Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 28, 2019 | Jun. 30, 2018 | |
Document And Entity Information | |||
Entity Registrant Name | Celsion CORP | ||
Entity Central Index Key | 0000749647 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 52,100,000 | ||
Entity Common Stock, Shares Outstanding | 19,562,020 | ||
Trading Symbol | CLSN | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 13,353,543 | $ 11,444,055 |
Investment securities - available for sale, at fair value | 14,257,998 | 12,724,020 |
Accrued interest receivable on investment securities | 68,309 | 54,440 |
Advances and deposits on clinical programs and other current assets | 451,293 | 89,186 |
Total current assets | 28,131,143 | 24,311,701 |
Property and equipment (at cost, less accumulated depreciation and amortization) | 184,627 | 175,771 |
Other assets: | ||
In-process research and development, net | 15,736,491 | 20,246,491 |
Goodwill | 1,976,101 | 1,976,101 |
Other intangible assets, net | 568,292 | 795,608 |
Deposits and other assets | 258,933 | 8,761 |
Total other assets | 18,539,817 | 23,026,961 |
Total assets | 46,855,587 | 47,514,433 |
Current liabilities: | ||
Accounts payable - trade | 3,020,638 | 3,416,863 |
Other accrued liabilities | 2,585,898 | 2,282,827 |
Deferred revenue - current portion | 500,000 | 500,000 |
Total current liabilities | 6,106,536 | 6,199,690 |
Earn-out milestone liability | 8,907,664 | 12,538,525 |
Note Payable, net of deferred financing costs | 9,417,037 | |
Deferred revenue - non-current portion | 1,500,000 | 2,000,000 |
Other liabilities - non-current | 63,278 | 71,710 |
Total liabilities | 25,994,515 | 20,809,925 |
Commitments | ||
Stockholders' equity: | ||
Preferred Stock - $0.01 par value (100,000 shares authorized, and no shares issued or outstanding at December 31, 2018 and 2017) | ||
Common stock - $0.01 par value (112,500,000 shares authorized; 18,832,168 and 17,277,299 shares issued at December 31, 2018 and 2017, respectively, and 18,831,834 and 17,276,965 shares outstanding at December 31, 2018 and 2017, respectively) | 188,322 | 172,772 |
Additional paid-in capital | 294,393,313 | 288,408,976 |
Accumulated other comprehensive gain (loss) | 29,872 | (10,164) |
Accumulated deficit | (273,665,247) | (261,781,888) |
Total stockholders' equity before treasury stock | 20,946,260 | 26,789,696 |
Treasury stock, at cost (334 shares at December 31, 2018 and 2017) | (85,188) | (85,188) |
Total stockholders' equity | 20,861,072 | 26,704,508 |
Total liabilities and stockholders' equity | $ 46,855,587 | $ 47,514,433 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 100,000 | 100,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 112,500,000 | 112,500,000 |
Common stock, shares issued | 18,832,168 | 17,277,299 |
Common stock, shares outstanding | 18,831,834 | 17,276,965 |
Treasury stock, shares | 334 | 334 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Technology development and licensing revenue | $ 500,000 | $ 500,000 |
Operating expenses: | ||
Research and development | 11,865,523 | 13,078,710 |
General and administrative | 9,699,521 | 5,889,722 |
Total operating expenses | 21,565,044 | 18,968,432 |
Loss from operations | (21,065,044) | (18,468,432) |
Other income (expense): | ||
Gain from change in earn-out milestone liability | 3,630,861 | 649,701 |
Impairment of in-process research and development | (4,510,000) | (2,520,000) |
Investment income, net | 353,682 | 26,041 |
Interest expense | (712,025) | (91,756) |
Other income | 52 | 2,270 |
Total other expense | (1,237,430) | (1,933,744) |
Net loss before income tax benefit | (22,302,474) | (20,402,176) |
Income tax benefit | 10,419,115 | |
Net loss | (11,883,359) | (20,402,176) |
Deemed dividend related to warrant modification | (345,685) | |
Net loss attributable to common shareholders | $ (11,883,359) | $ (20,747,861) |
Net loss attributable to common shareholders per common share - basic and diluted | $ (0.68) | $ (2.72) |
Weighted average common shares outstanding - basic and diluted | 17,582,879 | 7,627,210 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (11,883,359) | $ (20,402,176) |
Changes in: | ||
Realized loss on investment securities recognized in investment income, net | 10,164 | |
Unrealized gain (loss) on investment securities | 29,872 | (10,164) |
Other comprehensive income (loss) | 40,036 | (10,164) |
Comprehensive loss | $ (11,843,323) | $ (20,412,340) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (11,883,359) | $ (20,402,176) |
Non-cash items included in net loss: | ||
Depreciation and amortization | 356,859 | 553,010 |
Change in fair value of earn-out milestone liability | (3,630,861) | (649,701) |
Impairment of in-process research and development | 4,510,000 | 2,520,000 |
Stock-based compensation | 4,604,415 | 1,105,245 |
Shares issued in exchange for services | 29,841 | |
Shares issued to satisfy certain obligations | 235,072 | |
Amortization of deferred finance charges and debt discount associated with note payable | 199,153 | 35,370 |
Change in deferred rent liability | (8,432) | 59,358 |
Net changes in: | ||
Interest receivable on investments | (13,869) | (50,432) |
Advances and deposits on clinical programs and other current assets | (362,107) | 115,222 |
Other assets | (250,172) | |
Accounts payable - trade | (396,225) | 537,885 |
Deferred revenue | (500,000) | (500,000) |
Other accrued liabilities | 303,071 | (200,929) |
Net cash used in operating activities | (7,041,686) | (16,642,076) |
Cash flows from investing activities: | ||
Purchases of investment securities | (16,973,942) | (12,734,184) |
Proceeds from sale and maturity of investment securities | 15,480,000 | 1,680,000 |
Refund on security for letter of credit | 100,000 | |
Purchases of property and equipment | (138,399) | (38,629) |
Net cash (used in) provided by investing activities | (1,632,341) | (10,992,813) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock equity, net of issuance costs | 858,515 | 17,910,401 |
Proceeds from note payable, net of issuance costs | 9,725,000 | |
Proceeds from exercise of common stock warrants | 21,140,304 | |
Principal payments on note payable | (2,595,923) | |
Net cash provided by financing activities | 10,583,515 | 36,454,782 |
Increase in cash and cash equivalents | 1,909,488 | 8,819,893 |
Cash and cash equivalents at beginning of period | 11,444,055 | 2,624,162 |
Cash and cash equivalents at end of period | 13,353,543 | 11,444,055 |
Cash (paid for) received from: | ||
Interest paid | (512,872) | (56,386) |
Income tax benefit | 10,419,115 | |
Non-cash financing activities: | ||
Fair value of common stock issued as equity issuance costs charged against paid in capital | 450,000 | |
Fair value of common stock and warrants issued in connection with notes payable | 507,116 | |
Fair value of stock issued in exchange for cancelation of warrants | 8,207 | |
Fair value of modification of warrant exercise prices included in paid in capital | 345,685 | |
Fair value of deemed dividend related to modification of warrant exercise prices charged against paid in capital | $ (345,685) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid in Capital [Member] | Treasury Stock [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 22,305 | $ 248,168,421 | $ (85,188) | $ (241,379,712) | $ 6,725,826 | |
Balance, shares at Dec. 31, 2016 | 2,230,118 | 334 | ||||
Net loss | (20,402,176) | (20,402,176) | ||||
Registered direct and ATM common stock offerings | $ 72,964 | 17,837,437 | 17,910,401 | |||
Registered direct and ATM common stock offerings, shares | 7,296,352 | |||||
Exercise of common stock warrants | $ 76,171 | 21,064,133 | 21,140,304 | |||
Exercise of common stock warrants, shares | 7,617,148 | |||||
Shares issued to satisfy certain obligations | $ 1,301 | 233,771 | 235,072 | |||
Shares issued to satisfy certain obligations, shares | 130,055 | |||||
Realized and unrealized gains and losses, net, on investments securities | (10,164) | (10,164) | ||||
Stock-based compensation expense | 1,105,245 | 1,105,245 | ||||
Issuance of restricted stock | $ 34 | (34) | ||||
Issuance of restricted stock, shares | 3,357 | |||||
Modification of warrant exercise prices | 345,685 | 345,685 | ||||
Deemed dividend related to warrant exercise price modifications | (345,685) | (345,685) | ||||
Effect of reverse stock split | $ (3) | 3 | ||||
Effect of reverse stock split, shares | (65) | |||||
Balance at Dec. 31, 2017 | $ 172,772 | 288,408,976 | $ (85,188) | (10,164) | (261,781,888) | 26,704,508 |
Balance, shares at Dec. 31, 2017 | 17,276,965 | 334 | ||||
Net loss | (11,883,359) | (11,883,359) | ||||
Realized and unrealized gains and losses, net, on investments securities | 40,036 | 40,036 | ||||
Stock-based compensation expense | 4,604,415 | 4,604,415 | ||||
Issuance of restricted stock | $ 123 | 29,718 | 29,841 | |||
Issuance of restricted stock, shares | 12,250 | |||||
Sale of equity through ATM and common stock purchase agreement | $ 5,572 | 983,528 | 989,100 | |||
Sale of equity through ATM and common stock purchase agreement, shares | 557,070 | |||||
Common stock issuance in exchange for cancellation of common stock warrants | $ 8,207 | (138,792) | (130,585) | |||
Common stock issuance in exchange for cancellation of common stock warrants, shares | 820,714 | |||||
Common stock and warrants to purchase common stock issued in connection with equity and debt facilities | $ 1,648 | 505,468 | 507,116 | |||
Common stock and warrants to purchase common stock issued in connection with equity and debt facilities, shares | 164,835 | |||||
Balance at Dec. 31, 2018 | $ 188,322 | $ 294,393,313 | $ (85,188) | $ 29,872 | $ (273,665,247) | $ 20,861,072 |
Balance, shares at Dec. 31, 2018 | 18,831,834 | 334 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 1. Description of Business Celsion Corporation (“Celsion” and the “Company”) is a fully-integrated development stage oncology drug company focused on advancing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA based therapies. Our lead product candidate is ThermoDox ®, Basis of Presentation The accompanying consolidated financial statements of Celsion have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States and include the accounts of the Company and CLSN Laboratories, Inc. All intercompany balances and transactions have been eliminated. The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates, and assumptions that affect the amount reported in the Company’s financial statements and accompanying notes. Actual results could differ materially from these estimates. Events and conditions arising subsequent to the most recent balance sheet date through the date of the issuance of these consolidated financial statements have been evaluated for their possible impact on the financial statements and accompanying notes. No events and conditions would give rise to any information that required accounting recognition or disclosure in the financial statements other than those arising in the ordinary course of business. Use of Estimates The preparation of financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates using historical experience and other factors, including the current economic environment. Significant items subject to such estimates are assumptions used for purposes of determining stock-based compensation, the fair value of the convertible notes, and accounting for research and development activities. Management believes its estimates to be reasonable under the circumstances. Actual results could differ significantly from those estimates. Significant estimates in these financials are the valuation of options granted and valuation methods used to determine the recoverability of goodwill and other intangible assets. Revenue Recognition On January 1, 2018, the Company adopted the new accounting standard ASC 606, Revenue from Contracts with Customers and all related amendments (the “new revenue standard”) to all contracts with customers using the modified retrospective method. The adoption of the new revenue standard had no impact on retained earnings as of December 31, 2017 and, accordingly, no cumulative adjustment was required. We do not expect the new revenue standard to have a significant impact on our net income on an ongoing basis. The Company’s sole revenue stream is related to the Hisun agreement described in Note 16. There were no accounts receivable as of December 31, 2018 or 2017. Contract liabilities from the Hisun agreement amounted to $1,500,000 and $2,000,000 at December 31, 2018 and 2017, respectively. Contract liabilities values represent the value of cash received before the services were provided. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company received or expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The application of these five steps necessitates the development of assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines and probabilities of technical and regulatory success. Cash and Cash Equivalents Cash and cash equivalents include cash on hand and investments purchased with an original maturity of three months or less. A portion of these funds are not covered by FDIC insurance. Fair Value of Investment Securities The carrying values of investment securities approximate their respective fair values. Short Term Investments The Company classifies its investments in marketable securities with readily determinable fair values as investments available-for-sale in accordance with Accounting Standards Codification (ASC) 320, Investments - Debt and Equity Securities. Available-for-sale securities consist of debt and equity securities not classified as trading securities or as securities to be held to maturity. The Company has classified all of its investments as available-for-sale. Unrealized holding gains and losses on available-for-sale securities are reported as a net amount in accumulated other comprehensive gain or loss in stockholders’ equity until realized. Gains and losses on the sale of available-for-sale securities are determined using the specific identification method. The Company’s short-term investments consist of corporate bonds. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is provided over the estimated useful lives of the related assets, ranging from three to seven years, using the straight-line method. Amortization is recognized over the lesser of the life of the asset or the lease term. Major renewals and improvements are capitalized at cost and ordinary repairs and maintenance are charged against operating expenses as incurred. Depreciation expense was approximately $130,000 and $326,000 for the years ended December 31, 2018 and 2017, respectively. The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An asset is considered impaired if its carrying amount exceeds the future net undiscounted cash flows that the asset is expected to generate. If such asset is considered to be impaired, the impairment recognized is the amount by which the carrying amount of the asset, if any, exceeds its fair value determined using a discounted cash flow model. Deposits Deposits include real property security deposits and other deposits which are contractually required and of a long-term nature. In-Process Research and Development, Other Intangible Assets and Goodwill During 2014, the Company acquired certain assets of EGEN, Inc. As more fully described in Note 5, the acquisition was accounted for under the acquisition method of accounting which required the Company to perform an allocation of the purchase price to the assets acquired and liabilities assumed. Under the acquisition method of accounting, the total purchase price is allocated to net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date. Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of its long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. Comprehensive Income (Loss) Accounting Standards Codification (“ASC”) 220, Comprehensive Income 220 Research and Development Research and development costs are expensed as incurred. Equipment and facilities acquired for research and development activities that have alternative future uses are capitalized and charged to expense over their estimated useful lives. Net Loss Per Common Share Basic and diluted net loss per common share was computed by dividing net loss for the year by the weighted average number of shares of common stock outstanding, both basic and diluted, during each period. The impact of common stock equivalents has been excluded from the computation of diluted weighted average common shares outstanding in periods where there is a net loss, as their effect is anti-dilutive. For the years ended December 31, 2018 and 2017, the total number of shares of common stock issuable upon exercise of warrants and equity awards is 4,764,405 and 3,761,844 respectively. For the year ended December 31, 2018 and 2017, diluted loss per common share is the same as basic loss per common share as all options and all warrants that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings attributable to common stockholders per common share as their effect would be anti-dilutive. Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax asset and liabilities of a change in tax rates is recognized in results of operations in the period that the tax rate change occurs. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. In accordance with ASC 740, Income Taxes, not” As more fully discussed in Note 9, the Company the Company completed the sale of a portion of its New Jersey net operating losses totaling approximately $11.1 for net proceeds of approximately $10.4 million. Such proceeds are reflected as a tax benefit for the year ended December 31, 2018. Stock-Based Compensation In March 2016, 2016 09, Compensation Stock Compensation Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to our operations. In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09 “Revenue from Contracts with Customers (Topic 606),” which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. ASU 2014 - 09 was originally going to be effective on January 1, 2017; however, the FASB issued ASU 2015-14, “Revenue from Contracts with Customers (Topic 606) - Deferral of the Effective Date,” which deferred the effective date of ASU 2014-09 by one year to January 1, 2018. In March 2016, the FASB issued ASU No. 2016 - 8, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations. The amendments in this ASU do not change the core principle of ASU No. 2014 - 09 but the amendments clarify the implementation guidance on reporting revenue gross versus net. The effective date for the amendments in this ASU is the same as the effective date of ASU No. 2014-09. In April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Identifying Performance Obligations and Licensing),” to clarify the implementation guidance on identifying performance obligations and licensing (collectively “the new revenue standards”). The new revenue standards allow for either “full retrospective” adoption, meaning the standard is applied to all periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. The new revenue standard became effective for us on January 1, 2018. Under the new revenue standards, we recognize revenue following a five-step model prescribed under ASU No. 2014-09; (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation. As further described in Note 16, the Company currently has only one contract subject to the new revenue standards. After performance of the five-step model discussed above, the Company concluded the adoption of the new revenue standards as of January 1, 2018 did not change our revenue recognition policy nor does it have an effect on our financial statements using either the full retrospective or the modified retrospective adoption methods. In January 2016, the FASB issued Accounting Standards Update No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities,” which requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income (other than those accounted for under the equity method of accounting). This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Based on the Company’s evaluation, the adoption of the ASU 2016-01 does not have a material impact on its consolidated financial statements or its disclosures. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, “Leases” (Topic 842), which requires that lessees recognize assets and liabilities for leases with lease terms greater than twelve months in the statement of financial position. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This update also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. The update is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that reporting period. The FASB subsequently issued the following amendments to ASU 2016-02, which have the same effective date and transition date of January 1, 2019: ● ASU No. 2018-10, Codification Improvements to Topic 842, Leases ● ASU No. 2018-11, Leases (Topic 842): Targeted Improvements We evaluated ASU 2016-02 and its impact on the consolidated financial statements and related disclosures. We have identified all of our leases which consist of the New Jersey corporate office lease and the Alabama lab facility lease, see Note 17, and we estimate the adoption of this standard will result in the recognition of right-of-use assets and related lease liabilities on the consolidated balance sheets as of January 1, 2019 of approximately $1.1 to $1.3 million related to our operating lease commitments, with no material impact to the opening balance of retained earnings. In January 2017, the FASB issued Accounting Standard Update No. 2017-04, “Intangibles-Goodwill and Other, Simplifying the Test for Goodwill Impairment,” which eliminated Step 2 not |
