TEL
AVIV, Israel & RALEIGH,
N.C., Nov. 14, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that it has
received approval from the Listing Qualifications Department of The
Nasdaq Stock Market LLC ("Nasdaq") to transfer the listing of the
American Depositary Shares ("ADSs") to the Nasdaq Capital Market.
The ADSs will be transferred to the Nasdaq Capital Market at the
opening of business on November 15,
2023.
Trading of RedHill ADSs will be unaffected by the transfer, with
no break in trading, and will continue under the same ticker symbol
of "RDHL" and utilizing the existing CUSIP number.
Having not regained compliance with the minimum Market Value of
Publicly Held Shares ("MVPHS") requirement pursuant to Nasdaq
Listing Rule 5450(b)(3)(C) by the applicable compliance period, the
Company received a delisting notification letter from Nasdaq on
November 8, 2023, which notified the
Company that the ADSs would be delisted from the Nasdaq Global
Market, and also offered the Company the option of pursuing a
listing on the Nasdaq Capital Market. As previously disclosed, on
May 9, 2023, the Company received a
written notification from Nasdaq, indicating that the Company was
not in compliance with the MVPHS requirement for a period of 30
consecutive business days, set forth in the Nasdaq Listing Rules
for continued Nasdaq listing.
Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the Company was
granted a compliance period of 180 calendar days (or until
November 6, 2023) to achieve
compliance with the MVPHS requirement. On November 9, 2023, the Company submitted its
application to transfer the listing of the ADSs from the Nasdaq
Global Market to the Nasdaq Capital Market, and on November 13, 2023, the Company received a written
notice from Nasdaq approving the transfer of the listing of the
ADSs to the Nasdaq Capital Market at the opening of business on
November 15, 2023. Completion of the
transfer to the Nasdaq Capital Market will result in the closure of
the Company's compliance review.
As previously disclosed, on September 19,
2023, the Company received a letter from the Listing
Qualifications Department of Nasdaq indicating that the bid price
of the ADSs had closed at less than $1.00 per share over the previous 30 consecutive
business days, and, as a result, it did not comply with Listing
Rule 5450(a)(1). Therefore, in accordance with Listing Rule
5810(c)(3)(A), the Company was provided 180 calendar days, or until
March 18, 2024, to regain compliance. The transfer to the Nasdaq
Capital Market will not affect this compliance period.
If compliance with the $1.00
minimum bid price requirement cannot be demonstrated by
March 18, 2024, the Company may be
eligible for an additional compliance period if it meets the
continued listing requirement for MVPHS and all other initial
listing standards for the Nasdaq Capital Market, with the exception
of the minimum bid price requirement, which includes, among other
things, a minimum MVPHS requirement of $15
million, or alternatively $5
million and the required net income $750,000 from continuing operations in the most
recent completed fiscal year or in two of the three most recent
completed fiscal years.
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, 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. 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 comply with the
listing requirements of Nasdaq to remain listed for trade on Nasdaq
and will not be successful in its application for a hearing or that
such a hearing may not change the current delisting notification
status, 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.