Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 09, 2020 | |
Document Information Line Items | ||
Entity Registrant Name | SOLIGENIX, INC. | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 29,847,288 | |
Amendment Flag | false | |
Entity Central Index Key | 0000812796 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 000-16929 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 11,342,794 | $ 5,420,708 |
Contracts and grants receivable | 394,402 | 1,018,835 |
Research and development incentives receivable | 312,378 | 444,043 |
Prepaid expenses and other current assets | 680,088 | 609,739 |
Total current assets | 12,729,662 | 7,493,325 |
Security deposit | 22,757 | 22,757 |
Office furniture and equipment, net | 27,511 | 36,093 |
Deferred issuance cost | 57,884 | 39,324 |
Intangible assets, net | 19,699 | |
Right-of-use lease assets | 259,837 | 125,412 |
Research and development incentives receivable | 125,303 | |
Other assets | 27,124 | 38,750 |
Total assets | 13,250,078 | 7,775,360 |
Current liabilities: | ||
Accounts payable | 2,444,919 | 2,735,442 |
Accrued expenses | 2,647,224 | 3,157,386 |
Accrued compensation | 74,028 | 298,173 |
Paycheck Protection Program loan | 255,341 | |
Lease liabilities - current | 114,392 | 121,075 |
Total current liabilities | 5,535,904 | 6,312,076 |
Non-current liabilities: | ||
Paycheck Protection Program loan, net of current | 162,489 | |
Lease liabilities, net of current | 146,214 | 6,149 |
Total liabilities | 5,844,607 | 6,318,225 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock, 350,000 shares authorized, none issued or outstanding | ||
Common stock, $.001 par value; 50,000,000 shares authorized; 29,847,288 shares and 21,753,124 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 29,847 | 21,753 |
Additional paid-in capital | 195,058,736 | 177,006,004 |
Accumulated other comprehensive loss | (9,243) | (45,010) |
Accumulated deficit | (187,673,869) | (175,525,612) |
Total shareholders’ equity | 7,405,471 | 1,457,135 |
Total liabilities and shareholders’ equity | $ 13,250,078 | $ 7,775,360 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 29,847,288 | 21,753,124 |
Common stock, shares outstanding | 29,847,288 | 21,753,124 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues: | ||||
Contract revenue | $ 507,171 | $ 946,982 | $ 1,644,818 | $ 2,647,417 |
Grant revenue | 101,640 | 307,922 | 393,835 | 1,297,238 |
Total revenues | 608,811 | 1,254,904 | 2,038,653 | 3,944,655 |
Cost of revenues | (386,641) | (965,453) | (1,579,485) | (2,980,191) |
Gross profit | 222,170 | 289,451 | 459,168 | 964,464 |
Operating expenses: | ||||
Research and development | 1,266,527 | 2,266,799 | 6,136,743 | 5,763,467 |
General and administrative | 768,420 | 789,251 | 2,422,863 | 2,432,550 |
Research and development expense - milestone | 5,000,000 | |||
Total operating expenses | 2,034,947 | 3,056,050 | 13,559,606 | 8,196,017 |
Loss from operations | (1,812,777) | (2,766,599) | (13,100,438) | (7,231,553) |
Foreign currency transaction gain/(loss) | (7,647) | 8,809 | (34,465) | 11,479 |
Interest income | 486 | 37,007 | 24,450 | 125,467 |
Research and development incentives | 29,778 | 125,303 | ||
Net loss before income taxes | (1,790,160) | (2,720,783) | (12,985,150) | (7,094,607) |
Income tax benefit | 836,893 | 610,676 | ||
Net loss applicable to common stockholders | $ (1,790,160) | $ (2,720,783) | $ (12,148,257) | $ (6,483,931) |
Basic and diluted net loss per share (in Dollars per share) | $ (0.06) | $ (0.14) | $ (0.45) | $ (0.34) |
Basic and diluted weighted average common shares outstanding (in Shares) | 29,572,392 | 20,094,930 | 26,639,116 | 18,877,657 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (1,790,160) | $ (2,720,783) | $ (12,148,257) | $ (6,483,931) |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | 27,708 | (7,985) | 35,767 | (11,324) |
Comprehensive loss | $ (1,762,452) | $ (2,728,768) | $ (12,112,490) | $ (6,495,255) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2018 | $ 17,683 | $ 172,436,176 | $ 3,669 | $ (166,170,020) | $ 6,280,170 |
Balance (in Shares) at Dec. 31, 2018 | 17,682,839 | ||||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | $ 2,529 | 2,551,618 | 2,554,147 | ||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement (in Shares) | 2,529,050 | ||||
Issuance costs associated with FBR At Market Issuance Sales Agreement | (101,277) | (101,277) | |||
Issuance of common stock to vendors | $ 246 | 205,492 | 205,738 | ||
Issuance of common stock to vendors (in Shares) | 245,700 | ||||
Share-based compensation expense | 233,992 | 233,992 | |||
Foreign currency translation adjustment | (11,324) | (11,324) | |||
Net loss | (6,483,931) | (6,483,931) | |||
Balance at Sep. 30, 2019 | $ 20,458 | 175,326,001 | (14,993) | (172,653,951) | 2,677,515 |
Balance (in Shares) at Sep. 30, 2019 | 20,457,589 | ||||
Balance at Jun. 30, 2019 | $ 18,741 | 173,557,669 | (7,008) | (169,933,168) | 3,636,234 |
Balance (in Shares) at Jun. 30, 2019 | 18,741,210 | ||||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | $ 1,668 | 1,710,235 | 1,711,903 | ||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement (in Shares) | 1,667,698 | ||||
Issuance costs associated with FBR At Market Issuance Sales Agreement | (68,062) | (68,062) | |||
Issuance of common stock to vendors | $ 49 | 44,632 | 44,681 | ||
Issuance of common stock to vendors (in Shares) | 48,681 | ||||
Share-based compensation expense | 81,527 | 81,527 | |||
Foreign currency translation adjustment | (7,985) | (7,985) | |||
Net loss | (2,720,783) | (2,720,783) | |||
Balance at Sep. 30, 2019 | $ 20,458 | 175,326,001 | (14,993) | (172,653,951) | 2,677,515 |
Balance (in Shares) at Sep. 30, 2019 | 20,457,589 | ||||
Balance at Dec. 31, 2019 | $ 21,753 | 177,006,004 | (45,010) | (175,525,612) | 1,457,135 |
Balance (in Shares) at Dec. 31, 2019 | 21,753,124 | ||||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | $ 5,797 | 12,685,471 | 12,691,268 | ||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement (in Shares) | 5,797,403 | ||||
Issuance costs associated with FBR At Market Issuance Sales Agreement | (591,079) | (591,079) | |||
Issuance of common stock for milestone | $ 1,956 | 4,998,044 | 5,000,000 | ||
Issuance of common stock for milestone (in Shares) | 1,956,182 | ||||
Issuance of common stock to vendors | $ 30 | 58,970 | 59,000 | ||
Issuance of common stock to vendors (in Shares) | 30,000 | ||||
Exercise of common stock options | $ 6 | 4,981 | 4,987 | ||
Exercise of common stock options (in Shares) | 5,758 | ||||
Exercise of warrants | $ 305 | 685,079 | 685,384 | ||
Exercise of warrants (in Shares) | 304,821 | ||||
Share-based compensation expense | 211,266 | 211,266 | |||
Foreign currency translation adjustment | 35,767 | 35,767 | |||
Net loss | (12,148,257) | (12,148,257) | |||
Balance at Sep. 30, 2020 | $ 29,847 | 195,058,736 | (9,243) | (187,673,869) | 7,405,471 |
Balance (in Shares) at Sep. 30, 2020 | 29,847,288 | ||||
Balance at Jun. 30, 2020 | $ 28,591 | 191,922,671 | (36,951) | (185,883,709) | 6,030,602 |
Balance (in Shares) at Jun. 30, 2020 | 28,591,432 | ||||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | $ 1,252 | 3,230,067 | 3,231,319 | ||
Issuance of common stock pursuant to FBR At Market Issuance Sales Agreement (in Shares) | 1,252,287 | ||||
Issuance costs associated with FBR At Market Issuance Sales Agreement | (165,555) | (165,555) | |||
Exercise of common stock options | $ 4 | 4,981 | 4,985 | ||
Exercise of common stock options (in Shares) | 3,569 | ||||
