Full Press Release Details
ENTERA BIO ANNOUNCES MANAGEMENT CHANGES
BOSTON, Massachusetts & JERUSALEM,
Israel (August 10, 2020) - Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule
therapeutics, announced today that its Board of Directors has appointed Roger Garceau as Interim Chief Executive Officer, effective
immediately. Dr. Garceau will succeed Chief Executive Officer and Board Member Adam Gridley, who has resigned from the company
to pursue a new opportunity. Dr. Garceau will continue to serve as a Director of Entera Bio.
"I look forward to working with the
talented team at Entera as interim CEO to ensure that the EB613 development program remains on track and that we continue to advance
our pipeline, including the selection of a formulation of EB612 that we intend to move into a Phase 2b or Phase 3 pivotal clinical
trial. With several important data readouts for the Company over the coming months, including the final Phase 2 data from the EB613
Phase 2 trial in the first half of 2021, as well as numerous potential business development opportunities for our platform technology,
I am excited to join the management team," said Dr. Garceau.
Dr. Garceau is a seasoned pharmaceutical
executive with more than 30 years of industry experience and has served as a Director of the Company since March 2016 and as Chief
Development Advisor since December 2016. Prior to joining Entera, Dr. Garceau served as Chief Medical Officer and Executive Vice
President of NPS Pharmaceuticals, Inc. (NPS), since December 2008 and January 2013 respectively, until February 2015, when NPS
was acquired by Shire plc. Prior to his time at NPS, Dr. Garceau served in several managerial positions Sanofi-aventis and Pharmacia
Corporation. Dr Garceau has been a non-executive director of Enterome SA since December 2016. He is a board-certified pediatrician
and is a Fellow of the American Academy of Pediatrics. Dr. Garceau holds B.S. in Biology from Fairfield University in Fairfield,
Connecticut and an M.D. from the University of Massachusetts Medical School.
"On behalf of the Board, I would
like to thank Adam for his contributions and am excited that Roger is assuming the role of CEO. Roger's background, including
his experience with oral parathyroid hormone (PTH 1-34), makes him uniquely qualified to lead the Company at this exciting time.
With EB613 Phase 2 data on the horizon and the results of our recently completed market research which demonstrated the clear unmet
need for oral therapies that may offer osteoporosis patients a more convenient, needle free alternative to the current injectable
products currently available, this is a very exciting time for the Company," stated Gerald Lieberman, Entera's Chairman
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: 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 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; 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 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; Entera's interpretation of the results of the market research studies conducted to date; 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 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. 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.
Jonathan Lieber, CFO
Tel: +972-2-532-7151