<SEC-DOCUMENT>0001564590-15-002307.txt : 20150401
<SEC-HEADER>0001564590-15-002307.hdr.sgml : 20150401
<ACCEPTANCE-DATETIME>20150401080524
ACCESSION NUMBER:		0001564590-15-002307
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150401
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150401
DATE AS OF CHANGE:		20150401

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ORGANOVO HOLDINGS, INC.
		CENTRAL INDEX KEY:			0001497253
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				271488943
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			0331

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35996
		FILM NUMBER:		15741362

	BUSINESS ADDRESS:	
		STREET 1:		6275 NANCY RIDGE DRIVE
		STREET 2:		SUITE 110
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		858-550-9994

	MAIL ADDRESS:	
		STREET 1:		6275 NANCY RIDGE DRIVE
		STREET 2:		SUITE 110
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	REAL ESTATE RESTORATION & RENTAL, INC.
		DATE OF NAME CHANGE:	20100722
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>onvo-8k_20150401.htm
<DESCRIPTION>8-K
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:16pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:16pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">ORGANOVO HOLDINGS, INC.</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Commission File Number: 001-35996</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">San Diego, California 92121</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Former Name or Former Address, if Changed Since Last Report)</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160; </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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):</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#111;</font><font style="font-family:Times New Roman;"> Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item&#160;7.01 Regulation FD Disclosure</p>
<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On April 1, 2015, Organovo Holdings, Inc. (the &#8220;Company&#8221;) issued a press release regarding data presented at the 2015 Experimental Biology conference in Boston, Massachusetts regarding the Company&#8217;s <font style="font-style:italic;">in vitro</font> 3D bioprinted kidney tissue.&nbsp;&nbsp;A copy of the press release is attached hereto as Exhibit&#160;99.1. </p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The information furnished on this Form 8-K, including Exhibit 99.1, shall not be deemed &#8220;filed&#8221; for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall the information 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. </p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item&#160;9.01 Financial Statements and Exhibits </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;<font style="font-size:10pt;">Press Release, dated April 1, 2015.</font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
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<p style="text-align:right;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Exhibit 99.1 </p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:21pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Organovo Describes First Fully Cellular 3D Bioprinted Kidney Tissue</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">April 1, 2015</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">SAN DIEGO, April 1, 2015 /PRNewswire/ -- <font style="font-weight:bold;">Organovo Holdings, Inc. (NYSE MKT: ONVO)</font> ("Organovo"), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, presented data on the company's in vitro three-dimensional kidney tissue at the 2015 Experimental Biology conference in Boston, Massachusetts. </p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">"Kidney represents an ideal extension of Organovo&#8217;s capabilities to 3D bioprint organ tissues that can be tremendously useful in pharmaceutical research," said Keith Murphy, Chairman and Chief Executive Officer at Organovo. &#8220;The results released today admirably demonstrate a proof of concept that kidney is on the way to becoming another core commercial tissue for Organovo.&nbsp;&nbsp;The product that we intend to build from these initial results can be an excellent expansion for our core customers in toxicology, who regularly express to us an interest in having better solutions for the assessment of human kidney toxicity.&#8221;</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">For the first time, fully human kidney proximal tubular tissues have been generated that are three-dimensional, and consist of multiple tissue-relevant cell types arranged to recapitulate the renal tubular / interstitial interface. The tissues are fabricated using Organovo's proprietary NovoGen<sup style="font-size:85%; vertical-align:top">TM</sup> bioprinting platform, and will ultimately join the company&#8217;s exVive3D<sup style="font-size:85%; vertical-align:top">TM</sup> Liver tissues to expand the repertoire of physiologically-relevant tissue systems available for toxicity and efficacy testing as well as disease modeling.&nbsp;&nbsp;Dr. Sharon Presnell, Chief Technology Officer and Executive Vice President of Research and Development, stated, "Our bioprinted human kidney tissue represents a significant technical advance over the simple monolayer cell line cultures that predominate today. The histologic and functional features of the initial prototypes are compelling, and the <font style="font-style:italic;">in vitro</font> durability of the system will likely enable the assessment of drug effects at chronic, physiologically relevant doses. Furthermore, the cellular complexity of the system will likely support mechanistic investigations into drug responses, including end points that have been difficult or impossible to assess <font style="font-style:italic;">in vitro</font>, including tubular fibrosis and post-injury recovery.&#8221;</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Key findings and attributes from Organovo's research include:</p>
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<p style="margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">The kidney&#160;proximal tubule&#160;tissue is multi-cellular&#160;and fully human, consisting of polarized&#160;renal proximal tubular epithelial cells (RPTEC) and a living interstitial layer comprised of renal fibroblasts (RF), and endothelial cells (EC)</p></td></tr></table></div>
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<p style="margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Immunohistochemical analysis shows clear evidence of intercellular junction formation (E-Cadherin+) between the epithelial cells, extensive formation of microvascular structures, and&#160;stable maintenance of the&#160;layered&#160;architecture&#160;for at least two weeks in vitro</p></td></tr></table></div>
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<p style="margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">The epithelial cells within the multi-layered tubular model express CYP450 mRNAs and possess gamma glutamyl transferase (GGT) activity, both of which are indicators of RPTEC function. Importantly, our initial characterization shows that the expression of GGT increases over two weeks post-fabrication, indicating a gain-of-function over time</p></td></tr></table></div>
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">About Organovo Holdings, Inc.</p>
<p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human disease models through internal development and in collaboration with pharmaceutical and academic partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. The company recently launched its initial product of the planned exVive3D&#8482; portfolio offering, a 3D Human Liver Tissue for use in Toxicology and other preclinical drug testing. Additional products are in development, with anticipated release for an exVive3DTM Human Kidney Tissue in the latter half of calendar year 2016. The Company also actively </p>

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<p style="margin-bottom:0pt;margin-top:6pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">conducts early research on specific tissues for therapeutic use in direct surgical applications. In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous other media outlets. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Sign up for email updates and connect with us on Twitter (@Organovo).</p>
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Safe Harbor Statement</p>
<p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 Quarterly Report on Form 10-Q filed with the SEC on February 6, 2015.&nbsp;&nbsp;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.</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">SOURCE Organovo Holdings, Inc.</p>
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Barry Michaels, Chief Financial Officer, 858-224-1000, ext. 3, IR@organovo.com, or Gerry Amato, Amato and Partners, LLC, Investor Relations, gerald@amatoandpartners.com; Media Contact, Mike Renard, EVP, Commercial Operations, 858-224-1006, mrenard@organovo.com</p></body>
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