Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 19, 2022 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-37853 | |
Entity Registrant Name | First Wave BioPharma, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-4993860 | |
Entity Address, Address Line One | 777 Yamato Road, Suite 502 | |
Entity Address, City or Town | Boca Raton | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33431 | |
City Area Code | 561 | |
Local Phone Number | 589-7020 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | FWBI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 21,635,338 | |
Entity Central Index Key | 0001604191 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 5,694,988 | $ 8,248,684 |
Other receivables | 28,055 | |
Prepaid expenses | 827,128 | 1,176,268 |
Total Current Assets | 6,550,171 | 9,424,952 |
Property, equipment, and leasehold improvements, net | 65,793 | 73,110 |
Other Assets: | ||
Goodwill | 1,862,069 | 1,911,705 |
Operating lease right-of-use assets | 313,009 | 336,197 |
Deposits | 34,397 | 44,012 |
Total Other Assets | 2,209,475 | 2,291,914 |
Total Assets | 8,825,439 | 11,789,976 |
Current Liabilities: | ||
Accounts payable | 3,449,928 | 2,707,731 |
Accrued expenses | 717,514 | 393,253 |
Accrued dividend payable | 556,153 | 465,361 |
Note payable. | 402,766 | 641,236 |
Operating lease liabilities | 70,784 | 77,989 |
Payable related to acquisition - current | 9,000,000 | 8,000,000 |
Other current liabilities | 18,575 | 14,818 |
Total Current Liabilities | 14,215,720 | 12,300,388 |
Non-current operating lease liabilities | 264,460 | 311,138 |
Payable related to acquisition - long term | 3,585,044 | 7,000,000 |
Total Liabilities | 18,065,224 | 19,611,526 |
Commitments and Contingencies | ||
Stockholders' Deficit: | ||
Common stock - Par value $0.0001 per share; 50,000,000 shares authorized; 21,548,835 and 14,855,848 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 2,154 | 1,485 |
Additional paid-in capital | 155,571,487 | 147,305,147 |
Accumulated deficit | (163,530,886) | (153,904,047) |
Accumulated other comprehensive loss | (1,282,540) | (1,224,135) |
Total Stockholders' Deficit | (9,239,785) | (7,821,550) |
Total Liabilities and Stockholders' Deficit | 8,825,439 | 11,789,976 |
Series B Preferred Stock [Member] | ||
Stockholders' Deficit: | ||
Preferred stock | 0 | 0 |
Series C Preferred Stock [Member] | ||
Stockholders' Deficit: | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 21,548,835 | 14,855,848 |
Common stock, shares outstanding (in shares) | 21,548,835 | 14,855,848 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 10,000,000 | |
Series B Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 5,194.81 | 5,194.81 |
Preferred stock, shares issued (in shares) | 645.21 | 662.25 |
Preferred stock, shares outstanding (in shares) | 645.20 | 662.25 |
Series C Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 57,000 | 57,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating expenses: | ||
Research and development expenses | $ 4,976,517 | $ 2,516,027 |
General and administrative expenses | 4,405,555 | 5,697,514 |
Total operating expenses | 9,382,072 | 8,213,541 |
Loss from operations | (9,382,072) | (8,213,541) |
Other (expense) income: | ||
Interest expense | (5,605) | (5,144) |
Interest income | 139 | 403 |
Other expense | (239,301) | |
Change in fair value of liability | 532,653 | |
Total other (expense) income | (244,767) | 527,912 |
Net loss | (9,626,839) | (7,685,629) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | (58,405) | (134,797) |
Total comprehensive loss | (9,685,244) | (7,820,426) |
Net loss | (9,626,839) | (7,685,629) |
Deemed dividend on preferred stock | (4,507,125) | |
Deemed dividend on preferred stock exchanges | (17,584,048) | |
Deemed dividend on warrant modification | (594,975) | |
Preferred stock dividends | (90,792) | (204,382) |
Net loss applicable to common shareholders | $ (10,312,606) | $ (29,981,184) |
Basic weighted average number of shares outstanding | 15,544,679 | 5,534,813 |
Diluted weighted average number of shares outstanding | 15,544,679 | 5,534,813 |
Loss per share, Basic | $ (0.66) | $ (5.42) |
Loss per share, Diluted | $ (0.66) | $ (5.42) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($) | Common Stock, Pre-funded Warrants, and Cash Warrants [Member]Convertible preferred stock (1)Series B Convertible Preferred Stock [Member] | Common Stock, Pre-funded Warrants, and Cash Warrants [Member]Common Stock [Member] | Common Stock, Pre-funded Warrants, and Cash Warrants [Member]Additional Paid-in Capital [Member] | Common Stock, Pre-funded Warrants, and Cash Warrants [Member]Retained Earnings [Member] | Common Stock, Pre-funded Warrants, and Cash Warrants [Member]AOCI Attributable to Parent [Member] | Common Stock, Pre-funded Warrants, and Cash Warrants [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member]Convertible preferred stock (1)Series B Convertible Preferred Stock [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member]Common Stock [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member]Additional Paid-in Capital [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member]Retained Earnings [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member]AOCI Attributable to Parent [Member] | Conversion of Series B Preferred Shares Into Common Stock [Member] | Series B Preferred Stock Converted into Common Stock [Member] | Convertible preferred stock (1)Series B Convertible Preferred Stock [Member] | Convertible preferred stock (1)Series C Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at the beginning (in shares) at Dec. 31, 2020 | 2,774 | 0 | 3,115,031 | |||||||||||||||||
Balance at the beginning 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 (in shares) | 10,670 | |||||||||||||||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs | 0 | $ 0 | 0 | 7,105,167 | 0 | 0 | 7,105,167 | |||||||||||||
Issuance of Series C preferred stock to settle liability arising from acquisition (in shares) | 3,290 | |||||||||||||||||||
Issuance of Series C preferred stock to settle liability arising from acquisition | 0 | $ 0 | 0 | 2,467,648 | 0 | 0 | 2,467,648 | |||||||||||||
Beneficial conversion feature of Series C preferred stock | 0 | 0 | 0 | 4,507,125 | 0 | 0 | 4,507,125 | |||||||||||||
Deemed dividend on preferred stock | $ 0 | $ 0 | 0 | (4,507,125) | 0 | 0 | (4,507,125) | |||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock (in shares) | (1,306) | 13,500 | ||||||||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock | $ 0 | $ 0 | 0 | (1,009) | 0 | 0 | (1,009) | |||||||||||||
Warrants issued in connection with exchange of Series B preferred stock into Series C preferred stock | 0 | 0 | 0 | 17,585,057 | 0 | 0 | 17,585,057 | |||||||||||||
Deemed dividend of Series B preferred stock | $ 0 | 0 | $ 0 | (17,584,048) | 0 | 0 | (17,584,048) | |||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (259) | 258,278 | ||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock | $ 0 | 0 | $ 258 | (258) | 0 | 0 | 0 | |||||||||||||
Deemed dividend on preferred stock | (4,507,125) | |||||||||||||||||||
Issuance of stock upon conversion of securities | $ 2,000,000 | |||||||||||||||||||
Deemed dividend on preferred stock exchanges | (17,584,048) | |||||||||||||||||||
Dividends on preferred stock | 0 | $ 0 | $ 0 | (204,382) | 0 | 0 | (204,382) | |||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock (in shares) | (27,460) | 2,561,544 | ||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock | 0 | $ 0 | $ 2,562 | (2,559) | 0 | 0 | 3 | |||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs (in shares) | 580,000 | |||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs | 0 | 0 | $ 580 | 9,058,710 | 0 | 0 | 9,059,290 | |||||||||||||
Common stock issued upon exercise of warrants (in shares) | 912,807 | |||||||||||||||||||
Common stock issued upon exercise of warrants | 0 | 0 | $ 913 | 4,622,929 | 0 | 0 | 4,623,842 | |||||||||||||
Issuance of common stock in connection with settlement with former investment bank (in shares) | 7,500 | |||||||||||||||||||
Issuance of common stock in connection with settlement with former investment bank | 0 | 0 | $ 7 | 94,492 | 0 | 0 | 94,499 | |||||||||||||
Common stock and warrants issued to consultants | 0 | 0 | $ 58 | 944,441 | 0 | 0 | 944,499 | |||||||||||||
Common stock and warrants issued to consultants (in shares) | 57,530 | |||||||||||||||||||
Stock-based compensation | 0 | 0 | $ 0 | 772,240 | 0 | 0 | 772,240 | |||||||||||||
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 | (134,797) | (134,797) | |||||||||||||
Net loss | $ 0 | $ 0 | $ 0 | 0 | (7,685,629) | 0 | (7,685,629) | |||||||||||||
Balance at the end (in shares) at Mar. 31, 2021 | 1,209 | 0 | 7,492,690 | |||||||||||||||||
Balance at the end at Mar. 31, 2021 | $ 0 | $ 0 | $ 7,493 | 118,693,364 | (103,051,827) | (1,247,343) | 14,401,687 | |||||||||||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 2,774 | 0 | 3,115,031 | |||||||||||||||||
Balance at the beginning at Dec. 31, 2020 | $ 0 | $ 0 | $ 3,115 | 93,834,936 | (95,366,198) | (1,112,546) | (2,640,693) | |||||||||||||
Balance at the end (in shares) at Dec. 31, 2021 | 662 | 14,855,848 | ||||||||||||||||||
Balance at the end at Dec. 31, 2021 | $ 0 | $ 1,485 | 147,305,147 | (153,904,047) | (1,224,135) | (7,821,550) | ||||||||||||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 2,774 | 0 | 3,115,031 | |||||||||||||||||
Balance at the beginning at Dec. 31, 2020 | $ 0 | $ 0 | $ 3,115 | 93,834,936 | (95,366,198) | (1,112,546) | (2,640,693) | |||||||||||||
Balance at the end (in shares) at Mar. 31, 2022 | 645 | 21,548,835 | ||||||||||||||||||
Balance at the end at Mar. 31, 2022 | $ 0 | $ 2,154 | 155,571,487 | (163,530,886) | (1,282,540) | (9,239,785) | ||||||||||||||
Balance at the beginning (in shares) at Dec. 31, 2021 | 662 | 14,855,848 | ||||||||||||||||||
Balance at the beginning at Dec. 31, 2021 | $ 0 | $ 1,485 | 147,305,147 | (153,904,047) | (1,224,135) | (7,821,550) | ||||||||||||||
Deemed dividend of Series B preferred stock | 0 | $ 0 | (90,792) | 0 | 0 | (90,792) | ||||||||||||||
Warrant modification | 594,975 | 594,975 | ||||||||||||||||||
Deemed dividend on warrant modification | (594,975) | (594,975) | ||||||||||||||||||
Issuance of stock and warrants for cash, net of offering costs (in shares) | 1,650,000 | |||||||||||||||||||
Issuance of stock and warrants for cash, net of offering costs | $ 0 | $ 165 | $ 7,971,926 | $ 0 | $ 0 | $ 7,972,091 | ||||||||||||||
Exercise of pre-funded warrants into common stock (in shares) | 4,848,195 | |||||||||||||||||||
Exercise of pre-funded warrants into common stock | 0 | $ 485 | 47,997 | 0 | 0 | 48,482 | ||||||||||||||
Issuance of stock upon conversion of securities (in shares) | (17) | 104,735 | ||||||||||||||||||
Issuance of stock upon conversion of securities | $ 0 | $ 10 | $ (10) | $ 0 | $ 0 | $ 0 | ||||||||||||||
Common stock and warrants issued to consultants (in shares) | 90,057 | |||||||||||||||||||
Common stock and warrants issued to consultants | 0 | $ 9 | 118,990 | 0 | 0 | 118,999 | ||||||||||||||
Stock-based compensation | 0 | 0 | 218,229 | 0 | 0 | 218,229 | ||||||||||||||
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | (58,405) | (58,405) | ||||||||||||||
Net loss | $ 0 | $ 0 | 0 | (9,626,839) | 0 | (9,626,839) | ||||||||||||||
Balance at the end (in shares) at Mar. 31, 2022 | 645 | 21,548,835 | ||||||||||||||||||
