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 4, 2013
ORGANOVO HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 000-54621
| 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
On April 4, 2013, the Company will be providing a live webcast presentation to investors via RetailInvestorConferences.com. The presentation will take place at 12:00PM EDT and investors may access the presentation at www.retailinvestorconferences.com > click on red “register / watch event now” button. A copy of the presentation slides (the “Investor Presentation”) is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
Forward Looking Statements
Any statements contained in the Investor Presentation 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 are based on our current expectations, but are subject to a number of risks and uncertainties. The factors that could cause our actual future results to differ materially from our 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 availability of substantial additional funding to support the Company’s operations; the Company’s ability to enter into successful collaboration arrangements; and the Company’s ability to achieve its 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 March 15, 2013. You should not place undue reliance on forward-looking statements, which speak only as of the date of the Investor Presentation. Except as required by applicable law, 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.
The information furnished on this Form 8-K, including 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 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Exhibits
(d) Exhibits
The following exhibit is filed as part of this report:
| Exhibit No. |
Description | |
| 99.1 |
Investor Presentation, dated April 4, 2013. | |
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 4, 2013 |
/s/ Barry Michaels | |||
| Barry Michaels | ||||
| Chief Financial Officer | ||||
Exhibits
| Exhibit No. |
Description | |
| 99.1 |
Investor Presentation, dated April 4, 2013. | |
Exhibit 99.1
Changing the Shape of Medical Research and Practice
Keith Murphy
Chairman and Chief Executive Officer
© Copyright 2013, Organovo Holdings, Inc. This report is solely for the use of intended audience. No part of it may be circulated, quoted, or reproduced for distribution outside the organization without prior written approval from Organovo Holdings, Inc.
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SAFE HARBOR STATEMENT
Any statements contained in this presentation 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 are based on our current expectations, but are subject to a number of risksand uncertainties. The factors that could cause our actual future results to differ materially from our 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 availability of substantial additional funding to support the Company’s operations; the Company’s ability to enter into successful collaboration arrangements; and the Company’s ability to achieve its 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 March 15, 2013. You should not place undue reliance on forward-looking statements, which speak only as of the date of this presentation. Except as required by applicable law, 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.
OTC QX: ONVO
Changing the shape of medical research and practice
© Copyright 2012 Organovo Holdings, Inc.
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Organovo holds rights to proprietary bio-printing technology developed at the University of Missouri with a $5M National Science Foundation grant
Based in San Diego in a 15,000 sq ft facility with dedicated bioprinting / tissue culture and analytical laboratories
A leader in “3D printing” of human tissue targeting in vitro and in vivo applications
©Copyright 2013 Organovo, Inc.
Changing the shape of medical research and practice
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Changing the shape of medical research and practice
© Copyright 2013 Organovo Holdings, Inc.3
Organovo’s pioneering technology creates functional human tissues without scaffolds
Changing the shape of medical research and practice
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Tissue sheets, branched tubes, and layered tubes have been bioprinted
(A) Bio-ink composed of chick cardiac cell aggregates; (B) Bio-ink composed of CHO cells; (C) A bi-layered tube composed of fibroblasts and smooth muscle cells (brown = smooth muscle actin). Adapted from Biofabrication 2:1, 2010, coauthored by K. Murphy and G. Forgacs, ONVO’s CEO and Scientific Founder.
© Copyright 2013 Organovo Holdings, Inc.5
Changing the shape of medical research and practice
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Drug discovery: There is an imperative for pharmacos to kill drugs faster and cheaper
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Market research reveals opportunity
Cell Assay Products
Identified specific market opportunity >$500M by 2018†
High unmet customer need and market opportunity identified that can be met with 3D cell assay products†
Overall cell biology market growing to $17B by 2016, 12% CAGR†
Disease models † Source: 2012 Scientia Advisors market research, sponsored by company
Qualitative market research conducted to target initial opportunities – including Oncology
Focus on Pharma co. “lead optimization” as entry point
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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We have partnered with corporate and academic partners to develop 3D tissues
©Copyright 2013 Organovo, Inc.
