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Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
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Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
↓
Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
↓
Corbus Pharmaceuticals Holdings, Inc.
Response Received
2 company response(s)
High - file number match
↓
↓
Company responded
2020-04-30
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2020-04-30
Generating summary...
Corbus Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-07-15
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2019-07-15
Generating summary...
Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-06-10
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2019-06-10
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↓
Company responded
2019-06-25
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2019-06-25
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Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2018-01-11
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2018-01-11
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↓
Company responded
2018-01-16
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2018-01-16
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Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-11-18
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2015-11-18
Generating summary...
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Company responded
2015-11-18
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2015-11-18
Generating summary...
Corbus Pharmaceuticals Holdings, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2014-10-02
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2014-10-02
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Company responded
2014-10-02
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2014-10-02
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Company responded
2014-10-02
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2014-10-02
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Corbus Pharmaceuticals Holdings, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2014-09-23
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2014-09-23
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Company responded
2014-09-30
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2014-09-30
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↓
Company responded
2014-09-30
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2014-09-30
Generating summary...
Corbus Pharmaceuticals Holdings, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-08-25
Corbus Pharmaceuticals Holdings, Inc.
References: August 12, 2014
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2014-08-25
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↓
Company responded
2014-09-03
Corbus Pharmaceuticals Holdings, Inc.
Filing - Correspondence from Corbus Pharmaceuticals Holdings, Inc.
CORRESP · 2014-09-03
Generating summary...
Corbus Pharmaceuticals Holdings, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-07-29
Corbus Pharmaceuticals Holdings, Inc.
Filing - SEC Comment Letter to Corbus Pharmaceuticals Holdings, Inc.
UPLOAD · 2014-07-29
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2026-03-13 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | 333-294217 | Read Filing View |
| 2024-03-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-03-15 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | 333-277888 | Read Filing View |
| 2023-06-07 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-06-07 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-24 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-13 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-07-15 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-06-25 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-06-10 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2018-01-16 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2018-01-11 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2015-11-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2015-11-18 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-23 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-03 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-08-25 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-07-29 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-13 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | 333-294217 | Read Filing View |
| 2024-03-15 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | 333-277888 | Read Filing View |
| 2023-06-07 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-13 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-07-15 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-06-10 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2018-01-11 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2015-11-18 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-23 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-08-25 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-07-29 | SEC Comment Letter | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2024-03-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2023-06-07 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2020-04-24 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2019-06-25 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2018-01-16 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2015-11-18 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-10-02 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
| 2014-09-03 | Company Response | Corbus Pharmaceuticals Holdings, Inc. | DE | N/A | Read Filing View |
2026-03-18 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm CORRESP Corbus Pharmaceuticals Holdings, Inc. 500 River Ridge Drive Norwood, MA 02062 March 18, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Corbus Pharmaceuticals Holdings, Inc. (the “Company”) Registration Statement on Form S-3 (File No. 333-294217) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:30 p.m., Eastern Time, on March 20, 2026, or as soon as practicable thereafter, or at such later time as the Company or its counsel may request via telephone call to the staff. Please call Stephen Zapf of Lowenstein Sandler LLP at (973) 422-6708 to confirm the effectiveness of the Registration Statement or with any questions. Very truly yours, CORBUS PHARMACEUTICALS HOLDINGS, INC. By: /s/ Sean Moran Name: Sean Moran Title: Chief Financial Officer
2026-03-13 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc. File: 333-294217
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 13, 2026 Yuval Cohen Chief Executive Officer Corbus Pharmaceuticals Holdings, Inc. 500 River Ridge Drive Norwood, MA 02062 Re: Corbus Pharmaceuticals Holdings, Inc. Registration Statement on Form S-3 Filed March 11, 2026 File No. 333-294217 Dear Yuval Cohen: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Stephen G. Zapf, Esq. </TEXT> </DOCUMENT>
2024-03-18 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
CORRESP
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
March 18, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Corbus Pharmaceuticals Holdings, Inc. (the “Company”)
Registration Statement on Form S-3 (File No. 333-277888)
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:15 p.m., Eastern Time, on March 20, 2024, or as soon as practicable thereafter, or at such later time as the Company or its counsel may request via telephone call to the staff.
Please call Stephen Zapf of Lowenstein Sandler LLP at (973) 422-6708 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
CORBUS PHARMACEUTICALS
HOLDINGS, INC.
By:
/s/ Sean Moran
Name:
Sean Moran
Title:
Chief Financial Officer
2024-03-15 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc. File: 333-277888
United States securities and exchange commission logo
March 15, 2024
Yuval Cohen, Ph.D.
Chief Executive Officer
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
Re:Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-3
Filed March 13, 2024
File No. 333-277888
Dear Yuval Cohen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael J. Lerner, Esq.
2023-06-07 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
United States securities and exchange commission logo
June 7, 2023
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
Re:Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-3
Filed June 1, 2023
File No. 333-272314
Dear Sean Moran:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Lerner
2023-06-07 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
CORRESP
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
June 7, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Corbus Pharmaceuticals Holdings, Inc. (the “Company”)
Registration Statement on Form S-3 (File No. 333-272314)
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:15 p.m., Eastern Time, on June 9, 2023, or as soon as practicable thereafter, or at such later time as the Company or its counsel may request via telephone call to the staff.
Please call Michael J. Lerner of Lowenstein Sandler LLP at (973) 597-6394 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
CORBUS PHARMACEUTICALS
HOLDINGS, INC.
By:
/s/ Sean Moran
Name:
Sean Moran
Title:
Chief Financial Officer
2020-04-30 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Corbus
Pharmaceuticals Holdings, Inc.
500
River Ridge Drive
Norwood,
MA 02062
April
30, 2020
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re: Corbus
Pharmaceuticals Holdings, Inc. (the “Company”)
Registration
Statement on Form S-3, as amended (File No. 333-237588)
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration
Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:15 p.m.,
Eastern Time, on May 1, 2020, or as soon as practicable thereafter.
Please
call Michael J. Lerner of Lowenstein Sandler LLP at (973) 597-6394 to confirm the effectiveness of the Registration Statement
or with any questions.
[Signature
page follows.]
U.S.
Securities and Exchange Commission
April
30, 2020
Page
2
Very
truly yours,
CORBUS
PHARMACEUTICALS
HOLDINGS,
INC.
By:
/s/
Sean Moran
Name:
Sean
Moran
Title:
Chief
Financial Officer
-2-
2020-04-24 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
April
24, 2020
VIA
EDGAR TRANSMISSION
Tim
Buchmiller, Staff Attorney
Celeste
Murphy, Legal Branch Chief
U.S.
