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
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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