Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 17, 2017 | Jun. 30, 2016 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | SOLIGENIX, INC. | ||
Entity Central Index Key | 812,796 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 18,585,798 | ||
Entity Common Stock, Shares Outstanding | 5,472,532 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 | |
Current assets: | |||
Cash and cash equivalents | $ 8,772,567 | $ 4,921,545 | |
Contracts and grants receivable | 1,206,777 | 1,985,212 | |
Prepaid expenses | 134,431 | 244,267 | |
Total current assets | 10,113,775 | 7,151,024 | |
Office furniture and equipment, net | 26,702 | 47,366 | |
Intangible assets, net | 126,628 | 188,732 | |
Total assets | 10,267,105 | 7,387,122 | |
Current liabilities: | |||
Accounts payable | 1,708,091 | 2,869,392 | |
Accrued expenses | 806,118 | 1,510,544 | |
Notes payable | 292,719 | ||
Warrant liability | 2,434,101 | ||
Accrued compensation | 355,648 | 298,675 | |
Total current liabilities | 2,869,857 | 7,405,431 | |
Commitments and contingencies | |||
Shareholders' equity (deficiency): | |||
Preferred stock: 350,000 shares authorized; none issued or outstanding | |||
Common stock, $.001 par value; 10,000,000 shares and 5,000,000 shares authorized at December 31, 2016 and 2015, respectively; 5,470,032 and 3,126,952 shares issued and outstanding in 2016 and 2015, respectively | 5,470 | 3,127 | |
Additional paid-in capital | [1] | 157,514,740 | 146,856,143 |
Accumulated deficit | (150,122,962) | (146,877,579) | |
Total shareholders' equity (deficiency) | 7,397,248 | (18,309) | |
Total liabilities and shareholders' equity (deficiency) | $ 10,267,105 | $ 7,387,122 | |
[1] | Adjusted to reflect the reverse stock split of one-for-ten effective October 7, 2016. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
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 | 10,000,000 | 5,000,000 |
Common stock, shares issued | 5,470,032 | 3,126,952 |
Common stock, shares outstanding | 5,470,032 | 3,126,952 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | ||
Revenues: | |||
Contract revenue | $ 10,448,794 | $ 8,641,348 | |
Grant revenue | 127,042 | ||
Total revenues | 10,448,794 | 8,768,390 | |
Cost of revenues | (8,433,671) | (6,882,204) | |
Gross profit | 2,015,123 | 1,886,186 | |
Operating expenses: | |||
Research and development | 4,295,867 | 5,399,839 | |
General and administrative | 3,428,838 | 3,596,623 | |
Total operating expenses | 7,724,705 | 8,996,462 | |
Loss from operations | (5,709,582) | (7,110,276) | |
Other income (expense): | |||
Change in fair value of warrant liability | 1,541,241 | (1,201,870) | |
Gain on settlement of liability | 390,599 | ||
Interest income (expense) | 2,216 | (8,017) | |
Total other income (expense) | 1,934,056 | (1,209,887) | |
Net loss before income taxes | (3,775,526) | (8,320,163) | |
Income tax benefit | 530,143 | 488,933 | |
Net loss | $ (3,245,383) | $ (7,831,230) | |
Basic net loss per share | [1] | $ (0.93) | $ (3) |
Diluted net loss per share | [1] | $ (1.34) | $ (3) |
Basic weighted average common shares outstanding | [1] | 3,481,460 | 2,606,577 |
Diluted weighted average common shares outstanding | [1] | 3,583,587 | 2,606,577 |
[1] | Adjusted to reflect the reverse stock split of one-for-ten effective October 7, 2016. |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Deficiency) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning Balance at Dec. 31, 2014 | $ (153,889) | $ 2,394 | $ 138,890,066 | $ (139,046,349) |
Beginning Balance, Shares at Dec. 31, 2014 | 2,393,657 | |||
Issuance of common stock pursuant to Lincoln Park Equity line | 1,339,177 | $ 84 | 1,339,093 | |
Issuance of common stock pursuant to lincoln park equity line, Shares | 84,135 | |||
Issuance of common stock pursuant to Equity Line Purchase Agreement | 2,500,000 | $ 455 | 2,499,545 | |
Issuance of common stock pursuant to equity line purchase agreement, Shares | 454,577 | |||
Stock issuance costs associated with Equity Line Purchase Agreement | (453,162) | (453,162) | ||
Issuance of common stock to vendors | 232,212 | $ 16 | 232,196 | |
Issuance of common stock to vendors, Shares | 16,628 | |||
Issuance of shares from exercise of stock options | 19,250 | $ 3 | 19,247 | |
Issuance of shares from exercise of stock options, shares | 3,312 | |||
Issuance of shares for exercise of warrants | 1,117,521 | $ 175 | 1,117,346 | |
Issuance of shares for exercise of warrants, Shares | 174,643 | |||
Reclassification of warrant liability upon partial exercise of warrants issued in unit offering | 2,557,331 | 2,557,331 | ||
Ending Balance, Shares at Dec. 31, 2015 | 3,126,952 | |||
Share-based compensation expense | 654,481 | 654,481 | ||
Net loss | (7,831,230) | (7,831,230) | ||
Ending Balance at Dec. 31, 2015 | (18,309) | 3,127 | 146,856,143 | (146,877,579) |
Issuance of common stock pursuant to Lincoln Park Equity line | 1,712,320 | $ 277 | 1,712,043 | |
Issuance of common stock pursuant to lincoln park equity line, Shares | 277,135 | |||
Issuance of common stock to vendors | 52,500 | $ 8 | 52,492 | |
Issuance of common stock to vendors, Shares | 7,500 | |||
Issuance of common stock and warrants in public offering | 5,278,940 | $ 1,670 | 5,277,270 | |
Issuance of common stock and warrants in public offering, Shares | 1,670,000 | |||
Stock issuance costs associated with public offering | 809,277 | (809,277) | ||
Cost associated with Lincoln Park Equity Line | (41,381) | (41,381) | ||
Issuance of common stock in reverse stock split | 1 | $ 1 | ||
Issuance of common stock in reverse stock split, Shares | 1,525 | |||
Issuance of common stock to SciClone | 3,000,000 | $ 353 | 2,999,647 | |
Issuance of common stock to SciClone, Shares | 352,942 | |||
Cashless exercise of warrants and reclassification of warrant liability to equity | 892,860 | $ 34 | 892,826 | |
Cashless exercise of warrants and reclassification of warrant liability to equity, Shares | 33,978 | |||
Ending Balance, Shares at Dec. 31, 2016 | 5,470,032 | |||
Share-based compensation expense | 574,977 | 574,977 | ||
Net loss | (3,245,383) | 3,245,383 | ||
Ending Balance at Dec. 31, 2016 | $ 7,397,248 | $ 5,470 | $ 157,514,740 | $ (150,122,962) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Operating activities: | ||
Net loss | $ (3,245,383) | $ (7,831,230) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 89,928 | 247,458 |
Amortization of discount on debt | 7,281 | 10,648 |
Share-based compensation | 574,977 | 654,481 |
Gain on settlement of liability | (390,599) | |
Issuance of common stock for services | 52,500 | 232,212 |
Change in fair value of warrant liability | (1,541,241) | 1,201,870 |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | 778,435 | (1,190,445) |
Prepaid expenses | 109,836 | (71,339) |
Accounts payable and accrued expenses | (1,475,128) | 1,376,391 |
Accrued compensation | 56,973 | (16,354) |
Total adjustments | (1,737,038) | 2,444,922 |
Net cash used in operating activities | (4,982,421) | (5,386,308) |
Investing activities: | ||
Purchases of office furniture and equipment | (7,159) | (22,098) |
Net cash used in investing activities | (7,159) | (22,098) |
Financing activities: | ||
Proceeds from issuance of common stock and warrants from public offering | 5,278,940 | |
Stock issuance costs associated with public offering | (809,277) | |
Proceeds from issuance of common stock pursuant to the equity lines | 1,712,320 | 3,839,177 |
Stock issuance cost associated with equity lines | (41,381) | (171,091) |
Repayment of notes payable | (300,000) | |
Proceeds from issuance of common stock to SciClone | 3,000,000 | |
Proceeds from exercise of options and warrants | 1,136,771 | |
Net cash provided by financing activities | 8,840,602 | 4,804,857 |
Net increase (decrease) in cash and cash equivalents | 3,851,022 | (603,549) |
Cash and cash equivalents at beginning of period | 4,921,545 | 5,525,094 |
Cash and cash equivalents at end of period | 8,772,567 | 4,921,545 |
Supplemental disclosure of non cash financing activities: | ||
Reclassification of warrant liability to additional paid-in capital | 892,860 | 2,557,331 |
Notes payable issued in connection with Equity Purchase Agreement | 282,071 | |
Supplemental information: | ||
Cash paid for state income taxes | $ 5,030 | $ 7,542 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2016 | |
Nature of Business [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 florescent 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™, its ricin toxin vaccine candidate, OrbeShield ® ® ® The Company generates revenues under government grants primarily from the National Institutes of Health (the “NIH”) and government contracts from BARDA and NIAID. The NIAID contract will be completed during the first quarter of 2017 along with the BARDA contract base period, with BARDA electing not to extend the current contract beyond the base period. We will continue to apply for additional government funding. 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, 2016, the Company had an accumulated deficit of $150,122,962. During the year ended December 31, 2016, the Company incurred a loss of $3,245,383 and used $4,982,421 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 partnership and/or financings. Based on the Company’s approved operating budget, management believes that it will have sufficient capital to meet the anticipated cash needs for working capital and capital expenditures through at least March 31, 2018. Based on the Company’s current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, proceeds available from the equity line with Lincoln Park, LLC (“Lincoln Park”) and proceeds from the State of New Jersey Technology Business Tax Certificate Transfer Program, 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 twelve months following the issuance of this report. As of December 31, 2016, the Company had cash and cash equivalents of $8,772,567 as compared to $4,921,545 as of December 31, 2015, representing an increase of $3,851,022 or 78%. The increase in cash was primarily the result of net proceeds received from financing activities of $8,840,602, primarily from a public offering of the Company’s stock and the Company’s stock purchase agreement with SciClone Pharmaceuticals, Inc. This was partially offset by cash used in operations of $4,982,421. As of December 31, 2016, the Company had working capital of $7,243,918 as compared to working capital of $2,179,694, which excludes a non-cash warrant liability of $2,434,101, as of December 31, 2015, representing an increase of $5,064,224 or 232%. The increase in working capital was primarily the result of the increase in cash received from our financing activities. Management’s business strategy can be outlined as follows: ● Complete enrollment and report preliminary results in the pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL; ● Obtain agreement from the FDA on a pivotal Phase 3 protocol of SGX942 for the treatment of oral mucositis in head and neck cancer patients and initiate the trial; ● Initiate a pivotal Phase 3 clinical trial of SGX203 for the treatment of pediatric Crohn’s disease; ● Continue development of RiVax™ in combination with the Company’s ThermoVax ® ● Advance the preclinical and manufacturing development of OrbeShield ® ● 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 $17.3 million in active government contract and grant funding still available to support its associated research programs through 2017 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 pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program. Based on the receipt of $530,143 in proceeds from the sale from NJ NOL in 2016, the Company expects to participate in the program during 2017 and beyond as long as the program is 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 $10.3 million available from an equity facility expiring in March 2019; and ● The Company may seek additional capital in the private and/or public equity markets, pursue government contracts and grants as well as business development activities to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company evaluates 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. Reverse Stock Split On October 7, 2016, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-ten, whereby, once effective, every ten shares of its common stock was exchanged for one share of its common stock. The Company’s common stock began trading on the OTCQB on a reverse split basis at the market opening on October 7, 2016. All share and per share data have been restated to reflect this reverse stock split. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant 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 BARDA and 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, 2016 or 2015. 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, 2016 and 2015. 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, 2016 or 2015. 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, notes payable and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. As a result, certain warrants issued in connection with the Company’s June 2013 registered public offering were accounted for as derivatives. See Note 5, Warrant Liability 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 Accounting for Warrants The Company considered FASB ASC 815, Evaluating Whether an Instrument is Considered Indexed to an Entity’s Own Stock 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 For the year ended December 31, 2016, the Company issued 66,875 stock options at a weighted average exercise price of $5.30 per share. The fair value of options issued during the years ended December 31, 2016 and 2015 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 84% - 121% for 2016 and 121% - 141% for 2015; ● forfeitures at a rate of 12%; and ● risk-free interest rates ranging from 0.96% to 1.70% and 0.98% to 1.53% for 2016 and 2015, respectively. The fair value of each option grant made during 2016 and 2015 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. 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, 2016 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 2016 and 2015. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2016 and 2015. 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. For the Year Ended For the Year Ended December 31, December 31, Numerator: Net loss for basic earnings per share $ (3,245,383 ) $ (7,831,230 ) Less change in fair value of warrant liability 1,541,241 - Net loss for diluted earnings per share $ (4,786,624 ) $ (7,831,230 ) Denominator: Weighted-average basic common shares outstanding 3,481,460 2,606,577 Assumed conversion of dilutive securities: Common stock purchase warrants 102,127 - Denominator for diluted earnings per share – adjusted weighted-average shares 3,583,587 2,606,577 Basic net loss per share ($ 0.93 ) ($ 3.00 ) Diluted net loss per share ($ 1.34 ) ($ 3.00 ) The following table summarizes potentially dilutive adjustments to the weighted average number of common shares which were excluded from the calculation because their effect would be anti-dilutive. For the Year Ended For the Year Ended December 31, December 31, Common stock purchase warrants 2,853,575 492,612 Stock options 330,605 276,861 Total 3,184,180 769,473 The weighted average exercise price of the Company’s stock options and warrants outstanding at December 31, 2016 were $17.07 and $4.13 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 August 2014, FASB issued Accounting Standards Update (“ASU”) No. 2014-15, “Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” The amendments in this ASU are intended to define management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. Specifically, this ASU provides a definition of the term substantial doubt and requires an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). It also requires certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans and requires an express statement and other disclosures when substantial doubt is not alleviated. The new standard is effective for annual periods ending after December 15, 2016, and interim periods thereafter. The Company adopted the new standard effective December 31, 2016, and the adoption of the standard did not have an impact on the Company’s consolidated financial statements and disclosures. 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 recognizing lease assets and lease liabilities on the balance sheet 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 is evaluating the impact of the adoption of this update on our consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting, which amends ASC Topic 718, and intends to simplify various aspects related to how share-based payments are accounted for and presented in the financial statements. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within that reporting period. Early adoption is permitted. The Company is currently evaluating the impact of adoption of this update on our consolidated financial statements and related disclosures. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2016 | |
Intangible Assets [Abstract] | |
Intangible Assets | Note 3. Intangible Assets The following is a summary of intangible assets which consists of licenses and patents: Cost Accumulated Net Book Value December 31, 2016 Licenses $ 462,234 $ 361,044 $ 101,190 Patents 1,893,185 1,867,747 25,438 Total $ 2,355,419 $ 2,228,791 $ 126,628 December 31, 2015 Licenses $ 462,234 $ 333,732 $ 128,502 Patents 1,893,185 1,832,955 60,230 Total $ 2,355,419 $ 2,166,687 $ 188,732 Amortization expense was $62,104 and $221,217 in 2016 and 2015, respectively. Based on the balance of licenses and patents at December 31, 2016, future annual amortization expense is expected to be as follows: Year Amortization Expense 2017 $ 61,800 2018 $ 37,300 2019 $ 27,528 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, 2016 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: For the Years Ended 2016 2015 Clinical trial expenses $ 741,174 $ 1,168,021 Executive bonuses - 275,355 Other 64,944 67,168 Total $ 806,118 $ 1,510,544 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2016 | |
Notes Payable [Abstract] | |
Notes Payable | Note 5. Notes Payable On July 29, 2015, the Company entered into equity purchase agreements (the “Equity Line Purchase Agreements”) and registration rights agreements with certain accredited institutional investors (see Note 7). In consideration for entering into the Equity Line Purchase Agreements, the Company issued to the investors promissory notes having an aggregate principal amount of $300,000, which were recorded as stock issuance costs. The promissory notes had an issuance date present value of $282,071 and were repaid on April 15, 2016. The promissory notes did not include terms for interest, therefore the interest was imputed at 9%. Total discount amortization of $7,281 and $10,648 was recorded as interest expense for the years ended December 31, 2016 and 2015, respectively. The discount was accreted over the term of the promissory notes using the effective interest rate method. |
Warrant Liability
Warrant Liability | 12 Months Ended |
Dec. 31, 2016 | |
Warrant Liability [Abstract] | |
Warrant Liability | Note 6. Warrant Liability On June 25, 2013, the Company consummated a public offering in which the Company issued shares of common stock, together with warrants to purchase shares of common stock. These warrants contained provisions that protected holders from a decline in the issue price of the Company’s common stock (or “down-round” provision) and contained net settlement provisions. As a result, the Company accounted for these warrants as liabilities instead of equity instruments. Down-round provisions reduce the exercise or conversion price of a warrant if the Company issues equity shares for a price that is lower than the exercise or conversion price of the warrants. Net settlement provisions allow the holder of the warrant to surrender shares underlying the warrant equal to the exercise price as payment of its exercise price, instead of exercising the warrant by paying cash. The Company evaluates whether warrants to acquire its common stock contain provisions that protect holders from declines in the stock price or otherwise could result in modification of the exercise price and/or the number of shares to be issued under the respective warrant agreements based on a variable that is not an input to the fair value of a “fixed for fixed” option. As a result of the Company’s December 2014 registered public unit offering, the exercise price of warrants outstanding in connection with the public offering completed in June 2013 was adjusted to $6.10 per share. As a result of the Company’s December 2015 drawings on the Equity Line Purchase Agreements, the exercise price of warrants outstanding in connection with the public offering conducted in June 2013 was adjusted to $5.10 per share. The Company recognized these warrants as liabilities at their fair value on the date of grant and remeasured them to fair value on each reporting date. The Company recognized an initial warrant liability for the warrants issued in connection with the registered public offering completed in June 2013 totaling $4,827,788, which was based on the June 25, 2013 closing price of a share of the Company’s common stock as reported on OTC Markets of $9.60. During November 2016, the Company entered into amendments with the holders of those warrants pursuant to which the Company agreed to reduce the exercise price (after giving effect to the one-for-ten reverse stock split effective October 7, 2016) from $5.10 per share to $0.80 per share and permit those warrants to be exercised on a “cashless exercise” basis, and the Company eliminated the “down round” provision of those warrants not immediately exercised. As a result of the amendments, the warrant liability was remeasured as of the date of the modification, which resulted in an approximate $1,541,000 decrease in the carrying value of the warrant liability, which was recognized in the statement of operations for the year ended December 31, 2016. The warrant liability related to the warrants not immediately exercised was then reclassified to equity as the amended terms of the warrants qualified them to be accounted for as equity instruments. Of the 303,694 shares of common stock that remained issuable upon the exercise of such warrants as of the amendment date, warrants to purchase a total of 42,444 shares were exercised on a cashless basis and as a result 33,978 shares of common stock were issued on November 9, 2016. The assumptions used in the valuation of the warrants issued in the June 25, 2013 financing on November 9, 2016 using the Black Scholes model and for the year ended December 31, 2015 using the binomial method, respectively, were as follows: November 9, December 31, Number of shares underlying the warrants 303,694 303,694 Exercise price $ 0.80 $ 5.10 Volatility 93 % 98 % Risk-free interest rate 0.81 % 1.19 % Expected dividend yield 0 % 0 % Expected warrant life (years) 1.63 2.48 Stock price $ 3.65 $ 11.30 Recurring Level 3 Activity and Reconciliation The table below provides a reconciliation of the beginning and ending balances for the liability measured at fair value using significant unobservable inputs (Level 3). Fair Value Measurements Using Significant Unobservable Inputs (Level 3): December 31, Decrease in Fair Value Reclassification of warrant liability to equity in 2016 December 31, Warrant liability $ 2,434,101 $ (1,541,241 ) $ (892,860 ) $ 0 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes [Abstract] | |
Income Taxes | Note 7. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2016 and December 31, 2015: 2016 2015 Federal $ - $ - State (530,143 ) (488,933 ) Income tax benefit $ (530,143 ) $ (488,933 ) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2016 and 2015 are as follows: 2016 2015 Net operating loss carry forwards $ 32,028,000 $ 31,216,000 Orphan drug and research and development credit carry forwards 6,374,000 4,909,000 Equity based compensation 1,943,000 1,923,000 Intangibles 1,921,000 2,090,000 Total 42,266,000 40,138,000 Valuation allowance (42,266,000 ) (40,138,000 ) Net deferred tax assets $ - $ - The Company had gross NOLs at December 31, 2016 of approximately $93,635,000 for federal tax purposes and approximately $3,233,000 of New Jersey NOL carry forwards remaining after the sale of unused net operating loss carry forwards, portions of which will begin to expire in 2018. In addition, the Company has $6,374,000 of various tax credits which expire from 2018 to 2035. 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 years ended December 31, 2016 and 2015, 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 $530,143 and $488,933 of income tax benefit, net of transaction costs, respectively. 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, 2016 and 2015 were as follows: 2016 2015 Income tax loss at federal statutory rate (34.0 )% (34.0 )% State tax benefits, plus sale of NJ NOLs, net of federal benefit (7.9 ) (4.3 ) Permanent differences 10.3 15.0 Orphan drug and research and development credits (38.8 ) (16.3 ) Change in valuation allowance 56.4 33.7 Income tax benefit (14.0 )% (5.9 )% |
Shareholders' Deficiency
Shareholders' Deficiency | 12 Months Ended |
Dec. 31, 2016 | |
Shareholders' Deficiency [Abstract] | |
Shareholders' Deficiency | Note 8. Shareholders’ Deficiency 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, 2016: ● The Company issued Lincoln Park Capital Fund, LLC (“Lincoln Park”) 277,135 shares of common stock pursuant to the equity line purchase agreement; ● On May 31, 2016, the Company issued 5,000 shares of common stock to a vendor for partial consideration for services performed. ● On August 29, 2016, the Company issued 2,500 shares of common stock to a vendor for partial consideration for services performed. ● On September 9, 2016, the Company entered into a common stock purchase agreement with SciClone pursuant to which we sold 352,942 shares of the Company’s common stock to SciClone for an aggregate price of $3,000,000. ● In November 2016, warrants to purchase a total of 42,444 shares were exercised on a cashless basis and as a result 33,978 shares of common stock were issued. ● On December 16, 2016, 1,670,000 shares of the Company’s common stock and warrants to purchase 2,087,500 shares of the Company’s common stock at a combined offering price of $3.16 were issued in a registered public offering. In addition, the underwriters partially exercised the over-allotment to purchase an additional 282,505 warrants. The warrants have a per share exercise price of $3.95 and are exercisable immediately. The following items represent transactions in the Company’s common stock for the year ended December 31, 2015: ● In February 2015, the Company issued 70,179 shares of common stock in connection with the exercise of stock warrants; ● In March 2015, the Company issued 48,200 shares of common stock in connection with the exercise of stock warrants; ● In March 2015, the Company issued 15,301 shares of common stock pursuant to the Lincoln Park facility; ● In April 2015, the Company issued 35,679 shares of common stock in connection with the exercise of stock warrants; ● In April 2015, the Company issued 812 shares of common stock in connection with the exercise of stock options; ● In May 2015, the Company issued 7,636 shares of common stock pursuant to the Lincoln Park facility; ● In June 2015, the Company issued 38,425 shares of common stock pursuant to the Lincoln Park facility; ● In June 2015, the Company issued 19,871 shares of common stock in connection with the exercise of stock warrants; ● In July 2015, the Company issued 714 shares of common stock in connection with the exercise of stock warrants; ● In September 2015, the Company issued 60,954 shares of common stock pursuant to an Equity Line Purchase Agreement; ● In September 2015, the Company issued 2,500 shares of common stock in connection with the exercise of stock options; ● In October 2015, the Company issued 15,184 shares of common stock pursuant to the Lincoln Park facility; ● In November 2015, the Company issued 7,589 shares of common stock pursuant to the Lincoln Park facility; ● In December 2015, the Company issued 393,623 shares of common stock pursuant to an Equity Line Purchase Agreement; ● In nine separate transactions, the Company issued 16,628 fully vested shares of common stock as partial consideration for services performed Equity Line Purchase Agreement On July 29, 2015, the Company entered into the Equity Line Purchase Agreements and registration rights agreements with accredited institutional investors, Kodiak Capital Group, LLC (“Kodiak Capital”), Kingsbrook Opportunities Master Fund LP (“Kingsbrook”) and River North Equity, LLC (“River North” and, together with Kodiak Capital and Kingsbrook, the “Investors”). Under the Equity Line Purchase Agreements, the Investors agreed to purchase from the Company up to an aggregate of $10 million worth of shares of common stock, from time to time. In accordance with the registration rights agreements, the Company has filed with the U.S. Securities and Exchange Commission (“SEC”) a registration statement to register for resale under the Securities Act of 1933, as amended, the shares of common stock that may be issued to the Investors under the Equity Line Purchase Agreements. From the date that the SEC declared the registration statement effective in August 2015, the Company had the right to sell up to $5 million, $4 million and $1 million worth of shares of common stock to Kodiak Capital, Kingsbrook and River North, respectively. The purchase price of the shares was equal to eighty percent (80%) of the lowest daily volume weighted average price of