Balance at the end at Mar. 31, 2022 | $ 0 | $ 2,154 | $ 155,571,487 | $ (163,530,886) | $ (1,282,540) | $ (9,239,785) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (9,626,839) | $ (7,685,629) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 7,317 | 1,021 | |
Amortization | 131,887 | ||
Change in right-of-use assets | 23,188 | (4,855) | |
Stock-based compensation | 218,229 | 772,240 | |
Common stock and warrants granted to consultants | 118,999 | 1,038,998 | |
Changes in assets and liabilities: | |||
Other receivables | (28,055) | 17,592 | |
Prepaid expenses | 349,140 | 613,076 | |
Lease liabilities | (53,883) | 11,654 | |
Deposits | 9,615 | (1,356) | |
Accounts payable and accrued expenses | 1,066,458 | 53,938 | |
Accrued dividends payable | 204,382 | ||
Other liabilities | 3,757 | (226,342) | |
Net cash used in operating activities | (7,912,074) | (5,073,394) | |
Cash flows from financing activities: | |||
Proceeds from issuance of preferred stock, net | 7,105,167 | ||
Proceeds from issuance of common stock, net | 7,972,091 | 9,059,290 | |
Proceeds from exercise of warrants | 48,482 | 4,623,842 | |
Payment made related to acquisition agreement | (2,414,956) | ||
Payment made related to license agreement | (9,532,353) | ||
Repayments of note payable | (238,470) | (205,323) | |
Net cash provided by financing activities | 5,367,147 | 11,050,623 | |
Net (decrease) increase in cash | (2,544,927) | 5,977,229 | |
Effect of exchange rate changes on cash | (8,769) | (13,738) | |
Cash and cash equivalents, beginning balance | 8,248,684 | 6,062,141 | $ 6,062,141 |
Cash and cash equivalents, ending balance | 5,694,988 | 12,025,632 | $ 8,248,684 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest | 5,144 | ||
Non-cash investing and financing activities: | |||
Deemed dividend on preferred stock issuances | (4,507,125) | ||
Deemed dividend on preferred stock exchanges | (17,584,048) | ||
Deemed dividend on warrant modification | (594,975) | ||
Accrued dividends on preferred stock | (90,792) | (204,382) | |
Common stock issued upon conversion of preferred stock | $ (10) | ||
Issuance 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, 2022 | |
The Company and Basis of Presentation | |
The Company and Basis of Presentation | Note 1 - The Company and Basis of Presentation The Company First Wave BioPharma, Inc. (“ First Wave GI The Company is currently focused on developing its pipeline of gut-restricted GI clinical drug candidates, including the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties.The Company’s adrulipase programs are focused on the development of an oral, non-systemic, biologic capsule for the treatment of exocrine pancreatic insufficiency (“ EPI CF CP IBD The Company is developing its product candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Since its inception, the Company has devoted substantially all its efforts to research and development, business development, and raising capital, and has financed its operations through issuance of common stock, convertible preferred stock, convertible debt, and other debt/equity instruments. Risks and Uncertainties 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. The Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The extent to which the ongoing COVID-19 pandemic impacts the Company’s business, clinical development and regulatory efforts, corporate development objectives and the value of and market for its 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, Asia 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 the Company’s business, financial condition, results of operations and growth prospects. In February 2022, the Russian Federation and Belarus commenced a military action with the country of Ukraine. As a result of this action, various nations, including the United States, have instituted economic sanctions against the Russian Federation and Belarus. Further, the impact of this action and related sanctions on the world economy are not determinable as of the date of these financial statements and the specific impact on the Company's financial condition, results of operations, and cash flows is also not determinable as of the date of these financial statements. 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. Principles of Consolidation The accompanying unaudited interim condensed 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 condensed 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, 2021, has been derived from audited financial statements of that date. The unaudited interim condensed 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 condensed 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, 2021, filed with the SEC on March 31, 2022 (as amended on Form 10-K/A filed with the SEC on May 10, 2022). Going Concern Uncertainty The accompanying unaudited interim condensed 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, 2022, the Company had cash and cash equivalents of approximately $ 5.7 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 one year from the date these financial statements are issued. 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, 2022 | |
Significant Accounting Policies and Recent Accounting Pronouncements | |
Significant Accounting Policies and Recent Accounting Pronouncements | Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements Use of Estimates The accompanying unaudited condensed 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 and intangible assets), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. Reverse Stock Split On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, with a corresponding 1-for-10 reduction in the number of authorized shares of common stock, but without any change in the par value per share. All share and per share amounts have been retroactively restated to reflect the reverse stock split. Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. 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, 2022, and December 31, 2021, 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, 2022, and December 31, 2021, the Company had approximately $4.9 million and $7.5 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 also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. 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 The Company’s foreign subsidiary has operations denominated in a foreign currency, and 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 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 The carrying amounts of finite-lived intangible assets are evaluated for recoverability whenever events or changes in circumstances indicate that the Company may be unable to recover the asset’s carrying amount. Given changes in the projected usage of the patents, the Company recognized impairment charges of approximately $2.4 million at December 31, 2021. 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 Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. Research and Development Research and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related to patents. 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 CDMOs CMC Research and Development – On December 31, 2020, the Company entered into a license agreement (the “ FWB License Agreement On September 13, 2021, the Company completed its acquisition of FWB, which the Company concluded should be accounted for as an asset acquisition rather than a business combination under ASC 805, Business Combinations. The merger was accounted for as an asset acquisition because substantially all the fair value of the assets being acquired are concentrated in a single asset – intellectual property, which does not constitute a business. The former FWB stockholders are also entitled to (i) up to $ 207.0 million of cash milestone payments contingent upon the achievement of specified development, regulatory and sales goals for the use of the acquired assets, and (ii) certain revenue-sharing. During the year ended December 31, 2021, the Company achieved one development milestone pursuant to the FWB License Agreement totaling $1.0 million, which was expensed in research and development. During the year ended December 31, 2021, the Company achieved one development milestone pursuant to the Merger Agreement totaling $2.0 million, which was expensed in research and development. Depending on the status of development at the time a contingent payment is recognized the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized (See Note 4 for the discussion on the quarter ended March 31, 2022 milestones). Due to the recent topline results of the Phase 2 RESERVOIR COVID-19 GI clinical trial (see Note 1), the Company has suspended payments to the former FWB stockholders and is seeking to renegotiate its obligations to the former FWB stockholders. On May 19, 2022, the Representative filed a complaint against the Company (see Note 17 – The FWB Action 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. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (the “ FASB SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements. The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. In November 2019, the FASB issued ASU 2019-10 – Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date for certain companies. The standard is effective for public companies eligible to be smaller reporting companies for annual and interim periods beginning after December 15, 2022. Early adoption is available. The Company is currently evaluating the potential impact ASU 2016-13, and related updates, will have on its consolidated financial statements and disclosures. The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. |
Fair Value Disclosures
Fair Value Disclosures | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures | |
Fair Value Disclosures | Note 3 - 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 March 31, 2022 (unaudited): Money market funds $ 501,546 $ 501,546 $ — $ — $ 501,546 Note payable 402,766 — 402,766 — 402,766 December 31, 2021: Money market funds 501,607 501,607 — — 501,607 Note payable $ 641,236 $ — $ 641,236 $ — $ 641,236 At March 31, 2022 and December 31, 2021, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Asset Acquisition
Asset Acquisition | 3 Months Ended |
Mar. 31, 2022 | |
Asset Acquisition | |
