SEC Comment Letter for VivoSim Labs, INC. (VIVS) (CIK 0001497253) (VIVS) — Jan 21, 2020
VivoSim Labs, INC. (VIVS) (CIK 0001497253)
Date: Jan. 21, 2020 · CIK: 0001497253 · Accession: 0000000000-20-000493
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File numbers found in text: 333-235683
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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
FirstName LastNameCraig Kussman
Comapany NameOrganovo Holdings, Inc.
January 19, 2020 Page 2
FirstName LastName
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
7.With respect to Organovo's material patents and patent applications, please disclose the
foreign jurisdictions where you own or license patents and where you have pending patent
applications.
FirstName LastNameCraig Kussman
Comapany NameOrganovo Holdings, Inc.
January 19, 2020 Page 3
FirstName LastName
Craig Kussman
Organovo Holdings, Inc.
January 19, 2020
Page 3
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.
FirstName LastNameCraig Kussman
Comapany NameOrganovo Holdings, Inc.
January 19, 2020 Page 4
FirstName LastName
Craig Kussman
Organovo Holdings, Inc.
January 19, 2020
Page 4
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.