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 second quarter ended June 30, 2018 and recent
operational highlights. Fibrocell will host a conference call and
webcast today at 8:30 a.m. EDT.
“During the second quarter of 2018, we attained
important milestones that continue to advance the development of
our gene therapy candidates for rare and devastating conditions
affecting the skin and connective tissue,” said John Maslowski,
President and Chief Executive Officer of Fibrocell. “In May, we
reported on interim results on the adult patients in the Phase 1
portion of our Phase 1/2 clinical trial of FCX-007 for the
treatment of recessive dystrophic epidermolysis bullosa (RDEB). The
data continued to show positive trends in safety, wound healing and
pharmacology. Furthermore, we continue to progress the Phase 2
portion of the trial, including dosing our first patient and
enrolling three pediatric patients.”
“Our FCX-013 gene therapy program for the
treatment of moderate to severe localized scleroderma also made
notable progress this quarter. The U.S. Food and Drug
Administration (FDA) allowed our Investigational New Drug
application earlier this year, and in August, we initiated the
first investigator site for clinical enrollment for our open label,
single arm Phase 1/2 clinical trial,” said Mr. Maslowski.
Recent program highlights and new updates are as
follows:
FCX-007
- The first patient enrolled in the Phase 2 portion of the trial
was dosed in June.
- Three additional patients have been enrolled in the Phase 2
portion of the trial, for a total of four patients. The three new
patients are all pediatric ages, while the recently dosed patient
is an adult. Fibrocell expects to enroll a total of six
patients ages seven and older by the end of the third quarter of
2018.
- Fibrocell reported on interim data from four adult patients in
the Phase 1 portion of the Phase 1/2 clinical trial of FCX-007 for
the treatment of RDEB and provided a trial update, which was also
presented at the 7th International Investigative Dermatology
meeting. The safety data from these patients dosed with FCX-007
showed the product was well-tolerated up to 52 weeks
post-administration. There were no serious adverse events and no
product related adverse events reported. No type VII collagen
(COL7) autoantibody response was noted. In addition, continued
positive trends were noted in wound healing and pharmacology
signals, including COL7 expression and evidence of anchoring
fibrils.
- Fibrocell expects to provide another interim data report and
trial update in the first quarter of 2019.
FCX-013
- Fibrocell obtained allowance from the FDA of the
Investigational New Drug Application for FCX-013 to progress to
clinical trials for the treatment of moderate to severe localized
scleroderma in the first quarter of 2018, and the Company initiated
the first investigator site for clinical enrollment for a Phase 1/2
clinical trial of FCX-013 in August.
Corporate
- Fibrocell closed a $4.0 million registered direct public
offering of its common stock in July, which was priced
at-the-market. In a concurrent private placement, the Company also
issued unregistered warrants to purchase shares of Fibrocell common
stock, representing 65% of the shares of common stock purchased in
the registered direct public offering. The net proceeds of
these offerings were approximately $3.5 million.
- Fibrocell closed a $6.0 million registered direct public
offering of its common stock in May, which was priced
at-the-market. In a concurrent private placement, the Company also
issued unregistered warrants to purchase shares of Fibrocell common
stock, representing 75% of the shares of common stock purchased in
the registered direct public offering. The net proceeds of these
offerings were approximately $5.2 million.
- Fibrocell implemented a one-for-five reverse stock split of its
issued and outstanding shares of common stock in May. The Company’s
common stock began trading on the Nasdaq Capital Market (Nasdaq) on
a split adjusted basis beginning with the opening of trading on May
25, 2018. The reverse stock split was intended to increase the per
share trading price of the Company’s common stock to permit it to
regain compliance with the continued listing requirements of The
Nasdaq Capital Market. On June 11, 2018, the Company received
written notice from Nasdaq notifying the Company that the closing
bid price of the Company's common stock had been at $1.00 per share
or greater for a minimum of ten consecutive business days and
accordingly, the Company had regained compliance with Nasdaq
Listing Rule 5550(a)(2).
- Fibrocell announced that its Board of Directors is conducting a
comprehensive review of strategic alternatives focused on
maximizing stockholder value in April. Fibrocell has engaged
Canaccord Genuity LLC as its strategic financial advisor to assist
with this review process. The Board of Directors has established a
Special Committee to explore and evaluate potential strategic
alternatives which may include a sale of the Company, a business
combination, a merger or reverse merger with another company, a
strategic investment into the Company, a sale, license or other
disposition of corporate assets of the Company or continuing with
the current business plan. Fibrocell has not set a timetable
for completion of the review process. No decision has been
made as to whether the Company will engage in a transaction or
transactions, and there can be no assurance that this process will
result in any transaction, or the terms or timing of any potential
transaction.
Financial Results for the Six Months
Ended June 30, 2018
For the six months ended June 30, 2018,
Fibrocell reported a diluted net loss of $1.03 per share, compared
to a diluted net loss of $7.82 per share for the same period in
2017.
The 2018 period included approximately $0.3
million of non-cash warrant revaluation income, as compared to
approximately $9.7 million of non-cash warrant revaluation expense
for the same period in 2017. Additionally, the 2018 period included
non-cash derivative revaluation income of approximately $0.2
million as compared to approximately $0.5 million in non-cash
derivative revaluation income included in the 2017 period.
