<SEC-DOCUMENT>0000000000-21-002332.txt : 20210604
<SEC-HEADER>0000000000-21-002332.hdr.sgml : 20210604
<ACCEPTANCE-DATETIME>20210226133005
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-002332
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210226

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Anebulo Pharmaceuticals, Inc.
		CENTRAL INDEX KEY:			0001815974
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				851170950
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		1415 RANCH ROAD 629 SOUTH, SUITE 201
		CITY:			LAKEWAY
		STATE:			TX
		ZIP:			78734
		BUSINESS PHONE:		737 203 5270

	MAIL ADDRESS:	
		STREET 1:		1415 RANCH ROAD 629 SOUTH, SUITE 201
		CITY:			LAKEWAY
		STATE:			TX
		ZIP:			78734
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                             February 26, 2021

       Daniel Schneeberger, M.D.
       Chief Executive Officer
       Anebulo Pharmaceuticals, Inc.
       1415 Ranch Road 620 South, Suite 201
       Lakeway, TX 78734

                                                        Re: Anebulo
Pharmaceuticals, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted January
29, 2021
                                                            CIK No. 0001815974

       Dear Dr. Schneeberger:

              We have reviewed your draft registration statement and have the
following comments. In
       some of our comments, we may ask you to provide us with information so
we may better
       understand your disclosure.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your
response.

             After reviewing the information you provide in response to these
comments and your
       amended draft registration statement or filed registration statement, we
may have additional
       comments.

       Draft Registration Statement on Form S-1, Submitted January 29, 2021

       Prospectus Summary
       Our Company, page 1

   1.                                                   Please revise the
Summary and Business sections to clarify what work you and
                                                        your employees have
conducted to date. For instance, it should be clear whether clinical
                                                        and pre-clinical work
was performed you and your employees or whether that work was
                                                        performed by Vernalis
(R&D) Limited or another third-party.
   2.                                                   We note your disclosure
in the first sentence on page 1 that you are a "clinical-stage
                                                        biotechnology company
developing novel solutions for people suffering from cannabinoid
                                                        overdose and substance
abuse." Please balance your Summary disclosure to clearly state
 Daniel Schneeberger, M.D.
FirstName LastNameDanielInc.
                           Schneeberger, M.D.
Anebulo Pharmaceuticals,
Comapany26,
February  NameAnebulo
            2021         Pharmaceuticals, Inc.
February
Page 2 26, 2021 Page 2
FirstName LastName
         upfront, if true, that you have not conducted any clinical trials for
any of your product
         candidates.
3.       On page 1 and elsewhere you state that ANEB-001 has the potential to
be a "first-in-class"
         therapeutic. This implies the likelihood of regulatory approval and
comparisons to other
         products and product candidates. This statement is speculative in
light of its regulatory
         status, please remove the "first-in-class" references.
Our Product Candidates, page 2

4.       Please revise page 2 to (i) disclose more information about the
rimonabant data you
         reviewed, such as the number of subjects and duration of the trial(s),
(ii) clarify the
         meaning of    no clear sign of increased depression and suicide risk
 and state how such
         determination compares to the FDA findings on this topic, and (iii)
state why you believe
         ANEB-002 may be less likely to cause psychiatric side effects than
rimonabant. Please
         also revise your statement referring to rimonabant as efficacious, as
determinations as to
         efficacy are solely within the authority of the FDA and comparable
regulatory bodies.
5.       In your pipeline table, please visually clarify the need for FDA
approval. For instance,
         remove the    marketed    column as it implies that once you complete
Phase 3 trials your
         product candidates will be marketed. Also clarify the    potential for
second commercial
         product    in your pipeline chart so as to not suggest you will have
at least one product
         approved. Separately, please shorten the arrow for ANEB-001 as it has
not begun Phase 2
         trials yet.
6.       We note the inclusion of ANEB-002 in the table on pages 2 and 62
indicating, for
         instance, that your ANEB-002 is in the midst of a preclinical
development for substance
         abuse. Please revise your disclosure on page 68 to provide a more
fulsome discussion of
         this program. In your revised disclosure, please ensure to discuss
preclinical studies or
         other development activities conducted. Alternatively, remove ANEB-002
from
         your pipeline table.
7.       We note your statement referencing the Journal of Pharmacology and
Experimental
         Therapeutics on page 2. Please revise to remove any implication that
preclinical trials can
         establish efficacy.
Our Market Opportunity, page 4

8.       We note your reference to data from a commissioned market research
report from
         Guidepoint Global, LLC. Please file such party   s consent as an
exhibit to the registration
         statement. Refer to Securities Act Rule 436.
Our Clinical Trials and Development Plan, page 5

9.       Please revise page 5 to provide the basis for the statement that
ANEB-001 was able to
         significantly reverse the action of THC.
 Daniel Schneeberger, M.D.
FirstName LastNameDanielInc.
                           Schneeberger, M.D.
Anebulo Pharmaceuticals,
Comapany26,
February  NameAnebulo
            2021         Pharmaceuticals, Inc.
February
Page 3 26, 2021 Page 3
FirstName LastName
10.      We note that two Phase 1 studies were conducted by Vernalis for
ANEB-001 from 2006
         to 2007. Please revise to provide the program name and target
indication. To the extent
         that Vernalis was targeting a different indication, please revise the
charts on page 2 and
         62 to indicate that ANEB-001 is still in the preclinical stage for
cannabinoid
         overdose. Similarly, please revise the chart to clarify, if true, that
you have not yet filed
         an IND for cannabinoid overdose. Please include similar disclosure
with respect to the
         EMA or any other drug regulatory authorities.
11.      On page 8 you state that the Phase 2 study will lay the foundation for
you to conduct a
         more extensive clinical trial to establish ANEB-001   s quality,
safety and efficacy with a
         larger subject population. Please revise this statement as safety and
efficacy are
         determinations within the authority of the U.S. Food and Drug
Administration and
         comparable regulatory bodies.
Our Growth Strategy, page 8

