TEL
AVIV, Israel and RALEIGH,
N.C., Jan. 25, 2024 /PRNewswire/ --
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company, today announced
that it has entered into definitive agreements with institutional
investors 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 a registered direct
offering. In addition, in a concurrent private placement, the
Company will issue unregistered warrants to purchase up to
10,000,000 ADSs. The warrants will have an exercise price of
$1.00 per ADS, will be immediately
exercisable upon issuance and have a term of five
years following the issuance date. The closing of the
offering is expected to occur on or about January 29, 2024, subject to the satisfaction of
customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement
agent for the offering.
The gross proceeds to the Company from the
offering are expected to be $8
million, before deducting the 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) are being 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 is made only by means of a prospectus,
including a prospectus supplement, forming a part of the effective
registration statement. A final prospectus supplement and
accompanying prospectus relating to the offering of ADSs will be
filed with the SEC. Electronic copies of the final prospectus
supplement and accompanying prospectus may be obtained, when
available, 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 are being 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
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 completion of the offering, the satisfaction of
customary closing conditions related thereto and 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 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 ability of the Company to satisfy all conditions
precedent to the closing of the offering, the completion of the
offering, the intended use of proceeds from the offering, 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.