Securities and Exchange Commission
Office
of Life Sciences
Division
of Corporation Finance
Washington,
D.C. 20549
RE: Corbus
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-3
Filed
April 7, 2020
File
No. 333-237588
Dear
Mr. Buchmiller and Ms. Murphy:
I
am writing on behalf of Corbus Pharmaceuticals Holdings, Inc. (the “Company”), in response to the letter from
the Staff of the Division of Corporation Finance (the “Staff”), of the U.S. Securities and Exchange Commission,
dated April 9, 2020 (the “Comment Letter”) relating to the above-referenced Registration Statement on Form
S-3 (the “Registration Statement”). Set forth below is the Company’s response to the comment raised in
the Comment Letter. For the convenience of the Staff, the comment in the Comment Letter is reprinted in bold and is followed by
the Company’s response.
Concurrently
with this letter, the Company is filing Amendment No. 1 to the Registration Statement (“Amendment No. 1”) which
reflects revisions made to the Registration Statement in response to the comments of the Staff. Unless otherwise noted, the page
numbers in the bold headings and the responses below refer to pages in the Registration Statement. Capitalized terms used but
not defined herein have the meaning given to such terms in the Registration Statement.
April
24, 2020
Page
2
Registration
Statement on Form S-3 filed April 7, 2020
Exhibit
3.1 – Amended and Restated Certificate of Incorporation, page II-1
1. We
note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please revise your prospectus to clearly describe this provision and to
describe any risks or other impacts on investors. Risks may include, but are not limited
to, increased costs to bring a claim and that these provisions can discourage claims
or limit investors’ ability to bring a claim in a judicial forum that they find
favorable. Also 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 document 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.
Response:
The Company respectfully advises the Staff that the Company’s forum selection provision
provides that the Court of Chancery of the State of Delaware has exclusive jurisdiction
over only certain matters to the “fullest extent permitted by law”. Accordingly,
this provision is not intended to apply to claims arising under the Securities Exchange
Act of 1934, as amended, for which federal courts have exclusive jurisdiction, and will
not apply to claims arising under the Securities Act of 1933, as amended. In response
to the Staff’s comment, the Company has revised its disclosure on page 7 of
the base prospectus included in the Registration Statement and on page 11 of the prospectus
related to the offering pursuant to the Open Market Sale AgreementSM with
Jefferies LLC included in the Registration Statement (the “ATM Prospectus”)
to describe this provision and associated risks and to clarify the intent of the
Company’s forum selection provision. The Company has also added a risk factor on
page 5 of the ATM Prospectus describing the Company’s forum selection
provision and its intent. The Company will also include similar disclosure in its risk
factors in its Annual Report on Form 10-K and in future registration statements, as applicable.
Should
the Staff have additional questions or comments regarding the foregoing or Amendment No. 1, please contact me at 973-597-6394.
Very
truly yours,
By:
/s/
Michael J. Lerner, Esq.
Michael
J. Lerner, Esq.
cc: Yuval
Cohen, Ph.D.
Corbus
Pharmaceuticals Holdings, Inc.
-2-
2020-04-13 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
April 9, 2020
Yuval Cohen, Ph.D.
Chief Executive Officer
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
Re:Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-3
Filed April 7, 2020
File No. 333-237588
Dear Dr. Cohen:
We have limited our review of your registration statement to those issues we have
addressed in our comment. In our comment, we may ask you to provide us with information so
we may better understand your disclosure.
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
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to our comment, we may have additional comments.
Registration Statement on Form S-3 filed April 7, 2020
Exhibit 3.1 -- Amended and Restated Certificate of Incorporation, page II-1
1.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please revise your prospectus to clearly describe this provision and to describe
any risks or other impacts on investors. Risks may include, but are not limited to,
increased costs to bring a claim and that these provisions can discourage claims or limit
investors’ ability to bring a claim in a judicial forum that they find favorable. Also
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
FirstName LastNameYuval Cohen, Ph.D.
Comapany NameCorbus Pharmaceuticals Holdings, Inc.
April 9, 2020 Page 2
FirstName LastName
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
April 9, 2020
Page 2
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 document 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.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Tim Buchmiller at (202) 551-3635 or Celeste Murphy at (202) 551-3257
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael J. Lerner, Esq.
2019-07-15 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
July 15, 2019
Sean M. Moran
Chief Financial Officer
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
Re:Corbus Pharmaceuticals Holdings, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 12, 2019
File No. 001-37348
Dear Mr. Moran:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-06-25 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
June
25, 2019
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
Office
of Healthcare & Insurance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Corbus
Pharmaceuticals Holdings, Inc.
Form
10-K for the Fiscal Year Ended December 31, 2018
Fled
March 12, 2019
Form
10-Q for the Quarterly Period Ended March 31, 2019
Filed
May 9, 2019
File
No. 001-37348
Ladies
and Gentleman:
On
behalf of Corbus Pharmaceuticals Holdings, Inc.
(the “Company”), we are hereby responding to the letter, dated June 10, 2019
(the “Comment Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of
Healthcare & Insurance with respect to the Company’s Annual Report on Form 10-K for the year ended December 31, 2018
filed on March 12, 2019 and the Quarterly Report on Form 10-Q for the Quarterly Period Ended March 31, 2019 filed on May
9, 2019 (the “Form 10-Q”).
For
ease of reference, set forth below are the comments from the Staff, as reflected in the Comment Letter. The Company’s response
is set forth below each comment. Unless otherwise indicated, all capitalized terms used and not otherwise defined herein shall
have the meanings set forth in the Form 10-Q and page number references refer to page numbers in the Form 10-Q.
The
Company has authorized us to respond to the Comment Letter as follows:
Form
10-Q for the Quarterly Period Ended March 31, 2019
Notes
to Unaudited Condensed Consolidated Financial Statements
8.
DEVELOPMENT AWARDS AND DEFERRED REVENUE
Collaboration
with Kaken, page 19
Your
disclosure on page 19 indicates that under the agreement with Kaken you will be responsible for conducting clinical studies and
other development activities for the initial indications of the licensed products. It is unclear how you considered these development
obligations when assessing the material promises under the agreement. Please tell us how you determined whether your development
obligations represent a material promise under the agreement. Please also explain how you determined that the license and know-how
transfer were distinct from your development obligations, thus warranting separate recognition as a performance obligation.
Response:
With respect to the Company’s determination that the sharing of clinical data gathered through the conduct of the Global
Development Plan (as defined in the Agreement) for the Initial Indications (referred to as “development obligations”
in the comment letter received from the Staff, hereafter referred to “Initial Indications Development Plan”) is a
material promise, the Company considered the guidance in ASC 606-10-25-16 through ASC 606-10-25-18.