Asset Acquisition | Note 4 – Asset Acquisition The Asset Acquisition On September 13, 2021, the Company completed its acquisition of FWB, in accordance with the terms of an Agreement and Plan of Merger dated as of September 13, 2021 (the “ Merger Agreement Merger Sub Merger At the effective time of the Merger, the former FWB stockholders received an applicable pro rata share of (i) $3.0 million in cash and (ii) 624,025 shares of the Common Stock (equivalent to cash of $4.0 million). The remaining non-contingent purchase price was payable to the former FWB stockholders on a pro rata basis upon the Company’s payment of (i) $8.0 million in cash, payable within 45 days of the Merger, and (ii) $7.0 million in cash, payable by March 31, 2022 for a total purchase price of $22.0 million. On October 29, 2021, Fortis Advisors LLC, the hired representative (in such capacity, the “ Representative On November 15, 2021, the Company reached an agreement (the “ Settlement Agreement The former FWB stockholders are entitled to up to a total of $207 million of cash milestone payments contingent upon the achievement of specified development, regulatory and sales goals relating to the use of the acquired assets. All milestone payments will be payable in cash, provided that 25% of the milestone payments attributable to a certain IBD indications may be payable in Common Stock, at the option of the Company. In addition, the former FWB stockholders are entitled to 10% of certain specified revenue received by the Company from any third-party with a pre-existing niclosamide development program relating to COVID. During the quarter ended March 31, 2022 the Company paid an aggregate of $2.4 million in cash towards the purchase price. During the year ended December 31, 2021, the Company paid an aggregate of $7.0 million (in cash and shares) towards the purchase price and $2.0 million in milestone payments. Due to the recent topline results of the Phase 2 RESERVOIR COVID-19 GI clinical trial (see Note 1), the Company has suspended payments to the former FWB stockholders and is seeking to renegotiate its obligations to the former FWB stockholders. On May 19, 2022, the Representative filed a complaint against the Company (see Note 17 – The FWB Action Accounting Treatment The Company concluded that the Merger should be accounted for as an asset acquisition under ASC 805 because substantially all the fair value of the assets being acquired are concentrated in a single asset - intellectual property, which does not constitute a business. Because the acquired intellectual property has not received regulatory approval, the $21.3 million non-contingent purchase price was immediately expensed in the Company’s statements of operations as research and development – intellectual property acquired in the year ended December 31, 2021. The $0.9 million of transaction expenses paid at closing were classified in general and administrative expenses in the year ended December 31, 2021. The Common Stock issued for the asset acquisition was valued at $4.0 million, which is equal to the 624,025 common shares issued multiplied by $6.41 per share. The potential milestone payments and revenue share are not yet considered probable, therefore no milestone payments have been accrued as of March 31, 2022. Depending on the status of development at the time a contingent payment is recognized the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized. |
Property, Equipment and Leaseho
Property, Equipment and Leasehold Improvements | 3 Months Ended |
Mar. 31, 2022 | |
Property, Equipment and Leasehold Improvements | |
Property, Equipment and Leasehold Improvements | Note 5 – Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements consisted of the following: March 31, 2022 December 31, (unaudited) 2021 Computer equipment and software $ 11,540 $ 11,540 Office equipment 48,278 48,278 Leasehold improvements 28,000 28,000 Total property, plant, and equipment 87,818 87,818 Less accumulated depreciation (22,025) (14,708) Property, plant and equipment, net $ 65,793 $ 73,110 Depreciation expense for the three months ended March 31, 2022 and 2021 was approximately $7,300 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 3 Months Ended |
Mar. 31, 2022 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | Note 6 – Intangible Assets and Goodwill Patents Pursuant to the Mayoly asset purchase agreement entered in March 2019 (see Note 13), in which the Company purchased all remaining rights, title and interest in and to adrulipase 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, 2022 December 31, (unaudited) 2021 Patents $ — $ 3,802,745 Less accumulated amortization — (1,450,757) Intangible asset impairment — (2,351,988) Patents, net $ — $ — Amortization expense was approximately $132,000 for the three months ended March 31, 2021. During the year ended December 31, 2021, the Company recorded impairment charges of approximately $2.4 million related to patents that the Company determined were no longer sufficient for the commercialization of adrulipase. Goodwill is as follows: Goodwill Balance on January 1, 2021 $ 2,054,048 Foreign currency translation (142,343) Balance on December 31, 2021 1,911,705 Foreign currency translation (49,636) Balance on March 31, 2022 (unaudited) $ 1,862,069 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses | |
Accrued Expenses | Note 7 - Accrued Expenses Accrued expenses consisted of the following: March 31, 2022 December 31, (unaudited) 2021 Professional fees $ 443,030 $ 15,000 Clinical trials 147,842 — Consulting fees 109,260 104,100 Payroll and benefits 17,382 274,153 Total accrued expenses $ 717,514 $ 393,253 |
Note Payable
Note Payable | 3 Months Ended |
Mar. 31, 2022 | |
Note Payable | |
Note Payable | Note 8 – Note Payable Directors and Officer ’ s Liability Insurance On November 30, 2021, the Company entered into a 9-month |
Other Liabilities
Other Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Other Liabilities | |
Other Liabilities | Note 9 - Other Liabilities Other liabilities consisted of the following: March 31, 2022 December 31, (unaudited) 2021 Current Lease liabilities $ 70,784 $ 77,989 Other liabilities 18,575 14,818 Liabilities related to Merger consideration 9,000,000 8,000,000 Total other current liabilities $ 9,089,359 $ 8,092,807 Long-term Lease liabilities $ 264,460 $ 311,138 Liabilities related to Merger consideration 3,585,044 7,000,000 Total other long-term liabilities $ 3,849,504 $ 7,311,138 |
Capital Stock
Capital Stock | 3 Months Ended |
Mar. 31, 2022 | |
Capital Stock | |
Capital Stock | Note 10 – Common Stock and Preferred Stock The Company’s certificate of incorporation, as amended and restated, (the “ Charter On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, with a corresponding 1-for-10 reduction in the number of authorized shares of common stock, but without any change in the par value per share. All share and per share amounts have been retroactively restated to reflect the reverse stock split. The Company had 21,548,835 and 14,855,848 shares of its Common Stock issued outstanding The Company had approximately 645.21 and 662.25 shares of Series B preferred stock issued outstanding The Company had 0 shares of Series C preferred stock issued and outstanding on March 31, 2022 and December 31, 2021, respectively. Series B Preferred Stock Waiver Agreements Between February 1 and February 7, 2022, the Company entered into waiver agreements (the “ Waiver Series B Preferred Stock Pursuant to the Series B Preferred Stock Certificate of Designations (the “ Series B Certificate of Designations Subsequent Financing Series B Exchange Right The Company entered into Waivers with holders of approximately $2.88 million of stated value of Series B Preferred Stock. The Company also entered into Waivers with Company insiders holding approximately $0.474 million of stated value of Series B Preferred Stock for which the Company did not pay a waiver fee. The cash waivers paid of approximately $0.233 million were recorded as other expense on the Company’s condensed consolidated statements of operations for the three months ending March 31, 2022. 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 Common Stock that may be issued under the Equity Line Agreement may be sold by the Company to Lincoln Park at the Company’s discretion from time-to-time over a 30-month There is approximately $14.0 million of availability left for issuance pursuant to the Equity Line Agreement. The Company has not issued At The Market Agreement with H.C. Wainwright On May 26, 2021, the Company entered into an At The Market Offering Agreement (the “ ATM Agreement Wainwright Common Stock Issuances Q1 2022 Issuances During the three months ended March 31, 2022, the Company completed a registered direct offering (the “ March 2022 Offering March 2022 Warrants March 2022 Placement Agent Warrants During the three months ended March 31, 2022, the Company issued an aggregate of 4,848,195 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.01 (See Note 11). During the three months ended March 31, 2022, the Company issued an aggregate of 104,735 shares of Common Stock and accompanying Series C warrant upon the exchange of an aggregate of 17.05 shares of Series B Preferred Stock with a stated value of approximately $131,000 plus accrued dividends of approximately $14,000. The Series C warrants have an exercise price of $1.26 per share and will be exercisable for five years from the issuance date. During the three months ended March 31, 2022, the Company issued an aggregate of 90,057 shares of its Common Stock to consultants with a grant date fair value of approximately $119,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. Q1 2021 Issuances During the three months ended March 31, 2021, the Company issued an aggregate of 57,530 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 7,500 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 2,561,544 shares of Common Stock upon the conversion of an aggregate of 2,746 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 912,807 shares of Common Stock upon the exercise of an aggregate of 919,752 investor warrants, including an aggregate of 399,187 pre-funded warrants (See Note 11). During the three months ended March 31, 2021, the Company issued an aggregate of 258,278 shares of Common Stock upon the conversion of an aggregate of 26 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 completed a registered direct offering (the “ March 2021 Offering March 2021 Warrants March 2021 Placement Agent Warrants Q1 2021 Series C Purchase Agreement During the three months ended March 31, 2021, the Company closed on a securities purchase agreement (the “ Series C Purchase Agreement January 2021 Registered Direct Offering Concurrently with the January 2021 Registered Direct Offering, in a private placement offering pursuant to the Series C Purchase Agreement (the “ January 2021 Private Placement January 2021 Investor Warrants The net proceeds to the Company from the offerings described above (the “ January 2021 Offerings The Company also issued warrants to the placement agent (the “ January 2021 Placement Agent Warrants During the three months ended March 31, 2021, all outstanding shares of Series C Preferred Stock were converted to Common Stock. Q1 2021 Series B Exchanges into the January 2021 Offerings During the three months ended March 31, 2021, pursuant to the Series B Exchange Right, the Company issued an aggregate of 13,501.08 shares of Series C Preferred Stock and warrants to purchase an aggregate of 1,350,066 shares of Common Stock in connection with the exchange of approximately 1,306.30 shares of Series B Preferred Stock. The Company analyzed the exchanges pursuant to the Series B Exchange Right from preferred stock to preferred stock qualitatively and determined that the exchanges result in a substantive change and should be accounted for as an extinguishment. As such, for the three months ended March 31, 2021, the Company recognized an aggregate deemed dividend of approximately $17.6 million as calculated by the difference in the carrying value of the Series B Preferred Stock exchanged and the fair value of the Series C Preferred Stock and January 2021 Investor Warrants issued on each exchange date. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2022 | |
Warrants | |