Share-based compensation expense | 66,572 | 66,572 | |||
Foreign currency translation adjustment | 27,708 | 27,708 | |||
Net loss | (1,790,160) | (1,790,160) | |||
Balance at Sep. 30, 2020 | $ 29,847 | $ 195,058,736 | $ (9,243) | $ (187,673,869) | $ 7,405,471 |
Balance (in Shares) at Sep. 30, 2020 | 29,847,288 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Operating activities: | ||
Net loss | $ (12,148,257) | $ (6,483,931) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Amortization and depreciation | 52,635 | 37,892 |
Non-cash lease expense | 100,720 | 91,185 |
Share-based compensation | 211,266 | 233,992 |
Issuance of common stock for milestone | 5,000,000 | |
Issuance of common stock for services | 59,000 | 159,238 |
Realized gain on sale of office furniture | (3,843) | |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | 624,433 | 332,418 |
Prepaid expenses and other current assets | (70,500) | (432,038) |
Research and development incentives receivable | (5,164) | |
Operating lease liability | (101,779) | (89,919) |
Deferred revenue | 34,988 | |
Accounts payable and accrued expenses | (827,680) | 1,509,729 |
Accrued compensation | (224,145) | (255,999) |
Total adjustments | 4,818,786 | 1,617,643 |
Net cash used in operating activities | (7,329,471) | (4,866,288) |
Investing activities: | ||
Purchases of office furniture and equipment | (7,147) | |
Proceeds from sale of office furniture | 5,500 | |
Net cash provided by (used in) investing activities | (7,147) | 5,500 |
Financing activities: | ||
Proceeds from issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | 12,691,268 | 2,554,147 |
Costs associated with FBR At Market Issuance Sales Agreement | (551,755) | (102,169) |
Proceeds from the exercise of warrants | 685,384 | |
Financing lease principal repayments | (5,566) | (5,039) |
Paycheck Protection Program loan | 417,830 | |
Proceeds from the exercises of stock options | 4,987 | |
Net cash provided by financing activities | 13,242,148 | 2,446,939 |
Effect of exchange rate on cash and cash equivalents | 16,556 | (18,075) |
Net increase (decrease) in cash and cash equivalents | 5,922,086 | (2,431,924) |
Cash and cash equivalents at beginning of period | 5,420,708 | 8,983,717 |
Cash and cash equivalents at end of period | 11,342,794 | 6,551,793 |
Supplemental information: | ||
Cash paid for state income taxes | 4,021 | 5,000 |
Cash paid for lease liabilities: | ||
Operating lease | 106,950 | 104,625 |
Financing lease | 6,408 | 6,408 |
Non-cash activities: | ||
Right-of-use assets and lease liabilities recorded | 240,727 | 255,962 |
Deferred issuance cost included in accounts payable | 57,884 | |
Deferred issuance cost reclassified to additional-paid-in capital | 124,981 | 24,033 |
Issuance of restricted common stock to vendor for website re-development | $ 46,500 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [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: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”), its first-in-class innate defense regulator 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 disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201). The Company’s Public Health Solutions business segment includes active development programs for RiVax ® TM ® The Company generates revenues under government grants primarily from the National Institutes of Health (“NIH”) and government contracts from NIAID. The Company is currently developing RiVax ® The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the United States (“U.S.”) Food and Drug Administration regulations, and other regulatory authorities, litigation, and product liability. Results for the three and nine months ended September 30, 2020 are not necessarily indicative of results that may be expected for the full year. 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 September 30, 2020, the Company had an accumulated deficit of $187,673,869. During the nine months ended September 30, 2020, the Company incurred a net loss of $12,148,257 and used $7,329,471 of cash in operating activities. 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, current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, and proceeds available from the At Market Issuance Sales Agreement (“FBR Sales Agreement”) with B. Riley FBR Inc. (“FBR”), management believes that its current cash will be sufficient to meet the anticipated cash needs for working capital and capital expenditures for at least the next 12 months from issuance of the financial statements. As of September 30, 2020, the Company had cash and cash equivalents of $11,342,794 as compared to $5,420,708 $5,922,086 or $6,012,509 or 508%. proceeds received from the utilization of the FBR Sales Agreement and warrant exercises during the nine months ended September 30, 2020 . Management’s business strategy can be outlined as follows: Following positive primary endpoint topline analysis for the Phase 3 clinical trial of SGX301, as well as further statistically significant improvement in response rates with longer treatment (18 weeks compared to 12 and 6 weeks), continue to explore partnership and commercialization while pursuing New Drug Application filing; Following positive interim analysis and enrollment completion, report final topline results in the Company’s pivotal Phase 3 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; Continue development of RiVax ® (ricin toxin vaccine) and CiVax TM ® technology to develop Continue development of our therapeutic SGX943 and our vaccine programs targeting filoviruses (such as Marburg and Ebola) with DTRA and NIAID funding support; Pursue business development opportunities for the Company’s pipeline programs, as well as explore all strategic alternatives, including but not limited to 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 The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. The Company plans to pursue potential partnerships for pipeline programs; however, there can be no assurances that it can consummate such transactions. The Company has $20.0 November 09, , as no sales have been made under the FBR Sales Agreement since July 28, 2020. The Company has obtained a Paycheck Protection Program Loan through financial stimulus packages authorized by both the federal and state governments based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19. The loan amount totaling The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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: Specialized BioTherapeutics and Public Health Solutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for doubtful amounts has been established. If amounts become uncollectible, they are charged to operations. Intangible Assets The Company determines whether to capitalize or expense patent and license costs 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 three or nine months ended September 30, 2020 and 2019. Website Development Costs In February 2019, Altamont Pharmaceutical Holdings, LLC, a company which since January 1, 2019 beneficially owned 5% or more of the shares of the Company’s outstanding common stock but which has beneficially owned less than 5% of the Company’s outstanding common stock since April 30, 2020, signed a service agreement with a third-party vendor to re-develop the Company’s website. Upon completion of the project at the end of June 2019, the Company capitalized the related website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs”, which was reported in other assets in the accompanying consolidated balance sheets. Beginning with the three months ended September 30, 2019, the Company started amortizing the website development costs on a straight-line basis over three years, the estimated useful life of the website. The Company will also review its capitalized website development costs periodically for impairment. Website amortization expense for the three months ended September 30, 2020 was Impairment of Long-Lived Assets Office furniture and equipment, website development costs 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 three or nine months ended September 30, 2020 or 2019. 