SEC Comment Letter for Fortress Biotech, Inc. (FBIO, FBIOP) (CIK 0001429260) (FBIO) — Aug 10, 2011
Fortress Biotech, Inc. (FBIO, FBIOP) (CIK 0001429260)
Date: Aug. 10, 2011 · CIK: 0001429260 · Accession: 0000000000-11-048312
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File numbers found in text: 000-54463
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August 9, 2011
Via E-mail
Bobby W. Sandage, Jr., Ph.D. President and Chief Executive Officer Coronado Biosciences, Inc.
45 Rockefeller Plaza, Suite 2000
New York, New York 10111
Re: Coronado Biosciences, Inc.
Registration Statement on Form 10-12G Filed July 15, 2011
File No. 000-54463
Dear Dr. Sandage:
We have reviewed your filing 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 amendi ng your filing or by providing the requested
information, as applicable. If you do not beli eve our comments appl y to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
General
1. Please note that where we provide examples to illustrate what we mean by our comments,
they are examples and not exhaus tive lists. If our comments are applicable to portions of
the filing that we have not cited as examples , make the appropriate changes in accordance
with our comments.
2. We note that you have submitted an application for confidential treatment with respect to
some of the documents you have filed as exhi bits to your registration statement. Please
be advised that we will review this app lication independently and will forward you any
comments relating to your confidential tr eatment request under separate cover.
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 2
Cautionary Note Regarding Forw ard-Looking Statements, page 3
3. We note your disclaimer as to forward-l ooking statements and your reference to the
Private Securities Litigation Re form Act of 1995. Please note that you are not eligible for
the safe harbor for forward-looking statem ents available under the PSLRA because you
are not currently a U.S. reporting company. Pl ease revise your disclosure here and in
your management discussion and an alysis at page 29 to clarify that the safe harbor does
not apply to any forward- looking statements containe d in the prospectus.
Item 1. Business
Industry, page 4
4. We note that your registration statemen t includes the following statements:
On page 4: “Although immunosuppressant and TNF- inhibitors are effective
maintenance therapies, fewer than 50% of patients maintain long-term remission with
these drugs;”
On page 4: “The majority of Crohn’s pa tients require surgery during their lifetime
despite available therapies;” and
On page 4: “…research strongly sugges ts that genetic su sceptibility and
environmental factors, coupled with an a bnormal immune response, contribute to the
development of the disease.”
Please provide your basis for these statements or delete them from your registration
statement.
Our Product Candidates, page 5
5. We note your statement that CNDO-201 origin ates from the work of Dr. Joel V.
Weinstock and your reference to his research with regard to parasitic helminth (worm)
infections. Please revise your disclosure to discuss whether and when Dr. Weinstock
published the results of his res earch that determined that a beneficial immune response
results from T. suis being administered to pa tients to IBD. Please also indicate whether
Dr. Weinstock has consented to your use of his research and whet her you have entered
into any contractual arrangements with Dr. Weinstock to use data derived from his
research in the development of CNDO-201.
6. We note that the four paragraphs under th e heading “Background” on pages five and six
include numerous statements and conclusions without citing a source or providing an
independent basis for the disclosed informa tion. For example, we note the following:
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 3
Statements concerning the incidence of IBD in the developed and non-developed
world and in persons from di fferent socioeconomic strata;
Statements with respect to the prevalence of helminthes in certain climates and
populations;
Statements as to the incidence of IBD over the past several decades; and
Statements as to the impact of exposure to helminth population.
Please revise your disclosure to provide a s ource or independent basis for each of the
statements made. In particular, where you refe r to data, findings, or conclusions, please
provide the source for this information. If you are unable to cite a source for the
information you disclose, please remove th ese statements from your registration
statement.
Third Party Clinical Trials, page 6
7. Please revise your disclosure to indicate whether any signifi cant adverse events were
observed or reported in each of the third party clinical trials you discuss on page 6 of the
registration statement.
8. Please revise your disclosure to indicate whether and when Professor Lowdell published
the results of his preclinical studies and research with re gard to NK Cells and AML.
Please also indicate whether Professor Lo wdell has consented to your use of his
preclinical research and results and i ndicate whether you have entered into any
contractual arrangements with Professor Lowdell relating to the use of data derived from
his research in the development of CNDO-109.
9. Please revise your disclosure to indicate whether any signifi cant adverse events were
observed or reported in the pre-clinical stud ies conducted by Professor Lowdell in
relation the use of NK Cells as cancer treatment.
Completed Clinical Trial, page 8
10. Please identify the party that c onducted the “Phase 1 clinical trial of CNDO-109 activated
haploidentical NK cells conducted in the Unite d Kingdom” that you cite at the bottom of
page 8.
Manufacturing, page 9
11. Please include in your disclosure all materi al terms of the service agreement you have
entered into with BioReliance. In addition, please file this agreem ent as an exhibit to
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 4
your registration statement or pr ovide a legal analysis as to why you are not required to
file it as an exhibit.