Warrants | Note 11 – Warrant activity for the three months ended March 31, 2022 and 2021 was as follows: Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2022 5,527,390 $ 9.49 3.95 Issued 11,841,016 0.76 4.92 Expired (7,366) 49.71 — Exercised (4,848,195) 0.01 4.92 Warrants outstanding and exercisable on March 31, 2022 12,512,845 $ 4.88 4.39 Warrants outstanding and exercisable on January 1, 2021 2,517,722 $ 12.20 4.04 Issued 3,358,519 7.75 5.12 Expired (2,423) 60.90 — Exercised (919,752) 5.22 2.34 Warrants outstanding and exercisable on March 31, 2021 4,954,066 $ 10.45 4.55 The outstanding warrants expire from 2022 through 2027. In connection with the March 2022 Offering, the Company entered into a warrant amendment agreement with an investor pursuant to which the Company agreed to amend the investor’s existing warrants to purchase up to 1,066,666 shares of the Company’s Common Stock at an exercise price of $8.00 per share issued in January 2021 and warrants to purchase up to 392,927 shares of the Company’s Common stock at an exercise price of $12.10 per share issued in March 2021 (the “Existing Warrants”), in consideration for such investor’s purchase of $9.0 million of securities in the March Offering and payment of $0.0281 per share for each share of common stock issuable upon exercise of the Existing Warrants to (i) lower the exercise price of the Existing Warrants to $1.26 per share and (ii) extend the termination date of the existing Warrants to March 2, 2027. As a result of the change in fair value of the warrant amendment described above, the Company recorded a deemed dividend of approximately $0.595 million in the quarter ended March 31, 2022. During the three months ended March 31, 2022, the Company issued Series C warrants, pre-funded warrants, and placement agent warrants to purchase 11,736,281 shares of the Company’s Common Stock in connection with the March 2022 Offering, as well as Series C warrants to purchase 104,735 shares of the Company’s Common Stock in connection with a Series B Preferred Stock exchange (See Note 10). During the three months ended March 31, 2021, the Company issued warrants, pre-funded warrants, and placement agent warrants to purchase 1,334,664 and 653,789 shares of the Company’s Common Stock in connection with the January 2021 Offerings and the March 2021 Offering, respectively, and warrants to purchase 1,350,066 shares of the Company’s Common Stock in connection with Series B Preferred Stock exchanges (See Note 10). Additionally, on February 8, 2021, warrants to purchase 20,000 shares of the Company’s Common Stock were issued to a consultant at an exercise price of $16.90 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 5,000 shares of Common Stock vested, with a grant date fair value of approximately $53,000, which was recorded as stock-based compensation as part of general and administrative expense. |
Equity Incentive Plan
Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2022 | |
Equity Incentive Plan | |
Equity Incentive Plan | Note 12 – 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 Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “ 2020 Plan ISOs As of January 1, 2022, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 2,114,360. As of March 31, 2022, there were an aggregate of 2,114,360 shares available under the 2020 Plan, of which 777,455 shares were issued and outstanding and 1,336,905 shares were available for potential issuances. As of March 31, 2022, there were an aggregate of 301,916 shares available under the 2014 Plan, of which 263,216 shares were issued and outstanding and 38,700 shares are reserved subject to issuance of restricted stock and restricted stock unit awards (“ RSUs During the three months ended March 31, 2022 and 2021, stock option activity under the 2014 Plan and 2020 Plan was as follows: Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2022 439,192 $ 11.58 7.28 $ — Granted 678,392 1.39 9.11 — Canceled (2,646) 9.68 — — Forfeited (74,267) 3.97 — — Outstanding at March 31, 2022 1,040,671 $ 5.49 8.67 $ — Exercisable at March 31, 2022 380,559 $ 10.60 7.15 $ — Outstanding at January 1, 2021 407,029 $ 13.80 7.94 $ — Granted 34,365 10.08 10.00 — Canceled (13,550) 24.46 2.87 — Outstanding at March 31, 2021 427,844 $ 11.89 7.93 $ 1,599,166 Exercisable at March 31, 2021 222,156 $ 14.80 6.67 $ 637,269 During the three months ended March 31, 2022 and 2021, the Board approved the grant of options to purchase 678,392 and 34,365 shares of Common Stock, respectively. All option grants were pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36-month period. During the three months ended March 31, 2022 and 2021, stock options to purchase an aggregate of 2,646 and 13,550 shares of Common Stock under the 2020 Plan were cancelled. During the three months ended March 31, 2022, stock options to purchase 74,267 shares of Common Stock were forfeited. For the three months ended March 31, 2022 and 2021, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions: 2022 2021 Contractual term (in years) 10 10 Expected Volatility 90.92 % 84.89 % Risk-free interest rate 1.11 % 1.12 % Expected Dividend yield 0 % 0 % Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock granted during the three months ended March 31, 2022 and 2021 was $1.37 and $8.28, respectively. As of March 31, 2022, the Company had unrecognized stock-based compensation expense of approximately $1.9 million. Approximately $1.2 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 9.57 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 $320,000 of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable. As of March 31, 2022 and 2021, the Company had 27,500 shares of restricted stock that had not yet vested and 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 Adrulipase 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, 2022. The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows: Three Months Ended March 31, 2022 2021 Research and development $ 46,407 $ 398,312 General and administrative 171,822 373,928 Total stock-based compensation expense $ 218,229 $ 772,240 |
Agreements
Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Agreements | |
Agreements | Note 13 – Agreements License Agreement with First Wave Bio, Inc. (FWB) On December 31, 2020, the Company entered into the FWB License Agreement, pursuant to which FWB granted us a worldwide, exclusive right to develop, manufacture, and commercialize FWB’s proprietary immediate release and enema formulations of niclosamide (the “ Niclosamide Product In consideration of the license and other rights granted by FWB, the Company agreed to pay FWB a $9.0 million upfront cash payment due within 10 days, which was paid in January 2021, and was obligated to make an additional payment of $1.25 million due on June 30, 2021, which was paid in July 2021. In addition, the Company was obligated to pay potential milestone payments to FWB totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. In September 2021, the Company achieved a milestone related to clinical development of niclosamide in the COVID-19 field and has expensed $1.0 million in research and development. Under the FWB License Agreement, the Company was obligated to pay FWB royalties as a mid-single digit percentage of net sales of the Niclosamide Product, subject to specified reductions. The Company was also obligated to issue to FWB 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 FWB License Agreement, or $9.118 per share, convertible into an aggregate of 329,019 shares of Common Stock. On January 8, 2021, the Company entered into a securities purchase agreement with FWB (the “FWB Purchase Agreement”) to issue junior convertible preferred stock to FWB. Pursuant to the FWB Purchase Agreement, the Company issued to FWB 3,290.1960 shares of Series C Preferred Stock, at an initial stated value of $750.00 per share and a conversion price of $7.50 per share, which is convertible into an aggregate of 32,902 shares of Common Stock. The shares of Series C Preferred Stock automatically converted into Common Stock upon the stockholder approval on February 24, 2021. The FWB Purchase Agreement contains demand and piggyback registration rights with respect to the Common Stock issuable upon conversion. 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. Upon the 2021 Stockholder Approval on February 24, 2021, the Company recognized a change in fair value of approximately $0.5 million based on the difference in fair value of the $3.0 million liability initially recorded pursuant to the FWB License Agreement as of December 31, 2020 and the fair value of approximately $2.5 million of Series C Preferred Stock issued pursuant to the FWB Purchase Agreement to settle the liability. Following the 2021 Stockholder Approval, the shares of Series C Preferred Stock were automatically converted into Common Stock. Upon consummating the Merger on September 13, 2021, the FWB License Agreement was effectively canceled. Mayoly Agreement On March 27, 2019, the Company and Laboratories Mayoly Spinder (“ Mayoly Mayoly APA JDLA |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases | |
Leases | Note 14 – The Company leases its offices under operating leases which are subject to various rent provisions and escalation clauses. The Company is a party to three The Company’s leases expire at various dates through 2026. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments. Lease expense amounted to approximately $28,000 and $52,000, respectively, for the three months ended March 31, 2022 and 2021. The weighted-average remaining lease term and weighted-average discount rate under operating leases as of March 31, 2022 are: March 31, 2022 Lease term and discount rate Weighted-average remaining lease term (years) 4.3 Weighted-average discount rate 7.94 % Maturities of operating lease liabilities as of March 31, 2022, were as follows: 2022 (remainder of year) $ 61,290 2023 83,691 2024 86,202 2025 88,788 Thereafter 60,593 Total lease payments 380,564 Less imputed interest (45,320) Present value of lease liabilities $ 335,244 |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Common Share | |
Net Loss per Common Share | Note 15 - 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. In periods where the Company records a net loss, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. All shares of Common Stock that may potentially be issued in the future are as follows: March 31, 2022 March 31, 2021 (unaudited) (unaudited) Common stock warrants 12,512,845 4,954,066 Stock options 1,040,671 427,844 Convertible preferred stock (1) 717,408 1,236,055 Total shares of common stock issuable 14,270,924 6,617,965 (1) Convertible preferred stock is assumed to be converted at the rate of $7.70 per common share, which is the conversion price as of March 31, 2022. |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2021 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 16 - 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 $46,000 and $32,000 for the three months ended March 31, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events | |
