Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 11, 2021 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2021 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 000-16929 | |
Entity Registrant Name | SOLIGENIX, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 41-1505029 | |
Entity Address, Address Line One | 29 EMMONS DRIVE, SUITE B-10 | |
Entity Address, City or Town | PRINCETON, | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 538-8200 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000812796 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Common Stock, Shares Outstanding | 40,103,760 | |
Amendment Flag | false | |
Common Stock | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $.001 per share | |
Trading Symbol | SNGX | |
Security Exchange Name | NASDAQ | |
Purchase warrants | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock Purchase Warrants | |
Trading Symbol | SNGXW | |
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 28,979,969 | $ 18,676,663 |
Contracts and grants receivable | 117,680 | 203,774 |
Research and development incentives receivable | 106,598 | 361,096 |
Prepaid expenses and other current assets | 148,594 | 225,473 |
Total current assets | 29,352,841 | 19,467,006 |
Security deposit | 22,777 | 22,777 |
Office furniture and equipment, net of accumulated depreciation of $161,037 and $154,769 | 17,242 | 23,510 |
Deferred issuance cost | 5,796 | 53,523 |
Right-of-use lease assets | 167,608 | 228,027 |
Research and development incentive receivable | 28,525 | 73,142 |
Other assets | 15,500 | 23,250 |
Total assets | 29,610,289 | 19,891,235 |
Current liabilities: | ||
Accounts payable | 1,482,359 | 2,129,844 |
Accrued expenses | 2,461,630 | 2,638,308 |
Accrued compensation | 67,053 | 875,096 |
Paycheck Protection Program loan | 324,979 | |
Lease liabilities - current | 113,664 | 112,294 |
Total current liabilities | 4,124,706 | 6,080,521 |
Non-current liabilities: | ||
Convertible debt, net of debt discount of $164,787 and $140,261 | 9,835,213 | 9,859,739 |
Paycheck Protection Program loan, net of current | 92,851 | |
Lease liabilities, net of current | 54,180 | 116,296 |
Total liabilities | 14,014,099 | 16,149,407 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock, 350,000 shares authorized, none issued or outstanding | ||
Common stock, $.001 par value; 75,000,000 shares authorized; 40,078,760 shares and 30,643,656 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 40,079 | 30,644 |
Additional paid-in capital | 213,061,849 | 196,949,655 |
Accumulated other comprehensive loss | (32,058) | (24,337) |
Accumulated deficit | (197,473,680) | (193,214,134) |
Total shareholders' equity | 15,596,190 | 3,741,828 |
Total liabilities and shareholders' equity | $ 29,610,289 | $ 19,891,235 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Accumulated depreciation | $ 161,037 | $ 154,769 |
Debt discount, noncurrent | $ 164,787 | $ 140,261 |
Preferred stock, shares authorized | 350,000 | 350,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, shares issued | 40,078,760 | 30,643,656 |
Common stock, shares outstanding | 40,078,760 | 30,643,656 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Contract revenue | $ 292,461 | $ 33,351 | $ 1,137,647 | |
Revenues | $ 214,824 | 505,288 | 362,417 | 1,429,842 |
Cost of revenues | (204,317) | (363,339) | (326,677) | (1,192,844) |
Gross profit | 10,507 | 141,949 | 35,740 | 236,998 |
Operating expenses: | ||||
Research and development | 2,104,872 | 2,170,045 | 3,472,272 | 4,870,216 |
General and administrative | 915,280 | 785,776 | 1,806,720 | 1,654,443 |
Research and development expense - milesetone | 5,000,000 | |||
Total operating expenses | 3,020,152 | 2,955,821 | 5,278,992 | 11,524,659 |
Loss from operations | (3,009,645) | (2,813,872) | (5,243,252) | (11,287,661) |
Gain on forgiveness of PPP loan | 421,584 | 421,584 | ||
Foreign currency transaction gain/(loss) | 17,330 | (3,583) | 44,583 | (26,818) |
Interest (expense)/income | (214,750) | 2,017 | (428,255) | 23,964 |
Research and development incentives | 23,671 | 38,675 | 81,052 | 95,525 |
Net loss before income taxes | (2,761,810) | (2,776,763) | (5,124,288) | (11,194,990) |
Income tax benefit | 864,742 | 864,742 | 836,893 | |
Net loss applicable to common stockholders | $ (1,897,068) | $ (2,776,763) | $ (4,259,546) | $ (10,358,097) |
Basic and diluted net loss per share (in Dollars per share) | $ (0.05) | $ (0.10) | $ (0.11) | $ (0.41) |
Basic and diluted weighted average common shares outstanding (in Shares) | 40,074,275 | 26,901,781 | 38,455,210 | 25,153,350 |
Grant | ||||
Revenues: | ||||
Revenues | $ 214,824 | $ 212,827 | $ 329,066 | $ 292,195 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (1,897,068) | $ (2,776,763) | $ (4,259,546) | $ (10,358,097) |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | 3,617 | (8,184) | (7,721) | 8,059 |
Comprehensive loss | $ (1,893,451) | $ (2,784,947) | $ (4,267,267) | $ (10,350,038) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) | Common Stock | Additional Paid-In Capital | Acculated other comprehensive loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 21,753 | $ 177,006,004 | $ (45,010) | $ (175,525,612) | $ 1,457,135 |
Balance (in shares) at Dec. 31, 2019 | 21,753,124 | ||||
Issuance of common stock pursuant to FBR at Market Issuance | $ 4,545 | 9,455,404 | 9,459,949 | ||
Issuance of common stock pursuant to FBR at Market Issuance (in shares) | 4,545,116 | ||||
Issuance costs associated with FBR at Market Issuance Sales 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 vendor | $ 30 | 58,970 | 59,000 | ||
Issuance of common stock to vendor (in shares) | 30,000 | ||||
Exercise of common stock options | $ 2 | 2 | |||
Options exercised (in shares) | 2,189 | ||||
Excerise 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 Issuance | $ 2,813 | 5,467,910 | 5,470,723 | ||
Issuance of common stock pursuant to FBR at Market Issuance (in shares) | 2,813,001 | ||||
Issuance costs associated with FBR at Market Issuance Sales 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 | ||||
Balance at Dec. 31, 2020 | $ 30,644 | 196,949,655 | (24,337) | (193,214,134) | 3,741,828 |
Balance (in shares) at Dec. 31, 2020 | 30,643,656 | ||||
Issuance of common stock pursuant to FBR at Market Issuance | $ 9,435 | 16,480,894 | 16,490,329 | ||
Issuance of common stock pursuant to FBR at Market Issuance (in shares) | 9,435,091 | ||||
Issuance costs associated with FBR at Market Issuance Sales Agreement | (544,177) | (544,177) | |||
