Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.0001 per share | |
Trading Symbol | FWBI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 2,475,090 | |
Entity Central Index Key | 0001604191 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current Assets: | ||
Cash and cash equivalents | $ 3,431,913 | $ 3,711,770 |
Prepaid expenses | 4,058,053 | 1,244,466 |
Total Current Assets | 7,489,966 | 4,956,236 |
Property, equipment, and leasehold improvements, net | 25,749 | 14,565 |
Other Assets: | ||
Restricted cash | 21,522 | 21,522 |
Patents and tradenames | 365,486 | |
In - process R&D | 63,000,000 | |
Goodwill | 20,038,508 | 1,684,182 |
Operating lease right-of-use assets | 181,421 | 195,440 |
Deposits | 11,250 | 11,250 |
Total Other Assets | 83,618,187 | 1,912,394 |
Total Assets | 91,133,902 | 6,883,195 |
Current Liabilities: | ||
Accounts payable | 1,996,519 | 554,277 |
Accrued expenses | 2,554,446 | 825,290 |
Accrued dividend payable | 1,135,760 | 1,069,616 |
Note payable | 386,769 | 612,784 |
Operating lease liabilities | 71,216 | 67,111 |
Other current liabilities | 28,546 | 4,239 |
Total Current Liabilities | 6,173,256 | 3,133,317 |
Long - term debt | 6,397,889 | |
Deferred tax liability | 571,221 | |
Non-current operating lease liabilities | 127,592 | 146,949 |
Total Liabilities | 13,269,958 | 3,280,266 |
Mezzanine Equity: | ||
Total Mezzanine Equity | 61,681,100 | |
Stockholders' Equity: | ||
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 2,025,208 and 1,560,998 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 203 | 156 |
Additional paid-in capital | 194,943,707 | 187,931,445 |
Accumulated deficit | (178,761,066) | (184,328,672) |
Total Stockholders' Equity | 16,182,844 | 3,602,929 |
Total Liabilities, Mezzanine Equity and Stockholders' Equity | 91,133,902 | 6,883,195 |
Series B Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series C Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series D Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series E Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | 0 |
Series F Preferred Stock | ||
Stockholders' Equity: | ||
Preferred stock | 0 | $ 0 |
Series G Preferred Stock | ||
Mezzanine Equity: | ||
Total Mezzanine Equity | $ 61,681,100 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued | 2,025,208 | 1,560,998 |
Common stock, shares outstanding (in shares) | 2,025,208 | 1,560,998 |
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) | 504.81 | 514.96 |
Preferred stock, shares outstanding (in shares) | 504.81 | 514.96 |
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 |
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 |
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 |
Series G Preferred Stock | ||
Temporary Equity, Par or Stated Value Per Share | $ 0.0001 | |
Temporary Equity, Shares Authorized | 13,000 | |
Temporary Equity, Shares Issued | 12,373.2260 | 0 |
Temporary Equity, Shares Outstanding | 12,373.2260 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development expenses | $ 565,962 | $ 1,361,683 |
General and administrative expenses | 8,659,692 | 2,700,742 |
Total operating expenses | 9,225,654 | 4,062,425 |
Loss from operations | (9,225,654) | (4,062,425) |
Other (expenses) income: | ||
Interest expense | (66,202) | (8,987) |
Interest income | 228 | 1,873 |
Other expense | (653) | (1,114) |
Total other expenses | (66,627) | (8,228) |
Loss before income tax benefit | (9,292,281) | (4,070,653) |
Income tax benefit | 14,859,887 | |
Net income (loss) | 5,567,606 | (4,070,653) |
Preferred stock dividends | (66,144) | (87,431) |
Net income (loss) applicable to common shareholders | $ 5,501,462 | $ (4,158,084) |
Basic weighted average shares outstanding | 1,761,953 | 114,033 |
Diluted weighted average shares outstanding | 14,511,461 | 114,033 |
Income (loss) per share - basic | $ 3.12 | $ (36.46) |
Income (loss) per share - diluted | $ 0.38 | $ (36.46) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited) - USD ($) | Convertible preferred stock Series G Convertible Preferred Stock | Convertible preferred stock Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at the beginning (in shares) at Dec. 31, 2022 | 550 | 49,750 | ||||
Balance at the beginning at Dec. 31, 2022 | $ 5 | $ 171,275,836 | $ (168,533,689) | $ 2,742,152 | ||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs | $ 1 | 3,769,910 | 3,769,911 | |||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs (in shares) | 6,400 | |||||
Exercise of pre-funded warrants into common stock | $ 2 | 299 | 301 | |||
Exercise of pre-funded warrants into common stock (in shares) | 21,473 | |||||
Deemed dividend of Series B preferred stock | (87,431) | $ (87,431) | ||||
Conversion of Series B preferred shares into common stock (in shares) | (4) | 4 | ||||
Stock cancelled during period, shares, acquisitions (in shares) | 148 | |||||
Effect of cancelled shares from the reverse stock split (in shares) | (148) | |||||
Stock-based compensation | 358,316 | $ 358,316 | ||||
Net income (loss) | (4,070,653) | (4,070,653) | ||||
Balance at the end (in shares) at Mar. 31, 2023 | 546 | 77,479 | ||||
Balance at the end at Mar. 31, 2023 | $ 8 | 175,316,930 | (172,604,342) | 2,712,596 | ||
Balance at the beginning (in shares) at Dec. 31, 2023 | 515 | 1,560,998 | ||||
Balance at the beginning at Dec. 31, 2023 | $ 156 | 187,931,445 | (184,328,672) | 3,602,929 | ||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs | $ 17 | 3,604,919 | 3,604,936 | |||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs (in shares) | 173,100 | |||||
Issuance of stock upon acquisition of IMGX | $ 57,790,474 | $ 4 | 2,300,496 | 2,300,500 | ||
Issuance of stock upon acquisition of IMGX (in shares) | 11,777 | 36,830 | ||||
Issuance of stock to financial advisors | $ 3,890,626 | $ 2 | 120,646 | 120,648 | ||
Issuance of stock to financial advisors (in shares) | 596 | 18,475 | ||||
Exercise of pre-funded warrants into common stock | $ 9 | 9 | ||||
Exercise of pre-funded warrants into common stock (in shares) | 83,525 | |||||
Deemed dividend of Series B preferred stock | (66,144) | (66,144) | ||||
Conversion of Series B preferred shares into common stock (in shares) | (10) | 9 | ||||
Common stock issued to consultants | $ 10 | 780,990 | 781,000 | |||
Common stock issued to consultants (in shares) | 100,000 | |||||
Issuance of common stock from RSU vest | $ 5 | (5) | ||||
Issuance of common stock from RSU vest (in shares) | 52,271 | |||||
Stock-based compensation | 271,360 | 271,360 | ||||
Net income (loss) | 5,567,606 | 5,567,606 | ||||
Balance at the end (in shares) at Mar. 31, 2024 | 12,373 | 505 | 2,025,208 | |||
Balance at the end at Mar. 31, 2024 | $ 61,681,100 | $ 203 | $ 194,943,707 | $ (178,761,066) | $ 16,182,844 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited) (Parenthetical) - shares | 3 Months Ended | |||
Dec. 18, 2023 | Jan. 18, 2023 | Aug. 26, 2022 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (unaudited) | ||||
Reverse stock splits (in shares) | 20 | 7 | 30 | 1 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 5,567,606 | $ (4,070,653) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 12,293 | 7,318 |
Change in right-of-use assets | 18,251 | 15,528 |
Stock-based compensation | 271,360 | 358,316 |
Common stock granted to consultants | 781,000 | |
Common stock issued to financial advisors at acquisition | 120,648 | |
Series G convertible preferred stock issued to financial advisors at acquisition | 3,890,626 | |
Deferred taxes | (14,859,887) | |
Changes in assets and liabilities: | ||
Other receivables | 73,014 | |
Prepaid expenses | 318,342 | 511,393 |
Lease liabilities | (18,863) | (15,751) |
Accounts payable | 526,033 | (250,280) |
Accrued expenses | (398,672) | 525,552 |
Other liabilities | 24,307 | (15) |
Net cash used in operating activities | (3,746,956) | (2,845,578) |
Cash flows from investing activities: | ||
Cash acquired in acquisition of IMGX | 88,169 | |
Net cash provided by investing activities | 88,169 | |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, prefunded warrants and warrants, net | 3,604,936 | 3,769,911 |
Proceeds from exercise of warrants | 9 | 301 |
Repayments of note payable | (226,015) | (223,104) |
Net cash provided by financing activities | 3,378,930 | 3,547,108 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (279,857) | 701,530 |
Cash, cash equivalents and restricted cash, beginning balance | 3,733,292 | 1,384,423 |
Cash, cash equivalents and restricted cash, ending balance | 3,453,435 | 2,085,953 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 21,969 | 8,987 |
Non-cash investing and financing activities: | ||
Fair value of common shares issued in the IMGX acquisition, net of cash | 152,331 | |
Fair value of the Series G preferred stock issued in the IMGX acquisition | 57,790,474 | |
Fair value of options assumed in the IMGX acquisition | 1,271,000 | |
Fair value of warrants assumed in the IMGX acquisition | 789,000 | |
Accrued dividends on preferred stock | $ (66,144) | $ (87,431) |
The Company and Basis of Presen
The Company and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
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 IMGX GI In March 2024, the Company acquired IMGX, a private, clinical-stage biopharmaceutical company founded in 2013, which was developing the biologic, Latiglutenase, for celiac disease. IMGX was also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (“ GFDs The Company is currently focused on developing its pipeline of gut-restricted GI clinical drug candidates, including Latiglutenase, a targeted oral biotherapeutic for celiac disease; the biologic Adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients; Capeserod, a selective 5-HT4 receptor partial agonist which the Company will pursue for GI indications; and Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties. 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. Worldwide supply chain constraints and economic and capital markets uncertainty arising out of conflicts between Russia and Ukraine and conflicts in the Middle East triggered by attacks on Israel in October of 2023 have disrupted commercial and capital markets and emerged as new barriers to long - term economic recovery. Capital markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise capital when needed. 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 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, 2023, 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, 2023, filed with the SEC on March 29, 2024. Substantial Doubt about the Company’s Ability to Continue as a Going Concern 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, 2024, the Company had cash and cash equivalents of approximately $3.4 million, an accumulated deficit of approximately $178.8 million and working capital of approximately $1.3 million. Subsequent to March 31, 2024, the Company raised aggregate gross proceeds of approximately $1.1 million from a May 2024 Registered Direct Offering. 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, 2024, the Company anticipates having sufficient cash to fund planned operations into June 2024, 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, 2024 | |
