Item 8.01. Other Events.
Supplemental Disclosures
As previously
disclosed, on December 13, 2019, Organovo Holdings, Inc. (the “Company” or “Organovo”) entered into an Agreement and Plan of Merger and Reorganization, as amended (the “Merger Agreement”), with Tarveda
Therapeutics, Inc. (“Tarveda”). Upon the terms and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, including approval of the transaction by Organovo’s stockholders and Tarveda’s
stockholders, Opal Merger Sub, a wholly-owned subsidiary of Organovo (“Merger Sub”), will merge with and into Tarveda, with Tarveda becoming a wholly-owned subsidiary of Organovo and the surviving corporation of the merger (the
“Merger”). On February 24, 2020, Organovo filed a definitive proxy statement/prospectus/information statement (the “Definitive Proxy Statement”), as such may be supplemented from time to time, with the Securities and
Exchange Commission (the “SEC”) with respect to the special meeting of Organovo’s stockholders scheduled to be held on March 26, 2020 (the “Organovo Special Meeting”).
Supplemental Disclosures to Definitive Proxy Statement
The additional disclosures in this Current Report on Form 8-K supplement the disclosures contained in
the Definitive Proxy Statement and should be read in conjunction with the Definitive Proxy Statement, which in turn should be read in its entirety. To the extent that information in this Current Report on Form
8-K differs from or updates information contained in the Definitive Proxy Statement, the information in this Current Report on Form 8-K shall supersede or supplement the
information in the Definitive Proxy Statement. All page references in the information below are to pages in the Definitive Proxy Statement, and all defined and capitalized terms used below shall have the meanings ascribed to such terms in the
Definitive Proxy Statement. Paragraph references used herein refer to the Definitive Proxy Statement before any additions or deletions resulting from the information set forth below. Without admitting in any way that the disclosures below are
material or otherwise required by law, Organovo and Tarveda make the following supplemental disclosures:
The disclosure under the
heading “The Merger – Background of the Merger – Potential Strategic Alternatives” is hereby supplemented by inserting the following disclosure as a new paragraph immediately following the end of the first
paragraph on page 98 of the Definitive Proxy Statement:
Organovo’s form confidentiality and standstill agreement contained a one-year standstill period and a provision, known as a “don’t ask, don’t waive” provision, prohibiting potential bidders from requesting, privately or publicly, that Organovo agree to waive or
amend the standstill restrictions so as to allow the potential bidder to make another bid during the standstill period. If requested by potential bidders during negotiations, however, Organovo did agree to amend the terms of its form confidentiality
and standstill agreement to either delete the “don’t ask, don’t waive” provision or to add language that caused the standstill period to automatically terminate upon the occurrence of certain events, including but not limited to,
the Company’s announcement that it had entered into the Merger Agreement. Four of the 51 companies who signed confidentiality and standstill agreements with Organovo requested an amendment to the “don’t ask, don’t waive”
provision or the term of the standstill period, and Organovo agreed to amend its form of confidentiality and standstill agreement for each of these four parties. After signing the Merger Agreement, Organovo has not, and does not plan to, interpret
the confidentiality and standstill agreements it signed to preclude any bidder from requesting to be relieved of its standstill obligations for the sole purpose of making a Superior Offer as the term is described in the Merger Agreement.
The disclosure under the bulleted sub-heading “The Merger – Background of the
Merger – History of Strategic Alternatives Discussions and Significant Corporate Events – Tarveda” on page 109 is hereby supplemented by adding the following disclosure immediately prior to the first full sentence on page
110:
To support its expectations regarding Tarveda’s opportunity to progress to clinical data read-outs with the combined
organization’s anticipated cash at closing, the Organovo special committee reviewed the projections Tarveda provided regarding the total operating expenses it expected incur to support its product development plans for calendar year 2020, which
forecasted total quarterly operating expenses of approximately $5.0-6.0 million a quarter in 2020. The Organovo special committee also considered Tarveda’s estimate that the combined cash of the
company would be sufficient to fund its development plans and operations into the second half of 2021.
* * *
SEC Investigation
On March 4, 2020,
Organovo received a letter from the SEC indicating that it had initiated an investigation of the Company and attaching a subpoena seeking information and documents for the period from January 1, 2017 to the present, relating to, among other things,
disclosures to investors regarding the efficacy and/or tissue duration of the Company’s liver therapeutic program and products, the Company’s communications with the FDA, and purchases or sales of Company stock by the Company’s
officers and directors. The Company intends to cooperate with the SEC’s investigation.
Tarveda Press Release
On March 19, 2020, Tarveda issued a press release announcing that it has entered into a licensing agreement with SciClone Pharmaceuticals for
PEN-866, the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.