Subsequent Events | Note 17 - Subsequent Events The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were available to be issued. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements except for the items noted below. Dismissal of Previous Independent Registered Public Accounting Firm On April 27, 2022, the Audit Committee of the Company’s Board of Directors (the “Board”) approved the dismissal of Mazars USA LLP as the Company’s independent registered public accounting firm, effective immediately and the engagement of Marcum LLP as the Company’s new independent registered public accounting firm as of and for the year ending December 31, 2022. RESERVOIR Topline Results and Business Operations Update On April 29, 2022, the Company announced that the Phase 2 RESERVOIR trial examining the safety and efficacy of FW-COV, a proprietary oral formulation of niclosamide, as potential treatment for COVID-19-related GI infections did not meet its efficacy endpoint but FW-COV was demonstrated to be safe with no serious adverse events reported by the more than 150 patients that participated in the trial. As a result of the RESERVOIR trial results, the Company will be reducing its workforce by 20 percent and closing its California office at the end of May 2022 and its facility in Langlade, France. The Company has also suspended payments related to the Company’s acquisition of FWB and is seeking to renegotiate its obligations to the former FWB stockholders; however, no assurance can be given that the Company will be able to restructure those obligations on acceptable terms, if at all. In the event the Company is not able to significantly restructure those obligations, or the Representative prevails in the FWB Action (see Note 17 – The FWB Action Series B Exchange Right Waiver Solicitation Effective May 12, 2022, the holders of 81.3% of the outstanding shares of the Series B Preferred Stock permanently waived for themselves and all other holders of the Series B Preferred Stock the Series B Exchange Right (as defined below) with respect to any Subsequent Financing (as defined below) occurring on or after January 1, 2022 (the “Permanent Waiver”). Holders of Series B Preferred Stock as of the April 27, 2022 record date were entitled to notice of and to consent to the Permanent Waiver (the “Record Holders”). Pursuant to the Certificate of the Designations, Powers, Preferences and Rights creating the Series B Preferred Stock, as filed with the Secretary of State of the State of Delaware on July 16, 2020 (the “Certificate of Designations”), in the event of 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”), each holder of the Company’s Series B Preferred Stock had the right, subject to certain exceptions set forth in the Certificate of Designations, at its option, to exchange (in lieu of cash subscription payments) all or some of the Series B Preferred Stock then held (with a value per share of Series B Preferred Stock equal to the stated value of each share of Series B Preferred Stock, or $7,700.00, plus accrued and unpaid dividends thereon, of the Series B Preferred Stock) for any securities or units issued in a Subsequent Financing on a dollar-for-dollar basis (the “Series B Exchange Right”). Pursuant to the terms of the Certificate of Designations, the written consent of the holders of at least a majority of the Series B Preferred Stock outstanding was required to consent to the Permanent Waiver (the “Required Consent”). The Company requested that the Record Holders consent to the Permanent Waiver by executing and delivering a joinder to the Waiver Agreement (as defined below). The execution and delivery of the joinder to the Waiver Agreement was deemed, for purposes of Section 228 of the General Corporation Law of the State of Delaware, to be an action by written consent in lieu of a meeting to approve the Permanent Waiver. The Company’s solicitation of consents to the Permanent Waiver terminated in accordance with its terms at 5:00 p.m., Eastern Time, on May 12, 2022 (the “Expiration Date”). The Record Holders who consented to the Permanent Waiver prior to the Expiration Date are referred to herein as the “Consenting Holders”. The Required Consent has been obtained from the Consenting Holders and the solicitation has terminated in accordance with its terms as of the Expiration Date. The Permanent Waiver was effective immediately upon the Expiration Date and is binding on all holders of the Series B Preferred Stock, including those holders that did not timely consent to the Permanent Waiver prior to the Expiration Date. The Permanent Waiver will also be applicable to any future holder of Series B Preferred Stock. A notation of the Permanent Waiver will be made on the books and records of the Company’s transfer agent and a legend reflecting the Permanent Waiver will be placed on any physical share certificate representing shares of Series B Preferred Stock. Pursuant to the terms of a Waiver Agreement entered into by the Company and the Consenting Holders (the “Waiver Agreement”), the Company has permanently reduced the exercise price of the Series B Warrants originally issued on July 16, 2020 (the “Warrants”) held by the Consenting Holders to $0.25 per share or, in the case of Consenting Holders who are officers and directors of the Company, $0.3294 (the “Exercise Price Reduction”). Only Consenting Holders are entitled to the Exercise Price Reduction. Warrants to purchase an aggregate of approximately 251,742 shares of Common Stock received the Exercise Price Reduction which was effective as of the Expiration Date. Nasdaq Minimum Bid Price Deficiency Notice On May 16, 2022, the Company received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company is not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market (the “Notice”). The Company is provided a compliance period of 180 calendar days from the date of the Notice, or until November 14, 2022, to regain compliance with the minimum closing bid requirement. If at any time before November 14, 2022, the closing bid price of the Company’s Common Stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period to 20 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement, and the matter would be resolved. If the Company does not regain compliance during the compliance period ending November 14, 2022, then Nasdaq may grant the Company a second 180 calendar day period to regain compliance, provided the Company meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and notifies Nasdaq of its intent to cure the deficiency. The FWB Action On May 19, 2022, the Representative filed a complaint against the Company in the Court of Chancery in the State of Delaware (the “ FWB Action |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Significant Accounting Policies and Recent Accounting Pronouncements | |
Use of Estimates | Use of Estimates The accompanying unaudited condensed 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 and intangible assets), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. |
Reverse Stock Split | Reverse Stock Split On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, with a corresponding 1-for-10 reduction in the number of authorized shares of common stock, but without any change in the par value per share. All share and per share amounts have been retroactively restated to reflect the reverse stock split. |
Reclassifications | Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. |
Cash and Cash Equivalents | 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, 2022, and December 31, 2021, respectively. |
Concentrations of Credit Risk | 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, 2022, and December 31, 2021, the Company had approximately $4.9 million and $7.5 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 also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. |
Fair Value Measurements | 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 | Foreign Currency Translation The Company’s foreign subsidiary has operations denominated in a foreign currency, and 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 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 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 The carrying amounts of finite-lived intangible assets are evaluated for recoverability whenever events or changes in circumstances indicate that the Company may be unable to recover the asset’s carrying amount. Given changes in the projected usage of the patents, the Company recognized impairment charges of approximately $2.4 million at December 31, 2021. |
Impairment of Long-Lived Assets | 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 |
Leases | Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. |
Research and Development | Research and Development Research and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related to patents. 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 CDMOs CMC Research and Development – On December 31, 2020, the Company entered into a license agreement (the “ FWB License Agreement On September 13, 2021, the Company completed its acquisition of FWB, which the Company concluded should be accounted for as an asset acquisition rather than a business combination under ASC 805, Business Combinations. The merger was accounted for as an asset acquisition because substantially all the fair value of the assets being acquired are concentrated in a single asset – intellectual property, which does not constitute a business. The former FWB stockholders are also entitled to (i) up to $ 207.0 million of cash milestone payments contingent upon the achievement of specified development, regulatory and sales goals for the use of the acquired assets, and (ii) certain revenue-sharing. During the year ended December 31, 2021, the Company achieved one development milestone pursuant to the FWB License Agreement totaling $1.0 million, which was expensed in research and development. During the year ended December 31, 2021, the Company achieved one development milestone pursuant to the Merger Agreement totaling $2.0 million, which was expensed in research and development. Depending on the status of development at the time a contingent payment is recognized the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized (See Note 4 for the discussion on the quarter ended March 31, 2022 milestones). Due to the recent topline results of the Phase 2 RESERVOIR COVID-19 GI clinical trial (see Note 1), the Company has suspended payments to the former FWB stockholders and is seeking to renegotiate its obligations to the former FWB stockholders. On May 19, 2022, the Representative filed a complaint against the Company (see Note 17 – The FWB Action |
Stock-Based Compensation | 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (the “ FASB SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements. The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. In November 2019, the FASB issued ASU 2019-10 – Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date for certain companies. The standard is effective for public companies eligible to be smaller reporting companies for annual and interim periods beginning after December 15, 2022. Early adoption is available. The Company is currently evaluating the potential impact ASU 2016-13, and related updates, will have on its consolidated financial statements and disclosures. The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. |
Fair Value Disclosures (Tables)
Fair Value Disclosures (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures | |
Summary of financial instruments | Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value March 31, 2022 (unaudited): Money market funds $ 501,546 $ 501,546 $ — $ — $ 501,546 Note payable 402,766 — 402,766 — 402,766 December 31, 2021: Money market funds 501,607 501,607 — — 501,607 Note payable $ 641,236 $ — $ 641,236 $ — $ 641,236 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Equipment and Leasehold Improvements | |
Summary of Property, equipment and leasehold improvements | March 31, 2022 December 31, (unaudited) 2021 Computer equipment and software $ 11,540 $ 11,540 Office equipment 48,278 48,278 Leasehold improvements 28,000 28,000 Total property, plant, and equipment 87,818 87,818 Less accumulated depreciation (22,025) (14,708) Property, plant and equipment, net $ 65,793 $ 73,110 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Intangible Assets and Goodwill | |
