Entera Bio Regains Compliance with Nasdaq Minimum Bid Price Requirement
March 04 2024 - 8:30AM
Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides, announced
today that it received notice from The NASDAQ Stock Market LLC
(NASDAQ) on March 1, 2024, informing the Company that it has
regained compliance with the minimum bid price requirement under
NASDAQ Listing Rule 5550(a)(2) (the “Rule”) for continued listing
on The NASDAQ Capital Market and the matter is now closed.
To regain compliance with the Rule, the
Company’s ordinary shares were required to maintain a minimum
closing bid price of $1.00 or more for at least 10 consecutive
business days, which was achieved on March 1st, 2024.
About Entera Bio
Entera is a clinical stage company focused on
developing oral peptide or protein replacement therapies for
significant unmet medical needs where an oral tablet form holds the
potential to transform the standard of care. The Company leverages
on a disruptive and proprietary technology platform and its
pipeline includes five differentiated, first-in-class oral peptide
programs, expected to enter the into the clinic (Phase 1 to Phase
3) by 2025. The Company’s most advanced product candidate, EB613
(oral PTH (1-34), teriparatide), is being developed as the first
oral, osteoanabolic (bone building) once-daily tablet
treatment for post-menopausal women with low BMD and high-risk
osteoporosis, with no prior fracture. A placebo controlled, dose
ranging Phase 2 study of EB613 tablets (n= 161) met primary
(PD/bone turnover biomarker) and secondary endpoints (BMD). Entera
is preparing to initiate a Phase 3 registrational study for EB613
pursuant to the FDA’s qualification of a quantitative BMD endpoint
which is expected to occur in 2024. The EB612 program is being
developed as the first oral PTH(1-34) tablet peptide replacement
therapy for hypoparathyroidism. Entera is also developing the first
oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in
tablet form for the treatment of obesity; and first oral GLP-2
peptide tablet as an injection-free alternative for patients
suffering from rare malabsorption conditions such as short bowel
syndrome in collaboration with OPKO Health. For more information on
Entera Bio, visit www.enterabio.com
Cautionary Statement Regarding Forward
Looking Statements
Various statements in this press release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements (other
than statements of historical facts) in this press release
regarding our prospects, plans, financial position, business
strategy and expected financial and operational results may
constitute forward-looking statements. 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 the
interpretation of clinical data; results of our clinical trials;
the FDA’s interpretation and review of our results from and
analysis of our clinical trials; 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; the
potential disruption and delay of manufacturing supply chains; loss
of available workforce resources, either by Entera or its
collaboration and laboratory partners; impacts to research and
development or clinical activities that Entera may be contractually
obligated to provide; overall regulatory timelines; the size and
growth of the potential markets for our product candidates; 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 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 “Cautionary
Statements Regarding Forward-Looking Statements,” “Risk Factors”
and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” sections of Entera’s most recent Annual
Report on Form 10-K filed with the SEC, as well as the company’s
subsequently filed Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K. 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 or implied in such
forward-looking statements and estimates will be achieved. Entera
cautions investors not to rely on the forward-looking statements
Entera makes in this press release. The information in this press
release is provided only as of the date of this press release, and
Entera undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise, except to the extent required by
law.
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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