Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 22, 2022 | Jun. 30, 2021 | |
[DocumentAndEntityInformationAbstract] | |||
Entity Registrant Name | SOLIGENIX, INC. | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 42,954,091 | ||
Entity Public Float | $ 39,976,044 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0000812796 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity File Number | 000-16929 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 41-1505029 | ||
Entity Address, Address Line One | 29 EMMONS DRIVE | ||
Entity Address, Address Line Two | 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 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Trading Symbol | SNGX | ||
Security Exchange Name | NASDAQ | ||
ICFR Auditor Attestation Flag | false | ||
Entity Interactive Data Current | Yes | ||
Auditor Name | EISNERAMPER LLP | ||
Auditor Firm ID | 274 | ||
Auditor Location | Iselin, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 26,043,897 | $ 18,676,663 |
Contracts and grants receivable | 138,889 | 203,774 |
Research and development incentives receivable | 103,832 | 361,096 |
Prepaid expenses and other current assets | 282,903 | 225,473 |
Total current assets | 26,569,521 | 19,467,006 |
Security deposit | 22,777 | 22,777 |
Office furniture and equipment, net of accumulated depreciation of $167,848 and $154,769 | 22,220 | 23,510 |
Deferred issuance cost | 20,266 | 53,523 |
Right-of-use lease assets | 106,155 | 228,027 |
Research and development incentives receivable | 121,238 | 73,142 |
Other assets | 7,750 | 23,250 |
Total assets | 26,869,927 | 19,891,235 |
Current liabilities: | ||
Accounts payable | 2,925,544 | 2,129,844 |
Accrued expenses | 2,956,545 | 2,638,308 |
Accrued compensation | 302,936 | 875,096 |
Paycheck protection program loan | 324,979 | |
Lease liabilities - current | 106,151 | 112,294 |
Total current liabilities | 6,291,176 | 6,080,521 |
Non-current liabilities: | ||
Convertible debt, net of debt discount of $143,847 and $140,261 | 9,856,153 | 9,859,739 |
Paycheck Protection Program loan, net of current | 0 | 92,851 |
Lease liabilities, net of current | 116,296 | |
Total liabilities | 16,147,329 | 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; 42,873,445 shares and 30,643,656 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 42,873 | 30,644 |
Additional paid-in capital | 216,402,890 | 196,949,655 |
Accumulated other comprehensive income/(loss) | 41,942 | (24,337) |
Accumulated deficit | (205,765,107) | (193,214,134) |
Total shareholders' equity | 10,722,598 | 3,741,828 |
Total liabilities and shareholders' equity | $ 26,869,927 | $ 19,891,235 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Office furniture and equipment, net | $ 167,848 | $ 154,769 |
Debt discount | $ 143,847 | $ 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 | 42,873,445 | 30,643,656 |
Common stock, shares outstanding | 42,873,445 | 30,643,656 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | ||
Total revenues | $ 824,268 | $ 2,359,447 |
Cost of revenues | (728,640) | (1,820,949) |
Gross Profit | 95,628 | 538,498 |
Operating expenses: | ||
Research and development | 8,389,387 | 9,796,167 |
General and administrative | 4,847,126 | 4,328,838 |
Research and development expense - milestone | 5,000,000 | |
Total operating expenses | 13,236,513 | 19,125,005 |
Loss from operations | (13,140,885) | (18,586,507) |
Other (expense)/income: | ||
Gain on forgiveness of PPP loan | 421,584 | |
Foreign currency transaction loss | (39,361) | (23,385) |
Interest expense | (862,577) | (10,882) |
Research and development incentives | 174,770 | 95,359 |
Other income | 30,754 | |
Total other (expense)/income | (274,830) | 61,092 |
Net loss before income taxes | (13,415,715) | (18,525,415) |
Income tax benefit | 864,742 | 836,893 |
Net loss applicable to common stockholders | $ (12,550,973) | $ (17,688,522) |
Basic net loss per share (per share) | $ (0.31) | $ (0.64) |
Diluted net loss per share (per share) | $ (0.31) | $ (0.64) |
Basic weighted average common shares outstanding (in shares) | 40,132,182 | 27,486,949 |
Diluted weighted average common shares outstanding (in shares) | 40,132,182 | 27,486,949 |
Contract revenue | ||
Revenues: | ||
Total revenues | $ 33,351 | $ 1,930,533 |
Grant revenue | ||
Revenues: | ||
Total revenues | $ 790,917 | $ 428,914 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (12,550,973) | $ (17,688,522) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | 66,279 | 20,673 |
Comprehensive loss | $ (12,484,694) | $ (17,667,849) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
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 B. Riley At Market Issuance Sales Agreement | $ 6,439 | 14,191,721 | 14,198,160 | ||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 6,438,431 | ||||
Cost associated with issuance of common stock | (580,456) | (580,456) | |||
Issuance of common stock for milestones | $ 1,956 | 4,998,044 | 5,000,000 | ||
Issuance of common stock for milestones (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 warrants | $ 460 | 860,458 | 860,918 | ||
Exercise of warrants (in shares) | 460,161 | ||||
Exercise of common stock options | $ 6 | 4,981 | $ 4,987 | ||
Exercise of common stock options (in shares) | 5,758 | 5,758 | |||
Share-based compensation expense | 409,933 | $ 409,933 | |||
Foreign currency translation adjustment | 20,673 | 20,673 | |||
Net loss | (17,688,522) | (17,688,522) | |||
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 B. Riley At Market Issuance Sales Agreement | $ 12,174 | 19,693,473 | 19,705,647 | ||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 12,174,515 | ||||
Cost associated with issuance of common stock | (655,156) | (655,156) | |||
Issuance of common stock to vendors | $ 25 | 27,475 | 27,500 | ||
Issuance of common stock to vendors (in shares) | 25,000 | ||||
Exercise of warrants | 79 | 79 | |||
Exercise of warrants (in shares) | 20 | ||||
Exercise of common stock options | $ 30 | 25,805 | $ 25,835 | ||
Exercise of common stock options (in shares) | 30,254 | 30,254 | |||
Share-based compensation expense | 361,559 | $ 361,559 | |||
Foreign currency translation adjustment | 66,279 | 66,279 | |||
Net loss | (12,550,973) | (12,550,973) | |||
Balance at Dec. 31, 2021 | $ 42,873 | $ 216,402,890 | $ 41,942 | $ (205,765,107) | $ 10,722,598 |
Balance (in shares) at Dec. 31, 2021 | 42,873,445 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | ||
Net loss | $ (12,550,973) | $ (17,688,522) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 34,161 | 62,372 |
Non-cash lease expense | 116,290 | 130,670 |
Share-based compensation | 361,559 | 409,933 |
Issuance of common stock for milestone | 5,000,000 | |
Issuance of common stock to vendors | 27,500 | 59,000 |
Deferred issuance costs written off | 61,609 | |
Amortization of deferred issuance costs associated with convertible debt | 41,926 | 1,205 |
Gain on forgiveness of PPP loan | (421,584) | |
Change in operating assets and liabilities: | ||
Contracts and grants receivable | 64,885 | 815,061 |
Prepaid expenses and other current assets | (57,430) | 384,424 |
Security deposit | (20) | |
Research and development incentives receivable | 205,237 | 21,924 |
Operating lease liability | (116,290) | (131,845) |
Accounts payable and accrued expenses | 1,127,259 | (1,157,160) |
Accrued compensation | (572,160) | 576,923 |
Net cash used in operating activities | (11,739,620) | (11,454,426) |
Investing activities: | ||
Purchases of office furniture and equipment | (11,789) | (7,147) |
Net cash used in investing activities | (11,789) | (7,147) |
Financing activities: | ||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 19,705,647 | 14,198,160 |
Costs associated with B. Riley At Market Issuance Sales Agreement | (621,899) | (656,264) |
Proceeds from the exercise of warrants | 79 | 860,918 |
Proceeds from the exercises of stock options | 25,835 | 4,987 |
Proceeds from Convertible Debt | 10,000,000 | |
Costs associated with issuance of convertible debt | (45,512) | (141,466) |
Principal repayment - financing lease | (6,149) | (7,516) |
Proceeds from paycheck protection program | 417,830 | |
