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SEC Comment Letter for Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097) (CRBP) — Sep 23, 2014

Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097)
Date: Sept. 23, 2014 · CIK: 0001595097 · Accession: 0000000000-14-047691

Regulatory Compliance Financial Reporting Internal Controls

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
September 3, 2014
Author
/s/ Daniel Greenspan for
Form
UPLOAD
Company
Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097)

Letter

September 23 , 2014 Via E -mail Yuval Cohen, Ph.D. Chief Executive Officer Corbus Pharmaceuticals Holdings, Inc. 100 River Ridge Drive Norwood, MA 02062

Re: Corbus Pharmaceuticals Holdings, Inc. Registration Statement on Form S -1 Filed September 3, 2014 File No. 333 -198563

Dear Dr. Cohen:

We have reviewed your registration statement and have the following additional comment.

Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comment applies to your facts and circu mstances or do not believe an amendment is a ppropriate, please tell us why in your response.

After revie wing any amendment to your registration statement and the infor mation you provide in response to this com ment, we may have additio nal co mments.

Prospectus Summary Our Pipeline, page 3

1. We note your response to our prior comment 1. Please disclose the information contained in your response in your prospectus. Specifically, please disclose that you believe you are able rely on all prior non -clinical and Phase 1 clinical data generated by the prior licensee based on the pre -IND meeting you held with the FDA on October 26, 2012, and disclose that the FDA first required you to conduct a rat chronic toxicology study, which you have completed. If that toxicology study is one of the studies referenced on page 47, please clarify disclosure to indicate this fact.

We urge all persons who are responsible for the accuracy and adequacy of the disclos ure in the filing to be ce rtain that the filing includ es the information the Secu rities Act of 1933 and all applicable Securities Act rules require. Since the co mpany and its manag ement are in

Yuval Cohen, Ph.D. Corbus Pharmaceuticals Holdings, Inc. September 23 , 2014 Page 2

possession of all facts r elating to a co mpany’s disclosure, they are responsi ble for the acc uracy and adequacy of the disclos ures they have made.

Notwithstanding our comment, in the e vent you request acceleration of the effective date of the pe nding registration s tatement please pr ovide a writt en state ment from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Com mission from taking any action with respect to the filing;

 the action of the Com mission or the staff, acting pursuant to delegated authority, in declaring the filing effecti ve, does not relieve the co mpany from its full responsibility for the adequacy and accuracy of the discl osure in the filing; and

 the co mpany may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initia ted by the Commission or any person under the federal securiti es laws of the United Stat es.

Please refer to Rules 460 and 461 re garding requests for acceleration. We will consider a written reque st for acceleration of the effective date of the registration state ment as confir mation of the fact that those requesting ac celeration are aware of t heir respective res ponsibilities und er the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the secur ities specified in the above registration state ment. Please all ow adequate ti me for us to review any a mendment prior to the requested effecti ve date of the registration state ment.

You may contact Frank Wyman at (202) 551 -3660 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Austin Stephenson at (202) 551 -3192, John Krug at (202) 551 -3862, or me at (202) 551 - 3715 with any other questions.

Sincerely,
/s/ Daniel Greenspan for

Show Raw Text
September 23 , 2014

Via E -mail
Yuval Cohen, Ph.D.
Chief Executive Officer
Corbus Pharmaceuticals Holdings, Inc.
100 River Ridge Drive
Norwood, MA 02062

Re: Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S -1
Filed September 3, 2014
File No. 333 -198563

Dear Dr. Cohen:

We have reviewed your registration statement and have the following additional
comment.

Please respond to this letter by amending your registration statement and providing the
requested information.  If you do  not believe our comment applies to your facts and
circu mstances or do not believe an  amendment is a ppropriate, please tell us why in your
response.

After revie wing any amendment to  your registration statement and the infor mation you
provide  in response to this com ment, we may have additio nal co mments.

Prospectus Summary
Our Pipeline, page 3

1. We note your response to our prior comment 1.  Please disclose the information
contained in  your response in your prospectus.  Specifically, please disclose that
you believe you are able rely on all prior non -clinical and Phase 1 clinical data
generated by the prior licensee based on the pre -IND meeting you held with the
FDA on October 26, 2012,  and disclose that the FDA first required you to conduct
a rat chronic toxicology study, which you have completed.  If that toxicology study
is one of the studies referenced on page 47, please clarify disclosure to indicate this
fact.

We urge all persons who are responsible for the accuracy and adequacy of the disclos ure
in the filing to  be ce rtain that the filing includ es the information the Secu rities Act of 1933 and
all applicable  Securities Act rules  require.  Since the co mpany and its manag ement are in

Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
September 23 , 2014
Page 2

 possession of all facts r elating to a co mpany’s disclosure, they are responsi ble for the acc uracy
and adequacy  of the disclos ures they have made.

Notwithstanding our comment, in the e vent you request acceleration of the effective date
of the pe nding registration s tatement please pr ovide a writt en state ment from  the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare
the filing effective, it does not foreclose the Com mission from  taking  any action
with respect to the  filing;

 the action of the Com mission or the staff,  acting pursuant to delegated authority, in
declaring the filing effecti ve, does  not relieve the co mpany from  its full
responsibility for the adequacy  and accuracy of the discl osure in the filing; and

 the co mpany may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initia ted by the Commission or any person under the
federal securiti es laws of the United Stat es.

Please refer to Rules 460  and 461 re garding requests for acceleration.  We will consider a
written reque st for acceleration of the effective date of the registration state ment as confir mation
of the fact that those requesting ac celeration are aware of t heir respective res ponsibilities und er
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public  offering of the secur ities specified in the above registration state ment.  Please all ow
adequate ti me for us to review any a mendment prior to the requested effecti ve date of the
registration state ment.

You may contact Frank Wyman at (202) 551 -3660 or Mary Mast at (202) 551 -3613  if
you have questions regarding comments on the financial statements and related matters. Please
contact Austin Stephenson at (202) 551 -3192, John Krug at (202) 551 -3862, or me at (202) 551 -
3715 with any other questions.

Sincerely,

         /s/ Daniel Greenspan for

Jeffrey P. R iedler
Assista nt Direct or

cc: Via E -Mail
Steven M. Skolnick, Esq.
 Lowenstein Sandler LLP