On August 7, 2024, TenX Keane Acquisition (Nasdaq: TENKU, TENK,
TENKR) (“TenX”), a publicly traded special purpose acquisition
company, was notified by The Nasdaq Stock Market that trading in
TenX’s securities had been halted for “additional information
requested” from the company. The trading halt was imposed following
volatility in the trading price and volume of TenX’s securities on
Wednesday, August 7, 2024. TenX and its advisors have been in
contact with representatives of Nasdaq regarding the lifting of the
trading halt. While the trading halt is in place, TenX understands
that its securities cannot be traded on any other exchange or in
the over-the-counter market.
On August 8, 2024, Citius Pharmaceuticals, Inc.
(“Citius Pharma”) (Nasdaq: CTXR) announced that the FDA had
approved LYMPHIR™ (denileukin diftitox-cxdl) for the treatment of
relapsed or refractory (r/r) cutaneous T-cell lymphoma after at
least one prior systemic therapy.
TenX and Citius Pharma are working diligently
toward closing and expect it to occur in the near future. The newly
combined public company is to be renamed Citius Oncology, Inc. and
will continue to trade on the Nasdaq stock exchange under the
symbol “CTOR.”
About the Merger
Pursuant to the business combination 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 will be converted into the right
to receive common stock of the new public company, Citius Oncology.
As a result, upon closing, Citius Pharma will hold approximately
65.6 million shares of common stock of Citius Oncology which will
represent approximately 90% of the new public company. As part of
the transaction, Citius Pharma will contribute up to $10 million in
cash to Citius Oncology to fund transaction expenses and working
capital post-closing. An additional 12.75 million existing options
will be assumed by Citius Oncology from Citius Pharma’s
subsidiary.
The description of the transaction contained
herein is only a summary and is qualified in its entirety by
reference to the business combination agreement, a copy of which
has been filed by TenX in a Current Report on Form 8-K, filed with
the U.S. Securities and Exchange Commission on October 24,
2023.
Advisors
Newbridge Securities Corporation is acting as
exclusive financial advisor to TenX and Maxim Group LLC is acting
as exclusive financial advisor to Citius Pharma. The Crone Law
Group, P.C., Han Kun Law Offices, Ogier are acting as U.S., PRC,
and Cayman legal advisors to TenX, respectively. Wyrick Robbins
Yates & Ponton LLP is acting as legal advisor to Citius Pharma
and Citius Oncology.
About TenX Keane
Acquisition
TenX Keane Acquisition is a blank check company,
also commonly referred to as a special purpose acquisition company
(SPAC) formed for the purpose of effecting a merger, share
exchange, asset acquisition, share purchase, reorganization, or
similar business combination with one or more businesses or
entities. TenX is led by Xiaofeng Yuan, Chairman and Chief
Executive Officer, and Taylor Zhang, Chief Financial Officer, who
are growth-oriented executives with a long track record of value
creation across industries.
About Citius Oncology, Inc.
Citius Oncology will serve as a platform to
develop and commercialize novel targeted oncology therapies. In
August 2024, the U.S. Food and Drug Administration (FDA) approved
LYMPHIR for an orphan indication in the treatment of adults with
relapsed or refractory 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 targeted immune therapy for r/r
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.
About Citius Pharmaceuticals,
Inc.
Citius Pharma 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. 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 TenX. 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; risks relating to the results
of research and development activities, including those from our
existing and any new pipeline assets; the need for substantial
additional funds; the ability to commercialize products if approved
by the FDA; the dependence on third-party suppliers; the estimated
markets for product candidates and the acceptance thereof by any
market; the ability of product candidates to impact the quality of
life of target patient populations; the 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 December 31, 2023, filed with the SEC
on April 16, 2024, 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:
Taylor Zhangtarget@TenXkeane.com
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