SEC Comment Letter 0000000000-23-013614 to CITIUS ONCOLOGY, INC. (CTOR)
CITIUS ONCOLOGY, INC.
Date: Dec. 14, 2023 · CIK: 0001851484 · Accession: 0000000000-23-013614
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File numbers found in text: 333-275506
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United States securities and exchange commission logo
December 13, 2023
Taylor Zhang
Chief Financial Officer
TenX Keane Acquisition
420 Lexington Ave Suite 2446
New York, NY 10170
Re:TenX Keane Acquisition
Registration Statement on Form S-4
Filed November 13, 2023
File No. 333-275506
Dear Taylor Zhang:
We have reviewed your registration statement and have the following comment(s).
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-4
Cover Page
1.We note your disclosure that after the completion of the Business Combination, Citius
Pharma will control a majority of the voting power and therefore New Citius Oncology
will be a controlled company. Please also revise the cover page to include Citius Pharma's
ownership percentage.
Questions and Answers
Q: What equity stake will current TenX Shareholders and SpinCo stockholders hold in New
Citius Oncology immediately after..., page 16
2.Please revise to disclose all possible sources and extent of dilution that shareholders who
elect not to redeem their shares may experience in connection with the Business
Combination. Provide disclosure of the impact of each significant source of dilution,
including the amount of equity held by founders and convertible securities retained by
redeeming shareholders at each of the redemption levels detailed in your sensitivity
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TenX Keane Acquisition
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analysis, including any needed assumptions.
How does the Sponsor intend to vote its shares?, page 26
3.We note the disclosure on page 26 indicating that the Sponsor may purchase TenX
Ordinary Shares, TenX Units or TenX Rights in privately negotiated transactions or in the
open market either prior to or following the Business Combination and that the Sponsor
intends to vote such shares in favor of the Business Combination. Please provide your
analysis on how such purchases will comply with Rule 14e-5. To the extent that you are
relying on Tender Offer Compliance and Disclosure Interpretation 166.01 (March 22,
2022), please provide an analysis regarding how it applies to your circumstances.
Summary of the Proxy Statement/Prospectus, page 30
4.Please revise the Summary to include an organizational chart depicting the parties to the
transaction both prior to and after the Domestication and Business Combination.
SpinCo, page 31
5.We note your disclosure that on July 28, 2023, the FDA issued a complete response letter
regarding your BLA. We also note your disclosure that "[t]he FDA has required SpinCo to
incorporate enhanced product testing, and additional controls agreed to with the FDA
during the market application review." Please provide further details regarding the
underlying issues outlined in the FDA's complete response letter. Additionally, please
provide further details about the "enhanced product testing" and "additional controls" that
were agreed to with the FDA.
Amended & Restated Shared Services Agreement, page 35
6.We note your disclosure that "the fees for each of the services are set forth in the A&R
Shared Services Agreement as a quarterly fee[.]" Please disclose the quarterly fee here.
Interests of TenX's Directors and Executive Officers in the Business Combination, page 40
7.Please disclose the Sponsor and its affiliates' total potential ownership interest in the
combined company, assuming the exercise and conversion of all securities.
Unaudited Pro Forma Condensed Combined Financial Information
General, page 49
8.Please revise to clarify the financial statement periods included in your pro forma
Statements of Operations and how such information was derived. In this respect, it
appears that given the difference in fiscal year-ends between the registrant and SpinCo,
certain adjustments were made to the historical financial statements of SpinCo to conform
to the annual and interim periods presented by the registrant. Refer to Article 11-02(c)(3)
of Regulation S-X. Please also clarify whether the combined company will adopt
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TenX Keane Acquisition
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December 31st as its new fiscal year-end.
Risk Factors
Risks Related to SpinCo's Business and its Industry
SpinCo relies exclusively on third parties to formulate and manufacture its product candidates,
page 70
9.We note your disclosure that one of the contract manufacturers for LYMPHIR is foreign.
Please disclose where this manufacturer is located.
The Combined Company's Proposed Certificate of Incorporation will provide that the Court...,
page 98
10. Please revise your risk factor to disclose that there is also a risk that
your exclusive forum provision may result in increased costs for investors to bring a claim
in the chosen forum.
