Fibrocell Science (FCSC) 10-Q 4 Aug 16 2016 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2016	Jul. 29, 2016
Document And Entity Information [Abstract]
Entity Registrant Name	Fibrocell Science, Inc.
Entity Central Index Key	357,097
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Trading Symbol	fcsc
Document Type	10-Q
Document Period End Date	Jun. 30, 2016
Document Fiscal Year Focus	2,016
Document Fiscal Period Focus	Q2
Amendment Flag	false
Entity Common Stock, Shares Outstanding		43,898,785

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents	$ 8,161	$ 29,268
Inventory, net	109	482
Prepaid expenses and other current assets	636	1,244
Total current assets	8,906	30,994
Property and equipment, net of accumulated depreciation of $1,401 and $1,242, respectively	1,546	1,582
Intangible assets, net of accumulated amortization of $0 and $2,204, respectively	0	4,136
Other assets	64	0
Total assets	10,516	36,712
Current liabilities:
Accounts payable	553	499
Related party payable	924	10,720
Accrued expenses	1,253	1,779
Deferred revenue	408	457
Warrant liability, current	5	1,910
Total current liabilities	3,143	15,365
Warrant liability, long term	759	6,365
Deferred rent	785	779
Total liabilities	4,687	22,509
Stockholders’ equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares outstanding as of June 30, 2016 and December 31, 2015	0	0
Common stock, $0.001 par value; 150,000,000 shares authorized, 43,898,785 shares issued and outstanding as of June 30, 2016; 100,000,000 shares authorized, 43,898,785 shares issued and outstanding as of December 31, 2015	44	44
Additional paid-in capital	162,555	161,330
Accumulated deficit	(156,770)	(147,171)
Total stockholders’ equity	5,829	14,203
Total liabilities and stockholders’ equity	$ 10,516	$ 36,712

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015
Statement of Financial Position [Abstract]
Property and equipment, accumulated depreciation (in dollars)	$ 1,401	$ 1,242
Intangible assets, accumulated amortization (in dollars)	$ 0	$ 2,204
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (shares)	5,000,000	5,000,000
Preferred stock, shares outstanding (shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (shares)	150,000,000	100,000,000
Common stock, shares issued (shares)	43,898,785	43,898,785
Common stock, shares outstanding (shares)	43,898,785	43,898,785

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Revenue from product sales	$ 73	$ 55	$ 85	$ 168
Collaboration revenue	14	82	18	163
Total revenue	87	137	103	331
Cost of product sales	392	77	409	221
Cost of collaboration revenue	0	85	1	88
Total cost of revenue	392	162	410	309
Gross (loss) profit	(305)	(25)	(307)	22
Research and development expense	2,352	2,567	4,954	4,814
Selling, general and administrative expense	2,540	3,640	5,280	6,564
Intangible asset impairment expense	3,905	0	3,905	0
Restructuring costs	292	0	292	0
Operating loss	(10,319)	(7,359)	(16,987)	(14,223)
Other income (expense):
Warrant revaluation income (expense)	2,254	602	7,511	(1,061)
Other expense	(31)	0	(31)	0
Interest income	4	1	8	3
Loss before income taxes	(8,092)	(6,756)	(9,499)	(15,281)
Income tax benefit	0	0	0	0
Net loss	$ (8,092)	$ (6,756)	$ (9,499)	$ (15,281)
Per Share Information:
Basic net loss (usd per share)	$ (0.18)	$ (0.17)	$ (0.22)	$ (0.37)
Diluted net loss (usd per share)	$ (0.18)	$ (0.17)	$ (0.26)	$ (0.37)
Weighted average number of common shares outstanding:
Basic weighted average number of common shares outstanding, shares	43,898,785	40,889,732	43,898,785	40,875,704
Diluted weighted average number of common shares outstanding, shares	43,898,785	40,889,732	43,934,819	40,875,704
Affiliated Entity
Research and development expense	$ 925	$ 1,127	$ 2,249	$ 2,867

Condensed Consolidated Stateme5

Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional paid-in capital	Accumulated deficit
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Cumulative effect from adoption of new accounting standard			$ 100	$ (100)
Balance at Dec. 31, 2015	$ 14,203	$ 44	161,330	(147,171)
Balance (shares) at Dec. 31, 2015	43,898,785	43,898,785
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 1,125		1,125
Net loss	(9,499)			(9,499)
Balance at Jun. 30, 2016	$ 5,829	$ 44	$ 162,555	$ (156,770)
Balance (shares) at Jun. 30, 2016	43,898,785	43,898,785

Condensed Consolidated Stateme6

Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015
Cash flows from operating activities:
Net loss	$ (9,499)	$ (15,281)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	1,125	1,044
Warrant revaluation (income) expense	(7,511)	1,061
Depreciation and amortization	391	346
Provision for (recovery of) doubtful accounts	(12)	(1)
Inventory reserve	151	0
Intangible asset impairment	3,905	0
Loss on disposal or impairment of property and equipment	65	0
Decrease (increase) in operating assets:
Accounts receivable	12	2
Inventory	222	87
Prepaid expenses and other current assets	728	549
Other assets	(64)	0
Increase (decrease) in operating liabilities:
Accounts payable	(3)	1,061
Related party payable	(9,796)	(338)
Accrued expenses and deferred rent	(518)	599
Deferred revenue	(49)	84
Net cash used in operating activities	(20,853)	(10,787)
Cash flows from investing activities:
Purchase of property and equipment	(143)	(111)
Net cash used in investing activities	(143)	(111)
Cash flows from financing activities:
Payment of deferred offering costs	(109)	0
Proceeds from the exercise of stock options	0	255
Principle payments on capital lease obligations	(2)	(2)
Net cash (used in) provided by financing activities	(111)	253
Net decrease in cash and cash equivalents	(21,107)	(10,645)
Cash and cash equivalents, beginning of period	29,268	37,495
Cash and cash equivalents, end of period	8,161	26,850
Supplemental Cash Flow Disclosures:
Property and equipment in accounts payable	46	0
Deferred offering costs in accounts payable	$ 11	$ 0

Business and Organization

Business and Organization	6 Months Ended
	Jun. 30, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Business and Organization	Business and Organization Organization Fibrocell Science, Inc. (as used herein, “we,” “us,” “our,” “Fibrocell” or the “Company”) is the parent company of Fibrocell Technologies, Inc. (Fibrocell Tech). Fibrocell Tech is the parent company of Isolagen International, S.A., a company organized under the laws of Switzerland (Isolagen Switzerland). The Company’s international activities are currently immaterial. Effective April 1, 2016, Fibrocell Science Hong Kong Limited (“Fibrocell Hong Kong”), a company organized under the laws of Hong Kong and former subsidiary of Fibrocell, was dissolved. As this entity had no historical financial or operational activities, the impact of the dissolution did not, and is not expected to have, a material impact on the Company’s present or future consolidated financial statements. Business Overview Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs. The Company is focused on discovering and developing therapies for the localized treatment of diseases affecting the skin and connective tissue. All of the Company’s product candidates incorporate its proprietary autologous fibroblast technology. The Company’s research and development efforts focus on gaining regulatory approvals of its product candidates in the United States. Liquidity and Financial Condition The Company expects to continue to incur losses and will require additional capital to advance its product candidates through development to commercialization. As of June 30, 2016 , the Company had cash and cash equivalents of approximately $ 8.2 million and working capital of approximately $ 5.8 million . The Company believes that its cash and cash equivalents at June 30, 2016 will be sufficient to fund operations into the fourth quarter of 2016. The Company will require additional capital to fund operations beyond that point. To meet its capital needs, the Company intends to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. These conditions raise substantial doubt about its ability to continue as a going concern. Consequently, the audit report prepared by the Company’s independent registered public accounting firm related to its Consolidated Financial Statements for the year ended December 31, 2015 included a going concern explanatory paragraph.

