United States securities and exchange commission logo
January 21, 2022
Richard Garr
Chief Executive Officer
Curative Biotechnology, Inc.
1825 NW Corporate Blvd, Suite 110
Boca Raton, FL 33431
Re: Curative
Biotechnology, Inc.
Amendment No. 1 to
Draft Registration
Statement on Form S-1
Submitted January
10, 2022
CIK No. 0001400271
Dear Mr. Garr:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement of Form S-1 submitted
January 10, 2022
Prospectus Summary
What We Do, page 1
1. We note the inclusion
of your Metformin Reformulation for multiple indications in your
pipeline table on pages
2 and 39. Given the limited amount of disclosure related to certain
potential indications
for your Metformin Reformulation and your disclosure that, "[you]
are primarily focusing
on developing a treatment for Intermediate Dry Macular
Degeneration and
Geographic Atrophy (late-stage Dry AMD)," please explain why the
following indications
(Stargardt Disease, Retinitis Pigmentosa, Choroideremia, Late-
Onsent Retinal
Degeneration and Diabetic Retinopathy) are sufficiently material to your
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany
January 21,NameCurative
2022 Biotechnology, Inc.
January
Page 2 21, 2022 Page 2
FirstName LastName
business to warrant inclusion in your pipeline table at this time. If
they are material, please
expand your disclosure in your Business section to provide a more
fulsome discussion of
these programs, including a description of preclinical studies or
development activities
conducted or planned to date. Alternatively, remove any programs that
are not
currently material from your pipeline table on pages 2 and 39.
2. We note your response to our prior comment 2 and your disclosure that
you have
"proposed INDs" and are, "prepare[ing] for the regulatory submissions
of one or more
investigational new drug application[s]." We contrast this with the
pipeline table on page
2 which shows all of your product candidates at the start of the
"research and preclinical"
column, implying that research and preclinical trials or studies have
yet to be
conducted. To the extent you have yet to conduct the preclinical
trials or IND-enabling
studies required as a prerequisite to preparing an IND for submission,
please revise your
disclosure both in the Summary and elsewhere to clarify this point.
Orphan Designation, page 4
3. We note your response to our prior comment 3 and revised disclosure on
page 4, including
your disclosure that you "have received Orphan drug designation with
respect to [y]our
proposed Rabies therapeutic." Please further revise your disclosure to
clarify whether you
have received Orphan drug designation from the FDA, EMA or both
agencies and when
such designation was granted.
Use of Proceeds, page 29
4. We note your disclosure elsewhere that you have not filed INDs for any
of your product
candidates. However, we note your disclosure for various indications
included in your Use
of Proceeds section states clearly the costs of your initial clinical
trial, but the cost for
completing the necessary preclinical or IND-enabling studies or
preparing and submitting
the IND application is unclear. For each of your four programs listed
here please revise
your disclosure so it is clear how much of the proceeds you expect to
use for each of your
programs' preclinical trials, IND-enabling studies and other costs
related to submitting
IND applications for each of your material product candidates. Please
conform your use of
proceeds disclosure in the Summary accordingly.
Product Development, page 39
5. We note your response to our prior comment 13 and various statements
throughout this
section that imply ongoing testing, studies or trials. In relation to
each of your therapeutic
areas of focus, please revise your disclosure to clearly describe the
current stage of
development of each product candidate discussed, including any
material preclinical
studies or trials and results, and any regulatory submissions or
filings made to date. To the
extent no preclinical studies or trials have been completed or none
are ongoing please
clarify.
6. We note your response to prior comment 14, including the fact that you
have "remove[d]
Richard Garr
FirstName LastNameRichard
Curative Biotechnology, Inc. Garr
Comapany
January 21,NameCurative
2022 Biotechnology, Inc.
January
Page 3 21, 2022 Page 3
FirstName LastName
references to FDA Priority Review Voucher as [you] have determined
such disclosure to
be premature." However, we note that your website continues to
reference the priority
review voucher, including on your pipeline section of the website as
well as your recent
press releases and investor presentations. Please ensure your
registration statement is
complete and accurate, and that the information on your website and in
future press
releases is consistent with such disclosure.
Licenses, page 41
7. We note your response to prior comment 12 and your revised disclosure
on pages 41 and
42, including your disclosure regarding certain termination provisions
for each of your
NIH licenses. Please revise your disclosure further for each of your
license agreements
with NIH to describe the material terms of Appendices D and E.
Specifically, please
disclose any near-term, material specific milestones you must achieve
under each
agreement to avoid being subject to the potential termination
provisions of each
agreement or otherwise advise.
Choice of Forum, page 59
8. We note your response to our prior comment 26 and reissue in part.
Your revised
disclosure states that the choice of forum provision is in your
amended and restated
bylaws. However, your disclosure also states that it is "contained in
[y]our amended and
restated certificate of incorporation." Please correct this
inconsistency or otherwise advise.
In addition, please add a risk factor describing the attendant risks
to investors. For
example, please highlight that such a provision may limit a
shareholder s ability to bring a
claim in a judicial forum that it finds favorable for disputes with
directors, officers or
other employees, and may discourage lawsuits with respect to such
claims.
Financial Statements
Statements of Operations, page F-4
9. We note from your response that in the interim statements, Payroll
and share based
compensation of $2,964,089 and Professional fees and share based
compensation of
$836,194 are both components of general and administrative expenses,
but have been
excluded from the General and administrative expenses line item.
Therefore the
reported amount of general and administrative expenses is materially
understated. Since
the line item 'General and administrative expenses' represents only
approximately one
percent of total operating expenses for the nine months ended
September 30, 2021, please
reclassify the 'payroll and share based compensation' and the
'professional fees and share
based compensation' line items into the functional expense line item,
'general and
administrative expenses' and disclose the share based compensation
amounts in the notes.
Alternatively, revise the name of the line items to clarify they are
all a part of general and
administrative expenses. This comment also applies to the disclosures
on page F-19. In
addition, please revise Management's Discussion and Analysis
accordingly.
Richard Garr
Curative Biotechnology, Inc.
January 21, 2022
Page 4
General
10. We note the information and Section 5 analysis provided in your response
letter in
relation to our prior comment 30. We are unable to agree, based on the
information
provided, with your analysis. As a non-reporting company, you do not
appear to be
eligible to rely on the Rule 168 safe harbor. In addition, we note your
disclosure on page
28 where you indicate your common stock has previously been classified as
a penny
stock. The Rule 163A safe harbor is not available to an issuer that
is, or during the past
three years was (or any of whose predecessors during the last three years
was): (i) a blank
check company as defined in Rule 419(a)(2); (ii) a shell company, other
than a business
combination related shell company, each as defined in Rule 405; or (iii)
an issuer for an
offering of penny stock as defined in Rule 3a51-1 of the Securities
Exchange Act of 1934.
To the extent you continue to believe the safe harbor in Rule 163A
applies, please provide
us your analysis. Alternatively, please explain how your communication
complied with
Section 5. See our prior comment 30.
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
January 21, 2022 Page 4
cc: Raul Silvestre, Esq.
FirstName LastName