Per
the Collaboration and License Agreement, dated January 3, 2019 between the Company and Kaken Pharmaceutical Co., Ltd. (the “Agreement”),
the Company is responsible for conducting or having conducted the Initial Indications Development Plan and transferring all data
obtained from the Company’s Phase 3 study of lenabasum to Kaken for the purposes of obtaining regulatory approval in the
Territory. The Company is conducting such Phase 3 study, which is the most significant component of the Initial Indications Development
Plan, for its own purposes as part of its overall development strategy for lenabasum, for which the Company retains its rights
outside of the Territory. The Company believes that data obtained from the Initial Indications Development Plan supports Kaken’s
obtaining regulatory approval in the Territory and the Company obtaining regulatory approval in the rest of the world. Therefore,
the conduct of the Initial Indications Development Plan is not solely a promise made to transfer a good or service to Kaken and
the performance of the development itself is not a promise to a customer in the scope of ASC 606. In the event that data gathered
from the Initial Indications Development Plan is not positive, the Company may abandon the trial and is under no obligation to
continue to conduct such trials solely for the benefit of Kaken in the Territory. Therefore, the obligation to share with Kaken
clinical data obtained while conducting the Initial Indications Development Plan (that is, the Phase 3 study) represents a material
promise in the scope of ASC 606 as it was a bargained for element of the arrangement that is an obligation for the Company and
transfers a “good” in the form of clinical data for the benefit of the customer.
With
respect to the determination that the license and know-how transfer are distinct from the sharing of clinical data gathered through
the conduct of the Initial Indications Development Plan, the Company considered the guidance in ASC 606-10-25-19 through ASC 606-10-25-21.
Kaken
can use and benefit from the license and know-how once the know-how is transferred, without the performance of the Initial Indications
Development Plan or receipt of the associated data. In assessing whether a promise or performance obligation is distinct from
the other promises, the Company considers factors such as the research, development, manufacturing and commercialization capabilities
of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, the Company
considers whether a collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining
promise, whether the value of the promise is dependent on the unsatisfied promise, whether there are other vendors that could
provide the remaining promise, and whether it is separately identifiable from the remaining promise. Upon receipt of the license
and completion of the know-how transfer, Kaken has the right and the resources to perform clinical trials in the Territory (either
on its own or by outsourcing to a contract research organization). Kaken negotiated with the Company to also have access to the
data obtained by conducting the Initial Indications Development Plan (in addition to the data provided in the know-how transfer)
because (a) the Initial Indications Development Plan is expected to satisfy local regulatory requirements and (b) it was more
convenient and efficient to work directly with the Company on the Phase 3 study rather than separately perform a study or engage
an outside party. Based on these factors, the Company determined the license and know-how transfer together meet the criterion
of ASC 606-10-25-19(a) and are capable of being distinct from the sharing of clinical data gathered through of the conduct of
the Initial Indications Development Plan.
As
it relates to the criterion included in ASC 606-10-25-19(b), the sharing of clinical data gathered through the conduct of the
Initial Indications Development Plan is separately identifiable from the combined promises (or combined performance obligation)
to transfer the license and complete the know-how transfer. The Company is not providing a significant service of integrating
the license, initial technology transfer and sharing of clinical data but rather is providing distinct (not combined) outputs
to Kaken. The “good” provided to Kaken of the data generated under the Initial Indications Development Plan is explicitly
described in the Agreement and is intended to support the regulatory approval in the Territory separately from the license and
initial technology and the timing of the delivery of each item are significantly different (over time as the Phase 3 study is
completed versus upfront upon execution of the Agreement). The promise to share clinical data from the conduct of the Initial
Indications Development Plan is not contingent on other inputs or outputs. The clinical data obtained through conducting the Initial
Indications Development Plan does not significantly modify or customize the license and know-how transfer. That is, the formulation
of lenabasum was established prior to the execution of the Agreement and has already been subject to successful Phase 1 and Phase
2 studies. The purpose of the Phase 3 study is to expand the scale of the original studies and further demonstrate the efficacy
and safety of the treatment. Based on these factors, the Company determined the license and know-how transfer together are distinct
in the context of the contract from the sharing of clinical data gathered through of the conduct of the Initial Indications Development
Plan. As the criteria in ASC 606-10-25-19 are met, the Company concluded the Kaken Agreement contains two distinct performance
obligations; (a) the combined License and know-how transfer and (b) the sharing of clinical data gathered through of the conduct
of the Initial Indications Development Plan.
-2-
Any
questions regarding the contents of this letter, the Form 10-K or the Form 10-Q should be addressed to the undersigned at (973)
597-2476.
Very
truly yours,
/s/
Steven M. Skolnick
Steven
M. Skolnick
Cc:
Sean
Moran
Yuval
Cohen
-3-
2019-06-10 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
June 10, 2019
Sean M. Moran
Chief Financial Officer
Corbus Pharmaceuticals Holdings, Inc.
500 River Ridge Drive
Norwood, MA 02062
Re:Corbus Pharmaceuticals Holdings, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 12, 2019
Form 10-Q for the Quarterly Period Ended March 31, 2019
Filed May 9, 2019
File No. 001-37348
Dear Mr. Moran:
We have limited our review of your filings to the financial statements and related
disclosures and have the following comment. In our comment we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-Q for the Quarterly Period Ended March 31, 2019
Notes to Unaudited Condensed Consolidated Financial Statements
8. DEVELOPMENT AWARDS AND DEFERRED REVENUE
Collaboration with Kaken, page 19
1.Your disclosure on page 19 indicates that under the agreement with Kaken you will be
responsible for conducting clinical studies and other development activities for the initial
indications of the licensed products. It is unclear how you considered these development
obligations when assessing the material promises under the agreement. Please tell us how
you determined whether your development obligations represent a material promise under
the agreement. Please also explain how you determined that the license and know-how
transfer were distinct from your development obligations, thus warranting separate
recognition as a performance obligation.
FirstName LastNameSean M. Moran
Comapany NameCorbus Pharmaceuticals Holdings, Inc.
June 10, 2019 Page 2
FirstName LastName
Sean M. Moran
Corbus Pharmaceuticals Holdings, Inc.
June 10, 2019
Page 2
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Ibolya Ignat at (202) 551-3636 or Angela Connell at (202) 551-
3426 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-01-16 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Corbus
Pharmaceuticals Holdings, Inc.
100
River Ridge Drive
Norwood,
MA 02062
January
16, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Corbus
Pharmaceuticals Holdings, Inc.
