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 Allenir@citiuspharma.com
Citius Pharmaceuticals Media
Contact:
STiR-communicationsGreg
SalsburgGreg@STiR-communications.com
TenX Contact
Taylor Zhangtarget@TenXkeane.com
TenX Keane Acquisition (NASDAQ:TENK)
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