Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 10, 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 | Jun. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
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 ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 11,168,305 | $ 5,420,708 |
Contracts and grants receivable | 334,787 | 1,018,835 |
Research and development incentives receivable | 299,749 | 444,043 |
Prepaid expenses and other current assets | 174,482 | 609,739 |
Total current assets | 11,977,323 | 7,493,325 |
Security deposit | 22,757 | 22,757 |
Office furniture and equipment, net | 32,846 | 36,093 |
Deferred issuance costs | 39,715 | 39,324 |
Intangible assets, net | 6,117 | 19,699 |
Right-of-use lease assets | 55,393 | 125,412 |
Research and development incentives receivable | 95,525 | |
Other assets | 30,998 | 38,750 |
Total assets | 12,260,674 | 7,775,360 |
Current liabilities: | ||
Accounts payable | 2,521,494 | 2,735,442 |
Accrued expenses | 3,157,532 | 3,157,386 |
Accrued compensation | 76,660 | 298,173 |
Paycheck Protection Program loan | 185,702 | |
Lease liabilities - current | 54,455 | 121,075 |
Total current liabilities | 5,995,843 | 6,312,076 |
Non-current liabilities: | ||
Paycheck Protection Program loan, net of current | 232,128 | |
Lease liabilities, net of current | 2,101 | 6,149 |
Total liabilities | 6,230,072 | 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; 28,591,432 shares and 21,753,124 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 28,591 | 21,753 |
Additional paid-in capital | 191,922,671 | 177,006,004 |
Accumulated other comprehensive loss | (36,951) | (45,010) |
Accumulated deficit | (185,883,709) | (175,525,612) |
Total shareholders’ equity | 6,030,602 | 1,457,135 |
Total liabilities and shareholders’ equity | $ 12,260,674 | $ 7,775,360 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 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, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 28,591,432 | 21,753,124 |
Common stock, shares outstanding | 28,591,432 | 21,753,124 |
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Contract revenue | $ 292,461 | $ 1,060,877 | $ 1,137,647 | $ 1,700,435 |
Grant revenue | 212,827 | 484,087 | 292,195 | 989,317 |
Total revenues | 505,288 | 1,544,964 | 1,429,842 | 2,689,752 |
Cost of revenues | (363,339) | (1,086,814) | (1,192,844) | (2,014,738) |
Gross profit | 141,949 | 458,150 | 236,998 | 675,014 |
Operating expenses: | ||||
Research and development | 2,170,045 | 1,853,950 | 4,870,216 | 3,496,668 |
General and administrative | 785,776 | 769,091 | 1,654,443 | 1,643,300 |
Research and development expense - milestone | 5,000,000 | |||
Total operating expenses | 2,955,821 | 2,623,041 | 11,524,659 | 5,139,968 |
Loss from operations | (2,813,872) | (2,164,891) | (11,287,661) | (4,464,954) |
Foreign currency transaction gain/(loss) | (3,583) | 1,519 | (26,818) | 6,526 |
Interest income, net | 2,017 | 39,851 | 23,964 | 84,604 |
Research and development incentives | 38,675 | 95,525 | ||
Net loss before income taxes | (2,776,763) | (2,123,521) | (11,194,990) | (4,373,824) |
Income tax benefit | 836,893 | 610,676 | ||
Net loss applicable to common stockholders | $ (2,776,763) | $ (2,123,521) | $ (10,358,097) | $ (3,763,148) |
Basic & diluted net loss per share (in Dollars per share) | $ (0.10) | $ (0.12) | $ (0.41) | $ (0.21) |
Basic & diluted weighted average common shares outstanding (in Shares) | 26,901,781 | 18,436,894 | 25,153,350 | 18,258,932 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (2,776,763) | $ (2,123,521) | $ (10,358,097) | $ (3,763,148) |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | (8,184) | (3,988) | 8,059 | (3,339) |
Comprehensive loss | $ (2,784,947) | $ (2,127,509) | $ (10,350,038) | $ (3,766,487) |
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 Sales Issuance Agreement | $ 861 | 841,383 | 842,244 | ||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement (in Shares) | 861,352 | ||||
Issuance costs associated with FBR At Market Sales Issuance Agreement | (33,215) | (33,215) | |||
Issuance of common stock to vendors | $ 197 | 160,860 | 161,057 | ||
Issuance of common stock to vendors (in Shares) | 197,019 | ||||
Share-based compensation expense | 152,465 | 152,465 | |||
Foreign currency translation adjustment | (3,339) | (3,339) | |||
Net loss | (3,763,148) | (3,763,148) | |||
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 | ||||
Balance at Mar. 31, 2019 | $ 18,189 | 173,076,044 | (3,020) | (167,809,647) | 5,281,566 |
Balance (in Shares) at Mar. 31, 2019 | 18,189,208 | ||||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement | $ 415 | 319,245 | 319,660 | ||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement (in Shares) | 414,983 | ||||
Issuance costs associated with FBR At Market Sales Issuance Agreement | (13,832) | (13,832) | |||
Issuance of common stock to vendors | $ 137 | 103,320 | 103,457 | ||
Issuance of common stock to vendors (in Shares) | 137,019 | ||||
Share-based compensation expense | 72,892 | 72,892 | |||
Foreign currency translation adjustment | (3,988) | (3,988) | |||
Net loss | (2,123,521) | (2,123,521) | |||
