Entera Bio Ltd. - 1638097

Entera Bio Ltd. - 1638097 - 2025

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 September 30, 2025

☐ 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 November 10, 2025, the registrant had 45,857,242 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 September 30, 2025 and December 31, 2024 (unaudited)	5
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024 (unaudited)	6
	Condensed Consolidated Statement of Changes in Shareholders’ Equity for the three and nine months ended September 30, 2025 and 2024 (unaudited)	7
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30

PART II – OTHER INFORMATION		31

Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	32
Item 3.	Defaults Upon Senior Securities	32
Item 4.	Mine Safety Disclosures	32
Item 5.	Other Information	32
Item 6.	Exhibits	32

SIGNATURES		33

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, 2024 (the “2024 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 or other oral peptides for hypoparathyroidism, obesity, metabolic disorders 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 continue as a going concern absent access to sources of liquidity;

•

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 oral peptide technology (“N-Tab™”) 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

•

Notwithstanding the current ceasefire between Israel and Hamas, the ultimate resolution of 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, 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 2024 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 SEPTEMBER 30, 2025

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

ENTERA BIO LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

Assets	September 30,			December 31,
	2025			2024
CURRENT ASSETS:
Cash and cash equivalents		8,574			8,660
Accounts receivable		-			126
Restricted cash		8,028			-
Other current assets		405			186
TOTAL CURRENT ASSETS		17,007			8,972

NON-CURRENT ASSETS:
Property and equipment, net		114			57
Operating lease right-of-use assets		194			275
Restricted deposit		86			80
Funds in respect of employee rights upon retirement		6			6
TOTAL NON-CURRENT ASSETS		400			418
TOTAL ASSETS		17,407			9,390
Liabilities and shareholders' equity
CURRENT LIABILITIES:
Accounts payable		216			132
Accrued expenses and other payables		1,185			874
Current maturities of operating lease		170			170
TOTAL CURRENT LIABILITIES		1,571			1,176
NON-CURRENT LIABILITIES:
Operating lease liabilities		41			102
Other long-term liability		527			-
Liability for employee rights upon retirement		34			32
TOTAL NON-CURRENT LIABILITIES		602			134
TOTAL LIABILITIES		2,173			1,310
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares, NIS 0.0000769 par value: 140,010,000 shares authorized as of September 30, 2025 and December 31, 2024; issued and outstanding as of September 30, 2025 and December 31, 2024, 45,664,506 and 38,837,220 shares, respectively		1			1
Additional paid-in capital		137,542			121,965
Accumulated other comprehensive income		41			41
Accumulated deficit		(122,350	)		(113,927	)
TOTAL SHAREHOLDERS' EQUITY		15,234			8,080
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		17,407			9,390

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)

	Nine Months Ended September 30,						Three Months Ended September 30,
	2025			2024			2025			2024

REVENUES		42			99			-			42
COST OF REVENUES		42			90			-			42
GROSS PROFIT		-			9			-			-
OPERATING EXPENSES:
Research and development, net		4,286			3,298			1,643			1,477
General and administrative		4,201			3,959			1,613			1,544
TOTAL OPERATING EXPENSES		8,487			7,257			3,256			3,021
OPERATING LOSS		8,487			7,248			3,256			3,021
FINANCIAL INCOME, NET		(64	)		(65	)		(56	)		-
NET LOSS		8,423			7,183			3,200			3,021

LOSS PER SHARE BASIC AND DILUTED		0.18			0.19			0.07			0.08

WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE		45,829,501			37,163,478			47,089,814			37,644,612

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, 2025		38,837,220		1		121,965		41		(113,927	)		8,080
Net loss		-		-		-		-		(8,423	)		(8,423	)
Exercise of warrants to Ordinary Shares		353,292		*		354		-		-			354
Exercise of options to Ordinary Shares		1,125		*		1		-		-			1
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		2,731,574		*		6,067		-		-			6,067
Vested restricted share units		56,069		*		-		-		-			-
Share-based compensation		-		-		2,040		-		-			2,040
BALANCE AT SEPTEMBER 30, 2025		45,664,506		1		137,542		41		(122,350	)		15,234

