TEL-AVIV, Israel and RALEIGH, NC, July 22,
2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq:
RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical
company, today announced the signing of a Global Termination
Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and
HCR Redhill SPV, LLC (the "Agreement"). As a result of the
Agreement, RedHill received approximately $9.9 million in cash and gained full control over
an additional $0.74 million currently
held in a restricted account, leading to an increase of
approximately $12.2 million in
liabilities for RedHill, reflecting assumed and settled liabilities
between the parties, resulting in a net balance sheet reduction of
approximately $2.3 million. In
addition, the Agreement ends all existing credit ties with the
Agreement parties, removes the existing lien against
Talicia® and restores control over cash collections
back to RedHill.
Razi Ingber, RedHill's Chief
Financial Officer, said: "We are very pleased to reach this
smooth conclusion, which strengthens RedHill's cash position and
greatly enhances our ability to manage our cash. The Agreement
eliminates substantially all encumbrances related to the previous
Movantik divestment and Credit Agreements, allowing us to better
focus on our R&D and commercial activities and return the
Company to a growth mode. This is a new chapter for RedHill."
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 / X.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. 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 8, 2024. 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: Commercial
[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.