Proposal No. 1 - The Business Combination Proposal
Summary of the Merger Agreement
Fees and Expenses, page 129
11.We note your disclosure that the Sponsor has agreed to pay any transaction expenses of
"Parent" in excess of $500,000. Please revise your disclosure here to clarify, if true, that
"Parent" refers to Citius Pharma.
Amended & Restated Registration Rights Agreement, page 130
12.Please revise here and throughout, as appropriate, to disclose how many shares will be
covered by the Amended & Restated Registration Rights Agreement.
Sponsor Support Agreement, page 130
13.We note that the Sponsor agreed to waive its redemption rights. Please describe any
consideration provided in exchange for this agreement.
Background of the Business Combination, page 131
14.Please disclose here whether the Sponsor, management, or any affiliates of TenX have a
track record with SPACs. If so, please provide disclosure about this record and the
outcomes of those prior transactions.
15.We note that you reviewed approximately 15 potential targets, eight of which were
eliminated, leading you to engage in detailed discussions with seven potential
combination targets. Further, you signed non-disclosure agreements with five potential
targets and entered into non-binding letters of intent with two companies. Please expand
this section to discuss how these targets were identified, which industries they were in,
when these discussions took place and what criteria was used to eliminate certain
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companies.
16.We note that you entered into two non-binding letters of intent with two companies.
Please provide a general description of the two potential targets. Additionally, we note
that you allowed the exclusive period of negotiations with respect to these two parties to
terminate in early February 2023 and April 2023. Please revise your disclosure to specify
why these companies did not represent attractive targets, explain the nature of the
difference in valuation expectations, and provide further context regarding one of the
potential target's unwillingness to engage with you given conflicting business objectives.
17.We note your disclosure that in May 2022, Citius Pharma announced that it "intended to
split its assets into two separate publicly traded entities." Please revise your disclosure in
this section to explain whether Citius Pharma considered any transaction structures aside
from a SPAC business combination in order to effectuate the "split of its assets into two
separate publicly traded entities." If so, please explain why Citius Pharma elected to
pursue a SPAC business combination as opposed to an alternative transaction structure.
18.We note that TenX was made aware of SpinCo through Maxim on April 25, 2023 and that
a letter of intent was signed in May 2023. Please disclose if during this time TenX was in
discussions with any other companies.
19.We note that on May 6, 2023, Citius Pharma sent to Ten X an initial draft of the LOI, on
May 6 and 7, 2023 Maxim worked on a possible valuation of SpinCo, on May 8, 2023
TenX provided overall comments on the scope of the draft, and on May 9, 2023 a revised
LOI was provided to TenX and on the same day Citius Pharma, SpinCo, and TenX
negotiated the draft LOI. Please include a discussion as to how the material terms and
consideration evolved during the negotiations.
20.We note your disclosure that on June 1, 2023, Citius Pharma and SpinCo "confirmed that
a full spin-off of SpinCo from Citius Pharma prior to closing of the proposed transaction
would not take place." Please explain what is meant by "full spin-off" in this instance and
please also explain why and how it was confirmed that a "full spin-off" would not take
place prior to closing.
21.Please disclose how the provision of the Merger Agreement that permits Citius Pharma to
seek an alternative transaction to the Business Combination was negotiated.
Opinion of Revere Securities, page 136
22.Please disclose whether any companies that met the comparable selection criteria were
excluded from the analyses. If so, please explain why.
23.Please explain why Revere reviewed the values of the companies set forth in the
Comparable Public Company Analysis as of October 8, 2023.
24.You state that "[t]he estimates of the future performance of New Citius Oncology in or
underlying Revere Securities’ analyses are not necessarily indicative of actual values or
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actual future results[.]" Please clarify if Revere relied on any financial projections in
analyzing the transaction and rendering the opinion.
Fees and Expenses, page 140
25.Please disclose here the fees that Revere will receive upon completion of the Business
Combination.
