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SEC Filings


S-3
FIBROCELL SCIENCE, INC. filed this Form S-3 on 01/18/2019
Entire Document
 


We have incurred significant losses since our inception, which we anticipate will continue for the foreseeable future. As of September 30, 2018, we had an accumulated deficit of $187.5 million.

We have never generated significant revenue from product sales and may never be profitable.

Our business is highly dependent on the success of FCX-007, our lead product candidate.

We may encounter difficulties enrolling or retaining subjects in our clinical trials.

Clinical product development is costly and time consuming and involves uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results.

We may not be able to submit investigational new drug applications, commence clinical trials or report data on the timelines we expect, and even if we are able to, the U.S. Food and Drug Administration, or FDA, may not permit us to proceed.

If our product candidates fail to demonstrate quality, safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

We will need to obtain additional funding for commercialization. Failure to obtain additional funding when needed may force us to delay, limit or terminate our product development efforts or other operations.

There is substantial doubt relating to our ability to continue as a going concern as determined by management and as reflected in the report of our independent registered public accounting firm. We will need to raise substantial additional capital to fund our operations.

If we are unable to remain in compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market.

We have relied and expect to rely on third parties to conduct aspects of our research and development and clinical trials. If they terminate our arrangements, fail to meet deadlines or perform in an unsatisfactory manner, our business could be harmed.

The potential commercial success of any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.

Description of Private Placement
 
On December 7, 2018, we entered into a securities purchase agreement, or the Purchase Agreement, with EB Research Partnership, Inc. and Epidermolysis Bullosa Medical Research Foundation, or the December 2018 Private Placement Purchasers, pursuant to which we issued and sold to the December 2018 Private Placement Purchasers an aggregate of 443,350 shares of our common stock at a per share price of $2.03, which represented the consolidated closing bid price of our common stock, as reported by the Nasdaq Capital Market, on the business day immediately preceding the execution of the Purchase Agreement. We refer to the sale of these shares of common stock as the December 2018 Private Placement. We received approximately $900,000 in gross proceeds from the December 2018 Private Placement.

Pursuant to the terms of the Purchase Agreement, we are required to (i) file a registration statement with the SEC to register the sale of the shares sold pursuant to the Purchase Agreement within 45 days of the execution of the Purchase Agreement and (ii) use our commercially reasonable efforts to cause such registration statement to become effective within 90 days of the execution of the Purchase Agreement and to keep such registration statement effective at all times until (a) such shares of common stock are sold under such registration statement or pursuant to Rule 144 under the Securities Act of 1933, as amended, or the Securities Act, (b) such shares of common stock may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 under the Securities Act, or (c) the five-

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