Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 $0.0001 per share | |
Trading Symbol | FWBI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,813,663 | |
Entity Central Index Key | 0001604191 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 2,064,435 | $ 1,362,910 |
Other receivables | 20,000 | 93,014 |
Prepaid expenses | 1,445,438 | 1,956,831 |
Total Current Assets | 3,529,873 | 3,412,755 |
Property, equipment, and leasehold improvements, net | 36,521 | 43,839 |
Other Assets: | ||
Restricted Cash | 21,518 | 21,513 |
Goodwill | 1,684,182 | 1,684,182 |
Operating lease right-of-use assets | 243,733 | 259,261 |
Deposits | 18,149 | 18,149 |
Total Other Assets | 1,967,582 | 1,983,105 |
Total Assets | 5,533,976 | 5,439,699 |
Current Liabilities: | ||
Accounts payable | 469,760 | 720,040 |
Accrued expenses | 845,728 | 320,176 |
Accrued dividend payable | 848,919 | 761,488 |
Note payable | 380,390 | 603,494 |
Operating lease liabilities | 67,936 | 66,151 |
Other current liabilities | 12,123 | 12,138 |
Total Current Liabilities | 2,624,856 | 2,483,487 |
Non-current operating lease liabilities | 196,524 | 214,060 |
Total Liabilities | 2,821,380 | 2,697,547 |
Stockholders' Equity: | ||
Common stock - Par value $0.0001 per share; 50,000,000 shares authorized; 1,549,581 and 995,003 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 155 | 100 |
Additional paid-in capital | 175,316,783 | 171,275,741 |
Accumulated deficit | (172,604,342) | (168,533,689) |
Total Stockholders' Equity | 2,712,596 | 2,742,152 |
Total Liabilities and Stockholders' Equity | 5,533,976 | 5,439,699 |
Series B Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | ||
Series C Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | ||
Series D Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | ||
Series E Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | ||
Series F Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Mar. 31, 2023 | Jan. 31, 2023 | Dec. 31, 2022 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | ||
Common stock, shares issued (in shares) | 1,549,581 | 995,003 | ||
Common stock, shares outstanding (in shares) | 1,549,581 | 995,003 | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||
Preferred stock, shares designated (in shares) | 10,000,000 | |||
Series B Preferred Stock | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated (in shares) | 5,194.81 | 5,194.81 | ||
Preferred stock, shares issued (in shares) | 545.94 | 550.17 | ||
Preferred stock, shares outstanding (in shares) | 545.94 | 550.17 | ||
Series C Preferred Stock | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated (in shares) | 75,000 | 75,000 | ||
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 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |
Series E Preferred Stock | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated (in shares) | 150 | 150 | ||
Preferred stock, shares issued (in shares) | 0 | 0 | ||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||
Series F Preferred Stock | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated (in shares) | 7,000 | 7,000 | ||
Preferred stock, shares issued (in shares) | 0 | 0 | ||
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development expenses | $ 1,361,683 | $ 4,976,517 |
General and administrative expenses | 2,700,742 | 4,405,555 |
Total operating expenses | 4,062,425 | 9,382,072 |
Loss from operations | (4,062,425) | (9,382,072) |
Other expense: | ||
Interest expense | (8,987) | (5,605) |
Interest income | 1,873 | 139 |
Other expense | (1,114) | (239,301) |
Total expense | (8,228) | (244,767) |
Net loss | (4,070,653) | (9,626,839) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | (58,405) | |
Total comprehensive loss | (4,070,653) | (9,685,244) |
Net loss | (4,070,653) | (9,626,839) |
Preferred stock dividends | (87,431) | (90,792) |
Net loss applicable to common shareholders | $ (4,158,084) | $ (9,717,631) |
Basic weighted average shares outstanding | 2,280,679 | 74,022 |
Diluted weighted average shares outstanding | 2,280,679 | 74,022 |
Loss per share - basic | $ (1.82) | $ (138.28) |
Loss per share -diluted | $ (1.82) | $ (138.28) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) - USD ($) | Convertible preferred stock Series B Convertible Preferred Stock | Common Stock Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
Balance at the beginning at Dec. 31, 2021 | $ 7 | $ 147,306,625 | $ (153,904,047) | $ (1,224,135) | $ (7,821,550) | ||
Balance at the beginning (in shares) at Dec. 31, 2021 | 662 | 70,742 | |||||
Issuance of common stock, pre-funded warrants and warrants in Private placement and registered direct offering, net of issuance costs (in shares) | 7,857 | ||||||
Issuance of common stock, pre-funded warrants and warrants in Private placement and registered direct offering, net of issuance costs | $ 1 | 7,972,090 | 7,972,091 | ||||
Exercise of pre-funded warrants into common stock | $ 2 | 48,480 | 48,482 | ||||
Exercise of pre-funded warrants into common stock (in shares) | 23,086 | ||||||
Deemed dividend of Series B preferred stock | (90,792) | (90,792) | |||||
Conversion of Series B preferred shares into common stock (in shares) | (17) | 499 | |||||
Common stock and warrants issued to consultants | 118,999 | 118,999 | |||||
Common stock and warrants issued to consultants (in shares) | 429 | ||||||
Stock-based compensation | 218,229 | 218,229 | |||||
Foreign currency translation adjustment | (58,405) | (58,405) | |||||
Net loss | (9,626,839) | (9,626,839) | |||||
Balance at the end at Mar. 31, 2022 | $ 10 | 155,573,631 | (163,530,886) | $ (1,282,540) | (9,239,785) | ||
Balance at the end (in shares) at Mar. 31, 2022 | 645 | 102,613 | |||||
Balance at the beginning at Dec. 31, 2022 | $ 100 | 171,275,741 | (168,533,689) | 2,742,152 | |||
Balance at the beginning (in shares) at Dec. 31, 2022 | 550 | 995,003 | |||||
Issuance of common stock, pre-funded warrants and warrants in Private placement and registered direct offering, net of issuance costs (in shares) | 128,000 | ||||||
Issuance of common stock, pre-funded warrants and warrants in Private placement and registered direct offering, net of issuance costs | $ 13 | 3,769,898 | 3,769,911 | ||||
Exercise of pre-funded warrants into common stock | $ 42 | 259 | 301 | ||||
Exercise of pre-funded warrants into common stock (in shares) | 429,475 | ||||||
Deemed dividend of Series B preferred stock | (87,431) | (87,431) | |||||
Conversion of Series B preferred shares into common stock (in shares) | (4) | 70 | |||||
Effect of cancelled shares from the 1-for-7 reverse stock split (in shares) | (2,967) | ||||||
Stock-based compensation | 358,316 | 358,316 | |||||
Net loss | (4,070,653) | (4,070,653) | |||||
Balance at the end at Mar. 31, 2023 | $ 155 | $ 175,316,783 | $ (172,604,342) | $ 2,712,596 | |||
Balance at the end (in shares) at Mar. 31, 2023 | 546 | 1,549,581 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) (Parenthetical) - shares | 3 Months Ended | |||
Jan. 18, 2023 | Aug. 26, 2022 | Sep. 13, 2021 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) | ||||
Reverse stock splits (in shares) | 7 | 30 | 10 | 1 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (4,070,653) | $ (9,626,839) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 7,318 | 7,317 |
Change in right-of-use assets | 15,528 | 23,188 |
Stock-based compensation | 358,316 | 218,229 |
Common stock granted to consultants | 118,999 | |
Changes in assets and liabilities: | ||
Other receivables | 73,014 | (28,055) |
Prepaid expenses | 511,393 | 349,140 |
Lease liabilities | (15,751) | (53,883) |
Deposits | 9,615 | |
Accounts payable | (250,280) | 1,996,602 |
