|ENTERA BIO LTD ANNOUNCES FINANCIAL AND OPERATING RESULTS FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2019|
|By: GlobenewsWire - 26 Mar 2020||Back to overview list
? Three Month Biomarker Data from Phase 2 Clinical Trial of EB613 Expected in the Second Quarter of 2020 with Additional Data Readouts Expected in 2020 and Early 2021 ?
BOSTON and JERUSALEM, Israel, March 26, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced its financial and operational results for the quarter and year ended December 31, 2019.
“Over the last several weeks we have seen significant changes across the world due to the spread of COVID-19 and the resulting impact on our employees, clinical trials, and the financial markets. We have developed risk mitigation and contingency plans that prioritize the safety of our patients and employees, balanced carefully with a goal of maintaining our operations and clinical trials according to the changing government and hospital regulations. Despite the uncertainty and impact from COVID-19, we have a balance sheet, that with our recently completed $14.3 million financing, provides us with funding into the second quarter of 2021, which we believe positions us well to achieve a number of important milestones in 2020,” stated Adam Gridley, CEO of Entera. “With multiple potential data readouts from our Phase 2 dose-ranging study of EB613 in osteoporosis patients and the potential for additional business development collaborations, we are rapidly responding to the emerging COVID-19 challenges to reorient our internal operations and business strategy to ensure Entera can achieve its goal to become a leader in the oral delivery of large molecule therapeutics.”
2019 and Recent Milestones
“In 2019 we prioritized our development efforts to therapeutic indications that we believe will create the most value for Entera and our shareholders. We have been executing on our plan to complete enrollment in the Phase 2 clinical trial of EB613 in osteoporosis patients and the related regulatory filings with the FDA to support a potential global Phase 3 program, finalizing formulations for EB612 for Hypoparathyroidism, focusing on business development opportunities and enhancing our investor relations activities,” stated Mr. Gridley. “We had been tracking to achieve our previously communicated timelines for our ongoing Phase 2 clinical trial in EB613. However, based on COVID-19 directives implemented in March 2020 by the Israeli Ministry of Health and our medical institutions, we have temporarily suspended enrollment of new patients in the Phase 2 clinical trial. We are continuing to collect patient data from the currently enrolled patients in this trial through various monitoring methods established by the regulatory authorities and continue to plan at this point to report our three-month interim biomarker data in the second quarter of 2020. Completion of enrollment and the associated full biomarker and six-month BMD data may be impacted by approximately one quarter at this juncture.”
2020 Corporate Objectives
Our corporate objectives for 2020 may be materially and negatively impacted by the COVID-19 pandemic. The extent to which the COVID-19 pandemic impacts us will depend on the duration and magnitude of such impact as well as on numerous factors that the company may not be able to accurately predict.
Financial Results for the Year Ended December 31, 2019
Revenue for the year ended December 31, 2019 was $0.2 million compared to $0.5 million for the year ended December 31, 2018. The decline was largely due to the recognition in 2018 of a majority of the up-front payment received from Amgen in accordance with current accounting guidance. The cost of revenues for the year ended December 31, 2019 was $0.2 million compared to $0.0 million for the year ended December 31, 2018. In 2019, the cost of revenue was attributable to the R&D services provided to Amgen and there were no such costs in 2018. Operating expenses were $11.5 million for the year ended December 31, 2019, compared to $11.4 million for the year ended December 31, 2018. Entera’s operating loss was $(11.5) million for the year ended December 31, 2019, compared to $(10.9) million for the year ended December 31, 2018.
Research and development expenses were $7.2 million for the year ended December 31, 2019, compared to $8.5 million for the year ended December 31, 2018. The decrease was primarily due to reductions in materials and production costs and share-based compensation expenses which were partially offset by increases in consulting expenses and fees related to the preparation of the Company’s IND application for EB613 and the initiation and conduct of the Phase 2 clinical trial of EB613. General and administrative expenses were $4.3 million for the year ended December 31, 2019, compared to $2.8 million for the year ended December 31, 2018. The increase was primarily due to increases in compensation related expenses, director’s fees and insurance costs related to Entera’s public company status for the full year in 2019 relative to only half of the year ended December 31, 2018.
Net comprehensive loss was $(10.8) million for the year ended December 31, 2019, or $(0.89) per ordinary share, compared to $(10.3) million, or $(1.30) per ordinary share – basic and $(1.31) per ordinary share – diluted, for the year ended December 31, 2018. The increase in net loss attributable to common stockholders is attributable to the increased operating loss in 2019 relative to 2018 which was partially offset by changes in the fair value of the warrants and other financial expenses in 2019 as compared to 2018.
At December 31, 2019, Entera had cash and cash equivalents of $15.2 million, compared to $11.5 million at December 31, 2018. Cash at December 31, 2019 excludes approximately $0.8 million, net of expenses, received in February 2020 in connection with the final closing of the private placement that was completed in December 2019.
Entera expects an operating loss of between $10 million and $12 million for the year ending December 31, 2020 subject to the impact of COVID-19 and believes its current cash position will be sufficient to fund its operations into the second quarter of 2021.
Conference Call and Webcast Information
Entera’s management will host a conference call on Thursday, March 26, 2020 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 “4939469” 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 macromolecule 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: the impact of COVID-19 on Entera’s business operations including enrollment in the Phase 2 clinical trial for EB613 in patients with osteoporosis and the ability to collect the necessary data from the Phase 2 trial of EB613; a possible suspension of the Phase 2 clinical 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 so far are insufficient to initiate a Phase 3 trial, or a 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; 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; Entera’s ability 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 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, 2019, to be filed with the SEC in the first quarter of 2020. 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.
ENTERA BIO LTD.
CONTACT: Contact: Jonathan Lieber, CFO Tel: +972-2-532-7151 firstname.lastname@example.org
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