UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16

OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2021

Commission file number: 001-38556

ENTERA BIO LTD.

(Exact Name of Registrant as Specified in Its Charter)

Kiryat Hadassah
Minrav Building – Fifth Floor

Jerusalem, Israel
(Address of principal executive office)

_____________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒         Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

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, thereunto duly authorized.

Date: March 18, 2021

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ENTERA BIO LTD ANNOUNCES OPERATING AND FINANCIAL RESULTS FOR THE

FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2020

‒ Achieved Primary Endpoint in EB613 Phase 2 Clinical Trial ‒

 ‒ Final Data, Including Bone Mineral Density, Expected in Q2:21 ‒

 ‒ FDA Approval of EB613 IND for the Treatment of Osteoporosis Enables Initial U.S. Clinical Trial ‒

 ‒ Amgen Collaboration Continues to Progress; Company Evaluating Additional Molecules, Including GLP-2, in Mutiple Pre-clinical Studies ‒

 ‒ Company Strengthened Balance Sheet and Now Funded into the Second Quarter of 2022 ‒

 ‒ Company to Host Conference Call and Webcast Today at 8:30 a.m. ET ‒

 

BOSTON, Massachusetts & JERUSALEM, Israel (March 18, 2021) – Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced its financial and operating results for the quarter and year ended December 31, 2020 and provided an update on its clinical programs and pre-clinical programs.

2020 and Recent Highlights

“We continue to leverage Entera’s oral protein delivery platform, with a goal of developing a robust pipeline of orally-delivered large molecules across several therapeutic areas. We believe that the ability to replace a daily injection with an orally delivered alternative, will improve convenience, compliance and outcomes while lowering the total cost of care,” stated Entera CEO Spiros Jamas. “We are highly encouraged by the data we have released to date from our EB613 Phase 2 trial in osteoporosis and we are working toward several additional milestones in 2021 including the announcement, of the BMD results from this trial in the second quarter of 2021”.

Financial Results for the Year Ended December 31, 2020

Revenues for the year ended December 31, 2020 were $365,000 as compared to $236,000 for the year ended December 31, 2019, with revenues in both years attributable to R&D services provided to Amgen. The cost of revenues for year ended December 31, 2020 and 2019 were $209,000 and $210,000 respectively and were comprised of salaries and related expenses in connection with the R&D services provided to Amgen.

Operating expenses were $11.3 million for the year ended December 31, 2020, compared to $11.5 million for the year ended December 31, 2019. Entera’s operating loss was $(11.1) million for the year ended December 31, 2020, compared to $(11.5) million for the year ended December 31, of 2019.

Research and development expenses were $6.4 million for the year ended December 31, 2020, compared to $7.2 million for the year ended December 31, 2019. An increase in clinical trial expense in 2020 primarily due to the conduct of the Phase 2 clinical trial of EB613 was offset by decreases in compensation and consulting expenses and manufacturing costs.

General and administrative expenses were $4.9 million for the year ended December 31, 2020, compared to $4.3 million for the year ended December 31, 2019. The increase was primarily due to increases in compensation related expenses, professional and legal fees and insurance costs.

Net comprehensive loss was $(10.0) million or $(0.55) per ordinary share (diluted) for the year ended December 31, 2020 compared to $(10.8) million, or $(0.89) per ordinary share (basic and diluted) for the year ended December 31, 2019. The change in net loss is primarily due to decrease in the operating loss and an increase in financial income related to the change in fair value of outstanding warrants.

At December 31, 2020, Entera had cash and cash equivalents of $8.6 million, compared to $15.2 million at December 31, 2019 and in the 20F the Company intends to file today, it will report $15.4 million in cash and cash equivalents at March 16, 2021. This amount includes total net proceeds of $13.3 million from the sale of ordinary shares under Company’s previously filed Equity Distribution Agreement, which has now been fully utilized. Entera currently has approximately 23.7 million primary ordinary shares outstanding.

Entera expects an operating loss of between $11 and $12 million for the year ending December 31, 2021, and believes its current cash position will be sufficient to fund its operations into the second quarter of 2022.

Conference Call and Webcast Information

Entera’s management will host a conference call on Thursday, March 18, 2021 at 8:30 a.m. EDT. A question-and-answer session will follow Entera’s remarks. To participate on the live call, please dial (855) 547-3865 (US) or (409) 217-8787 (international) and provide the conference ID “5557946” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of Entera’s website, please click here. A replay of the webcast will be archived on Entera’s website for approximately 45 days following the presentation.

About Entera Bio Ltd.

Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Forward Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

 

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others:  changes in our interpretation of the complete 3-month biomarker data and the interim BMD data from the ongoing Phase 2 clinical trial of EB613, the timing of data readouts from the ongoing Phase 2 clinical trial of EB613, the full results of the Phase 2 clinical trial of EB613, which is still ongoing and our analysis of those full results, the FDA’s interpretation and review of our results from and analysis of our Phase 2 trial of EB613, including with regards to potential discussions regarding the design of a pivotal Phase 3 non-inferiority trial based on such results; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical or data-related reasons; the impact of COVID-19 on Entera’s business operations including the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as pursuant to Entera’s agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected are insufficient to initiate a Phase 3 trial, or an otherwise meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera’s other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing Entera’s product candidates including EB612 and GLP-2; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s expectations regarding its expenses, revenue, cash resources, liquidity and financial condition; Entera’s ability to raise additional capital; Entera’s interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s annual and current filings which are on file with the SEC and available free of charge on the SEC’s website at http://www.sec.gov. Additional factors may be set forth in those sections of Entera’s Annual Report on Form 20-F for the year ended December 31, 2020, to be filed with the SEC in the first quarter of 2021. In addition to the risks described above and in Entera’s annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera’s results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

ENTERA BIO LTD.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(US$ in thousands, except share and per share data)

ENTERA BIO LTD.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(US$ in thousands)

Contact:

Spiros Jamas, CEO

Tel: +001 617-362-3579

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