Financial Condition
Financial Condition | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Financial Condition | 2. FINANCIAL CONDITION Since inception, the Company has incurred substantial operating losses, principally from expenses associated with the Company’s research and development programs, clinical trials conducted in connection with the Company’s product candidates, and applications and submissions to the U.S. Food and Drug Administration. We have not generated significant revenue and have incurred significant net losses in each year since our inception. We have incurred approximately $274 million of cumulated net losses. As of December 31, 2018, we had approximately $27.7 million in cash, investment securities and interest receivable. We have substantial future capital requirements to continue our research and development activities and advance our product candidates through various development stages. The Company believes these expenditures are essential for the commercialization of its technologies. The Company expects its operating losses to continue for the foreseeable future as it continues its product development efforts, and when it undertakes marketing and sales activities. The Company’s ability to achieve profitability is dependent upon its ability to obtain governmental approvals, manufacture, and market and sell its new product candidates. There can be no assurance that the Company will be able to commercialize its technology successfully or that profitability will ever be achieved. The operating results of the Company have fluctuated significantly in the past. We have substantial future capital requirements associated with our continued research and development activities and to advance our product candidates through various stages of development. The Company believes these expenditures are essential for the commercialization of its technologies. The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond the Company’s control. These factors include the following: ● the progress of research activities; ● the number and scope of research programs; ● the progress of preclinical and clinical development activities; ● the progress of the development efforts of parties with whom the Company has entered into research and development agreements; ● the costs associated with additional clinical trials of product candidates; ● the ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements; ● the ability to achieve milestones under licensing arrangements; ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and ● the costs and timing of regulatory approvals. The Company has based its estimate on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates. Potential sources of financing include strategic relationships, public or private sales of the Company’s shares or debt, the additional sales from the sale of its State of New Jersey net operating losses in the future and other sources. If the Company raises funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of existing stockholders may be diluted. Annually, the State of New Jersey enables approved technology and biotechnology businesses with New Jersey net operating tax losses the opportunity to sell these losses through the Technology Business Tax Certificate Program (the “NOL Program”), thereby providing cash to companies to help fund their operations. The Company determined it met the eligibility requirements of the NOL Program for 2018 and filed its application with the New Jersey Economic Development Authority (NJEDA) in June 2018. In this application, the Company requested authorization of up to $12.5 million in tax benefits from its cumulative New Jersey net operating losses to be eligible for sale. In September 2018, the NJEDA notified the Company that its application received approval under the NOL Program for 2018 and after receiving approval from the NJEDA to transfer $11.1 million of tax benefits in December 2018, the Company successfully transferred these approved tax benefits which resulted in receipt of $10.4 million in net cash proceeds to the Company at the end of 2018. The Company has approximately $3.9 million in future tax benefits remaining under the NOL Program for future years. With $27.7 million in cash, investment securities and interest receivable at December 31, 2018, the Company believes it has sufficient capital resources to fund its operations into the third quarter of 2020. The Company will be required to obtain additional funding to continue development of its current product candidates within the anticipated time periods, if at all, and to continue to fund operations. As more fully discussed in Note 10, the Company has approximately $31 million available collectively for future sale of equity securities under a common stock purchase agreement with Aspire Capital Fund, LLC and a common stock sales agreement with JonesTrading International Services LLC. |
Short Term Investments Availabl
Short Term Investments Available for Sale | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Short Term Investments Available for Sale | 3. SHORT TERM INVESTMENTS AVAILABLE FOR SALE Short-term investments available for sale of $14,257,998 and $12,724,020 as of December 31, 2018 and 2017, respectively, consist of corporate debt securities. These investments are valued at estimated fair value, with unrealized gains and losses reported as a separate component of stockholders’ equity in accumulated other comprehensive loss. Securities available for sale are evaluated periodically to determine whether a decline in their value is other than temporary. The term “other than temporary” is not intended to indicate a permanent decline in value. Rather, it means that the prospects for near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security. Management reviews criteria such as the magnitude and duration of the decline, as well as the reasons for the decline, to predict whether the loss in value is other than temporary. Once a decline in value is determined to be other than temporary, the value of the security is reduced and a corresponding charge to earnings is recognized. A summary of the cost, fair value and maturities of the Company’s short-term investments is as follows: December 31, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investments Corporate debt securities $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 Total $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 December 31, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investment maturities Within 3 months $ 5,383,488 $ 5,393,743 $ - $ - Between 3-12 months 8,844,638 8,864,255 12,734,184 12,724,020 Total $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 The following table shows the Company’s investment securities gross unrealized gains (losses) and fair value by investment category and length of time that individual securities have been in a continuous unrealized loss position at December 31, 2018 and 2017. The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary. December 31, 2018 December 31, 2017 Available for sale securities Fair Value Unrealized Holding Gains (Losses) Fair Value Unrealized Holding Gains (Losses) Investments with unrealized gains $ 7,515,676 $ 38,068 $ 748,148 $ 570 Investments with unrealized losses 6,742,322 (8,196 ) 11,975,872 (10,734 ) Total $ 14,257,998 $ 29,872 $ 12,724,020 $ (10,164 ) Investment income, which includes net realized losses on sales of available for sale securities and investment income interest and dividends, is summarized as follows: 2018 2017 Interest and dividends accrued and paid $ 331,780 $ 26,041 Accretion of investment discounts and premiums, net 32,066 - Losses investment maturity and sales, net (10,164 ) - Investment income net $ 353,682 $ 26,041 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 4. FAIR VALUES OF FINANCIAL INSTRUMENTS FASB Accounting Standards Codification (ASC) Section 820 “Fair Value Measurements and Disclosures,” establishes a three-level hierarchy for fair value measurements which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of inputs that may be used to measure fair value are as follows: Level 1: Quoted prices (unadjusted) or identical assets or liabilities in active markets that the entity has the ability to access as of the measurement date; Level 2: Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data; and Level 3: Significant unobservable inputs that reflect a reporting entity’s own assumptions that market participants would use in pricing an asset or liability. Cash and cash equivalents, other current assets, accounts payable and other accrued liabilities are reflected in the condensed consolidated balance sheet at their approximate estimated fair values primarily due to their short-term nature. The fair values of securities available for sale is determined by relying on the securities’ relationship to other benchmark quoted securities and classified its investments as Level 2 items in both 2018 and 2017. There were no transfers of assets or liabilities between Level 1 and Level 2 and no transfers in or out of Level 3 during the year ended December 31, 2018 or 2017. The changes in Level 3 liabilities were the result of changes in the fair value of the earn-out milestone liability included in earnings and in-process R&D. The earnout milestone liability is valued using a risk-adjusted assessment of the probability of payment of each milestone, discounted to present value using an estimated time to achieve the milestone (see Note 12). The in-process R&D – GBM is valued using a multi-period excess earnings method (see note 5). Assets and liabilities measured at fair value are summarized below: Total Fair Value Quoted Prices In Active Markets For Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Recurring items as of December 31, 2018 Corporate debt securities, available for sale $ 14,257,998 $ ─ $ 14,257,998 $ ─ Recurring items as of December 31, 2017 Corporate debt securities, available for sale $ 12,724,020 $ ─ $ 12,724,020 $ ─ Liabilities: Recurring items as of December 31, 2018 Earn-out milestone liability (Note 12) $ 8,907,664 $ ─ $ ─ $ 8,907,664 Non-recurring items as of December 31, 2018 In process R&D (Note 5) $ 15,736,491 $ ─ $ ─ $ 15,736,491 Recurring items as of December 31, 2017 Earn-out milestone liability (Note 12) $ 12,538,525 $ ─ $ ─ $ 12,538,525 Non-recurring items as of December 31, 2017 In process R&D (Note 5) $ 20,246,491 $ ─ $ ─ $ 20,246,491 |
Acquisition of EGEN, Inc.
Acquisition of EGEN, Inc. | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Acquisition of EGEN, Inc. | 5 On June 20, 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama corporation, which has changed its company name to EGWU, Inc. after the closing of the acquisition (“EGEN”), pursuant to an Asset Purchase Agreement dated as of June 6, 2014, by and between EGEN and Celsion (the “Asset Purchase Agreement”). We acquired all of EGEN’s right, title and interest in and to substantially all of the assets of EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits, equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. In addition, CLSN Laboratories assumed certain specified liabilities of EGEN, including the liabilities arising out of the acquired contracts and other assets relating to periods after the closing date. At the time of the acquisition, thew total purchase price for the asset acquisition was up to $44.4 million, including potential future earnout payments of up to $30.4 million contingent upon achievement of certain earnout milestones set forth in the Asset Purchase Agreement. We paid approximately $3.0 million in cash after the expense adjustment and issued 241,590 shares of our common stock to EGEN. The shares of common stock were issued in a private transaction exempt from registration under the Securities Act, pursuant to Section 4 (2) thereof. The following table summarizes the fair values of these assets acquired and liabilities assumed related to the acquisition. Property and equipment, net $ 35,000 In-process research and development 24,211,000 Other Intangible assets (Covenant not to compete) 1,591,000 Goodwill 1,976,000 Total assets: 27,813,000 Accounts payable and accrued liabilities (235,000 ) Net assets acquired $ 27,578,000 Acquired In-process Research and Development Acquired in-process research and development (IPR&D) consists of EGEN’s drug technology platforms: TheraPlas and TheraSilence. The fair value of the IPR&D drug technology platforms was estimated to be $24.2 million as of the acquisition date. As of the closing of the acquisition, the IPR&D was considered indefinite lived intangible assets and will not be amortized. IPR&D is reviewed for impairment at least annually as of our third quarter ended September 30, and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. At December 31, 2016, the Company determined one of the IPR&D assets related to the development of its RNA delivery system being developed with collaborators using their RNA product candidates may be impaired and after an assessment, the Company concluded that this asset, valued at $1.4 million, was impaired. Therefore, the Company wrote off the value of this IPR&D asset, incurring a non-cash charge of $1.4 million in the fourth quarter of 2016. At September 30, 2018 and 2017, after the Company’s annual assessments of the totality of the events that could impair IPR&D, the Company determined certain IPR&D assets related to the development of its glioblastoma multiforme cancer (GBM) product candidate may be impaired. To arrive at this determination, the Company assessed the status of studies in GBM conducted by its competitors and the Company’s strategic commitment of resources to its studies in primary liver cancer and ovarian cancer. The Company estimated the fair value of the IPR&D related to GBM at September 30, 2018 and 2017 using the multi-period excess earnings method (MPEEM). Significant unobservable assumptions used by the Company in the MPEEM model are potential FDA approval, commercialization dates, dosage pricing, profitability and present value factor. After its assessment on September 30, 2017, the Company concluded that the GBM asset, valued at $9.4 million, was partially impaired and wrote down the GBM asset to $6.9 million on September 30, 2017, incurring a non-cash charge of $2.5 million in the third quarter of 2017. After its assessment on September 30, 2018, the Company concluded that the GBM asset, valued at $6.9 million, was partially impaired and wrote down the GBM asset to $2.4 million on September 30, 2018, incurring a non-cash charge of $4.5 million in the third quarter of 2018. After recognizing the impairment related to the IPR&D costs of $4,510,000 in 2018 and $2,520,000 in 2017, the resulting carrying value of its IPR&D costs totaled $15,736,491 and $20,246,491 at December 31, 2018 and 2017, respectively. At September 30, 2018 and 2017, the Company evaluated its IPR&D of the ovarian cancer indication and concluded that it is not more likely than not that the asset is impaired. As no other indicators of impairment existed during the fourth quarter of 2018, the Company concluded none of the other IPR&D assets were impaired at December 31, 2018. The carrying amount of the ovarian cancer indication was $13.3 million at December 31, 2018 and 2017. Covenants Not To Compete Pursuant to the EGEN Purchase Agreement, EGEN provided certain covenants (“Covenant Not To Compete”) to the Company whereby EGEN agreed, during the period ending on the seventh anniversary of the closing date of the acquisition on June 20, 2014, not to enter into any business, directly or indirectly, which competes with the business of the Company nor will it contact, solicit or approach any of the employees of the Company for purposes of offering employment. The Covenant Not to Compete which was valued at approximately $1.6 million at the date of the EGEN acquisition has a definitive life and is amortized on a straight-line basis over its life of 7 years. The Company recognized amortization expense of $227,316 in 2018 and 2017. The carrying value of the Covenant Not to Compete was $568,292, net of $1,022,922 accumulated amortization, as of December 31, 2018 and $795,608, net of $795,606 accumulated amortization, respectively, as of December 31, 2017 Following is a schedule of future amortization amounts during the remaining life of the Covenant Not to Compete. Year Ended December 31, 2019 $ 227,316 2020 227,316 2021 113,660 Total $ 568,292 Goodwill The purchase price exceeded the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as Goodwill. Goodwill represents the difference between the total purchase price for the net assets purchased from EGEN and the aggregate fair values of tangible and intangible assets acquired, less liabilities assumed. Goodwill is reviewed for impairment at least annually as of our third quarter ended September 30 or sooner if we believe indicators of impairment exist. As of September 30, 2018, we concluded that the Company’s fair value exceeded its carrying value therefore “it is not more likely than not” that the Goodwill was impaired. As no other indicators of impairment existed during the fourth quarter of 2018, the Company concluded it is “not more likely than not” Goodwill was impaired. Following is a summary of the net fair value of the assets acquired in the EGEN acquisition for the two years ended December 31, 2018: IPR&D Goodwill Covenant Not To Compete Balance at January 1, 2017, net $ 22,766,491 $ 1,976,101 1,022,924 Amortization - - (227,316 ) Impairment charge (2,520,000 ) - - Balance at December 31, 2017, net 20,246,491 1,976,101 795,608 Amortization - - (227,316 ) Impairment charge (4,510,000 ) - - Balance at December 31, 2018, net 15,736,491 1,976,101 568,292 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 6. Year Ended December 31, 2018 2017 Machinery and equipment (5-7 year life) $ 2,596,170 $ 2,495,959 Furniture and fixtures (3-5 year life) 267,712 248,709 Leasehold improvements (5-7 year life) 289,004 269,819 3,152,886 3,014,487 Less accumulated depreciation and amortization (2,968,259 ) (2,838,716 ) Total $ 184,627 $ 175,771 |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | 7. Other accrued liabilities at December 31, 2018 2017 Year Ended December 31, 2018 2017 Amounts due to contract research organizations and other contractual agreements $ 749,369 $ 665,373 Accrued payroll and related benefits 1,592,590 1,258,265 Accrued professional fees 198,654 264,668 Other 45,285 94,521 Total $ 2,585,898 $ 2,282,827 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Notes Payable | 8. NOTES PAYABLE Horizon Credit Agreement On June 27, 2018, the Company entered into a loan agreement with Horizon Technology Finance Corporation (“Horizon”) that provided $10 million in new capital (the “Horizon Credit Agreement”). The Company drew down $10 million upon closing of the Horizon Credit Agreement on June 27, 2018. The Company will use the funding provided under the Horizon Credit Agreement for working capital and advancement of its product pipeline. The obligations under the Horizon Credit Agreement are secured by a first-priority security interest in substantially all assets of Celsion other than intellectual property assets. The obligations will bear interest at a rate calculated based on one-month LIBOR plus 7.625%. The effective interest rate at December 31, 2018 was 9.98%. Payments under the loan agreement are interest only for the first twenty-four (24) months after loan closing, followed by a 24-month amortization period of principal and interest through the scheduled maturity date. At its option, the Company can prepay all of the outstanding principal balance by prepaying the outstanding principal balance and an amount equal to 1-3% of the outstanding principal balance at that time, based on the amount of time prior to the maturity date of the notes. The Horizon Credit Agreement contains customary representations, warranties and affirmative and negative covenants including, among other things, covenants that limit or restrict Celsion’s ability to grant liens, incur indebtedness, make certain restricted payments, merge or consolidate and make dispositions of assets. Upon the occurrence of an event of default under the Horizon Credit Agreement, the lenders may cease making loans, terminate the Horizon Credit Agreement, declare all amounts outstanding to be immediately due and payable and foreclose on or liquidate Celsion’s assets that comprise the lenders’ collateral. The Horizon Credit Agreement specifies a number of events of default (some of which are subject to applicable grace or cure periods), including, among other things, non-payment defaults, covenant defaults, a material adverse effect on Celsion or its assets, cross-defaults to other material indebtedness, bankruptcy and insolvency defaults and material judgment defaults. As a fee in connection with the Horizon Credit Agreement, Celsion issued Horizon warrants exercisable for a total of 190,114 shares of Celsion’s common stock (the “Horizon Warrants”) at a per share exercise price of $2.63. The Horizon Warrants are immediately exercisable for cash or by net exercise from the date of grant and will expire after ten