Entera Bio nine-month net loss widens to $26.4M
Following the July financing's close, BVF gained rights to designate two board nominees, subject to ownership thresholds and other conditions.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Entera Bio Ltd. reported no revenue for the nine months ended September 30, 2026, and a $26.4 million net loss, compared with an $8.4 million net loss a year earlier. Research and development expenses were $10.4 million, up from $4.3 million, primarily reflecting EB613 Phase 3 preparation and collaboration programs.
A July private placement generated approximately $275.0 million gross and $260.9 million net. As of September 30, cash, cash equivalents and restricted cash were $272.4 million. Management expects current resources to fund planned operations into 2030, based on its current operating plan. The company intends to use the placement proceeds primarily for EB613 Phase 3 activities, EB612 development, working capital and general corporate purposes.
Entera presented a planned EB613 Phase 3 study expected to enroll approximately 900 postmenopausal women, randomized 2:1 to EB613 or placebo. Participants completing 12 months may enroll in a planned extension through Month 24. The company is preparing to open the study in late 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major point. Forward-looking: it has not happened yet and may not happen.Management expects cash to fund planned operations into 2030.
Negative
- Moderate pointNine-month net loss increased 214%, including a $10.3 million noncash warrant remeasurement loss. 2% of market cap
Filing Explained
The completed placement diluted existing holders through issued shares; a further 11,842,695 shares remained conditional on warrant exercise at September 30, 2026.
Entera completed its July 28 private placement, issuing 122,961,215 ordinary shares and pre-funded warrants for 11,842,695 more shares; it reported 173,922,428 ordinary shares outstanding at
The issued shares increase the share count and reduce existing holders’ percentage ownership; the additional warrant shares had not been issued because none of the pre-funded warrants had been exercised by
The July pre-funded warrants were immediately exercisable at
Separately, 11,741,683 April 2026 ordinary-share warrants became exercisable on
A non-cash
Key Figures
Key Terms
Pre-Funded Warrants financial
505(b)(2) application regulatory
surrogate efficacy endpoint regulatory
IND-enabling studies medical
at-the-market offering financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What securities did ENTX issue in its July 2026 private placement?
What is the primary endpoint for ENTX's EB613 Phase 3 trial?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
ACT OF 1934
For the quarterly period ended
OR
ACT OF 1934
For the transition period from ____________ to ____________
Commission File Number:
(Exact name of Registrant as specified in its charter)
| Not applicable | ||
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
|
|
||
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | ||
|
NIS 0.0000769 per share |
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
Yes ☐ No
As of November 2, 2026, the registrant had
Table of Contents
| Page | ||
| CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS | 1 | |
| PART I – FINANCIAL INFORMATION | 3 | |
| Item 1. | Financial Statements | 3 |
| Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 (unaudited) | 5 | |
| Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2026 and 2025 (unaudited) | 6 | |
| Condensed Consolidated Statement of Changes in Shareholders’ Equity for the three and nine months ended September 30, 2026 and 2025 (unaudited) | 7 | |
| Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 (unaudited) | 8 | |
| Notes to Condensed Consolidated Financial Statements (unaudited) | 9 | |
| Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 20 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 33 |
| Item 4. | Controls and Procedures | 33 |
| PART II – OTHER INFORMATION | 34 | |
| Item 1. | Legal Proceedings | 34 |
| Item 1A. | Risk Factors | 34 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 36 |
| Item 3. | Defaults Upon Senior Securities | 36 |
| Item 4. | Mine Safety Disclosures | 36 |
| Item 5. | Other Information | 36 |
| Item 6. | Exhibits | 36 |
| SIGNATURES | 37 | |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Quarterly 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 Quarterly 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 Quarterly 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 Quarterly 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 available to our management. Words including, but not limited to, “anticipate,” “believe,” “contemplates,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “likely,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “will,” “would,” “seek,” “should,” “target,” or the negative of these terms and similar expressions or words, identify forward-looking statements. The events and circumstances reflected in our forward-looking statements may not occur and actual results could differ materially from those projected in our forward-looking statements. These factors include those described in “Part II, Item 1A-Risk Factors” of this Quarterly Report and in “Part I, Item 1A-Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”). Meaningful factors that could cause actual results to differ from those expressed in forward-looking statements include, but are not limited to:
· | Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates; |
| · | The regulatory approval processes of the U.S. Food and Drug Administration (“FDA”) and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed; |
| · | Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all; |
| · | Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed or in later stage trials; |
| · | The scope, progress and costs of developing our product candidates such as EB613 for osteoporosis and EB612 for hypoparathyroidism or other oral peptides for the treatment of obesity, metabolic disorders (EB618) and gastrointestinal rare diseases may alter over time based on various factors such as regulatory requirements, collaboration agreements, the competitive environment and new data from pre-clinical and clinical studies; |
| · | 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; |
| · | We rely on third-party contract manufacturers for clinical trial supplies of our product candidates; |
| · | The accuracy of our estimates regarding expenses, capital requirements, the sufficiency of our cash resources and the need for additional financing; |
| · | Our ability to raise additional funds or consummate strategic partnerships to offset additional required capital to pursue our business objectives, which may not be available on acceptable terms or at all. A failure to obtain this additional capital when needed, or failure to consummate strategic partnerships, could delay, limit or reduce our product development, and other operations; |
| · | Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success; |
| · | 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; |
1
| · | Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue; |
| · | If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected; |
| · | Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain; |
| · | Our reliance on third parties to conduct our clinical trials and on third-party suppliers to supply or produce our product candidates; |
| · | Our interpretation of FDA feedback and guidance and how such guidance may impact our clinical development plan; |
| · | Our ability to use and expand our N-Tab® platform to additional product candidates; |
| · | Our operation as a development stage company with limited operating history and a history of operating losses and our ability to fund our operations going forward; |
| · | Our competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome and other rare gastrointestinal disorders, obesity, metabolic and inflammatory conditions and other disease categories we pursue; |
| · | Our ability to establish and maintain development and commercialization collaborations; |
| · | Our ability to manufacture and supply enough material to support our clinical trials and any potential future commercial requirements; |
| · | The size of any market we may target and the adoption of our product candidates, if approved, by physicians and patients; |
| · | Our ability to obtain, maintain and protect our intellectual property and operate our business without infringing, misappropriating, or otherwise violating any intellectual property rights of others; |
| · | Our ability to retain key personnel and recruit additional qualified personnel; |
| · | Our ability to comply with laws and regulations that currently apply or become applicable to our business; |
| · | Our ability to manage growth; and |
| · | The Israel-Hamas conflict, that has been ongoing since October 2023, including involvement from Hezbollah, Iran and its proxies in the Middle East, such as the Houthis in Yemen and militias in Iraq and Syria, as well as the hostilities between the United States, Israel and Iran, and their impact on our operations and workforce, remains unknown. |
All forward-looking statements contained in this Quarterly Report are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely heavily on the forward-looking statements we make. Except as required by applicable law, we are under no duty, and expressly disclaim any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult all further disclosures we make in each annual, quarterly or current report that we file with the Securities and Exchange Commission (“SEC”).
We encourage you to read Part II, Item 1A of this Quarterly Report and Part I, Item 1A of our 2025 Annual Report, each entitled “Risk Factors,” and Part I, Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity, Capital Resources and Cash Requirements” of this Quarterly Report for additional discussion of the risks and uncertainties associated with our business. There can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
2
PART I.
ITEM 1. FINANCIAL STATEMENTS
ENTERA BIO LTD.
UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS OF SEPTEMBER 30, 2026
3
TABLE OF CONTENTS
| Page | |
| CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | |
| Condensed Consolidated Balance Sheets (unaudited) | 5 |
| Condensed Consolidated Statements of Operations (unaudited) | 6 |
| Condensed Consolidated Statements of Changes in Shareholders' Equity (unaudited) | 7 |
| Condensed Consolidated Statements of Cash Flows (unaudited) | 8 |
| Notes to the Condensed Consolidated Financial Statements (unaudited) | 9 |
4
ENTERA BIO LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
| Assets | September 30, | December 31, | ||||||
| 2026 | 2025 | |||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | ||||||||
| Restricted cash | ||||||||
| Other current assets | ||||||||
| TOTAL CURRENT ASSETS | ||||||||
| NON-CURRENT ASSETS: | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Restricted deposit | ||||||||
| Funds in respect of employee rights upon retirement | ||||||||
| TOTAL NON-CURRENT ASSETS | ||||||||
| TOTAL ASSETS | ||||||||
| Liabilities and shareholders' equity | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | ||||||||
| Accrued expenses and other payables | ||||||||
| Current maturities of operating lease liabilities | ||||||||
| TOTAL CURRENT LIABILITIES | ||||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Operating lease liabilities | ||||||||
| Other long-term liabilities | ||||||||
| Liability for employee rights upon retirement | ||||||||
| TOTAL NON-CURRENT LIABILITIES | ||||||||
| TOTAL LIABILITIES | ||||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares, NIS |
||||||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive income | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| TOTAL SHAREHOLDERS' EQUITY | ||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
5
ENTERA BIO LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
|
Nine Months Ended September 30, |
Three Months Ended September 30, |
|||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| REVENUES | ||||||||||||||||
| COST OF REVENUES | ||||||||||||||||
| GROSS PROFIT | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development, net | ||||||||||||||||
| General and administrative | ||||||||||||||||
| TOTAL OPERATING EXPENSES | ||||||||||||||||
| OPERATING LOSS | ||||||||||||||||
| FINANCIAL EXPENSES (INCOME), NET | ( |
) | ( |
) | ||||||||||||
| NET LOSS | ||||||||||||||||
| LOSS PER SHARE BASIC AND DILUTED | ||||||||||||||||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | ||||||||||||||||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
6
ENTERA BIO LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
| Ordinary shares | ||||||||||||||||||||||||
| Number of shares issued | Amounts | Additional paid-in capital | Accumulated other Comprehensive income | Accumulated deficit | Total | |||||||||||||||||||
| BALANCE AT JANUARY 1, 2026 | ( |
) | ||||||||||||||||||||||
| Net loss | - | ( |
) | ( |
) | |||||||||||||||||||
| Exercise of options to Ordinary Shares | * | |||||||||||||||||||||||
| Exercise of 2023 warrants and pre-funded warrants | * | |||||||||||||||||||||||
| Issuance of Ordinary Shares and warrants, net of issuance costs | 4 | |||||||||||||||||||||||
| Reclassification of pre-funded warrants to equity | - | |||||||||||||||||||||||
| Vested restricted share units | * | - | * | |||||||||||||||||||||
| Settlement in shares of board members compensation (see note 4) | ||||||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2026 | ( |
) | ||||||||||||||||||||||
| BALANCE AT JULY 1, 2026 | ( |
) | ||||||||||||||||||||||
| Net loss | - | ( |
) | ( |
) | |||||||||||||||||||
| Exercise of options to Ordinary Shares | * | |||||||||||||||||||||||
| Exercise of 2023 warrants and pre-funded warrants | * | |||||||||||||||||||||||
| Issuance of Ordinary Shares, net of issuance costs | 4 | |||||||||||||||||||||||
| Reclassification of pre-funded warrants to equity | - | |||||||||||||||||||||||
| Vested restricted share units |
* |
* | ||||||||||||||||||||||
| Settlement in shares of board members compensation (see note 4) | ||||||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2026 | ( |
) | ||||||||||||||||||||||
| BALANCE AT JANUARY 1, 2025 | ( |
) | ||||||||||||||||||||||
| Net loss | - | ( |
) | ( |
) | |||||||||||||||||||
| Exercise of warrants to Ordinary Shares | * | |||||||||||||||||||||||
| Exercise of options to Ordinary Shares | * | |||||||||||||||||||||||
| Issuance of Ordinary Shares under collaboration agreement, net | * | |||||||||||||||||||||||
| Issuance of Ordinary Shares under ATM program, net of issuance costs | * | |||||||||||||||||||||||
| Vested restricted share units | * | * | * | |||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2025 | ( |
) | ||||||||||||||||||||||
| BALANCE AT JULY 1, 2025 | ( |
) | ||||||||||||||||||||||
| Net loss | - | ( |
) | ( |
) | |||||||||||||||||||
| Exercise of warrants to Ordinary Shares | * | |||||||||||||||||||||||
| Exercise of options to Ordinary Shares | * | |||||||||||||||||||||||
| Issuance of Ordinary Shares under ATM program, net of issuance costs | * | |||||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2025 | ( |
) | ||||||||||||||||||||||
* Represents an amount less than one thousand U.S. dollars.
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
7
ENTERA BIO LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
|
Nine months ended September 30, |
||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | 2026 | 2025 | ||||||
| Net loss | ( |
) | ( |
) | ||||
| Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Share-based compensation | ||||||||
| Other finance expenses (income), net | ( |
) | ||||||
| Changes in fair value of pre-funded warrants classified as liability | ||||||||
| Issuance cost allocated to pre-funded warrants | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in other current assets | ( |
) | ( |
) | ||||
| Decrease in accounts receivable | ||||||||
| Increase (decrease) in accounts payable | ( |
) | ||||||
| Increase in accrued expenses and other payables and other long-term liabilities | ||||||||
| Net cash used in operating activities | ( |
) | ( |
) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Purchase of property and equipment | ( |
) | ( |
) | ||||
| Net cash used in investing activities | ( |
) | ( |
) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from issuance of Ordinary Shares, warrants and pre-funded warrants | ||||||||
| Proceeds from issuance of Ordinary Shares under ATM program | ||||||||
| Issuance costs | ( |
) | ( |
) | ||||
| Issuance of Ordinary Shares, under collaboration agreement | ||||||||
| Exercise of warrants and options to Ordinary Shares | ||||||||
| Net cash provided by financing activities | ||||||||
| INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS | ||||||||
| EFFECT OF EXCHANGE RATE CHANGE ON CASH AND CASH EQUIVALENTS | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS AT BEGINNING OF THE PERIOD | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS AT END OF THE PERIOD | ||||||||
| Reconciliation in amounts on consolidated balance sheets: | ||||||||
| Cash and cash equivalents | ||||||||
| Restricted cash and deposits | ||||||||
| Total cash and cash equivalents and restricted cash and deposit | ||||||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS: | ||||||||
| Interest received | ||||||||
| SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||||||||
| Reclassification of pre-funded warrants liability to equity | ||||||||
| Operating lease right-of-use assets obtained in exchange for new operating lease liabilities | ||||||||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
8
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 1 - DESCRIPTION OF BUSINESS
| a. | Entera Bio Ltd. (collectively with its subsidiary, the "Company" or “Entera”) 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 peptides. 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) tablet treatment for post-menopausal women with osteoporosis. In February 2026, the Company submitted to the U.S. Food and Drug Administration (the “FDA”) a clinical amendment which included the EB613 Phase 3 protocol, statistical analysis plan and open-label extension synopsis. In June 2026, the Company received feedback from the FDA on the submitted Phase 3 registrational plan for EB613.
The Company’s second product candidate, EB612, is being developed as the first oral acylated PTH(1-34) protein replacement tablet for patients with hypoparathyroidism. In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 6) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (“OPKO”), to advance this program jointly. Currently, the Company is advancing EB612 through IND-enabling studies and plans to initiate a Phase 1 Single Ascending Dose (SAD) study in 2027.
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 potential once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders.
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 |
| c. | The Company has incurred recurring operating losses and negative cash flows from operations since inception and expects to continue to incur operating losses as it advances the development of its product candidates. As of September 30, 2026, the Company has incurred an accumulated deficit in the amount of $ |
As described in Note 3b, on July 28, 2026, the Company completed a private placement financing (the "July 2026 Private Placement") of an aggregate of
9
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Based on the Company's current operating plan, management believes that its existing cash and cash equivalents will be sufficient to fund its planned operations for at least twelve months from the date of issuance of these unaudited condensed consolidated financial statements.
| d. | Since October 2023, Israel has been involved in an armed conflict with Hamas, which has expanded to include hostilities involving Hezbollah, Iran and other armed groups in the region. During 2026, military activity escalated, including direct military exchanges involving Israel, Iran and the United States, as well as renewed hostilities along Israel's northern border. A ceasefire between the United States and Iran that was formalized in June 2026 subsequently broke down, and hostilities between the United States and Iran resumed beginning in late June 2026. Although ceasefire arrangements have been announced from time to time, the regional security situation remains uncertain, and there can be no assurance that hostilities will not continue or further escalate. |
The Company's research personnel and certain members of management are located in Israel, while its clinical, regulatory and supply chain activities are primarily conducted outside Israel. As of September 30, 2026, the Company's operations have remained largely unaffected by these events. For the nine months ended September 30, 2026 and 2025, and for the year ended December 31, 2025, the impact of these events on the Company's results of operations and financial condition was not material.
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
| a. | Basis of presentation of the financial statements |
These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of September 30, 2026, the consolidated results of operations and statements of changes in shareholders' equity for the three and nine months ended September 30, 2026 and 2025, and cash flows for the nine months ended September 30, 2026 and 2025.
The consolidated results of operations for the three and nine months ended September 30, 2026, are not necessarily indicative of the results to be expected for the year ending December 31, 2026.
These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company as of and for the year ended December 31, 2025, as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 27, 2026.
10
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
| b. | Loss per share |
Basic loss per share is computed on the basis of net loss for the period divided by the weighted average number of outstanding ordinary shares, equity classified pre-funded warrants and vested restricted share units (“RSUs”) during the period. Each outstanding pre-funded warrant has no expiration and is exercisable at an exercise price of $
Diluted loss per share is based upon the weighted average number of ordinary shares and ordinary share equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options, liability classified pre-funded warrants, warrants and RSUs, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share did not include options, liability classified pre-funded warrants, warrants and RSUs exercisable into
| c. | Fair value |
The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows:
| Level 1: | Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
| Level 2: | Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. |
| Level 3: | Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
11
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
| d. | Newly issued and recently adopted accounting pronouncements: |
Recently issued accounting pronouncements not yet adopted
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
In December 2025, the FASB issued ASU 2025-10 “Government Grants (Topic 832)” to establish authoritative guidance on the accounting for government grants received by business entities. This update is effective beginning with the Company’s 2029 fiscal year annual reporting period, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements.
NOTE 3 - ISSUANCE OF ORDINARY SHARES, PRE-FUNDED WARRANTS AND WARRANTS
| a. | April 2026 Private Placement |
On April 1, 2026, the Company entered into a securities purchase agreement with certain funds affiliated with BVF Partners L.P. (collectively, “BVF”), providing for the private placement to BVF of an aggregate of
Each 2026 Ordinary Share Warrant has an exercise price of $
The April 2026 Pre-Funded Warrants were originally issued with an exercise price of NIS
12
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
The proceeds of the 2026 Private Placement were allocated first to the April 2026 Pre-Funded Warrants based on their fair value as of the closing date of $
The Company had issuance costs of approximately $
Through August 21, 2026, the pre-funded warrants liability was measured at fair value on a recurring basis based on the quoted price of the Company’s ordinary shares (Level 2) based on the Company's share's market price less the nominal exercise price.