Net cash provided by financing activities | 19,058,001 | 24,676,649 |
Effect of exchange rate on cash and cash equivalents | 60,642 | 40,879 |
Net increase in cash and cash equivalents | 7,367,234 | 13,255,955 |
Cash and cash equivalents at beginning of period | 18,676,663 | 5,420,708 |
Cash and cash equivalents at end of period | 26,043,897 | 18,676,663 |
Supplemental information: | ||
Cash paid for state income taxes | 7,727 | 4,021 |
Cash paid for interest | 668,715 | 34,406 |
Cash paid for lease liabilities: | ||
Operating lease | 133,300 | 141,050 |
Financing lease | 6,408 | 8,544 |
Right-of use assets and lease liabilities recorded | 240,727 | |
Deferred issuance cost reclassified to additional-paid-in capital | $ 33,257 | $ 67,733 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2021 | |
Nature of Business | |
Nature of Business | Soligenix, Inc. and Subsidiaries Notes to Consolidated Financial Statements 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 toward commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic (hypericin), a novel photodynamic therapy (“PDT”) utilizing 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 expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator (“IDR”) 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 (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203). 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 the 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. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2021, the Company had an accumulated deficit of $205,765,107. During the year ended December 31, 2021, the Company incurred a net loss of $12,550,973 and used $11,739,620 of cash in operations. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be largely determined by the budgeted operational expenditures incurred in regards to the progression of its product candidates. The Company’s plans to meet its liquidity needs primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through potential partnerships and/or financings. Based on the Company’s approved operating budget, current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, and proceeds available from the B. Riley Sales Agreement with B. Riley, management believes that its current cash will be sufficient to meet the anticipated cash needs for working capital and capital expenditures for at least the next 12 months from issuance of the financial statements. As of December 31, 2021, the Company had cash and cash equivalents of $26,043,897 as compared to $18,676,663 as of December 31, 2020, representing an increase of $7,367,234 or 39%. As of December 31, 2021, the Company had working capital of $20,278,345 as compared to working capital of $13,386,485, for the prior year, representing an increase of 51%. The increase in cash and cash equivalents was primarily the result of proceeds from financing activities partially offset by cash used in operations. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 FLASH (Florescent Light Activated Synthetic Hypericin) clinical trial of HyBryte™ in CTCL, 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. ● Expand development of synthetic hypericin under the research name SGX302 into psoriasis following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. ● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that the SGX942 Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) clinical trial, having missed its primary endpoint, would not support a potential marketing authorization and that a second Phase 3 study would be needed, analyze the DOM-INNATE study full dataset and design a second Phase 3 study; attempt to identify a potential partner(s) to continue this development program. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), CiVax™ (COVID-19 vaccine) and filovirus vaccines for Ebola, Sudan, and Marburg Viruses, with U.S. government 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 $1.35 million in active government grant funding still available as of December 31, 2021 to support its associated research programs through November 2022, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding; ● 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 $26.8 million remaining from the B. Riley Sales Agreement as of March 22, 2022 under the prospectus supplement updated August 13, 2021; and ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 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. Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2020 were reclassified to conform to the current year presentation. 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 (“Altamont”), 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 2021 and 2020 was $15,500 and $15,500, respectively, and accumulated amortization was $38,750 and $23,250, respectively, as of December 31, 2021 and 2020. Website development costs are included in the other assets in the accompanying consolidated balance sheets. Impairment of Long-Lived Assets Office furniture and equipment, and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 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 sheets 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 maturity of these instruments. The carrying amounts reported in the consolidated balance sheets for convertible debt and the loan under the Paycheck Protection Program (“PPP”) 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 license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. 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 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 years ended December 31, 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 84% - 87% for 2021 and 77% - 85% for 2020; and ● risk-free interest rates ranging from 0.27% to 1.13% in 2021 and 0.22% to 1.66% in 2020. The fair value of each option grant made during 2021 and 2020 was recognized as share-based compensation 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 years ended December 31, 2021 and 2020, respectively, The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2021 and 2020. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2021 or 2020. 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 R&D tax relief scheme are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of approximately $225,000 and $434,000 as of December 31, 2021 and 2020, respectively in the consolidated balance sheets. 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 — 122,877 122,877 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 1,634 (1,639) (5) Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 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. December 31, December 31, 2021 2020 Common stock purchase warrants 3,328,072 5,731,477 Stock options 2,115,825 1,933,804 Total 5,443,897 7,665,281 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 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. |
Leases
Leases | 12 Months Ended |
Dec. 31, 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 December 31, 2021 and 2020, the Company’s consolidated balance sheets included a right-of-use lease asset of $106,155 and $222,445 for the office space and $0 and $5,582 for the copy machine, respectively. Lease liabilities in the Company’s consolidated balance sheets as of December 31, 2021 and 2020 included corresponding lease liabilities of $106,151 and $112,294 for the office space and $0 and $6,149 for the copy machine, respectively. The following represent 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 Contractual cash payments for the remaining lease term as of December 31, 2021: 2022 $ 111,083 $ — Total $ 111,083 $ — Discount rate applied 10 % 10 % Remaining lease term (months) as of December 31, 2021 10 — Right-of-use lease asset: Right-of-use lease asset, January 1,2020 $ 112,388 $ 13,025 Add: new lease extension 240,727 — Less: reduction/amortization 130,670 7,443 Right-of-use lease asset, December 31, 2020 222,445 5,582 Less: reduction/amortization 116,290 5,582 Right-of-use lease asset, December 31, 2021 $ 106,155 $ — Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Add: new lease extension 240,727 Less: repayments 131,845 7,516 Lease liability, December 31, 2020 222,441 6,149 Less: repayments 116,290 6,149 Lease liability, December 31, 2021 $ 106,151 $ — Lease expenses for the year ending December 31, 2020: Lease expense $ 139,876 $ — Amortization expense — 7,443 Interest expense — 1,028 Total $ 139,876 $ 8,471 Lease expenses for the year ending December 31, 2021: Lease expense $ 133,300 $ — Amortization expense — 5,582 Interest expense — 259 Total $ 133,300 $ 5,841 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Accrued Expenses | Note 4. The following is a summary of the Company’s accrued expenses: December 31, 2021 2020 Clinical trial expenses $ 2,911,960 $ 2,510,111 Other 44,585 128,197 Total $ 2,956,545 $ 2,638,308 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Debt | Note 5. On December 16, 2020, the Company entered into a $20 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 had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and have an interest only period through December 2022 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. Affirmative covenants include, among others, covenants requiring us to protect and maintain our intellectual property and comply with all applicable laws, deliver certain financial reports, maintain a minimum cash balance and maintain insurance coverage. Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time over during the initial 12 months of the loan and the third tranche of $5 million upon filing of the HyBryte™ new drug application, subject to certain conditions. The Company has elected to let both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively. Interest expense incurred during the years ended December 31, 2021 and 2020 was $894,808 and $34,306, respectively. Interest expense paid during the years ended December 31, 2021 and 2020 was $668,715 and $34,306, respectively. The Company amortized $41,926 and $1,205 of issuance costs during the years ended December 31, 2021 and 2020, respectively. The net deferred issuance costs of $143,847 has been recorded as a reduction of the carrying value of the $10,000,000 convertible debt borrowed as of December 31, 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 is as follows: Year Principal Interest Total 2022 $ — $ 847,000 $ 847,000 2023 4,000,000 719,138 4,719,138 2024 4,000,000 380,338 4,380,338 2025 2,000,000 60,566 2,060,566 Total $ 10,000,000 $ 2,007,042 $ 12,007,042 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 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 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 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 maintains its employment and compensation within certain parameters during the forgiveness period and complied with other relevant conditions. The Company used the proceeds for purposes consistent with the PPP and met the conditions for the 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 | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | Note 6. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2021 and 2020: 2021 2020 Federal $ — $ — Foreign — — State (864,742) (836,893) Income tax benefit $ (864,742) $ (836,893) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2021 and 2020 are as follows: 2021 2020 Net operating loss carry forwards $ 28,065,000 $ 27,022,000 Orphan drug and research and development credit carry forwards 8,605,000 8,149,000 Equity based compensation 264,000 264,000 Intangibles 1,953,000 817,000 Total 38,887,000 36,252,000 Valuation allowance (38,887,000) (36,252,000) Net deferred tax assets $ — $ — The Company had gross NOLs at December 31, 2021 of approximately $123,800,000 for federal tax purposes, approximately $25,200,000 for state tax purposes and approximately $1,400,000 for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8,605,000 of various tax credits which credit the Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the NOL carry forwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs may be substantially limited. The Company and one or more of its subsidiaries files income tax returns in the U.S. Federal jurisdiction, and various state and local jurisdictions. During the year ended December 31, 2021 in accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carry forwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carry forwards, resulting in the recognition of $864,742 of income tax benefit, net of transaction costs. The Company has not yet sold its 2021 New Jersey NOLs but may do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended December 31, 2021 and 2020 were as follows: 2021 2020 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (7.6) (5.8) Foreign tax rate difference 0.1 0.1 Orphan drug and research and development credits (4.3) 4.8 Permanent differences 1.3 1.4 Foreign NOL adjustments 0.6 0.4 Expiration of tax attributes 4.9 6.9 Change in valuation allowance 19.6 8.7 Income tax benefit (6.4) % (4.5) % Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2021, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from 2011, the earliest year with a net operating loss carryover, because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2021 and 2020. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' 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 year ended December 31, 2021: ● During the year ended December 31, 2021, the Company issued 20 shares of common stock as a result of a warrant exercise. The weighted average exercise price per share was $ 3.95 . ● During the year ended December 31, 2021, the Company issued 12,174,515 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $1.62 per share. ● During the year ended December 31, 2021, the Company issued 30,254 shares of common stock as a result of option exercises. The weighted average exercise price per share was $0.85 . ● The Company issued a vendor 25,000 fully vested shares of common stock with a fair value of $1.10 per share on September 29, 2021. ● The Company issued 10,000 shares of restricted common stock on January 8, 2020, February 10, 2020 and March 12, 2020 for a total of 30,000 shares to a vendor as consideration for its service performed. The fair values for the shares issued were $1.68 , $2.25 and $1.97 per share, respectively. The shares were fully vested on the date of grant and resulted in the recognition of $59,000 of expense during the year ended December 31, 2020. ● On March 23, 2020, the Company issued 1,956,182 fully vested shares of common stock to Hy Biopharma, Inc. (“Hy Biopharma”) as payment for a milestone. The fair value of the shares was $2.56 per share. ● On November 25, 2020, the Company increased its authorized shares of common stock from 50,000,000 to 75,000,000 . ● During the year ended December 31, 2020, the Company issued 460,161 shares of common stock as a result of warrant exercises and 5,758 shares of common stock as a result of option exercises. The weighted average exercise price per warrant and option was $1.87 and $1.19 , respectively. The cash exercise price of $1,882 for 2,189 shares issued upon the exercise of such options was received in December 2019. ● During the year ended December 31, 2020, the Company issued 6,438,431 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $2.21 per share. All issuances of the Company’s common stock for the years ended December 31, 2021 and 2020 described above, other than shares issued under the B. Riley Sales Agreement and those issued to Hy Biopharma, were issued under the 2015 Plan and are registered on a Registration Statement on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act of 1933, as amended, restrictive legend. The shares issued to Hy Biopharma and those issued under the B. Riley Sales Agreement were registered on a Registration Statement on Form S-3 (SEC File No. 333-239928). B. Riley At Market Issuance Sales Agreement On August 11, 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 13, 2021, 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 $30.0 million under the July 2020 Registration Statement. As of March 22, 2022, there was $26.8 million available for the sale of common stock under the B. Riley Sales Agreement. |
Related Party Transaction
