Cover
Cover | 3 Months Ended |
Mar. 31, 2024 shares | |
Document Information [Line Items] | |
Document Type | 10-Q |
Document Quarterly Report | true |
Document Transition Report | false |
Entity Interactive Data Current | Yes |
Amendment Flag | false |
Document Period End Date | Mar. 31, 2024 |
Document Fiscal Year Focus | 2024 |
Document Fiscal Period Focus | Q1 |
Entity Information [Line Items] | |
Entity Registrant Name | CORMEDIX INC. |
Entity Central Index Key | 0001410098 |
Entity File Number | 001-34673 |
Entity Tax Identification Number | 20-5894890 |
Entity Incorporation, State or Country Code | DE |
Current Fiscal Year End Date | --12-31 |
Entity Current Reporting Status | Yes |
Entity Shell Company | false |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Contact Personnel [Line Items] | |
Entity Address, Address Line One | 300 Connell Drive |
Entity Address, Address Line Two | Suite 4200 |
Entity Address, City or Town | Berkeley Heights |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 07922 |
Entity Phone Fax Numbers [Line Items] | |
City Area Code | (908) |
Local Phone Number | 517-9500 |
Entity Listings [Line Items] | |
Title of 12(b) Security | Common stock, $0.001 par value |
Trading Symbol | CRMD |
Security Exchange Name | NASDAQ |
Entity Common Stock, Shares Outstanding | 54,959,270 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 35,180,529 | $ 43,642,684 |
Restricted cash | 75,540 | 77,453 |
Short-term investments | 23,370,989 | 32,388,130 |
Inventories | 2,320,396 | 2,106,345 |
Prepaid research and development expenses | 295,845 | 353,574 |
Other prepaid expenses and current assets | 2,166,267 | 882,214 |
Total current assets | 63,409,566 | 79,450,400 |
Property and equipment, net | 1,905,704 | 1,866,224 |
License intangible asset | 2,000,000 | |
Restricted cash, long-term | 103,838 | 103,055 |
Operating lease right-of-use asset | 604,634 | 640,278 |
TOTAL ASSETS | 68,023,742 | 82,059,957 |
Current liabilities | ||
Accounts payable | 2,826,322 | 4,279,679 |
Accrued expenses | 6,553,311 | 6,970,217 |
Operating lease liability, short-term | 154,801 | 150,619 |
Total current liabilities | 9,534,434 | 11,400,515 |
Operating lease liability, net of current portion | 476,588 | 517,013 |
TOTAL LIABILITIES | 10,011,022 | 11,917,528 |
COMMITMENTS AND CONTINGENCIES (Note 4) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 182 | 182 |
Common stock - $0.001 par value: 160,000,000 shares authorized; 54,959,270 and 54,938,258 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 54,959 | 54,938 |
Accumulated other comprehensive gain | 83,461 | 94,108 |
Additional paid-in capital | 394,040,254 | 391,693,214 |
Accumulated deficit | (336,166,136) | (321,700,013) |
TOTAL STOCKHOLDERS’ EQUITY | 58,012,720 | 70,142,429 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 68,023,742 | $ 82,059,957 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 181,622 | 181,622 |
Preferred stock, shares outstanding | 181,622 | 181,622 |
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 160,000,000 | 160,000,000 |
Common stock, shares issued | 54,959,270 | 54,938,258 |
Common stock, shares outstanding | 54,959,270 | 54,938,258 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
Revenues, net | ||
Cost of sales | (818,539) | |
Gross loss | (818,539) | |
Operating Expenses | ||
Research and development | (837,445) | (3,407,502) |
Selling, general and administrative | (15,048,252) | (7,609,677) |
Total operating expenses | (15,885,697) | (11,017,179) |
Loss From Operations | (16,704,236) | (11,017,179) |
Other Income (Expense) | ||
Interest income | 857,186 | 446,384 |
Foreign exchange transaction (loss) gain | (4,008) | 12,345 |
Interest expense | (9,835) | (8,776) |
Total other income | 843,343 | 449,953 |
Net Loss Before Income Taxes | (15,860,893) | (10,567,226) |
Tax benefit | 1,394,770 | |
Net Loss | (14,466,123) | (10,567,226) |
Other Comprehensive (Loss) Income | ||
Unrealized (loss) gain from investment | (10,903) | 16,393 |
Foreign currency translation gain | 256 | 2,096 |
Total other comprehensive (loss) income | (10,647) | 18,489 |
Other Comprehensive Loss | $ (14,476,770) | $ (10,548,737) |
Net Loss Per Common Share - Basic (in Dollars per share) | $ (0.25) | $ (0.24) |
Weighted Average Common Shares Outstanding - Basic (in Shares) | 57,503,154 | 44,090,998 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
Net Loss Per Common Share - Diluted | $ (0.25) | $ (0.24) |
Weighted Average Common Shares Outstanding - Diluted | 57,503,154 | 44,090,998 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Changes In Stockholders’ Equity (Unaudited) - USD ($) | Common Stock | Preferred Stock – Series C-3, Series E, Series F and Series G Shares | Accumulated Other Comprehen-sive Gain (Loss) | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning at Dec. 31, 2022 | $ 42,815 | $ 182 | $ 82,743 | $ 330,294,782 | $ (275,360,786) | $ 55,059,736 |
Beginning (in Shares) at Dec. 31, 2022 | 42,815,196 | 181,622 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 1,685 | 7,198,721 | 7,200,406 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 1,684,592 | |||||
Stock-based compensation | 2,216,349 | 2,216,349 | ||||
Other comprehensive gain | 18,489 | 18,489 | ||||
Net loss | (10,567,226) | (10,567,226) | ||||
Ending at Mar. 31, 2023 | $ 44,500 | $ 182 | 101,232 | 339,709,852 | (285,928,012) | 53,927,754 |
Ending (in Shares) at Mar. 31, 2023 | 44,499,788 | 181,622 | ||||
Beginning at Dec. 31, 2023 | $ 54,938 | $ 182 | 94,108 | 391,693,214 | (321,700,013) | 70,142,429 |
Beginning (in Shares) at Dec. 31, 2023 | 54,938,258 | 181,622 | ||||
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | $ 43 | (97,161) | (97,118) | |||
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes (in Shares) | 42,844 | |||||
Cancellation of shares held in escrow | $ (22) | 22 | ||||
Cancellation of shares held in escrow (in Shares) | (21,832) | |||||
Stock-based compensation | 2,444,179 | 2,444,179 | ||||
Other comprehensive gain | (10,647) | (10,647) | ||||
Net loss | (14,466,123) | (14,466,123) | ||||
Ending at Mar. 31, 2024 | $ 54,959 | $ 182 | $ 83,461 | $ 394,040,254 | $ (336,166,136) | $ 58,012,720 |
Ending (in Shares) at Mar. 31, 2024 | 54,959,270 | 181,622 |
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 loss | $ (14,466,123) | $ (10,567,226) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,444,179 | 2,216,349 |
Change in right-of-use assets | 35,644 | 32,582 |
Depreciation | 21,826 | 16,863 |
Changes in operating assets and liabilities: | ||
Increase in inventory | (214,051) | |
Increase in prepaid expenses and other current assets | (1,226,454) | (419,578) |