12. Please revise your disclosure to indicate in the discussion of your license agreement with
OvaMed that you are obligated to pay a r oyalty of 4% on net sales of CNDO-201 as
disclosed on page F-28 of your registration st atement. With regard to your license
agreement with UCL, please provide the range of potential royalties that you will have to
pay based on net sales of CNDO-109. In a ddition, for both of these license agreements,
please identify the percentage range of consid eration received from sublicensees that you
will be obligated to pay OvaMed and UCL. Pl ease limit your disclosed royalties to a ten
percent range (e.g. “si ngle-digits,” “teens,” “twenties”).
Item 1A. Risk Factors, page 17
General
13. Please include a risk factor describing the ma terial risks to your shareholders presented
by the anti-takeover provisions that are present in your cer tificate of incorporation and
your by-laws, as well as by the restricti ons imposed on you by Section 203 of the
Delaware General Corporation Law, and how these provisions may prevent you from
entering into a merger or business combina tion that might benefit your stockholders.
“Because we in-licensed our product candidates fr om third parties, any dispute with or non-
performance by us or by our licensors . . .,” page 17
14. Please provide a general descri ption of OvaMed’s material obligations under its license
agreement with the University of Iowa Re search Foundation and c onfirm whether there
has been any conflict, dispute, disagreem ent, or issue of non-performance under the
agreement.
“We intend to rely on third parties to conduct our clin ical trials. If these third parties do not meet
our deadlines or otherwise conduct the trials as required . . .,” page 20
15. Please include in your Business section a si milar discussion as to how you intend to
utilize contract research organizatio ns to conduct clinical trials.
“We may experience delays in the commencement of our clinical tria ls or in the receipt of date
from third parties…,” page 19
16. Please identify the third party sources you intend to rely upon for precl inical, clinical and
quality data to support your IND submission. Please also discuss the availability of this
data and any factors that may impact your acce ss to this data for inclusion in your IND
submission.
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 5
“We rely completely on OvaMed and other thir d parties to manufacture our preclinical and
clinical pharmaceutical supplies . . .,” page 21
17. Please note in this risk factor the extent to which you are also reliant on ProgenitorTM
Cell Therapy, LLC and BioReliance for your supply of CNDO-109.
“If we fail to attract and retain key management and clinical development personnel…,” page 22
18. To the extent you have experienced problems attracting and retaining highly qualified
personnel in the recent past, please re vise to describe these problems.
“We are a development stage company with a hist ory of operating losses that are expected to
continue . . .,” page 25
19. Please include in this risk factor the opera ting loss you have experienced in each of the
last three fiscal years.
“We will need substantial additi onal funding and may be unable to raise capital when needed . .
.,” page 25
20. Please include in this risk factor your resear ch and development expenses for each of the
last three fiscal years.
Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page
29
Critical Accounting Policies and Use of Estimates, page 30
R&D Expenses, page 33
21. You disclose research and development expe nse from inception to date by project.
Please expand this disclosure to quantify re search and development expense by project
for each period presented in the financial statements.
Item 4. Security Ownership of Certain Beneficial Owners and Management, page 40
22. In footnote 11 to your table, pl ease state the name(s) of th e individual(s) who has voting
or dispositive power over the shares held by Manche ster Securities Corp.
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 6
Item 6. Executive Compensation, page 45
Non-Executive Director Compensation, page 56
23. We note that the aggregate fair value for th e options awarded to Dr. Harvey, Mr. Lobell,
and Dr. Rosenwald, appear to $1.56 while the ag gregate fair value of the options awarded
to Dr. Rowinsky appears to be $1.77. Pleas e explain why the opti ons awarded to the
directors have different valu ations and confirm that the amounts reflected in your non-
executive director compensation table present the aggregate grant date fair value of the options awarded.
Financial Statements
Note 14. Stock-Based Compensation, page F-23
24. Please disclose the vesting period of the options granted as required by ASC 718-10-50-
2. Confirm if the options granted to non-employ ees in 2010 were granted to directors. If
the options were granted to directors tell us why you re-measure compensation expense
each period. Reference the supporting authoritative literature.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
Bobby W. Sandage, Jr., Ph.D. Coronado Biosciences, Inc. August 9, 2011 Page 7
You may contact James Peklenk at (202) 551-3661 or Lisa Va njoske at (202) 551-3614 if
you have questions regarding comments on the fina ncial statements and related matters. Please
contact Scot Foley at (202) 551-3383, Bryan P itko at (202) 551-3203 or me at (202) 551-3715
with any other questions.
Sincerely,
/s/ Bryan J. Pitko for
Jeffrey Riedler Assistant Director
cc: Fran Stoller, Esq.
Loeb & Loeb LLP 345 Park Avenue New York, NY 10154