years from the date of grant. Celsion registered the Horizon Warrants on Form S-3 (File No. 333 - 227236) filed with the Securities and Exchange Commission on September 7, 2018 and declared effective on October 10, 2018. The Company valued the Horizon Warrants issued using the Black-Scholes option pricing model and recorded a total of $507,116 as a direct deduction from the debt liability consistent with the presentation of a debt discount and are being amortized as interest expense using the effective interest method over the life of the loan. In connection with the Horizon Credit Agreement, the Company incurred financing fees and expenses totaling $175,000 which are recorded and classified as debt discount. In addition, the Company paid loan origination fees of $100,000 which has been recorded and classified as debt discount. These debt discount amounts totaling $782,116 are being amortized as interest expense using the effective interest method over the life of the loan. Also, in connection with each of the Horizon Credit Agreements, the Company is required to pay an end of term charge equal to 4.0% of the original loan amount at time of maturity. Therefore, these amounts totaling $400,000 are being amortized as interest expense using the effective interest method over the life of the loan. During 2018, the Company incurred $512,872 in interest expense and amortized $199,153 respectively, as interest expense for debt discounts and end of term charges in connection with the Horizon Credit Agreement. Following is a schedule of future principle payments, net of unamortized debt discounts and amortized end of term charges, due on the Horizon Credit Agreement: For the year ending December 31, 2019 $ - 2020 - 2021 4,583,333 2022 5,000,000 2023 and thereafter 416,667 Subtotal of future principle payments 10,000,000 Unamortized debt issuance costs, net (582,963 ) Total $ 9,417,037 Hercules Credit Agreement In November 2013, the Company entered into a loan agreement with Hercules Technology Growth Capital, Inc. (Hercules) which permits up to $20 million in capital to be distributed in multiple tranches (the Hercules Credit Agreement). The Company drew the first tranche of $5 million upon closing of the Hercules Credit Agreement in November 2013 and used approximately $4 million of the proceeds to repay the outstanding obligations under its loan agreement with Oxford Finance LLC and Horizon Technology Finance Corporation as discussed further below. On June 10, 2014, the Company closed the second $5 million tranche under the Hercules Credit Agreement. The proceeds were used to fund the $3.0 million upfront cash payment associated with Celsion’s acquisition of EGEN, as well as the Company’s transaction costs associated with the EGEN acquisition. Upon the closing of the second tranche, the Company had drawn down a total of $10 million under the Hercules Credit Agreement. The obligations under the Hercules Credit Agreement were in the form of secured indebtedness bearing interest at a calculated prime-based variable rate (11.25% per annum since inception through December 17, 2015, 11.50% from December 18, 2015 through December 15, 2016 and 11.75% since). Payments under the loan agreement were interest only for the first twelve months after loan closing, followed by a 30 -month amortization period of principal and interest through the scheduled maturity date of June 1, 2017. In connection with the Hercules Credit Agreement, the Company incurred cash expenses of $122,378 which were recorded as deferred financing fees. These deferred financing fees were amortized as interest expense using the effective interest method over the life of the loan. In addition, the Company paid loan origination fees of $230,000 which has been classified as debt discount. This amount is being amortized as interest expense using the effective interest method over the life of the loan. As a fee associated with the Hercules Credit Agreement, the Company issued Hercules a warrant for a total of 6,963 shares of the Company’s common stock (the Hercules Warrant) at a per share exercise price of $50.26, exercisable for cash or by net exercise from November 25, 2013. Upon the closing of the second tranche on June 10, 2014, this warrant became exercisable for an additional 6,963 shares of the Company’s common stock. The Hercules Warrant expired on November 25, 2018. Hercules has certain rights to register the common stock underlying the Hercules Warrant pursuant to a Registration Rights Agreement with the Company dated November 25, 2013. The registration rights expired on the date when such stock may be sold under Rule 144 without restriction or upon the first-year anniversary of the registration statement for such stock, whichever is earlier. The common stock issuable pursuant to the Hercules Warrant was filed pursuant to Rule 415 under the Securities Act of 1933 on the Prospectus for Registration Statement No. 333 - 193936 and was declared effective on September 30, 2014. The Company valued the Hercules Warrants issued using the Black-Scholes option pricing model and recorded a total of $476,261 as a direct deduction from the debt liability consistent with the presentation of a debt discount and are being amortized as interest expense using the effective interest method over the life of the loan. Also, in connection with each of the $5.0 million tranches, the Company was required to pay an end of term charge equal to 3.5% of each original loan amount at time of maturity. Therefore, these amounts totaling $350,000 were amortized as interest expense using the effective interest method over the life of the loan. The loan balance and end of term charges on the Hercules Credit Agreement was paid in full in June 2017. For 2017, the Company incurred $56,386 in interest expense and amortized $35,370 as interest expense for deferred fees, debt discount and end of term charges in connection with the Hercules Credit Agreement. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. INCOME TAXES On December 22, 2017, the President of the United States signed into law the Tax Reform Act. The Tax Reform Act significantly changes U.S. tax law by, among other things, lowering corporate income tax rates, implementing a quasi-territorial tax system, providing a one -time transition toll charge on foreign earnings, creating a new limitation on the deductibility of interest expenses and modifying the limitation on officer compensation. The Tax Reform Act permanently reduces the U.S. corporate income tax rate from a maximum of 35% to a flat 21% rate, effective January 1, 2018. The income tax provision (benefit) for the years ended December 31, 2018 and 2017 consists of the following: 2018 2017 Federal Current $ - $ - Deferred - - State and Local - - Current (10,419,000 ) - Deferred - - Effective tax rate $ (10,419,000 ) - A reconciliation of the Company’s statutory tax rate to the effective rate for the years ended December 31, 2018 and 2017 is as follows: 2018 2017 Federal statutory rate 21.0 % 21.0 % State taxes, net of federal tax benefit 36.9 6.6 Permanent differences (3.8 ) - Other (9.4 ) - Change in valuation allowance and deferred rate change, net 2.0 (27.6 ) Effective tax rate 46.7 % - % The components of the Company’s deferred tax asset as of December 31, 2018 and 2017 are as follows: December 31, 2018 2017 Net operating loss carryforwards $ 51,498,000 $ 62,216,000 Other Deferred tax assets, net 1,092,000 2,415,000 Subtotal 52,590,000 64,631,000 Valuation allowance (52,590,000 ) (64,631,000 ) Total deferred tax asset $ - $ - The evaluation of the realizability of such deferred tax assets in future periods is made based upon a variety of factors that affect the Company’s ability to generate future taxable income, such as intent and ability to sell assets and historical and projected operating performance. At this time, the Company has established a valuation reserve for all of its deferred tax assets. Such tax assets are available to be recognized and benefit future periods. As of December 31, 2018, the Company had net operating losses of approximately $229.7 million of which $222.2 million, if unused, will expire starting in 2023 through 2037. The Federal net operating loss generated for the year ended December 31, 2018 of approximately $7.5 million can be carried forward indefinitely. However, the deduction for net operating losses incurred in tax years beginning after January 1, 2018 is limited to 80% of annual taxable income During 2018, 2017 and in prior years, the Company performed analyses to determine if there were changes in ownership, as defined by Section 382 of the Internal Revenue Code that would limit its ability to utilize certain net operating loss and tax credit carry forwards. The Company determined that it experienced ownership changes, as defined by Section 382, in connection with certain common stock offerings in July 2011, February 2013, June 2013, June 2015, February 2017, June 2017, October 2017 and August 2018. As a result, the utilization of the Company’s federal tax net operating loss carry forwards generated prior to the ownership changes are limited. As of December 31, 2018, the Company has net operating loss carry forwards for U.S. federal and state tax purposes of approximately $233 million, before excluding net operating losses that have been limited as a result of Section 382 limitations. The annual limitation due to Section 382 for net operating loss carry forward utilization is approximately $4.2 million per year for approximately $90 million in net operating loss carry forwards existing at the ownership change occurring in July 2011, approximately $1.4 million per year for approximately $34 million of additional net operating losses occurring from July 2011 to the ownership change that occurred in February 2013, approximately $1.5 million per year for approximately $4 million of additional net operating losses occurring from February 2013 to the ownership change that occurred in June 2013, approximately $1.6 million per year for approximately $40 million of additional net operating losses occurring from June 2013 to the ownership change that occurred in June 2015, approximately $0.3 million per year for approximately $35 million of additional net operating losses occurring from June 2015 to the ownership change that occurred in February 2017, approximately $0.3 million per year for approximately $7 million of additional net operating losses occurring from February 2017 to the ownership change that occurred in June 2017, approximately $0.8 million per year for approximately $5 million of additional net operating losses occurring from June 2017 to the ownership change that occurred in October 2017, and approximately $1.5 million per year for approximately $30 million of additional net operating losses occurring from October 2017 to the ownership change that occurred in August 2018. The utilization of these net operating loss carry forwards may be further limited if the Company experiences future ownership changes as defined in Section 382 of the Internal Revenue Code. Sale of New Jersey Net Operating Losses The Company received approval to sell a portion of the Company’s New Jersey NOLs as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other companies. In December 2018, the Company received cash proceeds of $10.4 million from the sale of NOLs. Such proceeds are reflected as a tax benefit for the year ended December 31, 2018. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 10. STOCKHOLDERS’ EQUITY In September 2018, the Company filed with the SEC a new $75 million shelf registration statement on Form S-3 (the 2018 Shelf Registration Statement) (File No. 333-227236) that allows the Company to issue any combination of common stock, preferred stock or warrants to purchase common stock or preferred stock. This shelf registration was declared effective on October 12, 2018 and will expire three years from that date. Increase in the Number of Authorized Shares At the 2016 Annual Meeting of Stockholders of the Company in June 2016, the Company’s stockholders approved an increase in the number of the authorized shares of the Company’s common stock from 75,000,000 shares to 112,500,000 shares. The number of the authorized shares of preferred stock remains at 100,000 shares. The aggregate number of shares of all classes of stock that the Company may issue, after giving effect to such amendment as approved by the stockholders, will be 112,600,000 shares. Reverse Stock Split On May 26, 2017, the Company effected a 14-for-1 reverse stock split of its common stock which was made effective for trading purposes as of the commencement of trading on May 30, 2017. As of that date, each 14 shares of issued and outstanding common stock and equivalents was consolidated into one share of common stock. All shares have been restated to reflect the effects of the 14 -for- 1 reverse stock split. In addition, at the market open on May 30, 2017, the Company’s common stock started trading under a new CUSIP number 15117N503 although the Company’s ticker symbol, CLSN, remained unchanged. The reverse stock split was previously approved by the Company’s stockholders at the 2017 Annual Meeting held on May 16, 2017, and the Company subsequently filed a Certificate of Amendment to its Certificate of Incorporation to effect the stock consolidation. The primary reasons for the reverse stock split and the amendment are: ● To increase the market price of the Company’s common stock making it more attractive to a broader range of institutional and other investors, and ● To provide the Company with additional capital resources and flexibility sufficient to execute its business plans including the establishment of strategic relationships with other companies and to ensure its ability to raise additional capital as necessary. Immediately prior to the reverse stock split, the Company had 56,982,418 shares of common stock outstanding which consolidated into 4,070,172 shares of the Company’s common stock. No fractional shares were issued in connection with the reverse stock split. Holders of fractional shares have been paid out in cash for the fractional portion with the Company’s overall exposure for such payouts consisting of a nominal amount. The number of outstanding options and warrants were adjusted accordingly, with outstanding options being reduced from approximately 2.4 million to approximately 0.2 million and outstanding warrants being reduced from approximately 33.5 million to approximately 2.4 million. October 2017 Underwritten Offering On October 27, 2017, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer& Co. Inc. (the “Underwriter”), relating to the issuance and sale (the “Offering”) of 2,640,000 shares (the “Shares”) of the Company’s common stock, $0.01 par value per share (the “Common Stock”), and warrants to purchase an aggregate of 1,320,000 shares of Common Stock. Each share of Common Stock is being sold together with 0.5 warrants (the “Investor Warrants”), each whole Investor Warrant being exercisable for one share of Common Stock, at an offering price of $2.50 per share and related Investor Warrants. Pursuant to the terms of the Underwriting Agreement, the Underwriter agreed to purchase the Shares and related Investor Warrants from the Company at a price of $2.325 per share and related Investor Warrants. Each Investor Warrant is exercisable six months from the date of issuance. The Investor Warrants have an exercise price of $3.00 per whole share and expire five years from the date first exercisable. On October 26, 2018, the Company and the holders of the Investor Warrants entered into Warrant Exchange Agreements (the “Exchange Agreements”) whereby each of the holders of the Investor Warrants elected to surrender Investor Warrants, representing 1,320,000 shares of Common Stock collectively. In exchange for the surrender of the Investor Warrants, these holders received 820,714 shares of Common Stock. In connection with this exchange and the exchange discussed below with 321,428 warrants from the February 14, 2017 Public Offering, the Company incurred approximately $130,000 of broker and legal fees which are presented as a component of stockholders equity. The Company received $6.6 million of gross proceeds from the sale of the Shares and Investor Warrant. This Offering was made pursuant to the Company’s effective shelf registration statement on Form S- 3 (File No. 333 - 206789) filed with the Securities and Exchange Commission on September 4, 2015, and declared effective on September 25, 2015, including the base prospectus dated September 25, 2017 included therein and the related prospectus supplement. The Company also issued to the Underwriter warrants to purchase up to 66,000 shares of the Company’s common stock, such issuance being exempt from registration pursuant to Section 4 (a)(2) of the Securities Act. Each Underwriter warrant is exercisable six months from the date of issuance, have an exercise price of $2.87 per whole share, and expire five years from the date first exercisable. July 6, 2017 Common Stock Offering On July 6, 2017, the Company entered into a securities purchase agreement with several investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering, an aggregate of 2,050,000 shares of common stock of the Company at an offering price of $2.07 per share for gross proceeds of $4,243,500 before the deduction of the placement agent fee and offering expenses. In addition, the Company sold Pre-Funded Series CCC Warrants to purchase 385,000 shares of common stock (and the shares of common stock issuable upon exercise of the Pre-Funded Series CCC Warrants), in lieu of shares of common stock to the extent that the purchase of common stock would cause the beneficial ownership of the Purchaser, together with its affiliates and certain related parties, to exceed 9.99% of our common stock. The Pre-Funded Series CCC Warrants were sold at an offering price of $2.06 per share for gross proceeds of $793,100, are immediately exercisable for $0.01 per share of common stock and do not have an expiration date. In a concurrent private placement, the Company agreed to issue to each investor, for each share of common stock and pre-funded warrant purchased in the offering, a Series AAA Warrant and Series BBB Warrant, each to purchase one share of common stock. The Series AAA Warrants are initially exercisable six months following issuance and terminate five and one-half years following issuance. The Series AAA Warrants have an exercise price of $2.07 per share and are exercisable to purchase an aggregate of 2,435,000 shares of common stock. The Series BBB Warrants are immediately exercisable following issuance and terminate twelve months following issuance. The Series BBB Warrants have an exercise price of $4.75 per share and are exercisable to purchase an aggregate of 2,435,000 shares of common stock. Subject to limited exceptions, a holder of a Series AAA and Series BBB Warrant will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. During the fourth quarter of 2017, all 385,000 of the Series CCC Pre-Funded warrants were exercised in full. On October 4, 2017, the Company entered into letter agreements (the “Exercise Agreements”) with the holders of the Series AAA and Series BBB Warrants issued in the July 6, 2017 Common Stock Offering (the “Exercising Holders”). The Exercise Agreements amended the Series AAA Warrants to permit their immediate exercise. Prior to the execution of the Exercise Agreements, the Series AAA Warrants were not exercisable until January 11, 2018. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that the Exercising Holders would exercise all of their Existing Warrants with respect to 4,665,000 shares of Common Stock underlying such Existing Warrants. The Series AAA Warrants and Series BBB Warrants were exercised at a price of $2.07 per share and $4.75 per share, respectively, which were their respective original exercise prices. The Company received approximately $16.6 million in gross proceeds from the sale of these warrants. The Exercise Agreements amended the Series AAA Warrants to permit their immediate exercise. Prior to the execution of the Exercise Agreements, the Series AAA Warrants were not exercisable until January 11, 2018. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that the Exercising Holders would exercise all of their Existing Warrants with respect to 4,665,000 shares of Common Stock underlying such Existing Warrants. The Series AAA Warrants and Series BBB Warrants were exercised at a price of $2.07 per share and $4.75 per share, respectively, which were their respective original exercise prices. The Company received approximately $16.6 million in gross proceeds from the sale of these warrants. The Exercise Agreements also provide for the issuance of 1,166,250 Series DDD Warrants, each to purchase one share of Common Stock (the “Series DDD Warrants”). The Series DDD Warrants have an exercise price $6.20, are exercisable one year following issuance and terminate six months after they are initially exercisable. The Series DDD Warrants and the shares of Common Stock issuable upon the exercise of the Series DDD Warrants were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act or Rule 506(b) promulgated thereunder. Pursuant to the Exercise Agreements, the Series DDD Warrants shall be substantially in the form of the Existing Warrants and the Company will be required to register for resale the shares of Common Stock underlying the Series DDD Warrants. February 14, 2017 Public Offering On February 14, 2017, the Company entered into a securities purchase agreement whereby it sold, in a public offering (the “February 2017 Public Offering”), an aggregate of 1,384,704 shares of common stock of the Company at an offering price of $3.22 per share. In addition, the Company sold Series AA Warrants (the “Series AA Warrants”) to purchase up to 1,177,790 shares of common stock and Pre-Funded Series BB Warrants (the “Pre-Funded Series BB Warrants”) to purchase up to 185,713 shares of common stock. The Series AA Warrants have an exercise price of $3.22 per share, have a five-year life and are immediately exercisable. The Pre-Funded Series BB Warrants were offered at $3.08 per share, were immediately exercisable for $0.14 per share of common stock, do not have an expiration date and were issued in lieu of shares of common stock to the extent that the purchase of common stock would cause the beneficial ownership of the purchaser of such shares, together with its affiliates and certain related parties, to exceed 9.99% of our common stock. The Company received approximately $5.0 million in gross proceeds before the deduction of the placement agent fees and offering expenses (excluding any proceeds from the exercise of the warrants) in the February 2017 Public Offering. Concurrently with the exchange agreements associated with the Investor Warrants discussed above on October 26, 2018, the Company and certain holders of the Series AA Warrants entered into Exchange Agreements whereby certain holders of the Series AA Warrants elected to surrender their Series AA Warrants, representing 321,428 shares of Common Stock collectively. In exchange for the surrender of their Series AA Warrants, these holders received 160,414 shares of Common Stock. Collectively the Company incurred broker and legal fees of approximately $0.1 million associated with the Exchange Agreements and recorded these as costs of equity financing and charged against additional paid-in capital. In connection with the February 2017 Public Offering, the Company filed with the SEC a registration statement on Form S-1 (Registration No. 333-215321) on December 23, 2016, as amended by Pre-Effective Amendment No. 1 filed with the Commission on January 20, 2017, as further amended by Pre-Effective Amendment No. 2 filed with the Commission on February 13, 2017, as further amended by Pre-Effective Amendment No. 3 filed with the Commission on February 13, 2017 and as further amended by Pre-Effective Amendment No. 4 filed with the Commission on February 14, 2017 for the registration of the securities issued and sold under the Securities Act of 1933, as amended. As of December 31, 2017, all 185,713 of the Series BB Pre-Funded warrants were exercised in full. During 2017, we received approximately $2.4 million from the exercise of Series AA Warrants to purchase 747,254 shares of common stock. Reduced Exercise Price of Warrants On February 22, 2013, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company agreed, among other things, to issue warrants (the “2013 Warrants”) to purchase up to 95,811 shares of our common stock at an exercise price of $74.34 per share to such investors in a registered direct offering. On January 15, 2014, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company agreed, among other things, to issue warrants (the “2014 Warrants”) to purchase up to 64,348 shares of our common stock at an exercise price of $57.40 per share to such investors in a registered direct offering. On June 9, 2017, the Company entered into warrant exercise agreements (the “Exercise Agreements”) with certain holders of the 2013 Warrants, the 2014 Warrants and the June 2016 Warrants (the “Exercising Holders”), which Exercising Holders own, in the aggregate, warrants exercisable for 790,410 shares of our common stock. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that the Exercising Holders would exercise their 2013 Warrants, the 2014 Warrants and the June 2016 Warrants with respect to 790,410 shares of our common stock underlying such warrants for a reduced exercise price equal to $2.70 per share. The Company received aggregate gross proceeds of approximately $2.1 million from the exercise of the 2013 Warrants, the 2014 Warrants and the June 2016 Warrants by the Exercising Holders. The reduced exercise price of the 2013 Warrants, the 2014 Warrants and the June 2016 Series C Warrants increased the fair value of the warrants by approximately $0.2 million. This increase in fair value is recorded as a deemed dividend in additional paid in capital due to the retained deficit and it increased the net loss available to common shareholders on the consolidate statement of operations. On May 27, 2015, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company agreed, among other things, to issue warrants (the “2015 Warrants”) to purchase up to 139,284 shares of the Company’s common stock at an exercise price of $36.40 per share, to such investors in a registered direct offering. Between June 22, 2017 through June 26, 2017, the Company and holders of the 2015 Warrants and the December 2016 Warrants (the “Exercising Investors”) entered into agreements whereby the Company agreed that the Exercising investors would exercise their 2015 Warrants and the June 2016 Warrants with respect to 506,627 shares of our common stock underlying such warrants for a reduced exercise price equal to $1.65 per share. The Company received aggregate gross proceeds of approximately $0.8 million from the exercise of the 2015 Warrants and the June 2016 Warrants by the Exercising Investors. The reduced exercise price of the 2015 Warrants increased the fair value of the warrants by approximately $0.1 million. This increase in fair value is recorded as a deemed dividend in additional paid in capital due to the retained deficit and it increased the net loss available to common shareholders on the consolidate statement of operations. Aspire Purchase Agreement On August 31, 2018, we entered into a common stock purchase agreement (the “Aspire Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $15.0 million of shares of the Company’s common stock over the 24-month term of the Aspire Purchase Agreement. On October 12, 2018, the Company filed with the SEC a prospectus supplement to the 2018 Shelf Registration Statement registering all of the shares of common stock that may be offered to Aspire Capital from time to time. Under the Aspire Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a “Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 100,000 shares of the Company’s common stock per business day, up to $15.0 million of the Company’s common stock in the aggregate at a per share price (the “Purchase Price”) equal to the lesser of: ● the lowest sale price of the Company’s common stock on the purchase date; or ● the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date. The Company and Aspire Capital also may mutually agree to increase the number of shares that may be sold to as much as an additional 2,000,000 shares per business day. In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to at least 100,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on its principal market on the next trading day (the “VWAP Purchase Date”), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company’s common stock traded on its principal market on the VWAP Purchase Date. The Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the Purchase Price. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed. There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of the Company’s common stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future funding, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 164,835 shares of the Company’s common stock (the “Commitment Shares”). The Company’s policy is to record specific incremental costs directly attributable to an offering as a charge against the gross proceeds, if any, when the offering becomes effective. These Commitment Shares valued at $450,000 were recorded in September 2018 as costs of equity financing and charged against additional paid-in capital. The Aspire Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company. Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Company’s common stock during any time prior to the termination of the Purchase Agreement. Any proceeds from the Company receives under the Aspire Purchase Agreement are expected to be used for working capital and general corporate purposes. During 2018 and as of December 31, 2018, the Company sold and issued an aggregate of 100,000 shares under the Purchase Agreement, receiving approximately $0.2 million. During 2019 and as of March 28, 2019, the Company sold and issued an aggregate of 600,000 shares under the Purchase Agreement, receiving approximately $1.3 million. Capital on Demand TM On December 4, 2018, the Company entered into a Capital on Demand TM The Company is not obligated to sell any Common Stock under the Capital on Demand Agreement and, subject to the terms and conditions of the Capital on Demand Agreement, JonesTrading will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of The NASDAQ Capital Market, to sell Common Stock from time to time based upon Celsion’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose. Under the Capital on Demand Agreement, JonesTrading may sell Common Stock by any method deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Capital on Demand Agreement will terminate upon the earlier of (i) the sale of all shares of our common stock subject to the Sales Agreement, and (ii) the termination of the Capital on Demand Agreement by JonesTrading or Celsion. The Capital on Demand Agreement may be terminated by JonesTrading or the Company at any time upon 10 days’ notice to the other party, or by JonesTrading at any time in certain circumstances, including the occurrence of a material adverse change in the Company. The Company will pay JonesTrading a commission of 3.0% of the aggregate gross proceeds from each sale of Common Stock and has agreed to provide JonesTrading with customary indemnification and contribution rights. The Shares will be issued pursuant to Celsion’s previously filed and effective Registration Statement on Form S-3 (File No. 333-227236), the base prospectus dated October 12, 2018, filed as part of such Registration Statement, and the prospectus supplement dated December 4, 2018, filed by Celsion with the Securities and Exchange Commission. The Company did not sell any shares under the Capital on Demand Agreement as of December 31, 2018. During 2019 and as of March 28, 2019, the Company sold and issued an aggregate of 122,186 shares under the Capital on Demand Agreement, receiving approximately $0.3 million. Controlled Equity Offering On February 1, 2013, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which Celsion could offer and sell, from time to time, through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (the “ATM Shares”) pursuant to the 2015 Shelf Registration Statement. Under the ATM Agreement, Cantor may sell ATM Shares by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The NASDAQ Capital Market, on any other existing trading market for our common stock or to or through a market maker. On October 10, 2018, the Company delivered notice to Cantor terminating the ATM effective as of October 20, 2018. The Company has no further obligations under the Sales Agreement. During 2018, the Company received approximately $1.2 million in proceeds from the sale of 457,070 shares of common stock under the ATM Agreement and during 2017, it received approximately $3.9 million in proceeds from the sale of 1,221,348 shares of common stock under the ATM Agreement. From February 1, 2013 through September 30, 2018, the Company sold and issued an aggregate of 1,784,396 shares of common stock under the ATM Agreement, receiving approximately $12.8 million in gross proceeds. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 11. STOCK-BASED COMPENSATION The Company has long-term compensation plans that permit the granting of equity based-awards in the form of stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, and performance awards. At the 2018 Annual Stockholders Meeting of the Company held on May 15, 2018, stockholders approved the Celsion Corporation 2018 Stock Incentive Plan (the “2018 Plan”). The 2018 Plan, as adopted, permits the granting of 2,700,000 shares of Celsion common stock as equity awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, performance awards, or in any combination of the foregoing. Prior to the adoption of the 2018 Plan, the Company had maintained the Celsion Corporation 2007 Stock Incentive Plan (the 2007 Plan). The 2007 Plan permitted the granting of 688,531 shares of Celsion common stock as equity awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, phantom stock, performance awards, or in any combination of the foregoing. The 2018 Plan replaced the 2007 Plan although the 2007 Plan remains in effect for awards previously granted under the 2007 Plan. Under the terms of the 2018 Plan, any shares subject to an award under the 2007 Plan which are not delivered because of the expiration, forfeiture, termination or cash settlement of the award will become available for grant under the 2018 Plan. The Company has issued stock awards to employees and directors in the form of stock options and restricted stock. Options are generally granted with strike prices equal to the fair market value of a share of Celsion common stock on the date of grant. Incentive stock options may be granted to purchase shares of common stock at a price not less than 100% of the fair market value of the underlying shares on the date of grant, provided that the exercise price of any incentive stock option granted to an eligible employee owning more than 10% of the outstanding stock of Celsion must be at least 110% of such fair market value on the date of grant. Only officers and key employees may receive incentive stock options. Option and restricted stock awards vest upon terms determined by the Compensation Committee of the Board of Directors and are subject to accelerated vesting in the event of a change of control or certain terminations of employment. The Company issues new shares to satisfy its obligations from the exercise of options or the grant of restricted stock awards. On September 28, 2018, the Compensation Committee of the Board of Directors approved the grant of (i) inducement stock options (the “Inducement Option Grants”) to purchase a total of 164,004 shares of Celsion common stock and (ii) inducement restricted stock awards (the “Inducement Stock Grants”) totaling 19,000 shares of Celsion common stock to three new employees. All awards have a grant date of September 28, 2018. Each of Inducement Option Grant has an exercise price per share equal to $2.77, the closing price of Celsion’s common stock as reported by Nasdaq on September 28, 2018. Each Inducement Option Grant will vest over three years, with one-third vesting on the one-year anniversary of the employee’s first day of employment with the Company and one-third vesting on the second and third anniversaries thereafter, subject to the new employee’s continued service relationship with the Company on each such date. Each Inducement Option Grant has a ten-year term and is subject to the terms and conditions of the applicable stock option agreement. Each of Inducement Stock Grant will vest on the one-year anniversary of the employee’s first day of employment with the Company and are subject to the new employee’s continued service relationship with the Company through such date and is subject to the terms and conditions of the applicable restricted stock agreement. As of December 31, 2018, there were a total of 3,399,893 shares of Celsion common stock reserved for issuance under the 2018 Plan, which were comprised of 3,064,741 shares of Celsion common stock subject to equity awards previously granted under the 2018 Plan and 2007 Plan and 335,152 shares of Celsion common stock available for future issuance under the 2018 Plan. As of December 31, 2018, there were a total of 106,502 of Celsion common stock subject to outstanding inducement awards. Total compensation cost charged related to stock options and restricted stock awards amounted to $4.6 million and $1.1 million during 2018 and 2017, respectively as was recognized in operating expenses. As of December 31, 2018, there was $1.8 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements. That cost is expected to be recognized over a weighted-average period of 0.9 years. The weighted average grant date fair values of the stock options granted during 2018 and 2017 was $2.36 and 2.32, respectively. A summary of stock option awards as of December 31, 2018 and changes during the two-year period ended December 31, 2018 is presented below: Stock Options Number Outstanding Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2017 211,213 $ 61.59 Granted 535,964 $ 2.69 Canceled or expired (43,735 ) $ 164.12 Outstanding at December 31, 2017 703,442 $ 10.34 Granted 2,629,004 $ 2.26 Canceled or expired (183,703 ) $ 25.96 Outstanding at December 31, 2018 3,148,743 $ 2.67 9.2 $ - Exercisable at December 31, 2018 1,689,902 $ 2.97 9.1 $ - A summary of the status of the Company’s non-vested restricted stock awards as of December 31, 2018 and changes during the two year period ended December 31, 2018, is presented below: Restricted Stock Number Outstanding Weighted Average Grant Date Fair Value Non-vested stock awards outstanding at January 1, 2017 4,785 $ 37.42 Granted (3,357 ) $ 42.20 Vested and issued (1,428 ) $ 26.18 Non-vested stock awards outstanding at December 31, 2017 - $ - Granted 35,000 $ 2.71 Vested and issued (6,000 ) $ 2.77 Forfeited (6,500 ) $ 2.64 Non-vested stock awards outstanding at December 31, 2018 22,500 $ 2.72 A summary of stock options outstanding at December 31, 2018 by price range is as follows: Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Number Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Up to $5.00 3,084,252 9.2 $ 2.34 1,625,807 9.2 $ 2.34 Above $5.00 to $81.90 64,491 7.0 $ 19.00 64,095 7.0 $ 19.00 3,148,743 1,689,902 The fair values of stock options granted were estimated at the date of grant using the Black-Scholes option pricing model. The Black-Scholes model was originally developed for use in estimating the fair value of traded options, which have different characteristics from Celsion’s stock options. The model is also sensitive to changes in assumptions, which can materially affect the fair value estimate. The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model: Year Ended December 31, 2018 2017 Risk-free interest rate 2.82 to 3.02 % 2.21 to 2.32 % Expected volatility 99.9 - 102.12 % 90.4 - 100.8 % Expected life (in years) 8.5 to 10 10 Expected dividend yield 0.0 % 0.0 % Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. Starting in 2017, the Company made the election to account for forfeitures when they occur. |
Earn-out Milestone Liability
Earn-out Milestone Liability | 12 Months Ended |
Dec. 31, 2018 | |
Earn-out Milestone Liability | |
Earn-out Milestone Liability | 12. EARN-OUT MILESTONE LIABILITY The total aggregate purchase price for the EGEN Acquisition included potential future Earn-out Payments contingent upon achievement of certain milestones. The difference between the aggregate $30.4 million in future Earn-out Payments and the $13.9 million included in the fair value of the acquisition consideration at June 20, 2014 was based on the Company’s risk-adjusted assessment of each milestone (10% to 67%) and utilizing a discount rate based on the estimated time to achieve the milestone (1.5 to 2.5 years). The earn-out milestone liability will be fair valued at the end of each quarter and any change in their value will be recognized in the financial statements. At December 31, 2018, the Company fair valued the earn-out milestone liability at $8.9 million and recognized a non-cash gain of $3.6 million during 2018 as a result of the change in the fair value of earn-out milestone liability of $12.5 million at December 31, 2017. Included in the non-cash gain during 2018, was the reduction of the liability by $3.9 million during the third quarter of 2017 related to the write down of one of the in-process research and development assets (see Note 5) as the Company believes there is a de minimis probability of the payout of the related earn-out milestone liabilities. The fair value of the remaining earn-out milestone liabilities at December 31, 2018 was based on the Company’s risk-adjusted assessment of each milestone (80%) utilizing a discount rate based on the estimated time to achieve the milestone (1.25 years). At December 31, 2017, the Company fair valued the earn-out milestone liability at $12.5 million and recognized a non-cash gain of $0.6 million during 2017 as a result of the change in the fair value of earn-out milestone liability of $13.2 million at December 31, 2016. The non-cash gain during 2017 resulted from the reduction of the liability by $1.4 million during the third quarter of 2017 related to the partial write down of one of the in-process research and development assets (see Note 5) as the Company believes there is a reduced probability of the payout of the related earn-out milestone liabilities. The fair value of the remaining earn-out milestone liabilities at December 31, 2017 was based on the Company’s risk-adjusted assessment of each milestone (50% to 80%) utilizing a discount rate based on the estimated time to achieve the milestone (1.3 to 1.5 years). The following is a summary of the changes in the earn-out milestone liability for 2017 and 2018: Balance at January 1, 2017 $ 13,188,226 Non-cash gain from the adjustment for the change in fair value included in 2017 net loss (649,701 ) Balance at December 31, 2017 12,538,525 Non-cash gain from the adjustment for the change in fair value included in 2018 net loss (3,630,861 ) Balance at December 31, 2018 $ 8,907,664 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2018 | |
