Entera Bio Ltd.

For the period ended Mar 31, 2026. Filed May 8, 2026.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 8, 2026

ENTX$3.25+3.5%Stored close · as of Nov 9, 2026

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Contents

Notes to Condensed Consolidated Financial Statements (unaudited)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1 - DESCRIPTION OF BUSINESS

a.	Entera Bio Ltd. (collectively with its subsidiary, the "Company") 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 tablet formats of peptides or protein replacement therapies. 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) once-daily tablet treatment for post-menopausal women with osteoporosis. In February 2026, the Company submitted to the FDA a clinical amendment which included the EB613 Phase 3 protocol, statistical analysis plan and open-label extension synopsis.

The Company’s second product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 5) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (“OPKO”), to advance the first oral long-acting PTH analog (“LA-PTH”) as a once-daily tablet for patients with hypoparathyroidism.

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 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 0.0000769 par value per share (“ordinary shares”), are listed on the Nasdaq Capital Market under the symbol “ENTX”.

c.	Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred negative cash flows from operating activities. The Company has incurred an accumulated deficit in the amount of $128.9 million as of March 31, 2026.

NOTE 1 - DESCRIPTION OF BUSINESS (Cont.)

As disclosed in Note 7, in April 2026, the Company completed a private placement financing resulting in gross proceeds of approximately $10.0 million. The Company expects to use the net proceeds, in part, to support activities related to the preparation and initiation of its Phase 3 registrational study of EB613, as well as for general working capital and corporate purposes. The Company's management is of the opinion that its available funds as of March 31, 2026, including the proceed from the private placement disclosed in note 7, will be sufficient to support the Company’s ongoing operations under its current plans through the first quarter of 2027, including activities related to the preparation for its planned Phase 3 registrational study of EB613. The Company’s current capital resources do not include the capital required to fully fund the Company's proposed Phase 3 program for EB613 in osteoporosis. These factors raise substantial doubt as to the Company's ability to continue as a going concern. Management continually evaluates various financing alternatives and strategic collaborations, as the Company will need to finance future research and clinical development with additional capital. However, there is no certainty that the Company will be able to obtain such funding. These condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.

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 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, the United States and Israel conducted preemptive strikes targeting Iranian military infrastructure. Iran retaliated with extensive ballistic missile and drone attacks against Israel. On March 2, 2026, Hezbollah resumed hostilities by launching projectiles into northern Israel, ending the November 2024 ceasefire. Israel responded with airstrikes on Lebanon and ground operations in Southern Lebanon, marking a significant escalation in the regional conflict. 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. However, the ceasefire's durability remains uncertain. The United States has maintained a naval blockade of Iranian ports, and Iran has responded by intermittently restricting commercial vessel passage through the Strait of Hormuz, declaring that the waterway would remain effectively closed until the blockade is lifted. There can be no assurance that this ceasefire will hold or be extended, and hostilities between the United States, Israel and Iran could resume 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. The parties have requested that the United States facilitate further direct negotiations with the objective of achieving a comprehensive agreement for lasting security and peace. 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. 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. The Company’s research personnel and certain management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel.

Currently, the Company’s activities in Israel remain largely unaffected by the foregoing events. For the three months ended March 31, 2026 and 2025 and the year ended December 31, 2025, the impact of such events on the Company’s results of operations and financial condition was immaterial.

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 March 31, 2026, the consolidated results of operations and statements of changes in shareholders' equity for the three months ended March 31, 2026 and 2025, and cash flows for the three months ended March 31, 2026 and 2025.

The consolidated results of operations for the three months ended March 31, 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.

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, pre-funded warrants and vested restricted share units (“RSUs”) during the period. Each outstanding pre-funded warrant has no expiration and is exercisable at a price of NIS 0.0000769 per ordinary share.

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, warrants and “RSUs”, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include options, RSUs and warrants exercisable into 17,323,164 ordinary shares and 16,186,270 ordinary shares for the three months ended March 31, 2026 and 2025, respectively, because the effect would have been anti-dilutive.

c.	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.

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (Cont.)

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.

In December 2025, the FASB issued ASU 2025-11, “Interim Reporting (Topic 270) Narrow-Scope Improvements.” The amendments in this Update clarify interim disclosure requirements and the applicability of Topic 270. The objective of the update is to provide clarity about current interim requirements. The amendments in this update also include a disclosure principle that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. The amendments in this ASU are required to be adopted for interim periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company does not expect ASU 2025-11 to have a material impact on its consolidated financial statements disclosures.

NOTE 3 - EQUITY AND SHARE-BASED COMPENSATION

Changes in Share Capital:

On January 1, 2026, the Company issued 148,872 ordinary shares to five non-executive members of the board of directors in lieu of cash board fees for fiscal year 2025, which was approved by the Company’s shareholders at a meeting of the Company’s shareholders held on July 31, 2024. The fair value of the ordinary shares on the grant date was $289 thousand.

b.	In February 2026, two former non-executive board members exercised options for an aggregate of 216,666 ordinary shares for total consideration of $130 thousand.

Share-based Compensation:

On January 1, 2026, an aggregate of 167,525 options to purchase ordinary shares was granted to five non-executive board members with an exercise price of $1.94 per share. The options vest over one year in four equal quarterly installments, starting on January 1, 2026. This grant was approved by the shareholders of the Company on October 4, 2021. The fair value of the options at the date of grant was $227 thousand.