Excerise of warrants | 51 | 51 | |||
Exercise of warrants (in shares) | 13 | ||||
Share-based compensation expense | 175,426 | 175,426 | |||
Foreign currency translation adjustment | (7,721) | (7,721) | |||
Net loss | (4,259,546) | (4,259,546) | |||
Balance at Jun. 30, 2021 | $ 40,079 | 213,061,849 | (32,058) | (197,473,680) | 15,596,190 |
Balance (in Shares) at Jun. 30, 2021 | 40,078,760 | ||||
Balance at Mar. 31, 2021 | $ 40,020 | 212,890,844 | (35,675) | (195,576,612) | 17,318,577 |
Balance (in shares) at Mar. 31, 2021 | 40,020,461 | ||||
Issuance of common stock pursuant to FBR at Market Issuance | $ 59 | 94,664 | 94,723 | ||
Issuance of common stock pursuant to FBR at Market Issuance (in shares) | 58,299 | ||||
Issuance costs associated with FBR at Market Issuance Sales Agreement | (4,280) | (4,280) | |||
Share-based compensation expense | 80,621 | 80,621 | |||
Foreign currency translation adjustment | 3,617 | 3,617 | |||
Net loss | (1,897,068) | (1,897,068) | |||
Balance at Jun. 30, 2021 | $ 40,079 | $ 213,061,849 | $ (32,058) | $ (197,473,680) | $ 15,596,190 |
Balance (in Shares) at Jun. 30, 2021 | 40,078,760 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Operating activities: | ||
Net loss | $ (4,259,546) | $ (10,358,097) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Amortization and depreciation | 17,739 | 35,448 |
Non-cash lease expense | 56,698 | 66,298 |
Share-based compensation | 175,426 | 144,694 |
Issuance of common stock for milestone | 5,000,000 | |
Issuance of common stock for services | 59,000 | |
Amortization of deferred issuance costs associated with convertible debt | 20,986 | |
Gain on forgiveness of PPP loan | (421,584) | |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | 86,094 | 684,048 |
Prepaid expenses and other current assets | 76,879 | 434,877 |
Research and development incentives receivable | 306,651 | 19,754 |
Operating lease liability | (56,698) | (67,004) |
Accounts payable and accrued expenses | (838,749) | (136,035) |
Accrued compensation | (808,043) | (221,513) |
Total adjustments | (1,384,601) | 6,019,567 |
Net cash used in operating activities | (5,644,147) | (4,338,530) |
Investing activities: | ||
Purchases of office furniture and equipment | (7,147) | |
Net cash used in investing activities | (7,147) | |
Financing activities: | ||
Proceeds from issuance of common stock pursuant to FBR At Market Issuance Sales Agreement | 16,490,329 | 9,459,949 |
Costs associated with FBR At Market Issuance Sales Agreement | (496,450) | (425,915) |
Proceeds from the exercise of warrants | 51 | 685,384 |
Costs associated with issuance of convertible debt | (45,512) | |
Proceeds from paycheck protection program | 417,830 | |
Principal repayment - financing lease | (4,048) | (3,664) |
Net cash provided by financing activities | 15,944,370 | 10,133,584 |
Effect of exchange rate on cash and cash equivalents | 3,083 | (40,310) |
Net increase in cash and cash equivalents | 10,303,306 | 5,747,597 |
Cash and cash equivalents at beginning of period | 18,676,663 | 5,420,708 |
Cash and cash equivalents at end of period | 28,979,969 | 11,168,305 |
Supplemental information: | ||
Cash paid for state income taxes | 7,382 | |
Cash paid for interest | 444,814 | |
Cash paid for lease liabilities: | ||
Operating lease | 66,650 | 71,298 |
Financing lease | 4,272 | 4,272 |
Non-cash activities: | ||
Deferred issuance cost in accounts payable | 85,657 | |
Deferred issuance cost reclassified to additional-paid-in capital | $ 47,727 | 85,266 |
Issuance of stock options, cash exercise price received in December 2019 | $ 1,882 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2021 | |
Nature of Business | |
Nature of Business | Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing and moving towards commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With a successful Phase 3 study complete, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the United States (“U.S.”). Development programs in this business segment also include the Company’s first-in-class innate defense regulator technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including 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 has a subcontract of approximately $700,000 from a NIAID grant over five years for its thermostabilization technology, a DTRA subcontract of approximately $600,000 over three years for SGX943 and a subcontract of approximately $1.5 million from a NIAID grant over two years for development of CiVax™. The Company will continue to apply for additional government funding. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the 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, 2021 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, 2021, the Company had an accumulated deficit of $197,473,680. During the six months ended June 30, 2021, the Company incurred a net loss of $4,259,546 and used $5,644,147 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely 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, cash available from the loan from Pontifax Medison Finance, proceeds received from the sale of shares of the Company’s common stock via the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc., and management of the Company’s cash burn, 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, 2021, the Company had cash and cash equivalents of $28,979,969 as compared to $18,676,663 as of December 31, 2020, representing an increase of $10,303,306 or 55%. As of June 30, 2021, the Company had working capital of $25,228,135 as compared to working capital of $13,386,485 as of December 31, 2020, representing an increase of $11,841,650 or 88%. The increase in cash and working capital was primarily related to proceeds received from the utilization of the B. Riley Sales Agreement, partially offset by cash used in operating activities. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 clinical trial of HyBryte™ as well as further statistically significant improvement in response rates with longer treatment (18 weeks compared to 12 and 6 weeks of treatment), pursue New Drug Application (“NDA”) filing and commercialization in the U.S. while continuing to explore ex-U.S. partnership. ● Continue to analyze the full dataset from the Phase 3 clinical trial of SGX942, including data from long-term (12 month) follow-up, to better understand why the study did not achieve the statistically significant benefit expected, despite demonstrating clinically meaningful reductions in oral mucositis consistent with the previous Phase 2 study. Any clarity gained from further analysis, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, will be communicated to and discussed with the U.S. and/or European regulatory health authorities. ● Continue development of RiVax ® in combination with the Company’s ThermoVax ® technology to develop a new heat stable vaccine in biodefense with 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. ● Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline 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 $ 1.8 million in active government contract and grant funding still available as of June 30, 2021 to support its associated research programs through 2022, provided the federal agencies 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 as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions; ● The Company has up to $10.0 million remaining available from the loan and security agreement with Pontifax Medison Finance as of August 13, 2021, which includes an immediately available $5 million line of credit and a $5 million late withdrawal loan that is contingent upon the initial filing of the NDA for CTCL; ● The Company has up to $2.0 million remaining from the B. Riley Sales Agreement as of August 13, 2021 under the prospectus supplement updated August 28, 2020; and ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
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. Website Development Costs In February 2019, Altamont Pharmaceutical Holdings, LLC, a company which owned 5% or more of the Company’s shares of common stock at the time, 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.” During the quarter ended September 30, 2019, the Company began 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, 2021 and 2020 was $3,875 and $3,875, respectively, and accumulated amortization was $31,000 and $15,502, respectively, as of June 30, 2021 and 2020. Website amortization expense for the six months ended June 30, 2021 and 2020 was $7,750 and $7,752, respectively. Website development costs are included in other assets in the accompanying consolidated balance sheets. 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, 2021 or 2020. 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, 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. The carrying amounts reported in the consolidated balance sheets for convertible debt and the loan under the Paycheck Protection Program approximate their fair value based on their maturity dates. 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 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 the Company’s 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 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, 2021 and 2020 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 87% for 2021 and 77% - 79% for 2020; and ● risk free interest rates of 0.27% - 0.60% for 2021 and 1.38% - 1.66% for 2020. The fair value of each option grant made during the six months ended June 30, 2021 and 2020 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 $864,742 and $836,893 from the sale of New Jersey NOL carryforwards during the six months ended June 30, 2021 and 2020, respectively. The Company recognized 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, 2021 or 2020. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at June 30, 2021 or December 31, 2020. Research and Development Incentive Income and Receivable The Company recognizes other income from UK 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 UK research and development incentives receivable from December 31, 2020 to June 30, 2021: Current Long-Term Total Balance at December 31, 2020 $ 361,096 $ 73,142 $ 434,238 UK research and development incentives, transfer 73,142 (73,142) — UK research and development incentives — 29,159 29,159 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 4,400 (634) 3,766 Balance at June 30, 2021 $ 106,598 $ 28,525 $ 135,123 Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable 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, 2021 2020 Common stock purchase warrants 5,731,464 5,886,817 Stock options 1,939,386 1,499,580 Total 7,670,850 7,386,397 The weighted average exercise price of the Company’s warrants and stock options outstanding at June 30, 2021 were $2.96 and $2.75 per share, respectively, and at June 30, 2020 were $2.92 and $3.20 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 to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates and presentation. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Leases | Note 3. 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 copy machine in the office as an operating lease and a financing lease, respectively, and recorded related right-of-use lease assets and lease liabilities accordingly. As of June 30, 2021 and December 31, 2020, the Company’s consolidated balance sheets included a right-of-use lease asset of $165,747 and $222,445 for the office space and $1,861 and $5,582 for the copy machine, respectively. Lease liabilities in the Company’s consolidated balance sheets as of June 30, 2021 and December 31, 2020 included corresponding lease liabilities of $165,743 and $222,441 for the office space and $2,101 and $6,149 for the copy machine, respectively. 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 Financing Lease Lease Right-of-use lease asset: Right-of-use lease asset, January 1,2021 $ 222,445 $ 5,582 Reduction/amortization (56,698) (3,721) Right of use lease asset, June 30, 2021 $ 165,747 $ 1,861 Lease liability: Lease liability, January 1, 2021 $ 222,441 $ 6,149 Repayments (56,698) (4,048) Lease liability, June 30, 2021 $ 165,743 $ 2,101 Lease expense for the six months ended June 30, 2021: Lease expense $ 66,650 $ — Amortization expense — 3,721 Interest expense — 224 Total $ 66,650 $ 3,945 Contractual cash payments for the remaining lease term as of June 30, 2021: 2021 $ 66,650 $ 2,136 2022 111,083 — Total $ 177,733 $ 2,136 Remaining lease term (months) as of June 30, 2021 16 3 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Expenses | |
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: June 30, December 31, 2021 2020 Clinical trial expenses $ 2,442,105 $ 2,510,111 Other 19,525 128,197 Total $ 2,461,630 $ 2,638,308 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt | |
Debt | Note 5. Debt In December 2020, the Company entered into a $20.0 million convertible debt financing agreement with Pontifax Medison Debt Financing (“Pontifax”), the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the agreement with Pontifax, the Company will have access to up to $20.0 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and have an interest only period for the first two years with an interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. The agreement is secured by a lien covering substantially all of the Company’s assets, other than intellectual property. The agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes. Upon the closing of this transaction, the Company accessed the first tranche of $10.0 million, and has the option to draw the second tranche of $5.0 million at any time by December 15, 2021 and the third tranche of $5.0 million upon filing of the HyBryte™ NDA, subject to certain conditions. Interest expense incurred and paid for the three and six month ended June 30, 2021 was $223,636 and $444,814, respectively. The Company amortized $10,831 and $20,986 of issuance costs during the three and six month period ended June 30, 2021, respectively. Net deferred issuance costs of $164,787 has been recorded as a reduction of the carrying value of the $10.0 million convertible debt borrowed as of June 30, 2021. Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment at a conversion price of $4.10 per share. The Company also has the ability to force the conversion of the loan into shares of the Company’s common stock at the same conversion price, subject to certain conditions. Principal and interest payments due, assuming no conversion or additional borrowings over the next five years is as follows: Year Principal Interest Total July 2021 to December 2021 $ — $ 452,186 $ 452,186 2022 — 897,000 897,000 2023 4,000,000 769,138 4,769,138 2024 4,000,000 430,338 4,430,338 2025 2,000,000 110,566 2,110,566 Total $ 10,000,000 $ 2,659,228 $ 12,659,228 CARES Act Loan In April 2020, the Company was advised that its principal bank, 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 in March 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 had a term of two years, was unsecured, and was guaranteed by the Small Business Administration (“SBA”). The Loan bore interest at a fixed rate of 0.98% per annum, with interest and principal deferred during the eight-week or twenty-four-week period following the Loan origination date (“the loan forgiveness period”) and subsequent 10 months. Some or all of the Loan was eligible for forgiveness if at least 60% of the Loan proceeds were used by the Company to cover payroll costs, including benefits and if the Company maintained its employment and compensation within certain parameters during the loan forgiveness period and complied with other relevant conditions. The Company used the proceeds for purposes consistent with the PPP and met the conditions for forgiveness of the Loan. On June 29, 2021, the SBA and JPMorgan notified the Company that the entire balance of this note has been forgiven. The Company recorded the forgiveness of the principal and accrued interest of $421,584 as a gain on forgiveness in other income on the consolidated statement of operations. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Taxes | |
Income Taxes | Note 6. Income Taxes The Company had gross NOLs at December 31, 2020 of approximately $114 million for federal tax purposes, approximately $20 million for state tax purposes and approximately $1.2 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.2 million of various tax credits which expire from 2021 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 2021 and 2020, 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 $864,742 and $836,893 of income tax benefit, net of transaction costs, during the six months ended June 30, 2021 and 2020, respectively. The Company has not yet sold its 2020 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, 2021 | |
Shareholders' Equity | |
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, 2021: ● During the six months ended June 30, 2021, the Company issued 13 shares of common stock as a result of a warrant exercise. The weighted average exercise price per warrant was $3.95 . ● During the six months ended June 30, 2021, the Company issued 9,435,091 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $1.75 per share. The issuances of the Company’s common stock (a) as a result of the warrant exercise described above was registered on a Registration Statement on Form S-1, and (b) pursuant to the B. Riley Sales Agreement described above were registered on a Registration Statement on Form S-3. B. Riley At Market Issuance Sales Agreement In August 2017, the Company entered into the B. Riley 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 B. Riley acts as sales agent. Under the B. Riley 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 B. Riley Sales Agreement provides that B. Riley 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 B. Riley Sale Agreement. The Company has no obligation to sell any shares under the B. Riley Sales Agreement, and may suspend solicitation and offers under the B. Riley 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 was available to be utilized for a period up to six months or until a new shelf registration statement was declared effective, whichever occurred first. All sales under the B. Riley Sales Agreement from August 11, 2017 through August 10, 2020 were made pursuant to the May 2017 Registration Statement. All sales of common stock made pursuant to the B. Riley Sales Agreement since the expiration of the May 2017 Registration Statement have been, and future sales will be, made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333- 239928) filed on July 17, 2020 (the “July 2020 Registration Statement”) with the SEC, and any amendments thereto, the base prospectus filed as part of such registration statement, and any prospectus supplements. The July 2020 Registration Statement was declared effective on August 28, 2020. On August 28, 2020, the Company filed a prospectus supplement to the B. Riley Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $20.0 million under the July 2020 Registration Statement. As of August 13, 2021, there was $2.0 million available for future sale of common stock under the B. Riley Sales Agreement. |
Concentrations
Concentrations | 6 Months Ended |
Jun. 30, 2021 | |
Concentrations | |
