TenX Keane Acquisition (Nasdaq: TENKU, TENK, TENKR) (the “TenX”), a
publicly traded special purpose acquisition company, today
announced that on August 2, 2024, at the extraordinary general
meeting, its shareholders voted to approve the previously announced
business combination with the wholly owned oncology subsidiary of
Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), a
late-stage biopharmaceutical company dedicated to the development
and commercialization of first-in-class critical care products. 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 TenX, Citius Pharma, and Citius Pharma’s
oncology subsidiary. 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.
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. 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. 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
transiently 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 peripheral T-cell
lymphoma (PTCL) and CTCL, respectively. In 2021, denileukin
diftitox received regulatory approval in Japan for the treatment of
CTCL and 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.
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 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; 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; 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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