Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 13, 2018 | |
Document And Entity Information | ||
Entity Registrant Name | Celsion CORP | |
Entity Central Index Key | 749,647 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 18,731,834 | |
Trading Symbol | CLSN | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,018 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 3,371,303 | $ 11,444,055 |
Investment securities - available for sale, at fair value | 18,579,731 | 12,724,020 |
Accrued interest receivable on investment securities | 76,746 | 54,440 |
Advances, deposits and other current assets | 224,614 | 89,186 |
Subtotal current assets | 22,252,394 | 24,311,701 |
Property and equipment (at cost, less accumulated depreciation and amortization of $2,929,742 and $2,838,716, respectively) | 166,523 | 175,771 |
Other assets: | ||
In-process research and development | 15,736,491 | 20,246,491 |
Other intangible assets, net | 625,121 | 795,608 |
Goodwill | 1,976,101 | 1,976,101 |
Patent licensing fees, deposits and other assets, net | 155,324 | 8,761 |
Subtotal other assets | 18,493,037 | 23,026,961 |
Total assets | 40,911,954 | 47,514,433 |
Current liabilities: | ||
Accounts payable ? trade | 3,159,627 | 3,416,863 |
Other accrued liabilities | 2,140,128 | 2,282,827 |
Deferred revenue - current portion | 500,000 | 500,000 |
Subtotal current liabilities | 5,799,755 | 6,199,690 |
Earn-out milestone liability | 8,970,854 | 12,538,525 |
Notes payable - non-current portion | 9,319,579 | |
Deferred revenue - non-current portion | 1,625,000 | 2,000,000 |
Other liabilities - non-current portion | 65,701 | 71,710 |
Total liabilities | 25,780,889 | 20,809,925 |
Stockholders equity: | ||
Preferred Stock - $0.01 par value (100,000 shares authorized; no shares issued or outstanding at September 30, 2018 and December 31, 2017) | ||
Common stock - $0.01 par value (112,500,000 shares authorized; 17,911,454 and 17,277,299 shares issued at September 30, 2018 and December 31, 2017, respectively;17,911,120 and 17,276,965 shares outstanding at September 30, 2018 and December 31, 2017, respectively) | 179,114 | 172,772 |
Additional paid-in capital | 294,162,004 | 288,408,976 |
Accumulated other comprehensive gain (loss) | 20,960 | (10,164) |
Accumulated deficit | (279,145,825) | (261,781,888) |
Subtotal | 15,216,253 | 26,789,696 |
Treasury stock, at cost (334 shares at September 30, 2018 and December 31, 2017) | (85,188) | (85,188) |
Total stockholders equity | 15,131,065 | 26,704,508 |
Total liabilities and stockholders equity | $ 40,911,954 | $ 47,514,433 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Property and equipment, accumulated depreciation | $ 2,929,742 | $ 2,838,716 |
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 | 17,911,154 | 17,277,299 |
Common stock, shares outstanding | 17,911,120 | 17,276,965 |
Treasury stock, shares | 334 | 334 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Licensing revenue | $ 125,000 | $ 125,000 | $ 375,000 | $ 375,000 |
Operating expenses: | ||||
Research and development | 2,187,317 | 3,348,847 | 9,521,937 | 9,870,754 |
General and administrative | 1,959,903 | 1,174,250 | 7,167,740 | 4,291,482 |
Total operating expenses | 4,147,220 | 4,523,097 | 16,689,677 | 14,162,236 |
Loss from operations | (4,022,220) | (4,398,097) | (16,314,677) | (13,787,236) |
Other (expense) income: | ||||
Gain from change in valuation of earn-out milestone liability | 4,114,995 | 1,246,151 | 3,567,671 | 670,172 |
Impairment of in-process research and development | (4,510,000) | (2,520,000) | (4,510,000) | (2,520,000) |
Investment income | 106,565 | 524 | 253,750 | 3,941 |
Interest expense | (345,728) | (360,759) | (91,756) | |
Other income | 2 | 93 | 78 | 3,545 |
Total other (expense) income, net | (634,166) | (1,273,232) | (1,049,260) | (1,934,098) |
Net loss | (4,656,386) | (5,671,329) | (17,363,937) | (15,721,334) |
Deemed dividend related to warrant modification | (345,685) | |||
Net loss attributable to common shareholders | $ (4,656,386) | $ (5,671,329) | $ (17,363,937) | $ (16,067,019) |
Net loss per common share | ||||
Basic and diluted | $ (0.26) | $ (0.70) | $ (1) | $ (3.04) |
Weighted average shares outstanding | ||||
Basic and diluted | 17,801,230 | 8,054,658 | 17,447,921 | 5,171,699 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Changes in: | ||||
Realized gain on investment securities recognized in investment income, net | $ (2,788) | $ (11,125) | ||
Unrealized gain on investment securities | 29,665 | 42,249 | ||
Change in unrealized gain on available for sale securities | 26,877 | 31,124 | ||
Net loss | (4,656,386) | (5,671,329) | (17,363,937) | (15,721,334) |
Comprehensive loss | $ (4,629,509) | $ (5,671,329) | $ (17,332,813) | $ (15,721,334) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (17,363,937) | $ (15,721,334) |
Non-cash items included in net loss: | ||
Depreciation and amortization | 261,513 | 511,587 |
Change in fair value of earn-out milestone liability | (3,567,671) | (670,172) |
Impairment of in-process research and development | 4,510,000 | 2,520,000 |
Recognition of deferred revenue | (375,000) | (375,000) |
Stock-based compensation costs | 3,985,829 | 951,488 |
Restricted shares issued | 29,841 | |
Amortization of deferred finance charges and debt discount associated with notes payable | 101,695 | 35,370 |
Change in deferred rent liability | (6,009) | 61,328 |
Net changes in: | ||
Accrued interest on investment securities | (22,306) | 4,008 |
Advances, deposits and other current assets | (231,991) | 115,106 |
Accounts payable and accrued liabilities | (399,935) | 134,440 |
Net cash (used in) operating activities: | (13,077,971) | (12,433,179) |
Cash flows from investing activities: | ||
Purchases of investment securities | (15,574,587) | |
Proceeds from sale and maturity of investment securities | 9,750,000 | 1,680,000 |
(Deposit) refund on corporate office lease | (50,000) | 100,000 |
Purchases of property and equipment | (81,778) | (21,126) |
Net cash (used in) provided by investing activities | (5,956,365) | 1,758,874 |
Cash flows from financing activities: | ||
Proceeds from sale of common stock equity, net of issuance costs | 1,236,584 | 8,405,190 |
Proceeds from notes payable, net of issuance costs | 9,725,000 | |
Proceeds from exercise of common stock warrants | 4,925,886 | |
Principal payments on notes payable | (2,595,923) | |
Net cash provided by financing activities | 10,961,584 | 10,735,153 |
(Decrease) increase in cash and cash equivalents | (8,072,752) | 60,848 |
Cash and cash equivalents at beginning of period | 11,444,055 | 2,624,162 |
Cash and cash equivalents at end of period | 3,371,303 | 2,685,010 |
Supplemental disclosures of cash flow information: | ||
Interest paid | 259,064 | 56,386 |
Non-cash financing activities: | ||
Fair value of common stock issued as equity issuance costs and charged against paid in capital | 450,000 | |
Fair value of warrants issued in connection with notes payable | 507,116 | |
Total non-cash financing activites | $ 957,116 |
Business Description