The fair value of the April 2026 Pre-Funded Warrants was $
| b. | July 2026 Private Placement |
On July 26, 2026, in connection with the July 2026 Private Placement, the Company entered into a securities purchase agreement (the “July 2026 Purchase Agreement”) with certain institutional and accredited investors, including BVF, providing for the issuance and sale of an aggregate of
The July 2026 Pre-Funded Warrants were originally issued with an exercise price of NIS
The proceeds of the July 2026 Private Placement were allocated first to the July 2026 Pre-Funded Warrants based on their fair value as of the closing date of $
The fair value of the July 2026 Pre-Funded Warrants as of August 21, 2026, was approximately $
13
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Effective upon the closing of the July 2026 Private Placement, the Company granted BVF certain rights to designate two nominees to the Company’s board of directors, subject to specified ownership thresholds and other conditions. In connection with the July 2026 Private Placement, the Company also agreed to submit to its shareholders an increase in the number of ordinary shares reserved under the 2018 Equity Incentive Plan (the “2018 Plan”) and certain equity awards to executive officers.
| c. | Amendment of the April 2026 and July 2026 Pre-Funded Warrants |
On August 21, 2026, the Company and BVF, the holder of all outstanding April 2026 and July 2026 Pre-Funded Warrants, amended the terms of such pre-funded warrants to change the exercise price from NIS
Through August 21, 2026, the pre-funded warrant liability was measured at fair value on a recurring basis based on the quoted price of the Company’s ordinary shares (Level 2).
The following table presents the changes in the pre-funded warrants liability (Level 2):
| April 2026 | July 2026 | Total | ||||||||||
| U.S. dollars in thousands | ||||||||||||
| Balance as of January 1, 2026 | ||||||||||||
| Initial recognition at fair value | ||||||||||||
| Change in fair value recognized in statement of operations | ( |
) | ||||||||||
| Reclassification to additional paid-in capital | ( |
) | ( |
) | ( |
) | ||||||
| Balance as of September 30, 2026 | ||||||||||||
14
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 4 - EQUITY AND SHARE-BASED COMPENSATION
Changes in Share Capital:
| a. | On January 1, 2026, the Company issued |
| b. | In February and April 2026, two former non-executive board members exercised options for an aggregate of |
| c. | On July 14, 2026, the Company’s shareholders approved an increase in the Company’s authorized share capital to |
| d. | On August 7, 2026, the Company issued |
| e. | During the nine months ended September 30, 2026, certain holders of warrants issued in the Company’s December 2023 private placement exercised an aggregate of |
Share-based Compensation:
| a. | The following tables summarizes option activity during the nine months ended September 30, 2026: |
|
Nine months ended September 30, 2026 |
||||||||
|
Number of options |
Weighted average exercise price | |||||||
| Outstanding at beginning of the period |
$ | |||||||
| Granted | ||||||||
| Exercised | ( |
) | ||||||
| Forfeited | ( |
) | ||||||
| Expired | ( |
) | ||||||
| Outstanding at end of the period | $ | |||||||
| Exercisable at end of the period | $ | |||||||
15
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 4 - EQUITY AND SHARE-BASED COMPENSATION (Cont.)
Share-based Compensation (Cont.):
|
Three months ended September 30, 2026 |
||||||||
|
Number of options |
Weighted average exercise price | |||||||
| Outstanding at beginning of the period |
$ | |||||||
| Granted | ||||||||
| Exercised | ( |
) | ||||||
| Forfeited | ( |
) | ||||||
| Outstanding at end of the period | $ | |||||||
| Exercisable at end of the period |
$ |
|||||||
| b. | The fair value of each option granted was estimated as of the date of grant using the Black-Scholes option-pricing model, using the following assumptions: |
|
Nine months ended September 30, 2026 |
|||
| Exercise price |
$ |
||
| Dividend yield | |||
| Expected volatility |
|
||
| Risk-free interest rate |
|
||
| Expected life - in years |
|
| c. | On May 7, 2026, the board of directors approved the grant of |
16
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 4 - EQUITY AND SHARE-BASED COMPENSATION (Cont.)
Share-based Compensation (Cont.):
| d. |
In connection with the transactions contemplated by the July 2026 Private Placement, on September 16, 2026, the Company's Board of Directors approved one-time equity awards to the Company's Chief Executive Officer, Chief Financial Officer, Chief Operating Officer and Chief of Research and Development, consisting of
These equity awards are subject to shareholder approval at the Company's Special Meeting of Shareholders scheduled for November 24, 2026. |
| e. | Restricted shares units grants to employees and consultants: |
The following tables summarize information concerning RSUs:
| Nine Months Ended September 30, 2026 | Three Months Ended September 30, 2026 | |||||||||||||||
| Number of RSU | Weighted Average Grant Date Fair Value | Number of RSU | Weighted Average Grant Date Fair Value | |||||||||||||
| Outstanding at beginning of period | ||||||||||||||||
| Changes during the period: | - | |||||||||||||||
| Granted | ||||||||||||||||
| Vested | ( |
) | ( |
) | ||||||||||||
| Outstanding at end of period | ||||||||||||||||
17
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Balance sheets:
| September 30, | December 31, | |||||||
| Other current assets: | 2026 | 2025 | ||||||
| Prepaid expenses | ||||||||
| Receivable in respect of collaborative arrangement | ||||||||
| VAT receivable | ||||||||
| Other | ||||||||
| September 30, | December 31, | |||||||
| Accrued expenses and other payables: | 2026 | 2025 | ||||||
| Employees and employees related | ||||||||
| Provision for vacation | ||||||||
| Payables in respect of collaborative arrangement | ||||||||
| Accrued expenses | ||||||||
| Other payables (See Note 6) | ||||||||
NOTE 6 - COLLABORATION AND RESEARCH AGREEMENTS
On March 16, 2025, the Company entered into a collaboration agreement with OPKO (the “2025 Collaboration Agreement”), which is accounted for as a collaboration arrangement within the scope of ASC 808.
Under the terms of the 2025 Collaboration Agreement, the
On February 3, 2026, the Company and OPKO amended and restated the 2025 Collaboration Agreement (the “A&R Collaboration Agreement”) to expand the scope of the collaboration to include the EB612 Program. Development costs and proceeds related to the EB612 Program are shared equally between the parties. Except for the foregoing expansion, the material terms of the 2025 Collaboration Agreement remain unchanged.
For the three and nine months ended September 30, 2026, the Company recognized net expenses of $
18
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
| a. | The Company is legally headquartered, and the Company’s laboratories are located, in Israel as a single operating segment. |
| b. | Segment information: |
|
Nine Months Ended September 30, |
Three Months Ended September 30, |
|||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues | $ | |||||||||||||||
| Less: | ||||||||||||||||
| Research and development, net: | ||||||||||||||||
| Clinical trial, sub-contractors and consulting expense (EB613) | $ | $ | $ | $ | ||||||||||||
| Net expenses related to OPKO Collaboration Agreement | ||||||||||||||||
| Payroll and related expenses | ||||||||||||||||
| Share-based compensation | ||||||||||||||||
| Rent and related expenses | ||||||||||||||||
| Other development expenses | ||||||||||||||||
| Other segment expenses* | ||||||||||||||||
| Segment net loss | $ | $ | $ | $ | ||||||||||||
* Other segment expenses mainly related to general and administrative expenses, including payroll and related expenses, share-based compensation, legal and audit fees and others, and to financial expenses (income), net, including changes in the fair value of the pre-funded warrants liability.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis provides information we believe is relevant to an assessment and understanding of our results of operations, financial condition, liquidity and cash flows for the periods presented below. This discussion should be read in conjunction with the interim unaudited condensed consolidated financial statements and related notes contained elsewhere in this Quarterly Report, Part II, Item 1A-Risk Factors in this Quarterly Report, and Part I, Item 1A-Risk Factors in our 2025 Annual Report. As discussed in the section above titled “Cautionary Note Regarding Forward-Looking Statements,” the following discussion contains forward-looking statements that are based upon our current expectations, including with respect to our future operations, revenues and operating results. Our actual results may differ materially from those anticipated in such forward-looking statements as a result of various factors. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included under Part II, Item 1A below, as well as in Part I, Item 1A-Risk Factors in our 2025 Annual Report. Unless otherwise provided, references to the “Company,” “we,” “us” and “our” refer to Entera Bio Ltd. and its consolidated subsidiary.
Business Overview
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs. We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm. Our pipeline includes first-in-class oral PTH(1-34), GLP-1/Glucagon and GLP-2 agonists in tablet form, with indications across women centric endocrine conditions and metabolic and inflammatory disorders.
Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections. In chronic progressive conditions, these cumbersome, often painful and high-priced injections limit adherence, access and can create a major treatment gap.
From a technical standpoint, the development of orally available peptides is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream. We leverage our N-Tab® platform, which is designed to simultaneously stabilize large (4kD+), linear, hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream.
EB613 Program (Oral PTH(1-34))
Our most advanced product candidate, EB613, oral PTH (1-34), is being developed as the first oral, anabolic (bone building) tablet for osteoporosis. Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in increased susceptibility to fracture. Multiple guidelines recommend anabolic treatment as frontline treatment because of their superiority in rapidly increasing Bone Mineral Density (“BMD”) and lowering fracture risk versus anti-resorptive treatments. The three approved anabolic drugs (Forteo®, Tymlos®, Evenity®) require daily/”in-office” monthly subcutaneous (SC) injections which limits both clinician and patient access and are estimated to be used in a minority of very high-risk patients.
EB613 is intended to provide the first oral anabolic option to patients earlier in their treatment journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality.
EB613 is being developed under a 505(b)(2) application to the listed drug, Forteo® (teriparatide daily SC injection, Eli Lilly), which was first approved by the FDA in 2002 for the treatment of postmenopausal women with osteoporosis at high risk of fracture and later indicated for men with osteoporosis and osteoporosis associated with sustained systemic glucocorticoid therapy. Forteo® has been in clinical use for over 20 years with a well-established benefit-risk profile.
A placebo controlled, dose ranging Phase 2 study of EB613 oral tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). In April 2024, Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. At 6 months of treatment, EB613 2.5mg produced comparable total hip BMD increases as those that have been reported for Forteo® at 6 months.