Accrued expenses | 525,552 | (930,144) |
Other liabilities | (15) | 3,757 |
Net cash used in operating activities | (2,845,578) | (7,912,074) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, prefunded warrants and warrants, net | 3,769,911 | 7,972,091 |
Proceeds from exercise of warrants | 301 | 48,482 |
Payment made related to acquisition agreement | (2,414,956) | |
Repayments of note payable | (223,104) | (238,470) |
Net cash provided by financing activities | 3,547,108 | 5,367,147 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 701,530 | (2,544,927) |
Effect of exchange rate changes on cash | (8,769) | |
Cash, cash equivalents and restricted cash, beginning balance | 1,384,423 | 8,248,684 |
Cash, cash equivalents and restricted cash, ending balance | 2,085,953 | 5,694,988 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 8,987 | 5,605 |
Non-cash investing and financing activities: | ||
Accrued dividends on preferred stock | $ (87,431) | $ (90,792) |
The Company and Basis of Presen
The Company and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
The Company and Basis of Presentation | |
The Company and Basis of Presentation | Note 1 - The Company and Basis of Presentation The Company First Wave BioPharma, Inc. (“ First Wave FWB GI The Company is currently focused on developing its pipeline of gut-restricted GI clinical drug candidates, including the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties. The Company’s adrulipase programs are focused on the development of an oral, non-systemic, biologic capsule for the treatment of exocrine pancreatic insufficiency (“ EPI CF CP The Company is developing its product candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Since its inception, the Company has devoted substantially all its efforts to research and development, business development, and raising capital, and has financed its operations through issuance of common stock, convertible preferred stock, convertible debt, and other debt/equity instruments. 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. 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 maintain 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. 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, 2022, 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, 2022, filed with the SEC on March 20, 2023. Going Concern Uncertainty The accompanying unaudited interim condensed consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On March 31, 2023, the Company had cash and cash equivalents of approximately $2.1 million, an accumulated deficit of approximately $172.6 million, and working capital of approximately $0.9 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 March 31, 2023, the Company anticipates having sufficient cash to fund planned operations through June 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 | 3 Months Ended |
Mar. 31, 2023 | |
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 the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. Reverse Stock Split On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, with a corresponding 1-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 2023 presentation. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less from the date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at March 31, 2023 and December 31, 2022. As of March 31, 2023 and December 31, 2022, the Company has classified approximately $0.02 million as restricted cash. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At March 31, 2023 the Company had approximately $2.1 million in one account in the U.S. which was in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. Fair Value Measurements The Company follows Accounting Standards Codification ( ASC ( ASC 820 As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. Foreign Currency Translation For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities were translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items were translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments were accumulated in a separate component of stockholders’ equity up until the dissolution of AzurRx SAS in October 2022, at which time cumulative translation adjustments were recognized as a loss for the year ended December 31, 2022. Goodwill Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through March 31, 2023 related to goodwill. Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment ( ASC 360 Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. Research and Development Research and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related to patents. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“ CROs CDMOs CMC Research and Development – 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 September 13, 2021, the Company entered into an agreement with FWB for the acquisition of intellectual property and patents for the worldwide, exclusive right to develop, manufacture, and commercialize proprietary formulations of niclosamide for the fields of treating ICI-AC and COVID-19 in humans, which was accounted for as an asset acquisition (see Note 4). On July 29, 2022, the Company reached an agreement to restructure its obligations to the former FWB stockholders (the “ July 2022 Term Sheet Second Payment Stock-Based Compensation The Company’s board of directors (the “ Board 2014 Plan 2020 Plan ASC 718 For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (the “ FASB ASU 2020-06 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements (“ ASU 2016-13 In June 2022, the FASB issued ASU 2022-03 - Fair Value Measurement, or Topic 820: Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ ASU 2022-03 The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. |
Fair Value Disclosures
Fair Value Disclosures | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures | |
Fair Value Disclosures | Note 3 - Fair Value Disclosures Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The fair value of the Company’s financial instruments are as follows: Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value March 31, 2023 (unaudited): Money market funds $ 11,777 $ 11,777 $ — $ — $ 11,777 Note payable 380,390 — 380,390 — 380,390 December 31, 2022: Money market funds 509,890 509,890 — — 509,890 Note payable $ 603,494 $ — $ 603,494 $ — $ 603,494 At March 31, 2023 and December 31, 2022, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Asset Acquisition
Asset Acquisition | 3 Months Ended |
Mar. 31, 2023 | |
Asset Acquisition | |
Asset Acquisition | Note 4 – Asset Acquisition The Asset Acquisition During the three months ended March 31, 2022, the Company paid an aggregate of $2.4 million in cash towards the purchase price of FWB in accordance with the terms of an Agreement and Plan of Merger dated as of September 13, 2021 (the “ Merger Agreement November 2021 Settlement Agreement On May 19, 2022, Fortis Advisors LLC, the hired representative (in such capacity, the " Representative FWB Action July 2022 Term Sheet Second Payment Payments In the July 2022 Term Sheet, the Representative agreed to stay the FWB Action for a period of 90 days and to eliminate the Company’s obligation to pay a portion of any offering proceeds to the Representative. In addition, the Company’s obligation to use commercially reasonable efforts to develop niclosamide will be deferred for a period of 24 months from the date of the July 2022 Term Sheet. Effective upon the Second Payment, the Representative dismissed the FWB Action with prejudice and extinguished the remaining fixed payment obligations owed to the former FWB shareholders. On November 30, 2022, the Company entered into a formal settlement agreement with the Representative on substantially the same terms as the July 2022 Term Sheet. (the " November 2022 Settlement Agreement Accounting Treatment 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 third payment obligation of $2.0 million due and paid by November 30, 2022 was recorded as research and development expense in the three months ended December 31, 2022. The remaining unachieved potential milestone payments and revenue share are not yet considered probable, therefore have not been accrued as of March 31, 2023. Depending on the status of development at the time a contingent payment is recognized, the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized. |