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 December 18, 2023, the Company effected a reverse stock split, whereby every twenty 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 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. 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, 2024 and December 31, 2023. As of March 31, 2024 and December 31, 2023, 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, 2024 the Company had approximately $3.4 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. 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, 2024 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 Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ ASC 740 The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At March 31, 2024 and 2023, the Company does not have any significant uncertain tax positions. Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. 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 acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“ IPR&D Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. For tax purposes, intangible assets related to IPR&D are considered definite-lived intangible assets. 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 The Company has evaluated 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. |
Business Acquisition
Business Acquisition | 3 Months Ended |
Mar. 31, 2024 | |
Business Acquisition | |
Business Acquisition | Note 3 – Business Acquisition On March 13, 2024, the Company acquired ImmunogenX, Inc.(the “ Merger Merger Agreement First Merger Sub Second Merger Sub First Merger Second Merger IMGX Merger Under the terms of the Merger Agreement, following the consummation of the Merger (the “ Closing issued The Company incurred transaction costs of $5,456,038 which are included in the Company’s condensed consolidated statement of operations. In addition, the Company assumed (i) all IMGX stock options immediately outstanding prior to the First Merger, each becoming an option to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “ Assumed Options Assumed Warrants The Assumed Warrants are exercisable for an aggregate of 127,680 shares of Common Stock, have exercise prices ranging from $3.03 to $3.92 and expire between September 30, 2032 and September 6, 2033. Tungsten Partners LLC (“ Tungsten The Merger was accounted for as a business combination under the acquisition method of accounting with First Wave as the accounting acquirer. Under the acquisition method, the total purchase price of the acquisition is allocated to the net identifiable tangible and intangible assets acquired and liabilities assumed based on the fair values as of the date of such acquisition. The preliminary fair value of the consideration totaled approximately $60.1 million, summarized as follows: Amount Common stock issued to IMGX stockholders $ 240,500 Replacement options 1,271,000 Replacement warrants 789,000 Preferred stock issued to IMGX stockholders 57,790,474 Total consideration paid $ 60,090,974 The Company has made a provisional allocation of the purchase price of the Merger to the assets acquired and the liabilities assumed as of the purchase date. The following table summarizes the provisional purchase price allocations relating to the Merger: Assets acquired: Cash and cash equivalents $ 88,169 Prepaid expenses and other current assets 3,131,929 Property and equipment, net 18,963 Intangibles 63,370,000 Operating lease right-of-use assets 4,232 Total assets $ 66,613,293 Liabilities assumed: Accounts payable 916,209 Accrued expenses and other current liabilities 2,131,439 Long term debt 6,397,889 Deferred tax liability 15,431,108 Total liabilities $ 24,876,645 Goodwill recorded: Goodwill $ 18,354,326 Net assets acquired $ 60,090,974 The fair value of IPR&D was capitalized as of the IMGX Merger date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the IMGX Merger is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of such acquisition. The goodwill recorded is not deductible for tax purposes. All intangible assets acquired are subject to amortization and their associated estimated acquisition date fair values are as follows: Estimated Acquisition Date Intangible Asset Useful Life Fair Value Patents 2 $ 140,000 Trade names and trademarks 6 230,000 IPR&D – Latiglutenase Indefinite 54,000,000 IPR&D - CypCel Indefinite $ 9,000,000 Net income in the Condensed Consolidated Statement of Operations for the three months ended March 31, 2024 includes net losses of IMGX from the date of acquisition to March 31, 2024 of approximately $0.1 million. Pro forma disclosure for the IMGX acquisition The unaudited pro forma information for the three months ended March 31, 2024 and 2023 was impracticable for disclosure as IMGX was a private company. |
Fair Value Disclosures
Fair Value Disclosures | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures | |
Fair Value Disclosures | Note 4 - 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, 2024 (unaudited): Money market funds $ 12,244 $ 12,244 $ — $ — $ 12,244 Note payable 386,769 — 386,769 — 386,769 December 31, 2023: Money market funds 12,131 12,131 — — 12,131 Note payable $ 612,784 $ — $ 612,784 $ — $ 612,784 At March 31, 2024 and December 31, 2023, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Property, Equipment and Leaseho
Property, Equipment and Leasehold Improvements | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 December 31, (unaudited) 2023 Computer equipment and software $ 21,316 $ 11,540 Office equipment 57,465 48,278 Leasehold improvements 28,000 28,000 Total property, equipment and leasehold improvements 106,781 87,818 Less accumulated depreciation (81,032) (73,253) Property, equipment and leasehold improvements, net $ 25,749 $ 14,565 Depreciation expense for the three months ended March 31, 2024 was approximately $7,779 and for the three months ended March 31, 2023 was approximately $7,300. |
Goodwill
Goodwill | 3 Months Ended |
Mar. 31, 2024 | |
Goodwill | |
Goodwill | Note 6 –Goodwill Goodwill is as follows: Goodwill Balance on January 1, 2023 $ 1,684,182 Balance on December 31, 2023 1,684,182 Goodwill associated with IMGX acquisition 18,354,326 Balance on March 31, 2024 (unaudited) $ 20,038,508 |
Intangible Assets and In-Proces
Intangible Assets and In-Process R&D | 3 Months Ended |
Mar. 31, 2024 | |
Intangible Assets and In-Process R&D | |
Intangible Assets and In-Process R&D | Note 7 – Intangible Assets and In-Process R&D Intangible assets as of March 31, 2024 consist of in-process R&D, patents, tradenames and trademarks acquired from IMGX. Intangible assets and in-process R&D are as follows: Estimated March 31, Useful Life 2024 Patents 2 $ 140,000 Trademarks and trade names 6 230,000 Less: Accumulated Amortization (4,514) Intangible Assets, Net 365,486 In-Process R&D 63,000,000 Total Intangible Assets and In-Process R&D, Net $ 63,365,486 Expected future amortization expense as of March 31, 2024 is as follows: 2024 (remainder of year) $ 81,250 2025 108,333 2026 52,917 2027 38,333 Thereafter 84,653 Total $ 365,486 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses | |
Accrued Expenses | Note 8 - Accrued Expenses Accrued expenses consisted of the following: March 31, 2024 December 31, (unaudited) 2023 Accrued interest $ 1,328,669 $ — Consulting fees 662,947 75,972 Professional fees 507,844 253,577 Payroll and benefits 54,986 495,741 Total accrued expenses $ 2,554,446 $ 825,290 |
Capital Stock
Capital Stock | 3 Months Ended |
Mar. 31, 2024 | |
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 The Company had 2,025,208 and 1,560,998 shares of its Common Stock issued outstanding The Company had approximately 504.81 and 514.96 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, 2024 and December 31, 2023. 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 Permanent Waiver Record Holders As of March 31, 2024, (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 395 shares of Common Stock (which conversion the Company has elected to make in full), and additional Investor Warrants exercisable for up to an aggregate of 395 shares of Common Stock, (ii) holders of approximately 140.33 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $1.3 million had previously elected to exercise their Series B Exchange Rights into 110 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 44 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 44 shares of Common Stock. Mezzanine Equity Series G Preferred Stock The Company had 12,373.226 shares of Series G stock issued and outstanding December 31, 2023 On March 13, 2024, the Company issued 12,373.226 shares of Series G Preferred stock in connection with the IMGX Merger. The following is a summary of the principal terms of the Series G Preferred Stock as set forth in the Certificate of Designation of the Series G Preferred Stock: General; Transferability Conversion The Series G Preferred Stock is redeemable for cash at the option of the holder thereof at any time following the date that is six months after the initial issuance of the Series G Preferred Stock (without regard to the lack of obtaining the requisite stockholder approval to convert the Series G Preferred Stock into Common Stock), at a price per share equal to the then-current fair value of the Series G Preferred Stock, which shall be the last reported closing sale price of the Company’s Common Stock as reported on the Nasdaq Stock Market as of the trading day immediately prior to the conversion event. As such, Series G Preferred Stock is classified as Mezzanine Equity on the balance sheet. Voting Rights Liquidation Preference Dividend Rights Redemption Trading Market. 