Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-37853 | |
Entity Registrant Name | First Wave BioPharma, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-4993860 | |
Entity Address, Address Line One | 777 Yamato Road, Suite 502 | |
Entity Address, City or Town | Boca Raton | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33431 | |
City Area Code | 561 | |
Local Phone Number | 589-7020 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | FWBI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,795,404 | |
Entity Central Index Key | 0001604191 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 1,657,013 | $ 8,248,684 |
Other receivables | 191,984 | |
Prepaid expenses | 561,459 | 1,176,268 |
Deferred offering costs | 138,684 | |
Total Current Assets | 2,549,140 | 9,424,952 |
Property, equipment, and leasehold improvements, net | 51,157 | 73,110 |
Other Assets: | ||
Goodwill | 1,714,787 | 1,911,705 |
Restricted cash | 21,505 | |
Operating lease right-of-use assets | 274,516 | 336,197 |
Deposits | 34,298 | 44,012 |
Total Other Assets | 2,045,106 | 2,291,914 |
Total Assets | 4,645,403 | 11,789,976 |
Current Liabilities: | ||
Accounts payable | 3,582,988 | 2,707,731 |
Accrued expenses | 272,268 | 393,253 |
Accrued dividend payable | 763,556 | 465,361 |
Note payable | 641,236 | |
Operating lease liabilities | 64,397 | 77,989 |
Payable related to acquisition - current | 2,000,000 | 8,000,000 |
Other current liabilities | 10,951 | 14,818 |
Total Current Liabilities | 6,694,160 | 12,300,388 |
Non-current operating lease liabilities | 231,292 | 311,138 |
Payable related to acquisition - long term | 7,000,000 | |
Total Liabilities | 6,925,452 | 19,611,526 |
Commitments and Contingencies | ||
Stockholders' Deficit: | ||
Common stock - Par value $0.0001 per share; 50,000,000 shares authorized; 2,307,008 and 495,194 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 231 | 50 |
Additional paid-in capital | 163,722,141 | 147,306,582 |
Accumulated deficit | (164,547,700) | (153,904,047) |
Accumulated other comprehensive loss | (1,454,721) | (1,224,135) |
Total Stockholders' Deficit | (2,280,049) | (7,821,550) |
Total Liabilities and Stockholders' Deficit | 4,645,403 | 11,789,976 |
Series B preferred stock | ||
Stockholders' Deficit: | ||
Preferred stock | 0 | 0 |
Series C preferred stock | ||
Stockholders' Deficit: | ||
Preferred stock | 0 | 0 |
Series D preferred stock | ||
Stockholders' Deficit: | ||
Preferred stock | 0 | 0 |
Series E preferred stock | ||
Stockholders' Deficit: | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Feb. 13, 2022 | Dec. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized (in shares) | 50,000,000 | 25,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 2,307,008 | 495,194 | |
Common stock, shares outstanding (in shares) | 2,307,008 | 495,194 | |
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) | 5,194.805195 | 5,194.805195 | |
Preferred stock, shares issued (in shares) | 631.34 | 662.25 | |
Preferred stock, shares outstanding (in shares) | 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) | 57,000 | 57,000 | |
Preferred stock, shares issued (in shares) | 0 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 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 | |
Preferred stock, shares issued (in shares) | 0 | 0 | |
Preferred stock, shares outstanding (in shares) | 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 | |
Preferred stock, shares issued (in shares) | 0 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development expenses | $ 791,067 | $ 3,052,791 | $ 8,674,480 | $ 11,216,616 |
Research and development (recovery) expenses- intellectual property acquired | (8,085,045) | 21,325,527 | (8,085,045) | 21,325,527 |
General and administrative expenses | 2,904,448 | 6,021,160 | 9,808,960 | 15,347,764 |
Total operating (recovery) expenses | (4,389,530) | 30,399,478 | 10,398,395 | 47,889,907 |
Income (loss) from operations | 4,389,530 | (30,399,478) | (10,398,395) | (47,889,907) |
Other income (expenses): | ||||
Interest expense | (863) | (742) | (9,686) | (8,840) |
Interest income | 2,664 | 3,729 | ||
Other (expense) income | (568) | (239,301) | 1,032 | |
Change in fair value of liability | 532,353 | |||
Total other income (expenses) | 1,801 | (1,310) | (245,258) | 524,545 |
Net income (loss) | 4,391,331 | (30,400,788) | (10,643,653) | (47,365,362) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustment | (35,235) | (41,604) | (230,586) | (154,561) |
Total comprehensive income (loss) | 4,356,096 | (30,442,392) | (10,874,239) | (47,519,923) |
Net income (loss) | 4,391,331 | (30,400,788) | (10,643,653) | (47,365,362) |
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) | (47,300) | ||
Preferred stock dividends | (110,278) | (118,089) | (298,195) | (349,132) |
Net income (loss) applicable to common shareholders | $ 4,233,753 | $ (30,518,877) | $ (10,989,148) | $ (73,229,872) |
Basic weighted average shares outstanding | 1,601,415 | 311,411 | 952,794 | 253,118 |
Diluted weighted average shares outstanding | 1,625,736 | 311,411 | 952,794 | 253,118 |
Net income (loss) per share - basic | $ 2.64 | $ (98) | $ (11.53) | $ (289.31) |
Net income (loss) per share - diluted | $ 2.60 | $ (98) | $ (11.53) | $ (289.31) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Deficit (unaudited) - USD ($) | Common Stock, Pre-funded Warrants, and Cash Warrants [Member] Common Stock | Common Stock, Pre-funded Warrants, and Cash Warrants [Member] Additional Paid-in Capital | Common Stock, Pre-funded Warrants, and Cash Warrants [Member] | 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 D Preferred Stock And Warrants | 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 | Issuance Of Series E Preferred Stock And Warrants | Conversion of Series B Preferred Shares Into Common Stock Convertible preferred stock Series B Convertible Preferred Stock | Conversion of Series B Preferred Shares Into Common Stock Common Stock | 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 Series D Convertible Preferred Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Series E Convertible Preferred Stock | Series D Convertible Preferred Stock | Total |
Balance at the beginning (in shares) at Dec. 31, 2020 | 2,774 | 103,834 | ||||||||||||||||||||||||
Balance at the beginning at Dec. 31, 2020 | $ 10 | $ 93,838,041 | $ (95,366,198) | $ (1,112,546) | $ (2,640,693) | |||||||||||||||||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs (in shares) | 10,667 | 10,667 | 10,667 | |||||||||||||||||||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs | $ 1 | $ 1 | $ 1 | 7,105,167 | 7,105,168 | |||||||||||||||||||||
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 (in shares) | (1,839) | 19,140 | 19,140 | 19,140 | ||||||||||||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock | $ 1 | $ 1 | $ 1 | (1,431) | (1,430) | |||||||||||||||||||||
Warrants issued in connection with exchange of Series B preferred stock into Series C preferred stock | 21,009,683 | 21,009,683 | ||||||||||||||||||||||||
Deemed dividend of Series C preferred stock | (4,507,125) | (4,507,125) | ||||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (259) | 8,609 | ||||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock | $ 1 | (1) | ||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | (33,097) | (33,097) | (33,097) | |||||||||||||||||||||||
Issuance of Series C preferred stock to for license acquired (in shares) | 3,290 | 3,290 | 3,290 | |||||||||||||||||||||||
Issuance of Series C preferred stock to for license acquired | $ 1 | $ 1 | $ 1 | 2,467,648 | 2,467,649 | |||||||||||||||||||||
Deemed dividend on preferred stock issuances | (4,507,125) | |||||||||||||||||||||||||
Deemed dividend related to exchange of Series B preferred stock | (21,008,253) | (21,008,253) | ||||||||||||||||||||||||
Exercise of pre-funded warrants into common stock (in shares) | 31,521 | |||||||||||||||||||||||||
Exercise of pre-funded warrants into common stock | $ 3 | 4,906,627 | 4,906,630 | |||||||||||||||||||||||
Deemed dividend on preferred stock exchanges | (21,008,253) | |||||||||||||||||||||||||
Dividends on preferred stock | (349,132) | (349,132) | ||||||||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock (in shares) | 104,182 | |||||||||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock | $ (3) | (3) | (3) | $ 10 | (7) | |||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs (in shares) | 54,182 | |||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs | $ 6 | 14,156,044 | 14,156,050 | |||||||||||||||||||||||
Effect of cancelled shares from the 10-for-1 reverse stock split (in shares) | (56) | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 55,041 | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 6 | 8,325,189 | 8,325,195 | |||||||||||||||||||||||
Common stock issued for intellectual property acquired, net (in shares) | (20,800) | |||||||||||||||||||||||||
Common stock issued for intellectual property acquired, net | $ 2 | 3,999,998 | 4,000,000 | |||||||||||||||||||||||
Common stock cancelled in connection with acquisition of First Wave Bio, Inc. | $ (1) | 1 | ||||||||||||||||||||||||
Common stock cancelled in connection with acquisition of First Wave Bio, Inc. (in shares) | (11,097) | |||||||||||||||||||||||||
Common stock and warrants issued to consultants (in shares) | 3,241 | |||||||||||||||||||||||||
Issuance of common stock in connection with settlement with former investment bank (in shares) | 250 | |||||||||||||||||||||||||
Issuance of common stock in connection with settlement with former investment bank | 94,499 | 94,499 | ||||||||||||||||||||||||
Common stock and warrants issued to consultants | 1,215,859 | 1,215,859 | ||||||||||||||||||||||||
Stock-based compensation | 1,268,710 | 1,268,710 | ||||||||||||||||||||||||
Foreign currency translation adjustment | (154,561) | (154,561) | ||||||||||||||||||||||||
Net loss | (47,365,362) | (47,365,362) | ||||||||||||||||||||||||
Balance at the end (in shares) at Sep. 30, 2021 | 676 | 370,507 | ||||||||||||||||||||||||
Balance at the end at Sep. 30, 2021 | $ 37 | 137,028,642 | (142,731,560) | (1,267,107) | (6,969,988) | |||||||||||||||||||||
Balance at the beginning (in shares) at Jun. 30, 2021 | 676 | 275,283 | ||||||||||||||||||||||||
Balance at the beginning at Jun. 30, 2021 | $ 28 | 120,593,171 | (112,330,772) | (1,225,503) | 7,036,924 | |||||||||||||||||||||
Issuance of Series C preferred stock upon exchange of Series B preferred stock | (118,089) | (118,089) | ||||||||||||||||||||||||
Dividends on preferred stock (in shares) | 5,639 | |||||||||||||||||||||||||
Common stock and pre-funded warrants issued upon conversion of Series C preferred stock (in shares) | 20,800 | |||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs (in shares) | 34,848 | |||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs | $ 3 | 5,096,757 | 5,096,760 | |||||||||||||||||||||||
Effect of cancelled shares from the 10-for-1 reverse stock split (in shares) | (56) | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 50,055 | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 5 | 7,150,842 | 7,150,847 | |||||||||||||||||||||||
Common stock issued for intellectual property acquired, net (in shares) | (5,639) | |||||||||||||||||||||||||
Common stock issued for intellectual property acquired, net | 2 | 3,999,998 | 4,000,000 | |||||||||||||||||||||||
Common stock cancelled in connection with acquisition of First Wave Bio, Inc. | $ (1) | 1 | ||||||||||||||||||||||||
Common stock cancelled in connection with acquisition of First Wave Bio, Inc. (in shares) | (11,096) | |||||||||||||||||||||||||
