Press ReleaseView printer-friendly version Back
Fibrocell Reports Third Quarter 2018 Financial Results and Recent Highlights
- Company to Host Conference Call and Webcast Today at
- Announces patient enrollment completed in Phase 2 of Phase 1/2 clinical trial for FCX-007 for recessive dystrophic epidermolysis bullosa -
“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
“In addition, we completed a Type C meeting with the
“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
Recent program highlights and new updates are as follows:
- Fibrocell completed a Type C meeting with the
FDAto discuss the design of a Phase 3 clinical trial protocol for FCX-007 for the treatment of RDEB. The FDAprovided 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
- The FDA’s
Office of Orphan Products Development(OOPD) awarded a $1.4 millionclinical 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.
- 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
FDAfor the treatment of moderate to severe localized scleroderma. Previously, the FDAgranted Orphan Drug and Rare Pediatric Designation to FCX-013.
- 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
For the nine months ended
The 2018 period included approximately
Research and development expenses decreased 50.2% to approximately
Costs for the FCX-013 program decreased approximately
Selling, general and administrative expenses decreased 8.1% to approximately
Fibrocell used approximately
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.
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
Fibrocell®, the Fibrocell logo, and
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
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
Investor & Media Relations Contact:
|Fibrocell Science, Inc.
Condensed Consolidated Statements of Operations
($ in thousands, except share and per share data)
|Nine Months Ended
|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|
|Other income (expense):|
|Warrant revaluation income (expense)||591||(4,742||)|
|Derivative revaluation income (expense)||266||287|
|Other income, net||227||33|
|Loss before income taxes||(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:|
|Weighted average number of common shares outstanding:|
|Condensed Consolidated Balance Sheets Data:||September 30,||December 31,|
|Cash and cash equivalents||$||16,111||$||17,417|
|Warrant liability, long term||482||1,073|
|Total stockholders’ equity||10,184||9,007|