Entera Bio Ltd. - 1638097

Entera Bio Ltd. - 1638097 - 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-38556

ENTERA BIO LTD.

(Exact name of Registrant as specified in its charter)

Israel		Not applicable
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

Kiryat Hadassah Minrav Building – Fifth Floor
Jerusalem, Israel		9112002
(Address of principal executive offices)		(Zip Code)

972-2-532-7151

(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
Ordinary Shares, par value NIS 0.0000769 per share		ENTX		Nasdaq Capital Market

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.

Yes ☒ No ☐

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).

Yes ☒ No ☐

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	☐
Non-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 August 3, 2026, the registrant had 173,141,831 ordinary shares, par value NIS 0.0000769 per share (“Ordinary Shares”) outstanding.

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 June 30, 2026 and December 31, 2025 (unaudited)	4
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026 and 2025 (unaudited)	5
	Condensed Consolidated Statement of Changes in Shareholders’ Equity for the three and six months ended June 30, 2026 and 2025 (unaudited)	6
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 (unaudited)	7
	Notes to Condensed Consolidated Financial Statements (unaudited)	8
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33

PART II – OTHER INFORMATION		33

Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	35
Item 3.	Defaults Upon Senior Securities	35
Item 4.	Mine Safety Disclosures	35
Item 5.	Other Information	35
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;

•

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;

•

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 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 Operation—Liquidity and Capital Resources” 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.

PART I.

ITEM 1. FINANCIAL STATEMENTS

ENTERA BIO LTD.

UNAUDITED CONDENSED

CONSOLIDATED FINANCIAL STATEMENTS

AS OF JUNE 30, 2026

TABLE OF CONTENTS

	Page
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
Condensed Consolidated Balance Sheets (unaudited)	4
Condensed Consolidated Statements of Operations (unaudited)	5
Condensed Consolidated Statements of Changes in Shareholders' Equity (unaudited)	6
Condensed Consolidated Statements of Cash Flows (unaudited)	7
Notes to the Condensed Consolidated Financial Statements (unaudited)	8

ENTERA BIO LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands, except share data)

(Unaudited)

Assets	June 30,			December 31,
	2026			2025
CURRENT ASSETS:
Cash and cash equivalents		11,309			7,108
Restricted cash		7,122			7,775
Other current assets		465			415
TOTAL CURRENT ASSETS		18,896			15,298

NON-CURRENT ASSETS:
Property and equipment, net		121			134
Operating lease right-of-use assets		362			465
Restricted deposit		95			90
Funds in respect of employee rights upon retirement		6			6
TOTAL NON-CURRENT ASSETS		584			695
TOTAL ASSETS		19,480			15,993
Liabilities and shareholders' equity
CURRENT LIABILITIES:
Accounts payable		575			448
Accrued expenses and other payables		1,330			1,525
Current maturities of operating lease		199			230

TOTAL CURRENT LIABILITIES		2,104			2,203
NON-CURRENT LIABILITIES:
Operating lease liabilities		226			260
Other long-term liabilities		284			393
Liability for employee rights upon retirement		37			36
Pre-funded warrants liability		9,563			-
TOTAL NON-CURRENT LIABILITIES		10,110			689
TOTAL LIABILITIES		12,214			2,892
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares, NIS 0.0000769 par value: Authorized - as of June 30, 2026 and December 31, 2025, 140,010,000 shares; issued and outstanding as of June 30, 2026 and December 31, 2025, 49,290,233 and 46,178,630 shares, respectively		1			1
Additional paid-in capital		143,407			138,425
Accumulated other comprehensive income		41			41
Accumulated deficit		(136,183	)		(125,366	)
TOTAL SHAREHOLDERS' EQUITY		7,266			13,101
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		19,480			15,993

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

ENTERA BIO LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. dollars in thousands, except share and per share data)

(Unaudited)

	Six Months Ended June 30,					Three Months Ended June 30,
	2026		2025			2026		2025