The TenX Board's Discussion of Valuation and Reasons for the Approval..., page 140
26.You state on page 143 that the TenX Board also considered that the initial TenX
Shareholders, including TenX directors and executive officers, have interests in the
Business Combination as individuals that are in addition to, and may be different from,
the interests of TenX Shareholders generally. You also state that Revere "reviewed and
considered these interests in its fairness opinion delivered to the TenX Board[.]" Please
clarify, if true, that Revere reached an opinion regarding only the merger consideration
and, although Revere may have considered the initial TenX Shareholders' interests, it did
not reach a conclusion as to the fairness of those interests.
27.Please revise your disclosure in this section to explain whether the TenX Board
considered any potential risks associated with SpinCo holding an exclusive license for its
lead drug candidate as opposed to owning the patent rights to that candidate.
28.We note your disclosure that the TenX Board determined that "SpinCo's clinical data for
LYMPHIR is significant and likely to be approved by the FDA." Please remove the
statement that SpinCo's clinical data is "likely to be approved by the FDA[,]" as such a
determination is not within the control of the company.
Information About the SpinCo Business
Phase 3 Trial (E7777-G000-302) Design, page 191
29.We note your disclosure that "no new safety signals were identified compared to
ONTAK." Please note that you do not have a basis to compare your candidate to other
products or third-party product candidates unless you have conducted head-to-head trials.
Please revise your registration statement accordingly, or advise.
30.We note your disclosure of your Phase III trial design and results. Please expand your
disclosure to discuss when the Phase III trial was conducted or commenced, the duration
of the trial, who conducted the trial, where it was conducted, any primary or secondary
endpoints and whether they were met.
31.We note your table listing the adverse reactions in patients with relapsed or refractory
stage I-III CTCL who received LYMPHIR. Please include a short description of the
different grades identified.
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Investigator Initiated Trials, page 193
32.We note that you initiated a Phase I trial in June 2021 at the University of Minnesota,
Masonic Cancer Center and initiated a second Phase I study in September 2022 at the
University of Pittsburg Medical Center, Hillman Cancer Center. Given the passage of
time, please include a description of the current status of each study and whether each is
currently ongoing.
LYMPHIR License Agreement, page 195
33.Please clarify here and elsewhere as appropriate, if true, that Eisai owns the intellectual
property rights of the LYMPHIR product and that SpinCo is an exclusive licensee of that
intellectual property.
34.We note your disclosure that the exclusive license with Eisai includes the rights to
develop and commercialize LYMPHIR "in all markets except for Japan and certain parts
of Asia." Please specify the "certain parts of Asia" that are excluded from this agreement.
Obligations to Dr. Reddy's under the License Agreement, page 196
35.We note your description of the obligations to Dr. Reddy's under the License Agreement.
Please revise to include a description of all the material terms of the agreement including a
description of each party's rights and obligations and the termination provisions.
36.We note your disclosure that pursuant to the License Agreement, SpinCo will be obligated
to pay on a fiscal quarter basis tiered royalties equal to "low double-digit percentages of
net product sales." Please revise this disclosure to specify a percentage rate or range that
does not exceed ten percentage points.
LYMPHIR Patents, page 197
37.We note your disclosure that Citius Pharma acquired and later transferred to SpinCo
two method of use patents. Please include the expected expiration dates of each issued
patent and applicable jurisdictions for the international patent.
Regulation
U.S. Government Regulation, page 197
38.We note your discussion of the FDA process that must be completed in order to be able to
market your product candidate in the U.S. In each step listed, please expand your
discussion to include more detail to properly reflect what each step consists of so that
investors can understand and make informed decisions based on the current status of your
products.
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Management of New Citius Oncology After Business Combination
Executive Officers, page 207
39.We note your descriptions of each executive officer and director. Please revise to describe
the business experience during the past five years of each executive officer and director.
In this regard, we note that the discussion of Jaime Bartushak and Myron S. Czuczman do
not cover this period. Refer to Item 401(e) of Regulation S-K for guidance.
Report of Independent Registered Public Accounting Firm, page F-2
40.Please have Marcum LLP revise and reissue their audit report to identify the name of the
company whose financial statements were audited. Refer to PCAOB Auditing Standard
(AS) 3101.08a.
Citius Acquisition Corp
Financial Statements for the Year Ended September 30, 2022
Balance Sheet, page