Citius Pharmaceuticals, Inc. to receive
$675 million in equity of Citius
Oncology, Inc. and retain approximately 90% majority control in
publicly listed Citius Oncology, Inc. post transaction
Transaction anticipated to close in the first
half of 2024
CRANFORD, N.J. and NEW YORK, Oct. 24,
2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc.
("Citius Pharma" or the "Company") (Nasdaq: CTXR), a
biopharmaceutical company developing and commercializing
first-in-class critical care products, and TenX Keane Acquisition
("TenX") (NASDAQ: TENKU), a publicly traded special purpose
acquisition company (SPAC), today announced that they have
entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX
and Citius Pharma's wholly owned oncology subsidiary that will
continue as a public company listed on the Nasdaq exchange. The
newly combined public company will be named Citius Oncology, Inc.
("Citius Oncology"). Upon closing, pursuant to the terms of the
merger agreement, Citius Pharma would receive 67.5 million shares
in Citius Oncology at $10 per share
and retain majority ownership of approximately 90%. The transaction
has been approved by the Board of Directors of both companies and
is expected to close in the first half of 2024.
CITIUS ONCOLOGY OVERVIEW
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. 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. 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.
Preparations are underway for a Biologics License Application
(BLA) resubmission in early 2024. If approved, LYMPHIR could be
commercially available as early as the second half of 2024 for the
treatment of 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.
The transaction is expected to provide Citius Oncology with
improved access to the public equity markets and thereby facilitate
the commercialization of LYMPHIR and position the company to
explore additional value creating opportunities more fully.
CITIUS PHARMA AND TENX COMMENTS
"We believe this transaction will allow us to unlock the value
of LYMPHIR, and solidly position Citius Pharma to advance our
diversified pipeline. This transaction will enable Citius Oncology,
with access to the broader capital markets, to better support the
successful commercialization of LYMPHIR, if approved, and explore
additional potential targeted oncology therapies. Our majority
ownership position and shared services agreement ensures that the
Citius Pharma management team will remain fully engaged with the
development and commercialization efforts at Citius Oncology. As
previously announced, the Company is in the process of formulating
a plan of distribution of a portion of the shares of Citius
Oncology to its shareholders. At Citius Pharma, we intend to focus
on completing the Mino-Lok trial and continuing to evaluate next
steps with our Halo-Lido program," stated Leonard Mazur, Chairman and CEO of Citius
Pharma.
"We are very pleased to announce the proposed merger with Citius
Oncology," said Mr. Xiaofeng Yuan,
Chairman and CEO of TenX. "After undertaking a comprehensive
process with external advisors to explore and evaluate numerous
potential business combination targets, our board and management
team believe that this transaction with Citius Oncology represents
the best opportunity to create substantial value for our
stockholders. This business combination, if consummated, will
result in TenX investors owning an equity stake in a company that
is focused on developing and commercializing LYMPHIR to improve the
lives of patients with CTCL and additional potential upside from
combinations with other drugs as immuno-oncology therapies with
even larger addressable markets. We are thrilled to support Citius
Oncology at an inflection point in its development and to provide
an avenue for Citius to expeditiously meet its development
milestones."
THE PROPOSED MERGER AGREEMENT
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 receive 67.5 million shares of common stock of Citius
Oncology which, at an implied value of $10.00 per share, would be $675 million in equity of Citius Oncology, before
fees and expenses. 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 to support ongoing operations and planned
commercialization efforts. 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.
Upon closing, Citius Oncology will operate under a shared
services agreement with Citius Pharma, with fees payable quarterly
to 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.
The transaction, which has been unanimously approved by both
Boards of Directors of Citius Pharma and TenX, is subject to
approval by stockholders of TenX and other customary closing
conditions. Citius Pharma, as the sole holder of Citius Oncology
common stock, has approved the transaction. The proposed business
combination is expected to be completed in the first half of
2024.
A more detailed description of the transaction terms and a copy
of the business combination agreement will be included in a Current
Report on Form 8-K to be filed by each of Citius Pharma and TenX
with the United States Securities and Exchange Commission ("SEC").
In connection with the transaction, TenX intends to file a
registration statement (which will contain a proxy
statement/prospectus) with the SEC.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation or sale
would be unlawful prior to the registration or qualification under
the securities laws of any such state or jurisdiction.