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, tax receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term nature of these instruments. Revenue Recognition The Company’s revenues are primarily generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to our employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended (the “Securities Act”) restrictive legend. Stock compensation expense for equity-classified awards to nonemployees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the nine months ended September 30, 2020 and 2019 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 77.08% - 84.57% for 2020 and 90.87% - 92.93% for 2019 risk free interest rates ranging from 0.215 % - 1.66% for 2020 and 1.835% - 2.50% fo The fair value of each option grant made during the nine months ended September 30, 2020 and 2019 was estimated on the date of each grant using the Black-Scholes option pricing model and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly owned subsidiary in the United Kingdom (“UK”) from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company recognized an income tax benefit of $836,893 and $610,676 from the sale of New Jersey NOL carryforwards during the nine months ended September 30, 2020 and 2019, respectively. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of the income tax provision. There were no tax related interest and penalties recorded for the nine months ended September 30, 2020 or 2019. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2020 and December 31, 2019. Research and Development Incentive Income and Receivable The Company recognizes other income from United Kingdom research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The following table shows the change in the United Kingdom research and development incentives receivable from December 31, 2019 to September 30, 2020: Long-term Current Balance at December 31, 2019 $ - $ 444,043 UK research and development incentives 125,303 - UK research and development incentives cash receipt - (120,136 ) Foreign currency translation - (11,529 ) Balance at September 30, 2020 $ 125,303 $ 312,378 Reclassifications Certain amounts in the statement of operations for the three and nine months ended September 30, 2019 were reclassified to conform to the current year presentation. Earnings Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of September 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,550,704 1,331,172 Total 7,437,521 7,634,815 The weighted average exercise price of the Company’s warrants and stock options outstanding at September 30, 2020 were 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, accruals for clinical trials in process 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 and presentation. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 3. Intangible Assets The following is a summary of intangible assets which consists of licenses and patents: Cost Accumulated Amortization Net Book Value September 30, 2020 Licenses $ 462,234 $ 462,234 $ - Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,355,419 $ - December 31, 2019 Licenses $ 462,234 $ 442,535 $ 19,699 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,335,720 $ 19,699 Amortization expense was $6,117 and $6,791 $19,699 and $20,373 Based on the balance of licenses and patents at September 30, 2020, no future amortization expense is expected through December 31, 2020. License fees and royalty payments are expensed as incurred, as the Company does not attribute any future benefits of such payments. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Text Block [Abstract] | |
Leases | Note 4. Leases The Company classifies a lease for its office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey and a lease for a copier machine in the office as an operating lease and a financing lease, respectively, and records related right-of-use lease assets and lease liabilities accordingly. Pursuant to an amendment executed on July 7, 2020, the lease has been extended to October 2022 The current rent of $11,883 per month, or approximately $23.00 per square foot will be reduced to $21.50 per square foot, making the monthly payment $11,108 starting in November 2020 for the remainder of the two year lease extension . Our office space is sufficient to satisfy our current needs. The following represents a reconciliation of contractual lease cash flows to the right-of-use lease assets and liabilities recognized in the financial statements: Operating Lease Financing Lease Right-of-use lease asset: Right-of-use lease asset, January 1, 2020 $ 112,387 $ 13,025 Extended lease terms 240,727 Reduction/amortization (100,720 ) (5,582 ) Right of use lease asset, September 30, 2020 $ 252,394 $ 7,443 Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Extended lease terms 240,727 Repayments (101,779 ) (5,566 ) Lease liability, September 30, 2020 $ 252,507 $ 8,099 Lease expense for the nine months ended September 30, 2020: Lease expense $ 105,893 $ - Amortization expense - 5,582 Interest expense - 842 Total $ 105,893 $ 6,424 Contractual cash payments for the remaining lease term as of September 30, 2020: 2020 $ 34,100 $ 2,136 2021 133,300 6,408 2022 111,083 - Total $ 278,483 $ 8,544 Remaining lease term (months) as of September 30, 2020 25 12 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Note 5. Accrued Expenses The following is a summary of the Company’s accrued expenses: September 30, December 31, 2020 2019 Clinical trial expenses $ 2,538,702 $ 3,020,030 Other 108,522 137,356 Total $ 2,647,224 $ 3,157,386 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 6. Income Taxes The Company had gross NOLs at December 31, 2019 of approximately $107,767,000 for federal tax purposes, approximately $16,180,000 for state tax purposes and approximately $815,000 for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has $8,315,000 of various tax credits which expire from 2020 to 2037. The Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the NOL carryforwards 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 2020 and 2019, 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 carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carryforwards, resulting in the recognition of $836,893 and $610,676 of income tax benefit, net of transaction costs, respectively. The Company has not yet sold its 2019 New Jersey NOLs but may be able to do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity Note [Abstract] | |
