Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 16, 2023 | Jun. 30, 2022 | |
Document And Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 4.5 | ||
Entity Common Stock, Shares Outstanding | 1,549,581 | ||
Entity Central Index Key | 0001604191 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Firm ID | 339 | ||
Auditor Name | Mazars USA LLP | ||
Auditor Location | New York, New York |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 1,362,910 | $ 8,248,684 |
Other receivables | 93,014 | |
Prepaid expenses | 1,956,831 | 1,176,268 |
Total Current Assets | 3,412,755 | 9,424,952 |
Property, equipment, and leasehold improvements, net | 43,839 | 73,110 |
Other Assets: | ||
Restricted cash | 21,513 | |
Goodwill | 1,684,182 | 1,911,705 |
Operating lease right-of-use assets | 259,261 | 336,197 |
Deposits | 18,149 | 44,012 |
Total Other Assets | 1,983,105 | 2,291,914 |
Total Assets | 5,439,699 | 11,789,976 |
Current Liabilities: | ||
Accounts payable | 720,040 | 2,707,731 |
Accrued expenses | 320,176 | 393,253 |
Accrued dividend payable | 761,488 | 465,361 |
Note payable | 603,494 | 641,236 |
Operating lease liabilities - current | 66,151 | 77,989 |
Payable related to acquisition - current | 8,000,000 | |
Other current liabilities | 12,138 | 14,818 |
Total Current Liabilities | 2,483,487 | 12,300,388 |
Payable related to acquisition - non-current | 7,000,000 | |
Operating lease liabilities - non-current | 214,060 | 311,138 |
Total Liabilities | 2,697,547 | 19,611,526 |
Stockholders' Equity: | ||
Common stock - Par value $0.0001 per share; 50,000,000 shares authorized; 995,003 and 70,742 shares issued and outstanding at December 31, 2022 and 2021, respectively. | 100 | 7 |
Additional paid-in capital | 171,275,741 | 147,306,625 |
Accumulated deficit | (168,533,689) | (153,904,047) |
Accumulated other comprehensive loss | (1,224,135) | |
Total Stockholders' Equity | 2,742,152 | (7,821,550) |
Total Liabilities and Stockholders' Equity | 5,439,699 | 11,789,976 |
Series B preferred stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series C preferred stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series D preferred stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series E preferred stock | ||
Stockholders' Equity: | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 05, 2022 | Nov. 28, 2022 | Nov. 25, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Jan. 16, 2021 | Jul. 16, 2020 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | |||||
Common stock, shares issued (in shares) | 995,003 | 70,742 | ||||||
Common stock, shares outstanding (in shares) | 995,003 | 70,742 | ||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||||||
Preferred stock, shares designated (in shares) | 10,000,000 | |||||||
Series B preferred stock | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares designated (in shares) | 5,194.81 | 5,194.81 | 5,194.81 | |||||
Preferred stock, shares issued (in shares) | 550.17 | 662.25 | ||||||
Preferred stock, shares outstanding (in shares) | 550.17 | 631.34 | 662.25 | |||||
Series C preferred stock | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares designated (in shares) | 75,000 | 75,000 | 75,000 | |||||
Preferred stock, shares issued (in shares) | 0 | |||||||
Preferred stock, shares outstanding (in shares) | 0 | |||||||
Series D preferred stock | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares designated (in shares) | 150 | 150 | 150 | |||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||
Series E preferred stock | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares designated (in shares) | 150 | 150 | 150 | |||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||
Series F Preferred Stock | ||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares designated (in shares) | 7,000 | 7,000 | 7,000 | |||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||||
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development expenses | $ 8,776,302 | $ 16,994,828 |
Research and development (recovery) expenses - intellectual property acquired | (8,085,045) | 21,325,527 |
General and administrative expenses | 11,986,809 | 18,384,545 |
Intangible asset impairment | 2,351,988 | |
Total operating expenses | 12,678,066 | 59,056,888 |
Loss from operations | (12,678,066) | (59,056,888) |
Other (expenses) income: | ||
Interest expense | (15,879) | (11,235) |
Interest income | 8,415 | 1,173 |
Loss on dissolution of foreign entity | (1,711,371) | |
Change in fair value of liability | 532,353 | |
Other (expense) income | (232,741) | (3,252) |
Total other (expenses) income | (1,951,576) | 519,039 |
Net loss | (14,629,642) | (58,537,849) |
Other comprehensive loss: | ||
Dissolution of foreign entity | 1,711,371 | |
Foreign currency translation adjustment | (487,236) | (111,589) |
Total comprehensive loss | (13,405,507) | (58,649,438) |
Net loss | (14,629,642) | (58,537,849) |
Deemed dividend on preferred stock | (4,507,125) | |
Deemed dividend on preferred stock exchanges | (21,008,253) | |
Deemed dividend on warrant modifications | (47,300) | |
Preferred stock dividends | (296,127) | (465,361) |
Net loss applicable to common shareholders | $ (14,973,069) | $ (84,518,588) |
Basic weighted average shares outstanding | 718,249 | 42,503 |
Diluted weighted average shares outstanding | 718,249 | 42,503 |
Loss per share applicable to common shareholders - basic | $ (21) | $ (1,988.53) |
Loss per share applicable to common shareholders -diluted | $ (21) | $ (1,988.53) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Issuance of Series D Preferred Stock And Warrants Convertible preferred stock Series D Convertible Preferred Stock | Issuance of Series D Preferred Stock And Warrants Common Stock | Issuance of Series D Preferred Stock And Warrants Additional Paid-in Capital | Issuance Of Series E Preferred Stock And Warrants Convertible preferred stock Series E Convertible Preferred Stock | Issuance Of Series E Preferred Stock And Warrants Common Stock | Issuance Of Series E Preferred Stock And Warrants Additional Paid-in Capital | Private placement Additional Paid-in Capital | Private placement | Public warrant Common Stock | Public warrant Additional Paid-in Capital | Public warrant | Convertible preferred stock Series B Convertible Preferred Stock | Convertible preferred stock Series C Convertible Preferred Stock | Convertible preferred stock Series E Convertible Preferred Stock | Convertible preferred stock Series D Convertible Preferred Stock | Common Stock | Additional Paid-in Capital Series E Convertible Preferred Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Series E Convertible Preferred Stock | Total |
Balance at the beginning at Dec. 31, 2020 | $ 1 | $ 93,838,050 | $ (95,366,198) | $ (1,112,546) | $ (2,640,693) | |||||||||||||||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 2,774 | 14,833 | ||||||||||||||||||||
Issuance of preferred stock and warrants for cash, net of offering costs | $ 1 | 7,105,167 | 7,105,168 | |||||||||||||||||||
Issuance of preferred stock and warrants for cash, net of offering costs (in shares) | 10,667 | |||||||||||||||||||||
Issuance of common stock upon exchange of Series B preferred stock (shares) | (14) | 159 | ||||||||||||||||||||
Issuance of Series C preferred stock to for license acquired | $ 1 | 2,467,648 | 2,467,649 | |||||||||||||||||||
Issuance of Series C preferred stock to for license acquired (in shares) | 3,290 | |||||||||||||||||||||
Beneficial conversion feature of Series C preferred stock | 4,507,125 | 4,507,125 | ||||||||||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock | $ 1 | (1,430) | (1,429) | |||||||||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock (in shares) | (1,839) | 19,140 | ||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (259) | 1,229 | ||||||||||||||||||||
Deemed dividend of Series C preferred stock | (4,507,125) | (4,507,125) | ||||||||||||||||||||
Deemed dividend on preferred stock | (4,507,125) | |||||||||||||||||||||
Warrants issued in connection with exchange of Series B preferred stock into Series C preferred stock | 21,009,683 | 21,009,683 | ||||||||||||||||||||
Deemed dividend related to exchange of Series B preferred stock | (21,008,253) | (21,008,253) | ||||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock | $ (3) | $ 1 | 2 | |||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock (in shares) | (33,097) | 14,883 | ||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs | $ 1 | 14,156,049 | $ 14,156,050 | |||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs (in shares) | 7,741 | |||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 14,883 | |||||||||||||||||||||
Exercise of pre-funded warrants into common stock | $ 1 | 4,906,629 | $ 4,906,630 | |||||||||||||||||||
Exercise of pre-funded warrants into common stock (in shares) | 4,503 | |||||||||||||||||||||
Dividends on preferred stock | (465,361) | (465,361) | ||||||||||||||||||||
Effect of cancelled shares from the 10-for-1 reverse stock split (in shares) | (5) | |||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 3 | 18,506,811 | 18,506,814 | |||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 25,396 | |||||||||||||||||||||
Common stock issued for intellectual property acquired, net | 4,000,000 | $ 4,000,000 | ||||||||||||||||||||
Common stock issued for intellectual property acquired, net (in shares) | 2,971 | |||||||||||||||||||||
Common stock cancelled in connection with acquisition of First Wave Bio, Inc. (in shares) | (1,585) | (5) | ||||||||||||||||||||
Issuance of common stock in connection with settlement with former investment bank | 94,498 | $ 94,498 | ||||||||||||||||||||
Issuance of common stock in connection with settlement with former investment bank (in shares) | 35 | |||||||||||||||||||||
Common stock and warrants issued to consultants | 1,326,062 | 1,326,062 | ||||||||||||||||||||
Common stock and warrants issued to consultants (in shares) | 582 | |||||||||||||||||||||
Stock-based compensation | 1,371,070 | 1,371,070 | ||||||||||||||||||||
Foreign currency translation adjustment | (111,589) | (111,589) | ||||||||||||||||||||
Net loss | (58,537,849) | (58,537,849) | ||||||||||||||||||||
Balance at the end at Dec. 31, 2021 | $ 7 | 147,306,625 | (153,904,047) | (1,224,135) | (7,821,550) | |||||||||||||||||
Balance at the end (in shares) at Dec. 31, 2021 | 662 | 70,742 | ||||||||||||||||||||
Issuance of preferred stock and warrants for cash, net of offering costs | 178,336 | 178,336 | ||||||||||||||||||||
Issuance of preferred stock and warrants for cash, net of offering costs (in shares) | 150 | |||||||||||||||||||||
Issuance of stock for cash, net of offering costs | $ 20,663 | $ 20,663 | ||||||||||||||||||||
Issuance of stock for cash, net of offering costs (in shares) | 150 | |||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs | $ 8 | $ 5,185,558 | $ 5,185,566 | $ 1 | 7,971,930 | 7,971,931 | ||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 2,199,586 | 2,199,586 | 76,913 | 7,857 | ||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock | $ 1 | $ (1) | $ 1 | $ (1) | ||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (150) | 4,761 | (150) | 4,761 | ||||||||||||||||||
Deemed dividend of Series B preferred stock | (296,127) | (296,127) | ||||||||||||||||||||
Warrant modification | 47,300 | 47,300 | ||||||||||||||||||||
Deemed dividend on warrant modifications | (47,300) | (47,300) | ||||||||||||||||||||
Dissolution of foreign entity | 1,711,371 | 1,711,371 | ||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | (112) | 2,234 | ||||||||||||||||||||
Exercise of pre-funded warrants into common stock | $ 60 | 48,359 | 48,419 | |||||||||||||||||||
Exercise of pre-funded warrants into common stock (in shares) | 603,138 | |||||||||||||||||||||
Effect of cancelled shares from the 10-for-1 reverse stock split (in shares) | (12) | |||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 21 | 7,691,200 | 7,691,221 | |||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 217,036 | |||||||||||||||||||||
Common stock and warrants issued to consultants | $ 1 | 200,489 | 200,490 | |||||||||||||||||||
Common stock and warrants issued to consultants (in shares) | 7,573 | |||||||||||||||||||||
Stock-based compensation | 769,124 | 769,124 | ||||||||||||||||||||
Foreign currency translation adjustment | $ (487,236) | (487,236) | ||||||||||||||||||||
Net loss | (14,629,642) | (14,629,642) | ||||||||||||||||||||
Balance at the end at Dec. 31, 2022 | $ 100 | $ 171,275,741 | $ (168,533,689) | $ 2,742,152 | ||||||||||||||||||
Balance at the end (in shares) at Dec. 31, 2022 | 550 | 995,003 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - shares | 12 Months Ended | ||||
Jan. 18, 2023 | Aug. 26, 2022 | Sep. 13, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Changes in Stockholders' Equity | |||||
Reverse stock splits (in shares) | 7 | 30 | 10 | 30 | 10 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (14,629,642) | $ (58,537,849) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Intangible asset impairment | 2,351,988 | |
Depreciation | 29,271 | 14,707 |
Amortization | 527,548 | |
Change in right-of-use assets | 76,936 | (4,855) |
Change in fair value of liability | (532,353) | |
Stock-based compensation | 769,124 | 1,371,070 |
Realized foreign currency translation loss from dissolution of subsidiary | 1,711,371 | |
Common stock issued for intellectual property acquired, net | 4,000,000 | |
Common stock and warrants granted to consultants and former placement agent | 200,490 | 1,420,561 |
Changes in operating assets and liabilities: | ||
Other receivables | (93,014) | 551,489 |
Prepaid expenses | (177,069) | 79,886 |
Lease liabilities | (108,916) | (257,104) |
Deposits | 25,863 | (16,092) |
Accounts payable | (1,987,691) | 1,415,381 |
Accrued expenses | (73,077) | |
Payable related to acquisition | (8,085,045) | 15,000,000 |
Other liabilities | (2,680) | 327,405 |
Net cash used in operating activities | (22,344,079) | (32,288,218) |
Cash flows from investing activities: | ||
Payment related to license agreement | (10,250,000) | |
Purchase of property and equipment | (69,488) | |
Net cash used in investing activities | (10,319,488) | |
Cash flows from financing activities: | ||
Proceeds from issuance of preferred stock, net | 198,999 | 7,105,168 |
Proceeds from issuance of common stock, pre-funded warrants and warrants, net of offering costs | 15,357,083 | 14,156,050 |
Proceeds from exercise of warrants | 48,419 | 4,906,630 |
Issuance of common stock at-the-market for cash, net of offering costs | 7,691,221 | 18,506,814 |
Payment related to acquisition | (6,914,955) | |
(Repayment) issuance of note payable | (641,236) | 88,831 |
Net cash provided by financing activities | 15,739,531 | 44,763,493 |
(Decrease) increase in cash and cash equivalents | (6,604,548) | 2,155,787 |
Effect of exchange rate changes on cash | (259,713) | 30,756 |
Cash, cash equivalents and restricted cash, beginning balance | 8,248,684 | 6,062,141 |
Cash, cash equivalents and restricted cash, ending balance | 1,384,423 | 8,248,684 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 15,879 | 11,235 |
Non-cash investing and financing activities: | ||
Deemed dividend on preferred stock issuances | (4,507,125) | |
Deemed dividend on preferred stock exchanges | (21,008,253) | |