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 2024 Registered Direct Offering On March 6, 2024, the Company completed a Registered Direct Offering (the “ March 2024 Offering March 2024 Pre-Funded Warrants March 2024 Warrants The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $400,000. 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 $300,000. Common Stock Issuances Q1 2024 Issuances During the three months ended March 31, 2024, the Company issued 173,100 shares of Common Stock under the March 2024 Offering for which the Company received net proceeds of approximately $3.6 million. During the three months ended March 31, 2024, the Company issued an aggregate of 36,830 shares of Common Stock with a value of $2.3 million in connection with the IMGX acquisition. During the three months ended March 31, 2024, the Company issued an aggregate of 18,475 shares of Common Stock with a value of $0.1 million to its financial advisors in connection with the IMGX acquisition. During the three months ended March 31, 2024, the Company issued an aggregate of 83,525 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001 (See Note 10). During the three months ended March 31, 2024, the Company issued an aggregate of 9 shares of Common Stock upon the exchange of an aggregate of 10.15 shares of Series B Preferred Stock with a stated value of approximately $78,125 plus accrued dividends of approximately $22,770. During the three months ended March 31, 2024, the Company issued an aggregate of 100,000 shares of its Common Stock to consultants with a grant date fair value of approximately $781,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense. During the three months ended March 31, 2024, the Company issued an aggregate of 52,271 shares of Common Stock upon the vesting of RSUs (See Note 11). Q1 2023 Issuances During the three months ended March 31, 2023, the Company issued 6,400 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 21,473 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001 (See Note 10). During the three months ended March 31, 2023, the Company issued an aggregate of 4 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 148 shares of Common Stock in connection with the 1 -for-7 reverse stock split on January 18, 2023. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Warrants | |
Warrants | Note 10 – Warrant activity for the three months ended March 31, 2024 and 2023 was as follows: Weighted Weighted Average Average Number of Exercise Price Remaining Warrants Per Share Term in Years Outstanding and exercisable on January 1, 2024 1,779,780 $ 19.29 4.99 Issued 878,150 4.48 4.93 Assumed from IMGX 127,680 3.48 8.97 Exercised (83,525) — 4.93 Warrants outstanding and exercisable on March 31, 2024 2,702,085 $ 14.32 5.00 Warrants outstanding and exercisable on January 1, 2023 108,797 $ 383.20 5.50 Issued 147,053 51.00 4.96 Exercised (21,473) — 5.28 Warrants outstanding and exercisable on March 31, 2023 234,377 $ 210.00 5.07 As of March 31, 2024, the outstanding warrants expire from 2024 through 2033. During the three months ended March 31, 2024, the Company issued warrants to purchase 525,625 shares of the Company’s Common Stock and pre-funded warrants to purchase 352,525 shares of the Company’s Common Stock in connection with the March 2024 Offering (See Note 9). Additionally, the Company assumed warrants to purchase 127,680 shares of the Company’s Common Stock in connection with the IMGX acquisition. During the three months ended March 31, 2023, the Company issued warrants to purchase 102,302 shares of the Company’s Common Stock and pre-funded warrants to purchase 44,751 shares of the Company’s Common Stock in connection with the March 2023 Offering (See Note 9). |
Equity Incentive Plan
Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2024 | |
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 238 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, the 2020 Plan, or the IMGX Plan. The number of shares permitted to be issued as “incentive stock options” (“ ISOs On March 13, 2024, in connection with the IMGX acquisition, the Company assumed the IMGX Plan, including all 200,652 IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. Such stock options were the only awards that had been made under the IMGX Plan as of the closing of the IMGX acquisition. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan. As of January 1, 2024, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 334,078 under the 2020 Plan’s evergreen provision. As of March 31, 2024, there were an aggregate of 73 total shares available (but un-issuable) under the 2014 Plan, of which 28 are issued and outstanding, and 9 shares are reserved subject to issuance of restricted stock and RSUs. As of March 31, 2024, there were an aggregate of 350,000 total shares available (but un - issuable) under the IMGX 2021 Plan, of which 200,652 are issued and outstanding. As of March 31, 2024, 334,078 total shares were authorized under the 2020 Plan, of which 178,874 were issued and outstanding and 155,204 shares were available for potential issuances. During the three months ended March 31, 2024 and 2023, stock option activity under the 2014 Plan, 2020 Plan, and IMGX 2021 Plan was as follows: Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2024 426 $ 6,103.81 8.53 $ — Assumed from IMGX 200,652 0.81 7.56 716,328 Outstanding at March 31, 2024 201,078 $ 13.74 7.56 $ 716,350 Exercisable at March 31, 2024 201,054 $ 11.99 7.56 $ 716,341 Outstanding at January 1, 2023 176 $ 15,956.72 8.22 $ — Granted 250 74.60 9.91 — Outstanding at March 31, 2023 429 $ 8,900.40 9.07 $ — Exercisable at March 31, 2023 200 $ 17,091.40 8.40 $ — During the three months ended March 31, 2024, the Company assumed fully vested options to purchase 200,652 shares of the Company’s Common Stock issued under the IMGX 2021 Plan. During the three months ended March 31, 2023, the Board approved the grant of options to purchase 250 shares of the Company’s Common Stock pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36 For the three months ended March 31, 2024 and 2023, 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: 2024 2023 Contractual term (in years) 7.6 6.5 Expected Volatility 110.35 % 98.80 % Risk-free interest rate 4.20 % 4.08 % 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 assumed during the three months ended March 31, 2024 was $6.32. The estimated weighted average fair value of an option to purchase one share of common stock granted during the three months ended and March 31, 2023 was $61.00. 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 each March 31, 2024 and March 31, 2023, under the 2014 Plan, the Company had 5 shares of restricted stock outstanding and an aggregate unrecognized restricted Common Stock expense of approximately $269,500, which will be recognized when vesting of certain milestones become probable. During the three months ended March 31, 2024 and 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, 2024 52,271 $ 4.31 9.96 Awarded 120,532 3.80 — Vested (52,271) 4.31 — Non-vested Outstanding at March 31, 2024 120,532 $ 3.82 9.76 Non-vested Outstanding at January 1, 2023 — — — Awarded 7,997 $ 124.00 — Vested (2,003) 124.00 — Non-vested Outstanding at March 31, 2023 5,994 $ 124.00 0.75 During the three months ended March 31, 2024 and March 31, 2023, the Board approved the grant of 120,532 and 7,997 RSUs, respectively. 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, 2024 2023 Research and development $ 42,378 $ 38,080 General and administrative 228,982 320,236 Total stock-based compensation expense $ 271,360 $ 358,316 As of March 31, 2024, the Company had unrecognized stock-based compensation expense related to stock options and RSUs of approximately $0.6 million. Approximately $0.5 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock awards of 0.76 years. Approximately $0.1 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, 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. |
Agreements
Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Agreements | |
Agreements | Note 12 – Agreements License Agreement with Sanofi On September 13, 2023, the Company entered into a License Agreement with Sanofi, pursuant to which the Company received a license to obtain certain exclusive worldwide rights to develop and commercialize Capeserod, a selective 5-HT4 receptor partial agonist which the Company intends to repurpose and develop for gastrointestinal indications. The Company paid Sanofi an upfront payment of $500,000 in October 2023 and Sanofi will be eligible to receive up to $46 million in potential development and regulatory milestone payments and up to $235 million in potential commercial milestone payments. Sanofi will also be eligible to receive mid-to-high single-digit royalties on net sales, as well as a percentage of sublicense and transfer revenues with respect to Capeserod. Sanofi will also have a right of first refusal with respect to Capeserod out-licensing transactions. The upfront payment of $500,000 was recorded as research and development expense in the year ended December 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. The License Agreement shall expire on a country-by-country basis upon the later of: (i) the expiration of the last to expire valid claim of an applicable patent in such country covering such licensed product, (ii) the expiration of the regulatory exclusivity for such licensed product in the applicable country and (iii) the tenth anniversary of the date of first commercial sale of a licensed product in such country. Each party may terminate the License Agreement if the other party materially breaches its obligations under the License Agreement and fails to cure such material breach within 60 days from the date of such notice of breach, except in the case of payment breach, as to which the breaching party will have only a ten-day cure period. Sanofi may terminate the License Agreement upon any bankruptcy proceedings by the Company. The Company may terminate the License Agreement by providing Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled to any and all payments due and owed to Sanofi prior to the effective date of termination. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