Concentrations | Note 8. Concentrations At June 30, 2021 and 2020, the Company had deposits in major financial institutions that exceeded the amount under protection by the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $250,000 by the FDIC and at times maintains cash balances in excess of the FDIC coverage. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $450,000 as of June 30, 2021 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 expires in October 2022. This office space currently serves as the Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. The rent for the first 10 months of 2020 was approximately $11,883 per month, or $23.00 per square foot, and then decreased to approximately $11,108 per month, or $21.50 per square foot, starting November 2020, which rate will continue for the remainder of the lease period. In September 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 $3.75 million. 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 issued 1,956,182 shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of 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 purchase agreement. Provided the sole remaining future success-oriented milestone is attained, the Company will be required to make an additional payment of $5.0 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares do not exceed 19.9% ownership of the Company’s outstanding stock. As of June 30, 2021, no other milestone or royalty payments have been paid or accrued. 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: Research and Property and Year Development Other Leases Total July 1 through December 31, 2021 $ 50,000 $ 68,786 $ 118,786 2022 100,000 111,083 211,083 2023 100,000 — 100,000 2024 100,000 — 100,000 2025 100,000 — 100,000 Total $ 450,000 $ 179,869 $ 629,869 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. COVID-19 Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. The continued global spread of COVID-19 has affected the Company’s operations but did not have a material impact on its business, operating results, financial condition or cash flows as of and for the three and six months ended June 30, 2021. In particular, the third party manufacturers of HyBryte™ have experienced certain delays due to disruptions in their normal human operations, supply chain and other related logistical matters. In part due to these delays, the Company has decided not to pursue a rolling NDA submission for HyBryte™ at this time, in order to provide additional supportive data for inclusion in the NDA filing. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus. Emergent BioSolutions Legal Proceedings In July 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. (“Emergent”) and certain of its subsidiaries with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses (see Part II, Item 1 – Legal Proceeding). The Company is seeking to recover damages in excess of $19 million from Emergent. While the Company intends to vigorously pursue this arbitration, the Company cannot offer any assurances that it will recover any damages from Emergent. The Company has received invoices from Emergent related to the above matter. No accrual has been made for these invoices as management deems them invalid and not probable of being required to pay them based on the numerous breaches cited in the pending arbitration. These invoices total approximately $331,000. |
Operating Segments
Operating Segments | 6 Months Ended |
Jun. 30, 2021 | |
Operating Segments | |
Operating Segments | Note 10. 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 June 30, 2021 2020 Revenues Public Health Solutions $ 214,824 $ 468,009 Specialized BioTherapeutics — 37,279 Total $ 214,824 $ 505,288 Loss from Operations Public Health Solutions $ (231,954) $ (50,737) Specialized BioTherapeutics (1,720,566) (1,808,652) Corporate (1,057,125) (954,483) Total $ (3,009,645) $ (2,813,872) Amortization and Depreciation Expense Public Health Solutions $ 311 $ 7,318 Specialized BioTherapeutics 1,862 3,167 Corporate 6,667 7,317 Total $ 8,840 $ 17,802 Other Income, Net Specialized BioTherapeutics $ 41,001 35,091 Corporate 206,834 2,018 Total $ 247,835 $ 37,109 Share-Based Compensation Public Health Solutions $ 7,189 $ 8,377 Specialized BioTherapeutics 28,731 18,962 Corporate 44,701 53,664 Total $ 80,621 $ 81,003 Six Months Ended June 30, 2021 2020 Revenues Public Health Solutions $ 362,417 $ 1,376,818 Specialized BioTherapeutics — 53,024 Total $ 362,417 $ 1,429,842 Loss from Operations Public Health Solutions $ (362,735) $ (209,239) Specialized BioTherapeutics (2,832,974) (9,166,503) Corporate (2,047,543) (1,911,919) Total $ (5,243,252) $ (11,287,661) Amortization and Depreciation Expense Public Health Solutions $ 627 $ 14,621 Specialized BioTherapeutics 3,761 6,237 Corporate 13,351 14,590 Total $ 17,739 $ 35,448 Other Income/(Loss), Net Specialized BioTherapeutics $ 125,635 $ 68,706 Corporate (6,671) 23,965 Total $ 118,964 $ 92,671 Share-Based Compensation Public Health Solutions $ 13,484 $ 17,842 Specialized BioTherapeutics 58,310 44,251 Corporate 103,632 82,601 Total $ 175,426 $ 144,694 As of As of June 30, December 31, 2021 2020 Identifiable Assets Public Health Solutions $ 123,427 $ 176,447 Specialized BioTherapeutics 34,272 147,784 Corporate 29,452,590 19,567,004 Total $ 29,610,289 $ 19,891,235 |
Accounting Policies (Policies)
Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
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. |
Website Development Costs | Website Development Costs In February 2019, Altamont Pharmaceutical Holdings, LLC, a company which owned 5% or more of the Company’s shares of common stock at the time, 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.” During the quarter ended September 30, 2019, the Company began 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, 2021 and 2020 was $3,875 and $3,875, respectively, and accumulated amortization was $31,000 and $15,502, respectively, as of June 30, 2021 and 2020. Website amortization expense for the six months ended June 30, 2021 and 2020 was $7,750 and $7,752, respectively. Website development costs are included in other assets in the accompanying consolidated balance sheets. |
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, 2021 or 2020. |
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, 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. The carrying amounts reported in the consolidated balance sheets for convertible debt and the loan under the Paycheck Protection Program approximate their fair value based on their maturity dates. |