Deemed dividend on warrant modifications | (47,300) | |
Accrued dividends on preferred stock | (296,127) | (465,361) |
Issuance of series C preferred stock to settle liability related to license agreement | $ 2,467,649 | |
Common stock issued upon conversion of preferred stock | $ (2) |
The Company and Basis of Presen
The Company and Basis of Presentation | 12 Months Ended |
Dec. 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 FWB GI On September 13, 2021, the Company consummated its acquisition of FWB, a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease (“ IBD 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 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. Since its inception, the Company has devoted substantially all of 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. 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 operations. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. As of December 31, 2022, the Company had approximately $1.4 million in cash and cash equivalents. The Company has incurred recurring losses, has experienced recurring negative operating cash flows and requires significant cash resources to execute its business plans. The Company has an accumulated deficit of approximately $168.5 In addition, the Company is subject to other challenges and risks specific to its business and ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidates; delays or problems in the manufacture and supply of its product candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its 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. Going Concern Uncertainty The accompanying 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 December 31, 2022, the Company had cash and cash equivalents of approximately $1.4 million, and an accumulated deficit of approximately $168.5 Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“ GAAP On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock were converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock were converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock were 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 splits referenced above. Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 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 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 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 January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. 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 All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above. Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at December 31, 2022 and 2021, respectively. As of December 31, 2022 and December 31, 2021, the Company has classified approximately $0.022 million and $0 million, respectively, as restricted cash. 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. At December 31, 2022 and 2021, the Company had approximately $0.9 million and $7.6 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. Equity-Based Payments to Non-Employees Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. Fair Value Measurements The Company follows Accounting Standards Codification (“ ASC ASC 820 As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. Foreign Currency Translation For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities were translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items were translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments were accumulated in a separate component of stockholders’ equity up until the dissolution of AzurRx SAS in October 2022, at which time cumulative translation adjustments were recognized as a loss for the year ended December 31, 2022. Goodwill and Intangible Assets Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through December 31, 2022 related to goodwill. Intangible assets subject to amortization consist of in patents, process research and development and licenses, reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over their estimated useful lives. 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” Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ ASC 740 The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2022 and 2021, the Company does not have any significant uncertain tax positions. Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. Loss Per Share Basic loss per share (“ EPS The dilutive effect of stock options is determined using the treasury stock method. Stock options to purchase shares of Common Stock of the Company during fiscal 2022 and 2021 were not included in the computation of diluted EPS because the Company has incurred a loss for the years ended December 31, 2022 and 2021 and the effect would be anti-dilutive. 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 – Intellectual Property Acquired The Company records intellectual property in asset acquisitions that have not reached technological feasibility and which have no alternative future use, as an expense at the acquisition date. On December 31, 2020, the Company entered into a license agreement (the “ FWB License Agreement On July 29, 2022, the Company reached an agreement to restructure its obligations to the former FWB stockholders (the “ July 2022 Term Sheet Second Payment 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 ASU 2020-06 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements (“ ASU 2016-13 In June 2022, the FASB issued ASU 2022-03 - Fair Value Measurement, or Topic 820: Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ ASU 2022-03 ”). This new standard clarifies the guidance in Topic 820 when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security and introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The Company has assessed the impact of the update and determined it does not have a material impact on the accompanying 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 | 12 Months Ended |
Dec. 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. 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 December 31, 2022: Money market funds $ 509,890 $ 509,890 $ — $ — $ 509,890 Note payable 603,494 — 603,494 — 603,494 December 31, 2021: Money market funds 501,607 501,607 — — 551,489 Note payable $ 641,236 $ $ 641,236 $ — $ 641,236 At December 31, 2022 and 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 | 12 Months Ended |
Dec. 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) 2,971 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. The former FWB stockholders were 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 were payable in cash, provided that 25% of the milestone payments attributable to certain IBD indications could be payable in Common Stock, at the option of the Company. In addition, the former FWB stockholders were 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. 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 “ November 2021 Settlement Agreement During the year ended December 31, 2022, the Company paid an aggregate of $6.9 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. 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 July 2022 Term Sheet Second Payment Payments In the July 2022 Term Sheet, the Representative agreed to stay the FWB Action for a period of 90 days and to eliminate the Company’s obligation to pay a portion of any offering proceeds to the Representative. In addition, the Company’s obligation to use commercially reasonable efforts to develop niclosamide will be deferred for a period of 24 months from the date of the July 2022 Term Sheet. Effective upon the Second Payment, the Representative dismissed the FWB Action with prejudice and extinguished the remaining fixed payment obligations owed to the former FWB shareholders. On November 30, 2022, the Company entered into a formal settlement agreement with the Representative on substantially the same terms as the July 2022 Term Sheet. (the “ November 2022 Settlement Agreement 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 2,971 common shares issued multiplied by $1,346.10 per share. Under the July 2022 Term Sheet, the $1.5 million in cash due and paid on July 29, 2022, as well as the Second Payment due and paid in September 2022, were recorded as a reduction to current liabilities for the year ended December 31, 2022. Effective upon the Second Payment, the approximately $10.1 million of remaining fixed payment obligations previously owed to the former FWB shareholders was settled. The third payment obligation of $2.0 million due and paid by November 30, 2022 was recorded as research and development expense in the year ended December 31, 2022. The remaining unachieved potential milestone payments and revenue share are not yet considered probable, therefore have not been accrued as of December 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 | 12 Months Ended |
Dec. 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: December 31, 2022 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 (43,979) (14,708) Property, plant and equipment, net $ 43,839 $ 73,110 Depreciation expense was approximately $29,000 for the year ended December 31, 2022 and $15,000 for the year ended December 31, 2021. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | Note 6 – Intangible Assets and Goodwill Patents Pursuant to the Mayoly APA entered into in March 2019 (see Note 12), 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: December 31, 2022 2021 Patents $ — $ 3,802,745 Less accumulated amortization — (1,450,757) Intangible asset impairment — (2,351,988) Patents, net $ — $ — Amortization expense was approximately $528,000 for the year ended December 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 was reinstated on the Company’s books in U.S. dollars due to the dissolution of AzurRx SAS in October 2022. Going forward, there will no longer be a foreign translation adjustment. 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 (227,523) Balance on December 31, 2022 $ 1,684,182 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses | |
Accrued Expenses | Note 7 - Accrued Expenses Accrued expenses consisted of the following: December 31, December 31, 2022 2021 Professional fees $ 309,867 $ 15,000 Clinical trials 5,340 — Consulting 4,969 104,100 Payroll and benefits — 274,153 Total accrued expenses $ 320,176 $ 393,253 |
Note Payable
Note Payable | 12 Months Ended |
Dec. 31, 2022 | |
Note Payable | |
Note Payable | Note 8 – Note Payable Directors and Officer’s and Other Liability Insurances On November 30, 2022, the Company entered into 9-month On November 30, 2021, the Company entered into a 9-month |
Capital Stock
Capital Stock | 12 Months Ended |
Dec. 31, 2022 | |
Capital Stock | |
Capital Stock | Note 9 – Capital Stock Our certificate of incorporation, as amended and restated (the “ Charter On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. 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 splits referenced above. Common Stock The Company had 995,003 and 70,742 shares of its Common Stock issued outstanding Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. The Company’s Charter and Amended and Restated Bylaws (the “ Bylaws In addition, the holders of the Company’s Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current policy of the Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of the Company’s Common Stock will be entitled to share ratably in all assets that are legally available for distribution. Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that it may designate and issue in the future. Preferred Stock The Board is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The Board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance. On July 16, 2020, the Company designated approximately 5,194.81 shares as Series B Preferred Stock. As of December 31, 2022 and 2021, 550.17 and 662.25 shares of Series B Preferred Stock were issued outstanding On January 5, 2021, the Company designated 75,000 shares as Series C Preferred Stock. Shares of Series C Preferred Stock converted into Common Stock (or Prefunded Warrants, as applicable) or redeemed shall be canceled and shall not be reissued. As of December 31, 2022 and 2021, 0 shares of Series C Preferred Stock were issued and outstanding, with approximately 41,903 shares of Series C Preferred Stock remaining authorized but unissued. On July 15, 2022, the Company designated 150 shares as Series D Preferred Stock and had 0 shares of Series D Preferred Stock issued and outstanding on December 31, 2022 and 2021. On July 15, 2022, the Company designated 150 shares as Series E Preferred Stock and had 0 shares of Series E Preferred Stock issued and outstanding on December 31, 2022 and 2021. On November 28, 2022, the Company designated 7,000 shares as Series F Preferred Stock and had 0 shares of Series F Preferred Stock issued and outstanding on December 31, 2022 and 2021. At December 31, 2022, the Company had approximately 9,999,449.83 shares of preferred stock remaining authorized but unissued. Series B Convertible Preferred Stock Pursuant to the Certificate of Designation of Rights and Preferences of the Series B Preferred Stock (the “ Series B Certificate of Designation Series B Stated Value Under the Certificate of Designations, each share of Series B Preferred Stock carries a liquidation preference equal to the Series B Stated Value (as adjusted thereunder) plus accrued and unpaid dividends thereon (the “ Liquidation Preference Each share of Series B Preferred Stock will be convertible at the holder’s option at any time, into Common Stock at a conversion rate equal to the quotient of (i) the Series B Stated Value divided by (ii) the conversion price of $1,617.00. In addition, at any time after the six month anniversary of the Series B Closing Date, if the closing sale price per share of Common Stock exceeds 250% of the conversion price, or $4,042.50, for 20 consecutive trading days, then all of the outstanding shares of Series B Preferred Stock will automatically convert (the “ Automatic Conversion The holders of the Series B Preferred Stock, voting as a separate class, will have customary consent rights with respect to certain corporate actions of the Company. The Company may not take the following actions without the prior consent of the holders of at least a majority of the Series B Preferred Stock then outstanding: (a) authorize, create, designate, establish, issue or sell an increased number of shares of Series B Preferred Stock or any other class or series of capital stock ranking senior to or on parity with the Series B Preferred Stock as to dividends or upon liquidation; (b) reclassify any shares of Common Stock or any other class or series of capital stock into shares having any preference or priority as to dividends or upon liquidation superior to or on parity with any such preference or priority of Series B Preferred Stock; (c) amend, alter or repeal the Certificate of Incorporation or Bylaws of the Company and the powers, preferences, privileges, relative, participating, optional and other special rights and qualifications, limitations and restrictions thereof, which would adversely affect any right, preference, privilege or voting power of the Series B Preferred Stock; (d) issue any indebtedness or debt security, other than trade accounts payable, insurance premium financings and/or letters of credit, performance bonds or other similar credit support incurred in the ordinary course of business, or amend, renew, increase, or otherwise alter in any material respect the terms of any such indebtedness existing as of the date of first issuance of shares of Series B Preferred Stock; (e) redeem, purchase, or otherwise acquire or pay or declare any dividend or other distribution on (or pay into or set aside for a sinking fund for any such purpose) any capital stock of the Company; (f) declare bankruptcy, dissolve, liquidate, or wind up the affairs of the Company; (g) effect, or enter into any agreement to effect, a Change of Control (as defined in the Certificate of Designations); or (h) materially modify or change the nature of the Company’s business. Most Favored Nations Exchange Right and Waiver Agreements In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “ Subsequent Financing Exchange Amount Series B Exchange Right Between February 1, 2022 and February 7, 2022, the Company entered into waiver agreements (the “ Waiver During the year ended December 31, 2022, 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 $0.047 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 year ended December 31, 2022. 