REVENUES		-		42			-		-
COST OF REVENUES		-		42			-		-
GROSS PROFIT		-		-			-		-
OPERATING EXPENSES:
Research and development, net		5,452		2,643			3,201		1,520
General and administrative		2,650		2,588			1,362		1,148
TOTAL OPERATING EXPENSES		8,102		5,231			4,563		2,668
OPERATING LOSS		8,102		5,231			4,563		2,668
FINANCIAL EXPENSES (INCOME), NET		2,715		(8	)		2,749		(12	)
NET LOSS		10,817		5,223			7,312		2,656

LOSS PER SHARE BASIC AND DILUTED		0.22		0.12			0.14		0.06

WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE		49,098,428		45,146,415			50,451,232		46,836,700

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

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		46,178,630		1		138,425		41		(125,366	)		13,101
Net loss		-		-		-		-		(10,817	)		(10,817	)
Exercise of options to Ordinary Shares		394,748		*		260		-		-			260
Issuance of Ordinary Shares and warrants, net of issuance costs		2,425,000		*		3,137		-		-			3,137
Vested restricted share units		142,983		*		*		-		-			*
Settlement in share of board members compensation (see note 4)		148,872		-		289		-		-			289
Share-based compensation		-		-		1,296		-		-			1,296
BALANCE AT JUNE 30, 2026		49,290,233		1		143,407		41		(136,183	)		7,266

BALANCE AT APRIL 1, 2026		46,622,239		1		139,516		41		(128,871	)		10,687
Net loss		-		-		-		-		(7,312	)		(7,312	)
Exercise of options to Ordinary Shares		178,082		*		130		-		-			130
Issuance of Ordinary Shares and warrants, net of issuance costs		2,425,000		*		3,137		-		-			3,137
Vested restricted share units		64,912		*		*		-		-			*
Share-based compensation		-		-		624		-		-			624
BALANCE AT JUNE 30, 2026		49,290,233		1		143,407		41		(136,183	)		7,266

BALANCE AT JANUARY 1, 2025		38,837,220		1		121,965		41		(113,927	)		8,080
Net loss		-		-		-		-		(5,223	)		(5,223	)
Exercise of warrants to Ordinary Shares		149,700		*		150		-		-			150
Exercise of options to Ordinary Shares		23,952		*		24		-		-			24
Issuance of Ordinary Shares under collaboration agreement, net		3,685,226		*		7,115		-		-			7,115
Issuance of Ordinary Shares under ATM program, net of issuance costs		2,700,000		*		5,997		-		-			5,997
Vested restricted share units		56,069		*		*		-		-			*
Share-based compensation		-		-		1,113		-		-			1,113
BALANCE AT JUNE 30, 2025		45,452,167		1		136,364		41		(119,150	)		17,256

BALANCE AT APRIL 1, 2025		45,420,677		1		135,831		41		(116,494	)		19,379
Net loss		-		-		-		-		(2,656	)		(2,656	)
Exercise of options to Ordinary Shares		23,952		*		24		-		-			24
Vested restricted share units		7,538		*		*		-		-			*
Share-based compensation		-		-		509		-		-			509
BALANCE AT JUNE 30, 2025		45,452,167		1		136,364		41		(119,150	)		17,256

* Represents an amount less than one thousand U.S. dollars.

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.

ENTERA BIO LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands)

(Unaudited)

	Six months ended June 30,
	2026			2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss		(10,817	)		(5,223	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		16			15
Share-based compensation		1,296			1,113
Finance expenses, net		18			18
Changes in fair value of pre-funded warrants liability		2,755			-
Issuance cost		116			-
Changes in operating asset and liabilities:
Increase in other current assets		(48	)		(252	)
Decrease in accounts receivable		-			126
Increase in accounts payable		127			251
Increase (decrease) in accrued expenses and other payables and other long-term liabilities		(17	)		917
Net cash used in operating activities		(6,554	)		(3,035	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment