Fibrocell Expects Significant Cost Savings from Wind-Down of azficel-T Operations
June 29 2016 - 4:30PM
Fibrocell Science, Inc. (NASDAQ:FCSC) today announced significant
cost savings are expected from the wind-down of its azficel-T
operations and that the Company is focusing its efforts and
resources on its gene therapy portfolio of product candidates that
are developed in conjunction with Intrexon Corporation—FCX-007 for
the treatment of recessive dystrophic epidermolysis bullosa (RDEB),
FCX-013 for the treatment of linear scleroderma, and
genetically-modified fibroblasts for the treatment of arthritis and
related conditions.
“We believe our innovative gene therapy programs
have the potential to be transformative for patients suffering from
debilitating genetic diseases that have few treatment options,”
said David Pernock, Chairman and Chief Executive Officer of
Fibrocell. “We are uniquely positioned to leverage our versatile
autologous fibroblast technology with our collaborator Intrexon’s
genetic engineering expertise to be a leader in developing
cell-based gene therapies. Earlier this month, we initiated
adult patient recruitment in our Phase I/II clinical trial for
FCX-007 and expect to enroll the first subject shortly.”
With the focus now on its gene therapy
portfolio, Fibrocell is actively seeking an acquiror for azficel-T
and is winding down azficel-T manufacturing and related operations
at its Exton, PA facility and reducing the workforce that supports
such operations. Fibrocell expects that these measures will result
in significant cost savings and believes its monthly cash burn for
the remainder of 2016 will decrease to an average of approximately
$1.6 million, as compared to a year-to-date monthly average of $2.2
million. Resources supporting the Company’s gene therapy
programs are unaffected.
Mr. Pernock continued, “Our announcement today
provides a strong foundation for future growth. However, this
decision impacts many of our talented team members. I want to
personally thank those affected for their dedication and
contributions to Fibrocell.”
About FCX-007FCX-007 is
Fibrocell's clinical-stage, gene-therapy product candidate for the
treatment of recessive dystrophic epidermolysis bullosa (RDEB), a
congenital and progressive orphan skin disease caused by the
deficiency of the protein type VII collagen (COL7). FCX-007 is
a genetically-modified autologous fibroblast that encodes the gene
for COL7 and is being developed in collaboration with
Intrexon. By genetically modifying autologous fibroblasts ex
vivo to produce COL7, culturing them and then treating wounds
locally via injection, FCX-007 offers the potential to address the
underlying cause of the disease by providing high levels of COL7
directly to the affected areas while avoiding systemic
distribution. To learn more about the FCX-007 Phase I/II clinical
trial, please visit www.clinicaltrials.gov and search the
identifier NCT02810951.
About FCX-013
FCX-013 is Fibrocell’s gene-therapy product
candidate for the treatment of linear scleroderma, a chronic
autoimmune disease characterized by thickening of the skin and
connective tissue that can be debilitating and painful. FCX-013 is
an autologous fibroblast cell genetically modified to express a
protein to breakdown excess type I collagen and type III collagen
at the site of the localized disease and is also being developed in
collaboration with Intrexon. FCX-013 incorporates Intrexon’s
proprietary RheoSwitch Therapeutic System®, a biologic switch
activated by an orally administered compound which allows control
of future protein expression once the initial fibrosis has been
resolved.
About Fibrocell
Fibrocell is an autologous cell and gene therapy
company translating personalized biologics into medical
breakthroughs for diseases affecting the skin, connective tissue
and joints using genetically-modified autologous fibroblasts.
Fibrocell’s most advanced gene-therapy product candidate, FCX-007,
is entering a Phase I/II trial for the treatment of recessive
dystrophic epidermolysis bullosa (RDEB). Fibrocell is in
pre-clinical development of FCX-013, its gene-therapy product
candidate for the treatment of linear scleroderma. Both
FCX-007 and FCX-013 are being developed in collaboration with
Intrexon Corporation, a leader in synthetic biology. In
addition, Fibrocell and Intrexon are in collaboration to develop a
gene therapy for the treatment of arthritis and related
conditions. For more information, visit www.fibrocell.com or
follow us on Twitter at @Fibrocell.
Trademarks
Fibrocell, the Fibrocell logo and Fibrocell
Science are trademarks of Fibrocell Science, Inc. and/or its
affiliates. All other names may be trademarks of their
respective owners.
Forward-Looking Statements
This press release contains, and our officers
and representatives may from time to time make, statements that are
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995. All statements that are not historical facts are hereby
identified as forward-looking statements for this purpose and
include, among others, statements relating to: Fibrocell’s focus on
the advancement of its gene therapy programs; the cost savings
expected from the wind-down of azficel-T operations; expected
average monthly cash burn for the remainder of 2016; expected
enrollment of the first adult subject in the Phase I/II clinical
trial of FCX-007; the potential advantages of Fibrocell’s product
candidates; and other statements regarding Fibrocell’s future
operations, financial performance and financial position,
prospects, strategies, objectives and other future events.
Forward-looking statements are based upon
management’s current expectations and assumptions and are subject
to a number of risks, uncertainties and other factors that could
cause actual results and events to differ materially and adversely
from those indicated herein including, among
others: Fibrocell’s ability to obtain additional capital to
fund its operations; unanticipated or excess costs relating
to the wind-down of azficel-T operations and the development of
Fibrocell’s gene therapy product candidates; FDA allowance to treat
pediatric subjects in the Phase II portion of the Phase I/II
clinical trial of FCX-007; uncertainties relating to the initiation
and completion of pre-clinical and clinical trials; whether
pre-clinical and clinical trial results will validate and support
the safety and efficacy of Fibrocell’s product candidates;
Fibrocell’s ability to maintain its collaboration with Intrexon
Corporation; and the risks, uncertainties and other factors
discussed under the caption “Item 1A. Risk Factors” in Fibrocell’s
most recent Form 10-K filing. As a result, you are cautioned not to
place undue reliance on any forward-looking statements. While
Fibrocell may update certain forward-looking statements from time
to time, Fibrocell specifically disclaims any obligation to do so,
whether as a result of new information, future developments or
otherwise.
Investor Relations Contact:
John Woolford
443.213.0506
john.woolford@westwicke.com
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