TEL
AVIV, Israel and RALEIGH, N.C.,
Jan. 26,
2024 /PRNewswire/ -- RedHill Biopharma Ltd.
(NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that it has closed its
previously announced registered direct offering for the purchase
and sale of 10,000,000 of the Company's American Depositary Shares
("ADSs"), each ADS representing four hundred (400) ordinary shares,
at a purchase price of $0.80 per ADS.
In addition, in a concurrent private placement, the Company issued
unregistered warrants to purchase up to 10,000,000 ADSs. The
warrants have an exercise price of $1.00 per ADS, are immediately exercisable upon
issuance and have a term of five years following the issuance
date.
H.C. Wainwright & Co. acted as the exclusive placement agent
for the offering.
The gross proceeds to the Company from the offering were
$8 million, before deducting
placement agent's fees and other offering expenses payable by the
Company. The Company intends to use the net proceeds from the
offering for general working capital, acquisitions, research and
development, and general corporate purposes.
The ADSs described above (but not the warrants issued in the
private placement or the ADSs underlying the warrants) were offered
by the Company pursuant to a "shelf" registration statement on Form
F-3 (File No. 333-258259) previously filed with the Securities and
Exchange Commission (the "SEC") on July 29,
2021, and declared effective by the SEC on August 9, 2021. The offering of the ADSs was made
only by means of a prospectus, including a prospectus supplement,
forming a part of the effective registration statement. A
prospectus supplement and accompanying prospectus relating to the
offering of ADSs have been filed with the SEC. Electronic copies of
the prospectus supplement and accompanying prospectus may be
obtained on the SEC's website at http://www.sec.gov or by
contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd
Floor, New York, NY 10022, by
phone at (212) 865-5711 or e-mail at placements@hcwco.com.
The warrants described above were issued in a concurrent private
placement under Section 4(a)(2) of the Securities Act of 1933, as
amended (the "Securities Act"), and Regulation D promulgated
thereunder and, along with the ADSs underlying the warrants, have
not been registered under the Securities Act, or applicable state
securities laws. Accordingly, the warrants and underlying ADSs may
not be offered or sold in the United
States except pursuant to an effective registration
statement or an applicable exemption from the registration
requirements of the Securities Act and such applicable state
securities laws.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or other jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other
jurisdiction.
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 adults1,
and Aemcolo®, for the treatment of
travelers' diarrhea in
adults2. 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 from the offering, 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 the risk that the Company will not
comply with the listing requirements of the Nasdaq Capital Market
("Nasdaq") to remain listed for trading on Nasdaq, the
addition of new revenue generating products, out-licensing of the
Company's development pipeline assets, timing of opaganib's
development for Acute Radiation Syndrome, non-dilutive development
funding from RHB-107 and its inclusion in a key platform study.
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
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.