UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report
of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month
of January 2021
Commission File No.:001-35773
REDHILL BIOPHARMA LTD.
(Translation of
registrant’s name into English)
21
Ha'arba'a Street, Tel Aviv, 6473921, Israel
(Address of
principal executive offices)
Indicate by check mark whether the registrant files or will file
annual reports under cover Form 20-F or Form
40-F.
Form
20-F ☒ Form 40-F ☐
Indicate by check mark if the Registrant
is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the Registrant
is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): ____
Attached
hereto and incorporated by reference herein is a press release
issued by the Registrant entitled: "RedHill Biopharma Announces Closing of $25
Million Bought Deal Offering".
This Form 6-K
shall not constitute an offer to sell or the solicitation of an
offer to buy the securities described herein, nor shall there be
any sale of the securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such
jurisdiction.
This Form 6-K
is incorporated by reference into the Company's Registration
Statements on Form S-8 filed with the Securities and Exchange
Commission on May 2, 2013 (Registration No. 333-188286), on October
29, 2015 (Registration No. 333-207654), on July 25, 2017
(Registration No. 333-219441), on May 23, 2018 (Registration No.
333-225122) and on July 24, 2019 (File No. 333-232776) and its
Registration Statements on Form F-3 filed with the Securities and
Exchange Commission on February 25, 2016 (Registration No.
333-209702), on July 23, 2018 (File No. 333-226278) and on July 24,
2019 (File No. 333-232777).
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
|
|
REDHILL BIOPHARMA LTD.
|
|
|
|
(the "Registrant")
|
|
|
|
|
|
|
|
Date: January 14, 2021
|
By:
|
/s/ Dror
Ben-Asher
|
|
|
|
Dror Ben-Asher
|
|
|
|
Chief Executive Officer
|
|
RedHill Biopharma Announces Closing of $25 Million Bought
Deal Offering
TEL
AVIV, Israel and RALEIGH, NC, January 14, 2021, RedHill Biopharma
Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a
specialty biopharmaceutical company, today announced the closing of
its previously announced underwritten offering of 3,188,776
American Depositary Shares (ADSs) of the Company, at a price to the
public of $7.84 per ADS. Each ADS represents ten ordinary shares,
par value NIS 0.01 per share, of the Company.
H.C. Wainwright & Co. acted 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, are 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 were 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 was 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 securities offered have
been filed with the SEC and are available on the SEC's website at
http://www.sec.gov and may also be obtained 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
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; 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.
