Overview
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- TickerENTX on Nasdaq1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersL31
- Incorporated inIsrael2
- Business addressKiryat Hadassah, Minrav Building, Fifth Floor, Jerusalem, 91120022
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. We concentrate on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue1¢$42.0K
- Research and development93¢$6.0M
- Selling, general and admin6¢$398.0K
Out of $42.0K in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| REVENUES | $42.0K | $181.0K |
| COST OF REVENUES | $42.0K | $172.0K |
| GROSS PROFIT | $0 | $9.0K |
| Research and development, net | $6.0M | $4.5M |
| General and administrative | $5.5M | $5.1M |
| TOTAL OPERATING EXPENSES | $11.5M | $9.6M |
| OPERATING LOSS | $11.5M | $9.6M |
| FINANCIAL INCOME, NET | -$90.0K | -$58.0K |
| LOSS BEFORE INCOME TAX | $11.4M | $9.5M |
| INCOME TAX EXPENSES | $0 | $14.0K |
| NET LOSS | $11.4M | $9.5M |
| LOSS PER SHARE BASIC | $0.25 | $0.25 |
| LOSS PER SHARE DILUTED | $0.25 | $0.25 |
| WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC LOSS PER SHARE | 46.2M shares | 37.7M shares |
| WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF DILUTED LOSS PER SHARE | 46.2M shares | 37.7M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $7.1M | $8.7M | |
| Accounts receivable | $0 | $126.0K | |
| Restricted cash | $7.8M | $0 | |
| Other current assets | $415.0K | $186.0K | |
| TOTAL CURRENT ASSETS | $15.3M | $9.0M | |
| Property and equipment, net | $134.0K | $57.0K | |
| Operating lease right-of-use assets | $465.0K | $275.0K | |
| Restricted deposit | $90.0K | $80.0K | |
| Funds in respect of employee rights upon retirement | $6.0K | $6.0K | |
| TOTAL NON-CURRENT ASSETS | $695.0K | $418.0K | |
| TOTAL ASSETS | $16.0M | $9.4M | |
| Accounts payable | $448.0K | $132.0K | |
| Accrued expenses and other payables | $1.5M | $874.0K | |
| Current maturities of operating lease | $230.0K | $170.0K | |
| TOTAL CURRENT LIABILITIES | $2.2M | $1.2M | |
| Operating lease liabilities | $260.0K | $102.0K | |
| Other long-term liability | $393.0K | $0 | |
| Liability for employee rights upon retirement | $36.0K | $32.0K | |
| TOTAL NON-CURRENT LIABILITIES | $689.0K | $134.0K | |
| TOTAL LIABILITIES | $2.9M | $1.3M | |
| Ordinary Shares, NIS 0.0000769 par value: Authorized - as of December 31, 2025 and December 31, 2024, 140,010,000 shares; issued and outstanding as of December 31, 2025, and December 31, 2024, 46,178,630 and 38,837,220 shares, respectively | $1.0K | $1.0K | |
| Additional paid-in capital | $138.4M | $122.0M | |
| Accumulated other comprehensive income | $41.0K | $41.0K | |
| Accumulated deficit | -$125.4M | -$113.9M | |
| TOTAL SHAREHOLDERS' EQUITY | $13.1M | $8.1M | $10.4M |
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | $16.0M | $9.4M | |
| Ordinary share, par value | 0.00 ILS | 0.00 ILS | |
| Ordinary shares, authorized | 140.0M shares | 140.0M shares | |
| Ordinary shares, issued | 46.2M shares | 38.8M shares | |
| Ordinary shares, outstanding | 46.2M shares | 38.8M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $7.1M | $8.7M | |
| Accounts receivable | $0 | $126.0K | |
| Restricted cash | $7.8M | $0 | |