Changing the shape of medical research and practice
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Academic Partnership in Drug Discovery
OHSU Partnership
Cancer research top investigators (Gleevec, FISH)
Allows Organovo to move upstream in discovery efforts
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Organovo’s opportunities reach beyond pharma
Bioprinted surgical tissues
TREAT TISSUES
Heart muscles Renal patches
TRANSPLANT TISSUES
Livers Lungs Kidneys
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Organovo has made tremendous progress
Recent Milestones
Successfully hit targets in Pfizer collaboration
Expanded contract with United Therapeutics
Autodesk & ZenBio partnerships
Opened 15,000 sq. ft. new facility
Completed initial market research
OTC QX uplist
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Recent positives
Autodesk Partnership
Develop 3D Bioprinting design software
Organovo will be engaging with technology partners that complement our core capabilities in 3D functional human tissues
Raised funds
End 2012 Cash on hand $14.8M
Warrant call ending March 14 raised additional $2.3M
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Organovo will keep delivering: 2013 Milestones
Major new data on 3D liver this month
Functional validation of 3D liver by Dec 2013
Initiate alpha testing with KOLs by Apr 2014
Liver assay launch by Dec 2014
3D Bone assay in development
Additional technology partnerships to develop bioprinting
Change in fiscal year to year end Mar 31
Continue make progress and stay on track for application for NYSE or NASDAQ uplisting by mid-year
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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Organovo’s bioprinting technology
Accelerates breakthrough research
Better recreation of “human biology in a petri dish”
Better than animal models
Better than cells alone
Has broad applications for unmet needs
Pharma Drug Discovery (Now)
Toxicology Testing (Now)
Transplant tissues (Next)
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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LEADERSHIP
KEITH MURPHY, CEO & President
19 years of experience in biotechnology
Amgen, 10 years, Global Operations Leader, Prolia/Xgeva
Alkermes, drug delivery technology background
UCLA, School of Business
MIT, Chemical Engineering
BARRY MICHAELS, CFO & Secretary
30 years of financial and general management experience in medical device and biotechnology
CFO of three private and three publicly traded companies
Finalist, San Diego CFO of the Year for 2012
BDY
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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LEADERSHIP
SHARON PRESNELL, PhD
CHIEF TECHNOLOGY OFFICER & EVP, R&D
15 years of leadership experience in product-focused R&D
SVP of R&D Tengion, Inc.
6 years R&D at Becton Dickinson
Asst. Professor, U. of North Carolina, Chapel Hill
ERIC MICHAEL DAVID, M.D., J.D. CHIEF STRATEGY OFFICER
Associate Partner, McKinsey & Company
Life Science Pipeline and R&D Strategy Consulting
Assistant Professor, Rogosin Institute
Adjunct Faculty, Rockefeller University
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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LEADERSHIP
MIKE RENARD, EXEC VP COMMERCIAL
Proven revenue generating product wins in research and diagnostics instrumentation and consumables
25+ years in life sciences
Experience building and launching products at Beckman Coulter and Sanofi
Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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SCIENTIFIC ADVISORY BOARD
DAVID MOONEY, PhD – Harvard
Professor of Bioengineering, Harvard University
Faculty, Wyss Institute for Biologically Inspired Engineering
GORDANA VUNJAK-NOVAKOVIC, PhD – Columbia
Professor of Biomedical Engineering, Columbia University
Co-wrote the text on cell culture in tissue engineering
GLENN PRESTWICH, PhD – U. of Utah
Professor of Chemistry (Biomaterials)
Accomplished entrepreneur (Four biomedical companies launched)
CRAIG KENT, MD – Chief of Surgery, U. of Wisconsin
Former Chairman, Society for Vascular Surgery
Extremely well published in vascular biology
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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OTC QX: ONVO
Organovo Contacts:
Investor Relations Booke and Company admin@bookeandco.com (646) 571-2439
Website http://www.organovo.com
© Copyright 2013 Organovo Holdings, Inc.
Changing the shape of medical research and practice
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