12.      Please revise your statement on page 8 and elsewhere that you intend
to rapidly develop
         and commercialize ANEB-001. Clinical development is a lengthy process
and indications
         that you will be successful in developing and commercializing your
product candidate in a
         rapid or accelerated manner are speculative.
Private Placement and Recapitalization, page 9

13.      Please revise page 9 to state whether you have a written agreement
pursuant to which each
         of 22NW, LP and Mr. English has agreed to purchase the milestone
warrants and exercise
         them on a net-exercise basis into Series A preferred stock in
connection with the closing
         of this offering. If so, please also file such agreement as an
exhibit.
Risk Factors
Risks Related to Ownership of Our Common Stock and this Offering, page 37

14.      We note your exclusive forum provision on page 2 says that the federal
district courts will
         be the exclusive forum for resolving any complaint asserting a cause
of action arising
         under the Securities Act unless you consent to an alternative forum.
In that regard, we
         note that Section 22 of the Securities Act creates concurrent
jurisdiction for federal and
         state courts over all suits brought to enforce any duty or liability
created by the Securities
         Act. Please include a risk factor discussing any uncertainty regarding
enforceability of this
         provision and clearly describe any risks or other impacts on
investors. Risks may include,
         but are not limited to, increased costs to bring a claim and that
these provisions can
         discourage claims or limit investors    ability to bring a claim in a
judicial forum that they
         find favorable.
Use of Proceeds, page 45

15.      Please revise to disclose an estimate of how far in your development
and
         commercialization of ANEB-001 and ANEB-002 the proceeds from this
offering will
 Daniel Schneeberger, M.D.
FirstName LastNameDanielInc.
                           Schneeberger, M.D.
Anebulo Pharmaceuticals,
Comapany26,
February  NameAnebulo
            2021         Pharmaceuticals, Inc.
February
Page 4 26, 2021 Page 4
FirstName LastName
         allow you to reach with respect to each product candidate, including
specific phases of
         preclinical and clinical trials. Also, please disclose the total
estimated cost of each of the
         specified purposes for which the net proceeds are intended to be used,
and, if material
         amounts of other funds are necessary to accomplish the specified
purposes, provide an
         estimate of the amounts of such other funds and the sources thereof.
Additionally, on page
         54 you mention that you may use a portion of the proceeds to repay
certain debt. If any
         material part of the proceeds is to be used to discharge indebtedness,
set forth the interest
         rate and maturity of such indebtedness. If the indebtedness to be
discharged was incurred
         within one year, describe the use of the proceeds of such indebtedness
other than short-
         term borrowings used for working capital. Refer to Item 504 of
Regulation S-K.
Capitalization, page 47

16.      Please revise the table to only include long-term indebtedness,
convertible preferred stock,
         and stockholders' equity in the total capitalization line item. If you
present a cash and
         cash equivalents line item, please include a double line underneath
that line so as to
         distinguish it from the capitalization line items.
Dilution, page 48

17.      Please revise the presentation to disclose historical net tangible
book value prior to the
         presentation of pro forma net tangible book value.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Contractual Obligations and Commitments, page 56

18.      Please revise to include a description of your contractual obligations
under the Vernalis
         license agreement considering its significance in your operations.
Business
Our Clinical Trials and Milestones, page 65

19.      We note that the preclinical trials discussed in this section provide
results without
         providing proper context for such results. For each of the
pre-clinical trials discussed in
         this section, please disclose the date(s) of the trials, the sponsor
and the location; scope
         and size; dosage and duration; and actual results observed.
20.      Please provide p-values for both Phase 1 studies and explain how
statistical significance
         relates to FDA standards of efficacy. Please also state the number of
subjects in your
         Phase 1b study.
Protection of Intellectual Property, page 76

21.      With respect to all of your patents and patent applications, including
those licensed from
         Vernalis to the extent not described elsewhere, please revise your
discussion on page 76 to
         state (i) the specific products, product groups and technologies to
which such patents
 Daniel Schneeberger, M.D.
Anebulo Pharmaceuticals, Inc.
February 26, 2021
Page 5
      relate, (ii) whether the patents are owned or licensed, (iii) the type of
patent protection
      (composition of matter, use or process), (iv) patent expiration dates and
(v) identify the
      jurisdiction(s) covered.
22.   Please revise page 76 to explain the requirements that must be met to
achieve the cited
      regulatory periods of exclusivity.
Management, page 77

23.   Please revise page 84 to state whether you compensated your directors in
2020, and if so,
      provide the information required by Item 402(r) of Regulation S-K.
Exhibits

24.   Please file the Investors    Rights Agreement and Consultancy Agreement
with Traxeus
      Pharma Services Limited as an exhibit pursuant to Item 601 of Regulation
S-K, or advise.
General

25.   Please supplementally provide us with copies of all written
communications, as defined in
      Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
      present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
      not they retain copies of the communications.
       You may contact Li Xiao at 202-551-4391 or Mary Mast at 202-551-3613 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with any
other questions.



                                                             Sincerely,
FirstName LastNameDaniel Schneeberger, M.D.
                                                             Division of
Corporation Finance
Comapany NameAnebulo Pharmaceuticals, Inc.
                                                             Office of Life
Sciences
February 26, 2021 Page 5
cc:       Spencer G. Feldman, Esq.
FirstName LastName
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