| Other current assets | $415.0K | $186.0K | |
| TOTAL CURRENT ASSETS | $15.3M | $9.0M | |
| Property and equipment, net | $134.0K | $57.0K | |
| Operating lease right-of-use assets | $465.0K | $275.0K | |
| Restricted deposit | $90.0K | $80.0K | |
| Funds in respect of employee rights upon retirement | $6.0K | $6.0K | |
| TOTAL NON-CURRENT ASSETS | $695.0K | $418.0K | |
| TOTAL ASSETS | $16.0M | $9.4M | |
| Accounts payable | $448.0K | $132.0K | |
| Accrued expenses and other payables | $1.5M | $874.0K | |
| Current maturities of operating lease | $230.0K | $170.0K | |
| TOTAL CURRENT LIABILITIES | $2.2M | $1.2M | |
| Operating lease liabilities | $260.0K | $102.0K | |
| Other long-term liability | $393.0K | $0 | |
| Liability for employee rights upon retirement | $36.0K | $32.0K | |
| TOTAL NON-CURRENT LIABILITIES | $689.0K | $134.0K | |
| TOTAL LIABILITIES | $2.9M | $1.3M | |
| Ordinary Shares, NIS 0.0000769 par value: Authorized - as of December 31, 2025 and December 31, 2024, 140,010,000 shares; issued and outstanding as of December 31, 2025, and December 31, 2024, 46,178,630 and 38,837,220 shares, respectively | $1.0K | $1.0K | |
| Additional paid-in capital | $138.4M | $122.0M | |
| Accumulated other comprehensive income | $41.0K | $41.0K | |
| Accumulated deficit | -$125.4M | -$113.9M | |
| TOTAL SHAREHOLDERS' EQUITY | $13.1M | $8.1M | $10.4M |
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | $16.0M | $9.4M | |
| Ordinary share, par value | 0.00 ILS | 0.00 ILS | |
| Ordinary shares, authorized | 140.0M shares | 140.0M shares | |
| Ordinary shares, issued | 46.2M shares | 38.8M shares | |
| Ordinary shares, outstanding | 46.2M shares | 38.8M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Income (Loss) | -$11.4M | -$9.5M |
| Depreciation | $30.0K | $46.0K |
| Deferred income taxes | $0 | $14.0K |
| Share-based compensation | $2.8M | $2.6M |
| Finance income, net | $32.0K | -$5.0K |
| Decrease (increase) in accounts receivable | $126.0K | -$126.0K |
| Increase in other current assets | -$229.0K | -$14.0K |
| Increase in accounts payable | $316.0K | $49.0K |
| Increase in accrued expenses and other payables and other long-term liability | $1.0M | $203.0K |
| Net cash used in operating activities | -$7.4M | -$6.8M |
| Purchase of property and equipment | -$107.0K | -$3.0K |
| Net cash used in investing activities | -$107.0K | -$3.0K |
| Proceeds from ordinary issuance of shares through ATM programs | $6.3M | $4.0M |
| Issuance of ordinary shares, under collaboration agreement | $7.2M | $0 |
| Issuance costs | -$262.0K | -$323.0K |
| Exercise of warrants into ordinary shares | $508.0K | $90.0K |
| Exercise of options into ordinary shares | $20.0K | $749.0K |
| Net cash provided by financing activities | $13.7M | $4.5M |
| EFFECT OF EXCHANGE RATE CHANGE ON CASH AND CASH EQUIVALENTS | $36.0K | $0 |
| INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS | $6.2M | -$2.3M |
| Interest received | $180.0K | $68.0K |
| Operating lease right of use assets obtained in exchange for operating lease liabilities | $386.0K | $32.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Entera Bio Ltd. sits at the top of its group. 1 entity on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Entera Bio Ltd.
- BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13D on Entera Bio Ltd., latest Aug 4, 2026
- Longitude Capital Partners V, LLC Filed SCHEDULE 13G on Entera Bio Ltd., latest Aug 4, 2026
- Seven Fleet Capital Management LP Filed SCHEDULE 13G on Entera Bio Ltd., latest Aug 4, 2026
- TCG Crossover GP III, LLC Filed SCHEDULE 13G on Entera Bio Ltd., latest Aug 4, 2026
- Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G on Entera Bio Ltd., latest Aug 4, 2026
- Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Entera Bio Ltd., latest Nov 14, 2025 (2 filings since Jan 6, 2025)
- Opko Health Inc. Filed SCHEDULE 13G on Entera Bio Ltd., latest Apr 2, 2025
- Knoll Capital Management, LLC Filed SC 13G/A on Entera Bio Ltd., latest Nov 20, 2024 (2 filings since Jan 16, 2024)
- CENTILLION FUND INC. Filed SC 13G/A on Entera Bio Ltd., latest Aug 20, 2024 (5 filings since Nov 10, 2022)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Entera Bio Ltd., latest Feb 14, 2023
- Capital Point Ltd. Filed SC 13G/A on Entera Bio Ltd., latest Feb 14, 2022
- Entera Bio Ltd. L3
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Entera Bio Ltd. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $134.0K5 Dec 31, 2025 | $57.0K5 Dec 31, 2024 | +135.1% |
| Operating-lease assets (leased space) | $465.0K5 Dec 31, 2025 | $275.0K5 Dec 31, 2024 | +69.1% |
Investments
Properties, in its own words
Our facilities in Israel, which house our research and development and certain production and management functions, are in Jerusalem, Israel. Most of our clinical development, clinical operations and regulatory functions are located in the United States. Under a lease agreement with Unihead Biopark Ltd., we lease approximately 622 square meters of office and laboratory space. This lease has a term that extends through 2028.The average rent over the current term is $180,000 per year.
We believe that our current office and laboratory space in Israel is sufficient to meet our anticipated needs for the foreseeable future and is suitable for the conduct of our business. We believe that suitable additional space would be available if required in the future on commercially reasonable terms.
Item 2 of the 10-K filed Mar 27, 2026.4
Leadership
Who has led Entera Bio Ltd., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerSpiros Jamas Jan 20, 2022 to Jan 24, 202213
- Chief executive officerMiranda Jayne Toledano Sep 9, 2022 to now14
- Chief financial officerRamesh Ratan Jan 14, 2022 to Jan 24, 202215
- Chief financial officerDana Yaacov-Garbeli Feb 8, 2022 to now16
- Chief operating officerHillel Galitzer Jan 14, 2022 to now17
Board members and other officers (14)
- Chief Medical OfficerRiccardo Paolo Camisasca Aug 21, 2026 to now18
- Chief Business OfficerLeslie Velka Gautam May 20, 2025 to now19
- Chief of R&DGregory Burshtein Jun 7, 2024 to now20
- Chief Medical OfficerArthur C. Santora Ii. Jan 14, 2022 to Apr 25, 202321
- Board memberGeno J. Germano Feb 9, 2026 to now22
- Board memberHaya Taitel Aug 24, 2023 to now23
- Board memberGerald M. Lieberman Jan 11, 2022 to now24
- Board memberMiranda Jayne Toledano Jan 11, 2022 to now25
- Board memberRoger Garceau Jan 11, 2022 to Jan 3, 202426
- Board memberRon Mayron Jan 11, 2022 to Jan 3, 202427
- Board memberGerald M. Ostrov Jan 13, 2022 to now28
- Board memberSean Ellis Jan 14, 2022 to now29
- Board memberYonatan Malca Jan 14, 2022 to now30
- Board memberSpiros Jamas Jan 20, 2022 to Jan 20, 202213
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorSteven D. Rubin named Aug 12, 202631
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Entera Bio Inc. Delaware3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Oct 6, 20268-K Executive or director change; Regulation FD disclosure32
- Aug 18, 20268-K Regulation FD disclosure; Other events33
- Aug 7, 20268-K Results of operations; Regulation FD disclosure34
- Jul 28, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change35
- Jul 16, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote36
- May 8, 20268-K Results of operations; Regulation FD disclosure37
