Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Jun. 30, 2018 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | SOLIGENIX, INC. | |
Entity Central Index Key | 0000812796 | |
Trading Symbol | SNGX | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Type | 10-K | |
Document Fiscal Period Focus | FY | |
Document Period End Date | Dec. 31, 2018 | |
Document Fiscal Year Focus | 2018 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Entity Public Float | $ 8,437,036 | |
Entity Common Stock, Shares Outstanding | 8,750,801 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 8,983,717 | $ 7,809,487 |
Contracts and grants receivable | 1,201,715 | 926,251 |
Prepaid expenses | 157,278 | 263,254 |
Income tax receivable | 416,810 | |
Total current assets | 10,342,710 | 9,415,802 |
Security deposit | 22,734 | 22,734 |
Office furniture and equipment, net | 19,634 | 37,163 |
Deferred issuance costs | 59,761 | |
Intangible assets, net | 46,863 | 73,952 |
Total assets | 10,491,702 | 9,549,651 |
Current liabilities: | ||
Accounts payable | 2,126,215 | 1,753,614 |
Accrued expenses | 1,790,689 | 1,143,306 |
Accrued compensation | 294,628 | 333,019 |
Total current liabilities | 4,211,532 | 3,229,939 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock: 350,000 shares authorized; none issued or outstanding | ||
Common stock, $.001 par value; 50,000,000 and 25,000,000 shares authorized at December 31, 2018 and 2017, respectively; 17,682,839 and 8,730,640 shares issued and outstanding at December 31, 2018 and 2017, respectively | 17,683 | 8,731 |
Additional paid-in capital | 172,436,176 | 163,581,026 |
Accumulated other comprehensive loss | (3,669) | |
Accumulated deficit | (166,170,020) | (157,270,045) |
Total shareholders' equity | 6,280,170 | 6,319,712 |
Total liabilities and shareholders' equity | $ 10,491,702 | $ 9,549,651 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 350,000 | 350,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 25,000,000 |
Common stock, shares issued | 17,682,839 | 8,730,640 |
Common stock, shares outstanding | 17,682,839 | 8,730,640 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | ||
Contract revenue | $ 3,965,496 | $ 4,749,294 |
Grant revenue | 1,275,952 | 683,178 |
Total revenues | 5,241,448 | 5,432,472 |
Cost of revenues | (4,597,715) | (4,310,083) |
Gross profit | 643,733 | 1,122,389 |
Operating expenses: | ||
Research and development | 6,750,954 | 5,507,033 |
General and administrative | 2,951,760 | 3,209,155 |
Total operating expenses | 9,702,714 | 8,716,188 |
Loss from operations | (9,058,981) | (7,593,799) |
Other income: | ||
Interest income | 159,006 | 29,906 |
Net loss before income taxes | (8,899,975) | (7,563,893) |
Income tax benefit | 416,810 | |
Net loss | $ (8,899,975) | $ (7,147,083) |
Basic and diluted net loss per share | $ (0.68) | $ (1.16) |
Basic and diluted weighted average common shares outstanding | 13,178,154 | 6,144,237 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (8,899,975) | $ (7,147,083) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | (3,669) | |
Comprehensive loss | $ (8,903,644) | $ (7,147,083) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2016 | $ 5,470 | $ 157,514,740 | $ (150,122,962) | $ 7,397,248 | |
Beginning Balance, Shares at Dec. 31, 2016 | 5,470,032 | ||||
Issuance of common stock pursuant to Lincoln Park Equity Line | $ 50 | 115,880 | 115,930 | ||
Issuance of common stock pursuant to Lincoln Park Equity Line, Shares | 50,483 | ||||
Issuance of common stock pursuant to FBR At-the-Market Sales Agreement | $ 450 | 1,014,815 | 1,015,265 | ||
Issuance of common stock pursuant to FBR At-the-Market Sales Agreement, Shares | 450,000 | ||||
Costs associated with FBR At-the-Market Sales Agreement | (164,825) | (164,825) | |||
Issuance of common stock from cashless exercise of warrants | $ 200 | (200) | |||
Issuance of common stock from cashless exercise of warrants, Shares | 200,125 | ||||
Issuance of common stock in concurrent public and private offerings | $ 2,558 | 5,112,443 | 5,115,001 | ||
Issuance of common stock in concurrent public and private offerings, Shares | 2,557,500 | ||||
Costs associated with concurrent public and private offerings | (507,536) | (507,536) | |||
Issuance of common stock to vendors | $ 3 | 5,922 | 5,925 | ||
Issuance of common stock to vendors, Shares | 2,500 | ||||
Share-based compensation expense | 489,787 | 489,787 | |||
Net loss | (7,147,083) | (7,147,083) | |||
Ending Balance at Dec. 31, 2017 | $ 8,731 | 163,581,026 | (157,270,045) | 6,319,712 | |
Ending Balance, Shares at Dec. 31, 2017 | 8,730,640 | ||||
Issuance of common stock pursuant to Lincoln Park Equity Line | $ 20 | 38,380 | 38,400 | ||
Issuance of common stock pursuant to Lincoln Park Equity Line, Shares | 20,161 | ||||
Issuance of common stock in public offering | $ 8,932 | 8,628,014 | 8,636,946 | ||
Issuance of common stock in public offering, Shares | 8,932,038 | ||||
Costs associated with public offerings | (192,130) | (192,130) | |||
Share-based compensation expense | 380,886 | 380,886 | |||
Foreign currency translation adjustment | (3,669) | (3,669) | |||
Net loss | (8,899,975) | (8,899,975) | |||
Ending Balance at Dec. 31, 2018 | $ 17,683 | $ 172,436,176 | $ (3,669) | $ (166,170,020) | $ 6,280,170 |
Ending Balance, Shares at Dec. 31, 2018 | 17,682,839 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities: | ||
Net loss | $ (8,899,975) | $ (7,147,083) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 44,060 | 68,563 |
Share-based compensation | 380,886 | 489,787 |
Issuance of common stock for services | 5,925 | |
Loss on disposition of office furniture | 1,483 | |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | (275,464) | 280,526 |
Prepaid expenses | 105,976 | (128,823) |
Security deposit | (22,734) | |
Income tax receivable | 416,810 | (416,810) |
Accounts payable and accrued expenses | 1,019,984 | 382,711 |
Accrued compensation | (38,391) | (22,629) |
Total adjustments | 1,655,344 | 636,516 |
Net cash used in operating activities | (7,244,631) | (6,510,567) |
Investing activities: | ||
Purchases of office furniture and equipment | (1,925) | (26,348) |
Proceeds from sale of office furniture | 1,000 | |
Net cash used in investing activities | (925) | (26,348) |
Financing activities: | ||
Proceeds from issuance of common stock and warrants pursuant to public and private offerings | 8,636,946 | 5,115,001 |
Stock issuance costs associated with public and private offerings | (251,891) | (507,536) |
Proceeds from issuance of common stock pursuant to FBR At-the-Market Sales Agreement | 1,015,265 | |
Costs associated with FBR At-the-Market Sales Agreement | (164,825) | |
Proceeds from issuance of common stock pursuant to the equity line | 38,400 | 115,930 |
Net cash provided by financing activities | 8,423,455 | 5,573,835 |
Effect of exchange rate on cash and cash equivalents | (3,669) | |
Net increase (decrease) in cash and cash equivalents | 1,174,230 | (963,080) |
Cash and cash equivalents at beginning of year | 7,809,487 | 8,772,567 |
Cash and cash equivalents at end of year | 8,983,717 | 7,809,487 |
Supplemental information: | ||
Cash paid for state income taxes | $ 2,580 | $ 5,077 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: BioTherapeutics and Vaccines/BioDefense. The Company’s BioTherapeutics business segment is developing a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (“CTCL”), its first-in-class innate defense regulator (“IDR”) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201). The Company’s Vaccines/BioDefense business segment includes active development programs for RiVax ® ® ® The Company generates revenues under government grants primarily from the National Institutes of Health (“NIH”) and government contracts from NIAID. The Company is currently developing RiVax ® The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the United States Food and Drug Administration (the U.S. “FDA”) regulations, and other regulatory authorities, litigation, and product liability. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2018, the Company had an accumulated deficit of $166,170,020. During the year ended December 31, 2018, the Company incurred a net loss of $8,899,975 and used $7,244,631 of cash in operations. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be largely determined by the budgeted operational expenditures incurred in regards to the progression of its product candidates. The Company’s plans to meet its liquidity needs primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through potential partnerships and/or financings. Based on the Company’s approved operating budget, current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, and proceeds available from the At Market Issuance Sales Agreement (“FBR Sales Agreement”) with B. Riley FBR, Inc. (“FBR”) management believes that its current cash will be sufficient to meet the anticipated cash needs for working capital and capital expenditures for at least the next 12 months from issuance of the financial statements. As of December 31, 2018, the Company had cash and cash equivalents of $8,983,717 as compared to $7,809,487 as of December 31, 2017, representing an increase of $1,174,230 or 15%. As of December 31, 2018, the Company had working capital of $6,131,178, as compared to working capital of $6,185,863 for the prior year, representing a decrease of $54,685. The increase in cash and cash equivalents was primarily the result of the Company’s financing activities through its public offering of common stock. The decrease in working capital was primarily related to the expenditures incurred in the expansion of the pivotal Phase 3 trial of SGX942 in addition to the ongoing expenditures incurred in the pivotal Phase 3 clinical trial of SGX301. Management’s business strategy can be outlined as follows: ● Following positive interim analysis, complete enrollment and report final results in the Company’s pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL; ● Continue enrollment of the pivotal Phase 3 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ● Continue development of RiVax ® ® ● Continue to apply for and secure additional government funding for each of the Company’s BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore merger/acquisition strategies; and ● Acquire or in-license new clinical-stage compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to $14.6 million in active government contract and grant funding still available as of December 31, 2018, to support its associated research programs through 2019 and beyond, provided the federal agencies exercise all options and do not elect to terminate the contracts or grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies; ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future; ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if available; ● The Company plans to pursue potential partnerships for pipeline programs. However, there can be no assurances that we can consummate such transactions; ● The Company has up to $8.5 million remaining from the FBR Sales Agreement as of March 20, 2019 under the prospectus supplement updated October 3, 2018; and ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: BioTherapeutics and Vaccines/BioDefense. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for doubtful amounts has been established. If amounts become uncollectible, they are charged to operations. Intangible Assets One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730, Research and Development The Company did not capitalize any patent related costs during the years ended December 31, 2018 or 2017. These intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and carrying value of the related asset or group of assets. No such write downs have occurred during the years ended December 31, 2018 and 2017. Impairment of Long-Lived Assets Office furniture and equipment and intangible assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2018 or 2017. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. Revenue Recognition The Company’s revenues are primarily generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed. Typically these instruments vest upon issuance and therefore the entire share-based compensation expense is recognized upon issuance to the vendors and/or consultants. Share-based compensation expense for options, warrants and shares of common stock granted to non-employees has been determined in accordance with and FASB ASC 505-50, Equity-Based Payments to Non-Employees During the year ended December 31, 2018, the Company issued 370,420 stock options at a weighted average exercise price of $1.14 per share. The fair value of options issued during the years ended December 31, 2018 and 2017 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0%; ● an expected life of 4 years; ● volatility of 91% - 94% for 2018 and 90% - 93% for 2017; ● forfeitures at a rate of 12%; and ● risk-free interest rates ranging from 2.68% to 2.93% in 2018 and 1.60% to 2.02% in 2017. The fair value of each option grant made during 2018 and 2017 was estimated on the date of each grant using the Black-Scholes option pricing model and amortized ratably over the option vesting periods, which approximates the service period. Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly owned subsidiary in the United Kingdom (“UK”) from inactive to active and incurred expenditures in multiple currencies including the US dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. No current or deferred income taxes have been provided through December 31, 2018 due to the net operating losses incurred by the Company since its inception. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2018 and 2017. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2018 and 2017. Earnings Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period. For the Year Ended For the Year Ended December 31, 2018 December 31, 2017 Common stock purchase warrants 6,303,643 2,577,238 Stock options 1,022,095 785,655 Total 7,325,738 3,362,893 The weighted average exercise price of the Company’s stock options and warrants outstanding at December 31, 2018 were $5.32 and $3.09 per share, respectively. Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and the useful life of intangibles that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases” (Topic 842). The FASB issued this update to increase transparency and comparability among organizations by requiring all leases with terms longer than 12 months be recognized by the lessee on its balance sheet as a right-of-use asset and a corresponding lease liability, including leases currently accounted for as operating leases, and disclosing key information about leasing arrangements. The updated guidance is effective for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption of the update is permitted. The Company adopted the new standard on January 1, 2019 using a modified retrospective approach. Upon the adoption of this standard, we recognized right-of-use assets and corresponding operating lease liabilities pertaining to our operating leases on our balance sheets. The adoption of this standard did not have a material impact on our consolidated financial statements. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 3. Intangible Assets The following is a summary of intangible assets which consists of licenses and patents: Cost Accumulated Amortization Net Book Value December 31, 2018 Licenses $ 462,234 $ 415,371 $ 46,863 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,308,556 $ 46,863 December 31, 2017 Licenses $ 462,234 $ 388,282 $ 73,952 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,281,467 $ 73,952 Amortization expense was $27,089 and $52,676 in 2018 and 2017, respectively. Based on the balance of licenses and patents at December 31, 2018, future annual amortization expense is expected to be as follows: Year Amortization Expense 2019 $ 27,164 2020 $ 19,699 License fees and royalty payments are expensed annually as incurred, as the Company does not attribute any future benefits of such payments. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: As of 2018 2017 Clinical trial expenses $ 1,633,713 $ 1,011,666 Other 156,976 131,640 Total $ 1,790,689 $ 1,143,306 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 5. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2018 and December 31, 2017: 2018 2017 Federal $ - $ - Foreign - - State - (416,810 ) Income tax benefit $ - $ (416,810 ) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2018 and 2017 are as follows: 2018 2017 Net operating loss carry forwards $ 22,996,000 $ 21,286,000 Orphan drug and research and development credit carry forwards 8,333,000 7,878,000 Equity based compensation 1,331,000 1,332,000 Intangibles 1,164,000 1,289,000 Total 33,824,000 31,785,000 Valuation allowance (33,824,000 ) (31,785,000 ) Net deferred tax assets $ - $ - The Company had gross NOLs at December 31, 2018 of approximately $104,131,000 for federal tax purposes, approximately $14,028,000 for state tax purposes and approximately $688,000 for foreign tax purposes. Portions of these NOLs will begin to expire in 2019. In addition, the Company has $8,333,000 of various tax credits which expire from 2019 to 2037. The Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the NOL carry forwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs may be substantially limited. The Company and one or more of its subsidiaries files income tax returns in the U.S. Federal jurisdiction, and various state and local jurisdictions. During the year ended December 31, 2017, in accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carry forwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carry forwards, resulting in the recognition of $416,810 of income tax benefit, net of transaction costs. The Company has not yet sold its 2017 New Jersey NOLs but may be able to do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended December 31, 2018 and 2017 were as follows: 2018 2017 Federal tax at statutory rate (21.0 )% (34.0 )% State tax benefits, plus sale of NJ NOL, net of federal benefit (12.5 ) (11.6 ) Foreign tax rate difference 0.2 - Permanent differences 0.9 5.7 Orphan drug and research and development credits 1.1 (13.9 ) Change in statutory rate - 186.9 Expiration of tax attributes 8.4 - Change in valuation allowance 22.9 (138.6 ) Income tax benefit - % (5.5 )% On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act significantly revises U.S. corporate income taxation by, among other things, lowering the U.S. corporate income tax rate from 35.0 % to 21.0% effective January 1, 2018. Tax Reform did not have any impact to the tax provision due to the full valuation allowance on its deferred tax assets and the most significant impact on its consolidated financial statements was the reduction of approximately $14 million for the deferred tax assets related to net operating losses and other assets recorded in the 2017 financial statements. Such reduction is fully offset by changes to the Company’s valuation allowance. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' Equity | Note 6. Shareholders’ Equity Preferred Stock The Company has 350,000 shares of preferred stock authorized, none of which are issued or outstanding. Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2018: ● On February 21, 2018, the Company issued 10,083 shares of common stock pursuant to the equity line with Lincoln Park Capital Fund, LLC (“Lincoln Park”); ● On April 6, 2018, the Company issued 10,078 shares of common stock under the equity line with Lincoln Park; ● On July 2, 2018, the Company closed an underwritten public offering of 7,766,990 shares of its common stock and warrants to purchase 3,106,796 shares of common stock at a combined offering price of $1.03; ● On July 9, 2018, the underwriter for the Company’s underwritten public offering exercised the over-allotment option to purchase 1,165,048 additional shares of common stock and warrants to purchase 466,019 shares of common stock at a combined offering price of $1.03. The following items represent transactions in the Company’s common stock for the year ended December 31, 2017: ● On January 3, 2017, the Company issued 2,500 shares to a vendor for partial consideration for services performed. The fair value of the fully vested shares was $2.37 per share; ● On May 4, 2017, warrants to purchase a total of 250,000 shares were exercised on a cashless basis and as a result 200,125 shares of common stock were issued; ● On May 24, 2017, the Company issued 10,096 shares of common stock pursuant to the equity line with Lincoln Park; ● In July 2017, the Company issued 40,387 shares of common stock pursuant to the equity line with Lincoln Park; ● Between August 14 and October 25, 2017, the Company issued FBR 450,000 shares of common stock pursuant to the FBR Sales Agreement. ● On November 3, 2017, the Company issued 1,575,500 shares of common stock at a purchase price of $2.00 per share in a registered direct offering and 982,000 shares of common stock at a purchase price of $2.00 per share in a concurrent private placement. Lincoln Park Equity Line In March 2016, the Company entered into a common stock purchase agreement with Lincoln Park. The Lincoln Park equity facility allows the Company to require Lincoln Park to purchase up to 10,000 shares (“Regular Purchase”) of the Company’s common stock every two business days, up to an aggregate of $12.0 million over approximately a 36-month period with such amounts increasing as the quoted stock price increases. The Regular Purchase may be increased up to 15,000 shares of common stock if the closing price of the common shares is not below $10.00, up to 20,000 shares of common stock if the closing price of the common shares is not below $15.00 and up to 25,000 shares of common stock if the closing price of the common shares is not below $20.00. The purchase price for the Regular Purchase shall be equal to the lesser of (i) the lowest sale price of the common shares during the purchase date, or (ii) the average of the three lowest closing sale prices of the common shares during the twelve business days prior to the purchase date. Each Regular Purchase shall not exceed $750,000. Furthermore, for each purchase by Lincoln Park, additional commitment shares in commensurate amounts up to a total of 50,000 shares will be issued based upon the relative proportion of the aggregate amount of $12.0 million. In addition to the Regular Purchase and provided that the closing price of the common shares is not below $7.50 on the purchase date, the Company in its sole discretion may direct Lincoln Park on each purchase date to purchase on the next stock trading day (“Accelerated Purchase Date”) additional shares of Company stock up to the lesser of (i) three times the number of shares purchased following a Regular Purchase or (ii) 30% of the trading volume of shares traded on the Accelerated Purchase Date at a price equal to the lesser of the closing sale price on the Accelerated Purchase Date or 95% of the Accelerated Purchase Date’s volume weighted average price. As of December 31, 2018, the Company had $10.1 million available under the equity facility. The common stock purchase agreement with Lincoln Park will expire on March 31, 2019, and any issuable amounts of common stock remaining at the expiration date will be forfeited. During the year ended December 31, 2017, the Company sold 50,000 shares of common stock and issued 483 commitment shares and received proceeds of $115,930. The value of commitment shares on the date granted was $1,125, which was accounted for as a stock issuance cost. During the year ended December 31, 2018, the Company sold 20,000 shares of common stock and issued 161 commitment shares and received proceeds of $38,400. The value of commitment shares on the date granted was $309, which was accounted for as a stock issuance cost. FBR At Market Issuance Sales Agreement On August 11, 2017, the Company entered into the FBR Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program under which FBR acts as sales agent. Under the FBR Sales Agreement, the Company sets the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The FBR Sales Agreement provides that FBR is entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the FBR Sale Agreement. The Company has no obligation to sell any shares under the FBR Sales Agreement, and may suspend solicitation and offers under the FBR Sales Agreement at any time. Sales of common stock made pursuant to the FBR Sales Agreement, if any, will be made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-217738) filed on May 5, 2017 with the SEC, the base prospectus filed as part of such registration statement, and any prospectus supplements. The shares sold pursuant to the FBR Sales Agreement have been and will be issued pursuant to General Instruction I.B.6 of Form S-3, which permits the Company to sell shelf securities in a public primary offering with a value not exceeding one-third of the average market value of the Company’s voting and non-voting common equity held by non-affiliates in any 12-month period as long as the aggregate market value of the Company’s outstanding voting and non-voting common equity held by non-affiliates is less than $75 million. On August 11, 2017, the Company filed a prospectus supplement for the sale of up to $4.8 million of shares of common stock pursuant to the FBR Sales Agreement, and the Company sold an aggregate of approximately $1 million of shares thereunder. The offering costs incurred to register the shares pursuant to the prospectus supplement dated August 11, 2017 were $164,825. On October 3, 2018, the Company filed an updated prospectus supplement with the SEC and may offer and sell shares of the Company’s common stock pursuant to the FBR Sales Agreement having an aggregate offering price of up to $9.0 million, from time to time. The prospectus supplement filed on October 3, 2018, supersedes the prospectus supplement dated August 11, 2017, and no additional shares will be offered or sold pursuant to the prospectus supplement dated August 11, 2017. As of March 20, 2019, there was $8.5 million available for the sale of common stock under the FBR Sales Agreement. |
