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Entera Bio Ltd.

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Business Summary

Entera Bio Ltd. is a clinical-stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies for underserved, chronic medical conditions . The company leverages its proprietary N-Tab® platform, designed to stabilize large hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream .

The core business model revolves around the development of oral peptide and protein replacement therapies. The company generates revenue through research services, as evidenced by $42 thousand in revenue for the year ended December 31, 2025, and $181 thousand for the year ended December 31, 2024, attributable to a research services agreement with an external party . The company has not yet generated any revenue from product sales .

Entera Bio's pipeline includes several differentiated oral peptide programs. The most advanced product candidate is EB613 (oral teriparatide, or oral PTH[1-34]), which is being developed as the first oral, osteoanabolic (bone building) tablet treatment for osteoporosis . EB613 is being developed under a 505(b)(2) application to the listed drug, Forteo® (teriparatide SC injection, Eli Lilly) . The company has completed a comprehensive nonclinical and clinical package for EB613, including three Phase 1 comparative studies with Forteo® and three Phase 2 clinical studies, with EB613 safely administered to a total of 270 study participants . The Phase 2, 6-month, 161-patient, placebo-controlled study met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD . At 6 months of treatment, EB613 2.5mg produced comparable total hip BMD increases as those reported for Forteo® at 6 months . The company retains global rights to EB613 .

Another product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism . EB612 has been granted orphan drug designation by the FDA and EMA for this indication . In December 2025, new in vivo PK/PD data supported the development of a proprietary long-acting PTH (LA-PTH) analog, utilizing the N-Tab® platform, demonstrating a markedly prolonged plasma half-life and sustained elevation of serum calcium levels for more than three days following a single oral administration . This supports the development of a once-daily oral PTH tablet for hypoparathyroidism . Entera and OPKO each own 50% of the rights related to the LA-PTH hypoparathyroidism EB612 program .

The EB618 program focuses on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity, metabolic, and fibrotic disorders, also utilizing the N-Tab® platform . In September 2024, topline PK/PD results for the OXM program showed significant systemic exposure across two in vivo models, a favorable PK profile, and bioavailability, with high plasma concentrations consistent with semaglutide (Rybelsus®) . Oral OXM also showed a statistically significant reduction in plasma glucose levels compared with placebo . Under a collaboration and license agreement with OPKO, Entera and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively .

The Oral GLP-2 program aims to develop the first glucagon-like-peptide 2 (GLP-2) peptide tablet alternative for patients suffering from short bowel syndrome (SBS) and other disorders involving mucosal inflammation and nutrient malabsorption . In late 2023, a proof of concept single dose pharmacokinetic study in rodents showed oral GLP-2 tablets exhibited significant systemic exposure, with plasma levels approximately 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label) . Pharmacokinetic data from a mini-pig study in September 2025 demonstrated a plasma half-life of approximately 15 hours, supporting once-daily oral dosing .

For the fiscal year ended December 31, 2025, the company reported total revenues of $42 thousand , with a gross profit of $0 . Operating expenses totaled $11.529 million , leading to an operating loss of $11.529 million . Net loss for the year was $11.439 million , resulting in a basic and diluted EPS of $0.25 . Cash and cash equivalents were $7.108 million , with restricted cash of $7.775 million , and total assets of $15.993 million . Total liabilities were $2.892 million . The company had an accumulated deficit of $125.4 million as of December 31, 2025.

Comparing 2025 to 2024, revenues decreased by $139 thousand , or 77% , from $181 thousand in 2024 to $42 thousand in 2025 . Cost of revenues also decreased by $130 thousand , or 76% , from $172 thousand in 2024 to $42 thousand in 2025 . Research and development expenses increased by $1.5 million , or 33% , from $4.5 million in 2024 to $6.0 million in 2025 . General and administrative expenses increased by $0.4 million , or 8% , from $5.1 million in 2024 to $5.5 million in 2025 . The operating loss increased by $1.944 million , or 20% , from $9.585 million in 2024 to $11.529 million in 2025 . Net loss increased by $1.898 million , or 20% , from $9.541 million in 2024 to $11.439 million in 2025 . Financial income, net, increased from $58 thousand in 2024 to $90 thousand in 2025 .