Notes To Financial Statements [Abstract] | |
Warrants | 13. WARRANTS As more fully described in Notes 8 and 10, the Company completed a series of equity and debt financing transactions in 2018 and 2017 that included the issuance of warrants to purchase 190,114 and 9,231,628 shares, respectively, of the Company’s common stock. During 2018, the Company and certain investors holding warrants to collectively purchase 1.6 million shares of the Company’s common stock, which were received in the February 2017 Public Offering and the October 2017 Underwritten Offering, entered into warrant exchange agreements whereby the Company issued 820,714 shares of its common stock in exchange for the cancellation of the warrants. Investors exercised warrants to purchase 7,617,148 shares of common stock providing $22.0 million in gross proceeds to the Company during 2017. Warrants to purchase 13,927 and 44,037 shares of common stock expired during 2018 and 2017, respectively. After the warrant exchange, warrants outstanding totaled approximately 1.6 million with a weighted average exercise price of $5.75 per share as of December 31, 2018. Approximately 1.2 million of these outstanding warrants with a strike price of $6.20 per share will expire on April 4, 2019. Following is a summary of all warrant activity for the two years ended December 31, 2018: Warrants Number of Warrants Issued Weighted Average Exercise Price Warrants outstanding at January 1, 2017 1,487,958 $ 9.39 Warrants issued in connection with 2017 equity transactions 9,231,628 $ 3.46 Warrants exercised during 2017 (7,617,147 ) $ 2.89 Warrants expired during 2017 (44,037 ) $ 209.23 Warrants outstanding at December 31, 2017 3,058,402 $ 5.29 Warrants issued in connection with 2018 debt transaction 190,114 $ 2.63 Warrants cancelled in exchange for common stock (1,641,427 ) $ 3.04 Warrants expired during 2018 (13,927 ) $ 226.24 Warrants outstanding and exercisable at December 31, 2018 1,593,162 $ 5.36 Aggregate intrinsic value of outstanding warrants at December 31, 2018 $ - Weighted average remaining contractual terms (years) 1.87 |
Celsion Employee Benefit Plans
Celsion Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Defined Benefit Plan [Abstract] | |
Celsion Employee Benefit Plans | 14. CELSION EMPLOYEE BENEFIT PLANS Celsion maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code. The plan covers substantially all employees over the age of 21. Participating employees may defer a portion of their pretax earnings, up to the IRS annual contribution limit. The Company makes a matching contribution up to a maximum of 3% of an employee’s annual salary. The Company’s total matching contributions for the years ended December 31, 2018 and 2017 was $93,948 and $77,352 respectively. During 2018 and 2017, the Company also provided a discretionary contribution totaling $181,999 and $172,497, respectively, which represented 6% of each eligible participant’s annual salary in each of 2018 and 2017. These amounts were paid in January in each of the subsequent years. |
Licenses of Intellectual Proper
Licenses of Intellectual Property and Patents | 12 Months Ended |
Dec. 31, 2018 | |
Intangible Assets, Net (Including Goodwill) [Abstract] | |
Licenses of Intellectual Property and Patents | 15. LICENSES OF INTELLECTUAL PROPERTY AND PATENTS On November 10, 1999, the Company entered into a license agreement with Duke University (“Duke”) under which the Company received worldwide exclusive rights (subject to certain exceptions) to commercialize and use Duke’s thermally sensitive liposome technology. The license agreement contains annual royalty and minimum payment provisions due on net sales. The agreement also required milestone-based royalty payments measured by various events, including product development stages, FDA applications and approvals, foreign marketing approvals and achievement of significant sales. However, in lieu of such milestone-based cash payments, Duke agreed to accept shares of the Company’s common stock to be issued in installments at the time each milestone payment is due, with each installment of shares to be calculated at the average closing price of the common stock during the 20 trading days prior to issuance. The total number of shares issuable to Duke under these provisions is subject to adjustment in certain cases, and Duke has piggyback registration rights for public offerings taking place more than one year after the effective date of the license agreement. On January 31, 2003, the Company issued 253,691 shares of common stock to Duke University valued at $2.2 million as payment for milestone-based royalties under this license agreement. An amendment to the Duke license agreement contains certain development and regulatory milestones, and other performance requirements that the Company has met with respect to the use of the licensed technologies. The Company will be obligated to make royalty payments based on sales to Duke upon commercialization, until the last of the Duke patents expire. For the years ended December 31, 2018 and 2017, the Company has not incurred any expense under this agreement and will not incur any future liabilities until commercial sales commence. Under the November 1999 license agreement with Duke, the Company has rights to the thermally sensitive liposome technology, including Duke’s U.S. patents covering the technology as well as all foreign counter parts and related pending applications. Foreign counterpart applications have been issued in the EU, Hong Kong, Australia and Canada and have been allowed in Japan. The EU patent has been validated in Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg, Monaco, Spain and Switzerland. In addition, the Duke license agreement provides the Company with rights to multiple issued and pending U.S. patents related to the formulation, method of making and use of heat sensitive liposomes. The Company’s rights under the license agreement with Duke extend for the life of the last-to-expire of the licensed patents. The Company has licensed from Valentis, CA certain global rights covering the use of pegylation for temperature sensitive liposomes. In addition to the rights available to the Company under completed or pending license agreements, the Company is actively pursuing patent protection for technologies developed by the Company. Among these patents is a family of pending US and international patent applications which seek to protect the Company’s proprietary method of storing ThermoDox® which is critical for worldwide distribution channels. ThermoDox® is a registered trademark in the U.S., Argentina, Australia, Canada, China, Columbia, the EU Member States: (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Korea, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the United Kingdom), Hong Kong, Israel, Japan, New Zealand, Peru, Philippines, Russia, Singapore, South Korea and Taiwan. The Company has registered transliterations of ThermoDox® in China, Hong Kong, Japan, Singapore, South Korea and Taiwan. The Company has an additional 14 trademark protection applications pending for ThermoDox® in countries world-wide. Finally, through proprietary information agreements with employees, consultants and others, the Company seeks to protect its own proprietary know-how and trade secrets. The Company cannot offer assurances that these confidentiality agreements will not be breached, that the Company will have adequate remedies for any breach, or that these agreements, even if fully enforced, will be adequate to prevent third-party use of the Company’s proprietary technology. Similarly, the Company cannot guarantee that technology rights licensed to it by others will not be successfully challenged or circumvented by third parties, or that the rights granted will provide the Company with adequate protection. |
Technology Development and Lice
Technology Development and Licensing Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Technology Development And Licensing Agreements | |
Technology Development and Licensing Agreements | 16. TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS On May 7, 2012, the Company entered into a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for the production of ThermoDox® in the China territory. In accordance with the terms of the agreement, Hisun will be responsible for providing all of the technical and regulatory support services, including the costs of all technical transfer, registration and bioequivalence studies, technical transfer costs, Celsion consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for the manufacture of ThermoDox®. Celsion will repay Hisun for the aggregate amount of these development costs and fees commencing on the successful completion of three registration batches of ThermoDox®. Hisun is also obligated to certain performance requirements under the agreement. The agreement will initially be limited to a percentage of the production requirements of ThermoDox® in the China territory with Hisun retaining an option for additional global supply after local regulatory approval in the China territory. In addition, Hisun will collaborate with Celsion around the regulatory approval activities for ThermoDox® with the China State Food and Drug Administration (CHINA FDA). During the first quarter of 2015, Hisun completed the successful manufacture of three registration batches of ThermoDox®. On January 18, 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable research and development fee of $5 million to support our development of ThermoDox ® ® ® ® On July 19, 2013, the Company and Hisun entered into a Memorandum of Understanding to pursue ongoing cooperation for the continued clinical development of ThermoDox® as well as the technology transfer relating to the commercial manufacture of ThermoDox® for the China territory. This expanded level of cooperation includes development of the next generation liposomal formulation with the goal of creating safer, more efficacious versions of marketed cancer chemotherapeutics. Among the key provisions of the Celsion-Hisun Memorandum of Understanding are: ● Hisun will provide the Company with internal resources necessary to complete the technology transfer of the Company’s proprietary manufacturing process and the production of registration batches for the China territory; ● Hisun will coordinate with the Company around the clinical and regulatory approval activities for ThermoDox® as well as other liposomal formations with the CHINA FDA; and ● Hisun will be granted a right of first On August 8, 2016, we signed a Technology Transfer, Manufacturing and Commercial Supply Agreement (“GEN-1 Agreement”) with Hisun to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN- 1, Celsion’s proprietary gene mediated, IL- 12 immunotherapy, for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. The GEN- 1 Agreement will help to support supply for both ongoing and planned clinical studies in the U.S., and for potential future studies of GEN- 1 in China. GEN- 1 is currently being evaluated by Celsion in first line ovarian cancer patients. Key provisions of the GEN-1 Agreement are as follows: ● the GEN-1 Agreement has targeted unit costs for clinical supplies of GEN- 1 ● once approved, the cost structure for GEN- 1 ● Celsion will provide Hisun a certain percentage of China’s commercial unit demand, and separately of global commercial unit demand, subject to regulatory approval; ● Hisun and Celsion will commence technology transfer activities relating to the manufacture of GEN- 1, ● Hisun will collaborate with Celsion around the regulatory approval activities for GEN- 1 The Company evaluated the Hisun arrangement in accordance with ASC 606 and determined that its performance obligations under the agreement include the non-exclusive, royalty-free license, research and development services to be provided by the Company, and its obligation to serve on a joint committee. The Company concluded that the license was not distinct since its value is closely tied to the ongoing research and development activities. As such, the license and the research and development services are be bundled as a single performance obligation. Since the provision of the license and research and development services are considered a single performance obligation, the $5,000,000 upfront payment is being recognized as revenue ratably through 2022. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 17. COMMITMENTS In July 2011, the Company executed a lease (the “Lease”) with Brandywine Operating Partnership, L.P. (Brandywine), a Delaware limited partnership for a 10,870 square foot premises located in Lawrenceville, New Jersey. In October 2011, the Company relocated its offices to Lawrenceville, New Jersey from Columbia, Maryland. The lease has a term of 66 months and provides for 6 months of rent free, with the first monthly rent payment of approximately $23,000 due and paid in April 2012. Also, as required by the Lease, the Company provided Brandywine with an irrevocable and unconditional standby letter of credit for $250,000, which the Company secured with an escrow deposit at its banking institution of this same amount. The standby letter of credit was reduced by $50,000 on each of the 19th, 31st and 43rd months from the initial term, and the remaining $100,000 amount was reduced when the Lease term expired in April 2017. In late 2015, Lenox Drive Office Park LLC, purchased the real estate and office building and assumed the lease. This lease was set to expire on April 30, 2017. In April 2017, the Company and the landlord amended the Lease effective May 1, 2017. The Lease amendment extended the term of the agreement for an additional 64 months, reduced the premises to 7,565 square feet, reduced the monthly rent and provided four months free rent. On February 1, 2019, we amended the current terms of the lease to increase the size of the premises by 2,285 square feet to 9,850 square feet and also extended the lease term by one year to September 1, 2023. In conjunction with the February 1, 2019 lease amendment, we agreed to modify our one-time option to cancel the lease as of the 36th month after the May 1, 2017 lease commencement date. The monthly rent will range from approximately $18,900 in the first year to approximately $20,500 in the final year of the amendment. The Company also has a one-time option to cancel the lease as of the 24th month after the commencement date of the Lease amendment. In connection with the EGEN Asset Purchase Agreement in June 2014, the Company assumed the existing lease with another landlord for an 11,500 square foot premises located in Huntsville Alabama. This lease has a remaining term of one month with rent a payment of approximately $23,200 per month. In January 2018, the Company and this landlord entered into a new 60 -month lease which reduced the premises to 9,049 square feet with rent payments of approximately $18,100 per month. The Company paid $457,321 and $502,716 in connection with these leases in 2018 and 2017, respectively. Following is a summary of the future minimum payments required under leases that have initial or remaining lease terms of one year or more as of December 31, 2018: For the year ending December 31: Operating Leases 2019 $ 450,430 2020 454,213 2021 457,995 2022 379,823 18,098 Total minimum lease payments $ 1,760,559 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. SUBSEQUENT EVENTS On March 28, 2019, the Company and EGWU, Inc, entered into an amendment to the Asset Purchase Agreement discussed in Note 5 (the “Amended Asset Purchase Agreement”). Pursuant to the Amended Asset Purchase Agreement, payment of the earnout milestone liability related to the Ovarian Cancer Indication of $12.4 million has been modified. The Company has the option to make the payment as follows: a) $7.0 million in cash within 10 business days of achieving the milestone; or b) $12.4 million in cash, common stock of the Company, or a combination of either, within one year of achieving the milestone. The Company will provide EGWU, Inc. 200,000 warrants to purchase common stock at a strike price of $0.01 per warrant share as consideration for entering into this agreement. The Company will record this transaction in the first quarter of 2019. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Celsion Corporation (“Celsion” and the “Company”) is a fully-integrated development stage oncology drug company focused on advancing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA based therapies. Our lead product candidate is ThermoDox ®, |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements of Celsion have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States and include the accounts of the Company and CLSN Laboratories, Inc. All intercompany balances and transactions have been eliminated. The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates, and assumptions that affect the amount reported in the Company’s financial statements and accompanying notes. Actual results could differ materially from these estimates. Events and conditions arising subsequent to the most recent balance sheet date through the date of the issuance of these consolidated financial statements have been evaluated for their possible impact on the financial statements and accompanying notes. No events and conditions would give rise to any information that required accounting recognition or disclosure in the financial statements other than those arising in the ordinary course of business. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates using historical experience and other factors, including the current economic environment. Significant items subject to such estimates are assumptions used for purposes of determining stock-based compensation, the fair value of the convertible notes, and accounting for research and development activities. Management believes its estimates to be reasonable under the circumstances. Actual results could differ significantly from those estimates. Significant estimates in these financials are the valuation of options granted and valuation methods used to determine the recoverability of goodwill and other intangible assets. |
Revenue Recognition | Revenue Recognition On January 1, 2018, the Company adopted the new accounting standard ASC 606, Revenue from Contracts with Customers and all related amendments (the “new revenue standard”) to all contracts with customers using the modified retrospective method. The adoption of the new revenue standard had no impact on retained earnings as of December 31, 2017 and, accordingly, no cumulative adjustment was required. We do not expect the new revenue standard to have a significant impact on our net income on an ongoing basis. The Company’s sole revenue stream is related to the Hisun agreement described in Note 16. There were no accounts receivable as of December 31, 2018 or 2017. Contract liabilities from the Hisun agreement amounted to $1,500,000 and $2,000,000 at December 31, 2018 and 2017, respectively. Contract liabilities values represent the value of cash received before the services were provided. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company received or expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The application of these five steps necessitates the development of assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines and probabilities of technical and regulatory success. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash on hand and investments purchased with an original maturity of three months or less. A portion of these funds are not covered by FDIC insurance. |
Fair Value of Investment Securities | Fair Value of Investment Securities The carrying values of investment securities approximate their respective fair values. |
Short Term Investments | Short Term Investments The Company classifies its investments in marketable securities with readily determinable fair values as investments available-for-sale in accordance with Accounting Standards Codification (ASC) 320, Investments - Debt and Equity Securities. Available-for-sale securities consist of debt and equity securities not classified as trading securities or as securities to be held to maturity. The Company has classified all of its investments as available-for-sale. Unrealized holding gains and losses on available-for-sale securities are reported as a net amount in accumulated other comprehensive gain or loss in stockholders’ equity until realized. Gains and losses on the sale of available-for-sale securities are determined using the specific identification method. The Company’s short-term investments consist of corporate bonds. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is provided over the estimated useful lives of the related assets, ranging from three to seven years, using the straight-line method. Amortization is recognized over the lesser of the life of the asset or the lease term. Major renewals and improvements are capitalized at cost and ordinary repairs and maintenance are charged against operating expenses as incurred. Depreciation expense was approximately $130,000 and $326,000 for the years ended December 31, 2018 and 2017, respectively. The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An asset is considered impaired if its carrying amount exceeds the future net undiscounted cash flows that the asset is expected to generate. If such asset is considered to be impaired, the impairment recognized is the amount by which the carrying amount of the asset, if any, exceeds its fair value determined using a discounted cash flow model. |
