Correspondence 0001493152-24-024184 from CITIUS ONCOLOGY, INC. (CTOR)
CITIUS ONCOLOGY, INC.
Date: June 17, 2024 · CIK: 0001851484 · Accession: 0001493152-24-024184
AI Filing Summary & Sentiment
File numbers found in text: 333-275506
Referenced dates: May 17, 2024
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CORRESP
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filename1.htm
Mark
Crone
Managing
Partner
mcrone@cronelawgroup.com
VIA
EDGAR
June
17, 2024
THE
UNITED STATES SECURITIES
AND
EXCHANGE COMMISSION
Division
of Corporation Finance
Washington,
D.C. 20549
Attn:
Division
of Corporation Finance
Office
of Life Sciences
Re:
TenX
Keane Acquisition
Amendment
No. 2 to Registration Statement on Form S-4
Filed
May 3, 2024
File
No. 333-275506
Ladies
and Gentlemen:
On
behalf of our client, TenX Keane Acquisition, a Cayman Islands exempted company (the “Company”), we are responding
to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in the letter dated May 17, 2024 (the “Comment Letter”), relating to the above referenced amended Registration
Statement on Form S-4, filed May 3, 2024 (the “Registration Statement”). Concurrently with the submission of this letter,
the Company is filing Amendment No. 3 to the Registration Statement (“Amendment No. 3”).
Set
forth below are the Company’s responses to the Staff’s comments. The Staff’s comments are repeated below in bold and
are followed by the Company’s responses. Page references in the text of this response letter correspond to the page numbers of
the Registration Statement.
Amendment
No. 2 to Registration Statement on Form S-4
Risk
Factors and Risk Factor Summary
If
TenX is deemed to be an investment company under the Investment Company Act..., page 92
1. We
note your response to our prior comment 4 regarding the risks associated with being deemed
to be an unregistered investment company. Please also state that if you are deemed to be
an unregistered investment company you may be required to change your operations and that
with respect to the consequences to investors any TenX Rights would expire worthless.
Response:
The Company acknowledges the Staff’s comment and has included the additional requested disclosure on page 92 of Amendment
No. 3.
United
States Securities and Exchange Commission
June
17, 2024
Page
2
The
TenX Board’s Discussion of Valuation and Reasons for the Approval..., page 142
2. We
note that SpinCo agreed to transfer the patent rights immediately after it is commercially
able to do so. Please clarify if there is an agreement in place. If so, please discuss all
material terms and file such agreement as an exhibit or otherwise advise.
Response:
The Company acknowledges the Staff’s comment and has included clarifying disclosure on page 145 of Amendment No. 3.
LYMPHIR
(denileukin diftitox-cdxl)
Phase
3 Trial (E7777-G000-302) Design, page 193
3. You
make several assertions regarding the safety and efficacy of your lead candidate LYMPHIR.
Please revise your disclosure to eliminate suggestions of safety and efficacy as those determinations
are solely within the authority of the FDA or comparable foreign regulators. Note that you
may present clinical trial end points and objective data without concluding efficacy and
you may state that your product is well tolerated, if accurate. For instance, and without
limitation, we note the following statements:
● “the
primary and secondary endpoints of Study E7777-G000-302 demonstrated safety and efficacy
of 9 μg/kg/day LYMPHIR...”;
● “per
protocol, LYMPHIR was considered efficacious...”;
● and
“FDA accepted the Study E7777-G000-302 data which demonstrated both safety and efficacy...”.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 193 and 194 of Amendment No. 3 accordingly.
Please
feel free to contact me should you require additional information at (917) 538-1775 or emendelson@cronelawgroup.com.
THE
CRONE LAW GROUP, P.C.
By:
/s/
Eric Mendelson
Eric
Mendelson