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SEC Comment Letter for Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097) (CRBP) — Jul 29, 2014

Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097)
Date: July 29, 2014 · CIK: 0001595097 · Accession: 0000000000-14-038396

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
July 29, 2014
Author
/s/ Daniel Greenspan for
Form
UPLOAD
Company
Corbus Pharmaceuticals Holdings, Inc. (CRBP) (CIK 0001595097)

Letter

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

Show Raw Text
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