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Fibrocell Reports Second Quarter 2019 Financial Results and Recent Operational Highlights
- Company to Host Conference Call and Webcast on
“Our dedicated team has continued to make progress during the second quarter of 2019 by achieving key milestones that, we believe, will serve as catalysts for advancing our gene therapy clinical programs for rare genetic conditions of the skin and connective tissue,” said
Recent program highlights are as follows:
- Fibrocell announced in
May 2019that the U.S. Food and Drug Administration( FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation to FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The RMAT designation augments the Orphan Drug, Rare Pediatric Disease and Fast Track designations previously granted to FCX-007 by the FDA.
- Based on guidance from a Type C meeting and a Type B end-of-Phase 2 meeting with the
FDAon the design of a proposed Phase 3 clinical trial of FCX-007, Fibrocell updated the Chemistry, Manufacturing and Controls (CMC) information filed to the Investigational New Drug (IND) application for FCX-007 in early July 2019. Fibrocell’s Phase 3 clinical trial, named DEFI-RDEB (dermal fibroblasts-RDEB), is designed as an open label, multi-centered, intra-patient controlled trial expected to enroll 15-20 patients.
- In late
July 2019, Fibrocell initiated the Phase 3 clinical trial of FCX-007. Fibrocell projects enrollment and dosing of Phase 3 patients will be completed in the third quarter of 2020, and data collection for the primary endpoint will be completed in the fourth quarter of 2020. The Phase 3 trial’s primary outcome measure is the comparison of the proportion of FCX-007 treated and untreated matched wounds with complete wound closure at week 12. If the Phase 3 clinical trial is successful and completed within the projected timeframe, Fibrocell expects to file a Biologics License Agreement (BLA) for FCX-007 in 2021.
- Fibrocell is currently enrolling the Phase 1 portion of a Phase 1/2 clinical trial for FCX-013 for the treatment of moderate to severe localized scleroderma and expects to complete enrollment of Phase 1 adult patients in the third quarter of 2019. The Company projects that safety and efficacy data for the adult patients will be available in mid-2020.
Financial Results for the Six Months Ended
For the six months ended
Revenue for the six months ended
Cost of revenue for the six months ended
Research and development expenses decreased approximately
Selling, general and administrative costs increased approximately
Fibrocell used approximately
Conference Call and Webcast
To participate on the live call, please dial 888-254-3590 (domestic) or +1-929-477-0448 (international) and provide the conference code 3755211 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.
FCX-007 is Fibrocell's clinical stage, gene therapy product candidate for the treatment of RDEB, a congenital and progressive orphan skin disease caused by the deficiency of the protein COL7. FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution.
FCX-007 has been granted Orphan Drug designation, Rare Pediatric Disease designation, Fast Track designation and RMAT designation by the
Fibrocell is developing FCX-007 in collaboration with
FCX-013 is Fibrocell’s clinical stage, gene therapy candidate for the treatment of moderate to severe localized scleroderma. FCX-013 is an autologous fibroblast genetically modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 incorporates Intrexon’s proprietary RheoSwitch Therapeutic System®, a biologic switch activated by veledimex—an orally administered compound—to control protein expression at the site of the localized scleroderma lesions. FCX‑013 is designed to be injected under the skin at the location of the fibrotic lesions where the genetically-modified fibroblast cells will produce MMP-1 to break down excess collagen accumulation.
Fibrocell is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. The Company is utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease. Fibrocell’s pipeline of localized gene therapy candidates include FCX-007 for the treatment of RDEB, a life-threatening genetic disorder diagnosed in infancy with no cure or treatment approved by the
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; Fibrocell’s potential to earn future milestone and profit share payments under the Castle Creek Pharmaceuticals Agreement; the expected trial design of DEFI-RDEB, and expectation to enroll 15-20 patients therein; the timing of Fibrocell’s Phase 1/2 clinical trial of FCX-013, including its expectation to complete enrollment of Phase 1 adult patients in the third quarter of 2019; Fibrocell’s projection to complete enrollment and dosing of FCX-007 Phase 3 patients in the third quarter of 2020 and complete data collection for the primary endpoint in the fourth quarter of 2020; Fibrocell’s expectation to file a BLA for FCX-007 in 2021; Fibrocell’s projection that safety and efficacy data for the adult patients in the Phase 1 portion of a Phase 1/2 clinical trial for FCX-013 will be available in mid-2020; the potential advantages of FCX-007, FCX-013 and Fibrocell’s other product candidates; the potential benefits of the Fast Track designation, Orphan Drug designation, Rare Pediatric Disease designation and RMAT designation; the Company’s belief that its cash and cash equivalents, along with the anticipated milestone payment due upon enrollment of the first patient in the Phase 3 clinical trial of FCX-007 and the reimbursement of development costs for FCX-007 under the Castle Creek Pharmaceuticals Agreement, will be sufficient to fund operations into the third quarter of 2020 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: the ability of
Investor & Media Relations Contact:
Condensed Consolidated Statements of Operations (unaudited)
($ in thousands, except share and per share data)
|Three Months Ended
|Six Months Ended June 30,
|Cost of license - related party||3,750||—||3,750||—|
|Cost of collaboration revenue||1,355||—||1,355||—|
|Cost of collaboration revenue - related party||67||—||67||—|
|Total cost of revenue||5,172||—||5,172||—|
|Research and development expense||600||1,415||2,543||3,060|
|Research and development expense - related party (see Note 10)||(4||)||106||40||(197||)|
|Selling, general and administrative expense||2,456||1,556||4,326||3,195|
|Operating income (loss)||13,568||(3,077||)||9,711||(6,058||)|
|Other income (expense):|
|Warrant revaluation income||37||91||8||326|
|Derivative revaluation income (expense)||(1,138||)||242||(1,083||)||179|
|Other income, net||110||41||472||139|
|Income (loss) before income taxes||12,377||(2,894||)||8,711||(5,795||)|
|Income tax (expense)||(634||)||—||(634||)||—|
|Net income (loss)||11,743||(2,894||)||8,077||(5,795||)|
|Dividend paid in-kind to preferred stockholders||(86||)||(83||)||(171||)||(165||)|
|Deemed dividend on preferred stock (see Note 12)||(145||)||(126||)||(285||)||(247||)|
|Net income (loss) attributable to common stockholders||$||11,512||$||(3,103||)||$||7,621||$||(6,207||)|
|Per Share Information:|
|Net income (loss):|
|Weighted average number of common shares outstanding:|
|Condensed Consolidated Balance Sheets Data:||June 30,||December 31,|
|Cash and cash equivalents||$||13,675||$||14,430|
|Warrant liability, long term||144||152|
|Total stockholders’ equity||17,863||9,557|
Source: Fibrocell Science Inc.