Shareholders’ Equity | Note 7. Shareholders’ Equity Preferred Stock The Company has 350,000 shares of preferred stock authorized, none of which are issued or outstanding. Common Stock The following items represent transactions in the Company’s common stock for the nine months ended September 30, 2020: During the nine months ended September 30, 2020, the Company issued 5,758 shares of common stock as a result of an option exercises. The weighted average exercise price of the options was $1.19 per share. The cash exercise price of $1,882 for 2,189 of those shares was received in December 2019. The Company issued a vendor 10,000 shares of common stock with a fair value of $1.68 per share on January 8, 2020, another 10,000 shares of common stock with a fair value of $2.25 per share on February 10, 2020 and another 10,000 shares of common stock with a fair value of $1.97 per share on March 12, 2020, in each case as partial consideration for its service performed. The shares were fully vested on the date of grant and resulted in the recognition of $59,000 of expense during the nine months ended September 30, 2020. On February 10, 2020, the Company issued 206 shares of common stock as a result of a cashless exercise of warrants. The exercise price of the warrants was $2.50. On March 23, 2020, the Company issued 1,956,182 shares of common stock for payment on an achieved milestone. The fair value of the shares was $2.56 per share based upon a formula set forth in the asset purchase agreement. During the nine months ended September 30, 2020, the Company issued 304,615 shares of common stock as a result of warrant exercises. The exercise price of the warrants was $2.25 per share. During the nine months ended September 30, 2020, the Company sold 5,797,403 shares of common stock pursuant to the FBR Sales Agreement at a weighted average price of $2.19 per share. The issuances of the Company’s common stock to vendors and as a result of option exercises described above were issued under the 2015 Plan and, are registered on a Registration Statement on Form S-8. However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act restrictive legend. The issuances of the Company’s common stock (a) as a result of warrant exercises described above, other than upon cashless exercise, were registered on a Registration Statement on Form S-1, (b) for payment on an achieved milestone described above were registered on a Registration Statement on Form S-3 and (c) pursuant to the FBR Sales Agreement described above were registered on a Registration Statement on Form S-3. The Company’s common stock issued as a result of the cashless exercise of the warrants described above were exempt from registration pursuant to Section 3(a)(9) of the Securities Act. FBR At Market Issuance Sales Agreement On August 11, 2017, the Company entered into the FBR Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program under which FBR acts as sales agent. Under the FBR Sales Agreement, the Company sets the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The FBR Sales Agreement provides that FBR is entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the FBR Sale Agreement. The Company has no obligation to sell any shares under the FBR Sales Agreement, and may suspend solicitation and offers under the FBR Sales Agreement at any time. The Company’s shelf registration statement on Form S-3 (File No. 333- 217738) filed on May 5, 2017 (the “May 2017 Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) expired on August 10, 2020, but which was available to be utilized for a period up to six months or until a new shelf registration statement was declared effective, whichever occurred first. All sales under the FBR Sales Agreement from August 11, 2017 through August 10, 2020 were made pursuant to the May 2017 Registration Statement. All sales of common stock made pursuant to the FBR Sales Agreement since the expiration of the May 2017 Registration Statement have been, and future sales will be, made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333- 239928) filed on July 17, 2020 (the "July 2020 Registration Statement") with the SEC, and any amendments thereto, the base prospectus filed as part of such registration statement, and any prospectus supplements. The July 2020 Registration Statement was declared effective on August 28, 2020. Through July 28, 2020, the shares sold pursuant to the FBR Sales Agreement were issued pursuant to General Instruction I.B.6 of Form S-3, which permits the Company to sell shelf securities in a public primary offering with a value not exceeding one-third of the average market value of the Company’s voting and non-voting common equity held by non-affiliates in any 12-month period as long as the aggregate market value of the Company’s outstanding voting and non-voting common equity held by non-affiliates is less than $75 million. As of July 28, 2020, the Company’s outstanding voting and non-voting common equity held by non-affiliates exceeded $75 million. On August 28, 2020, the Company filed a prospectus supplement to the FBR Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $20.0 million under the July 2020 Registration Statement. As of November 09, 2020, there was |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $450,000 The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expired in October 2020. This office space currently serves as the Company’s corporate headquarters. Pursuant to an amendment on July 7, 2020, the lease has been extended fro m November 202 November 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 U.S. In March 2020, the Company filed a prospectus supplement covering the offer and sale of up to 1,956,182 shares of the Company’s common stock which were issued to Hy Biopharma. The Company was required to issue the shares to Hy Biopharma as payment following the achievement of a milestone under the asset purchase agreement, specifically, the Phase 3 clinical trial of SGX301 being successful in the treatment of CTCL. The number of shares of the Company’s common stock issued to Hy Biopharma was calculated using an effective price of $2.56 per share, based upon a formula set forth in the asset purchase agreement, for total expense of $5 million. Provided all future success-oriented milestones are attained, the Company will be required to make additional payments of up to $5.0 million to Hy Biopharma, 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. In January 2020, the Company’s Board of Directors authorized the amendment of Dr. Schaber’s employment agreement to increase the number of shares of the Company’s common stock from 5,000 to 500,000 issuable 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 employment agreement has been amended to include the Company's obligation to issue the increased number of shares if such event occurs. As a result of the above agreements, the Company has the following contractual obligations: Year Research and Development Property and Other Leases Total October 1 through December 31, 2020 $ 50,000 36,236 $ 86,236 2021 100,000 139,708 239,708 2022 100,000 111,083 211,083 2023 100,000 - 100,000 2024 100,000 - 100,000 Total $ 450,000 $ 287,027 $ 737,027 CARES Act Loan On April 13, 2020, the Company was advised that one of its principal banks, JPMorgan Chase Bank, N.A., had approved a $417,830 loan (the “Loan”) under the Paycheck Protection Program (“PPP”) pursuant to the Coronavirus Aid, Relief and Economic Security Act that was signed into law on March 27, 2020. As a U.S. small business, the Company qualified for the PPP, which allows businesses and nonprofits with fewer than 500 employees to obtain loans of up to $10 million to incentivize companies to maintain their workers as they manage the business disruptions caused by the COVID-19 pandemic. The PPP provides for loans for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The