the common stock for any trading day during the five consecutive trading days immediately following the date of the Company’s notice to the Investors requesting the purchase. In consideration for entering into the Equity Line Purchase Agreements, the Company issued to each of the Investors a promissory note having a principal amount equal to 3% of the total amount committed by such Investor. The principal amount due under the promissory notes did not accrue interest and was payable by April 15, 2016. The promissory notes were repaid on April 15, 2016 (see Note 4). The initial drawdown under the Equity Line Purchase Agreements was $500,000 offset by issuance cost of $453,162, which is included in the Consolidated Statements of Changes in Shareholders’ Deficiency for the year ended December 31, 2015. Issuance costs include professional fees, 3% commitment fee (promissory notes payable by April 15, 2016) and SEC filing fees. In December 2015, a second drawdown was made, whereby under the Equity Line Purchase Agreements, the Company issued 393,624 shares of common stock receiving proceeds of $2,000,000. On March 7, 2016, in accordance with the terms of the Equity Line Purchase Agreements, the Company exercised its right to terminate the Purchase Agreements upon written notice to the Investors. The Company did not incur any penalties as a result of this termination. Equity Line In November 2013, the Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). The Lincoln Park equity facility allowed the Company to require Lincoln Park to purchase up to $10.6 million of our common stock over a 36-month period depending on certain conditions. During the year ended December 31, 2015, the Company sold 82,500 shares of common stock and issued 1,635 commitment shares to Lincoln Park receiving net proceeds of $1,339,177. During the year ended December 31, 2016, there were no sales of common stock under the Lincoln Park 2013 equity facility. The 2013 Lincoln Park equity facility expired in November 2016 in accordance with the terms of the agreement. In March 2016, the Company entered into a common stock purchase agreement with Lincoln Park. The 2016 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. Upon entering into the agreement, the Company issued 10,000 shares of common stock as consideration for its commitment to purchase shares of the Company’s common stock under the purchase agreement. The value of these shares on the date granted was $81,000, which was accounted for as a stock issuance cost. During the year ended December 31, 2016, the Company sold 260,000 shares of common stock and issued 7,135 commitment shares and received proceeds of $1,712,320. The value of commitment shares on the date granted was $47,244 which was accounted for as a stock issuance cost. |
Stock Option Plans and Warrants
Stock Option Plans and Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2016 | |
Stock Option Plans and Warrants to Purchase Common Stock [Abstract] | |
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 was replaced by the 2015 Equity Incentive Plan (“2015 Plan”), approved in June 2015, with 300,000 shares available under the 2015 Plan, and is 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. The 2005 Equity Incentive Plan (“2005 Plan”) also was 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 issued common stock or 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. The 2005 Plan expired in 2015 and thus no securities remain available for future issuance under that plan. The table below accounts only for transactions occurring as part of the 2015 Plan. Shares available for grant at January 1, 2016 252,300 Options granted (66,875 ) Options forfeited 344 Shares available for grant at December 31, 2016 185,679 The total option activity for the amended 2005 Plan and the 2015 Plan for the years ended December 31, 2016 and 2015 was as follows: Options Weighted Average Options Exercise Price Balance outstanding at December 31, 2014 248,828 $ 24.00 Granted 60,534 11.90 Exercised (3,312 ) 5.80 Forfeited (29,189 ) 31.30 Balance outstanding at December 31, 2015 276,861 $ 21.30 Granted 66,875 5.30 Increase post reverse stock split 1,851 17.07 Exercised - - Forfeited (14,982 ) 48.52 Balance outstanding at December 31, 2016 330,605 $ 17.07 As of December 31, 2016, there were 258,996 options exercisable with a weighted average exercise price of $19.58, a weighted average remaining contractual term of 7.43 years and an intrinsic value of $0. The intrinsic value of options exercised during the year ended December 31, 2015 was $18,181. As of December 31, 2016, there were 330,605 options outstanding and expected to vest with a weighted average exercise price of $17.07, weighted average remaining term of 5.82 years and an intrinsic value of $0. The aggregate intrinsic value represents the total pre-tax intrinsic value (the difference between the closing price of our common stock on the last trading day on December 31, 2016 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2016. This amount changes based on the fair market value of our common stock. The Company awarded 66,875 and 60,534 stock options to new employees and existing Board members during the years ended December 31, 2016 and 2015, respectively, which had a weighted average grant date fair value per share of $3.90 and $9.48, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2016 was: Price Range Weighted Average Remaining Contractual Life in Years Outstanding Options Exercisable Options $2.25-$19.50 6.14 235,475 165,144 $20.00-$41.00 6.36 63,080 61,802 $46.40-$94.00 2.43 32,050 32,050 Total 5.82 330,605 258,996 The Company’s share-based compensation expense for the years ended December 31, 2016 and 2015 was recognized as follows: Share-based compensation 2016 2015 Research and development $ 230,573 $ 260,204 General and administrative 344,404 394,277 Total $ 574,977 $ 654,481 At December 31, 2016, the total compensation cost for stock options not yet recognized was approximately $407,520 and will be expensed over the next three years. Warrants to Purchase Common Stock As described in Note 5. Warrant Liability, during November 2016, the Company entered into amendments with the holders of the price protected warrants issued in the June 2013 registered public offering eliminating the “down round” provision and permitting those warrants to be exercised on a “cashless exercise” basis. Of the 303,694 shares of common stock that remained issuable on the date of the amendments upon the exercise of such warrants, warrants to purchase a total of 42,444 shares were exercised on a cashless basis on November 9, 2016. The fair value of the warrant liability of $892,860 related to the remaining 261,250 warrants outstanding after the amendment and exercises was reclassified to equity as the amended terms of the warrants qualified them to be accounted for as equity instruments. On December 16, 2016, 1,670,000 shares of our common stock and warrants to purchase 2,087,500 shares of the Company’s common stock at a combined offering price of $3.16 were issued in a registered public offering. In addition, the underwriters partially exercised the over-allotment to purchase an additional 282,505 warrants. Commencing on the date of issuance, holders of the warrants may exercise their right to acquire the common stock and pay an exercise price of $3.95 per share, prior to five years from the date of issuance, after which date any unexercised warrants will expire and have no further value. The warrants are traded on the Nasdaq Capital Market under the symbol “SNGXW”. In connection with the registered public offering, a warrant to purchase 33,400 shares of the Company’s common stock was issued to the representative of the underwriters of the offering. The warrant is exercisable at $3.95 per share of common stock underlying the warrant for a four-year period commencing one year from the effective date of the offering. Warrant activity for the years ended December 31, 2016 and 2015 was as follows: Warrants Weighted Average Warrant Exercise Price Balance at December 31, 2014 726,950 $ 11.50 Exercised (174,643 ) 6.40 Expired (59,693 ) 55.90 Balance at December 31, 2015 492,614 $ 7.40 Granted 2,403,405 3.95 Exercised (42,444 ) 0.80 Balance at December 31, 2016 2,853,575 $ 4.13 The weighted-average remaining life, by grant date, for outstanding warrants at December 31, 2016 was: Grant Date Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding Warrants Exercisable Warrants 11/15/2012 $ 6.80 0.87 5,000 5,000 12/20/2012 5.30 0.97 44,488 44,488 12/20/2012 5.80 0.97 28,000 28,000 6/25/2013 0.80 1.48 261,250 261,250 12/5/2013 20.50 1.93 500 500 12/24/2014 14.80 2.98 110,932 110,932 12/16/2016 $ 3.95 4.96 2,403,405 2,370,005 Total 4.45 2,853,575 2,820,175 |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2016 | |
Concentrations [Abstract] | |
Concentrations | Note 10. Concentrations At December 31, 2016 and 2015, 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, 2016 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 11. Commitments and Contingencies The Company has commitments of approximately $500,000 at December 31, 2016 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. As of December 31, 2016, no milestones or royalty payments have been paid or accrued. In December 2014, the Company entered into a lease agreement through May 31, 2018 for existing and expanded office space. The rent for the first 12 months was approximately $12,300 per month, or approximately $20.85 per square foot. This rent increased to approximately $12,375 per month, or approximately $20.95 per square foot, for the next 12 months and will increase to approximately $12,460 per month, or approximately $21.13 per square foot for the remainder of the lease. Rent expense was $148,336 and $142,935 for 2016 and 2015, respectively. 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, 2016, 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 2017 $ 100,000 $ 151,000 $ 251,000 2018 100,000 52,000 152,000 2019 100,000 - 100,000 2020 100,000 - 100,000 2021 100,000 - 100,000 Total $ 500,000 $ 203,000 $ 703,000 |