Related Party Transaction | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transaction | |
Related Party Transaction | Note 8. Related Party Transaction In February 2019, the Company issued Altamont, a company which owned 5% or more of the Company’s shares of common stock at the time, 12,845 shares of the Company’s common stock with a fair value of $9,120 as consideration for its contractual investor relations and web hosting services. The Company recognized $2,550 of expense for the services provided during the year ended December 31, 2020. |
Stock Option Plans and Warrants
Stock Option Plans and Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Stock Option Plans and Warrants to Purchase Common Stock | |
Stock Option Plans and Warrants to Purchase Common Stock | Note 9. Stock Option Plans and Warrants to Purchase Common Stock Stock Option Plans The Amended and Restated 2005 Equity Incentive Plan (“2005 Plan”) was replaced by the 2015 Plan, which was approved in June 2015. No securities are available for future issuance under the 2005 Plan. As of December 31, 2021, there are no shares currently available for grants under the 2015 Plan. In accordance with the 2015 Plan and the rules of the Nasdaq Stock Market, any additional grants offered may not be exercised until the Company’s stockholders approve an amendment increasing the number of shares authorized for issuance under the 2015 Plan. The plan is divided into four separate equity programs: 1) the Discretionary Option Grant Program, under which eligible persons may, at the discretion of the Plan Administrator, be granted options to purchase shares of common stock, 2) the Salary Investment Option Grant Program, under which eligible employees may elect to have a portion of their base salary invested each year in options to purchase shares of common stock, 3) the Automatic Option Grant Program, under which eligible nonemployee Board members will automatically receive options at periodic intervals to purchase shares of common stock, and 4) the Director Fee Option Grant Program, under which non-employee Board members may elect to have all, or any portion, of their annual retainer fee otherwise payable in cash applied to a special option grant. Shares available for grant under the 2015 Plan were as follows: Shares available for grant at January 1, 2021 214,689 Options granted (452,189) Options forfeited 207,246 Options exercised 30,254 Shares available for grant at December 31, 2021 — Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2021 and 2020 Weighted Average Exercise Options Price Balance outstanding at December 31, 2019 1,506,972 $ 3.77 Granted 520,812 2.17 Forfeited (88,222) 13.06 Exercised (5,758) 1.19 Balance outstanding at December 31, 2020 1,933,804 $ 2.96 Granted 452,189 0.91 Forfeited (239,914) 3.65 Exercised (30,254) 0.85 Balance outstanding at December 31, 2021 2,115,825 $ 2.48 As of December 31, 2021, there were 1,548,346 options exercisable with a weighted average exercise price of $2.89 and a weighted average remaining contractual term of 6.92 years. As of December 31, 2021, there were 2,115,825 options outstanding with a weighted average remaining term of 7.55 years. Options outstanding as of December 31, 2021 had no intrinsic value. Options exercised during the year ended December 31, 2021 had an intrinsic value of approximately $7,000 on the dates of exercise. The Company awarded 452,189 and 520,812 stock options during the years ended December 31, 2021 and 2020, respectively, which had a weighted average grant date fair value per share of $0.56 and $0.97, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2021 was: Weighted Average Remaining Contractual Outstanding Exercisable Price Range Life in Years Options Options $0.71-$3.00 7.97 1,941,203 1,373,724 $6.40-$15.60 3.13 129,310 129,310 $20.10-$22.60 2.00 45,312 45,312 Total 7.55 2,115,825 1,548,346 The Company’s share-based compensation expense for the years ended December 31, 2021 and 2020 was recognized as follows: Share-based compensation 2021 2020 Research and development $ 158,478 $ 195,560 General and administrative 203,081 214,373 Total $ 361,559 $ 409,933 At December 31, 2021, the total compensation cost for stock options not yet recognized was approximately $457,000 and will be expensed over the next three years. Warrants to Purchase Common Stock Warrant activity for the years ended December 31, 2021 and 2020 was as follows: Weighted Average Exercise Warrants Price Balance at December 31, 2019 6,192,711 $ 2.88 Granted — — Exercised (461,234) 1.87 Expired — — Balance at December 31, 2020 5,731,477 $ 2.96 Granted — — Exercised (20) 3.95 Expired (2,403,385) 3.95 Balance at December 31, 2021 3,328,072 $ 2.25 The remaining life, by grant date, for outstanding warrants at December 31, 2021 was: Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants 11/1/2017 $ 2.50 0.83 49,872 49,872 3/29/2018 $ 1.95 1.24 10,000 10,000 7/2/2018 $ 2.25 0.01 3,268,200 3,268,200 Total 3,328,072 3,328,072 |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2021 | |
Concentrations | |
Concentrations | Note 10. Concentrations At December 31, 2021 and 2020, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”). Currently, the Company is covered up to $250,000 by the SIPC and at times maintains cash balances in excess of the SIPC coverage. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 11. Commitments and Contingencies The Company has commitments of approximately $100,000 per year for the next five years at December 31, 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. In June 2018, the Company paid approximately $197,000 in milestone payments. The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease that 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 approximately $23.00 per square foot, and then decreased to approximately $11,108, or approximately $21.50 per square foot, starting November 2020, which rate will continue for the remainder of the lease period. On September 3, 2014, the Company entered into an asset purchase agreement with 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. The Company is required to issue Hy Biopharma shares of common stock upon the achievement of certain milestones. In March 2020, the Company issued 1,956,182 fully vested 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 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. As of December 31, 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 future contractual obligations over the next five years as follows: Research and Property and Year Development Other Leases Total 2022 $ 100,000 $ 111,083 $ 211,083 2023 100,000 — 100,000 2024 100,000 — 100,000 2025 100,000 — 100,000 2026 100,000 — 100,000 Total $ 500,000 $ 111,083 $ 611,083 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. COVID-19 Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus. Emergent BioSolutions Legal Proceedings On July 1, 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. 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. 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 sited in the pending arbitration. These invoices total approximately $331,000. |
Operating Segments
Operating Segments | 12 Months Ended |
Dec. 31, 2021 | |
Operating Segments | |
Operating Segments | Note 12. 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. For the Years Ended December 31, 2021 2020 Revenues Specialized BioTherapeutics $ — $ 117,369 Public Health Solutions 824,268 2,242,078 Total $ 824,268 $ 2,359,447 Loss from Operations Specialized BioTherapeutics $ (7,280,936) $ (13,610,715) Public Health Solutions (647,600) (85,417) Corporate (5,212,349) (4,890,375) Total $ (13,140,885) $ (18,586,507) Amortization and Depreciation Expense Specialized BioTherapeutics $ 7,804 $ 11,839 Public Health Solutions 16,801 21,672 Corporate 9,556 28,861 Total $ 34,161 $ 62,372 Other (Expense)/Income, Net Specialized BioTherapeutics $ 135,409 $ 71,974 Corporate (410,239) (10,882) Total $ (274,830) $ 61,092 Share-Based Compensation Specialized BioTherapeutics $ 136,594 $ 148,107 Public Health Solutions 21,884 47,453 Corporate 203,081 214,373 Total $ 361,559 $ 409,933 As of December 31, 2021 2020 Identifiable Assets Specialized BioTherapeutics $ 128,645 $ 176,447 Public Health Solutions 146,296 147,784 Corporate 26,594,986 19,567,004 Total $ 26,869,927 $ 19,891,235 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 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. |
