UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 29, 2014
ORGANOVO HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 001-35996
| Delaware | 27-1488943 | |||
| (State or other jurisdiction of incorporation) |
(I.R.S. Employer Identification No.) |
6275 Nancy Ridge Dr.,
San Diego, California 92121
(Address of principal executive offices, including zip code)
(858) 550-9994
(Registrant’s telephone number, including area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure
Contract Revenue Recognition
Organovo Holdings, Inc. (“Organovo”) has initiated the signing of contracts for research services using its 3D Human Liver Tissue. As Organovo has previously guided, contracts in this space may be in the tens of thousands of dollars per compound and hundreds of thousands of dollars per project. The contracted services to date total in the low hundreds of thousands of dollars ($100k to $400k range). The company has invoiced any amount due upon contract initiation, although our revenue recognition policy will likely result in booked revenue at the completion of the projects, currently estimated to be between September 2014 and November 2014 for contracts signed in fiscal Q1 2015 (April to June 2014).
As additional contracts are signed, Organovo does not expect to provide specific updates as to number of contracts or total value of contracts signed, but rather to report revenue in its quarterly and annual filings consistent with its established revenue recognition policies as reported in SEC filings.
Press Release
On April 29, 2014, Organovo issued a press release announcing that it has initiated contracting for toxicity testing using its 3D Human Liver Tissue for selected clients prior to full release. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information furnished on this Form 8-K, including the press release attached as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
| (d) | Exhibits |
| 99.1 | Press Release, dated April 29, 2014. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| ORGANOVO HOLDINGS, INC. | ||||||
| Date: April 29, 2014 | /s/ Keith Murphy | |||||
| Keith Murphy Chief Executive Officer | ||||||
Exhibit Index
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated April 29, 2014. | |
Exhibit 99.1
Organovo Announces Pre-Release Availability of 3D Liver Contract Services
04/29/2014
SAN DIEGO, April 29, 2014 /PRNewswire/ — Organovo Holdings, Inc. (NYSE MKT: ONVO) (“Organovo”), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, today announced that it has initiated contracting for toxicity testing using its 3D Human Liver Tissue for selected clients prior to full release.
Organovo’s Chairman and Chief Executive Officer, Keith Murphy, commented “Organovo has received interest in advance of our planned launch from top 15 pharma company customers, small to midsize pharma companies, biotechnology companies, and private venture capital backed pharmaceutical development firms. The compelling data already generated on the performance of the 3D Human Liver Tissue has driven this interest, we believe, and I’m pleased that our team was able in a short time to accomplish all of the hard work that allowed us to begin signing contracts. We’ll be able to deliver results for proprietary compounds and other needs, while completing the work for fuller product and service launch on our original timeline.”
Organovo is making 3D Human Liver Tissue technology available to clients who have specific testing needs in their preclinical drug discovery programs. The company has begun signing research service contracts and is in discussions with additional customers for near-term needs, in a limited initial release of this service. Customers with needs in a research setting that align with the preliminary offering will be able to engage in the coming months, with fuller testing services including metabolic function to be offered over time. All testing will be performed at Organovo’s facility by the Company’s laboratory services tissue experts.
The Company believes that its 3D Human Liver tissue model represents a new and novel approach to the drug discovery and development process, providing significant added value to preclinical assessment studies. The long lasting viability and function of the tissue allows for extended study durations in vitro, enabling the assessment of the effects of low dose or repeated dosing regimens across a spectrum of biochemical, molecular, and histologic end points.
For more information or to discuss specific study requirements, clients can contact us at sales@organovo.com.
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The Company is collaborating with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. In addition to numerous scientific publications, the Company’s technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous others. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the market acceptance of the Company’s products; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including our prospectus supplement filed with the SEC on November 27, 2013 and our transition report on Form 10-KT filed with the SEC on May 24, 2013 as well as our other filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.
SOURCE Organovo Holdings, Inc.
Investor Contact, Barry Michaels, Chief Financial Officer, 858-224-1000, ext. 3, IR@organovo.com, or Gerry Amato, Booke & Company Investor Relations, admin@bookeandco.com; Media Contact, Mike Renard, EVP, Commercial Operations, 858-224-1006, mrenard@organovo.com