Operating Segments
Operating Segments | 12 Months Ended |
Dec. 31, 2016 | |
Operating Segments [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, 2016 2015 Revenues Vaccines/BioDefense $ 10,448,794 $ 8,754,418 BioTherapeutics - 13,972 Total $ 10,448,794 $ 8,768,390 Income (Loss) from Operations Vaccines/BioDefense $ 1,563,884 $ 1,263,709 BioTherapeutics (3,399,933 ) (4,487,988 ) Corporate (3,873,533 ) (3,885,997 ) Total $ (5,709,582 ) $ (7,110,276 ) Amortization and Depreciation Expense Vaccines/BioDefense $ 40,186 $ 39,925 BioTherapeutics 41,395 199,661 Corporate 8,347 7,872 Total $ 89,928 $ 247,458 Other Income (Expense), Net Corporate $ 1,934,056 $ (1,209,887 ) Share-Based Compensation Vaccines/BioDefense $ 99,410 $ 111,960 BioTherapeutics 131,163 148,244 Corporate 344,404 394,277 Total $ 574,977 $ 654,481 As of December 31, 2016 2015 Identifiable Assets Vaccines/BioDefense $ 1,297,986 $ 2,123,676 BioTherapeutics 49,422 76,183 Corporate 8,919,698 5,187,263 Total $ 10,267,105 $ 7,387,122 |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant 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 BARDA and 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, 2016 or 2015. 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, 2016 and 2015. |
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, 2016 or 2015. |
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, notes payable and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. As a result, certain warrants issued in connection with the Company’s June 2013 registered public offering were accounted for as derivatives. See Note 5, Warrant Liability |
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 |
Accounting for Warrants | Accounting for Warrants The Company considered FASB ASC 815, Evaluating Whether an Instrument is Considered Indexed to an Entity’s Own Stock |
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 For the year ended December 31, 2016, the Company issued 66,875 stock options at a weighted average exercise price of $5.30 per share. The fair value of options issued during the years ended December 31, 2016 and 2015 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 84% - 121% for 2016 and 121% - 141% for 2015; ● forfeitures at a rate of 12%; and ● risk-free interest rates ranging from 0.96% to 1.70% and 0.98% to 1.53% for 2016 and 2015, respectively. The fair value of each option grant made during 2016 and 2015 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. |
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, 2016 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 2016 and 2015. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2016 and 2015. |
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. For the Year Ended For the Year Ended December 31, December 31, Numerator: Net loss for basic earnings per share $ (3,245,383 ) $ (7,831,230 ) Less change in fair value of warrant liability 1,541,241 - Net loss for diluted earnings per share $ (4,786,624 ) $ (7,831,230 ) Denominator: Weighted-average basic common shares outstanding 3,481,460 2,606,577 Assumed conversion of dilutive securities: Common stock purchase warrants 102,127 - Denominator for diluted earnings per share – adjusted weighted-average shares 3,583,587 2,606,577 Basic net loss per share ($ 0.93 ) ($ 3.00 ) Diluted net loss per share ($ 1.34 ) ($ 3.00 ) The following table summarizes potentially dilutive adjustments to the weighted average number of common shares which were excluded from the calculation because their effect would be anti-dilutive. For the Year Ended For the Year Ended December 31, December 31, Common stock purchase warrants 2,853,575 492,612 Stock options 330,605 276,861 Total 3,184,180 769,473 The weighted average exercise price of the Company’s stock options and warrants outstanding at December 31, 2016 were $17.07 and $4.13 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 August 2014, FASB issued Accounting Standards Update (“ASU”) No. 2014-15, “Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” The amendments in this ASU are intended to define management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. Specifically, this ASU provides a definition of the term substantial doubt and requires an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). It also requires certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans and requires an express statement and other disclosures when substantial doubt is not alleviated. The new standard is effective for annual periods ending after December 15, 2016, and interim periods thereafter. The Company adopted the new standard effective December 31, 2016, and the adoption of the standard did not have an impact on the Company’s consolidated financial statements and disclosures. 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 recognizing lease assets and lease liabilities on the balance sheet 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 is evaluating the impact of the adoption of this update on our consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting, which amends ASC Topic 718, and intends to simplify various aspects related to how share-based payments are accounted for and presented in the financial statements. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within that reporting period. Early adoption is permitted. The Company is currently evaluating the impact of adoption of this update on our consolidated financial statements and related disclosures. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of earnings per share | For the Year Ended For the Year Ended December 31, December 31, Numerator: Net loss for basic earnings per share $ (3,245,383 ) $ (7,831,230 ) Less change in fair value of warrant liability 1,541,241 - Net loss for diluted earnings per share $ (4,786,624 ) $ (7,831,230 ) Denominator: Weighted-average basic common shares outstanding 3,481,460 2,606,577 Assumed conversion of dilutive securities: Common stock purchase warrants 102,127 - Denominator for diluted earnings per share – adjusted weighted-average shares 3,583,587 2,606,577 Basic net loss per share ($ 0.93 ) ($ 3.00 ) Diluted net loss per share ($ 1.34 ) ($ 3.00 ) |
Schedule of weighted average number of common shares | For the Year Ended For the Year Ended December 31, December 31, Common stock purchase warrants 2,853,575 492,612 Stock options 330,605 276,861 Total 3,184,180 769,473 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Intangible Assets [Abstract] | |
Summary of intangible assets | Cost Accumulated Net Book Value December 31, 2016 Licenses $ 462,234 $ 361,044 $ 101,190 Patents 1,893,185 1,867,747 25,438 Total $ 2,355,419 $ 2,228,791 $ 126,628 December 31, 2015 Licenses $ 462,234 $ 333,732 $ 128,502 Patents 1,893,185 1,832,955 60,230 Total $ 2,355,419 $ 2,166,687 $ 188,732 |
Summary of annual amortization expense | Year Amortization Expense 2017 $ 61,800 2018 $ 37,300 2019 $ 27,528 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accrued Expenses [Abstract] | |
Summary of accrued expenses | For the Years Ended 2016 2015 Clinical trial expenses $ 741,174 $ 1,168,021 Executive bonuses - 275,355 Other 64,944 67,168 Total $ 806,118 $ 1,510,544 |
Warrant Liability (Tables)
Warrant Liability (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Warrant Liability [Abstract] | |
Summary of assumptions used in the valuation of warrants issued | November 9, December 31, Number of shares underlying the warrants 303,694 303,694 Exercise price $ 0.80 $ 5.10 Volatility 93 % 98 % Risk-free interest rate 0.81 % 1.19 % Expected dividend yield 0 % 0 % Expected warrant life (years) 1.63 2.48 Stock price $ 3.65 $ 11.30 |
Summary of fair value measurements using significant unobservable inputs (level 3) | December 31, Decrease in Fair Value Reclassification of warrant liability to equity in 2016 December 31, Warrant liability $ 2,434,101 $ (1,541,241 ) $ (892,860 ) $ 0 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes [Abstract] | |
Schedule of income tax benefit | 2016 2015 Federal $ - $ - State (530,143 ) (488,933 ) Income tax benefit $ (530,143 ) $ (488,933 ) |
Schedule of deferred tax assets and liabilities | 2016 2015 Net operating loss carry forwards $ 32,028,000 $ 31,216,000 Orphan drug and research and development credit carry forwards 6,374,000 4,909,000 Equity based compensation 1,943,000 1,923,000 Intangibles 1,921,000 2,090,000 Total 42,266,000 40,138,000 Valuation allowance (42,266,000 ) (40,138,000 ) Net deferred tax assets $ - $ - |
Schedule of reconciliation of income tax rate | 2016 2015 Income tax loss at federal statutory rate (34.0 )% (34.0 )% State tax benefits, plus sale of NJ NOLs, net of federal benefit (7.9 ) (4.3 ) Permanent differences 10.3 15.0 Orphan drug and research and development credits (38.8 ) (16.3 ) Change in valuation allowance 56.4 33.7 Income tax benefit (14.0 )% (5.9 )% |
Stock Option Plans and Warran25
Stock Option Plans and Warrants to Purchase Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Summary of option and warrant activity | Shares available for grant at January 1, 2016 252,300 Options granted (66,875 ) Options forfeited 344 Shares available for grant at December 31, 2016 185,679 |
Share Based Compensation [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Summary of option and warrant activity | Share-based compensation 2016 2015 Research and development $ 230,573 $ 260,204 General and administrative 344,404 394,277 Total $ 574,977 $ 654,481 |
Stock options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Summary of option and warrant activity | Options Weighted Average Options Exercise Price Balance outstanding at December 31, 2014 248,828 $ 24.00 Granted 60,534 11.90 Exercised (3,312 ) 5.80 Forfeited (29,189 ) 31.30 Balance outstanding at December 31, 2015 276,861 $ 21.30 Granted 66,875 5.30 Increase post reverse stock split 1,851 17.07 Exercised - - Forfeited (14,982 ) 48.52 Balance outstanding at December 31, 2016 330,605 $ 17.07 |