Common stock and warrants issued to consultants | 123,548 | 123,548 | ||||||||||||||||||||||||
Common stock and warrants issued to consultants (in shares) | 673 | |||||||||||||||||||||||||
Stock-based compensation | 182,414 | 182,414 | ||||||||||||||||||||||||
Foreign currency translation adjustment | (41,604) | (41,604) | ||||||||||||||||||||||||
Net loss | (30,400,788) | (30,400,788) | ||||||||||||||||||||||||
Balance at the end (in shares) at Sep. 30, 2021 | 676 | 370,507 | ||||||||||||||||||||||||
Balance at the end at Sep. 30, 2021 | $ 37 | 137,028,642 | (142,731,560) | (1,267,107) | (6,969,988) | |||||||||||||||||||||
Balance at the beginning (in shares) at Dec. 31, 2021 | 662 | 495,194 | ||||||||||||||||||||||||
Balance at the beginning at Dec. 31, 2021 | $ 50 | 147,306,582 | (153,904,047) | (1,224,135) | (7,821,550) | |||||||||||||||||||||
Deemed dividend of Series B preferred stock | (298,195) | (298,195) | ||||||||||||||||||||||||
Warrant modification | 47,300 | 47,300 | ||||||||||||||||||||||||
Deemed dividend on warrant modifications | (47,300) | (47,300) | ||||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (150) | 33,332 | (150) | 33,332 | ||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock | $ 3 | $ (3) | $ 3 | $ (3) | ||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 55,000 | |||||||||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs | $ 6 | $ 7,971,926 | $ 7,971,932 | $ 150 | $ 178,336 | $ 178,336 | ||||||||||||||||||||
Exercise of pre-funded warrants into common stock (in shares) | 161,606 | |||||||||||||||||||||||||
Exercise of pre-funded warrants into common stock | $ 16 | 47,997 | 48,013 | |||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | (31) | 6,374 | ||||||||||||||||||||||||
Effect of cancelled shares from the 10-for-1 reverse stock split (in shares) | (98) | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 1,519,257 | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 150 | $ 153 | $ 20,664 | 7,691,069 | $ 20,664 | 7,691,222 | ||||||||||||||||||||
Common stock and warrants issued to consultants (in shares) | 3,011 | |||||||||||||||||||||||||
Common stock and warrants issued to consultants | 118,990 | 118,990 | ||||||||||||||||||||||||
Stock-based compensation | 684,778 | 684,778 | ||||||||||||||||||||||||
Foreign currency translation adjustment | (230,586) | (230,586) | ||||||||||||||||||||||||
Net loss | (10,643,653) | (10,643,653) | ||||||||||||||||||||||||
Balance at the end (in shares) at Sep. 30, 2022 | 631 | 2,307,008 | ||||||||||||||||||||||||
Balance at the end at Sep. 30, 2022 | $ 231 | 163,722,141 | (164,547,700) | (1,454,721) | (2,280,049) | |||||||||||||||||||||
Balance at the beginning (in shares) at Jun. 30, 2022 | 631 | 756,660 | ||||||||||||||||||||||||
Balance at the beginning at Jun. 30, 2022 | $ 76 | 156,168,578 | (168,939,031) | (1,419,486) | (14,189,863) | |||||||||||||||||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs (in shares) | 150 | 150 | ||||||||||||||||||||||||
Issuance of Series C preferred stock and warrants for cash, net of offering costs | 178,336 | $ 178,336 | 20,664 | $ 20,664 | ||||||||||||||||||||||
Deemed dividend of Series B preferred stock | (110,278) | (110,278) | ||||||||||||||||||||||||
Deemed dividend on warrant modifications | (47,000) | |||||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock (in shares) | (150) | 33,332 | (150) | 33,332 | ||||||||||||||||||||||
Common stock issued upon conversion of Series B preferred stock | $ 3 | $ (3) | $ 3 | $ (3) | ||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | (98) | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs (in shares) | 1,483,782 | |||||||||||||||||||||||||
Issuance of common stock at-the-market for cash, net of offering costs | $ 149 | 7,373,206 | 7,373,355 | |||||||||||||||||||||||
Stock-based compensation | 91,641 | 91,641 | ||||||||||||||||||||||||
Foreign currency translation adjustment | (35,235) | (35,235) | ||||||||||||||||||||||||
Net loss | 4,391,331 | 4,391,331 | ||||||||||||||||||||||||
Balance at the end (in shares) at Sep. 30, 2022 | 631 | 2,307,008 | ||||||||||||||||||||||||
Balance at the end at Sep. 30, 2022 | $ 231 | $ 163,722,141 | $ (164,547,700) | $ (1,454,721) | $ (2,280,049) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Deficit (unaudited) (Parenthetical) - shares | 3 Months Ended | 9 Months Ended | ||||
Aug. 26, 2022 | Sep. 13, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Condensed Consolidated Statements of Changes in Stockholders' Deficit (unaudited) | ||||||
Reverse stock splits (in shares) | 30 | 10 | 30 | 10 | 30 | 10 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (10,643,653) | $ (47,365,362) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 21,953 | 9,390 |
Amortization | 395,661 | |
Change in right-of-use assets | 61,681 | (4,855) |
Change in fair value liability | (532,353) | |
Stock-based compensation | 684,778 | 1,268,710 |
Common stock and warrants granted to consultants | 118,990 | 1,310,358 |
Changes in assets and liabilities: | ||
Other receivables | (191,984) | 551,489 |
Prepaid expenses | 614,809 | 964,310 |
Lease liabilities | (93,438) | (289,409) |
Deposits | 9,714 | (16,114) |
Accounts payable | 875,257 | 2,179,334 |
Accrued expenses | (120,985) | (282,031) |
Payable related to acquisition | (8,085,045) | 15,000,000 |
Other liabilities | (3,867) | 385,440 |
Net cash used in operating activities | (16,751,790) | (26,425,432) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (71,448) | |
Net cash used in investing activities | (71,448) | |
Cash flows from financing activities: | ||
Proceeds from issuance of preferred stock, net | 199,000 | 7,105,168 |
Proceeds from issuance of common stock, net | 7,971,932 | 18,156,050 |
Proceeds from exercise of warrants | 48,013 | 4,906,630 |
Payment made related to license agreement | (10,250,000) | |
Payment made related to acquisition | (4,914,955) | |
Issuance of common stock at-the-market for cash, net of offering costs | 7,691,222 | 8,325,195 |
Deferred offering costs | (138,684) | |
Repayments of note payable | (641,236) | (552,405) |
Net cash provided by financing activities | 10,215,292 | 27,690,638 |
Net (decrease) increase in cash and restricted cash | (6,536,498) | 1,193,758 |
Effect of exchange rate changes on cash | (33,668) | (45,254) |
Cash, cash equivalents and restricted cash, beginning balance | 8,248,684 | 6,062,141 |
Cash, cash equivalents and restricted cash, ending balance | 1,678,518 | 7,210,645 |
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 | $ (298,195) | (349,132) |
Issuance of Series C preferred stock to settle liability related to license agreement | $ 2,467,649 |
The Company and Basis of Presen
The Company and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
The Company and Basis of Presentation | |
The Company and Basis of Presentation | Note 1 - The Company and Basis of Presentation The Company First Wave BioPharma, Inc. (“ First Wave GI The Company is currently focused on developing its pipeline of gut-restricted GI clinical drug candidates, including the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties. The Company’s adrulipase programs are focused on the development of an oral, non-systemic, biologic capsule for the treatment of exocrine pancreatic insufficiency (“ EPI CF CP IBD The Company is developing its product candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Since its inception, the Company has devoted substantially all its efforts to research and development, business development, and raising capital, and has financed its operations through issuance of common stock, convertible preferred stock, convertible debt, and other debt/equity instruments. Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations. The Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The extent to which the ongoing COVID-19 pandemic impacts the Company’s business, clinical development and regulatory efforts, corporate development objectives and the value of and market for its Common Stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe, Asia and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects. In February 2022, the Russian Federation and Belarus commenced a military action with the country of Ukraine. As a result of this action, various nations, including the United States, have instituted economic sanctions against the Russian Federation and Belarus. Further, the impact of this action and related sanctions on the world economy are not determinable as of the date of these financial statements and the specific impact on the Company’s financial condition, results of operations, and cash flows is also not determinable as of the date of these financial statements. In addition, the Company is subject to other challenges and risks specific to its business, its ability to comply with the terms of the extension granted by the Nasdaq hearings panel and to regain compliance with the continued listing requirements of The Nasdaq Capital Market and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“ GAAP FWB In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2021, has been derived from audited financial statements of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the SEC. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022 (as amended on Form 10-K/A filed with the SEC on May 10, 2022). Going Concern Uncertainty The accompanying unaudited interim condensed consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On September 30, 2022, the Company had cash and cash equivalents of approximately $1.7 million, an accumulated deficit of approximately $164.5 million, and negative working capital of approximately $4.1 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. Based on its cash on hand at September 30, 2022, and the approximately $5.2 million in net proceeds received from a follow-on offering that closed on October 11, 2022, the Company anticipates having sufficient cash to fund planned operations into the first quarter of 2023, however, the acceleration or reduction of cash outflows by Company management can significantly impact the timing for the need to raise additional capital to complete development of its products. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies and Recent Accounting Pronouncements | |
Significant Accounting Policies and Recent Accounting Pronouncements | Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements Use of Estimates The accompanying unaudited condensed consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill and intangible assets), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. Reverse Stock Split On 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. Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. Cash, 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 balances were highly liquid on September 30, 2022, and December 31, 2021, respectively. As of September 30, 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. On September 30, 2022, and December 31, 2021, the Company had approximately $1.1 million and $7.5 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. Fair Value Measurements The Company follows Accounting Standards Codification ( ASC ( ASC 820 As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. Foreign Currency Translation The Company’s foreign subsidiary has operations denominated in a foreign currency, and assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of stockholders’ equity. Goodwill and Intangible Assets Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not Intangible assets subject to amortization consist of in process research and development, license agreements, and patents reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: Patents 7.2 years The carrying amounts of finite-lived intangible assets are evaluated for recoverability whenever events or changes in circumstances indicate that the Company may be unable to recover the asset’s carrying amount. Given changes in the projected usage of the patents, the Company recognized impairment charges Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment ( ASC 360 Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ ROU 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 – 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 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements. The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. In November 2019, the FASB issued ASU 2019-10 – Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date for certain companies. The standard is effective for public companies eligible to be smaller reporting companies for annual and interim periods beginning after December 15, 2022. Early adoption is available. The Company does not expect the adoption of this standard to have a material effect on its financial statements and related disclosures . 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, or ASU 2016-13. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures | |
Fair Value Disclosures | Note 3 - Fair Value Disclosures Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The fair value of the Company’s financial instruments are as follows: Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value September 30, 2022 (unaudited): Money market funds $ 505,179 $ 505,179 $ — $ — $ 505,179 Note payable — — — — — December 31, 2021: Money market funds 501,607 501,607 — — 501,607 Note payable $ 641,236 $ — $ 641,236 $ — $ 641,236 At September 30, 2022 and December 31, 2021, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Asset Acquisition
Asset Acquisition | 9 Months Ended |
Sep. 30, 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) 20,800 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 three and nine months ended September 30, 2022 the Company paid an aggregate of $2.5 million and $4.9 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. 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 20,800 common shares issued multiplied by $192.30 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 three months ended September 30, 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 remaining payment obligation of $2.0 million due by November 30, 2022 was recorded as research and development expense in the three months ended September 30, 2022. The remaining unachieved potential milestone payments and revenue share are not yet considered probable, therefore have not been accrued as of September 30, 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 | 9 Months Ended |
Sep. 30, 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: September 30, 2022 December 31, (unaudited) 2021 Computer equipment and software $ 11,540 $ 11,540 Office equipment 48,278 48,278 Leasehold improvements 28,000 28,000 Total property, plant, and equipment 87,818 87,818 Less accumulated depreciation (36,661) (14,708) Property, plant and equipment, net $ 51,157 $ 73,110 Depreciation expense for the three months ended September 30, 2022 and 2021 was approximately $7,300 and $6,000, respectively, and for the nine months ended September 30, 2022 and 2021 was approximately $22,000 and $9,000, respectively. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2022 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | Note 6 – Intangible Assets and Goodwill Patents Pursuant to the Mayoly asset purchase agreement entered in March 2019 (see Note 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 Total Patents $ 3,802,745 Intangible assets are as follows: September 30, 2022 December 31, (unaudited) 2021 Patents $ — $ 3,802,745 Less accumulated amortization — (1,450,757) Intangible asset impairment — (2,351,988) Patents, net $ — $ — Amortization expense was approximately $132,000 and $396,000 for the three and nine months ended September 30, 2021, respectively. During the year ended December 31, 2021, the Company recorded impairment charges 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 (196,918) Balance on September 30, 2022 (unaudited) $ 1,714,787 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Accrued Expenses | Note 7 - Accrued Expenses Accrued expenses consisted of the following: September 30, 2022 December 31, (unaudited) 2021 Professional fees $ 205,932 $ 15,000 Payroll and benefits 40,771 274,153 Consulting fees 25,565 104,100 Total accrued expenses $ 272,268 $ 393,253 |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2022 | |
Note Payable | |
Note Payable | Note 8 – Note Payable Directors and Officer ’ s Liability Insurance On November 30, 2021, the Company entered into a 9-month |
Capital Stock
Capital Stock | 9 Months Ended |
Sep. 30, 2022 | |
Capital Stock | |
Capital Stock | Note 9 – Common Stock and Preferred Stock The Company’s certificate of incorporation, as amended and restated on February 14, 2022, (the “ Charter 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. The Company had 2,307,008 and 495,194 shares of its Common Stock issued outstanding The Company has designated 5,194.805195 shares as Series B Preferred Stock and had approximately 631.34 and 662.25 shares of Series B preferred stock issued outstanding The Company has designated 57,000 shares as Series C Preferred Stock and had 0 shares of Series C Preferred Stock issued and outstanding on September 30, 2022 and December 31, 2021, respectively. The Company has designated 150 shares as Series D Preferred Stock and had 0 shares of Series D Preferred Stock issued and outstanding on September 30, 2022 and December 31, 2021, respectively. The Company has designated 150 shares as Series E Preferred Stock and had 0 shares of Series E Preferred Stock issued and outstanding on September 30, 2022 and December 31, 2021, respectively. 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 Series B Preferred Stock Waiver Agreements Between February 1 and February 7, 2022, the Company entered into waiver agreements (the “ Waiver Series B Preferred Stock Pursuant to the Series B Certificate of Designation, in the event of any issuance by the Company or any of its subsidiaries of Common Stock or common stock equivalents for cash consideration or a combination of units thereof (a “ Subsequent Financing Series B Exchange Right During the nine months ended September 30, 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 nine months ended September 30, 2022. Series B Exchange Right Permanent Waiver 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 Series B Exchanges into the January 2021 Offerings During the nine months ended September 30, 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 63,800 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 nine months ended September 30, 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. Equity Line with Lincoln Park In November 2019, the Company entered into a purchase agreement (the “ Equity Line Agreement Lincoln Park Registration Rights Agreement Equity Line Commitment Shares The Company did not issue shares of Common Stock, during either of the three or nine months ended September 30, 2022 and 2021, in connection with the Equity Line Agreement. The Equity Line Agreement expired by its terms on July 31, 2022. 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 July 2022 Private Placement On July 15, 2022, the Company completed a private placement (the “ July 2022 Offering July 2022 Warrants 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 in a private placement warrants (the “ Placement Agent Warrants During the three months ended September 30, 2022, all of the Series D Preferred Shares and the Series E Preferred Shares were converted into 66,666 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 proceeds from the March 2022 Offering were allocated to the Common Stock, Pre-Funded warrants, and March 2022 Investor Warrants based on their relative fair values. The total proceeds of approximately $9.0 million, net of $1.0 million offering costs, were allocated as follows: approximately $2.3 million to the Common Stock, approximately $0.3 million to the Pre-Funded Warrants, and approximately $6.4 million to the March 2022 Warrants. The total offering costs of approximately $1.0 million were recognized in equity. July 2021 Offering On July 22, 2021, the Company entered into an underwriting agreement with Wainwright (the “ July 2021 Offering 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 2,437 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 proceeds from the March 2021 Offering were allocated to the Common Stock, March 2021 Pre-Funded Warrants, and March 2021 Warrants based on their relative fair values. The total proceeds of approximately $9.1 million, net of $0.9 million offering costs, were allocated as follows: approximately $3.9 million to the Common Stock, approximately $2.6 million to the pre-funded warrants, and approximately $3.5 million to the March 2021 Warrants. The total offering costs of approximately $0.9 million were recognized in equity. Common Stock Issuances Issuances for the Three and Nine Months Ended September 30, 2022 During the three months ended September 30, 2022, the Company issued and sold an aggregate of 1,483,782 shares of Common Stock under the ATM Agreement for which the Company received net proceeds of approximately $7.4 million. During the three months ended September 30, 2022, the Company issued an aggregate of 66,666 shares of Common Stock upon the conversion of Series E During the three months ended September 30, 2022, the Company cancelled an aggregate of 98 shares of Common Stock in connection with the 30-for-1 reverse stock split on August 26, 2022. During the nine months ended September 30, 2022, the Company issued 55,000 shares of Common Stock under the March 2022 Offering for which the Company received net proceeds of approximately $8.0 million. During the nine months ended September 30, 2022, the Company issued an aggregate of 161,606 shares of Common Stock upon the conversion of the March 2022 Pre-Funded Warrants issued at a par value of $0.30 (See Note 10). During the nine months ended September 30, 2022, the Company issued an aggregate of 6,374 shares of Common Stock and accompanying Exchange Warrants upon the exchange of an aggregate of 30.92 shares of Series B Preferred Stock with a stated value of approximately $238,000 plus accrued dividends of approximately $27,000. During the nine months ended September 30, 2022, the Company issued an aggregate of 3,001 shares of its Common Stock to consultants with a grant date fair value of approximately $119,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the nine months ended September 30, 2022, the Company issued and sold an aggregate of 1,519,257 shares of Common Stock under the ATM Agreement for which the Company received net proceeds of approximately $7.7 million. During the nine months ended September 30, 2022, the Company cancelled an aggregate of 98 shares of Common Stock in connection with the 30-for-1 reverse stock split on August 26, 2022. Issuances for the Three and Nine Months Ended September 30, 2021 During the three months ended September 30, 2021, the Company issued an aggregate of 673 shares of its Common Stock to consultants with a grant date fair value of approximately $124,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the three months ended September 30, 2021, the Company issued an aggregate of 34,848 shares of Common Stock in connection with the July 2021 Offering. During the three months ended September 30, 2021, the Company issued an aggregate of 20,800 shares of Common Stock in connection with the FWB Merger and canceled and 11,097 shares of Common Stock held by FWB immediately prior to the FWB Merger, which shares of Common Stock are authorized and unissued (see Note 4). During the three months ended September 30, 2021, the Company cancelled an aggregate of 56 shares of Common Stock in connection with the 10-for-1 reverse stock split on September 13, 2021. During the nine months ended September 30, 2021, the Company issued an aggregate of 3,240 shares of its Common Stock to consultants with a grant date fair value of approximately $1.2 million for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the nine months ended September 30, 2021, the Company issued an aggregate 250 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 nine months ended September 30, 2021, the Company issued an aggregate of 104,182 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 nine months ended September 30, 2021, the Company issued an aggregate of 31,521 shares of Common Stock upon the exercise of an aggregate of 31,712 investor warrants, including an aggregate of 13,305 pre-funded warrants (See Note 10). During the nine months ended September 30, 2021, the Company issued an aggregate of 8,609 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 nine months ended September 30, 2021, the Company issued an aggregate of 54,181 shares of Common Stock in connection with the March 2021 Offering and July 2021 Offering, as detailed below. 