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:

Exercise price	$1.94
Dividend yield	-
Expected volatility	84.2%
Risk-free interest rate	5.74%
Expected life - in years	5.3

NOTE 4 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Balance sheets:

	March 31,	December 31,
	2026	2025
Other current assets:
Prepaid expenses	310	37
Receivable in respect of collaborative arrangement	-	219
Other	256	159
	566	415

	March 31,	December 31,
	2026	2025
Accrued expenses and other payables:
Employees and employees related	242	264
Provision for vacation	211	168
Payable in respect of collaborative arrangement	46	-
Accrued expenses	455	726
Other payables	163	367
	1,117	1,525

NOTE 5 - 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 Company and OPKO have agreed to collaborate with respect to the preclinical and clinical development and decision making related to the oral delivery of a dual agonist GLP-1/glucagon peptide in an oral dosage form using Entera’s N-Tab™ technology platform for the treatment of obesity, metabolic and fibrotic disorders in humans. The Company and OPKO share in the economics and development costs of such program at 40% and 60%, respectively, subject to certain opt-out provisions. In connection with the agreement, the Company issued 3,685,226 ordinary shares to OPKO for aggregate gross proceeds of $8.0 million, which were allocated between equity and the collaboration components of the arrangement. Amounts allocated to the collaboration component are recognized over the period of performance and presented within other liabilities in the consolidated balance sheet.

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 preclinical and clinical development of a daily LA-PTH tablet for the treatment of hypoparathyroidism (EB612) and additional indications. Development costs related to the LA-PTH 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 months ended March 31, 2026, the Company recognized net expenses of $523 thousand relating to the A&R Collaboration Agreement.

NOTE 6 - SEGMENT INFORMATION

The Company operates in Israel as a single operating segment. The Company’s Chief Executive Officer is the chief operating decision marker (the “CODM”). The CODM makes decisions on resource allocation, assesses performance of the business and monitors budget versus actual results on a consolidated basis based on net losses.

b.	Segment information:

	March 31,	March 31,
	2026	2025
Revenues	-	42
Less:
Research and development, net:
Sub-contractors and consulting expense (EB613)	780	373
Net expenses related to OPKO Collaboration Agreement	523	-
Payroll and related expenses	435	395
Share-based compensation	313	176
Rent and related expenses	128	123
Other development expenses*	72	56
Other segment expenses**	1,254	1,486
Segment net loss	3,505	2,567

Other development expenses include materials and productions and others.

** Other segment expenses mainly related to general and administrative expenses, including payroll and related expenses, share-based compensation, legal and audit fees and others.

NOTE 7 - SUBSEQUENT EVENTS

On April 1, 2026, the Company entered into a securities purchase agreement with certain funds affiliated with BVF Partners LP (collectively, the "Purchaser"), providing for the private placement to the Purchaser of an aggregate of 7,916,879 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 "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), the issuance costs was $57. On April 2, 2026 (the "Closing Date"), the Company issued 2,425,000 ordinary shares, 5,402,789 2026 Pre-Funded Warrants, and 11,741,683 2026 Ordinary Share Warrants in connection with this offering.

Each 2026 Ordinary Share Warrant has an exercise price of $1.24 per share, becomes exercisable six months following the 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 the Company has an effective registration statement registering the shares underlying the 2026 Ordinary Share Warrants. The 2026 Pre-Funded Warrants have an exercise price of NIS 0.0000769 per share, are immediately exercisable and may be exercised at any time and have no expiration date.

b.	In April 2026, two former non-executive board members exercised options for an aggregate of 178,082 ordinary shares for a total consideration of $130 thousand.

On May 7, 2026, the board of directors approved the following options grants: 1) options to purchase an aggregate of 1,772,000 ordinary shares were granted to employees, executive officers and a key consultant with an exercise price of $1.37 per share, which was the closing share price on the grant date. 1,120,000 of the options grants are subject to the filing of an S-8 registrational statement registering the shares underlying such option grants. 2) options to purchase an aggregate of 500,000 ordinary shares were granted to the Company’s Chief Executive Officer with an exercise price of $1.37 per share, which was the closing share price on the grant date. This grant is subject to shareholder approval and the filing of an S-8 registrational statement registering the shares underlying such grant. These options vest over three years from the date of grant; 33.33% vest on the first anniversary of the date of grant and the remaining 66.67% of the options will vest in eight equal quarterly installments over the remaining two year period. 3) options to purchase an aggregate of 40,000 ordinary shares were granted to a board member with an exercise price of $1.37 per share, which was the closing share price on the grant date. These options vest immediately at the date of grant. This grant is subject to shareholder approval and the filing of an S-8 registration statement registering the shares underlying such grant. 4) options to purchase an aggregate of 83,367 ordinary shares were granted to certain board members with an exercise price of $1.37 per share, which was the closing share price on the grant date. These options vest over three years from the date of grant in twelve equal quarterly installments following the vesting commencement date. These grants are subject to shareholder approval and the filing of an S-8 registrational statement registering the shares underlying such option grants. 5) options to purchase an aggregate of 86,418 ordinary shares were granted to certain board members with an exercise price of $1.37 per share, which was the closing share price on the grant date. These options vest over one year ended December 31, 2026 in quarterly installments. This grant is subject to shareholder approval and the filing of an S-8 registrational statement registering the shares underlying such option grants. In addition, the board of directors approved the grant of 734,428 RSUs to executive officers and key consultants in lieu of a cash bonus and partial salary raise. The grant of 420,559 of these RSUs is subject to shareholder approval.

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