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 | ||||
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 Sales Issuance Agreement | $ 4,545 | 9,455,404 | 9,459,949 | ||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement (in Shares) | 4,545,116 | ||||
Issuance costs associated with FBR At Market Sales Issuance Agreement | (425,524) | (425,524) | |||
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 | $ 2 | 2 | |||
Exercise of common stock options (in Shares) | 2,189 | ||||
Exercise of warrants | $ 305 | 685,079 | 685,384 | ||
Exercise of warrants (in Shares) | 304,821 | ||||
Share-based compensation expense | 144,694 | 144,694 | |||
Foreign currency translation adjustment | 8,059 | 8,059 | |||
Net loss | (10,358,097) | (10,358,097) | |||
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 | ||||
Balance at Mar. 31, 2020 | $ 25,778 | 186,624,561 | (28,767) | (183,106,946) | 3,514,626 |
Balance (in Shares) at Mar. 31, 2020 | 25,778,431 | ||||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement | $ 2,813 | 5,467,910 | 5,470,723 | ||
Issuance of common stock pursuant to FBR At Market Sales Issuance Agreement (in Shares) | 2,813,001 | ||||
Issuance costs associated with FBR At Market Sales Issuance Agreement | (250,803) | (250,803) | |||
Share-based compensation expense | 81,003 | 81,003 | |||
Foreign currency translation adjustment | (8,184) | (8,184) | |||
Net loss | (2,776,763) | (2,776,763) | |||
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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities: | ||
Net loss | $ (10,358,097) | $ (3,763,148) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 35,448 | 22,992 |
Non-cash lease expenses | 66,298 | 60,041 |
Share-based compensation | 144,694 | 152,465 |
Issuance of common stock for milestone | 5,000,000 | |
Issuance of common stock for services | 59,000 | 114,557 |
Realized gain on sale of office furniture | (3,843) | |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | 684,048 | (473,830) |
Prepaid expenses and other current assets | 434,877 | 7,504 |
Research and development incentives receivable | 19,754 | |
Operating lease liability | (67,004) | (59,197) |
Deferred revenue | 69,976 | |
Accounts payable and accrued expenses | (136,035) | 1,308,577 |
Accrued compensation | (221,513) | (244,466) |
Total adjustments | 6,019,567 | 954,776 |
Net cash used in operating activities | (4,338,530) | (2,808,372) |
Investing activities: | ||
Purchases of office furniture and equipment | (7,147) | |
Proceeds from the 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 Sales Issuance Agreement | 9,459,949 | 842,244 |
Costs associated with FBR At Market Sales Issuance Agreement | (425,915) | (29,291) |
Proceeds from the exercise of warrants | 685,384 | |
Financing lease principal repayments | (3,664) | (3,317) |
Paycheck Protection Program loan | 417,830 | |
Net cash provided by financing activities | 10,133,584 | 809,636 |
Effect of foreign exchange rate on cash and cash equivalents | (40,310) | (4,192) |
Net increase/(decrease) in cash and cash equivalents | 5,747,597 | (1,997,428) |
Cash and cash equivalents at beginning of period | 5,420,708 | 8,983,717 |
Cash and cash equivalents at end of period | 11,168,305 | 6,986,289 |
Supplemental information: | ||
Cash paid for state income tax | 5,000 | |
Cash paid for lease liabilities: | ||
Operating lease | 71,298 | 69,750 |
Financing lease | 4,272 | 4,272 |
Non-cash investing and financing activities: | ||
Right-of-use assets and lease liabilities recognized on January 1, 2019 | 255,962 | |
Deferred issuance cost included in accounts payable | 85,657 | 18,537 |
Deferred issuance cost reclassified to additional-paid-in capital | 85,266 | 7,679 |
Issuance of restricted common stock to vendor for website re-development | $ 46,500 | |
Issuance of stock options, cash exercise price received December 2019 | $ 1,882 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 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 (formerly “BioTherapeutics”) and Public Health Solutions (formerly “Vaccines/BioDefense”). The Company’s Specialized BioTherapeutics business segment is developing a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (“CTCL”), its first-in-class innate defense regulator 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 ® ® 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 (the “FDA”) regulations, and other regulatory authorities, litigation, and product liability. Results for the three and six months ended June 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 June 30, 2020, the Company had an accumulated deficit of $185,883,709. During the six months ended June 30, 2020, the Company incurred a net loss of $10,358,097 and used $4,338,530 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 June 30, 2020, the Company had cash and cash equivalents of $11,168,305 as compared to $5,420,708 as of December 31, 2019, representing an increase of $5,747,597 or 106%. As of June 30, 2020, the Company had working capital of $5,992,411 as compared to working capital of $1,181,249 as of December 31, 2019, representing an