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Fibrocell Reports Second Quarter 2018 Financial Results and Recent Highlights
“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
“Our FCX-013 gene therapy program for the treatment of moderate to severe localized scleroderma also made notable progress this quarter.
Recent program highlights and new updates are as follows:
- 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.
- Fibrocell obtained allowance from the
FDAof 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.
- Fibrocell closed a
$4.0 millionregistered 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 millionregistered 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 $1.00per 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 LLCas 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
For the six months ended
The 2018 period included approximately
Research and development expenses decreased 54.8% to approximately
Selling, general and administrative expenses of approximately
Fibrocell used approximately
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.
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
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 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
Investor & Media Relations Contact:
Fibrocell Science, Inc.
Condensed Consolidated Statements of Operations
($ in thousands, except share and per share data)
|Six Months Ended
|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|
|Other income (expense):|
|Warrant revaluation income (expense)||326||(9,723||)|
|Derivative revaluation income||179||541|
|Other income, net||139||6|
|Loss before income taxes||(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:|
|Weighted average number of common shares outstanding:|
|Condensed Consolidated Balance Sheets Data:||June 30,||December 31,|
|Cash and cash equivalents||$||15,410||$||17,417|
|Warrant liability, long term||747||1,073|
|Total stockholders’ equity||9,368||9,007|