TEL
AVIV, Israel and RALEIGH,
N.C., Sept. 5, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that it
received confirmation from the Listings Qualifications Department
of The Nasdaq Stock Market LLC (the "Listings Qualifications
Department") that the Company had regained compliance with the
minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2)
for continued listing on The Nasdaq Capital Market ("Nasdaq"), and
is now compliant with applicable listing standards for continued
Nasdaq listing. To regain compliance with Nasdaq Listing Rule
5550(a)(2), the Company was required to maintain a minimum closing
bid price for its American Depositary Shares (the "ADSs") of
$1.00 per share or more for at least
10 consecutive business days, which was achieved on September 3, 2024.
About RedHill Biopharma
RedHill Biopharma Ltd.
(Nasdaq: RDHL) is a specialty biopharmaceutical company primarily
focused on gastrointestinal and infectious diseases. RedHill
promotes the gastrointestinal drugs Talicia®, for
the treatment of Helicobacter pylori (H. pylori) infection
in adults[1], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[2]. RedHill's key clinical late-stage
development programs include: (i) opaganib (ABC294640),
a first-in-class oral broad-acting, host-directed
SPHK2 selective inhibitor with potential for pandemic preparedness,
targeting multiple indications with a U.S. government collaboration
for development for Acute Radiation Syndrome (ARS), a Phase 2/3
program for hospitalized COVID-19, and a Phase 2 program in
oncology; (ii) RHB-107 (upamostat), an oral
broad-acting, host-directed, serine protease inhibitor with
potential for pandemic preparedness is in late-stage development as
a treatment for non-hospitalized symptomatic COVID-19, with
non-dilutive external funding covering the entirety of the RHB-107
arm of the 300-patient Phase 2 adaptive platform trial, and is also
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iii) RHB-102, with potential UK submission
for chemotherapy and radiotherapy induced nausea and vomiting,
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D;
(iv) RHB-104, with positive results from a first Phase
3 study for Crohn's disease; and (v) RHB-204, a
Phase 3-stage program for pulmonary nontuberculous mycobacteria
(NTM) disease.
More information about the Company is available at
www.redhillbio.com / X.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. Such
statements may be preceded by the words "intends," "may," "will,"
"plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential" or similar
words and include, among others, statements regarding the Company's
ability to maintain compliance with Nasdaq's minimum bid price and
other continued listing requirements. Forward-looking statements
are based on certain assumptions and are subject to various known
and unknown risks and uncertainties, many of which are beyond the
Company's control and cannot be predicted or quantified, and
consequently, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, without limitation: market and other
conditions; the risk that the addition of new revenue generating
products or out-licensing transactions will not occur; the risk
that acceptance onto the RNCP Product Development Pipeline will not
guarantee ongoing development or that any such development will not
be completed or successful; the risk that the FDA does not agree
with the Company's proposed development plans for opaganib for any
indication; the risk that observations from preclinical studies are
not indicative or predictive of results in clinical trials; the
risk that the FDA pre-study requirements will not be met and/or
that the Phase 3 study of RHB-107 in COVID-19 outpatients will not
be approved to commence or if approved, will not be completed or,
should that be the case, that we will not be successful in
obtaining alternative non-dilutive development funding for RHB-107;
the risk that RHB-107's late-stage development for non-hospitalized
COVID-19 will not benefit from the resources redirected from the
terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19
study for RHB-107 may not be successful and, even if successful,
such studies and results may not be sufficient for regulatory
applications, including emergency use or marketing applications,
and that additional COVID-19 studies for opaganib and RHB-107 are
likely to be required; the risk that the Company will not
successfully commercialize its products; as well as risks and
uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, pre-clinical
studies, clinical trials, and other therapeutic candidate
development efforts, and the timing of the commercial launch of its
commercial products and ones it may acquire or develop in the
future; (ii) the Company's ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
pre-clinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
extent and number and type of additional studies that the Company
may be required to conduct and the Company's receipt of regulatory
approvals for its therapeutic candidates, and the timing of other
regulatory filings, approvals and feedback; (iv) the manufacturing,
clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates and
Talicia®; (v) the Company's ability to
successfully commercialize and promote Talicia®
and Aemcolo®; (vi) the Company's ability to
establish and maintain corporate collaborations; (vii) the
Company's ability to acquire products approved for marketing in the
U.S. that achieve commercial success and build its own marketing
and commercialization capabilities; (viii) the interpretation of
the properties and characteristics of the Company's therapeutic
candidates and the results obtained with its therapeutic candidates
in research, pre-clinical studies or clinical trials; (ix) the
implementation of the Company's business model, strategic plans for
its business and therapeutic candidates; (x) the scope of
protection the Company is able to establish and maintain for
intellectual property rights covering its therapeutic candidates
and its ability to operate its business without infringing the
intellectual property rights of others; (xi) parties from whom the
Company licenses its intellectual property defaulting in their
obligations to the Company; (xii) estimates of the Company's
expenses, future revenues, capital requirements and needs for
additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry; and (xv) the hiring and
employment commencement date of executive managers. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on April 8, 2024. All
forward-looking statements included in this press release are made
only as of the date of this press release. The Company assumes no
obligation to update any written or oral forward-looking statement,
whether as a result of new information, future events or otherwise
unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
[1] Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is indicated for the treatment of H. pylori infection in
adults. For full prescribing information see: www.Talicia.com.
[2] Aemcolo® (rifamycin) is indicated
for the treatment of travelers' diarrhea caused by noninvasive
strains of Escherichia coli in adults. For full prescribing
information see: www.Aemcolo.com.
View original
content:https://www.prnewswire.com/news-releases/redhill-biopharma-regains-compliance-with-nasdaq-minimum-bid-price-requirement-302239249.html
SOURCE RedHill Biopharma Ltd.