Citius Pharmaceuticals to receive 65.6 million
shares of TenX Keane, which will be renamed Citius Oncology,
Inc.
Citius Pharmaceuticals to retain approximately
90% majority control post transaction
Post-merger company expected to trade on
Nasdaq as Citius Oncology, Inc.
Transaction expected to support
commercialization of LYMPHIR, if approved, and exploration of
additional oncology assets
CRANFORD, N.J., Aug. 5, 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
shareholders of TenX Keane Acquisition ("TenX") (Nasdaq:
TENK), a publicly traded special
purpose acquisition company, have voted to approve the previously
announced business combination with Citius Pharma's oncology
subsidiary. The newly combined public company will continue to
trade on the Nasdaq stock exchange and is to be renamed Citius
Oncology, Inc. ("Citius Oncology").
The transaction has been unanimously approved by the Board of
Directors of both companies and Citius Pharma. Subject to certain
contractual as well as customary closing conditions, the merger is
expected to be completed in the coming weeks.
The transaction is expected to provide Citius Oncology with
improved access to the public equity markets, support the
commercialization of LYMPHIR, if approved, and position the company
to explore additional targeted oncology opportunities.
"We look forward to closing this transaction in the coming weeks
and unlocking and growing the value of our oncology asset,"
stated Leonard Mazur, Chairman and
CEO of Citius Pharma.
About the Merger
Pursuant to the proposed agreement, TenX will acquire Citius
Pharma's wholly owned subsidiary via a merger, with the newly
combined publicly traded company to be named Citius Oncology, Inc.
In the transaction, all shares of Citius Pharma's wholly owned
subsidiary would be converted into the right to receive common
stock of Citius Oncology. As a result, upon closing, Citius
Pharma would hold approximately 65.6 million shares of common stock
of Citius Oncology which would represent approximately 90% of the
newly public company. As part of the transaction, Citius Pharma
will contribute $10 million in cash
to Citius Oncology. An additional 12.75 million existing options
will be assumed by Citius Oncology.
At closing, any cash remaining in TenX's trust account along
with the cash provided by Citius Pharma will be contributed to
Citius Oncology for working capital and general corporate purposes
of Citius Oncology following the transaction. References to
available cash from the TenX trust account and retained transaction
proceeds are subject to any redemptions by the public stockholders
of TenX and payment of transaction fees and expenses.
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. The company is
seeking approval from the U.S. Food and Drug Administration (FDA)
of LYMPHIR™ for an orphan indication in the treatment of persistent
or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of
non-Hodgkin lymphoma. 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.
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. If approved, LYMPHIR would be
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. The FDA is reviewing a Biologics License
Application (BLA) for LYMPHIR and has set August 13, 2024, as the PDUFA target action date.
If approved, LYMPHIR could be commercially available as early as
the fourth quarter of 2024 for the treatment of persistent or
recurrent CTCL. 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.
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical company
dedicated to the development and commercialization of
first-in-class critical care products. The Company's diversified
pipeline includes two late-stage product candidates. In
May 2024, Citius Pharma announced
positive topline data of Mino-Lok®, its antibiotic lock solution to
salvage catheters in patients with catheter-related bloodstream
infections. Following the expected merger of Citius Oncology and
TenX, Citius Pharma would hold approximately 90% of Citius
Oncology, a standalone publicly traded company, with LYMPHIR as its
primary asset. In addition, Citius Pharma completed
enrollment in its Phase 2b trial of
CITI-002 (Halo-Lido), a topical formulation for the relief of
hemorrhoids. 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 are: the planned transaction between
TenX Keane Acquisition and Citius Pharma to form Citius Oncology
may not be completed for failure to meet closing conditions or
other reasons; the anticipated benefits of the transaction may not
be realized fully, if at all, or may take longer to realize than
expected; the FDA may not approve LYMPHIR; risks relating to the
results of research and development activities, including those
from our existing and any new pipeline assets; our need for
substantial additional funds; our ability to commercialize our
products if approved by the FDA; our dependence on third-party
suppliers; our (including that of Citius Oncology as a majority
owned subsidiary) 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
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.
