United States securities and exchange commission logo
December 21, 2021
Richard Garr
Chief Executive Officer
Curative Biotechnology, Inc.
1825 NW Corporate Blvd, Suite 110
Boca Raton, FL 33431
Re: Curative
Biotechnology, Inc.
Draft Registration
Statement on Form S-1
Submitted November
24, 2021
CIK No. 0001400271
Dear Mr. Garr:
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 November 24, 2021
Cover Page
1. We note that a group of
your officers and directors control a significant portion of the
Company. Please tell us
whether you will be deemed a controlled company as defined
by the market on which
you intend to list and, if so, whether you intend to rely on any
exemptions as a
controlled company. If applicable, please disclose on the prospectus
cover page and in the
prospectus summary that you are a controlled company, and include
a risk factor that
discusses the effect, risks and uncertainties of being designated
a controlled company.
Prospectus Summary
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany21,
December NameCurative
2021 Biotechnology, Inc.
December
Page 2 21, 2021 Page 2
FirstName LastName
What We Do, page 1
2. Please revise your Summary to provide a more detailed overview of each
of the
Company's four programs and the current development status of each.
Your disclosure in
this section should be balanced by noting the challenges the Company
faces in developing
such programs, including competition, the Company's history of net
losses, and the
uncertainty surrounding its ability to continue as a going concern.
3. We note your disclosure that "[o]ne of [y]our major focuses is on
diseases defined by the
United State Food and Drug Administration, or FDA, as Orphan
Diseases. "
"Orphan" has a specific meaning in FDA regulations, and your product
candidates have
not yet received orphan designation from the FDA. As such, you should
revise disclosure
here and throughout the prospectus as applicable to remove any
possible inference that
your product candidates have been or will be granted orphan
designation. You may retain
disclosure indicating that you intend to seek such designation and an
explanation of the
process and benefits if granted.
Risk Factors, page 4
4. We note your risk factor discussion is greater than fifteen pages.
Please revise to provide a
section with a series of concise, bulleted or numbered statements that
is no more than two
pages summarizing the principal factors that make an investment in the
registrant or
offering speculative or risky. See Item 105(b) of Regulation S-K. In
addition, please
revise to comply with Item 105(a) of Regulation S-K by relocating
risks that could
generically apply to any registrant or offering to the end of the
section under the caption
"General Risk Factors."
We have a limited operating history, which may make it difficult for investors
to predict future
performance based on current operations., page 4
5. We note references in your risk factor disclosure on page 4 discussing
cannabis and other
flora. However, we do not note any other cannabis related disclosure
elsewhere in your
draft registration statement, including your business section. Please
revise your risk factor
disclosure to make this risk factor more specific to your business or
otherwise advise.
We are an early-stage company, have no product revenues, are not profitable and
may never be
profitable., page 4
6. Please revise your statement that "initial data from [y]our research
appear promising" to
eliminate conclusions or predictions that your product candidates are
effective as
determinations of efficacy are solely within the authority of the FDA.
You may provide a
summary of the data that you used to draw these conclusions, and such
discussion is more
appropriate in the Business section where full and proper context can
be provided.
You may experience future dilution as a result of future equity offerings.,
page 22
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany21,
December NameCurative
2021 Biotechnology, Inc.
December
Page 3 21, 2021 Page 3
FirstName LastName
7. We note your disclosure elsewhere that you will issue an additional
6,500,000 and
17,5000,000 shares of Common Stock upon the occurrence of certain
milestones under
your license agreements with Mid-Atlanta BioTherapeutics, Inc. Please
revise your
disclosure here or where you deem appropriate to describe the future
dilution that may
occur pursuant to your material agreements.
Use of Proceeds, page 24
8. We note your disclosure that you intend to use portions of the
proceeds of this offering to
(i) begin manufacturing of all four of our development stage
therapeutics, (ii) begin
preparation for regulatory submissions and clinical trials, (iii)
prosecute patent
applications worldwide and (iv) general corporate purposes. Please
specify what amounts
will be allocated to each of these uses. In addition, please revise
you disclosure to allocate
the amount of proceeds you expect to use for each of your four
programs and specify how
far in the clinical development of your product candidates you expect
to reach with the net
proceeds. If any material amounts of other funds are necessary to
accomplish the specified
purposes, state the amounts and sources of other funds needed for each
specified purpose
and the sources. For guidance, please refer to Item 504 of Regulation
S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
26
9. We note your disclosure appears to leave out the "Trends & Outlook"
section referenced
in your second bullet on page 26. Please revise your disclosure here
or otherwise advise.
Our Business, page 32
10. We note your disclosure of your Scientific Advisory Board on page 26,
in your Results of
Operation section, in your financial statements and on your website.
If material, please
include disclosure that describes the role or function of your
Scientific Advisors, whether
there are any rules of procedures governing this board as well as how
the Scientific
Advisors are compensated.
Licenses, page 33
11. We note your disclosure here indicates that both of your license
agreements with Mid-
Atlanta BioTherapeutics, Inc. contain termination provisions if you do
not raise certain
amounts of funds for each of your product candidates specific to each
agreement. However, your disclosure in your draft registration
statement regarding the
term and termination provision appears to be inconsistent with the
actual language in
Section 12 of each License Agreement filed as Exhibit 10.09 and 10.13.
Please reconcile
this apparent inconsistency or otherwise advise.
12. For each of your material licenses described in this section please
update your disclosure
to include a description of the termination provisions available to
the licensor under each
agreement.
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany21,
December NameCurative
2021 Biotechnology, Inc.
December
Page 4 21, 2021 Page 4
FirstName LastName
Products Development, page 33
13. We note that your disclosure for each of your four development
programs (Rabies,
Glioblastoma, Retinal Degenerative Disease and COVID-19) only includes
brief
discussions of each program with no detail regarding the current phase
of development or
steps taken by the Company after in-licensing each candidate. In
addition, we note your
website and your "Corporate Overview" investor presentation currently
available on
your website contain more detailed material information that is not
disclosed in your draft
registration statement, including, for example only, (i) mechanism of
action of your
product candidates, (ii) preclinical animal data, (iii) specific
indications you plan to pursue
and (iv) description of planned regulatory pathways. Please revise
your disclosure for each
of your four programs to discuss each program's current stage of
development, any prior
material preclinical studies and results, and any regulatory
submissions or filings made to
date.
14. We note your disclosure that "[o]btaining the PRV is a primary
business goal for the
Company for this program." Please revise your disclosure in this
section to explain the
conditions for and the impact of receiving a FDA Priority Review
Voucher.
15. In relation to your glioblastoma program, we note your statement that
"the company plans
on manufacturing the drug and taking it through an FDA approved Phase
1 proof of
concept trial." Please revise your disclosure to indicate whether you
have submitted an
IND to the FDA and whether such submission has been accepted. In the
event you have
not submitted an IND, please revise this statement to remove the
implication that you will
assuredly progress to Phase 1 trials, as such statement appears
premature.
16. We note your disclosure that you were licensed the "first ever CD56
fully humanized
monoclonal antibodies." Please provide your basis for this statement.
NIH License L-088-20210 - "Druggable target to treat retinal degeneration",
page 34
17. We note your disclosure that you "may choose to extend the term for
the life of the patents
underlying the licensed assets for $45,000." Please update your
disclosure to further
describe the length of such potential extension. In addition, we note
section 13.2(b)(ii) of
Exhibit 10.11 states that you must provide the licensor written
evidence of commercially
reasonable progress toward your clinical studies of the Licensed
Product and adherence
with the Commercial Development Plan in addition to the $45,000
extension royalty in
order to the extend the term of the agreement. Please update your
disclosure accordingly
to reflect this provision or otherwise advise.
Competition, page 35
18. We note your disclosure regarding competition in the drug development
industry. Please
expand your disclosure to also discuss competition among each of your
material programs
or product candidates, including the Company's competitive position in
the industry and
methods of competition, as required by Item 101(h)(4)(iv) of
Regulation S-K.
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany21,
December NameCurative
2021 Biotechnology, Inc.
December
Page 5 21, 2021 Page 5
FirstName LastName
Intellectual Property, page 35
19. Please revise your intellectual property disclosure to disclose for
each
material patent and patent application the specific products or
technologies to which such
patents or patent applications relate. Also clearly describe on an
individual basis the type
of patent protection granted for each product or technology
(composition of matter, use, or
process), whether the patents are owned or licensed, the expiration of
each patent held,
and the jurisdiction, including any foreign jurisdiction, of each
pending or issued patent.
In this regard, it may be useful to provide this disclosure in tabular
form to support the
narrative already included.
Description of Securities, page 45
20. Your disclosure does not describe that you are registering Units and
the warrants portion
of the Unit and the common stock underlying the warrants. Please state
all securities that
you are registering. Refer to Item 202 of Regulation S-K. In addition,
please file the form
of unit agreement or otherwise advise.
Common Stock Purchase Options, page 47
21. We note your disclosure that the Company issued a "consultant" certain
options to
purchase common stock of 1% of the issued and outstanding capital
stock of the Company
on a fully diluted basis. Please update your disclosure here to
identify the consultant and
disclose if he/she is still providing services to the Company. In
addition, please describe
the consulting and management services provided by the consulting
agreement in greater
detail in your business section or where you deem appropriate. Please
disclose
the material terms of the agreement including the parties rights
and obligations, payment
terms and termination provisions. In addition, please file the
agreement as an exhibit to
your registration statement as required under Item 601(b)(10) of
Regulation S-K.