Schedule of 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 |
Schedule of Intangible Assets | March 31, 2022 December 31, (unaudited) 2021 Patents $ — $ 3,802,745 Less accumulated amortization — (1,450,757) Intangible asset impairment — (2,351,988) Patents, net $ — $ — |
Schedule of Goodwill | Goodwill Balance on January 1, 2021 $ 2,054,048 Foreign currency translation (142,343) Balance on December 31, 2021 1,911,705 Foreign currency translation (49,636) Balance on March 31, 2022 (unaudited) $ 1,862,069 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses | |
Summary of accounts payable and accrued expense | March 31, 2022 December 31, (unaudited) 2021 Professional fees $ 443,030 $ 15,000 Clinical trials 147,842 — Consulting fees 109,260 104,100 Payroll and benefits 17,382 274,153 Total accrued expenses $ 717,514 $ 393,253 |
Other Liabilities (Tables)
Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Other Liabilities | |
Schedule of other liabilities | March 31, 2022 December 31, (unaudited) 2021 Current Lease liabilities $ 70,784 $ 77,989 Other liabilities 18,575 14,818 Liabilities related to Merger consideration 9,000,000 8,000,000 Total other current liabilities $ 9,089,359 $ 8,092,807 Long-term Lease liabilities $ 264,460 $ 311,138 Liabilities related to Merger consideration 3,585,044 7,000,000 Total other long-term liabilities $ 3,849,504 $ 7,311,138 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Warrants | |
Schedule of warrant transactions | Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2022 5,527,390 $ 9.49 3.95 Issued 11,841,016 0.76 4.92 Expired (7,366) 49.71 — Exercised (4,848,195) 0.01 4.92 Warrants outstanding and exercisable on March 31, 2022 12,512,845 $ 4.88 4.39 Warrants outstanding and exercisable on January 1, 2021 2,517,722 $ 12.20 4.04 Issued 3,358,519 7.75 5.12 Expired (2,423) 60.90 — Exercised (919,752) 5.22 2.34 Warrants outstanding and exercisable on March 31, 2021 4,954,066 $ 10.45 4.55 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity Incentive Plan | |
Schedule of Stock Option Activity | Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2022 439,192 $ 11.58 7.28 $ — Granted 678,392 1.39 9.11 — Canceled (2,646) 9.68 — — Forfeited (74,267) 3.97 — — Outstanding at March 31, 2022 1,040,671 $ 5.49 8.67 $ — Exercisable at March 31, 2022 380,559 $ 10.60 7.15 $ — Outstanding at January 1, 2021 407,029 $ 13.80 7.94 $ — Granted 34,365 10.08 10.00 — Canceled (13,550) 24.46 2.87 — Outstanding at March 31, 2021 427,844 $ 11.89 7.93 $ 1,599,166 Exercisable at March 31, 2021 222,156 $ 14.80 6.67 $ 637,269 |
Stock Options-pricing Model with Weighted Average Assumptions | 2022 2021 Contractual term (in years) 10 10 Expected Volatility 90.92 % 84.89 % Risk-free interest rate 1.11 % 1.12 % Expected Dividend yield 0 % 0 % |
Schedule of stock-based compensation expense | Three Months Ended March 31, 2022 2021 Research and development $ 46,407 $ 398,312 General and administrative 171,822 373,928 Total stock-based compensation expense $ 218,229 $ 772,240 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases | |
Weighted Average Remaining Lease Term and Discount Rate Under Operating Lease | March 31, 2022 Lease term and discount rate Weighted-average remaining lease term (years) 4.3 Weighted-average discount rate 7.94 % |
Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities as of March 31, 2022, were as follows: 2022 (remainder of year) $ 61,290 2023 83,691 2024 86,202 2025 88,788 Thereafter 60,593 Total lease payments 380,564 Less imputed interest (45,320) Present value of lease liabilities $ 335,244 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Common Share | |
Schedule of Common Stock that may potentially be issued in the future | March 31, 2022 March 31, 2021 (unaudited) (unaudited) Common stock warrants 12,512,845 4,954,066 Stock options 1,040,671 427,844 Convertible preferred stock (1) 717,408 1,236,055 Total shares of common stock issuable 14,270,924 6,617,965 (1) Convertible preferred stock is assumed to be converted at the rate of $7.70 per common share, which is the conversion price as of March 31, 2022. |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
The Company and Basis of Presentation | ||
Cash and cash equivalents | $ 5,694,988 | $ 8,248,684 |
Accumulated deficit | (163,530,886) | $ (153,904,047) |
working capital | $ 7,700,000 |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Sep. 13, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Number of shares recuded due to reverse stock split | 10 | |||
Cash in US banks in excess of FDIC insurance limits | $ 4,900 | $ 7,500 | ||
Finite-Lived Intangible Asset, Useful Life (Year) | 7 years 2 months 12 days | |||
Intangible asset impairment | 2,400 | |||
Asset impairment charges | $ 0 | |||
First Wave License Agreement [Member] | ||||
Asset acquisition consideration transferred | $ 13,300 | |||
Payments to Acquire Intangible Assets | 10,300 | |||
Cash consideration | $ 3,000 | $ 3,000 | ||
Asset acquisition cash milestone payments | 1,000 | |||
FWB [Member] | Maximum [Member] | ||||
Asset acquisition cash milestone payments | $ 207,000 | |||
Merger Agreement [Member] | ||||
Asset acquisition cash milestone payments | $ 2,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Cash and cash equivalents | $ 5,694,988 | $ 8,248,684 |
Note payable | 402,766 | 641,236 |
Carrying Amount | ||
Note payable | 402,766 | 641,236 |
Fair Value, Inputs, Level 2 | ||
Note payable | 402,766 | 641,236 |
Money Market Funds | ||
Cash and cash equivalents | 501,546 | 501,607 |
Money Market Funds | Carrying Amount | ||
Cash and cash equivalents | 501,546 | 501,607 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Cash and cash equivalents | $ 501,546 | $ 501,607 |
Asset Acquisition (Details)
Asset Acquisition (Details) - USD ($) | Nov. 15, 2021 | Oct. 29, 2021 | Sep. 13, 2021 | Mar. 31, 2022 | Aug. 31, 2022 | Jul. 31, 2023 | Dec. 31, 2021 | Mar. 31, 2021 |
Shares issued price per share (in dollars per share) | $ 1.375 | $ 12.725 | ||||||
First Wave Bio Inc [Member] | ||||||||
Payment to acquire | $ 3,000,000 | |||||||
Asset acquired equity issued (in shares) | 624,025 | |||||||
Asset acquisition total purchase price | $ 22,000,000 | |||||||
Asset acquisition consideration transferred liabilities incurred | $ 8,000,000 | $ 7,000,000 | ||||||
Maximum term for the payment of purchase price | 45 days | |||||||
Asset Acquisition, Potential Milestone Payments | 0 | $ 2,000,000 | ||||||
Asset acquisition consideration transferred | $ 2,400,000 | 7,000,000 | ||||||
Cash consideration | $ 4,000,000 | |||||||
Asset acquired equity issued (in shares) | 624,025 | |||||||
Shares issued price per share (in dollars per share) | $ 6.41 | |||||||
First Wave Bio Inc [Member] | Research and development | ||||||||
Non-contingent purchase price | 21,300,000 | |||||||
First Wave Bio Inc [Member] | General and administrative expense. | ||||||||
Consideration transaction cost | $ 900,000 | |||||||
First Wave Bio Inc [Member] | Former Stockholders | ||||||||
Milestone payment | $ 2,000,000 | |||||||
Awarded to other party | $ 8,000,000 | |||||||
First Wave Bio Inc [Member] | Development Achievement Threshold [Member] | ||||||||
Asset Acquisition, Potential Milestone Payments | $ 207,000,000 | |||||||
Percentage of cash milestone payments | 25.00% | |||||||
First Wave Bio Inc [Member] | Patent Infringement [Member] | ||||||||
Percentage of cash consideration | 10.00% | |||||||
First Wave Bio Inc [Member] | Settlement Agreement | ||||||||
Milestone payment | $ 2,000,000 | |||||||
Awarded to other party | $ 15,000,000 | |||||||
Percentage of amount on the transactions consummated by the company | 10.00% | |||||||
Specified amount of transactions for applying percentage | $ 10,000,000 | |||||||
Stock cancelled during period, shares, acquisitions (in shares) | 332,913 | |||||||
First Wave Bio Inc [Member] | Settlement Agreement | Forecast | ||||||||
Payment of periodic installments | $ 500,000 | $ 1,000,000 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements - Property (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Total property, plant, and equipment | $ 87,818 | $ 87,818 | |
Less accumulated depreciation | (22,025) | (14,708) | |
Property, plant and equipment, net | 65,793 | 73,110 | |
Depreciation expense | 7,317 | $ 1,000 | |
Computer Equipment And Software [Member] | |||
Total property, plant, and equipment | 11,540 | 11,540 | |
Office Equipment [Member] | |||
Total property, plant, and equipment | 48,278 | 48,278 | |
Leasehold Improvements [Member] | |||
Total property, plant, and equipment | $ 28,000 | $ 28,000 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Patents (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Patents | $ 3,800,000 | $ 3,802,745 | ||
Common Stock Issued At Signing To Mayoly [Member] | ||||
Patents | $ 1,740,959 | |||
Mayoly [Member] | ||||
Patents | $ 393,120 | $ 449,280 | ||
Assumed Mayoly Liabilities And Forgiveness Of Mayoly Debt [ Member] | ||||
Patents | $ 1,219,386 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Intangible Assets (Details) | Dec. 31, 2021USD ($) |
Intangible Assets and Goodwill | |
Patents | $ 3,802,745 |
Less accumulated amortization | (1,450,757) |
Intangible asset impairment | $ (2,351,988) |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2021 | |
Intangible Assets and Goodwill | ||
Amortization expense | $ 132,000 | |
Intangible asset impairment | $ 2,400,000 |
Intangible Assets and Goodwil_5
Intangible Assets and Goodwill - Goodwill (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Intangible Assets and Goodwill | ||
Balance | $ 1,911,705 | $ 2,054,048 |
Foreign currency translation | (49,636) | (142,343) |
Balance | $ 1,862,069 | $ 1,911,705 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Professional fees | $ 443,030 | $ 15,000 |
Clinical trials | 147,842 | |
Consulting fees | 109,260 | 104,100 |
Payroll and benefits | 17,382 | 274,153 |
Total accrued expenses | $ 717,514 | $ 393,253 |
Note Payable (Details)
Note Payable (Details) - USD ($) | Nov. 30, 2021 | Mar. 31, 2022 | Dec. 31, 2021 |
Note payables | $ 403,000 | $ 641,000 | |
Financing Agreement for Directors and Officer's Liability Insurance [Member] | |||
Debt Instrument, term | 9 months | ||
Debt Instrument, face amount | $ 957,000 | ||
Debt instrument, interest Rate | 3.99% | ||
Debt instrument, periodic payment | $ 81,000 |
Other Liabilities (Details)
Other Liabilities (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Other Liabilities, Current [Abstract] | ||
Lease liabilities | $ 70,784 | $ 77,989 |
Other liabilities | 18,575 | 14,818 |
Liabilities related to Merger consideration | 9,000,000 | 8,000,000 |
Total other current liabilities | 9,089,359 | 8,092,807 |
Long-term | ||
Lease liabilities | 264,460 | 311,138 |
Liabilities related to Merger consideration | 3,585,044 | 7,000,000 |
Total other long-term liabilities | $ 3,849,504 | $ 7,311,138 |
Capital Stock (Details)
Capital Stock (Details) - USD ($) | Feb. 07, 2022 | Sep. 13, 2021 | May 26, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Jan. 31, 2021 | Nov. 30, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Mar. 31, 2022 | Feb. 08, 2021 |
Common Stock, Shares Authorized (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | ||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||
Number of shares recuded due to reverse stock split | 10 | |||||||||||
