International Stem
Cell Corp., a California-based biotechnology company developing novel stem
cell-based therapies and biomedical products, today offered a business update
and announced fourth quarter and year-end financial results for the year ended
December 31, 2013.
Among numerous
highlights within the company’s business is its work with its Parkinson’s
disease program. The company continues to execute on its plan to develop human
parthenogenetic neural stem cells (hPNSC) as a clinical product candidate for
the treatment of Parkinson’s disease (PD). ISCO has published what they term a
‘breakthrough method of manufacturing hPNSC,’ in Scientific Reports, a primary
research publication from the publishers of Nature. ISCO also reported positive
results demonstrating the safety and efficacy of hPNSC in both rodent and
non-human primate models of PD, presenting the results at the American Academy
of Neurology 65th Annual Meeting in San Diego, CA, the American Society of Gene
and Cell Therapy meeting in Salt Lake City, UT and the American Neurological Association
2013 Annual Meeting in New Orleans, LA. Among other highlights include
beginning the IND-enabling non-human primate pharmacology and toxicology GLP
study under the supervision of Yale School of Medicine Professor, D. Eugene
Redmond Jr. MD.
In February 2014 the
company held a pre-IND meeting with the FDA and subsequently announced that it
will be working to complete the FDA required pharmacology and safety studies by
the end of 2014, and file the IND shortly thereafter. In 2014 ISCO will also be
working toward bringing forward additional indications for hPNSC. One
noteworthy research and development activity includes the announcement of a
significant advancement in human induced pluripotent stem cells (iPS)
derivation using a novel protein-based reprogramming method at the American
Society of Gene and Cell Therapy meeting in Salt Lake City, UT.
Notable fiscal year
2013 financial highlights include $6.15 million in revenue for the year ended
December 31, 2013, an increase of 35% compared to 2012, Lifeline Skin Care
sales up 47% and Lifeline Cell Technology sales up 24%, gross margin improving
to 73% in 2013 from 72% in 2012, subsidiaries generating operating income in
2013 of $0.65 million compared to operating loss in 2012 and an average net
cash used in operating activities of $0.47 million per month for the twelve
months ending December 31, 2013. The company ended 2013 with cash of $2.24
million.
“In 2013 ISCO made
important progress in Research and Development, primarily in the Parkinson’s
disease program, achieving a number of milestones that move us closer to the
clinic. In 2014 we will be endeavoring to complete our IND-enabling studies in
order to file our first IND for our new experimental treatment of PD,” stated
Dr. Andrey Semechkin, ISCO’s CEO and Co-chairman. “At the same time we continue
to execute on our business plan, growing revenues in our commercial
subsidiaries while maintaining costs,” Dr. Semechkin concluded.
For more
information, visit www.internationalstemcell.com
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