Registration
Statement on Form S-3 (File No. 333-222447)
Filed
on January 5, 2018
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, Corbus Pharmaceuticals Holdings, Inc. (the “Company”)
hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared
effective by the Securities and Exchange Commission (the “Commission”) at 4:30 p.m., Eastern Standard Time,
on January 17, 2018, or as soon as practicable thereafter.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement
or with any questions.
[Signature
page follows.]
U.S.
Securities and Exchange Commission
January
16, 2018
Page
2
Very truly yours,
CORBUS PHARMACEUTICALS
HOLDINGS, INC.
By:
/s/
Sean Moran
Name:
Sean
Moran
Title:
Chief
Financial Officer
-2-
2018-01-11 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
January 11, 2018
Yuval Cohen
Chief Executive Officer
Corbus Pharmaceuticals Holdings, Inc.
100 River Ridge Drive
Norwood, MA 02062
Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-3
Filed January 5, 2018
File No. 333-222447Re:
Dear Mr. Cohen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven Skolnick
2015-11-18 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP 1 filename1.htm Correspondence Corbus Pharmaceuticals Holdings, Inc. 100 River Ridge Drive Norwood, MA 02062 November 18, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Corbus Pharmaceuticals Holdings, Inc. Registration Statement on Form S-3 (File No. 333-207936) Filed on November 10, 2015 Ladies and Gentlemen: In accordance with Rules 460 and 461 under the Securities Act of 1933, as amended, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the “Commission”) at 4:30 p.m., Eastern Standard Time, on November 19, 2015, or as soon as practicable thereafter. In connection with the acceleration of the Registration Statement, the Company hereby acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions. Very truly yours, CORBUS PHARMACEUTICALS HOLDINGS, INC. By: /s/ Sean Moran Name: Sean Moran Title: Chief Financial Officer
2015-11-18 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
Mail Stop 4720 November 1 8, 2015 Via E -mail Yuval Cohen Chief Executive Officer Corbus Pharmaceuticals Holdings, Inc. 100 River Ridge Drive Norwood, MA 02062 Re: Corbus Pharmaceuticals Holdings, Inc. Registration Statement on Form S-3 Filed November 10 , 2015 File No. 333-207936 Dear Mr. Cohen : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. 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 the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement 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 Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure i n the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Yuval Cohen Corbus Pharmaceuticals Holdings, Inc. November 1 8, 2015 Page 2 Please refer to Rules 460 an d 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilitie s under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Scot Foley at (202) 551 -3383 or me a t (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director cc: Michael J. Lerner, Esq. Steven M. Skolnick, Esq. Lowenstein Sandler LLP 1251 Avenue of the Americas New York, New York 10020
2014-10-02 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
October 1 , 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. Amendment No. 1 to Registration Statement on Form S -1 Filed September 30 , 2014 File No. 333 -198563 Dear Dr. Cohen: We have reviewed your amended 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 re viewing 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 Reverse Stock Split Range Authorization 1. We note that your board of directors recently ap proved a reverse stock split and that you are currently seeking approval from shareholders to effect the split. Please fully disclose the reasons for and effects of the reverse stoc k split proposal . For example, you disclose that you are seeking approval for the split “to provide [your] board of directors with flexibility to effect” the split. You should explain why your directors desire this flexibility and for what specific purposes . Your discu ssion of the effects of the split should include details relating to dilution, change in the number of outstanding shares, the treatment of any resulting fractional shares and odd lots, and any other material information. Finally, please tell us how prosp ective investors and selling stockholders will be informed if and when a reverse split is effected. Yuval Cohen, Ph.D. Corbus Pharmaceuticals Holdings, Inc. October 1 , 2014 Page 2 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 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 pending 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 auth ority, 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 effe ctive date of the registration state ment as confir mation of the fact that those requesting ac celeration are aware of t heir respective responsibilities 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
2014-10-02 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
October 2, 2014
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Corbus Pharmaceuticals Holdings, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 30, 2014
File No. 333-198563
Ladies and Gentlemen:
On behalf of Corbus Pharmaceuticals
Holdings, Inc. (the “Company”), we are hereby responding to the letter, dated October 1, 2014 (the “Comment Letter”),
from Jeffrey P. Riedler, Assistant Director of the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”), regarding the Company’s first amendment to the Registration Statement on Form S-1, submitted on
September 30, 2014 (the “Amendment”). In response to the Comment Letter and to update certain information in the Registration
Statement, the Company is submitting the Amendment No. 2 to the Registration Statement with the Commission (the “Second Amendment”).
For ease of reference,
set forth below are the comments of the Staff with respect to the Amendment, as reflected in the Comment Letter. The Company’s
response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Amendment unless defined
herein.
The Company has authorized
us to respond to the Comment Letter as follows:
Prospectus Summary
Reverse Stock Split Range Authorization
1. We note that your board of directors recently approved a reverse stock split and that you are
currently seeking approval from shareholders to effect the split. Please fully disclose the reasons for and effects of the reverse
stock split proposal. For example, you disclose that you are seeking approval for the split “to provide [your] board of directors
with flexibility to effect” the split. You should explain why your directors desire this flexibility and for what specific
purposes. Your discussion of the effects of the split should include details relating to dilution, change in the number of outstanding
shares, the treatment of any resulting fractional shares and odd lots, and any other material information. Finally, please tell
us how prospective investors and selling stockholders will be informed if and when a reverse split is effected.
Page 2
October 2, 2014
Response: The
Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 6 and 35 in response to
the Staff’s comment. The Staff is supplementally advised that in the event the board of directors of the Company
effects a reverse stock split within the reverse stock split range, the Company will file a post-effective amendment to the
Second Amendment reflecting the reverse stock split.
Any questions regarding
the contents of this letter, the Registration Statement, or this Second Amendment should be addressed to the undersigned at (973)
597-2476.
Very truly yours,
/s/ Steven M. Skolnick
Steven M. Skolnick
Enclosures
cc: Sean Moran
Mark Tepper
2014-10-02 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Corbus Pharmaceuticals Holdings, Inc.
100 River Ridge Drive
Norwood, MA 02062
October 2, 2014
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.W.
Washington, D.C. 20549
Attention: Austin Stephenson
Re:
Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1 (File No. 333-198563)
Dear Mr. Stephenson:
In accordance with
Rule 461 under the Securities Act of 1933, as amended, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) hereby
requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the
Securities and Exchange Commission (the “Commission”) at 4:00 p.m., Eastern Standard Time, on October 3, 2014, or as
soon as practicable thereafter.