Business Description | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Description | Note 1. Business Description Celsion Corporation, a Delaware corporation based in Lawrenceville, New Jersey, and its wholly owned subsidiary, CLSN Laboratories, Inc., also a Delaware corporation, referred to herein as “Celsion”, “we”, or “the Company,” as the context requires, is a fully-integrated, development stage oncology drug company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. Our lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. Our product pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Our product pipeline is based on three platform technologies that have demonstrated the potential to address a broad range of solid tumor cancer indications including novel nucleic acid-based immunotherapies, anti-cancer DNA or RNA therapies, and heat sensitive liposomal formulations of known chemotherapeutics. With these technologies we are working to develop and commercialize efficient, effective and targeted therapeutics that minimize the side-effects common to cancer treatments. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Note 2. Basis of Presentation The accompanying unaudited condensed consolidated financial statements, which include the accounts of Celsion Corporation and its wholly owned subsidiary CLSN Laboratories, Inc, have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. All intercompany balances and transactions have been eliminated. Certain information and disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments, consisting only of normal recurring accruals considered necessary for a fair presentation, have been included in the accompanying unaudited condensed consolidated financial statements. Operating results for the three and nine-month periods ended September 30, 2018 are not necessarily indicative of the results that may be expected for any other interim period(s) or for any full year. For further information, refer to the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on March 27, 2018. 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 those estimates. Events and conditions arising subsequent to the most recent balance sheet date 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. |
Financial Condition and Busines
Financial Condition and Business Plan | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Financial Condition and Business Plan | Note 3. Financial Condition and Business Plan 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 $279 million of cumulated net losses. As of September 30, 2018, we had approximately $22.0 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 sale of its State of New Jersey net operating losses 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 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. The Company expects that the successful transfer of these credits will result in receipt of approximately $10 million in net cash proceeds to the Company prior to the end of 2018. With $22.0 million in cash, investment securities and interest receivable at September 30, 2018 and the impending sale of its New Jersey NOLs, the Company believes it has sufficient capital resources to fund its operations into the fourth quarter of 2020. The Company will be required to obtain additional funding in order to continue the 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 11, the Company has $15.0 million available for future sale of equity securities under a common stock purchase agreement with Aspire Capital Fund, LLC. |
New Accounting Pronouncements
New Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
New Accounting Pronouncements | Note 4. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by 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 15, 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. Early adoption is permitted. We are evaluating the impact of ASU 2016-2, which we plan to adopt on January 1, 2019, on our consolidated financial statements. To date, we have identified all of our leases which consist of the New Jersey corporate office lease and the Alabama lab facility lease, and we anticipate that adoption of ASU 2016-2 will result in the recognition of additional assets and lease liabilities, along with the associated recognition of amortization expense for the right-to-use assets. In August 2016, the FASB issued Accounting Standard Update No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments.” This update clarifies how certain cash receipts and payments should be presented in the statement of cash flows and is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. Based on the Company’s evaluation, the adoption of the ASU 2016-01 did not have a material impact on its consolidated financial statements or its disclosures. In November 2016, the FASB issued Accounting Standard Update No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. This update amends the guidance in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. This guidance is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. Based on the Company’s evaluation, the adoption of the ASU 2016 - 01 did not have a material impact on its consolidated financial statements or its disclosures. In January 2017, the FASB issued Accounting Standard Update No. 2017-01, “Business Combinations (Topic 805): Clarifying the Definition of a Business,” which clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. The Company does not believe the adoption of ASU 2017-01 will have an impact on our financial statement or disclosures. In January 2017, the FASB issued Accounting Standard Update No. 2017 04, 2 not |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Note 5. Net Loss per Common Share Basic loss per share is calculated based upon the net loss available to common shareholders divided by the weighted average number of common shares outstanding during the period. Diluted loss per share is calculated after adjusting the denominator of the basic earnings per share computation for the effects of all dilutive potential common shares outstanding during the period. The dilutive effects of preferred stock, options and warrants and their equivalents are computed using the treasury stock method. The total number of shares of common stock issuable upon exercise of warrants, stock option grants and equity awards were 6,496,261 and 6,208,389 shares for the three and nine-month periods ended September 30, 2018 and 2017, respectively. For the three and nine month periods ended September 30, 2018 and 2017, diluted loss per common share was the same as basic loss per common share as all options and all warrants that were exercisable into shares of the Company’s common stock were excluded from the calculation of diluted earnings attributable to common shareholders per common share as their effect would have been anti-dilutive. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Note 6. Fair Value of Financial Instruments Short-term investments available for sale of $18,579,731 and $12,724,020 as of September 30, 2018 and December 31, 2017, respectively, consist of money market funds, commercial paper, corporate debt securities, and government agency 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: September 30, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investments Certificate of deposit $ 3,128,390 $ 3,144,875 $ - $ - Corporate debt securities 15,430,381 15,434,856 12,734,184 12,724,020 Total $ 18,558,771 $ 18,579,731 $ 12,734,184 12,724,020 September 30, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investment maturities Within 3 months $ 5,714,421 $ 5,724,554 $ - $ - Between 3-12 months 12,844,350 12,855,177 12,734,184 12,724,020 Total $ 18,558,771 $ 18,579,731 $ 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 September 30, 2018 and December 31, 2017. The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary. September 30, 2018 December 31, 2017 Available for sale securities Fair Value Unrealized Holding Gains (Losses) Fair Value Unrealized Holding Gains (Losses) Investments with unrealized gains $ 10,845,595 $ 27,352 $ 748,148 $ 570 Investments with unrealized losses 7,734,136 (6,392 ) 11,975,872 (10,734 ) Total $ 18,579,731 $ 20,960 $ 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: Three Months Ended September 30, 2018 2017 Interest and dividends accrued and paid $ 103,777 $ 524 Realized gains 2,788 - Investment income, net $ 106,565 $ 524 Nine Months Ended September 30, 2018 2017 Interest and dividends accrued and paid $ 242,625 $ 3,941 Realized gains 11,125 - Investment income, net $ 253,750 $ 3,941 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 7. Fair Value Measurements 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. The fair values of securities available for sale are determined by obtaining quoted prices on nationally recognized exchanges (Level 1 inputs) or matrix pricing, which is a mathematical technique widely used in the industry to value debt securities without relying exclusively on quoted prices for the specific securities but rather by relying on the securities’ relationship to other benchmark quoted securities (Level 2 inputs). 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. 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 nine months ended September 30, 2018 or 2017. All changes in Level 3 liabilities were the result of changes in the fair value of the earn-out milestone liability included in earnings (see Note 13). 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 September 30, 2018 Investment securities, available for sale $ 18,579,731 $ 18,579,731 $ ─ $ ─ Recurring items as of December 31, 2017 Investment securities, available for sale $ 12,724,020 $ 12,724,020 $ ─ $ ─ Liabilities: Recurring items as of September 30, 2018 Earn-out milestone liability (Note 13) $ 8,970,854 $ ─ $ ─ $ 8,970,854 Recurring items as of December 31, 2017 Earn-out milestone liability (Note 13) $ 12,538,525 $ ─ $ ─ $ 12,538,525 |
Acquisition of EGEN Assets
Acquisition of EGEN Assets | 9 Months Ended |
Sep. 30, 2018 | |
Business Combinations [Abstract] | |
Acquisition of EGEN Assets | Note 8. Acquisition of EGEN Assets 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. The total purchase price for the asset acquisition is 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. At the closing, we paid approximately $3.0 million in cash after the expense adjustment and issued 193,728 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. In addition, 47,862 shares of common stock were held back by us at the closing and are issuable to EGEN pending satisfactory resolution of any post-closing adjustments for expenses or in relation to EGEN’s indemnification obligations under the Asset Purchase Agreement (the “Holdback Shares”). These shares were issued to EGEN on June 16, 2017. After its review in 2017, management concluded that there was no immediate opportunity to out-license TheraSilence. Because of this analysis, the earnout payments were adjusted prior to 2017. In conjunction with its review, management determined the earnout payments may be up to $24.4 million that may become payable, in cash, shares of our common stock or a combination thereof, at our option, upon achievement of the remaining two major milestone events as follows: ● $12.4 million will become payable upon achieving certain specified development milestones relating to an ovarian cancer study of GEN-1 (formerly known as EGEN-001) to be conducted by us or our subsidiary; and ● $12.0 million will become payable upon achieving certain specified development milestones relating to a GEN-1 glioblastoma multiforme brain cancer study to be conducted by us or our subsidiary. 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 (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). 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. In connection with the write down of this IPR&D asset on September 30, 2017, the Company concluded there was a reduced probability of payments of the earn-out milestones associated with the GBM asset and therefore reduced the earn-out milestone liability from $13.8 million to $12.5 million, recording a non-cash gain of approximately $1.3 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. In connection with the write down of this IPR&D asset, the Company concluded there was a reduced probability of payment of the earn-out milestones associated with the GBM asset and therefore reduced the earn-out milestone liability from $13.1 million to $9.0 million, recording a non-cash gain of approximately $4.1 million in the third quarter of 2018. As no other indicators of impairment existed during the first nine months of 2018, the Company concluded none of the other IPR&D assets were impaired at September 30, 2018. 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 $56,829 and $170,487 in each of the three and nine-month periods ended September 30, 2018 and 2017, respectively. The carrying value of the Covenant Not to Compete was $625,121, net of $966,093 accumulated amortization, as of September 30, 2018 and $795,608, net of $795,606 accumulated amortization, as of December 31, 2017 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. |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Note 9. Accrued Liabilities Other accrued liabilities as of September 30, 2018 and December 31, 2017 include the following: September 30, 2018 December 31, 2017 Amounts due to contract research organizations and other contractual agreements $ 730,811 $ 665,373 Accrued payroll and related benefits 1,048,077 1,258,265 Accrued professional fees 341,240 264,668 Other 20,000 94,521 Total $ 2,140,128 $ 2,282,827 |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Note Payable | Note 10. Note 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%. 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 is required to register the common stock underlying the Horizon Warrants within 90 days from the date of grant and use its best efforts to keep it effective. 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. For the three and nine-month periods ended September 30, 2018 the Company incurred $248,270 and $259,064, respectively, in interest expense and amortized $97,458 and $101,695, 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 September 30 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 (680,421 ) Total $ 9,319,579 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 will expire 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 expire 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 the three-month period ended September 30, 2017 the Company did not incur any interest expense and it did not amortize any interest expense for deferred fees, debt discount and end of term charges in connection with the Hercules Credit Agreement. For the nine-month period ended September 30, 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. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Note 11. Stockholders’ Equity In September 2015, the Company filed with the SEC a $75 million shelf registration statement on Form S-3 (the 2015 Shelf Registration Statement) (File No. 333-206789) 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 September 25, 2015. The 2015 Shelf Registration Statement expired on September 25, 2018. 