Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 28, 2023 | Jun. 30, 2022 | |
Document Information Line Items | |||
Entity Registrant Name | CORMEDIX INC. | ||
Trading Symbol | CRMD | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 44,499,788 | ||
Entity Public Float | $ 163.9 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001410098 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-34673 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-5894890 | ||
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 | ||
City Area Code | (908) | ||
Local Phone Number | 517-9500 | ||
Title of 12(b) Security | Common Stock, $0.001 Par Value | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Auditor Name | Marcum LLP | ||
Auditor Firm ID | 711 | ||
Auditor Location | Marlton, NJ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 43,148,323 | $ 53,317,405 |
Restricted cash | 124,102 | 131,567 |
Short-term investments | 15,644,062 | 12,149,003 |
Trade receivables, net | 45,368 | |
Inventories | 3,008 | |
Prepaid research and development expenses | 11,016 | 51,993 |
Other prepaid expenses and current assets | 623,672 | 770,485 |
Total current assets | 59,551,175 | 66,468,829 |
Property and equipment, net | 1,609,679 | 1,474,937 |
Restricted cash, long term | 102,320 | 102,305 |
Operating lease right-of-use assets | 775,085 | 899,505 |
TOTAL ASSETS | 62,038,259 | 68,945,576 |
Current liabilities | ||
Accounts payable | 2,202,149 | 2,209,552 |
Accrued expenses | 3,973,941 | 3,014,156 |
Operating lease liabilities, short-term | 134,801 | 121,368 |
Total current liabilities | 6,310,891 | 5,345,076 |
Operating lease liabilities, net of current portion | 667,632 | 802,433 |
TOTAL LIABILITIES | 6,978,523 | 6,147,509 |
COMMITMENTS AND CONTINGENCIES (Note 6) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at December 31, 2022 and 2021 | 182 | 182 |
Common stock - $0.001 par value: 160,000,000 shares authorized at December 31, 2022 and 2021; 42,815,196 and 38,086,437 shares issued and outstanding at December 31, 2022 and 2021, respectively | 42,815 | 38,086 |
Accumulated other comprehensive gain | 82,743 | 87,130 |
Additional paid-in capital | 330,294,782 | 308,331,750 |
Accumulated deficit | (275,360,786) | (245,659,081) |
TOTAL STOCKHOLDERS’ EQUITY | 55,059,736 | 62,798,067 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 62,038,259 | $ 68,945,576 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 42,815,196 | 38,086,437 |
Common stock, shares outstanding | 42,815,196 | 38,086,437 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Net sales | $ 65,408 | $ 190,936 |
Cost of sales | (3,734) | (148,938) |
Gross profit | 61,674 | 41,998 |
Operating Expenses: | ||
Research and development | (10,679,549) | (13,132,982) |
Selling, general and administrative | (20,006,093) | (16,346,601) |
Total operating expenses | (30,685,642) | (29,479,583) |
Loss From Operations | (30,623,968) | (29,437,585) |
Other Income (Expense): | ||
Interest income | 326,016 | 14,403 |
Foreign exchange transaction income (loss) | 37,145 | (21,287) |
Interest expense | (26,515) | (15,943) |
Total other (expense) income | 336,646 | (22,827) |
Net Loss Before Income Taxes | (30,287,322) | (29,460,412) |
Tax benefit | 585,617 | 1,250,186 |
Net Loss | (29,701,705) | (28,210,226) |
Other Comprehensive Income (Loss): | ||
Unrealized gain (loss) from investments | 5,055 | (4,655) |
Foreign currency translation loss | (9,442) | (10,221) |
Total other comprehensive loss | (4,387) | (14,876) |
Comprehensive Loss | $ (29,706,092) | $ (28,225,102) |
Net Loss Per Common Share – Basic and Diluted (in Dollars per share) | $ (0.74) | $ (0.75) |
Weighted Average Common Shares Outstanding – Basic and Diluted (in Shares) | 40,274,273 | 37,666,081 |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Income (Loss) (Parentheticals) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net Loss Per Common Share – Basic and Diluted | $ (0.74) | $ (0.75) |
Weighted Average Common Shares Outstanding – Basic and Diluted | 40,274,273 | 37,666,081 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ Equity - USD ($) | Common Stock | Preferred Stock – Series C-2, C-3, Series D, Series E, Series F and Series G | Accumulated Other Comprehensive Income (Loss) | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 33,558 | $ 242 | $ 102,006 | $ 261,536,061 | $ (217,448,855) | $ 44,223,012 |
Balance (in Shares) at Dec. 31, 2020 | 33,558,096 | 241,623 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 3,738 | 41,451,892 | 41,455,630 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 3,737,862 | |||||
Stock issued in connection with warrants exercised, cash | $ 31 | 164,855 | 164,886 | |||
Stock issued in connection with warrants exercised, cash (in Shares) | 31,407 | |||||
Stock issued in connection with warrants exercised, cashless | $ 70 | (70) | ||||
Stock issued in connection with warrants exercised, cashless (in Shares) | 70,269 | |||||
Stock issued in connection with options exercised | $ 33 | 137,002 | 137,035 | |||
Stock issued in connection with options exercised (in Shares) | 32,734 | |||||
Conversion of Series G preferred shares to common stock | $ 556 | $ (10) | (546) | |||
Conversion of Series G preferred shares to common stock (in Shares) | 556,069 | (10,001) | ||||
Conversion of Series C-3 preferred shares to common stock | $ 100 | $ (50) | (50) | |||
Conversion of Series C-3 preferred shares to common stock (in Shares) | 100,000 | (50,000) | ||||
Stock-based compensation | 5,042,606 | 5,042,606 | ||||
Other comprehensive loss | (14,876) | (14,876) | ||||
Net loss | (28,210,226) | (28,210,226) | ||||
Balance at Dec. 31, 2021 | $ 38,086 | $ 182 | 87,130 | 308,331,750 | (245,659,081) | 62,798,067 |
Balance (in Shares) at Dec. 31, 2021 | 38,086,437 | 181,622 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 4,705 | 17,764,911 | 17,769,616 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 4,704,259 | |||||
Stock issued in connection with warrants exercised, cash | $ 24 | 128,601 | 128,625 | |||
Stock issued in connection with warrants exercised, cash (in Shares) | 24,500 | |||||
Stock-based compensation | 4,069,520 | 4,069,520 | ||||
Other comprehensive loss | (4,387) | (4,387) | ||||
Net loss | (29,701,705) | (29,701,705) | ||||
Balance at Dec. 31, 2022 | $ 42,815 | $ 182 | $ 82,743 | $ 330,294,782 | $ (275,360,786) | $ 55,059,736 |
Balance (in Shares) at Dec. 31, 2022 | 42,815,196 | 181,622 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (29,701,705) | $ (28,210,226) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,069,520 | 5,042,606 |
Change in right-of-use assets | 124,420 | 115,130 |
Depreciation | 84,618 | 61,890 |
Changes in operating assets and liabilities: | ||
Decrease (Increase) in trade receivables | 42,143 | (44,080) |
Decrease in inventory | 3,008 | 145,456 |
Decrease in prepaid expenses and other current assets | 187,235 | 666,628 |
(Decrease) Increase in accounts payable | (6,566) | 1,082,129 |
Increase in accrued expenses | 961,963 | 94,279 |
Decrease in operating lease liabilities | (121,368) | (109,035) |
Net cash used in operating activities | (24,356,732) | (21,155,223) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term investments | (31,140,004) | (15,289,586) |
Maturity of short-term investments | 27,650,000 | 7,580,000 |
Purchase of equipment | (219,360) | (1,425,329) |
Net cash used in investing activities | (3,709,364) | (9,134,915) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock from at-the-market program, net | 17,769,616 | 41,455,630 |
Proceeds from exercise of warrants | 128,625 | 164,886 |
Proceeds from exercise of stock options | 137,035 | |
Net cash provided by financing activities | 17,898,241 | 41,757,551 |
Foreign exchange effects on cash | (8,677) | (12,919) |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (10,176,532) | 11,454,494 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR | 53,551,277 | 42,096,783 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR | 43,374,745 | 53,551,277 |
Cash paid for interest | 26,516 | 15,943 |
Supplemental Disclosure of Non-Cash Financing and Investing Activities: | ||
Conversion of Series G preferred stock to common stock | 10 | |
Conversion of Series C-3 preferred stock to common stock | 50 | |
Unrealized gain (loss) from investments | 5,055 | (4,655) |
Deposit on equipment reclassified from prepaid expenses and current assets to property and equipment, net | $ 501,821 |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