Stock Option Plans and Warrants
Stock Option Plans and Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Stock Option Plans And Warrants To Purchase Common Stock | |
Stock Option Plans and Warrants to Purchase Common Stock | Note 9. Stock Option Plans and Warrants to Purchase Common Stock Stock Option Plans The Amended and Restated 2005 Equity Incentive Plan (“2005 Plan”) was replaced by the 2015 Equity Incentive Plan (“2015 Plan”), which was approved in June 2015. No securities are available for future issuance under the 2005 Plan. As of December 31, 2018, approximately 153,000 shares are available for grants under the 2015 Plan, and are divided into four separate equity programs: 1) the Discretionary Option Grant Program, under which eligible persons may, at the discretion of the Plan Administrator, be granted options to purchase shares of common stock, 2) the Salary Investment Option Grant Program, under which eligible employees may elect to have a portion of their base salary invested each year in options to purchase shares of common stock, 3) the Automatic Option Grant Program, under which eligible nonemployee Board members will automatically receive options at periodic intervals to purchase shares of common stock, and 4) the Director Fee Option Grant Program, under which non-employee Board members may elect to have all, or any portion, of their annual retainer fee otherwise payable in cash applied to a special option grant. Shares available for grant under the 2015 Plan were as follows: Shares available for grant at January 1, 2018 13,969 Increase in shares available for grant 400,000 Options granted (370,420 ) Options forfeited 109,600 Shares available for grant at December 31, 2018 153,149 Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2018 and 2017 was as follows: Options Weighted Average Options Exercise Price Balance outstanding at December 31, 2016 330,605 $ 17.07 Granted 476,100 2.24 Forfeited (21,050 ) 51.62 Balance outstanding at December 31, 2017 785,655 $ 7.15 Granted 370,420 1.14 Forfeited (133,980 ) 4.66 Balance outstanding at December 31, 2018 1,022,095 $ 5.32 As of December 31, 2018, there were 598,953 options exercisable with a weighted average exercise price of $8.02 and a weighted average remaining contractual term of 7.28 years. As of December 31, 2018, there were 1,022,095 options outstanding with a weighted average exercise price of $5.32 and remaining term of 8.20 years. The Company awarded 370,420 and 476,100 shares of stock options during the years ended December 31, 2018 and 2017, respectively, which had a weighted average grant date fair value per share of $0.77 and $1.54, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2018 was: Price Range Weighted Average Remaining Contractual Life in Years Outstanding Options Exercisable Options $0.97-$17.20 8.60 942,314 519,172 $20.10-$39.80 4.50 53,293 53,293 $41.00-$62.00 1.61 26,488 26,488 Total 8.20 1,022,095 598,953 The Company’s share-based compensation expense for the years ended December 31, 2018 and 2017 was recognized as follows: Share-based compensation 2018 2017 Research and development $ 174,877 $ 213,944 General and administrative 206,009 275,843 Total $ 380,886 $ 489,787 At December 31, 2018, the total compensation cost for stock options not yet recognized was approximately $421,000 and will be expensed over the next three years. Warrants to Purchase Common Stock On November 3, 2017, 1,575,500 shares of common stock were issued at a purchase price of $2.00 per share and 982,000 shares of common stock were issued at a purchase price of $2.00 per share in a concurrent private placement. In connection with the concurrent registered public offering and the private placement, warrants to purchase 51,151 shares of the Company’s common stock were issued to the representatives of the underwriters of the offering. The warrants are exercisable at $2.50 per share of common stock underlying the warrants for a four-year period commencing six months from the effective date of the offering. On April 1, 2018, warrants to purchase 10,000 shares of the Company’s common stock were issued to a third party consultant in Europe. The warrants are exercisable upon the achievement of specified performance milestones at a per share price of $1.95 for a five-year period from issuance. As of December 31, 2018, warrants to purchase 5,000 shares of common stock were exercisable and compensation expense was recognized. On July 2, 2018, the Company closed an underwritten public offering of 7,766,990 shares of its common stock and exercisable warrants to purchase up to an aggregate of 3,106,796 shares of its common stock at a combined offering price of $1.03. In addition, at the closing the underwriters exercised the over-allotment option to purchase 1,165,048 additional shares of common stock and warrants to purchase up to 466,019 shares of common stock at a combined offering price of $1.03. The warrants have a per share exercise price of $2.25 and will expire 42 months from the date of issuance. On July 9, 2018, warrants to purchase 155,340 shares of the Company’s common stock were issued to representatives of the underwriters of the offering. The warrants are exercisable at a per share price of $1.13 and are exercisable twelve months from the effective date of the offering and will expire 42 months from the effective date of the offering. Warrant activity for the years ended December 31, 2018 and 2017 was as follows: Warrants Weighted Average Exercise Price Balance at December 31, 2016 2,853,575 $ 4.13 Granted 51,151 2.50 Exercised (250,000 ) 0.80 Expired (77,488 ) 5.58 Balance at December 31, 2017 2,577,238 $ 4.38 Granted 3,738,155 2.20 Exercised - - Expired (11,750 ) 1.64 Balance at December 31, 2018 6,303,643 $ 3.09 The remaining life, by grant date, for outstanding warrants at December 31, 2018 was: Grant Date Exercise Price Remaining Contractual Life in Years Outstanding Warrants Exercisable 12/24/2014 $ 14.80 0.98 110,932 110,932 12/16/2016 $ 3.95 2.96 2,403,405 2,403,405 11/3/2017 $ 2.50 3.83 51,151 51,151 4/1/2018 $ 1.95 4.25 10,000 5,000 7/2/2018 $ 2.25 3.05 3,572,815 3,572,815 7/2/2018 $ 1.13 3.05 155,340 - Total $ 3.09 2.98 6,303,643 6,143,303 |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2018 | |
Concentrations [Abstract] | |
Concentrations | Note 10. Concentrations At December 31, 2018 and 2017, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”). Currently, the Company is covered up to $1,000,000 by the SIPC and at times maintains cash balances in excess of the SIPC coverage. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11. Commitments and Contingencies The Company has commitments of approximately $500,000 at December 31, 2018 for several licensing agreements with consultants and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to $7.9 million and/or royalties up to 6% of net sales of covered products, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. In June 2018, the Company paid approximately $197,000 in milestone payments. The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expires in October 2020. This office space currently serves as the Company’s corporate headquarters. The rent for the first 12 months was approximately $11,367 per month, or approximately $22.00 per square foot. The rent increased to approximately $11,625 per month, or approximately $22.50 per square foot, for the 12 months beginning November 1, 2018 and will increase beginning November 1, 2019 to approximately $11,883 per month, or approximately $23.00 per square foot for the remainder of the lease. On September 3, 2014, the Company entered into an asset purchase agreement with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 184,912 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3,750,000. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the United States. Provided all future success-oriented milestones are attained, the Company will be required to make additional payments of up to $10.0 million, if and when achieved. Payments will be payable in restricted securities of the Company provided they do not exceed 19.9% ownership of the Company’s outstanding stock. As of December 31, 2018, no milestone or royalty payments have been paid or accrued. In February 2007, the Company’s Board of Directors authorized the issuance of 5,000 shares of the Company’s common stock to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by its Board of Directors whereby, directly or indirectly, a majority of its capital stock or a majority of its assets are transferred from the Company and/or its stockholders to a third party. Dr. Schaber’s amended employment agreement includes the Company’s obligation to issue such shares if such event occurs. As a result of the above agreements, the Company has future contractual obligations over the next five years as follows: Year Research and Development Property and Other Leases Total 2019 $ 100,000 $ 148,561 $ 248,561 2020 100,000 127,377 227,377 2021 100,000 4,984 104,984 2022 100,000 - 100,000 2023 100,000 - 100,000 Total $ 500,000 $ 280,922 $ 780,922 |