Leases | Note 13 – Leases 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 Newport Beach, California with a term through April 30, 2025. 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 $35,000 and $37,000, respectively, for the three months ended March 31, 2024 and 2023. The weighted-average remaining lease term and weighted-average discount rate under operating leases as of March 31, 2024 are: March 31, 2024 Lease term and discount rate Weighted-average remaining lease term (years) 2.4 Weighted-average discount rate 7.00 % Maturities of operating lease liabilities as of March 31, 2024, were as follows: 2024 (remainder of year) $ 67,308 2025 88,788 2026 60,593 Total lease payments 216,689 Less imputed interest (17,881) Present value of lease liabilities $ 198,808 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2024 | |
Debt | |
Debt | Note 14 – Debt Debt consists of the following: Related Directors party and Officer’s Revolving promissory Liability line of credit notes EIDL loan Insurance Total Principal balance March 31, 2024 $ 5,359,860 $ 1,000,000 $ 500,000 $ 386,769 $ 7,246,629 Debt discount — — (461,971) — (461,971) Total debt as of March 31, 2024 $ 5,359,860 $ 1,000,000 $ 38,029 $ 386,769 $ 6,784,658 Current portion $ — $ — $ — $ 386,769 $ 386,769 Long-term portion, net $ 5,359,860 $ 1,000,000 $ 38,029 $ — $ 6,397,889 Aggregate future minimum principal maturities of notes payable as of December 31, are as follows: 2024 $ 386,769 2025 6,359,860 2026 — 2027 — Thereafter 500,000 Total $ 7,246,629 Revolving line of credit In connection with the IMGX acquisition, the Company assumed a revolving line of credit. In October 2022, IMGX entered into a credit agreement, which allowed for a revolving line of credit (the “ Revolver First Amendment Second Amendment As of March 31, 2024, the outstanding balance of the Revolver was $5.4 million with no available borrowings and accrued interest of $1.3 million. Promissory notes In connection with the IMGX acquisition, the Company assumed two promissory notes, one of which is with a related party. The notes are each in the amount of $0.5 million, accrue interest at a rate of the prime rate plus 4.5% per annum, and have a maturity date of September 30, 2025. EIDL loan In connection with the IMGX acquisition, the Company assumed an EIDL loan with a principal balance of $0.5 million bearing interest of 3.75% per annum, with interest payable monthly in arrears. All unpaid principal and interest are due at maturity on June 30, 2050. Directors and Officer ’ s Liability Insurance On November 30, 2023, the Company entered into 9-month |
Net Income (Loss) per Common Sh
Net Income (Loss) per Common Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Income (Loss) per Common Share | |
Net Income (Loss) per Common Share | Note 15 – 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 debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options, warrants, and RSUs is computed using the treasury stock method. The dilutive effect of the outstanding Series G convertible preferred stock and Series B convertible preferred stock is computed using the if-converted method. As of March 31, 2024, basic and diluted weighted average shares outstanding includes pre-funded warrants of 269,000 which had not yet been converted into Common Stock. For the three months ended March 31, 2024 stock options in the amount of 31,542 and warrants in the amount of 2,584,001 were excluded from the calculation of diluted net income per share as they did not have a dilutive effect. As of March 31, 2023, basic weighted average shares outstanding includes pre-funded warrants of 44,750 which had not yet been converted into Common Stock. Basic and diluted net income per share was calculated as follows: Three Months Ended March 31, 2024 Net income applicable to common shareholders - basic $ 5,501,462 Preferred stock dividends 66,144 Net income applicable to common shareholders - diluted $ 5,567,606 Basic weighted average shares outstanding 1,761,953 Series G convertible preferred stock 12,373,226 Series B convertible preferred stock 139 Stock options 169,536 Common stock warrants 118,084 RSUs not yet issued 88,523 Diluted weighted average shares outstanding 14,511,461 Basic net income per share $ 3.12 Diluted net income per share $ 0.38 All shares of Common Stock that may potentially be issued in the future are as follows: March 31, 2024 March 31, 2023 (unaudited) (unaudited) Series G convertible preferred stock 12,373,226 — Common stock warrants 2,702,085 234,377 Stock options 201,078 429 RSUs not yet issued 120,537 8,011 Series B convertible preferred stock (1) 139 155 Restricted stock not yet issued 4 8 Total shares of common stock issuable 15,397,069 242,980 (1) Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of March 31, 2024. |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2024 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 16 - Employee Benefit Plans 401(k) Plan Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company. All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions. Employer contributions under this 401(k) plan amounted to approximately $37,000 and $26,000 for the three months ended March 31, 2024 and 2023, respectively. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | Note 17 - Income Taxes The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. Although the Company believes that it has adequately reserved for uncertain tax positions (including interest and penalties), it can provide no assurance that the final tax outcome of these matters will not be materially different. The Company makes adjustments to these reserves in accordance with the income tax accounting guidance when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences will affect the provision for income taxes in the period in which such determination is made and could have a material impact on the Company’s financial condition and operating results. Carryforward attributes that were generated in tax years prior to those that remain open for examination may still be adjusted by relevant tax authorities upon examination if they either have been, or will be, used in a future period. In applying the estimated annual effective tax rate approach prescribed under ASC 740 - 270 and based on present evidence and conclusions around the realizability of deferred tax assets, the Company determined that any deferred tax benefits related to the forecasted tax rate and pretax activity during the first quarters of 2024 and 2023 are neither more likely than not to be realized in the current year nor realizable as a deferred tax asset at the end of the year. Therefore, the appropriate amount of income tax benefit to recognize related to deferred tax assets generated during the three months ended March 31, 2024 and 2023 is zero. The Company’s effective income tax rate was approximately 160% and 0% for the three months ended March 31, 2024 and 2023, respectively. The income tax provision for interim periods is determined using an estimate of the annual effective tax rate adjusted for discrete items. The Company’s effective tax rate for the three months ended March 31, 2024 differs from the applicable statutory tax rate primarily due to the impact of the accounting for the IMGX Merger during the period, which resulted in the release of a portion of the valuation allowance that had previously been recorded against the deferred tax assets of the Company, resulting in a $14.9 million income tax benefit for the three months ended March 31, 2024. The change in valuation allowance was determined based on the weight of available evidence as of the present reporting period and accounted for by the Company pursuant to ASC 805 - 740 - 30 - 3 in the Statement of Operations. The Company’s effective tax rate for the three months ended March 31, 2023 differs from the applicable statutory tax rate primarily due to the full valuation allowance recorded against its deferred tax assets during the period. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events | |
Subsequent Events | Note 18 - Subsequent Events The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were available to be issued. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements except for the items noted below. Registered Direct Offering On May 14, 2024, the Company closed on a Registered Direct Offering with an institutional investor for the purchase and sale of 366,000 shares of the Company’s Common Stock (or Common Stock equivalents) at a price of $2.95 per share. In addition, the Company issued to the investor warrants to purchase up to 732,000 shares of Common Stock. The warrants have an exercise price of $2.70 per share, are exercisable immediately following the date of issuance, and have a term of six years following the date of issuance. Roth Capital Partners acted as the exclusive placement agent for the offering. The gross proceeds to the Company from this offering were approximately $1.1 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. Share Issuances In April 2024, an investor exercised pre-funded warrants to purchase 269,000 shares of the Company’s Common Stock in connection with the March 2024 Offering, the Company issued an aggregate of 150,000 shares of its Common Stock to consultants, and an aggregate of 30,882 shares of Common Stock upon the vesting of RSUs. |
Significant Accounting Polici_2
Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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 December 18, 2023, the Company effected a reverse stock split, whereby every twenty 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 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. |
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, 2024 and December 31, 2023. As of March 31, 2024 and December 31, 2023, 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, 2024 the Company had approximately $3.4 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. |
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, 2024 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 |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ ASC 740 The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At March 31, 2024 and 2023, the Company does not have any significant uncertain tax positions. |
Leases | Leases Leases are recorded on the balance sheet as right of use assets and lease obligations. |
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 acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“ IPR&D Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. For tax purposes, intangible assets related to IPR&D are considered definite-lived intangible assets. |
