January 19, 2020
Craig Kussman
Chief Financial Officer
Organovo Holdings, Inc.
440 Stevens Avenue, Suite 200
Solana Beach, California 92075
Re: Organovo Holdings, Inc.
Registration Statement on Form S-4
Filed December 23, 2019
File No. 333-235683
Dear Mr. Kussman:
We have reviewed your 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.
Registration Statement on Form S-4
Even after completion of the Merger, Tarveda will require substantial
additional funding to
finance its operations, page 41
1. We note your disclosure here that Tarveda believes that the $13.6
million of gross
proceeds from the December private placement of its Series 1 preferred
stock and
recapitalization, the anticipated cash that Organovo will have on its
balance sheet at the
effective time of the Merger, together with its existing cash and cash
equivalents as of
September 30, 2019, will fund the combined organization's current
operating plans
through at least the next 18 months from the anticipated effective time
of the Merger.
Please reconcile this disclosure with the statement on page 211 that
Tarveda expects that
its existing cash and cash equivalents, including $13.6 million of gross
proceeds from the
Craig Kussman
Organovo Holdings, Inc.
January 19, 2020
Page 2
December 2019 equity financing, will be sufficient to fund its
operating expenses, capital
expenditure requirements and debt service payments through September
2020.
Background of the Merger, page 96
2. We note your disclosure of certain discussions regarding potential
strategic alternatives
that predated both the August 2019 announcement that Organovo would be
pursuing
strategic alternatives and the strategic alternative process conducted
by Roth. Please
disclose how these discussions were initiated with the various
parties.
3. Please identify the members of the Special Committee of the Organovo
board of directors
that was formed to evaluate strategic alternatives and establish the
material terms of the
transaction with Tarveda.
4. We note your disclosure that of the 27 companies that submitted
non-binding indications
of interest, eight were invited to present to the Organovo board of
directors. Please revise
to disclose the material terms of the bids from those eight companies
and why the special
committee selected those eight companies. We also note your disclosure
that Organovo
discussed and negotiated term sheets for a potential strategic
transaction with four life
sciences companies. Please revise this section to disclose how the
material terms of the
transaction were negotiated with those four companies, including how
the deal value,
pricing mechanism, exchange ratio and ownership split were negotiated.
Please also
disclose what led the special committee to select Tarveda's offer over
the other three
parties.
5. Please supplementally provide us with copies of all materials prepared
by Roth and shared
with your board of directors and their representatives, including
copies of all board books
and all transcripts and summaries, that were material to the board's
decision to approve
the Merger Agreement.
Summary of Material Financial Analysis, page 121
6. With respect to the analyses where Roth selected certain companies for
purposes of
comparison, please disclose whether any companies meeting the
selection criteria were
excluded from the analyses, and if so, why they were excluded.
Organovo Business
Intellectual Property, page 182
FirstName LastNameCraig Kussman
7. With respect to Organovo's material patents and patent applications,
please disclose the
Comapany NameOrganovo where you Inc. or license patents and where you have
pending patent
foreign jurisdictions Holdings, own
applications.
January 19, 2020 Page 2
FirstName LastName
Craig Kussman
FirstNameHoldings, Inc. Kussman
Organovo LastNameCraig
Comapany NameOrganovo Holdings, Inc.
January 19, 2020
Page 3
January 19, 2020 Page 3
FirstName LastName
Tarveda Business, page 184
8. We note several references to "improved efficacy" in the charts and
graphs in this section.
Please revise your disclosure to remove these statements as
determinations of efficacy are
solely within the authority of the FDA.
Tarveda's Product Pipeline, page 189
9. We note that your pipeline table includes three programs in the
discovery stage. Please
provide us your analysis as to why you believe these programs are
material enough to be
included in your pipeline table.
10. Please include a column for each of Phase 1, Phase 2 and Phase 3 in
your product pipeline
table.
Madrigal Pharmaceuticals, Inc. License Agreement, page 193
11. Please disclose the aggregate future potential milestone payments
under the agreement
and the royalty term.
Intellectual Property, page 195
12. With respect to Tarveda's material patents and patent applications,
please disclose the type
of patent protection and the applicable foreign jurisdictions.
Loan and Security Agreement with Oxford, page 222
13. We note your disclosure that the 2019 Oxford Loan contains customary
negative
covenants limiting Tarveda's ability to consummate mergers such as the
one currently
contemplated. Please revise your disclosure to indicate whether you
require Oxford's
consent to consummate the merger, and, if so, whether such consent has
been obtained.
Unaudited Pro Forma Combined Financial Information
Unaudited Pro Forma Condensed Combined Balance Sheet, page 252
14. We note that you accumulate several pro forma merger adjustments to
equity and show
only the cumulative amount of the adjustments. So that we, and
investors, may better
understand your accounting and the impact of each adjustment, please
quantify the
amount of each adjustment separately either on the pro forma balance
sheet or as part of
your footnote disclosure in Note 4.
Principal Stockholders of Organovo, page 271
15. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by ARK Investment
Management, LLC.
Craig Kussman
FirstNameHoldings, Inc. Kussman
Organovo LastNameCraig
Comapany NameOrganovo Holdings, Inc.
January 19, 2020
January 19, 2020 Page 4
Page 4
FirstName LastName
Incorporation of Certain Documents by Reference, page 282
16. We note that you have incorporated by reference certain information
about the registrant.
It appears that you are not S-3 eligible and are, therefore,
ineligible to incorporate by
reference certain information that Form S-4 requires. Refer to General
Instruction B.1 of
Form S-4. Please provide an analysis as to your eligibility, or revise
to include the
disclosure required by Item 14 of Form S-4.
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 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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Jeffrey C. Thacker, Esq.