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 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 the Company’s 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 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, 2021 and 2020 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 87% for 2021 and 77% - 79% for 2020; and ● risk free interest rates of 0.27% - 0.60% for 2021 and 1.38% - 1.66% for 2020. The fair value of each option grant made during the six months ended June 30, 2021 and 2020 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 $864,742 and $836,893 from the sale of New Jersey NOL carryforwards during the six months ended June 30, 2021 and 2020, respectively. The Company recognized 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, 2021 or 2020. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at June 30, 2021 or December 31, 2020. |
Research and Development Incentive Income and Receivable | Research and Development Incentive Income and Receivable The Company recognizes other income from UK 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 UK research and development incentives receivable from December 31, 2020 to June 30, 2021: Current Long-Term Total Balance at December 31, 2020 $ 361,096 $ 73,142 $ 434,238 UK research and development incentives, transfer 73,142 (73,142) — UK research and development incentives — 29,159 29,159 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 4,400 (634) 3,766 Balance at June 30, 2021 $ 106,598 $ 28,525 $ 135,123 |
Loss Per Share | Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable 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, 2021 2020 Common stock purchase warrants 5,731,464 5,886,817 Stock options 1,939,386 1,499,580 Total 7,670,850 7,386,397 The weighted average exercise price of the Company’s warrants and stock options outstanding at June 30, 2021 were $2.96 and $2.75 per share, respectively, and at June 30, 2020 were $2.92 and $3.20 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 to accrue for clinical trials in process 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, 2021 | |
Summary of Significant Accounting Policies | |
Schedule of united kingdom research and development incentives receivable | Current Long-Term Total Balance at December 31, 2020 $ 361,096 $ 73,142 $ 434,238 UK research and development incentives, transfer 73,142 (73,142) — UK research and development incentives — 29,159 29,159 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 4,400 (634) 3,766 Balance at June 30, 2021 $ 106,598 $ 28,525 $ 135,123 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of June 30, 2021 2020 Common stock purchase warrants 5,731,464 5,886,817 Stock options 1,939,386 1,499,580 Total 7,670,850 7,386,397 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Reconcilation of lease cash flows to the right-of-use lease assets and liablities recognized in the financial statements. | Operating Financing Lease Lease Right-of-use lease asset: Right-of-use lease asset, January 1,2021 $ 222,445 $ 5,582 Reduction/amortization (56,698) (3,721) Right of use lease asset, June 30, 2021 $ 165,747 $ 1,861 Lease liability: Lease liability, January 1, 2021 $ 222,441 $ 6,149 Repayments (56,698) (4,048) Lease liability, June 30, 2021 $ 165,743 $ 2,101 Lease expense for the six months ended June 30, 2021: Lease expense $ 66,650 $ — Amortization expense — 3,721 Interest expense — 224 Total $ 66,650 $ 3,945 Contractual cash payments for the remaining lease term as of June 30, 2021: 2021 $ 66,650 $ 2,136 2022 111,083 — Total $ 177,733 $ 2,136 Remaining lease term (months) as of June 30, 2021 16 3 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, December 31, 2021 2020 Clinical trial expenses $ 2,442,105 $ 2,510,111 Other 19,525 128,197 Total $ 2,461,630 $ 2,638,308 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt | |
Schedule of principle and interest payments due | Year Principal Interest Total July 2021 to December 2021 $ — $ 452,186 $ 452,186 2022 — 897,000 897,000 2023 4,000,000 769,138 4,769,138 2024 4,000,000 430,338 4,430,338 2025 2,000,000 110,566 2,110,566 Total $ 10,000,000 $ 2,659,228 $ 12,659,228 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies. | |
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total July 1 through December 31, 2021 $ 50,000 $ 68,786 $ 118,786 2022 100,000 111,083 211,083 2023 100,000 — 100,000 2024 100,000 — 100,000 2025 100,000 — 100,000 Total $ 450,000 $ 179,869 $ 629,869 |
Operating Segments (Tables)
Operating Segments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Operating Segments | |
Schedule of operating segments | Three Months Ended June 30, 2021 2020 Revenues Public Health Solutions $ 214,824 $ 468,009 Specialized BioTherapeutics — 37,279 Total $ 214,824 $ 505,288 Loss from Operations Public Health Solutions $ (231,954) $ (50,737) Specialized BioTherapeutics (1,720,566) (1,808,652) Corporate (1,057,125) (954,483) Total $ (3,009,645) $ (2,813,872) Amortization and Depreciation Expense Public Health Solutions $ 311 $ 7,318 Specialized BioTherapeutics 1,862 3,167 Corporate 6,667 7,317 Total $ 8,840 $ 17,802 Other Income, Net Specialized BioTherapeutics $ 41,001 35,091 Corporate 206,834 2,018 Total $ 247,835 $ 37,109 Share-Based Compensation Public Health Solutions $ 7,189 $ 8,377 Specialized BioTherapeutics 28,731 18,962 Corporate 44,701 53,664 Total $ 80,621 $ 81,003 Six Months Ended June 30, 2021 2020 Revenues Public Health Solutions $ 362,417 $ 1,376,818 Specialized BioTherapeutics — 53,024 Total $ 362,417 $ 1,429,842 Loss from Operations Public Health Solutions $ (362,735) $ (209,239) Specialized BioTherapeutics (2,832,974) (9,166,503) Corporate (2,047,543) (1,911,919) Total $ (5,243,252) $ (11,287,661) Amortization and Depreciation Expense Public Health Solutions $ 627 $ 14,621 Specialized BioTherapeutics 3,761 6,237 Corporate 13,351 14,590 Total $ 17,739 $ 35,448 Other Income/(Loss), Net Specialized BioTherapeutics $ 125,635 $ 68,706 Corporate (6,671) 23,965 Total $ 118,964 $ 92,671 Share-Based Compensation Public Health Solutions $ 13,484 $ 17,842 Specialized BioTherapeutics 58,310 44,251 Corporate 103,632 82,601 Total $ 175,426 $ 144,694 As of As of June 30, December 31, 2021 2020 Identifiable Assets Public Health Solutions $ 123,427 $ 176,447 Specialized BioTherapeutics 34,272 147,784 Corporate 29,452,590 19,567,004 Total $ 29,610,289 $ 19,891,235 |
Nature of Business (Details)
Nature of Business (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Aug. 13, 2021USD ($) | Dec. 31, 2019USD ($) | |
Nature of business: | |||||||
Operating segments | segment | 2 | ||||||
