Free
Writing Prospectus dated January 12, 2021
Filed
pursuant to Rule 433
Relating
to the Preliminary Prospectus Supplement dated
January
11, 2021
Registration Statement No. 333-226278
RedHill Biopharma Increases Previously Announced
Bought
Deal to $25 Million
TEL AVIV, Israel and RALEIGH, NC, January 12,
2021, RedHill Biopharma Ltd. (Nasdaq: RDHL)
(“RedHill” or the “Company”), a specialty biopharmaceutical
company, today announced that due to demand, the underwriter has
agreed to increase the size of the previously announced offering
and purchase on a firm commitment basis 3,188,776 American
Depositary Shares (ADSs) of the Company, at a price to the public
of $7.84 per ADS, less underwriting discounts and commissions. Each
ADS represents ten ordinary shares, par value NIS 0.01 per share,
of the Company. The closing of the offering is expected to occur on
or about January 14, 2021, subject to satisfaction of customary
closing conditions.
H.C.
Wainwright & Co. is acting as the sole book-running manager for
the offering.
The Company also has granted to the
underwriter a 30-day option to purchase up to additional 478,316
ADSs at the public offering price, less underwriting discounts and
commissions.
The gross proceeds to RedHill,
before deducting underwriting discounts and commissions and
offering expenses and assuming no exercise of the underwriter’s
option to purchase additional ADSs, are expected to be
approximately $25 million. The Company intends to use the net
proceeds from this offering to fund its clinical development
programs, commercialization activities and for acquisitions and
general corporate purposes.
The securities
described above are being offered by RedHill pursuant to a "shelf"
registration statement on Form F-3 (File No. 333-226278) previously
filed with the Securities and Exchange Commission (the “SEC”) on
July 23, 2018 and declared effective by the SEC on July 31, 2018.
The offering of the securities is being made only by means of a
prospectus, including a prospectus supplement, forming a part of
the effective registration statement. A preliminary prospectus
supplement and accompanying prospectus relating to the securities
being offered have been filed with the SEC and are available on the
SEC's website at http://www.sec.gov. A final
prospectus supplement and the accompanying prospectus relating to
the offering will be filed with the SEC and , upon filing, 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 (646) 975-6996 or e-mail at
placements@hcwco.com.
This press
release shall not constitute an offer to sell or a solicitation of
an offer to buy these securities, 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,
Movantik®
for opioid-induced constipation in adults1,
Talicia® for
the treatment of Helicobacter
pylori (H. pylori) infection in adults2,
and Aemcolo®
for the treatment of travelers’ diarrhea in adults3.
RedHill’s key clinical late-stage development programs include: (i)
RHB-204, with an ongoing Phase 3 study for
pulmonary nontuberculous mycobacteria (NTM) disease; (ii)
opaganib (Yeliva®),
a first-in-class SK2 selective inhibitor
targeting multiple indications with a Phase 2/3 program for
COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a
first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®),
with positive results from a Phase 3 study for acute
gastroenteritis and gastritis and positive results from a Phase 2
study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine
protease inhibitor with a planned Phase 2/3 study in symptomatic
COVID-19 and targeting multiple other cancer and inflammatory
gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation.
More information about the Company is available at
www.redhillbio.com.
This
press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements may be preceded by the words “intends,” “may,”
“will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar
words. Forward-looking statements include statements regarding: the
completion of the offering, the satisfaction of customary closing
conditions related to the offering and the intended use of net
proceeds from the offering. 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 and the satisfaction of customary closing conditions
related to the offering; the risk that the Company will not succeed
to complete the patient recruitment; the risk that the Company will
not receive the relevant data required for benefiting from the Fast
Track designation; the risk that the U.S. Phase 3 clinical study
evaluating RHB-204 will not be successful or, if successful, will
not suffice for regulatory marketing approval without the need for
additional clinical and/or other studies; 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®
and Movantik®;
(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 March 4, 2020. 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
|
Media contact
(U.S.):
Bryan
Gibbs
Vice
President
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
|
1
Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
2
Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
3
Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
2