In connection with
the acceleration of the Registration Statement, the Company hereby acknowledges the following:
· should the Commission or the staff, acting pursuant to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure
in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness of the Registration
Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Please call Steven M. Skolnick
of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
Corbus Pharmaceuticals Holdings, Inc.
By:
/s/ Yuval Cohen Ph.D.
Yuval Cohen, Ph.D
Chief Executive Officer
2014-09-30 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Corbus Pharmaceuticals Holdings, Inc.
100 River Ridge Drive
Norwood, MA 02062
September 30, 2014
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.W.
Washington, D.C. 20549
Attention: Austin Stephenson
Re: Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1 (File No. 333-198563)
Dear Mr. Stephenson:
In accordance with
Rule 461 under the Securities Act of 1933, as amended, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) hereby
requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the
Securities and Exchange Commission (the “Commission”) at 4:00 p.m., Eastern Standard Time, on October 2, 2014, or as
soon as practicable thereafter.
In connection with
the acceleration of the Registration Statement, the Company hereby acknowledges the following:
· should the Commission or the staff, acting pursuant to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure
in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness of the Registration
Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Please call Steven M. Skolnick
of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
Corbus Pharmaceuticals Holdings, Inc.
By:/s/ Yuval Cohen Ph.D.
Yuval Cohen, Ph.D
Chief Executive Officer
2014-09-30 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Steven M. Skolnick
Partner
1251 Avenue of the Americas
New York, NY 10020
T 973 597 2476
F 973 597 2477
sskolnick@lowenstein.com
September 30, 2014
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Corbus Pharmaceuticals Holdings, Inc.
Registration Statement on Form S-1
Filed September 3, 2014
File No. 333-198563
Ladies and Gentlemen:
On behalf of Corbus Pharmaceuticals
Holdings, Inc. (the “Company”), we are hereby responding to the letter, dated September 23, 2014 (the “Comment
Letter”), from Jeffrey P. Riedler, Assistant Director of the staff (the “Staff”) of the Securities and Exchange
Commission (the “Commission”), regarding the Company’s Registration Statement on Form S-1, submitted on September
3, 2014 (the “Registration Statement”). In response to the Comment Letter and to update certain information in the
Registration Statement, the Company is submitting the Amendment No. 1 to the Registration Statement with the Commission (the “Amendment”).
For ease of reference,
set forth below are the comments of the Staff with respect to the Registration Statement, as reflected in the Comment Letter. The
Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Registration
Statement unless defined herein.
The Company has authorized
us to respond to the Comment Letter as follows:
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.
Response: The
Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 3 and 47 in response
to the Staff’s comment.
Any questions regarding
the contents of this letter, the Registration Statement, or the Amendment should be addressed to the undersigned at (973) 597-2476.
Very truly yours,
/s/ Steven M. Skolnick
Steven M. Skolnick
Enclosures
cc: Sean Moran
Mark Tepper
2014-09-23 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
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
2014-09-03 - CORRESP - Corbus Pharmaceuticals Holdings, Inc.
CORRESP
1
filename1.htm
Steven M. Skolnick
Partner
1251 Avenue of the Americas
New York, NY 10020
T 973 597 2476
F 973 597 2477
sskolnick@lowenstein.com
September 3, 2014
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Corbus Pharmaceuticals Holdings, Inc.
Amendment No. 1
to Confidential Draft Registration Statement on Form S-1
Submitted August
12, 2014
CIK No. 0001595097
Ladies and Gentlemen:
On behalf of Corbus Pharmaceuticals
Holdings, Inc. (the “Company”), we are hereby responding to the letter, dated August 25, 2014 (the “Comment Letter”),
from Jeffrey P. Riedler, Assistant Director of the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”), regarding the Company’s second confidential draft Registration Statement on Form S-1, submitted
on August 12, 2014 (the “Registration Statement”). In response to the Comment Letter and to update certain information
in the Registration Statement, the Company is publicly submitting the revised Registration Statement with the Commission (the “Amendment”).
For ease of reference,
set forth below are the comments of the Staff with respect to the Registration Statement, as reflected in the Comment Letter. The
Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Registration
Statement unless defined herein.
The Company has authorized
us to respond to the Comment Letter as follows:
Prospectus Summary
Our Pipeline, page 3
1. We note your response to our prior comment 7 and your revised disclosure indicating you intend
to rely on data from Phase 1 trials conducted by another company to launch directly into Phase 2 clinical studies for scleroderma
and cystic fibrosis. Please tell us how you are able to rely on results from studies conducted by another company in order to advance
Resunab into Phase 2. Separately, please disclose whether you have had or plan to have any discussion with the FDA regarding this
development plan prior to filing an IND for Resunab. If there is a possibility that the FDA might require you to conduct your own
Phase 1 safety studies, or if there are any other regulatory risks that stem from not conducting Phase 1 safety studies, you should
disclose the risks here and elsewhere as applicable.
September 3, 2014
Page 2
Response: The
Company respectfully acknowledges the Staff’s comment and supplementally advises the Staff that it is in possession of
all prior non-clinical and Phase 1 clinical study reports and data generated by the prior licensee for Resunab which will be
submitted as part of the Company’s IND filing. The Company previously submitted a summary of the prior preclinical and
clinical data to the FDA and held a preIND meeting with the FDA division of Pulmonology, Allergy and Rheumatology on October
26, 2012 to discuss the prior preclinical and Phase 1 data and to discuss the Company’s planned clinical development
program for Systemic Sclerosis. The FDA advised the Company that prior to filing an IND it needed to conduct a rat chronic
toxicology study in the intended dose and obtain an acceptable safety margin of >1X, the no-observed effect level. The
Company completed this chronic rat toxicology study and successfully achieved the necessary safety margin.
Business
Human Clinical Results
to Date, page 48
2. We note your response to our prior comment 15 and revised disclosure on page 48. Please disclose,
to the extent known to you, why Indevus Pharmaceuticals elected not to continue with further clinical trials of Resunab and terminated
the license.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 48 in response to the
Staff’s comment.
3. We note your response to our prior comment 16 and your revised disclosure on page 48. Please
disclose your definition of “clinically significant” as applied to the adverse events observed and disclose what the
adverse events were.
Response: The Company respectfully acknowledges the Staff’s comment and
has deleted the reference to “clinically significant” on page 48 and revised the disclosure on page 48 in
response to
the Staff’s
comment.
4. We note your response to our prior comment 17 and revised disclosure on page 48 that “greater
than 10% of all subjects” experienced the relevant treatment-emergent adverse events in the single and multiple dose stages.
You should disclose the exact number of patients that experienced each type of adverse event and the severity of the events (e.g.,
mild, moderate, severe, etc.).