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 with respect to any Subsequent Financing occurring on or after January 1, 2022 (the “ Permanent Waiver Record Holders Pursuant to the terms of the Series B Certificate of Designation, 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 Expiration Date Consenting Holders The Required Consent was obtained from the Consenting Holders and the solicitation terminated in accordance with its terms as of the Expiration Date. The Permanent Waiver was effective immediately upon the Expiration Date and was 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 was made on the books and records of the Company’s transfer agent and a legend reflecting the Permanent Waiver was 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 Series B Warrants Exercise Price Reduction As of December 31, 2022, (i) holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 9,058 shares of Common Stock (which conversion the Company has elected to make in full), and additional Investor Warrants exercisable for up to an aggregate of 9,058 shares of Common Stock, (ii) holders of approximately 94.970 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $841,000 had previously elected to exercise their Series B Exchange Rights into 1,482 shares of Common Stock with no warrants, and (iii) holders of approximately 30.91 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $265,000 had previously elected to exercise their Series B Exchange Rights into 909 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 909 shares of Common Stock. Series B Exchanges into the January 2021 Offerings During the year ended December 31, 2021, pursuant to the Series B Exchange Right, the Company issued an aggregate of 19,140.14 shares of Series C Preferred Stock and warrants to purchase an aggregate of 9,058 shares of Common Stock in connection with the exchange of approximately 1,839.76 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 resulted in a substantive change and should be accounted for as an extinguishment. As such, for the year ended December 31, 2021, the Company recognized an aggregate deemed dividend of approximately $21.0 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. Series C Purchase Agreement On January 5, 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 The proceeds from the January 2021 Offerings were allocated to the Series C Preferred Stock and the January 2021 Investor Warrants based on their relative fair values. The total proceeds of approximately $7.1 million, net of $0.9 million offering costs, were allocated as follows: approximately $4.6 million to the Series C Preferred Stock and approximately $3.4 million to the January 2021 Investor Warrants. After allocation of the proceeds, the effective conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of approximately $4.5 million equal to the intrinsic value of the beneficial conversion feature and recognized on the closing date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. The total offering costs of approximately $0.9 million were recognized in equity. During the year ended December 31, 2021, all outstanding shares of Series C Preferred Stock were converted to Common Stock. Series F Preferred Stock On November 25, 2022, the board of directors of the Company declared a dividend of 0.001 of a share of Series F Preferred Stock, par value $0.0001 per share, for each outstanding share of Company common stock, par value $0.0001 per share to stockholders of record on December 5, 2022. Each share of Series F Preferred Stock entitled the holder thereof to 1,000,000 votes per share (each 0.001 of a share of Series F Preferred Stock would entitle the holder thereof to 1,000 votes). The outstanding shares of Series F Preferred Stock voted together with the outstanding shares of Common Stock of the Company as a single class exclusively with respect to (1) any proposal to reclassify the outstanding shares of Common Stock into a smaller number of shares of Common Stock at a ratio specified in or determined in accordance with the terms of such amendment (the “ Reverse Stock Split Adjournment Proposal The Series F Preferred Stock will rank senior to the Common Stock as to any distribution of assets upon a liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily (a “ Dissolution 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 November 2022 Private Placement On November 22, 2022, the Company completed a private placement (the “ November 2022 Offering November 2022 Pre-Funded Warrants November 2022 Pre-Funded Warrant Shares Common Stock November 2022 Common Warrants November 2022 Warrants November 2022 Common Warrant Shares November 2022 Warrant Shares The issuance of the November 2022 Pre-Funded Warrant Shares in excess of 19.99% of the shares of Common Stock outstanding prior to the Offering and the issuance of the November 2022 Common Warrant Shares was subject to stockholder approval under Nasdaq rules (the “ Stockholder Approval five As compensation to Wainwright, who was the exclusive placement agent in connection with the November 2022 Offering, the Company paid Wainwright a cash fee of 7% of the aggregate gross proceeds raised and reimbursement of certain expenses and legal fees. The Company received net proceeds of approximately $2.2 million after deducting the Placement Agent fees and other Offering expenses. The Company intends to use the net proceeds from the November 2022 Offering for working capital purposes. October 2022 Public Offering On October 11, 2022, the Company completed a public offering (the “ October 2022 Offering Common Stock October 2022 Pre-Funded Warrants October 2022 Pre-Funded Warrant Shares October 2022 Warrants As compensation to Wainwright, who was the exclusive placement agent in connection with the October 2022 Offering, the Company paid Wainwright a cash fee of 7% of the aggregate gross proceeds raised and reimbursement of certain expenses and legal fees. The Company received net proceeds of approximately $5.2 million after deducting the Placement Agent fees and other Offering expenses. The Company intends to use the net proceeds from the Offering for working capital purposes. July 2022 Private Placement On July 15, 2022, the Company completed a private placement (the “ July 2022 Offering July 2022 Warrants The Company received net proceeds of approximately $200,000 after deducting the offering expenses payable by the Company. As compensation to Wainwright, who was the exclusive placement agent in connection with the July 2022 Offering, the Company paid Wainwright a cash fee of 7% of the aggregate gross proceeds raised and reimbursement of certain expenses and legal fees. The Company also issued to designees of Wainwright warrants (the “ Placement Agent Warrants During the year ended December 31, 2022, all of the Series D Preferred Shares and the Series E Preferred Shares were converted into 9,522 shares of Common Stock. March 2022 Registered Direct Offering On March 2, 2022, the Company completed a registered direct offering (the “ March 2022 Offering March 2022 Pre-Funded Warrants March 2022 Warrants March 2022 Placement Agent Warrants The Company received net proceeds of approximately $8.0 million after deducting the Placement Agent fees and other Offering expenses. The Company intends to use the net proceeds from the Offering for working capital purposes. July 2021 Offering On July 22, 2021, the Company entered into an underwriting agreement with Wainwright (the “ July 2021 Offering The Company received net proceeds of approximately $5.1 million after deducting the Placement Agent fees and other Offering expenses. The Company paid Wainwright an underwriting discount equal to 8.0% of the gross proceeds of the offering, and reimbursed Wainwright for a non-accountable expense allowance of $35,000, $125,000 in legal fees and $15,950 for clearing expenses. Additionally, as partial compensation for Wainwright’s services as underwriter in the offering, the Company issued to Wainwright (or its designees) warrants to purchase 348 shares of Common Stock equal to 7.0% of the aggregate number of shares of Common Stock sold in the offering (the “ Wainwright Warrants March 2021 Registered Direct Offering On March 10, 2021, the Company completed a registered direct offering (the “ March 2021 Offering March 2021 Pre-Funded Warrants March 2021 Warrants March 2021 Placement Agent Warrants The Company received net proceeds of approximately $9.1 million after deducting the Placement Agent fees and other Offering expenses. Common Stock Issuances 2022 Issuances During the year ended December 31, 2022, the Company issued 7,857 shares of Common Stock under the March 2022 Offering for which the Company received net proceeds of approximately $8.0 million. During the year ended December 31, 2022, the Company issued an aggregate of 23,087 shares of Common Stock upon the conversion of the March 2022 Pre-Funded Warrants issued at a par value of $2.10 (See Note 10). During the year ended December 31, 2022, the Company issued an aggregate of 9,522 shares of Common Stock upon the conversion of Series E and Series D preferred stock. During the year ended December 31, 2022, the Company issued and sold an aggregate of 217,036 shares of Common Stock under the ATM Agreement for which the Company received net proceeds of approximately $7.7 million. During the year ended December 31, 2022, the Company cancelled an aggregate of 12 shares of Common Stock in connection with the 30-for-1 reverse stock split on August 26, 2022. During the year ended December 31, 2022, the Company issued 76,913 shares of Common Stock under the October 2022 Offering for which the Company received net proceeds of approximately $5.2 million. During the year ended December 31, 2022, the Company issued an aggregate of 414,286 shares of Common Stock upon the conversion of the October 2022 Pre-Funded Warrants issued at a par value of $0.001 (See Note 10). During the year ended December 31, 2022, the Company issued an aggregate of 165,765 shares of Common Stock upon the conversion of the November 2022 Pre-Funded Warrants issued at a par value of $0.001 (See Note 10). During the year ended December 31, 2022, the Company issued an aggregate of 2,234 shares of Common Stock and accompanying Exchange Warrants upon the exchange of an aggregate of 112.08 shares of Series B Preferred Stock with a stated value of approximately $863,000 plus accrued dividends of approximately $129,000. During the year ended December 31, 2022, the Company issued an aggregate of 7,573 shares of its Common Stock to consultants with a grant date fair value of approximately $200,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. 2021 Issuances During the year ended December 31, 2021, the Company issued an aggregate of 582 shares of its Common Stock to consultants with a grant date fair value of approximately $1.3 million for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the year ended December 31, 2021, the Company issued an aggregate 35 shares of its Common Stock with a grant date fair value of approximately $94,000 in connection with the settlement with the Company’s former investment bank, which was recorded as stock-based compensation and included as part of general and administrative expense. During the year ended December 31, 2021, the Company issued an aggregate of 14,883 shares of Common Stock upon the conversion of an aggregate of 33,097.10 shares of Series C Preferred Stock with a stated value of approximately $24.7 million plus accrued dividends of approximately $198,000. During the year ended December 31, 2021, the Company issued an aggregate of 4,503 shares of Common Stock upon the exercise of an aggregate of 4,530 investor warrants, including an aggregate of 1,900 pre-funded warrants (see Note 10). During the year ended December 31, 2021, the Company issued an aggregate of 1,229 shares of Common Stock upon the conversion of an aggregate of 258.08 shares of Series B Preferred Stock with a stated value of approximately $2.0 million plus accrued dividends of approximately $3,000. During the year ended December 31, 2021, the Company issued an aggregate of 159 shares of Common Stock upon the exchange of 13.80 shares of Series B Preferred Stock with a stated value of approximately $0.1 million plus accrued dividends of approximately $8,000 into shares of Common Stock. During the year ended December 31, 2021, the Company issued an aggregate of 7,741 shares of Common Stock in connection with the March 2021 Offering and July 2021 Offering. During the year ended December 31, 2021, the Company issued and sold an aggregate of 25,396 shares of Common Stock under the ATM Agreement for which the Company received net proceeds of approximately $18.5 million. During the year ended December 31, 2021, the Company issued a net of 1,386 shares of Common Stock related to the acquisition of FWB. During the year ended December 31, 2021, the Company cancelled an aggregate of 5 shares of Common Stock in connection with the 10-for-1 reverse stock split on September 13, 2021. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Warrants | |