Decrease in accounts payable | (1,453,352) | (755,582) |
Decrease in accrued expenses | (2,415,719) | (884,872) |
Decrease in operating lease liabilities | (36,244) | (32,422) |
Net cash used in operating activities | (17,310,294) | (10,393,886) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term investments | (7,693,762) | (25,422,039) |
Maturity of short-term investments | 16,700,000 | 10,750,000 |
Purchase of equipment | (61,306) | (14,766) |
Net cash provided by (used in) investing activities | 8,944,932 | (14,686,805) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of employee withholding taxes on vested restricted stock units | (97,118) | |
Proceeds from sale of common stock from at-the-market program, net | 7,200,406 | |
Net cash (used in) provided by financing activities | (97,118) | 7,200,406 |
Foreign exchange effect on cash | (805) | 2,284 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (8,463,285) | (17,878,001) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD | 43,823,192 | 43,374,745 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - END OF PERIOD | 35,359,907 | 25,496,744 |
Cash paid for interest | 9,835 | 8,776 |
Supplemental Disclosure of Non-Cash Investing Activities: | ||
Liability related to license agreement | 2,000,000 | |
Unrealized gain (loss) from investments | $ 10,903 | $ (16,393) |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Business and Basis of Presentation [Abstract] | |
Organization, Business and Basis of Presentation | Note 1 - Organization, Business and Basis of Presentation: Organization and Business CorMedix Inc. (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The Company’s primary focus is on the commercialization of its lead product, DefenCath ® Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions for Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2024 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 12, 2024. The accompanying consolidated balance sheet as of December 31, 2023 has been derived from the audited financial statements included in such Annual Report on Form 10-K. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Liquidity and Uncertainties | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract] | |
Summary of Significant Accounting Policies and Liquidity and Uncertainties | Note 2 - Summary of Significant Accounting Policies and Liquidity and Uncertainties: Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current commercial plans and development plans for DefenCath and its other operating requirements, the Company’s existing cash, cash equivalents and short-term investments at March 31, 2024 are expected to fund its operations for at least twelve months from the issuance of this Quarterly Report on Form 10-Q. In March 2024, the Company received $1,395,000, net of expenses, from the sale of its unused New Jersey net operating losses (“NOL”), that was eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”). The NJEDA Program allowed the Company to sell its available NOL tax benefits for the state fiscal year 2023 in the amount of approximately $1,529,000. The Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions and/or out-licensing. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of March 31, 2024, the Company has $104,400,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 5). The Company’s operations are subject to a number of other factors that can affect its operating results and cash flow projections over the next twelve months from the issuance of these financial statements. Such factors include, but are not limited to: the ability to market DefenCath and generate necessary revenue in the time periods required; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated balance sheets and the reported amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions. As future events and their effects cannot be determined with precision, actual results could differ significantly from those estimates. Reclassifications Certain reclassifications were made to the prior year’s amounts to conform to the 2024 presentation. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: March 31, March 31, Cash and cash equivalents $ 35,180,529 $ 25,268,225 Restricted cash 179,378 228,519 Total cash, cash equivalents and restricted cash $ 35,359,907 $ 25,496,744 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt classified as available-for-sale and equity securities are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense). The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at March 31, 2024 or December 31, 2023. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of March 31, 2024 and December 31, 2023, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at March 31, 2024 and December 31, 2023: Amortized Gross Gross Fair Value March 31, 2024: Money Market Funds included in Cash Equivalents $ 28,343,324 $ - $ - $ 28,343,324 U.S. Government Agency Securities 20,690,147 (480 ) 315 20,689,982 Commercial Paper 2,682,664 (1,657 ) - 2,681,007 Subtotal 23,372,811 (2,137 ) 315 23,370,989 Total March 31, 2024 $ 51,716,135 $ (2,137 ) $ 315 $ 51,714,313 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360 Fair Value Measurements In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of March 31, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 March 31, 2024: Money Market Funds and Cash Equivalents $ 28,343,324 $ 28,343,324 $ - $ - U.S. Government Agency Securities 20,689,982 20,689,982 - - Commercial Paper 2,681,007 - 2,681,007 - Subtotal 23,370,989 20,689,982 2,681,007 $ - Total March 31, 2024 $ 51,714,313 $ 49,033,306 $ 2,681,007 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ - Inventories The Company engages third parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costs related to the manufacturing of DefenCath incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as research and development expenses (“R&D”) as incurred. Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. Inventories expensed as R&D prior to FDA approval that can be used for commercial purposes amounted to approximately $6,388,000. Inventory is valued utilizing the standard cost method, which approximates costs determined on the first-in first-out basis. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of March 31, 2024 and December 31, 2023, no reserves were deemed necessary. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: March 31, December 31, Raw materials $ 1,424,409 $ 1,525,420 Work in progress 471,415 580,925 Finished goods 424,572 - Total $ 2,320,396 $ 2,106,345 License Agreement The Company’s rights under the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost and will amortize using the straight-line method over estimated economic life of the intangible asset. The Company will amortize the intangible asset over its useful life, based on its assessment of various factors impacting estimated useful lives and cash flows of the acquired rights. Such factors include the launch date of DefenCath, the strength of the intellectual property protection of DefenCath and various other competitive, developmental and regulatory considerations, and contractual terms. See Note 4 – Commitments and Contingencies for further discussion. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities (included in accrued expenses), and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 6). Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore basic and diluted loss per share are the same for all periods presented. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended 2024 2023 (Number of Shares of Common Stock Issuable) Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 7,996,361 6,126,080 Shares underlying restricted stock units 366,235 207,469 Total potentially dilutive shares 13,811,527 11,782,480 Stock-Based Compensation Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions. Stock-based compensation is recognized as expense over the requisite service period on a straight-line basis or when the achievement of the performance condition is probable. Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. ASU No. 2023-09 In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740). The standard requires disaggregation of the effective rate reconciliation into standard categories, enhances disclosure of income taxes paid, and modifies other income tax-related disclosures. The standard will be effective for CorMedix beginning in annual reporting period ending December 31, 2025, with early adoption permitted. CorMedix is currently assessing the impact of adopting this guidance on its consolidated financial statements. ASU No. 2023-07 In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting - Improving Reportable Segment Disclosures (Topic 280). The standard requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker (CODM), a description of other segment items by reportable segment, and any additional measures of a segment’s profit or loss used by the CODM when deciding how to allocate resources. The ASU also requires all annual disclosures currently required by Topic 280 to be included in interim periods. The standard is effective for CorMedix beginning in annual reporting period ending December 31, 2024 and interim periods beginning in fiscal year 2025, with early adoption permitted and requires retrospective application to all prior periods presented in the financial statements. CorMedix is currently assessing the impact of adopting this guidance on its consolidated financial statements. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 3 - Accrued Expenses: Accrued Expenses Accrued expenses consist of the following: March 31, December 31, Professional and consulting fees $ 1,340,502 $ 2,270,022 Accrued payroll and payroll taxes 2,636,726 2,718,770 License agreement payable (see Note 4 – Commitments and Contingencies) 2,000,000 - Manufacturing related 349,421 1,835,101 Other 226,662 146,324 Total $ 6,553,311 $ 6,970,217 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 4 - Commitments and Contingencies: Contingency Matters In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.) On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933. On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded the original complaints in In re CorMedix Securities Litigation. On March 21, 2024, the court denied Defendant’s motion to dismiss without prejudice and granted lead plaintiff leave to amend the complaint. On April 22, 2024, lead plaintiff filed a third amended consolidated complaint that superseded the second amended consolidated complaint. In the third amended complaint, the lead plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive. The third amended complaint names as defendants the Company and six (6) current and former officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a). In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier. The Company intends to vigorously contest such claims. Defendants’ motion to dismiss the third amended complaint is due on or before June 6, 2024. Lead plaintiff’s opposition is due on or before July 22, 2024. Defendants’ reply is due on or before August 21, 2024. In re CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.) On or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. The individual defendants intend to vigorously contest such claims. On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit described in the foregoing paragraph is pending. The stay may be terminated before the motion to dismiss is resolved according to certain circumstances described in the stipulation available on the Court’s public docket. On or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al. On or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al. On or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation Voter Demand Letter On or about June 23, 2022, the Company’s Board received a letter demanding it investigate and pursue causes of action, purportedly on behalf of Company, against certain current and former directors, officers, and/or other employees of the Company (the “Letter”), which the Board believes are duplicative of the claims already asserted in the Derivative Litigation. As set forth in the Board’s response to the Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress of the Derivative Litigation. License and Assignment Agreement In 2008, the Company entered into a License and Assignment Agreement (the “ND License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the ND License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). As consideration in part for the rights to the NDP Technology, upon execution of the ND License Agreement, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 7,996 shares of the Company’s common stock. Under the ND License Agreement, the Company is required to make cash payments to NDP upon the achievement of certain milestones. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. As of December 31, 2022, the shares remaining in escrow were cancelled in accordance with the terms of the escrow agreement. Under the ND License Agreement, the maximum aggregate amount of cash payments due upon achievement of milestones was $3,000,000, with the balance being $2,000,000 as of March 31, 2024 and December 31, 2023. The initial licensing fee of $325,000, the fair value of the 5% equity interest and an additional $500,000, as a result of the achievement of one milestone, were recognized on the Company’s statement of operations in R&D in prior periods, as the related milestones were achieved by the Company prior to the FDA approval. During the three months ended March 31, 2024, the Company determined it was probable that the net sales milestones will be achieved in future periods and, as a result, the Company recorded a license intangible asset of $2,000,000 and a license agreement liability of $2,000,000, which is included within accrued expenses in the Company’s condensed consolidated balance sheet as of March 31, 2024. The license intangible asset will be amortized as cost of goods sold over its estimated economic life, beginning in the second quarter of 2024, correlating with the product launch of DefenCath and the first period in which revenue will be recognized. The ND License Agreement will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in a given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, we will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country. The ND License Agreement also may be terminated by NDP if the Company materially breaches or defaults under the ND License Agreement and that breach is not cured within 60 days following the delivery of written notice to the Company, or by the Company on a country-by-country basis upon 60 days prior written notice in the event the Company’s Board determines not to proceed with the development of the NDP Technology. If the ND License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | Note 5 - Stockholders’ Equity: Common Stock On August 12, 2021, the Company filed a shelf registration statement (the “2021 Shelf Registration Statement”) for the issuance of up to $150,000,000. As of March 31, 2024, the Company has $104,000,000 available under the 2021 Shelf Registration Statement. On June 28, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets, LLC and Truist Securities, Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an aggregate of 7,500,000 shares of the Company’s common stock, and in lieu of common stock to certain investors, pre-funded warrants to purchase 2,500,625 shares of common stock to the underwriters. Pursuant to the Underwriting Agreement, the Company also granted the underwriters a 30-day option to purchase up to 1,500,093 additional shares of common stock. The offering pursuant to the 2021 Shelf Registration Statement closed on July 3, 2023. Upon closing, the Company issued and sold an aggregate of 7,500,000 shares of its common stock at a public offering price of $4.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its commons stock at a price of $3.999 per pre-funded warrant (see Pre-Funded Warrants below). The Company realized net proceeds of approximately $37,300,000 from the sale of its common stock and the pre-funded warrants. On July 26, 2023, the underwriters’ representatives fully exercised the option to purchase additional shares of the Company’s common stock, and on July 28, 2023, the Company issued and sold an aggregate of 1,500,093 shares of its common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions, and the Company realized net proceeds of approximately $5,600,000. During the quarter ended March 31, 2023, the Company sold an aggregate of 1,684,592 of its common stock under the previous ATM program and realized net proceeds of $7,200,000. The Company did not sell any common stock during the quarter ended March 31, 2024. Restricted Stock Units In January 2024, the Company granted 283,333 restricted stock units (“RSUs”) to its executive officers under its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $3.47 per share. The fair market value of the RSUs was estimated to be the closing price of the Company’s common stock on the date of grant. These RSUs vest 25% on the grant date and 25% each on the first, second and third anniversaries of the grant date, subject to continued service as an employee or consultant through the applicable vesting date. The Company issued 42,844 shares upon the vesting of 25% of these RSUs and 27,989 shares were withheld in lieu of withholding taxes. As of March 31, 2024 and 2023, the Company has 366,235 and 207,469 outstanding RSUs, respectively, for which the Company recorded $362,000 and $86,000 compensation expense for the quarter ended March 31, 2024 and 2023, respectively. As of March 31, 2024, unrecognized compensation expense related to unvested RSUs is $999,000, will be recognized over a weighted average remaining period of 1.8 at March 31, 2024. Preferred Stock The Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of March 31, 2024 and Preferred Liquidation Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665 Stock Options During the three months ended March 31, 2024 and 2023, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 1,911,167 and 1,747,000 shares, respectively, of the Company’s common stock under the Amended and Restated 2019 Omnibus Stock Incentive Plan. The weighted average exercise price of these options is $3.52 and $4.36 per share, respectively. During the three months ended March 31, 2024 and 2023, stock-based compensation expense for stock options issued to employees, directors, officers and consultants was $2,082,000 and $2,130,000, respectively. As of March 31, 2024, there was approximately $9,132,000 in total unrecognized compensation expense related to stock options granted, which will be recognized over an expected remaining weighted average period of 1.6 years. The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model. The following assumptions were used for the Black-Scholes option pricing model for the stock options granted during the three months ended March 31, 2024: Expected term (in years) 5.96 Volatility weighted average 98.98 % Dividend yield weighted average 0 % Risk-free interest rate weighted average 4.13 % Weighted average grant date fair value of options granted during the period $ 2.82 During the three months ended March 31, 2024, the Company uses the simplified method to calculate the expected term which takes into account the vesting term and the expiration date of the stock options. The expected term of the stock options granted to consultants, if any, is based upon the full term of the respective option agreements. The expected stock price volatility for the Company’s stock options is calculated based on the historical volatility of the Company’s stock price for the expected term. The expected dividend yield of 0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Leases | Note 6 - Leases: The Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020. The Company entered into an