Basis of Presentation

Basis of Presentation	6 Months Ended
	Jun. 30, 2016
Basis of Presentation [Abstract]
Basis of Presentation	Basis of Presentation General The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnote disclosures required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. These financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 (2015 Form 10-K), filed with the Securities and Exchange Commission (SEC). The Company’s significant accounting policies are described in the Notes to Consolidated Financial Statements in the 2015 Form 10-K and updated, as necessary, in Note 3 in this Form 10-Q. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or full year. All intercompany accounts and transactions have been eliminated in consolidation. The Company's international operations are immaterial and it has no unrealized gains or losses from the sale of investments. As a result, it does not have any items that would be classified as other comprehensive income in such a statement. Reclassifications The prior year Condensed Consolidated Financial Statements presented in this Form 10-Q contain certain reclassifications made to the Condensed Consolidated Statement of Operations and the Condensed Consolidated Statement of Cash Flows to conform to the current year’s presentation. Specifically, related party payables were reclassified from accounts payable and accrued expenses as of June 30, 2015.

Summary of Significant Accounti

Summary of Significant Accounting Policies	6 Months Ended
	Jun. 30, 2016
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Summary of Significant Accounting Policies Intangible Assets Intangible assets are research and development assets related to the Company’s primary study on azficel-T that were capitalized on the balance sheet upon emergence from bankruptcy. The portion of the reorganization value which was attributed to identifiable intangible assets was $6.3 million . Azficel-T had two current or target indications: the Company's FDA-approved product LAVIV ® and a clinical development program for azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia. Effective January 1, 2012, the Company launched LAVIV and as a result, the research and development intangible assets related to the Company’s primary study were considered to be finite-lived intangible assets and began amortizing over 12 years , the estimated useful life of the assets which is analogous with the exclusivity period granted to the Company under the BLA. Finite-lived intangible assets are recorded at cost, net of accumulated amortization and, if applicable, impairment charges. Amortization of finite-lived intangible assets is provided over their estimated useful lives on a straight-line basis. The Company reviews the estimated remaining useful life of its intangible assets on an annual basis with any changes, if applicable, accounted for prospectively. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 360-10-35, Impairment or Disposal of Long-Lived Assets , the Company reviews its finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In June 2016, based on its failure to achieve primary efficacy endpoints for its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring, the Company determined to wind-down its azficel-T operations as more fully described in Note 9. As a result, management concluded that the Company’s intangible assets had become fully impaired. Accordingly, a non-cash impairment charge of approximately $3.9 million was recorded during the three months ended June 30, 2016 and is included in the Condensed Consolidated Statement of Operations. Stock-Based Compensation The Company follows ASC 718, Compensation – Stock Compensation (ASC 718) , or ASC 505-50, Equity – Equity Based Payments to Non-Employees, where applicable. The Company accounts for stock-based awards to employees using the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. In addition, the Company accounts for stock-based compensation to non-employees in accordance with the accounting guidance for equity instruments that are issued to entities or persons other than employees. The Company uses a Black-Scholes option-pricing model to determine the fair value of each option grant as of the date of grant for expense incurred. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, expected stock price volatility and expected term of the options. The value of the award that is ultimately expected to vest based on the achievement of a performance condition (i.e., service period) is recognized as expense on a straight-line basis over the requisite service period. See Note 7 for additional details. Previously, ASC 718 required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differed from those estimates. In the first quarter of 2016, the Company adopted FASB Accounting Standards Update (ASU) 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which allows an entity to elect as an accounting policy either to continue to estimate the total number of awards for which the requisite service period will not be rendered or to account for forfeitures when they occur. In connection with the adoption of this ASU, the Company made an accounting policy election to account for forfeitures as they occur and applied this change in accounting policy on a modified retrospective basis. As a result, the Company recorded a cumulative-effect adjustment to retained earnings which resulted in an increase to accumulated deficit of $0.1 million with an offsetting increase to additional paid-in capital (zero net total equity impact) as of the date of adoption, principally related to additional stock compensation expense that would have been recognized on unvested outstanding options unadjusted for estimated forfeitures. Restructuring Costs Restructuring charges are primarily comprised of severance costs related to workforce reductions, contract termination and wind-down costs, asset impairments and costs of decommissioning the Company’s azficel-T manufacturing facility. In accordance with ASC 420, Exit or Disposal Cost Obligations , the Company recognizes restructuring charges when the liability has been incurred, except for one-time employee termination benefits that are incurred over time. Generally, one-time employee termination benefits (i.e. severance costs) are accrued at the date management has committed to a plan of termination and employees have been notified of their termination dates and expected severance payments. Other costs, including but not limited to, contract termination and wind-down costs and manufacturing facility decommissioning costs, will be recorded as incurred. Asset impairment charges have been, and will be, recognized when management has concluded that the assets have been impaired in accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets , or other applicable authoritative guidance. See Note 9 for additional details. Income Taxes In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the six months ended June 30, 2016 and 2015 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2016 or December 31, 2015 because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of June 30, 2016 and December 31, 2015 , the Company had no uncertain tax positions. Recently Issued Accounting Pronouncements Management does not believe that any recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had or is expected to have a material impact on the Company’s present or future consolidated financial statements.

Inventory

Inventory	6 Months Ended
	Jun. 30, 2016
Inventory Disclosure [Abstract]
Inventory	Inventory Inventories consist of raw materials and work in process intended for use in the manufacture of LAVIV, which was approved by the FDA in 2011 for the improvement of nasolabial fold wrinkles in adults. However, raw materials may be used for clinical trials and are charged to research and development (R&D) expense when consumed for such activities. Inventories consisted of the following as of: ($ in thousands) June 30, 2016 December 31, 2015 Raw materials (LAVIV and product candidates) $ 71 $ 338 Work in process (LAVIV) 189 144 Total inventory, gross 260 482 Less: Reserve for work in process expiration (151 ) — Total inventory, net $ 109 $ 482 In connection with the wind-down of the Company’s azficel-T operations, as more fully described in Note 9, the Company recognized inventory write-downs of approximately $0.2 million in cost of goods sold and recorded a reserve for work in process expiration of approximately $0.2 million during the second quarter of 2016. With respect to LAVIV, the Company is no longer accepting new prescriptions.

