- Company to Host Conference Call and
Webcast Today at 8:30 a.m. EST –
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, 2018 and recent
operational highlights. Fibrocell will host a conference call and
webcast today at 8:30 a.m. EST.
“During the third quarter, Fibrocell made
important progress with the clinical development of our gene
therapy programs focused on rare diseases of the skin and
connective tissue,” said John Maslowski, President and Chief
Executive Officer of Fibrocell. “Most recently, we completed
enrollment in the Phase 2 portion of our Phase 1/2 clinical trial
for FCX-007 for the treatment of recessive dystrophic epidermolysis
bullosa (RDEB).”
“In addition, we completed a Type C meeting with
the U.S. Food and Drug Administration (FDA) to discuss the design
of a Phase 3 clinical trial protocol for FCX-007. We received
valuable guidance from the FDA on the trial’s design and Chemistry,
Manufacturing and Control (CMC) requirements. As a result of the
feedback from this meeting, we plan to submit the Phase 3 clinical
trial protocol in the fourth quarter of 2018 and expect to initiate
the trial in the first half of 2019.”
“Our FCX-013 gene therapy program also continued
to advance this quarter. We initiated the first investigator site
for clinical enrollment in a Phase 1/2 clinical trial for FCX-013
for the treatment of moderate to severe localized scleroderma.
Additionally, the FDA granted Fast Track Designation to FCX-013,
which augments its Orphan Drug and Rare Pediatric Disease
Designations,” said Mr. Maslowski.
Recent program highlights and new updates are as
follows:
FCX-007
- Fibrocell completed a Type C meeting with the FDA to discuss
the design of a Phase 3 clinical trial protocol for FCX-007 for the
treatment of RDEB. The FDA provided guidance on various clinical
trial design aspects and Chemistry, Manufacturing and Control
requirements of the proposed Phase 3 clinical trial. Based on the
feedback from the meeting, Fibrocell plans to submit the Phase 3
clinical trial protocol in the fourth quarter of 2018 and will
provide details on the clinical trial design once it is finalized.
The Company expects to initiate the Phase 3 clinical trial in the
first half of 2019.
- Fibrocell completed the targeted enrollment of six patients in
the Phase 2 portion of the Phase 1/2 clinical trial for FCX-007,
and has over-enrolled by one patient for a total of seven patients.
The Phase 2 population consists of one adult and six pediatric
patients. The Company expects to report an interim data analysis
for FCX-007’s Phase 1/2 clinical trial and provide a clinical trial
update from Phase 1 patients, including available data from Phase 2
patients, in the first quarter of 2019. Fibrocell plans to continue
the Phase 2 portion of its ongoing Phase 1/2 clinical trial to
collect additional data while submitting the Phase 3 clinical trial
protocol to the FDA in parallel.
- The FDA’s Office of Orphan Products Development (OOPD) awarded
a $1.4 million clinical trial research grant for Fibrocell’s
continued clinical development of FCX-007. This grant, which will
be distributed over the next four years, was presented through the
FDA OOPD’s Orphan Products Clinical Trials Grants Program.
FCX-013
- Fibrocell initiated the first investigator site for clinical
enrollment in an open label, single arm Phase 1/2 clinical trial
for FCX-013.
- FCX-013 was granted Fast Track Designation by the FDA for the
treatment of moderate to severe localized scleroderma. Previously,
the FDA granted Orphan Drug and Rare Pediatric Designation to
FCX-013.
Corporate
- Fibrocell closed a registered direct public offering of its
common stock in July, which was priced at-the-market, for gross
proceeds of approximately $3.9 million. In a concurrent private
placement, the Company also issued unregistered warrants,
representing 65% of the shares of common stock purchased in the
registered direct public offering, to purchase shares of Fibrocell
common stock for gross proceeds of approximately $0.1
million. The net proceeds of these offerings were
approximately $3.5 million.
Financial Results for the Nine Months
Ended September 30, 2018
For the nine months ended September 30, 2018,
Fibrocell reported a diluted net loss of $1.31 per share, compared
to a diluted net loss of $7.92 per share for the same period in
2017.
The 2018 period included approximately $0.6
million of non-cash warrant revaluation income, as compared to
approximately $4.7 million of non-cash warrant revaluation expense
for the same period in 2017.
Research and development expenses decreased
50.2% to approximately $4.5 million for the nine months ended
September 30, 2018, as compared to approximately $9.0 million for
the same nine-month period in 2017. This decrease was due primarily
to decreased costs for our FCX-007 program of approximately $3.0
million, or 83.0%, to approximately $0.6 million for the nine
months ended September 30, 2018, as compared to approximately $3.6
million for the same period in 2017. These decreased costs were the
result primarily of transitioning from dosing of adult patients and
analysis of data in the Phase 1 portion of the Phase 1/2 clinical
trial for FCX-007 to recruitment for the Phase 2 portion of the
trial, and moving our manufacturing operations for the drug product
used in the Phase 1/2 clinical trial for FCX-007 in-house from a
third party manufacturer.
Costs for the FCX-013 program decreased
approximately $1.5 million, or 79.5%, to approximately $0.4 million
for the nine months ended September 30, 2018, as compared to
approximately $1.8 million for the same period in 2017. This
decrease was related primarily to decreased costs from Precigen of
approximately $1.3 million, as substantially all of the costs of
the pre-clinical phase of the FCX-013 program were incurred at the
end of 2017, while the first nine months of 2018 has been used for
clinical trial start-up activities.