CITIUS PHARMA AND TENX STOCKHOLDERS AND OTHER INTERESTED
PERSONS ARE ADVISED TO READ, ONCE AVAILABLE, THE REGISTRATION
STATEMENT AND THE PRELIMINARY PROXY STATEMENT/PROSPECTUS AND ANY
AMENDMENTS THERETO AND, ONCE AVAILABLE, THE DEFINITIVE PROXY
STATEMENT/PROSPECTUS IN CONNECTION WITH THE BUSINESS COMBINATION,
BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT
CITIUS PHARMA, TENX, CITIUS ONCOLOGY AND THE PROPOSED
MERGER.
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. The Crone
Law Group P.C. is acting as legal advisor to TenX.
IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION
AND WHERE TO FIND IT
In connection with the proposed business combination, TenX
intends to file a registration statement on Form S-4 that will
include a proxy statement of TenX and a prospectus of Citius
Oncology. The proxy statement/prospectus will be sent to all TenX
stockholders. Before making any voting decision, securities holders
of TenX are urged to read the proxy statement/prospectus and all
other relevant documents filed or that will be filed with the SEC
in connection with the proposed business combination as they become
available because they will contain important information about the
proposed business combination and the parties to the proposed
business combination.
Investors and securities holders will be able to obtain free
copies of the proxy statement/prospectus and all other relevant
documents filed or that will be filed with the SEC by TenX and
Citius Pharma through the website maintained by the SEC at
www.sec.gov. In addition, the documents filed by Citius Pharma may
be obtained free of charge from Citius Pharma's website at
www.citiuspharma.com, or by written request to Citius
Pharmaceuticals, Inc., 11 Commerce Drive, 1st Floor, Cranford, New Jersey 07016, Attention Chief
Financial Officer. The documents filed by TenX may be obtained free
of charge by written request to TenX Keane Acquisition, 420
Lexington Avenue, Suite 2446, New York,
New York 10170.
PARTICIPANTS IN THE SOLICITATION
Citius Pharma and Tenx and certain of their respective
directors, executive officers, and other members of management and
employees may, under SEC rules, be deemed to be participants in the
solicitations of proxies from TenX's shareholders in connection
with the proposed transaction. Information regarding Citius
Pharma's directors and executive officers is available in its
definitive proxy statement on Schedule 14A for the 2023 annual
meeting of stockholders, which was filed with the SEC on
December 22, 2022. Information about
TenX's directors and executive officers and their ownership of
TenX's securities is set forth in TenX's filings with the SEC,
including TenX's Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, which was
filed with the SEC on April 17, 2023.
To the extent that holdings of TenX's securities have changed since
the amounts printed in TenX's Annual Report, such changes have been
or will be reflected on Statements of Change in Ownership on Form 4
filed with the SEC.
Additional information regarding the participants in the proxy
solicitation and a description of their direct and indirect
interests will be included in the proxy statement/prospectus when
it becomes available. Shareholders, potential investors, and other
interested persons in respect of Citius Pharma and TenX should read
the proxy statement/prospectus carefully when it becomes available
before making any voting or investment decisions. You may obtain
free copies of these documents from the sources indicated
above.
About Citius Oncology, Inc.
Citius Oncology is a late-stage pharmaceutical company focused
on developing and commercializing targeted oncology
therapies. Its strategy centers on achieving a market
leading position by advancing innovative therapies with reduced
development and clinical risks, and leveraging competitive
advantages supported by intellectual property and regulatory
exclusivity protection. This includes new formulations of
previously approved drugs with substantial existing safety and
efficacy data or expanded indications for approved therapies.
Citius Oncology's lead product candidate is LYMPHIR, an
engineered IL-2 diphtheria toxin fusion protein, for the treatment
of patients with persistent or recurrent CTCL, a rare form of
non-Hodgkin lymphoma. Management believes the market for LYMPHIR
for CTCL, estimated to exceed $400
million, is attractive, growing and underserved by existing
treatments. On July 28, 2023, the FDA
issued a complete response letter (CRL) in response to the LYMPHIR
BLA. The FDA is requiring enhanced product testing and additional
controls agreed to with the FDA during the market application
review. There were no concerns relating to the safety and
efficacy of the clinical data package submitted with the BLA, or
the proposed prescribing information. In September 2023, Citius
Pharma announced that the FDA has agreed with the plans to
address the requirements outlined in the CRL. This guidance has
clarified the path forward in completing the necessary activities
to support the resubmission of the BLA for LYMPHIR. The BLA
resubmission is anticipated in early 2024.
Citius Oncology was founded in August
2021 as Citius Acquisition Corp., a Delaware corporation and wholly owned
subsidiary of Citius Pharma and began operations in April 2022. The corporate name was changed to
Citius Oncology, Inc. in May 2023.
