CRANFORD,
N.J., Jan. 6, 2025 /PRNewswire/ -- Citius
Oncology, Inc. ("Citius Oncology" or "the Company") (Nasdaq: CTOR),
a majority-owned subsidiary of Citius Pharmaceuticals, Inc.
("Citius Pharma") (Nasdaq: CTXR), today announced that it has
retained Jefferies LLC as its exclusive financial advisor to assist
in evaluating strategic alternatives aimed at maximizing
shareholder value.
The engagement of Jefferies underscores Citius
Oncology's commitment to exploring all avenues for enhancing its
strategic positioning and advancing its mission to improve patient
outcomes in oncology. Strategic alternatives under consideration
may include, but are not limited to, partnerships, joint ventures,
mergers, acquisitions, licensing or other strategic
transactions.
"We are excited to partner with Jefferies, a
leading global investment bank with deep expertise in the life
sciences sector, to help us explore opportunities that align with
our long-term vision. As we prepare to launch our first cancer
therapy, now is an opportune time to review options that would be
in the best interests of patients and shareholders," said
Leonard Mazur, Chief Executive
Officer of Citius Oncology. "Our goal is to deliver value to
shareholders by making a meaningful impact in the oncology
space."
Citius Oncology is committed to commercializing
LYMPHIR™, recently approved by the U.S. Food and Drug
Administration (FDA) for the treatment of patients with relapsed or
refractory Stage I-III cutaneous T-cell lymphoma (CTCL) following
at least one prior systemic therapy.
The Company has not set a specific timeline for
the strategic engagement and does not intend to disclose
developments unless and until its Board of Directors has approved a
specific transaction or course of action, or the company otherwise
determines that disclosure is appropriate or necessary. There can
be no assurance, however, that this process will result in a
strategic transaction or other alternative.
About LYMPHIR™ (denileukin
diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed
or refractory CTCL indicated for use in Stage I-III disease after
at least one prior systemic therapy. It is a recombinant fusion
protein that combines the IL-2 receptor binding domain with
diphtheria toxin fragments. The agent specifically binds to IL-2
receptors on the cell surface, causing diphtheria toxin fragments
that have entered cells to inhibit protein synthesis. After uptake
into the cell, the DT fragment is cleaved and the free DT fragments
inhibit protein synthesis, resulting in cell death. Denileukin
diftitox-cxdl demonstrated the ability to deplete immunosuppressive
regulatory T lymphocytes (Tregs) and antitumor activity through a
direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory
approval in Japan for the
treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired
an exclusive license with rights to develop and commercialize
LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR was approved by the FDA in
August 2024.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a
platform to develop and commercialize novel targeted oncology
therapies. In August 2024, its
primary asset, LYMPHIR, was approved by the FDA for the treatment
of adults with relapsed or refractory CTCL who had had at least one
prior systemic therapy. Management estimates the initial market for
LYMPHIR currently exceeds $400
million, is growing, and is underserved by existing
therapies. Robust intellectual property protections that span
orphan drug designation, complex technology, trade secrets and
pending patents for immuno-oncology use as a combination therapy
with checkpoint inhibitors would further support Citius Oncology's
competitive positioning. For more information, please visit
www.citiusonc.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a
biopharmaceutical company dedicated to the development and
commercialization of first-in-class critical care products. In
August 2024, the FDA approved
LYMPHIR, a targeted immunotherapy for an initial indication in the
treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage
pipeline also includes Mino-Lok®, an antibiotic lock
solution to salvage catheters in patients with catheter-related
bloodstream infections, and CITI-002 (Halo-Lido), a topical
formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial
for Mino-Lok and a Phase 2b trial for
Halo-Lido were completed in 2023. Mino-Lok met primary and
secondary endpoints of its Phase 3 Trial. Citius is actively
engaged with the FDA to outline next steps for both programs.
Citius Pharmaceuticals owns 92% of Citius Oncology. For more
information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
Such statements are made based on our expectations and beliefs
concerning future events impacting Citius. You can identify these
statements by the fact that they use words such as "will,"
"anticipate," "estimate," "expect," "plan," "should," and "may" and
other words and terms of similar meaning or use of future dates.
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial
condition and stock price. Factors that could cause actual
results to differ materially from those currently anticipated, and,
unless noted otherwise, that apply to Citius Pharma and Citius
Oncology, are: whether the objectives of the strategic alternative
review process will be achieved; the timing, terms, structure,
benefits and costs of a strategic transaction, if any; the risk
that the strategic alternatives review and its announcement could
have an adverse effect on the ability of the Company to retain and
hire key personnel and maintain business relationships and on its
operating results and business generally; our ability to
commercialize LYMPHIR and any of our other product candidates that
may be approved by the FDA; our need for substantial additional
funds; the estimated markets for our product candidates and the
acceptance thereof by any market; the ability of our product
candidates to impact the quality of life of our target patient
populations; risks relating to the results of research and
development activities, including those from our existing and any
new pipeline assets; our dependence on third-party suppliers; our
ability to procure cGMP commercial-scale supply; our ability to
obtain, perform under and maintain financing and strategic
agreements and relationships; uncertainties relating to preclinical
and clinical testing; the early stage of products under
development; market and other conditions; risks related to our
growth strategy; patent and intellectual property matters; our
ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis;
government regulation; competition; as well as other risks
described in our SEC filings. These risks have been and may be
further impacted by any future public health risks. Accordingly,
these forward-looking statements do not constitute guarantees of
future performance, and you are cautioned not to place undue
reliance on these forward-looking statements. Risks regarding our
business are described in detail in our Securities and Exchange
Commission ("SEC") filings which are available on the SEC's website
at www.sec.gov, including in Citius Oncology's and Citius Pharma's
Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on
December 27, 2024, as updated by our
subsequent filings with the SEC. These forward-looking statements
speak only as of the date hereof, and we expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Oncology, Inc.