increase of $4,811,162 or 407%. The increase in cash and working capital was primarily related to the management of the Company’s expenses, and proceeds received from the utilization of the FBR Sales Agreement and warrant exercises during the six months ended June 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 (12 weeks compared to 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 ® ® ● Continue development of our therapeutic SGX943 and our vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses with DTRA and NIAID funding support; ● Continue to apply for and secure additional government funding for each of the Company’s Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements; ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore merger/acquisition strategies; and ● Acquire or in-license new clinical-stage compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to $1.54 million in active government contract and grant funding still available as of June 30, 2020, to support its associated research programs through 2020 and beyond, provided the federal agencies exercise all options and do not elect to terminate the contracts or grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if available. ● The Company plans to pursue potential partnerships for pipeline programs; however, there can be no assurances that it can consummate such transactions. ● The Company has up to $1.5 million remaining from the FBR Sales Agreement as of August 10, 2020 under the prospectus supplement filed April 10, 2020. ● The Company has been granted a Paycheck Protection Program Loan through the financial stimulus packages afforded by both the federal and state governments based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19. The Company was granted a total of $417,830 from JPMorgan Chase Bank, N.A. to fund the Company’s payroll costs and other expenses allowed by the program. The Company will continue to explore and evaluate additional funding options through financial stimulus packages afforded by both the federal and state governments based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19 as they become available. ● 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 | 6 Months Ended |
Jun. 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 One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730, Research and Development The Company did not capitalize any patent related costs during the three or six months ended June 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 beneficially owned less than 5% of the Company’s outstanding common stock as of June 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 June 30, 2020 was $3,875 and for the six months ended June 30, 2020 was $7,752 and accumulated amortization was $15,502 as of June 30, 2020. 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 six months ended June 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 six months ended June 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% - 78.96% for 2020 and 90.87% - 92.93% for 2019 ● risk free interest rates ranging from 1.38% - 1.66% for 2020 and 1.835% - 2.50% for 2019 The fair value of each option grant made during the six months ended June 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 six months ended June 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 six months ended June 30, 2020 or 2019. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at June 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 June 30, 2020: Long-term Current Balance at December 31, 2019 $ - $ 444,043 UK research and development incentives 95,525 (115,278 ) Foreign currency translation - (29,016 ) Balance at June 30, 2020 $ 95,525 $ 299,749 Reclassifications Certain amounts in the statement of operations for the three and six months ended June 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 June 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,499,580 1,093,032 Total 7,386,397 7,396,675 The weighted average exercise price of the Company’s warrants and stock options outstanding at June 30, 2020 were $2.92 and $3.20 per share, respectively, and at June 30, 2019 were $4.97 and $3.09 per share, respectively. Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and, stock options and the useful life of intangibles that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates and presentation. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 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 June 30, 2020 Licenses $ 462,234 $ 456,117 $ 6,117 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,349,302 $ 6,117 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 $6,791 for each of the three months ended June 30, 2020 and 2019. Amortization expense was $13,582 for each of the six months ended June 30, 2020 and 2019. Based on the balance of licenses and patents at June 30, 2020, future amortization expense through December 31, 2020 is expected to be $6,117. License fees and royalty payments are expensed as incurred, as the Company does not attribute any future benefits of such payments. |
Leases
Leases | 6 Months Ended |