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 the prevention and treatment of infectious and inflammatory diseases. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH and in May 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U. As announced in May 2022, the Company began the process of winding down its operations in the EU and expects to discontinue Neutrolin sales in both the EU and the Middle East by the end of 2022. The Company’s primary focus is to develop its lead product candidate, DefenCath™, for potential commercialization in the United States (“U.S.”) and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize DefenCath and Neutrolin ® |
Liquidity and Uncertainties
Liquidity and Uncertainties | 12 Months Ended |
Dec. 31, 2022 | |
Liquidity And Uncertainties [Abstract] | |
Liquidity and Uncertainties | Note 2 — Liquidity and Uncertainties: The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“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 development plans for DefenCath/Neutrolin in both the U.S. and foreign markets and its other operating requirements, the Company’s existing cash and cash equivalents and short-term investments at December 31, 2022 are expected to fund its operations for at least twelve months from the issuance of this Annual Report on Form 10-K, after taking into consideration the costs for resubmission of the NDA and initial preparations for the commercial launch for DefenCath. The Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions or out-licensing of its products in order to commercially launch DefenCath upon NDA approval and until profitability is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of December 31, 2022, the Company has $50.0 million available under its At-the-Market Issuance Sales Agreement (the “ATM program”) and has $150.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 9). The Company’s operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 — Summary of Significant Accounting Policies: Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make 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 and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Basis of Consolidation The consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U. 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 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: December 31, 2022 2021 Cash and cash equivalents $ 43,148,323 $ 53,317,405 Restricted cash, short-term and long-term 226,422 233,872 Total cash, cash equivalents and restricted cash $ 43,374,745 $ 53,551,277 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 and equity securities classified as available-for-sale 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 net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. 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 December 31, 2022 or 2021. 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 December 31, 2022 and 2021, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at December 31, 2022 and 2021: December 31, 2022: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 7,311,327 $ - $ 572 $ 7,311,899 U.S. Government Agency Securities 12,072,127 (3,184 ) 2,056 12,070,999 Corporate Securities 2,684,235 (183 ) 909 2,684,961 Commercial Paper 888,875 (773 ) - 888,102 Subtotal 15,645,237 (4,140 ) 2,965 15,644,062 Total December 31, 2022 $ 22,956,564 $ (4,140 ) $ 3,537 $ 22,955,961 December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,877 $ (23 ) $ - $ 10,462,854 U.S. Government Agency Securities 2,806,597 (1,261 ) - 2,805,336 Corporate Securities 7,548,493 (4,467 ) 1 7,544,027 Commercial Paper 1,799,548 - 92 1,799,640 Subtotal 12,154,638 (5,728 ) 93 12,149,003 Total December 31, 2021 $ 22,617,515 $ (5,751 ) $ 93 $ 22,611,857 Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities and accounts payable. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. 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, which is set out below. 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. ● 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 as of December 31, 2022 and 2021: December 31, 2022: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 7,311,899 $ 7,311,899 $ - $ - U.S. Government Agency Securities 12,070,999 12,070,999 - - Corporate Securities 2,684,961 - 2,684,961 - Commercial Paper 888,102 - 888,102 - Subtotal 15,644,062 12,070,999 3,573,063 - Total December 31, 2022 $ 22,955,961 $ 19,382,898 $ 3,573,063 $ - December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,854 10,462,854 - - U.S. Government Agency Securities 2,805,336 2,805,336 - - Corporate Securities 7,544,027 - 7,544,027 - Commercial Paper 1,799,640 - 1,799,640 - Subtotal 12,149,003 2,805,336 9,343,667 - Total December 31, 2021 $ 22,611,857 $ 13,268,190 $ 9,343,667 $ - Foreign Currency Translation and Transactions The consolidated financial statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the year. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign currency translation loss of $9,442 and $10,221 for the year ended December 31, 2022 and 2021, respectively. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. Restricted Cash As of December 31, 2022, and 2021 the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 8). The Company was required by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit for the first and second instances, respectively, in connection with the unfair competition proceedings in Cologne. During the year ended December 31, 2021, approximately $48,000 was released by the court for the reimbursement of legal fees and other costs which was removed from restricted cash. As of December 31, 2022 and 2021, restricted cash in connection with the patent and utility model infringement proceedings were $124,000 and $132,000, respectively. As of December 31, 2022, the Company had $102,000 in long-term restricted cash for a lease security deposit. Prepaid Research and Development and Other Prepaid Expenses Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, pre-clinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. Inventories Inventories are valued at the lower of cost or net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath product. Inventories consist of the following: December 31, 2022 2021 Finished goods $ - $ 3,008 Property and Equipment Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost. Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2022 and 2021 were $1,609,679 and $1,474,937, respectively, net of accumulated depreciation of $449,787 and $365,169, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years or remaining term of the lease Computer equipment 5 years Computer software 3 years 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, and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 11). 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. Revenue Recognition The Company uses Accounting Standards Codification (“ASC”) 606, “ Revenue from Contracts with Customers,” The Company recognizes net sales upon shipment of product to the dialysis centers and upon meeting the five-step model prescribed by ASC 606 outlined above. 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. Diluted 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 entity. 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, basic and diluted loss per share are the same as potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. 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: Number of Shares of Common Stock Issuable At December 31, 2022 2021 Series C non-voting preferred stock 4,000 4,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding warrants - 56,455 Shares underlying outstanding stock options 4,454,369 3,358,131 Restricted stock units 207,469 - Total potentially dilutive shares 10,110,769 8,863,517 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. For options with market-based vesting, share-based compensation cost is measured at grant date using the Monte Carlo option pricing model and the expense is recognized over the derived service period. 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. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary 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 expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. Legal Costs The Company records legal costs associated with loss contingencies when they are probable and reasonably estimable. |