Common Stock, Shares, Issued, Total (in shares) | 21,548,835 | 21,548,835 | 14,855,848 | 21,548,835 | ||||||||
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 21,548,835 | 21,548,835 | 14,855,848 | 21,548,835 | ||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 7.70 | $ 7.70 | $ 7.70 | |||||||||
Shares Issued, Price Per Share (in dollars per share) | 1.375 | $ 12.725 | 1.375 | $ 12.725 | 1.375 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,350,066 | 1,350,066 | 20,000 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.26 | $ 1.26 | $ 1.26 | $ 1.26 | $ 1.26 | $ 16.90 | ||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | 5 years | 5 years | 5 years | 5 years | 4 years | ||||||
Proceeds from Issuance of Common Stock | $ 7,972,091 | $ 9,059,290 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | 1 | 1 | |||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 1,650,000 | 580,000 | ||||||||||
Pre-funded warrants to purchase of common stock | 205,854 | |||||||||||
Class of Warrant or Rights, Investor and Pre_funded Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 392,927 | 392,927 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.10 | $ 0.10 | ||||||||||
January 2021 Investor Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,066,666 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 8 | |||||||||||
Series C Warrants | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 6,498,195 | 6,498,195 | 6,498,195 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.26 | $ 1.26 | $ 1.26 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | 5 years | 5 years | |||||||||
Pre-Funded Warrant | ||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.385 | $ 1.385 | $ 1.385 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 4,848,195 | 4,848,195 | 4,848,195 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.73 | $ 1.73 | $ 1.73 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | 5 years | 5 years | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | 1 | 1 | |||||||||
January 2021 Placement Agent Warrants [Member] | ||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 7.50 | $ 7.50 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 74,667 | 74,667 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 9.375 | $ 9.375 | ||||||||||
Percentage Of Common Stock Issued In Offering | 7.00% | |||||||||||
March 2021 Placement Agent Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 55,008 | 55,008 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 15.906 | $ 15.906 | ||||||||||
Equity Offering, Price Per Share (in dollars per share) | $ 12.725 | $ 12.725 | ||||||||||
Percentage of warrants issued | 7.00% | |||||||||||
Percentage of exercise price of warrants | 125.00% | |||||||||||
Series C Preferred Stock Converted into Common Stock [Member] | ||||||||||||
Issuance of stock upon conversion of securities (in shares) | 2,561,544 | |||||||||||
Conversion of Stock, Shares Converted (in shares) | 2,746 | |||||||||||
Issuance of stock upon conversion of securities | $ 20,600,000 | |||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ 76,000 | |||||||||||
Series B Preferred Stock Converted into Common Stock [Member] | ||||||||||||
Conversion of Stock, Shares Issued (in shares) | 258,278 | |||||||||||
Conversion of Stock, Shares Converted (in shares) | 26 | |||||||||||
Issuance of stock upon conversion of securities | $ 2,000,000 | |||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ 3,000 | |||||||||||
Series B Preferred Stock Exchanged for Common Shares [Member] | ||||||||||||
Conversion of Stock, Shares Converted (in shares) | 17.05 | |||||||||||
Issuance of stock upon conversion of securities | $ 131,000 | |||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ 14,000 | |||||||||||
Series B Preferred Stock Exchanged for Common Shares [Member] | Series C Warrants | ||||||||||||
Conversion of Stock, Shares Issued (in shares) | 104,735 | |||||||||||
Consultants [Member] | ||||||||||||
Stock Issued During Period, Shares, Settlement (in shares) | 90,057 | 57,530 | ||||||||||
Stock Issued During Period, Value, Settlement | $ 119,000 | $ 891,000 | ||||||||||
Former Investor Bank [Member] | ||||||||||||
Stock Issued During Period, Value, Settlement | $ 94,000 | |||||||||||
Shares issued for settlement (in shares) | 7,500 | |||||||||||
Equity Line Agreement [Member] | Lincoln Park [Member] | ||||||||||||
Common Stock, Shares, Issued, Total (in shares) | 48,716 | |||||||||||
Fair value of commitment shares on grant date | $ 297,000 | |||||||||||
Term of Equity Line Agreement for Sale of Shares | 30 months | |||||||||||
Stock Issued During Period, Value, New Issues | $ 0 | |||||||||||
Stock Purchase Agreement, Committed Shares, Remaining Value | $ 14,000,000 | |||||||||||
Market Agreement [Member] | H C Wainwright Co L L C [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 5,333,345 | |||||||||||
Stock issuance costs | $ 601,000 | |||||||||||
Proceeds from Issuance of Common Stock | $ 19,200,000 | |||||||||||
At The Market Offering Agreement [Member] | Wainwright [Member] | ||||||||||||
Stock Sales Agreement, Commission on Shares Sold, Percentage | 3.00% | |||||||||||
Stock Sales Agreement, Number of Shares Authorized (in shares) | 50,000,000 | |||||||||||
January 2021 Offering | ||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 7,100,000 | |||||||||||
Direct offering | Pre-Funded Warrant | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 389,891 | 389,891 | 389,891 | |||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 6.00% | |||||||||||
Warrants [Member] | ||||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 919,752 | |||||||||||
Pre-Funded Warrants [Member] | ||||||||||||
Conversion of Stock, Shares Issued (in shares) | 4,848,195 | |||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 399,187 | |||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Series B Preferred Stock [Member] | ||||||||||||
Preferred Stock, Shares Authorized (in shares) | 5,194.81 | 5,194.81 | 5,194.81 | 5,194.81 | ||||||||
Issuance of stock upon conversion of securities (in shares) | 1,306.30 | |||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Preferred Stock, Shares Issued, Total (in shares) | 645.21 | 645.21 | 662.25 | 645.21 | ||||||||
Preferred stock, shares outstanding (in shares) | 645.20 | 645.20 | 662.25 | 645.20 | ||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 645.20 | 645.20 | 662.25 | 645.20 | ||||||||
Series B Preferred Stock [Member] | Waiver | ||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | |||||||||||
Cash waiver fee (in percentage) | 10.00% | |||||||||||
Preferred stock, alternate redemption value | $ 7,700 | |||||||||||
Value of preferred stock agreed to be waived with holders of preferred stock | 2,880,000 | |||||||||||
Value of preferred stock agreed to be waived with insiders | $ 474,000 | |||||||||||
Waiver fee paid | $ 233,000 | |||||||||||
Series C Preferred Stock [Member] | ||||||||||||
Preferred Stock, Shares Authorized (in shares) | 57,000 | 57,000 | 57,000 | 57,000 | ||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Preferred Stock, Shares Issued, Total (in shares) | 0 | 0 | 0 | 0 | ||||||||
Convertible Preferred Stock, Shares Issued upon Conversion (in shares) | 13,501.08 | 13,501.08 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,350,066 | 1,350,066 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | ||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | 0 | 0 | ||||||||
Deemed dividends on preferred stock issuances | $ 17,600,000 | |||||||||||
Series C Preferred Stock [Member] | January 2021 Placement Agent Warrants [Member] | ||||||||||||
Percentage of effective purchase price per share of preferred stock | 125.00% | |||||||||||
Series C Preferred Stock [Member] | January 2021 Registered Direct Offering [Member] | ||||||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 7.50 | $ 7.50 | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 5,333.33 | |||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 750 | $ 750 | ||||||||||
Convertible Preferred Stock, Shares Issued upon Conversion (in shares) | 533,333 | 533,333 | ||||||||||
Series C Preferred Stock [Member] | January 2021 Private Placement [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 5,333.33 | |||||||||||
Common Stock [Member] | ||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 912,807 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 12.10 | $ 12.10 | ||||||||||
Common Stock [Member] | Pre-Funded Warrant | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Common Stock [Member] | Waiver | ||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | |||||||||||
Maximum [Member] | Equity Line Agreement [Member] | Lincoln Park [Member] | ||||||||||||
Issuance of available Equity Line Agreement | $ 15,000,000 |
Warrant Transactions (Details)
Warrant Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Mar. 31, 2022 | Mar. 31, 2021 | Feb. 08, 2021 | Jan. 31, 2021 | |
Number of Warrants [Roll Forward] | ||||
Warrants outstanding and exercisable, beginning (in shares) | 5,527,390 | 2,517,722 | ||
Issued (in shares) | 11,841,016 | 3,358,519 | ||
Expired (in shares) | (7,366) | (2,423) | ||
Exercised (in shares) | (4,848,195) | (919,752) | ||
Warrants outstanding and exercisable, ending (in shares) | 12,512,845 | 4,954,066 | ||
Exercise Price Per Share [Roll Forward] | ||||
Warrants outstanding and exercisable, beginning (in dollars per share) | $ 9.49 | $ 12.20 | ||
Issued (in dollars per share) | 0.76 | 7.75 | ||
Expired (in dollars per share) | 49.71 | 60.90 | ||
Exercised (in dollars per share) | 0.01 | 5.22 | ||
Warrants outstanding and exercisable, ending (in dollars per share) | 4.88 | 10.45 | ||
Weighted Average Price [Roll Forward] | ||||
Warrants outstanding and exercisable, beginning (in dollars per share) | $ 3.95 | $ 4.04 | ||
Issued (in dollars per share) | 4.92 | 5.12 | ||
Expired (in dollars per share) | 0 | 0 | ||
Exercised (in dollars per share) | 4.92 | 2.34 | ||
Warrants outstanding and exercisable, ending (in dollars per share) | $ 4.39 | $ 4.55 | ||
Warrants to purchase of stock | 1,350,066 | 20,000 | ||
Warrant exercise price | 1.26 | $ 1.26 | $ 16.90 | |
Shares Issued, Price Per Share (in dollars per share) | $ 1.375 | 12.725 | ||
Deemed dividend | $ 595 | |||
Warrant Amendment Agreement [Member] | ||||
Weighted Average Price [Roll Forward] | ||||
Warrant exercise price | $ 12.10 | $ 8 | ||
March Offering [Member] | ||||
Weighted Average Price [Roll Forward] | ||||
Consideration for purchase of securities | $ 9,000 | |||
Shares Issued, Price Per Share (in dollars per share) | $ 0.0281 | |||
Maximum [Member] | Warrant Amendment Agreement [Member] | ||||
Weighted Average Price [Roll Forward] | ||||
Warrants to purchase of stock | 392,927 | 1,066,666 |
Warrant Transactions - Series C
Warrant Transactions - Series C, Pre-funded and Placement agent Warrants (Details) - USD ($) | Feb. 08, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 20,000 | 1,350,066 | |
Warrant exercise price | $ 16.90 | $ 1.26 | $ 1.26 |
Warrants term | 4 years | 5 years | 5 years |
Stock-based compensation | $ 218,229 | $ 772,240 | |
General and administrative expense. | |||
Class of Warrant or Right [Line Items] | |||
Stock-based compensation | $ 171,822 | $ 373,928 | |
Series C warrants, pre-funded warrants, and placement agent warrants | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 11,736,281 | ||
Series C Warrants | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 6,498,195 | ||