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 “October 2017 Underwritten 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. The Company received $6.6 million of gross proceeds from the sale of the Shares and Investor Warrant. The October 2017 Underwritten Offering was made pursuant to the 2015 Shelf Registration Statement 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 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. 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 fundings, 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. 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. 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 | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Note 12. 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 September 30, 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 September 30, 2018, there were a total of 183,004 of Celsion common stock subject to outstanding inducement awards. Total compensation cost charged related to stock options and restricted stock awards amounted to $614,528 and $146,896 for the three-month periods ended September 30, 2018 and 2017, respectively. Total compensation cost charged related to stock options and restricted stock awards amounted to $3,985,829 and $951,488 for the nine-month periods ended September 30, 2018 and 2017, respectively. As of September 30, 2018, there was $2.5 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 1.1 years. The weighted average grant date fair values of the stock options granted during then nine-month periods ended September 30, 2018 and 2017 was $2.36 and $2.69, respectively. A summary of stock option awards and restricted stock grants for the nine-months ended September 30, 2018 is presented below: Stock Options Restricted Stock Awards Weighted Average Equity Awards Options Outstanding Weighted Average Exercise Price Non-vested Restricted Stock Outstanding Weighted Average Grant Date Fair Value Contractual Terms of Equity Awards (in years) Equity awards outstanding at January 1, 2018 703,442 $ 10.34 - $ - Equity awards granted 2,629,004 $ 2.26 35,000 $ 2.71 Vested and issued - $ - (6,000 ) $ 2.64 Equity awards forfeited, cancelled or expired (113,701 ) $ 40.23 - $ - Equity awards outstanding at September 30, 2018 3,218,745 $ 2.67 29,000 $ 2.72 9.4 Aggregate intrinsic value of outstanding equity awards at September 30, 2018 $ 1,384,245 $ 1,700 Equity awards exercisable at September 30, 2018 1,677,998 $ 2.94 9.3 Aggregate intrinsic value of equity awards exercisable at September 30, 2018 $ 706,552 The fair values of stock options granted were estimated at the date of grant using the Black-Scholes option pricing model. The Black-Scholes option pricing 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: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.82 – 3.02 % 2.21 % Expected volatility 99.9 -102.1 % 90.4 % Expected life (in years) 8.0 - 10.0 10.00 Expected dividend yield - % - % Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. The risk-free interest rate is derived from values assigned to U.S. Treasury bonds with terms that approximate the expected option lives in effect at the time of grant. Starting in 2017, the Company elected to account for any forfeitures when they occur. |
Earn-out Milestone Liability
Earn-out Milestone Liability | 9 Months Ended |
Sep. 30, 2018 | |
Earn-out Milestone Liability | |
Earn-out Milestone Liability | Note 13. 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. As of September 30, 2018, June 30, 2018 and December 31, 2017, the Company fair valued these milestones at $9.0 million, $13.1 million and $12.5 million, respectively, and recognized a non-cash gain of $4,114,995 and $3,567,671 during the three and nine months ended September 30, 2018 as a result of the change in the fair value of these milestones from the beginning of each period, respectively. As of September 30, 2017, June 30, 2017 and December 31, 2016, the Company fair valued these milestones at $12.5 million, $13.8 million and $13.2 million, respectively, and recognized a non-cash gain of $1,246,151 and $670,172 during the three and nine months ended September 30, 2017 as a result of the change in the fair value of these milestones from the beginning of each period, respectively The following is a summary of the changes in the earn-out milestone liability for 2018: Balance at January 1, 2018 $ 12,538,525 Non-cash gain from the adjustment for the change in fair value (3,567,671 ) Balance at September 30, 2018 $ 8,970,854 The following is a schedule of the Company’s risk-adjustment assessment of each milestone: Date Risk-adjustment Assessment of each Milestone Discount Rate Estimated Time to Achieve September 30, 2018 0% to 80% 9% 0.00 to 1.17 year June 30, 2018 35% to 80% 9% 0.83 to 1.00 years December 31, 2017 35% to 80% 9% 1.33 to 1.50 years September 30, 2017 35% to 80% 9% 1.25 to 1.75 years June 30, 2017 50% to 80% 9% 1.50 to 2.00 years December 31, 2016 50% to 80% 9% 2.00 to 2.50 years |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2018 | |
Warrants | |
Warrants | Note 14. Warrants Common Stock Warrants Following is a summary of all warrant activity for the nine months ended September 30, 2018: Warrants Number of Warrants Issued Weighted Average Exercise Price Warrants outstanding at December 31, 2017 3,058,402 $ 5.29 Warrants issued during the nine months ended September 30, 2018 (see Note 10) 190,114 $ 2.63 Warrants outstanding at September 30, 2018 3,248,516 $ 5.14 Aggregate intrinsic value of outstanding warrants at September 30, 2018 $ 69,229 Weighted average remaining contractual terms at September 30, 2018 (in years) 3.24 On October 29, 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 warrants. After the warrant exchange, warrants outstanding totaled 1.6 million with a weighted average exercise price of $5.75 per share. Approximately 1.2 million of these outstanding warrants with a strike price of $6.20 per share will expire on April 4, 2019. |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 9 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingent Liabilities and Commitments | Note 15. Contingent Liabilities and 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. 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 expired at the end of January 2018. 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. |
Technology Development and Lice
Technology Development and Licensing Agreements | 9 Months Ended |
Sep. 30, 2018 | |
Technology Development And Licensing Agreements | |