Geographic Information
Geographic Information | 12 Months Ended |
Dec. 31, 2022 | |
Geographic Information [Abstract] | |
Geographic Information | Note 4 — Geographic Information: Geographic Information The following table summarizes the geographic information: December 31, 2022 2021 Reported revenues $ 65,408 $ 190,936 Revenues attributable to European and Mideast operations, which are based in Germany 65,408 190,936 Total assets 62,038,259 68,945,576 Total assets located in the United States, with the remainder in the European Union $ 61,740,478 $ 68,558,413 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 5 — Accrued Expenses: Accrued Expenses Accrued expenses consist of the following: December 31, 2022 2021 Professional and consulting fees $ 514,354 $ 311,408 Accrued payroll and payroll taxes 2,180,581 2,508,398 Manufacturing development related 1,214,550 99,614 Other 64,456 94,736 Total $ 3,973,941 $ 3,014,156 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 6 — Related Party Transactions: In February 2021, Manchester Securities Corp., Elliott Associates LP and Elliott International LP (collectively, “Elliott”), an existing institutional investor who collectively beneficially own the largest portion of the Company’s common stock, converted an aggregate of 10,001 Series G preferred shares into an aggregate of 556,069 shares of the Company’s common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 7 — Income Taxes: The Company’s U.S. and foreign loss before income taxes are set forth below: December 31, 2022 2021 United States $ (29,973,763 ) $ (29,031,585 ) Foreign (313,559 ) (428,827 ) Total $ (30,287,322 ) $ (29,460,412 ) There were no current or deferred income tax provisions for the years ended December 31, 2022 and 2021 because the Company has incurred operating losses since inception. The Company’s deferred tax assets consist of the following: December 31, 2022 2021 Net operating loss carryforwards – Federal $ 47,683,000 $ 44,085,000 Net operating loss carryforwards – State 1,592,000 3,717,000 Net operating loss carryforwards – Foreign 10,000 5,000 Capitalized licensing fees 304,000 449,000 Stock-based compensation 5,270,000 4,430,000 Accrued compensation 172,000 320,000 Section 174 capitalization 2,702,000 - Other 28,000 (17,000 ) Totals 57,761,000 52,989,000 Less valuation allowance (57,761,000 ) (52,989,000 ) Deferred tax assets $ - $ - The Company had the following potentially utilizable net operating loss tax carryforwards: December 31, 2022 2021 Federal $ 227,068,000 $ 209,930,000 State $ 22,389,000 $ 52,280,000 Foreign $ 38,000 $ 20,000 The net operating losses generated will start to expire in 2026 for Federal purposes whereas the operating losses for state purposes will begin expiring in 2040. The Tax Cuts and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80% of taxable income for losses arising in tax years beginning after December 31, 2017. However, the net operating losses now have an indefinite carryforward as opposed to the former 20-year carryforward. The foreign net operating loss tax carryforwards do not expire. Our federal and state operating loss carryforwards include windfall tax deductions from stock option exercises. The utilization of the Company’s net operating losses may be subject to a substantial limitation due to the “change of ownership provisions” under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carryforwards before their utilization. During 2021, the Company’s German subsidiary was audited by the German taxing authorities for the years 2013-2015. It was determined that the amount of German income was not sufficient, so the taxing authorities made adjustments accordingly. Further, amended returns were filed for the subsequent years to provide the German subsidiary sufficient income. As a result of these changes, the German NOL was fully utilized and no longer has a carryforward attribute. Since such adjustments are statutory adjustments in Germany for tax purposes, there is no material effect on the Company’s financial statements. The foreign net operating loss carryforward relates to the Company’s Spanish subsidiary. The Company’s foreign earnings are derived from its German subsidiary. The Company does not expect any foreign earnings to be repatriated in the U.S. in the near future. As announced in May 2022, the Company began the process of winding down its operations in the EU and expects to derive no income after the end of 2022. The Company’s effective tax rate varied from the statutory rate as follows: December 31, 2022 2021 Statutory federal tax rate 21.0 % 21.0 % State income tax rate (net of federal) (4.3 )% 3.5 % Change in foreign NOL (0.2 )% (8.3 )% NJ NOL adjustment 1.9 % 4.2 % Other permanent differences (0.8 )% (0.9 )% Effect of valuation allowance (15.7 )% (15.3 )% Effective tax rate 1.9 % 4.2 % In assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the appropriate character during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce taxable income. In making its assessment, the Company considered all sources of taxable income including carryback potential, future reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections of future taxable income exclusive of reversing temporary differences and carryforwards. At December 31, 2022 and 2021, the Company maintained a full valuation allowance against its net deferred tax assets. The Company will continue to assess all available evidence during future periods to evaluate the realization of its deferred tax assets. The following table presents the changes in the deferred tax asset valuation allowance for the periods indicated: Year Ended Balance at Beginning of Increase (Decrease) Charged (Credited) to Increase (Decrease) Charged (Credited) Balance at End of December 31, 2022 $ 52,989,000 $ 4,805,000 $ (32,000 ) $ 57,762,000 December 31, 2021 $ 48,480,000 $ 4,541,000 $ (32,000 ) $ 52,989,000 Accounting for uncertainty in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are expected to be paid within one year. The Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial statements as of December 31, 2022 and 2021. The Company recognizes interest and penalties related to uncertain tax positions if any as a component of income tax expense. The Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state and local perspective the years that remain open to examination are consistent with each jurisdiction’s statute of limitations. From a foreign perspective, tax years 2016 to 2020 remain open to examination. During the years ended December 31, 2022 and 2021, the Company received net proceeds of $586,000 and $1,250,000, respectively, from the sale of most of its remaining unused New Jersey net operating losses (“NOL”) 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 $626,000 of its total $626,000 in available NOL tax benefits for the state fiscal year 2021 and $1,337,000 of its total $1,337,000 for the state fiscal year 2020. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 8 — Commitments and Contingencies: Contingency Matters 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-cv014020-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. In the second amended complaint, the lead plaintiff seeks to represent two classes of shareholders: (i) shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive; and (ii) shareholders who purchased CorMedix securities pursuant or traceable to the Company’s November 27, 2020 offering pursuant to CorMedix’s Form S-3 Registration Statement, its Prospectus Supplement, dated November 27, 2020, and its Prospectus Supplement, dated August 12, 2021. The second amended complaint names as defendants the Company and twelve (12) current and former directors and 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”) as well as Janet Dillione, Myron Kaplan, Alan W. Dunton, Steven Lefkowitz, Paulo F. Costa, Greg Duncan (the “Director Defendants”). The second amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5), the Officer Defendants violated Section 20(a), the Director Defendants, CorMedix, Baluch, and David violated Section 11 of the Securities Act, and that the Director Defendants, Baluch, and David violated Section 15. 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. The Company and the other Defendants filed their motion to dismiss the second amended complaint on November 23, 2022; the lead plaintiff filed his opposition to the Defendants’ motions to dismiss on January 7, 2023; and Defendants filed their reply brief on February 6, 2023. 