Operating Segments
Operating Segments | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Operating Segments | Note 12. Operating Segments The Company maintains two active operating segments: BioTherapeutics and Vaccines/BioDefense. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments. For the Years Ended December 31, 2018 2017 Revenues Vaccines/BioDefense $ 4,156,641 $ 4,749,294 BioTherapeutics 1,084,807 683,178 Total $ 5,241,448 $ 5,432,472 Income (Loss) from Operations Vaccines/BioDefense $ (237,640 ) $ 232,166 BioTherapeutics (5,439,294 ) (4,181,811 ) Corporate (3,382,047 ) (3,644,154 ) Total $ (9,058,981 ) $ (7,593,799 ) Amortization and Depreciation Expense Vaccines/BioDefense $ 17,951 $ 33,183 BioTherapeutics 21,018 30,614 Corporate 5,091 4,766 Total $ 44,060 $ 68,563 Other Income, Net Corporate $ 159,006 $ 29,906 Share-Based Compensation Vaccines/BioDefense $ 57,307 $ 76,625 BioTherapeutics 117,570 137,319 Corporate 206,009 275,843 Total $ 380,886 $ 489,787 As of December 31, 2018 2017 Identifiable Assets Vaccines/BioDefense $ 1,181,114 $ 906,416 BioTherapeutics 78,336 116,344 Corporate 9,232,252 8,526,891 Total $ 10,491,702 $ 9,549,651 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. |
Operating Segments | Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: BioTherapeutics and Vaccines/BioDefense. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. |
Contracts and Grants Receivable | Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for doubtful amounts has been established. If amounts become uncollectible, they are charged to operations. |
Intangible Assets | Intangible Assets One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730, Research and Development The Company did not capitalize any patent related costs during the years ended December 31, 2018 or 2017. These intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and carrying value of the related asset or group of assets. No such write downs have occurred during the years ended December 31, 2018 and 2017. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Office furniture and equipment and intangible assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2018 or 2017. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. |
Revenue Recognition | Revenue Recognition The Company’s revenues are primarily generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development |
Share-Based Compensation | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed. Typically these instruments vest upon issuance and therefore the entire share-based compensation expense is recognized upon issuance to the vendors and/or consultants. Share-based compensation expense for options, warrants and shares of common stock granted to non-employees has been determined in accordance with and FASB ASC 505-50, Equity-Based Payments to Non-Employees During the year ended December 31, 2018, the Company issued 370,420 stock options at a weighted average exercise price of $1.14 per share. The fair value of options issued during the years ended December 31, 2018 and 2017 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0%; ● an expected life of 4 years; ● volatility of 91% - 94% for 2018 and 90% - 93% for 2017; ● forfeitures at a rate of 12%; and ● risk-free interest rates ranging from 2.68% to 2.93% in 2018 and 1.60% to 2.02% in 2017. The fair value of each option grant made during 2018 and 2017 was estimated on the date of each grant using the Black-Scholes option pricing model and amortized ratably over the option vesting periods, which approximates the service period. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly owned subsidiary in the United Kingdom (“UK”) from inactive to active and incurred expenditures in multiple currencies including the US dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with ASC 830 Foreign Currency Matters |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. No current or deferred income taxes have been provided through December 31, 2018 due to the net operating losses incurred by the Company since its inception. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2018 and 2017. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2018 and 2017. |
Earnings Per Share | Earnings Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period. For the Year Ended For the Year Ended December 31, 2018 December 31, 2017 Common stock purchase warrants 6,303,643 2,577,238 Stock options 1,022,095 785,655 Total 7,325,738 3,362,893 The weighted average exercise price of the Company’s stock options and warrants outstanding at December 31, 2018 were $5.32 and $3.09 per share, respectively. |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and the useful life of intangibles that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases” (Topic 842). The FASB issued this update to increase transparency and comparability among organizations by requiring all leases with terms longer than 12 months be recognized by the lessee on its balance sheet as a right-of-use asset and a corresponding lease liability, including leases currently accounted for as operating leases, and disclosing key information about leasing arrangements. The updated guidance is effective for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption of the update is permitted. The Company adopted the new standard on January 1, 2019 using a modified retrospective approach. Upon the adoption of this standard, we recognized right-of-use assets and corresponding operating lease liabilities pertaining to our operating leases on our balance sheets. The adoption of this standard did not have a material impact on our consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | For the Year Ended For the Year Ended December 31, 2018 December 31, 2017 Common stock purchase warrants 6,303,643 2,577,238 Stock options 1,022,095 785,655 Total 7,325,738 3,362,893 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | Cost Accumulated Amortization Net Book Value December 31, 2018 Licenses $ 462,234 $ 415,371 $ 46,863 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,308,556 $ 46,863 December 31, 2017 Licenses $ 462,234 $ 388,282 $ 73,952 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,281,467 $ 73,952 |
Schedule of future annual amortization expense | Year Amortization Expense 2019 $ 27,164 2020 $ 19,699 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | As of 2018 2017 Clinical trial expenses $ 1,633,713 $ 1,011,666 Other 156,976 131,640 Total $ 1,790,689 $ 1,143,306 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax benefit | 2018 2017 Federal $ - $ - Foreign - - State - (416,810 ) Income tax benefit $ - $ (416,810 ) |
Schedule of deferred tax assets and liabilities | 2018 2017 Net operating loss carry forwards $ 22,996,000 $ 21,286,000 Orphan drug and research and development credit carry forwards 8,333,000 7,878,000 Equity based compensation 1,331,000 1,332,000 Intangibles 1,164,000 1,289,000 Total 33,824,000 31,785,000 Valuation allowance (33,824,000 ) (31,785,000 ) Net deferred tax assets $ - $ - |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2018 2017 Federal tax at statutory rate (21.0 )% (34.0 )% State tax benefits, plus sale of NJ NOL, net of federal benefit (12.5 ) (11.6 ) Foreign tax rate difference 0.2 - Permanent differences 0.9 5.7 Orphan drug and research and development credits 1.1 (13.9 ) Change in statutory rate - 186.9 Expiration of tax attributes 8.4 - Change in valuation allowance 22.9 (138.6 ) Income tax benefit - % (5.5 )% |
Stock Option Plans and Warran_2
Stock Option Plans and Warrants to Purchase Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity Incentive Plan [Member] | |
Summary of option and warrant activity | Shares available for grant at January 1, 2018 13,969 Increase in shares available for grant 400,000 Options granted (370,420 ) Options forfeited 109,600 Shares available for grant at December 31, 2018 153,149 |
Share Based Compensation[Member] | |
Summary of option and warrant activity | Share-based compensation 2018 2017 Research and development $ 174,877 $ 213,944 General and administrative 206,009 275,843 Total $ 380,886 $ 489,787 |
Employee Stock Option [Member] | |