Jun. 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. As of June 30, 2020, the Company’s consolidated balance sheet included a right-of-use lease asset of $46,089 for the office space and $9,304 for the copier machine. Lease liabilities in the Company’s consolidated balance sheet included corresponding lease liabilities of $46,555 and $10,001 respectively. During the six months ended June 30, 2020, the Company recognized lease expense of $70,595 for the operating lease, in addition to amortization expense of $3,721 and interest expense of $608 for the financing lease in the Company’s consolidated statement of operations. 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 Less: reduction/amortization 66,298 3,721 Right-of-use lease asset, June 30, 2020 $ 46,089 $ 9,304 Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Less: repayments 67,004 3,664 Lease liability, June 30, 2020 $ 46,555 $ 10,001 Lease expenses for the six months ended June 30, 2020: Lease expense $ 70,595 $ - Amortization expense - 3,721 Interest expense - 608 Total $ 70,595 $ 4,329 Contractual cash payments for the remaining lease term as of June 30, 2020: 2020 $ 47,533 $ 4,272 2021 - 6,408 Total $ 47,533 $ 10,680 Remaining lease term (months) as of June 30, 2020 4 15 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Note 5. Accrued Expenses The following is a summary of the Company’s accrued expenses: June 30, December 31, Clinical trial expenses $ 3,047,866 $ 3,020,030 Other 109,666 137,356 Total $ 3,157,532 $ 3,157,386 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 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 | 6 Months Ended |
Jun. 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 six months ended June 30, 2020: ● On January 8, 2020, the Company issued 2,189 shares of common stock as a result of an option exercise. The exercise price of the option was $0.86 per share. The cash exercise price for 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 six months ended June 30, 2020. ● On February 20, 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 six months ended June 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 six months ended June 30, 2020, the Company sold 4,545,116 shares of common stock pursuant to the FBR Sales Agreement at a weighted average price of $2.08 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 may be utilized for a period up to six months or until a new shelf registration statement is declared effective, whichever occurs 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. Future sales of common stock made pursuant to the FBR Sales Agreement, if any, will be made pursuant to the May 2017 Registration Statement or, once declared effective, the Company’s shelf registration statement on Form S-3 (File No. 333- 239928) filed on July 17, 2020 with the SEC, and any amendments thereto, the base prospectus filed as part of such registration statement, and any prospectus supplements. 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. As of August 10, 2020, there was $1.5 million available for the sale of common stock under the FBR Sales Agreement. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 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 as of June 30, 2020 for several licensing agreements with consultants and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to $7.9 million and/or royalties up to 6% of net sales of covered products, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that was amended in October 2017 and expires in October 2020. This office space currently serves as the Company’s corporate headquarters. The rent is currently $11,883 per month, or approximately $23.00 per square foot, which rate will continue for the remainder of the lease. On September 3, 2014, the Company entered into an asset purchase agreement with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 184,912 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3,750,000. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the 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, 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. As a result of the above agreements, the Company has the following contractual obligations: Year Research and Development Property and Other Leases Total July 1 through December 31, 2020 $ 50,000 $ 51,805 $ 101,805 2021 100,000 6,408 106,408 2022 100,000 - 100,000 2023 100,000 - 100,000 2024 100,000 - 100,000 Total $ 450,000 $ 58,213 $ 508,213 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 $185,702 and the long-term portion of the Loan is $232,128 with accrued interest expense of $682 as of June 30, 2020. 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. The Company intends to use the proceeds for purposes consistent with the PPP and expects to meet the conditions for forgiveness of the Loan. Contingencies 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. |
Operating Segments
Operating Segments | 6 Months Ended |