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, and Phoebe Mounts 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. The case was administratively terminated on March 16, 2022 while the stay is pending. 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 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. On September 9, 2014, the Company filed in the District Court of Mannheim, Germany, (the “Court”) a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by the European Patent Office (the “EPO”) on January 8, 2014 (the “Prosl European Patent”). The Prosl European Patent covers the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining patency and preventing infection in hemodialysis catheters. In this action, the Company claims that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of ND Partners’ utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims were tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German PTO”) based on the similar arguments as those in the opposition against the Prosl European Patent. The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility Model. The EPO held a hearing in the opposition proceeding on November 25, 2015. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art. The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. The Company filed an appeal against the ruling on September 7, 2016. An oral hearing was held on September 17, 2019 in which the German Federal Patent Court affirmed the first instance decision that the Utility Model was invalid. The decision has only a declaratory effect, as the Utility Model had expired in November 2015. On April 28, 2020, the Company filed a withdrawal of the complaint on the German utility model, thereby waiving its claims on these proceedings. The proceedings were closed and during the year ended December 31, 2020, final reimbursement of approximately $30,000 for the costs in connection with the utility model infringement were paid to TauroPharm . On November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter. At the hearing, the panel held that the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law. The Company disagrees with this decision and has appealed the decision. In a hearing on October 27, 2022 before the EPO Board of Appeals, the Board expressed the view that the patent claims of the Prosl European Patent on file were not inventive over prior art presented by TauroPharm. The Company thus withdrew its appeal against the first instance decision. This means that the invalidation of the patent has become final and that, as a consequence, the infringement proceedings, which are formally still ongoing, will also be closed because there is no underlying patent anymore. In view of the invalidation of the Prosl European Patent, on November 9, 2022, the Defendants requested the infringement proceedings (docket number 7 O 118/14) to be resumed and to dismiss our infringement action. In order to avoid a dismissal, on January 12, 2023, the Company withdrew the infringement action with prejudice. The Defendants consented to the withdrawal on February 2, 2023 and requested that the Company, as plaintiff, bears the costs of the proceedings. Given that pursuant to statutory law, a plaintiff that withdraws an action, has to bear the costs of the proceedings, The Company put the decision on who has to bear the costs in the District Court of Mannheim’s discretion. Due to the withdrawal, there will be no decision on the merits, however, the District Court of Mannheim will issue a decision that the Company has to bear the cost of the proceedings. Given that the court fees have already been paid by the Company, the cost of the proceedings are the costs that will have to be reimbursed to the Defendants, i.e mainly statutory attorney’s fees and expenses. On January 16, 2015, the Company filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company alleged violation of the German Unfair Competition Act by TauroPharm and that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLock TM In connection with the aforementioned patent and utility model infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of Mannheim and Cologne to provide security deposits to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. As of December 31, 2022, the aggregate deposit was approximately $124,000, which the Company recorded as restricted cash on the consolidated balance sheets. On February 8, 2023, the Regional Court of Cologne informed the Company that the security deposit in two proceedings (81 HL 448/15 and 81 HL 903/19), in the amount of 36,000 EUR and 10,000 EUR, (approximately in aggregate of $49,000), will be refunded to CorMedix and that it instructed their accounting department to wire transfer the two security deposits. The remaining aggregate deposit of about $75,000 remains in security deposit. Commitments In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the NDP 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”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, 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. The Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 29,109 shares. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. The number of shares held in escrow as of December 31, 2022 is 21,832 shares of common stock. The maximum aggregate amount of cash payments due upon achievement of milestones is $3,000,000 with the balance being $2,500,000 as of December 31, 2022 and 2021. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. There were no milestones achieved during the years ended December 31, 2022 and 2021. The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 9 — Stockholders’ Equity: Common Stock: In November 2020, the Company filed a shelf registration statement, (the “2020 Shelf Registration”), under which the Company could issue and sell up to an aggregate of $100,000,000 of shares of its common stock, $0.001 par value per share. On November 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (the “Amended Sales Agreement”) with FBR Securities, Inc. (formerly known as B. Riley FBR Inc.) and Needham & Company, LLC as sales agents. The Amended Sales Agreement relates to the sale of shares of up to $50,000,000 of its common stock under its at-the-market program (the “ATM program”), of which the Company may issue and sell common stock from time to time through the sales agents, subject to limitations imposed by the Company and subject to the sales agents’ acceptance, such as the number or dollar amount of shares registered under the 2020 Shelf Registration to which the offering relates. Sales agents are entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the year ended December 31, 2021, the ATM program under the Amended Sales Agreement had been fully sold. On August 12, 2021, the Company entered into a new At Market Issuance Sales Agreement with Truist Securities, Inc. and JMP Securities LLC, as sales agents, pursuant to which the Company may sell, from time to time, an aggregate of up to $50,000,000 of its common stock through the sales agents under its ATM program, subject to limitations imposed by the Company and subject to the sales agents’ acceptance, such as the number or dollar amount of shares registered under the 2020 Shelf Registration to which the offering relates. The sales agents are entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. As of December 31, 2022, the Company has $31,600,000 available under its ATM program relating to its 2020 Shelf Registration filed in November 2020. Also, on August 12, 2021, the Company filed a new shelf registration statement (the “2021 Shelf Registration”) for the issuance of up to $150,000,000 of shares of its common stock which is currently available for the issuance of equity, debt or equity-linked securities. During the year ended December 31, 2022 and 2021, the Company sold an aggregate of 4,704,259 and 3,737,862 shares of its common stock under the ATM program, respectively, and realized net proceeds of $17,770,000 and $41,456,000, respectively. During the year ended December 31, 2022 and 2021, the Company issued an aggregate of 24,500 and 31,407 shares of its common stock, respectively, upon cash exercise of warrants, resulting in net proceeds to the Company of $129,000 and $165,000, respectively. During the year ended December 31, 2021, the Company issued an aggregate of 656,069 shares of its common stock upon conversion of 50,000 Series C-3 preferred shares by an unrelated party and 10,001 Series G preferred shares by a related party. During the year ended December 31, 2021, the Company issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants. During the year ended December 31, 2021, the Company issued an aggregate of 32,734 shares of its common stock upon exercise of stock options, resulting in net proceeds to the Company of $137,000. Restricted Stock Units On May 10, 2022, the Company granted 207,469 restricted stock units (“RSUs”) to its chief executive officer under its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $3.38 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 as to 50% on the first anniversary of the grant date, as to 30% on the second anniversary of the grant date, and as to 20% on the third anniversary of the grant date, subject to continued service as an employee or consultant through the applicable vesting date. During the year ended December 31, 2022, compensation expense recorded for the RSUs was $226,000. Unrecognized compensation expense for these RSUs amounted to $475,000. The expected weighted average period for the expense to be recognized is 1.4 years. 