Property, Equipment and Leaseho
Property, Equipment and Leasehold Improvements | 3 Months Ended |
Mar. 31, 2023 | |
Property, Equipment and Leasehold Improvements | |
Property, Equipment and Leasehold Improvements | Note 5 – Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements consisted of the following: March 31, 2023 December 31, (unaudited) 2022 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 (51,297) (43,979) Property, plant and equipment, net $ 36,521 $ 43,839 Depreciation expense for each of the three months ended March 31, 2023 and 2022 was approximately $7,300. |
Goodwill
Goodwill | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill. | |
Goodwill | Note 6 –Goodwill Goodwill is as follows: Goodwill Balance on January 1, 2022 $ 1,911,705 Foreign currency translation (227,523) Balance on December 31, 2022 1,684,182 Foreign currency translation — Balance on March 31, 2023 (unaudited) $ 1,684,182 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses | |
Accrued Expenses | Note 7 - Accrued Expenses Accrued expenses consisted of the following: March 31, 2023 December 31, (unaudited) 2022 Clinical trials $ 630,587 $ 5,340 Professional fees 215,141 309,867 Consulting fees — 4,969 Total accrued expenses $ 845,728 $ 320,176 |
Note Payable
Note Payable | 3 Months Ended |
Mar. 31, 2023 | |
Note Payable | |
Note Payable | Note 8 – Note Payable Directors and Officer ’ s Liability Insurance On November 30, 2022, the Company entered into 9-month |
Capital Stock
Capital Stock | 3 Months Ended |
Mar. 31, 2023 | |
Capital Stock | |
Capital Stock | Note 9 – Common Stock and Preferred Stock The Company’s amended and restated certificate of incorporation, as amended to date, (the “ Charter On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above. The Company had 1,549,581 and 995,003 shares of its Common Stock issued outstanding The Company had approximately 545.94 and 550.17 shares of Series B preferred stock issued outstanding The Company had 0 shares of Series C, Series D, Series E and Series F preferred stock issued and outstanding on March 31, 2023 and December 31, 2022. Most Favored Nations Exchange Right and Waiver Agreements In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “ Subsequent Financing Exchange Amount Series B Exchange Right Between February 1, 2022 and February 7, 2022, the Company entered into waiver agreements (the “ Waiver During the three months ended March 31, 2022, the Company entered into Waivers with holders of approximately $2.88 million of stated value of Series B Preferred Stock. The Company also entered into Waivers with Company insiders holding approximately $0.047 million of stated value of Series B Preferred Stock for which the Company did not pay a waiver fee. The cash waivers paid of approximately $0.233 million were recorded as other expense on the Company’s condensed consolidated statements of operations for the three months ended March 31, 2022. Effective May 12, 2022, the holders of 81.3% of the outstanding shares of the Series B Preferred Stock permanently waived for themselves and all other holders of the Series B Preferred Stock the Series B Exchange Right with respect to any Subsequent Financing occurring on or after January 1, 2022 (the “ Permanent Waiver Record Holders Pursuant to the terms of a Waiver Agreement entered into by the Company and the Consenting Holders (the “ Waiver Agreement Series B Warrants Exercise Price Reduction As of March 31, 2023, (i) holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 9,058 shares of Common Stock (which conversion the Company has elected to make in full), and additional warrants exercisable for up to an aggregate of 9,058 shares of Common Stock, (ii) holders of approximately 99.200 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $880,000 had previously elected to exercise their Series B Exchange Rights into 1,552 shares of Common Stock with no warrants, and (iii) holders of approximately 30.91 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $265,000 had previously elected to exercise their Series B Exchange Rights into 909 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 909 shares of Common Stock. 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 March 2023 Private Placement On March 15, 2023, the Company completed a private placement offering (the “ March 2023 Offering March 2023 Pre-Funded Warrants March 2023 Warrants The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $230,000. March 2022 Registered Direct Offering On March 2, 2022, the Company completed a registered direct offering (the “ March 2022 Offering March 2022 Pre-Funded Warrants March 2022 Warrants March 2022 Placement Agent Warrants The Company received gross proceeds of approximately $9.0 million less placement agent’s fees and other offering expenses of approximately $1.0 million. Common Stock Issuances Q1 2023 Issuances During the three months ended March 31, 2023, the Company issued 128,000 shares of Common Stock under the March 2023 Offering for which the Company received net proceeds of approximately $3.8 million. During the three months ended March 31, 2023, the Company issued an aggregate of 429,475 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001 During the three months ended March 31, 2023, the Company issued an aggregate of 70 shares of Common Stock upon the exchange of an aggregate of 4.23 shares of Series B Preferred Stock with a stated value of approximately $32,600 plus accrued dividends of approximately $6,200. During the three months ended March 31, 2023, the Company cancelled an aggregate of 2,967 shares of Common Stock in connection with the 1 Q1 2022 Issuances During the three months ended March 31, 2022, the Company issued 7,857 shares of Common Stock under the March 2022 Offering for which the Company received net proceeds of approximately $8.0 million. During the three months ended March 31, 2022, the Company issued an aggregate of 23,086 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.01 (See Note 10). During the three months ended March 31, 2022, the Company issued an aggregate of 499 shares of Common Stock and accompanying Series C warrant upon the exchange of an aggregate of 17.05 shares of Series B Preferred Stock with a stated value of approximately $131,000 plus accrued dividends of approximately $14,000. The Series C warrants have an exercise price of $264.60 per share and will be exercisable for five years from the issuance date. During the three months ended March 31, 2022, the Company issued an aggregate of 429 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. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Warrants | |
Warrants | Note 10 – Warrant activity for the three months ended March 31, 2023 and 2022 was as follows: Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2023 2,179,798 $ 19.16 5.50 Issued 2,941,054 2.55 4.96 Exercised (429,473) 0.00 5.28 Warrants outstanding and exercisable on March 31, 2023 4,691,379 $ 10.50 5.07 Warrants outstanding and exercisable on January 1, 2022 26,089 $ 1,992.90 3.95 Issued 56,382 160.37 4.92 Expired (33) 10,414.73 — Exercised (23,087) 2.10 4.92 Warrants outstanding and exercisable on March 31, 2022 59,351 $ 1,019.89 4.39 As of March 31, 2023, the outstanding warrants expire from 2023 through 2028. During the three months ended March 31, 2023, the Company issued warrants and pre-funded warrants to purchase 2,941,054 shares of the Company's Common Stock in connection with the March 2023 Offering (See Note 9). During the three months ended March 31, 2022, the Company issued warrants, pre-funded warrants, and placement agent warrants to purchase 55,883 shares of the Company’s Common Stock in connection with the March 2022 Offering, as well as Series C warrants to purchase 499 shares of the Company’s Common Stock in connection with a Series B Preferred Stock exchange (See Note 9). |
Equity Incentive Plan
Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plan | |
Equity Incentive Plan | Note 11 – Equity Incentive Plan The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “ 2014 Plan 2020 Plan The 2020 Plan allows for the issuance of securities, including stock options to employees, Board members and consultants. The initial number of shares of Common Stock available for issuance under the 2020 Plan was 4,761 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10)% of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan or the 2020 Plan. The number of shares permitted to be issued as “incentive stock options” (“ ISOs As of January 1, 2023, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 317,480 under the 2020 Plan's evergreen provision. As of March 31, 2023, there were an aggregate of 1,477 total shares available (but un-issuable) under the 2014 Plan, of which 834 are issued and outstanding, and 292 shares are reserved subject to issuance of restricted stock and RSUs. As of March 31, 2023, 317,480 total shares were authorized under the 2020 Plan, of which 168,470 were issued and outstanding and 149,010 shares were available for potential issuances. During the three months ended March 31, 2023 and 2022, 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, 2023 4,076 $ 958.14 8.22 $ — Granted 5,000 3.73 9.91 — Forfeited (11) 573.68 — — Outstanding at March 31, 2023 9,065 $ 445.02 9.07 $ — Exercisable at March 31, 2023 4,007 $ 854.57 8.40 $ — Outstanding at January 1, 2022 1,941 $ 2,470.99 7.28 $ — Granted 3,219 291.90 9.11 — Canceled (12) 2,032.80 — — Forfeited (353) 833.70 — — Outstanding at March 31, 2022 4,795 $ 1,152.90 8.67 $ — Exercisable at March 31, 2022 1,812 $ 2,226.00 7.15 $ — During the three months ended March 31, 2023 and 2022, the Board approved the grant of options to purchase 5,000 and 3,219 shares of Common Stock, respectively. All option grants were pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36-month period. During the three months ended March 31, 2023 and 2022, stock options to purchase 11 and 353 shares of Common Stock, respectively, were forfeited. During the three months ended March 31, 2022, stock options to purchase 12 shares of Common Stock under the 2020 Plan were cancelled. For the three months ended March 31, 2023 and 2022, 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: 2023 2022 Contractual term (in years) 6.5 10 Expected Volatility 98.80 % 90.92 % Risk-free interest rate 4.08 % 1.11 % Expected Dividend yield 0 % 0 % Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock granted during the three months ended March 31, 2023 and 2022 was $3.05 and $224.01, respectively. Restricted Stock and Restricted Stock Units Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock units (" RSUs As of March 31, 2023 and 2022, under the 2014 Plan, the Company had 130 shares of restricted stock outstanding and an aggregate unrecognized restricted Common Stock expense of approximately $388,000, which will be recognized when vesting of certain milestones become probable. During the three months ended March 31, 2023, RSU activity under the 2020 Plan was as follows: Weighted-Average Weighted-Average Number Grant Date Remaining Recognition of Shares Fair Value Period (Years) Non-vested Outstanding at January 1, 2023 — $ — — Awarded 160,239 6.20 Vested (40,064) 6.20 Non-vested Outstanding at March 31, 2023 120,175 $ 6.20 0.75 During the three months ended March 31, 2023, the Board approved the grant of 160,239 RSUs. All grants of RSUs were pursuant to the 2020 Plan and vest quarterly over a one-year period. The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows: Three Months Ended March 31, 2023 2022 Research and development $ 38,080 $ 46,407 General and administrative 320,236 171,822 Total stock-based compensation expense $ 358,316 $ 218,229 As of March 31, 2023, the Company had unrecognized stock-based compensation expense related to stock options and RSUs 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 awards of 0.94 years. Approximately $0.2 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 March 31, 2022, the Company had unrecognized stock-based compensation expense related to stock options of approximately $1.9 million. Approximately $1.2 million of this unrecognized expense will be recognized over the average remaining vesting term of 9.57 years. Approximately $730,000 of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones. The Company will recognize the expense related to these milestones when the milestones become probable. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases | |
Leases | Note 12 – 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 expenses amounted to approximately $37,000 and $28,000, respectively, for the three months ended March 31, 2023 and 2022. The weighted-average remaining lease term and weighted-average discount rate under operating leases as of March 31, 2023 are: March 31, 2023 Lease term and discount rate Weighted-average remaining lease term (years) 3.4 Weighted-average discount rate 7.00 % Maturities of operating lease liabilities as of March 31, 2023, were as follows: 2023 (remainder of year) $ 63,128 2024 86,202 2025 88,788 2026 60,593 Total lease payments 298,711 Less imputed interest (34,251) Present value of lease liabilities $ 264,460 |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Common Share | |
Net Loss per Common Share | Note 13 - Net Loss per Common Share Basic net loss per share is computed by dividing net loss available to Common Stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options and warrants is computed using the treasury stock method. The Company previously determined that approximately $0.595 million was incorrectly classified as a deemed dividend in the three months ended March 31, 2022. The Company corrected this misclassification as presented in its condensed consolidated financial statements for the three-month periods presented ending March 31, 2022. As of March 31, 2023, basic weighted average shares outstanding includes pre-funded warrants of 895,018 which had not yet been converted into Common Stock. All shares of Common Stock that may potentially be issued in the future are as follows: March 31, 2023 March 31, 2022 (unaudited) (unaudited) Common stock warrants 4,691,379 59,351 Stock options 9,065 4,795 RSUs not yet issued 160,239 — Convertible preferred stock (1) 3,102 3,416 Restricted stock not yet issued 162 162 Total shares of common stock issuable 4,863,947 67,724 (1) Convertible preferred stock is assumed to be converted at the rate of $1,617.70 per common share, which is the conversion price as of March 31, 2023. |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2023 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 14 - 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 $26,000 and $46,000 for the three months ended March 31, 2023 and 2022, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events | |