Jun. 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 2020 2019 Revenues Public Health Solutions $ 468,009 $ 1,095,865 Specialized BioTherapeutics 37,279 449,099 Total $ 505,288 $ 1,544,964 Income/(Loss) from Operations Public Health Solutions $ (50,737 ) $ 204,121 Specialized BioTherapeutics (1,808,652 ) (1,462,334 ) Corporate (954,483 ) (905,678 ) Total $ (2,813,872 ) $ (2,164,891 ) Amortization and Depreciation Expense Public Health Solutions $ 7,318 $ 4,316 Specialized BioTherapeutics 3,167 4,168 Corporate 7,317 4,448 Total $ 17,802 $ 12,932 Other Income, Net Specialized BioTherapeutics $ 35,091 $ (2,339 ) Corporate 2,018 43,709 Total $ 37,109 $ 41,370 Share-Based Compensation Public Health Solutions $ 8,377 $ 8,072 Specialized BioTherapeutics 18,962 19,094 Corporate 53,664 45,726 Total $ 81,003 $ 72,892 Six Months Ended 2020 2019 Revenues Public Health Solutions $ 1,376,818 $ 1,776,218 Specialized BioTherapeutics 53,024 913,534 Total $ 1,429,842 $ 2,689,752 Income/(Loss) from Operations Public Health Solutions $ (209,239 ) $ 195,110 Specialized BioTherapeutics (9,166,503 ) (2,798,891 ) Corporate (1,911,919 ) (1,861,173 ) Total $ (11,287,661 ) $ (4,464,954 ) Amortization and Depreciation Expense Public Health Solutions $ 14,621 $ 8,718 Specialized BioTherapeutics 6,237 8,845 Corporate 14,590 5,429 Total $ 35,448 $ 22,992 Other Income, Net Specialized BioTherapeutics $ 68,706 $ 2,670 Corporate 23,965 88,460 Total $ 92,671 $ 91,130 Share-Based Compensation Public Health Solutions $ 17,842 $ 13,268 Specialized BioTherapeutics 44,251 40,002 Corporate 82,601 99,195 Total $ 144,694 $ 152,465 As of As of June 30, December 31, 2020 2019 Identifiable Assets Public Health Solutions $ 273,943 $ 1,018,673 Specialized BioTherapeutics 86,639 41,705 Corporate 11,900,092 6,714,982 Total $ 12,260,674 $ 7,775,360 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 10. Subsequent Events Sales Pursuant to FBR At Market Issuance Sales Agreement From July 1, 2020 through August 10, 2020, the Company issued 1,252,287 shares of common stock pursuant to the FBR Sales Agreement at a weighted average price of $2.58 per share for total proceeds of $3,231,319. Office Lease Amendment The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as the Company’s corporate headquarters. Pursuant to an amendment on July 7, 2020, the lease has been extended from November 2020 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 $10,850 starting in November 2020. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 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 One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730, Research and Development The Company did not capitalize any patent related costs during the three or six months ended June 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 beneficially owned less than 5% of the Company’s outstanding common stock as of June 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 June 30, 2020 was $3,875 and for the six months ended June 30, 2020 was $7,752 and accumulated amortization was $15,502 as of June 30, 2020. |
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 six months ended June 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 six months ended June 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% - 78.96% for 2020 and 90.87% - 92.93% for 2019 ● risk free interest rates ranging from 1.38% - 1.66% for 2020 and 1.835% - 2.50% for 2019 The fair value of each option grant made during the six months ended June 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 six months ended June 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 six months ended June 30, 2020 or 2019. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at June 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 June 30, 2020: Long-term Current Balance at December 31, 2019 $ - $ 444,043 UK research and development incentives 95,525 (115,278 ) Foreign currency translation - (29,016 ) Balance at June 30, 2020 $ 95,525 $ 299,749 |
Reclassifications | Reclassifications Certain amounts in the statement of operations for the three and six months ended June 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 June 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,499,580 1,093,032 Total 7,386,397 7,396,675 The weighted average exercise price of the Company’s warrants and stock options outstanding at June 30, 2020 were $2.92 and $3.20 per share, respectively, and at June 30, 2019 were $4.97 and $3.09 per share, respectively. |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and, stock options and the useful life of intangibles that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates and presentation. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 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 95,525 (115,278 ) Foreign currency translation - (29,016 ) Balance at June 30, 2020 $ 95,525 $ 299,749 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of June 30, 2020 2019 Common stock purchase warrants 5,886,817 6,303,643 Stock options 1,499,580 1,093,032 Total 7,386,397 7,396,675 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | Cost Accumulated Amortization Net Book Value June 30, 2020 Licenses $ 462,234 $ 456,117 $ 6,117 Patents 1,893,185 1,893,185 - Total $ 2,355,419 $ 2,349,302 $ 6,117 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) | 6 Months Ended |