Summary of option and warrant activity | Options Weighted Average Options Exercise Price Balance outstanding at December 31, 2016 330,605 $ 17.07 Granted 476,100 2.24 Forfeited (21,050 ) 51.62 Balance outstanding at December 31, 2017 785,655 $ 7.15 Granted 370,420 1.14 Forfeited (133,980 ) 4.66 Balance outstanding at December 31, 2018 1,022,095 $ 5.32 |
Summary of weighted-average range of exercise prices for options and warrants outstanding and exercisable | Price Range Weighted Average Remaining Contractual Life in Years Outstanding Options Exercisable Options $0.97-$17.20 8.60 942,314 519,172 $20.10-$39.80 4.50 53,293 53,293 $41.00-$62.00 1.61 26,488 26,488 Total 7.28 1,022,095 598,953 |
Warrants [Member] | |
Summary of option and warrant activity | Warrants Weighted Average Exercise Price Balance at December 31, 2016 2,853,575 $ 4.13 Granted 51,151 2.50 Exercised (250,000 ) 0.80 Expired (77,488 ) 5.58 Balance at December 31, 2017 2,577,238 $ 4.38 Granted 3,738,155 2.20 Exercised - - Expired (11,750 ) 1.64 Balance at December 31, 2018 6,303,643 $ 3.09 |
Summary of weighted-average range of exercise prices for options and warrants outstanding and exercisable | Grant Date Exercise Price Remaining Contractual Life in Years Outstanding Warrants Exercisable 12/24/2014 $ 14.80 0.98 110,932 110,932 12/16/2016 $ 3.95 2.96 2,403,405 2,403,405 11/3/2017 $ 2.50 3.83 51,151 51,151 4/1/2018 $ 1.95 4.25 10,000 5,000 7/2/2018 $ 2.25 3.05 3,572,815 3,572,815 7/2/2018 $ 1.13 3.05 155,340 - Total $ 3.09 2.98 6,303,643 6,143,303 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of future contractual obligations | Year Research and Development Property and Other Leases Total 2019 $ 100,000 $ 148,561 $ 248,561 2020 100,000 127,377 227,377 2021 100,000 4,984 104,984 2022 100,000 - 100,000 2023 100,000 - 100,000 Total $ 500,000 $ 280,922 $ 780,922 |
Operating Segments (Tables)
Operating Segments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Summary of operating segments | For the Years Ended December 31, 2018 2017 Revenues Vaccines/BioDefense $ 4,156,641 $ 4,749,294 BioTherapeutics 1,084,807 683,178 Total $ 5,241,448 $ 5,432,472 Income (Loss) from Operations Vaccines/BioDefense $ (237,640 ) $ 232,166 BioTherapeutics (5,439,294 ) (4,181,811 ) Corporate (3,382,047 ) (3,644,154 ) Total $ (9,058,981 ) $ (7,593,799 ) Amortization and Depreciation Expense Vaccines/BioDefense $ 17,951 $ 33,183 BioTherapeutics 21,018 30,614 Corporate 5,091 4,766 Total $ 44,060 $ 68,563 Other Income, Net Corporate $ 159,006 $ 29,906 Share-Based Compensation Vaccines/BioDefense $ 57,307 $ 76,625 BioTherapeutics 117,570 137,319 Corporate 206,009 275,843 Total $ 380,886 $ 489,787 As of December 31, 2018 2017 Identifiable Assets Vaccines/BioDefense $ 1,181,114 $ 906,416 BioTherapeutics 78,336 116,344 Corporate 9,232,252 8,526,891 Total $ 10,491,702 $ 9,549,651 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Nature of Business (Textual) | |||
Cash and cash equivalents | $ 8,983,717 | $ 7,809,487 | $ 8,772,567 |
Net increase in cash and cash equivalents | $ 1,174,230 | (963,080) | |
Percentage increase in cash and cash equivalents | 15.00% | ||
Cash in operations | $ (7,244,631) | (6,510,567) | |
Working capital | 6,131,178 | 6,185,863 | |
Decrease in working capital | 54,685 | ||
Government contract and grant funding available | 14,600,000 | ||
Accumulated deficit | (166,170,020) | (157,270,045) | |
Net loss | $ (8,899,975) | $ (7,147,083) | |
Remaining from FBR sales agreement, description | The Company has up to $8.5 million remaining from the FBR Sales Agreement as of March 20, 2019 under the prospectus supplement updated October 3, 2018 | ||
Contracts from NIH and NIAID, description | The Company is currently developing RiVax® under a NIAID contract of up to $24.7 million over six years, and SGX301 and SGX942 under two separate NIH grants of approximately $1.5 million each over two years. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Dilutive adjustments to the number of common shares | ||
Total | 7,325,738 | 3,362,893 |
Common stock purchase warrants [Member] | ||
Dilutive adjustments to the number of common shares | ||
Total | 6,303,643 | 2,577,238 |
Stock options [Member] | ||
Dilutive adjustments to the number of common shares | ||
Total | 1,022,095 | 785,655 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details Textual) | 12 Months Ended | |
Dec. 31, 2018USD ($)Segment$ / sharesshares | Dec. 31, 2017USD ($) | |
Summary of Significant Accounting Policies (Textual) | ||
Number of operating segments | Segment | 2 | |
Deferred tax assets | $ | $ 14,000,000 | |
Foreign currency transaction gains | $ | $ 437 | |
Foreign currency translation loss | $ | $ (3,669) | |
Stock Option [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Weighted average exercise price, outstanding | $ / shares | $ 5.32 | |
Dividend yield | 0.00% | |
Expected term | 4 years | |
Forfeiture rate | 12.00% | |
Stock option vesting, description | Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. | |
Weighted average exercise price, granted | $ / shares | $ 1.14 | |
Granted | shares | 370,420 | |
Warrant [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Weighted average exercise price, outstanding | $ / shares | $ 3.09 | |
Maximum [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Intangible assets, estimated useful life | 16 years | |
Risk-free interest rate | 2.93% | |
Maximum [Member] | Stock Option [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Volatility rate | 94.00% | 93.00% |
Risk-free interest rate | 2.02% | |
Minimum [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Intangible assets, estimated useful life | 11 years | |
Risk-free interest rate | 2.68% | |
Minimum [Member] | Stock Option [Member] | ||
Summary of Significant Accounting Policies (Textual) | ||
Volatility rate | 91.00% | 90.00% |
Risk-free interest rate | 1.60% |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Summary of intangible assets | ||
Cost | $ 2,355,419 | $ 2,355,419 |
Accumulated Amortization | 2,308,556 | 2,281,467 |
Net Book Value | 46,863 | 73,952 |
Licenses [Member] | ||
Summary of intangible assets | ||
Cost | 462,234 | 462,234 |
Accumulated Amortization | 415,371 | 388,282 |
Net Book Value | 46,863 | 73,952 |
Patents [Member] | ||
Summary of intangible assets | ||
Cost | 1,893,185 | 1,893,185 |
Accumulated Amortization | 1,893,185 | 1,893,185 |
Net Book Value |
Intangible Assets (Details 1)
Intangible Assets (Details 1) | Dec. 31, 2018USD ($) |
Future amortization expense | |
2019 | $ 27,161 |
2020 | $ 19,699 |
Intangible Assets (Details Text
Intangible Assets (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible Assets (Textual) | ||
Amortization expense | $ 27,089 | $ 52,676 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Clinical trial expenses | $ 1,633,713 | $ 1,011,666 |
Other | 156,976 | 131,640 |
Total | $ 1,790,689 | $ 1,143,306 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal | ||
Foreign | ||
State | (416,810) | |
Income tax benefit | $ (416,810) |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carry forwards | $ 22,996,000 | $ 21,286,000 |
Orphan drug and research and development credit carry forwards | 8,333,000 | 7,878,000 |
Equity based compensation | 1,331,000 | 1,332,000 |
Intangibles | 1,164,000 | 1,289,000 |
Total | 33,824,000 | 31,785,000 |
Valuation allowance | (33,824,000) | (31,785,000) |
Net deferred tax assets |
Income Taxes (Details 2)
Income Taxes (Details 2) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal tax at statutory rate | (21.00%) | (34.00%) |
State tax benefits, plus sale of NJ NOL, net of federal benefit | (12.50%) | (11.60%) |
Foreign tax rate difference | 0.20% | |
Permanent differences | 0.90% | 5.70% |
Orphan drug and research and development credits | 1.10% | (13.90%) |
Change in statutory rate | 186.90% | |
Expiration of tax attributes | 8.40% | |
Change in valuation allowance | 22.90% | (138.60%) |
Income tax benefit | (5.50%) |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |
Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes (Textual) | |||
Federal tax | $ 104,131,000 | ||
State tax | 14,028,000 | ||
Foreign tax | 688,000 | ||
Various tax credits, amount | $ 8,333,000 | ||
Period of expiration of various tax credits | Expire from 2019 to 2037. | ||
Net operating loss carry forwards, limitations on use, description | Limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. | ||
Income tax receivable | $ 416,810 | ||
U.S. corporate income tax rate, description | U.S. corporate income tax rate from 35.0 % to 21.0% effective January 1, 2018. | ||
Deferred tax assets related to net operating losses | $ 22,996,000 | $ 21,286,000 | |
U.S. government [Member] | |||
Income Taxes (Textual) | |||