operating lease for office space in Germany that began in July 2017 that is set to expire in June 2024. The rental agreement has a three-month term which automatically renews and includes a monthly cost of 400 Euros. The Company elected to apply the short-term practical expedient to the office lease. Operating lease expense in the Company’s condensed consolidated statements of operations and comprehensive loss for each of the three months ended March 31, 2024 and 2023 was approximately $52,000, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At March 31, 2024, the Company has a total operating lease liability of $632,000, of which approximately $155,000 and $477,000 were classified as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated balance sheet. At December 31, 2023, the Company’s total operating lease liability was $668,000, of which $151,000 was classified as operating lease liabilities, short-term and $517,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating ROU assets as of March 31, 2024 and December 31, 2023 were $605,000 and $640,000, respectively. For the three months ended March 31, 2024 and 2023, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $51,000 and $50,000, respectively. The weighted average remaining lease term as of March 31, 2024 and 2023 were 3.6 and 4.6 years, respectively, and the weighted average discount rate for operating leases was 9% at March 31, 2024 and 2023. As of March 31, 2024, maturities of lease liabilities were as follows: 2024 (excluding the three months ended March 31, 2024) $ 154,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 742,000 Less imputed interest (110,000 ) Total $ 632,000 |
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) | $ (14,466,123) | $ (10,567,226) |
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 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract] | |
Liquidity and Uncertainties | Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current commercial plans and development plans for DefenCath and its other operating requirements, the Company’s existing cash, cash equivalents and short-term investments at March 31, 2024 are expected to fund its operations for at least twelve months from the issuance of this Quarterly Report on Form 10-Q. In March 2024, the Company received $1,395,000, net of expenses, from the sale of its unused New Jersey net operating losses (“NOL”), that was eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”). The NJEDA Program allowed the Company to sell its available NOL tax benefits for the state fiscal year 2023 in the amount of approximately $1,529,000. The Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions and/or out-licensing. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of March 31, 2024, the Company has $104,400,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 5). The Company’s operations are subject to a number of other factors that can affect its operating results and cash flow projections over the next twelve months from the issuance of these financial statements. Such factors include, but are not limited to: the ability to market DefenCath and generate necessary revenue in the time periods required; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated balance sheets and the reported amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions. As future events and their effects cannot be determined with precision, actual results could differ significantly from those estimates. |
Reclassifications | Reclassifications Certain reclassifications were made to the prior year’s amounts to conform to the 2024 presentation. |
Basis of Consolidation | Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Financial Instruments | Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: March 31, March 31, Cash and cash equivalents $ 35,180,529 $ 25,268,225 Restricted cash 179,378 228,519 Total cash, cash equivalents and restricted cash $ 35,359,907 $ 25,496,744 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt classified as available-for-sale and equity securities are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense). The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at March 31, 2024 or December 31, 2023. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of March 31, 2024 and December 31, 2023, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at March 31, 2024 and December 31, 2023: Amortized Gross Gross Fair Value March 31, 2024: Money Market Funds included in Cash Equivalents $ 28,343,324 $ - $ - $ 28,343,324 U.S. Government Agency Securities 20,690,147 (480 ) 315 20,689,982 Commercial Paper 2,682,664 (1,657 ) - 2,681,007 Subtotal 23,372,811 (2,137 ) 315 23,370,989 Total March 31, 2024 $ 51,716,135 $ (2,137 ) $ 315 $ 51,714,313 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360 |
Fair Value Measurements | Fair Value Measurements In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of March 31, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 March 31, 2024: Money Market Funds and Cash Equivalents $ 28,343,324 $ 28,343,324 $ - $ - U.S. Government Agency Securities 20,689,982 20,689,982 - - Commercial Paper 2,681,007 - 2,681,007 - Subtotal 23,370,989 20,689,982 2,681,007 $ - Total March 31, 2024 $ 51,714,313 $ 49,033,306 $ 2,681,007 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ - |
Inventories | Inventories The Company engages third parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costs related to the manufacturing of DefenCath incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as research and development expenses (“R&D”) as incurred. Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. Inventories expensed as R&D prior to FDA approval that can be used for commercial purposes amounted to approximately $6,388,000. Inventory is valued utilizing the standard cost method, which approximates costs determined on the first-in first-out basis. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of March 31, 2024 and December 31, 2023, no reserves were deemed necessary. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: March 31, December 31, Raw materials $ 1,424,409 $ 1,525,420 Work in progress 471,415 580,925 Finished goods 424,572 - Total $ 2,320,396 $ 2,106,345 |