Warrants | Note 10 – Warrants Warrant activity for the years ending December 31, 2022 and 2021 were as follows: Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Warrants outstanding and exercisable on January 1, 2022 26,089 $ 1,992.90 3.95 Issued during the period 2,757,521 3.75 5.40 Expired during the period (674) 1,102.85 — Exercised during the period (603,138) 0.08 5.36 Warrants outstanding and exercisable on December 31, 2022 2,179,798 $ 19.16 5.50 Warrants outstanding and exercisable on January 1, 2021 12,254 $ 2,562.00 4.04 Granted during the period 18,958 1,630.83 3.89 Expired during the period (623) 7,056.03 — Exercised during the period (4,500) 1,109.29 3.85 Warrants outstanding and exercisable on December 31, 2021 26,089 $ 1,992.90 3.95 The weighted average fair value of warrants granted during the years ended December 31, 2022 and 2021, was $204.52 and $1,812.30 per share, respectively. The grant date fair values were calculated using the Black-Scholes model with the following weighted average assumptions: December 31, 2022 2021 Expected life (in years) 5.04 4.38 Volatility 92.0 - 101.6 % 83.8- 90.8 % Risk-free interest rate 1.74- 4.14 % 0.36-0.90 % Dividend yield — % — % The outstanding warrants expire from 2023 through 2028. In connection with the November 2022 Offering, the Company entered into a warrant amendment agreement (the “ Warrant Amendment Agreement November Existing Warrants Purchase Commitment Warrant Amendment 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 5,080 shares of Common Stock at an exercise price of $1,680.00 per share issued in January 2021 and warrants to purchase up to 1,872 shares of Common stock at an exercise price of $2,541.00 per share issued in March 2021 (the “ March Existing Warrants During the year ended December 31, 2022, the Company issued March 2022 Warrants, March 2022 Pre-Funded Warrants, and March 2022 Placement Agent Warrants to purchase 55,885 shares of Common Stock in connection with the March 2022 Offering, Exchange Warrants to purchase 910 shares of Common Stock in connection with a Series B Preferred Stock exchange, July 2022 Warrants to purchase 9,524 shares of Common Stock in connection with the July 2022 Offering, October 2022 Warrants and October 2022 Pre-Funded Warrants to purchase 905,486 shares of Common Stock in connection with the October 2022 Offering, and November 2022 Warrants and November 2022 Pre-Funded Warrants to purchase 1,785,716 shares of Common Stock in connection with the November 2022 Offering (See Note 9). During the year ended December 31, 2021, the Company issued warrants, pre-funded warrants, and placement agent warrants to purchase 6,353 and 3,109 shares of the Company’s Common Stock in connection with the January 2021 Offerings and the March 2021 Offering, respectively, placement agent warrants to purchase 346 shares of the Company’s Common Stock in connection with the July 2021 Offering, warrants to purchase 9,055 shares of the Company’s Common Stock in connection with exchanges made pursuant to the Series B Exchange Right (See Note 9), as well as warrants to purchase 571 shares of Common Stock issued to consultants. |
Equity Incentive Plan
Equity Incentive Plan | 12 Months Ended |
Dec. 31, 2022 | |
Equity Incentive Plan | |
Equity Incentive Plan | Note 11 – Equity Incentive Plan The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “ 2014 Plan 2020 Plan The 2020 Plan allows for the issuance of securities, including stock options to employees, Board members and consultants. The initial number of shares of Common Stock available for issuance under the 2020 Plan was 4,761 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10)% of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan or the 2020 Plan. The number of shares permitted to be issued as “incentive stock options” (“ ISOs As of December 31, 2022, there were an aggregate of 1,477 total shares available (but un-issuable) under the 2014 Plan, of which 695 are issued and outstanding, and 283 shares are reserved subject to issuance of restricted stock and RSUs. As of December 31, 2022, 10,068 total shares were authorized under the 2020 Plan, of which 3,241 were issued and outstanding and 6,827 shares were available for potential issuances. As of January 1, 2023, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased by 317,498 to 324,325 under the 2020 Plan’s evergreen provision. The following table summarizes the Company’s stock option activity: Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding as of January 1, 2022 1,941 $ 2,470.99 7.28 $ — Granted 3,266 288.19 7.23 — Canceled (555) 2,478.29 — — Forfeited (716) 904.99 — — Outstanding as of December 31, 2022 3,936 $ 958.14 8.22 $ — Exercisable as of December 31, 2022 2,153 $ 1,354.72 7.70 $ — Outstanding as of January 1, 2021 1,788 $ 2,616.60 7.94 $ — Granted 825 1,808.10 8.32 — Canceled (672) 2,198.70 — — Outstanding as of December 31, 2021 1,941 $ 2,470.99 7.28 $ — Exercisable as of December 31, 2021 1,340 $ 2,816.10 6.55 $ — During the year ended December 31, 2022, stock options to purchase an aggregate of 298 shares and 257 shares of Common Stock under the 2014 Plan and 2020 Plan, respectively, were canceled. During the year ended December 31, 2021, stock options to purchase an aggregate of 632 shares and 40 shares of Common Stock under the 2014 Plan and 2020 Plan, respectively, were canceled. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions: December 31, 2022 2021 Contractual term (in years) 6.5 9 10 Volatility 90.9 % 88.7 % Risk-free interest rate 1.12 % 1.29 % Dividend yield — % — % The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s Common Stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future. The weighted average fair value of stock options granted during the years ended December 31, 2022 and 2021 was $223.68 and $1,398.16, respectively, per share. The total fair value of the stock options vested, subject to service-based milestone vesting conditions, during the years ended December 31, 2022 and 2021 was approximately $769,000 and $552,000, respectively. The total fair value of the stock options vested, subject to performance-based milestone vesting conditions, during the years ended December 31, 2022 and 2021 was approximately $0 and $623,000, respectively. The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows: Year Ending December 31, 2022 2021 Research and development $ 106,466 $ 640,244 General and administrative 662,658 730,826 Total stock-based compensation expense $ 769,124 $ 1,371,070 As of December 31, 2022, the Company had unrecognized stock-based compensation expense of approximately $0.8 million. Approximately $0.3 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 8.49 years. Approximately $0.5 million of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. As of December 31, 2021, the Company had unrecognized stock-based compensation expense of approximately $1.1 million. Approximately $0.9 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 1.85 years. Approximately $0.2 million of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. Restricted Stock and Restricted Stock Units Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock unit awards (“ RSUs As of December 31, 2022, and 2021, the Company had an aggregate unrecognized restricted Common Stock expense of approximately $388,000, which will be recognized when vesting of certain milestones will be become probable. |
Agreements
Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Agreements | |
Agreements | Note 12 – Agreements License Agreement with First Wave Bio, Inc. On December 31, 2020, we 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, we agreed to pay FWB a $9.0 million upfront cash payment due within 10 days, which was paid in January 2021 and are obligated to make an additional payment of $1.25 million due on June 30, 2021. In addition, we are obligated to pay potential milestone payments to FWB totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. Under the FWB License Agreement we were obligated to pay FWB royalties as a mid-single digit percentage of net sales of the Niclosamide Product, subject to specified reductions. We were also obligated to issue to 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 4,700 shares of Common Stock. This was classified as a liability in the consolidated balance sheet because of certain NASDAQ restrictions and the requirement to obtain stockholder approval. On January 8, 2021, we entered into a securities purchase agreement with FWB (the “ FWB Purchase Agreement The conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of approximately $230,000 equal to the intrinsic value of the beneficial conversion feature and recognized on the issuance date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. 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 | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Leases | Note 13 – The Company leases its offices under operating leases which are subject to various rent provisions and escalation clauses. The Company is a party to two real property operating leases for the rental of office space. The Company has office space of 3,472 square feet in Boca Raton, Florida that is used for its corporate headquarters with a term through August 31, 2026. The Company also has office space in in Brooklyn, New York on a month-to-month basis. The Company was previously a party to office space in Hayward, California with a term through May 31, 2022, which was not renewed upon its expiration. 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 $157,000 and $261,000 for the years ended December 31, 2022 and 2021, respectively. The weighted-average remaining lease term and weighted-average discount rate under operating leases at December 31, 2022 were: December 31, 2022 Lease term and discount rate Weighted-average remaining lease term 3.7 years Weighted-average discount rate 7.00 % Maturities of operating lease liabilities at December 31, 2022 were as follows: 2023 $ 83,691 2024 86,202 2025 88,788 2026 60,593 Total lease payments 319,274 Less imputed interest (39,063) Present value of lease liabilities $ 280,211 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | Note 14 - Income Taxes The Company is subject to taxation at the federal level in both the United States and France and at the state level in the United States. At December 31, 2022 and 2021, the Company had no tax provision for either jurisdictions. At December 31, 2022 and 2021, the Company had gross deferred tax assets of approximately $29.5 million and $31.6 million, respectively. As the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of approximately $29.5 million and $31.6 million has been established at December 31, 2022 and 2021, respectively. The change in the valuation allowance was approximately $2.1 million and $5.6 million in 2022 and 2021, respectively. The significant components of the Company’s net deferred tax assets and liabilities consisted of: December 31, 2022 2021 Gross deferred tax assets: Net operating loss carry-forwards $ 18,916,000 $ 30,576,000 Stock compensation 733,000 112,000 Accruals — 30,000 Change in accounts payable — 138,000 Intangible assets 5,708,000 791,000 Capitalized research and development 2,022,000 — Research and development credits 1,715,000 — Unrealized loss 318,000 — Other 102,000 — Deferred tax assets before valuation allowance $ 29,514,000 $ 31,647,000 Valuation allowance (29,450,000) (31,647,000) Deferred tax assets net of valuation allowance $ 64,000 $ — Gross deferred tax liabilities: Right of use asset (64,000) — Total deferred tax liability $ (64,000) $ — Total deferred tax asset, net $ — $ — Income taxes computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, 2022 2021 Income tax benefit (expense) at statutory rate 21.0 % 21.0 % State income tax 4.9 % 4.2 % Non-deductible expense 8.7 % (10.3) % Change in valuation allowance 14.6 % (9.5) % Prior year adjustments (7.7) % (4.7) % Dissolution of foreign subsidiary (45.9) % — % Other 4.4 % (0.7) % Total income tax benefit (expense) 0.0 % 0.0 % As of December 31, 2022, the Company has federal and state net operating loss carryforwards of approximately $79.7 million and $62.2 million, respectively, to offset future federal and state taxable income. Of the approximately $79.7 million of federal net operating loss carryforwards, approximately $14.8 million will begin to expire starting in 2034. The remaining federal net operating loss carryforwards do not expire, but their utilization is limited to 80% of taxable income. The state net operating loss carryforwards of approximately $62.2 million will begin to expire in 2035. As of December 31, 2022, the Company also has federal research and development tax credit carryforwards of approximately $1.7 million to offset future income taxes, which expire beginning in 2040. The Company’s ability to use its NOL carryforwards may be limited if it experiences an “ownership change” as defined in Section 382 of the Internal Revenue Code of 1986, as amended. An ownership change generally occurs if certain stockholders increase their aggregate percentage ownership of a corporation’s stock by more than 50 percentage points over their lowest percentage ownership at any time during the testing period, which is generally the three-year period preceding any potential ownership change. The Company has not completed a study to determine whether transactions that have occurred over the past three years may have triggered an ownership change limitation. The Company had taken no uncertain tax positions that would require disclosure under ASC 740, Accounting for Income Taxes, at December 31, 2022 and 2021, respectively. |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 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. At December 31, 2022, diluted net loss per share did not include the effect of 3,054 shares of Common Stock issuable upon the conversion of Series B preferred stock, 1,750,324 shares of Common Stock issuable upon the exercise of outstanding warrants, 283 shares of restricted stock not yet issued, and 3,936 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. Also excluded from the diluted net loss per are the potentially dilutive effect of shares of Common Stock potentially issuable pursuant the Series B Exchange Right. At December 31, 2021, diluted net loss per share did not include the effect of 3,436 shares of Common Stock issuable upon the conversion of Series B preferred stock, 25,605 shares of Common Stock issuable upon the exercise of outstanding warrants, 178 shares of restricted stock not yet issued, and 2,091 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. Also excluded from the diluted net loss per are the potentially dilutive effect of shares of Common Stock potentially issuable pursuant the Series B Exchange Right. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
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 $112,000 and $107,000 for the years ended December 31, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events | |
