Fibrocell Reports First Quarter 2016 Financial Results and Operational Highlights
May 05 2016 - 8:00AM
Fibrocell Science, Inc. (NASDAQ:FCSC), an autologous cell and gene
therapy company focused on developing transformational therapies
for diseases affecting the skin, connective tissue and joints,
today reported financial results for the first quarter ended March
31, 2016 and recent operational highlights. Fibrocell will host a
conference call and webcast today at 8:30 a.m. EDT.
“The recent progress of our personalized
biologics pipeline is exciting and, we believe, positions Fibrocell
to achieve key value-creating milestones in the coming weeks,” said
David Pernock, Chairman and Chief Executive Officer. “In June, we
expect to report primary endpoint results from our Phase II
clinical trial of azficel-T for the treatment of vocal cord
scarring and also initiate a Phase I clinical trial of FCX-007, our
orphan gene-therapy product candidate for the treatment of
recessive dystrophic epidermolysis bullosa.”
Recent Operational Highlights and Upcoming
Milestones
azficel-T
- In April, the last subject visit for the primary endpoint
analysis was completed in Fibrocell’s Phase II clinical trial of
azficel-T for the treatment of vocal cord scarring resulting in
chronic or severe dysphonia. The study is a double-blind,
randomized, placebo-controlled trial designed to evaluate the
safety and efficacy of azficel-T in subjects with chronic or severe
dysphonia caused by idiopathic vocal cord scarring or atrophy.
Fibrocell expects to report primary endpoint results in June
2016.
FCX-007
- In April, Fibrocell received allowance from the U.S. Food and
Drug Administration (FDA) to initiate a Phase I/II clinical trial
for FCX-007 in adults. FCX-007 is Fibrocell’s lead orphan
gene-therapy product candidate for the treatment of recessive
dystrophic epidermolysis bullosa (RDEB). Fibrocell expects to
initiate the Phase I portion of the trial in June 2016. The primary
objective of this open label trial will be to evaluate the safety
of FCX-007 in RDEB subjects. Additionally, the trial will
evaluate type VII collagen expression and the presence of anchoring
fibrils resulting from FCX-007, as well as evidence of wound
healing. FCX-007 is being developed in collaboration with Intrexon
Corporation (NYSE:XON), a leader in synthetic biology.
FCX-013
- In April, Fibrocell received orphan drug designation from the
FDA for FCX-013 for the treatment of localized scleroderma, a
chronic autoimmune disease characterized by thickening of the skin
and connective tissue that can be debilitating and painful. FCX-013
is currently in pre-clinical development for the treatment of
linear scleroderma, a form of localized scleroderma.
- In January, Fibrocell completed a proof-of-concept study for
FCX-013 to determine its potential to reduce dermal thickness in
fibrotic tissue. FCX-013 was evaluated in a bleomycin-induced
scleroderma model, utilizing severe combined immunodeficiency
(SCID) mice. Data from the study demonstrated that FCX-013 reduced
the dermal thickness of fibrotic tissue to levels similar to
non-bleomycin (saline) treated skin and further reduced the
thickness of the sub-dermal muscle layer. Based upon these results
and the FDA’s feedback to our pre-IND briefing package, Fibrocell
is advancing FCX-013 into pre-clinical dose-ranging studies.
Fibrocell expects to submit an IND application for FCX-013 to the
FDA in 2017. FCX-013 is also being developed in collaboration with
Intrexon.
Financial Results for the Three Months
Ended March 31, 2016 and 2015
For the three months ended March 31, 2016,
Fibrocell reported a diluted net loss of $0.08 per share, compared
to a diluted net loss of $0.21 per share for the same period in
2015. The 2016 quarter included $5.3 million in non-cash warrant
revaluation income, compared to non-cash warrant revaluation
expense of $1.7 million in the prior year period.
Research and development expense remained
consistent at $3.9 million and $4.0 million for the quarters ended
March 31, 2016 and 2015, respectively. Decreases in costs related
to our ongoing programs were offset by increased compensation and
process development expenses.
Selling, general and administrative expense for
the quarter ended March 31, 2016 were approximately $2.7 million,
as compared to $2.9 million for the same period in 2015. The
slight decrease was primarily due to decreased professional fees
partially offset by increased compensation expense in the 2016
period as a result of the addition of new hires as well as higher
non-cash stock compensation.
As of March 31, 2016, the Company had cash and
cash equivalents of $13.1 million and working capital of $11.3
million. Fibrocell used $16.1 million in cash for operations
during the first quarter of 2016, as compared to $4.2 million used
in the first quarter of 2015. The $11.9 million increase was due to
the one time up-front $10 million technology access fee payment to
Intrexon in January 2016 in connection with the 2015 ECC and the
payment of employee bonuses and professional fees in the first
quarter of 2016. The Company believes that its current cash
and cash equivalents will be sufficient to fund operations into the
fourth quarter of 2016. Additional capital will be needed by the
Company to fund operations beyond that point.
Conference Call and Webcast
To participate on the live call, please dial
888-576-4387 (domestic) or +1-719-325-2144 (international), and
provide the conference code 8725246 five to ten minutes before the
start of the call. The conference call will also be webcast live
under the “Investors” section of Fibrocell's website at
www.fibrocell.com/investors/events and will be archived there for
30 days following the call. Please visit Fibrocell's website
several minutes prior to the start of the broadcast to ensure
adequate time for any software download that may be necessary.
