Entera Bio Ltd. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Entera Bio Ltd. has filed its 2023 10-K report, providing a comprehensive overview of its financial and operational status.</b>

AI Summary

Entera Bio Ltd. (ENTX) filed a Annual Report (10-K) with the SEC on March 8, 2024. Entera Bio Ltd. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The report details financial performance and business operations for the period. Key dates include the filing date of March 8, 2024, and the period of report ending December 31, 2023. The company is classified under SIC code 2836: Biological Products (No Diagnostic Substances). Business and mailing addresses are located in Jerusalem, Israel.

Why It Matters

For investors and stakeholders tracking Entera Bio Ltd., this filing contains several important signals. This 10-K filing is the primary source for investors and analysts to understand Entera Bio's financial health, strategic direction, and risks for the fiscal year 2023. The detailed information within the report is crucial for making informed investment decisions and assessing the company's performance against its peers and market expectations.

Risk Assessment

Risk Level: — Entera Bio Ltd. shows moderate risk based on this filing. The company's financial performance and future prospects are subject to the inherent risks of the biotechnology industry, including clinical trial success, regulatory approvals, and market adoption, which are not fully detailed in the provided snippet.

Analyst Insight

Review the full 10-K filing to understand Entera Bio's financial statements, risk factors, and management's discussion and analysis for a complete picture of its 2023 performance and outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of report)
• 2024-03-08 — Filing Date (Date the 10-K was filed)
• 2836 — SIC Code (Biological Products (No Diagnostic Substances))

Key Players & Entities

• Entera Bio Ltd. (company) — Filer name
• 2023-12-31 (date) — Period of report end date
• 2024-03-08 (date) — Filed as of date
• Jerusalem (location) — Business address city
• 2836 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

Entera Bio Ltd. operates in the biotechnology sector, focusing on the development of biological products.

Regulatory Implications

The company is subject to SEC regulations for public filings, including the requirement to submit a Form 10-K annually.

What Investors Should Do

1. Analyze the financial statements within the 10-K for revenue, expenses, and cash flow.
2. Review the 'Risk Factors' section for potential challenges and uncertainties.
3. Examine the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' for insights into business performance.

Key Dates

• 2023-12-31: Fiscal Year End — Defines the reporting period for the 10-K.
• 2024-03-08: 10-K Filing Date — Official date the annual report was submitted to the SEC.

Year-Over-Year Comparison

This is the initial filing snippet for the 2023 10-K; a comparison to the previous year's filing would require additional data.

Key Financial Figures

• $1.7 billion — ent which achieved peak annual sales of $1.7 billion prior to patent expiration. Osteoporo
• $25.3 billion — lion by 2025, resulting in an estimated $25.3 billion in costs each year. Worldwide, osteopor

Filing Documents

• zk2431054.htm (10-K) — 2261KB
• exhibit_10-10.htm (EX-10.10) — 15KB
• exhibit_10-11.htm (EX-10.11) — 88KB
• exhibit_10-12.htm (EX-10.12) — 169KB
• exhibit_21-1.htm (EX-21.1) — 3KB
• exhibit_23-1.htm (EX-23.1) — 4KB
• exhibit_31-1.htm (EX-31) — 14KB
• exhibit_31-2.htm (EX-31.2) — 14KB
• exhibit_32-1.htm (EX-32.1) — 5KB
• exhibit_32-2.htm (EX-32.2) — 5KB
• exhibit_97.htm (EX-97.0) — 83KB
• image00011.jpg (GRAPHIC) — 41KB
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• ex1015101.jpg (GRAPHIC) — 4KB
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• ex1015104.jpg (GRAPHIC) — 28KB
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• ex1015107.jpg (GRAPHIC) — 2KB
• 0001178913-24-000881.txt (&nbsp;) — 9462KB
• entx-20231231.xsd (EX-101.SCH) — 64KB
• entx-20231231_cal.xml (EX-101.CAL) — 36KB
• entx-20231231_def.xml (EX-101.DEF) — 150KB
• entx-20231231_lab.xml (EX-101.LAB) — 827KB
• entx-20231231_pre.xml (EX-101.PRE) — 292KB
• zk2431054_htm.xml (XML) — 1047KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 35 Item 1B. Unresolved Staff Comments 75 Item 1C. Cybersecurity 75 Item 2.

Properties

Properties 75 Item 3.

Legal Proceedings

Legal Proceedings 75 Item 4. Mine Safety Disclosures 75 PART II 76 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 76 Item 6. [Reserved] 76 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 85 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 86 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 112 Item 9A.

Controls and Procedures

Controls and Procedures 112 Item 9B. Other Information 112 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 112 PART III 113 Item 10. Directors, Executive Officers and Corporate Governance 113 Item 11.

Executive Compensation

Executive Compensation 121 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 130 Item 13. Certain Relationships and Related Transactions, and Director Independence 132 Item 14. Principal Accounting Fees and Services 133 PART IV 134 Item 15. Exhibits, Financial Statement Schedules 134 Item 16 Form 10-K Summary 135 3 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report") contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 ("PSLRA"), Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Various statements in this report are "forward-looking statements" within the meaning of the PSLRA and other U.S. Federal securities laws. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not be different, and historic results referred to in this Annual Report may be interpreted differently in light of additional research and clinical and preclinical trial results. Forward-looking statements include all statements that are not historical facts. We have based these forward-looking statements largely on our management's current expectations and future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are subject to risks and uncertainties and are based on information currently ava

BUSINESS

ITEM 1. BUSINESS Overview Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm. Currently, most protein therapies are administered via frequent intravenous, subcutaneous or intramuscular injections. In chronic diseases where patients require persistent management, these cumbersome, often painful and high-priced injections can create a major treatment gap. From a technical standpoint, oral delivery of therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream due to the protein's polarity and molecular weight. We leverage our N-Tab oral delivery technology, which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream. 6 Pipeline The following chart summarizes the current stage of development for each of our oral peptide candidates. Oral PTH(1-34) Programs Our 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 with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). Following the completion of a Type C and a Type D meeting with the U.S. Food and Drug Administration's (FDA), we announced the FDA's concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application ("NDA") for EB613. In November 2023, we reported that the American Society for Bone and

View Full Filing

View this 10-K filing on SEC EDGAR