Jun. 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 Less: reduction/amortization 66,298 3,721 Right-of-use lease asset, June 30, 2020 $ 46,089 $ 9,304 Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Less: repayments 67,004 3,664 Lease liability, June 30, 2020 $ 46,555 $ 10,001 Lease expenses for the six months ended June 30, 2020: Lease expense $ 70,595 $ - Amortization expense - 3,721 Interest expense - 608 Total $ 70,595 $ 4,329 Contractual cash payments for the remaining lease term as of June 30, 2020: 2020 $ 47,533 $ 4,272 2021 - 6,408 Total $ 47,533 $ 10,680 Remaining lease term (months) as of June 30, 2020 4 15 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | June 30, December 31, Clinical trial expenses $ 3,047,866 $ 3,020,030 Other 109,666 137,356 Total $ 3,157,532 $ 3,157,386 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of contractual obligation | Year Research and Development Property and Other Leases Total July 1 through December 31, 2020 $ 50,000 $ 51,805 $ 101,805 2021 100,000 6,408 106,408 2022 100,000 - 100,000 2023 100,000 - 100,000 2024 100,000 - 100,000 Total $ 450,000 $ 58,213 $ 508,213 |
Operating Segments (Tables)
Operating Segments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of operating segments | Three Months Ended 2020 2019 Revenues Public Health Solutions $ 468,009 $ 1,095,865 Specialized BioTherapeutics 37,279 449,099 Total $ 505,288 $ 1,544,964 Income/(Loss) from Operations Public Health Solutions $ (50,737 ) $ 204,121 Specialized BioTherapeutics (1,808,652 ) (1,462,334 ) Corporate (954,483 ) (905,678 ) Total $ (2,813,872 ) $ (2,164,891 ) Amortization and Depreciation Expense Public Health Solutions $ 7,318 $ 4,316 Specialized BioTherapeutics 3,167 4,168 Corporate 7,317 4,448 Total $ 17,802 $ 12,932 Other Income, Net Specialized BioTherapeutics $ 35,091 $ (2,339 ) Corporate 2,018 43,709 Total $ 37,109 $ 41,370 Share-Based Compensation Public Health Solutions $ 8,377 $ 8,072 Specialized BioTherapeutics 18,962 19,094 Corporate 53,664 45,726 Total $ 81,003 $ 72,892 Six Months Ended 2020 2019 Revenues Public Health Solutions $ 1,376,818 $ 1,776,218 Specialized BioTherapeutics 53,024 913,534 Total $ 1,429,842 $ 2,689,752 Income/(Loss) from Operations Public Health Solutions $ (209,239 ) $ 195,110 Specialized BioTherapeutics (9,166,503 ) (2,798,891 ) Corporate (1,911,919 ) (1,861,173 ) Total $ (11,287,661 ) $ (4,464,954 ) Amortization and Depreciation Expense Public Health Solutions $ 14,621 $ 8,718 Specialized BioTherapeutics 6,237 8,845 Corporate 14,590 5,429 Total $ 35,448 $ 22,992 Other Income, Net Specialized BioTherapeutics $ 68,706 $ 2,670 Corporate 23,965 88,460 Total $ 92,671 $ 91,130 Share-Based Compensation Public Health Solutions $ 17,842 $ 13,268 Specialized BioTherapeutics 44,251 40,002 Corporate 82,601 99,195 Total $ 144,694 $ 152,465 As of As of June 30, December 31, 2020 2019 Identifiable Assets Public Health Solutions $ 273,943 $ 1,018,673 Specialized BioTherapeutics 86,639 41,705 Corporate 11,900,092 6,714,982 Total $ 12,260,674 $ 7,775,360 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 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 | $ (185,883,709) | $ (185,883,709) | $ (175,525,612) | |||
Net loss | (2,776,763) | $ (2,123,521) | (10,358,097) | $ (3,763,148) | ||
Cash in operations | (4,338,530) | (2,808,372) | ||||
Cash and cash equivalents | 11,168,305 | $ 6,986,289 | 11,168,305 | $ 6,986,289 | 5,420,708 | $ 8,983,717 |
Net change in cash and cash equivalent | $ 5,747,597 | |||||
Percentage change in cash and cash equivalent | 106.00% | |||||
Working capital | $ 5,992,411 | $ 5,992,411 | $ 1,181,249 | |||
Increase in cash and cash equivalents | $ 4,811,162 | |||||
Increase in working capital, percentage | 407.00% | |||||
Government contract and grant funding available | $ 1,540,000 | |||||
Remaining from FBR sales agreement, description | ● The Company has up to $1.5 million remaining from the FBR Sales Agreement as of August 10, 2020 under the prospectus supplement filed April 10, 2020. | |||||
Increase (Decrease) in Notes Payable, Related Parties, Current | $ 417,830 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020USD ($)$ / shares | Jun. 30, 2019USD ($)$ / shares | Jun. 30, 2020USD ($)$ / shares | Jun. 30, 2019USD ($)$ / shares | |
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Number of operating segments | 2 | |||
Amortization expense | $ 3,875 | $ 7,752 | ||
Accumulated amortization expenses | 15,502 | |||
Foreign currency transaction gain (loss) | $ (3,583) | $ 1,519 | (26,818) | $ 6,526 |
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 Option [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 | 78.96% | 92.93% | ||
Risk-free interest rate, minimum | 1.38% | 1.835% | ||
Risk-free interest rate, maximum | 1.66% | 2.50% | ||
Common stock outstanding description | beneficially owned 5% or more of the shares of the Company’s outstanding common stock but which beneficially owned less than 5% of the Company’s outstanding common stock as of June 30, 2020 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ / shares | $ 3.20 | $ 4.97 | $ 3.20 | $ 4.97 |
