SecProbe.io

CORRESP
1
filename1.htm

November 21, 2024

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

  Attention:
  Tracie Mariner

  Division of Corporate Finance

  Office of Life Sciences

 Re: Rafael Holdings, Inc.

Registration Statement on Form S-4

Filed on October 9, 2024

File No. 333-282558

Dear Ms. Mariner:

Rafael Holdings, Inc., a Delaware
corporation (“Rafael” or “we”), has today filed with the Securities and Exchange Commission
(the “Commission”), pursuant to the requirements of the Securities Exchange Act of 1933, as amended (the “Securities
Act”), Pre-Effective Amendment No. 1 (the “Amendment”) to its Registration Statement on Form S-4
filed October 9, 2024 (as amended, the “Registration Statement”).

We are writing to respond
to the comments of the staff of the Commission (the “Staff”) raised in your letter to Rafael dated November
5, 2024. The responses below correspond to the captions and numbers of those comments (which are reproduced below in bold). For your convenience,
a copy of the Amendment is enclosed and has been marked to show changes from the Registration Statement filed October 9, 2024. References
to page numbers in our responses are to page numbers in the amended Registration Statement or the Joint Proxy Statement/Prospectus (the
“Prospectus”) that forms a part thereof. Capitalized terms defined in the Registration Statement and used in this letter but
not otherwise defined herein have the meanings assigned to them in the Registration Statement.

Securities and Exchange Commission

November 21, 2024

Page 2

Form S-4 filed October 9, 2024 General

 1. Please revise both letters to stockholders at the start of the joint proxy statement/prospectus to provide the following information:

 ● Where you state that the Exchange Ratio values each share
of Cyclo Common Stock at $0.95, please also state that this represented an approximately 75% discount to the trading price of Cyclo shares
on August 21, 2024, the day the companies entered into the Merger Agreement.

 ● Disclose the estimated valuation of Cyclo based on the
Exchange Ratio.

 ● State that the Exchange Ratio was initially estimated
to be 0.3112 shares of Rafael Class B Common Stock for each share of Cyclo Common Stock, as you have on pages 75, 106 and 126.

 ● Clarify that post-merger Cyclo stockholders will own approximately
21% of the outstanding Rafael Common Stock but only hold 2.5% of the voting power because each share of Rafael Class B Common Stock is
entitled to only one-tenth (1/10) of a vote per share.

Please also revise the Q&A entitled “What
will Cyclo stockholders receive as consideration in the Merger?” on page iii to include the same.

Response: We have revised
both letters to stockholders and the Q&A entitled “What will Cyclo stockholders receive as consideration in the Merger?”
on page iii accordingly to include the disclosures requested by the Staff.

Questions and Answers About the Transaction
and the Special Meetings, page ii

2.
Please include a Q&A addressing the conflicts of interest presented by Rafael’s substantial ownership of Cyclo prior to entering into
the Merger Agreement and its representation on the Cyclo board of directors. Please also summarize your disclosure regarding interests
of certain persons in the transaction, included in both the Summary and starting on page 70.

Response: We have
added a Q&A entitled “What Interests May Certain Persons be Deemed to Have in the Merger” on page vi of the Prospectus
summarizing the disclosure regarding interests of certain persons in the transaction.

3.
Please include a Q&A regarding how the companies will operate post-merger. In this regard, we note your disclosure elsewhere that
you plan to operate both businesses independently following the completion of the merger, with Cyclo’s business being held in the Surviving
Entity as a wholly owned subsidiary of Rafael, but that Rafael intends to focus its efforts on Trappsol Cyclo as its lead clinical program.

Response: We
have added a Q&A entitled “How will the companies operate post-merger” on page vii of the Prospectus to disclose
how the Surviving Entity and Rafael will operate post-Merger.

Securities and Exchange Commission

November 21, 2024

Page 3

4.
Please clarify, where appropriate, the total percentage of voting shares of each of Rafael and Cyclo covered by binding commitments to
support the Merger so that minority investors clearly understand the committed vote compared to the vote required for approval.

Response: We
have included the requested clarifications on pages 8 and 92 of the Prospectus.

5.
We note you include a risk factor at page 9 disclosing that the tax treatment of the transaction is complex, and that further discussion
of tax consequences is provided at page 107. Please also include a Q&A briefly discussing the tax consequences to Cyclo stockholders,
if any.

Response: We
have added a Q&A entitled “What are the expected federal income tax consequences to Cyclo stockholders?” on page
iv of the Prospectus to briefly discuss the tax consequences to Cyclo stockholders.