Subsequent Events | Note 15 - 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. Settlement with CRO On April 21, 2023, the Company reached a settlement and signed a binding agreement with a CRO in connection with disputes over two clinical trial agreements. The settlement agreement calls for a total payment of $600,000 to be paid over a period of six months beginning on the date of execution of the agreement. The Company has recorded this liability in full on its condensed consolidated financial statements as of March 31, 2023. |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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 the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates. |
Reverse Stock Split | Reverse Stock Split On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On August 26, 2022, the Company effected a reverse stock split, whereby every thirty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share. On September 13, 2021, the Company effected a reverse stock split, whereby every ten shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, with a corresponding 1-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 2023 presentation. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less from the date of purchase to be cash equivalents. All cash and cash equivalent balances were highly liquid at March 31, 2023 and December 31, 2022. As of March 31, 2023 and December 31, 2022, the Company has classified approximately $0.02 million as restricted cash. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At March 31, 2023 the Company had approximately $2.1 million in one account in the U.S. which was in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions. |
Fair Value Measurements | Fair Value Measurements The Company follows Accounting Standards Codification ( ASC ( ASC 820 As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument. The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period. |
Foreign Currency Translation | Foreign Currency Translation For foreign subsidiaries with operations denominated in a foreign currency, assets and liabilities were translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items were translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments were accumulated in a separate component of stockholders’ equity up until the dissolution of AzurRx SAS in October 2022, at which time cumulative translation adjustments were recognized as a loss for the year ended December 31, 2022. |
Goodwill | Goodwill Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through March 31, 2023 related to goodwill. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment ( ASC 360 |
Leases | Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. |
Research and Development | Research and Development Research and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related to patents. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“ CROs CDMOs CMC Research and Development – 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 September 13, 2021, the Company entered into an agreement with FWB for the acquisition of intellectual property and patents for the worldwide, exclusive right to develop, manufacture, and commercialize proprietary formulations of niclosamide for the fields of treating ICI-AC and COVID-19 in humans, which was accounted for as an asset acquisition (see Note 4). On July 29, 2022, the Company reached an agreement to restructure its obligations to the former FWB stockholders (the “ July 2022 Term Sheet Second Payment |
Stock-Based Compensation | Stock-Based Compensation The Company’s board of directors (the “ Board 2014 Plan 2020 Plan ASC 718 For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable. The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (the “ FASB ASU 2020-06 SEC In June 2016, the FASB issued accounting pronouncement ASU 2016-13 – Measurement of Credit Losses on Financial Statements (“ ASU 2016-13 In June 2022, the FASB issued ASU 2022-03 - Fair Value Measurement, or Topic 820: Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ ASU 2022-03 The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. |
Fair Value Disclosures (Tables)
Fair Value Disclosures (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures | |
Summary of financial instruments | Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value March 31, 2023 (unaudited): Money market funds $ 11,777 $ 11,777 $ — $ — $ 11,777 Note payable 380,390 — 380,390 — 380,390 December 31, 2022: Money market funds 509,890 509,890 — — 509,890 Note payable $ 603,494 $ — $ 603,494 $ — $ 603,494 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Equipment and Leasehold Improvements | |
Summary of property, equipment and leasehold improvements | March 31, 2023 December 31, (unaudited) 2022 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 (51,297) (43,979) Property, plant and equipment, net $ 36,521 $ 43,839 |
Goodwill (Tables)
Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill. | |
Schedule of goodwill | Goodwill Balance on January 1, 2022 $ 1,911,705 Foreign currency translation (227,523) Balance on December 31, 2022 1,684,182 Foreign currency translation — Balance on March 31, 2023 (unaudited) $ 1,684,182 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | March 31, 2023 December 31, (unaudited) 2022 Clinical trials $ 630,587 $ 5,340 Professional fees 215,141 309,867 Consulting fees — 4,969 Total accrued expenses $ 845,728 $ 320,176 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 2,179,798 $ 19.16 5.50 Issued 2,941,054 2.55 4.96 Exercised (429,473) 0.00 5.28 Warrants outstanding and exercisable on March 31, 2023 4,691,379 $ 10.50 5.07 Warrants outstanding and exercisable on January 1, 2022 26,089 $ 1,992.90 3.95 Issued 56,382 160.37 4.92 Expired (33) 10,414.73 — Exercised (23,087) 2.10 4.92 Warrants outstanding and exercisable on March 31, 2022 59,351 $ 1,019.89 4.39 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plan | |
Schedule of stock option activity | Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2023 4,076 $ 958.14 8.22 $ — Granted 5,000 3.73 9.91 — Forfeited (11) 573.68 — — Outstanding at March 31, 2023 9,065 $ 445.02 9.07 $ — Exercisable at March 31, 2023 4,007 $ 854.57 8.40 $ — Outstanding at January 1, 2022 1,941 $ 2,470.99 7.28 $ — Granted 3,219 291.90 9.11 — Canceled (12) 2,032.80 — — Forfeited (353) 833.70 — — Outstanding at March 31, 2022 4,795 $ 1,152.90 8.67 $ — Exercisable at March 31, 2022 1,812 $ 2,226.00 7.15 $ — |
Schedule of option pricing model with the following weighted-average assumptions | 2023 2022 Contractual term (in years) 6.5 10 Expected Volatility 98.80 % 90.92 % Risk-free interest rate 4.08 % 1.11 % Expected Dividend yield 0 % 0 % |
Schedule of RSU activity under the 2020 Plan | Weighted-Average Weighted-Average Number Grant Date Remaining Recognition of Shares Fair Value Period (Years) Non-vested Outstanding at January 1, 2023 — $ — — Awarded 160,239 6.20 Vested (40,064) 6.20 Non-vested Outstanding at March 31, 2023 120,175 $ 6.20 0.75 |
Schedule of stock-based compensation expense | Three Months Ended March 31, 2023 2022 Research and development $ 38,080 $ 46,407 General and administrative 320,236 171,822 Total stock-based compensation expense $ 358,316 $ 218,229 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases | |
Schedule of Weighted-average remaining lease term and weighted-average discount rate under operating leases | March 31, 2023 Lease term and discount rate Weighted-average remaining lease term (years) 3.4 Weighted-average discount rate 7.00 % |
Schedule of Maturities of operating lease liabilities | Maturities of operating lease liabilities as of March 31, 2023, were as follows: 2023 (remainder of year) $ 63,128 2024 86,202 2025 88,788 2026 60,593 Total lease payments 298,711 Less imputed interest (34,251) Present value of lease liabilities $ 264,460 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Common Share | |
Schedule of Common Stock that may potentially be issued in the future | March 31, 2023 March 31, 2022 (unaudited) (unaudited) Common stock warrants 4,691,379 59,351 Stock options 9,065 4,795 RSUs not yet issued 160,239 — Convertible preferred stock (1) 3,102 3,416 Restricted stock not yet issued 162 162 Total shares of common stock issuable 4,863,947 67,724 (1) Convertible preferred stock is assumed to be converted at the rate of $1,617.70 per common share, which is the conversion price as of March 31, 2023. |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
The Company and Basis of Presentation | ||
Cash and cash equivalents | $ 2,064,435 | $ 1,362,910 |
Accumulated deficit | (172,604,342) | $ (168,533,689) |
Working capital | $ 900,000 |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Jan. 18, 2023 | Nov. 30, 2022 | Sep. 29, 2022 | Aug. 26, 2022 | Jul. 29, 2022 | May 19, 2022 | Sep. 13, 2021 | Jul. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Significant accounting policies and recent accounting pronouncements | |||||||||||
Number of shares reduced due to reverse stock split | 7 | 30 | 10 | 1 | |||||||
Restricted cash | $ 20,000 | ||||||||||
Cash in US banks in excess of FDIC insurance limits | 2,100,000 | ||||||||||
Asset impairment charges | $ 0 | ||||||||||
First Wave Bio Inc | |||||||||||
Significant accounting policies and recent accounting pronouncements | |||||||||||
Asset acquisition consideration transferred | $ 2,000,000 | $ 1,000,000 | $ 1,500,000 | $ 2,400,000 | |||||||
Cash consideration | $ 1,500,000 | ||||||||||
Asset acquisition, consideration transferred, contingent consideration | $ 4,000,000 | ||||||||||
First Wave Bio Inc | Former Stockholders [Member] | |||||||||||
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 | ||||||||||
Third payment paid | 2,000,000 | ||||||||||
Extinguishment of remaining fixed payment obligations | $ 10,100,000 | ||||||||||
Payments made | $ 4,500,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair value disclosures | ||
Money market funds | $ 2,064,435 | $ 1,362,910 |
Note payable | 380,390 | 603,494 |
Carrying Amount | ||
Fair value disclosures | ||
Note payable | 380,390 | 603,494 |
Fair Value, Inputs, Level 2 | ||
Fair value disclosures | ||
Note payable | 380,390 | 603,494 |
Money Market Funds | ||
Fair value disclosures | ||
Money market funds | 11,777 | 509,890 |
Money Market Funds | Carrying Amount | ||
Fair value disclosures | ||
Money market funds | 11,777 | 509,890 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair value disclosures | ||
Money market funds | $ 11,777 | $ 509,890 |
Asset Acquisition (Details)
Asset Acquisition (Details) - First Wave Bio Inc - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||||
Nov. 30, 2022 | Sep. 29, 2022 | Jul. 29, 2022 | May 19, 2022 | Jul. 31, 2022 | Mar. 31, 2022 | Mar. 31, 2023 | |
Asset Acquisition | |||||||
Cash consideration | $ 1.5 | ||||||
Asset acquisition, potential milestone payments | $ 10.1 | ||||||
Milestone payment | $ 2 | ||||||
Asset acquisition consideration transferred | $ 2 | $ 1 | $ 1.5 | $ 2.4 | |||
Asset acquisition, consideration transferred, contingent consideration | $ 4 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements - Property (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | $ 87,818 | $ 87,818 | |
Less accumulated depreciation | (51,297) | (43,979) | |
Property, plant and equipment, net | 36,521 | 43,839 | |
Depreciation expense | 7,300 | $ 7,300 | |
Computer Equipment and Software | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | 11,540 | 11,540 | |
Office equipment | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | 48,278 | 48,278 | |
Leasehold improvements | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | $ 28,000 | $ 28,000 |
Goodwill (Details)
Goodwill (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Goodwill. | |
Beginning balance | $ 1,911,705 |
Foreign currency translation | (227,523) |
Ending balance | $ 1,684,182 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Clinical trials | $ 630,587 | $ 5,340 |
Professional fees | 215,141 | 309,867 |
Consulting fees | 4,969 | |
Total accrued expenses | $ 845,728 | $ 320,176 |
Note Payable (Details)
Note Payable (Details) - USD ($) | Nov. 30, 2022 | Mar. 31, 2023 | Dec. 31, 2022 |
Note Payable | |||
Notes payable balance | $ 380,000 | $ 603,000 | |
Financing Agreement for Directors and Officer's and Other Liability Insurances | |||
Note Payable | |||
Debt instrument, term | 9 months | ||
Debt instrument, face amount | $ 677,000 | ||
Debt instrument, interest Rate | 6.79% | ||
Debt instrument, periodic payment | $ 77,000 |
Capital Stock (Details)
Capital Stock (Details) | 3 Months Ended | |||||||||||||
Mar. 15, 2023 USD ($) $ / shares shares | Jan. 18, 2023 shares | Aug. 26, 2022 shares | May 12, 2022 $ / shares shares | Mar. 02, 2022 USD ($) $ / shares shares | Sep. 13, 2021 shares | May 26, 2021 shares | Mar. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2023 shares | Jan. 31, 2023 shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 shares | Nov. 30, 2019 USD ($) | |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | ||||||||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares designated (in shares) | 10,000,000 | |||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||
Number of shares reduced due to reverse stock split | 7 | 30 | 10 | 1 | ||||||||||
Common stock, shares, issued, total (in shares) | 1,549,581 | 995,003 | ||||||||||||
Common stock, shares, outstanding, ending balance (in shares) | 1,549,581 | 995,003 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 264.60 | |||||||||||||
Purchase of aggregate common stock | 4,691,379 | 59,351 | 2,179,798 | 26,089 | ||||||||||
Deemed dividend on warrant modifications | $ | $ (47,000) | |||||||||||||
Number of common stock shares called by warrants (in shares) | 1 | |||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 8,000,000 | |||||||||||||
Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs (in shares) | 7,857 | |||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 288.75 | |||||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||||
Common stock and warrants issued to consultants | $ | $ 118,999 | |||||||||||||
March 2022 Warrants | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 264.60 | |||||||||||||
Number of common stock shares called by warrants (in shares) | 30,943 | |||||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||||
Pre-Funded Warrant | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 363.30 | |||||||||||||
Number of common stock shares called by warrants (in shares) | 23,086 | |||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 290.85 | |||||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | |||||||||||||
March 2022 Pre-Funded warrants | ||||||||||||||
Number of common stock shares called by warrants (in shares) | 1 | |||||||||||||
Conversion of stock, shares issued (in shares) | 429,475 | |||||||||||||
Waiver | ||||||||||||||