Warrant [Member] | ||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||
Weighted average exercise price, outstanding warrants | $ / shares | $ 2.92 | $ 3.09 | $ 2.92 | $ 3.09 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of united Kingdom research and development incentives receivable | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Long-term Debt [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance, opening | |
UK research and development incentives | 95,525 |
Foreign currency translation | |
Balance, closing | 95,525 |
Current [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance, opening | 444,043 |
UK research and development incentives | (115,278) |
Foreign currency translation | (29,016) |
Balance, closing | $ 299,749 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of potentially dilutive adjustments to the weighted average number of common shares - shares | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 7,386,397 | 7,396,675 |
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 | 1,499,580 | 1,093,032 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2020 | |
Intangible Assets (Details) [Line Items] | |||||
Amortization expense | $ 6,791 | $ 6,791 | $ 13,582 | $ 13,582 | |
Forecast [Member] | |||||
Intangible Assets (Details) [Line Items] | |||||
Future annual amortization expense | $ 6,117 |
Intangible Assets (Details) - S
Intangible Assets (Details) - Schedule of intangible assets - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,355,419 | $ 2,355,419 |
Accumulated Amortization | 2,349,302 | 2,335,720 |
Net Book Value | 6,117 | 19,699 |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 462,234 | 462,234 |
Accumulated Amortization | 456,117 | 442,535 |
Net Book Value | 6,117 | 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) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure Text Block [Abstract] | |
Leases, description | the Company’s consolidated balance sheet included a right-of-use lease asset of $46,089 for the office space and $9,304 for the copier machine. Lease liabilities in the Company’s consolidated balance sheet included corresponding lease liabilities of $46,555 and $10,001 respectively. During the six months ended June 30, 2020, the Company recognized lease expense of $70,595 for the operating lease, in addition to amortization expense of $3,721 and interest expense of $608 for the financing lease in the Company’s consolidated statement of operations. |
Leases (Details) - Schedule of
Leases (Details) - Schedule of right-of-use lease | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Operating Lease [Member] | |
Right-of-use lease asset: | |
Right-of-use lease asset, begining | $ 112,387 |
Less: reduction/amortization | 66,298 |
Right-of-use lease asset, ending | 46,089 |
Lease liability: | |
Lease liability, | 113,559 |
Less: repayments | 67,004 |
Lease liability, | 46,555 |
Lease expenses for the six months ended June 30, 2020: | |
Lease expense | 70,595 |
Amortization expense | |
Interest expense | |
Total | 70,595 |
2020 | 47,533 |
2021 | |
Total | $ 47,533 |
Remaining lease term | 4 years |
Financing Lease [Member] | |
Right-of-use lease asset: | |
Right-of-use lease asset, begining | $ 13,025 |
Less: reduction/amortization | 3,721 |
Right-of-use lease asset, ending | 9,304 |
Lease liability: | |
Lease liability, | 13,665 |
Less: repayments | 3,664 |
Lease liability, | 10,001 |
Lease expenses for the six months ended June 30, 2020: | |
Lease expense | |
Amortization expense | 3,721 |
Interest expense | 608 |
Total | 4,329 |
2020 | 4,272 |
2021 | 6,408 |
Total | $ 10,680 |
Remaining lease term | 15 years |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of accrued expenses - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Schedule of accrued expenses [Abstract] | ||
Clinical trial expenses | $ 3,047,866 | $ 3,020,030 |
Other | 109,666 | 137,356 |
Total | $ 3,157,532 | $ 3,157,386 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2019 | Jun. 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 | ||
Various tax credits, amount | $ 8,315,000 | ||
Period of expiration of various tax credits | expire from 2020 to 2037 | ||
Net operating loss carry forwards, limitations on use, description | IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. | ||
NOL carryforwards | $ 836,893 | $ 610,676 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) | Mar. 23, 2020 | Feb. 20, 2020 | Aug. 11, 2017 | May 05, 2017 | Jun. 30, 2020 | Aug. 10, 2020 | Mar. 31, 2020 | Mar. 12, 2020 | Feb. 10, 2020 | Jan. 08, 2020 | Dec. 31, 2019 |
Shareholders' Equity (Details) [Line Items] | |||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | |||||||||
Fair value of share (in Dollars per share) | $ 2.56 | ||||||||||
Grant value (in Dollars) | $ 59,000 | ||||||||||
Fbr Capital Markets & Co [Member] | |||||||||||
Shareholders' Equity (Details) [Line Items] | |||||||||||
Common stock shares sold | 4,545,116 | ||||||||||
Weighted average price per share (in Dollars per share) | $ 2.08 | ||||||||||