PPP loan proceeds may be used for eligible purposes, including payroll, benefits, rent and utilities. The Loan, has a term of two years, is unsecured, and is guaranteed by the Small Business Administration. The short –term portion of the Loan is Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. COVID-19 Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus. Emergent BioSolutions Legal Proceedings On July 1, 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. ("Emergent") and certain of its subsidiaries with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. (see Part II, Item 1 – Legal Proceeding) The Company is seeking to recover damages in excess of $19 million from Emergent. While the Company intends to vigorously pursue this arbitration, the Company cannot offer any assurances that it will recover any damages from Emergent. The Company has received invoices from Emergent related to the above matter. No accrual has been made for these invoices as management deems them invalid because Emergent failed to perform under the applicable contracts, and not probable of being required to pay them based on the numerous breaches sited in the pending arbitration. These invoices total approximately $331,000. |
Operating Segments
Operating Segments | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Operating Segments | Note 9. Operating Segments The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. 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. Three Months Ended September 30, 2020 2019 Revenues Public Health Solutions $ 544,466 $ 991,087 Specialized BioTherapeutics 64,345 263,817 Total $ 608,811 $ 1,254,904 (Loss) Income from Operations Public Health Solutions $ (6,369 ) $ 72,491 Specialized BioTherapeutics (643,793 ) (1,926,883 ) Corporate (1,162,615 ) (912,207 ) Total $ (1,812,777 ) $ (2,766,599 ) Amortization and Depreciation Expense Public Health Solutions $ 6,651 $ 4,312 Specialized BioTherapeutics 3,201 4,141 Corporate 7,335 6,448 Total $ 17,187 $ 14,901 Other Income, Net Specialized BioTherapeutics $ 22,131 $ 8,809 Corporate 486 37,007 Total $ 22,617 $ 45,816 Share-Based Compensation Public Health Solutions $ 8,377 $ 8,072 Specialized BioTherapeutics 18,962 18,609 Corporate 39,233 54,846 Total $ 66,572 $ 81,527 Nine Months Ended September 30, 2020 2019 Revenues Public Health Solutions $ 1,921,284 $ 2,767,304 Specialized BioTherapeutics 117,369 1,177,351 Total $ 2,038,653 $ 3,944,655 (Loss) Income from Operations Public Health Solutions $ (215,608 ) $ 267,601 Specialized BioTherapeutics (9,810,296 ) (4,725,774 ) Corporate (3,074,534 ) (2,773,380 ) Total $ (13,100,438 ) $ (7,231,553 ) Amortization and Depreciation Expense Public Health Solutions $ 21,272 $ 13,030 Specialized BioTherapeutics 9,438 12,986 Corporate 21,925 11,876 Total $ 52,635 $ 37,892 Other Income, Net Specialized BioTherapeutics $ 90,838 $ 11,479 Corporate 24,450 125,467 Total $ 115,288 $ 136,946 Share-Based Compensation Public Health Solutions $ 26,219 $ 21,340 Specialized BioTherapeutics 63,213 58,611 Corporate 121,834 154,041 Total $ 211,266 $ 233,992 As of As of September 30, December 31, 2020 2019 Identifiable Assets Public Health Solutions $ 357,798 $ 1,018,673 Specialized BioTherapeutics 54,944 41,705 Corporate 12,837,336 6,714,982 Total $ 13,250,078 $ 7,775,360 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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: Specialized BioTherapeutics and Public Health Solutions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. |
Contracts and Grants Receivable | Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for doubtful amounts has been established. If amounts become uncollectible, they are charged to operations. |
Intangible Assets | Intangible Assets The Company determines whether to capitalize or expense patent and license costs 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 three or nine months ended September 30, 2020 and 2019. |
Website Development Costs | Website Development Costs In February 2019, Altamont Pharmaceutical Holdings, LLC, a company which since January 1, 2019 beneficially owned 5% or more of the shares of the Company’s outstanding common stock but which has beneficially owned less than 5% of the Company’s outstanding common stock since April 30, 2020, signed a service agreement with a third-party vendor to re-develop the Company’s website. Upon completion of the project at the end of June 2019, the Company capitalized the related website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs”, which was reported in other assets in the accompanying consolidated balance sheets. Beginning with the three months ended September 30, 2019, the Company started amortizing the website development costs on a straight-line basis over three years, the estimated useful life of the website. The Company will also review its capitalized website development costs periodically for impairment. Website amortization expense for the three months ended September 30, 2020 was |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Office furniture and equipment, website development costs 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 three or nine months ended September 30, 2020 or 2019. |
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, tax receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term nature of these instruments. |
Revenue Recognition | Revenue Recognition The Company’s revenues are primarily generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development |
Share-Based Compensation | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to our employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended (the “Securities Act”) restrictive legend. Stock compensation expense for equity-classified awards to nonemployees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the nine months ended September 30, 2020 and 2019 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 77.08% - 84.57% for 2020 and 90.87% - 92.93% for 2019 risk free interest rates ranging from 0.215 % - 1.66% for 2020 and 1.835% - 2.50% fo The fair value of each option grant made during the nine months ended September 30, 2020 and 2019 was estimated on the date of each grant using the Black-Scholes option pricing model and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly owned subsidiary in the United Kingdom (“UK”) from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company recognized an income tax benefit of $836,893 and $610,676 from the sale of New Jersey NOL carryforwards during the nine months ended September 30, 2020 and 2019, respectively. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of the income tax provision. There were no tax related interest and penalties recorded for the nine months ended September 30, 2020 or 2019. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2020 and December 31, 2019. |
Research and Development Incentive Income and Receivable | Research and Development Incentive Income and Receivable The Company recognizes other income from United Kingdom research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The following table shows the change in the United Kingdom research and development incentives receivable from December 31, 2019 to September 30, 2020: Long-term Current Balance at December 31, 2019 $ - $ 444,043 UK research and development incentives 125,303 - UK research and development incentives cash receipt - (120,136 ) Foreign currency translation - (11,529 ) Balance at September 30, 2020 $ 125,303 $ 312,378 |