Deferred tax assets related to net operating losses | $ 14,000,000 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) | Jul. 09, 2018 | Apr. 06, 2018 | Aug. 11, 2017 | May 05, 2017 | May 04, 2017 | Jan. 03, 2017 | Mar. 20, 2019 | Feb. 21, 2018 | Jul. 31, 2017 | May 24, 2017 | Mar. 31, 2016 | Oct. 25, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 02, 2018 | Nov. 03, 2017 |
Shareholders' Equity (Textual) | ||||||||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | ||||||||||||||
Preferred stock, shares issued | ||||||||||||||||
Preferred stock, shares outstanding | ||||||||||||||||
Common stock purchase agreement with FBR, description | The Company filed a prospectus supplement for the sale of up to $4.8 million of shares of common stock pursuant to the FBR Sales Agreement, and the Company sold an aggregate of approximately $1 million of shares thereunder. The offering costs incurred to register the shares pursuant to the prospectus supplement dated August 11, 2017 were $164,825. On October 3, 2018, the Company filed an updated prospectus supplement with the SEC and may offer and sell shares of the Company's common stock pursuant to the FBR Sales Agreement having an aggregate offering price of up to $9.0 million, from time to time. The prospectus supplement filed on October 3, 2018, supersedes the prospectus supplement dated August 11, 2017, and no additional shares will be offered or sold pursuant to the prospectus supplement dated August 11, 2017. | The Company issued FBR 450,000 shares of common stock pursuant to the FBR Sales Agreement. | ||||||||||||||
Issuance of common stock to vendor, shares | 2,500 | |||||||||||||||
Warrants issued to purchase shares | 466,019 | |||||||||||||||
Issuance of common stock pursuant to Lincoln Park Equity Line, Shares | 40,387 | 10,096 | ||||||||||||||
Common stock, shares issued | 1,165,048 | 200,125 | 17,682,839 | 8,730,640 | 982,000 | |||||||||||
Warrants exercise price | $ 2.37 | |||||||||||||||
Underwritten public offering of common stock shares | 7,766,990 | |||||||||||||||
Warrants to purchase up to an aggregate of common stock shares | 3,106,796 | |||||||||||||||
Warrants exercised on a cashless basis | 250,000 | |||||||||||||||
Market offering price | $ 1.03 | $ 1.03 | ||||||||||||||
Subsequent Event [Member] | ||||||||||||||||
Shareholders' Equity (Textual) | ||||||||||||||||
FBR ATM funding available | $ 8,500,000 | |||||||||||||||
Direct Offering [Member] | ||||||||||||||||
Shareholders' Equity (Textual) | ||||||||||||||||
Common stock, shares issued | 982,000 | |||||||||||||||
Purchase price, per share | $ 2 | |||||||||||||||
Common Stock [Member] | ||||||||||||||||
Shareholders' Equity (Textual) | ||||||||||||||||
Issuance of common stock to vendor, shares | 2,500 | |||||||||||||||
Issuance of common stock pursuant to Lincoln Park Equity Line, Shares | 20,161 | 50,483 | ||||||||||||||
Common stock, shares issued | 1,575,500 | |||||||||||||||
Purchase price, per share | $ 2 | |||||||||||||||
Value of shares granted | $ 309 | $ 1,125 | ||||||||||||||
Number of common stock shares sold | 20,000 | 50,000 | ||||||||||||||
Number of commitment shares issued | 161 | 483 | ||||||||||||||
Net proceeds from common stock sold | $ 38,400 | $ 115,930 | ||||||||||||||
Lincoln Park Capital Fund, LLC [Member] | ||||||||||||||||
Shareholders' Equity (Textual) | ||||||||||||||||
Regular purchase shares maximum amount per agreement | 10,000 | |||||||||||||||
Maximum amount of regular purchase per agreement | $ 750,000 | |||||||||||||||
Maximum additional commitment shares upon relative proportion of purchases in a regular purchase | 50,000 | |||||||||||||||
Maximum (possible) value of agreement | $ 12,000,000 | |||||||||||||||
Common stock purchase agreement with Lincoln Park, description | The Company entered into a common stock purchase agreement with Lincoln Park. The Lincoln Park equity facility allows the Company to require Lincoln Park to purchase up to 10,000 shares ("Regular Purchase") of the Company's common stock every two business days, up to an aggregate of $12.0 million over approximately a 36-month period with such amounts increasing as the quoted stock price increases. The Regular Purchase may be increased up to 15,000 shares of common stock if the closing price of the common shares is not below $10.00, up to 20,000 shares of common stock if the closing price of the common shares is not below $15.00 and up to 25,000 shares of common stock if the closing price of the common shares is not below $20.00. The purchase price for the Regular Purchase shall be equal to the lesser of (i) the lowest sale price of the common shares during the purchase date, or (ii) the average of the three lowest closing sale prices of the common shares during the twelve business days prior to the purchase date. Each Regular Purchase shall not exceed $750,000. Furthermore, for each purchase by Lincoln Park, additional commitment shares in commensurate amounts up to a total of 50,000 shares will be issued based upon the relative proportion of the aggregate amount of $12.0 million. In addition to the Regular Purchase and provided that the closing price of the common shares is not below $7.50 on the purchase date, the Company in its sole discretion may direct Lincoln Park on each purchase date to purchase on the next stock trading day ("Accelerated Purchase Date") additional shares of Company stock up to the lesser of (i) three times the number of shares purchased following a Regular Purchase or (ii) 30% of the trading volume of shares traded on the Accelerated Purchase Date at a price equal to the lesser of the closing sale price on the Accelerated Purchase Date or 95% of the Accelerated Purchase Date's volume weighted average price. | |||||||||||||||
Available from an equity line | $ 10,100,000 | |||||||||||||||
Issuance of common stock pursuant to Lincoln Park Equity Line, Shares | 10,078 | 10,083 | ||||||||||||||
FBR Capital Markets & Co. [Member] | ||||||||||||||||
Shareholders' Equity (Textual) | ||||||||||||||||
Common stock purchase agreement with FBR, description | The FBR Sales Agreement provides that FBR is entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the FBR Sale Agreement. | The shares sold pursuant to the FBR Sales Agreement have been and will be issued pursuant to General Instruction I.B.6 of Form S-3, which permits the Company to sell shelf securities in a public primary offering with a value not exceeding one-third of the average market value of the Company's voting and non-voting common equity held by non-affiliates in any 12-month period as long as the aggregate market value of the Company's outstanding voting and non-voting common equity held by non-affiliates is less than $75 million. |
Stock Option Plans and Warran_3
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Equity Incentive Plan [Member] | 12 Months Ended |
Dec. 31, 2018shares | |
Shares available for grant at January 1, 2018 | 13,969 |
Increase in shares available for grant | 400,000 |
Options granted | (370,420) |
Options forfeited | 109,600 |
Shares available for grant at December 31, 2018 | 153,149 |
Stock Option Plans and Warran_4
Stock Option Plans and Warrants to Purchase Common Stock (Details 1) - Options [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Options | ||
Beginning balance | 785,655 | 330,605 |
Granted | 370,420 | 476,100 |
Forfeited | (133,980) | (21,050) |
Ending balance | 1,022,095 | 785,655 |
Weighted Average Options Exercise Price | ||
Beginning balance | $ 7.15 | $ 17.07 |
Granted | 1.14 | 2.24 |
Forfeited | 4.66 | 51.62 |
Ending balance | $ 5.32 | $ 7.15 |
Stock Option Plans and Warran_5
Stock Option Plans and Warrants to Purchase Common Stock (Details 2) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
$0.97-$17.20 [Member] | |
Price Range, lower range limit | $ / shares | $ 0.97 |
Price Range, upper range limit | $ / shares | $ 17.20 |
Weighted Average Remaining Contractual Life in Years | 8 years 7 months 6 days |
Outstanding Options | 942,314 |
Exercisable Options | 519,172 |
$20.10-$39.80 [Member] | |
Price Range, lower range limit | $ / shares | $ 20.10 |
Price Range, upper range limit | $ / shares | $ 39.80 |
Weighted Average Remaining Contractual Life in Years | 4 years 6 months |
Outstanding Options | 53,293 |
Exercisable Options | 53,293 |
$41.00-$62.00 [Member] | |
Price Range, lower range limit | $ / shares | $ 41 |
Price Range, upper range limit | $ / shares | $ 62 |
Weighted Average Remaining Contractual Life in Years | 1 year 7 months 10 days |
Outstanding Options | 26,488 |
Exercisable Options | 26,488 |
Options [Member] | |
Weighted Average Remaining Contractual Life in Years | 8 years 2 months 12 days |
Outstanding Options | 1,022,095 |
