Knochendichte (BMD) als primärem Endpunkt für das Phase‑3‑Programm von EB613 zu – ein möglicher erster oraler anaboler Osteoporose‑Therapeutikum. Die FDA verzichtete außerdem auf zusätzliche Sicherheitsstudien, wodurch der Zulassungsweg vereinfacht wird.
Das Unternehmen verfügt über eine solide Finanzlage mit $18,9 Millionen in bar, davon $8,0 Millionen zweckgebunden für die Zusammenarbeit mit OPKO, was den Finanzierungszeitraum bis Mitte Q3 2026 sichert. Im 2. Quartal ergab sich ein Nettoverlust von $2,7 Millionen ($0,06 je Aktie), gegenüber $2,1 Millionen im 2. Quartal 2024.
Zur Pipeline gehören vielversprechende präklinische Daten für das Adipositas‑Programm mit OPKO: ein oraler GLP‑1/Glukagon‑Dualagonist zeigt im Blut vergleichbare Spiegel zu Wegovy™. Zudem soll die nächste Generation von EB613 im November 2025 in Phase‑1‑Studien eintreten.
- FDA agreement on BMD as primary endpoint for EB613 Phase 3, simplifying pathway to approval
- FDA waived requirements for additional carcinogenicity and toxicity studies, reducing regulatory burden
- Strong cash position of $18.9 million providing runway through mid-Q3 2026
- Promising preclinical data showing oral GLP-1/glucagon comparable to Wegovy plasma levels
- Net loss increased to $2.7 million in Q2 2025 from $2.1 million in Q2 2024
- R&D expenses increased by $0.4 million year-over-year
Insights
FDA's BMD endpoint approval for EB613 Phase 3 significantly streamlines Entera's path to commercializing first oral osteoporosis anabolic treatment.
The FDA's agreement to accept Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 trial represents a major regulatory victory for Entera Bio. This decision substantially reduces both the time and cost required to bring their oral PTH osteoporosis treatment to market, as traditional fracture endpoints typically require larger, longer, and more expensive trials. The agreement specifically allows for a single Phase 3 study with BMD as the primary endpoint and vertebral fracture as a secondary endpoint, with the 505(b)(2) pathway leveraging Forteo's established safety and efficacy data.
Entera's regulatory burden has been further reduced through FDA waivers for dedicated oral carcinogenicity studies and comprehensive reproductive toxicity studies. These regulatory concessions reflect confidence in Entera's clinical data and significantly de-risk the development timeline while preserving capital.
From a financial perspective, the
The addressable market opportunity is substantial - management cites that
- 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
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®, 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® 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™ 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™ 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™ (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
Net loss was
Research and development expenses were
General and administrative expenses were
Total operating expenses were
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 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.
Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
| ENTERA BIO LTD. | |||
| CONSOLIDATED BALANCE SHEETS | |||
| (U.S. dollars in thousands) | |||
| June 30, | December 31, | ||
| 2025 | 2024 | ||
| (Unaudited) | (Audited) | ||
| Cash and cash equivalents | 10,858 | 8,660 | |
| Accounts receivable and other current assets | 438 | 312 | |
| Restricted cash | 8,015 | - | |
| Property and equipment, net | 79 | 57 | |
| Other assets | 277 | 361 | |
| Total assets | 19,667 | 9,390 | |
| Accounts payable and other current liabilities | 1,844 | 1,176 | |
| Total non-current liabilities | 567 | 134 | |
| Total liabilities | 2,411 | 1,310 | |
| Total shareholders' equity | 17,256 | 8,080 | |
| Total liabilities and shareholders' equity | 19,667 | 9,390 | |
| ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited) | |||
| Three Months Ended June 30, | |||
| 2025 | 2024 | ||
| REVENUES | - | 57 | |
| COST OF REVENUES | - | 49 | |
| GROSS PROFIT | - | 9 | |
| OPERATING EXPENSES: | |||
| Research and development | 1,520 | 1,086 | |
| General and administrative | 1,148 | 1,088 | |
| TOTAL OPERATING EXPENSES | 2,668 | 2,174 | |
| OPERATING LOSS | 2,668 | 2,165 | |
| FINANCIAL INCOME, NET | (12) | (20) | |
| NET LOSS | 2,656 | 2,145 | |
| LOSS PER SHARE BASIC AND DILUTED | 0.06 | 0.06 | |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 46,836,700 | 37,090,160 | |
Contact: Corporate Contact: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: miranda@enterabio.com
FAQ
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