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July 8, 2019
Adam Gridley
President
Histogenics Corporation
c/o Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
One Marina Park Drive, Suite 900
Boston, MA 02210
Re: Histogenics Corporation
Registration Statement on Form S-4
Filed June 14, 2019
File No. 333-232147
Dear Mr. Gridley:
We have limited our review of your registration statement to those
issues we have
addressed in our comments. In some of our comments, we may ask you to provide
us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement
and providing the
requested information. If you do not believe our comments apply to your facts
and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.
After reviewing any amendment to your registration statement and the
information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4 filed June 14, 2019
OCU300 for Patients with oGVHD, page 230
1. Please revise the disclosure to include a brief explanation of the
phrase "not powered for
statistical significance" that is used under this heading, or "not
sufficiently powered" in
other locations such as on page 231, and describe the impact on the
related results of
Ocugen's studies. Also revise to ensure the significance of any
disclosed p-values related
to these studies in the context of the disclosure you provide in
response to this comment.
OCU310 for Patients with DED, page 231
2. We note the disclosure that "OCU310 is safe." Because approval by the
FDA and other
comparable regulatory agencies is dependent on their making a
determination according to
Adam Gridley
FirstName LastNameAdam Gridley
Histogenics Corporation
Comapany NameHistogenics Corporation
July 8, 2019
July 8, 2019 Page 2
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FirstName LastName
criteria specified in agency regulations that a product is both safe
and effective, please
clarify the basis for this statement.
Prospective Phase 1/2 placebo-controlled study, page 247
3. We note your disclosure in the first paragraph that this study was
"not powered for
statistical significance." Given that disclosure, please revise to
explain how you derived
the p-values indicated in the fourth paragraph of this section and the
conclusion of a
"statistically significant difference" in clause (1) of the fourth
paragraph, or revise your
disclosure as appropriate.
4. We note your assumption regarding independence between eyes within a
subject. If this
assumption factored into your disclosed conclusions for this study,
please explain the
basis for this assumption.
OCU310 Phase 2 Clinical Study, page 252
5. We note your disclosure in the first paragraph that this study was
"not powered for
statistical significance." Given that disclosure, please revise to
explain how you derived
the p-values indicated in the first paragraph under "Symptom
Assessment" on page 253, to
disclose the basis for your statements regarding statistical
significance in the second
paragraph under that heading, and the conclusion of "no statistical
difference" under
"Conclusion" on page 254, or revise your disclosure as appropriate.
6. Please explain the factors used to generate the VAS Scores and what
the score means.
License Agreements, page 263
7. Please provide more specificity with regard to when each agreement may
expire. For
example, disclose the date that the last of the licensed patents will
expire or how the
relevant statutory or regulatory exclusivity period will be
determined, as applicable.
Intellectual Property, page 265
8. Clarify which patents are owned and which are licensed and disclose
the foreign
jurisdictions where you have issued patents or pending patent
applications.
Unaudited Pro Forma Condensed Combined Financial Information
Introduction, page PF-2
9. We reference the disclosure that the acquisition of Histogenics is
expected to be accounted
for as an asset acquisition. Please explain to us how you considered
the guidance in ASC
805-10-55 in determining that substantially all the fair value of the
assets acquired is
concentrated in a single identifiable asset or group of similar
identifiable assets. As a
related matter, tell us why you have multiple references to "business
combination"
throughout the pro forma financial information.
Adam Gridley
Histogenics Corporation
July 8, 2019
Page 3
Unaudited Pro Forma Condensed Combined Balance Sheet, page PF-4
10. Please revise footnote (d) to clearly identify how all of the items
disclosed result in the
$24.4 million adjustment to cash and cash equivalents. In addition,
tell us why footnote
(i) relating to the mark to market adjustment for the warrant
liability resulted in an
adjustment to cash and cash equivalents.
11. Please revise footnote (f) to clarify how it relates to the $3,003
adjustment to derivative
liabilities.
12. Please explain how footnote (g) referencing the increase in accrued
expenses of $0.6
million relates to the $1.2 million adjustment to accrued expenses. In
addition, tell us how
the pro forma adjustments for accrued expenses foots across to
$13,697.
13. Please refer to footnotes (d), (f), (b) and (g). Revise to clarify how
the amounts discussed
in the footnotes agree with the adjustments to additional paid-in
capital and accumulated
deficit in the pro forma condensed combined balance sheet. Also,
clarify in footnote (c)
why the adjustment is different than the Histogenics additional
paid-in capital.
14. We reference the disclosure on page PF-8 that substantially all of the
fair value of the
asset acquisition is included in IPR&D. In this regard, we note that
you did not provide an
estimate of the fair value of the assets acquired and liabilities
assumed, including
IPR&D and the related allocation of the purchase price of Histogenics.
While we note
FirstName LastNameAdamcompleted the detailed valuation work, please tell us why
you have
that Ocugen has not Gridley
Comapanyprovided your best Corporationthe fair value of the assets and
liabilities acquired.
not NameHistogenics estimate of
July 8, Also, Page 3how you considered the guidance in ASC 805-50-30.
2019 tell us
FirstName LastName
Adam Gridley
FirstName LastNameAdam Gridley
Histogenics Corporation
Comapany NameHistogenics Corporation
July 8, 2019
July 8, 2019 Page 4
Page 4
FirstName LastName
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.
You may contact Kristin Lochhead at (202) 551-3664 or Brian Cascio,
Accounting
Branch Chief, at (202) 551-3676 if you have questions regarding comments on the
financial
statements and related matters. Please contact Tim Buchmiller at (202) 551-3635
or Geoff
Kruczek, Special Counsel, at (202) 551-3641 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of
Electronics and Machinery
cc: Marc F. Dupr , Esq.