10-K: Entera Bio Ltd. Reports Fiscal Year 2024 Results, Outlines Strategy for Oral Peptide Development

Entera Bio Ltd. files its 10-K report for the fiscal year ended December 31, 2024, highlighting its focus on developing oral peptide therapies and its plans for advancing key programs.

Summary

• Entera Bio Ltd. has filed its annual report on Form 10-K, detailing its financial results for the year ended December 31, 2024.
• The company is focused on developing oral tablet forms of peptide and protein replacement therapies.
• Entera's pipeline includes programs targeting PTH(1-34), GLP-1, and GLP-2.
• The lead product candidate, EB613, is an oral PTH(1-34) tablet for post-menopausal women with osteoporosis.
• Phase 2 study data for EB613 was published in the Journal of Bone and Mineral Research in April 2024.
• The FDA has concurred that a 2-year Phase 3 study with Total Hip BMD as the primary endpoint could support an NDA for EB613.
• EB612 is being developed as an oral PTH(1-34) tablet for patients with hypoparathyroidism.
• Phase 1 clinical data for EB612 was presented at the Endocrine Society ENDO 2024 Annual Meeting.
• Entera is collaborating with OPKO Health on oral GLP-2 and Oxyntomodulin (GLP-1/Glucagon) programs.
• Positive in vivo pharmacokinetic results were announced for the oral GLP-2 program in March 2024.
• Topline pharmacokinetic/pharmacodynamic results for the oral OXM program were jointly announced with OPKO in September 2024.
• A collaboration and license agreement with OPKO was entered into in March 2025 regarding the Oral OXM program.
• The company's goal is to develop first-in-class oral peptides and protein replacement therapies.
• As of March 20, 2025, Entera had cash and cash equivalents of approximately $21 million, expected to fund operations into the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis.
• The company has incurred net losses since inception, including $9.5 million in 2024 and $8.9 million in 2023.
• The report includes a cautionary statement regarding forward-looking statements and discusses various risk factors.

Sentiment

Score: 4

Explanation: The document presents a mixed sentiment. While there are positive developments in the company's clinical programs and collaborations, the recurring losses, going concern uncertainty, and need for additional funding raise concerns.

Positives

• FDA concurrence on Phase 3 study design for EB613 with Total Hip BMD as the primary endpoint.
• Positive Phase 1 clinical data for EB612 presented at the ENDO 2024 Annual Meeting.
• Positive in vivo pharmacokinetic results from the oral GLP-2 program in collaboration with OPKO.
• Topline pharmacokinetic/pharmacodynamic results for the oral OXM program in collaboration with OPKO.
• Collaboration and license agreement with OPKO for the Oral OXM program.
• Cash resources expected to fund operations into the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis.

Negatives

• The company has incurred net losses since inception, including $9.5 million in 2024 and $8.9 million in 2023.
• The report includes a going concern note from the independent registered public accounting firm.
• The company's ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing discussions with the FDA in connection with their anticipated qualification of the SABRE total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all.

Risks

• Clinical development involves a lengthy and expensive process with uncertain outcomes.
• Regulatory approval processes are lengthy, time-consuming, and unpredictable.
• Preclinical development is uncertain, and programs may not advance to clinical trials.
• Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results.
• The company's ability to continue as a going concern is dependent on access to sources of liquidity.
• The company's ability to raise additional funds or consummate strategic partnerships is uncertain.
• Market acceptance of product candidates, even if approved, is not guaranteed.
• The company relies on third parties to conduct clinical trials and supply product candidates.
• The company's competitive position is subject to change.
• The company's ability to obtain, maintain, and protect intellectual property is uncertain.
• The company's ability to retain key personnel and recruit additional qualified personnel is subject to risk.
• Security, political, and economic instability in the Middle East may harm the company's business.

Future Outlook

The company anticipates that its existing cash and cash equivalents will be sufficient to fund its operations into the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis. The company plans to file an Investigational New Drug application with the FDA later this year.

Industry Context

The company operates in the competitive pharmaceutical and biotechnology industries, facing competition from large pharmaceutical, specialty pharmaceutical, biotechnology, and generic drug companies, as well as academic and government institutions. The company is focused on developing oral peptide therapies for chronic medical conditions, which could potentially shift the treatment paradigm from injectable therapies.

Comparison to Industry Standards

• The current standard of care for osteoporosis includes antiresorptive and anabolic drugs, with injectable anabolic agents recommended for patients at very high fracture risk.
• The current standard of care for hypoparathyroidism includes calcium supplements, vitamin D supplements, and phosphate binders, with an injectable form of full-length human PTH (1-84) also available.
• The company's oral PTH product candidates aim to provide a more convenient alternative to injectable therapies.
• The company's oral GLP-2 program aims to provide an injection-free alternative to patients suffering from short bowel syndrome, where the only approved GLP-2 agonist requires daily sub-cutaneous injections.
• The company's oral GLP-1/Glucagon program aims to develop the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders, where there are currently no approved dual GLP-1/Glucagon agonists available.

Related Party Transactions

• The company entered into a patent transfer agreement with Oramed Ltd. in 2011, pursuant to which Oramed assigned to the company all of its rights, title and interest in the patent rights that Oramed licensed to the company when it was originally organized, subject to a worldwide, royalty-free, exclusive, irrevocable, perpetual and sub-licensable license granted to Oramed under the assigned patent rights to develop, manufacture and commercialize products or otherwise exploit such patent rights in the fields of diabetes and influenza.
• The company entered into a collaboration and license agreement with OPKO Health Inc. in March 2025 regarding the Oral OXM program.
• The company issued to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, representing a purchase price per share equal to approximately $2.17, which was the volume weighted average price per share for the 30 trading days immediately preceding the date of the 2025 Collaboration Agreement.

Stakeholder Impact

• Shareholders may experience dilution if the company raises additional capital through equity offerings.
• Employees may be affected by changes in the company's operations or financial condition.
• Patients may benefit from the development of new oral peptide therapies.
• Suppliers and creditors may be affected by the company's ability to meet its obligations.

Next Steps

• Continue clinical development of EB613, EB612, and other product candidates.
• Seek regulatory approval for product candidates.
• Establish manufacturing, sales, and marketing capabilities.
• Pursue strategic partnerships and collaborations.
• Obtain additional funding to support operations.

Key Dates

Keywords

Entera Bio, oral peptide, EB613, EB612, osteoporosis, hypoparathyroidism, GLP-2, Oxyntomodulin, OPKO Health, clinical trials, N-Tab, BMD, FDA, pharmaceuticals