Organovo Appoints New Board Member
December 06 2018 - 08:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology
company pioneering the development of 3D bioprinted tissues aimed
at treating a range of serious adult and pediatric liver diseases,
today announced that its board of directors has appointed one new
member. David Shapiro, M.D., Chief Medical Officer of
Intercept Pharmaceuticals, Inc. (“Intercept”), will join Organovo’s
board, effective immediately. Dr. Shapiro’s appointment
increases the number of Organovo directors to eight.
“David brings significant liver-focused clinical development and
medical expertise to our board,” said Taylor J. Crouch, CEO,
Organovo. “His senior leadership experience across the life
sciences sector adds to the strength of our already outstanding
board, and I’m confident he’ll make a significant contribution as
we complete the preclinical studies for our liver therapeutic
tissue and move toward our first Investigational New Drug (“IND”)
application in calendar 2020. David has played a key role in
establishing his current company as a leader in treating liver
disease, including a commercial product addressing primary biliary
cholangitis (“PBC”) and a late-stage development program focused on
non-alcoholic steatohepatitis (“NASH”). I’m grateful for his
willingness to join the board at such an important time in our
organizational development, as well as the ongoing support from all
of our directors.”
Dr. David Shapiro has over 30 years of clinical development
experience in the pharmaceutical industry. He has served as
the Chief Medical Officer of Intercept Pharmaceuticals, Inc. since
November 2017, having previously served as its Chief Medical
Officer and Executive Vice President, Research & Development
since 2008. Dr. Shapiro founded a consulting company,
Integrated Quality Resources, that focused on development stage
biopharmaceutical companies and was active in this role from 2005
to 2008. From 2000 to 2005, Dr. Shapiro was Executive Vice
President, Medical Affairs and Chief Medical Officer of Idun
Pharmaceuticals, Inc., prior to its acquisition by Pfizer
Inc. From 1995 to 1998, he was President of the Scripps
Medical Research Center at Scripps Clinic. He served as Vice
President, Clinical Research at Gensia and as Director and Group
Leader, Hypertension Clinical Research at Merck Research
Laboratories from 1985 to 1990.
About Organovo Holdings, Inc.Organovo is a
biotech platform company that has developed a leadership position
with its revolutionary ability to 3D bioprint tissues with human
functionality. The Company is pursuing multiple IND-track
programs to develop its NovoTissues® to address a number of serious
unmet medical needs in adult and pediatric populations, initially
focusing on liver disease. Organovo’s first IND-track program
for Alpha-1-antitrypsin deficiency recently received orphan drug
designation from the FDA, and the Company expects to file its first
IND in 2020. In order to support its plan to initiate
multiple IND-track programs, the Company is providing access to its
ExVive™ in vitro tissue disease modeling platform to facilitate
high value drug discovery and development collaborations.
Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the
Company and its clients with high quality human liver and kidney
cells for research applications. Organovo is changing the
shape of life science research and transforming medical care.
Learn more at www.organovo.com.
Forward-Looking Statements Any statements
contained in this press release that do not describe historical
facts 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. Forward-looking statements include, but are
not limited to, statements regarding the potential benefits and
therapeutic uses of the Company’s therapeutic liver tissue,
including the benefits of an orphan designation; the Company’s
expectations regarding the FDA regulatory pathway and anticipated
timelines for its regulatory filings; the potential market
opportunity for the Company’s therapeutic tissue candidates; the
Company’s ability to meet market demand; and customer demand for
and acceptance of its disease modeling and other in vitro tissue
platforms. The factors that could cause the Company's actual
future results to differ materially from current expectations
include, but are not limited to, risks and uncertainties relating
to the possibility that the final results of the Company's
preclinical studies may be different from the Company's studies or
interim preclinical data results and may not support further
clinical development of its therapeutic tissues; the Company may
not successfully complete the required preclinical and clinical
trials required to obtain regulatory approval for its therapeutic
tissues on a timely basis or at all; the Company may not be able to
obtain sufficient raw materials to meet market demand for its
therapeutic products; risks that competitive products may adversely
impact the market opportunity for the Company’s therapeutic tissue
candidates; the Company's ability to develop, market and sell
products and services based on its technology; the expected
benefits and efficacy of the Company's products, services and
technology; the Company’s ability to execute framework agreements
involving multi-year commitments and routine use on a timely basis,
or at all; the Company’s ability to successfully complete studies
and provide the technical information required to support market
acceptance of its products, services and technology, on a timely
basis or at all; the Company's business, research, product
development, regulatory approval, marketing and distribution plans
and strategies, including its use of third party distributors; the
Company’s ability to recognize deferred revenue; and the Company’s
ability to meet its fiscal-year 2019 goals and outlook. These and
other factors are identified and described in more detail in the
Company's filings with the SEC, including its Annual Report on Form
10-K filed with the SEC on May 31, 2018. 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 the Company may issue in the future. Except as required by
applicable law, including the securities laws of the United States,
the Company does 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.
Investor & Press Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
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