Who will serve as the management of Rafael
and the Surviving Entity following the Transactions?, page vi

6.
We note that you have not filed Schedule 3 to the Merger Agreement, which contains a listing of the directors and officers of the First
Surviving Corporation and the Surviving Entity post-merger. Please either file Schedule 3 with your next amendment or replace your references
to Schedule 3 throughout the filing to include the list of named individuals.

Response: We
have included the names of the directors and officers of the surviving entity following the transaction on pages vi, 80 and 88 of the
Prospectus.

Cyclo Therapeutics, Inc., page 1

7.
Please revise your disclosure regarding Cyclo’s business, both here and incorporated by reference from Cyclo’s Form 10-K, to remove or
revise all statements implying safety or efficacy, as the company’s product candidates have not yet received regulatory approval. Examples
of such statements include, but are not limited to, the following:

 ● “...to date, our clinical studies have preliminarily
demonstrated that Trappsol Cyclo is safe and efficacious in the treatment of NPC over a range of dose groups.”

 ● “Preliminary data from Cyclo’s completed clinical
studies suggest that Trappsol Cyclo clears toxic deposits of cholesterol and other lipids from cells, has a consistent pharmacokinetic
profile peripherally, and crosses the blood-brain- barrier in individuals suffering from NPC, and results in neurological and neurocognitive
benefits and other clinical improvements in NPC patients.”

Securities and Exchange Commission

November 21, 2024

Page 4

 ● “The patient also exhibited signs of improvement
with less volatility and shorter latency in word-finding.”

 ● “Initial patient enrollment in the U.S. Phase I study
commenced in September 2017, and in May 2020 Cyclo announced Top Line data showing a favorable safety and tolerability profile for Trappsol
Cyclo in this study.”

 ● “Cyclo announced via press release the publication
of positive data from its Phase 1 clinical trial, which demonstrated promising safety and efficacy results for Trappsol Cyclo in the
treatment of NPC.”

 ● “On June 29, 2023, Cyclo announced the publication
of positive, confirmatory data from its Phase I/II clinical trial, which demonstrated promising safety and efficacy results for Trappsol
Cyclo in the treatment of NPC.”

Safety and efficacy conclusions are within
the sole authority of the FDA or equivalent foreign regulators. Please remove or revise these statements to instead present the objective
data observed in your clinical trials.

Response: All references
to outcome measures around safety and efficacy have been removed from the Prospectus and, where appropriate, have been replaced with the
words “well tolerated.” Disclosure with respect to the preliminary data has also been removed.

8.
We note that Cyclo announced top line data in May 2020 from a Phase I study in the U.S. We also note that Cyclo completed a Phase I/II
study in the United Kingdom, Sweden and Israel under the purview of the EMA, and that in October 2020 the company was notified by the
FDA that it could proceed with a proposed Phase III clinical trial in the U.S. Please revise your disclosure to clarify whether Cyclo
conducted a Phase II study in the U.S. or whether it relied on data obtained from its Phase I/II trial abroad to support the commencement
of the Phase III trial. In the event Cyclo did conduct a Phase II trial in the U.S., please revise the disclosure in relation to clinical
studies to include information regarding the trial, including but not limited to the number of participants, demographic information,
and the resulting data including endpoints and p-values.

Response:
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 outside the U.S. to support the commencement of its Phase III trial in the U.S. The disclosure in the Prospectus on pages 2
and 31 has been revised to include this information.

Prospectus Summary Information about the
Companies Rafael Holdings, Inc., page 1

9.
We note your mention of a license agreement with Farber Partners, LLC on page 1 and elsewhere. Please disclose the material terms of this
agreement and file it as an exhibit pursuant to Item 601(b)(10) of Regulation S-K, or provide an analysis supporting your determination
that the agreement is not material.

Response:
The license agreement with Farber Partners, LLC is not material to Rafael. The licensed property consists of patents and related know-how
in early-stage research and there are no current commercial applications for the intellectual property. No revenue has been generated
and Rafael is not able at this time, to project the potential for generating revenue, or the magnitude of any such revenue. Rafael has
no future funding obligations related to the license or the licensed property.

Securities and Exchange Commission

November 21, 2024

Page 5

Risk Factors

The NYSE may not list the shares of Rafael
Class B Common Stock..., page 12

10.
We note the above entitled risk factor and your disclosure that Cyclo has the option to waive the listing condition under the Merger Agreement.
Please provide your analysis of the application of Rule 13e-3 to the transaction in the event the Rafael Class B Common Stock received
by Cyclo stockholders is not listed on a national securities exchange. See Rule 13e-3(g)(2)(iii) of the Exchange Act.