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 nine months ended September 30, 2021, all outstanding shares of Series C Preferred Stock were converted to Common Stock. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Warrants | |
Warrants | Note 10 – Warrant activity for the nine months ended September 30, 2022 and 2021 was as follows: Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2022 183,999 $ 284.70 3.95 Issued 464,245 20.36 4.49 Expired (4,279) 1,125.78 — Exercised (161,606) 0.30 4.42 Warrants outstanding and exercisable on September 30, 2022 482,359 $ 90.19 4.07 Warrants outstanding and exercisable on January 1, 2021 83,687 $ 366.00 4.04 Issued 133,114 233.03 4.11 Expired (1,698) 1,080.16 — Exercised (31,712) 159.32 4.10 Warrants outstanding and exercisable on September 30, 2021 183,391 $ 298.47 4.16 The outstanding warrants expire from 2022 through 2027. In connection with the March 2022 Offering, the Company entered into a warrant amendment agreement with an investor pursuant to which the Company agreed to amend the investor’s existing warrants to purchase up to 35,555 shares of Common Stock at an exercise price of $240.00 per share issued in January 2021 and warrants to purchase up to 13,097 shares of Common stock at an exercise price of $363.00 per share issued in March 2021 (the “ Existing Warrants During the nine months ended September 30, 2022, the Company issued March 2022 Warrants, March 2022 Pre-Funded Warrants, and March 2022 Placement Agent Warrants to purchase 391,205 shares of Common Stock in connection with the March 2022 Offering, Exchange Warrants to purchase 6,374 shares of Common Stock in connection with a Series B Preferred Stock exchange (See Note 9), as well as July 2022 Warrants to purchase 66,666 shares of Common Stock in connection with the July 2022 Offering. During the nine months ended September 30, 2021, the Company issued warrants, pre-funded warrants, and placement agent warrants to purchase 44,486 and 21,789 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 2,437 shares of the Company’s Common Stock in connection with the July 2021 Offering, warrants to purchase 63,736 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 666 shares of Common Stock issued to a consultant. |
Equity Incentive Plan
Equity Incentive Plan | 9 Months Ended |
Sep. 30, 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 The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “ 2020 Plan ISOs As of January 1, 2022, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 70,478. As of September 30, 2022, there were an aggregate of 70,478 shares available under the 2020 Plan, of which 22,946 shares were issued and outstanding and 47,532 shares were available for potential issuances. As of September 30, 2022, there were an aggregate of 8,680 shares available under the 2014 Plan, of which 5,012 shares were issued and outstanding and 2,094 shares are reserved subject to issuance of restricted stock and restricted stock unit awards (“ RSUs During the nine months ended September 30, 2022 and 2021, stock option activity under the 2014 Plan and 2020 Plan was as follows: Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2022 13,737 $ 353.73 7.28 $ — Granted 22,938 41.17 7.50 — Canceled (3,745) 355.14 — — Forfeited (4,972) 120.20 — — Outstanding at September 30, 2022 27,958 $ 138.63 8.45 $ — Exercisable at September 30, 2022 13,740 $ 215.59 7.75 $ — Outstanding at January 1, 2021 13,567 $ 373.80 7.94 $ — Granted 5,841 258.30 10.00 — Canceled (4,482) 314.10 2.87 — Outstanding at September 30, 2021 14,926 $ 346.50 7.57 $ — Exercisable at September 30, 2021 9,342 $ 412.80 6.78 $ — During the nine months ended September 30, 2022 and 2021, the Board approved the grant of options to purchase 22,938 and 5,841 shares of Common Stock, respectively. All option grants were pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36-month period. During the nine months ended September 30, 2022 and 2021, stock options to purchase an aggregate of 3,745 and 4,482 shares of Common Stock under the 2020 Plan were cancelled. During the nine months ended September 30, 2022, stock options to purchase 4,972 shares of Common Stock were forfeited. For the nine months ended September 30, 2022 and 2021, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions: 2022 2021 Contractual term (in years) 6.50 10.00 Expected Volatility 90.92 % 88.71 % Risk-free interest rate 1.12 % 1.29 % Expected Dividend yield 0 % 0 % Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock granted during the nine months ended September 30, 2022 and 2021 was $31.96 and $201.24, respectively. As of September 30, 2022, the Company had unrecognized stock-based compensation expense of approximately $0.9 million. Approximately $0.4 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 8.44 years. Approximately $0.5 million of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable. As of September 30, 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 $0.3 million of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable. As of September 30, 2022 and 2021, the Company had 916 shares of restricted stock that had not yet vested and unrecognized restricted common stock expense of approximately $394,000. Approximately $197,000 of this unrecognized expense vests upon the first commercial sale in the United States of Adrulipase and approximately $197,000 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable as of September 30, 2022. The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 22,623 $ 126,611 $ 93,870 $ 556,688 General and administrative 69,018 55,803 590,908 712,022 Total stock-based compensation expense $ 91,641 $ 182,414 $ 684,778 $ 1,268,710 |
Agreements
Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Agreements | |
Agreements | Note 12 – Agreements License Agreement with First Wave Bio, Inc. (FWB) On December 31, 2020, the Company entered into the FWB License Agreement, pursuant to which FWB granted us a worldwide, exclusive right to develop, manufacture, and commercialize FWB’s proprietary immediate release and enema formulations of niclosamide (the “ Niclosamide Product In consideration of the license and other rights granted by FWB, the Company agreed to pay FWB a $9.0 million upfront cash payment due within 10 days, which was paid in January 2021, and was obligated to make an additional payment of $1.25 million due on June 30, 2021, which was paid in July 2021. In addition, the Company was obligated to pay potential milestone payments to FWB totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. In September 2021, the Company achieved a milestone related to clinical development of niclosamide in the COVID-19 field and has expensed $1.0 million in research and development. Under the FWB License Agreement, the Company was obligated to pay FWB royalties as a mid-single digit percentage of net sales of the Niclosamide Product, subject to specified reductions. The Company was also obligated to issue to FWB junior convertible preferred stock, initially convertible into $3.0 million worth of Common Stock based upon the volume weighted average price of the Common Stock for the five-day period immediately preceding the date of the FWB License Agreement, or $273.54 per share, convertible into an aggregate of 10,967 shares of Common Stock. On January 8, 2021, the Company 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 | 9 Months Ended |
Sep. 30, 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 was approximately $36,000 and $79,000, respectively, for the three months ended September 30, 2022 and 2021 and $115,000 and $186,000, respectively, for the nine months ended September 30, 2022 and 2021. The weighted-average remaining lease term and weighted-average discount rate under operating leases as of September 30, 2022 are: September 30, 2022 Lease term and discount rate Weighted-average remaining lease term (years) 3.9 Weighted-average discount rate 7.00 % Maturities of operating lease liabilities as of September 30, 2022, were as follows: 2022 (remainder of year) $ 20,563 2023 83,691 2024 86,202 2025 88,788 2026 60,593 Total lease payments 339,837 Less imputed interest (44,148) Present value of lease liabilities $ 295,689 |
Net Income (Loss) per Common Sh
Net Income (Loss) per Common Share | 9 Months Ended |
Sep. 30, 2022 | |
Net Income (Loss) per Common Share | |
Net Income (Loss) per Common Share | Note 14 - Net Income (Loss) per Common Share Basic net income (loss) per share is computed by dividing net income (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 preferred stock that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options, warrants and preferred stock is computed using the treasury stock method. In periods where the Company records a net loss, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. For the three months ended September 30, 2022, stock options in the amount of 27,958 and warrants in the amount of 482,359 were excluded from the calculation of diluted net income per share as they did not have a dilutive effect. For the three months ended September 30, 2022, convertible preferred stock in the amount of 24,321 shares were included in the calculation of diluted net income per share. Basic and diluted net income (loss) per share was calculated as follows: Three Months Ended Nine Months Ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Net income (loss) $ 4,391,331 $ (30,400,788) $ (10,643,653) $ (47,365,362) Basic weighted average shares outstanding 1,601,415 311,411 952,794 253,118 Convertible preferred stock 24,321 — — — Diluted weighted average shares outstanding 1,625,736 311,411 952,794 253,118 Basic net income (loss) per share $ 2.64 $ (98.00) $ (11.53) $ (289.31) Diluted net income (loss) per share $ 2.60 $ (98.00) $ (11.53) $ (289.31) All shares of Common Stock that may potentially be issued in the future are as follows: September 30, 2022 September 30, 2021 (unaudited) (unaudited) Common stock warrants 482,359 183,391 Stock options 27,958 14,926 Convertible preferred stock (1) 24,321 24,045 Total shares of common stock issuable 534,638 222,362 (1) Convertible preferred stock is assumed to be converted at the rate of $231.00 per common share, which is the conversion price as of September 30, 2022 . |
Employee Benefit Plans
Employee Benefit Plans | 9 Months Ended |
Sep. 30, 2022 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 15 - 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 $21,000 and $26,000 for the three months ended September 30, 2022 and 2021, respectively, and approximately $97,000 and $81,000 for the nine months ended September 30, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events | |
Subsequent Events | Note 16 - Subsequent Events The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were available to be issued. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements except for the item noted below. Dissolution of AzurRx SAS Effective October 26, 2022, AzurRx SAS was dissolved. Public Offering On October 6, 2022, the Company entered into a securities purchase agreement with investors pursuant to which the Company agreed to sell, in a best efforts public offering (the “ October 2022 Offering October 2022 Pre-Funded Warrants October 2022 Warrants The net proceeds of the October 2022 Offering, after deducting the placement agent’s fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the October 2022 Warrants, is $5.2 million. The Company intends to use the net proceeds from the October 2022 Offering to make the final upfront payment owed to the former stockholders of FWB pursuant to the July 2022 Settlement Agreement. The Company intends to use the remaining net proceeds from the October 2022 Offering for working capital and general corporate purposes. The October 2022 Offering closed on October 11, 2022. July 2022 Offering On October 5, 2022, the Company entered into termination agreements with Wainwright to void 4,000 warrant shares issued to Wainwright pursuant to the July 2022 Offering. |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies and Recent Accounting Pronouncements | |
Use of Estimates | Use of Estimates The accompanying unaudited condensed consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill and intangible assets), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. |
Reverse Stock Split | Reverse Stock Split On 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. |
Reclassifications | Reclassifications Certain prior period balance sheet amounts have been reclassified to conform to the fiscal 2022 presentation. |
Cash, Cash Equivalents and Restricted Cash | Cash, 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 balances were highly liquid on September 30, 2022, and December 31, 2021, respectively. As of September 30, 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. On September 30, 2022, and December 31, 2021, the Company had approximately $1.1 million and $7.5 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros. |
Fair Value Measurements | Fair Value Measurements The Company follows Accounting Standards Codification ( ASC ( ASC 820 As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. |
Foreign Currency Translation | Foreign Currency Translation The Company’s foreign subsidiary has operations denominated in a foreign currency, and assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of stockholders’ equity. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not Intangible assets subject to amortization consist of in process research and development, license agreements, and patents reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows: Patents 7.2 years The carrying amounts of finite-lived intangible assets are evaluated for recoverability whenever events or changes in circumstances indicate that the Company may be unable to recover the asset’s carrying amount. Given changes in the projected usage of the patents, the Company recognized impairment charges |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment ( ASC 360 |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ ROU |
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 – 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 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements. The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. In November 2019, the FASB issued ASU 2019-10 – Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date for certain companies. The standard is effective for public companies eligible to be smaller reporting companies for annual and interim periods beginning after December 15, 2022. Early adoption is available. The Company does not expect the adoption of this standard to have a material effect on its financial statements and related disclosures . 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, or ASU 2016-13. 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) | 9 Months Ended |
Sep. 30, 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 September 30, 2022 (unaudited): Money market funds $ 505,179 $ 505,179 $ — $ — $ 505,179 Note payable — — — — — December 31, 2021: Money market funds 501,607 501,607 — — 501,607 Note payable $ 641,236 $ — $ 641,236 $ — $ 641,236 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Equipment and Leasehold Improvements | |
Summary of property, equipment and leasehold improvements | September 30, 2022 December 31, (unaudited) 2021 Computer equipment and software $ 11,540 $ 11,540 Office equipment 48,278 48,278 Leasehold improvements 28,000 28,000 Total property, plant, and equipment 87,818 87,818 Less accumulated depreciation (36,661) (14,708) Property, plant and equipment, net $ 51,157 $ 73,110 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 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 Total Patents $ 3,802,745 |
Schedule of intangible assets | September 30, 2022 December 31, (unaudited) 2021 Patents $ — $ 3,802,745 Less accumulated amortization — (1,450,757) Intangible asset impairment — (2,351,988) Patents, net $ — $ — |
Schedule of goodwill | Goodwill Balance on January 1, 2021 $ 2,054,048 Foreign currency translation (142,343) Balance on December 31, 2021 1,911,705 Foreign currency translation (196,918) Balance on September 30, 2022 (unaudited) $ 1,714,787 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Summary of accrued expenses | September 30, 2022 December 31, (unaudited) 2021 Professional fees $ 205,932 $ 15,000 Payroll and benefits 40,771 274,153 Consulting fees 25,565 104,100 Total accrued expenses $ 272,268 $ 393,253 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Warrants | |
Schedule of warrant activity | Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2022 183,999 $ 284.70 3.95 Issued 464,245 20.36 4.49 Expired (4,279) 1,125.78 — Exercised (161,606) 0.30 4.42 Warrants outstanding and exercisable on September 30, 2022 482,359 $ 90.19 4.07 Warrants outstanding and exercisable on January 1, 2021 83,687 $ 366.00 4.04 Issued 133,114 233.03 4.11 Expired (1,698) 1,080.16 — Exercised (31,712) 159.32 4.10 Warrants outstanding and exercisable on September 30, 2021 183,391 $ 298.47 4.16 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity Incentive Plan | |
Schedule of stock option activity | Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2022 13,737 $ 353.73 7.28 $ — Granted 22,938 41.17 7.50 — Canceled (3,745) 355.14 — — Forfeited (4,972) 120.20 — — Outstanding at September 30, 2022 27,958 $ 138.63 8.45 $ — Exercisable at September 30, 2022 13,740 $ 215.59 7.75 $ — Outstanding at January 1, 2021 13,567 $ 373.80 7.94 $ — Granted 5,841 258.30 10.00 — Canceled (4,482) 314.10 2.87 — Outstanding at September 30, 2021 14,926 $ 346.50 7.57 $ — Exercisable at September 30, 2021 9,342 $ 412.80 6.78 $ — |
Schedule of option pricing model with the following weighted-average assumptions | 2022 2021 Contractual term (in years) 6.50 10.00 Expected Volatility 90.92 % 88.71 % Risk-free interest rate 1.12 % 1.29 % Expected Dividend yield 0 % 0 % |
Schedule of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 22,623 $ 126,611 $ 93,870 $ 556,688 General and administrative 69,018 55,803 590,908 712,022 Total stock-based compensation expense $ 91,641 $ 182,414 $ 684,778 $ 1,268,710 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Weighted-average remaining lease term and weighted-average discount rate under operating leases | September 30, 2022 Lease term and discount rate Weighted-average remaining lease term (years) 3.9 Weighted-average discount rate 7.00 % |
Maturities of operating lease liabilities | Maturities of operating lease liabilities as of September 30, 2022, were as follows: 2022 (remainder of year) $ 20,563 2023 83,691 2024 86,202 2025 88,788 2026 60,593 Total lease payments 339,837 Less imputed interest (44,148) Present value of lease liabilities $ 295,689 |
Net Income (Loss) per Common _2
Net Income (Loss) per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net Income (Loss) per Common Share | |
Schedule of basic and diluted net income (loss) per share | Three Months Ended Nine Months Ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Net income (loss) $ 4,391,331 $ (30,400,788) $ (10,643,653) $ (47,365,362) Basic weighted average shares outstanding 1,601,415 311,411 952,794 253,118 Convertible preferred stock 24,321 — — — Diluted weighted average shares outstanding 1,625,736 311,411 952,794 253,118 Basic net income (loss) per share $ 2.64 $ (98.00) $ (11.53) $ (289.31) Diluted net income (loss) per share $ 2.60 $ (98.00) $ (11.53) $ (289.31) |
Schedule of Common Stock that may potentially be issued in the future | September 30, 2022 September 30, 2021 (unaudited) (unaudited) Common stock warrants 482,359 183,391 Stock options 27,958 14,926 Convertible preferred stock (1) 24,321 24,045 Total shares of common stock issuable 534,638 222,362 (1) Convertible preferred stock is assumed to be converted at the rate of $231.00 per common share, which is the conversion price as of September 30, 2022 . |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
The Company and Basis of Presentation | ||
Cash and cash equivalents | $ 1,657,013 | $ 8,248,684 |
Accumulated deficit | (164,547,700) | $ (153,904,047) |
Working capital | 4,100,000 | |
Proceeds from issuance of shares | $ 5,200,000 |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
Nov. 30, 2022 | Sep. 30, 2022 | Sep. 29, 2022 | Aug. 26, 2022 | Jul. 29, 2022 | Jul. 22, 2022 | May 19, 2022 | Sep. 13, 2021 | Dec. 31, 2020 | Jul. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Significant accounting policies and recent accounting pronouncements | |||||||||||||||
Number of shares reduced due to reverse stock split | 30 | 10 | 30 | 10 | 30 | 10 | |||||||||
Restricted cash | $ 22,000 | $ 22,000 | $ 22,000 | $ 0 | |||||||||||
Cash in US banks in excess of FDIC insurance limits | 1,100,000 | 1,100,000 | $ 1,100,000 | 7,500,000 | |||||||||||
Finite-lived intangible asset, useful life (year) | 7 years 2 months 12 days | ||||||||||||||
Intangible asset impairment | $ 2,400,000 | ||||||||||||||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense) | ||||||||||||||
Asset impairment charges | $ 0 | ||||||||||||||
First Wave License Agreement | |||||||||||||||
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 | |||||||||||||
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 | 2,500,000 | $ 4,900,000 | $ 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 | |||||||||||||||
Significant accounting policies and recent accounting pronouncements | |||||||||||||||
Initial payment | $ 1,500,000 | ||||||||||||||
Second payment | $ 1,000,000 | ||||||||||||||
Third payment on completion of one or more qualifying equity offerings | 2,000,000 | ||||||||||||||
Upfront payment paid | 1,500,000 | ||||||||||||||
Second payment paid | 1,000,000 | ||||||||||||||
Extinguishment of remaining fixed payment obligations | $ 10,100,000 | ||||||||||||||
Third payment recorded as expense | $ 2,000,000 | ||||||||||||||
Payments made | $ 2,500,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Fair value disclosures | ||
Money market funds | $ 1,657,013 | $ 8,248,684 |
Note payable | 641,236 | |
Carrying Amount | ||
Fair value disclosures | ||
Note payable | 641,236 | |
Fair Value, Inputs, Level 2 | ||
Fair value disclosures | ||
Note payable | 641,236 | |
Money Market Funds | ||
Fair value disclosures | ||
Money market funds | 505,179 | 501,607 |
Money Market Funds | Carrying Amount | ||
Fair value disclosures | ||
Money market funds | 505,179 | 501,607 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair value disclosures | ||
Money market funds | $ 505,179 | $ 501,607 |
Asset Acquisition (Details)
Asset Acquisition (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 11 Months Ended | 12 Months Ended | ||||||||||
Nov. 30, 2022 | Sep. 30, 2022 | Sep. 29, 2022 | Jul. 29, 2022 | May 19, 2022 | Nov. 15, 2021 | Oct. 29, 2021 | Sep. 13, 2021 | Jul. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Jul. 31, 2023 | Dec. 31, 2021 | Mar. 02, 2022 | Mar. 10, 2021 | |
Shares issued price per share (in dollars per share) | $ 41.25 | $ 381.75 | |||||||||||||
First Wave Bio Inc [Member] | |||||||||||||||
Payment to acquire | $ 3,000,000 | ||||||||||||||
Asset acquired equity issued (in shares) | 20,800 | ||||||||||||||
Asset acquisition total purchase price | $ 22,000,000 | ||||||||||||||
Asset acquisition consideration transferred liabilities incurred | $ 8,000,000 | $ 7,000,000 | |||||||||||||
Maximum term for the payment of purchase price | 45 days | ||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Asset Acquisition, Potential Milestone Payments | $ 10,100,000 | $ 10,100,000 | 10,100,000 | $ 2,000,000 | |||||||||||
Asset acquisition consideration transferred | $ 2,000,000 | $ 1,000,000 | $ 1,500,000 | $ 2,500,000 | 4,900,000 | 7,000,000 | |||||||||
Cash consideration | $ 4,000,000 | $ 1,500,000 | |||||||||||||
Asset acquired equity issued (in shares) | 20,800 | ||||||||||||||
Shares issued price per share (in dollars per share) | $ 192.30 | ||||||||||||||
Asset Acquisition, Consideration Transferred, Contingent Consideration | $ 4,000,000 | ||||||||||||||
First Wave Bio Inc [Member] | Research and development | |||||||||||||||
Non-contingent purchase price | 21,300,000 | ||||||||||||||
First Wave Bio Inc [Member] | General and administrative expense. | |||||||||||||||
Consideration transaction cost | $ 900,000 | ||||||||||||||
First Wave Bio Inc [Member] | Former Stockholders | |||||||||||||||
Payment to acquire | $ 2,500,000 | ||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Awarded to other party | $ 8,000,000 | ||||||||||||||
First Wave Bio Inc [Member] | Development Achievement Threshold [Member] | |||||||||||||||
Asset Acquisition, Potential Milestone Payments | $ 207,000,000 | ||||||||||||||
Percentage of cash milestone payments | 25% | ||||||||||||||
First Wave Bio Inc [Member] | Patent Infringement [Member] | |||||||||||||||
Percentage of cash consideration | 10% | ||||||||||||||
First Wave Bio Inc [Member] | Settlement Agreement | |||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Awarded to other party | $ 15,000,000 | ||||||||||||||
Percentage of amount on the transactions consummated by the company | 10% | ||||||||||||||
Specified amount of transactions for applying percentage | $ 10,000,000 | ||||||||||||||
Stock cancelled during period, shares, acquisitions (in shares) | 332,913 | ||||||||||||||
Payment of periodic installments | $ 500,000 | ||||||||||||||
First Wave Bio Inc [Member] | Settlement Agreement | Forecast | |||||||||||||||
Payment of periodic installments | $ 1,000,000 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements - Property (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Equipment and Leasehold Improvements | |||||
Total property, plant, and equipment | $ 87,818 | $ 87,818 | $ 87,818 | ||
Less accumulated depreciation | (36,661) | (36,661) | (14,708) | ||
Property, plant and equipment, net | 51,157 | 51,157 | 73,110 | ||
Depreciation expense | 7,300 | $ 6,000 | 22,000 | $ 9,000 | |
Computer equipment and software | |||||
Property, Equipment and Leasehold Improvements | |||||
Total property, plant, and equipment | 11,540 | 11,540 | 11,540 | ||
Office equipment | |||||
Property, Equipment and Leasehold Improvements | |||||
Total property, plant, and equipment | 48,278 | 48,278 | 48,278 | ||
Leasehold improvements | |||||
Property, Equipment and Leasehold Improvements | |||||
Total property, plant, and equipment | $ 28,000 | $ 28,000 | $ 28,000 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Patents (Details) - USD ($) | Sep. 30, 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) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2021 | |
Intangible Assets and Goodwill | |||
Amortization expense | $ 132,000 | $ 396,000 | |
Intangible asset impairment | $ 2,400,000 | ||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense) |
Intangible Assets and Goodwil_5
Intangible Assets and Goodwill - Goodwill (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Intangible Assets and Goodwill | ||
Balance | $ 1,911,705 | $ 2,054,048 |
Foreign currency translation | (196,918) | (142,343) |
Balance | $ 1,714,787 | $ 1,911,705 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Professional fees | $ 205,932 | $ 15,000 |
Payroll and benefits | 25,565 | 104,100 |
Consulting fees | 40,771 | 274,153 |
Total accrued expenses | $ 272,268 | $ 393,253 |
Note Payable (Details)
Note Payable (Details) - USD ($) | Nov. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2021 |
Note Payable | |||
Note payables | $ 0 | $ 641,000 | |
Financing Agreement for Directors and Officer's Liability Insurance | |||
Note Payable | |||
Debt Instrument, term | 9 months | ||
Debt Instrument, face amount | $ 957,000 | ||
Debt instrument, interest Rate | 3.99% | ||
Debt instrument, periodic payment | $ 81,000 |
Capital Stock (Details)
Capital Stock (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||
Aug. 26, 2022 $ / shares shares | Jul. 27, 2022 USD ($) shares | Jul. 22, 2022 USD ($) $ / shares shares | Jul. 15, 2022 USD ($) $ / shares shares | May 12, 2022 $ / shares shares | Mar. 02, 2022 USD ($) $ / shares shares | Feb. 07, 2022 USD ($) $ / shares | Sep. 13, 2021 shares | May 26, 2021 shares | Mar. 10, 2021 USD ($) $ / shares shares | Jan. 06, 2021 USD ($) | Mar. 31, 2021 USD ($) | Jan. 31, 2021 $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) shares | Jul. 31, 2022 | Feb. 13, 2022 shares | Nov. 30, 2019 USD ($) shares | |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | 25,000,000 | ||||||||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 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 | 30 | 10 | 30 | 10 | 30 | 10 | ||||||||||||||||
Common stock, shares, issued, total (in shares) | 2,307,008 | 2,307,008 | 495,194 | |||||||||||||||||||
Common stock, shares, outstanding, ending balance (in shares) | 2,307,008 | 2,307,008 | 495,194 | |||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 37.80 | |||||||||||||||||||||
Purchase of aggregate common stock | 482,359 | 183,391 | 482,359 | 183,391 | 183,999 | 83,687 | ||||||||||||||||
Deemed dividend on warrant modifications | $ | $ (47,000) | $ (47,300) | ||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 1 | 666 | 666 | |||||||||||||||||||
Stock issued during period, value, new issues | $ | $ 7,373,355 | $ 7,150,847 | 7,691,222 | $ 8,325,195 | ||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 8,000,000 | 7,971,932 | $ 18,156,050 | |||||||||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 55,000 | 19,333 | ||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 41.25 | $ 381.75 | ||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | 5 years | ||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 5,200,000 | |||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 4.50 | |||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 34,848 | |||||||||||||||||||||
Canceled | 98 | 56 | 98 | |||||||||||||||||||
Reverse stock split ratio | 30 | 10 | 30 | |||||||||||||||||||
Payments of Stock Issuance Costs | $ | $ 138,684 | |||||||||||||||||||||
Pre-funded warrants to purchase of common stock | 6,861 | |||||||||||||||||||||
FWB | ||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 11,097 | |||||||||||||||||||||
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 | $ 3 | |||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 13,097 | |||||||||||||||||||||
January 2021 Investor Warrants | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 240 | |||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 35,555 | |||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 3,400,000 | |||||||||||||||||||||
Series C Warrants | ||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 216,606 | |||||||||||||||||||||
Pre-Funded Warrant | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 51.90 | $ 0.9 | $ 0.9 | |||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 161,606 | |||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 41.55 | |||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | |||||||||||||||||||||
Offering costs | $ | $ 2,300,000 | |||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 300,000 | |||||||||||||||||||||
January 2021 Placement Agent Warrants | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 281.25 | $ 281.25 | ||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 2,488 | 2,488 | ||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 225 | $ 225 | ||||||||||||||||||||
Percentage Of Common Stock Issued In Offering | 7% | |||||||||||||||||||||
March 2022 Prefunded Warrants [Member] | ||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 1 | |||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | $ 6,400,000 | |||||||||||||||||||||
March 2021 Placement Agent Warrants | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 477.18 | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1,833 | |||||||||||||||||||||
Equity Offering, Price Per Share (in dollars per share) | $ / shares | $ 381.75 | |||||||||||||||||||||
Percentage of warrants issued | 7% | |||||||||||||||||||||
Percentage of exercise price of warrants | 125% | |||||||||||||||||||||
Waiver | ||||||||||||||||||||||
Purchase of aggregate common stock | 251,742 | |||||||||||||||||||||
Waiver | Warrants. | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.25 | |||||||||||||||||||||
Series C Preferred Stock Converted into Common Stock | ||||||||||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 104,182 | |||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 33,097.10 | |||||||||||||||||||||
Issuance of stock upon conversion of securities | $ | $ 24,700,000 | |||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 198,000 | |||||||||||||||||||||
Series B Preferred Stock Converted into Common Stock | ||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 8,609 | |||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 258.08 | |||||||||||||||||||||
Issuance of stock upon conversion of securities | $ | $ 2,000,000 | |||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 3,000 | |||||||||||||||||||||
Series B Preferred Stock Exchanged for Common Shares | ||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 30.92 | |||||||||||||||||||||