Technology Development and Licensing Agreements | Note 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 mainland China, Hong Kong and Macau (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 (the “CFDA”). 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 collaborations 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 collaboration 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 non-dilutive financing and the investment necessary to complete the technology transfer of its proprietary manufacturing process and the production of registration batches for the China territory; ● Hisun will collaborate with the Company around the clinical and regulatory approval activities for ThermoDox® as well as other liposomal formations with the CFDA; and ● Hisun will be granted a right of first offer for a commercial license to ThermoDox® for the sale and distribution of ThermoDox® in the China territory. 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 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 that are substantially competitive with the Company’s current suppliers; ● once approved, the cost structure for GEN-1 will support rapid market adoption and significant gross margins across global markets; ● 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, including all studies required by CFDA for site approval; and ● Hisun will collaborate with Celsion around the regulatory approval activities for GEN-1 with the CFDA. A local China partner affords Celsion access to accelerated CFDA review and potential regulatory exclusivity for the approved indication. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [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: September 30, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investments Certificate of deposit $ 3,128,390 $ 3,144,875 $ - $ - Corporate debt securities 15,430,381 15,434,856 12,734,184 12,724,020 Total $ 18,558,771 $ 18,579,731 $ 12,734,184 12,724,020 September 30, 2018 December 31, 2017 Cost Fair Value Cost Fair Value Short-term investment maturities Within 3 months $ 5,714,421 $ 5,724,554 $ - $ - Between 3-12 months 12,844,350 12,855,177 12,734,184 12,724,020 Total $ 18,558,771 $ 18,579,731 $ 12,734,184 $ 12,724,020 |
Schedule of Unrealized Losses and Fair Value of Investment Securities | 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 September 30, 2018 and December 31, 2017. The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary. September 30, 2018 December 31, 2017 Available for sale securities Fair Value Unrealized Holding Gains (Losses) Fair Value Unrealized Holding Gains (Losses) Investments with unrealized gains $ 10,845,595 $ 27,352 $ 748,148 $ 570 Investments with unrealized losses 7,734,136 (6,392 ) 11,975,872 (10,734 ) Total $ 18,579,731 $ 20,960 $ 12,724,020 $ (10,164 ) |
Schedule of Investment Income | Investment income, which includes net realized losses on sales of available for sale securities and investment income interest and dividends, is summarized as follows: Three Months Ended September 30, 2018 2017 Interest and dividends accrued and paid $ 103,777 $ 524 Realized gains 2,788 - Investment income, net $ 106,565 $ 524 Nine Months Ended September 30, 2018 2017 Interest and dividends accrued and paid $ 242,625 $ 3,941 Realized gains 11,125 - Investment income, net $ 253,750 $ 3,941 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Assets and Liabilities | 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 September 30, 2018 Investment securities, available for sale $ 18,579,731 $ 18,579,731 $ ─ $ ─ Recurring items as of December 31, 2017 Investment securities, available for sale $ 12,724,020 $ 12,724,020 $ ─ $ ─ Liabilities: Recurring items as of September 30, 2018 Earn-out milestone liability (Note 13) $ 8,970,854 $ ─ $ ─ $ 8,970,854 Recurring items as of December 31, 2017 Earn-out milestone liability (Note 13) $ 12,538,525 $ ─ $ ─ $ 12,538,525 |
Acquisition of EGEN Assets (Tab
Acquisition of EGEN Assets (Tables) | 9 Months Ended |
Sep. 30, 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 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Other Accrued Liabilities | Other accrued liabilities as of September 30, 2018 and December 31, 2017 include the following: September 30, 2018 December 31, 2017 Amounts due to contract research organizations and other contractual agreements $ 730,811 $ 665,373 Accrued payroll and related benefits 1,048,077 1,258,265 Accrued professional fees 341,240 264,668 Other 20,000 94,521 Total $ 2,140,128 $ 2,282,827 |
Note Payable (Tables)
Note Payable (Tables) | 9 Months Ended |
Sep. 30, 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 September 30 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 (680,421 ) Total $ 9,319,579 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock Option Awards and Restricted Stock Grants | A summary of stock option awards and restricted stock grants for the nine-months ended September 30, 2018 is presented below: Stock Options Restricted Stock Awards Weighted Average Equity Awards Options Outstanding Weighted Average Exercise Price Non-vested Restricted Stock Outstanding Weighted Average Grant Date Fair Value Contractual Terms of Equity Awards (in years) Equity awards outstanding at January 1, 2018 703,442 $ 10.34 - $ - Equity awards granted 2,629,004 $ 2.26 35,000 $ 2.71 Vested and issued - $ - (6,000 ) $ 2.64 Equity awards forfeited, cancelled or expired (113,701 ) $ 40.23 - $ - Equity awards outstanding at September 30, 2018 3,218,745 $ 2.67 29,000 $ 2.72 9.4 Aggregate intrinsic value of outstanding equity awards at September 30, 2018 $ 1,384,245 $ 1,700 Equity awards exercisable at September 30, 2018 1,677,998 $ 2.94 9.3 Aggregate intrinsic value of equity awards exercisable at September 30, 2018 $ 706,552 |
Schedule of Assumptions Used to Determine Fair Value of Options Granted | The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.82 – 3.02 % 2.21 % Expected volatility 99.9 -102.1 % 90.4 % Expected life (in years) 8.0 - 10.0 10.00 Expected dividend yield - % - % |
Earn-out Milestone Liability (T
Earn-out Milestone Liability (Tables) | 9 Months Ended |
Sep. 30, 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 2018: Balance at January 1, 2018 $ 12,538,525 Non-cash gain from the adjustment for the change in fair value (3,567,671 ) Balance at September 30, 2018 $ 8,970,854 |
Schedule of Milestone Risk Adjustment Assessment | The following is a schedule of the Company’s risk-adjustment assessment of each milestone: Date Risk-adjustment Assessment of each Milestone Discount Rate Estimated Time to Achieve September 30, 2018 0% to 80% 9% 0.00 to 1.17 year June 30, 2018 35% to 80% 9% 0.83 to 1.00 years December 31, 2017 35% to 80% 9% 1.33 to 1.50 years September 30, 2017 35% to 80% 9% 1.25 to 1.75 years June 30, 2017 50% to 80% 9% 1.50 to 2.00 years December 31, 2016 50% to 80% 9% 2.00 to 2.50 years |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Warrants | |
Summary of Warrant Activity | Following is a summary of all warrant activity for the nine months ended September 30, 2018: Warrants Number of Warrants Issued Weighted Average Exercise Price Warrants outstanding at December 31, 2017 3,058,402 $ 5.29 Warrants issued during the nine months ended September 30, 2018 (see Note 10) 190,114 $ 2.63 Warrants outstanding at September 30, 2018 3,248,516 $ 5.14 Aggregate intrinsic value of outstanding warrants at September 30, 2018 $ 69,229 Weighted average remaining contractual terms at September 30, 2018 (in years) 3.24 |
Financial Condition and Busin_2
Financial Condition and Business Plan (Details Narrative) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | |
Cumulated net losses | $ 279,145,825 | $ 261,781,888 |
Net cash proceeds for NOL | 10,000,000 | |
Cash, investment securities and interest receivable | 22,000,000 | |
Aggregate offering price, additions | 15,000,000 | |
New Jersey [Member] | Maximum [Member] | ||
Cumulated net losses | $ 12,500,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details Narrative) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Earnings Per Share [Abstract] | ||||
