Fibrocell Reports Third Quarter 2017 Financial Results and Recent Highlights
November 13 2017 - 8:00AM
Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company
focused on transformational autologous cell-based therapies for
skin and connective tissue diseases, today reported financial
results for the third quarter ended September 30, 2017 and recent
operational highlights. Fibrocell will host a conference call and
webcast today at 8:30 a.m. EST.
“The third quarter of 2017 was highlighted by
encouraging interim results for the first cohort of adult patients
dosed in the Phase 1/2 clinical trial of FCX-007, our product
candidate for the treatment of recessive dystrophic epidermolysis
bullosa (RDEB), a devastating genetic skin disease with high
mortality,” said John Maslowski, President and Chief Executive
Officer of Fibrocell. “In addition, we are working to complete the
remaining pre-clinical activities for FCX-013 for the treatment of
moderate to severe localized scleroderma and expect to file an
Investigational New Drug (IND) application in the fourth quarter of
this year.”
Recent program highlights and new updates are as
follows:
FCX-007
- In September, Fibrocell reported interim results from the Phase
1 portion of its Phase 1/2 clinical trial of FCX-007 for the
treatment of RDEB. Data from three adult NC1+ patients showed
FCX-007 was well-tolerated through 12 weeks post-administration. No
serious adverse events and no product-related adverse events were
reported. In addition to encouraging interim safety data, positive
early trends were noted in wound healing and pharmacology signals.
The Data Safety Monitoring Board for the trial reviewed the interim
data and concluded that safety and potential benefit were
established, and allowed continuation of enrollment and
dosing.
- Fibrocell expects to perform additional dosing of adult
patients in the Phase 1 portion of the clinical trial in the fourth
quarter of 2017.
- An RDEB adult has been enrolled as the first patient in the
Phase 2 portion of the Phase 1/2 trial of FCX-007.
Furthermore, upon obtaining allowance from the U.S. Food and Drug
Administration (FDA), the Company expects to initiate enrollment of
pediatric patients in the Phase 2 portion of the trial in the first
quarter of 2018.
- Fibrocell’s existing, current good manufacturing practices
(cGMP) cell therapy manufacturing facility in Exton, PA has been
designated as the production site for FCX-007 after incorporation
into the IND. The facility will be used for the remaining
clinical and future commercial manufacture of FCX-007, with
capacity to serve the U.S. market for RDEB. The ~13,000 square foot
facility previously supported commercial autologous fibroblast
manufacturing, with multiple FDA inspections conducted at the
site. The facility includes cleanroom cell therapy
manufacturing, quality control testing, cryogenic storage,
shipping/receiving and warehousing space.
FCX-013
- Fibrocell initiated the good laboratory practices (GLP)
toxicology/biodistribution study of FCX-013, performed dosing, and
advanced into follow-up evaluations during the third quarter of
2017 that continue to progress in the fourth quarter of this
year.
- Based on the progress of pre-clinical development, Fibrocell
expects to submit an IND application for FCX-013 to the FDA in
the fourth quarter of 2017, and initiate a human safety clinical
trial in 2018.
Financial Results for the Nine Months
Ended September 30, 2017
For the nine months ended September 30, 2017,
Fibrocell reported a diluted net loss of $1.58 per share, compared
to a diluted net loss of $0.94 per share for the same period in
2016.
The 2017 period included approximately $4.7
million of non-cash warrant revaluation expense, as compared to
approximately $10.5 million of non-cash warrant revaluation income
for the same period in 2016. Additionally, the 2017 period included
non-cash deemed dividends on Series A preferred stock of
approximately $4.0 million increasing net loss attributable to
common stockholders. No non-cash deemed dividends were recorded in
the same period in 2016.