During 2025, Entera Bio issued and sold to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million in connection with the 2025 Collaboration Agreement . The proceeds of $8.0 million are designated solely to fund development cost obligations under the A&R Collaboration Agreement . In February 2026, the company submitted a clinical amendment to the FDA, including the EB613 Phase 3 protocol, statistical analysis plan, and open-label extension synopsis .

Business Outlook

Management anticipates that existing cash and cash equivalents will be sufficient to fund ongoing operations through the middle of the third quarter of 2026 , excluding the initiation of the Phase 3 study for EB613 in osteoporosis . The ability to commence the Phase 3 study of EB613 in osteoporosis will require additional funding .

A major growth area for Entera Bio is the advancement of EB613 into Phase 3 for the treatment of osteoporosis. Building on FDA alignment in July 2025 and the FDA's December 2025 broad qualification of BMD as a regulatory endpoint for anti-osteoporosis drugs, the company submitted a streamlined Phase 3 protocol to the FDA in February 2026 . The planned multinational, randomized, double-blind, placebo-controlled Phase 3 study is expected to enroll approximately 750 postmenopausal women with osteoporosis and will evaluate the percentage change in total hip BMD from baseline to month 12 as the primary endpoint . An open-label extension study is also planned to provide safety and efficacy data for EB613 at 24 months as monotherapy and evaluate the sequence of 12 months of EB613 treatment followed by a standard anti-resorptive drug for an additional 12 months . Entera currently retains global rights to EB613 .

Another significant growth vector is the advancement of a proprietary long-acting PTH (LA-PTH) analog as a once-daily tablet for patients with hypoparathyroidism, as part of a collaboration with OPKO . Preclinical findings in 2025 demonstrated a markedly prolonged plasma half-life and sustained elevation of serum calcium levels for more than three days following administration of a single oral tablet , supporting once-daily oral dosing . The collaboration with OPKO was expanded in February 2026 to jointly advance this LA-PTH program . Entera and OPKO each own 50% of the rights related to this program , and development expenses through Phase 1 are expected to be funded from the $8 million in proceeds received from OPKO's equity investment in Entera in 2025 . The company currently expects to submit an IND application to the FDA in late 2026 .

The company also aims to identify and develop additional high-value oral peptides in collaboration with strategic partners, such as the Oxyntomodulin (Oral GLP-1/Glucagon) and Oral GLP-2 programs . In collaboration with OPKO, the company is focusing on developing the first oral OXM, a dual-targeted GLP-1/glucagon peptide, in tablet form for metabolic disorders . Entera and OPKO own 40% and 60%, respectively, of the rights related to the OXM EB618 program . OPKO is planning to initiate a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical study with the subcutaneous injection formulation of OXM, with data expected by the end of 2026 . Entera plans to file an IND for the oral OXM tablet formulation thereafter . For the Oral GLP-2 program, proof of concept has been completed for an oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions like short bowel syndrome .

The company plans to establish select global and regional development and commercial partnerships to diversify and shorten preclinical and clinical development in a capital-efficient manner . This includes pursuing research and clinical development partnerships with biopharmaceutical companies with specific domain expertise and those with proven commercial footprints to de-risk late-stage programs .

Planned capital allocation includes continued investment in research and development. For the year ended December 31, 2025, research and development expenses were $6.0 million , an increase from $4.5 million in 2024 . This increase was primarily due to $0.7 million in other consulting fees, including regulatory fees for the Type A meeting with the FDA and optimization for the EB613 Phase 3 program, $0.5 million for internal and collaboration programs, $0.4 million in compensation, and $0.1 million in other expenses . The company expects research and development expenses to increase significantly in future periods as clinical candidates advance and investments are made in additional preclinical candidates .