Number of shares of common stock issuable upon exercise of warrants and equity awards | 6,496,261 | 6,208,389 | 6,496,261 | 6,208,389 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details Narrative) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Investment securities - available for sale, at fair value | $ 18,579,731 | $ 12,724,020 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Cost, Fair Value and Maturities of Short Term Investments (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Short-term investments - Cost | $ 18,558,771 | $ 12,734,184 |
Short-term investments - Fair Value | 18,579,731 | 12,724,020 |
Short-term investment maturities - Within 3 months, cost | 5,714,421 | |
Short-term investment maturities - Between 3-12 months, cost | 12,844,350 | 12,734,184 |
Total, cost | 18,558,771 | 12,734,184 |
Short-term investment maturities - Within 3 months, fair value | 5,724,554 | |
Short-term investment maturities - Between 3-12 months, fair value | 12,855,177 | 12,724,020 |
Total, fair value | 18,579,731 | 12,724,020 |
Certificate of Deposit [Member] | ||
Short-term investments - Cost | 3,128,390 | |
Short-term investments - Fair Value | 3,144,875 | |
Corporate Debt Securities [Member] | ||
Short-term investments - Cost | 15,430,381 | 12,734,184 |
Short-term investments - Fair Value | $ 15,434,856 | $ 12,724,020 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Schedule of Unrealized Losses and Fair Value of Investment Securities (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Less than 12 months, unrealized gains, fair value | $ 10,845,595 | $ 748,148 |
Less than 12 months, unrealized losses, fair value | 7,734,136 | 11,975,872 |
Investment securities - available for sale, at fair value | 18,579,731 | 12,724,020 |
Less than 12 months, unrealized gains | 27,352 | 570 |
Less than 12 months, unrealized losses | (6,392) | (10,734) |
Unrealized gains (losses) | $ (20,960) | $ (10,164) |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Schedule of Investment Income (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | ||||
Interest and dividends accrued and paid | $ 103,777 | $ 524 | $ 242,625 | $ 3,941 |
Realized gains | 2,788 | 11,125 | ||
Investment income | $ 106,565 | $ 524 | $ 253,750 | $ 3,941 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | ||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Inputs Reconciliation, Transfers into Level 3 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Assets and Liabilities (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Investment securities, available for sale | $ 18,579,731 | $ 12,724,020 |
Earn-out milestone liability | 8,970,854 | 12,538,525 |
Fair Value, Measurements, Recurring [Member] | ||
Investment securities, available for sale | 18,579,731 | 12,724,020 |
Earn-out milestone liability | 8,970,854 | 12,538,525 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Investment securities, available for sale | 18,579,731 | 12,724,020 |
Earn-out milestone liability | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Investment securities, available for sale | ||
Earn-out milestone liability | ||
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Investment securities, available for sale | ||
Earn-out milestone liability | $ 8,970,854 | $ 12,538,525 |
Acquisition of EGEN Assets (Det
Acquisition of EGEN Assets (Details Narrative) - USD ($) | Jun. 16, 2017 | Jun. 20, 2014 | Dec. 31, 2016 | Jun. 20, 2014 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Asset impairment charges, total | $ 2,500,000 | ||||||||||||
Business Combination, Consideration Transferred, Liabilities Incurred | $ 9,000,000 | $ 13,100,000 | 12,500,000 | $ 13,800,000 | |||||||||
Gain (Loss) from Change in Fair Value of Earn out Milestone Liability | 4,100,000 | 1,300,000 | $ (3,567,671) | ||||||||||
Assets | 40,911,954 | 40,911,954 | $ 47,514,433 | ||||||||||
Finite-lived intangible assets, net, ending balance | 625,121 | 625,121 | 795,608 | ||||||||||
Purchase Agreement [Member] | |||||||||||||
Finite-lived intangible assets, net, ending balance | 625,121 | 625,121 | 795,608 | ||||||||||
Finite-lived intangible assets, accumulated amortization | 966,093 | 966,093 | 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 | 24,400,000 | ||||||||||
Payments to Acquire Businesses, Gross | $ 3,000,000 | ||||||||||||
Stock issued during period, shares, acquisitions | 193,728 | ||||||||||||
Number of common stock issued or issuable | 47,862 | ||||||||||||
Business Combination, Consideration Transferred, Liabilities Incurred | 13,900,000 | $ 13,100,000 | $ 13,800,000 | 9,000,000 | $ 12,500,000 | $ 12,500,000 | $ 13,200,000 | ||||||
Gain (Loss) from Change in Fair Value of Earn out Milestone Liability | 4,114,995 | 1,246,151 | 3,567,671 | 670,172 | |||||||||
Goodwill, acquisition | 2,000,000 | ||||||||||||
EGEN Inc [Member] | Purchase Agreement [Member] | |||||||||||||
Gain (Loss) from Change in Fair Value of Earn out Milestone Liability | 4,500,000 | ||||||||||||
Finite-lived intangible assets acquired | $ 1,600,000 | ||||||||||||
Finite-lived intangible asset, useful life | 7 years | ||||||||||||
Amortization expense | 56,829 | 170,487 | $ 56,829 | 170,487 | |||||||||
EGEN Inc [Member] | IPR&D Drug Technology Platforms [Member] | |||||||||||||
Indefinite lived intangible assets | 24,200,000 | ||||||||||||
EGEN Inc [Member] | Ovarian Cancer [Member] | |||||||||||||
Potential future earn-out payments | 12,400,000 | 12,400,000 | |||||||||||
Initial assets value | 6,900,000 | 6,900,000 | |||||||||||
Assets | 2,400,000 | 2,400,000 | |||||||||||
EGEN Inc [Member] | Glioblastoma Multiforme Brain Cancer [Member] | |||||||||||||
Potential future earn-out payments | $ 12,000,000 | $ 12,000,000 | |||||||||||
Asset impairment charges, total | $ 6,900,000 | $ 9,400,000 | |||||||||||
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 Assets - Sc
Acquisition of EGEN Assets - Schedule of Fair Values of Acquired Assets and Liabilities (Details) - USD ($) | Sep. 30, 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 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Other Accrued Liabilities (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Amounts due to contract research organizations and other contractual agreements | $ 730,811 | $ 665,373 |
Accrued payroll and related benefits | 1,048,077 | 1,258,265 |
Accrued professional fees | 341,240 | 264,668 |
Other | 20,000 | 94,521 |
Total | $ 2,140,128 | $ 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 | Sep. 30, 2018 | Sep. 30, 2017 | Jun. 10, 2014 | Sep. 30, 2018 | Dec. 15, 2016 | Sep. 30, 2018 | Dec. 17, 2015 | Jun. 26, 2017 |
Class of warrant or right, exercise price of warrants or rights | $ 1.65 | |||||||||||||
Hercules Warrant [Member] | ||||||||||||||
Debt instrument, unamortized discount, total | $ 476,261 | $ 476,261 | $ 476,261 | |||||||||||
Horizon Credit Agreement [Member] | ||||||||||||||
Precentage of outstanding principle balance, description | an amount equal to 1-3% | |||||||||||||
Interest expense, debt, total | $ 248,270 | $ 259,064 | ||||||||||||
Amortization of debt issuance costs | $ 97,458 | $ 101,695 | ||||||||||||
Horizon Credit Agreement [Member] | Horizon Warrants [Member] | ||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 190,114 | 190,114 | 190,114 | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.63 | $ 2.63 | $ 2.63 | |||||||||||