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 December 31, 2022 and 2021 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference 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 During the year ended December 31, 2021, 50,000 Series C-3 preferred shares were converted into 100,000 shares of the Company’s common stock by an unrelated party and 10,001 Series G preferred shares were converted into 556,069 shares of the Company’s common stock by a related party. The following rights, privileges, terms and condition apply to the outstanding preferred stock at December 31, 2022: Series C-3 Non-Voting Preferred Stock Rank. Conversion. Liquidation Preference. Voting Rights. Dividends Redemption Listing Fundamental Transactions Series E Voting Convertible Preferred Stock Rank. Conversion. Liquidation Preference. Voting Rights. Dividends. Redemption. Listing. Fundamental Transactions. Debt Restriction. Other Covenants. Purchase Rights. Series G Voting Convertible Preferred Stock Rank Conversion Liquidation Preference Voting Rights Dividends Redemption Listing Fundamental Transactions Debt Restriction Other Covenants Purchase Rights Stock Options: On October 13, 2022, the Company’s shareholders approved the CorMedix Inc. Amended and Restated 2019 Omnibus Stock Incentive Plan (the “A&R 2019 Plan”), pursuant to which the Company may issue an additional 4,800,000 shares of its common stock, plus any shares that remain available for grant under its existing plan as of the effective date, as long-term equity incentives to the Company’s employees, consultants, and directors. The long-term incentives may be in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other rights or benefits (collectively, “stock rights”) to employees, consultants, and directors of the Company or a related entity (collectively, “participants”). The Company believes that the effective use of long- term equity incentives is essential to attract, motivate, and retain employees, consultants and directors, to further align participants’ interests with those of the Company’s stockholders, and to provide participants incentive compensation opportunities that are competitive with those offered by other companies in the same industry and locations as the Company. The A&R 2019 Plan is a new equity compensation plan for the Company’s employees, consultants, and directors which replaced the 2019 Omnibus Stock Incentive Plan. The 2013 Stock Incentive Plan and the 2019 Omnibus Stock Incentive Plan are referred to collectively as the “Prior Plans”. No further awards will be granted under the Prior Plans after the approval of the A&R 2019 Plan. Awards outstanding under the Prior Plans will remain outstanding in accordance with their terms and the Prior Plans. During the years ended December 31, 2022 and 2021, the Company granted ten-year qualified and non-qualified stock options to its officers, directors, employees and consultants covering an aggregate of 1,627,850 and 1,664,700 shares of the Company’s common stock under the 2019 Plan, respectively. The weighted average exercise price of these options is $3.83 and $7.98 per share, respectively. During the years ended December 31, 2022 and 2021, total compensation expense for stock options issued to employees, directors, officers and consultants was $3,843,000 and $5,043,000, respectively. As of December 31, 2022, there was $4,985,000 total unrecognized compensation expense related to unvested stock options granted which expense is expected to be recognized over an expected remaining weighted average period of 1.5 years. All share-based awards are recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards are recognized in the period in which they occur. The fair value at grant dates of the grants issued subject to service and performance-based vesting conditions were determined using the Black-Scholes option pricing model with the following assumptions: Year Ended December 31, 2022 2021 Risk-free interest rate 1.76% - 4.31% 0.5% - 1.26% Expected volatility 89.68% - 107.2% 102.93% - 107.1% Expected term (years) 2.75 – 5 years 1.97-5 years Expected dividend yield 0.0% 0.0% Weighted-average grant date fair value of options granted during the period $2.90 $5.56 The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted to consultants 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 since the initial public offering of the Company’s common stock in March 2010. The expected dividend yield of 0.0% 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 which is 5 years for employees and 10 years for non-employees. The following table summarizes the Company’s stock options activity and related information for the year ended December 31, 2022: Shares Underlying Stock Options Weighted- Weighted- Aggregate Intrinsic Value Outstanding at December 31, 2021 3,358,131 $ 7.53 6.8 $ 337,075 Granted 1,627,850 $ 3.83 $ 793,792 Exercised - - $ - Expired/Canceled (60,053 ) $ 8.00 $ 4,968 Forfeited (471,559 ) $ 7.16 $ 12,849 Outstanding at December 31, 2022 4,454,369 $ 6.21 6.6 $ 1,113,050 Vested at December 31, 2022 2,638,516 $ 7.26 5.0 $ 366,528 Expected to vest in the future 1,815,853 $ 4.69 8.9 $ 746,522 The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Warrants: During the years ended December 31, 2022 and 2021, the Company issued an aggregate of 24,500 and 31,407 shares of its common stock, respectively, upon cash exercise of warrants, resulting in net proceeds to the Company of $129,000 and $165,000, respectively. During the year ended December 31, 2021, the Company issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants. The following table is the summary of warrant activities: Shares Underlying Warrants Weighted Weighted Average Remaining Contractual Life Outstanding at December 31, 2021 56,455 $ 5.25 0.61 Exercised (24,500 ) $ 5.25 - Expired (31,955 ) $ 5.25 - Outstanding at December 31, 2022 - - - Stock-based Deferred Compensation Plan for Non-Employee Directors In 2014, the Company established an unfunded stock-based deferred compensation plan, providing non-employee directors the opportunity to defer up to one hundred percent of fees and compensation, including restricted stock units. The amount of fees and compensation deferred by a non-employee director is converted into stock units, the number of which is determined based on the closing price of the Company’s common stock on the date such compensation would have otherwise been payable. At all times, the plan participants are one hundred percent vested in their respective deferred compensation accounts. On the tenth business day of January in the year following a director’s termination of service, the director will receive a number of common shares equal to the number of stock units accumulated in the director’s deferred compensation account. The Company accounts for this plan as stock-based compensation under ASC 718. During the years ended December 31, 2022 and 2021 no compensation was deferred under this plan. |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2022 | |
Concentrations [Abstract] | |