Reclassifications | Reclassifications Certain amounts in the statement of operations for the three and nine months ended September 30, 2019 were reclassified to conform to the current year presentation. |
Earnings Per Share | Earnings Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income (loss) available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of September 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,550,704 1,331,172 Total 7,437,521 7,634,815 The weighted average exercise price of the Company’s warrants and stock options outstanding at September 30, 2020 were |
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, accruals for clinical trials in process 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 and presentation. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of united Kingdom research and development incentives receivable | Long-term Current Balance at December 31, 2019 $ - $ 444,043 UK research and development incentives 125,303 - UK research and development incentives cash receipt - (120,136 ) Foreign currency translation - (11,529 ) Balance at September 30, 2020 $ 125,303 $ 312,378 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of September 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,550,704 1,331,172 Total 7,437,521 7,634,815 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | Cost Accumulated Amortization Net Book Value September 30, 2020 Licenses $ 462,234 $ 462,234 $ - Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,355,419 $ - December 31, 2019 Licenses $ 462,234 $ 442,535 $ 19,699 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,335,720 $ 19,699 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Text Block [Abstract] | |
Schedule of right-of-use lease | Operating Lease Financing Lease Right-of-use lease asset: Right-of-use lease asset, January 1, 2020 $ 112,387 $ 13,025 Extended lease terms 240,727 Reduction/amortization (100,720 ) (5,582 ) Right of use lease asset, September 30, 2020 $ 252,394 $ 7,443 Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Extended lease terms 240,727 Repayments (101,779 ) (5,566 ) Lease liability, September 30, 2020 $ 252,507 $ 8,099 Lease expense for the nine months ended September 30, 2020: Lease expense $ 105,893 $ - Amortization expense - 5,582 Interest expense - 842 Total $ 105,893 $ 6,424 Contractual cash payments for the remaining lease term as of September 30, 2020: 2020 $ 34,100 $ 2,136 2021 133,300 6,408 2022 111,083 - Total $ 278,483 $ 8,544 Remaining lease term (months) as of September 30, 2020 25 12 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | September 30, December 31, 2020 2019 Clinical trial expenses $ 2,538,702 $ 3,020,030 Other 108,522 137,356 Total $ 2,647,224 $ 3,157,386 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of contractual obligation | Year Research and Development Property and Other Leases Total October 1 through December 31, 2020 $ 50,000 36,236 $ 86,236 2021 100,000 139,708 239,708 2022 100,000 111,083 211,083 2023 100,000 - 100,000 2024 100,000 - 100,000 Total $ 450,000 $ 287,027 $ 737,027 |
Operating Segments (Tables)
Operating Segments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of operating segments | Three Months Ended September 30, 2020 2019 Revenues Public Health Solutions $ 544,466 $ 991,087 Specialized BioTherapeutics 64,345 263,817 Total $ 608,811 $ 1,254,904 (Loss) Income from Operations Public Health Solutions $ (6,369 ) $ 72,491 Specialized BioTherapeutics (643,793 ) (1,926,883 ) Corporate (1,162,615 ) (912,207 ) Total $ (1,812,777 ) $ (2,766,599 ) Amortization and Depreciation Expense Public Health Solutions $ 6,651 $ 4,312 Specialized BioTherapeutics 3,201 4,141 Corporate 7,335 6,448 Total $ 17,187 $ 14,901 Other Income, Net Specialized BioTherapeutics $ 22,131 $ 8,809 Corporate 486 37,007 Total $ 22,617 $ 45,816 Share-Based Compensation Public Health Solutions $ 8,377 $ 8,072 Specialized BioTherapeutics 18,962 18,609 Corporate 39,233 54,846 Total $ 66,572 $ 81,527 Nine Months Ended September 30, 2020 2019 Revenues Public Health Solutions $ 1,921,284 $ 2,767,304 Specialized BioTherapeutics 117,369 1,177,351 Total $ 2,038,653 $ 3,944,655 (Loss) Income from Operations Public Health Solutions $ (215,608 ) $ 267,601 Specialized BioTherapeutics (9,810,296 ) (4,725,774 ) Corporate (3,074,534 ) (2,773,380 ) Total $ (13,100,438 ) $ (7,231,553 ) Amortization and Depreciation Expense Public Health Solutions $ 21,272 $ 13,030 Specialized BioTherapeutics 9,438 12,986 Corporate 21,925 11,876 Total $ 52,635 $ 37,892 Other Income, Net Specialized BioTherapeutics $ 90,838 $ 11,479 Corporate 24,450 125,467 Total $ 115,288 $ 136,946 Share-Based Compensation Public Health Solutions $ 26,219 $ 21,340 Specialized BioTherapeutics 63,213 58,611 Corporate 121,834 154,041 Total $ 211,266 $ 233,992 As of As of September 30, December 31, 2020 2019 Identifiable Assets Public Health Solutions $ 357,798 $ 1,018,673 Specialized BioTherapeutics 54,944 41,705 Corporate 12,837,336 6,714,982 Total $ 13,250,078 $ 7,775,360 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||||||
Contracts from NIH and NIAID, description | The Company is currently developing RiVax® under a NIAID contract of up to $21.2 million over six years, and a one-year NIH grant of $150,000 in support of its SGX942 pediatric program. In addition, the Company has a subcontract of approximately $700,000 from a NIAID grant over five years for its thermostabilization technology, and a DTRA subcontract of approximately $600,000 over three years for SGX943. | |||||
Accumulated deficit | $ (187,673,869) | $ (187,673,869) | $ (175,525,612) | |||
Net loss | (1,790,160) | $ (2,720,783) | (12,148,257) | $ (6,483,931) | ||
Cash in operating activities | (7,329,471) | (4,866,288) | ||||
Cash and cash equivalents | 11,342,794 | $ 6,551,793 | 11,342,794 | 6,551,793 | 5,420,708 | $ 8,983,717 |
Net change in cash and cash equivalent | $ 5,922,086 | |||||
Percentage change in cash and cash equivalent | 109.00% | |||||
Working capital | 7,193,758 | $ 7,193,758 | $ 1,181,249 | |||
Increase in cash and cash equivalents | $ 6,012,509 | |||||
Increase in working capital, percentage | 508.00% | |||||
Government contract and grant funding amount | $ 900,000 | $ 900,000 | ||||
Remaining from FBR sales agreement, description | The Company has $20.0 million remaining from the FBR Sales Agreement as of November 09, 2020 under the prospectus supplement filed August 28, 2020, as no sales have been made under the FBR Sales Agreement since July 28, 2020. | |||||
Paycheck protection program loan amount | $ 417,830 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020USD ($)$ / shares | Sep. 30, 2019USD ($)$ / shares | Sep. 30, 2020USD ($)$ / shares | Sep. 30, 2019USD ($)$ / shares | |
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Number of operating segments | 2 | |||
Amortization expense | $ 3,875 | $ 11,627 | ||
Accumulated amortization expenses | 19,376 | |||
Foreign currency transaction gain (loss) | $ (7,647) | $ 8,809 | (34,465) | $ 11,479 |
Income tax benefit | $ 836,893 | 610,676 | ||
Minimum [Member] | ||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Intangible assets, estimated useful life | 11 years | |||
Maximum [Member] | ||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Intangible assets, estimated useful life | 16 years | |||
Stock Options [Member] | ||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Website development cost | $ 46,500 | |||