- Apr 3, 20268-K Entered a material agreement; Unregistered sale of shares38
- Mar 27, 20268-K Results of operations; Regulation FD disclosure39
- Mar 4, 20268-K Regulation FD disclosure40
- Feb 9, 20268-K Executive or director change; Regulation FD disclosure41
- Feb 4, 20268-K Entered a material agreement; Executive or director change; Regulation FD disclosure42
- Nov 14, 20258-K Results of operations; Regulation FD disclosure43
- Sep 9, 2022New chief executive Miranda Jayne Toledano becomes CEO14
- Jan 20, 2022New chief executive Spiros Jamas becomes CEO13
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.07) a share, on Nov 14, 2025.44
When it reported results
- Aug 7, 2026Reported quarterly or annual results34
- May 8, 2026Reported quarterly or annual results37
- Mar 27, 2026Reported quarterly or annual results39
- Nov 14, 2025Reported quarterly or annual results43
- Aug 8, 2025Reported quarterly or annual results45
- May 9, 2025Reported quarterly or annual results46
- Mar 28, 2025Reported quarterly or annual results47
- Nov 8, 2024Reported quarterly or annual results48
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
279 filings to the SEC since October 2021: 6 annual reports, 14 quarterly reports, 50 major events, 126 insider forms, 17 large holders, 2 private raises, 64 other. The latest 20:
- Oct 14, 2026DEF 14A EDGAR
- Oct 6, 20268-K EDGAR
- Sep 23, 2026PRE 14A EDGAR
- Aug 28, 2026EFFECT EDGAR
- Aug 28, 2026424B3 EDGAR
- Aug 21, 2026S-3 EDGAR
- Aug 21, 20263 EDGAR
- Aug 18, 20268-K EDGAR
- Aug 12, 2026D EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 2026S-8 EDGAR
- Aug 7, 202610-Q EDGAR
The 279 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
32 open-market trades by officers, directors and large owners since October 2021: 32 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Mar 9, 2026 | Germano Geno JDirector | Buy | 20,000 | $1.30 | $26.0K | Form 4 |
| Mar 5, 2026 | Ellis SeanDirector | Buy | 10,000 | $1.23 | $12.3K | Form 4 |
| Feb 12, 2026 | Rubin Steven DDirector | Buy | 5,000 | $1.49 | $7.5K | Form 4 |
| Feb 10, 2026 | Taitel HayaDirector | Buy | 7,500 | $1.48 | $11.1K | Form 4 |
| Feb 10, 2026 | Germano Geno JDirector | Buy | 20,000 | $1.49 | $29.8K | Form 4 |
| Feb 9, 2026 | Rubin Steven DDirector | Buy | 10,000 | $1.20 | $12.0K | Form 4 |
| Feb 9, 2026 | Ellis SeanDirector | Buy | 18,000 | $1.24 | $22.3K | Form 4 |
| Dec 29, 2025 | Toledano Miranda JayneChief Executive Officer | Buy | 11,000 | $1.81 | $19.9K | Form 4 |
| Jan 12, 2024 | Taitel HayaDirector | Buy | 9,500 | $0.99 | $9.4K | Form 4 |
| Jan 10, 2024 | Taitel HayaDirector | Buy | 7,615 | $0.77 | $5.9K | Form 4 |
| Dec 22, 2023 | LIEBERMAN GERALD MDirector | Buy | 23,952 | $0.71 | $17.0K | Form 4 |
| Dec 22, 2023 | Toledano Miranda JayneChief Executive Officer | Buy | 23,952 | $0.71 | $17.0K | Form 4 |
| Aug 22, 2023 | Taitel HayaDirector | Buy | 18,000 | $0.62 | $11.2K | Form 4 |
| Aug 21, 2023 | LIEBERMAN GERALD MDirector | Buy | 20,000 | $0.59 | $11.8K | Form 4 |
| Aug 21, 2023 | Ellis SeanDirector | Buy | 40,000 | $0.60 | $24.0K | Form 4 |
| Apr 4, 2023 | Toledano Miranda JayneChief Executive Officer | Buy | 30,000 | $1.01 | $30.3K | Form 4 |
| Nov 14, 2022 | Yaacov-Garbeli DanaChief Financial Officer | Buy | 26,580 | $0.54 | $14.4K | Form 4 |
| Nov 14, 2022 | LIEBERMAN GERALD MDirector | Buy | 50,000 | $0.57 | $28.5K | Form 4 |
| Nov 11, 2022 | Yaacov-Garbeli DanaChief Financial Officer | Buy | 30,000 | $0.52 | $15.6K | Form 4 |
| Nov 11, 2022 | Ellis SeanDirector | Buy | 30,000 | $0.53 | $15.9K | Form 4 |
All 32 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- BIOTECHNOLOGY VALUE FUND L PSCHEDULE 13D, 1 filing Aug 4, 202649
- Longitude Capital Partners V, LLCSCHEDULE 13G, 1 filing Aug 4, 202650
- Seven Fleet Capital Management LPSCHEDULE 13G, 1 filing Aug 4, 202651
- TCG Crossover GP III, LLCSCHEDULE 13G, 1 filing Aug 4, 202652
- Vivo Opportunity Fund Holdings, L.P.SCHEDULE 13G, 1 filing Aug 4, 202653
- Point72 Asset Management, L.P.SCHEDULE 13G/A, 2 filings Jan 6, 2025 to Nov 14, 202554
- Opko Health Inc.SCHEDULE 13G, 1 filing Apr 2, 202555