Research and development expenses decreased 4.4%
to approximately $9.0 million for the nine months ended September
30, 2017, as compared to approximately $9.4 million for the same
nine-month period in 2016. This decrease was due primarily to
reduced compensation and employee related expenses in the 2017
period as a result of our restructuring related initiatives
implemented in June 2016 in connection with the wind-down of our
azficel-T operations. This decrease was partially offset by the
increased costs related to the Phase 1/2 clinical trial of FCX-007
for the treatment of RDEB and pre-clinical development of FCX-013
for the treatment of moderate to severe localized scleroderma.
Selling, general and administrative expenses
decreased 36.2% to approximately $5.1 million for the nine months
ended September 30, 2017, as compared to approximately $8.0 million
for the same nine-month period in 2016. This decrease was due
primarily to reduced compensation and employee related
expenses.
As of September 30, 2017, the Company had cash
and cash equivalents of approximately $11.9 million and working
capital of approximately $8.7 million. Fibrocell used approximately
$12.9 million in cash for operations during the nine months ended
September 30, 2017, as compared to approximately $25.6 million used
for the same nine-month period in 2016.
The Company believes that its cash and cash
equivalents at September 30, 2017 will be sufficient to fund
operations into the second quarter of 2018.
Conference Call and Webcast
To participate on the live call, please dial
866-548-4713 (domestic) or +1-323-794-2093 (international), and
provide the conference code 9063692 five to ten minutes before the
start of the call. The conference call will also be webcast live
under the investor relations section of Fibrocell's website at
www.fibrocell.com/investors/events and will be archived there for
30 days following the call.
About Fibrocell
Fibrocell is an autologous cell and gene therapy
company translating personalized biologics into medical
breakthroughs for diseases affecting the skin and connective
tissue. Fibrocell’s most advanced product candidate, FCX-007,
is the subject of a Phase 1/2 clinical trial for the treatment of
recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in
pre-clinical development of FCX-013, its product candidate for the
treatment of moderate to severe localized
scleroderma. Fibrocell’s gene therapy portfolio is being
developed in collaboration with Intrexon Corporation (NYSE:XON), a
leader in synthetic biology. For more information, visit
www.fibrocell.com or follow Fibrocell 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
expectations regarding the timing of additional dosing and
reporting of results for the Phase 1 portion of its Phase 1/2
clinical trial of FCX-007; Fibrocell’s expectations regarding the
enrollment of pediatric patients in the Phase 2 portion of its
Phase 1/2 clinical trial of FCX-007; Fibrocell’s plans to increase
dosing of FCX-007 and Fibrocell’s expectations of the potential
results associated therewith; the expected completion of a
toxicology/biodistribution study and submission of an IND for
FCX-013 in 2017; the potential advantages of Fibrocell’s product
candidates; the sufficiency of the Company’s cash and cash
equivalents to fund operations into the second quarter of 2018 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: that interim
clinical trial results are not necessarily indicative of final
clinical results and final clinical trial results may not be
positive with regard to safety or efficacy of FCX-007;
uncertainties and delays relating to the initiation, enrollment and
completion of pre-clinical studies and clinical trials; whether
pre-clinical study and clinical trial results will validate and