Warrant exercise price | $ 1.26 | ||
Warrants term | 5 years | ||
Series C Warrants | March 2022 Offering [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 104,735 | ||
Warrants, pre-funded warrants, and placement agent warrants | January 2021 Offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 1,334,664 | ||
Warrants, pre-funded warrants, and placement agent warrants | March 2021 Offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 653,789 | ||
Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Grant date fair value of warrants | $ 214,000 | ||
Warrants vested | 5,000 | ||
Warrants [Member] | General and administrative expense. | |||
Class of Warrant or Right [Line Items] | |||
Stock-based compensation | $ 53,000 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional information (Details) | Sep. 11, 2020shares | Mar. 31, 2022USD ($)shares | Mar. 31, 2022USD ($)$ / sharesshares | Mar. 31, 2021USD ($)$ / sharesshares | Mar. 31, 2022USD ($)shares | Jan. 31, 2022shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted | 678,392 | 34,365 | ||||
Weighted average fair value of warrants granted (in dollars per share) | $ / shares | $ 1.37 | $ 8.28 | ||||
Unrecognized stock-based compensation expense | $ | $ 1,900,000 | $ 1,900,000 | $ 1,500,000 | $ 1,900,000 | ||
Average remaining vesting term of the stock options (in years) | 9 years 6 months 25 days | |||||
Vested during the period (in shares) | 27,500 | 27,500 | ||||
Consecutive trading days | $ | 20 | |||||
Unrecognized expense vests | $ | $ 197,000 | $ 197,000 | ||||
Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expense | $ | $ 1,000,000,000 | 1,000,000,000 | 1,000,000,000 | $ 1,000,000,000 | ||
Vesting Over Remaining Term | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expense | $ | 1,200,000 | $ 1,200,000 | $ 1,100,000 | 1,200,000 | ||
Average remaining vesting term of the stock options (in years) | 0 years | 2 years 2 months 26 days | ||||
Initiating Phase 3 Trial in US [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expense | $ | 730,000 | $ 730,000 | 730,000 | |||
Performance Based Milestone [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expense | $ | $ 320,000 | |||||
Incentive Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted | 1,500,000 | |||||
Restricted Stock | Common Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expense | $ | $ 394,000 | $ 394,000 | $ 394,000 | $ 394,000 | ||
2020 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available under equity incentive plan (in shares) | 1,000,000 | 2,114,360 | 2,114,360 | 2,114,360 | 2,114,360 | |
Percentage of common stock reserved for issuance equity incentive plan | 10.00% | |||||
Shares reserved subject to issuance (in shares) | 1,336,905 | 1,336,905 | 1,336,905 | |||
Options to purchase shares of common stock (in shares) | 777,455 | 777,455 | 777,455 | |||
Vesting period | 36 months | |||||
Options cancelled | 2,646 | 13,550 | ||||
Options forfeited | 74,267 | |||||
Equity Incentive Plan2014 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available under equity incentive plan (in shares) | 301,916 | 301,916 | 301,916 | |||
Options to purchase shares of common stock (in shares) | 263,216 | 263,216 | 263,216 | |||
The 2014 Omnibus Equity Incentive Plan | Restricted Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved subject to issuance (in shares) | 38,700 | 38,700 | 38,700 |
Equity Incentive Plan - Stock o
Equity Incentive Plan - Stock option activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numbers of shares | ||||
Granted | 678,392 | 34,365 | ||
Incentive Stock Options | ||||
Numbers of shares | ||||
Granted | 1,500,000 | |||
Equity Incentive Plan 2014 And Plan 2020 | Incentive Stock Options | ||||
Numbers of shares | ||||
Number of Shares, Beginning (in shares) | 439,192 | 407,029 | 407,029 | |
Granted | 678,392 | 34,365 | ||
Canceled | (2,646) | |||
Forfeited | (74,267) | (13,550) | ||
Number of Shares, Ending (in shares) | 1,040,671 | 427,844 | 439,192 | 407,029 |
Exercisable (in shares) | 380,559 | 222,156 | ||
Average Exercise Price | ||||
Average Exercise Price, Beginning (in dollars per share) | $ 11.58 | $ 13.80 | $ 13.80 | |
Average Exercise Price, Granted | 1.39 | 10.08 | ||
Average Exercise Price, Canceled | 9.68 | |||
Average Exercise Price, Forfeited | 3.97 | 24.46 | ||
Average Exercise Price, Ending (in dollars per share) | 5.49 | 11.89 | $ 11.58 | $ 13.80 |
Exercisable, average exercise price (in dollars per share) | $ 10.60 | $ 14.80 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||
Stock option outstanding, remaining contractual life (Year) | 8 years 8 months 1 day | 7 years 11 months 4 days | 7 years 3 months 10 days | 7 years 11 months 8 days |
Granted during the period remaining contractual life (Year) | 9 years 1 month 9 days | 10 years | ||
canceled during the period remaining contractual life (Year) | 0 years | |||
Forefeited during the period remaining contractual life (Year) | 0 years | 2 years 10 months 13 days | ||
Exercisable, Remaining Contract Life (Years) | 7 years 1 month 24 days | 6 years 8 months 1 day | ||
Stock options outstanding, intrinsic value | $ 1,599,166 | |||
Exercisable, intrinsic value | $ 637,269 |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-average assumptions (Details) - Stock Option | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Contractual term (in years) | 10 years | 10 years |
Expected Volatility | 90.92% | 84.89% |
Risk-free interest rate | 1.11% | 1.12% |
Expected Dividend yield | 0.00% | 0.00% |
Equity Incentive Plan - Total s
Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 218,229 | $ 772,240 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 46,407 | 398,312 |
General and administrative expense. | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 171,822 | $ 373,928 |
Agreements (Details)
Agreements (Details) - USD ($) | Sep. 13, 2021 | Feb. 24, 2021 | Jan. 08, 2021 | Jan. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2021 |
Research and Development Expense, Total | $ 4,976,517 | $ 2,516,027 | ||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 7.70 | |||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.375 | $ 12.725 | ||||||
Fair Value, Option, Changes in Fair Value, Gain (Loss) | $ 532,653 | |||||||
Deemed Dividends, Preferred Stock Issuances | $ 4,507,125 | |||||||
Series C Preferred Stock [Member] | ||||||||
Convertible Preferred Stock, Shares Issued upon Conversion (in shares) | 13,501.08 | |||||||
Series C Preferred Stock [Member] | First Wave Purchase Agreement [Member] | ||||||||
Deemed Dividends on Preferred Stock Issuances | $ 230,000 | |||||||
First Wave Bio Inc [Member] | ||||||||
Asset Acquisition, Consideration Transferred, Equity Interest Issued and Issuable | $ 4,000,000 | |||||||
Shares Issued, Price Per Share (in dollars per share) | $ 6.41 | |||||||
First Wave License Agreement [Member] | ||||||||
Upfront cash payment to be paid in first ten days | $ 9,000,000 | |||||||
Asset Acquisition, Additional Cash to be Paid | $ 1,250,000 | |||||||
Asset Acquisition, Contingent Consideration, Liability, Total | $ 37,000,000 | |||||||
Research and Development Expense, Total | 1,000,000 | |||||||
Asset Acquisition, Consideration Transferred, Equity Interest Issued and Issuable | $ 3,000,000 | $ 3,000,000 | ||||||
Period for conversion of common stock | 5 days | |||||||
Fair Value, Option, Changes in Fair Value, Gain (Loss) | $ 500,000 | |||||||
Convertible Preferred Stock, Nonredeemable or Redeemable, Issuer Option, Value | $ 3,000,000 | |||||||
Redeemable Noncontrolling Interest, Equity, Common, Fair Value | $ 2,500,000 | |||||||
First Wave License Agreement [Member] | First Wave Purchase Agreement [Member] | ||||||||
Upfront cash payment term | 10 days | |||||||
First Wave License Agreement [Member] | Convertible Preferred Stock [Member] | ||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 9.118 | |||||||
Convertible Preferred Stock, Shares Issued upon Conversion (in shares) | 329,019 | |||||||
First Wave License Agreement [Member] | Series C Preferred Stock [Member] | ||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 7.50 | |||||||
Convertible Preferred Stock, Shares Issued upon Conversion (in shares) | 32,902 | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,290.1960 | |||||||
Shares Issued, Price Per Share (in dollars per share) | $ 750 |
Leases (Details)
Leases (Details) | 3 Months Ended | |
Mar. 31, 2022USD ($)ft² | Mar. 31, 2021USD ($) | |
Lessee, Operating Lease, Term of Contract (Month) | 63 months | |
Operating Lease, Expense | $ | $ 28,000 | $ 52,000 |
Office Space at 777 Yamato Road, Suite 502, Boca Raton, FL 33431 [Member] | ||
Area of Real Estate Property (Square Foot) | ft² | 3,472 |
Leases - weighted-average remai
Leases - weighted-average remaining lease term (Details) | Mar. 31, 2022 |
Leases | |
Weighted-average remaining lease term (years) (Year) | 4 years 3 months 18 days |
Weighted-average discount rate | 7.94% |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) | Mar. 31, 2022USD ($) |
Leases | |
2022 | $ 61,290 |
2023 | 83,691 |
2024 | 86,202 |
2025 | 88,788 |
Thereafter | 60,593 |
Total lease payments | 380,564 |
Less imputed interest | (45,320) |
Present value of lease liabilities | $ 335,244 |
Net Loss per Common Share (Deta
Net Loss per Common Share (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 14,270,924 | 6,617,965 |
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 7.70 | |
Warrants. | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 12,512,845 | 4,954,066 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 1,040,671 | 427,844 |
Convertible preferred stock (1) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 717,408 | 1,236,055 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Defined Contribution Plan, Employers Matching Contribution, Annual Vesting Percentage | 6.00% | |
Defined Benefit Plan, Plan Assets, Contributions by Employer | $ 46,000 | $ 32,000 |
Minimum [Member] | ||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 1.00% | |
Maximum [Member] | ||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 100.00% |
Subsequent Events (Details)
Subsequent Events (Details) | Nov. 14, 2022$ / shares | May 16, 2022$ / shares | May 12, 2022USD ($)$ / sharesshares | Mar. 31, 2022USD ($)$ / sharesshares | Dec. 31, 2021$ / sharesshares | Mar. 31, 2021$ / sharesshares | Feb. 08, 2021$ / shares | Dec. 31, 2020shares |
Subsequent Event [Line Items] | ||||||||
Exercise Price Reduction | $ 1.26 | $ 1.26 | $ 16.90 | |||||
Purchase of aggregate common stock | shares | 12,512,845 | 5,527,390 | 4,954,066 | 2,517,722 | ||||
Consecutive trading days | $ | 20 | |||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Subsequent Event | ||||||||
Subsequent Event [Line Items] | ||||||||
Consecutive trading days | 180 | 30 | ||||||
Common stock, par value (in dollars per share) | $ 1 | $ 1 | ||||||
Subsequent Event | Waiver | Officers and Directors | ||||||||
Subsequent Event [Line Items] | ||||||||
Exercise Price Reduction | $ 0.3294 | |||||||
Subsequent Event | Waiver | Warrants. | ||||||||
Subsequent Event [Line Items] | ||||||||
Exercise Price Reduction | $ 0.25 | |||||||
Series B Preferred Stock [Member] | Subsequent Event | Waiver | ||||||||
Subsequent Event [Line Items] | ||||||||
Percentage of outstanding shares | 81.30% | |||||||
Accrued and unpaid dividends | $ | $ 7,700 | |||||||
Purchase of aggregate common stock | shares | 251,742 |