Warrants

Warrants	6 Months Ended
	Jun. 30, 2016
Warrants [Abstract]
Warrants	Warrants The Company accounts for common stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. As of June 30, 2016 and December 31, 2015 , all of the Company’s outstanding common stock warrants were classified as derivative liabilities and accounted for based on the guidance in ASC 815, Derivatives and Hedging as the warrants contain “down-round protection” or other terms that could potentially require “net cash settlement” and hence were determined not to be indexed to the Company’s own stock. The warrants will continue to be classified as a liability, regardless of the likelihood that such instruments will ever be settled in cash, until they are exercised, expire or are amended in a way that would no longer require these warrants to be classified as a liability. The following table summarizes outstanding liability-classified warrants to purchase common stock: Number of Warrants Liability-classified warrants June 30, 2016 December 31, 2015 Exercise Price Expiration Dates Issued in March 2010 financing — 319,789 $ 6.25 Mar 2016 Issued in June 2011 financing — 6,113 $ 22.50 Jun 2016 Issued in Series B and D Preferred Stock offerings 1,970,594 1,970,594 $ 6.25 Jul 2016 - Dec 2016 Issued in August 2011 financing 565,759 565,759 $ 18.75 Aug 2016 Issued to placement agents in August 2011 financing 50,123 50,123 $ 13.635 Aug 2016 Issued in Series E Preferred Stock offering 60,000 60,000 $ 2.50 Dec 2017 Issued with Convertible Notes 1,125,578 1,125,578 $ 2.50 Jun 2018 Issued in Series E Preferred Stock offering 1,568,823 1,568,823 $ 7.50 Dec 2018 Total 5,340,877 5,666,779 The table below is a summary of the Company’s warrant activity during the six months ended June 30, 2016 : Number of warrants Weighted- average exercise price Outstanding at December 31, 2015 5,666,779 $ 7.14 Granted — — Exercised — — Expired (325,902 ) 6.55 Outstanding at June 30, 2016 5,340,877 $ 7.18 Accounting for Liability-classified Warrants The foregoing warrants were recorded as derivative liabilities at their estimated fair value at the date of issuance, with subsequent changes in estimated fair value recorded in other income or expense in the Company’s Condensed Consolidated Statements of Operations in each subsequent period. The change in the estimated fair value of the warrant liability for the three and six months ended June 30, 2016 resulted in non-cash income of approximately $2.3 million and $7.5 million , respectively. The change in the estimated fair value of the warrant liability for the three and six months ended June 30, 2015 resulted in non-cash income of approximately $0.6 million and non-cash expense of approximately $1.1 million , respectively. The Company utilizes a Monte Carlo simulation valuation method to value its liability-classified warrants. Assumptions Used in Determining Fair Value of Warrants The estimated fair value of warrants is determined using Level 2 and Level 3 inputs. Inherent in the Monte Carlo simulation valuation method are the following assumptions: Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the expected remaining life of the warrants. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the valuation date commensurate with the expected remaining life assumption. Expected remaining life. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. Dividend rate. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero. Scenarios. The probability of complex features of the warrants being triggered is subjective (no observable inputs or available market data) and based on internal and external information known to management at the valuation date. The following table summarizes the calculated aggregate fair values, along with the inputs and assumptions utilized in each calculation: ($ in thousands except per share data) June 30, 2016 December 31, 2015 Calculated aggregate value $ 764 $ 8,275 Weighted average exercise price per share $ 7.18 $ 7.14 Closing price per share of common stock $ 1.15 $ 4.55 Volatility 97.2 % 85.2 % Weighted average remaining expected life 1 year, 3 months 1 year, 8 months Risk-free interest rate 0.49 % 0.98 % Dividend yield — —

Fair Value Measurements

Fair Value Measurements	6 Months Ended
	Jun. 30, 2016
Fair Value Disclosures [Abstract]
Fair Value Measurements	Fair Value Measurements Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company follows the guidance in ASC 820, Fair Value Measurement, to account for financial assets and liabilities measured at fair value on a recurring basis. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity’s own assumptions (unobservable inputs). The guidance requires fair value measurements be classified and disclosed in one of the following three categories within the hierarchy: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. • Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of: June 30, 2016 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 8,161 $ — $ — $ 8,161 Liabilities: Warrant liability $ — $ — $ 764 $ 764 December 31, 2015 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 29,268 $ — $ — $ 29,268 Liabilities: Warrant liability $ — $ — $ 8,275 $ 8,275 Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis - Common Stock Warrants The reconciliation of the warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows: Warrant ($ in thousands) Liability Balance at December 31, 2015 $ 8,275 Expiration of warrants (1) (62 ) Change in fair value of warrant liability (7,449 ) Balance at June 30, 2016 $ 764 (1) Represents the fair value as of the beginning of the year for warrants expiring during the year and has been recorded to warrant revaluation income or expense in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2016. Effect of Fibrocell’s Stock Price and Volatility Assumptions on the Calculation of Fair Value of Warrant Liabilities The fair value of the warrant liability is based on Level 3 inputs. As discussed in Note 5, the Company uses a Monte Carlo simulation valuation method to value its liability-classified warrants. The determination of fair value as of the reporting date is affected by Fibrocell’s stock price as well as assumptions regarding a number of subjective variables that do not have observable inputs or available market data to support the fair value. These variables include, but are not limited to, expected stock price volatility over the term of the warrants and the risk-free interest rate. The primary factors affecting the fair value of the warrant liability are the Company’s stock price and volatility as well as certain assumptions by the Company as to the likelihood of provisions to the underlying warrant agreements being triggered. The methods described above and in Note 5 may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation method is appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date. Fair Value of Certain Financial Assets and Liabilities The Company believes that the fair values of the Company’s current assets and liabilities approximate their reported carrying amounts. There were no transfers between Level 1, 2 and 3 during the periods presented.

Stock-Based Compensation

Stock-Based Compensation	6 Months Ended
	Jun. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	Stock-Based Compensation 2009 Equity Incentive Plan The Company’s Board of Directors (the Board) adopted the 2009 Equity Incentive Plan (as amended to date, the Plan) effective September 3, 2009. The Plan is intended to further align the interests of the Company and its stockholders with its employees, including its officers, non-employee directors, consultants and advisers by providing equity-based incentives. The Plan allows for the issuance of up to 7,600,000 shares of the Company’s common stock. In addition, there are 25,000 options outstanding that were issued outside the Plan to consultants in 2013. The types of awards that may be granted under the Plan include options (both non-qualified stock options and incentive stock options), stock appreciation rights, stock awards, stock units and other stock-based awards. The term of each award is determined by the Compensation Committee of the Board at the time each award is granted, provided that the terms of options do not exceed ten years . Vesting schedules for stock options vary, but generally vest 25% per year over four years for employee options and on the one -year anniversary date for non-employee director options. The Plan had 3,365,103 shares available for future grants as of June 30, 2016 . Accounting for Stock-Based Compensation The Company recognizes non-cash compensation expense for stock-based awards based on their grant date fair value, determined using the Black-Scholes option-pricing model. During the six months ended June 30, 2016 and 2015 , the weighted average fair market value for options granted was $1.53 and $3.57 , respectively. Total stock-based compensation expense recognized using the straight-line attribution method and included in operating expenses in the Condensed Consolidated Statements of Operations was approximately $0.6 million and $0.8 million for the three months ended June 30, 2016 and 2015 , respectively, and approximately $1.1 million and $1.0 million for the six months ended June 30, 2016 and 2015 , respectively. Assumptions Used in Determining Fair Value of Stock Options Inherent in the Black-Scholes option-pricing model are the following assumptions: Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the expected term of the stock options. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. Expected term . The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applied the simplified method of estimating the expected term of the options, described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted. Forfeitures. The Company accounts for forfeitures when they occur. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest. The fair market value of these stock options at the date of grant was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions for the six months ended: June 30, 2016 June 30, 2015 Expected term 6 years, 1 month 6 years, 1 month Interest rate 1.40 % 1.56 % Dividend yield — — Volatility (1) 92.4 % 103.3 % (1) For the six months ended June 30, 2016, the Company estimated expected volatility based on the historical volatility of its own common stock on a stand-alone basis. Prior to January 1, 2016, including the six months ended June 30, 2015, the Company estimated expected volatility based on the historical volatility of a peer group. Stock Option Activity The following table summarizes stock option activity for the six months ended June 30, 2016 : ($ in thousands except share and per share data) Number of shares Weighted- average exercise price Weighted- average remaining contractual term Aggregate intrinsic value Outstanding at December 31, 2015 3,134,094 $ 6.23 8 years $ 1,630 Granted 1,091,000 2.01 Exercised — — Forfeited (29,256 ) 4.61 Expired (188 ) 4.24 Outstanding at June 30, 2016 (1) 4,195,650 $ 5.15 8 years $ 43 Exercisable at June 30, 2016 1,954,190 $ 7.50 6 years, 11 months $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. The total fair value of options vested during the six months ended June 30, 2016 was approximately $1.6 million . Additionally, as of June 30, 2016 , there was approximately $4.7 million of unrecognized compensation expense related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.8 years.