Issuance of stock upon conversion of securities | $ | $ 238,000 | |||||||||||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 27,000 | |||||||||||||||||||||
Series B Preferred Stock Exchanged for Common Shares | Series C Warrants | ||||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 6,374 | |||||||||||||||||||||
Consultants [Member] | ||||||||||||||||||||||
Stock Issued During Period, Shares, Settlement (in shares) | 673 | 3,001 | 3,240 | |||||||||||||||||||
Stock Issued During Period, Value, Settlement | $ | $ 124,000 | $ 119,000 | $ 1,200,000 | |||||||||||||||||||
Officers and Directors | Waiver | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.3294 | |||||||||||||||||||||
Former Investor Bank | ||||||||||||||||||||||
Stock Issued During Period, Value, Settlement | $ | $ 94,000 | |||||||||||||||||||||
Shares issued for settlement (in shares) | 250 | |||||||||||||||||||||
Equity Line Agreement | Lincoln Park | ||||||||||||||||||||||
Common stock, shares, issued, total (in shares) | 1,623 | |||||||||||||||||||||
Fair value of commitment shares on grant date | $ | $ 297,000 | |||||||||||||||||||||
At The Market Offering Agreement | ||||||||||||||||||||||
Stock issued during period, value, new issues | $ | $ 7,400,000 | $ 7,700,000 | ||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 1,483,782 | 1,519,257 | ||||||||||||||||||||
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 | |||||||||||||||||||||
Market Agreement | H C Wainwright Co L L C | ||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 7,700,000 | 7,400,000 | $ 8,000,000 | $ 8,600,000 | ||||||||||||||||||
Stock issuance costs | $ | $ 293,000 | $ 228,000 | $ 309,000 | $ 274,000 | ||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 1,483,782 | 50,055 | 1,519,257 | 55,040 | ||||||||||||||||||
March 2021 Offering | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity Net | $ | $ 9,100,000 | |||||||||||||||||||||
Offering costs | $ | $ 900,000 | |||||||||||||||||||||
January 2021 offering | ||||||||||||||||||||||
Offering costs | $ | 900,000 | |||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ | 7,100,000 | $ 7,100,000 | ||||||||||||||||||||
March 2022 offering | ||||||||||||||||||||||
Stock issued during period, value, new issues | $ | $ 8,000,000 | |||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 55,000 | |||||||||||||||||||||
Proceeds from Issuance or Sale of Equity Net | $ | $ 1,000,000 | $ 9,000,000 | ||||||||||||||||||||
Offering costs | $ | $ 1,000,000 | |||||||||||||||||||||
July 2021 offering | ||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 5,100,000 | |||||||||||||||||||||
Underwriting option | 30 days | |||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 4,545 | |||||||||||||||||||||
July 2021 offering | Wainwright Warrants | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 206.25 | |||||||||||||||||||||
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 | ||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 2,437 | |||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 30,303 | |||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 165 | |||||||||||||||||||||
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% | |||||||||||||||||||||
Direct offering | Pre-Funded Warrant | ||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 12,996 | 2.6 | 2.6 | |||||||||||||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 6% | 3.50% | ||||||||||||||||||||
Private Placement | ||||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 4,000 | |||||||||||||||||||||
Gross proceeds from private placement | $ | $ 300,000 | |||||||||||||||||||||
Percentage of cash fees paid to placement agent | 7% | |||||||||||||||||||||
Warrant | ||||||||||||||||||||||
Class of warrant or right, exercised during period (in shares) | 31,712 | |||||||||||||||||||||
Pre-Funded Warrants | ||||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 0.30 | $ 0.30 | ||||||||||||||||||||
Conversion of stock, shares issued (in shares) | 161,606 | |||||||||||||||||||||
Class of warrant or right, exercised during period (in shares) | 13,305 | |||||||||||||||||||||
Series B Preferred Stock | ||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 5,194.805195 | 5,194.805195 | 5,194.805195 | |||||||||||||||||||
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) | 631.34 | 631.34 | 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 | $ | $ 764,000 | $ 465,000 | ||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 63,736 | 63,736 | ||||||||||||||||||||
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, shares outstanding (in shares) | 631.34 | 631.34 | 662.25 | |||||||||||||||||||
Series B Preferred Stock | Waiver | ||||||||||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||
Cash waiver fee (in percentage) | 10% | |||||||||||||||||||||
Preferred stock, alternate redemption value | $ | $ 7,700 | |||||||||||||||||||||
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 C Preferred Stock | ||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 57,000 | 57,000 | 57,000 | |||||||||||||||||||
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 | |||||||||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 19,140.14 | 19,140.14 | ||||||||||||||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 63,800 | 63,800 | ||||||||||||||||||||
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 | 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) | 17,777 | 17,777 | ||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 5,333.33 | |||||||||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 750 | $ 750 | ||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 225 | $ 225 | ||||||||||||||||||||
Series C Preferred Stock | January 2021 Private Placement | ||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 5,333.33 | |||||||||||||||||||||
Series C Preferred Stock | Private Placement | ||||||||||||||||||||||
Number of common shares issuable upon conversion | 33,333 | |||||||||||||||||||||
Series D Preferred Stock | ||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 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 | |||||||||||||||||||
Conversion of stock, shares issued (in shares) | 66,666 | |||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||||||||||||||
Series D Preferred Stock | Private Placement | ||||||||||||||||||||||
Number of shares reduced due to reverse stock split | 33,333 | |||||||||||||||||||||
Preferred stock, stated value per share (in dollars per share) | $ / shares | $ 1,000 | |||||||||||||||||||||
Number of common shares issuable upon conversion | 66,666 | 66,666 | ||||||||||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 66,666 | |||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 150 | |||||||||||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 4.50 | |||||||||||||||||||||
Series E Preferred Stock | ||||||||||||||||||||||
Preferred stock, shares designated (in shares) | 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 | |||||||||||||||||||
Conversion of stock, shares issued (in shares) | 66,666 | |||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||||||||||||||
Series E Preferred Stock | 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 | 33,333 | |||||||||||||||||||||
Number of common shares issuable upon conversion | 33,333 | |||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 4.50 | |||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 150 | |||||||||||||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 363 | |||||||||||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 20,800 | 31,521 | ||||||||||||||||||||
Common Stock | Pre-Funded Warrant | ||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.30 | $ 3.9 | $ 3.9 | |||||||||||||||||||
March 2021 and July 2021 Offering | ||||||||||||||||||||||
Stock issued during period, shares, new issues (in shares) | 54,181 | |||||||||||||||||||||
Maximum | Equity Line Agreement | Lincoln Park | ||||||||||||||||||||||
Issuance of available Equity Line Agreement | $ | $ 15,000,000 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2022 | Mar. 02, 2022 | Mar. 31, 2021 | Mar. 10, 2021 | Jan. 31, 2021 | |
Number of Warrants | |||||||||
Warrants outstanding and exercisable, beginning (in shares) | 183,999 | 83,687 | 83,687 | ||||||
Issued (in shares) | 464,245 | 133,114 | |||||||
Expired (in shares) | (4,279) | (1,698) | |||||||
Exercised (in shares) | (161,606) | (31,712) | |||||||
Warrants outstanding and exercisable, ending (in shares) | 482,359 | 183,391 | 183,999 | 83,687 | |||||
Weighted Average Exercise Price Per Share | |||||||||
Warrants outstanding and exercisable, beginning (in dollars per share) | $ 284.70 | $ 366 | $ 366 | ||||||
Issued (in dollars per share) | 20.36 | 233.03 | |||||||
Expired (in dollars per share) | 1,125.78 | 1,080.16 | |||||||
Exercised (in dollars per share) | 0.30 | 159.32 | |||||||
Warrants outstanding and exercisable, ending (in dollars per share) | $ 90.19 | $ 298.47 | $ 284.70 | $ 366 | |||||
Weighted Average Remaining Term in Years | |||||||||
Outstanding and exercisable (in years) | 4 years 25 days | 4 years 1 month 28 days | 3 years 11 months 12 days | 4 years 14 days | |||||
Issued (in years) | 4 years 5 months 26 days | 4 years 1 month 9 days | |||||||
Exercised (in years) | 4 years 5 months 1 day | 4 years 1 month 6 days | |||||||
Warrants to purchase of stock | 666 | 1 | |||||||
Warrant exercise price | $ 37.80 | ||||||||
Shares issued, price per share (in dollars per share) | $ 41.25 | $ 381.75 | |||||||
Warrant amendment agreement | |||||||||
Weighted Average Remaining Term in Years | |||||||||
Warrant exercise price | $ 0.8430 | $ 363 | $ 240 | ||||||
Consideration for purchase of securities | $ 9 | ||||||||
March Offering [Member] | |||||||||
Weighted Average Remaining Term in Years | |||||||||
Shares issued, price per share (in dollars per share) | $ 37.80 | ||||||||
Maximum | Warrant amendment agreement | |||||||||
Weighted Average Remaining Term in Years | |||||||||
Warrants to purchase of stock | 13,097 | 35,555 |
Warrant - Series B, Pre-funded
Warrant - Series B, Pre-funded and Placement agent Warrants (Details) - $ / shares | Sep. 30, 2022 | Mar. 02, 2022 | Sep. 30, 2021 |
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 1 | 666 | |
Warrant exercise price | $ 37.80 | ||
Series B preferred stock | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 63,736 | ||
July 2022 offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 66,666 | ||
July 2022 offering | Series B preferred stock | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 6,374 | ||
Warrants, pre-funded warrants, and placement agent warrants | January 2021 offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 44,486 | ||
Warrants, pre-funded warrants, and placement agent warrants | March 2021 offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 21,789 | ||
Warrants, pre-funded warrants, and placement agent warrants | March 2022 offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 391,205 | ||
Warrants, pre-funded warrants, and placement agent warrants | July 2021 offering | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase of Common stock | 2,437 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional information (Details) | 3 Months Ended | 9 Months Ended | 21 Months Ended | ||||
Sep. 11, 2020 shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Jan. 01, 2022 shares | |
Equity Incentive Plan | |||||||
Granted | 22,938 | 5,841 | |||||
Options cancelled | 98 | 56 | 98 | ||||
Unrecognized stock-based compensation expense | $ | $ 900,000 | $ 1,100,000 | $ 900,000 | $ 1,100,000 | $ 900,000 | ||
First commercial sale in the United States of Adrulipase | |||||||
