ONVO Organovo Holdings Inc

 

 

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): November 25, 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) 224-1000

(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))

 

 

 

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Item 7.01

Regulation FD Disclosure

Piper Jaffray Healthcare Conference: On November 20, 2014, Organovo Holdings, Inc. (the “Company”) announced that Keith Murphy, its Chairman, Chief Executive Officer and President, will be presenting at the 26th Annual Piper Jaffray Healthcare Conference, which will be held in New York on December 2-3, 2014, at The New York Palace Hotel, 455 Madison Avenue, New York, NY 10022. Mr. Murphy’s presentation will be on Tuesday, December 2nd at 4:30 p.m. ET. A press release regarding Mr. Murphy’s participation at the conference is attached hereto as Exhibit 99.1.

Retail Investor Conference: On December 4, 2014, Mr. Murphy will be participating in a live webcast presentation to investors via http://RetailInvestorConferences.com. The presentation will take place at 12:15 p.m. ET, and investors may access the presentation at http://retailinvestorconferences.com > click on red “register / watch event now” button.

The presentation will be a live, interactive online event where investors are invited to ask questions in real-time - both in the presentation hall as well as the Company’s “virtual trade booth.” A copy of the presentation slides will be available on the Company’s website under the “Investors” tab. If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available at http://retailinvestorconferences.com for 90 days. A press release regarding the live webcast presentation is attached hereto as Exhibit 99.2.

The information furnished on this Form 8-K, including the information contained in Exhibits 99.1 and 99.2, 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 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.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit No.		Description
99.1		Press Release (Piper Jaffray Healthcare Conference), dated November 20, 2014.
99.2		Press Release (Retail Investor Conference), dated November 20, 2014.

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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: November 25, 2014						/s/ Keith Murphy
						Keith Murphy
						Chief Executive Officer and President

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Exhibit Index

 

Exhibit No.		Description
99.1		Press Release (Piper Jaffray Healthcare Conference), dated November 20, 2014.
99.2		Press Release (Retail Investor Conference), dated November 20, 2014.

Exhibit 99.1

Organovo to Present at the 26th Annual Piper Jaffray Healthcare Conference

SAN DIEGO, Nov. 20, 2014 /PRNewswire/ — Organovo Holdings, Inc. (NYSE MKT: ONVO) (“Organovo”), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, has been invited to present at the 26th Annual Piper Jaffray Healthcare Conference, which will be held in New York December 2-3, 2014.

Organovo’s Chairman and Chief Executive Officer, Keith Murphy, will be presenting on Tuesday, December 2, at 4:30pm ET.

The goal of Piper Jaffray’s 26th Annual Healthcare Conference is to bring together key industry executives, investors and Piper professionals to provide multiple perspectives, investigate critical trends and identify the leaders in the markets that are driving our economy. The conference will be held at The New York Palace Hotel, 455 Madison Avenue, New York, NY 10022.

About Organovo Holdings, Inc.

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 exVive3DTM portfolio offering, a 3D Human Liver Tissue for use in Toxicology and other preclinical drug testing. Additional products, including a 3D Kidney Model, are in development with anticipated release for use in the latter half of calendar year 2016. Furthermore, the company actively 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 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 annual report on Form 10-K filed with the SEC on June 10, 2014 and its report on Form 10- Q

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filed with the SEC on November 7, 2014, as well as our other filings with the SEC. 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.

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

Exhibit 99.2

Organovo Holdings, Inc. to Provide Corporate Update and Investor Presentation in a Live, Interactive Webcast on December 4

Company invites individual and institutional investors as well as advisors to attend real-time, virtual Retail Investor Conferences Event

NEW YORK, Nov. 20, 2014 /PRNewswire/ — Organovo Holdings, Inc. (NYSE MKT: ONVO; “Organovo”) the San Diego-based regenerative medicine company focused on using its breakthrough NovoGen 3D human tissue printing technology to create tissue on demand for medical research and therapeutic applications, today announced today that Keith Murphy, CEO, will present live at RetailInvestorConferences.com on December 4.

This event will be focused on updates and current information regarding Organovo and its business.

For investors not yet familiar with the company and desire background, including an understanding of the 3D bioprinting used by Organovo to create functional living human tissues, investors can watch an informational background presentation on the Company’s website: http://www.organovo.com/investors/investor-overview

To view the live update and current information presentation, use these instructions at the time indicated:

DATE: Thursday, December 4, 2014

TIME: 9:15 AM PST / 12:15 PM EST

LINK: Click here to register/login or paste this URL into your browser’s address bar: http://bit.ly/1B2KGaL

It is recommended that investors pre-register to save time and receive event updates.

This will be a live, interactive online event where investors are invited to ask the company questions in real-time, both in the presentation hall as well as the association’s “virtual trade booth.” If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days.

Recent Company Highlights Include:

 

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Commercially released the exVive3D™ Human Liver Tissue for preclinical drug toxicology testing.

 

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Selected as a finalist in the Diagnostics & Research Tools category for the 2014 Most Innovative New Product Awards, sponsored by CONNECT.

 

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Recognized as a 2015 Technology Pioneer by the World Economic Forum for the ability to harness creativity to design and create transformative solutions.

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Key opinion leader reported Organovo’s exVive3D™ Human Liver Tissue was able to establish the toxicity of toxic drug known to induce liver injury in humans that did not show toxicity in animal and other pre-clinical testing, an achievement historically unmet by animal models or other liver cell model systems.

 

•

Initiated contracting for toxicity testing using its exVive3D™ Human Liver Tissue, for selected clients, in advance of its scheduled commercial release.

 

•

Entered into additional agreements to utilize 3D bio-printed tissue in drug discovery settings.

 

•

Reported that its 3D bio-printed breast cancer tissues enabled researchers to make compartment-specific assessments (i.e., epithelium, stroma, vasculature) of drug response — something that is not currently possible outside of in vivo models to date.

 

•

Announced an agreement with the University of Queensland directed toward development of source cell lines for 3D kidney tissue bioprinting activities.

 

•

Appointed Gregory T. Lucier, former Chairman and CEO of Life Technologies, as a corporate advisor.

About Organovo Holdings, Inc.

Organovo (NYSE MKT: ONVO) 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, their 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.Sign up for email updates and connect with us on Twitter (@Organovo).

About RetailInvestorConferences.com

Since 2010, RetailInvestorConferences.com, created by BetterInvesting (NAIC) and PRNewswire have been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with retail investors using a graphically-enhanced online platform.

Designed to replicate the look and feel of location-based investor conferences, Retail Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network.

SOURCE Organovo Holdings, Inc.

Organovo Holdings, Inc., Barry Michaels, Chief Financial Officer, 1-858-224-1003, IR@organovo.com; Gerry Amato, Booke & Company Investor Relations, admin@bookeandco.com; Retail Investor Conferences Event, Bradley H. Smith, Director of

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Marketing, IR and Compliance Services, PR Newswire, 1.201.947.7157, bradley.smith@prnewswire.com