In October 2026, we reported clinical data from a post-hoc analysis of our Phase 2 trial of EB613 at the ASBMR 2026 Annual Meeting in a poster presentation titled “EB613, Oral PTH(1-34) Tablet, Shows Markedly Enhanced Anabolic Effects in Postmenopausal Women with Osteoporosis at High Risk of Fracture: Insights from Phase 2 Trial”. This exploratory analysis, based on small patient groups, suggests a potentially greater treatment effect of EB613 in women with more severe osteoporosis (T-scores of -2.5 or lower) vs women with osteopenia (T-scores higher than -2.5). Our planned Phase 3 registrational program for EB613 is planned to enroll postmenopausal women with osteoporosis at high risk of fracture (T-scores of -2.5 or lower).
20
Osteoporosis is a major and growing public health issue worldwide. In the United States, osteoporosis results in over two million fractures annually, despite available treatment options. These fractures lead to chronic pain, decreased quality of life, increased disability and premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures in the United States is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely due to the aging population.
Postmenopausal women are at higher risk of developing osteoporosis-related fractures due to primary estrogen deficiency which leads to accelerated bone loss after menopause. After age 50, one in three women and one in five men are estimated to suffer an osteoporosis-related fracture in their remaining lifetime.
Regulatory Background
Initial approvals of new drugs for the treatment of osteoporosis have historically required a placebo-controlled trial demonstrating fracture risk reduction as the primary efficacy endpoint. The fracture endpoint is challenging due to ethical considerations and the very large sample sizes required to evaluate treatment effectiveness. The last drug approval for osteoporosis occurred in 2019.
In the United States, the Foundation for the National Institute of Health-American Society for Bone and Mineral Research-Study to Advance BMD as a Regulatory Endpoint (FNIH-ASBMR-SABRE, previously known as the FNIH-Bone Quality Project [FNIH-BQP], hereinafter “SABRE”) was launched in 2013. Total Hip BMD was qualified by FDA in December 2025 as a surrogate efficacy endpoint to fracture.
Since the end of our Phase 2 Meeting in December 2021, we have engaged with the FDA in various Type C, D, A and other meetings in 2022, 2023, 2024, 2025 and 2026 to obtain clarity and alignment an appropriate data package to support a new drug application (“NDA”) for EB613 under a 505(b)(2) application.
In February 2026, we submitted to the FDA a clinical amendment comprising a streamlined EB613 Phase 3 protocol, statistical analysis plan and extension synopsis. In June 2026, we announced that the FDA accepted our proposed registrational development plan for EB613 and that a randomized, double-blind, placebo-controlled, phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12, may support our NDA. The FDA agreed with our proposal to continue following the randomized patients to 24 months in an extension study and specified that the 120-day safety update should include data up to 18 months. We also plan to submit the complete 2-year data upon completion of the extension study to demonstrate durability of response of EB613 beyond the 12 months.
In addition, as aligned in 2022 and 2023 communications with FDA, to support the NDA under the 505(b)(2) regulatory pathway, the data package will include a scientific bridging analysis with Forteo® (teriparatide SC injection, Eli Lilly) which will be based on a PK exposure analysis with separate population PK and PK sub-studies planned. We also intend to conduct a transiliac crest bone biopsy sub-study in a small subset of patients as part of our registrational plan.
In October 2026, we presented the design of our planned Phase 3 study of EB613 at the ASBMR 2026 Annual Meeting. The study is expected to enroll approximately 900 postmenopausal women with osteoporosis, randomized 2:1 to EB613 (N ~ 600) or placebo (N ~ 300). Eligible participants will include postmenopausal women 50-90 years of age and ≥5 years from the last menstrual period with osteoporosis diagnosed by DXA with BMD T-score ≤-2.5 at either lumbar spine, total hip, or femoral neck. Participants completing 12 months of treatment in the registrational study will be eligible to enroll in the planned extension study through Month 24. We are currently preparing to open the Phase 3 study for EB613 in late 2026.
EB612 Program (Oral Acylated PTH(1-34))
Our product candidate, EB612, is being developed as the first oral acylated PTH(1-34) peptide replacement therapy in tablet form for patients with hypoparathyroidism.
This program is being developed as part of our February 2026 expanded collaboration with OPKO Biologics, Inc. (“OPKO Biologics”), a subsidiary of OPKO Health, Inc. (“OPKO”). Under the collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the EB612 program, and each is responsible for 50% of development costs.
21
In June 2026, at ENDO 2026, we presented preclinical data for EB612 from three animal models — a thyroparathyroidectomized (TPTx) rat model, a minipig model and a non-human primate model — showing sustained increases in serum calcium consistent with clinically validated injectable PTH-replacement therapies for hypoparathyroidism.
We are currently conducting IND enabling studies for EB612. We intend to initiate a PK Phase 1 Single Ascending Dose (SAD) phase 1 study with EB612 in 2027.
EB618 Program (Oral GLP-1/Glucagon)
In September 2023, we entered into a collaboration agreement with OPKO Biologics (the “2023 Collaboration Agreement”) to develop the first oral dual agonist GLP-1/Glucagon (OXM) peptide as a tablet for patients with obesity and metabolic disorders. Oxyntomodulin (OXM) is a hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life. Currently, there are no approved dual GLP-1/Glucagon agonists available.
In June 2026, at ENDO 2026, we presented preclinical data for EB618 from a single-dose pharmacokinetic-pharmacodynamic study in non-human primates, showing dose-proportional systemic exposure across three tablet strengths, a dose-proportional pharmacologic effect on postprandial blood glucose.
OPKO is conducting a single ascending dose (SAD) Phase 1 clinical study with a weekly subcutaneous injection of the OXM peptide. We plan to determine next steps of the clinical development plan for EB618 based on the outcomes of that study.
For additional information regarding our collaboration agreements with OPKO, see Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Patent Transfer, Licensing Agreements and Grant Funding—OPKO Collaboration and License Agreements, contained in this Quarterly Report.
Oral GLP-2
This program focuses on developing the first GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption. Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of SBS patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives.
In connection with the 2023 Collaboration Agreement, we and OPKO completed proof-of-concept pharmacokinetic studies in rodents and minipigs. Oral GLP-2 tablets exhibited significant systemic exposure with plasma levels about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label).
We are currently exploring potential collaboration and partnering options for this program.
Patent Transfer, Licensing Agreements and Grant Funding
OPKO Collaboration and License Agreements
2023 Collaboration Agreement
In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics. Under the terms of this agreement, OPKO has agreed to supply a proprietary long-acting GLP-2 peptide and certain OXM analogs for the development of oral tablet candidates using our proprietary N-Tab® platform. Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.
2025 Collaboration Agreement
In March 2025, we entered into the 2025 Collaboration Agreement with OPKO and OPKO Biologics to collaborate with respect to the preclinical and clinical development and decision making related to the Oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans (the “Program”).
Under the 2025 Collaboration Agreement, we granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of our intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/Glucagon dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to us a non-exclusive, non-sublicensable and non-transferable license to certain of its intellectual property and technology to the extent necessary for us to perform our obligations in relation to the Program, in each case subject to the exceptions contained therein.
22
Under the terms of the 2025 Collaboration Agreement, we and OPKO retain 40% and 60%, respectively, of all proceeds deriving from the EB618 Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively. Following the completion of the Phase 1 stage, we may continue to fund our 40% share of the Program to maintain our right to proceeds or opt-out (the “Opt-Out”). If we Opt-Out, then we and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program.
In connection with the execution of the 2025 Collaboration Agreement, we issued and sold to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, the proceeds of which we have agreed to use solely to fund our development cost obligations under the 2025 Collaboration Agreement, subject to the expiration or termination of the agreement.
Amended and Restated Collaboration Agreement
In February 2026, we entered into the A&R Collaboration Agreement with OPKO which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of long acting or acylated PTH(1-34) peptides for the treatment of hypoparathyroidism (EB612 Program) . Development costs incurred by the parties and proceeds relating to the EB612 program will be shared equally (50% / 50%) between Entera and OPKO.
Oramed Patent Transfer Agreement
In 2011, we entered into a patent transfer agreement with Oramed Ltd. (“Oramed”), which we refer to as the Patent Transfer Agreement, pursuant to which Oramed assigned to us all of its rights, title and interest in the patent rights Oramed licensed to us when we were 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. Additionally, we agreed not to engage, directly or indirectly, in any activities in the fields of diabetes and influenza that involve the use of, or utilize, the patents underlying the Patent Transfer Agreement. Under the terms of the Patent Transfer Agreement, we agreed to pay Oramed royalties equal to 3% of our net revenues generated, directly or indirectly, from our exploitation of the assigned patent rights, including the sale, lease or transfer of the assigned patent rights or sales of products or services covered by the assigned patent rights. On March 27, 2025, we entered into a Novation Agreement with Oramed, and Oramed NewCo Inc. ("Oramed NewCo") pursuant to which Oramed NewCo replaced Oramed as a party to the Patent Transfer Agreement. Under the Novation Agreement, Oramed NewCo assumed all of Oramed's rights and obligations under the Patent Transfer Agreement accruing on or after the effective date, Oramed was released from any obligations and liabilities owed to us under the Patent Transfer Agreement accruing or arising after such date, and we were released from any obligations and liabilities owed to Oramed accruing or arising after such date. All other provisions of the Patent Transfer Agreement remain in full force and effect.
Israeli Innovation Authority Grants
We have received grants of approximately $0.5 million from the Israeli Innovation Authority (“IIA”) to partially fund our PTH research and development for Osteoporosis. The grants are subject to certain requirements and restrictions under the Israeli Encouragement of Research, Development and Technological Innovation in Industry Law 5477 1984 (the “Research Law”). In general, until the grants are repaid with interest, royalties are payable to the Israeli government in the amount of 3% on revenues derived from sales of products or services developed in whole or in part using the IIA grants. The royalty rate may increase to 5%, with respect to approved applications filed following any year in which we achieve sales of over $70 million.