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 The Company has evaluated 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. |
Business Acquisition (Tables)
Business Acquisition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Business Acquisition | |
Schedule of preliminary fair value of the consideration | Amount Common stock issued to IMGX stockholders $ 240,500 Replacement options 1,271,000 Replacement warrants 789,000 Preferred stock issued to IMGX stockholders 57,790,474 Total consideration paid $ 60,090,974 |
Schedule of preliminary purchase price allocation | Assets acquired: Cash and cash equivalents $ 88,169 Prepaid expenses and other current assets 3,131,929 Property and equipment, net 18,963 Intangibles 63,370,000 Operating lease right-of-use assets 4,232 Total assets $ 66,613,293 Liabilities assumed: Accounts payable 916,209 Accrued expenses and other current liabilities 2,131,439 Long term debt 6,397,889 Deferred tax liability 15,431,108 Total liabilities $ 24,876,645 Goodwill recorded: Goodwill $ 18,354,326 Net assets acquired $ 60,090,974 |
Schedule of intangible assets acquired | Estimated Acquisition Date Intangible Asset Useful Life Fair Value Patents 2 $ 140,000 Trade names and trademarks 6 230,000 IPR&D – Latiglutenase Indefinite 54,000,000 IPR&D - CypCel Indefinite $ 9,000,000 |
Fair Value Disclosures (Tables)
Fair Value Disclosures (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures | |
Schedule of fair value of the Company's financial instruments | Fair Value Measured at Reporting Date Using Carrying Amount Level 1 Level 2 Level 3 Fair Value March 31, 2024 (unaudited): Money market funds $ 12,244 $ 12,244 $ — $ — $ 12,244 Note payable 386,769 — 386,769 — 386,769 December 31, 2023: Money market funds 12,131 12,131 — — 12,131 Note payable $ 612,784 $ — $ 612,784 $ — $ 612,784 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Equipment and Leasehold Improvements | |
Summary of property, equipment and leasehold improvements | March 31, 2024 December 31, (unaudited) 2023 Computer equipment and software $ 21,316 $ 11,540 Office equipment 57,465 48,278 Leasehold improvements 28,000 28,000 Total property, equipment and leasehold improvements 106,781 87,818 Less accumulated depreciation (81,032) (73,253) Property, equipment and leasehold improvements, net $ 25,749 $ 14,565 |
Goodwill (Tables)
Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Goodwill | |
Schedule of goodwill | Goodwill Balance on January 1, 2023 $ 1,684,182 Balance on December 31, 2023 1,684,182 Goodwill associated with IMGX acquisition 18,354,326 Balance on March 31, 2024 (unaudited) $ 20,038,508 |
Intangible Assets and In-Proc_2
Intangible Assets and In-Process R&D (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Intangible Assets and In-Process R&D | |
Summary of patents, tradenames and trademarks, intangible assets and in-process R&D from IMGX | Intangible assets as of March 31, 2024 consist of in-process R&D, patents, tradenames and trademarks acquired from IMGX. Intangible assets and in-process R&D are as follows: Estimated March 31, Useful Life 2024 Patents 2 $ 140,000 Trademarks and trade names 6 230,000 Less: Accumulated Amortization (4,514) Intangible Assets, Net 365,486 In-Process R&D 63,000,000 Total Intangible Assets and In-Process R&D, Net $ 63,365,486 |
Schedule of expected future amortization expense | Expected future amortization expense as of March 31, 2024 is as follows: 2024 (remainder of year) $ 81,250 2025 108,333 2026 52,917 2027 38,333 Thereafter 84,653 Total $ 365,486 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses | |
Schedule of accrued expenses | March 31, 2024 December 31, (unaudited) 2023 Accrued interest $ 1,328,669 $ — Consulting fees 662,947 75,972 Professional fees 507,844 253,577 Payroll and benefits 54,986 495,741 Total accrued expenses $ 2,554,446 $ 825,290 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 1,779,780 $ 19.29 4.99 Issued 878,150 4.48 4.93 Assumed from IMGX 127,680 3.48 8.97 Exercised (83,525) — 4.93 Warrants outstanding and exercisable on March 31, 2024 2,702,085 $ 14.32 5.00 Warrants outstanding and exercisable on January 1, 2023 108,797 $ 383.20 5.50 Issued 147,053 51.00 4.96 Exercised (21,473) — 5.28 Warrants outstanding and exercisable on March 31, 2023 234,377 $ 210.00 5.07 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity Incentive Plan | |
Schedule of stock option activity | Average Remaining Number Exercise Contract Intrinsic of Shares Price Life (Years) Value Outstanding at January 1, 2024 426 $ 6,103.81 8.53 $ — Assumed from IMGX 200,652 0.81 7.56 716,328 Outstanding at March 31, 2024 201,078 $ 13.74 7.56 $ 716,350 Exercisable at March 31, 2024 201,054 $ 11.99 7.56 $ 716,341 Outstanding at January 1, 2023 176 $ 15,956.72 8.22 $ — Granted 250 74.60 9.91 — Outstanding at March 31, 2023 429 $ 8,900.40 9.07 $ — Exercisable at March 31, 2023 200 $ 17,091.40 8.40 $ — |
Schedule of option pricing model with the following weighted-average assumptions | 2024 2023 Contractual term (in years) 7.6 6.5 Expected Volatility 110.35 % 98.80 % Risk-free interest rate 4.20 % 4.08 % 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, 2024 52,271 $ 4.31 9.96 Awarded 120,532 3.80 — Vested (52,271) 4.31 — Non-vested Outstanding at March 31, 2024 120,532 $ 3.82 9.76 Non-vested Outstanding at January 1, 2023 — — — Awarded 7,997 $ 124.00 — Vested (2,003) 124.00 — Non-vested Outstanding at March 31, 2023 5,994 $ 124.00 0.75 |
Schedule of stock-based compensation expense | Three Months Ended March 31, 2024 2023 Research and development $ 42,378 $ 38,080 General and administrative 228,982 320,236 Total stock-based compensation expense $ 271,360 $ 358,316 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
Schedule of weighted-average remaining lease term and weighted-average discount rate under operating leases | March 31, 2024 Lease term and discount rate Weighted-average remaining lease term (years) 2.4 Weighted-average discount rate 7.00 % |
Schedule of maturities of operating lease liabilities | Maturities of operating lease liabilities as of March 31, 2024, were as follows: 2024 (remainder of year) $ 67,308 2025 88,788 2026 60,593 Total lease payments 216,689 Less imputed interest (17,881) Present value of lease liabilities $ 198,808 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt | |
Schedule of debt | Related Directors party and Officer’s Revolving promissory Liability line of credit notes EIDL loan Insurance Total Principal balance March 31, 2024 $ 5,359,860 $ 1,000,000 $ 500,000 $ 386,769 $ 7,246,629 Debt discount — — (461,971) — (461,971) Total debt as of March 31, 2024 $ 5,359,860 $ 1,000,000 $ 38,029 $ 386,769 $ 6,784,658 Current portion $ — $ — $ — $ 386,769 $ 386,769 Long-term portion, net $ 5,359,860 $ 1,000,000 $ 38,029 $ — $ 6,397,889 |
Schedule of aggregate future minimum principal maturities of notes payable | 2024 $ 386,769 2025 6,359,860 2026 — 2027 — Thereafter 500,000 Total $ 7,246,629 |
Net Income (Loss) per Common _2
Net Income (Loss) per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Income (Loss) per Common Share | |
Schedule of net income (loss) per share | Three Months Ended March 31, 2024 Net income applicable to common shareholders - basic $ 5,501,462 Preferred stock dividends 66,144 Net income applicable to common shareholders - diluted $ 5,567,606 Basic weighted average shares outstanding 1,761,953 Series G convertible preferred stock 12,373,226 Series B convertible preferred stock 139 Stock options 169,536 Common stock warrants 118,084 RSUs not yet issued 88,523 Diluted weighted average shares outstanding 14,511,461 Basic net income per share $ 3.12 Diluted net income per share $ 0.38 |
Schedule of Common Stock that may potentially be issued in the future | March 31, 2024 March 31, 2023 (unaudited) (unaudited) Series G convertible preferred stock 12,373,226 — Common stock warrants 2,702,085 234,377 Stock options 201,078 429 RSUs not yet issued 120,537 8,011 Series B convertible preferred stock (1) 139 155 Restricted stock not yet issued 4 8 Total shares of common stock issuable 15,397,069 242,980 (1) Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of March 31, 2024. |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) - USD ($) | Apr. 01, 2024 | Mar. 31, 2024 | Dec. 31, 2023 |
The Company and Basis of Presentation | |||
Cash and cash equivalents | $ 3,431,913 | $ 3,711,770 | |
Accumulated deficit | (178,761,066) | $ (184,328,672) | |
Working capital | $ 1,300,000 | ||
May 2024 Registered Direct Offering | Subsequent events | |||
The Company and Basis of Presentation | |||
Proceeds from issuance of shares | $ 1,100,000 |
Significant Accounting Polici_3
Significant Accounting Policies and Recent Accounting Pronouncements (Details) - USD ($) | 3 Months Ended | |||||
Dec. 18, 2023 | Jan. 18, 2023 | Aug. 26, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Significant Accounting Policies and Recent Accounting Pronouncements | ||||||
Number of shares reduced due to reverse stock split | 20 | 7 | 30 | 1 | ||
Restricted cash | $ 20,000 | $ 20,000 | ||||
Cash in US banks in excess of FDIC insurance limits | 3,400,000 | |||||
Asset impairment charges | $ 0 |
Business Acquisition (Details)
Business Acquisition (Details) | Mar. 13, 2024 USD ($) $ / shares shares | Mar. 31, 2024 shares | Dec. 31, 2023 shares |
Business Acquisition | |||
Share issuable per each share of preferred stock converted | 1,000 | ||
Common stock. Shares outstanding | 2,025,208 | 1,560,998 | |
Common stock, shares issued | 2,025,208 | 1,560,998 | |
IMGX | |||
Business Acquisition | |||
Share issuable per each share of preferred stock converted | 1,000 | ||
Transaction costs | $ | $ 5,456,038 | ||
Preliminary fair value of consideration amount | $ | 60,100,000 | ||
Net losses of acquiree from the date of acquisition | $ | 100,000 | ||
Amount of advisory fees included in transaction cost | $ | $ 4,000,000 | ||
IMGX | Common Stock | |||
Business Acquisition | |||
Number of shares issued | 36,830 | ||
Common stock. Shares outstanding | 2,303,135 | ||
Common stock, shares issued | 2,303,135 | ||
IMGX | Common Stock | Tungsten Partners LLC | |||
Business Acquisition | |||
Issuance of stock to financial advisors (in shares) | 18,475 | ||
IMGX | Common Stock | Assumed Options | |||
Business Acquisition | |||
Number of shares issuable upon exercise of options or warrants | 200,652 | ||
Exercise price per share | $ / shares | $ 0.81 | ||