Reclassifications | Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2020 were reclassified to conform to the current year presentation. |
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 (“Altamont”), 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 2021 and 2020 was $15,500 and $15,500, respectively, and accumulated amortization was $38,750 and $23,250, respectively, as of December 31, 2021 and 2020. Website development costs are included in the other assets in the accompanying consolidated balance sheets. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Office furniture and equipment, and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 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 sheets 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 maturity of these instruments. The carrying amounts reported in the consolidated balance sheets for convertible debt and the loan under the Paycheck Protection Program (“PPP”) 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 license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. |
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 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 years ended December 31, 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 84% - 87% for 2021 and 77% - 85% for 2020; and ● risk-free interest rates ranging from 0.27% to 1.13% in 2021 and 0.22% to 1.66% in 2020. The fair value of each option grant made during 2021 and 2020 was recognized as share-based compensation 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 years ended December 31, 2021 and 2020, respectively, The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2021 and 2020. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2021 or 2020. |
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 R&D tax relief scheme are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of approximately $225,000 and $434,000 as of December 31, 2021 and 2020, respectively in the consolidated balance sheets. 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 — 122,877 122,877 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 1,634 (1,639) (5) Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 |
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. December 31, December 31, 2021 2020 Common stock purchase warrants 3,328,072 5,731,477 Stock options 2,115,825 1,933,804 Total 5,443,897 7,665,281 |
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 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 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 — 122,877 122,877 Additional 2019 incentive earned 51,893 — 51,893 UK research and development incentives cash receipt (383,933) — (383,933) Foreign currency translation 1,634 (1,639) (5) Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | December 31, December 31, 2021 2020 Common stock purchase warrants 3,328,072 5,731,477 Stock options 2,115,825 1,933,804 Total 5,443,897 7,665,281 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Reconciliation of lease cash flows to the right-of-use lease assets and liabilities recognized in the financial statements. | Operating Financing Lease Lease Contractual cash payments for the remaining lease term as of December 31, 2021: 2022 $ 111,083 $ — Total $ 111,083 $ — Discount rate applied 10 % 10 % Remaining lease term (months) as of December 31, 2021 10 — Right-of-use lease asset: Right-of-use lease asset, January 1,2020 $ 112,388 $ 13,025 Add: new lease extension 240,727 — Less: reduction/amortization 130,670 7,443 Right-of-use lease asset, December 31, 2020 222,445 5,582 Less: reduction/amortization 116,290 5,582 Right-of-use lease asset, December 31, 2021 $ 106,155 $ — Lease liability: Lease liability, January 1, 2020 $ 113,559 $ 13,665 Add: new lease extension 240,727 Less: repayments 131,845 7,516 Lease liability, December 31, 2020 222,441 6,149 Less: repayments 116,290 6,149 Lease liability, December 31, 2021 $ 106,151 $ — Lease expenses for the year ending December 31, 2020: Lease expense $ 139,876 $ — Amortization expense — 7,443 Interest expense — 1,028 Total $ 139,876 $ 8,471 Lease expenses for the year ending December 31, 2021: Lease expense $ 133,300 $ — Amortization expense — 5,582 Interest expense — 259 Total $ 133,300 $ 5,841 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, 2021 2020 Clinical trial expenses $ 2,911,960 $ 2,510,111 Other 44,585 128,197 Total $ 2,956,545 $ 2,638,308 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Schedule of principle and interest payments due | Year Principal Interest Total 2022 $ — $ 847,000 $ 847,000 2023 4,000,000 719,138 4,719,138 2024 4,000,000 380,338 4,380,338 2025 2,000,000 60,566 2,060,566 Total $ 10,000,000 $ 2,007,042 $ 12,007,042 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2021 2020 Federal $ — $ — Foreign — — State (864,742) (836,893) Income tax benefit $ (864,742) $ (836,893) |
Schedule of deferred tax assets and liabilities | 2021 2020 Net operating loss carry forwards $ 28,065,000 $ 27,022,000 Orphan drug and research and development credit carry forwards 8,605,000 8,149,000 Equity based compensation 264,000 264,000 Intangibles 1,953,000 817,000 Total 38,887,000 36,252,000 Valuation allowance (38,887,000) (36,252,000) Net deferred tax assets $ — $ — |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2021 2020 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (7.6) (5.8) Foreign tax rate difference 0.1 0.1 Orphan drug and research and development credits (4.3) 4.8 Permanent differences 1.3 1.4 Foreign NOL adjustments 0.6 0.4 Expiration of tax attributes 4.9 6.9 Change in valuation allowance 19.6 8.7 Income tax benefit (6.4) % (4.5) % |
Stock Option Plans and Warran_2
Stock Option Plans and Warrants to Purchase Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Grant 2015 Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of shares available for grant under the 2015 plan | Shares available for grant at January 1, 2021 214,689 Options granted (452,189) Options forfeited 207,246 Options exercised 30,254 Shares available for grant at December 31, 2021 — |
Stock options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of activity under the 2005 plan and the 2015 plan | Weighted Average Exercise Options Price Balance outstanding at December 31, 2019 1,506,972 $ 3.77 Granted 520,812 2.17 Forfeited (88,222) 13.06 Exercised (5,758) 1.19 Balance outstanding at December 31, 2020 1,933,804 $ 2.96 Granted 452,189 0.91 Forfeited (239,914) 3.65 Exercised (30,254) 0.85 Balance outstanding at December 31, 2021 2,115,825 $ 2.48 |
Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock | Weighted Average Remaining Contractual Outstanding Exercisable Price Range Life in Years Options Options $0.71-$3.00 7.97 1,941,203 1,373,724 $6.40-$15.60 3.13 129,310 129,310 $20.10-$22.60 2.00 45,312 45,312 Total 7.55 2,115,825 1,548,346 |
Share-based Payment Arrangement | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of share-based compensation expense | Share-based compensation 2021 2020 Research and development $ 158,478 $ 195,560 General and administrative 203,081 214,373 Total $ 361,559 $ 409,933 |
Warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of warrant activity | Weighted Average Exercise Warrants Price Balance at December 31, 2019 6,192,711 $ 2.88 Granted — — Exercised (461,234) 1.87 Expired — — Balance at December 31, 2020 5,731,477 $ 2.96 Granted — — Exercised (20) 3.95 Expired (2,403,385) 3.95 Balance at December 31, 2021 3,328,072 $ 2.25 |
Schedule of remaining life, by grant date, for outstanding warrants | Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants 11/1/2017 $ 2.50 0.83 49,872 49,872 3/29/2018 $ 1.95 1.24 10,000 10,000 7/2/2018 $ 2.25 0.01 3,268,200 3,268,200 Total 3,328,072 3,328,072 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total 2022 $ 100,000 $ 111,083 $ 211,083 2023 100,000 — 100,000 2024 100,000 — 100,000 2025 100,000 — 100,000 2026 100,000 — 100,000 Total $ 500,000 $ 111,083 $ 611,083 |