- Knoll Capital Management, LLCSC 13G/A, 2 filings Jan 16, 2024 to Nov 20, 202456
- CENTILLION FUND INC.SC 13G/A, 5 filings Nov 10, 2022 to Aug 20, 202457
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 1 filing Feb 14, 202358
- Capital Point Ltd.SC 13G/A, 1 filing Feb 14, 202259
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Miranda Toledano | $490 | $1.5K60 | |
| 2025 | Hillel Galitzer | $282 | $53160 | |
| 2025 | Gregory Burshtein | $217 | $50460 | |
| 2024 | Chief Executive Officer and director | $419 | $1.1K60 | |
| 2024 | Chief Operating Officer | $259 | $53160 | |
| 2024 | Chief of Research and Development | $172 | $33760 |
Money raised
Private offerings the company reported to the SEC on Form D.
SEC filer profile
How Entera Bio Ltd. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGAREntera Bio Ltd.1
- CIK0001638097
- Employer ID (EIN)00-00000004
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inIsrael4
- Fiscal year endsDecember 311
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business addressKiryat Hadassah, Minrav Building, Fifth Floor, Jerusalem, 9112002, Israel1
- Phone972-2-532-71511
- Shares outstanding173,141,831 as of Aug 3, 202612
- Public float$84.6M as of Jun 30, 20254
- AuditorKesselman & Kesselman, Tel-Aviv, Israel PCAOB ID 1309; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceMay 1, 20151
- Filings416 in all: 4 (101), 6-K (72), 8-K (49), 3 (20), CORRESP (19), SC 13G/A (17), UPLOAD (15), 10-Q (14)1
All 41 form types
SC 13G (10), EFFECT (9), F-1/A (7), 424B3 (6), DEF 14A (6), PRE 14A (6), S-3 (6), S-8 (6), SCHEDULE 13G (6), 10-K (5), ARS (4), D (4), 20-F (3), 3/A (3), 424B5 (3), DEFA14A (3), DRSLTR (3), 4/A (2), DRS/A (2), F-3 (2), 10-K/A (1), 20-F/A (1), 25-NSE/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), F-1 (1), PRER14A (1), S-3/A (1), SCHEDULE 13D (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 27, 2026
Quarterly report (10-Q) Aug 7, 2026
Proxy statement (DEF 14A) Oct 14, 2026
Latest 8-K (8-K) Oct 6, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Ordinary shares | ENTX | Nasdaq |
From the cover page of the 10-K filed Mar 27, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Entera Bio Ltd. names in Item 1A of its 10-K filed Mar 27, 2026: 67 risks under these headings, as written.4
- Any investment in our securities involves a high degree of risk. You should consider carefully the following factors and all other information contained in this Annual Report before you make a decision to invest in our Ordinary Shares. If any of the negative events referred to below occur, our business, prospects, financial condition and results of operations could be materially and adversely affected. In any such case, the trading price of our Ordinary Shares could decline, and you could lose all or part of your investment.
- Risks Related to Our Financial Position
- We have incurred significant losses since our inception and anticipate that we will continue to incur substantial losses for the next several years.
- Management has performed an analysis of our ability to continue as a going concern. In addition, our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern.
- Due to our limited resources and access to capital, we must and have in the past decided to prioritize development of certain product candidates; these decisions may prove to have been wrong and may adversely affect our current and any potential future revenues.
- We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, reduce or cease our product development activities and operations.
- We have a limited operating history and no history of late stage clinical studies and commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability and making an investment in our Ordinary Shares unsuitable for many investors.
- Raising additional capital may cause dilution to our shareholders, and these financings, or disputes with shareholders in connection therewith, may restrict our operations or require us to relinquish substantial rights or result in unanticipated legal or other costs.