IMGX | Common Stock | Assumed Warrants | |||
Business Acquisition | |||
Number of shares issuable upon exercise of options or warrants | 127,680 | ||
IMGX | Common Stock | Assumed Warrants | Maximum | |||
Business Acquisition | |||
Exercise price per share | $ / shares | $ 3.92 | ||
IMGX | Common Stock | Assumed Warrants | Minimum | |||
Business Acquisition | |||
Exercise price per share | $ / shares | $ 3.03 | ||
IMGX | Series G Preferred Stock | |||
Business Acquisition | |||
Number of shares issued | 11,777.418 | ||
IMGX | Series G Preferred Stock | Tungsten Partners LLC | |||
Business Acquisition | |||
Issuance of stock to financial advisors (in shares) | 595.808 |
Business Acquisition - Consider
Business Acquisition - Consideration (Details) - IMGX | Mar. 13, 2024 USD ($) |
Business Acquisition | |
Total Purchase Price | $ 60,090,974 |
Assumed Options | |
Business Acquisition | |
Replacement options/warrants | 1,271,000 |
Assumed Warrants | |
Business Acquisition | |
Replacement options/warrants | 789,000 |
Common Stock | |
Business Acquisition | |
Stock issued to IMGX stockholders | 240,500 |
Series G Preferred Stock | |
Business Acquisition | |
Stock issued to IMGX stockholders | $ 57,790,474 |
Business Acquisition - Assets a
Business Acquisition - Assets acquired and the liabilities assumed (Details) - USD ($) | Mar. 31, 2024 | Mar. 13, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Liabilities assumed: | ||||
Goodwill | $ 20,038,508 | $ 1,684,182 | $ 1,684,182 | |
IMGX | ||||
Assets acquired: | ||||
Cash and cash equivalents | $ 88,169 | |||
Prepaid expenses and other current assets | 3,131,929 | |||
Property and equipment, net | 18,963 | |||
Intangibles | 63,370,000 | |||
Operating lease right-of-use assets | 4,232 | |||
Total assets | 66,613,293 | |||
Liabilities assumed: | ||||
Accounts Payable | 916,209 | |||
Accrued expenses and other current liabilities | 2,131,439 | |||
Long term Debt | 6,397,889 | |||
Deferred tax liability | 15,431,108 | |||
Total liabilities | 24,876,645 | |||
Goodwill | 18,354,326 | |||
Net assets acquired | $ 60,090,974 |
Business Acquisition - Assets_2
Business Acquisition - Assets acquired and the liabilities assumed (Details) - IMGX | Mar. 13, 2024 USD ($) |
Business Acquisition | |
Acquisition Date Fair Value | $ 63,370,000 |
IPR&D - Latiglutenase | |
Business Acquisition | |
Acquisition Date Fair Value | 54,000,000 |
IPR&D - CypCel | |
Business Acquisition | |
Acquisition Date Fair Value | $ 9,000,000 |
Patents | |
Business Acquisition | |
Estimated Useful Life | 2 years |
Acquisition Date Fair Value | $ 140,000 |
Trademarks and Trade Names | |
Business Acquisition | |
Estimated Useful Life | 6 years |
Acquisition Date Fair Value | $ 230,000 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Disclosures | ||
Money market funds | $ 3,431,913 | $ 3,711,770 |
Note payable | 386,769 | 612,784 |
Carrying Amount | ||
Fair Value Disclosures | ||
Note payable | 386,769 | 612,784 |
Fair Value, Inputs, Level 2 | ||
Fair Value Disclosures | ||
Note payable | 386,769 | 612,784 |
Money Market Funds | ||
Fair Value Disclosures | ||
Money market funds | 12,244 | 12,131 |
Money Market Funds | Carrying Amount | ||
Fair Value Disclosures | ||
Money market funds | 12,244 | 12,131 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair Value Disclosures | ||
Money market funds | $ 12,244 | $ 12,131 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | $ 106,781 | $ 87,818 | |
Less accumulated depreciation | (81,032) | (73,253) | |
Property, plant and equipment, net | 25,749 | 14,565 | |
Depreciation | 7,779 | $ 7,300 | |
Computer equipment and software | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | 21,316 | 11,540 | |
Office equipment | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | 57,465 | 48,278 | |
Leasehold improvements | |||
Property, Equipment and Leasehold Improvements | |||
Total property, plant, and equipment | $ 28,000 | $ 28,000 |
Goodwill (Details)
Goodwill (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Goodwill | |
Beginning balance | $ 1,684,182 |
Goodwill associated with IMGX acquisition | 18,354,326 |
Ending balance | $ 20,038,508 |
Intangible Assets and In-Proc_3
Intangible Assets and In-Process R&D - Intangible assets acquired from IMGX (Details) | Mar. 31, 2024 USD ($) |
Intangible Assets and In-Process R&D | |
Less: Accumulated Amortization | $ (4,514) |
Intangible Assets, Net | 365,486 |
Total Intangible Assets and In-Process R&D, Net | 63,365,486 |
In Process Research and Development | |
Intangible Assets and In-Process R&D | |
In-Process R&D | 63,000,000 |
Patents | |
Intangible Assets and In-Process R&D | |
Finite-Lived Intangible Assets, Gross | $ 140,000 |
Finite-lived intangible asset, useful life (year) | 2 years |
Trademarks and Trade Names | |
Intangible Assets and In-Process R&D | |
Finite-Lived Intangible Assets, Gross | $ 230,000 |
Finite-lived intangible asset, useful life (year) | 6 years |
Intangible Assets and In-Proc_4
Intangible Assets and In-Process R&D - Future Amortization expense (Details) | Mar. 31, 2024 USD ($) |
Future amortization expense | |
2024 (remainder of year) | $ 81,250 |
2025 | 108,333 |
2026 | 52,917 |
2027 | 38,333 |
Thereafter | 84,653 |
Intangible Assets, Net | $ 365,486 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Expenses | ||
Accrued interest | $ 1,328,669 | |
Consulting fees | 662,947 | $ 75,972 |
Professional fees | 507,844 | 253,577 |
Payroll and benefits | 54,986 | 495,741 |
Total accrued expenses | $ 2,554,446 | $ 825,290 |
Capital Stock (Details)
Capital Stock (Details) | 3 Months Ended | |||||||||||
Mar. 06, 2024 USD ($) $ / shares shares | Dec. 18, 2023 shares | Mar. 15, 2023 USD ($) $ / shares shares | Jan. 18, 2023 shares | Aug. 26, 2022 shares | May 24, 2022 shares | May 12, 2022 | May 26, 2021 | Mar. 31, 2024 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) shares | Mar. 13, 2024 shares | Dec. 31, 2023 $ / shares shares | |
Capital Stock | ||||||||||||
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | ||||||||||
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 | 20 | 7 | 30 | 1 | ||||||||
Common stock, shares, issued, total (in shares) | 2,025,208 | 1,560,998 | ||||||||||
Common stock, shares outstanding (in shares) | 2,025,208 | 1,560,998 | ||||||||||
Stock cancelled during period, shares, acquisitions (in shares) | 148 | |||||||||||
Preferred Stock, Convertible, Conversion Ratio | 1,000 | |||||||||||
Reverse stock split ratio | 1 | |||||||||||
Stock issued during period, value, acquisitions | $ | $ 2,300,500 | |||||||||||
Issuance of stock to financial advisors | $ | $ 120,648 | |||||||||||
Consultants | ||||||||||||
Capital Stock | ||||||||||||
Stock issued during period, shares, settlement (in shares) | 100,000 | |||||||||||
Stock issued during period, value, settlement | $ | $ 781,000 | |||||||||||
Restricted Stock Units | ||||||||||||
Capital Stock | ||||||||||||
Conversion of stock, shares issued (in shares) | 52,271 | |||||||||||
At The Market Offering Agreement | Wainwright | ||||||||||||
Capital Stock | ||||||||||||
Stock sales agreement, commission on shares sold, percentage | 3% | |||||||||||
Stock sales agreement, number of shares authorized (in shares) | 8,000,000 | |||||||||||
March 2024 Registered Direct Offering | ||||||||||||
Capital Stock | ||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 7.61 | |||||||||||
Gross proceeds | $ | $ 4,000,000 | |||||||||||
Other offering expenses | $ | $ 400,000 | |||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | |||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||
Private placement | ||||||||||||
Capital Stock | ||||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 78.20 | |||||||||||
Gross proceeds | $ | $ 4,000,000 | |||||||||||
Other offering expenses | $ | $ 300,000 | |||||||||||
Number of common stock shares called by each warrant (in shares) | 1 | |||||||||||
Warrants and rights outstanding, term (year) | 5 years | |||||||||||
Pre-funded warrants | ||||||||||||
Capital Stock | ||||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 0.0001 | $ 0.0001 | ||||||||||
Conversion of stock, shares issued (in shares) | 83,525 | 21,473 | ||||||||||
Series B Preferred Stock | ||||||||||||
Capital 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 outstanding (in shares) | 504.81 | 514.96 | ||||||||||
Exchange Amount | $ | $ 7,700 | |||||||||||
Preferred stock, shares issued (in shares) | 504.81 | 514.96 | ||||||||||
Series B Preferred Stock | Waiver | ||||||||||||
Capital Stock | ||||||||||||
Percentage of outstanding shares | 81.30% | |||||||||||
Series B Preferred Stock | Series B Preferred Stock Converted into Common Stock | ||||||||||||
Capital Stock | ||||||||||||
Conversion of stock, shares converted (in shares) | 10.15 | 4.23 | ||||||||||
Common stock issued upon conversion of preferred stock | $ | $ 78,125 | $ 32,600 | ||||||||||
Conversion of stock, amount converted, accrued dividends | $ | 22,770 | $ 6,200 | ||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | ||||||||||||
Capital Stock | ||||||||||||
Exchange Amount | $ | $ 14,400,000 | |||||||||||
Conversion of stock, shares converted (in shares) | 1,839.76 | |||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 395 | |||||||||||
Series B Preferred Stock convertible into Series C Preferred Stock | Investor warrants | ||||||||||||
Capital Stock | ||||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 395 | |||||||||||
Series B Preferred Stock convertible into common stock with no warrants | ||||||||||||
Capital Stock | ||||||||||||
Exchange Amount | $ | $ 1,300,000 | |||||||||||
Conversion of stock, shares converted (in shares) | 140.33 | |||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 110 | |||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants | ||||||||||||
Capital Stock | ||||||||||||
Exchange Amount | $ | $ 265,000 | |||||||||||
Conversion of stock, shares converted (in shares) | 30.91 | |||||||||||
Conversion of Series B preferred shares into common stock (in shares) | 44 | |||||||||||
Series B Preferred Stock Convertible Into Common Stock With Series C Warrants | March 2024 Warrants | ||||||||||||
Capital Stock | ||||||||||||
Warrants to purchase of stock | 44 | |||||||||||
Series C Preferred Stock | ||||||||||||
Capital 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 outstanding (in shares) | 0 | 0 | ||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||||