Stock option vesting, description | Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. | |||
Dividend yield | 0.00% | |||
Expected term | 4 years | |||
Volatility rate, minimum | 77.08% | 90.87% | ||
Volatility rate, maximum | 84.57% | 92.93% | ||
Risk-free interest rate, minimum | 0.215% | 1.835% | ||
Risk-free interest rate, maximum | 1.66% | 2.50% | ||
Weighted average exercise price | $ / shares | $ 3.11 | $ 3.09 | $ 3.11 | $ 3.09 |
Warrant [Member] | ||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Weighted average exercise price | $ / shares | $ 2.92 | $ 4.25 | $ 2.92 | $ 4.25 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of united Kingdom research and development incentives receivable | 9 Months Ended |
Dec. 31, 2020USD ($) | |
Long-term Debt [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance | |
UK research and development incentives | 125,303 |
UK research and development incentives cash receipt | |
Foreign currency translation | |
Balance | 125,303 |
Current [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance | 444,043 |
UK research and development incentives | |
UK research and development incentives cash receipt | (120,136) |
Foreign currency translation | (11,529) |
Balance | $ 312,378 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of weighted average number of common shares potentially dilutive adjustments - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 7,437,521 | 7,634,815 |
Common stock purchase warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 5,886,817 | 6,303,643 |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,550,704 | 1,331,172 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization expense | $ 6,117 | $ 6,791 | $ 19,699 | $ 20,373 |
Intangible Assets (Details) - S
Intangible Assets (Details) - Schedule of intangible assets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,355,419 | $ 2,355,419 |
Accumulated Amortization | 2,355,419 | 2,335,720 |
Net Book Value | 19,699 | |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 462,234 | 462,234 |
Accumulated Amortization | 462,234 | 442,535 |
Net Book Value | 19,699 | |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,893,185 | 1,893,185 |
Accumulated Amortization | 1,893,185 | 1,893,185 |
Net Book Value |
Leases (Details)
Leases (Details) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Text Block [Abstract] | |
Leases, description | Pursuant to an amendment executed on July 7, 2020, the lease has been extended to October 2022. The current rent of $11,883 per month, or approximately $23.00 per square foot will be reduced to $21.50 per square foot, making the monthly payment $11,108 starting in November 2020 for the remainder of the two year lease extension. Our office space is sufficient to satisfy our current needs. As of September 30, 2020, the Company’s consolidated balance sheet included a right-of-use lease asset of $252,394 for the office space and $7,443 for the copier machine. Lease liabilities in the Company’s consolidated balance sheet included corresponding lease liabilities of $252,507 and $8,099 respectively. During the nine months ended September 30, 2020, the Company recognized lease expense of $105,893 for the operating lease, in addition to amortization expense of $5,582 and interest expense of $842 for the financing lease in the Company’s consolidated statement of operations. |
Leases (Details) - Schedule of
Leases (Details) - Schedule of right-of-use lease | 3 Months Ended |
Dec. 31, 2020USD ($) | |
Operating Lease [Member] | |
Right-of-use lease asset: | |
Right-of-use lease asset, beginning balance | $ 112,387 |
Extended lease terms | 240,727 |
Reduction/amortization | (100,720) |
Right-of-use lease asset, ending balance | 252,394 |
Lease liability: | |
Lease liability, beginning balance | 113,559 |
Extended lease terms | 240,727 |
Repayments | (101,779) |
Lease liability, ending balance | 252,507 |
Lease expense for the nine months ended September 30, 2020: | |
Lease expense | 105,893 |
Amortization expense | |
Interest expense | |
Total | 105,893 |
2020 | 34,100 |
2021 | 133,300 |
2022 | 111,083 |
Total | $ 278,483 |
Remaining lease term | 25 months |
Financing Lease [Member] | |
Right-of-use lease asset: | |
Right-of-use lease asset, beginning balance | $ 13,025 |
Reduction/amortization | (5,582) |
Right-of-use lease asset, ending balance | 7,443 |
Lease liability: | |
Lease liability, beginning balance | 13,665 |
Repayments | (5,566) |
Lease liability, ending balance | 8,099 |
Lease expense for the nine months ended September 30, 2020: | |
Lease expense | |
Amortization expense | 5,582 |
Interest expense | 842 |
Total | 6,424 |
2020 | 2,136 |
2021 | 6,408 |
Total | $ 8,544 |
Remaining lease term | 12 months |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of accrued expenses - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Schedule of accrued expenses [Abstract] | ||
Clinical trial expenses | $ 2,538,702 | $ 3,020,030 |
Other | 108,522 | 137,356 |
Total | $ 2,647,224 | $ 3,157,386 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |||
NOL for federal tax | $ 107,767,000 | ||
NOL for state tax | 16,180,000 | ||
NOL for foreign tax | 815,000 | ||
Period of expiration of various tax credits | In addition, the Company has $8,315,000 of various tax credits which expire from 2020 to 2037. | ||
Various tax credits, amount | $ 8,315,000 | ||
NOL carryforwards | $ 836,893 | $ 610,676 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) | Mar. 23, 2020 | Feb. 10, 2020 | Aug. 11, 2017 | Jul. 28, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Nov. 10, 2020 | Mar. 12, 2020 | Jan. 08, 2020 |
Shareholders' Equity (Details) [Line Items] | ||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | ||||||||
Common stock, shares issued option exercised | 2,189 | |||||||||
Weighted average cash exercise shares received (in Dollars) | $ 4,987 | $ 1,882 | ||||||||
Grant value (in Dollars) | $ 59,000 | |||||||||
Fbr Capital Markets & Co [Member] | ||||||||||
Shareholders' Equity (Details) [Line Items] | ||||||||||
Common stock shares sold | 5,797,403 | |||||||||
Weighted average price per share (in Dollars per share) | $ 2.19 | |||||||||
Common stock purchase agreement with FBR, description | The FBR Sales Agreement provides that FBR is entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the FBR Sale Agreement. | Through July 28, 2020, the shares sold pursuant to the FBR Sales Agreement were issued pursuant to General Instruction I.B.6 of Form S-3, which permits the Company to sell shelf securities in a public primary offering with a value not exceeding one-third of the average market value of the Company’s voting and non-voting common equity held by non-affiliates in any 12-month period as long as the aggregate market value of the Company’s outstanding voting and non-voting common equity held by non-affiliates is less than $75 million. As of July 28, 2020, the Company’s outstanding voting and non-voting common equity held by non-affiliates exceeded $75 million. | ||||||||
Fbr Capital Markets & Co [Member] | Subsequent Event [Member] | ||||||||||
Shareholders' Equity (Details) [Line Items] | ||||||||||
Common stock value under sale agreement (in Dollars) | $ 20,000,000 | |||||||||
Common Stock [Member] | ||||||||||
Shareholders' Equity (Details) [Line Items] | ||||||||||
Common stock, shares issued option exercised | 5,758 | |||||||||
Common stock exercise price (in Dollars per share) | $ 1.19 | |||||||||