Accumulated deficit | $ (197,473,680) | $ (197,473,680) | $ (193,214,134) | ||||
Net loss | (1,897,068) | $ (2,776,763) | (4,259,546) | $ (10,358,097) | |||
Net cash used in operating activities | (5,644,147) | (4,338,530) | |||||
Cash and cash equivalents | 28,979,969 | $ 11,168,305 | 28,979,969 | $ 11,168,305 | 18,676,663 | $ 5,420,708 | |
Cash and cash equivalents, period increase (decrease) | 10,303,306 | ||||||
Period increase (decrease) as a percent | 55 | ||||||
Working capital | 25,228,135 | $ 25,228,135 | 13,386,485 | ||||
Working capital increase, decrease | 11,841,650 | ||||||
Working capital increase (decrease) as a percent | 88.00% | ||||||
Grants Receivable, Current | 117,680 | $ 117,680 | 203,774 | ||||
Debt instrument, face amount | 10,000,000 | $ 10,000,000 | $ 20,000,000 | ||||
FBR Sales Agreement | |||||||
Nature of business: | |||||||
Borrowing capacity | $ 2,000,000 | ||||||
Late withdrawal loan | |||||||
Nature of business: | |||||||
Maximum borrowing capacity | 5,000,000 | ||||||
Line of credit | |||||||
Nature of business: | |||||||
Debt instrument, face amount | 5,000,000 | ||||||
Loan and security agreement | |||||||
Nature of business: | |||||||
Debt instrument, face amount | $ 10,000,000 | ||||||
CiVax | |||||||
Nature of business: | |||||||
Term (in years) | two years | ||||||
NIH | |||||||
Nature of business: | |||||||
Grants Receivable, Current | $ 1,800,000 | $ 1,800,000 | |||||
Collaborative arrangment, transaction with party | CiVax | |||||||
Nature of business: | |||||||
Revenue from collaborative arrangement | 1,500,000 | ||||||
Collaborative arrangment, transaction with party | NIAID | Government contract | |||||||
Nature of business: | |||||||
Revenue from collaborative arrangement | $ 700,000 | ||||||
Term (in years) | five years | ||||||
Collaborative arrangment, transaction with party | DTRA | Government contract | |||||||
Nature of business: | |||||||
Revenue from collaborative arrangement | $ 600,000 | ||||||
Term (in years) | three years |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2021USD ($)$ / shares | Mar. 31, 2021USD ($) | Jun. 30, 2020USD ($)$ / shares | Mar. 31, 2020 | Jun. 30, 2019USD ($) | Jun. 30, 2021USD ($)segment$ / shares | Jun. 30, 2020USD ($)$ / shares | Feb. 28, 2019 | |
Accounting policies: | ||||||||
Operating segments | segment | 2 | |||||||
Website development cost | $ 46,500 | |||||||
Amortization and depreciation | $ 8,840 | $ 17,802 | $ 17,739 | $ 35,448 | ||||
Intangible, amortization expense | $ 3,875 | 3,875 | ||||||
Intangible, accumulated amortization | $ 31,000 | 15,502 | 15,502 | |||||
Impairment of long-lived assets | 0 | 0 | $ 0 | $ 0 | ||||
Requisite period (in years) | three | |||||||
Expiration period | P10Y | |||||||
Option vesting rights | 25% | |||||||
Dividend yield | 0.00% | 0.00% | ||||||
Expected life | 4 years | 4 years | ||||||
Volatility rate | 87.00% | |||||||
Volatility rate minimum | 77.00% | |||||||
Volatility rate maximum | 79.00% | |||||||
Risk free interest rate, minimum | 1.38% | 0.27% | ||||||
Risk free interest rate, maximum | 1.66% | 0.60% | ||||||
Foreign currency transaction gain (loss) | 17,330 | $ (3,583) | $ 44,583 | $ 26,818 | ||||
Income tax benefit | (864,742) | (864,742) | $ (836,893) | |||||
Interest and penalties | $ 0 | $ 0 | ||||||
Weighted average exercise price, outstanding warrants | $ / shares | $ 2.96 | $ 2.92 | $ 2.96 | $ 2.92 | ||||
Weighted average exercise price | $ / shares | $ 2.75 | $ 3.20 | $ 2.75 | $ 3.20 | ||||
Termination benefits | ||||||||
Accounting policies: | ||||||||
Expiration period | three | |||||||
Altamont Pharmaceutical Holdings, LLC | ||||||||
Accounting policies: | ||||||||
Noncontrolling interest, ownership (as a percent) | 5.00% | |||||||
Directors, upon re-election | ||||||||
Accounting policies: | ||||||||
Requisite period (in years) | one | |||||||
Media Content | ||||||||
Accounting policies: | ||||||||
Intangible, amortization expense | $ 7,750 | $ 7,752 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - UK (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance, bgn | $ 434,238 |
UK research and development incentives, Q1 2021 | 29,159 |
Additional 2019 incentive earned | 51,893 |
UK research and development incentives cash receipt | (383,933) |
Foreign currency translation | 3,766 |
Balance, end | 135,123 |
Current | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance, bgn | 361,096 |
UK research and development incentives, transfer | 73,142 |
Additional 2019 incentive earned | 51,893 |
UK research and development incentives cash receipt | (383,933) |
Foreign currency translation | 4,400 |
Balance, end | 106,598 |
Long-term | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance, bgn | 73,142 |
UK research and development incentives, transfer | (73,142) |
UK research and development incentives, Q1 2021 | 29,159 |
Foreign currency translation | (634) |
Balance, end | $ 28,525 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Loss per share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 7,670,850 | 7,386,397 |
Common stock purchase warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 5,731,464 | 5,886,817 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 1,939,386 | 1,499,580 |
Leases (Details)
Leases (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Leases | ||
Right-of-use asset, operating lease | $ 165,747 | $ 222,445 |
Right of use asset, finance lease | 1,861 | 5,582 |
Lease liability, operating lease | 165,743 | 222,441 |
Lease liability, finance lease | $ 2,101 | $ 6,149 |
Leases - Reconcilation (Details
Leases - Reconcilation (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Leases | |
Right of use asset, bgn | $ 222,445 |
Reduction/amortization | (56,698) |
Right of use asset, end | 165,747 |
Lease liability - Operating, bgn | 222,441 |
Repayments | (56,698) |
Lease liability - Operating, end | 165,743 |
Lease liability - Financing, bgn | 6,149 |
Repayments | (4,048) |
Lease liability - Financing, end | 2,101 |
Right-of-use lease assset, finance | |
Right of use asset, bgn | 5,582 |
Right of use asset, end | 1,861 |
Lease expense | |
Lease expense, operating | 66,650 |
Amortization expense, financing lease | 3,721 |
Interest expense, finance lease | 224 |
Contractual cash payments, operating lease | |
Year one | 66,650 |
Year two | 111,083 |
Operating lease, total payments due | 177,733 |
2021 | 2,136 |
Finance lease, total payments due | $ 2,136 |
Remaining term of contract, operating | 16 months |