Series C Preferred Stock | March 2024 Registered Direct Offering | ||||||||||||
Capital Stock | ||||||||||||
Number of common shares issuable upon conversion | 352,525 | |||||||||||
Series C Preferred Stock | Private placement | ||||||||||||
Capital Stock | ||||||||||||
Number of common shares issuable upon conversion | 44,751 | |||||||||||
Series D Preferred Stock | ||||||||||||
Capital 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 outstanding (in shares) | 0 | 0 | ||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||||
Series D Preferred Stock | March 2024 Registered Direct Offering | ||||||||||||
Capital Stock | ||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||
Stock issued during period, shares, new issues (in shares) | 173,100 | |||||||||||
Series D Preferred Stock | Private placement | ||||||||||||
Capital Stock | ||||||||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 0.002 | |||||||||||
Stock issued during period, shares, new issues (in shares) | 6,400 | |||||||||||
Series G Preferred Stock | ||||||||||||
Capital Stock | ||||||||||||
Temporary Equity, Shares Issued | 12,373.2260 | 0 | ||||||||||
Temporary Equity, Shares Outstanding | 12,373.2260 | 0 | ||||||||||
Series G Preferred Stock | IMGX | ||||||||||||
Capital Stock | ||||||||||||
Temporary Equity, Shares Issued | 12,373.226 | |||||||||||
Series G Redeemable Preferred Stock | ||||||||||||
Capital Stock | ||||||||||||
Temporary Equity, Shares Issued | 12,373.226 | 0 | ||||||||||
Temporary Equity, Shares Outstanding | 12,373.226 | 0 | ||||||||||
Series E Preferred Stock | ||||||||||||
Capital 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 outstanding (in shares) | 0 | 0 | ||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||||
Series E Preferred Stock | March 2024 Registered Direct Offering | ||||||||||||
Capital Stock | ||||||||||||
Number of shares reduced due to reverse stock split | 7.48 | |||||||||||
Number of common shares issuable upon conversion | 525,625 | |||||||||||
Series E Preferred Stock | Private placement | ||||||||||||
Capital Stock | ||||||||||||
Number of shares reduced due to reverse stock split | 73.20 | |||||||||||
Number of common shares issuable upon conversion | 102,302 | |||||||||||
Common Stock | ||||||||||||
Capital Stock | ||||||||||||
Conversion of stock, shares issued (in shares) | 9 | 4 | ||||||||||
Common Stock | IMGX | ||||||||||||
Capital Stock | ||||||||||||
Common stock issued to consultants (in shares) | 18,475 | |||||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | 36,830 | |||||||||||
Stock issued during period, value, acquisitions | $ | $ 2,300,000 | |||||||||||
Issuance of stock to financial advisors (in shares) | 18,475 | |||||||||||
Issuance of stock to financial advisors | $ | $ 100,000 | |||||||||||
Common Stock | March 2024 Registered Direct Offering | ||||||||||||
Capital Stock | ||||||||||||
Stock issued during period, shares, new issues (in shares) | 173,100 | |||||||||||
Proceeds from Issuance of Common Stock | $ | $ 3,600,000 | |||||||||||
Common Stock | March 2023 offering | ||||||||||||
Capital Stock | ||||||||||||
Stock issued during period, shares, new issues (in shares) | 6,400 | |||||||||||
Warrants to purchase of stock | 102,302 | |||||||||||
Proceeds from Issuance of Common Stock | $ | $ 3,800,000 | |||||||||||
Maximum | Series G Preferred Stock | ||||||||||||
Capital Stock | ||||||||||||
Preferred Stock, Beneficial Ownership Held, Percentage | 19.90% | |||||||||||
Minimum | Series G Preferred Stock | ||||||||||||
Capital Stock | ||||||||||||
Threshold Limits of Ownership Percentage | 4.9 |
Warrants (Details)
Warrants (Details) - $ / shares | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Warrants | ||||
Outstanding and exercisable, beginning (in shares) | 1,779,780 | 108,797 | 108,797 | |
Issued (in shares) | 878,150 | 147,053 | ||
Assumed from IMGX (in shares) | 127,680 | |||
Exercised (in shares) | (83,525) | (21,473) | ||
Warrants outstanding and exercisable, ending (in shares) | 2,702,085 | 234,377 | 1,779,780 | 108,797 |
Weighted Average Exercise Price Per Share | ||||
Outstanding and exercisable, beginning (in dollars per share) | $ 19.29 | $ 383.20 | $ 383.20 | |
Issued (in dollars per share) | 4.48 | 51 | ||
Assumed from IMGX (in dollars per share) | 3.48 | |||
Warrants outstanding and exercisable, ending (in dollars per share) | $ 14.32 | $ 210 | $ 19.29 | $ 383.20 |
Weighted Average Remaining Term in Years | ||||
Outstanding and exercisable (in years) | 5 years | 5 years 25 days | 4 years 11 months 26 days | 5 years 6 months |
Issued (in years) | 4 years 11 months 4 days | 4 years 11 months 15 days | ||
Assumed from IMGX (in years) | 8 years 11 months 19 days | |||
Exercised (in years) | 4 years 11 months 4 days | 5 years 3 months 10 days | ||
March 2023 offering | Common Stock | ||||
Weighted Average Remaining Term in Years | ||||
Warrants to purchase of stock | 102,302 | |||
March 2024 Offering | Common Stock | ||||
Weighted Average Remaining Term in Years | ||||
Warrants to purchase of stock | 525,625 | |||
Warrants, pre-funded warrants, and placement agent warrants | March 2023 offering | Common Stock | ||||
Weighted Average Remaining Term in Years | ||||
Warrants to purchase of stock | 44,751 | |||
Warrants, pre-funded warrants, and placement agent warrants | March 2024 Offering | Common Stock | ||||
Weighted Average Remaining Term in Years | ||||
Warrants to purchase of stock | 352,525 |
Equity Incentive Plan (Details)
Equity Incentive Plan (Details) - USD ($) | 3 Months Ended | |||||
Sep. 11, 2020 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 13, 2024 | Jan. 01, 2024 | Dec. 31, 2023 | |
Equity Incentive Plan | ||||||
Unrecognized stock-based compensation expense | $ 600,000 | $ 1,100,000 | ||||
Remaining term | ||||||
Equity Incentive Plan | ||||||
Unrecognized stock-based compensation expense | $ 500,000 | $ 900,000 | ||||
Average remaining vesting term of the stock options (in years) | 9 months 3 days | 11 months 8 days | ||||
Clinical, corporate milestones | ||||||
Equity Incentive Plan | ||||||
Unrecognized stock-based compensation expense | $ 100,000 | $ 200,000 | ||||
Employee Stock Option | ||||||
Equity Incentive Plan | ||||||
Granted (in shares) | 357 | |||||
Stock option | ||||||
Equity Incentive Plan | ||||||
Weighted average fair value of warrants granted (in dollars per share) | $ 6.32 | $ 61 | ||||
2020 Equity Incentive Plan | ||||||
Equity Incentive Plan | ||||||
Shares available under equity incentive plan (in shares) | 238 | 334,078 | 334,078 | |||
Percentage of common stock reserved for issuance equity incentive plan | 10% | |||||
Options to purchase shares of common stock (in shares) | 178,874 | |||||
Shares reserved subject to issuance (in shares) | 155,204 | |||||
Options cancelled | 250 | |||||
Vesting period | 36 months | |||||
2020 Equity Incentive Plan | Restricted Stock Units | ||||||
Equity Incentive Plan | ||||||
Number of awards outstanding | 120,532 | 5,994 | 52,271 | |||
Awarded (in shares) | 120,532 | 7,997 | ||||
Vesting period | 1 year | |||||
Equity Incentive Plan 2014 | Restricted Stock | ||||||
Equity Incentive Plan | ||||||
Number of awards outstanding | 5 | |||||
Aggregate unrecognized restricted Common Stock expense | $ 269,500 | $ 269,500 | ||||
Omnibus Equity Incentive Plan | ||||||
Equity Incentive Plan | ||||||
Shares available under equity incentive plan (in shares) | 73 | |||||
Options to purchase shares of common stock (in shares) | 28 | |||||
Omnibus Equity Incentive Plan | Restricted Stock | ||||||
Equity Incentive Plan | ||||||
Shares reserved subject to issuance (in shares) | 9 | |||||
IMGX 2021 plan | ||||||
Equity Incentive Plan | ||||||
Shares available under equity incentive plan (in shares) | 350,000 | |||||
Options to purchase shares of common stock (in shares) | 200,652 | |||||
Number of share options assumed in business combination issued | 200,652 | |||||
IMGX Plan | ImmunogenX | ||||||
Equity Incentive Plan | ||||||
Options to purchase shares of common stock (in shares) | 200,652 |
Equity Incentive Plan - Stock o
Equity Incentive Plan - Stock option activity (Details) - Stock option - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Numbers of Shares | ||||
Granted (in shares) | 357 | |||
Amended and Restated Omnibus Equity Incentive Plan 2014, Omnibus Equity Incentive Plan 2020 and IMGX 2021 Plan | ||||
Numbers of Shares | ||||
Outstanding at beginning (in shares) | 426 | 176 | 176 | |
Assumed from IMGX (in shares) | 200,652 | |||
Granted (in shares) | 250 | |||
Outstanding at ending (in shares) | 201,078 | 429 | 426 | 176 |
Exercisable (in shares) | 201,054 | 200 | ||
Average Exercise Price | ||||
Outstanding at beginning (in dollars per share) | $ 6,103.81 | $ 15,956.72 | $ 15,956.72 | |
Assumed from IMGX (in dollars per share) | 0.81 | |||
Granted (in dollars per share) | 74.60 | |||
Outstanding at ending (in dollars per share) | 13.74 | 8,900.40 | $ 6,103.81 | $ 15,956.72 |
Exercisable (in dollars per share) | $ 11.99 | $ 17,091.40 | ||
Remaining Contract Life (Years) | ||||
Stock option outstanding, remaining contractual life (Years) | 7 years 6 months 21 days | 9 years 25 days | 8 years 6 months 10 days | 8 years 2 months 19 days |
Assumed from IMGX (in years) | 7 years 6 months 21 days | |||
Granted (in years) | 9 years 10 months 28 days | |||
Exercisable (in years) | 7 years 6 months 21 days | 8 years 4 months 24 days | ||
Assumed from IMGX, intrinsic value | $ 716,328 | |||
Exercisable, intrinsic value | 716,341 | |||
Stock options outstanding, intrinsic value | $ 716,350 |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-average assumptions (Details) - Stock option | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Equity Incentive Plan | ||
Contractual term (in years) | 7 years 7 months 6 days | 6 years 6 months |
Volatility | 110.35% | 98.80% |
Risk-free interest rate | 4.20% | 4.08% |
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 - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Number of Shares | |||
Outstanding at beginning (in shares) | 52,271 | ||
Awarded (in shares) | 120,532 | 7,997 | |
Vested (in shares) | (52,271) | (2,003) | |
Outstanding at ending (in shares) | 120,532 | 5,994 | 52,271 |
Weighted-Average Grant Date Fair Value | |||
Outstanding at beginning (in dollars per share) | $ 4.31 | ||
Awarded (in dollars per share) | 3.80 | $ 124 | |
Vested (in dollars per share) | 4.31 | 124 | |
Outstanding at ending (in dollars per share) | $ 3.82 | $ 124 | $ 4.31 |