September
3, 2014
Page 3
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 48 in response to the
Staff’s comment.
Intellectual Property, page 51
5. It appears, based on your revised disclosure on page 51, that you have only one issued patent
for Resunab relating to method of use. However, you state at the beginning of this section that you “own all of the intellectual
property related to the composition and uses of Resunab.” This statement could imply that you have other issued patents,
including a composition of matter patent. If you have other such issued patents, please discuss their nature, the protection afforded,
the applicable jurisdiction, and date of expiration. Alternately, please revise to remove any suggestion that you currently own
more than one issued patent.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 51 in response to the
Staff’s comment.
6. Please disclose the date of expiration for your issued patent covering the use of Resunab to
treat interstitial cystitis.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 51 in response to the
Staff’s comment.
Selling Stockholders,
page 79
7. We note your response to our prior comment 26 indicating that your plan of distribution contains
disclosure stating that selling stockholders “may be deemed” underwriters. It appears that several of the selling stockholders,
including Mr. Friefeld, Mr. Cates, Mr. Blitz, Mr. Janssen, and Mr. MacLean, are broker-dealers. As we noted, registration statement
registering the resale of shares offered by broker-dealers must identify the broker-dealers as underwriters if the shares were
not issued as underwriting compensation. It is not sufficient to disclose that broker-dealers “may be deemed” underwriters.
Please revise your disclosure to identify all selling stockholders who are also broker-dealers as underwriters.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 79 in response to the
Staff’s comment.
Financial Statements for the Six Months Ended June 30,
2014
1. Significant Accounting Policies, page F-7
8. You
disclose on pages F-6 and F-13 that you issued a significant number of warrants in the
six months ended June 30, 2014. Please provide the following information:
September 3, 2014
Page 4
· Clarify in the filing all the significant terms of the warrants issued and the accounting treatment.
Response: The
Company respectfully acknowledges the Staff’s comment. The Company has supplemented Footnote 10 (Warrants) on Page F-15
of its financial statements for the six months ended June 30, 2014 to include additional disclosure of the significant
terms and the accounting treatment for the warrants issued during the six months ended June 30, 2014.
· Explain to us the differences in terms governing the Replacement Warrants as compared to the
warrants previously held by the Corbus shareholders. Tell us why the replacement warrants were not accounted for as derivatives.
Response: The
Company respectfully acknowledges the Staff’s comment and has revised and supplemented its disclosures on Page F-6- Footnote
1 (Nature of Operations-Reverse Acquisition) and on Page F-33- Footnote 11 (Subsequent Event).
In addition, the Staff is supplementally
advised, that in connection with the reverse acquisition, the existing holders of warrants to purchase common stock of JB Therapeutics
prior to the reverse acquisition received the following:
· Replacement Warrants to purchase 27,839 shares of common stock at an exercise price of $0.60.
· Additional Replacement Warrants to purchase 350,000 shares of common stock at an exercise price
of $0.66
Except for the adjustment
to the exercise price for the exchange ratio, the terms of the Replacement Warrants are substantially equivalent to the warrants
previously held by the Corbus stockholders. The Replacement Warrants were not accounted for as derivatives because the terms of
the Replacement Warrants did not contain terms such as anti-dilution protection, repurchase rights, or other clauses requiring
the potential issuance of additional shares of common stock which would give rise to accounting as a derivative.
The Corbus warrants replaced
by the Additional Replacement Warrants were accounted for as a derivative in the Corbus financial statements for the year ended
December 31, 2013 because the terms of these warrant agreements provided for anti-dilution protection. The terms of the Additional
Replacement Warrants were modified to remove the anti-dilution protection so these warrants were no longer accounted for as derivatives
as of June 30, 2014 since these warrants did not contain terms such as anti-dilution protection, repurchase rights, or other clauses
requiring potentially the issuance of additional shares of common stock which would give rise to accounting as a derivative.
September 3, 2014
Page 5
· You disclose on page F-9 that certain warrants are recorded as liabilities and valued based
on the Black Scholes method at June 30, 2014. Please tell us which warrants are recorded as liabilities and why. Also tell us why
using the Black Scholes method is appropriate.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on Page
F9-Footnote 3 (Fair Value of Assets and Liabilities) to clarify that certain warrants that were classified as a warrant liability
at December 31, 2013 were reclassified to equity at June 30, 2014 due to a modification in terms. Accordingly, at June 30, 2014
there were no outstanding warrants with terms that would require a fair value calculation to record a derivative warrant liability.
The Company utilized the Black Scholes method for valuing the warrants as of June 30, 2014 because the terms of the warrants are
substantially similar to options, given the fixed exercise price and fixed number of shares. The warrants are considered immediately
vested and the term used in the valuation was the term of the warrant.
Any questions regarding
the contents of this letter, the Registration Statement, or the Amendment should be addressed to the undersigned at (973) 597-2476.
Very truly yours,
/s/ Steven M. Skolnick
Steven M. Skolnick
Enclosures
cc:
Sean Moran
Mark Tepper
2014-08-25 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
August 25 , 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. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted August 12, 2014 CIK No. 0001595097 Dear Dr. Cohen: We have reviewed your amended confidential draft registration statement and response letter dated August 12, 2014 and have the following additional comments. In some of our comments, we may ask you to provide us with infor mation so we may better understand your disclosure. Please respond to this letter by providing the requested infor mation and either sub mitting an amended confidential draft re gistration state ment or publicly filing your registration state ment on EDGAR. If you do not believe our comments apply to your facts and circu mstances or do not believe an amendment is a ppropriate, please tell us why in your respon se. After revie wing the infor mation you provide in response to these com ments and your amended confidential draft registration state ment or filed registration state ment, we may have additio nal co mments. Prospectus Summary Our Pipeline, page 3 1. We note your response to our prior comment 7 and your revised disclosure indicating you intend to rely on data from Phase 1 trials conducted by another company to launch directly into Phase 2 clinical studies for scleroderma and cystic fibrosis. Please te ll us how you are able to rely on results from studies conducted by another company in order to advance Resunab into Phase 2. Separately, please disclose whether you have had or plan to have any discussion with the FDA regarding this development plan prio r to filing an IND for Resunab. If there is a possibility that the FDA might require you to conduct your own Phase 1 safety studies, or if there are any other regulatory risks that stem from not conducting Phase 1 safety studies, you should disclose the r isks here and elsewhere as applicable. Yuval Cohen, Ph.D. Corbus Pharmaceuticals Holdings, Inc. August 25 , 2014 Page 2 Business Human Clinical Results to Date, page 48 2. We note your response to our prior comment 15 and revised disclosure on page 48. Please disclose, to the extent known to you, why Indevus Pharmaceuticals elected not to continue with further clinical trials of Resunab and terminated the license. 3. We not e your response to our prior comment 16 and your revised disclosure on page 48. Please disclose your definition of “clinically significant” as applied to the adverse events observed and disclose what the adverse events were. 4. We note your response to our prior comment 17 and revised disclosure on page 48 that “greater than 10% of all subjects” experienced the relevant treatment -emergent adverse events in the single and multiple dose stages. You should disclose the exact number of patients that experience d each type of adverse event and the severity of the events (e.g., mild, moderate, severe, etc.). Intellectual Property, page 51 5. It appears, based on your revised disclosure on page 51, that you have only one issued patent for Resunab relating to metho d of use. However, you state at the beginning of this section that you “own all of the intellectual property related to the composition and uses of Resunab.” This statement could imply that you have other issued patents, including a composition of matter patent. If you have other such issued patents, please discuss their nature, the protection afforded, the applicable jurisdiction, and date of expiration. Alternately, please revise to remove any suggestion that you currently own more than one issued pat ent. 6. Please disclose the date of expiration for your issued patent covering the use of Resunab to treat interstitial cystitis. Selling Stockholders, page 79 7. We note your response to our prior comment 26 indicating that your plan of distribution contains disclosure stating that selling stockholders “may be deemed” underwriters. It appears that several of the selling stockholders, including Mr. Friefeld, Mr. Cates, Mr. Blitz, Mr. Janssen, and Mr. MacLean, are broker -dealers. As we noted, registratio n statement registering the resale of shares offered by broker -dealers must identify the broker -dealers as underwriters if the shares were not issued as underwriting compensation. It is not sufficient to disclose that broker -dealers “may be deemed” underw riters. Please revise your disclosure to identify all selling stockholders who are also broker -dealers as underwriters. Yuval Cohen, Ph.D. Corbus Pharmaceuticals Holdings, Inc. August 25 , 2014 Page 3 Financial Statements for the Six Months Ended June 30, 2014 1. Significant Accounting Policies, page F -7 8. You disclose on pages F -6 and F -13 that you issued a significant number of warrants in the six months ended June 30, 2014. Please provide the following information: Clarify in the filing all the significant terms of the warrants issued and the accounting treatment. Explain to us the differences in terms governing the Replacement Warrants as compared to the warrants previously held by the Corbus shareholders. Tell us why the replacement warrants were not accounted for as derivatives. You disclose on page F -9 that certain warrant s are recorded as liabilities and valued based on the Black Scholes method at June 30, 2014. Please tell us which warrants are recorded as liabilities and why. Also tell us why using the Black Scholes method is appropriate. If you intend to respond t o these comments with an amended draft registration statement, please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/ corpfin/cfannouncements/drsfilingprocedures101512.htm. Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm) . If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. 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 (2 02) 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
2014-07-29 - UPLOAD - Corbus Pharmaceuticals Holdings, Inc.
July 29, 2014
Via E -mail
Yuval Cohen, Ph.D.
Chief Executive Officer
Corbus Pharmaceuticals Holdings, Inc.
100 River Ridge Road
Norwood, MA 02062
Re: Corbus Pharmaceuticals Holdings, Inc.
Confidential Draft Registration Statement on Form S -1
Submitted July 2, 2014
CIK No. 0001595097
Dear Dr. Cohen:
We have reviewed your confidential draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with infor mation so we may
better understand your disclosure.
Please respond to this letter by providing the requested infor mation and either sub mitting
an amended confidential draft re gistration state ment or publicly filing your registratio n state ment
on EDGAR. If you do not believe our comments apply 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 the infor mation you provide in response to these com ments a nd your
amended confidential draft registration state ment or filed registration state ment, we may have
additio nal co mments.
General
1. Please sub mit all outstanding exhibits as soon as prac ticable. We may have further
comments upon exa mination of these exhibits.
2. Please file the March 27, 2014 merger agreement as an exhibit to your registration
statement.
3. Please provide us proofs of all graphic, visual or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
4. 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
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 2
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications. Similarly, please
supplementally provide us with any research reports about you that are published or
distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by
Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is
participating or will participate in your offering.
5. Please address the follow ing with respect to the reverse acquisition:
Provide a complete analysis of your accounting treatment with references to the
technical guidance upon which you relied. Clarify in the filing if you accounted
for the reverse acquisition as a business combin ation or a recapitalization.
Since the private placement occurred simultaneously with the reverse merger,
please address the appropriateness of JB Therapeutics being the accounting
acquirer considering the total shares outstanding after the private place ment.
If you accounted for the reverse acquisition as a business combination, please
consider the need for pro forma information pursuant to Article 11 of
Regulation S -X.
Please include the financial statements for Corbus Pharmaceuticals Holdings, Inc.
for the period ended June 30, 2014, including a Statement of Shareholders’
Equity. If the reverse acquisition is accounted for as a business combination,
include the financial statements for the two years ended December 31, 2013.
Retroactively restate the shares outstanding in the historical financial statements
of JB Therapeutics to reflect the shares issued in the reverse merger, revise the
earnings per share, and any equity issuances taking into consideration the
exchange ratio.
Prospectus Summary
Overview, page 1
6. We note your disclosure that your product candidates treat “orphan” diseases with clear
unmet medical needs. “Orphan” has a specific meaning in FDA regulations, and your
product candidates have not yet received orphan designation from the F DA. As such,
you should revise disclosure here and throughout the prospectus as applicable to remove
any possible inference that your product candidates have been granted orphan
designation. You may retain disclosure indicating that you intend to seek su ch
designation and an explanation of the process and benefits if granted.
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 3
Our Pipeline, page 2
7. In footnote or narrative disclosure to the pipeline chart on this page, you should disclose
the identity of the entity that conducted pre -clinical and Phase 1 safety trials for Resunab
and when these trials were conducted. Please additionally disclose, if true, that you
expect to rely on data from these completed Phase 1 studies in order to file your INDs
and launch directly into Phase 2.
Risk Factors
“Our cash or cash equivalent will only fund our operations for a limited time…,” page 9
8. You should disclose in this section your total outstanding debt, of which $169,000 is
currently in default. Describe the risks, if any, pertaining to the effects that yo ur current
default could have on your ability to secure additional financing.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
Accounting for Stock -Based Compensation, page 37
9. We may have additional comments on your accounting for stock compensation once you
have disclosed an estimated offering price. Please supplementally provide us with a
quantitative and qualitative analysis explaining the difference between the estimate d
offering price and the fair value of each equity issuance through the date of effectiveness
for the preceding twelve months.