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 $2.25-$19.50 6.14 235,475 165,144 $20.00-$41.00 6.36 63,080 61,802 $46.40-$94.00 2.43 32,050 32,050 Total 5.82 330,605 258,996 |
Warrant [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Summary of option and warrant activity | Warrants Weighted Average Warrant Exercise Price Balance at December 31, 2014 726,950 $ 11.50 Exercised (174,643 ) 6.40 Expired (59,693 ) 55.90 Balance at December 31, 2015 492,614 $ 7.40 Granted 2,403,405 3.95 Exercised (42,444 ) 0.80 Balance at December 31, 2016 2,853,575 $ 4.13 |
Weighted-average range of exercise prices for options and warrants outstanding and exercisable | Grant Date Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding Warrants Exercisable Warrants 11/15/2012 $ 6.80 0.87 5,000 5,000 12/20/2012 5.30 0.97 44,488 44,488 12/20/2012 5.80 0.97 28,000 28,000 6/25/2013 0.80 1.48 261,250 261,250 12/5/2013 20.50 1.93 500 500 12/24/2014 14.80 2.98 110,932 110,932 12/16/2016 $ 3.95 4.96 2,403,405 2,370,005 Total 4.45 2,853,575 2,820,175 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies [Abstract] | |
Summary of future contractual obligations | Year Research and Development Property and Other Leases Total 2017 $ 100,000 $ 151,000 $ 251,000 2018 100,000 52,000 152,000 2019 100,000 - 100,000 2020 100,000 - 100,000 2021 100,000 - 100,000 Total $ 500,000 $ 203,000 $ 703,000 |
Operating Segments (Tables)
Operating Segments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Operating Segments [Abstract] | |
Summary of operating segments | For the Years Ended December 31, 2016 2015 Revenues Vaccines/BioDefense $ 10,448,794 $ 8,754,418 BioTherapeutics - 13,972 Total $ 10,448,794 $ 8,768,390 Income (Loss) from Operations Vaccines/BioDefense $ 1,563,884 $ 1,263,709 BioTherapeutics (3,399,933 ) (4,487,988 ) Corporate (3,873,533 ) (3,885,997 ) Total $ (5,709,582 ) $ (7,110,276 ) Amortization and Depreciation Expense Vaccines/BioDefense $ 40,186 $ 39,925 BioTherapeutics 41,395 199,661 Corporate 8,347 7,872 Total $ 89,928 $ 247,458 Other Income (Expense), Net Corporate $ 1,934,056 $ (1,209,887 ) Share-Based Compensation Vaccines/BioDefense $ 99,410 $ 111,960 BioTherapeutics 131,163 148,244 Corporate 344,404 394,277 Total $ 574,977 $ 654,481 As of December 31, 2016 2015 Identifiable Assets Vaccines/BioDefense $ 1,297,986 $ 2,123,676 BioTherapeutics 49,422 76,183 Corporate 8,919,698 5,187,263 Total $ 10,267,105 $ 7,387,122 |
Nature of Business (Details)
Nature of Business (Details) | 12 Months Ended | ||
Dec. 31, 2016USD ($)Segment | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Nature of Business (Textual) | |||
Number of operating segments | Segment | 2 | ||
Cash and cash equivalents | $ 8,772,567 | $ 4,921,545 | $ 5,525,094 |
Net increase in cash and cash equivalents | $ 3,851,022 | (603,549) | |
Percentage increase in cash and cash equivalents | 78.00% | ||
Net proceeds received from financing activities | $ 8,840,602 | 4,804,857 | |
Cash used in operations | (4,982,421) | (5,386,308) | |
Working capital | 7,243,918 | 2,179,694 | |
Non-cash warrant liability | 2,434,101 | ||
Increase in working capital | $ 5,064,224 | ||
Percentage of decrease in working capital | 232.00% | ||
Active grant funding available | 17,300,000 | ||
Proceeds from the sale of NJ NOL | 530,143 | ||
Equity facility, available amount | 10,300,000 | ||
Accumulated deficit | (150,122,962) | $ (146,877,579) | |
Incurred loss | $ (3,245,383) | $ (7,831,230) |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | ||
Numerator: | |||
Net loss for basic earnings per share | $ (3,245,383) | $ (7,831,230) | |
Less change in fair value of warrant liability | 1,541,241 | ||
Net loss for diluted earnings per share | $ (4,786,624) | $ (7,831,230) | |
Denominator: | |||
Weighted-average basic common shares outstanding | [1] | 3,481,460 | 2,606,577 |
Assumed conversion of dilutive securities: | |||
Common stock purchase warrants | 102,127 | ||
Denominator for diluted earnings per share - adjusted weighted-average shares | 3,583,587 | 2,606,577 | |
Basic net loss per share | [1] | $ (0.93) | $ (3) |
Diluted net loss per share | [1] | $ (1.34) | $ (3) |
[1] | Adjusted to reflect the reverse stock split of one-for-ten effective October 7, 2016. |
Summary of Significant Accoun30
Summary of Significant Accounting Policies (Details 1) - shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Dilutive adjustments to the weighted average number of common shares | ||
Total | 3,184,180 | 769,473 |
Common stock purchase warrants [Member] | ||
Dilutive adjustments to the weighted average number of common shares | ||
Total | 2,853,575 | 492,612 |
Stock options [Member] | ||
Dilutive adjustments to the weighted average number of common shares | ||
Total | 330,605 | 276,861 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies (Details Textual) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2016$ / shares | Dec. 31, 2016Segment$ / sharesshares | Dec. 31, 2015$ / shares | Dec. 31, 2014$ / shares | |
Summary of Significant Accounting Policies (Textual) | ||||
Number of operating segments | Segment | 2 | |||
Minimum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Intangible assets, estimated useful life | 11 years | |||
Maximum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Intangible assets, estimated useful life | 16 years | |||
Directors Upon Re-election [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Stock option, expiration period | 1 year | |||
Permanent Employees Or Director [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Stock option, expiration period | 10 years | |||
Terminated Employees Or Directors [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Stock option, expiration period | 3 months | |||
Stock Option [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Weighted average exercise price, outstanding | $ 17.07 | |||
Dividend yield | 0.00% | 0.00% | ||
Expected life of stock option | 4 years | 4 years | ||
Forfeiture rate | 12.00% | 12.00% | ||
Stock option vesting, description | Stock options issued to employees vest 25% on the grant date, then 25% each subsequent year for a period of three years. | |||
Options granted | shares | 66,875 | |||
Weighted average exercise price, granted | $ 5.30 | |||
Stock Option [Member] | Minimum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Volatility rate | 84.00% | 121.00% | ||
Risk free interest rate | 0.96% | 0.98% | ||
Stock Option [Member] | Maximum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Volatility rate | 121.00% | 141.00% | ||
Risk free interest rate | 1.70% | 1.53% | ||
Warrant [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Weighted average exercise price, outstanding | $ 4.13 | $ 7.40 | $ 11.50 | |
Weighted average exercise price, granted | $ 3.95 | |||
Warrant [Member] | Minimum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Investment warrants, exercise price | $ 0.80 | |||
Warrant [Member] | Maximum [Member] | ||||
Summary of Significant Accounting Policies (Textual) | ||||
Investment warrants, exercise price | $ 5.10 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Summary of intangible assets | ||
Cost | $ 2,355,419 | $ 2,355,419 |
Accumulated Amortization | 2,228,791 | 2,166,687 |
Net Book Value | 126,628 | 188,732 |
Licenses [Member] | ||
Summary of intangible assets | ||
Cost | 462,234 | 462,234 |
Accumulated Amortization | 361,044 | 333,732 |
Net Book Value | 101,190 | 128,502 |
Patents [Member] | ||
Summary of intangible assets | ||
Cost | 1,893,185 | 1,893,185 |
Accumulated Amortization | 1,867,747 | 1,832,955 |
Net Book Value | $ 25,438 | $ 60,230 |
Intangible Assets (Details 1)
Intangible Assets (Details 1) | Dec. 31, 2016USD ($) |
Annual amortization expense | |
2,017 | $ 61,800 |
2,018 | 37,300 |
2,019 | $ 27,528 |
Intangible Assets (Details Text
Intangible Assets (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Intangible Assets (Textual) | ||
Amortization expense | $ 62,104 | $ 221,217 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued Expenses [Abstract] | ||
Clinical trial expenses | $ 741,174 | $ 1,168,021 |
Executive bonuses | 275,355 | |
Other | 64,944 | 67,168 |
Total | $ 806,118 | $ 1,510,544 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jul. 29, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | |
Notes Payable (Textual) | |||
Amortization discount | $ 7,281 | $ 10,648 | |
Equity Line Purchase Agreements [Member] | |||
Notes Payable (Textual) | |||
Aggregate principal amount | $ 300,000 | ||
Maturity date | Apr. 15, 2016 | ||
Issuance of promissory notes, present value | $ 282,071 | ||
Interest rate | 9.00% |
Warrant Liability (Details)
Warrant Liability (Details) - Warrant [Member] - $ / shares | Nov. 09, 2016 | Dec. 31, 2015 |
Summary of assumptions used in the valuation of warrants issued | ||
Number of shares underlying the warrants | 303,694 | 303,694 |
Exercise price | $ 0.80 | $ 5.10 |
Volatility | 93.00% | 98.00% |
Risk-free interest rate | 0.81% | 1.19% |
Expected dividend yield | 0.00% | 0.00% |
Expected warrant life (years) | 1 year 7 months 17 days | 2 years 5 months 23 days |
Stock price | $ 3.65 | $ 11.30 |
Warrant Liability (Details 1)
Warrant Liability (Details 1) - Warrant [Member] | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Summary of fair value measurements using significant unobservable inputs (level 3) | |
Warrant liability, beginning balance | $ 2,434,101 |
Decrease in Fair Value | (1,541,241) |
Reclassification of warrant liability to equity in 2016 | (892,860) |
Warrant liability, ending balance | $ 0 |
Warrant Liability (Details Text
Warrant Liability (Details Textual) - USD ($) | Nov. 09, 2016 | Dec. 16, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Nov. 30, 2016 | Dec. 31, 2014 | Jun. 25, 2013 |