The amount that must be repaid may be increased up to six times the amount of the grant received and the interest. The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. Moreover, a payment of up to 600% of the grant received may be required upon the transfer of any IIA-related know-how to a non-Israeli entity. We signed a contract with a U.K.-based contract manufacturing organization to produce and supply tablets for trials performed worldwide. We believe that, because this production is not for commercial purposes, it will not affect the royalty rates to be paid to the IIA. Should the IIA successfully take a contrary position, the maximum royalties to be paid to the IIA will be approximately $1.5 million, which is three times the amount of the original grant (plus interest on the entire increased amount). Under a collaboration agreement that was previously mutually terminated in May 2023, from 2019 through March 31, 2023, we recognized an aggregate amount of $1.7 million of revenue in accordance with ASC 606, “Revenues from Contracts with Customers” with respect to revenue generated from the collaboration agreement. Prior to its termination, we had been required to pay to the IIA 5.38% of each payment made to us under such collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest. As of September 30, 2026, we had paid royalties to the IIA in the amount of $96 thousand.
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In addition to paying any royalties due, we must abide by other restrictions associated with receiving such grants under the Research Law that continue to apply following repayment to the IIA.
Recent Developments
Appointment of Chief Medical Officer
On August 18, 2026, we appointed Riccardo Paolo Camisasca, M.D., as our Chief Medical Officer, effective immediately. Dr. Camisasca has more than 30 years of experience spanning clinical development, medical affairs, regulatory strategy and research and development leadership. Most recently, he served as Global Head of Research & Development at Sumitomo Pharma Switzerland, and he previously held clinical development and medical affairs leadership roles at Bial, Syneos Health, Takeda and Novartis.
Appointment and Departure of Directors
Appointment of Directors
On October 6, 2026, our board of directors (the “Board”) appointed Laura Hamill as a Class I director of the Company, effective December 1, 2026, to serve until our 2027 annual general meeting of shareholders and until her successor has been duly elected and qualified. Ms. Hamill will also serve as a member of the audit committee and the corporate governance and nomination committee of the Board, in each case, effective December 1, 2026. Ms. Hamill has more than 35 years of biopharmaceutical commercial leadership experience. Most recently she served as Executive Vice President, Worldwide Commercial Operations at Gilead Sciences, Inc., and before that she held senior commercial leadership roles at Amgen Inc. for nearly two decades.
On October 27, 2026, the Board appointed Juan Camilo Arjona Ferreira, M.D., as a Class II director of the Company, effective December 1, 2026. Dr. Arjona Ferreira will serve as a director until the Company’s 2028 Annual Meeting of Shareholders and until his successor shall have been elected and qualified, or until his earlier death, resignation, retirement, disqualification or removal. Dr. Arjona Ferreira has also been appointed to serve as a member of the compensation committee of the Board, effective December 1, 2026. Dr. Arjona Ferreira is a seasoned physician and pharmaceutical executive and a longtime global advocate for women’s health, with more than 20 years of global clinical development experience. He currently serves as Head of Research & Development and Chief Medical Officer at Organon & Co. (NYSE: OGN), leading Organon’s global research and development organization, which spans early- and late-stage development, global regulatory affairs, pharmacovigilance and safety science, and medical affairs across a diverse portfolio focused on women’s health.
Departure of Directors
On October 6, 2026 and October 27, 2026, Yonatan Malca and Haya Taitel, respectively, notified the Board that he or she will step down as a director, effective December 1, 2026. Mr. Malca’s and Ms. Taitel’s departure are not the result of any disagreement with us on any matter relating to our operations, policies or practices.
Israel-Hamas War and Regional Conflict
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 with 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, following the breakdown of diplomatic efforts and heightened regional tensions, the United States and Israel conducted a series of preemptive strikes targeting Iranian military infrastructure and strategic assets. Immediately thereafter, Iran launched extensive retaliatory ballistic missile and drone attacks against multiple locations across Israel, including central and southern population centers, critical infrastructure facilities and military installations. On March 2, 2026, Hezbollah resumed hostilities, ending the November 2024 ceasefire, by launching projectiles into northern Israel, prompting Israeli airstrikes in Lebanon targeting Hezbollah operatives and assets. Since the outbreak of these hostilities, Israel has implemented nationwide emergency measures, including restrictions on public gatherings and large-scale reserve duty call-ups affecting the civilian workforce.
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In early April 2026, a two-week ceasefire between the United States and Iran was agreed and on April 21, 2026, U.S. President Donald Trump announced that the United States would extend the ceasefire with Iran, to allow Iran's leadership to present a unified proposal for negotiations. On June 17, 2026, the United States and Iran signed a memorandum of understanding formalizing the ceasefire, which ended the U.S. naval blockade of Iranian ports and provided for the reopening of the Strait of Hormuz; however, negotiations subsequently stalled, the ceasefire broke down and, beginning in late June 2026, Iran resumed attacks on commercial vessels and U.S. military facilities in the region. In July 2026, Iran announced the closure of the Strait of Hormuz and the United States reinstated its naval blockade of Iranian ports. Iran has since continued restricting commercial vessel passage through the Strait of Hormuz, declaring that the waterway would remain effectively closed until the blockade is lifted. Since early September 2026, no major attacks on land-based targets have been reported, although Iranian attacks on commercial shipping in and around the Strait of Hormuz intensified in October 2026, and the U.S. naval blockade of Iranian ports remains in effect. Hostilities could resume or escalate at any time. On April 16, 2026, following direct talks between Israeli and Lebanese officials in Washington, D.C., a 10-day cessation of hostilities between Israel and Lebanon was announced, brokered by the United States. On June 26, 2026, Israel, Lebanon and the United States facilitated a framework agreement providing for the disarmament of Hezbollah and a phased withdrawal of Israeli forces from southern Lebanon; however, implementation has been limited. Israeli forces remain stationed in southern Lebanon and Hezbollah has not accepted the terms as binding, stating that its fighters will remain deployed and will respond to any violations. The ceasefire remains fragile, with reports of continued military operations by both sides in southern Lebanon. In August 2026, Iran and Oman entered advanced negotiations on a new shipping arrangement for the Strait of Hormuz; however, Iran has conditioned reopening the waterway on additional demands, including U.S. compensation and the cessation of hostilities, while the United States has similarly demanded compensation from Iran as a precondition for further talks. As of the date of this Quarterly Report, those negotiations remain unresolved and the Strait of Hormuz remains effectively closed to normal commercial traffic.
The Company’s early research and development personnel and certain officers of the Company are located in Israel. The Company’s clinical operations and development team and our supply chain is located outside of Israel. During the three and nine months ended September 30, 2026 and 2025, the impact of these conflicts on the Company’s results of operations and financial condition was immaterial. See Item 1A. “Risk Factors—Security, political and economic instability in the Middle East may harm our business.”
Financial Overview
From our inception through September 30, 2026, we have financed our operations primarily through a combination of public and private equity offerings and the issuance of Ordinary Shares upon the exercise of options and warrants. Through September 30, 2026, we had raised an aggregate of approximately $397.3 million from these sources, including approximately $275.0 million of gross proceeds received in connection with the July 2026 Private Placement (as defined below).
Since inception, we have incurred significant operating losses and negative cash flows from operations as we have devoted substantially all of our resources to the research and development of our product candidates. We expect to incur significant operating losses for the foreseeable future as we advance our clinical development programs. For the three months ended September 30, 2026 and 2025, our operating losses were $7.3 million and $3.3 million, respectively. For the nine months ended September 30, 2026 and 2025, our operating losses were $15.4 million and $8.5 million, respectively.
As of September 30, 2026, we had an accumulated deficit of $151.8 million. Our operating results may increase significantly from period to period depending on, among other things, the timing and progress of our clinical trials, research and development activities, manufacturing activities, regulatory interactions, strategic collaborations and any third-party collaborations into which we may enter.
As of September 30, 2026, we had cash, cash equivalents and restricted cash of $272.4 million, of which $6.5 million has been designated to fund collaboration activities with OPKO under the A&R Collaboration Agreement.
On July 28, 2026, we consummated the July 2026 Private Placement and received aggregate gross proceeds of approximately $275.0 million and aggregate net proceeds of approximately $260.9 million after deducting placement agent fees and other offering expenses. Based on our current operating plan, we believe that our existing cash resources will be sufficient to fund our planned operations into 2030.
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Our estimate regarding the period through which our financial resources will be sufficient to support our operations is based on our current operating plan and assumptions regarding the timing and costs of our development programs and other operating activities. These assumptions are subject to change, and we may use our available capital resources sooner than currently anticipated.
As of September 30, 2026, we had a total of 27 employees based in Israel, the U.S., Switzerland and Canada. In addition, we employ a team of dedicated clinical, non-clinical, statistics, CMC, regulatory and development advisors. Our laboratories are in Jerusalem, Israel.
Revenue
To date, we have not generated any revenue from sales of our products, and we do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and successfully commercialize our products.
Research and Development Expenses
Research and development expenses consist of costs incurred for the development of our N-Tab® platform and our product candidates. We expense both internal and external research and development expenses to operations for the periods in which they are incurred. We mapped the majority of external research and development costs incurred for our product candidates and development programs.
Internal and certain general external research and development expenses that support multiple programs include:
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employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function; |
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costs associated with our research and development platform used across programs, process development, manufacturing, consulting fees and preclinical development for earlier stage programs and new technologies; |
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expenses incurred in operating our laboratories including our small-scale manufacturing facility; and |
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depreciation of research and development equipment, allocated overhead, rent and facilities-related expenses. |
External research and development expenses for our main clinical development programs include:
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expenses incurred under agreements with CROs and investigative sites that conduct our clinical trials; |
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other costs associated with pre-clinical and clinical activities; |
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supply, development and manufacturing costs relating to clinical trial materials; and |
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certain consulting and advisory services related to the program. |
Research and development activities are our primary focus. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase significantly in future periods as we advance our clinical candidates into later stages of clinical development and invest in additional preclinical candidates.
