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EXTON, Pa., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc. (NASDAQ:FCSC) today reported financial results for the second quarter ended June 30, 2016 and recent operational highlights. Fibrocell will host a conference call and webcast today at 8:30 a.m. EDT.
“Fibrocell is advancing into the second half of 2016 focused on innovative gene-therapy programs that have the potential to make transformative differences in the lives of patients suffering from debilitating genetic diseases affecting the skin and connective tissue,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “Progress with FCX-007, our product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), is significant, as two adult subjects are enrolled in our Phase I/II clinical trial. In addition, FCX-013, in development for the treatment of linear scleroderma, is proceeding into a pre-clinical dose-ranging study, followed by a toxicology/biodistribution study.”
Recent Operational Highlights
Wind-down of azficel-T Operations
Financial Results for the Six Months Ended June 30, 2016 and 2015
For the six months ended June 30, 2016, Fibrocell reported a diluted net loss of $0.26 per share, compared to a diluted net loss of $0.37 per share for the same period in 2015.
The 2016 period included $7.5 million in non-cash warrant revaluation income compared to non-cash warrant revaluation expense of $1.1 million for the same period in 2015. The 2016 period also included non-cash intangible asset impairment expense of $3.9 million and restructuring costs of $0.3 million related to the previously announced wind-down of Fibrocell’s azficel-T operations.
Research and development expense decreased to $7.2 million for the six months ended June 30, 2016, as compared to $7.7 million for the same period in 2015. The decrease was primarily the result of reduced costs related to Fibrocell’s ongoing development programs, offset by an increase in process development expenses.
Selling, general and administrative expense decreased to $5.3 million for the six months ended June 30, 2016, as compared to $6.6 million for the same period in 2015. The decrease was primarily due to reduced professional fees.
As of June 30, 2016, the Company had cash and cash equivalents of $8.2 million and working capital of $5.8 million. Fibrocell used $20.9 million in cash for operations during the six months ended June 30, 2016, as compared to $10.8 million used for the same period in 2015, primarily due to the $10.0 million upfront technology access fee paid to Intrexon Corporation in January 2016 in connection with the December 2015 Exclusive Channel Collaboration. The Company believes that its cash and cash equivalents at June 30, 2016 will be sufficient to fund operations into the fourth quarter of 2016.
Conference Call and Webcast
To participate on the live call, please dial 888-428-9490 (domestic) or +1-719-785-1753 (international), and provide the conference code 2654515 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.
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 gene-therapy product candidate, FCX-007, has begun 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. In addition, Fibrocell has a third gene-therapy program in the research phase for the treatment of arthritis and related conditions. 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 us on Twitter at @Fibrocell.
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.
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; Fibrocell’s expectations regarding the timing of the completion of adult subject enrollment, dosing and reporting of results for the Phase I portion of the Phase I/II clinical trial of FCX-007; the expected timing of the submission of an IND for FCX-013; the potential advantages of Fibrocell’s product candidates; the sufficiency of Fibrocell’s cash and cash equivalents to fund operations into the fourth quarter of 2016; 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 and continue as a going-concern; uncertainties and delays relating to the initiation, enrollment 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; FDA allowance to enroll pediatric subjects in the Phase II portion of the Phase I/II clinical trial of FCX-007; unanticipated or excess costs relating to the wind-down of azficel-T (including LAVIV) operations and the development of Fibrocell’s gene-therapy 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 and Form 10-Q 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.
|Fibrocell Science, Inc.|
Selected Financial Information
($ in thousands, except per share and share data)
|Three months ended||Six months ended|
|Condensed Consolidated Statements of Operations||June 30, 2016||June 30, 2015||June 30, 2016||June 30, 2015|
|Revenue from product sales||$||73||$||55||$||85||$||168|
|Cost of product sales||392||77||409||221|
|Cost of collaboration revenue||-||85||1||88|
|Total cost of revenue||392||162||410||309|
|Gross (loss) profit||(305||)||(25||)||(307||)||22|
|Research and development expense||2,352||2,567||4,954||4,814|
|Research and development expense – related party||925||1,127||2,249||2,867|
|Selling, general and administrative expense||2,540||3,640||5,280||6,564|
|Intangible asset impairment expense||3,905||-||3,905||-|
|Other income (expense):|
|Warrant revaluation income (expense)||2,254||602||7,511||(1,061||)|
|Loss before income taxes||(8,092||)||(6,756||)||(9,499||)||(15,281||)|
|Income tax benefit||-||-||-||-|
|Per share information:|
|Weighted average number of common shares outstanding|
|Condensed Consolidated Balance Sheet Data||June 30,||December 31,|
|Cash and cash equivalents||$||8,161||$||29,268|
|Warrant liability, current and long term||764||8,275|
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