Common stock purchase agreement with FBR, description | The FBR Sales Agreement provides that FBR is entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the FBR Sale Agreement. | the shares sold pursuant to the FBR Sales Agreement 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. | |||||||||
Fbr Capital Markets & Co [Member] | Subsequent Event [Member] | |||||||||||
Shareholders' Equity (Details) [Line Items] | |||||||||||
Common stock value under sale agreement (in Dollars) | $ 1,500,000 | ||||||||||
Common Stock [Member] | |||||||||||
Shareholders' Equity (Details) [Line Items] | |||||||||||
Common stock, shares issued option exercised | 2,189 | ||||||||||
Common stock exercise price (in Dollars per share) | $ 0.86 | ||||||||||
Common stock shares issued to vendors | 10,000 | 10,000 | 10,000 | ||||||||
Fair value of share (in Dollars per share) | $ 2.56 | $ 1.97 | $ 2.25 | $ 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 | Mar. 31, 2020USD ($)$ / shares | Jan. 31, 2020USD ($) | Jun. 30, 2020USD ($)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 | |||
Common stock 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 | ||||
Paycheck Protection Program loan | $ 185,702 | ||||
Paycheck Protection Program loan | 232,128 | ||||
Accrued interest expense | $ 682 | ||||
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. | ||||
Minimum [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Authorized shares to be issued to Dr. Schaber immediately prior to the completion of a transaction | $ 5,000 | ||||
Maximum [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Authorized shares to be issued to Dr. Schaber immediately prior to the completion of a transaction | $ 500,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of contractual obligation | Jun. 30, 2020USD ($) |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
2020 | $ 101,805 |
2021 | 106,408 |
2022 | 100,000 |
2023 | 100,000 |
2024 | 100,000 |
Total | 508,213 |
Research and Development [Member] | |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
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] | |
2020 | 51,805 |
2021 | 6,408 |
2022 | |
2023 | |
2024 | |
Total | $ 58,213 |
Operating Segments (Details)
Operating Segments (Details) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Number of operating segments | 2 |
Operating Segments (Details) -
Operating Segments (Details) - Schedule of operating segments - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Revenues | |||||
Revenues | $ 505,288 | $ 1,544,964 | $ 1,429,842 | $ 2,689,752 | |
Income/(Loss) from Operations | |||||
Loss from Operations | (2,813,872) | (2,164,891) | (11,287,661) | (4,464,954) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 17,802 | 12,932 | 35,448 | 22,992 | |
Other Income, Net | |||||
Other Income, Net | 37,109 | 41,370 | 92,671 | 91,130 | |
Share-Based Compensation | |||||
Share-Based Compensation | 81,003 | 72,892 | 144,694 | 152,465 | |
Identifiable Assets | |||||
Identifiable Assets | 12,260,674 | 12,260,674 | $ 7,775,360 | ||
Public Health Solutions [Member] | |||||
Revenues | |||||
Revenues | 468,009 | 1,095,865 | 1,376,818 | 1,776,218 | |
Income/(Loss) from Operations | |||||
Loss from Operations | (50,737) | 204,121 | (209,239) | 195,110 | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 7,318 | 4,316 | 14,621 | 8,718 | |
Share-Based Compensation | |||||
Share-Based Compensation | 8,377 | 8,072 | 17,842 | 13,268 | |
Identifiable Assets | |||||
Identifiable Assets | 273,943 | 273,943 | 1,018,673 | ||
Specialized BioTherapeutics [Member] | |||||
Revenues | |||||
Revenues | 37,279 | 449,099 | 53,024 | 913,534 | |
Income/(Loss) from Operations | |||||
Loss from Operations | (1,808,652) | (1,462,334) | (9,166,503) | (2,798,891) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 3,167 | 4,168 | 6,237 | 8,845 | |
Other Income, Net | |||||
Other Income, Net | 35,091 | (2,339) | 68,706 | 2,670 | |
Share-Based Compensation | |||||
Share-Based Compensation | 18,962 | 19,094 | 44,251 | 40,002 | |
Identifiable Assets | |||||
Identifiable Assets | 86,639 | 86,639 | 41,705 | ||
Corporate [Member] | |||||
Income/(Loss) from Operations | |||||
Loss from Operations | (954,483) | (905,678) | (1,911,919) | (1,861,173) | |
Amortization and Depreciation Expense | |||||
Amortization and Depreciation Expense | 7,317 | 4,448 | 14,590 | 5,429 | |
Other Income, Net | |||||
Other Income, Net | 2,018 | 43,709 | 23,965 | 88,460 | |
Share-Based Compensation | |||||
Share-Based Compensation | 53,664 | $ 45,726 | 82,601 | $ 99,195 | |
Identifiable Assets | |||||
Identifiable Assets | $ 11,900,092 | $ 11,900,092 | $ 6,714,982 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | Aug. 10, 2020USD ($)$ / sharesshares |
Subsequent Events (Details) [Line Items] | |
Common stock exercise warrants, Share | shares | 1,252,287 |
Weighted average price per share | $ / shares | $ 2.58 |
Total proceeds | $ | $ 3,231,319 |
Paycheck protection program, description | The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as the Company’s corporate headquarters. Pursuant to an amendment on July 7, 2020, the lease has been extended from November 2020 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 $10,850 starting in November 2020. |