Warrant Liability (Textual) | |||||||
Change in fair value of warrant liability | $ (1,541,241) | $ 1,201,870 | |||||
Warrants to purchase of common stock | 1,670,000 | ||||||
Warrant [Member] | |||||||
Warrant Liability (Textual) | |||||||
Change in fair value of warrant liability | $ 1,541,000 | ||||||
Warrants to purchase of common stock | 42,444 | ||||||
Issuance of common stock from exercise of warrants, shares | 33,978 | ||||||
Minimum [Member] | Warrant [Member] | |||||||
Warrant Liability (Textual) | |||||||
Exercise price of warrants | $ 0.80 | ||||||
Maximum [Member] | Warrant [Member] | |||||||
Warrant Liability (Textual) | |||||||
Exercise price of warrants | $ 5.10 | ||||||
June 2013 Registered Public Offering [Member] | Warrant [Member] | |||||||
Warrant Liability (Textual) | |||||||
Exercise price of warrants | $ 5.10 | $ 6.10 | |||||
Amount of initial warrant liability | $ 4,827,788 | ||||||
Closing price of common stock as reported on OTC markets | $ 9.60 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Abstract] | ||
Federal | ||
State | (530,143) | (488,933) |
Income tax benefit | $ 530,143 | $ 488,933 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes [Abstract] | ||
Net operating loss carry forwards | $ 32,028,000 | $ 31,216,000 |
Orphan drug and research and development credit carry forwards | 6,374,000 | 4,909,000 |
Equity based compensation | 1,943,000 | 1,923,000 |
Intangibles | 1,921,000 | 2,090,000 |
Total | 42,266,000 | 40,138,000 |
Valuation allowance | (42,266,000) | (40,138,000) |
Net deferred tax assets |
Income Taxes (Details 2)
Income Taxes (Details 2) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Abstract] | ||
Income tax loss at federal statutory rate | (34.00%) | (34.00%) |
State tax benefits, plus sale of NJ NOLs, net of federal benefit | (7.90%) | (4.30%) |
Permanent differences | 10.30% | 15.00% |
Orphan drug and research and development credits | (38.80%) | (16.30%) |
Change in valuation allowance | 56.40% | 33.70% |
Income tax benefit | (14.00%) | (5.90%) |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes (Textual) | ||
Net operating losses | $ 93,635,000 | |
Tax credit, amount | $ 6,374,000 | |
Period of expiration of various tax credits | Expire from 2018 to 2035. | |
Income tax benefit | $ (530,143) | $ (488,933) |
New Jersey Division of Taxation [Member] | ||
Income Taxes (Textual) | ||
Net operating losses | $ 3,233,000 |
Shareholders' Deficiency (Detai
Shareholders' Deficiency (Details) - USD ($) | Sep. 09, 2016 | Dec. 16, 2016 | Aug. 29, 2016 | May 31, 2016 | Mar. 31, 2016 | Nov. 30, 2015 | Oct. 31, 2015 | Sep. 30, 2015 | Aug. 31, 2015 | Jul. 31, 2015 | Jul. 29, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Nov. 30, 2016 | Nov. 09, 2016 | Apr. 30, 2015 |
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | |||||||||||||||||
Preferred stock, shares issued | |||||||||||||||||||
Preferred stock, shares outstanding | |||||||||||||||||||
Common stock purchase agreement | $ 3,000,000 | ||||||||||||||||||
Weighted average price of common stock percentage | 80.00% | ||||||||||||||||||
Promissory note principal amount, percentage | 3.00% | ||||||||||||||||||
Equity line purchase | $ 2,500,000 | ||||||||||||||||||
Issuance cost | $ (453,162) | ||||||||||||||||||
Commitment fee | 3.00% | ||||||||||||||||||
Net proceeds received from public offering | 2,000,000 | ||||||||||||||||||
Value of shares issued | $ 1,712,320 | $ 1,339,177 | |||||||||||||||||
Common stock, shares issued | 5,470,032 | 3,126,952 | 33,978 | 812 | |||||||||||||||
Common stock purchase agreement, 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. | ||||||||||||||||||
Additional issuance pursuant to equity line purchase agreement, second drawdown | 393,624 | ||||||||||||||||||
Warrant [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Issuance of common stock from exercise of stock options, shares | 42,444 | 174,643 | |||||||||||||||||
Underwriters partially exercised the over allotment | $ 282,505 | ||||||||||||||||||
Warrants exercise price | $ 3.95 | ||||||||||||||||||
Kodiak Capital [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Common stock right to sell in future period | $ 5,000,000 | ||||||||||||||||||
Kingsbrook [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Common stock right to sell in future period | 4,000,000 | ||||||||||||||||||
River North [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Common stock purchase agreement | $ 10,000,000 | ||||||||||||||||||
Common stock right to sell in future period | $ 1,000,000 | ||||||||||||||||||
Lincoln Park Capital Fund, LLC ("Lincoln Park") [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Value of shares issued | $ 12,000,000 | ||||||||||||||||||
Number of shares issued as commitment fee | 10,000 | ||||||||||||||||||
Maximum additional commitment shares upon relative proportion of purchases compared | 50,000 | ||||||||||||||||||
Proceed from common stock agreement gross | $ 12,000,000 | ||||||||||||||||||
Value of shares granted | $ 81,000 | ||||||||||||||||||
Number of common stock shares sold | 82,500 | ||||||||||||||||||
Number of commitment shares issued | 1,635 | ||||||||||||||||||
Net proceeds from common stock sold | $ 1,339,177 | ||||||||||||||||||
Common stock purchase agreement, description | The Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park"). The Lincoln Park equity facility allowed the Company to require Lincoln Park to purchase up to $10.6 million of our common stock over a 36-month period depending on certain conditions. | ||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Issuance of common stock from exercise of warrants, shares | 352,942 | ||||||||||||||||||
Issuance of common stock pursuant to lincoln park equity line, Shares | 277,135 | 84,135 | |||||||||||||||||
Issuance of common stock as partial consideration for services performed, shares | 2,500 | 5,000 | 7,500 | 16,628 | |||||||||||||||
Issuance of common stock from exercise of stock options, shares | 2,500 | 3,312 | |||||||||||||||||
Common stock purchase agreement | $ 353 | ||||||||||||||||||
Issuance of common stock pursuant to equity line purchase agreement, Shares | 454,577 | ||||||||||||||||||
Equity line purchase | $ 455 | ||||||||||||||||||
Issuance cost | |||||||||||||||||||
Value of shares issued | 277 | $ 84 | |||||||||||||||||
Value of shares granted | $ 47,244 | ||||||||||||||||||
Number of common stock shares sold | 260,000 | ||||||||||||||||||
Number of commitment shares issued | 7,135 | ||||||||||||||||||
Net proceeds from common stock sold | $ 1,712,320 | ||||||||||||||||||
Common Stock [Member] | Warrant [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Issuance of common stock from exercise of warrants, shares | 714 | 19,871 | |||||||||||||||||
Issuance of common stock from cashless exercise of warrants,shares | 48,200 | 70,179 | |||||||||||||||||
Common stock, shares issued | 2,087,500 | 42,442 | 35,679 | ||||||||||||||||
Common stock purchase agreement price | $ 3.16 | ||||||||||||||||||
Common Stock [Member] | Lincoln Park Capital Fund, LLC ("Lincoln Park") [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Issuance of common stock from exercise of warrants, shares | 7,589 | ||||||||||||||||||
Issuance of common stock pursuant to lincoln park equity line, Shares | 15,184 | 15,301 | |||||||||||||||||
Issuance of common stock pursuant to equity line purchase agreement, Shares | 60,954 | 393,623 | |||||||||||||||||
Common stock, shares issued | 38,425 | 277,135 | 7,636 | ||||||||||||||||
Common Stock [Member] | Sciclone [Member] | |||||||||||||||||||
Shareholders' Deficiency (Textual) | |||||||||||||||||||
Common stock, shares issued | 352,942 | ||||||||||||||||||
Common stock purchase agreement price | $ 3,000,000 |
Stock Option Plans and Warran45
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Equity Incentive Plan [Member] | 12 Months Ended |
Dec. 31, 2016shares | |
Summary of equity incentive plan | |
Shares available for grant at January 1, 2016 | 252,300 |
Options granted | (66,875) |
Options forfeited | 344 |
Shares available for grant at December 31, 2016 | 185,679 |
Stock Option Plans and Warran46
Stock Option Plans and Warrants to Purchase Common Stock (Details 1) - Stock options [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Beginning balance outstanding | 276,861 | 248,828 |
Granted | 66,875 | 60,534 |
Increase post reverse stock split | 1,851 | |
Exercised | (3,312) | |
Forfeited | (14,982) | (29,189) |
Ending balance outstanding | 330,605 | 276,861 |
Weighted average options exercise price, beginning balance | $ 21.30 | $ 24 |
Weighted average exercise price, granted | 3.90 | 9.48 |
Weighted average options exercise price, increase post reverse stock split | 17.07 | |
Weighted average options exercise price, exercised | 5.80 | |
Weighted average options exercise price, forfeited | 48.52 | 31.30 |
Weighted average options exercise price, ending balance | $ 17.07 | $ 21.30 |
Stock Option Plans and Warran47
Stock Option Plans and Warrants to Purchase Common Stock (Details 2) - Stock options [Member] | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
$2.25-$19.50 [Member] | |
Weighted-average Range of Exercise Prices for options outstanding and exercisable | |
Exercise price range, lower range limit | $ / shares | $ 2.25 |
Exercise price range, upper range limit | $ / shares | $ 19.50 |
Weighted Average Remaining Contractual Life in Years | 6 years 1 month 21 days |
Outstanding Options | shares | 235,475 |
Exercisable Options | shares | 165,144 |
$20.00-$41.00 [Member] | |
Weighted-average Range of Exercise Prices for options outstanding and exercisable | |
Exercise price range, lower range limit | $ / shares | $ 20 |
Exercise price range, upper range limit | $ / shares | $ 41 |
Weighted Average Remaining Contractual Life in Years | 6 years 4 months 10 days |
Outstanding Options | shares | 63,080 |