Research and development expenses decreased
54.8% to approximately $2.9 million for the six months ended June
30, 2018, as compared to approximately $6.3 million for the same
six-month period in 2017. This decrease was due primarily to
decreased costs for our FCX-007 program of approximately $2.8
million, or 95.4%, to approximately $0.1 million for the six months
ended June 30, 2018, as compared to approximately $3.0 million for
the same period in 2017. These decreased costs were primarily the
result of transitioning from dosing of adult patients and analysis
of data in the Phase 1 portion of the Phase 1/2 clinical trial of
FCX-007 to recruitment for the Phase 2 portion of the trial, and
moving our manufacturing operations in-house from a third party
contractor. Costs for our FCX-013 program decreased approximately
$0.7 million, or 68.1%, to approximately $0.3 million for the six
months ended June 30, 2018, as compared to approximately $1.1
million for the same period in 2017. This decrease was related
primarily to decreased costs from our clinical partner Precigen,
Inc., a wholly owned subsidiary of Intrexon Corporation, of
approximately $0.6 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 six months of 2018 has been used for
clinical trial start-up activities.
Selling, general and administrative expenses of
approximately $3.2 million were comparable for each of the six
months ended June 30, 2018 and 2017.
Fibrocell used approximately $7.5 million in
cash for operations during the six months ended June 30, 2018, and
used approximately $9.0 million in cash for operations during the
six months ended June 30, 2017.
As of June 30, 2018, the Company had cash and
cash equivalents of approximately $15.4 million and working capital
of approximately $13.8 million. In addition, and as described in
the Corporate highlights section of this release, the Company
closed a registered direct public offering and a concurrent private
placement in July 2018. The net proceeds of these offerings were
approximately $3.5 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
888-220-8451 (domestic) or +1-323-794-2588 (international), and
provide the conference code 2893286 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 product
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 (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 exploration of strategic alternatives;
the timing of dosing and reporting of interim data and trial
updates for its Phase 1/2 clinical trial of FCX-007; the completion
of enrollment in the Phase 2 portion of its Phase 1/2 clinical
trial of FCX-007; the initiation of the Phase 1 portion of its
Phase 1/2 clinical trial for FCX-013; the potential for FCX-007 and
FCX-013 to receive Priority Review Vouchers upon market
authorization; 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: uncertainties
associated with being able to identify, evaluate and complete any
strategic transaction or alternative; the impact of the
announcement of the Board of Directors’ review of strategic
alternatives, as well as any strategic transaction or alternative
that may be pursued, on the Company's business, including its
financial and operating results and its employees; 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 or FCX-013;
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 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)
|
|
Six Months EndedJune
30, |
|
|
2018 |
|
2017 |
|
Total revenues |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
Total cost of
revenue |
|
— |
|
|
— |
|
|
|
|
|
|
Gross
profit (loss) |
|
— |
|
|
— |
|
|
|
|
|
|
Research and
development expense |
|
3,060 |
|
|
3,143 |
|
Research
and development expense - related party (see Note 8) |
|
(197 |
) |
|
3,187 |
|
Selling, general and
administrative expense |
|
3,195 |
|
|
3,151 |
|
Operating
loss |
|
(6,058 |
) |
|
(9,481 |
) |
Other income
(expense): |
|
|
|
|
Warrant
revaluation income (expense) |
|
326 |
|
|
(9,723 |
) |
Derivative revaluation income |
|
179 |
|
|
541 |
|
Interest
expense |
|
(381 |
) |
|
(368 |
) |
Other
income, net |
|
139 |
|
|
6 |
|
Loss
before income taxes |
|
(5,795 |
) |
|
(19,025 |
) |
Income
taxes |
|
— |
|
|
— |
|
Net
loss |
|
(5,795 |
) |
|
(19,025 |
) |
Dividend
paid in-kind to preferred stockholders |
|
(165 |
) |
|
(100 |
) |
Deemed
dividend on preferred stock (see Note 10) |
|
(247 |
) |
|
(3,870 |
) |
Net loss
attributable to common stockholders |
|
$ |
(6,207 |
) |
|
$ |
(22,995 |
) |
|
|
|
|
|
Per Share
Information: |
|
|
|
|
Net loss: |
|
|
|
|
Basic |
|
$ |
(1.03 |
) |
|
$ |
(7.82 |
) |
Diluted |
|
$ |
(1.03 |
) |
|
$ |
(7.82 |
) |
Weighted average number
of common shares outstanding: |
|
|
|
|
Basic |
|
6,026,454 |
|
|
2,940,763 |
|
Diluted |
|
6,026,454 |
|
|
2,940,763 |
|
Condensed Consolidated Balance Sheets Data: |
June 30, |
|
December 31, |
|
2018 |
|
2017 |
Cash
and cash equivalents |
$ |
15,410 |
|
$ |
17,417 |
Working capital |
|
13,817 |
|
|
13,477 |
Total
assets |
|
17,278 |
|
|
19,411 |
Warrant liability, long term |
|
747 |
|
|
1,073 |
Total
liabilities |
|
7,910 |
|
|
10,404 |
Total
stockholders’ equity |
|
9,368 |
|
|
9,007 |
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