Concentrations | Note 10 — Concentrations: At December 31, 2022, there were no net accounts receivable from a customer that exceeded 10% of the Company’s accounts receivable and at December 31, 2021, one customer had exceeded 10% of the Company’s accounts receivable (100%). During the year ended December 31, 2022, the Company had revenue from two customers that exceeded 10% of its total sales (55% and 29%) and the Company had revenue from three customers that exceeded 10% of its total sales (60%, 14% and 10%) for the year ended December 31, 2021. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Note 11 — 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. 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. The Company also has an operating lease for office equipment. Operating lease expense in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2022 and 2021 was approximately $208,000 and $209,000, respectively, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At December 31, 2022 and 2021, the Company has a total operating lease liability of $803,000 and $924,000, respectively. At December 31, 2022, approximately $135,000 and $668,000 were classified as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated balance sheet. Operating ROU assets as of December 31, 2022 and 2021 are $775,000 and $900,000, respectively. For the year ended December 31, 2022 and 2021, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $199,000 and $195,000, respectively. As of December 31, 2022 and 2021, the weighted average remaining lease term were 4.8 years and 5.8 years, respectively and the weighted average discount rate of 9% and 9% at December 31, 2022 and 2021, respectively. As of December 31, 2022, maturities of lease liabilities were as follows: 2023 $ 202,000 2024 205,000 2025 208,000 2026 and thereafter 380,000 Total future minimum lease payments 995,000 Less imputed interest (192,000) Total $ 803,000 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 12 — Subsequent Events: On January 15, 2023, the Company entered into an employment agreement with Erin Mistry, pursuant to which she was promoted to the role of Executive Vice President and Chief Commercial Officer. The Board further appointed Ms. Mistry an officer, for purposes of Section 16 of the Securities Exchange Act of 1934. Through March 30, 2023, the Company sold an aggregate of 1,684,592 shares of its common stock under the ATM program (see Note 9) and realized net proceeds of approximately $7,200,000. As of the filing of this Annual Report on Form 10-K, the Company has $24,200,000 available balance under its ATM program and it has $150,000,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities. On March 2, 2023, the Company provided regulatory and manufacturing updates related to the FDA compliance remediation activities at its primary CMO and heparin API supplier, as well as updated timelines for potential resubmission of its NDA under various scenarios. More specifically: 1) The Company has been informed by its primary CMO (“CMO 1”) that all corrective actions stemming from the FDA’s June 2022 inspection have been completed and the CMO has provided to FDA documentation showing effectiveness of the corrective actions. The primary CMO awaits feedback from the FDA with respect to the compliance status of the facility, and 2) The Company has been informed by its existing supplier of heparin API (“API 1”) that all corrective actions related to its June 2022 FDA Warning Letter for a non-heparin API have been completed and implementation is underway, however it is unclear to the Company based on recent FDA actions if full resolution of the outstanding warning letter would still be required prior to approving the DefenCath NDA with reference to API 1. The supplier has informed the Company that it has made updates to the US Heparin Drug Master File (“DMF”) clarifying which activities take place at the site which is identified in the warning letter (early-stage processing) and which activities take place at a different FDA registered facility (final processing and release). The supplier has also informed the Company that subsequent to those updates, a supplement to an approved application referring to this DMF was recently approved by FDA. Based on this recent approval and the update to the DMF, it is possible that full resolution of the outstanding warning letter is no longer a barrier to FDA approval of the DefenCath NDA. The Company intends to seek confirmation from FDA on this issue set as follows: Given the progress made by CMO 1 on remediation of the inspectional observations and the potential precedent created by FDA’s approval of a supplement referencing the same heparin DMF utilized for DefenCath, the Company has submitted a Type A meeting request seeking additional guidance from the FDA prior to resubmission of the NDA application. The FDA granted the meeting request, and the meeting has been scheduled for mid-April. On March 23, 2023, Plaintiffs filed a letter, attaching a joint stipulation, requesting that the Voter v. Baluch et al DeSalvo v. Costa, et al., Scullion v. Baluch, et al., |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make 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 and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U. 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 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: December 31, 2022 2021 Cash and cash equivalents $ 43,148,323 $ 53,317,405 Restricted cash, short-term and long-term 226,422 233,872 Total cash, cash equivalents and restricted cash $ 43,374,745 $ 53,551,277 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 and equity securities classified as available-for-sale 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 net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. 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 December 31, 2022 or 2021. 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 December 31, 2022 and 2021, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at December 31, 2022 and 2021: December 31, 2022: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 7,311,327 $ - $ 572 $ 7,311,899 U.S. Government Agency Securities 12,072,127 (3,184 ) 2,056 12,070,999 Corporate Securities 2,684,235 (183 ) 909 2,684,961 Commercial Paper 888,875 (773 ) - 888,102 Subtotal 15,645,237 (4,140 ) 2,965 15,644,062 Total December 31, 2022 $ 22,956,564 $ (4,140 ) $ 3,537 $ 22,955,961 December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,877 $ (23 ) $ - $ 10,462,854 U.S. Government Agency Securities 2,806,597 (1,261 ) - 2,805,336 Corporate Securities 7,548,493 (4,467 ) 1 7,544,027 Commercial Paper 1,799,548 - 92 1,799,640 Subtotal 12,154,638 (5,728 ) 93 12,149,003 Total December 31, 2021 $ 22,617,515 $ (5,751 ) $ 93 $ 22,611,857 |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities and accounts payable. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. 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, which is set out below. 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. ● 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 as of December 31, 2022 and 2021: December 31, 2022: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 7,311,899 $ 7,311,899 $ - $ - U.S. Government Agency Securities 12,070,999 12,070,999 - - Corporate Securities 2,684,961 - 2,684,961 - Commercial Paper 888,102 - 888,102 - Subtotal 15,644,062 12,070,999 3,573,063 - Total December 31, 2022 $ 22,955,961 $ 19,382,898 $ 3,573,063 $ - December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,854 10,462,854 - - U.S. Government Agency Securities 2,805,336 2,805,336 - - Corporate Securities 7,544,027 - 7,544,027 - Commercial Paper 1,799,640 - 1,799,640 - Subtotal 12,149,003 2,805,336 9,343,667 - Total December 31, 2021 $ 22,611,857 $ 13,268,190 $ 9,343,667 $ - |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The consolidated financial statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the year. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign currency translation loss of $9,442 and $10,221 for the year ended December 31, 2022 and 2021, respectively. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. |
Restricted Cash | Restricted Cash As of December 31, 2022, and 2021 the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 8). The Company was required by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit for the first and second instances, respectively, in connection with the unfair competition proceedings in Cologne. During the year ended December 31, 2021, approximately $48,000 was released by the court for the reimbursement of legal fees and other costs which was removed from restricted cash. As of December 31, 2022 and 2021, restricted cash in connection with the patent and utility model infringement proceedings were $124,000 and $132,000, respectively. As of December 31, 2022, the Company had $102,000 in long-term restricted cash for a lease security deposit. |