Related Party Transactions

Related Party Transactions	6 Months Ended
	Jun. 30, 2016
Related Party Transactions [Abstract]
Related Party Transactions	Related Party Transactions The Company and Intrexon Corporation (Intrexon) are parties to two distinct exclusive channel collaboration agreements including the Exclusive Channel Collaboration Agreement entered into in October 2012 and amended in June 2013 and January 2014 (as amended, the 2012 ECC) and the Exclusive Channel Collaboration Agreement entered into in December 2015 (the 2015 ECC). Pursuant to these agreements, the Company engages Intrexon for support services for the research and development of product candidates covered under the respective agreements and reimburses Intrexon for its cost for time and materials for such work. For the three months ended June 30, 2016 and 2015 , the Company incurred total expenses of $0.9 million and $1.1 million , respectively, with Intrexon, for work performed under the 2012 ECC. During the same periods, no expenses were incurred for work performed under the 2015 ECC. Of the $0.9 million incurred during the 2016 period, $0.3 million related to direct expenses for work performed by Intrexon and $0.6 million related to pass-through costs. Of the $1.1 million incurred during the 2015 period, $0.8 million related to direct expenses for work performed by Intrexon and $0.3 million related to pass-through costs. For the six months ended June 30, 2016 and 2015 , the Company incurred total expenses of $2.2 million and $2.9 million , respectively, with Intrexon, for work performed under the 2012 ECC. During the same periods, no expenses were incurred for work performed under the 2015 ECC. Of the $2.2 million incurred during the 2016 period, $0.8 million related to direct expenses for work performed by Intrexon and $1.4 million related to pass-through costs. Of the $2.9 million incurred during the 2015 period, $1.7 million related to direct expenses for work performed by Intrexon and $1.2 million related to pass-through costs. As of June 30, 2016 and December 31, 2015 , the Company had outstanding payables to Intrexon of $0.9 million and $10.7 million , respectively. In connection with the 2015 ECC, in consideration for the license and the other rights that the Company receives under the agreement, the Company paid Intrexon an up-front technology access fee of $10 million in cash in January 2016. Randal J. Kirk is the chairman of the board and chief executive officer of Intrexon and, together with his affiliates, owns more than 50% of Intrexon’s common stock. Affiliates of Randal J. Kirk (including Intrexon) own approximately 38% of our common stock. Additionally, two of our directors, Julian Kirk (who is the son of Randal J. Kirk) and Marcus Smith, are employees of Third Security, LLC, which is an affiliate of Randal J. Kirk.

Restructuring Costs

Restructuring Costs	6 Months Ended
	Jun. 30, 2016
Restructuring and Related Activities [Abstract]
Restructuring Costs	Restructuring Costs In June 2016, the Company determined to wind-down its azficel-T operations at the Company’s Exton, PA facility and to reduce the workforce that supports such operations. This decision enables the Company to focus its resources towards pre-clinical and clinical research and development of its gene-therapy product candidates. Restructuring-related charges for both the three and six months ended June 30, 2016 totaled approximately $0.3 million and were comprised of approximately $0.3 million of employee severance and benefit related charges and less than $0.1 million of asset impairments. The restructuring and asset impairment activity for the six months ended June 30, 2016 was as follows: ($ in thousands) Employee Severance and Benefits Asset Impairments Total Accrued restructuring balance as of December 31, 2015 $ — $ — $ — Additional accruals 258 34 292 Cash payments — — — Non-cash settlements — (34 ) (34 ) Accrued restructuring balance as of June 30, 2016 $ 258 $ — $ 258 The restructuring-related charges incurred during the three and six months ended June 30, 2016 related to employee severance and benefits resulting from the reduction-in-workforce and the impairment of property and equipment. In connection with the reduction-in-workforce, 25 positions were eliminated, primarily in the areas of manufacturing and quality operations, representing approximately 50% of the Company's employees. The accrued restructuring balance as of June 30, 2016 relates to employee severance and benefits which are expected to be paid in the third quarter of 2016 and is recorded as a current liability within accrued expenses in the Condensed Consolidated Balance Sheet. Additionally, the Company recognized inventory write-downs in cost of goods sold related to the wind-down of its azficel-T operations as described in Note 4. The Company expects to incur additional charges in the future for employee severance and benefits, contract termination and wind-down costs, assets impairments and costs to decommission the Company’s azficel-T manufacturing facility, but cannot estimate them at this time.

Loss Per Share

Loss Per Share	6 Months Ended
	Jun. 30, 2016
Earnings Per Share [Abstract]
Loss Per Share	Loss Per Share Basic loss per share is computed by dividing net loss for the period by the weighted-average number of shares of common stock outstanding during that period. The diluted loss per share calculation gives effect to dilutive stock options, warrants and other potentially dilutive common stock equivalents outstanding during the period. Diluted loss per share is based on the treasury stock method and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and warrants, assuming the exercise of all in-the-money common stock equivalents based on the average market price during the period. Common stock equivalents have been excluded where their inclusion would be anti-dilutive. Details in the computation of basic and diluted loss per share are as follows: Three months ended June 30, Six months ended June 30, ($ in thousands, except share and per share data) 2016 2015 2016 2015 Loss per share - basic: Numerator for basic loss per share $ (8,092 ) $ (6,756 ) $ (9,499 ) $ (15,281 ) Denominator for basic loss per share 43,898,785 40,889,732 43,898,785 40,875,704 Basic loss per common share $ (0.18 ) $ (0.17 ) $ (0.22 ) $ (0.37 ) Loss per share - diluted: Numerator for diluted loss per share $ (8,092 ) $ (6,756 ) $ (9,499 ) $ (15,281 ) Adjust: Warrant revaluation income (expense) for dilutive warrants — — 1,958 — Net loss attributable to common share $ (8,092 ) $ (6,756 ) $ (11,457 ) $ (15,281 ) Denominator for basic loss per share 43,898,785 40,889,732 43,898,785 40,875,704 Plus: Incremental shares underlying dilutive warrants outstanding — — 36,034 — Denominator for diluted loss per share 43,898,785 40,889,732 43,934,819 40,875,704 Diluted net loss per common share $ (0.18 ) $ (0.17 ) $ (0.26 ) $ (0.37 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding, as their effect would be anti-dilutive: Three months ended June 30, Six months ended June 30, 2016 2015 2016 2015 “In the money” stock options 216,000 1,482,614 545,500 1,518,957 “Out of the money” stock options 3,979,650 1,654,200 3,556,497 1,442,200 “In the money” warrants — 1,201,698 — 1,201,698 “Out of the money” warrants 5,340,877 4,831,352 4,751,145 4,831,352 Other securities excluded from the calculation of diluted loss per share: Stock options with performance condition — 100,000 — 100,000

