Logo     Print Page  Close Window


SEC Filings


8-K
FIBROCELL SCIENCE, INC. filed this Form 8-K on 05/10/2018
Entire Document
 
 
FCX-013  Fibrocell obtained FDA allowance of the Investigational New Drug Application for FCX-013 to progress to clinical trials for the treatment of moderate to severe localized scleroderma. Fibrocell expects to initiate enrollment for a Phase 1/2 clinical trial of FCX-013 in the third quarter of 2018. Corporate  On April 18, 2018, Fibrocell announced that its Board of Directors is conducting a comprehensive review of strategic alternatives focused on maximizing stockholder value. 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 Three Months Ended March 31, 2018 For the three months ended March 31, 2018, Fibrocell reported a diluted net loss of $0.11 per share, compared to a diluted net loss of $0.60 per share for the same period in 2017. The 2018 period included approximately $0.2 million of non-cash warrant revaluation income, as compared to approximately $0.1 million of non-cash warrant revaluation expense for the same period in 2017. Additionally, the 2018 period included non-cash deemed dividends on Series A preferred stock of approximately $0.1 million as compared to the approximately $3.7 million in non-cash deemed dividends included in the 2017 period, increasing the net loss attributable to common stockholders. Research and development expenses decreased 54.9% to approximately $1.3 million for the three months ended March 31, 2018, as compared to approximately $3.0 million for the same three-month period in 2017. This decrease was due primarily to decreased costs for our FCX-007 program of approximately $1.3 million, or 105.4%, for the three months ended March 31, 2018 compared to 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 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 $0.4 million, or 59.9%, for the three months ended March 31, 2018 compared to the same period in 2017. This decrease was related primarily to decreased costs from our clinical partner Intrexon Corporation of approximately $0.4 million, as substantially all of the costs of the pre-clinical phase of the project were incurred at the end of 2017. Selling, general and administrative expenses increased 10.7% to approximately $1.6 million for the three months ended March 31, 2018, as compared to approximately $1.5 million for the same