Prepaid Research and Development and Other Prepaid Expenses | Prepaid Research and Development and Other Prepaid Expenses Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, pre-clinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath product. Inventories consist of the following: December 31, 2022 2021 Finished goods $ - $ 3,008 |
Property and Equipment | Property and Equipment Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost. Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2022 and 2021 were $1,609,679 and $1,474,937, respectively, net of accumulated depreciation of $449,787 and $365,169, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years or remaining term of the lease Computer equipment 5 years Computer software 3 years |
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, and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 11). 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. |
Revenue Recognition | Revenue Recognition The Company uses Accounting Standards Codification (“ASC”) 606, “ Revenue from Contracts with Customers,” The Company recognizes net sales upon shipment of product to the dialysis centers and upon meeting the five-step model prescribed by ASC 606 outlined above. |
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. Diluted 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 entity. 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, basic and diluted loss per share are the same as potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. 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: Number of Shares of Common Stock Issuable At December 31, 2022 2021 Series C non-voting preferred stock 4,000 4,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding warrants - 56,455 Shares underlying outstanding stock options 4,454,369 3,358,131 Restricted stock units 207,469 - Total potentially dilutive shares 10,110,769 8,863,517 |
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. For options with market-based vesting, share-based compensation cost is measured at grant date using the Monte Carlo option pricing model and the expense is recognized over the derived service period. |
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. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary 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 expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. |
Legal Costs | Legal Costs The Company records legal costs associated with loss contingencies when they are probable and reasonably estimable. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Schedule of cash and cash equivalents | December 31, 2022 2021 Cash and cash equivalents $ 43,148,323 $ 53,317,405 Restricted cash, short-term and long-term 226,422 233,872 Total cash, cash equivalents and restricted cash $ 43,374,745 $ 53,551,277 |
Schedule of marketable securities | December 31, 2022: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 7,311,327 $ - $ 572 $ 7,311,899 U.S. Government Agency Securities 12,072,127 (3,184 ) 2,056 12,070,999 Corporate Securities 2,684,235 (183 ) 909 2,684,961 Commercial Paper 888,875 (773 ) - 888,102 Subtotal 15,645,237 (4,140 ) 2,965 15,644,062 Total December 31, 2022 $ 22,956,564 $ (4,140 ) $ 3,537 $ 22,955,961 December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,877 $ (23 ) $ - $ 10,462,854 U.S. Government Agency Securities 2,806,597 (1,261 ) - 2,805,336 Corporate Securities 7,548,493 (4,467 ) 1 7,544,027 Commercial Paper 1,799,548 - 92 1,799,640 Subtotal 12,154,638 (5,728 ) 93 12,149,003 Total December 31, 2021 $ 22,617,515 $ (5,751 ) $ 93 $ 22,611,857 |
Schedule of carrying and fair value of financial assets | December 31, 2022: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 7,311,899 $ 7,311,899 $ - $ - U.S. Government Agency Securities 12,070,999 12,070,999 - - Corporate Securities 2,684,961 - 2,684,961 - Commercial Paper 888,102 - 888,102 - Subtotal 15,644,062 12,070,999 3,573,063 - Total December 31, 2022 $ 22,955,961 $ 19,382,898 $ 3,573,063 $ - December 31, 2021: Money Market Funds and Cash Equivalents $ 10,462,854 10,462,854 - - U.S. Government Agency Securities 2,805,336 2,805,336 - - Corporate Securities 7,544,027 - 7,544,027 - Commercial Paper 1,799,640 - 1,799,640 - Subtotal 12,149,003 2,805,336 9,343,667 - Total December 31, 2021 $ 22,611,857 $ 13,268,190 $ 9,343,667 $ - |
Schedule of inventories consist of raw materials | December 31, 2022 2021 Finished goods $ - $ 3,008 |
Schedule of property and equipment | Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years or remaining term of the lease Computer equipment 5 years Computer software 3 years |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share | Number of Shares of Common Stock Issuable At December 31, 2022 2021 Series C non-voting preferred stock 4,000 4,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding warrants - 56,455 Shares underlying outstanding stock options 4,454,369 3,358,131 Restricted stock units 207,469 - Total potentially dilutive shares 10,110,769 8,863,517 |
Geographic Information (Tables)
Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Geographic Information [Abstract] | |
Schedule of geographic information | December 31, 2022 2021 Reported revenues $ 65,408 $ 190,936 Revenues attributable to European and Mideast operations, which are based in Germany 65,408 190,936 Total assets 62,038,259 68,945,576 Total assets located in the United States, with the remainder in the European Union $ 61,740,478 $ 68,558,413 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | December 31, 2022 2021 Professional and consulting fees $ 514,354 $ 311,408 Accrued payroll and payroll taxes 2,180,581 2,508,398 Manufacturing development related 1,214,550 99,614 Other 64,456 94,736 Total $ 3,973,941 $ 3,014,156 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of U.S. and foreign loss before income taxes | December 31, 2022 2021 United States $ (29,973,763 ) $ (29,031,585 ) Foreign (313,559 ) (428,827 ) Total $ (30,287,322 ) $ (29,460,412 ) |
Schedule of deferred tax assets | December 31, 2022 2021 Net operating loss carryforwards – Federal $ 47,683,000 $ 44,085,000 Net operating loss carryforwards – State 1,592,000 3,717,000 Net operating loss carryforwards – Foreign 10,000 5,000 Capitalized licensing fees 304,000 449,000 Stock-based compensation 5,270,000 4,430,000 Accrued compensation 172,000 320,000 Section 174 capitalization 2,702,000 - Other 28,000 (17,000 ) Totals 57,761,000 52,989,000 Less valuation allowance (57,761,000 ) (52,989,000 ) Deferred tax assets $ - $ - |
Schedule of potentially utilizable net operating loss tax carryforwards | December 31, 2022 2021 Federal $ 227,068,000 $ 209,930,000 State $ 22,389,000 $ 52,280,000 Foreign $ 38,000 $ 20,000 |
Schedule of effective tax rate varied from the statutory rate | December 31, 2022 2021 Statutory federal tax rate 21.0 % 21.0 % State income tax rate (net of federal) (4.3 )% 3.5 % Change in foreign NOL (0.2 )% (8.3 )% NJ NOL adjustment 1.9 % 4.2 % Other permanent differences (0.8 )% (0.9 )% Effect of valuation allowance (15.7 )% (15.3 )% Effective tax rate 1.9 % 4.2 % |
Schedule of deferred tax asset valuation allowance | Year Ended Balance at Beginning of Increase (Decrease) Charged (Credited) to Increase (Decrease) Charged (Credited) Balance at End of December 31, 2022 $ 52,989,000 $ 4,805,000 $ (32,000 ) $ 57,762,000 December 31, 2021 $ 48,480,000 $ 4,541,000 $ (32,000 ) $ 52,989,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity [Abstract] | |
Schedule of preferred stock | As of December 31, 2022 and 2021 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference 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 |
Schedule of fair value of each stock option award estimated | Shares Underlying Stock Options Weighted- Weighted- Aggregate Intrinsic Value Outstanding at December 31, 2021 3,358,131 $ 7.53 6.8 $ 337,075 Granted 1,627,850 $ 3.83 $ 793,792 Exercised - - $ - Expired/Canceled (60,053 ) $ 8.00 $ 4,968 Forfeited (471,559 ) $ 7.16 $ 12,849 Outstanding at December 31, 2022 4,454,369 $ 6.21 6.6 $ 1,113,050 Vested at December 31, 2022 2,638,516 $ 7.26 5.0 $ 366,528 Expected to vest in the future 1,815,853 $ 4.69 8.9 $ 746,522 |