10. Please revise your disclosure to state that the valuations are highly subjective and that
you will no longer be required to estimate the fair value of your common shares
underlying new equity awards once those shares begin trading.
11. Please revise the Stock Compensation section to discuss the equity issuances of the
registrant. Please disclose the valuation methods used and the nature of material
assumptions for valuations performed since inception.
Business
Overview, page 41
12. Please expand the discussion to include the general development of your business and
any predecessor(s) during the past five years pursuant to Item 101(a) of Regulation S -K.
In this regard, we note your disclosure eon page 9 that you have been engaged in
developing Resunab since 2009. Please describe your reverse merger and the extent of
JB Therapeutics, Inc.’s operations and business prior to the m erger. The discussion
should include any material research and development carried on by JB Therapeutics
relating to Resunab prior to the merger.
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 4
Effect of Resunab in Fibrotic Disease Animal Models, page 47
13. Please explain in greater detail how you were able to translate the effects observed in in
vivo animal models to ex vivo human models as part of the Resunab mouse study, and
disclose whether there are any risks or limitations inherent in such translation. Further,
explain the significance of reduced TGF -beta levels to anti -fibrotic/anti -inflammatory
activity.
14. We note your disclosure that the responses observed in the ex vivo model were
statistically significant. Please disclose the specific results, how you measured statistical
significance, and the related p -values.
Human Clinical Results to Date, page 47
15. You disclose that the Phase 1 and Phase 2a clinical trials were conducted by “a prior
licensee” developing Resunab. Please identify the licensee and discuss the current status
of the prior deve lopment program, including the current status of any underlying
agreement with the prior licensee.
16. In describing the first Phase 1 study, you disclose that there were only 3 patients
reporting “treatment related” adverse events, but later disclose that “ the relevance to the
drug was considered unlikely.” Please reconcile these two characterizations in your
disclosure. Please additionally disclose the type of adverse events experienced by these 3
patients.
17. We note your disclosure that the adverse event s observed in the second Phase 1 study
were not “clinically significant.” Please explain what you mean by clinically significant
in this context. Please additionally disclose how many patients experienced adverse
events and whether any were considered tr eatment -related.
18. Regarding the completed Phase 2 a trial, please disclose, if true, that you may not rely on
the efficacy results discussed here to support your current c linical program, as the Phase
2a trial was designed to measure reduction in pain whi le your future studies will have
completely different efficacy endpoints.
Clinical Development Plan
Overview, page 48
19. In the first paragraph on this page, please briefly describe the requirements for fast -track
designation. Please additionally disclos e the other, specific pathway(s) for “accelerated
approval” referred to in this section.
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 5
Intellectual Property, page 49
20. We note your disclosure that you have submitted 3 new patent applications for Resunab.
You should additionally disclose information regarding your material issued patents, if
any, granted under the assignment of the intellectual property from Dr. Burstein. In
describing any such issued patents, you sho uld discuss the nature of the property covered,
the protection afforded, jurisdiction, and date of expiration. If you do not currently hold
any material issued patents, you should so disclose.
21. Please describe the material terms of any underlying assign ment agreement that you have
with Dr. Burstein, and file it as an exhibit to your registration statement pursuant to Item
601(b)(10) of Regulation S -K.
Management, page 58
22. Please disclose Dr. Tepper’s principal occupations and employment during the pas t five
years and the name and principal business of any corporation or other organization in
which such occupations and employment were carried on in accordance with Item
401(e)(1) of Regulation S -K.
23. Please explain how Dr. Zurier joined Corbus Pharmaceu ticals in 2009. For example, if
you refer to a predecessor company to Holdings prior to the 2014 reverse merger (i.e., JB
Therapeutics, Inc.), you should clarify your disclosure. Please make a similar
clarification where you reference Corbus Pharmaceutic als in Mr. Moran’s biography.
Principal Stockholders, page 69
24. It appears that there are several selling stockholders included in the table on page 78 that
beneficially own greater than 5% of your outstanding shares of common stock but that do
not appea r in the principal stockholders table on this page. Please reconcile this
discrepancy in your disclosure or explain to us the basis for the exclusion of such
stockholders from the principal stockholders table.
Selling Stockholders, pages 77 -81
25. You di sclose that the selling stockholders listed in the table have sole voting and
investment power with respect to all shares of common stock beneficially owned by them
unless otherwise indicated. Many of the selling stockholders in the table are entities
rather than natural persons. For all selling stockholders that are not natural persons,
please identify the person or persons who have voting or investment control over the
company’s securities that the entity owns in footnotes to the table. We refer you to
Questions 140.02 of the Regulation S -K Compliance & Disclosure Interpretations.
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 6
26. Please note that registration statements registering the resale of shares offered by broker -
dealers must identify the broker dealers as underwriters if the shares were not issued as
underwriting compensation. Additionally, for those selling stockholders that are affiliates
of broker -dealers, please advise us as to whether:
each seller purchased the securities in the ordinary course of business; and
at the time of purchase o f the securities to be resold, the seller had any
agreements or understandings, directly or indirectly, with any person to
distribute the securities.
Please additionally include this disclosure in the prospectus.
Notes to Unaudited Condensed Financial Statements
11. Subsequent Event, page F -12
27. You state in “Merger Agreement” on page 4 that in connection with the Merger, holders
of outstanding options of JB Therapeutics received, in substitution for such options,
options to purchase an aggregate of 905, 334 shares of your common stock with exercise
prices ranging from $0.11 to $0.17 per share. Please update the subsequent event
footnotes on pages F -12 and F -30. In addition, it does not appear that Item 15 on page II -
3 has properly reflected all option i ssuances. Please revise as appropriate.
Notes to Financial Statements
3. Significant Accounting Policies
Research and development expenses, page F -19
28. Please explain your basis for netting revenue under the SIBR research grant against
research and develo pment expenses, as disclosed on page 39. Refer us to the authoritative
literature upon which you relied.
If you intend to respond to these comments with an amended draft registration statement,
please submit it and any associated correspondence in accord ance with the guidance we provide
in the Division’s October 11, 2012 announcement on the SEC website at
http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm.
Please keep in mind that we may publicly post filing review corresp ondence in
accordance with our December 1, 2011 policy
(http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm). If you
intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the
correspondence you s ubmit on EDGAR, please properly mark that information in each of your
confidential submissions to us so we do not repeat or refer to that information in our comment
letters to you.
Yuval Cohen, Ph.D.
Corbus Pharmaceuticals Holdings, Inc.
July 29 , 2014
Page 7
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
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