Equity Incentive Plan | |||||||
Unrecognized expense vests | $ | 197,000 | 197,000 | |||||
Vesting Over Remaining Term | |||||||
Equity Incentive Plan | |||||||
Unrecognized stock-based compensation expense | $ | 400,000 | 900,000 | $ 400,000 | $ 900,000 | $ 400,000 | ||
Average remaining vesting term of the stock options (in years) | 8 years 5 months 8 days | 1 year 10 months 6 days | |||||
Vests upon total market capitalization exceeding one million | |||||||
Equity Incentive Plan | |||||||
Consecutive trading days | $ | 20 | ||||||
Unrecognized expense vests | $ | $ 197,000 | $ 197,000 | |||||
Vests upon total market capitalization exceeding one million | Maximum | |||||||
Equity Incentive Plan | |||||||
Unrecognized stock-based compensation expense | $ | 1,000,000,000 | 1,000,000,000 | 1,000,000,000 | 1,000,000,000 | $ 1,000,000,000 | ||
Clinical, corporate milestones | |||||||
Equity Incentive Plan | |||||||
Unrecognized stock-based compensation expense | $ | 500,000 | 300,000 | $ 500,000 | $ 300,000 | 500,000 | ||
Incentive Stock Options | |||||||
Equity Incentive Plan | |||||||
Granted | 50,000 | ||||||
Restricted Stock | |||||||
Equity Incentive Plan | |||||||
Vested during the period (in shares) | 916 | 916 | |||||
Restricted Stock | Common Stock | |||||||
Equity Incentive Plan | |||||||
Unrecognized stock-based compensation expense | $ | $ 394,000 | $ 394,000 | $ 394,000 | $ 394,000 | $ 394,000 | ||
Stock Option | |||||||
Equity Incentive Plan | |||||||
Weighted average fair value of warrants granted (in dollars per share) | $ / shares | $ 31.96 | $ 201.24 | |||||
2020 Equity Incentive Plan | |||||||
Equity Incentive Plan | |||||||
Shares available under equity incentive plan (in shares) | 33,333 | 70,478 | |||||
Percentage of common stock reserved for issuance equity incentive plan | 10% | ||||||
Shares reserved subject to issuance (in shares) | 47,532 | 47,532 | 47,532 | ||||
Options to purchase shares of common stock (in shares) | 22,946 | 22,946 | 22,946 | ||||
Vesting period | 36 months | ||||||
Options cancelled | 3,745 | 4,482 | |||||
Options forfeited | 4,972 | ||||||
Equity Incentive Plan2014 | |||||||
Equity Incentive Plan | |||||||
Shares available under equity incentive plan (in shares) | 8,680 | 8,680 | 8,680 | ||||
Options to purchase shares of common stock (in shares) | 5,012 | 5,012 | 5,012 | ||||
The 2014 Omnibus Equity Incentive Plan | Restricted Stock | |||||||
Equity Incentive Plan | |||||||
Shares reserved subject to issuance (in shares) | 2,094 | 2,094 | 2,094 |
Equity Incentive Plan - Stock o
Equity Incentive Plan - Stock option activity (Details) - $ / shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numbers of Shares | ||||||
Granted (in shares) | 22,938 | 5,841 | ||||
Canceled (in shares) | (98) | (56) | (98) | |||
Incentive Stock Options | ||||||
Numbers of Shares | ||||||
Granted (in shares) | 50,000 | |||||
Equity Incentive Plan 2014 And Plan 2020 | Incentive Stock Options | ||||||
Numbers of Shares | ||||||
Outstanding at beginning (in shares) | 13,737 | 13,567 | 13,567 | |||
Granted (in shares) | 22,938 | 5,841 | ||||
Canceled (in shares) | (3,745) | |||||
Forfeited (in shares) | (4,972) | (4,482) | ||||
Outstanding at ending (in shares) | 27,958 | 14,926 | 27,958 | 14,926 | 13,737 | 13,567 |
Exercisable (in shares) | 13,740 | 9,342 | 13,740 | 9,342 | ||
Average Exercise Price | ||||||
Outstanding at beginning (in dollars per share) | $ 353.73 | $ 373.80 | $ 373.80 | |||
Granted (in dollars per share) | 41.17 | 258.30 | ||||
Canceled (in dollars per share) | 355.14 | |||||
Forfeited (in dollars per share) | 120.20 | 314.10 | ||||
Outstanding at ending (in dollars per share) | $ 138.63 | $ 346.50 | 138.63 | 346.50 | $ 353.73 | $ 373.80 |
Exercisable (in dollars per share) | $ 215.59 | $ 412.80 | $ 215.59 | $ 412.80 | ||
Remaining Contract Life (Years) | ||||||
Stock option outstanding, remaining contractual life (Years) | 8 years 5 months 12 days | 7 years 6 months 25 days | 7 years 3 months 10 days | 7 years 11 months 8 days | ||
Granted (in years) | 7 years 6 months | 10 years | ||||
Canceled (in years) | 0 years | |||||
Forfeited (in years) | 0 years | 2 years 10 months 13 days | ||||
Exercisable (in years) | 7 years 9 months | 6 years 9 months 10 days |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-average assumptions (Details) - Stock Option | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Contractual term (in years) | 6 years 6 months | 10 years |
Expected Volatility | 90.92% | 88.71% |
Risk-free interest rate | 1.12% | 1.29% |
Expected Dividend yield | 0% | 0% |
Equity Incentive Plan - Total s
Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Equity Incentive Plan | ||||
Total stock-based compensation expense | $ 91,641 | $ 182,414 | $ 684,778 | $ 1,268,710 |
Research and development | ||||
Equity Incentive Plan | ||||
Total stock-based compensation expense | 22,623 | 126,611 | 93,870 | 556,688 |
General and administrative expense. | ||||
Equity Incentive Plan | ||||
Total stock-based compensation expense | $ 69,018 | $ 55,803 | $ 590,908 | $ 712,022 |
Agreements (Details)
Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Feb. 24, 2021 | Jan. 08, 2021 | Dec. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2020 | Aug. 26, 2022 | Mar. 02, 2022 | Jun. 30, 2021 | Mar. 10, 2021 | |
Agreements | |||||||||||||
Research and development expense, total | $ 791,067 | $ 3,052,791 | $ 8,674,480 | $ 11,216,616 | |||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ 4.50 | ||||||||||||
Shares issued, price per share (in dollars per share) | $ 41.25 | $ 381.75 | |||||||||||
Fair value, option, changes in fair value, gain (loss) | $ 532,353 | ||||||||||||
Series C Preferred Stock | |||||||||||||
Agreements | |||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 19,140.14 | 19,140.14 | 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 | $ 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 | 37,000,000 | |||||||||||
Research and development expense, total | $ 1,000,000 | ||||||||||||
Asset acquisition, consideration transferred, equity interest issued and issuable | 3,000,000 | $ 3,000,000 | |||||||||||
Period for conversion of common stock | 5 days | ||||||||||||
Fair value, option, changes in fair value, gain (loss) | $ 500,000 | ||||||||||||
Convertible preferred stock, nonredeemable or redeemable, issuer option, value | 3,000,000 | $ 3,000,000 | |||||||||||
Redeemable noncontrolling interest, equity, common, fair value | $ 2,500,000 | $ 2,500,000 | |||||||||||
First Wave License Agreement | Convertible Preferred Stock | |||||||||||||
Agreements | |||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ 273.54 | $ 273.54 | |||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 10,967 | 10,967 | |||||||||||
First Wave License Agreement | Series C Preferred Stock | |||||||||||||
Agreements | |||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ 225 | ||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 10,967 | ||||||||||||
Stock issued during period, shares, new issues (in shares) | 3,290.1960 | ||||||||||||
Shares issued, price per share (in dollars per share) | $ 750 |
Leases (Details)
Leases (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) ft² property | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² property | Sep. 30, 2021 USD ($) | |
Leases [Line Items] | ||||
Number of real property operating leases | property | 2 | 2 | ||
Operating lease, expense | $ | $ 36,000 | $ 79,000 | $ 115,000 | $ 186,000 |
Boca Raton, Florida | ||||
Leases [Line Items] | ||||
Area of real estate property (Square Foot) | ft² | 3,472 | 3,472 |
Leases - Weighted-average remai
Leases - Weighted-average remaining lease term (Details) | Sep. 30, 2022 |
Leases | |
Weighted-average remaining lease term (years) | 3 years 10 months 24 days |
Weighted-average discount rate | 7% |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) | Sep. 30, 2022 USD ($) |
Leases | |
2022 (remainder of year) | $ 20,563 |
2023 | 83,691 |
2024 | 86,202 |
2025 | 88,788 |
2026 | 60,593 |
Total lease payments | 339,837 |
Less imputed interest | (44,148) |
Present value of lease liabilities | $ 295,689 |
Net Income (Loss) per Common _3
Net Income (Loss) per Common Share - Basic and diluted net income (loss) per share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net income (loss) | $ 4,391,331 | $ (30,400,788) | $ (10,643,653) | $ (47,365,362) |
Basic weighted average shares outstanding | 1,601,415 | 311,411 | 952,794 | 253,118 |
Shares of common stock issuable | 534,638 | 222,362 | ||
Diluted weighted average shares outstanding | 1,625,736 | 311,411 | 952,794 | 253,118 |
Basic net income (loss) per share | $ 2.64 | $ (98) | $ (11.53) | $ (289.31) |
Diluted net income (loss) per share | $ 2.60 | $ (98) | $ (11.53) | $ (289.31) |
Convertible preferred stock | ||||
Shares of common stock issuable | 24,321 | 24,321 | 24,045 |
Net Income (Loss) per Common _4
Net Income (Loss) per Common Share - Common Stock that may potentially be issued (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Aug. 26, 2022 | |
Net Income (Loss) per Common Share | ||||
Total shares of common stock issuable | 534,638 | 222,362 | ||
Preferred stock, convertible, conversion price (in dollars per share) | $ 4.50 | |||
Common stock warrants | ||||
Net Income (Loss) per Common Share | ||||
Total shares of common stock issuable | 482,359 | 183,391 | ||
Stock options | ||||
Net Income (Loss) per Common Share | ||||
Total shares of common stock issuable | 27,958 | 14,926 | ||
Convertible preferred stock | ||||
Net Income (Loss) per Common Share | ||||
Total shares of common stock issuable | 24,321 | 24,321 | 24,045 | |
Preferred stock, convertible, conversion price (in dollars per share) | $ 231 | $ 231 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee Benefit Plans | ||||
Defined contribution plan, employers matching contribution, annual vesting percentage | 6% | |||
Defined benefit plan, plan assets, contributions by employer | $ 21,000 | $ 26,000 | $ 97,000 | $ 81,000 |
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) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||||||
Oct. 06, 2022 | Jul. 15, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Oct. 05, 2022 | Jul. 31, 2022 | Mar. 02, 2022 | Mar. 10, 2021 | |
Subsequent Event [Line Items] | ||||||||
Warrant exercise price | $ 37.80 | |||||||
Warrants term | 5 years | 5 years | ||||||
At The Market Offering Agreement | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 1,483,782 | 1,519,257 | ||||||
Series D Preferred Stock | Private Placement | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 150 | |||||||
Series E Preferred Stock | Private Placement | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 150 | |||||||
Warrant exercise price | $ 4.50 | |||||||
Warrants term | 5 years | |||||||
Subsequent Event | October 2022 Offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 255,000 | |||||||
Proceeds from issuance of warrants | $ 5.2 | |||||||
Subsequent Event | October 2022 Pre-Funded Warrants | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 3,183,396 | |||||||
Warrant exercise price | $ 0.0001 | |||||||
Warrant to purchase of shares | 1 | |||||||
Share price | $ 1.7449 | |||||||
Subsequent Event | October 2022 Warrants | ||||||||
Subsequent Event [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 3,438,396 | |||||||
Warrant exercise price | $ 1.62 | |||||||
Warrant to purchase of shares | 1 | |||||||
Share price | $ 1.745 | |||||||
Warrants term | 5 years | |||||||
Subsequent Event | July 2022 Offerings | ||||||||
Subsequent Event [Line Items] | ||||||||
Warrant to purchase of shares | 4,000 |