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrolment of patients in clinical trials. For the three months ended September 30, 2026 and 2025, our research and development expenses were $4.9 million and $1.6 million, respectively. For the nine months ended September 30, 2026 and 2025, our research and development expenses were $10.4 million and $4.3 million, respectively. Research and development expenses for the three and nine months ended September 30, 2026 were primarily for the development of the EB613 program, including start-up activities for the registrational Phase 3 study of EB613, and expenses related to our EB612 and EB618 programs in collaboration with OPKO. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:
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the uncertainty of the scope, rate of progress, results and cost of our clinical trials, nonclinical testing and other related activities; |
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the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop; |
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the number and characteristics of product candidates that we pursue; |
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the cost, timing and outcomes of regulatory approvals; |
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the cost and timing of establishing any sales, marketing, and distribution capabilities; and |
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the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder. |
A change in the outcome of any of these variables with respect to the development of EB613, EB612 and EB618 or any other product candidate that we may develop could significantly change the costs and timing associated with the development of any such product candidate. For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrolment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.
Our research and development expenses for the three and nine months ended September 30, 2026 and 2025 are summarized as follows:
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Nine Months Ended September 30, |
Three Months Ended September 30, |
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| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| (In thousands) | ||||||||||||||||
| Clinical trial, sub-contractors and consulting expenses (EB613) |
$ | 5,161 | $ | 1,544 | $ |
2,827 |
$ | 572 | ||||||||
| Net expenses related to OPKO Collaboration Agreement |
1,819 | 190 | 655 | 70 | ||||||||||||
| Payroll and related expenses | 1,546 | 1,184 | 627 | 418 | ||||||||||||
| Share-based compensation | 1,331 | 799 | 641 | 329 | ||||||||||||
| Rent and related expenses | 409 | 344 | 157 | 118 | ||||||||||||
| Other development expenses | 111 | 225 | 18 | 136 | ||||||||||||
| Research and development expenses | $ | 10,377 | $ | 4,286 | $ | 4,925 | $ | 1,643 | ||||||||
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related expenses, share-based compensation and related costs for directors and personnel in executive and finance functions. Other general and administrative expenses include D&O insurance and other insurance, professional fees for legal and accounting services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.
Financial Expenses (Income), Net
Financial expenses (income), net is composed primarily of changes in the fair value of the April 2026 Pre-Funded Warrants and the July 2026 Pre-Funded Warrants, which were classified as a financial liability until their reclassification to equity on August 21, 2026, the portion of offering costs allocated to such pre-funded warrants, interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar. Following the reclassification of the pre-funded warrants to equity, we do not expect to recognize further changes in their fair value, and we expect interest income on the net proceeds of the July 2026 Private Placement to be the primary component of financial expenses (income), net in future periods.
Taxes on Income
We have not generated taxable income since our inception, and, as of September 30, 2026, we had carryforward tax losses of $102.9 million.
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We anticipate that we will be able to carry forward these tax losses indefinitely to future tax years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carryforward tax losses. We provided a full valuation allowance with respect to the deferred tax assets related to these carryforward losses.
The Company’s subsidiary, Entera Bio Inc., is taxed separately under U.S. tax laws. As of September 30, 2026, Entera Bio Inc. had tax loss carryforwards of $0.2 million.
Results of Operations
Comparison of Three Months Ended September 30, 2026 and 2025
| Three Months Ended September 30, |
Increase (Decrease) | |||||||||||||||
| 2026 | 2025 | $ | % | |||||||||||||
| (In thousands, except for percentage information) | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses, net | $ | 4,925 | $ | 1,643 | 3,282 | 200 | % | |||||||||
| General and administrative expenses | $ | 2,340 | $ | 1,613 | 727 | 45 | % | |||||||||
| Operating loss | $ | 7,265 | $ | 3,256 | 4,009 | 123 | % | |||||||||
| Financial expenses (income), net | $ | 8,332 | $ | (56 | ) | 8,388 | (14,978 | )% | ||||||||
| Net loss | $ | 15,597 | $ | 3,200 | 12,397 | 387 | % | |||||||||
Research and Development Expenses
Research and development expenses for the three months ended September 30, 2026 were $4.9 million, as compared to $1.6 million for the three months ended September 30, 2025. The increase in expenses of $3.3 million was primarily attributable to an increase of $2.3 million in costs associated with preparatory and start-up activities for the registrational Phase 3 program of EB613, including clinical drug supply and contract research organization (CRO) activity, an increase of $0.6 million in connection with our collaboration programs with OPKO, mainly for EB612, and an increase of $0.5 million in personnel-related expenses, reflecting the appointment of our Chief Medical Officer, the expansion of our clinical and early development teams and non-cash share-based compensation expenses. These were partially offset by $0.1 million in regulatory expenses.
General and Administrative Expenses
General and administrative expenses for the three months ended September 30, 2026 were $2.3 million, as compared to $1.6 million for the three months ended September 30, 2025. The increase of $0.7 million was primarily due to an increase in non-cash share-based compensation.
Financial Expenses (Income), Net
Financial expenses, net for the three months ended September 30, 2026 were $8.3 million, as compared to financial income, net of $56 thousand for the three months ended September 30, 2025. The change was primarily driven by (i) a non-cash loss of $7.5 million resulting from the remeasurement to fair value of the April 2026 and July 2026 Pre-Funded Warrants through August 21, 2026, the date on which they were reclassified to equity, and (ii) $2.1 million of offering costs related to the April and July 2026 Private Placement allocated to the Pre-Funded Warrants and expensed as incurred. These were partially offset by interest income of $1.3 million.
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Comparison of Nine Months Ended September 30, 2026 and 2025
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Nine Months Ended |
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| 2026 | 2025 | $ | % | |||||||||||||
| (In thousands, except for percentage information) | ||||||||||||||||
| Revenues | $ | - | $ | 42 | (42 | ) | (100 | )% | ||||||||
| Cost of Revenues | $ | - | $ | 42 | (42 | ) | (100 | )% | ||||||||
| Gross Profit | $ | - | $ | - | $ | - | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses, net | $ | 10,377 | $ | 4,286 | 6,091 | 142 | % | |||||||||
| General and administrative expenses | $ | 4,990 | $ | 4,201 | 789 | 19 | % | |||||||||
| Operating loss | $ | 15,367 | $ | 8,487 | 6,880 | 81 | % | |||||||||
| Financial expenses (income), net | $ | 11,047 | $ | (64 | ) | 11,111 | (17,360 | )% | ||||||||
| Net loss | $ | 26,414 | $ | 8,423 | 17,991 | 214 | % | |||||||||
Revenues
Revenues for the nine months ended September 30, 2025 were $42 thousand, which were attributable to research services we provided pursuant to a research services agreement with an external party. The Company completed its obligations under the research services agreement in the first quarter of 2025. We did not recognize any revenue for the nine months ended September 30, 2026.
Cost of Revenues
Cost of revenues for the nine months ended September 30, 2025 were $42 thousand, which was attributable to research services we provided pursuant to a research services agreement with an external party. For the nine months ended September 30, 2026, we did not recognize any cost of revenues.
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2026 were $10.4 million, as compared to $4.3 million for the nine months ended September 30, 2025. The increase in expenses of $6.1 million was mainly attributable to an increase of $3.6 million in costs associated with preparatory and start-up activities for the registrational Phase 3 program of EB613, including clinical drug supply and contract research organization (CRO) activity and related to our Phase 1 safety and PK bridging study for the Next Generation of EB613, an increase of $1.6 million in connection with our collaboration programs with OPKO for EB612 and EB618 and an increase of $0.9 million in personnel-related expenses, reflecting the appointment of our Chief Medical Officer, the expansion of our clinical and early development teams and non-cash share-based compensation expenses.
General and Administrative Expenses
General and administrative expenses for the nine months ended September 30, 2026 were $5.0 million, as compared to $4.2 million for the nine months ended September 30, 2025. The increase was primarily due to an increase of $0.9 million in non-cash share-based compensation. This increase was partially offset by a decrease of $0.1 million in legal fees and other expenses.
Financial Expenses (Income), Net
Financial expenses, net for the nine months ended September 30, 2026 were $11.0 million, as compared to financial income, net of $64 thousand for the nine months ended September 30, 2025. The change was primarily driven by (i) a non-cash loss of $10.3 million from the remeasurement to fair value of the April 2026 and July 2026 Pre-Funded Warrants until their reclassification to equity on August 21, 2026, (ii) $2.1 million of offering costs related to the April and July 2026 Private Placements allocated to the Pre-Funded Warrants and expensed as incurred and (iii) exchange rate differences. These were partially offset by interest income of $1.4 million.
Liquidity, Capital Resources and Cash Requirements
Since our inception and through September 30, 2026, we have financed our operations primarily through a combination of public and private equity offerings, IIA grants and the issuance of Ordinary Shares upon the exercise of options and warrants. Through September 30, 2026, we had raised an aggregate of approximately $397.3 million from these sources, including the issuance of $36.4 million of Ordinary Shares through at-the-market-offering (“ATM”) programs and approximately $285.0 million of gross proceeds received in connection with the April and July 2026 Private Placements.
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As of September 30, 2026, we had cash and cash equivalents and restricted cash of $272.4 million, of which $6.5 million has been designated to fund our obligations under the A&R Collaboration Agreement.
Since inception, we have incurred significant operating losses and negative cash flows from operations as we have devoted substantially all of our resources to the research and development of our product candidates. We expect to incur significant operating losses for the foreseeable future as we advance our clinical development programs.
As previously disclosed, on July 28, 2026, we consummated the July 2026 Private Placement, which significantly strengthened our financial position and liquidity, providing us with the capital to execute our current operating plan, including our Phase 3 registrational program for EB613, the advancement of EB612 and our other development activities, and supporting our expected operations into 2030.
We intend to use the net proceeds from the July 2026 Private Placement primarily to fund our planned Phase 3 registrational program for EB613 in postmenopausal women with osteoporosis, including activities through the anticipated submission of an NDA, to advance EB612 in collaboration with OPKO, and for working capital and other general corporate purposes.
For the three months ended September 30, 2026 and 2025, our operating losses were $7.3 million and $3.3 million, respectively. For the nine months ended September 30, 2026 and 2025, our operating losses were $15.4 million and $8.5 million, respectively. As of September 30, 2026, we had an accumulated deficit of $151.8 million. We expect our operating expenses to increase significantly as we advance our planned Phase 3 registrational program for EB613, continue the development of EB612 and support our other research and development and general management activities. Based on our current operating plan, we believe that our existing cash resources will be sufficient to fund our planned operations into 2030.
Our estimate regarding the period through which our financial resources will be sufficient to support our operations is based on our current operating plan and assumptions regarding the timing and costs of our development programs and other operating activities. These assumptions are subject to change, and we may use our available capital resources sooner than currently anticipated.
Equity Offerings
On September 2, 2022, we entered into a Sales Agreement with Leerink Partners LLC (f/k/a SVB Securities LLC), as sales agent, to implement an ATM program (the “Leerink ATM Program”) under which we were originally able to sell up to 5,000,000 Ordinary Shares in an at-the-market offering registered under the Securities Act. The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as reimbursement of expenses. As of September 30, 2026, we had sold 4,940,156 Ordinary Shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs. We currently have the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program under our currently effective Registration Statement on Form S-3.
On December 20, 2023, we entered into a securities purchase agreement with certain investors, providing for the private placement (the “December 2023 Private Placement”) of an aggregate of 7,916,879 units, each consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “2023 Pre-Funded Warrants”)) and (ii) one warrant to purchase one Ordinary Share (the “2023 Ordinary Share Warrant”), for aggregate proceeds of approximately $6.6 million. The December 2023 Private Placement was priced at the market under applicable Nasdaq rules and closed on December 22, 2023.
Each 2023 Ordinary Share Warrant has an exercise price of $1.00 per share and expires five years from the date of issuance.
In connection with our entering into the 2025 Collaboration Agreement with OPKO, we 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 such agreement. We have agreed to use the proceeds from the issuance of such Ordinary Shares solely to fund our development cost obligations under the A&R Collaboration Agreement.
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April 2026 Private Placement
On April 1, 2026, we entered into a securities purchase agreement with certain funds affiliated with BVF Partners L.P. (collectively, “BVF”), providing for the private placement (the “April 2026 Private Placement”) to BVF of an aggregate of 7,827,789 units (the “2026 Units”), each 2026 Unit consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “April 2026 Pre-Funded Warrants”)) and (ii) one warrant to purchase one and one-half Ordinary Shares (the “2026 Ordinary Share Warrants”), for aggregate proceeds of approximately $10.0 million (or $1.2775 per 2026 Unit). On April 2, 2026 (the “April 2026 Closing Date”), the Company issued 2,425,000 Ordinary Shares, 5,402,789 April 2026 Pre-Funded Warrants, and 11,741,683 2026 Ordinary Share Warrants in connection with the April 2026 Private Placement.
Each 2026 Ordinary Share Warrant has an exercise price of $1.24 per share, became exercisable on October 2, 2026, six months following the April 2026 Closing Date, expires five years from the date of issuance, and is subject to customary adjustments. The 2026 Ordinary Share Warrants are exercisable only for cash so long as we have an effective registration statement registering the shares underlying the 2026 Ordinary Share Warrants. The April 2026 Pre-Funded Warrants have an exercise price of $0.000025 per share, are immediately exercisable and may be exercised at any time and have no expiration date.
July 2026 Private Placement
On July 26, 2026, we entered into a securities purchase agreement (the “July 2026 Purchase Agreement”) with certain institutional and accredited investors, including funds affiliated with BVF, providing for the private placement (the “July 2026 Private Placement”) of an aggregate of 134,803,910 Ordinary Shares, or, in lieu thereof, pre-funded warrants to purchase Ordinary Shares (the “July 2026 Pre-Funded Warrants”), at a purchase price of $2.04 per Ordinary Share, for aggregate gross proceeds of approximately $275.0 million, before deducting placement agent fees and other related offering expenses. On July 28, 2026 (the “Closing Date”), we issued 122,961,215 Ordinary Shares and July 2026 Pre-Funded Warrants to purchase 11,842,695 Ordinary Shares. Net proceeds from the July 2026 Private Placement were approximately $260.9 million, after deducting placement agent fees of approximately $13.8 million and other offering expenses of approximately $0.3 million.
The July 2026 Pre-Funded Warrants have an exercise price of $0.000025 per Ordinary Share, are immediately exercisable, do not expire and are subject to customary beneficial ownership limitations and adjustments. We intend to use the net proceeds from the July 2026 Private Placement to support activities related to the initiation of our Phase 3 registrational program of EB613 in postmenopausal women with osteoporosis and for general working capital and corporate purposes.
Pursuant to the July 2026 Purchase Agreement, effective upon the closing of the July 2026 Private Placement, we also granted BVF certain rights to designate two nominees to the Company’s board of directors, subject to specified ownership thresholds and other conditions as set forth in the July 2026 Purchase Agreement.
As of September 30, 2026, we have received approximately $1.1 million of net proceeds from the exercise of outstanding 2023 Ordinary Share Warrants, including $0.5 million received during the three months ended September 30, 2026. If all remaining 2023 Ordinary Share Warrants and all 2026 Ordinary Share Warrants were exercised for cash, then the Company would receive additional proceeds of approximately $21.8 million. There can be no assurance that the holders will exercise any of such warrants.
Funding Requirements
Based on our current operating plan, we believe that our existing cash resources will be sufficient to fund our planned operations into 2030.
We expect our operating expenses to increase significantly as we advance our planned Phase 3 registrational program for EB613, continue the development of EB612 and support our other research and development activities. Our current operating plan and expected cash runway into 2030 reflect these anticipated increases in operating expenditures. Our expectations are based on management’s current assumptions, clinical development plans and regulatory submission timelines, which may prove to be wrong, and we could spend our available financial resources much faster than we currently expect.
Although we believe that our existing cash resources are sufficient to execute our current operating plan, we may seek additional capital in the future to support strategic opportunities, expand our pipeline, accelerate the development of our product candidates or pursue other business development initiatives. We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab® platform to additional external parties through partnerships or research collaborations. However, any future financing may not be available on favorable terms, or at all, and any equity financing may result in dilution to our shareholders.
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Other than the Leerink ATM Program, we do not have any committed external sources of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our then-existing shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that may adversely affect our existing shareholders’ rights as shareholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may include requirements to hold minimum levels of funding. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financing or collaborations, when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts.
Cash Flows
Nine Months Ended September 30, 2026 compared to Nine Months Ended September 30, 2025
The following table sets forth the primary sources and uses of cash for each of the periods set forth below:
| Nine Months Ended September 30, (unaudited) |
||||||||
| 2026 | 2025 | |||||||
| (In thousands) | ||||||||
| Net Cash used in operating activities | $ | (13,953 | ) | (5,537 | ) | |||
| Net Cash used in investing activities | (24 | ) | (80 | ) | ||||
| Net Cash provided by financing activities | 271,500 | 13,536 | ||||||
| Effect of Exchange Rate change on cash and cash equivalents | 16 | 29 | ||||||
| Net increase in cash and cash equivalents, restricted cash and deposits | $ | 257,539 | $ | 7,948 | ||||
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2026 was $14.0 million, consisting primarily of our operating expenses of $15.4 million and an increase of $3.1 million in our net operating assets and liabilities, partially offset by approximately $3.1 million of share-based compensation and depreciation expenses and interest income of $1.4 million.
Net cash used in operating activities for the nine months ended September 30, 2025 was $5.5 million, consisting primarily of our operating loss of $8.5 million, which was partially offset by approximately $2.1 million of share-based compensation and depreciation expenses, a decrease of approximately $0.8 million in our net operating assets and liabilities and interest income of $0.1 million.
The change in cash used in operating activities for the nine months ended September 30, 2026 compared to the same period in 2025 was mainly attributed to an increase of $6.9 million in our operating loss and $3.9 million in our net operating assets, which was partially offset by an increase of $1.1 million in share-based compensation and depreciation expense and an increase of $1.3 million in interest income.
Net Cash Used in Investing Activities
Net cash used in investing activities for the nine months ended September 30, 2026 and 2025 consisted primarily of the purchase of property and equipment.
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Net Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2026 consisted of net proceeds of $270.7 million from the issuance of securities in the April 2026 and July 2026 Private Placements, and $0.8 million from the issuance of Ordinary Shares upon the exercise of 2023 Ordinary Share Warrants and outstanding options.
Net cash provided by financing activities for the nine months ended September 30, 2025 consisted of the net proceeds of $6.0 million from the issuance of Ordinary Shares under the Leerink ATM Program, $0.4 million from the issuance of Ordinary Shares upon the exercise of warrants and $7.1 million from issuance of Ordinary Shares under the 2025 Collaboration Agreement.
Contractual Obligations
There have not been any material changes in our assessment of material contractual obligations and commitments as set forth in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2025 Annual Report.
Critical Accounting Policies and Estimates
See Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies” and our consolidated financial statements and related notes included in the 2025 Annual Report for accounting policies and related estimates we believe are the most critical to understanding our consolidated financial statements, financial condition and results of operations and which require complex management judgment and assumptions, or involve uncertainties. The preparation of consolidated financial statements also requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Other than as described below, there have been no changes to our critical accounting policies or their application since the date of the 2025 Annual Report.
Pre-Funded Warrants
During the nine months ended September 30, 2026, we issued pre-funded warrants in the April 2026 Private Placement and the July 2026 Private Placement. We evaluated these instruments under ASC 480, Distinguishing Liabilities from Equity, and ASC 815-40, Contracts in Entity’s Own Equity, and initially classified them as liabilities measured at fair value, with changes in fair value recognized in financial expenses (income), net. Because the exercise price of the pre-funded warrants is nominal, their fair value was determined based on the quoted closing price of our Ordinary Shares (Level 2). Proceeds and offering costs were allocated first to the pre-funded warrants based on their fair value, with the residual allocated to the equity-classified instruments. Upon the August 21, 2026 amendments, we reassessed the classification of the pre-funded warrants, remeasured them to fair value and reclassified them to equity. The determination of the classification of these instruments required significant judgment. See Note 3c to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Recently Issued Accounting Pronouncements
Certain recently issued accounting pronouncements are discussed in Note 2 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not required for smaller reporting companies.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2026, which we refer to as the Evaluation Date. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the Evaluation Date, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting that occurred during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings.
ITEM 1A. RISK FACTORS
Except as set forth below in this Item 1A, there have been no material changes with respect to the risk factors disclosed in Part I, Item 1A. of our 2025 Annual Report.
Security, political and economic instability in the Middle East may harm our business.
Our research facilities and certain officers of the Company are located in Israel. Accordingly, political, economic and military conditions in the Middle East may affect our business directly. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries, Hamas (an Islamist militia and political group in the Gaza Strip), Hezbollah (an Islamist militia and political group in Lebanon), and Iran.
On October 7, 2023, thousands of Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of lethal attacks on Israeli civilians and some military targets. Hamas also launched extensive rocket attacks on the Israeli civilian population and industrial centers located along Israel’s border with the Gaza Strip and across the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped over 250 Israeli civilians and soldiers. Following the attack, Israel’s security cabinet commenced a counter-offense military campaign against Hamas in Gaza. Since the onset of these events, hostilities have persisted across Israel, along Israel’s northern border with Lebanon, primarily involving the Hezbollah terror organization, as well as other extremist groups in the region, including the Houthis in Yemen and various militia groups in Syria and Iraq. Israel has conducted multiple targeted strikes against these terror organizations.
In addition, since April 2024, Israel has experienced direct attacks from Iran, involving hundreds of drones and ballistic missiles launched towards mostly densely populated civilian towns across Israel and some military bases, threatening continued aggression while also exerting considerable influence over regional militia groups encouraging them to launch attacks against Israel. The Israeli defense systems, aided by international allies, successfully intercepted the majority of the ballistic missile attacks, minimizing physical damage and casualties. Additionally, since October 2023, the Houthis, a military organization based in Yemen, have launched a series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting Israel’s political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and the potential for further escalation exists. In October 2024, Israel initiated both air and ground operations against Hezbollah in Lebanon, culminating in a ceasefire agreement between Israel and Lebanon on November 27, 2024, the results of which remain uncertain. 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, following the breakdown of diplomatic efforts and heightened regional tensions, the United States and Israel conducted a series of preemptive strikes targeting Iranian military infrastructure and strategic assets. Immediately thereafter, Iran launched extensive retaliatory ballistic missile and drone attacks against multiple locations across Israel, including central and southern population centers, critical infrastructure facilities and military installations. On March 2, 2026, Hezbollah resumed hostilities, ending the November 2024 ceasefire, by launching projectiles into northern Israel, prompting Israeli airstrikes in Lebanon targeting Hezbollah operatives and assets. Since the outbreak of these hostilities, Israel has implemented nationwide emergency measures, including restrictions on public gatherings and large-scale reserve duty call-ups affecting the civilian workforce.
In early April 2026, a two-week ceasefire between the United States and Iran was agreed. On June 17, 2026, the United States and Iran signed a 14-point memorandum of understanding that formalized the ceasefire, ended the U.S. naval blockade of Iranian ports, provided for the reopening of the Strait of Hormuz and commenced a 60-day period to negotiate a final agreement. Those negotiations subsequently stalled and the ceasefire broke down. Beginning in late June 2026, Iran resumed attacks on commercial vessels transiting the Strait of Hormuz and on U.S. military facilities in Bahrain, Kuwait and Jordan, and the United States has resumed large-scale air strikes against Iranian military and maritime targets. In July 2026, Iran announced the closure of the Strait of Hormuz and the United States reinstated its naval blockade of Iranian ports. In August 2026, Iran and Oman entered advanced negotiations on a new shipping arrangement for the Strait of Hormuz; however, Iran has conditioned reopening the waterway on additional demands, including U.S. compensation and the cessation of hostilities, while the United States has similarly demanded compensation from Iran as a precondition for further talks. Since early September 2026, no major attacks on land-based targets have been reported; however, Iranian attacks on commercial shipping in and around the Strait of Hormuz intensified in October 2026. The U.S. naval blockade of Iranian ports remains in effect. As of the date of this Quarterly Report, those negotiations remain unresolved and the Strait of Hormuz remains effectively closed to normal commercial traffic. Although Israel has not participated in the current round of strikes on Iran, in June 2026 Iran launched ballistic missiles toward northern Israel and Israel conducted retaliatory strikes in Iran, and Israel’s Home Front Command has from time to time imposed restrictions on civilian activity. There can be no assurance that a ceasefire will be restored, and hostilities between the United States, Israel and Iran could resume or further escalate at any time.
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On April 16, 2026, following direct talks between Israeli and Lebanese officials in Washington, D.C., a 10-day cessation of hostilities between Israel and Lebanon was announced, brokered by the United States. On June 26, 2026, following further U.S.-brokered negotiations, Israel, Lebanon and the United States signed a trilateral framework agreement providing for the disarmament of Hezbollah by the Lebanese Armed Forces, beginning in designated pilot zones, and a phased withdrawal of Israeli forces from southern Lebanon. Implementation has been limited to date, Israeli forces remain stationed in southern Lebanon and Hezbollah has not accepted the terms as binding, stating that its fighters will remain deployed and will respond to any violations. The arrangement remains fragile, with reports of continued military operations by both sides in southern Lebanon.
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.
While we have a few employees who are in active military service, the ongoing conflicts, the escalation of Hezbollah’s attacks on Northern Israel, and the direct offensives from Iran and its proxies have not, to date, materially impacted our business or operations. Furthermore, we do not expect any delays to any of our programs as a result of such conflicts. While research and some management are located in Israel, other activities including clinical, regulatory and our supply chain are not. However, we cannot currently predict the intensity or duration of Israel’s conflicts with Hamas, Hezbollah and Iran, and its proxies, nor can we predict how such conflicts will ultimately affect our business and operations or Israel’s economy in general.
Additionally, political uprisings, social unrest and violence in various other countries in the Middle East, including Israel’s neighboring countries Syria, Lebanon, Egypt and Jordan, are affecting the political stability of those countries. This instability may lead to deterioration of the political relationships that exist between Israel and certain countries and have raised concerns regarding security in the region and the potential for a broader regional armed conflict. Since February 2026, there has been a significant escalation in hostilities involving the U.S., Israel, Iran and several other countries in the Middle East, including direct military exchanges, which resumed in late June 2026 following the breakdown of the June 2026 ceasefire. In addition, the ceasefire framework in Gaza remains in place but implementation of its later phases has stalled following the proposal in August 2026 of a U.S.-brokered 15-point plan for the second phase of the ceasefire, which has not been accepted by all parties. Reported attacks on commercial vessels in the Red Sea and the Bab al-Mandeb strait have also resumed, resulting in casualties and in advisories to commercial shipping operating in the region. These developments have increased regional instability and may further escalate into more severe and prolonged hostilities, which could affect Israel and us.
In addition, Israel held general elections on October 27, 2026, and as of the date of this Quarterly Report, a new government has not yet been formed. Coalition formation may take several weeks and, if unsuccessful, may lead to additional elections. Any deterioration in Israel’s security, political or economic conditions, could adversely affect the Israeli economy.
Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have a material adverse effect on our business. Although such hostilities did not have a material adverse impact on our business in the past, we cannot guarantee that hostilities will not be renewed and have such an effect in the future. These or other Israeli political or economic factors could harm our operations and product development. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations. We could experience disruptions if acts associated with such conflicts result in any serious damage to our operations.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
During the quarter ended September 30, 2026, none of our
ITEM 6. EXHIBITS
| Exhibit No. | Description of Exhibits |
| 10.1 | Securities Purchase Agreement, dated as of July 26, 2026, by and between Entera Bio Ltd. and the purchasers party thereto (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on July 28, 2026). |
| 10.2* | Form of Pre-Funded Warrant |
| 10.3 | Registration Rights Agreement, dated as of July 28, 2026, by and among Entera Bio Ltd. and the purchasers party thereto (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed by the Registrant on July 28, 2026). |
| 31.1 | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2 | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1** | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 32.2** | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 101.INS | XBRL Instance Document. |
| 101.SCH | XBRL Taxonomy Extension Schema Document. |
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. |
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. |
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document. |
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| ENTERA BIO LTD. | |
| Date: November 6, 2026 | /s/ Miranda Toledano |
| Miranda Toledano | |
| Chief Executive Officer | |
|
(Principal Executive Officer)
|
|
| Date: November 6, 2026 | /s/ Dana Yaacov-Garbeli |
| Dana Yaacov-Garbeli | |
| Chief Financial Officer | |
| (Principal Financial and Accounting Officer) |
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