support the safety and efficacy of Fibrocell’s product candidates;
unanticipated or excess costs relating to the development of
Fibrocell’s gene therapy product candidates; Fibrocell’s ability to
obtain additional capital to continue to fund operations;
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 and Form 10-Q filings. 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 & Media Relations
Contact:Karen Casey484.713.6133kcasey@fibrocell.com
Fibrocell Science, Inc. |
Selected Financial Information |
($ in thousands, except per share and share data) |
(unaudited) |
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September
30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
Revenue from product
sales |
|
$ |
— |
|
|
|
$ |
215 |
|
|
|
$ |
— |
|
|
$ |
300 |
|
|
|
Collaboration
revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
18 |
|
|
|
Total
revenue |
|
— |
|
|
|
215 |
|
|
|
— |
|
|
318 |
|
|
|
Cost of product
sales |
|
— |
|
|
|
287 |
|
|
|
— |
|
|
696 |
|
|
|
Cost of collaboration
revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
1 |
|
|
|
Total
cost of revenue |
|
— |
|
|
|
287 |
|
|
|
— |
|
|
697 |
|
|
|
Gross
loss |
|
— |
|
|
|
(72 |
) |
|
|
— |
|
|
(379 |
) |
|
|
Research and
development expense |
|
1,657 |
|
|
|
1,654 |
|
|
|
4,800 |
|
|
6,599 |
|
|
|
Research and
development expense - related party |
|
981 |
|
|
|
534 |
|
|
|
4,168 |
|
|
2,783 |
|
|
|
Selling, general and
administrative expense |
|
1,958 |
|
|
|
2,723 |
|
|
|
5,109 |
|
|
8,003 |
|
|
|
Intangible asset
impairment expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
3,905 |
|
|
|
Restructuring
costs |
|
— |
|
|
|
43 |
|
|
|
— |
|
|
335 |
|
|
|
Operating
loss |
|
(4,596 |
) |
|
|
(5,017 |
) |
|
|
(14,077 |
) |
|
(22,004 |
) |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Warrant
revaluation income (expense) |
|
4,981 |
|
|
|
3,007 |
|
|
|
(4,742 |
) |
|
10,518 |
|
|
|
Derivative revaluation income |
|
(254 |
) |
|
|
(251 |
) |
|
|
287 |
|
|
(251 |
) |
|
|
Interest
expense |
|
(273 |
) |
|
|
(46 |
) |
|
|
(641 |
) |
|
(46 |
) |
|
|
Other
income (expense), net |
|
27 |
|
|
|
8 |
|
|
|
33 |
|
|
(15 |
) |
|
|
Loss
before income taxes |
|
(115 |
) |
|
|
(2,299 |
) |
|
|
(19,140 |
) |
|
(11,798 |
) |
|
|
Income
taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
Net
loss |
|
(115 |
) |
|
|
(2,299 |
) |
|
|
(19,140 |
) |
|
(11,798 |
) |
|
|
Dividend
paid in-kind to preferred stockholders |
|
(82 |
) |
|
|
— |
|
|
|
(182 |
) |
|
— |
|
|
|
Deemed
dividend on preferred stock |
|
(111 |
) |
|
|
— |
|
|
|
(3,981 |
) |
|
— |
|
|
|
Net loss
attributable to common stockholders |
|
$ |
(308 |
) |
|
|
$ |
(2,299 |
) |
|
|
$ |
(23,303 |
) |
|
$ |
(11,798 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
Information: |
|
|
|
|
|
|
|
|
|
Net loss: |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.02 |
) |
|
|
$ |
(0.16 |
) |
|
|
$ |
(1.58 |
) |
|
$ |
(0.81 |
) |
|
|
Diluted |
|
$ |
(0.02 |
) |
|
|
$ |
(0.16 |
) |
|
|
$ |
(1.58 |
) |
|
$ |
(0.94 |
) |
|
|
Weighted average number
of common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
14,717,043 |
|
|
|
14,632,988 |
|
|
|
14,702,624 |
|
|
14,632,988 |
|
|
|
Diluted |
|
14,733,318 |
|
|
|
14,632,988 |
|
|
|
14,702,624 |
|
|
14,640,996 |
|
|
|
Condensed Consolidated Balance Sheets Data: |
|
September 30, |
|
December 31, |
|
|
2017 |
|
2016 |
Cash
and cash equivalents |
|
$ |
11,911 |
|
|
$ |
17,515 |
Working capital |
|
|
8,709 |
|
|
|
15,041 |
Total
assets |
|
|
13,781 |
|
|
|
19,582 |
Warrant liability, current and long term |
|
|
10,735 |
|
|
|
6,034 |
Total
liabilities |
|
|
17,107 |
|
|
|
11,721 |
Total
stockholders’ equity (deficit) |
|
|
(3,326 |
) |
|
|
7,861 |
|
|
|
|
|
|
|
|
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