Remaining term of contract, finance | 3 months |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses | ||
Clinical trail expenses | $ 2,442,105 | $ 2,510,111 |
Other | 19,525 | 128,197 |
Accrued expenses | $ 2,461,630 | $ 2,638,308 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Apr. 30, 2020 | |
Debt instruments | |||||
Debt instrument, face amount | $ 20,000,000 | $ 10,000,000 | $ 10,000,000 | ||
Tranches | three | ||||
Convertible debt | $ 9,859,739 | 9,835,213 | 9,835,213 | ||
Effective interest rate | 8.47% | ||||
Interest rate on not borrowed but available | 1.00% | ||||
Interest expense | 223,636 | 444,814 | |||
Deferred issuance costs | 164,787 | 164,787 | |||
Debt amortization | $ 10,831 | $ 20,986 | |||
Conversion price (in Dollars per share) | $ 4.10 | ||||
First Tranche | |||||
Debt instruments | |||||
Convertible note | $ 10,000,000 | ||||
Second Tranche | |||||
Debt instruments | |||||
Convertible note | 5,000,000 | ||||
Third Tranche | |||||
Debt instruments | |||||
Convertible note | 5,000,000 | ||||
CARES Act Loan - COVID | |||||
Debt instruments | |||||
Loan amount | $ 417,830 | ||||
Bears interest rate | 0.98% | ||||
Convertible Debt | |||||
Debt instruments | |||||
Debt instrument, face amount | $ 20,000,000 |
Debt- Payments due (Details)
Debt- Payments due (Details) | Jun. 30, 2021USD ($) |
Convertible Debt (Details) - Schedule of principle and interest payments due [Line Items] | |
April 2021 to December 2021 | $ 452,186 |
2022 | 897,000 |
2023 | 4,769,138 |
2024 | 4,430,338 |
2025 | 2,110,566 |
Total | 12,659,228 |
Principal [Member] | |
Convertible Debt (Details) - Schedule of principle and interest payments due [Line Items] | |
April 2021 to December 2021 | |
2022 | |
2023 | 4,000,000 |
2024 | 4,000,000 |
2025 | 2,000,000 |
Total | 10,000,000 |
Interest [Member] | |
Convertible Debt (Details) - Schedule of principle and interest payments due [Line Items] | |
April 2021 to December 2021 | 452,186 |
2022 | 897,000 |
2023 | 769,138 |
2024 | 430,338 |
2025 | 110,566 |
Total | $ 2,659,228 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | |
Income Taxes | |||
NOL for Federal tax | $ 114,000,000 | ||
NOL for State tax | 20,000,000 | ||
NOL for Foreign tax | $ 1,200,000 | ||
Net operating loss carry forwards, limitations on use, description | $8.2 | ||
NOL carryforwards | $ 864,742 | $ 836,893 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||
Mar. 31, 2021 | Aug. 17, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | |
Shareholders' Equity (Details) [Line Items] | ||||
Preferred stock, shares authorized | 350,000 | 350,000 | 350,000 | |
Weighted average price per share (in Dollars per share) | $ 1.75 | |||
Subsequent Event [Member] | ||||
Shareholders' Equity (Details) [Line Items] | ||||
Common stock available for sale (in Dollars) | $ 2 | |||
FBR Capital Markets & Co. [Member] | ||||
Shareholders' Equity (Details) [Line Items] | ||||
Shares issues (in shares) | 9,435,091 | |||
Common Stock | ||||
Shareholders' Equity (Details) [Line Items] | ||||
Warrants issued to purchase shares | 13 | |||
Common Stock | Maximum [Member] | ||||
Shareholders' Equity (Details) [Line Items] | ||||
Warrants exercise price (in Dollars per share) | $ 3.95 |
Concentrations (Details)
Concentrations (Details) - USD ($) $ in Millions | Mar. 31, 2021 | Mar. 31, 2020 |
Concentrations | ||
Deposits | $ 250,000 | $ 250,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | ||
Jan. 31, 2020USD ($) | Sep. 30, 2014USD ($)shares | Mar. 31, 2021USD ($)m²$ / shares | Mar. 31, 2020shares | |
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 | |||
Cash paid to acquire Hy Biopharma intangible asset | $ 275,000 | |||
Issuance of shares for assets (in shares) | shares | 184,912 | |||
Fair value of shares issued in connection with Hy BioPharma asset purchase | $ 3.75 | |||
Shares exercisable (in shares) | shares | 1,956,182 | |||
Effective price per share (in Dollars per share) | $ / shares | $ 2.56 | |||
Additional Payments | $ 5,000,000 | |||
Ownership of company outstanding | 19.90% | |||
Minimum [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Authorized shares to be issued | $ 5,000 | |||
Maximum [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Authorized shares to be issued | $ 500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Obligations (Details) | Mar. 31, 2021USD ($) |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
2022 | $ 211,083 |
2023 | 100,000 |
2024 | 100,000 |
2025 | 100,000 |
Total | 629,869 |
Licensing Fee [Member] | |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
2022 | 100,000 |
2023 | 100,000 |
2024 | 100,000 |
2025 | 100,000 |
Total | 450,000 |
Property and Other Leases [Member] | |
Commitments and Contingencies (Details) - Schedule of contractual obligation [Line Items] | |
2022 | 111,083 |
2023 | |
2024 | |
2025 | |
Total | $ 179,869 |
Operating Segments (Details)
Operating Segments (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Segment reporting | |||||
Revenues | $ 214,824 | $ 505,288 | $ 362,417 | $ 1,429,842 | |
Loss from operations | (3,009,645) | (2,813,872) | (5,243,252) | (11,287,661) | |
Amortization and depreciation | 8,840 | 17,802 | 17,739 | 35,448 | |
Other income, net | 247,835 | 37,109 | 118,964 | 92,671 | |
Share-based compensation | 80,621 | 81,003 | 175,426 | 144,694 | |
Identifiable Assets | 29,610,289 | 29,610,289 | $ 19,891,235 | ||
Public Health Solutions | |||||
Segment reporting | |||||
Revenues | 214,824 | 468,009 | 362,417 | 1,376,818 | |
Loss from operations | (231,954) | (50,737) | (362,735) | (209,239) | |
Amortization and depreciation | 311 | 7,318 | 627 | 14,621 | |
Share-based compensation | 7,189 | 8,377 | 13,484 | 17,842 | |
Identifiable Assets | 123,427 | 123,427 | 176,447 | ||
Specialized BioTherapeutics | |||||
Segment reporting | |||||
Revenues | 37,279 | 53,024 | |||
Loss from operations | (1,720,566) | (1,808,652) | (2,832,974) | (9,166,503) | |
Amortization and depreciation | 1,862 | 3,167 | 3,761 | 6,237 | |
Other income, net | 41,001 | 35,091 | 125,635 | 68,706 | |
Share-based compensation | 28,731 | 18,962 | 58,310 | 44,251 | |
Identifiable Assets | 34,272 | 34,272 | 147,784 | ||
Corporate | |||||
Segment reporting | |||||
Loss from operations | (1,057,125) | (954,483) | (2,047,543) | (1,911,919) | |
Amortization and depreciation | 6,667 | 7,317 | 13,351 | 14,590 | |
Other income, net | 206,834 | 2,018 | (6,671) | 23,965 | |
Share-based compensation | 44,701 | $ 53,664 | 103,632 | $ 82,601 | |
Identifiable Assets | $ 29,452,590 | $ 29,452,590 | $ 19,567,004 |