BOSTON and JERUSALEM, June 28, 2021 (GLOBE NEWSWIRE) – Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of large-molecule oral therapeutics, today announced that it will host a conference call to discuss the results of its completed Phase 2 clinical trial of EB613 for the treatment of osteoporosis. EB613 is an oral formulation of human parathyroid hormone (1-34), or PTH, and is positioned to be the first oral bone strengthening (anabolic) product to treat patients with osteoporosis.
Call participants will include osteoporosis expert and lead investigator of the Phase 2 study, Dr Liana Tripto-Shkolnik, Sheba Medical Center, Institute of Endocrinology. Dr Tripto-Shkolnik will provide background on the study results and the benefits of an oral medication for treating osteoporosis. Entera CEO Spiros Jamas will also participate in the call; President of R&D, Phillip Schwartz; Chief Physician, Art Santora; and CFO, Ramesh Ratan.
The conference call will take place on Wednesday, June 30, 2021 from 12:00 p.m. to 1:00 p.m. EDT and will include a question-and-answer session. To participate in the live call, please dial (844) 467-6041 (US) or (409) 217-8787 (international) and provide the conference ID “5298499” 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 after the presentation.
About Entera Bio
Entera is a leader in the development of orally administered large molecule therapies for use in areas of high unmet medical needs, where adoption of injectable therapies is limited due to concerns of cost, convenience and compliance 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 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.
Various statements contained in this press release are “forward-looking statements” under securities laws. Words such as, but not limited to, “anticipate”, “believe”, “can”, “could”, “expect”, “estimate”, “conceive”, “objective”, “have the goal”. ‘intention’, ‘may’, could ‘,’ objective ‘,’ plan ‘,’ foresee ‘,’ project ‘,’ target ‘,’ probable ‘,’ should ‘,’ will ‘and’ would ‘or the negative of such terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based on current expectations which involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be interpreted as a guarantee of future performance or results and may not be precise 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, but are not limited to: changes in our interpretation of the full 3-month biomarker data from the Phase 2 clinical trial ongoing on EB613, the timing of reading data 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 these comprehensive results, the FDA’s interpretation and review of our results and analysis of our Phase 2 trial of EB613, unexpected changes in our ongoing and planned preclinical developments and clinical trials, timing and our ability to complete 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 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; potential disruption and delay in manufacturing supply chains, loss of available labor resources, either by Entera or its collaboration and lab partners, due to travel restrictions, layoffs or forced closures or reassignment of hospitals; impacts on research and development or clinical activities that Entera is contractually obligated to provide, such as those under Entera’s agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are shut down for extended periods of time, choose to allocate resources to the review of COVID-19-related drugs or believe the amount of Phase 2 clinical data collected is insufficient to initiate a phase 3 trial, or a significant deterioration in the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of data from the phase 2 clinical trial of EB613 in patients with osteoporosis; the ability to 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 market expansion if an orally administered option is available in addition to an injectable formulation; the scope, progress and costs of the development of Entera’s product candidates, including EB612 and GLP-2; Entera’s dependence on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; the operation of Entera as a development stage company with limited operating history; the ability of Entera to continue operating in the absence of access to sources of liquidity; Entera’s expectations regarding its expenses, income, liquidity, liquidity and financial condition; Entera’s ability to raise additional capital; Entera’s interpretation of FDA’s comments and advice and the impact that such advice may have on 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 minimum listing standards and other matters related to meeting 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 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 documents. which are filed with the SEC and available free of charge on the SEC’s website at http://www.sec.gov. Additional factors may be set out in sections of Entera’s annual report on Form 20-F for the fiscal year ended December 31, 2020, 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 documents filed with the SEC, other unknown or unforeseeable factors could also affect Entera’s results. There can be no assurance that the actual results or developments anticipated by Entera will be achieved or, even if substantially achieved, that they will have the consequences or effects expected on Entera. Therefore, no assurance can be given that the results set forth in these forward-looking statements and estimates will be achieved.
All written and oral 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 place undue reliance on forward-looking statements made by Entera or made on its behalf. The information in this press release is provided only as of the date of this press release, and Entera assumes no obligation, and specifically disclaims any obligation, to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.