v3.26.1
DESCRIPTION OF BUSINESS
12 Months Ended
Dec. 31, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
DESCRIPTION OF BUSINESS
NOTE 1 - DESCRIPTION OF BUSINESS
 
a)
Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 and commenced operation on June 1, 2010. On January 8, 2018, the Company incorporated its wholly owned subsidiary, Entera Bio Inc., in Delaware, United States.
 
The Company is focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. The Company focuses on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.
 

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 bone mineral density (“BMD”) and high-risk osteoporosis without prior fracture. The Company is also developing a next-generation formulation of EB613 utilizing its proprietary N-Tab® platform, which is expected to provide significant advantages in administration, commercialization, and strategic partnering. The Company is preparing to submit final protocol to the FDA and initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint.

 

The Company’s product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 5) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (“OPKO”), to advance the first oral long-acting PTH analog (“LA-PTH”) as a once-daily tablet for patients with hypoparathyroidism.

 

In addition, EB618 is being developed pursuant to the Company’s collaboration with OPKO, pursuant to which the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment and as a weekly subcutaneous injection for patients with obesity, metabolic and fibrotic disorders. The oral program combines OPKO’s proprietary long-acting oxyntomodulin (“OXM”) analog (OPK-88006) and the Company’s proprietary N-Tab® platform.

 

In addition to its internal product development programs, the Company intends to license its proprietary N-Tab® platform to biopharmaceutical companies for use with their proprietary compounds.

 
b)
The Company's ordinary shares, NIS 0.0000769 par value per share (“ordinary shares”), are listed on the Nasdaq Capital Market under the symbol “ENTX”.
   
c)
Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred negative cash flows from operating activities. The Company has incurred an accumulated deficit in the amount of $125.4 million as of December 31, 2025.
 
The Company's management is of the opinion that its available funds as of December 31, 2025 will be sufficient to support the Company’s ongoing operations under its current plans through the middle of the third quarter of 2026.
 
The Company’s current capital resources do not include the capital required to fund the Company's proposed Phase 3 program for EB613 in osteoporosis. These factors raise substantial doubt as to the Company's ability to continue as a going concern. Management continually evaluates various financing alternatives and strategic collaborations, as the Company will need to finance future research and clinical development with additional capital. However, there is no certainty that the Company will be able to obtain such funding. These consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.
 
d)
In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war. Since the commencement of these events, there have been additional active hostilities, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and Iran. In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. On June 21, 2025, U.S. President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran. On October 9, 2025, a ceasefire had been reached. Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas. On February 28, 2026, the United States and Israel conducted preemptive strikes targeting Iranian military infrastructure. Iran retaliated with extensive ballistic missile and drone attacks against Israel. On March 2, 2026, Hezbollah resumed hostilities by launching projectiles into northern Israel, ending the November 2024 ceasefire. Israel responded with airstrikes on Lebanon and ground operations in Southern Lebanon, marking a significant escalation in the regional conflict. How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region become is unknown at this time and any continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict. The Company’s research personnel and certain management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel.

 

Currently, the Company’s activities in Israel remain largely unaffected by the foregoing events. During the years ended December 31, 2025 and December 31, 2024, the impact of such events on the Company’s results of operations and financial condition was immaterial.