Common stock shares issued to vendors | 10,000 | 10,000 | 10,000 | |||||||
Fair value of share (in Dollars per share) | $ 2.56 | $ 2.25 | $ 1.97 | $ 1.68 | ||||||
Common stock issued as a result of warrant exercises | 206 | |||||||||
Warrants exercise price (in Dollars per share) | $ 2.50 | $ 2.25 | ||||||||
Common stock for payment on achieved milestone | 1,956,182 | |||||||||
Warrants issued to purchase shares | 304,615 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Apr. 13, 2020USD ($) | Sep. 03, 2014USD ($)shares | Nov. 30, 2020USD ($) | Mar. 31, 2020USD ($)$ / shares | Jan. 31, 2020USD ($) | Sep. 30, 2020USD ($)m² |
Commitments and Contingencies (Details) [Line Items] | ||||||
Commitments related to agreements | $ 450,000 | |||||
Maximum payment for commitment milestones | $ 7,900,000 | |||||
Percentage for royalties | 6.00% | |||||
Office space (in Square Meters) | m² | 6,200 | |||||
Office rent amount | $ 11,883 | |||||
Office rent amount, per square foot | 23 | |||||
Cash paid to acquire Hy Biopharma intangible asset | $ 275,000 | |||||
Shares issued in connection with Hy BioPharma asset purchase agreement (in Shares) | shares | 184,912 | |||||
Fair value of shares issued in connection with Hy BioPharma asset purchase | $ 3,750,000 | $ 1,956,182 | ||||
Effective price per share (in Dollars per share) | $ / shares | $ 2.56 | |||||
Asset purchase agreement total expense | $ 5,000,000 | |||||
Additional Payments | $ 5,000,000 | |||||
ownership of the Company outstanding | 19.90% | |||||
CARES Act loan, description | the Company was advised that one of its principal banks, JPMorgan Chase Bank, N.A., had approved a $417,830 loan (the “Loan”) under the Paycheck Protection Program (“PPP”) pursuant to the Coronavirus Aid, Relief and Economic Security Act that was signed into law on March 27, 2020. As a U.S. small business, the Company qualified for the PPP, which allows businesses and nonprofits with fewer than 500 employees to obtain loans of up to $10 million to incentivize companies to maintain their workers as they manage the business disruptions caused by the COVID-19 pandemic. The PPP provides for loans for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The PPP loan proceeds may be used for eligible purposes, including payroll, benefits, rent and utilities. | |||||
Loan amount | $ 417,830 | |||||
Short term portion loan amount | $ 255,341 | |||||
Long term portion loan amount | 162,489 | |||||
Accrued interest expense | $ 1,706 | |||||
Loan description | The Loan bears interest at a fixed rate of 0.98% per annum, with the first six months of interest and principal deferred. Some or all of the Loan may be forgiven if at least 75% of the Loan proceeds are used by the Company to cover payroll costs, including benefits and if the Company maintains its employment and compensation within certain parameters during the eight-week or twenty-four-week period following the Loan origination date and complies with other relevant conditions. | |||||
Legal proceedings description | the Company filed a demand for arbitration against Emergent BioSolutions, Inc. ("Emergent") and certain of its subsidiaries with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. (see Part II, Item 1 – Legal Proceeding) The Company is seeking to recover damages in excess of $19 million from Emergent. While the Company intends to vigorously pursue this arbitration, the Company cannot offer any assurances that it will recover any damages from Emergent. The Company has received invoices from Emergent related to the above matter. No accrual has been made for these invoices as management deems them invalid because Emergent failed to perform under the applicable contracts, and not probable of being required to pay them based on the numerous breaches sited in the pending arbitration. These invoices total approximately $331,000. | |||||
Subsequent Event [Member] | ||||||
Commitments and Contingencies (Details) [Line Items] | ||||||
Office rent amount | $ 11,108 | |||||
Office rent amount, per square foot | 21.50 | |||||
Minimum [Member] | ||||||
Commitments and Contingencies (Details) [Line Items] | ||||||
Authorized shares to be issued | $ 5,000 | |||||
Maximum [Member] | ||||||
Commitments and Contingencies (Details) [Line Items] | ||||||
Authorized shares to be issued | $ 500,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of contractual obligation | Sep. 30, 2020USD ($) |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
October 1 through December 31, 2020 | $ 86,236 |
2021 | 239,708 |
2022 | 211,083 |
2023 | 100,000 |
2024 | 100,000 |
Total | 737,027 |
Research and Development [Member] | |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
October 1 through December 31, 2020 | 50,000 |
2021 | 100,000 |
2022 | 100,000 |
2023 | 100,000 |
2024 | 100,000 |
Total | 450,000 |
Property and Other Leases [Member] | |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
October 1 through December 31, 2020 | 36,236 |
2021 | 139,708 |
2022 | 111,083 |
2023 | |
2024 | |
Total | $ 287,027 |
Operating Segments (Details)
Operating Segments (Details) | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Number of operating segments | 2 |
Operating Segments (Details) -
Operating Segments (Details) - Schedule of operating segments - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Revenues | |||||
Revenues | $ 608,811 | $ 1,254,904 | $ 2,038,653 | $ 3,944,655 | |
(Loss) Income from Operations | |||||
(Loss) Income from Operations | (1,812,777) | (2,766,599) | (13,100,438) | (7,231,553) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 17,187 | 14,901 | 52,635 | 37,892 | |
Other Income, Net | |||||
Other Income, Net | 22,617 | 45,816 | 115,288 | 136,946 | |
Share-Based Compensation | |||||
Share-Based Compensation | 66,572 | 81,527 | 211,266 | 233,992 | |
Identifiable Assets | |||||
Identifiable Assets | 13,250,078 | 13,250,078 | $ 7,775,360 | ||
Public Health Solutions [Member] | |||||
Revenues | |||||
Revenues | 544,466 | 991,087 | 1,921,284 | 2,767,304 | |
(Loss) Income from Operations | |||||
(Loss) Income from Operations | (6,369) | 72,491 | (215,608) | 267,601 | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 6,651 | 4,312 | 21,272 | 13,030 | |
Share-Based Compensation | |||||
Share-Based Compensation | 8,377 | 8,072 | 26,219 | 21,340 | |
Identifiable Assets | |||||
Identifiable Assets | 357,798 | 357,798 | 1,018,673 | ||
Specialized BioTherapeutics [Member] | |||||
Revenues | |||||
Revenues | 64,345 | 263,817 | 117,369 | 1,177,351 | |
(Loss) Income from Operations | |||||
(Loss) Income from Operations | (643,793) | (1,926,883) | (9,810,296) | (4,725,774) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 3,201 | 4,141 | 9,438 | 12,986 | |
Other Income, Net | |||||
Other Income, Net | 22,131 | 8,809 | 90,838 | 11,479 | |
Share-Based Compensation | |||||
Share-Based Compensation | 18,962 | 18,609 | 63,213 | 58,611 | |
Identifiable Assets | |||||
Identifiable Assets | 54,944 | 54,944 | 41,705 | ||
Corporate [Member] | |||||
(Loss) Income from Operations | |||||
(Loss) Income from Operations | (1,162,615) | (912,207) | (3,074,534) | (2,773,380) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 7,335 | 6,448 | 21,925 | 11,876 | |
Other Income, Net | |||||
Other Income, Net | 486 | 37,007 | 24,450 | 125,467 | |
Share-Based Compensation | |||||
Share-Based Compensation | 39,233 | $ 54,846 | 121,834 | $ 154,041 | |
Identifiable Assets | |||||
Identifiable Assets | $ 12,837,336 | $ 12,837,336 | $ 6,714,982 |