Equity

Equity	6 Months Ended
	Jun. 30, 2016
Equity [Abstract]
Equity	Equity Common Stock - Shares Authorized In July 2016, the Company amended its Restated Certificate of Incorporation, as amended, to increase the number of shares of common stock that the Company is authorized to issue from 100,000,000 to 150,000,000 . The amendment was approved by stockholders in June at the Company’s 2016 Annual Meeting of Stockholders. Common Stock - “At-The-Market” Equity Program In January 2016, the Company entered into a Controlled Equity Offering™ Sales Agreement (the ATM Agreement) with Cantor Fitzgerald & Co. (Cantor Fitzgerald) to implement an "At-The-Market" (ATM) equity program under which the Company, from time to time, may offer and sell shares of its common stock having an aggregate offering price of up to $50.0 million (the Shares) through Cantor Fitzgerald. Subject to the terms and conditions of the ATM Agreement, Cantor Fitzgerald will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the ATM Agreement or terminate the ATM Agreement. Cantor Fitzgerald will be entitled to a fixed commission of up to 3.0% of the gross proceeds from Shares sold. Through June 30, 2016 , no Shares have been sold through the ATM equity program.

Summary of Significant Accoun18

Summary of Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2016
Accounting Policies [Abstract]
General	General The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnote disclosures required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. These financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 (2015 Form 10-K), filed with the Securities and Exchange Commission (SEC). The Company’s significant accounting policies are described in the Notes to Consolidated Financial Statements in the 2015 Form 10-K and updated, as necessary, in Note 3 in this Form 10-Q. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or full year. All intercompany accounts and transactions have been eliminated in consolidation. The Company's international operations are immaterial and it has no unrealized gains or losses from the sale of investments. As a result, it does not have any items that would be classified as other comprehensive income in such a statement.
Reclassifications	Reclassifications The prior year Condensed Consolidated Financial Statements presented in this Form 10-Q contain certain reclassifications made to the Condensed Consolidated Statement of Operations and the Condensed Consolidated Statement of Cash Flows to conform to the current year’s presentation. Specifically, related party payables were reclassified from accounts payable and accrued expenses as of June 30, 2015.
Intangible Assets	Intangible Assets Intangible assets are research and development assets related to the Company’s primary study on azficel-T that were capitalized on the balance sheet upon emergence from bankruptcy. The portion of the reorganization value which was attributed to identifiable intangible assets was $6.3 million . Azficel-T had two current or target indications: the Company's FDA-approved product LAVIV ® and a clinical development program for azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia. Effective January 1, 2012, the Company launched LAVIV and as a result, the research and development intangible assets related to the Company’s primary study were considered to be finite-lived intangible assets and began amortizing over 12 years , the estimated useful life of the assets which is analogous with the exclusivity period granted to the Company under the BLA. Finite-lived intangible assets are recorded at cost, net of accumulated amortization and, if applicable, impairment charges. Amortization of finite-lived intangible assets is provided over their estimated useful lives on a straight-line basis. The Company reviews the estimated remaining useful life of its intangible assets on an annual basis with any changes, if applicable, accounted for prospectively. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 360-10-35, Impairment or Disposal of Long-Lived Assets , the Company reviews its finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In June 2016, based on its failure to achieve primary efficacy endpoints for its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring, the Company determined to wind-down its azficel-T operations as more fully described in Note 9. As a result, management concluded that the Company’s intangible assets had become fully impaired.
Stock-Based Compensation	Stock-Based Compensation The Company follows ASC 718, Compensation – Stock Compensation (ASC 718) , or ASC 505-50, Equity – Equity Based Payments to Non-Employees, where applicable. The Company accounts for stock-based awards to employees using the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. In addition, the Company accounts for stock-based compensation to non-employees in accordance with the accounting guidance for equity instruments that are issued to entities or persons other than employees. The Company uses a Black-Scholes option-pricing model to determine the fair value of each option grant as of the date of grant for expense incurred. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, expected stock price volatility and expected term of the options. The value of the award that is ultimately expected to vest based on the achievement of a performance condition (i.e., service period) is recognized as expense on a straight-line basis over the requisite service period. See Note 7 for additional details. Previously, ASC 718 required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differed from those estimates. In the first quarter of 2016, the Company adopted FASB Accounting Standards Update (ASU) 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which allows an entity to elect as an accounting policy either to continue to estimate the total number of awards for which the requisite service period will not be rendered or to account for forfeitures when they occur. In connection with the adoption of this ASU, the Company made an accounting policy election to account for forfeitures as they occur and applied this change in accounting policy on a modified retrospective basis. As a result, the Company recorded a cumulative-effect adjustment to retained earnings which resulted in an increase to accumulated deficit of $0.1 million with an offsetting increase to additional paid-in capital (zero net total equity impact) as of the date of adoption, principally related to additional stock compensation expense that would have been recognized on unvested outstanding options unadjusted for estimated forfeitures.
Restructuring Costs	Restructuring Costs Restructuring charges are primarily comprised of severance costs related to workforce reductions, contract termination and wind-down costs, asset impairments and costs of decommissioning the Company’s azficel-T manufacturing facility. In accordance with ASC 420, Exit or Disposal Cost Obligations , the Company recognizes restructuring charges when the liability has been incurred, except for one-time employee termination benefits that are incurred over time. Generally, one-time employee termination benefits (i.e. severance costs) are accrued at the date management has committed to a plan of termination and employees have been notified of their termination dates and expected severance payments. Other costs, including but not limited to, contract termination and wind-down costs and manufacturing facility decommissioning costs, will be recorded as incurred. Asset impairment charges have been, and will be, recognized when management has concluded that the assets have been impaired in accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets , or other applicable authoritative guidance.
Income Taxes	Income Taxes In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the six months ended June 30, 2016 and 2015 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2016 or December 31, 2015 because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is not more likely than not that the Company will realize these future tax benefits.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements Management does not believe that any recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had or is expected to have a material impact on the Company’s present or future consolidated financial statements.
Assumptions Used in Determining Fair Value of Warrants	The Company accounts for common stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. As of June 30, 2016 and December 31, 2015 , all of the Company’s outstanding common stock warrants were classified as derivative liabilities and accounted for based on the guidance in ASC 815, Derivatives and Hedging as the warrants contain “down-round protection” or other terms that could potentially require “net cash settlement” and hence were determined not to be indexed to the Company’s own stock. The warrants will continue to be classified as a liability, regardless of the likelihood that such instruments will ever be settled in cash, until they are exercised, expire or are amended in a way that would no longer require these warrants to be classified as a liability. Assumptions Used in Determining Fair Value of Warrants The estimated fair value of warrants is determined using Level 2 and Level 3 inputs. Inherent in the Monte Carlo simulation valuation method are the following assumptions: Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the expected remaining life of the warrants. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the valuation date commensurate with the expected remaining life assumption. Expected remaining life. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. Dividend rate. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero. Scenarios. The probability of complex features of the warrants being triggered is subjective (no observable inputs or available market data) and based on internal and external information known to management at the valuation date.
Assets and Liabilities Measured at Fair Value on a Recurring Basis	Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company follows the guidance in ASC 820, Fair Value Measurement, to account for financial assets and liabilities measured at fair value on a recurring basis. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity’s own assumptions (unobservable inputs). The guidance requires fair value measurements be classified and disclosed in one of the following three categories within the hierarchy: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. • Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period.