Exercisable Options | shares | 61,802 |
$46.40-$94.00 [Member] | |
Weighted-average Range of Exercise Prices for options outstanding and exercisable | |
Exercise price range, lower range limit | $ / shares | $ 46.40 |
Exercise price range, upper range limit | $ / shares | $ 94 |
Weighted Average Remaining Contractual Life in Years | 2 years 5 months 5 days |
Outstanding Options | shares | 32,050 |
Exercisable Options | shares | 32,050 |
Total [Member] | |
Weighted-average Range of Exercise Prices for options outstanding and exercisable | |
Exercise price range, lower range limit | $ / shares | |
Exercise price range, upper range limit | $ / shares | |
Weighted Average Remaining Contractual Life in Years | 5 years 9 months 26 days |
Outstanding Options | shares | 330,605 |
Exercisable Options | shares | 258,996 |
Stock Option Plans and Warran48
Stock Option Plans and Warrants to Purchase Common Stock (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 574,977 | $ 654,481 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | 230,573 | 260,204 |
General and administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation | $ 344,404 | $ 394,277 |
Stock Option Plans and Warran49
Stock Option Plans and Warrants to Purchase Common Stock (Details 4) - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Summary of warrant activity | ||
Beginning balance outstanding | 492,612 | 726,950 |
Granted | 2,403,405 | |
Exercised | (42,444) | (174,643) |
Expired/Cancelled | (59,693) | |
Ending balance outstanding | 2,853,575 | 492,612 |
Weighted average warrant exercise price, beginning balance | $ 7.40 | $ 11.50 |
Weighted average warrant exercise price, granted | 3.95 | |
Weighted average warrant exercise price, exercised | 0.80 | 6.40 |
Weighted average warrant exercise price, expired | 55.90 | |
Weighted average warrant exercise price, ending balance | $ 4.13 | $ 7.40 |
Stock Option Plans and Warran50
Stock Option Plans and Warrants to Purchase Common Stock (Details 5) | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
11/15/2012 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 6.80 |
Weighted Average Remaining Contractual Life in Years | 10 months 13 days |
Outstanding Warrants | 5,000 |
Exercisable Warrants | 5,000 |
12/20/2012 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 5.30 |
Weighted Average Remaining Contractual Life in Years | 11 months 19 days |
Outstanding Warrants | 44,488 |
Exercisable Warrants | 44,488 |
12/20/2012 [member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 5.80 |
Weighted Average Remaining Contractual Life in Years | 11 months 19 days |
Outstanding Warrants | 28,000 |
Exercisable Warrants | 28,000 |
6/25/2013 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 0.80 |
Weighted Average Remaining Contractual Life in Years | 1 year 5 months 23 days |
Outstanding Warrants | 261,250 |
Exercisable Warrants | 261,250 |
12/5/2013 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 20.50 |
Weighted Average Remaining Contractual Life in Years | 1 year 11 months 5 days |
Outstanding Warrants | 500 |
Exercisable Warrants | 500 |
12/24/2014 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 14.80 |
Weighted Average Remaining Contractual Life in Years | 2 years 11 months 23 days |
Outstanding Warrants | 110,932 |
Exercisable Warrants | 110,932 |
12/16/2016 [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Exercise Price | $ / shares | $ 3.95 |
Weighted Average Remaining Contractual Life in Years | 4 years 11 months 16 days |
Outstanding Warrants | 2,403,405 |
Exercisable Warrants | 2,370,005 |
Total [Member] | |
Weighted-average Range of Exercise Prices for warrants outstanding and exercisable | |
Weighted Average Remaining Contractual Life in Years | 4 years 5 months 12 days |
Outstanding Warrants | 2,853,575 |
Exercisable Warrants | 2,820,175 |
Stock Option Plans and Warran51
Stock Option Plans and Warrants to Purchase Common Stock (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 16, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Nov. 09, 2016 | Jun. 30, 2015 | Apr. 30, 2015 | Dec. 31, 2013 | |
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Options intrinsic value | $ 18,181 | |||||||
Compensation cost for stock options not yet recognized | $ 407,520 | |||||||
Warrants to purchase of common stock | 1,670,000 | |||||||
Warrants outstanding | 261,250 | |||||||
Common Stock, Shares, Issued | 5,470,032 | 3,126,952 | 33,978 | 812 | ||||
Common Stock, Value, Issued | $ 5,470 | $ 3,127 | ||||||
Warrant [Member] | ||||||||
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Exercisable Options | 258,996 | |||||||
Warrants outstanding | 2,853,575 | 492,612 | 726,950 | |||||
Warrants granted | 2,403,405 | |||||||
Warrants to purchase of common stock | 2,087,500 | 42,444 | ||||||
Warrants outstanding | 303,694 | |||||||
Common Stock, Value, Issued | $ 3.16 | |||||||
Sale of Stock, Price Per Share | $ 3.95 | |||||||
Underwriters partially exercised the over allotment | $ 282,505 | |||||||
Weighted average grant fair value | $ 3.95 | |||||||
Warrant liability | $ 892,860 | |||||||
Warrant [Member] | Registered public offering [Member] | ||||||||
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Warrants to purchase of common stock | 33,400 | |||||||
Equity Incentive Plan [Member] | ||||||||
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Number of options available under Equity Incentive Plan | 2,523,000 | 3,000,000 | ||||||
Options granted | (477,000) | |||||||
Stock options [Member] | ||||||||
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Weighted average exercise price | $ 19.58 | |||||||
Exercisable, weighted average remaining contractual term | 7 years 5 months 5 days | |||||||
Options intrinsic value | $ 0 | |||||||
Options outstanding, shares | 330,605 | 276,861 | 248,828 | |||||
Weighted average exercise price | $ 17.07 | |||||||
Options granted | 66,875 | 60,534 | ||||||
Weighted average grant fair value | $ 3.90 | $ 9.48 | ||||||
2015 Equity Incentive Plan [Member] | ||||||||
Stock option plans and warrants to purchase common stock (Textual) | ||||||||
Number of options available under Equity Incentive Plan | 3,000,000 |
Concentrations (Details)
Concentrations (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Concentrations (Textual) | ||
Deposits under securities investor protection corporation | $ 1,000,000 | $ 1,000,000 |
Commitments and Contingencies53
Commitments and Contingencies (Details) | Dec. 31, 2016USD ($) |
Summary of future contractual obligations | |
2,017 | $ 251,000 |
2,018 | 152,000 |
2,019 | 100,000 |
2,020 | 100,000 |
2,021 | 100,000 |
Total | 703,000 |
Research and Development [Member] | |
Summary of future contractual obligations | |
2,017 | 100,000 |
2,018 | 100,000 |
2,019 | 100,000 |
2,020 | 100,000 |
2,021 | 100,000 |
Total | 500,000 |
Property and Other Leases [Member] | |
Summary of future contractual obligations | |
2,017 | 151,000 |
2,018 | 52,000 |
2,019 | |
2,020 | |
2,021 | |
Total | $ 203,000 |
Commitments and Contingencies54
Commitments and Contingencies (Detail Textual) | Sep. 03, 2014USD ($)shares | Feb. 28, 2007shares | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) |
Commitments and Contingencies (Textual) | |||||
Commitments related to agreements | $ 500,000 | ||||
Payment for commitment milestones | $ 10,000,000 | $ 7,900,000 | |||
Percentage for royalties | 6.00% | ||||
Monthly rent amount before increment | $ 12,300 | ||||
Monthly rent amount before increment, per square foot | 20.85 | ||||
Rent increases | 12,375 | ||||
Rent increase per square feet | 20.95 | ||||
Monthly rent amount after increment | 12,460 | ||||
Monthly rent amount after increment, per square foot | $ 21.13 | ||||
Rent expense | $ 148,336 | $ 142,935 | |||
Number of months after that rent increases | 12 months | ||||
Number of remaining months for which increased rent paid | 12 months | ||||
Assets acquired payments to cash | $ 275,000 | ||||
Lease agreement expire | May 31, 2018 | ||||
Percentage of ownership outstanding stock | 19.9 | ||||
Shares issued in connection with acquisition of in-process research and development | $ 3,750,000 | ||||
Common Stock [Member] | |||||
Commitments and Contingencies (Textual) | |||||
Shares issued in connection with asset purchase agreement, Shares | shares | 184,912 | ||||
Dr. 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, 2016 | Dec. 31, 2015 | |
Summary of segmental information | ||
Revenues | $ 10,448,794 | $ 8,768,390 |
Income (Loss) from Operations | (5,709,582) | (7,110,276) |
Amortization and Depreciation Expense | 89,928 | 247,458 |
Other Income (Expense), Net | 1,934,056 | (1,209,887) |
Share-Based Compensation | 574,977 | 654,481 |
Identifiable Assets | 10,267,105 | 7,387,122 |
Vaccines/BioDefense [Member] | ||
Summary of segmental information | ||
Revenues | 10,448,794 | 8,754,418 |
Income (Loss) from Operations | 1,563,884 | 1,263,709 |
Amortization and Depreciation Expense | 40,186 | 39,925 |
Other Income (Expense), Net | ||
Share-Based Compensation | 99,410 | 111,960 |
Identifiable Assets | 1,297,986 | 2,123,676 |
BioTherapeutics [Member] | ||
Summary of segmental information | ||
Revenues | 13,972 | |
Income (Loss) from Operations | (3,399,933) | (4,487,988) |
Amortization and Depreciation Expense | 41,395 | 199,661 |
Other Income (Expense), Net | ||
Share-Based Compensation | 131,163 | 148,244 |
Identifiable Assets | 49,422 | 76,183 |
Corporate [Member] | ||
Summary of segmental information | ||
Revenues | ||
Income (Loss) from Operations | (3,873,533) | (3,885,997) |
Amortization and Depreciation Expense | 8,347 | 7,872 |
Other Income (Expense), Net | 1,934,056 | (1,209,887) |
Share-Based Compensation | 344,404 | 394,277 |
Identifiable Assets | $ 8,919,698 | $ 5,187,263 |
Operating Segments (Details Tex
Operating Segments (Details Textual) | 12 Months Ended |
Dec. 31, 2016Segment | |
Operating Segments (Textual) | |
Number of operating segments | 2 |