Purchase of aggregate common stock | 1,196 | |||||||||||||
Waiver | Common Stock Warrants [Member] | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 52.50 | |||||||||||||
Series B Preferred Stock Exchanged for Common Shares | ||||||||||||||
Canceled | 70 | |||||||||||||
Reverse stock split ratio | 0.143 | 4.23 | ||||||||||||
Conversion of Stock, Shares Converted (in shares) | 17.05 | |||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 32,600 | $ 131,000 | ||||||||||||
Conversion of Stock, Amount Converted, Accrued Dividends | $ | $ 6,200 | $ 14,000 | ||||||||||||
Stock Cancelled During Period, Shares, Acquisitions (in shares) | 2,967 | |||||||||||||
Series B Preferred Stock Exchanged for Common Shares | March 2022 Warrants | ||||||||||||||
Conversion of stock, shares issued (in shares) | 499 | |||||||||||||
Consultants [Member] | ||||||||||||||
Stock Issued During Period, Shares, Settlement (in shares) | 429 | |||||||||||||
Stock Issued During Period, Value, Settlement | $ | $ 119,000 | |||||||||||||
Officers and Directors | Waiver | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 69.174 | |||||||||||||
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 | $ | $ 8,000,000 | |||||||||||||
Stock issuance costs | $ | 309,000 | |||||||||||||
Stock issued during period, shares, new issues (in shares) | 217,036 | |||||||||||||
March 2023 offering | ||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 3,800,000 | |||||||||||||
Stock issued during period, shares, new issues (in shares) | 128,000 | |||||||||||||
March 2022 Registered Direct Offering | ||||||||||||||
Gross proceeds | $ | $ 9,000,000 | |||||||||||||
Other offering expenses | $ | $ 1,000,000 | |||||||||||||
Direct offering | Pre-Funded Warrant | ||||||||||||||
Number of common stock shares called by warrants (in shares) | 1,856 | |||||||||||||
Class of Warrant or Right, Issued, Percentage of Common Stock Issued in Offering | 6% | |||||||||||||
July 2022 Private Placement | ||||||||||||||
Gross proceeds | $ | $ 4,000,000 | |||||||||||||
Other offering expenses | $ | $ 230,000 | |||||||||||||
Pre-Funded Warrants | ||||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 8 | |||||||||||||
Conversion of stock, shares issued (in shares) | 7,857 | |||||||||||||
Pre-Funded Warrants | Series B Preferred Stock Exchanged for Common Shares | ||||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 0.01 | |||||||||||||
Pre-Funded Warrants | Series B Preferred Stock Exchanged for Common Shares | March 2022 Warrants | ||||||||||||||
Conversion of stock, shares issued (in shares) | 23,086 | |||||||||||||
Series B Preferred Stock | ||||||||||||||
Preferred stock, shares designated (in shares) | 5,194.81 | 5,194.81 | ||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares issued, total (in shares) | 545.94 | 550.17 | ||||||||||||
Exchange Amount | $ | $ 7,700 | |||||||||||||
Number of common stock shares called by warrants (in shares) | 499 | |||||||||||||
Preferred stock, shares outstanding (in shares) | 545.94 | 550.17 | ||||||||||||
Series B Preferred Stock | Waiver | ||||||||||||||
Value of preferred stock agreed to be waived with holders of preferred stock | $ | $ 2,880,000 | |||||||||||||
Value of preferred stock agreed to be waived with insiders | $ | 47,000 | |||||||||||||
Waiver fee paid | $ | $ 233,000 | |||||||||||||
Percentage of outstanding shares | 81.30% | |||||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | ||||||||||||||
Exchange Amount | $ | $ 14,400,000 | $ 265,000 | ||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 9,058 | |||||||||||||
Conversion of Stock, Shares Converted (in shares) | 1,839.76 | |||||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | Investor warrants | ||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 9,058 | |||||||||||||
Series B Preferred Stock convertible into common stock with no warrants | ||||||||||||||
Exchange Amount | $ | $ 880,000 | |||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 1,552 | |||||||||||||
Conversion of Stock, Shares Converted (in shares) | 99.200 | |||||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants [Member] | ||||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 909 | |||||||||||||
Conversion of Stock, Shares Converted (in shares) | 30.91 | |||||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants [Member] | March 2022 Warrants | ||||||||||||||
Number of common stock shares called by warrants (in shares) | 909 | |||||||||||||
Series C Preferred Stock | ||||||||||||||
Preferred stock, shares designated (in shares) | 75,000 | 75,000 | ||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||||
Series C Preferred Stock | July 2022 Private Placement | ||||||||||||||
Number of common shares issuable upon conversion | 895,018 | |||||||||||||
Series D Preferred Stock | ||||||||||||||
Preferred stock, shares designated (in shares) | 150 | 150 | ||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | 0 | |||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||||||
Series D Preferred Stock | July 2022 Private Placement | ||||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 3.91 | |||||||||||||
Stock issued during period, shares, new issues (in shares) | 128,000 | |||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||
Series E Preferred Stock | ||||||||||||||
Preferred stock, shares designated (in shares) | 150 | 150 | ||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | ||||||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 66,666 | |||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||||
Series E Preferred Stock | July 2022 Private Placement | ||||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 2,046,036 | |||||||||||||
Number of shares reduced due to reverse stock split | 3.66 | |||||||||||||
Series F Preferred Stock | ||||||||||||||
Preferred stock, shares designated (in shares) | 7,000 | 7,000 | ||||||||||||
Preferred stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||
Preferred stock, shares issued, total (in shares) | 0 | 0 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||||
Common Stock | Pre-Funded Warrant | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 2.10 |
Warrants (Details)
Warrants (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 02, 2022 | |
Number of Warrants | |||||
Outstanding and exercisable, beginning (in shares) | 2,179,798 | 26,089 | 26,089 | ||
Issued (in shares) | 2,941,054 | 56,382 | |||
Expired (in shares) | (429,473) | (33) | |||
Exercised (in shares) | (23,087) | ||||
Warrants outstanding and exercisable, ending (in shares) | 4,691,379 | 59,351 | 2,179,798 | 26,089 | |
Weighted Average Exercise Price Per Share | |||||
Outstanding and exercisable, beginning (in dollars per share) | $ 19.16 | $ 1,992.90 | $ 1,992.90 | ||
Issued (in dollars per share) | 2.55 | 160.37 | |||
Expired (in dollars per share) | 0 | 10,414.73 | |||
Exercised (in dollars per share) | 2.10 | ||||
Warrants outstanding and exercisable, ending (in dollars per share) | $ 10.50 | $ 1,019.89 | $ 19.16 | $ 1,992.90 | |
Weighted Average Remaining Term in Years | |||||
Outstanding and exercisable (in years) | 5 years 25 days | 4 years 4 months 20 days | 5 years 6 months | 3 years 11 months 12 days | |
Issued (in years) | 4 years 11 months 15 days | 4 years 11 months 1 day | |||
Expired (in years) | 5 years 3 months 10 days | ||||
Exercised (in years) | 4 years 11 months 1 day | ||||
Warrants to purchase of stock | 1 | ||||
Series B Preferred Stock | |||||
Weighted Average Remaining Term in Years | |||||
Warrants to purchase of stock | 499 | ||||
Warrants, pre-funded warrants, and placement agent warrants | March 2022 offering | |||||