Debt instrument, unamortized discount, total | $ 507,116 | $ 507,116 | $ 507,116 | |||||||||||
Percentage for original debt, amount | 4.00% | |||||||||||||
Debt issuance costs, gross | $ 400,000 | $ 400,000 | $ 400,000 | |||||||||||
Horizon Credit Agreement [Member] | LIBOR plus [Member] | ||||||||||||||
Line of credit, interest rate | 7.625% | 7.625% | 7.625% | |||||||||||
Horizon Credit Agreement [Member] | Horizon [Member] | ||||||||||||||
Debt instrument, unamortized discount, total | $ 100,000 | $ 100,000 | $ 100,000 | |||||||||||
Debt issuance costs, gross | 782,116 | 782,116 | 782,116 | |||||||||||
Debt issuance costs, net, total | $ 175,000 | 175,000 | $ 175,000 | |||||||||||
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 | |||||||||||||
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) | Sep. 30, 2018USD ($) |
Debt Disclosure [Abstract] | |
2,019 | |
2,020 | |
2,021 | 4,583,333 |
2,022 | 5,000,000 |
2023 and thereafter | 416,667 |
Subtotal of future principle payments | 10,000,000 |
Net of unamortized debt issuance costs | (680,421) |
Total | $ 9,319,579 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Oct. 27, 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 | Aug. 31, 2018 | Sep. 30, 2015 | Dec. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Sep. 30, 2018 | Jun. 26, 2017 | Sep. 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 | 112,500,000 | |||||||||||||||||
Preferred stock, shares authorized | 100,000 | 100,000 | 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 | |||||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number, ending balance | 200,000 | ||||||||||||||||||||
Class of warrant or right, outstanding | 2,400,000 | ||||||||||||||||||||
Common stock, par or stated value per share | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 506,627 | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.65 | ||||||||||||||||||||
Proceeds from warrant exercises | $ 4,925,886 | ||||||||||||||||||||
Aggregate offering price, additions | 15,000,000 | ||||||||||||||||||||
Fair value of common stock issued as equity issuance costs and charged against paid in capital | $ 450,000 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Shares issued under the agreement | 2,050,000 | ||||||||||||||||||||
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 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Shares issued under the agreement | 1,384,704 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.22 | ||||||||||||||||||||
Class of warrant or right, term | 5 years | ||||||||||||||||||||
Stock issued during period, shares, exercise of warrants | 747,254 | ||||||||||||||||||||
Proceeds from warrant exercises | $ 2,400,000 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Stock issued during period, shares, exercise of warrants | 185,713 | ||||||||||||||||||||
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] | |||||||||||||||||||||
Stock issued during period, shares, new issues | 164,835 | ||||||||||||||||||||
Aggregate offering price | $ 15,000,000 | ||||||||||||||||||||
Maximum number of shares purchased per day | 100,000 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Shares issued under the agreement | 164,835 | ||||||||||||||||||||
ATM Agreement [Member] | |||||||||||||||||||||
Stock issued during period, shares, new issues | 1,784,396 | ||||||||||||||||||||
Proceeds from issuance of common stock | $ 12,800,000 | ||||||||||||||||||||
Shares issued under the agreement | 1,784,396 | ||||||||||||||||||||
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. | ||||||||||||||||||||
Shares issued under the agreement | 2,640,000 | ||||||||||||||||||||
Warrant [Member] | |||||||||||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number, ending balance | 2,400,000 | ||||||||||||||||||||
Class of warrant or right, outstanding | 33,500,000 | ||||||||||||||||||||
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 | ||||||||||||||||||||
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 | |||||||||||||||||||
Minimum [Member] | |||||||||||||||||||||
Common stock, shares authorized | 75,000,000 | ||||||||||||||||||||
Maximum [Member] | |||||||||||||||||||||
Common stock, shares authorized | 112,500,000 | ||||||||||||||||||||
Maximum [Member] | Warrant [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 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Sep. 28, 2018 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | May 16, 2017 |
Number of shares reserved for future issuance | 200,000 | |||||||
2018 Stock Incentive Plan [Member] | ||||||||
Equity awards, number of stock authorized | 2,700,000 | 2,700,000 | 2,700,000 | |||||
Percentage of fair market value of shares | 100.00% | 100.00% | 100.00% | |||||
Percentage of outstanding stock determining factor for incentive stock price | 10.00% | 10.00% | 10.00% | |||||
Compensation cost | $ 614,528 | $ 146,896 | $ 3,985,829 | $ 951,488 | ||||
Stock based compensation cost expected to be recognized, weighted average period | 1 year 1 month 6 days | |||||||
Weighted average grant date fair value of stock option awards granted | $ 2.36 | $ 2.69 | ||||||
2018 Stock Incentive Plan [Member] | Minimum [Member] | ||||||||
Percentage of fair market value of shares | 110.00% | 110.00% | 110.00% | |||||
Inducement Option Grants [Member] | Three New Employees [Member] | ||||||||
Inducement option grant, exercise price per share | $ 2.77 | |||||||
Number of equity awards granted | 183,004 | |||||||
Inducement Option Grants [Member] | Three New Employees [Member] | Restricted Stock Awards [Member] | ||||||||
Shares issued | 164,004 | |||||||
2007 Stock Incentive Plan [Member] | ||||||||
Equity awards, number of stock authorized | 688,531 | 688,531 | 688,531 | |||||
Unrecognized compensation cost related to non-vested stock based compensation | $ 2,700,000 | $ 2,700,000 | $ 2,700,000 | |||||
Stock Options [Member] | ||||||||
Options expiration period | 10 years | |||||||
Inducement option grant, exercise price per share | $ 2.26 | |||||||
Number of shares reserved for future issuance | 3,218,745 | 3,218,745 | 3,218,745 | 703,442 | ||||
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 | 3,399,893 | |||||
Number of equity awards granted | 3,064,741 | |||||||
Number of equity awards available for future issuance | 335,152 | 335,152 | 335,152 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Option Awards and Restricted Stock Grants (Details) | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Weighted average contractual terms of equity awards (in years), equity awards, outstanding, ending balance | 9 years 4 months 24 days |
Weighted average contractual terms of equity awards (in years), equity awards exercisable, ending balance | 9 years 3 months 19 days |
Stock Options [Member] | |
Equity awards, outstanding, beginning balance | shares | 703,442 |
Equity awards granted | shares | 2,629,004 |
Vested and issued | shares | |
Equity awards forfeited, cancelled or expired | shares | (113,701) |
Equity awards, outstanding, ending balance | shares | 3,218,745 |
Aggregate intrinsic value of outstanding awards, ending balance | $ | $ 1,384,245 |
Equity awards exercisable, ending balance | shares | 1,677,998 |
Aggregate intrinsic value of awards exercisable, ending balance | $ | $ 706,552 |
Weighted average exercise price, equity awards, outstanding, beginning balance | $ / shares | $ 10.34 |
Weighted average exercise price, equity awards granted | $ / shares | 2.26 |