Subsequent Events | Note 17 - Subsequent Events March 2023 Private Placement On March 12, 2023, the Company entered into a securities purchase agreement (the “ March 2023 Purchase Agreement March 2023 Private Placement March 2023 Pre-Funded Warrants March 2023 Pre-Funded Warrant Shares March 2023 Warrants March 2023 The March 2023 Private Placement closed on March 15, 2023. The gross proceeds from the offering were approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of the common stock and the shares of common stock underlying the warrants in the March 2023 Private Placement no later than the earlier of (i) Arbitration with CRO On March 7, 2023, the Company filed a demand for arbitration with a CRO in connection with two clinical trial agreements. The Company believes it has fulfilled all payment obligations to the CRO and is not carrying any amounts as payable on its books. The amount of potential payments due, if any, are not estimate-able nor probable at this time and therefore, a liability related to this matter has not been recorded as of December 31, 2022. Issuance of Restricted Stock Units On January 3, 2023, the Company issued to employees ten-year restricted stock units of 97,139 shares of Common Stock, subject to service-based milestones vesting quarterly over one year under the 2020 Plan as payment for services rendered. Such issuance was exempt from registration under 4(a)(2) of the Securities Act. On January 3, 2023, the Company issued to consultants ten-year restricted stock units of 2,570 shares of Common Stock, subject to service-based milestones vesting quarterly over one year under the 2020 Plan as payment for services rendered. Such issuance was exempt from registration under 4(a)(2) of the Securities Act. On January 3, 2023, the Company issued to the Board of Directors ten-year restricted stock units of 60,530 shares of Common Stock, subject to service-based milestones vesting quarterly over one year under the 2020 Plan as payment for services rendered. Such issuance was exempt from registration under 4(a)(2) of the Securities Act. |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Significant Accounting Policies and Recent Accounting Pronouncements | |
Use of Estimates | Use of Estimates The accompanying 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 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 January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. 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 All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above. |
Reclassifications | Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at December 31, 2022 and 2021, respectively. As of December 31, 2022 and December 31, 2021, the Company has classified approximately $0.022 million and $0 million, respectively, as restricted cash. |
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. At December 31, 2022 and 2021, the Company had approximately $0.9 million and $7.6 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. |
Equity-Based Payments to Non-Employees | Equity-Based Payments to Non-Employees Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. |
Fair Value Measurements | 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 For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities were translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items were translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments were accumulated in a separate component of stockholders’ equity up until the dissolution of AzurRx SAS in October 2022, at which time cumulative translation adjustments were recognized as a loss for the year ended December 31, 2022. |
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 recognized any impairment charges through December 31, 2022 related to goodwill. Intangible assets subject to amortization consist of in patents, process research and development and licenses, reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over their estimated useful lives. 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” |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ ASC 740 The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2022 and 2021, the Company does not have any significant uncertain tax positions. |
Leases | Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. |
Loss Per Share | Loss Per Share Basic loss per share (“ EPS The dilutive effect of stock options is determined using the treasury stock method. Stock options to purchase shares of Common Stock of the Company during fiscal 2022 and 2021 were not included in the computation of diluted EPS because the Company has incurred a loss for the years ended December 31, 2022 and 2021 and the effect would be anti-dilutive. |
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 – Intellectual Property Acquired The Company records intellectual property in asset acquisitions that have not reached technological feasibility and which have no alternative future use, as an expense at the acquisition date. On December 31, 2020, the Company entered into a license agreement (the “ FWB License Agreement On July 29, 2022, the Company reached an agreement to restructure its obligations to the former FWB stockholders (the “ July 2022 Term Sheet Second Payment |
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 ASU 2020-06 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements (“ ASU 2016-13 In June 2022, the FASB issued ASU 2022-03 - Fair Value Measurement, or Topic 820: Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ ASU 2022-03 ”). This new standard clarifies the guidance in Topic 820 when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security and introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The Company has assessed the impact of the update and determined it does not have a material impact on the accompanying 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) | 12 Months Ended |
Dec. 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 December 31, 2022: Money market funds $ 509,890 $ 509,890 $ — $ — $ 509,890 Note payable 603,494 — 603,494 — 603,494 December 31, 2021: Money market funds 501,607 501,607 — — 551,489 Note payable $ 641,236 $ $ 641,236 $ — $ 641,236 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Equipment and Leasehold Improvements | |
Summary of property, equipment and leasehold improvements | December 31, 2022 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 (43,979) (14,708) Property, plant and equipment, net $ 43,839 $ 73,110 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Dec. 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 | December 31, 2022 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 (227,523) Balance on December 31, 2022 $ 1,684,182 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses | |
Summary of accrued expenses | December 31, December 31, 2022 2021 Professional fees $ 309,867 $ 15,000 Clinical trials 5,340 — Consulting 4,969 104,100 Payroll and benefits — 274,153 Total accrued expenses $ 320,176 $ 393,253 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants | |
Schedule of warrant activity | Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Warrants outstanding and exercisable on January 1, 2022 26,089 $ 1,992.90 3.95 Issued during the period 2,757,521 3.75 5.40 Expired during the period (674) 1,102.85 — Exercised during the period (603,138) 0.08 5.36 Warrants outstanding and exercisable on December 31, 2022 2,179,798 $ 19.16 5.50 Warrants outstanding and exercisable on January 1, 2021 12,254 $ 2,562.00 4.04 Granted during the period 18,958 1,630.83 3.89 Expired during the period (623) 7,056.03 — Exercised during the period (4,500) 1,109.29 3.85 Warrants outstanding and exercisable on December 31, 2021 26,089 $ 1,992.90 3.95 |
Schedule of weighted average assumptions | December 31, 2022 2021 Expected life (in years) 5.04 4.38 Volatility 92.0 - 101.6 % 83.8- 90.8 % Risk-free interest rate 1.74- 4.14 % 0.36-0.90 % Dividend yield — % — % |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity Incentive Plan | |
Schedule of stock option activity | Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding as of January 1, 2022 1,941 $ 2,470.99 7.28 $ — Granted 3,266 288.19 7.23 — Canceled (555) 2,478.29 — — Forfeited (716) 904.99 — — Outstanding as of December 31, 2022 3,936 $ 958.14 8.22 $ — Exercisable as of December 31, 2022 2,153 $ 1,354.72 7.70 $ — Outstanding as of January 1, 2021 1,788 $ 2,616.60 7.94 $ — Granted 825 1,808.10 8.32 — Canceled (672) 2,198.70 — — Outstanding as of December 31, 2021 1,941 $ 2,470.99 7.28 $ — Exercisable as of December 31, 2021 1,340 $ 2,816.10 6.55 $ — |
Schedule of option pricing model with the following weighted-average assumptions | December 31, 2022 2021 Contractual term (in years) 6.5 9 10 Volatility 90.9 % 88.7 % Risk-free interest rate 1.12 % 1.29 % Dividend yield — % — % |
Schedule of stock-based compensation expense | Year Ending December 31, 2022 2021 Research and development $ 106,466 $ 640,244 General and administrative 662,658 730,826 Total stock-based compensation expense $ 769,124 $ 1,371,070 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Schedule of Weighted-average remaining lease term and weighted-average discount rate under operating leases | December 31, 2022 Lease term and discount rate Weighted-average remaining lease term 3.7 years Weighted-average discount rate 7.00 % |
Schedule of Maturities of operating lease liabilities | Maturities of operating lease liabilities at December 31, 2022 were as follows: 2023 $ 83,691 2024 86,202 2025 88,788 2026 60,593 Total lease payments 319,274 Less imputed interest (39,063) Present value of lease liabilities $ 280,211 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of significant components of the Company's net deferred tax assets and liabilities | December 31, 2022 2021 Gross deferred tax assets: Net operating loss carry-forwards $ 18,916,000 $ 30,576,000 Stock compensation 733,000 112,000 Accruals — 30,000 Change in accounts payable — 138,000 Intangible assets 5,708,000 791,000 Capitalized research and development 2,022,000 — Research and development credits 1,715,000 — Unrealized loss 318,000 — Other 102,000 — Deferred tax assets before valuation allowance $ 29,514,000 $ 31,647,000 Valuation allowance (29,450,000) (31,647,000) Deferred tax assets net of valuation allowance $ 64,000 $ — Gross deferred tax liabilities: Right of use asset (64,000) — Total deferred tax liability $ (64,000) $ — Total deferred tax asset, net $ — $ — |
Schedule of reconciliation of income taxes computed using the federal statutory income tax rate and the Company's effective tax rate | December 31, 2022 2021 Income tax benefit (expense) at statutory rate 21.0 % 21.0 % State income tax 4.9 % 4.2 % Non-deductible expense 8.7 % (10.3) % Change in valuation allowance 14.6 % (9.5) % Prior year adjustments (7.7) % (4.7) % Dissolution of foreign subsidiary (45.9) % — % Other 4.4 % (0.7) % Total income tax benefit (expense) 0.0 % 0.0 % |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) | 12 Months Ended | ||||
Mar. 12, 2023 USD ($) | Jan. 18, 2023 | Sep. 13, 2021 | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Company and basis of presentation | |||||
Cash and cash equivalents | $ 1,362,910 | $ 8,248,684 | |||
Accumulated deficit | $ (168,533,689) | $ (153,904,047) | |||
Reverse stock split ratio | 0.10 | 30 | 10 | ||
Ratio of reduction in number of authorized shares of common stock | 10 | ||||
Subsequent events | |||||
Company and basis of presentation | |||||
Reverse stock split ratio | 7 | ||||
March 2023 Purchase Agreement | |||||
Company and basis of presentation | |||||
Proceeds from issuance of shares | $ 4,000,000 | ||||
March 2023 Purchase Agreement | Subsequent events | |||||
Company and basis of presentation | |||||
Proceeds from issuance of shares | $ 4,000,000 |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Details) | 1 Months Ended | 12 Months Ended | |||||||||
Jan. 18, 2023 shares | Nov. 30, 2022 USD ($) | Sep. 29, 2022 USD ($) | Aug. 26, 2022 shares | Jul. 29, 2022 USD ($) | May 19, 2022 USD ($) | Sep. 13, 2021 USD ($) shares | Jul. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | |
Significant accounting policies and recent accounting pronouncements | |||||||||||
Number of shares reduced due to reverse stock split | shares | 7 | 30 | 10 | 30 | 10 | ||||||
Restricted cash | $ 22,000 | $ 0 | |||||||||
Cash in US banks in excess of FDIC insurance limits | 900,000 | 7,600,000 | |||||||||
Intangible asset impairment | 2,351,988 | ||||||||||
Uncertain tax positions | 0 | $ 0 | |||||||||
Asset impairment charges | $ 0 | ||||||||||
Reverse stock split ratio | 0.10 | 30 | 10 | ||||||||
First Wave License Agreement [Member] | |||||||||||
Significant accounting policies and recent accounting pronouncements | |||||||||||
Asset acquisition consideration transferred | $ 13,300,000 | ||||||||||
Payments to acquire intangible assets | 10,300,000 | ||||||||||
Cash consideration | $ 3,000,000 | $ 3,000,000 | |||||||||
Asset acquisition total purchase price | 22,000,000 | ||||||||||
First Wave Bio Inc [Member] | |||||||||||
Significant accounting policies and recent accounting pronouncements | |||||||||||
Asset acquisition consideration transferred | $ 2,000,000 | $ 1,000,000 | $ 1,500,000 | 6,900,000 | $ 7,000,000 | ||||||
Cash consideration | $ 4,000,000 | $ 1,500,000 | |||||||||
Asset acquisition, consideration transferred, contingent consideration | $ 4,000,000 | ||||||||||
Asset acquisition total purchase price | 22,000,000 | ||||||||||
Payments made | $ 3,000,000 | ||||||||||
First Wave Bio Inc [Member] | Former Stockholders [Member] | |||||||||||
Significant accounting policies and recent accounting pronouncements | |||||||||||
Initial payment | 1,500,000 | ||||||||||
Second payment | $ 1,000,000 | ||||||||||
Upfront payment paid | 1,500,000 | ||||||||||
Second payment paid | 1,000,000 | ||||||||||
Third payment paid | 2,000,000 | ||||||||||
Extinguishment of remaining fixed payment obligations | 10,100,000 | ||||||||||
Third payment recorded as expense | $ 2,000,000 | ||||||||||
Payments made | $ 4,500,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair value disclosures | ||
Money market funds | $ 1,362,910 | $ 8,248,684 |
Note payable | 603,494 | 641,236 |
Carrying Amount | ||
Fair value disclosures | ||
Note payable | 603,494 | 641,236 |
Fair Value, Inputs, Level 2 | ||
Fair value disclosures | ||
Note payable | 603,494 | 641,236 |
Money Market Funds | ||
Fair value disclosures | ||
Money market funds | 509,890 | 551,489 |
Money Market Funds | Carrying Amount | ||
Fair value disclosures | ||
Money market funds | 509,890 | 501,607 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair value disclosures | ||
Money market funds | $ 509,890 | $ 501,607 |
Asset Acquisition (Details)
Asset Acquisition (Details) - USD ($) | 1 Months Ended | 8 Months Ended | 11 Months Ended | 12 Months Ended | |||||||||||
Nov. 30, 2022 | Sep. 29, 2022 | Jul. 29, 2022 | May 19, 2022 | Nov. 15, 2021 | Oct. 29, 2021 | Sep. 13, 2021 | Nov. 30, 2022 | Jul. 31, 2022 | Mar. 31, 2022 | Aug. 31, 2022 | Jul. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 10, 2021 | |
Asset Acquisition | |||||||||||||||
Stock cancelled during period, shares, acquisitions (in shares) | 5 | ||||||||||||||
Shares issued price per share (in dollars per share) | $ 2,672.25 | ||||||||||||||
First Wave Bio Inc | |||||||||||||||
Asset Acquisition | |||||||||||||||
Payment to acquire | $ 3,000,000 | ||||||||||||||
Asset acquired equity issued (in shares) | 2,971 | ||||||||||||||
Cash consideration | $ 4,000,000 | $ 1,500,000 | |||||||||||||
Asset acquisition consideration transferred liabilities incurred | $ 8,000,000 | $ 7,000,000 | |||||||||||||
Maximum term for the payment of purchase price | 45 days | ||||||||||||||
Asset acquisition total purchase price | $ 22,000,000 | ||||||||||||||
Asset acquisition, potential milestone payments | $ 10,100,000 | $ 2,000,000 | |||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Asset acquisition consideration transferred | $ 2,000,000 | $ 1,000,000 | $ 1,500,000 | 6,900,000 | 7,000,000 | ||||||||||
Asset acquisition, consideration transferred, contingent consideration | $ 4,000,000 | ||||||||||||||
Asset acquired equity issued (in shares) | 2,971 | ||||||||||||||
