Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 18, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | AzurRx BioPharma, Inc. | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Amendment Flag | false | |
Entity Central Index Key | 0001604191 | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 78,575,131 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | DE | |
Entity File Number | 001-37853 | |
Entity Current Reporting Status | Yes | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash | $ 12,025,632 | $ 6,062,141 |
Other receivables | 501,660 | 551,489 |
Prepaid expenses | 643,131 | 1,256,154 |
Total current assets | 13,170,423 | 7,869,784 |
Property, equipment, and leasehold improvements, net | 92 | 18,329 |
Other Assets: | ||
Patents, net | 2,747,649 | 2,879,536 |
Goodwill | 1,973,963 | 2,054,048 |
Operating lease right-of-use assets | 61,524 | 74,238 |
Deposits | 29,242 | 27,920 |
Total other assets | 4,812,378 | 5,035,742 |
Total assets | 17,982,893 | 12,923,855 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 1,707,841 | 1,685,603 |
Payable related to license agreement | 1,250,000 | 13,250,000 |
Accrued dividends payable | 204,382 | 0 |
Notes payable | 347,082 | 552,405 |
Other current liabilities | 65,335 | 57,417 |
Total current liabilities | 3,574,640 | 15,545,425 |
Other liabilities | 6,566 | 19,123 |
Total liabilities | 3,581,206 | 15,564,548 |
Stockholders' Equity: | ||
Common stock - par value $0.0001 per share; 250,000,000 and 150,000,000 shares authorized; 74,926,902 and 31,150,309 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. | 7,493 | 3,115 |
Additional paid in capital | 118,693,364 | 93,834,936 |
Accumulated deficit | (103,051,827) | (95,366,198) |
Accumulated other comprehensive loss | (1,247,343) | (1,112,546) |
Total stockholders' equity | 14,401,687 | (2,640,693) |
Total liabilities and stockholders' equity | 17,982,893 | 12,923,855 |
Series B Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series C Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Common stock shares, par value | $ .0001 | $ 0.0001 |
Common stock shares, authorized | 250,000,000 | 150,000,000 |
Common stock shares, issued | 74,926,902 | 31,150,309 |
Common stock shares, outstanding | 74,926,902 | 31,150,309 |
Series B Preferred Stock | ||
Preferred stock shares, par value | $ .0001 | $ 0.0001 |
Preferred stock shares, authorized | 5,194.81 | 5,194.81 |
Preferred stock shares, issued | 1,209.52 | 2,773.6 |
Preferred stock shares, outstanding | 1,209.52 | 2,773.6 |
Series C Preferred Stock | ||
Preferred stock shares, par value | $ .0001 | $ .0001 |
Preferred stock shares, authorized | 75,000 | 75,000 |
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Statement [Abstract] | ||
Research and development expenses | $ 2,516,027 | $ 1,548,831 |
General and administrative expenses | 5,697,514 | 1,379,620 |
Total operating expenses | 8,213,541 | 2,928,451 |
Loss from operations | (8,213,541) | (2,928,451) |
Other income (expenses): | ||
Interest expense | (5,144) | (2,332,839) |
Interest income | 403 | 0 |
Change in fair value of liability | 532,653 | 0 |
Total other | 527,912 | (2,332,839) |
Loss before income taxes | (7,685,629) | (5,261,290) |
Income taxes | 0 | 0 |
Net loss | (7,685,629) | (5,261,290) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | (134,797) | 157,494 |
Total comprehensive loss | (7,820,426) | (5,103,796) |
Net loss | (7,685,629) | (5,261,290) |
Deemed dividend on preferred stock issuances | (4,507,125) | 0 |
Deemed dividend of preferred stock exchanges | (17,584,048) | 0 |
Preferred stock dividends | (204,382) | 0 |
Net loss applicable to common stockholders | $ (29,981,184) | $ (5,261,290) |
Basic and diluted weighted average shares outstanding | 55,348,130 | 26,941,803 |
Loss per share - basic and diluted | $ (0.14) | $ (0.20) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) | Series C Preferred Stock | Series B Preferred Stock | Common Stock | Additional Paid In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
Beginning balance, shares at Dec. 31, 2019 | 0 | 0 | 26,800,519 | ||||
Beginning balance, amount at Dec. 31, 2019 | $ 0 | $ 0 | $ 2,680 | $ 68,575,851 | $ (62,694,732) | $ (1,266,555) | $ 4,617,244 |
Common stock issued to settle related payable accounts payable, shares | 105,937 | ||||||
Common stock issued to settle related payable accounts payable, amount | $ 11 | 131,126 | 131,137 | ||||
Common stock and warrants issued to consultants, shares | 101,195 | ||||||
Common stock and warrants issued to consultants, amount | $ 10 | 87,095 | 87,105 | ||||
Common stock issued to Lincoln Park for Equity Purchase Agreement, shares | 150,000 | ||||||
Common stock issued to Lincoln Park for Equity Purchase Agreement, amount | $ 15 | 143,985 | 144,000 | ||||
Warrants issued in association with convertible debt issuances | 1,252,558 | 1,252,558 | |||||
Beneficial conversion feature on convertible debt issuances | 1,838,422 | 1,838,422 | |||||
Stock-based compensation | 74,453 | 74,453 | |||||
Foreign currency translation adjustment | 157,494 | 157,494 | |||||
Net loss | (5,261,290) | (5,261,290) | |||||
Ending balance, shares at Mar. 31, 2020 | 0 | 0 | 27,157,651 | ||||
Ending balance, amount at Mar. 31, 2020 | $ 0 | $ 0 | $ 2,716 | 72,103,490 | (67,956,022) | (1,109,061) | 3,041,123 |
Beginning balance, shares at Dec. 31, 2020 | 0 | 2,774 | 31,150,309 | ||||
Beginning balance, amount at Dec. 31, 2020 | $ 0 | $ 0 | $ 3,115 | 93,834,936 | (95,366,198) | (1,112,546) | (2,640,693) |
Issuance of Series C preferred stock and warrants for cash, net of offering costs, shares | 10,667 | ||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs, amount | $ 1 | 7,105,167 | 7,105,167 | ||||
Issuance of Series C preferred stock to settle liability arising from acquisition, shares | 3,290 | ||||||
Issuance of Series C preferred stock to settle liability arising from acquisition, amount | $ 1 | 2,467,648 | 2,467,648 | ||||
Beneficial conversion feature of Series C preferred stock | 4,507,125 | 4,507,125 | |||||
Deemed dividend of Series C preferred stock | (4,507,125) | (4,507,125) | |||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock, shares | 13,501 | (1,306) | |||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock, amount | $ 1 | (1,009) | (1,009) | ||||
Warrants issued in connection with exchange of Series B preferred stock | 17,585,057 | 17,585,057 | |||||
Deemed dividend related to exchange of Series B preferred stock | (17,585,057) | (17,585,057) | |||||
Common stock issued upon conversion of Series B preferred stock, shares | (259) | 2,582,782 | |||||
Common stock issued upon conversion of Series B preferred stock, amount | $ 258 | (258) | 0 | ||||
Dividends on preferred stock | (204,382) | (204,382) | |||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock, shares | (27,458) | 25,615,442 | |||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock, amount | $ (3) | $ 2,562 | (2,559) | 3 | |||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs, shares | 5,800,000 | ||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs, amount | $ 580 | $ 9,058,710 | 9,059,290 | ||||
Common stock issued upon exercise of warrants, shares | 9,128,068 | ||||||
Common stock issued upon exercise of warrants, amount | $ 913 | 4,622,929 | 4,623,842 | ||||
Common stock and warrants issued to consultants, shares | 575,301 | ||||||
Common stock and warrants issued to consultants, amount | $ 58 | 944,441 | 944,499 | ||||
Settlement with former investment bank, shares | 75,000 | ||||||
Settlement with former investment bank, amount | $ 7 | 94,492 | 94,499 | ||||
Stock-based compensation | 772,240 | 772,240 | |||||
Foreign currency translation adjustment | (134,797) | (134,797) | |||||
Net loss | (7,685,629) | (7,685,629) | |||||
Ending balance, shares at Mar. 31, 2021 | 0 | 1,209 | 74,926,902 | ||||
Ending balance, amount at Mar. 31, 2021 | $ 0 | $ 0 | $ 7,493 | $ 118,693,364 | $ (103,051,827) | $ (1,247,343) | $ 14,401,687 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (7,685,629) | $ (5,261,290) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,021 | 9,661 |
Amortization | 131,887 | 131,149 |
Non-cash lease expense | (4,855) | (6,065) |
Stock-based compensation | 772,240 | 54,950 |
Common stock issued to settle related party accounts payable | 0 | 131,137 |
Restricted stock granted to employees/directors | 0 | 19,503 |
Common stock and warrants granted to consultants | 1,038,998 | 87,105 |
Accreted interest on convertible debt | 0 | 164,281 |
Accretion of debt discount | 0 | 2,059,086 |
Changes in assets and liabilities, net of effects of acquisition: | ||
Other receivables | 17,592 | 2,064,252 |
Prepaid expenses | 613,076 | 87,906 |
Right of use assets | 11,654 | 0 |
Deposits | (1,356) | 0 |
Accounts payable and accrued expenses | 53,938 | (832,955) |
Accrued dividends payable | 204,382 | 0 |
Other liabilities | (226,342) | 0 |
Net cash used in operating activities | (5,073,394) | (1,291,280) |
Cash flows from investing activities: | ||
Purchase of property and equipment | 0 | (4,340) |
Net cash used in investing activities | 0 | (4,340) |
Cash flows from financing activities: | ||
Proceeds issuances of convertible debt, net | 0 | 3,227,002 |
Proceeds from issuance of preferred stock, net | 7,105,167 | 0 |
Proceeds from issuance of common stock, net | 9,059,290 | 144,000 |
Proceeds from exercise of warrants | 4,623,842 | 0 |
Payment made related to license agreement | (9,532,353) | 0 |
Repayments of notes payable | (205,323) | (164,748) |
Repayments of convertible debt | 0 | (450,000) |
Net cash provided by financing activities | 11,050,623 | 2,756,254 |
Increase in cash and cash equivalents | 5,977,229 | 1,460,634 |
Effect of exchange rate changes on cash | (13,738) | (6,423) |
Cash and cash equivalents, beginning balance | 6,062,141 | 175,796 |
Cash and cash equivalents, ending balance | 12,025,632 | 1,630,007 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 5,144 | 104,153 |
Non-cash investing and financing activities: | ||
Deemed dividend on preferred stock issuances | (4,507,125) | 0 |
Deemed dividend of preferred stock exchanges | (17,584,048) | 0 |
Accrued dividends on preferred stock | (204,382) | $ 0 |
Issuance of of Series C preferred stock to settle liability arising from acquisition | $ 2,467,648 |
The Company and Basis of Presen
The Company and Basis of Presentation | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company and Basis of Presentation | The Company AzurRx BioPharma, Inc. (“ AzurRx Parent ProteaBio Europe SAS ABS Company The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“ GI We are focused on developing our pipeline of gut-restricted GI clinical drug candidates, including MS1819 and niclosamide. Our lead drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“ EPI cystic fibrosis (“ CF CP , currently in two Phase 2 CF clinical trials. In March 2021, we announced topline results from our Phase 2b OPTION 2 monotherapy trial and in May 2021, we announced results from our Phase 2 Combination trial in Europe. In 2021, we intend to launch two new clinical programs using proprietary formulations of niclosamide, a small molecule with anti-helminthic, anti-viral and anti-inflammatory properties; FW-1022, for Severe Acute Respiratory Syndrome Coronavirus 2 (“ COVID-19 ICI-AC Since its inception, the Company has devoted substantially all its efforts to research and development, business development, and raising capital, and has primarily financed its operations through issuance of common stock, convertible preferred stock, convertible debt, and other debt/equity instruments. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. As of March 31, 2021, the Company had approximately $12.0 million in cash and cash equivalents. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. The Company has an accumulated deficit of approximately $103.0 million as of March 31, 2021. The Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our business. The extent to which the ongoing COVID-19 pandemic impacts our business, our clinical development and regulatory efforts, our corporate development objectives and the value of and market for our Common Stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. Basis of Presentation and Principles of Consolidation The accompanying unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“ GAAP In our opinion, the accompanying unaudited interim consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2020, has been derived from audited financial statements of that date. The unaudited interim consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the SEC. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report Form 10-K for the year ended December 31, 2020, filed with the SEC on March 31, 2021. Going Concern Uncertainty The accompanying unaudited interim consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On March 31, 2021, we had cash and cash equivalents of approximately $12.0 million, and an accumulated deficit of approximately $103.0 million. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plan and continue operations. Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies and Recent Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies and Recent Accounting Pronouncements | Use of Estimates The accompanying unaudited consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill, intangible assets, and contingent consideration), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash balances were highly liquid on March 31, 2021, and December 31, 2020, respectively. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. On March 31, 2021, and December 31, 2020, the Company had approximately $5.6 million and $2.7 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. Debt Instruments Detachable warrants issued in conjunction with debt are measured at their relative fair value, if they are determined to be equity instrument, or their fair value, if they are determined to be liability instruments, and recorded as a debt discount. Conversion features that are in the money at the commitment date constitute a beneficial conversion feature that is measured at its intrinsic value and recognized as debt discount. Debt discount is amortized as interest expense over the maturity period of the debt using the effective interest method. Contingent beneficial conversion features are recognized when the contingency has been resolved. Debt Issuance Costs Debt issuance costs are recorded as a direct reduction of the carrying amount of the related debt. Debt issuance costs are amortized over the maturity period of the related debt instrument using the effective interest method. Equity-Based Payments to Non-Employees Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. Fair Value Measurements The Company follows Accounting Standards Codification (“ASC” (“ASC 820” As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. Foreign Currency Translation For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of stockholders’ equity. Goodwill and Intangible Assets Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through March 31, 2021. Intangible assets subject to amortization consist of in process research and development, license agreements, and patents reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360” Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740” The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. On March 31, 2021, and December 31, 2020, the Company does not have any significant uncertain tax positions. All tax years are still open for audit. License Agreements As more fully discussed in Note 14, the Company entered into a license agreement (the “ First Wave License Agreement First Wave ICI-AC and COVID-19 GI infections. The acquisition of intellectual property and patents for As more fully discussed in Note 14, the Company entered into a sublicense agreement with TransChem, Inc. (“ TransChem Research and Development Research and development costs are charged to operations when incurred and are included in operating expense. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (CROs), investigative sites, consultants and contractors that conduct or provide other services relating to our clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (CDMOs) and third-party contractors relating to our chemistry, manufacturing and controls (“ CMC Stock-Based Compensation The Company’s board of directors (the “ Board 2014 Plan 2020 Plan ASC 718 For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. Recent Accounting Pronouncements In August 2020, the FASB issued accounting pronouncement (ASU 2020-06) related to the measurement and disclosure requirements for convertible instruments and contracts in an entity's own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity's own equity. As a smaller reporting company, as defined by the U.S. Securities and Exchange Commission (the "SEC" |
Fair Value Disclosures
Fair Value Disclosures | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures | Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The fair value of the Company's financial instruments are as follows: Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value On March 31, 2021: Cash and cash equivalents $ 12,025,632 $ 6,000,886 $ 6,024,746 $ - $ 12,025,632 Other receivables $ 501,660 $ $ $ 501,660 $ 501,660 Note payable $ 347,082 $ $ $ 347,082 $ 347,082 On December 31, 2020: Cash and cash equivalents $ 6,062,141 $ 3,000,184 $ 3,061,957 $ - $ 6,062,141 Other receivables $ 551,489 $ - $ - $ - $ 551,489 Note payable $ 552,405 $ - $ - $ - $ 552,405 On March 31, 2021, and December 31, 2020, cash and cash equivalents included approximately $6.0 million, and $3.0 million, respectively, held in high-quality money market funds quoted in an active market and included in level 1 in the table above. The fair value of other receivables approximates carrying value as these consist primarily of French research and development tax credits that are normally received the following year. The fair value of the note payable in connection with the financing of directors and officer’s liability insurance approximates carrying value due to the terms of such instruments and applicable interest rates. |
Other Receivables
Other Receivables | 3 Months Ended |
Mar. 31, 2021 | |
Receivables [Abstract] | |
Other Receivables | Other receivables consisted of the following: March 31, December 31, 2021 2020 Research and development tax credits $ 442,630 $ 493,906 Other 59,030 57,583 Total other receivables $ 501,660 $ 551,489 On March 31, 2021, and December 31, 2020, research and development tax credits were comprised of the 2020 refundable tax credits (CIR) for research conducted in France and Europe. On March 31, 2021, and December 31, 2020, other consisted of amounts due from U.S. research and development tax credits. |
Property, Equipment, and Leaseh
Property, Equipment, and Leasehold Improvements | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Equipment, and Leasehold Improvements | Property, equipment, and leasehold improvements consisted of the following: March 31, December 31, 2021 2020 Laboratory equipment $ - $ 2,410 Computer equipment 19,676 19,676 Office equipment - 5,483 Leasehold improvements - 29,163 Total property, plant, and equipment 19,676 56,732 Less accumulated depreciation (19,584 ) (38,403 ) Property, plant and equipment, net $ 92 $ 18,329 Depreciation expense for the three months ended March 31, 2021 and 2020 was approximately $1,000 and $10,000, respectively. For the three months ended March 31, 2021, approximately $1,000 of depreciation was included in research and development expense. For the three months ended March 31, 2020, approximately $5,000 of depreciation was included in research and development expense and approximately $5,000 of depreciation was included in general and administrative expense. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Patents Pursuant to the Mayoly APA entered into in March 2019 (see Note 14), in which the Company purchased all remaining rights, title and interest in and to MS1819 from Mayoly, the Company recorded Patents in the amount of approximately $3.8 million as follows: Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at December 31, 2019 449,280 Due to Mayoly at December 31, 2020 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745 Intangible assets are as follows: March 31, December 31, 2021 2020 Patents $ 3,802,745 $ 3,802,745 Less accumulated amortization (1,055,096 ) (923,209 ) Patents, net $ 2,747,649 $ 2,879,536 Amortization expense was approximately $132,000 and $131,000 for the three months ended March 31, 2021, and 2020, respectively. As of March 31, 2021, amortization expense related to patents is expected to be as follows for the next five years (2021 through 2025): 2021 (balance of year) $ 395,661 2022 527,548 2023 527,548 2024 527,548 2025 527,548 Goodwill is as follows: Goodwill Balance on January 1, 2020 $ 1,886,686 Foreign currency translation 167,362 Balance on December 31, 2020 2,054,048 Foreign currency translation (80,085 ) Balance on March 31, 2021 $ 1,973,963 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: March 31, December 31, 2021 2020 Trade payables $ 1,440,718 $ 1,558,591 Accrued expenses 267,123 127,012 Total accounts payable and accrued expenses $ 1,707,841 $ 1,685,603 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2021 | |
Notes Payable [Abstract] | |
Notes Payable | Directors and Officer’s Liability Insurance On November 30, 2020, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of approximately $620,000 that bears interest at an annual rate of 4.250%. Monthly payments, including principal and interest, of approximately $70,000 per month. The balance due under this financing agreement was approximately $347,000 on March 31, 2021. On December 5, 2019, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of approximately $500,000 that bears interest at an annual rate of 5.461%. Monthly payments, including principal and interest, were approximately $57,000 per month. The balance due under this financing agreement was approximately $280,000 on March 31, 2020. |
Convertible Debt
Convertible Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The ADEC Note Offering On February 14, 2019, the Company entered into a Note Purchase Agreement (the “ADEC NPA” “ADEC” “Note A” “Note B,” “ADEC Note,” “ADEC Notes” ADEC Note Offering The ADEC Notes accrued interest at a rate of 10% per annum; provided, however, that in the event the Company should elect to repay the full balance due under the terms of both ADEC Notes prior to December 31, 2019, then the interest rate would be reduced to 6% per annum. Interest would be payable at the time all outstanding principal amounts owed under each ADEC Note were repaid. The ADEC Notes were scheduled to mature on the earlier to occur of (i) the tenth business day following the receipt by ABS of certain tax credits that the Company expects to receive prior to July 2019 in the case of Note A (the “2019 Tax Credit” “2020 Tax Credit” “Maturity Dates” Each of the ADEC Notes was convertible, at ADEC’s option, into shares of Common Stock, at a conversion price equal to $2.50 per share; provided, however, that pursuant to the term of the ADEC Notes, ADEC could not convert all or a portion of the ADEC Notes if such conversion would result in the significant stockholder and/or entities affiliated with him beneficially owning in excess of 19.99% of the shares of Common Stock issued and outstanding immediately after giving effect to the issuance of the shares issuable upon conversion of the ADEC Notes (the “ ADEC Note Conversion Shares As additional consideration for entering into the ADEC NPA, the Company entered into a warrant amendment agreement, whereby the Company agreed to reduce the exercise price of 1,009,565 outstanding warrants previously issued by the Company to ADEC and its affiliates (the “ADEC Warrants” ADEC Warrant Amendment In December 2019, the Company repaid $1,550,000 principal amount of the ADEC Notes and on January 2, 2020 repaid the remaining principal balance of $450,000 plus outstanding accrued interest of approximately $104,000. As of March 31, 2021, no ADEC Notes were outstanding. Senior Convertible Promissory Note Offering On December 20, 2019, the Company began an offering of (i) Senior Convertible Promissory Notes (each a “ Promissory Note Promissory Notes Note Investors Note Warrants Promissory Promissory Note Offering In December 2019, the Company issued Promissory Notes to the Note Investors in the aggregate principal amount of approximately $3.4 million. The Promissory Notes were scheduled to mature on September 20, 2020, accrue interest at a rate of 9% per annum, and were convertible, at the sole option of the holder, into shares of Common Stock (the “ Promissory Note Conversion Shares Conversion Option Prepayment Option On January 2, 2020, January 3, 2020, and January 9, 2020, the Company issued Promissory Notes to the Note Investors in the aggregate principal amount of approximately $3.5 million. As additional consideration for the execution of the Promissory NPA, each Note Investor also received Note Warrants to purchase that number of shares of Common Stock equal to one-half (50%) of the Promissory Note Conversion Shares issuable upon conversion of the Promissory Notes (the “ Note Warrant Shares RRA In connection with the four closings in December 2019 of the Promissory Placement Agent Warrants In connection with the three closings in January 2020 of the Promissory The Company determined the Prepayment Option feature represents a contingent call option. The Company evaluated the Prepayment Option in accordance with ASC 815-15-25. The Company determined that the Prepayment Option feature is clearly and closely related to the debt host instrument and is not an embedded derivative requiring bifurcation. Additionally, the Company determined the Conversion Option represents an embedded call option. The Company evaluated the Conversion Option in accordance with ASC 815-15-25. The Company determined that the Conversion Option feature meets the scope exception from ASC 815 and is not an embedded derivative requiring bifurcation. The Company evaluated the Promissory Notes for a beneficial conversion feature in accordance with ASC 470-20. The Company determined that at each commitment date the effective conversion price was below the closing stock price (market value), and the Convertible Notes contained a beneficial conversion feature. Pursuant to the December 2019 closings of the Promissory Note Offering, the principal amount of approximately $3.4 million was first allocated based on the relative fair value of the Promissory Notes and the Note Warrants. The fair value of the Note Warrants amounted to approximately $913,000. Then the beneficial conversion feature was calculated, which amounted to approximately $1.4 million. The Company incurred debt issuance costs of approximately $0.6 million related to the offering. The initial carrying value of the Promissory Notes issued amounted to approximately $0.5 million. Pursuant to the January 2020 closings of the Promissory Note Offering, the principal amount of approximately $3.5 million was first allocated based on the relative fair value of the Promissory Notes and the Note Warrants. The fair value of the Note Warrants amounted to approximately $2.4 million. Then the beneficial conversion feature was calculated, which amounted to approximately $1.8 million. The Company incurred debt issuance costs of approximately $0.5 million related to the offering. The initial carrying value of the Promissory Notes issued amounted to approximately $0.1 million. On June 1, 2020, the Company entered into an amendment to a certain Promissory Note in the principal amount of $100,000 issued on December 20, 2019, to Edward J. Borkowski, the chairman of the Board, to increase the Conversion Price to $1.07 per share (the “ Note Amendment During the three months ended March 31, 2020, the Company recognized approximately $2.2 million of interest expense related to these Promissory Notes, including amortization of debt discount related to the value of the Note Warrants of approximately $660,000, amortization of the beneficial conversion feature of approximately $1.1 million, amortization of debt discount related to debt issuance costs of approximately $348,000, and accrued interest expense of approximately $150,000. Exchange of Promissory Notes into Series B Convertible Preferred Stock As more fully discussed in Note 11, on July 16, 2020, in connection with the Series B Private Placement, approximately 937.00 shares of Series B Preferred Stock, Series B Warrants to purchase 4,684,991 shares of Common Stock, and Exchange Warrants to purchase 1,772,937 shares of Common Stock were issued to certain holders of the Promissory Notes in exchange for such Promissory Notes for aggregate consideration of approximately $7.2 million consisting of approximately $6.9 million aggregate outstanding principal amount, together with accrued and unpaid interest thereon through the date of the Series B Private Placement of approximately $0.3 million. The Company prepaid the remaining outstanding balance of $25,000 aggregate principal amount of Promissory Notes, together with accrued and unpaid interest thereon through the prepayment date of approximately $1,000, held by those holders who did not participate in the Exchange. Following these transactions, no Promissory Notes remained outstanding. Accounting for the Exchange of Promissory Notes into Series B Private Placement The Company determined the Exchange of the Promissory Notes into Series B Preferred Stock and related warrants should be recognized as an extinguishment of the Promissory Notes which resulted in a loss on extinguishment of approximately $0.6 million. Additionally, the Company recorded interest expense of approximately $0.8 million related to the remaining unamortized discount resulting from initial beneficial conversion feature of the Promissory Notes on closing date of the Exchange. |