Deposits | Deposits Deposits include real property security deposits and other deposits which are contractually required and of a long-term nature. |
In-Process Research and Development, Other Intangible Assets and Goodwill | In-Process Research and Development, Other Intangible Assets and Goodwill During 2014, the Company acquired certain assets of EGEN, Inc. As more fully described in Note 5, the acquisition was accounted for under the acquisition method of accounting which required the Company to perform an allocation of the purchase price to the assets acquired and liabilities assumed. Under the acquisition method of accounting, the total purchase price is allocated to net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date. |
Impairment or Disposal of Long-Lived Assets | Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of its long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Accounting Standards Codification (“ASC”) 220, Comprehensive Income 220 |
Research and Development | Research and Development Research and development costs are expensed as incurred. Equipment and facilities acquired for research and development activities that have alternative future uses are capitalized and charged to expense over their estimated useful lives. |
Net Loss Per Common Share | Net Loss Per Common Share Basic and diluted net loss per common share was computed by dividing net loss for the year by the weighted average number of shares of common stock outstanding, both basic and diluted, during each period. The impact of common stock equivalents has been excluded from the computation of diluted weighted average common shares outstanding in periods where there is a net loss, as their effect is anti-dilutive. For the years ended December 31, 2018 and 2017, the total number of shares of common stock issuable upon exercise of warrants and equity awards is 4,764,405 and 3,761,844 respectively. For the year ended December 31, 2018 and 2017, diluted loss per common share is the same as basic loss per common share as all options and all warrants that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings attributable to common stockholders per common share as their effect would be anti-dilutive. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax asset and liabilities of a change in tax rates is recognized in results of operations in the period that the tax rate change occurs. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. In accordance with ASC 740, Income Taxes, not” As more fully discussed in Note 9, the Company the Company completed the sale of a portion of its New Jersey net operating losses totaling approximately $11.1 for net proceeds of approximately $10.4 million. Such proceeds are reflected as a tax benefit for the year ended December 31, 2018. |
Stock-Based Compensation | Stock-Based Compensation In March 2016, 2016 09, Compensation Stock Compensation |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to our operations. In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09 “Revenue from Contracts with Customers (Topic 606),” which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. ASU 2014 - 09 was originally going to be effective on January 1, 2017; however, the FASB issued ASU 2015-14, “Revenue from Contracts with Customers (Topic 606) - Deferral of the Effective Date,” which deferred the effective date of ASU 2014-09 by one year to January 1, 2018. In March 2016, the FASB issued ASU No. 2016 - 8, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations. The amendments in this ASU do not change the core principle of ASU No. 2014 - 09 but the amendments clarify the implementation guidance on reporting revenue gross versus net. The effective date for the amendments in this ASU is the same as the effective date of ASU No. 2014-09. In April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Identifying Performance Obligations and Licensing),” to clarify the implementation guidance on identifying performance obligations and licensing (collectively “the new revenue standards”). The new revenue standards allow for either “full retrospective” adoption, meaning the standard is applied to all periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. The new revenue standard became effective for us on January 1, 2018. Under the new revenue standards, we recognize revenue following a five-step model prescribed under ASU No. 2014-09; (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation. As further described in Note 16, the Company currently has only one contract subject to the new revenue standards. After performance of the five-step model discussed above, the Company concluded the adoption of the new revenue standards as of January 1, 2018 did not change our revenue recognition policy nor does it have an effect on our financial statements using either the full retrospective or the modified retrospective adoption methods. In January 2016, the FASB issued Accounting Standards Update No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities,” which requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income (other than those accounted for under the equity method of accounting). This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Based on the Company’s evaluation, the adoption of the ASU 2016-01 does not have a material impact on its consolidated financial statements or its disclosures. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, “Leases” (Topic 842), which requires that lessees recognize assets and liabilities for leases with lease terms greater than twelve months in the statement of financial position. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This update also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. The update is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that reporting period. The FASB subsequently issued the following amendments to ASU 2016-02, which have the same effective date and transition date of January 1, 2019: ● ASU No. 2018-10, Codification Improvements to Topic 842, Leases ● ASU No. 2018-11, Leases (Topic 842): Targeted Improvements We evaluated ASU 2016-02 and its impact on the consolidated financial statements and related disclosures. We have identified all of our leases which consist of the New Jersey corporate office lease and the Alabama lab facility lease, see Note 17, and we estimate the adoption of this standard will result in the recognition of right-of-use assets and related lease liabilities on the consolidated balance sheets as of January 1, 2019 of approximately $1.1 to $1.3 million related to our operating lease commitments, with no material impact to the opening balance of retained earnings. In January 2017, the FASB issued Accounting Standard Update No. 2017-04, “Intangibles-Goodwill and Other, Simplifying the Test for Goodwill Impairment,” which eliminated Step 2 not |
Short Term Investments Availa_2
Short Term Investments Available for Sale (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Short-term Investments [Abstract] | |
Schedule of Cost, Fair Value and Maturities of Short Term Investments | A summary of the cost, fair value and maturities of the Company’s short-term investments is as follows: December 31, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investments Corporate debt securities $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 Total $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 December 31, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investment maturities Within 3 months $ 5,383,488 $ 5,393,743 $ - $ - Between 3-12 months 8,844,638 8,864,255 12,734,184 12,724,020 Total $ 14,228,126 $ 14,257,998 $ 12,734,184 $ 12,724,020 |
Summary of Investment Securities Gross Unrealized Gains (losses) | The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary. December 31, 2018 December 31, 2017 Available for sale securities Fair Value Unrealized Holding Gains (Losses) Fair Value Unrealized Holding Gains (Losses) Investments with unrealized gains $ 7,515,676 $ 38,068 $ 748,148 $ 570 Investments with unrealized losses 6,742,322 (8,196 ) 11,975,872 (10,734 ) Total $ 14,257,998 $ 29,872 $ 12,724,020 $ (10,164 ) |
Summary of Net Realized Losses On Sales of Available for Sale Securities and Investment Income Interest and Dividends | Investment income, which includes net realized losses on sales of available for sale securities and investment income interest and dividends, is summarized as follows: 2018 2017 Interest and dividends accrued and paid $ 331,780 $ 26,041 Accretion of investment discounts and premiums, net 32,066 - Losses investment maturity and sales, net (10,164 ) - Investment income net $ 353,682 $ 26,041 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | Assets and liabilities measured at fair value are summarized below: Total Fair Value Quoted Prices In Active Markets For Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Recurring items as of December 31, 2018 Corporate debt securities, available for sale $ 14,257,998 $ ─ $ 14,257,998 $ ─ Recurring items as of December 31, 2017 Corporate debt securities, available for sale $ 12,724,020 $ ─ $ 12,724,020 $ ─ Liabilities: Recurring items as of December 31, 2018 Earn-out milestone liability (Note 12) $ 8,907,664 $ ─ $ ─ $ 8,907,664 Non-recurring items as of December 31, 2018 In process R&D (Note 5) $ 15,736,491 $ ─ $ ─ $ 15,736,491 Recurring items as of December 31, 2017 Earn-out milestone liability (Note 12) $ 12,538,525 $ ─ $ ─ $ 12,538,525 Non-recurring items as of December 31, 2017 In process R&D (Note 5) $ 20,246,491 $ ─ $ ─ $ 20,246,491 |
Acquisition of EGEN, Inc. (Tabl
Acquisition of EGEN, Inc. (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Schedule of Fair Value of Assets Acquired and Liabilities Assumed | The following table summarizes the fair values of these assets acquired and liabilities assumed related to the acquisition. Property and equipment, net $ 35,000 In-process research and development 24,211,000 Other Intangible assets (Covenant not to compete) 1,591,000 Goodwill 1,976,000 Total assets: 27,813,000 Accounts payable and accrued liabilities (235,000 ) Net assets acquired $ 27,578,000 |
Schedule of Future Amortization Amounts During the Remaining Life | Following is a schedule of future amortization amounts during the remaining life of the Covenant Not to Compete. Year Ended December 31, 2019 $ 227,316 2020 227,316 2021 113,660 Total $ 568,292 |
Schedule of Fair Value of Assets Acquired | Following is a summary of the net fair value of the assets acquired in the EGEN acquisition for the two years ended December 31, 2018: IPR&D Goodwill Covenant Not To Compete Balance at January 1, 2017, net $ 22,766,491 $ 1,976,101 1,022,924 Amortization - - (227,316 ) Impairment charge (2,520,000 ) - - Balance at December 31, 2017, net 20,246,491 1,976,101 795,608 Amortization - - (227,316 ) Impairment charge (4,510,000 ) - - Balance at December 31, 2018, net 15,736,491 1,976,101 568,292 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Year Ended December 31, 2018 2017 Machinery and equipment (5-7 year life) $ 2,596,170 $ 2,495,959 Furniture and fixtures (3-5 year life) 267,712 248,709 Leasehold improvements (5-7 year life) 289,004 269,819 3,152,886 3,014,487 Less accumulated depreciation and amortization (2,968,259 ) (2,838,716 ) Total $ 184,627 $ 175,771 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Other Accrued Liabilities | Other accrued liabilities at December 31, 2018 2017 Year Ended December 31, 2018 2017 Amounts due to contract research organizations and other contractual agreements $ 749,369 $ 665,373 Accrued payroll and related benefits 1,592,590 1,258,265 Accrued professional fees 198,654 264,668 Other 45,285 94,521 Total $ 2,585,898 $ 2,282,827 |
Note Payable (Tables)
Note Payable (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principle Payments, Net of Unamortized Debt Discounts | Following is a schedule of future principle payments, net of unamortized debt discounts and amortized end of term charges, due on the Horizon Credit Agreement: For the year ending December 31, 2019 $ - 2020 - 2021 4,583,333 2022 5,000,000 2023 and thereafter 416,667 Subtotal of future principle payments 10,000,000 Unamortized debt issuance costs, net (582,963 ) Total $ 9,417,037 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Provision (Benefit) | The income tax provision (benefit) for the years ended December 31, 2018 and 2017 consists of the following: 2018 2017 Federal Current $ - $ - Deferred - - State and Local - - Current (10,419,000 ) - Deferred - - Effective tax rate $ (10,419,000 ) - |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the Company’s statutory tax rate to the effective rate for the years ended December 31, 2018 and 2017 is as follows: 2018 2017 Federal statutory rate 21.0 % 21.0 % State taxes, net of federal tax benefit 36.9 6.6 Permanent differences (3.8 ) - Other (9.4 ) - Change in valuation allowance and deferred rate change, net 2.0 (27.6 ) Effective tax rate 46.7 % - % |
Schedule of Deferred Tax Assets and Liabilities | The components of the Company’s deferred tax asset as of December 31, 2018 and 2017 are as follows: December 31, 2018 2017 Net operating loss carryforwards $ 51,498,000 $ 62,216,000 Other Deferred tax assets, net 1,092,000 2,415,000 Subtotal 52,590,000 64,631,000 Valuation allowance (52,590,000 ) (64,631,000 ) Total deferred tax asset $ - $ - |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Awards | A summary of stock option awards as of December 31, 2018 and changes during the two-year period ended December 31, 2018 is presented below: Stock Options Number Outstanding Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2017 211,213 $ 61.59 Granted 535,964 $ 2.69 Canceled or expired (43,735 ) $ 164.12 Outstanding at December 31, 2017 703,442 $ 10.34 Granted 2,629,004 $ 2.26 Canceled or expired (183,703 ) $ 25.96 Outstanding at December 31, 2018 3,148,743 $ 2.67 9.2 $ - Exercisable at December 31, 2018 1,689,902 $ 2.97 9.1 $ - |
Summary of Non-vested Restricted Stock Awards | A summary of the status of the Company’s non-vested restricted stock awards as of December 31, 2018 and changes during the two year period ended December 31, 2018, is presented below: Restricted Stock Number Outstanding Weighted Average Grant Date Fair Value Non-vested stock awards outstanding at January 1, 2017 4,785 $ 37.42 Granted (3,357 ) $ 42.20 Vested and issued (1,428 ) $ 26.18 Non-vested stock awards outstanding at December 31, 2017 - $ - Granted 35,000 $ 2.71 Vested and issued (6,000 ) $ 2.77 Forfeited (6,500 ) $ 2.64 Non-vested stock awards outstanding at December 31, 2018 22,500 $ 2.72 |
Summary of Stock Options Outstanding | A summary of stock options outstanding at December 31, 2018 by price range is as follows: Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Number Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Up to $5.00 3,084,252 9.2 $ 2.34 1,625,807 9.2 $ 2.34 Above $5.00 to $81.90 64,491 7.0 $ 19.00 64,095 7.0 $ 19.00 3,148,743 1,689,902 |
Schedule of Assumptions Used to Determine Fair Value of Options Granted | The model is also sensitive to changes in assumptions, which can materially affect the fair value estimate. The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model: Year Ended December 31, 2018 2017 Risk-free interest rate 2.82 to 3.02 % 2.21 to 2.32 % Expected volatility 99.9 - 102.12 % 90.4 - 100.8 % Expected life (in years) 8.5 to 10 10 Expected dividend yield 0.0 % 0.0 % |
Earn-out Milestone Liability (T
Earn-out Milestone Liability (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earn-out Milestone Liability | |
Schedule of Changes in Earn-out Milestone Liability | The following is a summary of the changes in the earn-out milestone liability for 2017 and 2018: Balance at January 1, 2017 $ 13,188,226 Non-cash gain from the adjustment for the change in fair value included in 2017 net loss (649,701 ) Balance at December 31, 2017 12,538,525 Non-cash gain from the adjustment for the change in fair value included in 2018 net loss (3,630,861 ) Balance at December 31, 2018 $ 8,907,664 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes To Financial Statements [Abstract] | |
Summary of Warrant Activity | Following is a summary of all warrant activity for the two years ended December 31, 2018: Warrants Number of Warrants Issued Weighted Average Exercise Price Warrants outstanding at January 1, 2017 1,487,958 $ 9.39 Warrants issued in connection with 2017 equity transactions 9,231,628 $ 3.46 Warrants exercised during 2017 (7,617,147 ) $ 2.89 Warrants expired during 2017 (44,037 ) $ 209.23 Warrants outstanding at December 31, 2017 3,058,402 $ 5.29 Warrants issued in connection with 2018 debt transaction 190,114 $ 2.63 Warrants cancelled in exchange for common stock (1,641,427 ) $ 3.04 Warrants expired during 2018 (13,927 ) $ 226.24 Warrants outstanding and exercisable at December 31, 2018 1,593,162 $ 5.36 Aggregate intrinsic value of outstanding warrants at December 31, 2018 $ - Weighted average remaining contractual terms (years) 1.87 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Following is a summary of the future minimum payments required under leases that have initial or remaining lease terms of one year or more as of December 31, 2018: For the year ending December 31: Operating Leases 2019 $ 450,430 2020 454,213 2021 457,995 2022 379,823 18,098 Total minimum lease payments $ 1,760,559 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Accounts receivable | ||
Contract liabilities | 5,000,000 | |
Depreciation | $ 130,000 | $ 326,000 |
Number of shares of common stock issuable upon exercise of warrants and equity awards | 4,764,405 | 3,761,844 |
Right-of-use assets | $ 1,100,000 | |
Related lease liabilities | 1,300,000 | |
New Jersey [Member] | ||
Tax benefits of EDA | 11,100,000 | |
Net proceeds from sale of net operating losses | $ 10,400,000 | |
Minimum [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Maximum [Member] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Hisun Agreement [Member] | ||
Contract liabilities | $ 1,500,000 | $ 2,000,000 |
Financial Condition (Details Na
Financial Condition (Details Narrative) - USD ($) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cumulated net losses | $ (273,665,247) | $ (261,781,888) | |
Cash, investment securities and interest receivable | 27,700,000 | ||
Common Stock Sales Agreement [Member] | Aspire Capital Fund, LLC [Member] | |||
Proceeds from available future sale of equity under common stock purchase agreement | 31,000,000 | ||
New Jersey [Member] | |||
Tax benefits of EDA | 11,100,000 | ||
New Jersey [Member] | Maximum [Member] | |||
Tax benefits of EDA | $ (12,500,000) | ||
New Jersey [Member] | |||
Tax benefits of EDA | 11,100,000 | ||
Unrecognized tax benefits | $ 3,900,000 |
Short Term Investments Availa_3
Short Term Investments Available for Sale (Details Narrative) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Short-term investments - Fair Value | $ 14,257,998 | $ 12,724,020 |
Corporate Debt Securities [Member] | ||
Short-term investments - Fair Value | 14,257,998 | 12,724,020 |
Short-term Investments [Member] | Corporate Debt Securities [Member] | ||
Short-term investments - Fair Value | $ 14,257,998 | $ 12,724,020 |
Short Term Investments Availa_4
Short Term Investments Available for Sale - Schedule of Cost, Fair Value and Maturities of Short Term Investments (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Short-term investments - Cost | $ 14,228,126 | $ 12,734,184 |
Short-term investments - Fair Value | 14,257,998 | 12,724,020 |
Short-term investment maturities - Within 3 months, cost | 5,383,488 | |
Short-term investment maturities - Between 3-12 months, cost | 8,844,638 | 12,734,184 |
Total, cost | 14,228,126 | 12,734,184 |
Short-term investment maturities - Within 3 months, fair value | 5,393,743 | |
Short-term investment maturities - Between 3-12 months, fair value | 8,864,255 | 12,724,020 |
Total, fair value | 14,257,998 | 12,724,020 |
Corporate Debt Securities [Member] | ||
Short-term investments - Cost | 14,228,126 | 12,734,184 |
Short-term investments - Fair Value | $ 14,257,998 | $ 12,724,020 |
Short Term Investments Availa_5
Short Term Investments Available for Sale - Schedule of Unrealized Losses and Fair Value of Investment Securities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Less than 12 months, unrealized gains, fair value | $ 7,515,676 | $ 748,148 |
Less than 12 months, unrealized losses, fair value | 6,742,322 | 11,975,872 |
Investment securities - available for sale, at fair value | 14,257,998 | 12,724,020 |
Less than 12 months, unrealized holding gains | 38,068 | 570 |