- The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business, particularly after we are no longer a non-accelerated filer.
- Risks Related to Our Business and the Development of Our Product Candidates
- All of our product candidates are in preclinical or clinical development and we have not yet successfully completed the development of any product candidates.
- We depend on enrollment of patients in our clinical trials for our product candidates. If we are unable to enroll an adequate number of volunteers or patients in our clinical trials, our research and development efforts could be materially adversely affected.
The other 57 risks
- We may not be successful in our efforts to use and expand our N-Tab® platform, to other product candidates.
- If serious adverse, undesirable or unacceptable side effects are identified during the development of our product candidates, marketing approval may be delayed or we may need to abandon our development of such product candidates, and if such side effects are identified following regulatory approval, any approved product label may be limited or we may be subject to other significant negative consequences.
- We manage our business and develop our technology with a small number of employees and key advisors with deep functional domain expertise, and, in the event of their loss or unavailability, we may not be able to grow our business or develop and commercialize our products.
- We expect to grow our organization to supplement and expand our senior management, clinical development and regulatory capabilities and marketing infrastructure, and we may experience difficulties in managing these changes and this growth, which could disrupt our operations.
- We are increasingly dependent on information technology systems, infrastructure and data, and our internal computer systems, or those of our collaborators, third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- We are subject to risks related to restrictive data privacy regulations governing the collection, use, processing and cross-border transfer of personal information.
- Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
- Risks Related to Regulatory Approval of Our Product Candidates
- Clinical drug development is expensive, time consuming and uncertain. Development programs are subject to regulatory requirements, unanticipated delays and we may ultimately not be able to obtain regulatory approvals for the commercialization of our product candidates.
- The commencement and completion of clinical trials can be delayed or prevented for a number of reasons.
- The results of previous clinical trials may not be predictive of future results, our progress in trials for one product candidate may not be indicative of progress in trials for other product candidates, and our trials may not be designed so as to support regulatory approval.
- Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation. If we fail to comply with applicable current and future laws and government regulations, it could delay or prevent the promotion, marketing or sale of our products.
- Healthcare legislative changes may harm our business and future prospects.
- Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
- Risks Related to Commercialization of Our Product Candidates
- We are likely to face significant competition, and if our competitors’ products are more effective, safer or less expensive than ours, our commercial opportunities will be negatively affected. Our lead product candidates, if approved, would compete with existing products.
- We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products.
- We currently have no sales, marketing or distribution infrastructure. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of our products. If we enter into collaborations to market and sell any approved products, our revenue may be lower and we will be dependent on the efforts of a third party.
- Even if approved, if any of our product candidates do not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, our revenue generated from their sales will be limited.
- Even if we obtain regulatory approval of any of our product candidates in a major pharmaceutical market such as the United States or the EU, we may never obtain approval or commercialize our products in other major markets, which would limit our ability to realize their full market potential.
- The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and third-party payors establish adequate coverage and reimbursement levels and pricing policies.
- We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage; and our product liability insurance may not cover all damages from such claims.
- Risks Related to Our Dependence on Third Parties
- We are highly dependent upon our ability to enter into agreements with collaborators to develop, commercialize and market our products.
- We may not be able to secure and maintain research institutions to conduct our clinical trials.
- Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success.
- We contract with third parties for the supply of materials used in drug formulation for clinical testing and expect to contract with third parties for the manufacturing of our product candidates for large-scale testing. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
- Risks Related to Our Intellectual Property
- If we fail to establish, maintain, defend and enforce intellectual property rights with respect to our technology, our business, prospects, financial condition and results of operations may be materially adversely affected.
- We may become involved in proceedings to protect or enforce our proprietary rights, which could be expensive and time consuming, and may ultimately be unsuccessful.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. We may face claims that we are violating the intellectual property rights of others.
- We may not be able to protect and enforce our intellectual property rights throughout the world.
- Changes in U.S. patent law could diminish the value of our future patents, if issued, thereby impairing our ability to protect our product candidates.
- Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our Ordinary Shares to decline.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Under applicable employment laws, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees. In addition, our Israeli employees may be entitled to seek compensation for their inventions irrespective of their contractual agreements with us.
- We may not be able to protect the confidentiality of our technology, which, if disseminated, could negatively impact our plan of operations.