Inventory (Tables)

Inventory (Tables)	6 Months Ended
	Jun. 30, 2016
Inventory Disclosure [Abstract]
Inventories	Inventories consisted of the following as of: ($ in thousands) June 30, 2016 December 31, 2015 Raw materials (LAVIV and product candidates) $ 71 $ 338 Work in process (LAVIV) 189 144 Total inventory, gross 260 482 Less: Reserve for work in process expiration (151 ) — Total inventory, net $ 109 $ 482

Warrants (Tables)

Warrants (Tables)	6 Months Ended
	Jun. 30, 2016
Warrants [Abstract]
Outstanding Warrants to Purchase Common Stock	The following table summarizes outstanding liability-classified warrants to purchase common stock: Number of Warrants Liability-classified warrants June 30, 2016 December 31, 2015 Exercise Price Expiration Dates Issued in March 2010 financing — 319,789 $ 6.25 Mar 2016 Issued in June 2011 financing — 6,113 $ 22.50 Jun 2016 Issued in Series B and D Preferred Stock offerings 1,970,594 1,970,594 $ 6.25 Jul 2016 - Dec 2016 Issued in August 2011 financing 565,759 565,759 $ 18.75 Aug 2016 Issued to placement agents in August 2011 financing 50,123 50,123 $ 13.635 Aug 2016 Issued in Series E Preferred Stock offering 60,000 60,000 $ 2.50 Dec 2017 Issued with Convertible Notes 1,125,578 1,125,578 $ 2.50 Jun 2018 Issued in Series E Preferred Stock offering 1,568,823 1,568,823 $ 7.50 Dec 2018 Total 5,340,877 5,666,779
Schedule of Warrants Outstanding Roll Forward	The table below is a summary of the Company’s warrant activity during the six months ended June 30, 2016 : Number of warrants Weighted- average exercise price Outstanding at December 31, 2015 5,666,779 $ 7.14 Granted — — Exercised — — Expired (325,902 ) 6.55 Outstanding at June 30, 2016 5,340,877 $ 7.18
Summary of Other Assumptions Used by Entity	The following table summarizes the calculated aggregate fair values, along with the inputs and assumptions utilized in each calculation: ($ in thousands except per share data) June 30, 2016 December 31, 2015 Calculated aggregate value $ 764 $ 8,275 Weighted average exercise price per share $ 7.18 $ 7.14 Closing price per share of common stock $ 1.15 $ 4.55 Volatility 97.2 % 85.2 % Weighted average remaining expected life 1 year, 3 months 1 year, 8 months Risk-free interest rate 0.49 % 0.98 % Dividend yield — —

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	6 Months Ended
	Jun. 30, 2016
Fair Value Disclosures [Abstract]
Company's Financial Assets and Liability Measured at Fair Value on a Recurring Basis	The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of: June 30, 2016 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 8,161 $ — $ — $ 8,161 Liabilities: Warrant liability $ — $ — $ 764 $ 764 December 31, 2015 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 29,268 $ — $ — $ 29,268 Liabilities: Warrant liability $ — $ — $ 8,275 $ 8,275
Reconciliation of Warrant Liability Measured at Fair Value on Recurring Basis	The reconciliation of the warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows: Warrant ($ in thousands) Liability Balance at December 31, 2015 $ 8,275 Expiration of warrants (1) (62 ) Change in fair value of warrant liability (7,449 ) Balance at June 30, 2016 $ 764 (1) Represents the fair value as of the beginning of the year for warrants expiring during the year and has been recorded to warrant revaluation income or expense in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2016.

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	6 Months Ended
	Jun. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Schedule of Share-based Payment Award, Employee Stock Purchase Plan, Valuation Assumptions	The fair market value of these stock options at the date of grant was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions for the six months ended: June 30, 2016 June 30, 2015 Expected term 6 years, 1 month 6 years, 1 month Interest rate 1.40 % 1.56 % Dividend yield — — Volatility (1) 92.4 % 103.3 % (1) For the six months ended June 30, 2016, the Company estimated expected volatility based on the historical volatility of its own common stock on a stand-alone basis. Prior to January 1, 2016, including the six months ended June 30, 2015, the Company estimated expected volatility based on the historical volatility of a peer group.
Summary of Stock Option Activity	The following table summarizes stock option activity for the six months ended June 30, 2016 : ($ in thousands except share and per share data) Number of shares Weighted- average exercise price Weighted- average remaining contractual term Aggregate intrinsic value Outstanding at December 31, 2015 3,134,094 $ 6.23 8 years $ 1,630 Granted 1,091,000 2.01 Exercised — — Forfeited (29,256 ) 4.61 Expired (188 ) 4.24 Outstanding at June 30, 2016 (1) 4,195,650 $ 5.15 8 years $ 43 Exercisable at June 30, 2016 1,954,190 $ 7.50 6 years, 11 months $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition.

Restructuring Costs (Tables)

Restructuring Costs (Tables)	6 Months Ended
	Jun. 30, 2016
Restructuring and Related Activities [Abstract]
Restructuring and Related Costs	Restructuring-related charges for both the three and six months ended June 30, 2016 totaled approximately $0.3 million and were comprised of approximately $0.3 million of employee severance and benefit related charges and less than $0.1 million of asset impairments. The restructuring and asset impairment activity for the six months ended June 30, 2016 was as follows: ($ in thousands) Employee Severance and Benefits Asset Impairments Total Accrued restructuring balance as of December 31, 2015 $ — $ — $ — Additional accruals 258 34 292 Cash payments — — — Non-cash settlements — (34 ) (34 ) Accrued restructuring balance as of June 30, 2016 $ 258 $ — $ 258

Loss Per Share (Tables)

Loss Per Share (Tables)	6 Months Ended
	Jun. 30, 2016
Earnings Per Share [Abstract]
Schedule of Earnings Per Share, Basic and Diluted	Details in the computation of basic and diluted loss per share are as follows: Three months ended June 30, Six months ended June 30, ($ in thousands, except share and per share data) 2016 2015 2016 2015 Loss per share - basic: Numerator for basic loss per share $ (8,092 ) $ (6,756 ) $ (9,499 ) $ (15,281 ) Denominator for basic loss per share 43,898,785 40,889,732 43,898,785 40,875,704 Basic loss per common share $ (0.18 ) $ (0.17 ) $ (0.22 ) $ (0.37 ) Loss per share - diluted: Numerator for diluted loss per share $ (8,092 ) $ (6,756 ) $ (9,499 ) $ (15,281 ) Adjust: Warrant revaluation income (expense) for dilutive warrants — — 1,958 — Net loss attributable to common share $ (8,092 ) $ (6,756 ) $ (11,457 ) $ (15,281 ) Denominator for basic loss per share 43,898,785 40,889,732 43,898,785 40,875,704 Plus: Incremental shares underlying dilutive warrants outstanding — — 36,034 — Denominator for diluted loss per share 43,898,785 40,889,732 43,934,819 40,875,704 Diluted net loss per common share $ (0.18 ) $ (0.17 ) $ (0.26 ) $ (0.37 )
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share	The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding, as their effect would be anti-dilutive: Three months ended June 30, Six months ended June 30, 2016 2015 2016 2015 “In the money” stock options 216,000 1,482,614 545,500 1,518,957 “Out of the money” stock options 3,979,650 1,654,200 3,556,497 1,442,200 “In the money” warrants — 1,201,698 — 1,201,698 “Out of the money” warrants 5,340,877 4,831,352 4,751,145 4,831,352 Other securities excluded from the calculation of diluted loss per share: Stock options with performance condition — 100,000 — 100,000