Our Management
Executive Officers and Directors, page 49
22. We note your disclosure that Mr. Michaels and Dr. Ginsberg are
"co-founders" of the
Company. However, we note your disclosure elsewhere, including on page
44, that the
Company was originally incorporated in 1995 as Growth Industries, Inc.
and has
subsequently changed its name and reincorporated multiple times.
Please revise your
disclosure to clarify what specifically you mean when you state Mr.
Michaels and Dr.
Ginsberg are "co-founders" of the Company.
23. We note several of your executive and director biographies where the
principal occupation
and employment is unclear during the past five years. Please discuss
the principal
occupation and employment for the past five years, including the name,
and principal
business of any corporation or other organization. See Item 401(e) of
Regulation S-K.
Statements of Operations, page F-4
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany21,
December NameCurative
2021 Biotechnology, Inc.
December
Page 6 21, 2021 Page 6
FirstName LastName
24. It appears that you are presenting your expenses by function (general
and administrative)
and by nature (salaries and share based compensation and professional
fees and share
based compensation). Please revise to present your Statements of
Operations consistently
by function, or tell us why no revision is necessary. Refer to Rule
5-03 of Regulation S-X.
This comment also applies to the disclosures on page F-19.
Note 10 - Deficiency in Stockholders' Equity, page F-12
25. Please revise to disclose the specific services received for the stock
issued for services,
particularly related to the Series A and Series C preferred stock that
resulted in significant
compensation recorded in fiscal 2020. Please also disclose how these
shares were valued.
Exhibits
26. We note that your forum selection provision in Article X of your
Amended and Restated
Bylaws identifies the State Court of Florida as the exclusive forum
for certain litigation,
including any derivative action. Please disclose whether this
provision applies to actions
arising under the Securities Act or Exchange Act. In that regard, we
note that Section 27
of the Exchange Act creates exclusive federal jurisdiction over all
suits brought to enforce
any duty or liability created by the Exchange Act or the rules and
regulations thereunder,
and 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
or the rules and regulations thereunder. If the provision applies to
Securities Act claims,
please also revise your prospectus to state that there is uncertainty
as to whether a court
would enforce such provision and that investors cannot waive
compliance with the federal
securities laws and the rules and regulations thereunder. If this
provision does not apply to
actions arising under the Securities Act or Exchange Act, please also
ensure that the
exclusive forum provision in the governing documents states this
clearly, or tell us how
you will inform investors in future filings that the provision does
not apply to any actions
arising under the Securities Act or Exchange Act.
27. We note that you have not filed the form of warrant related to the
units being offered in
this registration statement. Please file the form of warrant. See Item
601(b)(4) of
Regulation S-K.
28. We note your exhibit list includes License Agreements 10.09 through
10.13. Please revise
your description of each license agreement to include the name of the
parties to each
agreement.
29. Please ensure that the agreements filed as exhibits are complete,
dated and executed
copies that include all of the material terms of the agreement. For
example only, we note
that it appears that pages 26 through 34 were admitted from Exhibit
10.11 and pages 21
through 25 were admitted from Exhibit 10.12. Please refile complete
and executed copies
of your agreements or otherwise advise.
Richard Garr
Curative Biotechnology, Inc.
December 21, 2021
Page 7
General
30. We note the interview with Mr. Garr with Dan Sfera on July 6, 2021 that
is available on
YouTube. In the interview, Mr. Garr references the Company s plans to
file a Form 10,
up-list to a different exchange and future financings. Please provide us
with your analysis
as to how this complies with Section 5 of the Securities Act.
31. We note that some information on your website is inconsistent with the
information
provided in your draft registration statement. For example only, on the
"Pipeline"
section on your website you state you have "A CURE FOR RABIES" and
"currently have
nine ongoing programs in three therapeutics areas." Please ensure your
registration
statement is complete and accurate, and that the information on your
website is consistent
with such disclosure.
32. Please provide the dealer prospectus delivery obligation as required by
Item 502(b)
of Regulation S-K.
33. 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 Jeanne Bennett at 202-551-3606 or Vanessa Robertson at
202-551-3649
if you have questions regarding comments on the financial statements and
related
matters. Please contact Jason Drory at 202-551-8342 or Laura Crotty at
202-551-7614 with any
other questions.
Sincerely,
FirstName LastNameRichard Garr
Division of
Corporation Finance
Comapany NameCurative Biotechnology, Inc.
Office of Life
Sciences
December 21, 2021 Page 7
cc: Raul Silvestre, Esq.
FirstName LastName