About Fibrocell
Fibrocell is an autologous cell and gene therapy
company translating personalized biologics into medical
breakthroughs. Fibrocell’s most advanced product candidate,
azficel-T, uses its proprietary autologous fibroblast technology
and is in a Phase II clinical trial for the treatment of vocal cord
scarring resulting in chronic or severe dysphonia. In collaboration
with Intrexon Corporation (NYSE:XON), a leader in synthetic
biology, Fibrocell is also developing gene therapies for diseases
affecting the skin, connective tissue and joints using
genetically-modified autologous fibroblasts. Fibrocell
recently received allowance from the FDA to initiate a Phase I/II
clinical trial of FCX-007 in adult subjects, and expects to
initiate the Phase I portion of the trial in June 2016. FCX-007 is
Fibrocell’s lead orphan gene-therapy product candidate for the
treatment of recessive dystrophic epidermolysis bullosa
(RDEB). Fibrocell is in pre-clinical development of FCX-013,
its orphan gene-therapy product candidate for the treatment of
linear scleroderma. In addition, Fibrocell and Intrexon are
in collaboration to develop a gene therapy for the treatment of
arthritis. For more information, visit www.fibrocell.com or
follow us on Twitter at @Fibrocell.
Trademarks
Fibrocell, the Fibrocell logo, Fibrocell Science
and LAVIV® 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: the initiation of
our Phase I/II clinical trial for FCX-007; the reporting of primary
endpoint results from our Phase II clinical trial for azficel-T;
the initiation and design of additional pre-clinical studies, and
submission of an IND for FCX-013; the potential advantages of our
product candidates; and other statements regarding our 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: our
ability to obtain additional capital to fund our operations;
changes in law affecting orphan- designated drugs; our ability to
maintain orphan drug designation for FCX-007 and FCX-013; FDA
allowance to treat pediatric subjects in the Phase II portion of
our 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 our product candidates; varying
interpretation of pre-clinical and clinical data; our ability to
maintain our collaboration with Intrexon Corporation; and the
risks, uncertainties and other factors discussed under the caption
“Item 1A. Risk Factors” in our most recent Form 10-K filing. As a
result, you are cautioned not to place undue reliance on any
forward-looking statements. While we may update certain
forward-looking statements from time to time, we specifically
disclaim any obligation to do so, whether as a result of new
information, future developments or otherwise.
|
|
Fibrocell Science, Inc. |
Selected Financial Information |
($ in thousands, except per share and share data) |
(unaudited) |
|
Condensed Consolidated Statements of Operations
Data: |
|
|
For the Three
MonthsEnded March 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
Revenue
from product sales |
$ |
12 |
|
|
$ |
113 |
|
Collaboration revenue |
|
4 |
|
|
|
81 |
|
Total revenue |
|
16 |
|
|
|
194 |
|
Cost
of product sales |
|
17 |
|
|
|
144 |
|
Cost
of collaboration revenue |
|
1 |
|
|
|
3 |
|
Total cost of revenue |
|
18 |
|
|
|
147 |
|
Gross (loss) profit |
|
(2 |
) |
|
|
47 |
|
Research
and development expense |
|
3,926 |
|
|
|
3,987 |
|
Selling,
general and administrative expense |
|
2,740 |
|
|
|
2,924 |
|
Operating loss |
|
(6,668 |
) |
|
|
(6,864 |
) |
Other
income (expense): |
|
|
|
Warrant revaluation income
(expense) |
|
5,257 |
|
|
|
(1,663 |
) |
Interest income |
|
4 |
|
|
|
2 |
|
Loss
before income taxes |
|
(1,407 |
) |
|
|
(8,525 |
) |
Income
tax benefit |
|
- |
|
|
|
- |
|
Net
loss |
$ |
(1,407 |
) |
|
$ |
(8,525 |
) |
|
|
|
|
Per share information: |
|
|
|
Net
loss: |
|
|
|
Basic |
$ |
(0.03 |
) |
|
$ |
(0.21 |
) |
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.21 |
) |
Weighted average number of common shares outstanding: |
|
|
|
Basic |
|
43,898,785 |
|
|
|
40,861,329 |
|
Diluted |
|
43,970,853 |
|
|
|
40,861,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
March 31, |
|
December 31, |
|
2016 |
|
2015 |
Cash
and cash equivalents |
$ |
13,095 |
|
|
$ |
29,268 |
|
Working capital |
|
11,255 |
|
|
|
15,629 |
|
Total
assets |
|
20,210 |
|
|
|
36,712 |
|
Warrant liability, current and long term |
|
3,018 |
|
|
|
8,275 |
|
Total
liabilities |
|
6,869 |
|
|
|
22,509 |
|
Stockholders’ equity |
|
13,341 |
|
|
|
14,203 |
|
Investor Relations Contact:
John Woolford
Westwicke Partners
443.213.0506
john.woolford@westwicke.com
Media Relations Contact:
Michael Parks
484.356.7105
michael@pitch360inc.com
Intrexon (NASDAQ:XON)
Historical Stock Chart
From Aug 2024 to Sep 2024
Intrexon (NASDAQ:XON)
Historical Stock Chart
From Sep 2023 to Sep 2024