- We may be subject to claims by third parties asserting that we or our employees, consultants or contractors have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- If trademarks and trade names related to our product candidates are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- Risks Related to Our Ordinary Shares
- The price of our Ordinary Shares may be volatile, and holders of our Ordinary Shares could lose all or part of their investment.
- We do not know whether a market for our Ordinary Shares will be sustained and as a result, it may be difficult for holders of our Ordinary Shares to sell their securities.
- Our stock price may continue to be volatile, and securities class action litigation has often been instituted against companies following periods of volatility of their stock price. Any such litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.
- Future sales by our shareholders may adversely affect our stock price and our ability to raise funds in new stock offerings.
- The market price of our Ordinary Shares could be negatively affected by future sales of our securities.
- We have never paid, and we currently do not intend to pay dividends.
- We may not have sufficient insurance to cover our liability in any current or future litigation claims either due to coverage limits or as a result of insurance carriers seeking to deny coverage of such claims.
- There is a risk that we may be a passive foreign investment company, for U.S. federal income tax purposes for any taxable year, which generally would result in certain adverse U.S. federal income tax consequences to our U.S. investors.
- We are a smaller reporting company and non-accelerated filer, and our compliance with the reduced reporting and disclosure requirements applicable to smaller reporting companies and non-accelerated filers could make our Ordinary Shares less attractive to investors and may make it more difficult to raise capital as and when we need it.
- Our Ordinary Shares may be delisted from the Nasdaq Capital Market if we are unable to maintain compliance with Nasdaq’s continued listing standards.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our Ordinary Shares.
- If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, our share price and trading volume could decline.
- Risks Relating to Our Incorporation and Location in Israel
- The Israeli government grants we have received for research and development expenditures restrict our ability to manufacture products and transfer technologies outside of Israel and require us to satisfy specified conditions. If we fail to satisfy these conditions, we may be required to refund grants previously received together with interest and penalties or to pay other amounts according to the formulas set out in the relevant laws.
- Legislative developments in Israel may have an adverse effect on the Company’s business.
- Security, political and economic instability in the Middle East may harm our business.
- Our operations may be disrupted by the obligations of personnel to perform military service.
- It may be difficult to enforce a U.S. judgment against us or our officers and directors, to assert U.S. securities laws claims in Israel or to serve process on our officers and directors.
- Provisions of Israeli law and our Articles may give rise to withholding obligations or delay, prevent or make difficult a change of control and therefore depress the price of our shares.
- Your rights and responsibilities as a shareholder are governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. companies.
- Our business could be negatively affected as a result of actions of activist shareholders, and such activism could impact the trading value of our securities.
Legal proceedings
We are not currently a party to any material legal proceedings.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGAREntera Bio Ltd. filings on SEC EDGAR
- 2SEC EDGAREntera Bio Ltd. filings on SEC EDGAR
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- 5SEC EDGAREntera Bio Ltd. 10-K for fiscal 2025
- 6SEC EDGAREntera Bio Ltd. 10-K for fiscal 2019
- 7SEC EDGAREntera Bio Ltd. 10-K for fiscal 2020
- 8SEC EDGAREntera Bio Ltd. 10-K for fiscal 2021
- 9SEC EDGAREntera Bio Ltd. 10-K for fiscal 2022
- 10SEC EDGAREntera Bio Ltd. 10-K for fiscal 2023
- 11SEC EDGAREntera Bio Ltd. 10-Q for fiscal 2026
- 12SEC EDGAREntera Bio Ltd. 10-Q for fiscal 2026
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- 20SEC EDGARGregory Burshtein, Chief of R&D
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- 22SEC EDGARGeno J. Germano, Board member
- 23SEC EDGARHaya Taitel, Board member
- 24SEC EDGARGerald M. Lieberman, Board member
- 25SEC EDGARMiranda Jayne Toledano, Board member
- 26SEC EDGARRoger Garceau, Board member
- 27SEC EDGARRon Mayron, Board member
- 28SEC EDGARGerald M. Ostrov, Board member
- 29SEC EDGARSean Ellis, Board member
- 30SEC EDGARYonatan Malca, Board member
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- 40SEC EDGARRegulation FD disclosure
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- 44NasdaqNasdaq calendar
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