Selling, general and administrative expenses
decreased 8.1% to approximately $4.7 million for the nine months
ended September 30, 2018, as compared to approximately $5.1 million
for the same nine-month period in 2017. This decrease was related
primarily to lower costs for professional fees.
Fibrocell used approximately $10.2 million in
cash for operations during the nine months ended September 30,
2018, and used approximately $12.9 million in cash for operations
during the nine months ended September 30, 2017.
As of September 30, 2018, the Company had cash
and cash equivalents of approximately $16.1 million and working
capital of approximately $14.6 million. The Company believes that
its cash and cash equivalents will be sufficient to fund operations
into the fourth quarter of 2019.
Conference Call and Webcast
To participate on the live call, please dial
877-260-1479 (domestic) or +1-334-323-0522 (international), and
provide the conference code 7133925 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
RDEB. Fibrocell is also developing FCX-013, the Company’s clinical
stage candidate for the treatment of moderate to severe localized
scleroderma. Fibrocell’s gene therapy portfolio is being
developed in collaboration with Precigen, Inc., a wholly owned
subsidiary of Intrexon Corporation (NASDAQ: 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 and clinical development of
FCX-007, including the Company’s plans to submit a Phase 3 clinical
trial protocol to the FDA in the fourth quarter of 2018 and
commence a Phase 3 clinical trial for FCX-007 in the first half of
2019; Fibrocell’s plans to continue the Phase 2 portion of its
ongoing Phase 1/2 clinical trial for FCX-007 to collect additional
data while submitting the Phase 3 protocol to the FDA in parallel;
the timing of reporting of interim data and trial updates for its
Phase 1/2 clinical trial of FCX-013; the potential advantages of
Fibrocell’s product candidates; the sufficiency of the Company’s
cash and cash equivalents to fund operations into the fourth
quarter of 2019 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 the FDA’s
official meeting minutes may differ materially from the Company’s
understanding of the results of the Type C meeting with the FDA;
uncertainties and delays in the FDA review and approval of the
Phase 3 clinical trial protocol for FCX-007; uncertainties and
delays relating to the initiation, enrollment and completion
of clinical trials; whether 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; uncertainties associated with being able to
identify, evaluate and complete any strategic transaction or
alternative; the impact of the announcement any strategic
transaction or alternative that may be pursued, on the Company's
business, including its financial and operating results and its
employees; Fibrocell’s ability to maintain its collaboration with
Precigen, Inc.; 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.Condensed
Consolidated Statements of
Operations(unaudited)($ in thousands,
except share and per share data) |
|
|
Nine Months EndedSeptember
30, |
|
|
2018 |
|
2017 |
Total revenues |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
Total cost of
revenue |
|
— |
|
|
— |
|
|
|
|
|
|
Gross
profit (loss) |
|
— |
|
|
— |
|
|
|
|
|
|
Research and
development expense |
|
4,601 |
|
|
4,800 |
|
Research
and development expense - related party (see Note 8) |
|
(134 |
) |
|
4,168 |
|
Selling, general and
administrative expense |
|
4,696 |
|
|
5,109 |
|
Operating
loss |
|
(9,163 |
) |
|
(14,077 |
) |
Other income
(expense): |
|
|
|
|
Warrant
revaluation income (expense) |
|
591 |
|
|
(4,742 |
) |
Derivative revaluation income (expense) |
|
266 |
|
|
287 |
|
Interest
expense |
|
(575 |
) |
|
(641 |
) |
Other
income, net |
|
227 |
|
|
33 |
|
Loss
before income taxes |
|
(8,654 |
) |
|
(19,140 |
) |
Income
taxes |
|
— |
|
|
— |
|
Net
loss |
|
(8,654 |
) |
|
(19,140 |
) |
Dividend
paid in-kind to preferred stockholders |
|
(250 |
) |
|
(182 |
) |
Deemed
dividend on preferred stock (see Note 10) |
|
(377 |
) |
|
(3,981 |
) |
Net loss
attributable to common stockholders |
|
$ |
(9,281 |
) |
|
$ |
(23,303 |
) |
|
|
|
|
|
Per Share
Information: |
|
|
|
|
Net loss: |
|
|
|
|
Basic |
|
$ |
(1.31 |
) |
|
$ |
(7.92 |
) |
Diluted |
|
$ |
(1.31 |
) |
|
$ |
(7.92 |
) |
Weighted average number
of common shares outstanding: |
|
|
|
|
Basic |
|
7,107,678 |
|
|
2,942,202 |
|
Diluted |
|
7,107,678 |
|
|
2,942,202 |
|
Condensed Consolidated Balance Sheets Data: |
|
September 30, |
|
December 31, |
|
|
|
2018 |
|
|
2017 |
Cash
and cash equivalents |
|
$ |
16,111 |
|
$ |
17,417 |
Working capital |
|
|
14,594 |
|
|
13,477 |
Total
assets |
|
|
17,701 |
|
|
19,411 |
Warrant liability, long term |
|
|
482 |
|
|
1,073 |
Total
liabilities |
|
|
7,517 |
|
|
10,404 |
Total
stockholders’ equity |
|
|
10,184 |
|
|
9,007 |
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