LYMPHIR™ for the treatment of cutaneous T-cell
lymphoma approved by the FDA
Citius Pharmaceuticals, Inc. holds
approximately 90% of publicly traded Citius Oncology, Inc.
Shares of Citius Oncology, Inc. anticipated to
begin trading on Nasdaq under the ticker "CTOR" on August 13, 2024
CRANFORD, N.J., Aug. 12, 2024 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq:
CTXR), a late-stage biopharmaceutical company dedicated to the
development and commercialization of first-in-class critical care
products, today announced that it has completed the previously
announced merger of its oncology subsidiary with TenX Keane
Acquisition ("TenX") (Nasdaq: TENK),
a publicly traded special purpose acquisition company. The combined
company will operate as Citius Oncology, Inc. ("Citius Oncology")
and is expected to begin trading on August
13, 2024 on the Nasdaq stock exchange under the ticker
symbol CTOR.
"This transaction is a significant milestone, providing us
greater financial and strategic flexibility to advance our
late-stage assets. We believe a publicly traded Citius Oncology
offers a unique pure play investment opportunity and is better
positioned to unlock the value of LYMPHIR, which was approved by
the FDA last week. With this transaction, we look forward to
launching LYMPHIR, facilitating future growth initiatives, and
exploring additional potential oncology assets. It is our intention
to distribute of a portion of our shares of Citius Oncology to
Citius Pharma shareholders in the future," stated Leonard Mazur, Chairman and CEO of Citius Pharma
and Citius Oncology.
"This transaction also enables Citius Pharma to focus on growing
and unlocking the value of other assets in its portfolio, including
our novel Mino-Lok antibiotic lock solution which
recently achieved primary and secondary endpoints in a Phase 3
Trial and is now another step closer to entering a $1.8 billion market," added Mazur.
As it has in the past, Citius Oncology will operate under a
shared services agreement with Citius Pharma for the services of
several key members of the Citius Pharma team, led by Leonard Mazur, Chief Executive Officer,
Jaime Bartushak, Chief Financial
Officer and Dr. Myron Czuczman,
Chief Medical Officer. Myron
Holubiak will serve as Executive Vice Chairman of the Citius
Oncology Board of Directors.
About the Merger
Pursuant to the agreement, TenX acquired Citius Pharma's wholly
owned subsidiary via a merger, with the newly combined publicly
traded company renamed Citius Oncology, Inc. As part of the
transaction, all shares of Citius Pharma's wholly owned subsidiary
were converted into the right to receive common stock of Citius
Oncology. Citius Pharma holds approximately 90% of the newly
public company. An additional 12.75 million existing options will
be assumed by Citius Oncology.
The description of the transaction contained herein is only a
summary and is qualified in its entirety by reference to the merger
agreement, a copy of which has been filed by Citius Pharma in a
Current Report on Form 8-K, filed with the U.S. Securities and
Exchange Commission on October 24,
2023.
Advisors
Maxim Group LLC is acting as exclusive financial advisor to
Citius Pharma and Newbridge Securities Corporation is acting as
exclusive financial advisor to TenX. Wyrick
Robbins Yates & Ponton LLP is acting as legal advisor to
Citius Pharma and Citius Oncology. The Crone Law Group P.C. is
acting as legal advisor to TenX.
About Citius Oncology, Inc.
Citius Oncology will serve as 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. Citius Oncology
is a publicly traded subsidiary of Citius Pharmaceuticals. For more
information, please visit www.citiusonc.com
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a specially engineered IL-2- diphtheria toxin fusion
protein made using recombinant DNA technology. It works by
targeting cells that have IL-2 receptors with a toxin derived from
diphtheria bacteria. Once inside the cell, this toxin stops the
cell from making proteins, which leads to cell death. LYMPHIR has
two main effects. It directly kills tumor cells by binding to the
IL-2 receptors and internalizing the diphtheria toxin directly into
the tumor cells, causing them to die. Additionally, it boosts the
body's immune response by reducing the number of regulatory T-cells
(Tregs) that suppress the immune system, thereby enhancing the
body's ability to fight the tumor. LYMPHIR is unique as the only
IL-2 receptor targeted CTCL therapy, offering a novel option to
patients cycling through multiple treatments.
In 2011 and 2013, the FDA granted orphan drug designation to
LYMPHIR for the treatment of PTCL and CTCL, respectively. In 2021,
denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and peripheral
T-cell lymphoma (PTCL). Subsequently, in 2021, Citius Pharma
acquired an exclusive license with rights to develop and
commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. In August
2024, 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.
Additional value-creating opportunities in larger markets
include potential indications in peripheral T-cell lymphoma or as a
combination therapy with CAR-T and PD-1 inhibitors, and in markets
outside the U.S. Currently, two investigator-initiated trials are
underway to explore LYMPHIR's potential as an immuno-oncology
combination therapy.
Please read Important Safety Information and full
Prescribing Information, including Boxed WARNING, for LYMPHIR at
www.lymphirhcp.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. 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 that is now being developed by Citius
Oncology. 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. 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 that apply to Citius Pharma and
Citius Oncology as our majority owned subsidiary, are: the
anticipated benefits of the transaction between TenX Keane
Acquisition and Citius Pharma to form Citius Oncology may not be
realized fully, if at all, or may take longer to realize than
expected; Citius Oncology's ability to commercialize LYMPHIR; our
need for substantial additional funds; risks relating to the
results of research and development activities, including those
from our existing and any new pipeline assets; our ability to
commercialize any of our other product candidates approved by the
FDA; our dependence on third-party suppliers; our ability to
procure cGMP commercial-scale supply; 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; 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 may be further
impacted by any future public health risks or geopolitical events.
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 our Annual Report on
Form 10-K for the year ended September 30,
2023, filed with the SEC on December
29, 2023, and 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
ir@citiusonc.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.