Weighted average exercise price, vested and issued | $ / shares | |
Weighted average exercise price, equity awards forfeited, cancelled or expired | $ / shares | 40.23 |
Weighted average exercise price, equity awards, outstanding, ending balance | $ / shares | 2.67 |
Weighted average exercise price, equity awards exercisable, ending balance | $ / shares | $ 2.94 |
Restricted Stock Awards [Member] | |
Non-vested restricted stock outstanding, equity awards, outstanding, beginning balance | shares | |
Non-vested restricted stock outstanding, equity awards granted | shares | 35,000 |
Non-vested restricted stock outstanding, vested and issued | shares | (6,000) |
Non-vested restricted stock outstanding, equity awards forfeited, cancelled or expired | shares | |
Non-vested restricted stock outstanding, equity awards, outstanding, ending balance | shares | 29,000 |
Non-vested restricted stock outstanding, aggregate intrinsic value of outstanding awards, ending balance | $ | $ 1,700 |
Weighted average grant date fair value, equity awards, outstanding, beginning balance | $ / shares | |
Weighted average grant date fair value, equity awards granted | $ / shares | 2.71 |
Weighted average grant date fair value, vested and issued | $ / shares | 2.64 |
Weighted average grant date fair value, equity awards forfeited, cancelled or expired | $ / shares | |
Weighted average grant date fair value, equity awards, outstanding, ending balance | $ / shares | $ 2.72 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions Used to Determine Fair Value of Options Granted (Details) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Risk-free interest rate | 2.21% | |
Expected volatility | 90.40% | |
Expected life (in years) | 10 years | |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Risk-free interest rate | 2.82% | |
Expected volatility | 99.90% | |
Expected life (in years) | 8 years | |
Maximum [Member] | ||
Risk-free interest rate | 3.02% | |
Expected volatility | 102.10% | |
Expected life (in years) | 10 years |
Earn-out Milestone Liability (D
Earn-out Milestone Liability (Details Narrative) - USD ($) | Jun. 20, 2014 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Fair value of Acquisition consideration | $ 9,000,000 | $ 13,100,000 | $ 12,500,000 | $ 13,800,000 | |||||
Gain (loss) from change in fair value of earn out milestone liability | $ 4,100,000 | $ 1,300,000 | $ (3,567,671) | ||||||
Minimum [Member] | |||||||||
Risk adjusted assessment of each milestone | 0.00% | 35.00% | 35.00% | 50.00% | 0.00% | 35.00% | 35.00% | 50.00% | |
Estimated time to achieve the milestone | 9 months 29 days | 1 year 6 months | 0 years | 1 year 2 months 30 days | 1 year 3 months 29 days | 2 years | |||
Maximum [Member] | |||||||||
Risk adjusted assessment of each milestone | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% | |
Estimated time to achieve the milestone | 1 year | 2 years | 1 year 2 months 1 day | 1 year 9 months | 1 year 6 months | 2 years 6 months | |||
EGEN Inc [Member] | |||||||||
Future earn-out payments | $ 30,400,000 | $ 24,400,000 | |||||||
Fair value of Acquisition consideration | $ 13,900,000 | $ 13,100,000 | $ 13,800,000 | $ 9,000,000 | $ 12,500,000 | $ 12,500,000 | $ 13,200,000 | ||
Gain (loss) from change in fair value of earn out milestone liability | $ 4,114,995 | $ 1,246,151 | $ 3,567,671 | $ 670,172 | |||||
EGEN Inc [Member] | Minimum [Member] | |||||||||
Risk adjusted assessment of each milestone | 10.00% | ||||||||
Estimated time to achieve the milestone | 1 year 6 months | ||||||||
EGEN Inc [Member] | Maximum [Member] | |||||||||
Future earn-out payments | $ 30,400,000 | ||||||||
Risk adjusted assessment of each milestone | 67.00% | ||||||||
Estimated time to achieve the milestone | 2 years 6 months |
Earn-out Milestone Liability -
Earn-out Milestone Liability - Schedule of Changes in Earn-out Milestone Liability (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | |
Earn-out Milestone Liability | |||
Earn-out liabilities, beginning balance | $ 12,538,525 | ||
Non-cash charge from the adjustment for the change in fair value included in net loss | $ 4,100,000 | $ 1,300,000 | (3,567,671) |
Earn-out liabilities, ending balance | $ 8,970,854 | $ 8,970,854 |
Earn-out Milestone Liability _2
Earn-out Milestone Liability - Schedule of Milestone Risk Adjustment Assessment (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Discount Rate | 9.00% | 9.00% | 9.00% | 9.00% | 9.00% | 9.00% |
Minimum [Member] | ||||||
Risk-adjustment Assessment of each Milestone | 35.00% | 50.00% | 0.00% | 35.00% | 35.00% | 50.00% |
Estimated Time to Achieve (in years) | 9 months 29 days | 1 year 6 months | 0 years | 1 year 2 months 30 days | 1 year 3 months 29 days | 2 years |
Maximum [Member] | ||||||
Risk-adjustment Assessment of each Milestone | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% | 80.00% |
Estimated Time to Achieve (in years) | 1 year | 2 years | 1 year 2 months 1 day | 1 year 9 months | 1 year 6 months | 2 years 6 months |
Warrants (Details Narrative)
Warrants (Details Narrative) - $ / shares | 9 Months Ended | ||
Sep. 30, 2018 | Jun. 26, 2017 | May 16, 2017 | |
Number of shares, Warrant rights | 506,627 | ||
Warrants outstanding | 2,400,000 | ||
Warrants, weighted average exercise price | $ 1.65 | ||
October 29, 2018 [Member] | |||
Number of shares, Warrant rights | 1,600,000 | ||
Common stock shares issued | 820,714 | ||
Warrants outstanding | 1,600,000 | ||
Warrants, weighted average exercise price | $ 5.75 | ||
Warrants expiring in 2019 | 1,200,000 | ||
Strike price per share | $ 6.20 | ||
Warrant expiration date | Apr. 4, 2019 |
Warrants - Summary of Warrant A
Warrants - Summary of Warrant Activity (Details) | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Warrants | |
Number of warrants issued warrants outstanding at December 31, 2017 | shares | 3,058,402 |
Number of warrants issued during the six months ended June 30, 2018 | shares | 190,114 |
Number of Warrants Issued Warrants outstanding at June 30, 2018 | shares | 3,248,516 |
Number of warrants issued aggregate intrinsic value of outstanding warrants at June 30, 2018 | $ | $ 69,229 |
Number of warrants issued weighted average remaining contractual terms at June 30, 2018 (in years) | 3 years 2 months 27 days |
Weighted average exercise price warrants outstanding at December 31, 2017 | $ / shares | $ 5.29 |
Weighted Average Exercise Price Warrants issued during the six months ended June 30, 2018 | $ / shares | 2.63 |
Weighted Average Exercise Price Warrants outstanding at June 30, 2018 | $ / shares | $ 5.14 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details Narrative) | 1 Months Ended | ||||||
Jan. 31, 2018USD ($)ft² | Apr. 30, 2017USD ($)ft² | Apr. 30, 2012USD ($) | Jul. 31, 2011ft² | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2014ft² | |
Irrevocable and unconditional standby letter of credit | $ 730,811 | $ 665,373 | |||||
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 | 11,500 | |||||
Lease term | 60 months | ||||||
Operating leases, monthly rent payment | $ 18,100 |
Technology Development and Li_2
Technology Development and Licensing Agreements (Details Narrative) - USD ($) | Jan. 18, 2013 | Mar. 31, 2013 | Jun. 30, 2013 |
Deferred revenue | $ 5,000,000 | ||
Deferred revenue amortization period | 10 years | ||
Hisun [Member] | |||
Non-refundable research and development fee | $ 5,000,000 |