Other Liabilities
Other Liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Other Liabilities [Abstract] | |
Other Liabilities | Other liabilities consisted of the following: March 31, December 31, Current 2021 2020 Lease liabilities $ 56,702 $ 57,417 Other liabilities 8,633 - $ 65,335 $ 57,417 March 31, December 31, Long-term 2021 2020 Lease liabilities $ 6,566 $ 19,123 $ 6,566 $ 19,123 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Equity | Our certificate of incorporation, as amended and restated on December 20, 2019 and February 24, 2021 (the “ Charter On February 24, 2021 the Company held a Special Meeting of Stockholders (the “ 2021 Special Meeting Reverse Split Common Stock The Company had 74,926,902 and 31,150,309 shares of its Common Stock issued and outstanding on March 31, 2021, and December 31, 2020, respectively. Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. Our Charter and Amended and Restated Bylaws (the “ Bylaws In addition, the holders of our Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current policy of our Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of our Common Stock will be entitled to share ratably in all assets that are legally available for distribution. Holders of our Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences, and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future. Preferred Stock We have 10,000,000 shares of preferred stock, par value $0.0001 per share, authorized and available for issuance in one or more series. The Board is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The Board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance. On July 16, 2020, we authorized 5,194.805195 shares as Series B Preferred Stock. Shares of Series B Preferred Stock that are converted into shares of Common Stock shall be retired and may not be reissued as Series B Preferred Stock but may be reissued as all or part of another series of Preferred Stock. On March 31, 2021, 1,209.52 shares of Series B Preferred Stock were issued and outstanding, with approximately 2,168.14 shares of Series B Preferred Stock remaining authorized but unissued. On January 5, 2021, we authorized 75,000 shares as Series C Preferred Stock. Shares of Series C Preferred Stock converted into Common Stock (or Prefunded Warrants, as applicable) or redeemed shall be canceled and shall not be reissued. On March 31, 2021, 0 shares of Series C Preferred Stock were issued and outstanding, with approximately 47,542.05 shares of Series C Preferred Stock remaining authorized but unissued. On March 31, 2021, the Company had approximately 1,209.52 shares of preferred stock issued and outstanding with approximately 9,969,515.38 shares of preferred stock remaining authorized but unissued. Series B Convertible Preferred Stock Pursuant to the Certificate of Designation of Rights and Preferences of the Series B Preferred Stock (the “ Series B Certificate of Designation Ranking The Series B Preferred Stock will rank senior to the Common Stock with respect to distributions of assets upon the liquidation, dissolution or winding up of the Company. Stated Value Each share of Series B Preferred Stock has a stated value of $7,700, subject to adjustment for stock splits, combinations, and similar events (the “ Series B Stated Value Dividends Each holder of shares of Series B Preferred Stock, in preference and priority to the holders of all other classes or series of stock of the Company, is entitled to receive dividends, commencing from the date of issuance. Such dividends may be paid by the Company only when, as and if declared by the Board, out of assets legally available therefor, semiannually in arrears on the last day of June and December in each year, commencing December 31, 2020, at the dividend rate of 9.0% per year, which is cumulative and continues to accrue on a daily basis whether or not declared and whether or not the Company has assets legally available therefor. The Company may pay such dividends at its option either in cash or in kind in additional shares of Series B Preferred Stock (rounded down to the nearest whole share), provided the Company must pay in cash the fair value of any such fractional shares in excess of $100.00. On March 31, 2021, aggregate dividends payable amounted to approximately $205,000. Liquidation Preference; Liquidation Rights Under the Certificate of Designations, each share of Series B Preferred Stock carries a liquidation preference equal to the Series B Stated Value (as adjusted thereunder) plus accrued and unpaid dividends thereon (the “ Liquidation Preference If the Company voluntarily or involuntarily liquidates, dissolves or winds up its affairs, each holder of the Series B Preferred Stock will be entitled to receive out of the Company’s assets available for distribution to stockholders, after satisfaction of liabilities to creditors, if any, but before any distribution of assets is made on the Common Stock or any of the Company’s shares of stock ranking junior as to such a distribution to the Series B Preferred Stock, a liquidating distribution in the amount of the Stated Value of all such holder’s Series B Preferred Stock plus all accrued and unpaid dividends thereon. On March 31, 2021, the value of the liquidation preference of the Series B Preferred Stock aggregated to approximately $9.5 million. Conversion Each share of Series B Preferred Stock will be convertible at the holder’s option at any time, into Common Stock at a conversion rate equal to the quotient of (i) the Series B Stated Value divided by (ii) the initial conversion price of $0.77, subject to specified adjustments for stock splits, cash or stock dividends, reorganizations, reclassifications other similar events as set forth in the Series B Certificate of Designations. In addition, at any time after the six month anniversary of the Series B Closing Date, if the closing sale price per share of Common Stock exceeds 250% of the initial conversion price, or $1.925, for 20 consecutive trading days, then all of the outstanding shares of Series B Preferred Stock will automatically convert (the “ Automatic Conversion Most Favored Nations (MFN) Exchange Right In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “ Subsequent Financing Series B Exchange Amount Series B Exchange Right Asof May 18, 2021, holders of approximately 1,622.29 shares of Series B Preferred Stock with an aggregate Series B Exchange Amount of approximately $12.6 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 16,820,841 shares of Common Stock (which conversion the Company has elected to make in full), and additional January 2021 Investor Warrants exercisable for up to an aggregate of 16,820,841 shares of Common Stock. As a result, as of May 18, 2021, we may be required to issue up to 9,483.38 additional shares of Series C Preferred Stock that are currently convertible up to 9,483,378 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 9,483,378 shares of Common Stock, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right in connection with up to 893.52 shares of Series B Preferred Stock plus accrued dividends of approximately $232,000. Any shares of Series C Preferred Stock to be issued pursuant to the Series B Exchange Right would, upon issuance, be immediately converted into underlying shares of Common Stock. Voting The holders of the Series B Preferred Stock, voting as a separate class, have customary consent rights with respect to certain corporate actions of the Company. The Company may not take the following actions without the prior consent of the holders of at least a majority of the Series B Preferred Stock then outstanding: (a) authorize, create, designate, establish, issue or sell an increased number of shares of Series B Preferred Stock or any other class or series of capital stock ranking senior to or on parity with the Series B Preferred Stock as to dividends or upon liquidation; (b) reclassify any shares of Common Stock or any other class or series of capital stock into shares having any preference or priority as to dividends or upon liquidation superior to or on parity with any such preference or priority of Series B Preferred Stock; (c) amend, alter or repeal the Certificate of Incorporation or Bylaws of the Company and the powers, preferences, privileges, relative, participating, optional and other special rights and qualifications, limitations and restrictions thereof, which would adversely affect any right, preference, privilege or voting power of the Series B Preferred Stock; (d) issue any indebtedness or debt security, other than trade accounts payable, insurance premium financings and/or letters of credit, performance bonds or other similar credit support incurred in the ordinary course of business, or amend, renew, increase, or otherwise alter in any material respect the terms of any such indebtedness existing as of the date of first issuance of shares of Series B Preferred Stock; (e) redeem, purchase, or otherwise acquire or pay or declare any dividend or other distribution on (or pay into or set aside for a sinking fund for any such purpose) any capital stock of the Company; (f) declare bankruptcy, dissolve, liquidate, or wind up the affairs of the Company; (g) effect, or enter into any agreement to effect, a Change of Control (as defined in the Certificate of Designations); or (h) materially modify or change the nature of the Company’s business. 2014 Equity Incentive Plan The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “ 2014 Plan The 2014 Plan allowed for the issuance of securities, including stock options to employees, Board members and consultants. The number of shares of Common Stock reserved for issuance under the 2014 Plan could not exceed ten percent (10%) of the issued and outstanding shares of Common Stock on an as converted basis (the “ As Converted Shares On July 16, 2020, the Board approved an amendment to the 2014 Plan. The amendment eliminates individual grant limits under the 2014 Plan that were intended to comply with the exemption for “performance-based compensation” under Section 162(m) of the Internal Revenue Code, which section has been repealed. The Company issued an aggregate of 0 and 335,006 stock options, during the three months ended March 31, 2021 and 2020, respectively, under the 2014 Plan (see Note 13). As of March 31, 2021, there were 3,924,770 shares issued and outstanding under the 2014 Plan and 387,000 shares are reserved subject to issuance of restricted stock and RSUs. Upon adoption of the 2020 Omnibus Equity Incentive Plan on September 11, 2020, the Company ceased making grants under the 2014 Plan. As of March 31, 2020, there were an aggregate of 4,245,905 total shares available under the 2014 Plan, of which 1,997,506 are issued and outstanding, 632,667 shares are reserved subject to issuance of restricted stock and RSUs and 1,615,732 shares are available for potential issuances. 2020 Equity Incentive Plan The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “ 2020 Plan ISOs The Company issued an aggregate of 343,685 stock options during the three months ended March 31, 2021, under the 2020 Plan (see Note 13). As of March 31, 2021, 10,000,000 total shares were available under the 2020 Plan, of which 353,685 were issued and outstanding and 9,646,315 shares were available for potential issuances. Equity Line with Lincoln Park In November 2019, the Company entered into a purchase agreement (the “ Equity Line Agreement Lincoln Park Registration Rights Agreement Equity Line Commitment Shares The remaining shares of our Common Stock that may be issued under the Equity Line Agreement may be sold by the Company to Lincoln Park at our discretion from time-to-time over a 30-month period commencing after the satisfaction of certain conditions set forth in the Equity Line Agreement, subject to the continued effectiveness of a registration statement covering such shares of Common Stock sold to Lincoln Park by the Company. The registration statement was filed with the SEC on December 31, 2019 and was declared effective on January 14, 2020. Under the Equity Line Agreement, on any business day over the term of the Equity Line Agreement, the Company has the right, in its sole discretion, to present Lincoln Park with a purchase notice (each, a “ Purchase Notice Regular Purchase Purchase Price ● the lowest sale price of Common Stock on the purchase date; and ● the average of the three lowest closing sale prices for the Common Stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of such shares. In addition, on any date on which the Company submits a Purchase Notice to Lincoln Park, the Company also has the right, in its sole discretion, to present Lincoln Park with an accelerated purchase notice (each, an “ Accelerated Purchase Notice Accelerated Purchase Accelerated Purchase Measurement Period ● 97% of the volume weighted average price of the Company’s common stock during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and ● the closing sale price of Common Stock on the applicable Accelerated Purchase Date. The Company may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Equity Line Agreement, to purchase an amount of stock (the “ Additional Accelerated Purchase Additional Accelerated Purchase Measurement Period ● 97% of the volume weighted average price of the Company’s common stock during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase; and ● the closing sale price of Common Stock on the applicable Additional Accelerated Purchase. Pursuant to the terms of the Equity Line Agreement, without first obtaining stockholder approval, the aggregate number of shares that the Company is permitted to sell to Lincoln Park thereunder, when aggregated with certain other private offerings of Common Stock, as applicable, may not exceed 19.99% of the Common Stock outstanding immediately prior to the execution of the Equity Line Agreement on November 13, 2019, unless the average price of all applicable sales thereunder exceeds $0.70 per share calculated by reference to the “Minimum Price” under Nasdaq Listing Rule 5635(d). On September 11, 2020, the Company received stockholder approval for the issuances of the full $15 million available under the Equity Line Agreement. There is approximately $14.0 million of availability left for issuance pursuant to the Equity Line Agreement. The Company issued an aggregate of 0, and 150,000 shares of Common Stock, during the three months ended March 31, 2021 and 2020, respectively, in connection with the Equity Line Agreement, resulting in net proceeds to the Company of approximately $0, and $144,000, respectively. Common Stock Issuances 2021 Issuances During the three months ended March 31, 2021, the Company issued an aggregate of 575,301 shares of its Common Stock to consultants with a grant date fair value of approximately $891,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the three months ended March 31, 2021, the Company issued an aggregate 75,000 shares of its Common Stock with a grant date fair value of approximately $94,000 in connection with the settlement with our former investment bank, which was recorded as stock-based compensation and included as part of general and administrative expense. During the three months ended March 31, 2021, the Company issued an aggregate of 25,615,442 shares of Common Stock upon the conversion of an aggregate of 27,457.95 shares of Series C Convertible Preferred Stock with a stated value of approximately $20.6 million plus accrued dividends of approximately $76,000. During the three months ended March 31, 2021, the Company issued an aggregate of 9,128,068 shares of Common Stock upon the exercise of an aggregate of 9,197,834 investor warrants, including an aggregate of 3,991,882 pre-funded warrants (See Note 12). During the three months ended March 31, 2021, the Company issued an aggregate of 2,582,782 shares of Common Stock upon the conversion of an aggregate of 258.08 shares of Series B Preferred Stock with a stated value of approximately $2.0 million plus accrued dividends of approximately $3,000. During the three months ended March 31, 2021, the Company issued an aggregate of 5,800,000 shares of Common Stock in connection with the March 2021 Offering as detailed below. 2020 Issuances During the three months ended March 31, 2020, the Company issued an aggregate of 101,195 shares of its Common Stock to consultants with a grant date fair value of approximately $87,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the three months ended March 31, 2020, the Company issued an aggregate of 105,937 shares of its Common Stock to outside Board members as payment of Board fees with an aggregate grant date fair value of approximately $131,000 that was recorded as stock-based compensation, included as part of general and administrative expense. The aggregate effective settlement price was $1.24 per share, and each individual stock issuance was based on the closing stock price of the Common Stock on the initial date the payable was accrued. Restricted Stock and Restricted Stock Units Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock unit awards (“ RSUs During the three months ended March 31, 2021, there was no vesting of restricted shares of Common Stock or RSUs. During the three months ended March 31, 2020, an aggregate of 5,417 unvested restricted shares of Common Stock subject to service conditions, vested with a total grant date fair value of approximately $19,500, and was recorded as stock-based compensation, included as part of general and administrative expense. As of March 31, 2021, the Company had unrecognized restricted common stock expense of approximately $394,000. Approximately $197,000 of this unrecognized expense vests upon the first commercial sale in the United States of MS1819 and approximately $197,000 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable on March 31, 2021. As of March 31, 2020, the Company had unrecognized restricted common stock expense of approximately $424,000. Approximately $31,000 of this unrecognized expense will be recognized over the average remaining vesting term of 0.4 years. Approximately $197,000 of this unrecognized expense vests upon the first commercial sale in the United States of MS1819 and approximately $197,000 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable on March 31, 2020. The Series B Private Placement and the Exchange On July 16, 2020 (the “ Series B Closing Date Series B Private Placement Series B Purchase Agreement Series B Investors Series B Preferred Stock Series B Warrants In connection with the Series B Private Placement, an aggregate of approximately 1,975.58 shares of Series B Preferred Stock initially convertible into 19,755,748 shares of Common Stock and related 9,877,835 Series B Warrants were issued for cash consideration, resulting in aggregate gross proceeds of approximately $15.2 million and aggregate net proceeds to the Company of approximately $13.2 million after deducting placement agent compensation and offering expenses. An aggregate of approximately 937.00 shares of Series B Preferred Stock initially convertible into 9,370,008 shares of Common Stock and related Series B Warrants to purchase 4,684,991 shares of Common Stock were issued to certain Series B Investors (the “ Exchange Investors Promissory Notes Exchange Exchange Addendum Exchange Warrants Pursuant to the Series B Private Placement and the Series B Purchase Agreement, for purposes of complying with Nasdaq Listing Rule 5635(c) and 5635(d), the Company was required to hold a meeting of its stockholders not later than 60 days following the Series B Closing Date to seek approval (the “ 2020 Stockholder Approval The Company prepaid the remaining outstanding balance of $25,000 aggregate principal amount of Promissory Notes, together with accrued and unpaid interest thereon through the prepayment date of approximately $1,000, held by those holders who did not participate in the Exchange. Following these transactions, no Promissory Notes remain outstanding. In connection with the Series B Private Placement, the Company paid the placement agent 9.0% of the gross cash proceeds received by the Company from investors introduced by the placement agent and 4.0% of the gross cash proceeds received by the Company for all other investors, or approximately $1.3 million. The Company also paid the placement agent a non-accountable cash fee equal to 1.0% of the gross cash proceeds and a cash financial advisory fee equal to 3.0% of the outstanding principal balance of the Promissory Notes that were submitted in the Exchange, or approximately $0.3 million in additional cash fees in the aggregate. In addition, the Company issued to the placement agent warrants to purchase up to 1,377,458 shares of Common Stock (the “ July Placement Agent Warrants Accounting for the Series B Private Placement Upon receiving the 2020 Stockholder Approval on September 11, 2020, the Company classified the Series B Preferred Stock as permanent equity because no features provide for redemption by the holders of the Series B Preferred Stock or conditional redemption, which is not solely within the Company’s control, and there are no unconditional obligations in that (1) the Company must or may settle in a variable number of its equity shares and (2) the monetary value is predominantly fixed, varying with something other than the fair value of the Company’s equity shares or varying inversely in relation to the Company’s equity shares. Because the Series B Preferred Stock contain certain embedded features that could affect the ultimate settlement of the Series B Preferred Stock, the Company analyzed the instrument for embedded derivatives that require bifurcation. The Company’s analysis began with determining whether the Series B Preferred Stock is more akin to equity or debt. The Company evaluated the following criteria/features in this determination: redemption, voting rights, collateral requirements, covenant provisions, creditor and liquidation rights, dividends, conversion rights and exchange rights. The Company determined that the Series B Preferred Stock was more akin to equity than to debt when evaluating the economic characteristics and risks of the entire Series B Preferred Stock, including the embedded features. The Company then evaluated the embedded features to determine whether their economic characteristics and risks were clearly and closely related to the economic characteristics and risks of the Series B Preferred Stock. Since the Series B Preferred Stock was determined to be more akin to equity than debt, and the underlying that causes the value of the embedded features to fluctuate would be the value of the Company’s common stock, the embedded features were considered clearly and closely related to the Series B Preferred Stock. As a result, the embedded features would not need to be bifurcated from the Series B Preferred Stock. The Company concluded the freestanding Series B Warrants did not contain any provision that would require liability classification and therefore should be classified in stockholder’s equity, based on their relative fair value. The proceeds from the January 2021 Offerings were allocated to the Series C Preferred Stock and the based on their relative fair values. The , net of $0.9 million offering costs, we After allocation of the proceeds, the effective conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of $4.3 million equal to the intrinsic value of the beneficial conversion feature and recognized on the closing date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. The total offering costs of approximately $0.9 million were recognized in equity. January 2021 Offerings On December 31, 2020, the Company entered into a securities purchase agreement (the “ Series C Purchase Agreement January 2021 Registered Direct Offering Concurrently with the Registered Direct Offering, in a private placement offering pursuant to the Series C Purchase Agreement (the “ January 2021 Private Placement, January 2021 Offerings January 2021 Investor Warrants In connection with the January 2021 Private Placement, we entered into a registration rights agreement, dated as of December 31, 2020, pursuant to which we filed a registration statement on Form S-1 (File No. 333-252087) to register the shares of Common Stock issuable upon the conversion of the Series C Preferred Stock sold in the January 2021 Private Placement and the exercise of the January 2021 Investor Warrants. The registration statement was declared effective by the SEC on January 21, 2021. On January 6, 2021, the January 2021 Offerings closed, and the Company received aggregate gross proceeds of approximately $8.0 million, excluding the net proceeds, if any, from the exercise of the January 2021 Investor Warrants. The net proceeds to the Company from the January 2021 Offerings, after deducting the placement agent’s fees and expenses, was approximately $7.1 million. The Company used the net proceeds to fund the payment of cash consideration to First Wave under the First Wave License Agreement, and for other general corporate purposes. The Company paid the placement agent a cash fee equal to 8.0% and a management fee equal to 1.0% of the aggregate gross proceeds received by the Company in the January 2021 Offerings, or approximately $700,000. The Company also agreed to issue to the placement agent or its designees warrants (the “ January 2021 Placement Agent Warrants Pursuant to the January 2021 Private Placement and the Series C Purchase Agreement, the Company was required to hold a meeting of its stockholders not later than March 31, 2021 to seek approval (the “ 2021 Stockholder Approval On February 24, 2021, the Company received the 2021 Stockholder Approval, and all outstanding shares of Series C Preferred Stock were converted to Common Stock. Accounting for the January 2021 Offerings Upon receiving the 2021 Stockholder Approval on February 24, 2021, the Company classified the Series C Preferred Stock as permanent equity because no features provide for redemption by the holders of the Series C Preferred Stock or conditional redemption, which is not solely within the Company’s control, and there are no unconditional obligations in that (1) the Company must or may settle in a variable number of its equity shares and (2) the monetary value is predominantly fixed, varying with something other than the fair value of the Company’s equity shares or varying inversely in relation to the Company’s equity shares. Because the Series C Preferred Stock contains certain embedded features that could affect the ultimate settlement of the Series C Preferred Stock, the Company analyzed the instrument for embedded derivatives that require bifurcation. The Company’s analysis began with determining whether the Series C Preferred Stock is more akin to equity or debt. The Company evaluated the following criteria/features in this determination: redemption, voting rights, collateral requirements, covenant provisions, creditor and liquidation rights, dividends, and conversion rights. The Company determined that the Series C Preferred Stock was more akin to equity than to debt when evaluating the economic characteristics and risks of the entire Series C Preferred Stock, including the embedded features. The Company then evaluated the embedded features to determine whether their economic characteristics and risks were clearly and closely related to the economic characteristics and risks of the Series C Preferred Stock. Since the Series C Preferred Stock was determined to be more akin to equity than debt, and the underlying that causes the value of the embedded features to fluctuate would be the value of the Company’s common stock, the embedded features were considered clearly and closely related to the Series C Preferred Stock. As a result, the embedded features would not need to be bifurcated from the Series C Preferred Stock. The Company concluded the freestanding did not contain any provision that would require liability classification and therefore should be classified in stockholder’s equity, based on their relative fair value. The proceeds from the January 2021 Offerings were allocated to the Series C Preferred Stock and the based on their relative fair values. The After allocation of the proceeds, the effective conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of $4.3 million equal to the intrinsic value of the beneficial conversion feature and recognized on the closing date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. The total offering costs of approximately $0.9 million were recognized in equity. Series B Most Favored Nations (MFN) Exchanges into the January 2021 Offerings Subject to the consummating the January 2021 Offerings, the holders of the Series B Preferred Stock became entitled to exercise their Series B Exchange Right to exchange their Series B Preferred Stock at the Series B Exchange Amount into the Series C Preferred Stock and related January 2021 Investor Warrants. During the three months ended March 31, 2021, holders of approximately 1,306.30 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $10.1 million had elected to exercise their Series B Exchange Rights into 13,501.10 shares of Series C Preferred Stock, convertible into an aggregate of 13,501,087 shares of Common Stock and additional January 2021 Investor Warrants exercisable for up to an aggregate of 13,501,087 shares of Common Stock. Immediately upon issuance of the Series C Preferred Stock pursuant to the Series B Exchange Right, an aggregate of 13,166.62 shares of Series C Preferred Stock were converted into 13,166,624 shares of Common Stock, at an effective conversion price of $0.77 per share, and an aggregate of 334.46 shares of Series C Preferred Stock, convertible into 334,463 shares of Common Stock, remained unconverted pending stockholder approval. Upon receiving the 2021 Stockholder Approval on February 24, 2021, the Company elected to convert all 334.46 remaining shares of Series C Preferred Stock issued pursuant to the Series B Exchange Right, plus accrued dividends thereon of approximately $2,000 into 336,994 shares of Common Stock. As a result, as of March 31, 2021, the Company may be required to issue up to 12,690.20 additional shares of Series C Preferred Stock that are currently convertible up to 12,690,204 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 12,690,204 shares of Common Stock, to any holders of Series B Preferred Stock who e |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2021 | |
