TEL
AVIV, ISRAEL and RALEIGH, N.C., Dec. 12,
2023 /PRNewswire/ -- RedHill Biopharma Ltd.
(Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that it received
confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it
had regained compliance with the minimum bid price requirement
under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing,
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 of $1.00 or more
for at least 10 consecutive trading days, which was achieved on
December 8, 2023.
As previously announced, on September 22,
2023, the Company reported that it had received notification
that for the previous thirty consecutive business days, the bid
price for the American Depositary Shares (the "ADSs") had closed
below the minimum $1.00 per share
requirement for continued listing. On December 11, 2023, the Company received
notification from the Nasdaq Listings Qualifications Department
that the ADSs had, for the last 10 consecutive business days, a
closing bid price at $1.00 per share
or greater, and accordingly had regained compliance with Nasdaq
Listing Rule 5550(a)(2).
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 / twitter.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements, including, but not limited to, statements
regarding the intended use of net proceeds therefrom, may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims,"
"believes," "hopes," "potential" or similar words and include
statements regarding compliance with the listing requirements of
the Nasdaq Capital Market ("Nasdaq"). 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 Company will not remain in compliance
with the listing requirements of Nasdaq to remain listed for
trading on Nasdaq, 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 HB-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, 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, as well as risks and
uncertainties associated with 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 28, 2023. 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.
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SOURCE RedHill Biopharma Ltd.