Entera Bio to Conduct Conference Call on June 30 to Discuss Phase 2 Results for EB613 Positioned to be the First Oral Bone-Bu...
June 28 2021 - 3:15PM
Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of
orally delivered large molecule therapeutics, today announced it
will conduct a conference call to discuss results from its
successfully 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 building (anabolic) product to treat osteoporosis
patients.
Attendees on the call will include osteoporosis
expert and Principal Investigator of the Phase 2 study Dr. Liana
Tripto-Shkolnik, Sheba Medical Center, Institute of Endocrinology.
Dr. Tripto-Shkolnik will provide context on the results of the
study and the benefits of an oral drug to treat osteoporosis. Also
on the call will be Entera CEO, Spiros Jamas; President of R&D,
Phillip Schwartz; Chief Medical Officer, Art Santora; and CFO,
Ramesh Ratan.
The conference call will take place on
Wednesday, June 30, 2021 from 12-1pm EDT and will include a
question-and-answer session. To participate on 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 following the
presentation.
About Entera Bio
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 complete3-month biomarker 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, 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 those 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 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 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 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, 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.
Contact:
Spiros Jamas, CEO
Tel: +001 617-362-3579
spiros@enterabio.com
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