SecProbe.io

December 11, 2024
William Conkling
Chief Executive Officer
Rafael Holdings, Inc.
520 Broad Street
Newark, New Jersey 07102
Re:Rafael Holdings, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed November 22, 2024
File No. 333-282558
Dear William Conkling:
            We have reviewed your amended registration statement and have the following
comments.
            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. Unless we note
otherwise, any references to prior comments are to comments in our November 5, 2024,
letter.
Amendment No. 1 to Form S-4 filed November 22, 2024
Questions and Answers About the Transactions and the Special Meetings, page ii
We note your response to prior comment 3 and re-issue the comment in part.  Please
expand your newly created Q&A “ How will the companies operate post-merger ” on
page vii to include disclosure, as mentioned elsewhere, that Rafael intends to focus its
efforts on Trappsol Cyclo as its lead clinical program. Please also briefly explain the
extent to which Rafael will continue to operate or invest in the Pharmaceutical
Companies and their described operations, discussing the potential impact of Rafael's
planned shift in focus to Trappsol Cyclo post-merger on these operations.

 1.

December 11, 2024
Page 2

Risk Factors
We are dependent on certain third-party suppliers, page 26
2.We note your response to prior comment 12. Please explain your assertion that Rafael
and Cyclo are not "involved in the targeted industry" that is the subject of the
BIOSECURE Act. In addition, your response states that you do not sell to any of the
biotechnology companies of concern; however, you have not indicated whether either
company purchases from any of the biotechnology companies of concern. Please
clarify.
Information About the Companies
Rafael Holdings, Inc., page 29
3.We note your disclosure both here and in the Rafael Form 10-K for the fiscal year
ended July 31, 2024, incorporated by reference, that Cornerstone received negative
results from its Avenger 500 Phase 3 study for Devimistat in pancreatic cancer as well
as a recommendation to stop its ARMADA 2000 Phase 3 study due to a determination
that the trial would unlikely achieve its primary endpoint. Please revise your
disclosure to clarify where the Phase 3 study and trial were being conducted, and
which regulatory authority oversaw such determinations.
4.We note your disclosure that LipoMedix has completed various clinical stages of
Promitil including a Phase 1A and 1B trial. Please revise your disclosure to state
where these trials were held. In addition, please provide data from the completed trials
where discussed, including information regarding endpoints and SAEs, to the extent
applicable.
Incorporation of Certain Information by Reference, page 138
5.We note your response to prior comment 7. Please further revise your disclosure
regarding Cyclo's business, incorporated by reference from Cyclo's Form 10-K for the
fiscal year ended December 31, 2023, to remove or revise the below statements
implying safety or efficacy, as the company's product candidates have not yet received
regulatory approval:
•The statement on page 4 of Cyclo’s Form 10-K/A filed November 26, 2024 that
"...to date, [Cyclo's] clinical studies have preliminarily demonstrated that Trappsol
Cyclo is safe and efficacious in the treatment of NPC over a range of dose
groups."
•The statements that Trappsol Cyclo demonstrated a "favorable safety profile" on
pages 5 and 34 of Cyclo’s Form 10-K/A filed November 26, 2024.
You may present objective data from your trials but should not draw conclusions
regarding safety and efficacy, as such determinations are within the sole purview of
the FDA and equivalent foreign regulators.
Please revise your disclosure regarding Rafael's Pharmaceutical Companies, both here
and in the Rafael Form 10-K for the fiscal year ended July 31, 2024, to remove or
revise all statements implying safety and/or efficacy, as the company's product
candidates have not yet received regulatory approval. Examples of such statements 6.

December 11, 2024
Page 3
include, but are not limited to, the following:
•". . . Promi-Fol holds the potential to be a safe and effective therapeutic alternative
to widely used instillation of mitomycin-c for local treatment of the growing
elderly patient population with superficial bladder cancer".
•"Preclinical studies have shown that MMC was effective in killing of BRCA2
mutant tumors. Clinical efficacy of MMC has also been reported in heavily
pretreated ovarian cancer patients with BRCA1 mutations."
•LipoMedix's product candidate holds the potential to be "an innovative, safe, and
effective cancer therapy".
•"In these studies, Promitil was found to be more efficacious and less toxic than
MMC by a 3-fold factor."
•Your references to the "improved safety profile of Promitil in humans".
•Your statements that "CPI-613...holds the potential to be minimally toxic to
healthy cells (i.e., safe and well-tolerated)", "exhibited anti-cancer activities" and
that "prolonged survival was observed".
Safety and efficacy conclusions are within the sole authority of the FDA or equivalent
foreign regulators. You may present the objective data observed in your clinical trials
but should not draw safety and efficacy conclusions based on such results.
7.In the Rafael Form 10-K for the fiscal year ended July 31, 2024, we note your listing
of some of the observed data from the U.S. Phase I Clinical Study of Trappsol Cylco.
Please clarify the material significance of the data point "[a]ll eligible patients
requested continuation of Trappsol ® Cyclo™ administration in the extension protocol
via home infusion."
8.Please amend your disclosure in the Rafael Form 10-K for the fiscal year ended July
31, 2024, to clarify where in the clinical development process Promi-Fol and Promi-
Dox currently are.
9.We note your statements, both in this filing and in Rafael's Form 10-K for the fiscal
year ended July 31, 2024, that Day Three "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 like Unlokt". Please amend your
filing to expand your disclosure regarding this technology, providing details regarding
its application, functionality and use, and provide support for this statement and your
references to such technology as "pharmaceutical-grade". To the extent the company
has received any form of approval or certification of the technology as a basis for
these claims, please describe where appropriate.
10.Please revise your disclosure both here and in the Rafael Form 10-K for the fiscal year
ended July 31, 2024, to provide more detail regarding the operations and product
candidates of Rafael Medical Devices, where appropriate. Your disclosure should
include information regarding the "surgical and procedural devices" the company is
currently developing. To the extent the company has not yet developed any devices
and has no devices in its product portfolio, please revise your disclosure to make clear
that the claims associated with Rafael Medical Devices are aspirational in nature and
are not references to current operations.

December 11, 2024
Page 4
11.Please revise the risk factor contained in Rafael's Form 10-K for the fiscal year ended
July 31, 2024, relating to Israel's war with Hamas to clarify whether the company has
experienced material disruptions to date based on the war and conflicts discussed,
either as a result of employees being called for service or otherwise.
12.Please revise your disclosure in the risk factor entitled " The relationship between
Howard S. Jonas and IDT Corporation, and Genie Energy could conflict with our
stockholders' interests " in Rafael's Form 10-K for the fiscal year ended July 31, 2024,
to provide more detail regarding the conflict of interest with stockholders briefly
noted in this risk factor.
            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:Dov Schwell