Operating Segments (Tables)
Operating Segments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Operating Segments | |
Schedule of operating segments | For the Years Ended December 31, 2021 2020 Revenues Specialized BioTherapeutics $ — $ 117,369 Public Health Solutions 824,268 2,242,078 Total $ 824,268 $ 2,359,447 Loss from Operations Specialized BioTherapeutics $ (7,280,936) $ (13,610,715) Public Health Solutions (647,600) (85,417) Corporate (5,212,349) (4,890,375) Total $ (13,140,885) $ (18,586,507) Amortization and Depreciation Expense Specialized BioTherapeutics $ 7,804 $ 11,839 Public Health Solutions 16,801 21,672 Corporate 9,556 28,861 Total $ 34,161 $ 62,372 Other (Expense)/Income, Net Specialized BioTherapeutics $ 135,409 $ 71,974 Corporate (410,239) (10,882) Total $ (274,830) $ 61,092 Share-Based Compensation Specialized BioTherapeutics $ 136,594 $ 148,107 Public Health Solutions 21,884 47,453 Corporate 203,081 214,373 Total $ 361,559 $ 409,933 As of December 31, 2021 2020 Identifiable Assets Specialized BioTherapeutics $ 128,645 $ 176,447 Public Health Solutions 146,296 147,784 Corporate 26,594,986 19,567,004 Total $ 26,869,927 $ 19,891,235 |
Nature of Business (Details)
Nature of Business (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Aug. 13, 2021USD ($) | |
Nature of Business | |||
Number of operating segments | segment | 2 | ||
Accumulated deficit | $ (205,765,107) | $ (193,214,134) | |
Net loss | (12,550,973) | (17,688,522) | |
Net cash used in operating activities | (11,739,620) | (11,454,426) | |
Cash and cash equivalents | 26,043,897 | 18,676,663 | |
Increase of cash and cash equivalents | $ 7,367,234 | ||
Percentage change in cash and cash equivalent | 39.00% | ||
Working capital | $ 20,278,345 | $ 13,386,485 | |
Working capital increase (decrease) as a percent | 51.00% | ||
Contracts and grants receivable | $ 138,889 | $ 203,774 | |
FBR Sales Agreement [Member] | |||
Nature of Business | |||
Borrowing Capacity | $ 26,800,000 | ||
CiVax | |||
Nature of Business | |||
Term (in years) | two years | ||
Subcontract revenue | $ 1,500,000 | ||
NIH | |||
Nature of Business | |||
Contracts and grants receivable | $ 1,350,000 | ||
NIAID | Contract revenue | |||
Nature of Business | |||
Term (in years) | five years | ||
Subcontract revenue | $ 700,000 | ||
DTRA | Contract revenue | |||
Nature of Business | |||
Term (in years) | three years | ||
Subcontract revenue | $ 600,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2019USD ($) | Sep. 30, 2019 | Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Feb. 28, 2019 | |
Finite-Lived Intangible Assets [Line Items] | |||||
Number of operating segments | segment | 2 | ||||
Website development cost | $ 46,500 | ||||
Amortization and depreciation | $ 34,161 | $ 62,372 | |||
Requisite period (in years) | 3 years | ||||
Expiration period | 10 years | ||||
Stock option vesting, description | 25% | ||||
Dividend yield | 0.00% | 0.00% | |||
Expected term | 4 years | ||||
Volatility rate minimum | 84.00% | 77.00% | |||
Volatility rate maximum | 87.00% | 85.00% | |||
Risk free interest rate, minimum | 0.27% | 0.22% | |||
Risk free interest rate, maximum | 1.13% | 1.66% | |||
Foreign currency transaction gain (loss) | $ (39,361) | $ (23,385) | |||
Income tax benefit | (864,742) | (836,893) | |||
Interest and penalties | 0 | 0 | |||
Foreign currency translation loss as cumulative translation adjustment | 41,942 | (24,337) | |||
Research and development incentive receivable | $ 225,000 | 434,000 | |||
Termination benefits | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Expiration period | 3 months | ||||
Altamont Pharmaceutical Holdings, LLC | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Ownership (as a percent) | 5.00% | ||||
Director [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Requisite period (in years) | 1 year | ||||
Website development | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Intangible assets, estimated useful life | 3 years | ||||
Intangible, amortization expense | $ 15,500 | 15,500 | |||
Intangible, accumulated amortization | $ 38,750 | $ 23,250 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - UK (Details) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance | $ 434,238 |
UK research and development incentives | 122,877 |
Additional 2019 incentive earned | 51,893 |
UK research and development incentives cash receipt | (383,933) |
Foreign currency translation | (5) |
Balance | 225,070 |
Current | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance | 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 | 1,634 |
Balance | 103,832 |
Long Term | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Balance | 73,142 |
UK research and development incentives, transfer | (73,142) |
UK research and development incentives | 122,877 |
Foreign currency translation | (1,639) |
Balance | $ 121,238 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Loss per share (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 5,443,897 | 7,665,281 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 3,328,072 | 5,731,477 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded | 2,115,825 | 1,933,804 |
Leases (Details)
Leases (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Leases | |||
Operating Lease, Right-of-use lease asset, end | $ 106,155 | $ 222,445 | $ 112,388 |
Right-of-use asset financing lease | 0 | 5,582 | 13,025 |
Lease liability - Operating lease | 106,151 | 112,294 | |
Lease liability - financing lease | $ 0 | $ 6,149 | $ 13,665 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Assets Held-in-trust, Noncurrent | Assets Held-in-trust, Noncurrent | Assets Held-in-trust, Noncurrent |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Assets Held-in-trust, Noncurrent | Assets Held-in-trust, Noncurrent | Assets Held-in-trust, Noncurrent |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease Liabilities Current | Lease Liabilities Current | Lease Liabilities Current |
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Lease Liabilities Current, Lease Liabilities Noncurrent | Lease Liabilities Current, Lease Liabilities Noncurrent | Lease Liabilities Current, Lease Liabilities Noncurrent |
Leases - Contractual cash payme
Leases - Contractual cash payments for the remaining lease term (Details) | Dec. 31, 2021USD ($) |
Leases | |
Operating, Lease, 2022 | $ 111,083 |
Operating Lease, Total | $ 106,151 |
Operating Lease, Discount rate applied | 10.00% |
Financing Lease, Discount rate applied | 10.00% |
Financing Lease, Remaining lease term (months) | 0 months |
Leases - Reconciliation (Detail
Leases - Reconciliation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Right-of-use lease asset: | ||
Operating Lease, Right-of-use lease asset, beginning | $ 222,445 | $ 112,388 |
Financing Lease, Right-of-use lease asset, beginning | 5,582 | 13,025 |
Operating Lease, Add: new lease extension | 240,727 | |
Operating Lease, Less: reduction/amortization | 116,290 | 130,670 |
Finance Lease, Less: reduction/amortization | 5,582 | 7,443 |
Operating Lease, Right-of-use lease asset, end | 106,155 | 222,445 |
Financing Lease, Right-of-use lease asset, end | 0 | 5,582 |
Lease liability: | ||
Operating lease liability, beginning | 222,441 | 113,559 |
Finance Lease liability, Beginning | 6,149 | 13,665 |
Operating Lease, Add: new lease extension | 240,727 | |
Operating Lease, Less: repayments | 116,290 | 131,845 |
Financing Lease, Less: repayments | 6,149 | 7,516 |
Operating lease liability, end | 106,151 | 222,441 |
Financing Lease liability, Ending | 0 | 6,149 |
Lease expenses | ||
Finance Lease, Amortization expense | 5,582 | 7,443 |
Finance Lease, Interest Expense | 259 | 1,028 |
Operating Lease, Total | 133,300 | 139,876 |
Financing Lease, Total | $ 5,841 | $ 8,471 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses | ||
Clinical trial expenses | $ 2,911,960 | $ 2,510,111 |
Other | 44,585 | 128,197 |
Total | $ 2,956,545 | $ 2,638,308 |
Debt (Details)
Debt (Details) - USD ($) | Dec. 16, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 13, 2020 |