WarrantsDisclosureTextBlock | |
Warrants | During During the three months ended March 31, 2021, in connection with the conversion of the Series C Preferred Stock issued in the January 2021 Offerings, the Company issued pre-funded warrants to the investor to purchase an aggregate of 1,933,334 shares of Common Stock as referenced in Note 11. These pre-funded warrants were issued on January 6, 2021, are exercisable at $0.001 per share and do not expire. The total grant date fair value of these pre-funded was determined to be approximately $1.6 million and was recorded as additional paid in capital (See Note 11). During the three months ended March 31, 2021, in connection with the January 2021 Offerings, the Company issued January 2021 Placement Agent Warrants to the placement agent and/or their designees to purchase an aggregate of 746,667 shares of Common Stock, as referenced in Note 11. These January 2021 Placement Agent Warrants were issued on January 6, 2021, are exercisable at $0.9375 per share and expire on July 6, 2026. The total grant date fair value of these warrants was determined to be approximately $392,000, as calculated using the Black-Scholes model, and had no effect on shareholders’ equity (See Note 11). During the three months ended March 31, 2021, the Company issued January 2021 Investor Warrants to purchase an aggregate of 13,501,087 shares of Common Stock to holders of Series B Preferred Stock elected to exercise their Series B Exchange Rights into Series C Preferred Stock and related warrants, as referenced in Note 11. These January 2021 Investor Warrants were issued between January 13, 2021 and March 25, 2021, are exercisable at $0.80 per share and expire on July 6, 2026. The exercise of these warrants was prohibited until the Company received stockholder approval on February 24, 2021. The total grant date fair value of these warrants was determined to be approximately $17.6 million, as calculated using the Black-Scholes model, and were recorded as a deemed dividend and recognized on the exchange date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. During the three months ended March 31, 2021, in connection with the March 2021 Offering, the Company issued March 2021 Warrants to the investor to purchase an aggregate of 3,929,274 shares of Common Stock, as referenced in Note 11. These March 2021 Warrants were issued on March 10, 2021, are exercisable at $1.21 per share and expire five years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $3.5 million, as calculated using the Black-Scholes model, and were recorded as additional paid in capital (See Note 11). During the three months ended March 31, 2021, in connection with March 2021 Offering, the Company issued pre-funded warrants to the investor to purchase an aggregate of 2,058,548 shares of Common Stock, as referenced in Note 11. These pre-funded warrants were issued on March 10, 2021, are exercisable at $0.01 per share and do not expire. The total grant date fair value of these pre-funded was determined to be approximately $2.6 million and was recorded as additional paid in capital (See Note 11). During the three months ended March 31, 2021, in connection with the March 2021 Offering, the Company issued March 2021 Placement Agent Warrants to the placement agent and/or their designees to purchase an aggregate of 550,099 shares of Common Stock, as referenced in Note 11. These March 2021 Placement Agent Warrants were issued on March 10, 2021, are exercisable at $1.5906 per share and expire five years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $453,000, as calculated using the Black-Scholes model, and had no effect on shareholders’ equity (See Note 11). During the three months ended March 31, 2021, the Company issued warrants to a consultant to purchase an aggregate of 200,000 shares of Common Stock that are subject to service-based milestone vesting conditions for investor relations services. These warrants were issued on February 8, 2021, are exercisable at $1.69 per share and expire four years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $214,000, as calculated using the Black-Scholes model. For the three months ended March 31, 2021, warrants to purchase a total of 50,000 shares of Common Stock vested, with a grant date fair value of approximately $53,000, which was recorded as stock-based compensation and was included as part of general and administrative expense. During the three months ended March 31, 2021, warrants to purchase an aggregate of 9,197,836 shares of Common Stock, including the pre-funded warrants issued in January 2021 and March 2021, were exercised for cash proceeds of approximately $4.6 million. During the three months ended March 31, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued Note Warrants to investors to purchase an aggregate of 1,813,257 shares of Common Stock with the issuance of the Promissory Notes as referenced in Note 9. These Note Warrants were issued between January 2, 2020 and January 9, 2020, and became exercisable commencing six (6) months following the issuance date at $1.07 per share and expire five years from issuance. The total grant date fair value of these warrants was determined to be approximately $1.6 million, as calculated using the Black-Scholes model, and were recorded as a debt discount based on their relative fair value. During the three months ended March 31, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued placement agent warrants to purchase an aggregate of 199,732 shares of Common Stock. These placement agent warrants were issued between January 2, 2020 and January 9, 2020, vested immediately, and expire five years from issuance. 41,495 of these Placement Agent Warrants are exercisable at $1.21 per share and 158,237 are exercisable at $1.42 per share. The total grant date fair value of these placement agent warrants was determined to be approximately $174,000, as calculated using the Black-Scholes model, and was charged to debt discount that will be amortized over the life of the debt. Warrant transactions for the three months ended March 31, 2021 and 2020 were as follows: Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable on January 1, 2020 5,378,288 $ 1.07 - 7.37 $ 2.53 Granted during the period 2,012,989 1.07 - 1.42 1.10 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable on March 31, 2020 7,391,277 $ 1.07 - 7.37 $ 2.14 Warrants outstanding and exercisable on January 1, 2021 25,179,192 $ 0.85 - 7.37 $ 1.22 Granted during the period 33,435,677 $ 0.0001-1.69 $ 0.77 Expired during the period 24,259 - - Exercised during the period (9,197,834 ) - - Warrants outstanding and exercisable on March 31, 2021 49,392,776 $ 0.80 – 6.60 $ 1.04 Warrants exercisable on March 31, 2021, were as follows: Exercise Price Number of Shares Under Warrants Weighted Average Remaining Contract Life in Years Weighted Average Exercise Price $ 0.00 - 0.99 38,787,490 4.85 $ 1.00 - 1.99 8,531,482 4.00 $ 2.00 - 2.99 320,063 2.32 $ 3.00 - 3.99 630,459 1.08 $ 4.00 - 4.99 164,256 1.03 $ 5.00 - 5.99 771,276 0.94 $ 6.00 - 6.99 187,750 0.51 Totals 49,392,776 4.55 $1.04 The weighted average fair value of warrants granted during the three months ended March 31, 2021, and 2020, was $0.95 and $0.87 per share, respectively. The grant date fair values were calculated using the Black-Scholes model with the following weighted average assumptions: March 31, 2021 Expected life (in years) 5.41 Volatility 83.8- 90.2 % Risk-free interest rate 0.36- 0.87 % Dividend yield - % |
Stock Options
Stock Options | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Stock Options | Under the 2014 Plan and the 2020 Plan, the fair value of options granted is estimated on the grant date using the Black-Scholes option valuation model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the volatility of the common stock price and the assumed risk-free interest rate. The Company recognizes stock-based compensation expense for only those shares expected to vest over the requisite service period of the award. No compensation cost is recorded for options that do not vest and the compensation cost from vested options, whether forfeited or not, is not reversed. During the three months ended March 31, 2021, the Company issued stock options under the 2020 Plan to new employees to purchase an aggregate of 343,685 shares of Common Stock with strike prices ranging from $0.92 to $1.54 per share and a term of ten years that vest in equal monthly installments over three years. These options had a total fair value of approximately $274,000, as calculated using the Black-Scholes model. During the three months ended March 31, 2021, stock options to purchase an aggregate of 135,514 shares of Common Stock under the 2014 Plan were cancelled with strike prices ranging between $0.85 and $3.60 per share. During the three months ended March 31, 2021, stock options to purchase an aggregate of 204,720 shares of Common Stock, subject to service-based milestone vesting conditions, vested with a total grant date fair value of approximately $149,000 which was recorded as stock-based compensation, of which approximately $121,000 was included as part of general and administrative expense and approximately $28,000 was included as part of research and development expense. During the three months ended March 31, 2021, stock options to purchase an aggregate of 755,000 shares of Common Stock, subject to performance-based milestone vesting conditions, vested due to the Company achieving certain clinical milestones, with a total grant date fair value of approximately $623,000 which was recorded as stock-based compensation, of which approximately $253,000 was included as part of general and administrative expense and approximately $370,000 was included as part of research and development expense. Stock options to purchase an aggregate of 437,500 shares of Common Stock, with a total grant date fair value of approximately $427,000, vested due to the Company completing enrollment of the Phase 2 OPTION 2 clinical trial. Stock options to purchase an aggregate of 210,000 shares of Common Stock, with a total grant date fair value of approximately $148,000, vested due to the Company’s public announcement of topline data for the Phase 2 OPTION 2 clinical trial. Stock options to purchase an aggregate of 7,500 shares of Common Stock, with a total grant date fair value of approximately $8,000, vested due to the Company completing enrollment of the Phase 2 Combination Trial in Europe. Stock options to purchase an aggregate of 100,000 shares of Common Stock, with a total grant date fair value of approximately $40,000, vested due to the Company determining that initiating a U.S. Phase 1 clinical trial for any product other than MS1819 became probable in connection with the initiation of the COVID-19 niclosamide trial. During the three months ended March 31, 2020, the Company issued stock options under the 2014 Plan to purchase an aggregate of 335,006 shares of Common Stock with a strike price of $1.03 per share and a term of ten years to its chief financial officer that vest in equal monthly installments over three years. These options had a total fair value of approximately $281,000, as calculated using the Black-Scholes model. During the three months ended March 31, 2020, stock options to purchase an aggregate of 15,000 shares of Common Stock were cancelled with strike prices ranging between $1.75 and $3.60 per share. During the three months ended March 31, 2020, stock options to purchase an aggregate of 57,917 shares of Common Stock, subject to service-based milestone vesting conditions, vested with a total grant date fair value of approximately $55,000 and recorded as stock-based compensation, and included as part of general and administrative expense. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: March 31, 2021 Contractual term (in years) 10 Volatility 83.8 - 90.1 % Risk-free interest rate 0.93 - 1.69 % Dividend yield - % The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s Common Stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future. During the three months ended March 31, 2021 and 2020, stock option activity under the 2014 Plan and 2020 Plan was as follows: Number of Shares Average Exercise Price Remaining Contract Life in Years Intrinsic Value Stock options outstanding on January 1, 2020 1,677,500 $ 2.17 5.37 $ - - Granted during the period 335,006 $ 1.03 10.00 - Expired during the period - - - - Canceled during the period (15,000 ) $ 2.80 3.28 - Exercised during the period - - - - Stock options outstanding on March 31, 2020 1,997,506 $ 2.08 5.91 $ - Exercisable on March 31, 2020 841,917 $ 3.23 4.33 $ - Non-vested stock options outstanding on January 1, 2020 883,500 $ 1.33 6.26 $ - Granted during the period 335,006 $ 1.03 10.00 - Vested during the period (57,917 ) $ 1.40 6.88 - Expired during the period - - - - Canceled during the period (5,000 ) $ 3.32 2.82 - Exercised during the period - - - - Non-vested stock options outstanding on March 31, 2020 1,155,589 $ 1.24 7.06 $ - Stock options outstanding on January 1, 2021 4,070,284 $ 1.38 7.94 $ - Granted during the period 343,685 $ 1.01 10.00 - Expired during the period - - - - Canceled during the period (135,514 ) $ 2.45 2.87 - Exercised during the period - - - - Stock options outstanding on March 31, 2021 4,278,455 $ 1.19 7.93 $ 1,599,166 Exercisable on March 31, 2021 2,221,569 $ 1.48 6.67 $ 637,269 Non-vested stock options outstanding on January 1, 2021 2,740,657 $ 0.99 8.42 $ - Granted during the period 343,685 $ 1.01 10.00 - Vested during the period (959,720 ) $ - - - Expired during the period - - - - Canceled during the period (67,736 ) $ - - - Exercised during the period - - - - Non-vested stock options outstanding on March 31, 2021 2,056,886 $ 0.87 9.28 $ 961,897 As of March 31, 2021, the Company had unrecognized stock-based compensation expense of approximately $1.5 million. Approximately $1.1 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 2.24 years. Approximately $40,000 of this unrecognized expense will vest upon initiating a Phase 3 clinical trial in the U.S. for MS1819. Approximately, $140,000 of this unrecognized expense will vest upon the public release of topline data of the complete Combination Trial results. Approximately, $140,000 of this unrecognized expense will vest upon signing of a definitive term sheet with Board approval for either (i) a strategic licensing, distribution, or commercialization agreement for MS1819 with a bona fide partner, or (ii) the substantial sale of the Company or the MS1819 asset, on or before December 31, 2021. The Company will recognize the expense related to these milestones when the milestones become probable. As of March 31, 2020, the Company had unrecognized stock-based compensation expense of approximately $965,000. Approximately $290,000 of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 2.74 years. Approximately $522,000 of this unrecognized expense will vest upon enrollment completion next of the Phase 2 OPTION 2 clinical trial. Approximately $73,000 of this unrecognized expense will vest upon enrollment completion of the ongoing Combination Trial in Europe. Approximately $40,000 of this unrecognized expense will vest upon the Company initiating a Phase 3 clinical trial in the U.S. for MS1819. Approximately $40,000 of this unrecognized expense will vest upon initiating a U.S. Phase 1 clinical trial for any product other than MS1819. The Company will recognize the expense related to these milestones when the milestones become probable. |
Agreements
Agreements | 3 Months Ended |
Mar. 31, 2021 | |
Agreements | |
Agreements | License Agreement with First Wave Bio, Inc. On December 31, 2020, we entered into the First Wave License Agreement, pursuant to which First Wave granted us a worldwide, exclusive right to develop, manufacture, and commercialize First Wave’s proprietary immediate release and enema formulations of niclosamide (the “ Niclosamide Product In consideration of the license and other rights granted by First Wave, we agreed to pay First Wave a $9.0 million upfront cash payment due within 10 days, which was paid in January 2021 and are obligated to make an additional payment of $1.25 million due on June 30, 2021. In addition, we are obligated to pay potential milestone payments to First Wave totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. Under the First Wave License Agreement we are obligated to pay First Wave royalties as a mid-single digit percentage of net sales of the Niclosamide Product, subject to specified reductions. We were also obligated to issue to First Wave junior convertible preferred stock, initially convertible into $3.0 million worth of Common Stock based upon the volume weighted average price of the Common Stock for the five-day period immediately preceding the date of the First Wave License Agreement, or $0.9118 per share, convertible into an aggregate of 3,290,196 shares of Common Stock. As of December 31, 2020, this was initially classified as a liability in the consolidated balance sheet because of certain NASDAQ restrictions and the requirement to obtain stockholder approval. On January 8, 2021, in connection with the securities purchase agreement with First Wave (the “ First Wave Purchase Agreement The conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of approximately $230,000 equal to the intrinsic value of the beneficial conversion feature and recognized on the issuance date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. Following the 2021 Stockholder Approval, the shares of Series C Preferred Stock automatically converted into Common Stock. The Company is now solely responsible, and has agreed to use commercially reasonable efforts, for all development, regulatory and commercial activities related to the Niclosamide Products in the ICI-AC and COVID-19 fields. The Company may sublicense its rights under the First Wave License Agreement and, if it does so, will be obligated to pay milestone payments and royalties to First Wave based on the sublicensee’s development and commercialization of the licensed Niclosamide Products. Pursuant to the First Wave License Agreement, First Wave retains rights to develop and commercialize the licensed niclosamide formulations outside the ICI-AC and COVID-19 fields, and to develop and commercialize other niclosamide formulations that are not licensed to Company. However, if prior to April 30, 2021, First Wave seeks to outlicense, sell to or otherwise grant rights to a third party related to any products containing niclosamide for use outside the ICI-AC or COVID-19 fields to develop or commercialize a product containing niclosamide for use outside of the Field then First Wave shall provide to AzurRx written notice of such proposal, in reasonable detail and AzurRx shall have the right and option to negotiate with First Wave with respect to a definitive agreement for the acquisition of First Wave. Pursuant to the First Wave License Agreement, the Company grants First Wave a worldwide, non-exclusive, royalty-free, perpetual, irrevocable license for use outside the ICI-AC and COVID-19 fields, with the right to grant sublicenses, under any Program IP and other intellectual property owned by the Company and incorporated into the Niclosamide Product. The First Wave License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on date of expiration of the last to expire royalty term with respect to the country. The First Wave License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the First Wave License Agreement by either party, termination by the Company in specified circumstances, termination by First Wave in specified circumstances, termination by the Company for convenience with advance notice, and termination upon a party’s insolvency or bankruptcy. After expiration of the royalty term, the Company shall have a non-exclusive, fully-paid, perpetual, royalty-free right and irrevocable license with respect to any Product in any country within the territory. In certain circumstances set forth in the First Wave License Agreement, in the event that First Wave seeks to outlicense, sell or otherwise grant to a third party rights relating to its proprietary formulations of niclosamide (or any products containing niclosamide) for use outside the ICI-AC and the COVID-19 field, then First Wave must provide the Company written notice and engage in good faith negotiations with the Company for a period of time to try to reach agreement on the terms of an acquisition of First Wave by the Company. In the event that First Wave and the Company fail to reach an agreement, then First Wave shall be free to negotiate a transaction, and the right of first refusal shall be of no further force or effect. The First Wave License Agreement also contains customary representations, warranties, and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality, and other matters. Mayoly Agreement In March 2019, the Company and Laboratories Mayoly Spinder (“ Mayoly Mayoly APA JDLA TransChem Sublicense In August 2017, the Company entered into a sublicense agreement with TransChem, pursuant to which TransChem granted the Company an exclusive license to patents and patent applications relating to Helicobacter pylori 5’methylthioadenosine nucleosidase inhibitors (the “TransChem Licensed Patents” “TransChem Sublicense Agreement” In March 2020, the Company provided TransChem with sixty (60) days prior written notice of its intent to terminate the TransChem Sublicense Agreement, which as of March 31, 2021 has been terminated. Employment Agreements James Sapirstein Effective October 8, 2019, the Company entered into an employment agreement with Mr. Sapirstein to serve as its President and Chief Executive Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Sapirstein originally provided for a base salary of $450,000 per year, which was subsequently increased to $480,000 per year during the year ended December 31, 2020. In addition to the base salary, Mr. Sapirstein is eligible to receive (i) a cash bonus of up to 40% of his base salary on an annual basis, based on certain milestones that are yet to be determined; (ii) 1% of net fees received by the Company upon entering into license agreements with any third-party with respect to any product current in development or upon the sale of all or substantially all assets of the Company; (iii) an award grant of 200,000 restricted stock units (“ RSUs In the event that Mr. Sapirstein’s employment is terminated by the Company for Cause, as defined in his employment agreement, or by Mr. Sapirstein voluntarily, then he will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. In the event that Mr. Sapirstein’s employment is terminated as a result of an Involuntary Termination Other than for Cause, as defined in his employment agreement, Mr. Sapirstein will be entitled to receive the following compensation: (i) severance in the form of continuation of his salary (at the base salary rate in effect at the time of termination, but prior to any reduction triggering Good Reason (as such term is defined in Mr. Sapirstein’s employment agreement) for a period of twelve months following the termination date; (ii) payment of Mr. Sapirstein’s premiums to cover COBRA for a period of twelve months following the termination date; and (iii) a prorated annual bonus. Daniel Schneiderman Effective January 2, 2020, the Company entered into an employment agreement with Mr. Schneiderman to serve as the Company’s Chief Financial Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Schneiderman provides for a base salary of $285,000 per year. In addition to the base salary, Mr. Schneiderman is eligible to receive (a) an annual milestone cash bonus based on certain milestones that will be established by the Company’s Board or the Compensation Committee, and (b) a grant of stock options to purchase 335,006 shares of common stock with an exercise price of $1.03 per share, which shall vest in three equal portions on each anniversary date of the execution of Mr. Schneiderman’s employment agreement, commencing on January 2, 2021, the first anniversary date of the agreement. Mr. Schneiderman is entitled to receive 20 days of paid vacation, participate in full employee health benefits, and receive reimbursement for all reasonable expenses incurred in connection with his service to the Company. The Company may terminate Mr. Schneiderman’s employment agreement at any time, with or without Cause, as such term is defined in his employment agreement. In the event that Mr. Schneiderman’s employment is terminated by the Company for Cause, as defined in Mr. Schneiderman’s employment agreement, or by Mr. Schneiderman voluntarily, then he will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. If the Company terminates his employment agreement without Cause, not in connection with a Change of Control, as such term is defined in Mr. Schneiderman’s employment agreement, he will be entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of his salary for the greater of a period of six months following the termination date or the remaining term of the employment agreement; (iv) payment of premiums to cover COBRA for a period of six months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the agreement. If the Company terminates Mr. Schneiderman’s employment agreement without Cause, in connection with a Change of Control, he will be entitled to the above and immediate accelerated vesting of any unvested options or other unvested awards. Dr. James E. Pennington Effective May 28, 2018, the Company entered into an employment agreement with Dr. Pennington to serve as its Chief Medical Officer. The employment agreement with Dr. Pennington provides for a base annual salary of $250,000. In addition to his salary, Dr. Pennington is eligible to receive an annual milestone bonus, awarded at the sole discretion of the Board based on his attainment of certain financial, clinical development, and/or business milestones established annually by the Board or Compensation Committee. The Company may terminate Dr. Pennington’s employment agreement at any time, with or without Cause, as such term is defined in Dr. Pennington’s employment agreement. In the event of termination by the Company other than for Cause, Dr. Pennington is entitled to three months’ severance payable over such period. In the event of termination by the Company other than for Cause in connection with a Change of Control as such term is defined in Dr. Pennington’s employment agreement, Dr. Pennington will receive six months’ severance payable over such period. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Leases | The Company adopted ASU 2016-02, Leases, as of January 1, 2019, using the modified retrospective approach. Prior year financial statements were not recast under the new standard. The Company leases its offices and research facilities under operating leases which are subject to various rent provisions and escalation clauses. The Company’s leases expire at various dates through 2022. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments. Lease expense amounted to approximately $52,000 and $35,000, respectively, for the three months ended March 31, 2021 and 2020. The weighted-average remaining lease term and weighted-average discount rate under operating leases on March 31, 2021, are: March 31, 2021 Lease term and discount rate Weighted-average remaining lease term 1.17 years Weighted-average discount rate 6.0% Maturities of operating lease liabilities on March 31, 2021, were as follows: 2021 $ 41,803 2022 23,375 Total lease payments 65,178 Less imputed interest (1,910 ) Present value of lease liabilities $ 63,268 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | The Company is subject to taxation at the federal level in both the United States and France and at the state level in the United States. On March 31, 2021, and December 31, 2020, the Company had no tax provision for either jurisdiction. On March 31, 2021, and December 31, 2020, the Company had gross deferred tax assets of approximately $25 million and $26.1 million, respectively. As the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of approximately $25 million and $26.1 million, respectively, has been established on March 31, 2021, and December 31, 2020. The change in the valuation allowance in the three months ended March 31, 2021 and 2020 was approximately $(1.3) million and $(0.4) million, respectively. On March 31, 2021, the Company has gross net operating loss (“ NOL Section 382 On March 31, 2021, and December 31, 2020, the Company had approximately $24.4 million and $23.0 million, respectively, in net operating losses which it can carryforward indefinitely to offset against future French income. On March 31, 2021, and December 31, 2020, the Company had taken no uncertain tax positions that would require disclosure under ASC 740, Accounting for Income Taxes |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options and warrants is computed using the treasury stock method. On March 31, 2021, diluted net loss per share did not include the effect of 12,360,554 shares of Common Stock issuable upon the conversion of Series B preferred stock, including accrued and unpaid dividends through March 31, 2021, 49,392,676 shares of Common Stock issuable upon the exercise of outstanding warrants, 112,000 shares of restricted stock and RSUs not yet issued, and 4,278,455 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. Also excluded from the diluted net loss per are the potentially dilutive effect of 12,690,204 shares of Common Stock issuable upon exercise of January 2021 Investor Warrants potentially issuable pursuant the Series B Exchange Right. On March 31, 2020, diluted net loss per share did not include the effect of 7,117,559 shares of Common Stock issuable upon the conversion of convertible debt, 7,391,277 shares of Common Stock issuable upon the exercise of outstanding warrants, 632,667 shares of Common Stock pursuant to unissued restricted stock and RSUs, and 1,997,506 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2021 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 401(k) Plan Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company. All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions. Employer contributions under this 401(k) plan amounted to approximately $32,000 and $22,000 for the three months ended March 31, 2021 and 2020, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | French R&D (CIR) Tax Credit In April 2021, the Company received payment for the 2020 refundable tax credits for research conducted in France of approximately $550,000. Series B Most Favored Nations (MFN) Exchanges From April 1 through May 21, 2021, holders of 315.99 shares of Series B Preferred Stock with an aggregate Series B Exchange Amount of approximately $2.5 million have elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 3,319,854 shares of Common Stock, and additional January 2021 Investor Warrants exercisable for up to an aggregate of 3,319,854 shares of Common Stock. As of May 21, 2021, holders of 1,622.29 shares of Series B Preferred Stock with an aggregate Series B Exchange Amount of approximately $12.6 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 16,820,841 shares of Common Stock, and additional January 2021 Investor Warrants exercisable for up to an aggregate of 16,820,841 shares of Common Stock. As a result, as of May 21, 2021, we may be required to issue up to 9,483.3780 additional shares of Series C Preferred Stock that are currently convertible up to 9,483,378 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 9,483,378 shares of Common Stock, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right in connection with up to 893.52 shares of Series B Preferred Stock plus accrued dividends of approximately $232,000. Any shares of Series C Preferred Stock to be issued pursuant to the Series B Exchange Right would, upon issuance, be immediately converted into underlying shares of Common Stock. |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Use of Estimates | The accompanying unaudited consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill, intangible assets, and contingent consideration), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. |
Cash and Cash Equivalents | The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash balances were highly liquid on March 31, 2021, and December 31, 2020, respectively. |
Concentrations of Credit Risk | Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. On March 31, 2021, and December 31, 2020, the Company had approximately $5.6 million and $2.7 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. |
Debt Instruments | Detachable warrants issued in conjunction with debt are measured at their relative fair value, if they are determined to be equity instrument, or their fair value, if they are determined to be liability instruments, and recorded as a debt discount. Conversion features that are in the money at the commitment date constitute a beneficial conversion feature that is measured at its intrinsic value and recognized as debt discount. Debt discount is amortized as interest expense over the maturity period of the debt using the effective interest method. Contingent beneficial conversion features are recognized when the contingency has been resolved. |
Debt Issuance Costs | Debt issuance costs are recorded as a direct reduction of the carrying amount of the related debt. Debt issuance costs are amortized over the maturity period of the related debt instrument using the effective interest method. |
Equity-Based Payments to Non-Employees | Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. |
Fair Value Measurements | The Company follows Accounting Standards Codification (“ASC” (“ASC 820” As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. |
Foreign Currency Translation | For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of stockholders’ equity. |
Goodwill and Intangible Assets | Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through March 31, 2021. Intangible assets subject to amortization consist of in process research and development, license agreements, and patents reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years |
Impairment of Long-Lived Assets | The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360” |
Income Taxes | Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740” The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. On March 31, 2021, and December 31, 2020, the Company does not have any significant uncertain tax positions. All tax years are still open for audit. |
License Agreements | As more fully discussed in Note 14, the Company entered into a license agreement (the “ First Wave License Agreement First Wave ICI-AC and COVID-19 GI infections. The acquisition of intellectual property and patents for As more fully discussed in Note 14, the Company entered into a sublicense agreement with TransChem, Inc. (“ TransChem |
Research and Development | Research and development costs are charged to operations when incurred and are included in operating expense. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (CROs), investigative sites, consultants and contractors that conduct or provide other services relating to our clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (CDMOs) and third-party contractors relating to our chemistry, manufacturing and controls (“ CMC |
Stock-Based Compensation | The Company’s board of directors (the “ Board 2014 Plan 2020 Plan ASC 718 For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. |
Subsequent Events | The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. |
Recent Accounting Pronouncements | In August 2020, the FASB issued accounting pronouncement (ASU 2020-06) related to the measurement and disclosure requirements for convertible instruments and contracts in an entity's own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity's own equity. As a smaller reporting company, as defined by the U.S. Securities and Exchange Commission (the "SEC" |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Goodwill and intangible assets | Patents 7.2 years In Process Research & Development 12 years License Agreements 5 years |
Fair Value Disclosures (Tables)
Fair Value Disclosures (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial instruments measured at fair value on a recurring basis | Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value On March 31, 2021: Cash and cash equivalents $ 12,025,632 $ 6,000,886 $ 6,024,746 $ - $ 12,025,632 Other receivables $ 501,660 $ $ $ 501,660 $ 501,660 Note payable $ 347,082 $ $ $ 347,082 $ 347,082 On December 31, 2020: Cash and cash equivalents $ 6,062,141 $ 3,000,184 $ 3,061,957 $ - $ 6,062,141 Other receivables $ 551,489 $ - $ - $ - $ 551,489 Note payable $ 552,405 $ - $ - $ - $ 552,405 |
Other Receivables (Tables)
Other Receivables (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Receivables [Abstract] | |
Other receivables | March 31, December 31, 2021 2020 Research and development tax credits $ 442,630 $ 493,906 Other 59,030 57,583 Total other receivables $ 501,660 $ 551,489 |
Property, Equipment, and Leas_2
Property, Equipment, and Leasehold Improvements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, equipment and leasehold improvements | March 31, December 31, 2021 2020 Laboratory equipment $ - $ 2,410 Computer equipment 19,676 19,676 Office equipment - 5,483 Leasehold improvements - 29,163 Total property, plant, and equipment 19,676 56,732 Less accumulated depreciation (19,584 ) (38,403 ) Property, plant and equipment, net $ 92 $ 18,329 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Patents | Common stock issued at signing to Mayoly $ 1,740,959 Due to Mayoly at December 31, 2019 449,280 Due to Mayoly at December 31, 2020 393,120 Assumed Mayoly liabilities and forgiveness of Mayoly debt 1,219,386 $ 3,802,745 |
Intangible assets | March 31, December 31, 2021 2020 Patents $ 3,802,745 $ 3,802,745 Less accumulated amortization (1,055,096 ) (923,209 ) Patents, net $ 2,747,649 $ 2,879,536 |
Future amortization expense | 2021 (balance of year) $ 395,661 2022 527,548 2023 527,548 2024 527,548 2025 527,548 |
Goodwill | Goodwill Balance on January 1, 2020 $ 1,886,686 Foreign currency translation 167,362 Balance on December 31, 2020 2,054,048 Foreign currency translation (80,085 ) Balance on March 31, 2021 $ 1,973,963 |
Other Liabilities (Tables)
Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Other Liabilities [Abstract] | |
Other liabilities | March 31, December 31, Current 2021 2020 Lease liabilities $ 56,702 $ 57,417 Other liabilities 8,633 - $ 65,335 $ 57,417 March 31, December 31, Long-term 2021 2020 Lease liabilities $ 6,566 $ 19,123 $ 6,566 $ 19,123 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
WarrantsDisclosureTextBlock | |
Stock warrant transactions | Exercise Weighted Price Per Average Warrants Share Exercise Price Warrants outstanding and exercisable on January 1, 2020 5,378,288 $ 1.07 - 7.37 $ 2.53 Granted during the period 2,012,989 1.07 - 1.42 1.10 Expired during the period - - - Exercised during the period - - - Warrants outstanding and exercisable on March 31, 2020 7,391,277 $ 1.07 - 7.37 $ 2.14 Warrants outstanding and exercisable on January 1, 2021 25,179,192 $ 0.85 - 7.37 $ 1.22 Granted during the period 33,435,677 $ 0.0001-1.69 $ 0.77 Expired during the period 24,259 - - Exercised during the period (9,197,834 ) - - Warrants outstanding and exercisable on March 31, 2021 49,392,776 $ 0.80 – 6.60 $ 1.04 |
Warrants by exercise price | Exercise Price Number of Shares Under Warrants Weighted Average Remaining Contract Life in Years Weighted Average Exercise Price $ 0.00 - 0.99 38,787,490 4.85 $ 1.00 - 1.99 8,531,482 4.00 $ 2.00 - 2.99 320,063 2.32 $ 3.00 - 3.99 630,459 1.08 $ 4.00 - 4.99 164,256 1.03 $ 5.00 - 5.99 771,276 0.94 $ 6.00 - 6.99 187,750 0.51 Totals 49,392,776 4.55 $1.04 |
Share-based payment weighted average assumptions | March 31, 2021 Expected life (in years) 5.41 Volatility 83.8- 90.2 % Risk-free interest rate 0.36- 0.87 % Dividend yield - % |
Stock Options (Tables)
Stock Options (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Share-based payment weighted average assumptions | March 31, 2021 Contractual term (in years) 10 Volatility 83.8 - 90.1 % Risk-free interest rate 0.93 - 1.69 % Dividend yield - % |
Stock option activity | Number of Shares Average Exercise Price Remaining Contract Life in Years Intrinsic Value Stock options outstanding on January 1, 2020 1,677,500 $ 2.17 5.37 $ - - Granted during the period 335,006 $ 1.03 10.00 - Expired during the period - - - - Canceled during the period (15,000 ) $ 2.80 3.28 - Exercised during the period - - - - Stock options outstanding on March 31, 2020 1,997,506 $ 2.08 5.91 $ - Exercisable on March 31, 2020 841,917 $ 3.23 4.33 $ - Non-vested stock options outstanding on January 1, 2020 883,500 $ 1.33 6.26 $ - Granted during the period 335,006 $ 1.03 10.00 - Vested during the period (57,917 ) $ 1.40 6.88 - Expired during the period - - - - Canceled during the period (5,000 ) $ 3.32 2.82 - Exercised during the period - - - - Non-vested stock options outstanding on March 31, 2020 1,155,589 $ 1.24 7.06 $ - Stock options outstanding on January 1, 2021 4,070,284 $ 1.38 7.94 $ - Granted during the period 343,685 $ 1.01 10.00 - Expired during the period - - - - Canceled during the period (135,514 ) $ 2.45 2.87 - Exercised during the period - - - - Stock options outstanding on March 31, 2021 4,278,455 $ 1.19 7.93 $ 1,599,166 Exercisable on March 31, 2021 2,221,569 $ 1.48 6.67 $ 637,269 Non-vested stock options outstanding on January 1, 2021 2,740,657 $ 0.99 8.42 $ - Granted during the period 343,685 $ 1.01 10.00 - Vested during the period (959,720 ) $ - - - Expired during the period - - - - Canceled during the period (67,736 ) $ - - - Exercised during the period - - - - Non-vested stock options outstanding on March 31, 2021 2,056,886 $ 0.87 9.28 $ 961,897 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Operating lease information | March 31, 2021 Lease term and discount rate Weighted-average remaining lease term 1.17 years Weighted-average discount rate 6.0% |
Maturities of operating lease liabilities | 2021 $ 41,803 2022 23,375 Total lease payments 65,178 Less imputed interest (1,910 ) Present value of lease liabilities $ 63,268 |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details Narrative) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash an cash equivalents | $ 12,025,632 | $ 6,062,141 | $ 1,630,007 | $ 175,796 |
Accumulated deficit | $ (103,051,827) | $ (95,366,198) |
Significant Accounting Polici_4
Significant Accounting Policies and Recent Accounting Pronouncements (Details) | 3 Months Ended |
Mar. 31, 2021 | |
Patents | |
Useful life | 7 years 2 months 12 days |
In Process Research & Development | |
Useful life | 12 years |
License Agreements | |
Useful life | 5 years |
Significant Accounting Polici_5
Significant Accounting Policies and Recent Accounting Pronouncements (Details Narrative) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Cash in excess of FDIC limit | $ 5,600,000 | $ 2,700,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Cash and cash equivalents | $ 12,025,632 | $ 6,062,141 | $ 1,630,007 | $ 175,796 |
Other receivables | 501,660 | 551,489 | ||
Note payable | 347,082 | 552,405 | ||
Level 1 | ||||
Cash and cash equivalents | 6,000,886 | 3,000,184 | ||
Other receivables | 0 | 0 | ||
Note payable | 0 | 0 | ||
Level 2 | ||||
Cash and cash equivalents | 6,024,746 | 3,061,957 | ||
Other receivables | 0 | 0 | ||
Note payable | 0 | 0 | ||
Level 3 | ||||
Cash and cash equivalents | 0 | 0 | ||
Other receivables | 501,660 | 0 | ||
Note payable | 347,082 | 0 | ||
Carrying Amount | ||||
Cash and cash equivalents | 12,025,632 | 6,062,141 | ||
Other receivables | 501,660 | 551,489 | ||
Note payable | $ 347,082 | $ 552,405 |
Other Receivables (Details)
Other Receivables (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Receivables [Abstract] | ||
Research and development tax credits | $ 442,630 | $ 493,906 |
Other | 59,030 | 57,583 |
Other receivables | $ 501,660 | $ 551,489 |
Property, Equipment, and Leas_3
Property, Equipment, and Leasehold Improvements (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Property, equipment and leasehold improvements, gross | $ 19,676 | $ 56,732 |
Less accumulated depreciation | (19,584) | (38,403) |
Property, equipment and leasehold improvements, net | 92 | 18,329 |
Laboratory Equipment | ||
Property, equipment and leasehold improvements, gross | 0 | 19,676 |
Computer Equipment | ||
Property, equipment and leasehold improvements, gross | 19,676 | 5,483 |
Office Equipment | ||
Property, equipment and leasehold improvements, gross | 0 | 2,410 |
Leasehold Improvements | ||
Property, equipment and leasehold improvements, gross | $ 0 | $ 29,163 |
Property, Equipment, and Leas_4
Property, Equipment, and Leasehold Improvements (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Depreciation expense | $ 1,021 | $ 9,661 |
Research and Development Expense | ||
Depreciation expense | $ 5,000 | 1,000 |
General and Administrative Expense | ||
Depreciation expense | $ 5,000 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Details) | Mar. 31, 2021USD ($) |
Patents | $ 3,802,745 |
Common Stock Issued at Signing to Mayoly | |
Patents | 1,740,959 |
Due to Mayoly at 12/31/19 | |
Patents | 449,280 |
Due to Mayoly at 12/31/20 | |
Patents | 393,120 |
Assumed Mayoly Liabilties and Forgiveness of Mayoly Debt | |
Patents | $ 1,219,386 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Details 1) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Intangible assets, gross | $ 3,802,745 | |
Patents | ||
Intangible assets, gross | 3,802,745 | $ 3,802,745 |
Less accumulated amortization | (1,055,096) | (923,209) |
Intangible assets, net | $ 2,747,649 | $ 2,879,536 |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill (Details 2) | Mar. 31, 2021USD ($) |
Amortization expense | |
2021 (balance of year) | $ 395,661 |
2022 | 527,548 |
2023 | 527,548 |
2024 | 527,548 |
2025 | $ 527,548 |
Intangible Assets and Goodwil_5
Intangible Assets and Goodwill (Details 3) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill, beginning | $ 2,054,048 | $ 1,886,686 |
Foreign currency translation | (80,085) | 167,362 |
Goodwill, ending | $ 1,973,963 | $ 2,054,048 |
Intangible Assets and Goodwil_6
Intangible Assets and Goodwill (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 132,000 | $ 131,000 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Trade payables | $ 1,440,718 | $ 1,558,591 |
Accrued expenses | 267,123 | 127,012 |
Total accounts payable and accrued expenses | $ 1,707,841 | $ 1,685,603 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 |
Notes Payable [Abstract] | |||
Notes payable | $ 347,082 | $ 552,405 | $ 280,000 |
Other Liabilities (Details)
Other Liabilities (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Other Liabilities [Abstract] | ||
Lease liabilities, current | $ 56,702 | $ 57,417 |
Other liabilities, current | 8,633 | 0 |
Total other liabilities, current | 65,335 | 57,417 |
Lease liabilities, noncurrent | 6,566 | 19,123 |
Total other liabilities, noncurrent | $ 6,566 | $ 19,123 |
Equity (Details Narrative)
Equity (Details Narrative) - shares | Mar. 31, 2021 | Dec. 31, 2020 |
Common stock shares, issued | 74,926,902 | 31,150,309 |
Common stock shares, outstanding | 74,926,902 | 31,150,309 |
Series B Preferred Stock | ||
Preferred stock shares, issued | 1,209.52 | 2,773.6 |
Preferred stock shares, outstanding | 1,209.52 | 2,773.6 |
Series C Preferred Stock | ||
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Warrants (Details)
Warrants (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Warrants issued and exercisable, beginning | 25,179,192 | 5,378,288 |
Granted | 33,435,677 | 2,012,989 |
Expired | 24,259 | 0 |
Exercised | (9,197,834) | 0 |
Warrants issued and exercisable, ending | 49,392,776 | 7,391,277 |
Exercise price expired | $ .00 | $ .00 |
Exercise price exercised | .00 | .00 |
Weighted average exercise price, beginning | 1.22 | 2.53 |
Weighted average exercise price, granted | 0.77 | 1.10 |
Weighted average exercise price warrants, expired | .00 | .00 |
Weighted average exercise price warrants, exercised | .00 | .00 |
Weighted average exercise price, ending | 1.04 | 2.14 |
Minimum | ||
Exercise price outstanding, beginning | .85 | 1.07 |
Exercise price granted | 0.0001 | 1.07 |
Exercise price outstanding, ending | .80 | 1.07 |
Maximum | ||
Exercise price outstanding, beginning | 7.37 | 7.37 |
Exercise price granted | 1.69 | 1.42 |
Exercise price outstanding, ending | $ 6.60 | $ 7.37 |
Warrants (Details 1)
Warrants (Details 1) | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of shares under warrants | 49,392,776 |
Weighted average remaining contract life in years | 4 years 6 months 18 days |
Weighted average exercise price | $ / shares | $ 1.04 |
Warrant 1 | |
Exercise price | $0.00 - $0.99 |
Number of shares under warrants | 38,787,490 |
Weighted average remaining contract life in years | 4 years 10 months 6 days |
Warrant 2 | |
Exercise price | $1.00 - $1.99 |
Number of shares under warrants | 8,531,482 |
Weighted average remaining contract life in years | 2 years |
Warrant 3 | |
Exercise price | $2.00 - $2.99 |
Number of shares under warrants | 320,063 |
Weighted average remaining contract life in years | 2 years 3 months 25 days |
Warrant 4 | |
Exercise price | $3.00 - $3.99 |
Number of shares under warrants | 630,459 |
Weighted average remaining contract life in years | 1 year 29 days |
Warrant 5 | |
Exercise price | $4.00 - $4.99 |
Number of shares under warrants | 164,256 |
Weighted average remaining contract life in years | 1 year 11 days |
Warrant 6 | |
Exercise price | $5.00 - $5.99 |
Number of shares under warrants | 771,276 |
Weighted average remaining contract life in years | 11 months 8 days |
Warrant 7 | |
Exercise price | $6.00 - $6.99 |
Number of shares under warrants | 187,750 |
Weighted average remaining contract life in years | 6 months 4 days |
Warrants (Details 2)
Warrants (Details 2) | 3 Months Ended |
Mar. 31, 2021 | |
WarrantsDisclosureTextBlock | |
Expected life (in years) | 5 years 4 months 28 days |
Volatility, minimum | 83.80% |
Volatility, maximum | 90.20% |
Risk-free interest rate, minimum | 0.36% |
Risk-free interest rate, maximum | 0.87% |
Dividend yield | 0.00% |
Stock Options (Details)
Stock Options (Details) | 3 Months Ended |
Mar. 31, 2021 | |
Expected life (in years) | 5 years 4 months 28 days |
Volatility, minimum | 83.80% |
Volatility, maximum | 90.20% |
Risk-free interest rate, minimum | 0.36% |
Risk-free interest rate, maximum | 0.87% |
Dividend yield | 0.00% |
Stock Option | |
Expected life (in years) | 10 years |
Volatility, minimum | 83.80% |
Volatility, maximum | 90.10% |
Risk-free interest rate, minimum | 0.93% |
Risk-free interest rate, maximum | 1.69% |
Dividend yield | 0.00% |
Stock Options (Details 1)
Stock Options (Details 1) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Stock Option | ||
Number of options outstanding, beginning | 4,070,284 | 1,677,500 |
Number of options granted | 343,685 | 335,006 |
Number of options expired | 0 | 0 |
Number of options canceled | (135,514) | (1,500) |
Number of options exercised | 0 | 0 |
Number of options outstanding, ending | 4,278,455 | 1,997,506 |
Number of options exercisable | 2,221,569 | 841,917 |
Weighted average exercise price outstanding, beginning | $ 1.38 | $ 2.17 |
Weighted average exercise price granted | 1.01 | 1.03 |
Weighted average exercise price expired | .00 | .00 |
Weighted average exercise price canceled | 2.45 | 2.80 |
Weighted average exercise price exercised | .00 | .00 |
Weighted average exercise price outstanding,ending | 1.19 | 2.08 |
Weighted average exercise price exercisable | $ 1.48 | $ 3.23 |
Weighted average remaining contract life in years, beginning | 7 years 11 months 8 days | 5 years 4 months 13 days |
Weighted average remaining contract life in years granted | 10 years | 10 years |
Weighted average remaining contract life in years expired | 0 years | 0 years |
Weighted average remaining contract life in years canceled | 2 years 10 months 13 days | 3 years 3 months 11 days |
Weighted average remaining contract life in years exercised | 0 years | 0 years |
Weighted average remaining contract life in years, ending | 7 years 11 months 5 days | 5 years 10 months 28 days |
Weighted average remaining contract life in years exercisable | 6 years 8 months 1 day | 4 years 3 months 29 days |
Aggregate intrinsic value outstanding, beginning | $ 0 | $ 0 |
Aggregate intrinsic value granted | 0 | 0 |
Aggregate intrinsic value expired | 0 | 0 |
Aggregate intrinsic value canceled | 0 | 0 |
Aggregate intrinsic value exercised | 0 | 0 |
Aggregate intrinsic value outstanding, ending | 1,599,166 | 0 |
Aggregate intrinsic value exercisable | $ 637,269 | $ 0 |
Non-vested Stock Option | ||
Number of options outstanding, beginning | 2,740,657 | 883,500 |
Number of options granted | 343,685 | 335,006 |
Number of options vested | (959,720) | (57,917) |
Number of options expired | 0 | 0 |
Number of options canceled | (67,736) | (5,000) |
Number of options exercised | 0 | 0 |
Number of options outstanding, ending | 2,056,886 | 1,155,589 |
Weighted average exercise price outstanding, beginning | $ .99 | $ 1.33 |
Weighted average exercise price granted | 1.01 | 1.03 |
Weighted average exercise price vested | .00 | 1.40 |
Weighted average exercise price expired | .00 | .00 |
Weighted average exercise price canceled | .00 | 3.32 |
Weighted average exercise price exercised | .00 | .00 |
Weighted average exercise price outstanding,ending | $ .87 | $ 1.24 |
Weighted average remaining contract life in years, beginning | 8 years 5 months 1 day | 6 years 3 months 4 days |
Weighted average remaining contract life in years granted | 10 years | 10 years |
Weighted average remaining contract life in years vested | 0 years | 6 years 10 months 17 days |
Weighted average remaining contract life in years expired | 0 years | 0 years |
Weighted average remaining contract life in years canceled | 0 years | 2 years 9 months 25 days |
Weighted average remaining contract life in years exercised | 0 years | 0 years |
Weighted average remaining contract life in years, ending | 9 years 3 months 11 days | 7 years 22 days |
Aggregate intrinsic value outstanding, beginning | $ 0 | $ 0 |
Aggregate intrinsic value granted | 0 | 0 |
Aggregate intrinsic value vested | 0 | 0 |
Aggregate intrinsic value expired | 0 | 0 |
Aggregate intrinsic value canceled | 0 | 0 |
Aggregate intrinsic value exercised | 0 | 0 |
Aggregate intrinsic value outstanding, ending | $ 961,897 | $ 0 |
Leases (Details)
Leases (Details) | Mar. 31, 2021 |
Leases [Abstract] | |
Weighted-average remaining lease term | 1 year 2 months 1 day |
Weighted-average discount rate | 6.00% |
Leases (Details 1)
Leases (Details 1) | Mar. 31, 2021USD ($) |
Leases [Abstract] | |
2021 | $ 41,803 |
2022 | 23,375 |
Total lease payments | 65,178 |
Less: imputed interest | 1,910 |
Present value of lease liabilities | $ 63,268 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Leases [Abstract] | ||
Lease expense | $ 52,000 | $ 35,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Gross deferred tax asset | $ 25,000,000 | $ 26,100,000 | |
Deferred tax asset valuation allowance | (25,000,000) | (26,100,000) | |
Change in valuation allowance | (1,300,000) | $ (400,000) | |
Domestic operating loss carry-forwards | 57,000,000 | 22,000,000 | |
Foreign operating loss carry-forwards | $ 24,400,000 | $ 23,000,000 |
Net Loss per Common Share (Deta
Net Loss per Common Share (Details Narrative) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Series B Preferred Stock | ||
Anti-dilutive shares excluded from earnings per share | 12,360,554 | |
Convertible Debt | ||
Anti-dilutive shares excluded from earnings per share | 7,117,559 | |
Warrants | ||
Anti-dilutive shares excluded from earnings per share | 49,392,676 | 7,391,277 |
Restricted Stock | ||
Anti-dilutive shares excluded from earnings per share | 112,000 | 632,667 |
Stock Option | ||
Anti-dilutive shares excluded from earnings per share | 4,278,455 | 1,997,506 |
Investor Warrants | ||
Anti-dilutive shares excluded from earnings per share | 12,690,204 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Retirement Benefits [Abstract] | ||
Employer contributions | $ 32,000 | $ 22,000 |