SEC Comment Letter for PURPLE BIOTECH LTD. (PPBT) (CIK 0001614744) (PPBT) — Aug 12, 2015
PURPLE BIOTECH LTD. (PPBT) (CIK 0001614744)
Date: Aug. 12, 2015 · CIK: 0001614744 · Accession: 0000000000-15-041307
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Mail Stop 4720
August 11, 2015
Via E -mail
Simcha Rock
Chief Financial Officer
Kitov Pharmaceuticals Holdings Ltd.
One Azrieli Center, Round Building,
Tel Aviv, 6701101
Israel
Re: Kitov Pharmaceuticals Holdings Ltd.
Confidential Draft Registration Statement on Form F -1
Submitted July 20, 2015
CIK No. 0001614744
Dear Mr. Rock:
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 th ese comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Cover Page
1. Please clarify here and throughout your registration statement whether the warrants you
are offering will be packaged an d sold with the ADSs or will be sold separately.
Table of Contents
2. Please remove the last two sentences from the fourth paragraph after the table of
contents, as they could be construed as an attempt to disclaim responsibility for
information included i n your registration statement. Similarly, please remove the
Simcha Rock
Kitov Pharmaceuticals Holdings Ltd.
August 11, 2015
Page 2
sentence on page 28 that notes that you have not independently verified information
obtained from industry and other sources.
Prospectus Summary
Our company, page 1
3. Please revise your descripti on of KIT -301 to note that naproxen is a generic drug and
identify the other generic drug included in the composition of this product.
4. Please revise your description of KIT -302 to identify its generic drug component in
addition to celecoxib. Please also state, if true, that celecoxib is the active ingredient in
the branded drug Celebrex where they first mention it.
5. Here, and wherever else in your registration statement that you state you will “consider”
the further development of KIT -301, please elaborat e on what the current status of this
product candidate is and the reason(s) you are apparently not pursuing its development at
this time.
Risks associated with our business, page 3
6. Please include a bullet point relating to the risk stemming from the pat ent protection
currently enjoyed by celecoxib and Celebrex.
Use of Proceeds, page 30
7. Here and on page 4 of the prospectus summary please amend your disclosure to indicate
the approximate amount of net proceeds you intend to allocate toward the expansion of
your clinical development pipeline.
Business
Intellectual Property, page 50
8. Please amend your disclosure to describe the nature of the patent protection that each
application may confer such as composition of matter, method of use, method of
manufacturi ng, etc. Also, please indicate approximately when the patents you are
applying for would, if granted, expire in each of the five jurisdictions.
Management
Executive compensation, page 63
9. Please file the three agreements with management you describe on pages 64 -66 as
exhibits .
Simcha Rock
Kitov Pharmaceuticals Holdings Ltd.
August 11, 2015
Page 3
Taxation and Government Programs
Passive Foreign Investment Company Consequences, page 104
10. Please indicate whether you were classified as a PFIC in fiscal 2014.
Exhibits and financial statement schedules, page II -3
11. Please tell us whether you intend to submit an application for confidential treatment for
any of your exhibits. If so, please indicate this by including a separate footnote next to the
agreement listed here.
Other Comments
12. Please be advised t hat we will defer any further review of your registration statement
until such time as you have identified an underwriter(s) for your offering.
13. Please suppl ement ally provide us with copies of all written communications, as defined
in Rule 405 und er the Securities Act, that you, or anyone authori zed to do so on your
behalf, present to po tential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
14. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus. If those are not the only graphics, please
provide any additional graphics prior to their use for our review.
15. We note that sev eral exhibits have yet to be submitted for our review. Please submit these
exhibits to us as soon as practicable after their completion. Please be advised that once
you file your registration statement publicly you must also file each exhibit as well, even
if you have already submitted them to us as part of your confidential submission.
You may contact Frank Wyman at (202) 551 -3660 or Mark Brunhofer at (202) 551 -3638
if you have questions regarding comments on the financial statements and related matters.
Please contact Scot Foley at (202) 551 -3383 or me at (202) 551 -3715 with any other questions.
Sincerely,
/s/ Jeffrey P. Riedler
Jeffrey P. Riedler
Assistant Director
Office of Healthcare and Insurance
Simcha Rock
Kitov Pharmaceuticals Holdings Ltd.
August 11, 2015
Page 4
cc: Perry Wildes, Adv.
Gross, Kleinhend ler, Hodak, Halevy, Greenberg & Co.
One Azrieli Center
Tel Aviv 67021 Israel