Debt Instrument [Line Items] | ||||
Gain on forgiveness of PPP loan | $ 421,584 | |||
Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt Instrument, Face Amount | $ 20,000,000 | |||
Number of Tranches | three | |||
Effective interest rate | 8.47% | |||
Interest rate amounts available but not accessed | 1.00% | |||
Interest expense | 894,808 | $ 34,306 | ||
Interest paid | 668,715 | 34,306 | ||
Amortized issuance costs | 41,926 | $ 1,205 | ||
Net cost | 143,847 | |||
Convertible debt borrowed | $ 10,000,000 | |||
Conversion price (in Dollars per share) | $ 4.10 | |||
Convertible Debt [Member] | Maximum [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt Instrument, Face Amount | $ 20,000,000 | |||
First Tranche [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Convertible note | 10,000,000 | |||
Second Tranche [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Convertible note | 5,000,000 | |||
Third Tranche [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Convertible note | $ 5,000,000 | |||
CARES Act Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 417,830 | |||
Bears interest rate | 0.98% | |||
Loan proceeds percentage | 60.00% |
Debt - Schedule of principle an
Debt - Schedule of principle and interest payments due (Details) | Dec. 31, 2021USD ($) |
Debt Instrument [Line Items] | |
2022 | $ 847,000 |
2023 | 4,719,138 |
2024 | 4,380,338 |
2025 | 2,060,566 |
Total | 12,007,042 |
Principal [Member] | |
Debt Instrument [Line Items] | |
2022 | 0 |
2023 | 4,000,000 |
2024 | 4,000,000 |
2025 | 2,000,000 |
Total | 10,000,000 |
Interest [Member] | |
Debt Instrument [Line Items] | |
2022 | 847,000 |
2023 | 719,138 |
2024 | 380,338 |
2025 | 60,566 |
Total | $ 2,007,042 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Taxes | ||
NOL for Federal tax | $ 123,800,000 | |
NOL for State tax | 25,200,000 | |
NOL for Foreign tax | 1,400,000 | |
Various tax credits, amount | 8,605,000 | |
NOL carryforwards | 864,742 | |
Unrecognized tax benefits | 0 | $ 0 |
Interest or penalties accrued | $ 0 |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income tax benefit (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Federal | $ 0 | $ 0 |
Foreign | 0 | 0 |
State | (864,742) | (836,893) |
Income tax benefit | $ (864,742) | $ (836,893) |
Income Taxes - Schedule of defe
Income Taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Taxes | ||
Net operating loss carry forwards | $ 28,065,000 | $ 27,022,000 |
Orphan drug and research and development credit carry forwards | 8,605,000 | 8,149,000 |
Equity based compensation | 264,000 | 264,000 |
Intangibles | 1,953,000 | 817,000 |
Deferred tax assets, gross | 38,887,000 | 36,252,000 |
Valuation allowance | (38,887,000) | (36,252,000) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of fede
Income Taxes - Schedule of federal and state statutory tax rates and the provision for income tax benefit (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Federal tax at statutory rate | (21.00%) | (21.00%) |
State tax benefits, plus sale of NJ NOL, net of federal benefit | (7.60%) | (5.80%) |
Foreign tax rate difference | 0.10% | 0.10% |
Orphan drug and research and development credits | (4.30%) | 4.80% |
Permanent differences | 1.30% | 1.40% |
Foreign NOL adjustments | 0.60% | 0.40% |
Expiration of tax attributes | 4.90% | 6.90% |
Change in valuation allowance | 19.60% | 8.70% |
Income tax benefit | (6.40%) | (4.50%) |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) | Sep. 29, 2021 | Mar. 23, 2020 | Aug. 11, 2017 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 28, 2022 | Aug. 13, 2021 | Nov. 25, 2020 | Nov. 24, 2020 | Mar. 31, 2020 | Mar. 12, 2020 | Feb. 10, 2020 | Jan. 08, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | |||||||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | 350,000 | ||||||||||||
Preferred Stock, Shares Issued | 0 | 0 | 0 | ||||||||||||
Preferred Stock, Shares Outstanding | 0 | 0 | 0 | ||||||||||||
Shares issues (in shares) | 1,933,804 | 2,115,825 | 1,933,804 | 1,506,972 | |||||||||||
Weighted Average Options Exercise Price Granted | $ 0.91 | $ 2.17 | |||||||||||||
Exercise of common stock options (in shares) | 30,254 | 5,758 | |||||||||||||
Weighted average exercise price (in Dollars per share) | $ 0.85 | $ 1.19 | |||||||||||||
Stock Issued During Period, Shares, New Issues | 25,000 | ||||||||||||||
Weighted average price per share (in Dollars per share) | $ 1.10 | ||||||||||||||
Recognition expense (in Dollars) | $ 59,000 | ||||||||||||||
Common Stock, Shares Authorized | 75,000,000 | 75,000,000 | 75,000,000 | 75,000,000 | 50,000,000 | ||||||||||
Exercise of common stock options (in Dollars) | $ 1,882 | ||||||||||||||
Exercise of common stock options | $ 25,835 | $ 4,987 | |||||||||||||
Exercise of common stock options, Shares | 2,189 | ||||||||||||||
Subsequent Event [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Common stock available for sale (in Dollars) | $ 26,800,000 | ||||||||||||||
Maximum [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Aggregate offering price (in Dollars) | $ 30,000,000 | ||||||||||||||
B.Riley Sales Agreement [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Threshold Percentage of Compensation from Gross Proceeds | 3.00% | ||||||||||||||
FBR Capital Markets & Co. [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issues (in shares) | 6,438,431 | 12,174,515 | 6,438,431 | ||||||||||||
Weighted Average Options Exercise Price Granted | $ 1.62 | $ 2.21 | |||||||||||||
Common Stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Warrants issued to purchase shares | 20 | 460,161 | |||||||||||||
Warrants exercise price (in Dollars per share) | $ 3.95 | $ 1.87 | |||||||||||||
Exercise of common stock options (in shares) | 30,254 | 5,758 | |||||||||||||
Weighted average exercise price (in Dollars per share) | $ 1.19 | ||||||||||||||
Issuance of common stock to vendors (in shares) | 1,956,182 | 25,000 | 30,000 | ||||||||||||
Restricted common stock shares issued to vendors | 30,000 | 10,000 | 10,000 | 10,000 | |||||||||||
Fair value of share (in Dollars per share) | $ 2.56 | $ 1.97 | $ 2.25 | $ 1.68 | |||||||||||
Issuance of common stock for milestones (in shares) | 1,956,182 | ||||||||||||||
Exercise of common stock options | $ 30 | $ 6 |
Related Party Transaction (Deta
Related Party Transaction (Details) - USD ($) | Sep. 29, 2021 | Jun. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 28, 2019 |
Related Party Transaction [Line Items] | |||||
Issued shares of common stock (in Shares) | 25,000 | ||||
Fair value amount | $ 9,120 | ||||
Website development cost | $ 46,500 | ||||
Hosting services | $ 2,550 | ||||
Website development | |||||
Related Party Transaction [Line Items] | |||||
Intangible, amortization expense | $ 15,500 | $ 15,500 |
Stock Option Plans and Warran_3
Stock Option Plans and Warrants to Purchase Common Stock (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | |||
Weighted average exercise price (in Dollars per share) | $ 0.85 | $ 1.19 | |
Options outstanding | 2,115,825 | 1,933,804 | 1,506,972 |
Total compensation cost (in Dollars) | $ 457,000 | ||
Stock Option Plans [Member] | |||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | |||
Exercisable options | 1,548,346 | ||
Weighted average exercise price (in Dollars per share) | $ 2.89 | ||
Exercisable, weighted average remaining contractual term | 6 years 11 months 1 day | ||
Options outstanding | 2,115,825 | ||
Weighted Average Remaining Term | 7 years 6 months 18 days | ||
Stock options awarded | 452,189 | 520,812 | |
Fair value per share (in Dollars per share) | $ 0.56 | $ 0.97 |
Stock Option Plans and Warran_4
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of shares available for grant under the 2015 plan (Details) - Grant 2015 Plan | 12 Months Ended |
Dec. 31, 2021shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of shares available for grant under the 2015 plan [Line Items] | |
Shares available for grant | 214,689 |
Options granted | (452,189) |
Options forfeited | 207,246 |
Options exercised | 30,254 |
Stock Option Plans and Warran_5