License Agreement | License Agreement The Company’s rights under the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost and will amortize using the straight-line method over estimated economic life of the intangible asset. The Company will amortize the intangible asset over its useful life, based on its assessment of various factors impacting estimated useful lives and cash flows of the acquired rights. Such factors include the launch date of DefenCath, the strength of the intellectual property protection of DefenCath and various other competitive, developmental and regulatory considerations, and contractual terms. See Note 4 – Commitments and Contingencies for further discussion. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities (included in accrued expenses), and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 6). Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. |
Loss Per Common Share | Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore basic and diluted loss per share are the same for all periods presented. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended 2024 2023 (Number of Shares of Common Stock Issuable) Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 7,996,361 6,126,080 Shares underlying restricted stock units 366,235 207,469 Total potentially dilutive shares 13,811,527 11,782,480 |
Stock-Based Compensation | Stock-Based Compensation Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions. Stock-based compensation is recognized as expense over the requisite service period on a straight-line basis or when the achievement of the performance condition is probable. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. ASU No. 2023-09 In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740). The standard requires disaggregation of the effective rate reconciliation into standard categories, enhances disclosure of income taxes paid, and modifies other income tax-related disclosures. The standard will be effective for CorMedix beginning in annual reporting period ending December 31, 2025, with early adoption permitted. CorMedix is currently assessing the impact of adopting this guidance on its consolidated financial statements. ASU No. 2023-07 In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting - Improving Reportable Segment Disclosures (Topic 280). The standard requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker (CODM), a description of other segment items by reportable segment, and any additional measures of a segment’s profit or loss used by the CODM when deciding how to allocate resources. The ASU also requires all annual disclosures currently required by Topic 280 to be included in interim periods. The standard is effective for CorMedix beginning in annual reporting period ending December 31, 2024 and interim periods beginning in fiscal year 2025, with early adoption permitted and requires retrospective application to all prior periods presented in the financial statements. CorMedix is currently assessing the impact of adopting this guidance on its consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: March 31, March 31, Cash and cash equivalents $ 35,180,529 $ 25,268,225 Restricted cash 179,378 228,519 Total cash, cash equivalents and restricted cash $ 35,359,907 $ 25,496,744 |
Schedule of Marketable Securities | The following table summarizes the amortized cost, unrealized gains and losses and the fair value at March 31, 2024 and December 31, 2023: Amortized Gross Gross Fair Value March 31, 2024: Money Market Funds included in Cash Equivalents $ 28,343,324 $ - $ - $ 28,343,324 U.S. Government Agency Securities 20,690,147 (480 ) 315 20,689,982 Commercial Paper 2,682,664 (1,657 ) - 2,681,007 Subtotal 23,372,811 (2,137 ) 315 23,370,989 Total March 31, 2024 $ 51,716,135 $ (2,137 ) $ 315 $ 51,714,313 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360 |
Schedule of Carrying and Fair Value of Financial Assets | The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of March 31, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 March 31, 2024: Money Market Funds and Cash Equivalents $ 28,343,324 $ 28,343,324 $ - $ - U.S. Government Agency Securities 20,689,982 20,689,982 - - Commercial Paper 2,681,007 - 2,681,007 - Subtotal 23,370,989 20,689,982 2,681,007 $ - Total March 31, 2024 $ 51,714,313 $ 49,033,306 $ 2,681,007 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ - |
Schedule of Inventories | Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: March 31, December 31, Raw materials $ 1,424,409 $ 1,525,420 Work in progress 471,415 580,925 Finished goods 424,572 - Total $ 2,320,396 $ 2,106,345 |
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended 2024 2023 (Number of Shares of Common Stock Issuable) Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 7,996,361 6,126,080 Shares underlying restricted stock units 366,235 207,469 Total potentially dilutive shares 13,811,527 11,782,480 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: March 31, December 31, Professional and consulting fees $ 1,340,502 $ 2,270,022 Accrued payroll and payroll taxes 2,636,726 2,718,770 License agreement payable (see Note 4 – Commitments and Contingencies) 2,000,000 - Manufacturing related 349,421 1,835,101 Other 226,662 146,324 Total $ 6,553,311 $ 6,970,217 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders’ Equity (Tables) [Line Items] | |
Schedule of Preferred Stock | The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of March 31, 2024 and Preferred Liquidation Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665 |
Black-Scholes Option [Member] | |
Stockholders’ Equity (Tables) [Line Items] | |
Schedule of Fair Value Assumptions | The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model. The following assumptions were used for the Black-Scholes option pricing model for the stock options granted during the three months ended March 31, 2024: Expected term (in years) 5.96 Volatility weighted average 98.98 % Dividend yield weighted average 0 % Risk-free interest rate weighted average 4.13 % Weighted average grant date fair value of options granted during the period $ 2.82 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Maturities of Lease Liabilities | As of March 31, 2024, maturities of lease liabilities were as follows: 2024 (excluding the three months ended March 31, 2024) $ 154,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 742,000 Less imputed interest (110,000 ) Total $ 632,000 |
Organization, Business and Ba_2
Organization, Business and Basis of Presentation (Details) | 3 Months Ended |
Mar. 31, 2024 | |
CorMedix Inc. [Member] | |
Organization, Business and Basis of Presentation [Line Items] | |
Entity incorporation date | Jul. 28, 2006 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Line Items] | |||
NOL tax benefits | $ 1,529,000 | ||
Current shelf registration amount | $ 104,400,000 | ||
Inventories expensed as research and development | $ 6,388,000 | ||
New Jersey [Member] | |||
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Line Items] | |||
Net of expenses | $ 1,395,000 | ||
Pre-Funded Warrants [Member] | |||