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, with a focus on oncology,
anti-infectives in adjunct cancer care, unique prescription
products, and stem cell therapies. The Company's diversified
pipeline includes two late-stage product candidates. Mino-Lok®, an
antibiotic lock solution for the treatment of patients with
catheter-related bloodstream infections, is enrolling patients in a
Phase 3 Pivotal superiority trial and was granted Fast Track
designation by the FDA. Citius Pharma is preparing to resubmit the
Biologics License Application for LYMPHIR, a novel IL-2R
immunotherapy for an initial indication in CTCL, in early 2024.
LYMPHIR received orphan drug designation by the FDA for the
treatment of CTCL and PTCL. At the end of March 2023, 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.
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.
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, including
statements regarding the benefits of the transaction, the
anticipated timing of the transaction, the products offered by
Citius Pharma and Citius Oncology and the markets in which each
operates, and Citius Pharma and Citius Oncology's projected future
results. These forward-looking statements generally are identified
by the words "believe," "project," "expect," "anticipate,"
"estimate," "intend," "strategy," "future," "opportunity," "plan,"
"may," "should," "will," "would," "will be," "will continue," "will
likely result," and similar expressions. Forward-looking statements
are predictions, projections and other statements about future
events that are based on current expectations and assumptions and,
as a result, are subject to risks and uncertainties. Many factors
could cause actual future events to differ materially from the
forward-looking statements in this document, including, but not
limited to: Such statements are made based on our expectations and
beliefs concerning future events impacting Citius Pharma. You can
identify these statements by the fact that they use words such as
"believe," "anticipate," "estimate," "expect," "plan," "would,"
"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 risk that the transaction may not be completed
in a timely manner or at all, which may adversely affect the price
of Citius Pharma's common stock; the risk that the transaction may
not be completed by TenX's business combination deadline and the
potential failure to obtain an extension of the business
combination deadline if sought by TenX; the failure to satisfy the
conditions to the consummation of the transaction, including the
adoption of the business combination agreement by the stockholders
of TenX; the satisfaction of the minimum trust account amount
following redemptions by TenX's public stockholders; the occurrence
of any event, change or other circumstance that could give rise to
the termination of the business combination agreement; the effect
of the announcement or pendency of the transaction on Citius
Pharma's business relationships, performance, and business
generally; risks that the proposed business combination disrupts
current plans or operations of Citius Pharma; the outcome of any
legal proceedings that may be instituted against Citius Pharma or
TenX related to the business combination agreement or the proposed
business combination; the ability to maintain the listing of TenX's
securities (which would be Citius Oncology securities) on Nasdaq
after the closing of the transaction; after the closing of the
transaction, the price of Citius Oncology's securities may be
volatile due to a variety of factors, including changes in the
competitive and highly regulated industries in which Citius
Oncology will operate, variations in performance across
competitors, changes in laws and regulations affecting Citius
Oncology's business and changes in its capital structure; the
ability to implement business plans, forecasts, and other
expectations after the completion of the proposed business
combination, and identify and realize additional opportunities
provided by the business combination; the cost and timing of the
resubmission of the BLA for LYMPHIR; the FDA may not approve our
BLA for LYMPHIR; our need for substantial additional funds; the
estimated markets for our product candidates and the acceptance
thereof by any market; our ability to commercialize our products if
approved by the FDA; our dependence on third-party suppliers; the
ability of our product candidates to impact the quality of life of
our target patient populations; our ability to successfully
undertake and complete clinical and non-clinical trials and the
results from those trials for our product candidates; risks
relating to the results of research and development activities,
including those from existing and new pipeline assets;
uncertainties relating to preclinical and clinical testing; the
early stage of products under development; market and other
conditions; our ability to attract, integrate, and retain key
personnel; risks related to our growth strategy; patent and
intellectual property matters; our ability to obtain, perform under
and maintain financing and strategic agreements and relationships;
our ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis; our
ability to procure cGMP commercial-scale supply; government
regulation; competition; as well as other risks described in our
SEC filings. These risks have been and may be further impacted by
Covid-19 and global geopolitical
events, such as the war in Ukraine
and the Middle East. 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, 2022, filed
with the SEC on December 22, 2022 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.
Citius Pharmaceuticals Investor Contact:
Ilanit Allen
ir@citiuspharma.com
Citius Pharmaceuticals Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
TenX Contact
Taylor
Zhang
target@TenXkeane.com
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SOURCE Citius Pharmaceuticals, Inc.