Weighted Average Remaining Term in Years | |||||
Warrants to purchase of stock | 55,883 | ||||
Warrants, pre-funded warrants, and placement agent warrants | March 2023 offering | |||||
Weighted Average Remaining Term in Years | |||||
Warrants to purchase of stock | 2,941,054 |
Equity Incentive Plan (Details)
Equity Incentive Plan (Details) - USD ($) | 3 Months Ended | ||||
Sep. 11, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Jan. 01, 2023 | Dec. 31, 2022 | |
Equity Incentive Plan | |||||
Granted (in shares) | 5,000 | 3,219 | |||
Unrecognized stock-based compensation expense | $ 1,100,000 | $ 1,900,000 | |||
Remaining Term | |||||
Equity Incentive Plan | |||||
Unrecognized stock-based compensation expense | $ 900,000 | $ 1,200,000 | |||
Average remaining vesting term of the stock options (in years) | 11 months 8 days | 9 years 6 months 25 days | |||
Clinical, corporate milestones | |||||
Equity Incentive Plan | |||||
Unrecognized stock-based compensation expense | $ 200,000 | $ 730,000 | |||
Incentive Stock Options | |||||
Equity Incentive Plan | |||||
Granted (in shares) | 7,142 | ||||
Stock Option | |||||
Equity Incentive Plan | |||||
Weighted average fair value of warrants granted (in dollars per share) | $ 3.05 | $ 224.01 | |||
2020 Equity Incentive Plan | |||||
Equity Incentive Plan | |||||
Shares available under equity incentive plan (in shares) | 4,761 | 149,010 | 317,480 | ||
Percentage of common stock reserved for issuance equity incentive plan | 10% | ||||
Options forfeited | 11 | 353 | |||
Options to purchase shares of common stock (in shares) | 168,470 | ||||
Options cancelled | 12 | ||||
Number of shares authorized under the plan | 317,480 | ||||
Vesting period | 36 months | ||||
2020 Equity Incentive Plan | Restricted stock units | |||||
Equity Incentive Plan | |||||
Number of awards outstanding | 120,175 | 0 | |||
Awards issued (in shares) | 160,239 | ||||
Vesting period | 1 year | ||||
Equity Incentive Plan 2014 | |||||
Equity Incentive Plan | |||||
Shares available under equity incentive plan (in shares) | 1,477 | ||||
Options to purchase shares of common stock (in shares) | 834 | ||||
Equity Incentive Plan 2014 | Restricted Stock | |||||
Equity Incentive Plan | |||||
Aggregate unrecognized restricted Common Stock expense | $ 388,000 | ||||
Number of awards outstanding | 130 | ||||
Omnibus Equity Incentive Plan | Restricted Stock | |||||
Equity Incentive Plan | |||||
Shares reserved subject to issuance (in shares) | 292 |
Equity Incentive Plan - Stock o
Equity Incentive Plan - Stock option activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Numbers of Shares | ||||
Granted (in shares) | 5,000 | 3,219 | ||
Incentive Stock Options | ||||
Numbers of Shares | ||||
Granted (in shares) | 7,142 | |||
Equity Incentive Plan | Incentive Stock Options | ||||
Numbers of Shares | ||||
Outstanding at beginning (in shares) | 4,076 | 1,941 | 1,941 | |
Granted (in shares) | 5,000 | 3,219 | ||
Canceled (in shares) | (12) | |||
Forfeited (in shares) | (11) | (353) | ||
Outstanding at ending (in shares) | 9,065 | 4,795 | 4,076 | 1,941 |
Exercisable (in shares) | 4,007 | 1,812 | ||
Average Exercise Price | ||||
Outstanding at beginning (in dollars per share) | $ 958.14 | $ 2,470.99 | $ 2,470.99 | |
Granted (in dollars per share) | 3.73 | 291.90 | ||
Canceled (in dollars per share) | 2,032.80 | |||
Forfeited (in dollars per share) | 573.68 | 833.70 | ||
Outstanding at ending (in dollars per share) | 445.02 | 1,152.90 | $ 958.14 | $ 2,470.99 |
Exercisable (in dollars per share) | $ 854.57 | $ 2,226 | ||
Remaining Contract Life (Years) | ||||
Stock option outstanding, remaining contractual life (Years) | 9 years 25 days | 8 years 8 months 1 day | 8 years 2 months 19 days | 7 years 3 months 10 days |
Granted (in years) | 9 years 10 months 28 days | 9 years 1 month 9 days | ||
Forfeited (in years) | 0 years | |||
Exercisable (in years) | 8 years 4 months 24 days | 7 years 1 month 24 days |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-average assumptions (Details) - Stock Option | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Incentive Plan | ||
Contractual term (in years) | 6 years 6 months | 10 years |
Expected Volatility | 98.80% | 90.92% |
Risk-free interest rate | 4.08% | 1.11% |
Expected Dividend yield | 0% | 0% |
Equity Incentive Plan - RSU act
Equity Incentive Plan - RSU activity under the 2020 Plan (Details) - 2020 Equity Incentive Plan - Restricted stock units | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Outstanding at beginning (in shares) | shares | 0 |
Awards issued (in shares) | shares | 160,239 |
Vested (in shares) | shares | (40,064) |
Outstanding at ending (in shares) | shares | 120,175 |
Weighted-Average Grant Date Fair Value | |
Outstanding at beginning (in dollars per share) | $ / shares | $ 0 |
Awarded (in dollars per share) | $ / shares | 6.20 |
Vested (in dollars per share) | $ / shares | 6.20 |
Outstanding at ending (in dollars per share) | $ / shares | $ 6.20 |
Weighted-Average Remaining Recognition Period (Years) | 9 months |
Equity Incentive Plan - Total s
Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 358,316 | $ 218,229 |
Research and development | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | 38,080 | 46,407 |
General and administrative expense | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 320,236 | $ 171,822 |
Leases (Details)
Leases (Details) | 3 Months Ended | |
Mar. 31, 2023 USD ($) ft² property | Mar. 31, 2022 USD ($) | |
Leases | ||
Number of real property operating leases | property | 2 | |
Operating lease, expense | $ | $ 37,000 | $ 28,000 |
Boca Raton, Florida | ||
Leases | ||
Area of real estate property (Square Foot) | ft² | 3,472 |
Leases - Weighted-average remai
Leases - Weighted-average remaining lease term and discount rate (Details) | Mar. 31, 2023 |
Leases | |
Weighted-average remaining lease term | 3 years 4 months 24 days |
Weighted-average discount rate | 7% |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) | Mar. 31, 2023 USD ($) |
Leases | |
2023 (remainder of year) | $ 63,128 |
2024 | 86,202 |
2025 | 88,788 |
2026 | 60,593 |
Total lease payments | 298,711 |
Less imputed interest | (34,251) |
Present value of lease liabilities | $ 264,460 |
Net Loss per Common Share - Com
Net Loss per Common Share - Common Stock that may potentially be issued (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss per Common Share | ||
Amount incorrectly classified as deemed dividend | $ 595 | |
Total shares of common stock issuable | 4,863,947 | 67,724 |
Common stock warrants | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 4,691,379 | 59,351 |
Warrant | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 895,018 | |
Stock options | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 9,065 | 4,795 |
RSUs not yet issued | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 160,239 | |
Convertible preferred stock | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 3,102 | 3,416 |
Preferred stock, convertible, conversion price (in dollars per share) | $ 1,617.70 | |
Restricted stock not yet issued | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 162 | 162 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Benefit Plans | ||
Defined benefit plan, plan assets, contributions by employer | $ 26,000 | $ 46,000 |
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) - Subsequent events | Apr. 21, 2023 USD ($) agreement |
Subsequent Events | |
Settlement agreement with CRO, Number of clinical trial agreements | agreement | 2 |
Settlement agreement with CRO, Total amount payable | $ | $ 600,000 |
Settlement agreement with CRO, Payment period | 6 months |