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Line Items] | |||
Underlying outstanding warrants (in Shares) | 2,500,625 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Cash and Cash Equivalents - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 35,180,529 | $ 43,642,684 | $ 25,268,225 | |
Restricted cash | 179,378 | 228,519 | ||
Total cash, cash equivalents and restricted cash | $ 35,359,907 | $ 43,823,192 | $ 25,496,744 | $ 43,374,745 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Marketable Securities - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Schedule of Marketable Securities [Line Items] | ||
Amortized Cost | $ 51,716,135 | $ 64,920,279 |
Gross Unrealized Losses | (2,137) | (1,425) |
Gross Unrealized Gains | 315 | 10,506 |
Fair Value | 51,714,313 | 64,929,360 |
Money Market Funds included in Cash Equivalents [Member] | ||
Schedule of Marketable Securities [Line Items] | ||
Amortized Cost | 28,343,324 | 32,541,230 |
Gross Unrealized Losses | ||
Gross Unrealized Gains | ||
Fair Value | 28,343,324 | 32,541,230 |
U.S. Government Agency Securities [Member] | ||
Schedule of Marketable Securities [Line Items] | ||
Amortized Cost | 20,690,147 | 29,701,677 |
Gross Unrealized Losses | (480) | |
Gross Unrealized Gains | 315 | 10,506 |
Fair Value | 20,689,982 | 29,712,183 |
Commercial Paper [Member] | ||
Schedule of Marketable Securities [Line Items] | ||
Amortized Cost | 2,682,664 | 2,677,372 |
Gross Unrealized Losses | (1,657) | (1,425) |
Gross Unrealized Gains | ||
Fair Value | 2,681,007 | 2,675,947 |
Subtotal [Member] | ||
Schedule of Marketable Securities [Line Items] | ||
Amortized Cost | 23,372,811 | 32,379,049 |
Gross Unrealized Losses | (2,137) | (1,425) |
Gross Unrealized Gains | 315 | 10,506 |
Fair Value | $ 23,370,989 | $ 32,388,130 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Carrying and Fair Value of Financial Assets - Fair Value, Recurring [Member] - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | $ 51,714,313 | $ 64,929,360 |
Level 1 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 49,033,306 | 62,253,413 |
Level 2 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 2,681,007 | 2,675,947 |
Level 3 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
Money Market Funds and Cash Equivalents [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 28,343,324 | 32,541,230 |
Money Market Funds and Cash Equivalents [Member] | Level 1 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 28,343,324 | 32,541,230 |
Money Market Funds and Cash Equivalents [Member] | Level 2 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
Money Market Funds and Cash Equivalents [Member] | Level 3 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
U.S. Government Agency Securities [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 20,689,982 | 29,712,183 |
U.S. Government Agency Securities [Member] | Level 1 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 20,689,982 | 29,712,183 |
U.S. Government Agency Securities [Member] | Level 2 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
U.S. Government Agency Securities [Member] | Level 3 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
Commercial Paper [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 2,681,007 | 2,675,947 |
Commercial Paper [Member] | Level 1 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
Commercial Paper [Member] | Level 2 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 2,681,007 | 2,675,947 |
Commercial Paper [Member] | Level 3 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | ||
Subtotal [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 23,370,989 | 32,388,130 |
Subtotal [Member] | Level 1 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 20,689,982 | 29,712,183 |
Subtotal [Member] | Level 2 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 2,681,007 | 2,675,947 |
Subtotal [Member] | Level 3 [Member] | ||
Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Inventories - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Schedule of Inventories [Abstract] | ||
Raw materials | $ 1,424,409 | $ 1,525,420 |
Work in progress | 471,415 | 580,925 |
Finished goods | 424,572 | |
Total | $ 2,320,396 | $ 2,106,345 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 13,811,527 | 11,782,480 |
Series C-3 non-voting preferred stock [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 4,000 | 4,000 |
Series E non-voting preferred stock [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 391,953 | 391,953 |
Series G non-voting preferred stock [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 5,004,069 | 5,004,069 |
Shares issuable for payment of deferred board compensation [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 48,909 | 48,909 |
Shares underlying outstanding stock options [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 7,996,361 | 6,126,080 |
Shares underlying restricted stock units [Member] | ||
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items] | ||
Total potentially dilutive shares | 366,235 | 207,469 |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of Accrued Expenses - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Expenses [Abstract] | ||
Professional and consulting fees | $ 1,340,502 | $ 2,270,022 |
Accrued payroll and payroll taxes | 2,636,726 | 2,718,770 |
License agreement payable (see Note 4 – Commitments and Contingencies) | 2,000,000 | |
Manufacturing related | 349,421 | 1,835,101 |
Other | 226,662 | 146,324 |
Total | $ 6,553,311 | $ 6,970,217 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies [Line Items] | ||
Amount of initial licensing fee | $ 325,000 | |
Shares of common stock (in Shares) | 7,996 | |
Number of shares released in escrow (in Shares) | 7,277 | |
Maximum aggregate amount of cash payments | $ 3,000,000 | |
Balance of cash payments due upon achievement of milestones | 2,000,000 | $ 2,000,000 |
Additional amount of achievement milestone | 500,000 | |
License agreement intangible | 2,000,000 | |
License agreement payable | $ 2,000,000 | |
NDP [Member] | ||
Commitments and Contingencies [Line Items] | ||
Equity interest percentage | 5% | |
ND License Agreement [Member] | ||
Commitments and Contingencies [Line Items] | ||
Amount of initial licensing fee | $ 325,000 | |
ND License Agreement [Member] | NDP [Member] | ||
Commitments and Contingencies [Line Items] | ||
Equity interest percentage | 5% |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||||||
Jul. 28, 2023 | Jul. 03, 2023 | Jun. 28, 2023 | Aug. 12, 2021 | Jan. 31, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Stockholders Equity [Line Items] | ||||||||