Risk Factors

Entera Bio faces substantial risks, including significant recurring losses from operations and negative cash flows, leading to substantial doubt about its ability to continue as a going concern . The company had an accumulated deficit of $125.4 million as of December 31, 2025 . Its current cash and cash equivalents of $12.6 million as of March 23, 2026, with $7.8 million designated for the OPKO collaboration, are only sufficient to fund operations through the middle of the third quarter of 2026, excluding the initiation of the EB613 Phase 3 study . Additional funding is required for the Phase 3 study and future operations, which may not be available on acceptable terms or at all, potentially leading to delays, curtailment, or cessation of product development . All product candidates are in preclinical or clinical development, with no successful completion of development or regulatory approval for any product candidate to date . Clinical trials are expensive, time-consuming, and uncertain, with potential for delays, unsatisfactory results, or failure to obtain regulatory approvals . The company is also subject to manufacturing risks, as it relies on third parties for clinical and commercial supply, and any issues could increase costs or limit supply . Competition from larger pharmaceutical companies with greater resources and existing products for osteoporosis, hypoparathyroidism, and short bowel syndrome could negatively affect commercial opportunities . The company is highly dependent on its ability to secure and maintain collaborations for product development and commercialization, and any failure to do so or issues with existing collaborations could adversely affect its business . Data privacy regulations, including HIPAA, GDPR, and the Israeli Privacy Protection Law, impose strict requirements, and non-compliance could result in significant fines or reputational harm . Global economic conditions, including inflation and geopolitical tensions like the Israel-Hamas conflict, could increase operating costs, disrupt supply chains, and affect the company's ability to raise capital . The company's intellectual property, including its N-Tab® platform, is crucial, and failure to establish, maintain, defend, or enforce patent rights could erode competitive advantages . Intellectual property litigation is costly and time-consuming, and the company may face claims of infringement from third parties .