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of activity under the 2005 plan and the 2015 plan (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of activity under the 2005 plan and the 2015 plan [Abstract] | ||
Options outstanding beginning balance | 1,933,804 | 1,506,972 |
Weighted Average Options Exercise Price outstanding beginning balance | $ 2.96 | $ 3.77 |
Options outstanding ending balance | 2,115,825 | 1,933,804 |
Weighted Average Options Exercise Price outstanding ending balance | $ 2.48 | $ 2.96 |
Options Granted | 452,189 | 520,812 |
Weighted Average Options Exercise Price Granted | $ 0.91 | $ 2.17 |
Options Forfeited | (239,914) | (88,222) |
Weighted Average Options Exercise Price Forfeited | $ 3.65 | $ 13.06 |
Options Exercised | (30,254) | (5,758) |
Weighted Average Options Exercise Price Exercised | $ 0.85 | $ 1.19 |
Stock Option Plans and Warran_6
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock (Details) - Stock options | 12 Months Ended |
Dec. 31, 2021shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Weighted Average Remaining Contractual Life in Years | 7 years 6 months 18 days |
Outstanding Options | 2,115,825 |
Exercisable Options | 1,548,346 |
$0.71-$2.79 [Member] | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Weighted Average Remaining Contractual Life in Years | 7 years 11 months 19 days |
Outstanding Options | 1,941,203 |
Exercisable Options | 1,373,724 |
$6.40-$15.60 [Member] | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Weighted Average Remaining Contractual Life in Years | 3 years 1 month 17 days |
Outstanding Options | 129,310 |
Exercisable Options | 129,310 |
$20.00-$39.80 [Member] | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Weighted Average Remaining Contractual Life in Years | 2 years |
Outstanding Options | 45,312 |
Exercisable Options | 45,312 |
Stock Option Plans and Warran_7
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of share-based compensation expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||
Share-based compensation, Total | $ 361,559 | $ 409,933 |
Research and development [Member] | ||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||
Share-based compensation, Total | 158,478 | 195,560 |
General and administrative [Member] | ||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||
Share-based compensation, Total | $ 203,081 | $ 214,373 |
Stock Option Plans and Warran_8
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of warrant activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||
Warrants, Granted | 452,189 | 520,812 |
Weighted Average Exercise Price, Granted | $ 0.91 | $ 2.17 |
Exercise of common stock options (in shares) | 30,254 | 5,758 |
Weighted Average Exercise Price, Exercised | $ 0.85 | $ 1.19 |
Warrants | ||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||
Warrants opening, Balance | 5,731,477 | 6,192,711 |
Weighted Average Exercise Price opening, Balance | $ 2.96 | $ 2.88 |
Warrants closing, Balance | 3,328,072 | 5,731,477 |
Weighted Average Exercise Price closing, Balance | $ 2.25 | $ 2.96 |
Exercise of common stock options (in shares) | (20) | (461,234) |
Weighted Average Exercise Price, Exercised | $ 3.95 | $ 1.87 |
Warrants, Expired | (2,403,385) | |
Weighted Average Exercise Price, Expired | $ 3.95 |
Stock Option Plans and Warran_9
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of remaining life, by grant date, for outstanding warrants (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding Warrants | 3,328,072 |
Exercisable Warrants | 3,328,072 |
11/1/2017 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price (in Dollars per share) | $ / shares | $ 2.50 |
Remaining Contractual Life in Years | 9 months 29 days |
Outstanding Warrants | 49,872 |
Exercisable Warrants | 49,872 |
3/29/2018 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price (in Dollars per share) | $ / shares | $ 1.95 |
Remaining Contractual Life in Years | 1 year 2 months 26 days |
Outstanding Warrants | 10,000 |
Exercisable Warrants | 10,000 |
7/2/2018 [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price (in Dollars per share) | $ / shares | $ 2.25 |
Remaining Contractual Life in Years | 3 days |
Outstanding Warrants | 3,268,200 |
Exercisable Warrants | 3,268,200 |
Concentrations (Details)
Concentrations (Details) | Dec. 31, 2021USD ($) |
Concentrations | |
Deposits | $ 250,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Sep. 03, 2014USD ($)shares | Jul. 31, 2020USD ($) | Mar. 31, 2020USD ($)$ / shares | Jan. 31, 2020USD ($) | Oct. 31, 2020USD ($)$ / ft² | Dec. 31, 2021USD ($)m² | Dec. 31, 2021USD ($)m²$ / ft² |
Other Commitments [Line Items] | |||||||
Commitments related to agreements | $ 100,000 | $ 100,000 | |||||
Maximum payment for commitment milestones | $ 7,900,000 | ||||||
Percentage for royalties | 6.00% | ||||||
Payments of milestone amount | $ 197,000 | ||||||
Office space (in Square Meters) | m² | 6,200 | 6,200 | |||||
Rent Expense Per Month | $ 11,883 | $ 11,108 | |||||
Rent Expense per Square Foot | $ / ft² | 23 | 21.50 | |||||
Cash paid to acquire Hy Biopharma intangible asset | $ 275,000 | ||||||
Shares issued in connection with Hy BioPharma asset purchase agreement (in Shares) | shares | 184,912 | ||||||
Fair value of shares issued in connection with Hy BioPharma asset purchase | $ 3,750,000 | $ 1,956,182 | |||||
Effective price per share (in Dollars per share) | $ / shares | $ 2.56 | ||||||
Additional Payments | $ 5,000,000 | ||||||
Ownership of company outstanding | 19.90% | ||||||
Emergent Biosolutions [Member] | |||||||
Other Commitments [Line Items] | |||||||
Amount of damages to be recovered | $ 19,000,000 | ||||||
Invoices | $ 331,000 | ||||||
Minimum [Member] | |||||||
Other Commitments [Line Items] | |||||||
Authorized shares to be issued | $ 5,000 | ||||||
Maximum [Member] | |||||||
Other Commitments [Line Items] | |||||||
Authorized shares to be issued | $ 500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of contractual obligation (Details) | Dec. 31, 2021USD ($) |
Other Commitments [Line Items] | |
2022 | $ 211,083 |
2023 | 100,000 |
2024 | 100,000 |
2025 | 100,000 |
2026 | 100,000 |
Total | 611,083 |
Licensing Fee [Member] | |
Other Commitments [Line Items] | |
2022 | 100,000 |
2023 | 100,000 |
2024 | 100,000 |
2025 | 100,000 |
2026 | 100,000 |
Total | 500,000 |
Property and Other Leases [Member] | |
Other Commitments [Line Items] | |
2022 | 111,083 |
Total | $ 111,083 |
Operating Segments (Details)
Operating Segments (Details) | 12 Months Ended |
Dec. 31, 2021segment | |
Operating Segments | |
Number of operating segments | 2 |
Operating Segments - Schedule o
Operating Segments - Schedule of operating segments (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Segment Reporting Information [Line Items] | ||
Revenues | $ 824,268 | $ 2,359,447 |
Loss from Operations | (13,140,885) | (18,586,507) |
Amortization and Depreciation Expense | 34,161 | 62,372 |
Other (Expense)/Income, Net | (274,830) | 61,092 |
Share-Based Compensation | 361,559 | 409,933 |
Identifiable Assets | 26,869,927 | 19,891,235 |
Public Health Solutions [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 824,268 | 2,242,078 |
Loss from Operations | (647,600) | (85,417) |
Amortization and Depreciation Expense | 16,801 | 21,672 |
Share-Based Compensation | 21,884 | 47,453 |
Identifiable Assets | 146,296 | 147,784 |
Specialized BioTherapeutics [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 117,369 | |
Loss from Operations | (7,280,936) | (13,610,715) |
Amortization and Depreciation Expense | 7,804 | 11,839 |
Other (Expense)/Income, Net | 135,409 | 71,974 |
Share-Based Compensation | 136,594 | 148,107 |
Identifiable Assets | 128,645 | 176,447 |
Corporate [Member] | ||
Segment Reporting Information [Line Items] | ||
Loss from Operations | (5,212,349) | (4,890,375) |
Amortization and Depreciation Expense | 9,556 | 28,861 |
Other (Expense)/Income, Net | (410,239) | (10,882) |
Share-Based Compensation | 203,081 | 214,373 |
Identifiable Assets | $ 26,594,986 | $ 19,567,004 |
Uncategorized Items - tmb-20211
Label | Element | Value |
Operating Lease, Weighted Average Remaining Lease Term | us-gaap_OperatingLeaseWeightedAverageRemainingLeaseTerm1 | 10 months |