Shares issued price per share (in dollars per share) | $ 1,346.10 | ||||||||||||||
First Wave Bio Inc | Research and development | |||||||||||||||
Asset Acquisition | |||||||||||||||
Non-contingent purchase price | 21,300,000 | ||||||||||||||
First Wave Bio Inc | General and administrative expense | |||||||||||||||
Asset Acquisition | |||||||||||||||
Consideration transaction cost | $ 900,000 | ||||||||||||||
First Wave Bio Inc | Former Stockholders | |||||||||||||||
Asset Acquisition | |||||||||||||||
Payment to acquire | $ 4,500,000 | ||||||||||||||
Awarded to other party | $ 8,000,000 | ||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
First Wave Bio Inc | Development Achievement Threshold | |||||||||||||||
Asset Acquisition | |||||||||||||||
Asset acquisition, potential milestone payments | $ 207,000,000 | ||||||||||||||
Percentage of cash milestone payments | 25% | ||||||||||||||
First Wave Bio Inc | Patent Infringement | |||||||||||||||
Asset Acquisition | |||||||||||||||
Percentage of cash consideration | 10% | ||||||||||||||
First Wave Bio Inc | Settlement Agreement | |||||||||||||||
Asset Acquisition | |||||||||||||||
Awarded to other party | $ 15,000,000 | ||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Payment of periodic installments | $ 500,000 | ||||||||||||||
Percentage of amount on the transactions consummated by the company | 10% | ||||||||||||||
Stock cancelled during period, shares, acquisitions (in shares) | 332,913 | ||||||||||||||
Specified amount of transactions for applying percentage | $ 10,000,000 | ||||||||||||||
First Wave Bio Inc | Settlement Agreement | Forecast | |||||||||||||||
Asset Acquisition | |||||||||||||||
Payment of periodic installments | $ 1,000,000 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements - Property (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Equipment and Leasehold Improvements | ||
Total property, plant, and equipment | $ 87,818 | $ 87,818 |
Less accumulated depreciation | (43,979) | (14,708) |
Property, plant and equipment, net | 43,839 | 73,110 |
Depreciation expense | 29,000 | 15,000 |
Computer equipment and software | ||
Property, Equipment and Leasehold Improvements | ||
Total property, plant, and equipment | 11,540 | 11,540 |
Office equipment | ||
Property, Equipment and Leasehold Improvements | ||
Total property, plant, and equipment | 48,278 | 48,278 |
Leasehold improvements | ||
Property, Equipment and Leasehold Improvements | ||
Total property, plant, and equipment | $ 28,000 | $ 28,000 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Patents (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2019 |
Patents | |||
Patents | $ 3,802,745 | ||
Common stock issued at signing to Mayoly | |||
Patents | |||
Patents | $ 1,740,959 | ||
Due to Mayoly | |||
Patents | |||
Patents | $ 393,120 | $ 449,280 | |
Assumed Mayoly liabilities and forgiveness of Mayoly debt | |||
Patents | |||
Patents | $ 1,219,386 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Intangible Assets (Details) | Dec. 31, 2021 USD ($) |
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) | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Intangible Assets and Goodwill | |
Amortization expense | $ 528,000 |
Intangible asset impairment | $ 2,351,988 |
Intangible Assets and Goodwil_5
Intangible Assets and Goodwill - Goodwill (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Intangible Assets and Goodwill | ||
Balance | $ 1,911,705 | $ 2,054,048 |
Foreign currency translation | (227,523) | (142,343) |
Balance | $ 1,684,182 | $ 1,911,705 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Professional fees | $ 309,867 | $ 15,000 |
Clinical trials | 5,340 | |
Consulting | 4,969 | 104,100 |
Payroll and benefits | 274,153 | |
Total accrued expenses | $ 320,176 | $ 393,253 |
Note Payable (Details)
Note Payable (Details) - USD ($) | Nov. 30, 2022 | Nov. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 |
Note Payable | ||||
Notes payable balance | $ 603,000 | $ 641,000 | ||
Financing Agreement for Directors and Officer's and Other Liability Insurances | ||||
Note Payable | ||||
Debt instrument, term | 9 months | 9 months | ||
Debt instrument, face amount | $ 677,000 | $ 957,000 | ||
Debt instrument, interest Rate | 6.79% | 3.99% | ||
Debt instrument, periodic payment | $ 77,000 | $ 81,000 |
Capital Stock (Details)
Capital Stock (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||||||||||||||||||
Jan. 18, 2023 shares | Nov. 25, 2022 USD ($) Vote $ / shares | Nov. 22, 2022 $ / shares shares | Oct. 11, 2022 $ / shares shares | Aug. 26, 2022 $ / shares shares | Jul. 15, 2022 USD ($) $ / shares shares | May 24, 2022 shares | May 12, 2022 $ / shares shares | Mar. 02, 2022 USD ($) $ / shares shares | Sep. 13, 2021 shares | Jul. 22, 2021 USD ($) $ / shares shares | May 26, 2021 shares | Mar. 10, 2021 USD ($) $ / shares shares | Jan. 06, 2021 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Nov. 30, 2022 USD ($) $ / shares | Oct. 31, 2022 USD ($) $ / shares shares | Jan. 31, 2021 $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) D $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) shares | Mar. 12, 2023 $ / shares | Dec. 05, 2022 $ / shares | Nov. 28, 2022 shares | Jul. 31, 2022 $ / shares | Mar. 31, 2022 $ / shares | Feb. 07, 2022 USD ($) | Jan. 16, 2021 shares | Jul. 20, 2020 shares | Jul. 16, 2020 shares | |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | ||||||||||||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 10,000,000 | 10,000,000 | |||||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||||||||||||||||||||||||||||
Number of shares reduced due to reverse stock split | 7 | 30 | 10 | 30 | 10 | ||||||||||||||||||||||||||||
Common stock, shares, issued, total (in shares) | 995,003 | 995,003 | 70,742 | ||||||||||||||||||||||||||||||
Common stock, shares, outstanding, ending balance (in shares) | 995,003 | 995,003 | 70,742 | ||||||||||||||||||||||||||||||
Purchase of aggregate common stock | 2,179,798 | 2,179,798 | 26,089 | 12,254 | |||||||||||||||||||||||||||||
Deemed dividend on warrant modifications | $ | $ (47,000) | $ (47,000) | $ (47,300) | ||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 571 | ||||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 14,883 | ||||||||||||||||||||||||||||||||
Stock issued during period, value, new issues | $ | $ 7,691,221 | $ 18,506,814 | |||||||||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 2,761 | ||||||||||||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 2,672.25 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Preferred Stock, Remaining Authorized but Unissued (in shares) | 9,999,449.83 | 9,999,449.83 | |||||||||||||||||||||||||||||||
Reverse stock split ratio | 0.10 | 30 | 10 | ||||||||||||||||||||||||||||||
Pre-funded warrants to purchase of common stock | 980 | ||||||||||||||||||||||||||||||||
Stock Cancelled During Period, Shares, Acquisitions (in shares) | 5 | ||||||||||||||||||||||||||||||||
Number of shares cancelled | 12 | ||||||||||||||||||||||||||||||||
Common stock and warrants issued to consultants | $ | $ 200,490 | ||||||||||||||||||||||||||||||||
Subsequent Event | |||||||||||||||||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||||||||||||||||||||||
Reverse stock split ratio | 7 | ||||||||||||||||||||||||||||||||
FWB | |||||||||||||||||||||||||||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | 1,386 | ||||||||||||||||||||||||||||||||
Class of Warrant or Rights, Investor and Pre_funded Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 21 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 1,871 | ||||||||||||||||||||||||||||||||
January 2021 Investor Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1,680 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 5,079 | ||||||||||||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 3,400,000 | ||||||||||||||||||||||||||||||||
January 2021 Placement Agent Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1,968.75 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 354 | ||||||||||||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 1,575 | ||||||||||||||||||||||||||||||||
Percentage Of Common Stock Issued In Offering | 7% | ||||||||||||||||||||||||||||||||
March 2022 Pre-Funded warrants | |||||||||||||||||||||||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 23,087 | ||||||||||||||||||||||||||||||||
Par value per warrant | $ / shares | $ 2.10 | ||||||||||||||||||||||||||||||||
The March 2021 Offering | |||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 9,100,000 | ||||||||||||||||||||||||||||||||
March 2021 Placement Agent Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 3,340.26 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 261 | ||||||||||||||||||||||||||||||||
Equity Offering, Price Per Share (in dollars per share) | $ / shares | $ 2,672.25 | ||||||||||||||||||||||||||||||||
Percentage of warrants issued | 7% | ||||||||||||||||||||||||||||||||
Percentage of exercise price of warrants | 125% | ||||||||||||||||||||||||||||||||
October 2022 Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 414,286 | ||||||||||||||||||||||||||||||||
Par value per warrant | $ / shares | $ 0.001 | ||||||||||||||||||||||||||||||||
Waiver | |||||||||||||||||||||||||||||||||
Purchase of aggregate common stock | 1,196 | ||||||||||||||||||||||||||||||||
Waiver | Common Stock Warrants [Member] | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 52.50 | ||||||||||||||||||||||||||||||||
Series C Preferred Stock Converted into Common Stock | |||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 33,097.10 | ||||||||||||||||||||||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 24,700,000 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 198,000 | ||||||||||||||||||||||||||||||||
Series B Preferred Stock Exchanged for Common Shares | |||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 112.08 | 13.80 | |||||||||||||||||||||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 863,000 | $ 100,000 | |||||||||||||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 129,000 | $ 8,000 | |||||||||||||||||||||||||||||||
Series B Preferred Stock Exchanged for Common Shares | March 2022 Warrants | |||||||||||||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 2,234 | ||||||||||||||||||||||||||||||||
Consultants [Member] | |||||||||||||||||||||||||||||||||
Stock Issued During Period, Shares, Issued for Services (in shares) | 573 | ||||||||||||||||||||||||||||||||
Stock Issued During Period, Shares, Settlement (in shares) | 582 | ||||||||||||||||||||||||||||||||
Stock Issued During Period, Value, Settlement | $ | $ 1,300,000 | ||||||||||||||||||||||||||||||||
Common stock and warrants issued to consultants | $ | $ 200,000 | ||||||||||||||||||||||||||||||||
Officers and Directors | Waiver | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 69.174 | ||||||||||||||||||||||||||||||||
H C Wainwright Co L L C | |||||||||||||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | 19,200,000 | ||||||||||||||||||||||||||||||||
Former Investor Bank | |||||||||||||||||||||||||||||||||
Stock Issued During Period, Value, Settlement | $ | $ 94,000 | ||||||||||||||||||||||||||||||||
Shares issued for settlement (in shares) | 35 | ||||||||||||||||||||||||||||||||
The 2014 Omnibus Equity Incentive Plan [Member] | |||||||||||||||||||||||||||||||||
Canceled | 298 | 632 | |||||||||||||||||||||||||||||||
At The Market Offering Agreement | |||||||||||||||||||||||||||||||||
Stock issued during period, value, new issues | $ | $ 18,500,000 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 217,036 | 25,396 | |||||||||||||||||||||||||||||||
Net proceeds | $ | $ 7,700,000 | ||||||||||||||||||||||||||||||||
At The Market Offering Agreement | Wainwright | |||||||||||||||||||||||||||||||||
Stock Sales Agreement, Commission on Shares Sold, Percentage | 3% | ||||||||||||||||||||||||||||||||
Stock Sales Agreement, Number of Shares Authorized (in shares) | 8,000,000 | 50,000,000 | |||||||||||||||||||||||||||||||
Market Agreement | H C Wainwright Co L L C | |||||||||||||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | 8,000,000 | ||||||||||||||||||||||||||||||||
Stock issuance costs | $ | $ 309,000 | $ 601,000 | |||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 217,036 | 25,396 | |||||||||||||||||||||||||||||||
January 2021 Offering [Member] | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 3,109 | ||||||||||||||||||||||||||||||||
Offering costs | $ | 900,000 | ||||||||||||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | 7,100,000 | $ 7,100,000 | |||||||||||||||||||||||||||||||
March 2022 Offering [Member] | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 5.901 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 7,857 | ||||||||||||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 264.60 | ||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 8,000,000 | ||||||||||||||||||||||||||||||||
March 2022 Registered Direct Offering | |||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 7,857 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Purchase price of warrants | $ / shares | $ 288.75 | ||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 8,000,000 | ||||||||||||||||||||||||||||||||
Public offering price for each share of Common Stock and accompanying warrant | $ / shares | $ 290.85 | ||||||||||||||||||||||||||||||||
March 2022 Registered Direct Offering | March 2022 Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 264.60 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 30,943 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||||||||||||||||||||||||
March 2022 Registered Direct Offering | Pre-Funded Warrant | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 363.30 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 1,856 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||||||||||||||||||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 6% | ||||||||||||||||||||||||||||||||
March 2022 Registered Direct Offering | March 2022 Pre-Funded warrants | |||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||||||||||||||||||||||||
March 2022 Registered Direct Offering | November 2022 Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 23,086 | ||||||||||||||||||||||||||||||||
November 2022 Private Placement | |||||||||||||||||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||||||||||||||||||||||
Percentage of cash fees paid to placement agent | 7% | ||||||||||||||||||||||||||||||||
Purchase price of warrants | $ / shares | $ 4.1993 | ||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 2,200,000 | ||||||||||||||||||||||||||||||||
November 2022 Private Placement | November 2022 Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.0007 | ||||||||||||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights, Contingently Issuable (in shares) | 595,239 | ||||||||||||||||||||||||||||||||
November 2022 Private Placement | November 2022 Common Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 5.3795 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 1,190,477 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years 6 months | ||||||||||||||||||||||||||||||||
October 2022 Offering | |||||||||||||||||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||||||||||||||||||||||