Available for issuance of equity, debt or equity-linked securities (in Dollars) | $ 104,400,000 | |||||||
Common stock shares issued | 54,959,270 | 54,938,258 | ||||||
Purchase of additional shares | 1,500,093 | |||||||
Public offering price (in Dollars per share) | $ 0.001 | $ 0.001 | ||||||
Compensation expense (in Dollars) | $ 362,000 | $ 86,000 | ||||||
Period of unrecognized compensation expense | 1 year 7 months 6 days | |||||||
Preferred stock, shares authorized | 2,000,000 | 2,000,000 | ||||||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 | ||||||
Expected dividend yield, percentage | 0% | |||||||
Underwriting Agreement [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock shares issued | 7,500,000 | |||||||
Warrants purchase shares | 2,500,625 | |||||||
Maximum [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Available for issuance of equity, debt or equity-linked securities (in Dollars) | $ 150,000,000 | |||||||
Stock Options [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
RSUs vested percentage | 25% | |||||||
Outstanding RSUs | 366,235 | 207,469 | ||||||
Unrecognized compensation expense (in Dollars) | $ 999,000 | |||||||
Period of unrecognized compensation expense | 1 year 9 months 18 days | |||||||
Stock Options [Member] | Second Anniversary [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
RSUs grant percentage | 25% | |||||||
Stock Options [Member] | First Anniversary [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
RSUs grant percentage | 25% | |||||||
Stock Options [Member] | Third Anniversary [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
RSUs grant percentage | 25% | |||||||
Stock Options [Member] | Chief Executive Officer [Member] | 2019 Omnibus Stock Incentive Plan [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Granted shares issued | 283,333 | |||||||
Weighted average grant date fair value (in Dollars per share) | $ 3.47 | |||||||
Stock Options [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Granted aggregate shares | 1,911,167 | 1,747,000 | ||||||
Employee Stock Option [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Unrecognized compensation expense (in Dollars) | $ 9,132,000 | |||||||
Chief Executive Officer [Member] | Stock Options [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
RSUs vested percentage | 25% | |||||||
Vested shares issued | 42,844 | |||||||
Restricted stock withholding tax | 27,989 | |||||||
Board of Directors [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Preferred stock, shares authorized | 2,000,000 | |||||||
Employees and Directors [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Stock-based compensation expense (in Dollars) | $ 2,082,000 | $ 2,130,000 | ||||||
Common Stock [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock shares issued | 1,500,093 | |||||||
Net proceed (in Dollars) | $ 37,300,000 | |||||||
Public offering price (in Dollars per share) | $ 4 | |||||||
Common Stock [Member] | Warrant [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock shares issued | 2,500,625 | |||||||
Common stock per share price (in Dollars per share) | $ 3.999 | |||||||
Common Stock [Member] | Stock Options [Member] | 2019 Omnibus Stock Incentive Plan [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Weighted average exercise price (in Dollars per share) | $ 3.52 | $ 4.36 | ||||||
IPO [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Net proceed (in Dollars) | $ 5,600,000 | |||||||
IPO [Member] | Common Stock [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock shares issued | 7,500,000 | |||||||
Common stock per share price (in Dollars per share) | $ 4 | |||||||
Market Program [Member] | ||||||||
Stockholders Equity [Line Items] | ||||||||
Net proceed (in Dollars) | $ 7,200,000 | |||||||
Aggregate of common stock under the ATM program | 1,684,592 |
Schedule of Preferred Stock (De
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items] | ||
Preferred Stock, Shares Outstanding | 181,622 | 181,622 |
Preferred Stock, Liquidation Preference, Value | $ 21,291,665 | $ 21,291,665 |
Series C-3 [Member] | ||
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items] | ||
Preferred Stock, Shares Outstanding | 2,000 | 2,000 |
Preferred Stock, Liquidation Preference Per Share | $ 10 | $ 10 |
Preferred Stock, Liquidation Preference, Value | $ 20,000 | $ 20,000 |
Series E Preferred Stock [Member] | ||
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items] | ||
Preferred Stock, Shares Outstanding | 89,623 | 89,623 |
Preferred Stock, Liquidation Preference Per Share | $ 49.2 | $ 49.2 |
Preferred Stock, Liquidation Preference, Value | $ 4,409,452 | $ 4,409,452 |
Series G Preferred Stock [Member] | ||
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items] | ||
Preferred Stock, Shares Outstanding | 89,999 | 89,999 |
Preferred Stock, Liquidation Preference Per Share | $ 187.36 | $ 187.36 |
Preferred Stock, Liquidation Preference, Value | $ 16,862,213 | $ 16,862,213 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - Schedule of Fair Value Assumptions - Minimum [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares | |
Schedule of Fair Value Assumptions [Line Items] | |
Expected term (in years) | 5 years 11 months 15 days |
Volatility weighted average | 98.98% |
Dividend yield weighted average | 0% |
Risk-free interest rate weighted average | 4.13% |
Weighted average grant date fair value of options granted during the period (in Dollars per share) | $ 2.82 |
Leases (Details)
Leases (Details) | 3 Months Ended | ||||
Sep. 16, 2020 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2024 EUR (€) | Dec. 31, 2023 USD ($) | |
Leases [Line Items] | |||||
Payments for leasing costs | $ 17,000 | ||||
Rental agreement expense (in Euro) | € | € 400 | ||||
Operating lease expense | $ 52,000 | $ 52,000 | |||
Operating lease liability | 632,000 | $ 668,000 | |||
Operating lease liability current | 154,801 | 150,619 | |||
Operating lease liability non current | 476,588 | 517,013 | |||
Operating lease right of use asset | 604,634 | $ 640,278 | |||
Operating leases | $ 51,000 | $ 50,000 | |||
Weighted average remaining lease term | 3 years 7 months 6 days | 4 years 7 months 6 days | 3 years 7 months 6 days | ||
Weighted average discount rate | 9% | 9% | 9% |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Maturities of Lease Liabilities - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Schedule of Maturities of Lease Liabilities [Abstract] | ||
2024 (excluding the three months ended March 31, 2024) | $ 154,000 | |
2025 | 208,000 | |
2026 | 211,000 | |
2027 | 169,000 | |
Total future minimum lease payments | 742,000 | |
Less imputed interest | (110,000) | |
Total | $ 632,000 | $ 668,000 |