BALANCE AT July 1, 2025		45,452,167		1		136,364		41		(119,150	)		17,256
Net loss		-		-		-		-		(3,200	)		(3,200	)
Exercise of warrants to Ordinary Shares		179,640		*		180		-		-			180
Exercise of options to Ordinary Shares		1,125		-		1		-		-			1
Issuance of Ordinary Shares under ATM program, net of issuance costs		31,574		*		70		-		-			70
Share-based compensation		-		-		927		-		-			927
BALANCE AT SEPTEMBER 30, 2025		45,664,506		1		137,542		41		(122,350	)		15,234

BALANCE AT JANUARY 1, 2024		35,476,341		1		114,730		41		(104,386	)		10,386
Net loss		-		-		-		-		(7,183	)		(7,183	)
Exercise of warrants to Ordinary Shares		89,820		*		90		-		-			90
Exercise of options to Ordinary Shares		469,340		*		568		-		-			568
Issuance of Ordinary Shares under ATM program, net of issuance costs		236,126		*		601		-		-			601
Vested restricted share units		240,587		*		*		-		-			-
Share-based compensation		-		-		1,990		-		-			1,990
BALANCE AT SEPTEMBER 30, 2024		36,512,214		1		117,979		41		(111,569	)		6,452

BALANCE AT July 1, 2024		36,314,579		1		117,038		41		(108,548	)		8,532
Net loss		-		-		-		-		(3,021	)		(3,021	)
Exercise of options to Ordinary Shares		22,048		*		13		-		-			13
Vested restricted share units		175,587		*		*		-		-			-
Share-based compensation		-		-		928		-		-			928
BALANCE AT SEPTEMBER 30, 2024		36,512,214		1		117,979		41		(111,569	)		6,452

* 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)

	Nine months ended September 30,
CASH FLOWS FROM OPERATING ACTIVITIES:	2025			2024
Net loss		(8,423	)		(7,183	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		23			35
Share-based compensation		2,040			1,990
Finance income, net		(8	)		(10	)
Changes in operating asset and liabilities:
Increase in other current assets		(219	)		(42	)
Decrease (increase) in accounts receivable		126			(133	)
Increase in accounts payable		84			101
Increase (decrease) in accrued expenses and other payables and other long-term liability		840			(109	)
Net cash used in operating activities		(5,537	)		(5,351	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		(80	)		-
Net cash used in investing activities		(80	)		-
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of Ordinary Shares under ATM program		6,254			620
Issuance of Ordinary Shares under collaboration agreement		7,190			-
Issuance cost		(262	)		(19	)
Exercise of warrants and options to Ordinary Shares		354			658
Net cash provided by financing activities		13,536			1,259

EFFECT OF EXCHANGE RATE CHANGE ON CASH AND CASH EQUIVALENTS		29			-
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS		7,919			(4,092	)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS AT BEGINNING OF THE PERIOD		8,740			11,085
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AND DEPOSITS AT END OF THE PERIOD		16,688			6,993
Reconciliation in amounts on consolidated balance sheets:
Cash and cash equivalents		8,574			6,915
Restricted cash and deposits		8,114			78
Total cash and cash equivalents and restricted cash and deposit		16,688			6,993
SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS:
Interest received		126			67
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Operating lease right of use assets obtained in exchange for new operating lease liabilities		59			32

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

Entera Bio Ltd. (collectively with its subsidiary, “Entera” or the "Company") was incorporated on September 30, 2009 and commenced operations on June 1, 2010. On January 8, 2018, the Company incorporated its wholly owned subsidiary, Entera Bio Inc., in Delaware, United States.

Entera is focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. The Company leverages its N-Tab™ platform, which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream. The Company concentrates on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.

Entera’s most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets in 161 post-menopausal women with low BMD and osteoporosis met primary and secondary endpoints. On July 28, 2025, the Company announced that in a written response to a Type A meeting request, the FDA agreed that the NDA filing for EB613 (oral PTH (1-34), teriparatide) would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24-month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint.

The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism.

In addition, Entera is developing the first oral o

SEC Form 10-Q filed by Entera Bio Ltd.