TEL
AVIV, Israel & RALEIGH,
N.C., Sept. 22, 2023 /PRNewswire/
-- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company, today announced
that on September 19, 2023, it
received a letter from the Listings Qualifications Department of
The Nasdaq Stock Market LLC ("Nasdaq") indicating that, for the
thirty consecutive business days from August
7, 2023, to September 18,
2023, the bid price for the Company's American Depositary
Shares ("ADSs") had closed below the minimum $1.00 per share requirement for continued listing
on The Nasdaq Global Market under Nasdaq Listing Rule 5450(a)(1).
The Nasdaq letter is only a notification of deficiency and has no
immediate effect on the listing or trading of the Company's
ADSs.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the
Company has been provided an initial period of 180 calendar days,
or until March 18, 2024, to regain
compliance. The letter states that the Nasdaq staff will provide
written notification that the Company has achieved compliance with
Rule 5450(a)(1) if at any time before March
18, 2024, the bid price of the Company's ADSs closes at
$1.00 per share or more for a minimum
of ten consecutive business days.
RedHill's ADSs will continue to trade on The Nasdaq Global
Market, and the Company's operations are not affected by the
receipt of the Notice. RedHill intends to monitor the closing bid
price of its ADSs and may, if appropriate, consider implementing
available options to regain compliance with the minimum bid price
requirement. If the Company does not regain compliance by
March 18, 2024, the Company may be
eligible for an additional 180 calendar day period to regain
compliance, provided that the Company meets the continued listing
requirement for market value of publicly held shares ("MVPHS") and
all other initial listing standards, with the exception of the bid
price requirement, and would need to provide written notice of its
intention to cure the deficiency during the second compliance
period. However, as previously disclosed, RedHill received a
written notification from Nasdaq on May 9,
2023, indicating that RedHill is not in compliance with the
minimum MVPHS set forth in the Nasdaq Listing Rules for continued
listing on Nasdaq, and RedHill has not regained compliance with the
minimum MVPHS requirement. Pursuant to Nasdaq Listing Rule
5810(c)(3)(D), RedHill has a compliance period of 180 calendar days
(or until November 6, 2023) to regain compliance with the minimum
MVPHS requirement. In the event that the Company does not regain
compliance by November 6, 2023, the Company would become subject to
delisting unless it timely requests a hearing before a Nasdaq
Hearings Panel (the "Panel"). Should the Company not regain
compliance by that date, it is the Company's present intention to
request a hearing before the Panel. The hearing request would stay
any delisting or suspension action pending the hearing and the
expiration of any additional extension period granted by the Panel
following the hearing. The maximum extension period that could be
granted by the Panel is 180 calendar days from the forthcoming
delisting notice.
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
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 comply with the listing requirements of Nasdaq to
remain listed for trade 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.