February 7, 2020
Craig Kussman
Chief Financial Officer
Organovo Holdings, Inc.
440 Stevens Avenue, Suite 200
Solana Beach, California 92075
Re: Organovo Holdings, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 29, 2020
File No. 333-235683
Dear Mr. Kussman:
We have reviewed your amended registration statement and have the
following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by 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. Unless
we note
otherwise, our references to prior comments are to comments in our January 19,
2020 letter.
Amendment No. 1 to Form S-4
Background of the Merger, page 96
1. We note your revised disclosure in response to our prior comment 4.
Please disclose how
the Organovo special committee considered the fact that Tarveda will
still require
substantial additional funding to finance its operations. For example,
in this regard, it
appears this was a consideration in evaluating the proposal from Company
L described on
pages 111-12.
Tarveda's Product Pipeline, page 200
2. We note your response to our prior comment 9. We believe that it is
premature to include
the two discovery stage programs in your pipeline table, particularly
where there is
Craig Kussman
Organovo Holdings, Inc.
February 7, 2020
Page 2
minimal discussion of these programs in your disclosure. Please remove
these programs
from the table. We do not object to a discussion of each program below
the table.
3. Please revise the pipeline table to reflect that you have yet to complete
the Phase 1 portion
of your Phase 1/2a trial for PEN-866 by shortening the line accordingly.
Madrigal Pharmaceuticals, Inc. License Agreement, page 204
4. We note your disclosure that the royalties are payable, on a product by
product and
country by country basis, until the latest to occur of expiration of the
last to expire valid
claim covering such product in such country or expiration of regulatory
exclusivity for
such product in such country. Please revise your description of this
agreement to clarify
when the royalty term ends.
Unaudited Pro Forma Combined Financial Statements
Note 4. Adjustments to Unaudited Pro Forma Combined Balance Sheet as of
September 30,
2019, page 270
5. We note your response to our prior comment 14. Please tell us how you
reflect the
issuance of Organovo common shares to effect the reverse merger in the
pro forma
balance sheet. In this regard, pro forma adjustment F appears to reflect
the conversion of
Tarveda's outstanding preferred stock into common stock, but it is not
clear whether this
adjustment also reflects the exchange of outstanding Tarveda common stock
into
Organovo common stock based on the exchange ratio set forth in the Merger
Agreement.
6. As a related matter, pro forma adjustment F also includes the elimination
of historical
Organovo equity. Please reconcile for us the adjustment to remove $273.2
million in
APIC to Organovo's historical APIC balance of $304.3 million as of
September 30, 2019.
You may contact Julie Sherman at 202-551-3640 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625
with any other
questions.
Sincerely,
FirstName LastNameCraig Kussman
Division of
Corporation Finance
Comapany NameOrganovo Holdings, Inc.
Office of Life
Sciences
February 7, 2020 Page 2
cc: Jeffrey C. Thacker, Esq.
FirstName LastName