Percentage of cash fees paid to placement agent | 7% | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 36,428 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||||||||||||||||||||||||
Purchase price of warrants | $ / shares | $ 12.2143 | ||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 5,200,000 | ||||||||||||||||||||||||||||||||
Public offering price for each share of Common Stock and accompanying warrant | $ / shares | $ 12.215 | ||||||||||||||||||||||||||||||||
October 2022 Offering | October 2022 Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | 0.0007 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 454,770 | ||||||||||||||||||||||||||||||||
October 2022 Offering | October 2022 Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 11.34 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Number of common stock shares called by each warrant (in shares) | 491,199 | ||||||||||||||||||||||||||||||||
July 2021 offering | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 346 | ||||||||||||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 5,100,000 | ||||||||||||||||||||||||||||||||
Underwriting option | 30 days | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 649 | ||||||||||||||||||||||||||||||||
July 2021 offering | Wainwright Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1,443.75 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 125% | ||||||||||||||||||||||||||||||||
July 2021 offering | Wainwright | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 348 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 4,329 | ||||||||||||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 1,155 | ||||||||||||||||||||||||||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 7% | ||||||||||||||||||||||||||||||||
Non-accountable Expenses | $ | $ 35,000 | ||||||||||||||||||||||||||||||||
Legal Fees | $ | 125,000 | ||||||||||||||||||||||||||||||||
Clearance Fees | $ | $ 15,950 | ||||||||||||||||||||||||||||||||
Underwriting discount | 8% | ||||||||||||||||||||||||||||||||
July 2022 Private Placement | |||||||||||||||||||||||||||||||||
Gross proceeds from private placement | $ | $ 200,000 | ||||||||||||||||||||||||||||||||
Percentage of cash fees paid to placement agent | 7% | ||||||||||||||||||||||||||||||||
July 2022 Private Placement | Placement Agent Warrants | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 571 | ||||||||||||||||||||||||||||||||
March 2021 and July 2021 Offering | |||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 7,741 | ||||||||||||||||||||||||||||||||
Warrant [Member] | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercised during period (in shares) | 4,530 | ||||||||||||||||||||||||||||||||
Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercised during period (in shares) | 1,900 | ||||||||||||||||||||||||||||||||
Pre-Funded Warrants | November 2022 Pre-Funded Warrants | |||||||||||||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 165,765 | ||||||||||||||||||||||||||||||||
Par value per warrant | $ / shares | $ 0.001 | ||||||||||||||||||||||||||||||||
Series B preferred stock | |||||||||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 5,194.81 | 5,194.81 | 5,194.81 | 5,194.81 | |||||||||||||||||||||||||||||
Preferred stock, shares remaining | 2,282.23 | ||||||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||||||
Preferred stock, shares issued, total (in shares) | 550.17 | 550.17 | 662.25 | ||||||||||||||||||||||||||||||
Preferred stock, stated value per share (in dollars per share) | $ / shares | $ 7,700 | $ 7,700 | |||||||||||||||||||||||||||||||
Preferred stock, dividend rate, percentage | 9% | ||||||||||||||||||||||||||||||||
Aggregate dividends payable | $ | $ 761,000 | $ 465,000 | |||||||||||||||||||||||||||||||
Value of liquidation preference | $ | $ 5,000,000 | $ 5,000,000 | $ 5,600,000 | ||||||||||||||||||||||||||||||
Threshold percentage by which the closing sale price of common stock exceeds the conversion price, considered for automatic conversion of preferred stock | 250% | ||||||||||||||||||||||||||||||||
Threshold closing sale price of common stock, considered for automatic conversion of preferred stock | $ / shares | $ 4,042.50 | ||||||||||||||||||||||||||||||||
Threshold consecutive trading days, considered for automatic conversion of preferred stock | D | 20 | ||||||||||||||||||||||||||||||||
Beneficial ownership percentage already held by the stockholder and its affiliates | 9.99% | 9.99% | |||||||||||||||||||||||||||||||
Threshold maximum beneficial ownership percentage that can be held by stockholder and its affiliates | 19.99% | 19.99% | |||||||||||||||||||||||||||||||
Exchange Amount | $ | $ 7,700 | $ 7,700 | |||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 9,055 | ||||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 1,839.76 | ||||||||||||||||||||||||||||||||
Preferred stock, dividends, payment of fractional shares amount | $ | $ 100 | ||||||||||||||||||||||||||||||||
Preferred Stock, Liquidation Preference, Value | $ | $ 5,000,000 | $ 5,000,000 | $ 5,600,000 | ||||||||||||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 1,617 | $ 1,617 | |||||||||||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 1,229 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 258.08 | ||||||||||||||||||||||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 2,000,000 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 3,000 | ||||||||||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 550.17 | 631.34 | 631.34 | 550.17 | 662.25 | ||||||||||||||||||||||||||||
Series B preferred stock | Waiver | |||||||||||||||||||||||||||||||||
Value of preferred stock agreed to be waived with holders of preferred stock | $ | $ 2,880,000 | $ 2,880,000 | |||||||||||||||||||||||||||||||
Value of preferred stock agreed to be waived with insiders | $ | $ 47,000 | ||||||||||||||||||||||||||||||||
Waiver fee paid | $ | $ 233,000 | ||||||||||||||||||||||||||||||||
Percentage of outstanding shares | 81.30% | ||||||||||||||||||||||||||||||||
Series B preferred stock | Series B Preferred Stock Exchanged for Common Shares | |||||||||||||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 159 | ||||||||||||||||||||||||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | |||||||||||||||||||||||||||||||||
Exchange Amount | $ | $ 14,400,000 | $ 14,400,000 | |||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 9,058 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 1,839.76 | ||||||||||||||||||||||||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | Investor warrants | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 9,058 | 9,058 | |||||||||||||||||||||||||||||||
Series B Preferred Stock convertible into common stock with no warrants | |||||||||||||||||||||||||||||||||
Exchange Amount | $ | $ 841,000 | $ 841,000 | |||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 1,482 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 94.970 | ||||||||||||||||||||||||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants [Member] | |||||||||||||||||||||||||||||||||
Exchange Amount | $ | $ 265,000 | $ 265,000 | |||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 909 | ||||||||||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 30.91 | ||||||||||||||||||||||||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants [Member] | March 2022 Warrants | |||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 909 | 909 | |||||||||||||||||||||||||||||||
Series C preferred stock | |||||||||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 75,000 | 75,000 | 75,000 | 75,000 | |||||||||||||||||||||||||||||
Preferred stock, shares remaining | 41,903 | ||||||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | |||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 19,140.14 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 9,058 | ||||||||||||||||||||||||||||||||
Deemed dividends on preferred stock issuances | $ | 4,500,000 | $ 21,000,000 | |||||||||||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 4,600,000 | ||||||||||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||||||||||||||||||||||
Series C preferred stock | January 2021 Placement Agent Warrants | |||||||||||||||||||||||||||||||||
Percentage of effective purchase price per share of preferred stock | 125% | ||||||||||||||||||||||||||||||||
Series C preferred stock | January 2021 Registered Direct Offering | |||||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 2,539 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 5,333.33 | ||||||||||||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 750 | ||||||||||||||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 1,575 | ||||||||||||||||||||||||||||||||
Series C preferred stock | January 2021 Private Placement | |||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 5,333.33 | ||||||||||||||||||||||||||||||||
Series C preferred stock | July 2022 Private Placement | |||||||||||||||||||||||||||||||||
Number of common shares issuable upon conversion | 4,761 | ||||||||||||||||||||||||||||||||
Series D preferred stock | |||||||||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 150 | 150 | 150 | 150 | 150 | ||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||||||||||||
Series D preferred stock | July 2022 Private Placement | |||||||||||||||||||||||||||||||||
Preferred stock, stated value per share (in dollars per share) | $ / shares | $ 1,000 | ||||||||||||||||||||||||||||||||
Number of common shares issuable upon conversion | 4,761 | ||||||||||||||||||||||||||||||||
Number of common stock shares called by warrants (in shares) | 9,522 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 150 | ||||||||||||||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 31.50 | ||||||||||||||||||||||||||||||||
Series E preferred stock | |||||||||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 150 | 150 | 150 | 150 | 150 | ||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||||||||||||
Series E preferred stock | July 2022 Private Placement | |||||||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 1,000 | ||||||||||||||||||||||||||||||||
Number of shares reduced due to reverse stock split | 4,761 | ||||||||||||||||||||||||||||||||
Number of common shares issuable upon conversion | 4,761 | ||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 31.50 | ||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 150 | ||||||||||||||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | ||||||||||||||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 31.50 | ||||||||||||||||||||||||||||||||
Series F Preferred Stock | |||||||||||||||||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 7,000 | 7,000 | 7,000 | 7,000 | |||||||||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | 0 | 0 | |||||||||||||||||||||||||||||
Dividends declared in shares per common stock | $ / shares | $ 0.001 | ||||||||||||||||||||||||||||||||
Number of votes per share | Vote | 1,000,000 | ||||||||||||||||||||||||||||||||
Number of votes per 0.001 share | Vote | 1,000 | ||||||||||||||||||||||||||||||||
Amount of cash per outstanding share that each shareholder is entitled upon dissolution | $ | $ 0.0001 | ||||||||||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | ||||||||||||||||||||||||||||||
Series D Preferred Shares and Series E Preferred Shares | |||||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 9,522 | ||||||||||||||||||||||||||||||||
Series D Preferred Shares and Series E Preferred Shares | July 2022 Private Placement | |||||||||||||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 9,522 | ||||||||||||||||||||||||||||||||
Common Stock | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 2,541 | ||||||||||||||||||||||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 4,503 | ||||||||||||||||||||||||||||||||
Common Stock | March 2022 Registered Direct Offering | Pre-Funded Warrant | |||||||||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 2.10 | ||||||||||||||||||||||||||||||||
October 2022 Offering | |||||||||||||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 76,913 | ||||||||||||||||||||||||||||||||
Net proceeds | $ | $ 5,200,000 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 30, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 10, 2021 | Jan. 31, 2021 | |
Number of Warrants | ||||||||
Warrants outstanding and exercisable, beginning (in shares) | 26,089 | 12,254 | ||||||
Issued (in shares) | 2,757,521 | 18,958 | ||||||
Expired (in shares) | (674) | (623) | ||||||
Exercised (in shares) | (603,138) | (4,500) | ||||||
Warrants outstanding and exercisable, ending (in shares) | 2,179,798 | 26,089 | 12,254 | |||||
Weighted Average Exercise Price Per Share | ||||||||
Warrants outstanding and exercisable, beginning (in dollars per share) | $ 1,992.90 | $ 2,562 | ||||||
Issued (in dollars per share) | 3.75 | 1,630.83 | ||||||
Expired (in dollars per share) | 1,102.85 | 7,056.03 | ||||||
Exercised (in dollars per share) | 0.08 | 1,109.29 | ||||||
Warrants outstanding and exercisable, ending (in dollars per share) | $ 19.16 | $ 1,992.90 | $ 2,562 | |||||
Weighted Average Remaining Term in Years | ||||||||
Outstanding and exercisable (in years) | 5 years 6 months | 3 years 11 months 12 days | 4 years 14 days | |||||
Issued (in years) | 5 years 4 months 24 days | 3 years 10 months 20 days | ||||||
Exercised (in years) | 5 years 4 months 9 days | 3 years 10 months 6 days | ||||||
Weighted average fair value of warrants granted (in dollars per share) | $ 204.52 | $ 1,812.30 | ||||||
Warrants to purchase of stock | 571 | |||||||
Shares issued, price per share (in dollars per share) | $ 2,672.25 | |||||||
Warrant amendment agreement | ||||||||
Weighted Average Remaining Term in Years | ||||||||
Warrant exercise price | $ 172.79 | $ 2,541 | $ 1,680 | |||||
Consideration for purchase of securities | $ 2.5 | |||||||
January 2021 offering | ||||||||
Weighted Average Remaining Term in Years | ||||||||
Warrants to purchase of stock | 3,109 | |||||||
March 2022 offering | ||||||||
Weighted Average Remaining Term in Years | ||||||||
Warrant exercise price | $ 5.901 | |||||||
Consideration for purchase of securities | $ 9 | |||||||
Shares issued, price per share (in dollars per share) | $ 264.60 | |||||||
Maximum | Warrant amendment agreement | ||||||||
Weighted Average Remaining Term in Years | ||||||||
Warrants to purchase of stock | 533,858 | 1,872 | 5,080 | |||||
Existing warrants | Warrant amendment agreement | ||||||||
Weighted Average Remaining Term in Years | ||||||||
Warrant exercise price | $ 5.3795 |
Warrants - Schedule of weighted
Warrants - Schedule of weighted average assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants | ||
Expected life (in years) | 5 years 14 days | 4 years 4 months 17 days |
Volatility | Minimum | ||
Warrants | ||
Measurement input | 0.920 | 0.838 |
Volatility | Maximum | ||
Warrants | ||
Measurement input | 1.016 | 0.908 |
Risk-free interest rate | Minimum | ||
Warrants | ||
Measurement input | 0.0174 | 0.0036 |
Risk-free interest rate | Maximum | ||
Warrants | ||
Measurement input | 0.0414 | 0.0090 |
Dividend yield | ||
Warrants | ||
Measurement input | 0 | 0 |
Warrants - Series B, Pre-funded
Warrants - Series B, Pre-funded and Placement agent Warrants (Details) - $ / shares | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Warrants | |||