Weighted-Average Remaining Recognition Period (Years) | 9 years 9 months 3 days | 9 months | 9 years 11 months 15 days |
Equity Incentive Plan - Total s
Equity Incentive Plan - Total stock-based compensation expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 271,360 | $ 358,316 |
Research and development | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | 42,378 | 38,080 |
General and administrative | ||
Equity Incentive Plan | ||
Total stock-based compensation expense | $ 228,982 | $ 320,236 |
Agreements (Details)
Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Sep. 13, 2023 | Oct. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Agreements | |||||
Research and development expenses | $ 565,962 | $ 1,361,683 | |||
License agreement | |||||
Agreements | |||||
Upfront payment made to the third party | $ 500,000 | ||||
License agreement | Sanofi | |||||
Agreements | |||||
Research and development expenses | $ 500,000 | ||||
Termination of contract, cure period | 60 days | ||||
Termination of contract, cure period for payment breach | 10 days | ||||
Number of days prior written notice to be issued | 60 days | ||||
License agreement | Sanofi | Development and regulatory milestone | |||||
Agreements | |||||
Amount eligible to receive by third party | $ 46,000,000 | ||||
License agreement | Sanofi | Commercial milestone | |||||
Agreements | |||||
Amount eligible to receive by third party | $ 235,000,000 |
Leases (Details)
Leases (Details) | 3 Months Ended | |
Mar. 31, 2024 USD ($) ft² property | Mar. 31, 2023 USD ($) | |
Leases | ||
Number of real property operating leases | property | 2 | |
Operating lease, expense | $ | $ 35,000 | $ 37,000 |
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, 2024 |
Leases | |
Weighted-average remaining lease term | 2 years 4 months 24 days |
Weighted-average discount rate | 7% |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) | Mar. 31, 2024 USD ($) |
Leases | |
2024 (remainder of year) | $ 67,308 |
2025 | 88,788 |
2026 | 60,593 |
Total lease payments | 216,689 |
Less imputed interest | (17,881) |
Present value of lease liabilities | $ 198,808 |
Debt (Details)
Debt (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Nov. 30, 2023 |
Debt | |||
Debt instrument, face amount | $ 7,246,629 | ||
Debt discount | (461,971) | ||
Total debt as of March 31, 2024 | 6,784,658 | ||
Current portion | 386,769 | ||
Long-term portion, net | 6,397,889 | ||
Revolving line of credit | |||
Debt | |||
Debt instrument, face amount | 5,359,860 | ||
Total debt as of March 31, 2024 | 5,359,860 | ||
Long-term portion, net | 5,359,860 | ||
Related party promissory notes | |||
Debt | |||
Debt instrument, face amount | 1,000,000 | ||
Total debt as of March 31, 2024 | 1,000,000 | ||
Long-term portion, net | 1,000,000 | ||
EIDL loan | |||
Debt | |||
Debt instrument, face amount | 500,000 | ||
Debt discount | (461,971) | ||
Total debt as of March 31, 2024 | 38,029 | ||
Long-term portion, net | 38,029 | ||
Directors and Officer's Liability Insurance | |||
Debt | |||
Debt instrument, face amount | 386,769 | $ 683,000 | |
Total debt as of March 31, 2024 | 386,769 | $ 613,000 | $ 387,000 |
Current portion | $ 386,769 |
Debt - Aggregate future minimum
Debt - Aggregate future minimum principal maturities (Details) - Notes payable | Mar. 31, 2024 USD ($) |
Aggregate future minimum principal maturities | |
2024 | $ 386,769 |
2025 | 6,359,860 |
Thereafter | 500,000 |
Total | $ 7,246,629 |
Debt - Additional information (
Debt - Additional information (Details) | 1 Months Ended | 3 Months Ended | ||||||
Nov. 30, 2024 | Mar. 13, 2024 | Nov. 30, 2023 USD ($) | Mar. 31, 2024 USD ($) item | Oct. 31, 2022 USD ($) | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Debt | ||||||||
Amount of debt | $ 7,246,629 | $ 7,246,629 | ||||||
Amount outstanding | 6,784,658 | 6,784,658 | ||||||
Revolving line of credit | ||||||||
Debt | ||||||||
Maximum amount of borrowings | $ 6,000,000 | $ 7,500,000 | ||||||
Amount of debt | 5,359,860 | 5,359,860 | ||||||
Amount outstanding | 5,359,860 | 5,359,860 | ||||||
Revolving line of credit | Revolver | ||||||||
Debt | ||||||||
Amount of draw downs | 0 | |||||||
Amount outstanding | 5,400,000 | 5,400,000 | ||||||
Amount of interest payable | $ 1,300,000 | 1,300,000 | ||||||
Revolving line of credit | Prime rate | ||||||||
Debt | ||||||||
Spread on interest rate (in percent) | 6% | 4.50% | ||||||
Related party promissory notes | ||||||||
Debt | ||||||||
Number of notes assumed | item | 2 | |||||||
Amount of debt | $ 1,000,000 | 1,000,000 | ||||||
Amount outstanding | 1,000,000 | 1,000,000 | ||||||
Related party promissory notes | Prime rate | ||||||||
Debt | ||||||||
Amount of debt | 500,000 | $ 500,000 | ||||||
Spread on interest rate (in percent) | 4.50% | |||||||
EIDL loan | ||||||||
Debt | ||||||||
Amount of debt | $ 500,000 | $ 500,000 | ||||||
Interest rate (in percent) | 3.75% | 3.75% | ||||||
Amount outstanding | $ 38,029 | $ 38,029 | ||||||
Directors and Officer's Liability Insurance | ||||||||
Debt | ||||||||
Term of debt | 9 months | |||||||
Amount of debt | $ 683,000 | 386,769 | 386,769 | |||||
Interest rate (in percent) | 7.90% | |||||||
Monthly payments, including principal and interest | $ 79,000 | |||||||
Amount outstanding | $ 387,000 | $ 386,769 | $ 386,769 | $ 613,000 |
Net Income (Loss) per Common _3
Net Income (Loss) per Common Share - Tabular disclosure of earnings per share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Loss per Common Share | ||
Net income applicable to common shareholders - basic | $ 5,501,462 | $ (4,158,084) |
Preferred stock dividends | (66,144) | $ (87,431) |
Net income applicable to common shareholders - diluted | $ 5,567,606 | |
Weighted average shares outstanding | ||
Basic weighted average shares outstanding | 1,761,953 | 114,033 |
Diluted weighted average shares outstanding | 14,511,461 | 114,033 |
Basic net income per share (in dollars per share) | $ 3.12 | $ (36.46) |
Diluted net income per share (in dollars per share) | $ 0.38 | $ (36.46) |
Series G convertible preferred stock | ||
Weighted average shares outstanding | ||
Weighted average shares outstanding, adjustment | 12,373,226 | |
Series B convertible preferred stock | ||
Weighted average shares outstanding | ||
Weighted average shares outstanding, adjustment | 139 | |
Stock option | ||
Weighted average shares outstanding | ||
Weighted average shares outstanding, adjustment | 169,536 | |
Common stock warrants | ||
Weighted average shares outstanding | ||
Weighted average shares outstanding, adjustment | 118,084 | |
RSUs not yet issued | ||
Weighted average shares outstanding | ||
Weighted average shares outstanding, adjustment | 88,523 |
Net Income (Loss) per Common _4
Net Income (Loss) per Common Share - Common Stock that may potentially be issued (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Loss per Common Share | ||
Total shares of common stock issuable | 15,397,069 | 242,980 |
Series G Preferred Stock | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 12,373,226 | |
Common stock warrants | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 2,702,085 | 234,377 |
Stock options | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 201,078 | 429 |
RSUs not yet issued | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 120,537 | 8,011 |
Series B convertible preferred stock | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 139 | 155 |
Preferred stock, convertible, conversion price (in dollars per share) | $ 32,340 | |
RSUs not yet issued | ||
Net Loss per Common Share | ||
Total shares of common stock issuable | 4 | 8 |
Net Income (Loss) per Common _5
Net Income (Loss) per Common Share - Additional information (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Loss per Common Share | ||
Incremental Common Shares Attributable to Dilutive Effect of Pre-funded Warrants Shares | 269,000 | 44,750 |
Shares of common stock issuable | 15,397,069 | 242,980 |
Stock option | ||
Net Loss per Common Share | ||
Shares of common stock issuable | 31,542 | |
Warrant | ||
Net Loss per Common Share | ||
Shares of common stock issuable | 2,584,001 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Employee Benefit Plans | ||
Defined contribution plan, employers matching contribution, annual vesting percentage | 6% | |
Defined benefit plan, plan assets, contributions by employer | $ 37,000 | $ 26,000 |
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% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Taxes | ||
Deferred tax assets | $ 0 | $ 0 |
Effective income tax | 160% | 0% |
Income tax benefit | $ (14,859,887) |
Subsequent Events - Registered
Subsequent Events - Registered Direct Offering and Share Issuances (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||
May 14, 2024 | Apr. 01, 2024 | Apr. 30, 2024 | Mar. 31, 2024 | Mar. 06, 2024 | |
Restricted Stock Units | |||||
Subsequent Events | |||||
Conversion of stock, shares issued (in shares) | 52,271 | ||||
Consultants | |||||
Subsequent Events | |||||
Stock issued during period, shares, settlement (in shares) | 100,000 | ||||
March 2024 Registered Direct Offering | |||||
Subsequent Events | |||||
Warrants and rights outstanding, term (year) | 5 years | ||||
Subsequent events | May 2024 Registered Direct Offering | |||||
Subsequent Events | |||||
Proceeds from issuance of shares | $ 1.1 | ||||
Subsequent events | May 2024 Registered Direct Offering | May 2024 Warrants | |||||
Subsequent Events | |||||
Stock issued during period, shares, new issues (in shares) | 366,000 | ||||
Shares issued, price per share (in dollars per share) | $ 2.95 | ||||
Number of shares issuable upon exercise of options or warrants | 732,000 | ||||
Warrant exercise price | $ 2.70 | ||||
Warrants and rights outstanding, term (year) | 6 years | ||||
Proceeds from issuance of shares | $ 1.1 | ||||
Subsequent events | March 2024 Offering | Restricted Stock Units | |||||
Subsequent Events | |||||
Conversion of stock, shares issued (in shares) | 30,882 | ||||
Subsequent events | March 2024 Offering | Consultants | |||||
Subsequent Events | |||||
Stock issued during period, shares, settlement (in shares) | 150,000 | ||||
Subsequent events | March 2024 Offering | Pre-funded warrants | |||||
Subsequent Events | |||||
Number of shares issuable upon exercise of options or warrants | 269,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ 5,567,606 | $ (4,070,653) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |