SEC Comment Letter 0000000000-24-012949 to Cyclo Therapeutics, Inc. (CYTH, CYTHW) (CIK 0000922247)
Cyclo Therapeutics, Inc. (CYTH, CYTHW) (CIK 0000922247)
Date: Nov. 21, 2024 · CIK: 0000922247 · Accession: 0000000000-24-012949
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File numbers found in text: 001-39780
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November 21, 2024
Joshua M. Fine
Chief Financial Officer
Cyclo Therapeutics, Inc.
6714 NW 16th Street, Suite B
Gainesville, Florida 32653
Re:Cyclo Therapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Response Dated November 7, 2024
File No. 001-39780
Dear Joshua M. Fine:
We have reviewed your November 7, 2024, response to our comment letter and have
the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Unless we note otherwise, any references to prior comments are to comments in our
November 5, 2024, letter.
Form 10-K for Fiscal Year Ended December 31, 2023
Item 1. Business
Overview, page 1
1.We note your response to prior comment 1, in which you state that all references to
outcome measures around safety and efficacy will be removed from future SEC
filings and, where appropriate, will be replaced with the words "well tolerated", and
that the preliminary data section will also be removed going forward. Please amend
your Form 10-K accordingly.
2.We note your response to prior comment 2 in which you state that Cyclo did not
conduct a Phase II trial in the U.S. and instead relied, with the consent of the FDA, on
the data obtained from its Phase I/II trial abroad to support the commencement of its
Phase III trial in the U.S. Please amend your Form 10-K to clarify this point.
November 21, 2024
Page 2
Competition, page 8
3.We note your response to prior comment 3 where you indicate that you will include
the following statement in future SEC filings: “Cyclo is pioneering the use of
cyclodextrins as an active pharmaceutical ingredient (API). While there are multiple
suppliers of industrial and excipient grade cyclodextrins, we remain the only company
engaged in the development of cyclodextrin therapy to treat disease.” In the same
response you indicate that in future SEC filings you will amend your disclosure to
clarify that the Japanese pharmaceutical preparations referenced on page 19 contain
cyclodextrins as an excipient. Please amend your Form 10-K accordingly.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Year Ended December 31, 2023 Compared to Year Ended December 31, 2022, page 35
4.We have read your response to prior comment 4, in which you indicate that sales of
cyclodextrin are very volatile and hard to predict, and the decrease in revenue was
caused by a reclassification of revenue derived from compassionate sales of Trappsol
HPB. Please amend your filing to discuss the reason(s) why your revenue from the
sales of Trappsol HPB decreased 24% from fiscal year 2022 to fiscal year 2023 and
the reason(s) why Trappsol "other products" decreased 18% from fiscal year 2022 to
fiscal year 2023.
Controls and Procedures, page 40
5.We have read your response to prior comment 5, in which you indicate
your disclosure contained a typographical error by not including the word “not” in
both your Form 10-K for the fiscal year ended December 31, 2023 and Form 10-Q for
the fiscal quarter ended March 31, 2024, but that the disclosure error was corrected in
your Form 10-Q for the fiscal quarter ended June 30, 2024. Please amend your Form
10-K to correct the error.
6.We have read your response to prior comment 6. Please amend your filing to disclose
the conclusion of the effectiveness of your internal control over financial reporting as
of the end of your fiscal period in your Management’s Report on Internal Control over
Financial Reporting, in accordance with Item 308(a)(3) of Regulation S-K.
Please contact Tracie Mariner at 202-551-3744 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Alison Newman