Less than 12 months, unrealized holding losses | (8,196) | (10,734) |
Unrealized holding gains (losses) | $ 29,872 | $ (10,164) |
Short Term Investments Availa_6
Short Term Investments Available for Sale - Schedule of Investment Income (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | ||
Interest and dividends accrued and paid | $ 331,780 | $ 26,041 |
Accretion of investment discounts and premiums, net | 32,066 | |
Losses investment maturity and sales, net | (10,164) | |
Investment income | $ 353,682 | $ 26,041 |
Fair Values of Financial Instru
Fair Values of Financial Instruments (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | ||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Inputs Reconciliation, Transfers into Level 3 |
Fair Values of Financial Inst_2
Fair Values of Financial Instruments - Schedule of Fair Value of Assets and Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Investment securities, available for sale | $ 14,257,998 | $ 12,724,020 |
Earn-out milestone liability | 8,907,664 | 12,538,525 |
Corporate Debt Securities [Member] | ||
Investment securities, available for sale | 14,257,998 | 12,724,020 |
Fair Value, Measurements, Recurring [Member] | ||
Earn-out milestone liability | 8,907,664 | 12,538,525 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Earn-out milestone liability | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Earn-out milestone liability | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Earn-out milestone liability | 8,907,664 | 12,538,525 |
Fair Value, Measurements, Recurring [Member] | Corporate Debt Securities [Member] | ||
Investment securities, available for sale | 14,257,998 | 12,724,020 |
Fair Value, Measurements, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Investment securities, available for sale | ||
Fair Value, Measurements, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Investment securities, available for sale | 14,257,998 | 12,724,020 |
Fair Value, Measurements, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Investment securities, available for sale | ||
Fair Value, Measurements, Non-Recurring [Member] | In Process R&D [Member] | ||
Liabilities, fair value | 15,736,491 | |
Fair Value, Measurements, Non-Recurring [Member] | In Process R&D [Member] | ||
Liabilities, fair value | 20,246,491 | |
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | ||
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | ||
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | ||
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | ||
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | $ 15,736,491 | |
Fair Value, Measurements, Non-Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | In Process R&D [Member] | ||
Liabilities, fair value | $ 20,246,491 |
Acquisition of EGEN, Inc. (Deta
Acquisition of EGEN, Inc. (Details Narrative) - USD ($) | Jun. 20, 2014 | Dec. 31, 2016 | Jun. 20, 2014 | Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Asset impairment charges, total | $ 2,400,000 | $ 2,500,000 | ||||||||
Business Combination, Consideration Transferred, Liabilities Incurred | 4,500,000 | |||||||||
Finite-lived intangible assets, net, ending balance | $ 1,022,924 | $ 795,608 | $ 1,022,924 | 568,292 | 795,608 | $ 1,022,924 | ||||
Gain (Loss) from Change in Fair Value of Earn out Milestone Liability | (3,630,861) | (649,701) | ||||||||
Assets | 47,514,433 | 46,855,587 | 47,514,433 | |||||||
Purchase Agreement [Member] | ||||||||||
Finite-lived intangible assets, net, ending balance | 795,608 | 568,292 | 795,608 | |||||||
Finite-lived intangible assets, accumulated amortization | 795,606 | 1,022,922 | 795,606 | |||||||
IPR&D Drug Technology Platforms [Member] | ||||||||||
Asset impairment charges, total | $ 1,400,000 | $ 1,400,000 | ||||||||
EGEN Inc [Member] | ||||||||||
Potential future earn-out payments | $ 30,400,000 | $ 30,400,000 | ||||||||
Payments to Acquire Businesses, Gross | $ 3,000,000 | |||||||||
Stock issued during period, shares, acquisitions | 241,590 | |||||||||
Business Combination, Consideration Transferred, Liabilities Incurred | 13,900,000 | 8,900,000 | 12,500,000 | $ 13,200,000 | ||||||
Gain (Loss) from Change in Fair Value of Earn out Milestone Liability | 3,900,000 | 3,600,000 | 600,000 | |||||||
Goodwill, acquisition | 2,000,000 | |||||||||
EGEN Inc [Member] | Purchase Agreement [Member] | ||||||||||
Finite-lived intangible assets acquired | $ 1,600,000 | |||||||||
Finite-lived intangible asset, useful life | 7 years | |||||||||
Amortization expense | $ 227,316 | 227,316 | ||||||||
EGEN Inc [Member] | IPR&D Drug Technology Platforms [Member] | ||||||||||
Indefinite lived intangible assets | 24,200,000 | |||||||||
EGEN Inc [Member] | Glioblastoma Multiforme Brain Cancer [Member] | ||||||||||
Asset impairment charges, total | $ 6,900,000 | 6,900,000 | $ 9,400,000 | 4,510,000 | 2,520,000 | |||||
IPR&D costs | 15,736,491 | 20,246,491 | ||||||||
EGEN Inc [Member] | Ovarian Cancer [Member] | ||||||||||
Finite-lived intangible assets, net, ending balance | $ 13,300,000 | 13,300,000 | $ 13,300,000 | |||||||
Initial assets value | 6,900,000 | |||||||||
Assets | $ 2,400,000 | |||||||||
EGEN Inc [Member] | Maximum [Member] | ||||||||||
Total purchase price for the asset acquisition | $ 44,400,000 | |||||||||
Potential future earn-out payments | $ 30,400,000 | $ 30,400,000 |
Acquisition of EGEN, Inc. - Sch
Acquisition of EGEN, Inc. - Schedule of Fair Values of Acquired Assets and Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Goodwill | $ 1,976,101 | $ 1,976,101 |
EGEN Inc [Member] | ||
Property and equipment, net | 35,000 | |
In-process research and development | 24,211,000 | |
Other Intangible assets (Covenant not to compete) | 1,591,000 | |
Goodwill | 1,976,000 | |
Total assets: | 27,813,000 | |
Accounts payable and accrued liabilities | (235,000) | |
Net assets acquired | $ 27,578,000 |
Acquisition of EGEN, Inc. - Amo
Acquisition of EGEN, Inc. - Amortization Schedule for Covenant Not to Complete (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Total | $ 568,292 | $ 795,608 | $ 1,022,924 |
Noncompete Agreements [Member] | |||
2019 | 227,316 | ||
2020 | 227,316 | ||
2021 | 113,660 | ||
Total | $ 568,292 |
Acquisition of EGEN, Inc. - S_2
Acquisition of EGEN, Inc. - Schedule of Fair Value of Assets Acquired (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets, beginning balance | $ 795,608 | $ 1,022,924 | ||
Amortization | (227,316) | (227,316) | ||
Impairment charge | $ 2,400,000 | $ 2,500,000 | ||
Intangible assets, ending balance | 568,292 | 795,608 | ||
IPR&D [Member] | ||||
Intangible assets, beginning balance | 20,246,491 | 22,766,491 | ||
Amortization | ||||
Impairment charge | (4,510,000) | (2,520,000) | ||
Intangible assets, ending balance | 15,736,491 | 20,246,491 | ||
Goodwill [Member] | ||||
Intangible assets, beginning balance | 1,976,101 | 1,976,101 | ||
Amortization | ||||
Impairment charge | ||||
Intangible assets, ending balance | $ 1,976,101 | $ 1,976,101 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property and equipment, gross | $ 3,152,886 | $ 3,014,487 |
Less accumulated depreciation and amortization | (2,968,259) | (2,838,716) |
Total | $ 184,627 | 175,771 |
Minimum [Member] | ||
Estimated useful life | 3 years | |
Maximum [Member] | ||
Estimated useful life | 7 years | |
Machinery and Equipment [Member] | ||
Property and equipment, gross | $ 2,596,170 | $ 2,495,959 |
Machinery and Equipment [Member] | Minimum [Member] | ||
Estimated useful life | 5 years | 5 years |
Machinery and Equipment [Member] | Maximum [Member] | ||
Estimated useful life | 7 years | 7 years |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | $ 267,712 | $ 248,709 |
Furniture and Fixtures [Member] | Minimum [Member] | ||
Estimated useful life | 3 years | 3 years |
Furniture and Fixtures [Member] | Maximum [Member] | ||
Estimated useful life | 5 years | 5 years |
Leasehold Improvements [Member] | ||
Property and equipment, gross | $ 289,004 | $ 269,819 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Estimated useful life | 5 years | 5 years |
Leasehold Improvements [Member] | Maximum [Member] | ||
Estimated useful life | 7 years | 7 years |
Other Accrued Liabilities - Sch
Other Accrued Liabilities - Schedule of Other Accrued Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Amounts due to contract research organizations and other contractual agreements | $ 749,369 | $ 665,373 |
Accrued payroll and related benefits | 1,592,590 | 1,258,265 |
Accrued professional fees | 198,654 | 264,668 |
Other | 45,285 | 94,521 |
Total | $ 2,585,898 | $ 2,282,827 |
Note Payable (Details Narrative
Note Payable (Details Narrative) - USD ($) | Jun. 27, 2018 | Jun. 10, 2014 | Jun. 10, 2014 | Nov. 25, 2013 | Jun. 20, 2014 | Nov. 30, 2013 | Jun. 10, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 15, 2016 | Dec. 31, 2018 | Dec. 17, 2015 | Jun. 26, 2017 |
Class of warrant or right, exercise price of warrants or rights | $ 5.75 | $ 5.75 | $ 1.65 | ||||||||||
Financing fees and expenses | $ 712,025 | $ 91,756 | |||||||||||
Hercules Warrant [Member] | |||||||||||||
Debt instrument, unamortized discount, total | $ 476,261 | $ 476,261 | $ 476,261 | ||||||||||
Horizon Credit Agreement [Member] | |||||||||||||
Percentage of outstanding principle balance, description | |||||||||||||
Interest expense, debt, total | $ 512,872 | ||||||||||||
Amortization of debt issuance costs | 199,153 | ||||||||||||
Horizon Credit Agreement [Member] | Horizon Warrants [Member] | |||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 190,114 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.63 | ||||||||||||
Debt instrument, unamortized discount, total | $ 507,116 | ||||||||||||
Horizon Credit Agreement [Member] | LIBOR plus [Member] | |||||||||||||
Line of credit, interest rate | 7.625% | ||||||||||||
Debt effective interest rate | 9.98% | ||||||||||||
Hercules Credit Agreement [Member] | |||||||||||||
Interest expense, debt, total | 56,386 | ||||||||||||
Amortization of debt issuance costs | $ 35,370 | ||||||||||||
Hercules Credit Agreement [Member] | Hercules Warrant [Member] | |||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 6,963 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 50.26 | ||||||||||||
Debt issuance costs, gross | 350,000 | $ 350,000 | 350,000 | ||||||||||
Warrant date | Nov. 25, 2018 | ||||||||||||
Hercules Credit Agreement [Member] | Prime Rate [Member] | |||||||||||||
Debt instrument, basis spread on variable rate | 11.50% | 11.75% | 11.25% | ||||||||||
Hercules Credit Agreement [Member] | Hercules [Member] | |||||||||||||
Proceeds from lines of credit, total | $ 10,000,000 | ||||||||||||
Debt instrument, unamortized discount, total | $ 230,000 | ||||||||||||
Debt issuance costs, net, total | 122,378 | ||||||||||||
EGEN Inc [Member] | |||||||||||||
Payments to acquire businesses, gross | $ 3,000,000 | ||||||||||||
EGEN Inc [Member] | Hercules Credit Agreement [Member] | |||||||||||||
Payments to acquire businesses, gross | $ 3,000,000 | ||||||||||||
Second Tranche [Member] | Hercules Credit Agreement [Member] | |||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 6,963 | 6,963 | 6,963 | ||||||||||
Percentage for original debt, amount | 3.50% | ||||||||||||
Original debt, amount | $ 5,000,000 | ||||||||||||
Loan Agreement [Member] | Horizon Technology Finance Corporation [Member] | |||||||||||||
Line of credit facility, maximum borrowing capacity | $ 10,000,000 | ||||||||||||
Loan Agreement [Member] | Hercules Technology Growth Capital, Inc. [Member] | |||||||||||||
Line of credit facility, maximum borrowing capacity | 20,000,000 | ||||||||||||
Horizon Credit Agreement [Member] | |||||||||||||
Proceeds from lines of credit, total | $ 10,000,000 | ||||||||||||
Percentage of outstanding principle balance, description | an amount equal to 1-3% | ||||||||||||
Debt instrument, unamortized discount, total | $ 782,116 | ||||||||||||
Financing fees and expenses | 175,000 | ||||||||||||
Loan origination fees | $ 100,000 | ||||||||||||
Percentage for original debt, amount | 4.00% | ||||||||||||
Debt issuance costs, gross | $ 400,000 | ||||||||||||
Hercules Credit Agreement [Member] | First Tranche [Member] | |||||||||||||
Proceeds from lines of credit, total | 5,000,000 | ||||||||||||
Repayments of lines of credit | $ 4,000,000 | ||||||||||||
Hercules Credit Agreement [Member] | Second Tranche [Member] | |||||||||||||
Proceeds from lines of credit, total | $ 5,000,000 |
Note Payable - Schedule of Futu
Note Payable - Schedule of Future Principle Payments, Net of Unamortized Debt Discounts (Details) | Dec. 31, 2018USD ($) |
Debt Disclosure [Abstract] | |
2019 | |
2020 | |
2021 | 4,583,333 |
2022 | 5,000,000 |
2023 and thereafter | 416,667 |
Subtotal of future principle payments | 10,000,000 |
Net of unamortized debt issuance costs | (582,963) |
Total | $ 9,417,037 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 1 Months Ended | 5 Months Ended | 11 Months Ended | 12 Months Ended | 20 Months Ended | 25 Months Ended | ||||
Jul. 31, 2011 | Oct. 31, 2017 | Jun. 30, 2017 | Jun. 30, 2013 | Aug. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Feb. 28, 2013 | Feb. 28, 2017 | Jun. 30, 2015 | |
Income tax, description | The Tax Reform Act permanently reduces the U.S. corporate income tax rate from a maximum of 35% to a flat 21% rate, effective January 1, 2018. | |||||||||
Income tax, U.S. corporate income tax rate | 21.00% | 21.00% | ||||||||
Net operating losses | $ 4,200,000 | $ 800,000 | $ 300,000 | $ 1,500,000 | $ 1,500,000 | $ 229,700,000 | $ 1,400,000 | $ 300,000 | $ 1,600,000 | |
Net operating losses, unused | $ 222,200,000 | |||||||||
Net operating losses expiration, description | Expire starting in 2023 through 2037 | |||||||||
Net operating losses carryforward limits, description | The deduction for net operating losses incurred in tax years beginning after January 1, 2018 is limited to 80% of annual taxable income | |||||||||
Operating loss carry forwards, limitation on use | $ 90,000,000 | $ 5,000,000 | $ 7,000,000 | $ 4,000,000 | $ 30,000,000 | $ 34,000,000 | $ 35,000,000 | $ 40,000,000 | ||
Operating loss carry forwards, limitation on use | The Company determined that it experienced ownership changes, as defined by Section 382, in connection with certain common stock offerings in July 2011, February 2013, June 2013, June 2015, February 2017, June 2017, October 2017 and August 2018. As a result, the utilization of the Company's federal tax net operating loss carry forwards generated prior to the ownership changes are limited. As of December 31, 2018, the Company has net operating loss carry forwards for U.S. federal and state tax purposes of approximately $233 million, before excluding net operating losses that have been limited as a result of Section 382 limitations. The annual limitation due to Section 382 for net operating loss carry forward utilization is approximately $4.2 million per year for approximately $90 million in net operating loss carry forwards existing at the ownership change occurring in July 2011, approximately $1.4 million per year for approximately $34 million of additional net operating losses occurring from July 2011 to the ownership change that occurred in February 2013, approximately $1.5 million per year for approximately $4 million of additional net operating losses occurring from February 2013 to the ownership change that occurred in June 2013, approximately $1.6 million per year for approximately $40 million of additional net operating losses occurring from June 2013 to the ownership change that occurred in June 2015, approximately $0.3 million per year for approximately $35 million of additional net operating losses occurring from June 2015 to the ownership change that occurred in February 2017, approximately $0.3 million per year for approximately $7 million of additional net operating losses occurring from February 2017 to the ownership change that occurred in June 2017, approximately $0.8 million per year for approximately $5 million of additional net operating losses occurring from June 2017 to the ownership change that occurred in October 2017, and approximately $1.5 million per year for approximately $30 million of additional net operating losses occurring from October 2017 to the ownership change that occurred in August 2018. The utilization of these net operating loss carry forwards may be further limited if the Company experiences future ownership changes as defined in Section 382 of the Internal Revenue Code. | |||||||||
New Jersey [Member] | ||||||||||
Proceeds from sale of NOLs | $ 10,400,000 | |||||||||
Federal Income Tax [Member] | ||||||||||
Net operating losses | 7,500,000 | |||||||||
U.S. Federal and State Tax [Member] | ||||||||||
Net operating losses | $ 23,300,000 | |||||||||
Tax Reform Act [Member] | ||||||||||
Income tax, U.S. corporate income tax rate | 21.00% |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Provision (Benefit) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal, Current | ||
Federal, Deferred | ||
State and Local, Current | (10,419,000) | |
State and Local, Deferred | ||
Effective tax rate | $ (10,419,115) |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
State taxes, net of federal tax benefit | 36.90% | 6.60% |
Permanent differences | 3.80% | 0.00% |
Other | (9.40%) | 0.00% |
Change in valuation allowance and deferred rate change, net | 2.00% | (27.60%) |
Effective tax rate | 46.70% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 51,498,000 | $ 62,216,000 |
Other Deferred tax assets, net | 1,092,000 | 2,415,000 |
Subtotal | 52,590,000 | 64,631,000 |
Valuation allowance | (52,590,000) | (64,631,000) |
Total deferred tax asset |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Dec. 04, 2018 | Oct. 27, 2018 | Oct. 26, 2018 | Aug. 31, 2018 | Oct. 27, 2017 | Oct. 27, 2017 | Oct. 04, 2017 | Jul. 06, 2017 | Jun. 09, 2017 | May 26, 2017 | May 16, 2017 | Feb. 14, 2017 | May 27, 2015 | Feb. 01, 2013 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2018 | Jun. 26, 2017 | Jun. 30, 2016 | Jan. 15, 2014 | Feb. 22, 2013 |
Shelf registration statement amount | $ 75,000,000 | ||||||||||||||||||||||
Common stock, shares authorized | 112,500,000 | 112,500,000 | 112,500,000 | 75,000,000 | |||||||||||||||||||
Preferred stock, shares authorized | 100,000 | 100,000 | 100,000 | ||||||||||||||||||||
Aggregate of common and preferred stock, shares authorized | 112,600,000 | ||||||||||||||||||||||
Reverse stock split | 14-for-1 reverse stock split | ||||||||||||||||||||||
Stock issued during period split stock | 14 | 56,982,418 | |||||||||||||||||||||
Stock issued during period reverse stock split | 14 | 4,070,172 | |||||||||||||||||||||
Class of warrant or right, outstanding | 2,400,000 | 1,600,000 | |||||||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number, ending balance | 200,000 | 3,148,743 | |||||||||||||||||||||
Common stock, par or stated value per share | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 9,231,628 | 190,114 | 9,231,628 | 506,627 | |||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 5.75 | $ 1.65 | |||||||||||||||||||||
Proceeds from warrant exercises | $ 21,140,304 | ||||||||||||||||||||||
Fair value of common stock issued as equity issuance costs and charged against paid in capital | 450,000 | ||||||||||||||||||||||
Series AA Warrant [Member] | |||||||||||||||||||||||
Stock issued during period, shares, exercise of warrants | 747,254 | ||||||||||||||||||||||
Proceeds from warrant exercises | $ 2,400,000 | ||||||||||||||||||||||
Pre-Funded Series BB Warrant [Member] | |||||||||||||||||||||||
Stock issued during period, shares, exercise of warrants | 185,713 | ||||||||||||||||||||||
2013 Warrants, 2014 Warrants, and June 2016 Warrants [Member] | |||||||||||||||||||||||
Proceeds from warrant exercises | $ 2,100,000 | ||||||||||||||||||||||
Increase (decrease) in fair value of warrants | $ 200,000 | ||||||||||||||||||||||
2015 Warrants [Member] | |||||||||||||||||||||||
Proceeds from warrant exercises | $ 800,000 | ||||||||||||||||||||||
Increase (decrease) in fair value of warrants | 100,000 | ||||||||||||||||||||||
June 2016 Warrants [Member] | |||||||||||||||||||||||
Proceeds from warrant exercises | $ 800,000 | ||||||||||||||||||||||
July 2017 Direct Offering [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 2,050,000 | ||||||||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 4,665,000 | ||||||||||||||||||||||
Share price | $ 2.07 | ||||||||||||||||||||||
Proceeds from issuance of common stock, gross | $ 4,243,500 | ||||||||||||||||||||||
Proceeds from issuance of warrants | $ 16,600,000 | ||||||||||||||||||||||
July 2017 Direct Offering [Member] | Pre-Funded Series CCC Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 385,000 | ||||||||||||||||||||||
Class of warrant or right, offered price of warrants or rights | $ 2.06 | ||||||||||||||||||||||
Beneficial ownership percentage threshold | 9.99% | ||||||||||||||||||||||
Proceeds from issuance of warrants | $ 793,100 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||||||||||||||
Class of warrant or right, exercised during period | 385,000 | ||||||||||||||||||||||
July 2017 Direct Offering [Member] | Series AAA Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 2,435,000 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.07 | $ 2.07 | |||||||||||||||||||||
July 2017 Direct Offering [Member] | Series BBB Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 2,435,000 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 4.75 | $ 4.75 | |||||||||||||||||||||