Business and Organization (Deta

Business and Organization (Details) - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015	Jun. 30, 2015	Dec. 31, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and cash equivalents	$ 8,161	$ 29,268	$ 26,850	$ 37,495
Working capital	$ 5,800

Summary of Significant Accoun26

Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands	Jan. 01, 2012	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015	Dec. 31, 2015	Sep. 03, 2009
New Accounting Pronouncement, Early Adoption [Line Items]
Intangible assets		$ 0		$ 0		$ 4,136	$ 6,300
Useful life	12 years
Intangible asset impairment		3,905	$ 0	3,905	$ 0
Income tax expense (benefit)		$ 0	$ 0	$ 0	$ 0
Accumulated deficit
New Accounting Pronouncement, Early Adoption [Line Items]
Cumulative effect from adoption of new accounting standard						(100)
Additional paid-in capital
New Accounting Pronouncement, Early Adoption [Line Items]
Cumulative effect from adoption of new accounting standard						100
Accounting Standards Update 2016-09 | Accumulated deficit | New Accounting Pronouncement, Early Adoption, Effect
New Accounting Pronouncement, Early Adoption [Line Items]
Cumulative effect from adoption of new accounting standard						(100)
Accounting Standards Update 2016-09 | Additional paid-in capital | New Accounting Pronouncement, Early Adoption, Effect
New Accounting Pronouncement, Early Adoption [Line Items]
Cumulative effect from adoption of new accounting standard						$ 100

Inventory (Details)

Inventory (Details) - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015
Inventory Disclosure [Abstract]
Raw materials (LAVIV and product candidates)	$ 71	$ 338
Work in process (LAVIV)	189	144
Total inventory, gross	260	482
Reserve for work in process expiration	(151)	0
Total inventory, net	$ 109	$ 482

Inventory - Narrative (Details)

Inventory - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended
	Jun. 30, 2016	Dec. 31, 2015
Inventory [Line Items]
Reserve for work in process expiration	$ 151	$ 0
Cost of Sales
Inventory [Line Items]
Inventory write-down	$ 200

Warrants - Liability-Classified

Warrants - Liability-Classified Warrants Outstanding (Details) - $ / shares	Jun. 30, 2016	Dec. 31, 2015
Warrants
Warrants issued to purchase common stock (shares)	5,340,877	5,666,779
Warrant exercise price (in dollars per share)	$ 7.18	$ 7.14
Issued in March 2010 financing
Warrants
Warrants issued to purchase common stock (shares)	0	319,789
Warrant exercise price (in dollars per share)	$ 6.25
Issued in June 2011 financing
Warrants
Warrants issued to purchase common stock (shares)	0	6,113
Warrant exercise price (in dollars per share)	$ 22.50
Issued in Series B and D Preferred Stock offerings
Warrants
Warrants issued to purchase common stock (shares)	1,970,594	1,970,594
Warrant exercise price (in dollars per share)	$ 6.25
Issued in August 2011 financing
Warrants
Warrants issued to purchase common stock (shares)	565,759	565,759
Warrant exercise price (in dollars per share)	$ 18.75
Issued to placement agents in August 2011 financing
Warrants
Warrants issued to purchase common stock (shares)	50,123	50,123
Warrant exercise price (in dollars per share)	$ 13.635
Issued in Series E Preferred Stock offering
Warrants
Warrants issued to purchase common stock (shares)	60,000	60,000
Warrant exercise price (in dollars per share)	$ 2.50
Issued with Convertible Notes
Warrants
Warrants issued to purchase common stock (shares)	1,125,578	1,125,578
Warrant exercise price (in dollars per share)	$ 2.50
Issued in Series E Preferred Stock offering
Warrants
Warrants issued to purchase common stock (shares)	1,568,823	1,568,823
Warrant exercise price (in dollars per share)	$ 7.50

Warrants - Warrant Activity (De

Warrants - Warrant Activity (Details)	6 Months Ended
	Jun. 30, 2016$ / sharesshares
Increase (Decrease) in Warrants Outstanding [Roll Forward]
Beginning balance, number of warrants outstanding (shares) | shares	5,666,779
Number of warrants granted during the period (shares) | shares	0
Number of warrants exercised during the period (shares) | shares	0
Number of warrants expired during the period (shares) | shares	(325,902)
Ending balance, number of warrants outstanding (shares) | shares	5,340,877
Beginning balance, weighted-average exercise price (usd per share) | $ / shares	$ 7.14
Weighted-average exercise price, warrants granted during the period (usd per share) | $ / shares	0
Weighted-average exercise price, warrants exercised during the period (usd per share) | $ / shares	0
Weighted-average exercise price, warrants expired during the period (usd per share) | $ / shares	6.55
Ending balance, weighted-average exercise price (usd per share) | $ / shares	$ 7.18

Warrants - Narrative (Details)

Warrants - Narrative (Details) - USD ($) $ in Millions	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Warrant | Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Non-cash expense (income)	$ (2.3)	$ (0.6)	$ (7.5)	$ 1.1

Warrants - Aggregate Fair Value

Warrants - Aggregate Fair Values, Inputs and Assumptions (Details) - Warrant Liability - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2016	Dec. 31, 2015
Fair value assumptions
Calculated aggregate value	$ 764	$ 8,275
Weighted average exercise price per share (usd per share)	$ 7.18	$ 7.14
Closing price per share of common stock (usd per share)	$ 1.15	$ 4.55
Volatility (as a percent)	97.20%	85.20%
Weighted average remaining expected life	1 year 3 months	1 year 8 months
Risk-free interest rate (as a percent)	0.49%	0.98%
Dividend yield	0.00%	0.00%

Fair Value Measurements - Fair

Fair Value Measurements - Fair Value Hierarchy (Details) - Recurring - Measured at fair value - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015
Assets
Cash and cash equivalents	$ 8,161	$ 29,268
Liabilities
Warrant liability	764	8,275
Level 1
Assets
Cash and cash equivalents	8,161	29,268
Liabilities
Warrant liability	0	0
Level 2
Assets
Cash and cash equivalents	0	0
Liabilities
Warrant liability	0	0
Level 3
Assets
Cash and cash equivalents	0	0
Liabilities
Warrant liability	$ 764	$ 8,275

Fair Value Measurements - Warra

Fair Value Measurements - Warrant Liability Reconciliation (Details) - Warrant $ in Thousands	6 Months Ended
	Jun. 30, 2016USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
December 31, 2015	$ 8,275
Expiration of warrants	(62)
Change in fair value of warrant liability	(7,449)
June 30, 2016	$ 764

Stock-Based Compensation - Narr

Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions	Sep. 03, 2009	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015	Dec. 31, 2015	Dec. 31, 2013
Equity-based compensation
Options issued (in shares)		4,195,650		4,195,650		3,134,094
Weighted average fair market value of options granted (in dollars per share)				$ 1.53	$ 3.57
Stock-based compensation expense		$ 0.6	$ 0.8	$ 1.1	$ 1
Fair value of options vested				1.6
Service Based Stock Options
Equity-based compensation
Unrecognized compensation cost		$ 4.7		$ 4.7
Recognition period (years)				2 years 9 months
The Plan
Equity-based compensation
Number of shares allowed for issuance (in shares)	7,600,000
The Plan | Options
Equity-based compensation
Terms of options, not to exceed (in years)	10 years
Vesting percentage per year	25.00%
Vesting period (in years)	4 years
Options available for grant (in shares)		3,365,103		3,365,103
Equity incentive outside of the Plan | Options
Equity-based compensation
Options issued (in shares)							25,000
Director | The Plan | Options
Equity-based compensation
Vesting period (in years)	1 year

Stock-Based Compensation - Weig

Stock-Based Compensation - Weighted Average Assumptions (Details)	6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Expected life	6 years 1 month	6 years 1 month
Interest rate	1.40%	1.56%
Dividend yield	0.00%	0.00%
Volatility	92.40%	103.30%

Stock-Based Compensation - Stoc

Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2016	Dec. 31, 2015
Number of shares
Outstanding at beginning of period (in shares)	3,134,094
Granted (in shares)	1,091,000
Exercised (shares)	0
Forfeited (in shares)	(29,256)
Expired (in shares)	(188)
Outstanding at end of period (in shares)	4,195,650	3,134,094
Exercisable at end of period (in shares)	1,954,190
Weighted-average exercise price
Outstanding at beginning of period (in dollars per share)	$ 6.23
Granted (in dollars per share)	2.01
Exercised (in dollars per share)	0
Forfeited (in dollars per share)	4.61
Expired (in dollars per share)	4.24
Outstanding at end of period (in dollars per share)	5.15	$ 6.23
Exercisable at end of period (in dollars per share)	$ 7.50
Additional disclosures
Weighted-average remaining contractual term (in years), outstanding	8 years	8 years
Weighted-average remaining contractual term (in years), exercisable	6 years 11 months
Aggregate intrinsic value, outstanding	$ 43	$ 1,630
Aggregate intrinsic value, exercisable	$ 0

Related Party Transactions (Det

Related Party Transactions (Details)	1 Months Ended	3 Months Ended		6 Months Ended
	Jan. 31, 2016USD ($)	Jun. 30, 2016USD ($)agreement	Jun. 30, 2015USD ($)	Jun. 30, 2016USD ($)directoragreement	Jun. 30, 2015USD ($)	Dec. 31, 2015USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Number of exclusive channel collaboration agreements (agreement) | agreement		2		2
Technology Access Fee
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Fees to Intrexon	$ 10,000,000
Affiliated Entity
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Expenses for work performed		$ 900,000	$ 1,100,000	$ 2,200,000	$ 2,900,000
Outstanding payables to Intrexon		$ 900,000		$ 900,000		$ 10,700,000
Shareholder ownership percentage of related party in affiliate, more than		50.00%		50.00%
Shareholder ownership percentage		38.00%		38.00%
Affiliated Entity | 2015 ECC
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Expenses for work performed				$ 0	0
Affiliated Entity | Direct Expenses for Work Performed
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Expenses for work performed		$ 300,000	800,000	800,000	1,700,000
Affiliated Entity | Pass-through Costs
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Expenses for work performed		$ 600,000	$ 300,000	$ 1,400,000	$ 1,200,000
Director
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Number of directors (director) | director				2

Restructuring Costs (Details)

Restructuring Costs (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016USD ($)	Jun. 30, 2015USD ($)	Jun. 30, 2016USD ($)employee	Jun. 30, 2015USD ($)
Restructuring Cost and Reserve [Line Items]
Restructuring costs	$ 292	$ 0	$ 292	$ 0
Number of employees impacted by reduction-in-force (employee) | employee			25
Percent of employee base impacted			50.00%
Employee Severance and Benefits
Restructuring Cost and Reserve [Line Items]
Restructuring costs			$ 258
Asset Impairments
Restructuring Cost and Reserve [Line Items]
Restructuring costs	$ 34		$ 34

Restructuring Costs - Changes i

Restructuring Costs - Changes in Restructuring Balance (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Restructuring Reserve [Roll Forward]
Accrued restructuring, beginning balance			$ 0
Additional accruals	$ 292	$ 0	292	$ 0
Cash payments			0
Non-cash settlements			(34)
Accrued restructuring, ending balance	258		258
Employee Severance and Benefits
Restructuring Reserve [Roll Forward]
Accrued restructuring, beginning balance			0
Additional accruals			258
Cash payments			0
Non-cash settlements			0
Accrued restructuring, ending balance	258		258
Asset Impairments
Restructuring Reserve [Roll Forward]
Accrued restructuring, beginning balance			0
Additional accruals	34		34
Cash payments			0
Non-cash settlements			(34)
Accrued restructuring, ending balance	$ 0		$ 0

Loss Per Share - Earnings Per S

Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Loss per share - basic:
Numerator for basic loss per share	$ (8,092)	$ (6,756)	$ (9,499)	$ (15,281)
Denominator for basic loss per share (shares)	43,898,785	40,889,732	43,898,785	40,875,704
Basic loss per common share (usd per share)	$ (0.18)	$ (0.17)	$ (0.22)	$ (0.37)
Loss per share - diluted:
Numerator for diluted loss per share	$ (8,092)	$ (6,756)	$ (9,499)	$ (15,281)
Adjust: Warrant revaluation income (expense) for dilutive warrants	0	0	1,958	0
Net loss attributable to common share	$ (8,092)	$ (6,756)	$ (11,457)	$ (15,281)
Denominator for basic loss per share (shares)	43,898,785	40,889,732	43,898,785	40,875,704
Plus: Incremental shares underlying dilutive warrants outstanding (shares)	0	0	36,034	0
Denominator for diluted loss per share (shares)	43,898,785	40,889,732	43,934,819	40,875,704
Diluted net loss per common share (usd per share)	$ (0.18)	$ (0.17)	$ (0.26)	$ (0.37)

Loss Per Share - Antidilutive S

Loss Per Share - Antidilutive Securities (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Performance based options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from EPS (shares)	0	100,000	0	100,000
“In the money” stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from EPS (shares)	216,000	1,482,614	545,500	1,518,957
“Out of the money” stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from EPS (shares)	3,979,650	1,654,200	3,556,497	1,442,200
“In the money” warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from EPS (shares)	0	1,201,698	0	1,201,698
“Out of the money” warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from EPS (shares)	5,340,877	4,831,352	4,751,145	4,831,352

Equity (Details)

Equity (Details) - USD ($)	1 Months Ended	6 Months Ended
	Jan. 31, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2015
Class of Stock [Line Items]
Common stock, shares authorized (shares)		150,000,000	100,000,000	100,000,000
Cantor Fitzgerald & Co.
Class of Stock [Line Items]
Stock issued during the period (shares)		0
Cantor Fitzgerald & Co. | Common Stock
Class of Stock [Line Items]
Aggregate offering price	$ 50,000,000
Cantor Fitzgerald & Co.
Class of Stock [Line Items]
Fixed commission (percent)	3.00%