Response:
Rafael and Cyclo do not intend to close the transaction unless the shares of Rafael’s Class B Common Stock received by the Cyclo
stockholders are listed on the NYSE. In the event such shares are not listed and we proceed to close the transaction, Rafael will comply
with the requirements of Rule 13e-3 and we have included disclosure to such effect on page 13 of the Prospectus.

A small number of our customers account
for a substantial portion of our revenue..., page 26

11.
Please disclose the names of the two major customers that accounted for 72% of Cyclo’s revenue in 2023.

Response: The
disclosure on page 26 of the Prospectus has been amended to provide the names of the two major customers that accounted for 72% of Cyclo’s
revenues in 2023.

We are dependent on certain third-party
suppliers, page 26

12.
We note your disclosure that Cyclo purchases substantially all of its Trappsol products from bulk manufacturers and distributors in the
U.S., Japan, China, and Europe. Please revise your disclosure, to the extent applicable, to discuss the potential impact of the BIOSECURE
Act on Cyclo’s operations.

Response: Cyclo
will not be impacted by the BIOSECURE Act as it does not receive federal funds, is not involved in the targeted industry and does
not sell to any of the five companies on the tentative blacklist. Therefore, no additional disclosure has been added to the Prospectus.

Our failure to meet the continued listing
requirements of the Nasdaq Capital Market..., page 27

13.
Please revise this risk factor discussion to disclose that Cyclo has until April 2, 2025, to regain compliance with the Nasdaq Listing
Rules.

Response: The
risk factor disclosure has been updated on page 27 of the Prospectus to address this comment.

Securities and Exchange Commission

November 21, 2024

Page 6

Information About the Companies Rafael Holdings,
Inc., page 29

14.
Please provide a legal analysis of whether Rafael meets the definition of “investment company” under Section 3(a) of the Investment
Company Act of 1940 (the “1940 Act”). Please include in your analysis all relevant calculations under Section 3(a)(1)(C) on
an unconsolidated basis, identifying each constituent part of the numerator(s) and denominator(s). Please also describe and discuss any
other substantive determinations and/or characterizations of assets that are material to your calculations. Additionally, if Rafael meets
the definition of “investment company” under Section 3(a) of the 1940 Act but relies or intends to rely on an exclusion therefrom
or a relevant exemption, please provide a legal analysis supporting such reliance.

Response:

Legal Background. Section
3(a)(1) of the 1940 Act defines an “investment company” in three ways, as an issuer which: (1) is or holds itself out as being
engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting, or trading in securities (an “intentional
investment company” and such definition the “intentional investment company definition”); (2) is engaged or proposes
to engage in the business of issuing face-amount certificates of the installment type, or has been engaged in such business and has any
such certificate outstanding (a “face-amount certificate company” and such definition the “face-amount certificate company
definition”); and (3) is engaged or proposes to engage in the business of investing, reinvesting, owning, holding, or trading in
securities, and owns or proposes to acquire investment securities having a value exceeding 40 per centum of the value of such issuer’s
total assets (exclusive of Government securities and cash items) on an unconsolidated basis (an “inadvertent investment company”
and such definition the “inadvertent investment company definition”).

Rafael’s Business.
As stated in its annual report filed on Form 10-K on November 7, 2024 (the “10-K”), Rafael is a company with interests in
clinical and early-stage pharmaceutical companies, including an investment in (and planned merger with) Cyclo Therapeutics Inc. (“Cyclo”),
a clinical stage biotechnology company dedicated to developing Trappsol® Cyclo™, which is being evaluated in clinical trials
for the potential treatment of Niemann-Pick Disease Type C1, a 95% interest in LipoMedix Pharmaceuticals Ltd (“LipoMedix”),
a clinical stage pharmaceutical company, a 100% interest in Barer Institute Inc. (“Barer”), a wholly-owned preclinical cancer
metabolism research operation, and a majority interest in Cornerstone Pharmaceuticals, Inc. (“Cornerstone”), formerly known
as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company. As also noted in the 10-K, Rafael also holds a majority
interest in Rafael Medical Devices, LLC (“Rafael Medical Devices”), an orthopedic-focused medical device company developing
instruments to advance minimally invasive surgeries, and a majority interest in Day Three Labs, Inc. (“Day Three”), a company
which empowers third-party manufacturers to reimagine their existing cannabis offerings enabling them to bring to market better, cleaner,
more precise and predictable versions by utilizing Day Three’s pharmaceutical-grade technology and innovation. Finally, historically
Rafael has owned and continues to own real estate assets through wholly- and majority-owne