July 2017 Direct Offering [Member] | Series DDD Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,166,250 | ||||||||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 1 | ||||||||||||||||||||||
Warrants issued, expiration period | 1 year | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 6.20 | ||||||||||||||||||||||
February 14, 2017 Public Offering [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 1,384,704 | ||||||||||||||||||||||
Shares issued, price per share | $ 3.22 | ||||||||||||||||||||||
Maximum beneficial ownership of the purchaser | 9.99% | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 5,000,000 | ||||||||||||||||||||||
February 14, 2017 Public Offering [Member] | Series AA Warrant [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,177,790 | ||||||||||||||||||||||
Number of warrant to surrender | 321,428 | ||||||||||||||||||||||
Number of exchange surrender received common stock | 160,414 | ||||||||||||||||||||||
Broker and legal fees | $ 100,000 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.22 | ||||||||||||||||||||||
Class of warrant or right, term | 5 years | ||||||||||||||||||||||
February 14, 2017 Public Offering [Member] | Pre-Funded Series BB Warrant [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 185,713 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.14 | ||||||||||||||||||||||
Shares issued, price per share | $ 3.08 | ||||||||||||||||||||||
May 2015 Common Stock Offering [Member] | 2015 Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 139,284 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 36.40 | ||||||||||||||||||||||
Aspire Purchase Agreement [Member] | |||||||||||||||||||||||
Fair value of common stock issued as equity issuance costs and charged against paid in capital | $ 450,000 | ||||||||||||||||||||||
ATM Agreement [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 1,784,396 | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 12,800,000 | ||||||||||||||||||||||
Aggregate offering price | $ 25,000,000 | ||||||||||||||||||||||
Proceeds from sale equity | $ 1,200,000 | $ 3,900,000 | |||||||||||||||||||||
Sale of common stock, shares | 457,070 | 1,221,348 | |||||||||||||||||||||
Investor [Member] | |||||||||||||||||||||||
Class of warrant or right, outstanding | 7,617,148 | 7,617,148 | |||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,600,000 | ||||||||||||||||||||||
Proceeds from issuance of warrants | $ 22,000,000 | ||||||||||||||||||||||
Underwriting Agreement [Member] | Oppenheimer & Co. Inc. [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 2,640,000 | ||||||||||||||||||||||
Common stock, par or stated value per share | $ 0.01 | $ 0.01 | |||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,320,000 | 1,320,000 | |||||||||||||||||||||
Warrant, description | Each share of Common Stock is being sold together with 0.5 warrants (the "Investor Warrants"), each whole Investor Warrant being exercisable for one share of Common Stock, at an offering price of $2.50 per share and related Investor Warrants. | ||||||||||||||||||||||
Warrant Exchange Agreements [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 820,714 | ||||||||||||||||||||||
Warrant Exchange Agreements [Member] | February 14, 2017 Public Offering [Member] | |||||||||||||||||||||||
Number of exchange surrender received common stock | 321,428 | ||||||||||||||||||||||
Broker and legal fees | $ 130,000 | ||||||||||||||||||||||
Warrant Exchange Agreements [Member] | Investor [Member] | |||||||||||||||||||||||
Number of warrant to surrender | 1,320,000 | ||||||||||||||||||||||
Number of exchange surrender received common stock | 820,714 | ||||||||||||||||||||||
Exercise Agreements [Member] | 2013 Warrants, 2014 Warrants, and June 2016 Warrants [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 790,410 | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.70 | ||||||||||||||||||||||
Aspire Purchase Agreement [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 164,835 | ||||||||||||||||||||||
Aggregate offering price, additions | $ 15,000,000 | ||||||||||||||||||||||
Aggregate offering price, term | 24 months | ||||||||||||||||||||||
Aggregate offering price | $ 15,000,000 | ||||||||||||||||||||||
Maximum number of shares purchased per day | 100,000 | ||||||||||||||||||||||
Aggregate offering price, description | The lowest sale price of the Company's common stock on the purchase date; or the arithmetic average of the three (3) lowest closing sale prices for the Company's common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date. | ||||||||||||||||||||||
Maximum number of shares purchased per day, additional | 2,000,000 | ||||||||||||||||||||||
Aspire purchase agreement, terms | In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to at least 100,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company's common stock traded on its principal market on the next trading day (the "VWAP Purchase Date"), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company's common stock traded on its principal market on the VWAP Purchase Date. | ||||||||||||||||||||||
Purchase Agreement [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 100,000 | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 200,000 | ||||||||||||||||||||||
Purchase Agreement [Member] | March 28, 2019 [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 600,000 | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 1,300,000 | ||||||||||||||||||||||
Capital on DemandTM Sales Agreement [Member] | |||||||||||||||||||||||
Aggregate offering price | $ 16,000,000 | ||||||||||||||||||||||
Aggregate offering price, description | (i) the sale of all shares of our common stock subject to the Sales Agreement, and (ii) the termination of the Capital on Demand Agreement by JonesTrading or Celsion. The Capital on Demand Agreement may be terminated by JonesTrading or the Company at any time upon 10 days' notice to the other party, or by JonesTrading at any time in certain circumstances, including the occurrence of a material adverse change in the Company. | ||||||||||||||||||||||
Commission percentage for gross proceeds from common stock | 3.00% | ||||||||||||||||||||||
Capital on Demand Agreement [Member] | March 28, 2019 [Member] | |||||||||||||||||||||||
Stock issued during period, shares, new issues | 122,186 | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 300,000 | ||||||||||||||||||||||
Warrant [Member] | |||||||||||||||||||||||
Class of warrant or right, outstanding | 33,500,000 | 1,200,000 | |||||||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number, ending balance | 2,400,000 | ||||||||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 2.325 | 2.325 | |||||||||||||||||||||
Class of warrant or right, offered price of warrants or rights | $ 3 | $ 3 | |||||||||||||||||||||
Warrants issued, expiration period | 5 years | ||||||||||||||||||||||
Warrant [Member] | Maximum [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 790,410 | 64,348 | 95,811 | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.70 | $ 57.40 | $ 74.34 | ||||||||||||||||||||
Investor Warrants [Member] | October 2017 Underwritten Offering [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 66,000 | 66,000 | |||||||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 2.87 | 2.87 | |||||||||||||||||||||
Warrants issued, expiration period | 5 years | ||||||||||||||||||||||
Proceeds from issuance of common stock and warrants | $ 6,600,000 | ||||||||||||||||||||||
Investor Warrants [Member] | Underwriting Agreement [Member] | Oppenheimer & Co. Inc. [Member] | |||||||||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 2.50 | 2.50 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Sep. 28, 2018 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | May 16, 2017 |
Number of shares reserved for future issuance | 3,148,743 | 3,148,743 | 200,000 | ||
2018 Stock Incentive Plan [Member] | |||||
Equity awards, number of stock authorized | 2,700,000 | 2,700,000 | |||
Percentage of fair market value of shares | 100.00% | 100.00% | |||
Percentage of outstanding stock determining factor for incentive stock price | 10.00% | 10.00% | |||
Compensation cost | $ 4,600,000 | $ 1,100,000 | |||
Stock based compensation cost expected to be recognized, weighted average period | 10 months 25 days | ||||
Weighted average grant date fair value of stock option awards granted | $ 2.36 | $ 2.32 | |||
2018 Stock Incentive Plan [Member] | Minimum [Member] | |||||
Percentage of fair market value of shares | 110.00% | 110.00% | |||
2007 Stock Incentive Plan [Member] | |||||
Equity awards, number of stock authorized | 688,531 | 688,531 | |||
Unrecognized compensation cost related to non-vested stock based compensation | $ 1,800,000 | $ 1,800,000 | |||
Inducement Option Grants [Member] | Three New Employees [Member] | |||||
Inducement option grant, exercise price per share | $ 2.77 | ||||
Options expiration period | 10 years | ||||
Number of equity awards granted | 106,502 | ||||
Inducement Option Grants [Member] | Three New Employees [Member] | Restricted Stock Awards [Member] | |||||
Shares issued | 164,004 | ||||
Restricted Stock Awards [Member] | |||||
Weighted average grant date fair value of stock option awards granted | $ 2.71 | $ 42.20 | |||
Restricted Stock Awards [Member] | Inducement Option Grants [Member] | Three New Employees [Member] | |||||
Shares issued | 19,000 | ||||
Equity Stock Awards [Member] | |||||
Number of shares reserved for future issuance | 3,399,893 | 3,399,893 | |||
Number of equity awards granted | 3,064,741 | ||||
Number of equity awards available for future issuance | 335,152 | 335,152 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Option Awards and Restricted Stock Grants (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number Outstanding, Ending Balance | 3,148,743 | |
Number Outstanding, Exercisable | 1,689,902 | |
Stock Options [Member] | ||
Number Outstanding, Outstanding, Beginning Balance | 703,442 | 211,213 |
Number Outstanding, Granted | 2,629,004 | 535,964 |
Number Outstanding, Cancelled or expired | (183,703) | (43,735) |
Number Outstanding, Ending Balance | 3,148,743 | 703,442 |
Number Outstanding, Exercisable | 1,689,902 | |
Weighted Average Exercise Price, Outstanding, Beginning Balance | $ 10.34 | $ 61.59 |
Weighted Average Exercise Price, Granted | 2.26 | 2.69 |
Weighted Average Exercise Price, Cancelled or expired | 25.96 | 164.12 |
Weighted Average Exercise Price, Outstanding, Ending Balance | 2.67 | $ 10.34 |
Weighted Average Exercise Price, Excercisable | $ 2.97 | |
Weighted Average Remaining Contractual Term (years), Outstanding, Ending Balance | 9 years 2 months 12 days | |
Weighted Average Remaining Contractual Term (years), Exercisable | 9 years 1 month 6 days | |
Aggregate Intrinsic Value, Outstanding, Ending Balance | ||
Aggregate Intrinsic Value, Exercisable |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-vested Restricted Stock Awards (Details) - Restricted Stock Awards [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number Outstanding, Non-vested stock awards outstanding, Beginning Balance | 4,785 | |
Number Outstanding, Non-vested stock awards outstanding, Granted | 35,000 | (3,357) |
Number Outstanding, Non-vested stock awards outstanding, Vested and issued | (6,000) | (1,428) |
Number Outstanding, Non-vested stock awards outstanding, Forfeited | (6,500) | |
Number Outstanding, Non-vested stock awards outstanding, Ending Balance | 22,500 | |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 37.42 | |
Weighted Average Grant Date Fair Value, Granted | 2.71 | 42.20 |
Weighted Average Grant Date Fair Value, Vested and issued | 2.77 | 26.18 |
Weighted Average Grant Date Fair Value, Forfeited | 2.64 | |
Weighted Average Grant Date Fair Value, Ending Balance | $ 2.72 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Options Outstanding (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | May 16, 2017 | |
Options Outstanding, Number | 3,148,743 | 200,000 |
Options Exercisable, Number | 1,689,902 | |
Exercise Price One [Member] | ||
Range of Exercise Prices, Upper | $ 5 | |
Options Outstanding, Number | 3,084,252 | |
Options Outstanding, Weighted Average Remaining Contractual Term (in years) | 9 years 2 months 12 days | |
Options Outstanding, Weighted Average Exercise Price | $ 2.34 | |
Options Exercisable, Number | 1,625,807 | |
Options Exercisable, Weighted Average Remaining Contractual Term (in years) | 9 years 2 months 12 days | |
Options Exercisable, Weighted Average Exercise Price | $ 2.34 | |
Exercise Price Two [Member] | ||
Range of Exercise Prices, Upper | 81.90 | |
Range of Exercise Prices, Lower | $ 5 | |
Options Outstanding, Number | 64,491 | |
Options Outstanding, Weighted Average Remaining Contractual Term (in years) | 7 years | |
Options Outstanding, Weighted Average Exercise Price | $ 19 | |
Options Exercisable, Number | 64,095 | |
Options Exercisable, Weighted Average Remaining Contractual Term (in years) | 7 years | |
Options Exercisable, Weighted Average Exercise Price | $ 19 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions Used to Determine Fair Value of Options Granted (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Expected life (in years) | 10 years | |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Risk-free interest rate | 2.82% | 2.21% |
Expected volatility | 99.90% | 90.40% |
Expected life (in years) | 8 years 6 months | |
Maximum [Member] | ||
Risk-free interest rate | 3.02% | 1.32% |
Expected volatility | 102.10% | 100.80% |
Expected life (in years) | 10 years |
Earn-out Milestone Liability (D
Earn-out Milestone Liability (Details Narrative) - USD ($) | Jun. 20, 2014 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Fair value of Acquisition consideration | $ 4,500,000 | |||||
Gain (loss) from change in fair value of earn out milestone liability | $ (3,630,861) | $ (649,701) | ||||
EGEN Inc [Member] | ||||||
Future earn-out payments | $ 30,400,000 | |||||
Fair value of Acquisition consideration | $ 13,900,000 | $ 8,900,000 | 12,500,000 | $ 13,200,000 | ||
Risk adjusted assessment of each milestone | 80.00% | |||||
Estimated time to achieve the milestone | 1 year 2 months 30 days | |||||
Gain (loss) from change in fair value of earn out milestone liability | $ 3,900,000 | $ 3,600,000 | $ 600,000 | |||
EGEN Inc [Member] | Minimum [Member] | ||||||
Risk adjusted assessment of each milestone | 10.00% | 50.00% | ||||
Estimated time to achieve the milestone | 1 year 6 months | 1 year 3 months 19 days | ||||
EGEN Inc [Member] | Maximum [Member] | ||||||
Future earn-out payments | $ 30,400,000 | |||||
Risk adjusted assessment of each milestone | 67.00% | 80.00% | ||||
Estimated time to achieve the milestone | 2 years 6 months | 1 year 6 months | ||||
EGEN Inc [Member] | ||||||
Gain (loss) from change in fair value of earn out milestone liability | $ 1,400,000 |
Earn-out Milestone Liability -
Earn-out Milestone Liability - Schedule of Changes in Earn-out Milestone Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Earn-out Milestone Liability | ||
Earn-out liabilities, beginning balance | $ 12,538,525 | $ 13,188,226 |
Non-cash charge from the adjustment for the change in fair value included in net loss | (3,630,861) | (649,701) |
Earn-out liabilities, ending balance | $ 8,907,664 | $ 12,538,525 |
Warrants (Details Narrative)
Warrants (Details Narrative) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Jun. 26, 2017 | May 16, 2017 | |
Number of shares, Warrant rights | 190,114 | 9,231,628 | 506,627 | |
Warrants outstanding | 1,600,000 | 2,400,000 | ||
Warrants, weighted average exercise price | $ 5.75 | $ 1.65 | ||
Warrants expiring | 44,037 | 13,927 | ||
Warrant [Member] | ||||
Warrants outstanding | 1,200,000 | 33,500,000 | ||
Strike price per share | $ 6.20 | |||
Warrant expiration date | Apr. 4, 2019 | |||
Warrant Exchange Agreements [Member] | ||||
Common stock shares issued | 820,714 | |||
Investor [Member] | ||||
Number of shares, Warrant rights | 1,600,000 | |||
Warrants outstanding | 7,617,148 | |||
Proceeds from warrant | $ 22,000,000 |
Warrants - Summary of Warrant A
Warrants - Summary of Warrant Activity (Details) - Warrant [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Warrants Issued, Warrants outstanding, Beginning Balance | 3,058,402 | 1,487,958 |
Number of Warrants Issued, Warrants issued | 190,114 | 9,231,628 |
Number of Warrants Issued, Warrants exercised | (7,617,147) | |
Number of Warrants Issued, Warrants cancelled in exchange for common stock | (1,641,427) | |
Number of Warrants Issued, Warrants expired | (13,927) | (44,037) |
Number of Warrants Issued, Warrants outstanding and exercisable, Ending Balance | 1,593,162 | 3,058,402 |
Weighted Average Exercise Price, Warrants outstanding, Beginning Balance | $ 5.29 | $ 9.39 |
Weighted Average Exercise Price, Warrants issued | 2.63 | 3.46 |
Weighted Average Exercise Price, Warrants exercised | 2.89 | |
Weighted Average Exercise Price, Warrants cancelled in exchange for common stock | 3.04 | |
Weighted Average Exercise Price, Warrants expired | 226.24 | 209.23 |
Weighted Average Exercise Price, Warrants outstanding and exercisable, Ending Balance | $ 5.36 | $ 5.29 |
Aggregate intrinsic value of outstanding warrants | ||
Weighted average remaining contractual terms (years) | 1 year 10 months 14 days |
Licenses of Intellectual Prop_2
Licenses of Intellectual Property and Patents (Details Textual) | 12 Months Ended | ||
Dec. 31, 2018USD ($)Trademarkshares | Dec. 31, 2017USD ($)shares | Jan. 31, 2003USD ($)shares | |
Common stock, shares, issued | shares | 18,832,168 | 17,277,299 | |
Common stock, value, issued | $ | $ 188,322 | $ 172,772 | |
Number of trademark protection application pending for thermo dox | Trademark | 14 | ||
License Agreement [Member] | Duke University [Member] | |||
Number of days before issuance factoring into average closing price | 20 days | ||
Amount of time after effective date of license agreement for registration rights to take place | 1 year | ||
Common stock, shares, issued | shares | 253,691 | ||
Common stock, value, issued | $ | $ 2,200,000 |
Technology Development and Li_2
Technology Development and Licensing Agreements (Details Narrative) - USD ($) | Jan. 18, 2013 | Mar. 31, 2013 | Dec. 31, 2018 | Sep. 30, 2013 |
Deferred revenue | $ 5,000,000 | |||
Deferred revenue amortization period | 10 years | |||
Contract liabilities | $ 5,000,000 | |||
Hisun [Member] | ||||
Non-refundable research and development fee | $ 5,000,000 |
Commitments (Details Narrative)
Commitments (Details Narrative) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jan. 31, 2018USD ($)ft² | Apr. 30, 2017USD ($)ft² | Apr. 30, 2012USD ($) | Jul. 31, 2011ft² | Jun. 30, 2014USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2014ft² | |
Irrevocable and unconditional standby letter of credit | $ 749,369 | $ 665,373 | ||||||
Payment of lease | $ 457,321 | $ 502,716 | ||||||
EGEN Asset Purchase Agreement [Member] | ||||||||
Area of premises | ft² | 11,500 | |||||||
Lease term | 1 year | |||||||
Operating lease, description | On February 1, 2019, we amended the current terms of the lease to increase the size of the premises by 2,285 square feet to 9,850 square feet and also extended the lease term by one year to September 1, 2023. In conjunction with the February 1, 2019 lease amendment, we agreed to modify our one-time option to cancel the lease as of the 36th month after the May 1, 2017 lease commencement date | |||||||
Operating leases, monthly rent payment in final year | $ 23,200 | |||||||
Standby Letter of Credit [Member] | ||||||||
Contractual obligation reduction nineteen months from initial term | $ 50,000 | |||||||
Contractual obligation remaining | 100,000 | |||||||
Lawrenceville New Jersey [Member] | ||||||||
Area of premises | ft² | 7,565 | 10,870 | ||||||
Lease term | 64 months | 66 months | ||||||
The number of months in which free rent is provided | 4 months | 6 months | ||||||
Payment for rent | 23,000 | |||||||
Operating leases, monthly rent payment in first year | $ 18,900 | |||||||
Operating leases, monthly rent payment in final year | $ 20,500 | |||||||
Lawrenceville New Jersey [Member] | Standby Letter of Credit [Member] | ||||||||
Irrevocable and unconditional standby letter of credit | $ 250,000 | |||||||
Huntsville Alabama [Member] | EGEN Asset Purchase Agreement [Member] | ||||||||
Area of premises | ft² | 9,049 | 2,285 | ||||||
Lease term | 60 months | |||||||
Operating leases, monthly rent payment | $ 18,100 |
Commitments - Summary of the Fu
Commitments - Summary of the Future Minimum Payments Required Under Leases (Details) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 450,430 |
2020 | 454,213 |
2021 | 457,995 |
2022 | 379,823 |
2023 | 18,098 |
Total minimum lease payments | $ 1,760,559 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Mar. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 26, 2017 |
Warrants to purchase common stock | 190,114 | 9,231,628 | 506,627 | |
Warrants strike price | $ 5.75 | $ 1.65 | ||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | EGWU, Inc [Member] | ||||
Warrants to purchase common stock | 200,000 | |||
Warrants strike price | $ 0.01 | |||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | Ovarian Cancer [Member] | ||||
Future earn-out payments | $ 12,400,000 | |||
Cash consideration payable | 7,000,000 | |||
Consideration payble by issuane of stock | $ 12,400,000 |