Management Priorities

Management's message to shareholders emphasizes the company's focus on developing first-in-class oral tablet formats of peptides or protein replacement therapies for underserved, chronic medical conditions, leveraging its N-Tab® platform. They anticipate that existing cash and cash equivalents will be sufficient to fund ongoing operations through the middle of the third quarter of 2026 , excluding the initiation of the Phase 3 study for EB613 in osteoporosis . The company's strategic priorities include advancing EB613 into Phase 3 for osteoporosis, with a planned multinational, randomized, double-blind, placebo-controlled Phase 3 study expected to enroll approximately 750 postmenopausal women with osteoporosis . Another key priority is advancing a proprietary long-acting PTH (LA-PTH) analog as a once-daily tablet for hypoparathyroidism in collaboration with OPKO, with an IND application to the FDA currently expected in late 2026 . Finally, management is focused on identifying and developing additional high-value oral peptides in collaboration with strategic partners, such as the Oxyntomodulin (Oral GLP-1/Glucagon) and Oral GLP-2 programs .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 7, MD&A — Results of Operations — Revenue
  4. [4] Item 7, MD&A — Results of Operations — Revenue
  5. [5] Item 7, MD&A — Results of Operations — Revenue
  6. [6] Item 7, MD&A — Revenue
  7. [7] Item 1, Business — EB613 Program
  8. [8] Item 1, Business — EB613 Program
  9. [9] Item 1, Business — EB613 Program
  10. [10] Item 1, Business — EB613 Program
  11. [11] Item 1, Business — EB613 Program
  12. [12] Item 1, Business — Our Strategy
  13. [13] Item 1, Business — EB612 (PTH) Hypoparathyroidism Program
  14. [14] Item 1, Business — EB612 (PTH) Hypoparathyroidism Program
  15. [15] Item 1, Business — EB612 (PTH) Hypoparathyroidism Program
  16. [16] Item 1, Business — EB612 (PTH) Hypoparathyroidism Program
  17. [17] Item 1, Business — Our Strategy
  18. [18] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  19. [19] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  20. [20] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  21. [21] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  22. [22] Item 1, Business — Oral GLP-2
  23. [23] Item 1, Business — Oral GLP-2
  24. [24] Item 1, Business — Oral GLP-2
  25. [25] Item 8, Consolidated Statements of Operations — Revenues
  26. [26] Item 8, Consolidated Statements of Operations — Gross Profit
  27. [27] Item 8, Consolidated Statements of Operations — Total Operating Expenses
  28. [28] Item 8, Consolidated Statements of Operations — Operating Loss
  29. [29] Item 8, Consolidated Statements of Operations — Net Loss
  30. [30] Item 8, Consolidated Statements of Operations — Loss Per Share Basic and Diluted
  31. [31] Item 8, Consolidated Balance Sheets — Cash and cash equivalents
  32. [32] Item 8, Consolidated Balance Sheets — Restricted cash
  33. [33] Item 8, Consolidated Balance Sheets — Total Assets
  34. [34] Item 8, Consolidated Balance Sheets — Total Liabilities
  35. [35] Item 8, Consolidated Balance Sheets — Accumulated deficit
  36. [36] Item 7, MD&A — Results of Operations — Revenue
  37. [37] Item 7, MD&A — Results of Operations — Revenue
  38. [38] Item 7, MD&A — Results of Operations — Revenue
  39. [39] Item 7, MD&A — Results of Operations — Revenue
  40. [40] Item 7, MD&A — Results of Operations — Revenue
  41. [41] Item 7, MD&A — Results of Operations — Cost of Revenues
  42. [42] Item 7, MD&A — Results of Operations — Cost of Revenues
  43. [43] Item 7, MD&A — Results of Operations — Cost of Revenues
  44. [44] Item 7, MD&A — Results of Operations — Cost of Revenues
  45. [45] Item 7, MD&A — Results of Operations — Cost of Revenues
  46. [46] Item 7, MD&A — Results of Operations — Research and Development Expenses
  47. [47] Item 7, MD&A — Results of Operations — Research and Development Expenses
  48. [48] Item 7, MD&A — Results of Operations — Research and Development Expenses
  49. [49] Item 7, MD&A — Results of Operations — Research and Development Expenses
  50. [50] Item 7, MD&A — Results of Operations — Research and Development Expenses
  51. [51] Item 7, MD&A — Results of Operations — General and Administrative Expenses
  52. [52] Item 7, MD&A — Results of Operations — General and Administrative Expenses
  53. [53] Item 7, MD&A — Results of Operations — General and Administrative Expenses
  54. [54] Item 7, MD&A — Results of Operations — General and Administrative Expenses
  55. [55] Item 7, MD&A — Results of Operations — General and Administrative Expenses
  56. [56] Item 7, MD&A — Results of Operations — Operating Loss
  57. [57] Item 7, MD&A — Results of Operations — Operating Loss
  58. [58] Item 7, MD&A — Results of Operations — Operating Loss
  59. [59] Item 7, MD&A — Results of Operations — Operating Loss
  60. [60] Item 7, MD&A — Results of Operations — Operating Loss
  61. [61] Item 7, MD&A — Results of Operations — Net Loss
  62. [62] Item 7, MD&A — Results of Operations — Net Loss
  63. [63] Item 7, MD&A — Results of Operations — Net Loss
  64. [64] Item 7, MD&A — Results of Operations — Net Loss
  65. [65] Item 7, MD&A — Results of Operations — Net Loss
  66. [66] Item 7, MD&A — Results of Operations — Financial Income, Net
  67. [67] Item 7, MD&A — Results of Operations — Financial Income, Net
  68. [68] Item 7, MD&A — Results of Operations — Financial Income, Net
  69. [69] Item 7, MD&A — Liquidity and Capital Resources — Equity Offerings
  70. [70] Item 7, MD&A — Liquidity and Capital Resources — Equity Offerings
  71. [71] Item 7, MD&A — Liquidity and Capital Resources — Equity Offerings
  72. [72] Item 7, MD&A — Liquidity and Capital Resources — Equity Offerings
  73. [73] Item 7, MD&A — Liquidity and Capital Resources — Equity Offerings
  74. [74] Item 1, Business — EB613 Program
  75. [75] Item 7, MD&A — Funding Requirements
  76. [76] Item 7, MD&A — Funding Requirements
  77. [77] Item 7, MD&A — Funding Requirements
  78. [78] Item 1, Business — Our Strategy
  79. [79] Item 1, Business — EB613 Program
  80. [80] Item 1, Business — EB613 Program
  81. [81] Item 1, Business — EB613 Program
  82. [82] Item 1, Business — Our Strategy
  83. [83] Item 1, Business — Our Strategy
  84. [84] Item 1, Business — Our Strategy
  85. [85] Item 1, Business — Our Strategy
  86. [86] Item 1, Business — EB612 (PTH) Hypoparathyroidism Program
  87. [87] Item 1, Business — Our Strategy
  88. [88] Item 1, Business — Our Strategy
  89. [89] Item 1, Business — Our Strategy
  90. [90] Item 1, Business — Our Strategy
  91. [91] Item 1, Business — Our Strategy
  92. [92] Item 1, Business — Our Strategy
  93. [93] Item 1, Business — Our Strategy
  94. [94] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  95. [95] Item 1, Business — EB618 Program (Oral GLP-1/Glucagon)
  96. [96] Item 1, Business — Our Strategy
  97. [97] Item 1, Business — Our Strategy
  98. [98] Item 1, Business — Our Strategy
  99. [99] Item 7, MD&A — Research and Development Expenses
  100. [100] Item 7, MD&A — Research and Development Expenses
  101. [101] Item 7, MD&A — Research and Development Expenses
  102. [102] Item 7, MD&A — Research and Development Expenses
  103. [103] Item 7, MD&A — Research and Development Expenses
  104. [104] Item 7, MD&A — Research and Development Expenses
  105. [105] Item 7, MD&A — Research and Development Expenses
  106. [106] Item 7, MD&A — Research and Development Expenses
  107. [107] Item 7, MD&A — Research and Development Expenses
  108. [108] Item 1A, Risk Factors — Risks Related to Our Financial Position
  109. [109] Item 1A, Risk Factors — Risks Related to Our Financial Position
  110. [110] Item 1A, Risk Factors — Risks Related to Our Financial Position
  111. [111] Item 1A, Risk Factors — Risks Related to Our Financial Position
  112. [112] Item 1A, Risk Factors — Risks Related to Our Financial Position
  113. [113] Item 1A, Risk Factors — Risks Related to Our Financial Position
  114. [114] Item 1A, Risk Factors — Risks Related to Our Financial Position
  115. [115] Item 1A, Risk Factors — Risks Related to Our Business and the Development of Our Product Candidates
  116. [116] Item 1A, Risk Factors — Risks Related to Regulatory Approval of Our Product Candidates
  117. [117] Item 1A, Risk Factors — Risks Related to Commercialization of Our Product Candidates
  118. [118] Item 1A, Risk Factors — Risks Related to Commercialization of Our Product Candidates
  119. [119] Item 1A, Risk Factors — Risks Related to Our Dependence on Third Parties
  120. [120] Item 1A, Risk Factors — Risks Related to Our Business and the Development of Our Product Candidates
  121. [121] Item 1A, Risk Factors — Risks Related to Our Business and the Development of Our Product Candidates
  122. [122] Item 1A, Risk Factors — Risks Related to Our Intellectual Property
  123. [123] Item 1A, Risk Factors — Risks Related to Our Intellectual Property
  124. [124] Item 7, MD&A — Financial Overview
  125. [125] Item 7, MD&A — Financial Overview
  126. [126] Item 1, Business — EB613 Program
  127. [127] Item 1, Business — Our Strategy
  128. [128] Item 1, Business — Our Strategy
  129. [129] Item 1, Business — Our Strategy

Analysis on 5/21/2026