Warrants to purchase of stock | 571 | ||
Series B preferred stock | |||
Warrants | |||
Warrants to purchase of stock | 9,055 | ||
January 2021 Offering [Member] | |||
Warrants | |||
Warrants to purchase of stock | 3,109 | ||
March 2022 Offering [Member] | |||
Warrants | |||
Warrant exercise price | $ 5.901 | ||
July 2022 offering | |||
Warrants | |||
Warrants to purchase of stock | 9,524 | ||
July 2022 offering | Series B preferred stock | |||
Warrants | |||
Warrants to purchase of stock | 910 | ||
July 2021 offering | |||
Warrants | |||
Warrants to purchase of stock | 346 | ||
Warrants, pre-funded warrants, and placement agent warrants | |||
Warrants | |||
Warrants to purchase of stock | 6,353 | ||
Warrants, pre-funded warrants, and placement agent warrants | March 2022 Offering [Member] | |||
Warrants | |||
Warrants to purchase of stock | 55,885 | ||
Warrants, pre-funded warrants, and placement agent warrants | October 2022 Offering | |||
Warrants | |||
Warrants to purchase of stock | 905,486 | ||
Warrants, pre-funded warrants, and placement agent warrants | November 2022 Offering | |||
Warrants | |||
Warrants to purchase of stock | 1,785,716 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional information (Details) - USD ($) | 12 Months Ended | |||
Jan. 01, 2023 | Sep. 11, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Incentive Plan | ||||
Unrecognized stock-based compensation expense | $ 800,000 | $ 1,100,000 | ||
Weighted average fair value of stock options granted per share | $ 223.68 | $ 1,398.16 | ||
Remaining Term | ||||
Equity Incentive Plan | ||||
Unrecognized stock-based compensation expense | $ 300,000 | $ 900,000 | ||
Average remaining vesting term of the stock options (in years) | 8 years 5 months 26 days | 1 year 10 months 6 days | ||
Clinical, corporate milestones | ||||
Equity Incentive Plan | ||||
Unrecognized stock-based compensation expense | $ 500,000 | $ 200,000 | ||
Incentive Stock Options | ||||
Equity Incentive Plan | ||||
Granted (in shares) | 7,142 | |||
Restricted Stock | ||||
Equity Incentive Plan | ||||
Aggregate unrecognized restricted Common Stock expense | $ 388,000 | 388,000 | ||
Stock options subject to service-based milestone vesting conditions | ||||
Equity Incentive Plan | ||||
Total fair value of stock options vested | 769,000 | 552,000 | ||
Stock options subject to performance-based milestone vesting conditions | ||||
Equity Incentive Plan | ||||
Total fair value of stock options vested | $ 0 | $ 623,000 | ||
2020 Equity Incentive Plan | ||||
Equity Incentive Plan | ||||
Shares available under equity incentive plan (in shares) | 324,325 | 4,761 | 10,068 | |
Percentage of common stock reserved for issuance equity incentive plan | 10% | |||
Options to purchase shares of common stock (in shares) | 3,241 | |||
Shares reserved subject to issuance (in shares) | 6,827 | |||
Shares of common stock available for issuance increased by | 317,498 | |||
Options cancelled | 257 | 40 | ||
Omnibus Equity Incentive Plan | ||||
Equity Incentive Plan | ||||
Shares available under equity incentive plan (in shares) | 1,477 | |||
Options to purchase shares of common stock (in shares) | 695 | |||
Shares reserved subject to issuance (in shares) | 283 | |||
Options cancelled | 298 | 632 |
Equity Incentive Plan - Stock o
Equity Incentive Plan - Stock option activity (Details) - Incentive Stock Options - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numbers of Shares | |||
Granted (in shares) | 7,142 | ||
Equity Incentive Plan | |||
Numbers of Shares | |||
Outstanding at beginning (in shares) | 1,941 | 1,788 | |
Granted (in shares) | 3,266 | 825 | |
Canceled (in shares) | (555) | ||
Forfeited (in shares) | (716) | (672) | |
Outstanding at ending (in shares) | 3,936 | 1,941 | 1,788 |
Exercisable (in shares) | 2,153 | 1,340 | |
Average Exercise Price | |||
Outstanding at beginning (in dollars per share) | $ 2,470.99 | $ 2,616.60 | |
Granted (in dollars per share) | 288.19 | 1,808.10 | |
Canceled (in dollars per share) | 2,478.29 | ||
Forfeited (in dollars per share) | 904.99 | 2,198.70 | |
Outstanding at ending (in dollars per share) | 958.14 | 2,470.99 | $ 2,616.60 |
Exercisable (in dollars per share) | $ 1,354.72 | $ 2,816.10 | |
Remaining Contract Life (Years) | |||
Stock option outstanding, remaining contractual life (Years) | 8 years 2 months 19 days | 7 years 3 months 10 days | 7 years 11 months 8 days |
Granted (in years) | 7 years 2 months 23 days | 8 years 3 months 25 days | |
Canceled (in years) | 0 years | 0 years | |
Forfeited (in years) | 0 years | ||
Exercisable (in years) | 7 years 8 months 12 days | 6 years 6 months 18 days |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-average assumptions (Details) - Stock Option | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Incentive Plan | ||
Contractual term (in years) | 6 years 6 months | |
Volatility | 90.90% | 88.70% |
Risk-free interest rate | 1.12% | 1.29% |
Maximum | ||
Equity Incentive Plan | ||
Contractual term (in years) | 10 years | |
Minimum | ||
Equity Incentive Plan | ||
Contractual term (in years) | 9 years |
Equity Incentive Plan - Total s
Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 769,124 | $ 1,371,070 |
Research and development | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | 662,658 | 730,826 |
General and administrative expense | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 106,466 | $ 640,244 |
Agreements (Details)
Agreements (Details) - USD ($) | 12 Months Ended | ||||||||
Feb. 24, 2021 | Jan. 08, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 10, 2021 | |
Agreements | |||||||||
Shares issued, price per share (in dollars per share) | $ 2,672.25 | ||||||||
Change in fair value | $ 532,353 | ||||||||
Series C preferred stock | |||||||||
Agreements | |||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 19,140.14 | ||||||||
Series C preferred stock | First Wave Purchase Agreement | |||||||||
Agreements | |||||||||
Deemed dividends on preferred stock issuances | $ 230,000 | ||||||||
First Wave License Agreement | |||||||||
Agreements | |||||||||
Upfront cash payment to be paid in first ten days | $ 9,000,000 | ||||||||
Upfront cash payment term | 10 days | ||||||||
Asset acquisition, additional cash to be paid | $ 1,250,000 | ||||||||
Asset acquisition, contingent consideration, liability, total | $ 37,000,000 | ||||||||
Asset acquisition, consideration transferred, equity interest issued and issuable | $ 3,000,000 | $ 3,000,000 | |||||||
Period for conversion of common stock | 5 days | ||||||||
Change in fair value | $ 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 | Convertible Preferred Stock | |||||||||
Agreements | |||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ 9.118 | ||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 4,700 | ||||||||
First Wave License Agreement | Series C preferred stock | |||||||||
Agreements | |||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ 52.50 | ||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 4,700 | ||||||||
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) | 12 Months Ended | |
Dec. 31, 2022 USD ($) ft² property | Dec. 31, 2021 USD ($) | |
Leases | ||
Number of real property operating leases | property | 2 | |
Operating lease, expense | $ | $ 157,000 | $ 261,000 |
Boca Raton, Florida | ||
Leases | ||
Area of real estate property (Square Foot) | ft² | 3,472 |
Leases - Weighted-average remai
Leases - Weighted-average remaining lease term and discount rate (Details) | Dec. 31, 2022 |
Leases | |
Weighted-average remaining lease term | 3 years 8 months 12 days |
Weighted-average discount rate | 7% |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) | Dec. 31, 2022 USD ($) |
Leases | |
2023 | $ 83,691 |
2024 | 86,202 |
2025 | 88,788 |
2026 | 60,593 |
Total lease payments | 319,274 |
Less imputed interest | (39,063) |
Present value of lease liabilities | $ 280,211 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Federal tax provision | $ 0 | $ 0 |
State tax provision | 0 | 0 |
Gross deferred tax assets | 29,514,000 | 31,647,000 |
Deferred tax asset, valuation allowance | 29,450,000 | 31,647,000 |
Change in the valuation allowance | $ 2,100,000 | $ 5,600,000 |
Income Taxes - Significant comp
Income Taxes - Significant components of the Company's net deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Gross deferred tax assets: | ||
Net operating loss carry-forwards | $ 18,916,000 | $ 30,576,000 |
Stock compensation | 733,000 | 112,000 |
Accruals | 30,000 | |
Change in accounts payable | 138,000 | |
Intangible assets | 5,708,000 | 791,000 |
Capitalized research and development | 2,022,000 | |
Research and development credits | 1,715,000 | |
Unrealized loss | 318,000 | |
Other | 102,000 | |
Deferred tax assets before valuation allowance | 29,514,000 | 31,647,000 |
Valuation allowance | (29,450,000) | $ (31,647,000) |
Deferred tax assets net of valuation allowance | 64,000 | |
Gross deferred tax liabilities: | ||
Right of use asset | (64,000) | |
Total deferred tax liability | $ (64,000) |
Income Taxes - Effective tax ra
Income Taxes - Effective tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Income tax benefit (expense) at statutory rate | 21% | 21% |
State income tax | 4.90% | 4.20% |
Non-deductible expense | 8.70% | (10.30%) |
Change in valuation allowance | 14.60% | (9.50%) |
Prior year adjustments | (7.70%) | (4.70%) |
Dissolution of foreign subsidiary | (45.90%) | |
Other | 4.40% | (0.70%) |
Total income tax benefit (expense) | 0% | 0% |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Taxes | ||
Federal research and development tax credit carryforwards, which expire beginning in 2040 | $ 1,700,000 | |
Uncertain tax positions | 0 | $ 0 |
Federal | ||
Income Taxes | ||
Net operating loss carryforwards | 79,700,000 | |
Net operating loss carryforwards, subject to expiration starting in 2034 | 14,800,000 | |
State | ||
Income Taxes | ||
Net operating loss carryforwards | $ 62,200,000 | |
Net operating loss carryforwards, not subject to expiration, Threshold utilization percentage | 80% |
Net Loss per Common Share - Com
Net Loss per Common Share - Common Stock that may potentially be issued (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrant | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 1,750,324 | 25,605 |
Stock options | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 3,936 | 2,091 |
Restricted Stock | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 283 | 178 |
Series B preferred stock | ||
Net Loss per Common Share | ||
Preferred stock, convertible, conversion price (in dollars per share) | $ 1,617 | |
Series B preferred stock | Performance Shares | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 3,054 | 3,436 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Benefit Plans | ||
Defined contribution plan, employers matching contribution, annual vesting percentage | 6% | |
Defined benefit plan, plan assets, contributions by employer | $ 112,000 | $ 107,000 |
Minimum | ||
Employee Benefit Plans | ||
Defined contribution plan, maximum annual contributions per employee, percent | 1% | |
Maximum | ||
Employee Benefit Plans | ||
Defined contribution plan, maximum annual contributions per employee, percent | 100% |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||||||||
Mar. 12, 2023 USD ($) $ / shares shares | Jan. 07, 2023 | Jan. 03, 2023 shares | Oct. 11, 2022 $ / shares shares | Oct. 31, 2022 $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 $ / shares shares | Dec. 05, 2022 $ / shares | Sep. 30, 2022 $ / shares | Jul. 15, 2022 shares | Mar. 10, 2021 | |
Subsequent Events | |||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||
Number of common stock shares called by warrants (in shares) | 571 | ||||||||||
Warrants term | 5 years | ||||||||||
Officers and Directors | Restricted stock units | 2020 Equity Incentive Plan | Non-employees | |||||||||||
Subsequent Events | |||||||||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||||||||||
Awards issued | 60,530 | ||||||||||
At The Market Offering Agreement | |||||||||||
Subsequent Events | |||||||||||
Stock issued during period, shares, new issues (in shares) | 217,036 | 25,396 | |||||||||
October 2022 Offering | |||||||||||
Subsequent Events | |||||||||||
Stock issued during period, shares, new issues (in shares) | 36,428 | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||
Public offering price for each share of common stock, march 2023 pre-funded warrant, and accompanying march 2023 warrant to purchase one share of common stock | $ / shares | $ 12.215 | ||||||||||
Private placement | Placement Agent Warrants [Member] | |||||||||||
Subsequent Events | |||||||||||
Number of common stock shares called by warrants (in shares) | 571 | ||||||||||
March 2023 Purchase Agreement | |||||||||||
Subsequent Events | |||||||||||
Proceeds from issuance of shares | $ | $ 4 | ||||||||||
Subsequent events | |||||||||||
Subsequent Events | |||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||
Number of clinical trial agreements for which the Company filed a demand for arbitration with a CRO | 2 | ||||||||||
Subsequent events | Restricted stock units | 2020 Equity Incentive Plan | Employees | |||||||||||
Subsequent Events | |||||||||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||||||||||
Awards issued | 97,139 | ||||||||||
Vesting period | 1 year | ||||||||||
Subsequent events | Officers and Directors | Restricted stock units | 2020 Equity Incentive Plan | Non-employees | |||||||||||
Subsequent Events | |||||||||||
Vesting period | 1 year | ||||||||||
Subsequent events | Consultants | Restricted stock units | 2020 Equity Incentive Plan | Non-employees | |||||||||||
Subsequent Events | |||||||||||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||||||||||
Awards issued | 2,570 | ||||||||||
Vesting period | 1 year | ||||||||||
Subsequent events | March 2023 Purchase Agreement | |||||||||||
Subsequent Events | |||||||||||
Stock issued during period, shares, new issues (in shares) | 128,000 | ||||||||||
Public offering price for each share of common stock, march 2023 pre-funded warrant, and accompanying march 2023 warrant to purchase one share of common stock | $ / shares | $ 3.91 | ||||||||||
Proceeds from issuance of shares | $ | $ 4 | ||||||||||
Period following the date of the agreement, that the company has agreed to file a registration statement with the SEC | 30 days | ||||||||||
Period following the date the Company files its annual report with the SEC, that the company has agreed to file a registration statement with the SEC | 5 days | ||||||||||
Subsequent events | March 2023 Purchase Agreement | March 2023 Pre-Funded Warrants | |||||||||||
Subsequent Events | |||||||||||
Number of common stock shares called by warrants (in shares) | 895,018 | ||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||
Warrant exercise price | $ / shares | $ 0.0001 | ||||||||||
Subsequent events | March 2023 Purchase Agreement | March 2023 Warrants | |||||||||||
Subsequent Events | |||||||||||
Number of common stock shares called by warrants (in shares) | 2,046,036 | ||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | ||||||||||
Warrant exercise price | $ / shares | $ 3.66 | ||||||||||
Warrants term | 5 years |