Exercisable Options | 598,953 |
Stock Option Plans and Warran_6
Stock Option Plans and Warrants to Purchase Common Stock (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation, Total | $ 380,886 | $ 489,787 |
Research and development [Member] | ||
Share-based compensation, Total | 174,877 | 213,944 |
General and administrative [Member] | ||
Share-based compensation, Total | $ 206,009 | $ 275,843 |
Stock Option Plans and Warran_7
Stock Option Plans and Warrants to Purchase Common Stock (Details 4) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted Average Exercise Price | ||
Exercised | $ 5.32 | |
Warrants [Member] | ||
Warrants | ||
Beginning balance | 2,577,238 | 2,853,575 |
Granted | 3,738,155 | 51,151 |
Exercised | (250,000) | |
Expired | (11,750) | (77,488) |
Ending balance | 6,303,643 | 2,577,238 |
Weighted Average Exercise Price | ||
Beginning balance | $ 4.38 | $ 4.13 |
Granted | 2.20 | 2.50 |
Exercised | 0.80 | |
Expired | 1.64 | 5.58 |
Ending balance | $ 3.09 | $ 4.38 |
Stock Option Plans and Warran_8
Stock Option Plans and Warrants to Purchase Common Stock (Details 5) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
12/24/2014 [Member] | |
Exercise Price | $ / shares | $ 14.80 |
Remaining Contractual Life in Years | 11 months 23 days |
Outstanding Warrants | 110,932 |
Exercisable Warrants | 110,932 |
12/16/2016 [Member] | |
Exercise Price | $ / shares | $ 3.95 |
Remaining Contractual Life in Years | 2 years 11 months 15 days |
Outstanding Warrants | 2,403,405 |
Exercisable Warrants | 2,403,405 |
11/3/2017 [Member] | |
Exercise Price | $ / shares | $ 2.50 |
Remaining Contractual Life in Years | 3 years 9 months 29 days |
Outstanding Warrants | 51,151 |
Exercisable Warrants | 51,151 |
4/1/2018 [Member] | |
Exercise Price | $ / shares | $ 1.95 |
Remaining Contractual Life in Years | 4 years 2 months 30 days |
Outstanding Warrants | 10,000 |
Exercisable Warrants | 5,000 |
7/2/2018 [Member] | |
Exercise Price | $ / shares | $ 2.25 |
Remaining Contractual Life in Years | 3 years 18 days |
Outstanding Warrants | 3,572,815 |
Exercisable Warrants | 3,572,815 |
7/2/2018 [Member] | |
Exercise Price | $ / shares | $ 1.13 |
Remaining Contractual Life in Years | 3 years 18 days |
Outstanding Warrants | 155,340 |
Exercisable Warrants | |
Warrant [Member] | |
Remaining Contractual Life in Years | 3 years 1 month 2 days |
Outstanding Warrants | 6,303,643 |
Exercisable Warrants | 6,143,303 |
Stock Option Plans and Warran_9
Stock Option Plans and Warrants to Purchase Common Stock (Details Textual) - USD ($) | Jul. 02, 2018 | Nov. 03, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 09, 2018 | Apr. 01, 2018 | May 04, 2017 | Dec. 31, 2016 |
Weighted average exercise price | $ 5.32 | |||||||
Exercisable, weighted average remaining contractual term | 8 years 2 months 12 days | |||||||
Fair value per share | $ 2 | |||||||
Warrants to purchase | 1,575,500 | 5,000 | 155,340 | 10,000 | ||||
Common stock shares issued | 982,000 | 17,682,839 | 8,730,640 | 1,165,048 | 200,125 | |||
Purchase price per share | $ 2 | $ 1.13 | $ 1.95 | |||||
Warrants to purchase, description | The Company closed an underwritten public offering of 7,766,990 shares of its common stock and exercisable warrants to purchase up to an aggregate of 3,106,796 shares of its common stock at a combined offering price of $1.03. In addition, at the closing the underwriters exercised the over-allotment option to purchase 1,165,048 additional shares of common stock and warrants to purchase up to 466,019 shares of common stock at a combined offering price of $1.03. The warrants have a per share exercise price of $2.25 and will expire 42 months from the date of issuance. On July 9, 2018, warrants to purchase 155,340 shares of the Company?s common stock were issued to representatives of the underwriters of the offering. The warrants are exercisable at a per share price of $1.13 and are exercisable twelve months from the effective date of the offering and will expire 42 months from the effective date of the offering. | In connection with the concurrent registered public offering and the private placement, warrants to purchase 51,151 shares of the Company's common stock were issued to the representatives of the underwriters of the offering. The warrants are exercisable at $2.50 per share of common stock underlying the warrants for a four-year period commencing six months from the effective date of the offering. | ||||||
Warrant [Member] | ||||||||
Weighted average exercise price | $ 0.80 | |||||||
Options outstanding | 6,303,643 | 2,577,238 | 2,853,575 | |||||
Warrants | 3,738,155 | 51,151 | ||||||
Warrants exercisable | $ 2.20 | $ 2.50 | ||||||
Stock Option Plans [Member] | ||||||||
Exercisable options | 598,953 | |||||||
Weighted average exercise price | $ 8.02 | |||||||
Exercisable, weighted average remaining contractual term | 7 years 3 months 11 days | |||||||
Options outstanding | 1,022,095 | |||||||
Shares available for grants | 153,000 | |||||||
Stock options awarded | 370,420 | 476,100 | ||||||
Fair value per share | $ 0.77 | $ 1.54 | ||||||
Total compensation cost | $ 421,000 |
Concentrations (Details)
Concentrations (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Concentrations (Textual) | ||
Deposits | $ 1,000,000 | $ 1,000,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Dec. 31, 2018USD ($) |
Summary of future contractual obligations | |
2019 | $ 248,561 |
2020 | 227,377 |
2021 | 104,984 |
2022 | 100,000 |
2023 | 100,000 |
Total | 780,922 |
Research and Development [Member] | |
Summary of future contractual obligations | |
2019 | 100,000 |
2020 | 100,000 |
2021 | 100,000 |
2022 | 100,000 |
2023 | 100,000 |
Total | 500,000 |
Property and Other Leases [Member] | |
Summary of future contractual obligations | |
2019 | 148,561 |
2020 | 127,377 |
2021 | 4,984 |
2022 | |
2023 | |
Total | $ 280,922 |
Commitments and Contingencies_3
Commitments and Contingencies (Details Textual) | Sep. 03, 2014USD ($)shares | Jun. 30, 2018USD ($) | Feb. 28, 2007shares | Dec. 31, 2018USD ($)ft² |
Commitments and Contingencies (Textual) | ||||
Commitments related to agreements | $ 500,000 | |||
Maximum payment for commitment milestones | $ 10,000,000 | $ 7,900,000 | ||
Lease amendment date | October 2017 | |||
Lease agreement expire | Oct. 31, 2020 | |||
Percentage for royalties | 6.00% | |||
Number of months after that rent increase | 12 months | |||
Monthly rent amount before increment | $ 11,367 | |||
Monthly rent amount before increment, per square foot | 22 | |||
Number of remaining months for which increased rent paid | 12 months | |||
Rent increase | $ 11,625 | |||
Rent increase, per square foot | 22.50 | |||
Monthly rent amount after increment | $ 11,883 | |||
Monthly rent amount after increment, per square foot | 23 | |||
Assets acquired payments to cash | $ 275,000 | |||
Shares issued in connection with asset purchase agreement, shares | shares | 184,912 | |||
Stock price on date of grant | $ 3,750,000 | |||
Maximum percentage of ownership outstanding stock | 19.90% | |||
Accrued payment | $ 197,000 | |||
Office space | ft² | 6,200 | |||
Doctor Schaber [Member] | ||||
Commitments and Contingencies (Textual) | ||||
Number of common shares transferred to third party | shares | 5,000 |
Operating Segments (Details)
Operating Segments (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Summary of segmental information | ||
Revenues | $ 5,241,448 | $ 5,432,472 |
Income (Loss) from Operations | (9,058,981) | (7,593,799) |
Amortization and Depreciation Expense | 44,060 | 68,563 |
Share-Based Compensation | 380,886 | 489,787 |
Identifiable Assets | 10,491,702 | 9,549,651 |
Vaccines/BioDefense [Member] | ||
Summary of segmental information | ||
Revenues | 4,156,641 | 4,749,294 |
Income (Loss) from Operations | (237,640) | 232,166 |
Amortization and Depreciation Expense | 17,951 | 33,183 |
Share-Based Compensation | 57,307 | 76,625 |
Identifiable Assets | 1,181,114 | 906,416 |
BioTherapeutics [Member] | ||
Summary of segmental information | ||
Revenues | 1,084,807 | 683,178 |
Income (Loss) from Operations | (5,439,294) | (4,181,811) |
Amortization and Depreciation Expense | 21,018 | 30,614 |
Share-Based Compensation | 117,570 | 137,319 |
Identifiable Assets | 78,336 | 116,344 |
Corporate [Member] | ||
Summary of segmental information | ||
Income (Loss) from Operations | (3,382,047) | (3,644,154) |
Amortization and Depreciation Expense | 5,091 | 4,766 |
Other Income, Net | 159,006 | 29,906 |
Share-Based Compensation | 206,009 | 275,843 |
Identifiable Assets | $ 9,232,252 | $ 8,526,891 |
Operating Segments (Details Tex
Operating Segments (Details Textual) | 12 Months Ended |
Dec. 31, 2018Segment | |
Operating Segments (Textual) | |
Number of operating segments | 2 |