Schedule of warrant activities | Shares Underlying Warrants Weighted Weighted Average Remaining Contractual Life Outstanding at December 31, 2021 56,455 $ 5.25 0.61 Exercised (24,500 ) $ 5.25 - Expired (31,955 ) $ 5.25 - Outstanding at December 31, 2022 - - - |
Black-Scholes Option [Member] | |
Stockholders' Equity [Abstract] | |
Schedule of fair value assumptions | Year Ended December 31, 2022 2021 Risk-free interest rate 1.76% - 4.31% 0.5% - 1.26% Expected volatility 89.68% - 107.2% 102.93% - 107.1% Expected term (years) 2.75 – 5 years 1.97-5 years Expected dividend yield 0.0% 0.0% Weighted-average grant date fair value of options granted during the period $2.90 $5.56 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of maturities of lease liabilities | 2023 $ 202,000 2024 205,000 2025 208,000 2026 and thereafter 380,000 Total future minimum lease payments 995,000 Less imputed interest (192,000) Total $ 803,000 |
Liquidity and Uncertainties (De
Liquidity and Uncertainties (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Liquidity And Uncertainties [Abstract] | |
At-the-Market issuance sales agreement | $ 50 |
Available for the issuance of equity | $ 150 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies [Abstract] | ||
Foreign currency translation loss | $ 9,442 | $ 10,221 |
Reimbursement of legal fees and other costs | 48,000 | |
Restricted cash for the patent and utility model infringement proceedings | 124,000 | 132,000 |
Long-term restricted cash for a lease security deposit | 102,000 | 102,000 |
Net property and equipment | 1,609,679 | 1,474,937 |
Property, Plant and Equipment, Other, Accumulated Depreciation | $ 449,787 | $ 365,169 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of cash and cash equivalents - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Recognition Measurement Presentation and Disclosure of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 43,148,323 | $ 53,317,405 |
Restricted cash, short-term and long-term | 226,422 | 233,872 |
Total cash, cash equivalents and restricted cash | $ 43,374,745 | $ 53,551,277 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of marketable securities - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 22,956,564 | $ 22,617,515 |
Gross Unrealized Losses | (4,140) | (5,751) |
Gross Unrealized Gains | 3,537 | 93 |
Fair Value | 22,955,961 | 22,611,857 |
Money Market Funds and Cash Equivalents [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 7,311,327 | 10,462,877 |
Gross Unrealized Losses | (23) | |
Gross Unrealized Gains | 572 | |
Fair Value | 7,311,899 | 10,462,854 |
U.S. Government Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 12,072,127 | 2,806,597 |
Gross Unrealized Losses | (3,184) | (1,261) |
Gross Unrealized Gains | 2,056 | |
Fair Value | 12,070,999 | 2,805,336 |
Corporate Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,684,235 | 7,548,493 |
Gross Unrealized Losses | (183) | (4,467) |
Gross Unrealized Gains | 909 | 1 |
Fair Value | 2,684,961 | 7,544,027 |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 888,875 | 1,799,548 |
Gross Unrealized Losses | (773) | |
Gross Unrealized Gains | 92 | |
Fair Value | 888,102 | 1,799,640 |
Subtotal [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 15,645,237 | 12,154,638 |
Gross Unrealized Losses | (4,140) | (5,728) |
Gross Unrealized Gains | 2,965 | 93 |
Fair Value | $ 15,644,062 | $ 12,149,003 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | $ 22,955,961 | $ 22,611,857 |
Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 7,311,899 | 10,462,854 |
U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 12,070,999 | 2,805,336 |
Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 2,684,961 | 7,544,027 |
Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 888,102 | 1,799,640 |
Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 15,644,062 | 12,149,003 |
Level 1 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 19,382,898 | 13,268,190 |
Level 1 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 7,311,899 | 10,462,854 |
Level 1 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 12,070,999 | 2,805,336 |
Level 1 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 1 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 1 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 12,070,999 | 2,805,336 |
Level 2 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,573,063 | 9,343,667 |
Level 2 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 2 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 2 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 2,684,961 | 7,544,027 |
Level 2 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 888,102 | 1,799,640 |
Level 2 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,573,063 | 9,343,667 |
Level 3 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) - Schedule of inventories consist of raw materials - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Inventories Consist of Raw Materials [Abstract] | ||
Finished goods | $ 3,008 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Details) - Schedule of property and equipment | 12 Months Ended |
Dec. 31, 2022 | |
Office Equipment and Furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years or remaining term of the lease |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Computer Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Details) - Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 10,110,769 | 8,863,517 |
Series C non-voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 4,000 | 4,000 |
Series E voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 391,953 | 391,953 |
Series G non-voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 5,004,069 | 5,004,069 |
Shares issuable for payment of deferred board compensation [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 48,909 | 48,909 |
Shares underlying outstanding warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 56,455 | |
Shares underlying outstanding stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 4,454,369 | 3,358,131 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 207,469 |
Geographic Information (Details
Geographic Information (Details) - Schedule of geographic information - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Geographic Information [Abstract] | ||
Reported revenues | $ 65,408 | $ 190,936 |
Revenues attributable to European and Mideast operations, which are based in Germany | 65,408 | 190,936 |
Total assets | 62,038,259 | 68,945,576 |
Total assets located in the United States, with the remainder in the European Union | $ 61,740,478 | $ 68,558,413 |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of accrued expenses - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Accrued Expenses [Abstract] | ||
Professional and consulting fees | $ 514,354 | $ 311,408 |
Accrued payroll and payroll taxes | 2,180,581 | 2,508,398 |
Manufacturing development related | 1,214,550 | 99,614 |
Other | 64,456 | 94,736 |
Total | $ 3,973,941 | $ 3,014,156 |
Related Party Transactions (Det
Related Party Transactions (Details) | Feb. 28, 2021 shares |
Related Party Transactions (Details) [Line Items] | |
Aggregate shares of common stock | 556,069 |
Series G Preferred Shares [Member] | |
Related Party Transactions (Details) [Line Items] | |
Converted an aggregate of preferred shares | 10,001 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Net operating loss deduction | 80% | ||
Net proceeds | $ 586,000 | $ 1,250,000 | |
NOL tax benefits sold | 626,000 | $ 1,337,000 | |
Available NOL tax benefits | $ 626,000 | $ 1,337,000 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of U.S. and foreign loss before income taxes - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes (Details) - Schedule of U.S. and foreign loss before income taxes [Line Items] | ||
Loss before income taxes | $ (30,287,322) | $ (29,460,412) |
United States [Member] | ||
Income Taxes (Details) - Schedule of U.S. and foreign loss before income taxes [Line Items] | ||
Loss before income taxes | (29,973,763) | (29,031,585) |
Foreign [Member] | ||
Income Taxes (Details) - Schedule of U.S. and foreign loss before income taxes [Line Items] | ||
Loss before income taxes | $ (313,559) | $ (428,827) |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of deferred tax assets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards – Federal | $ 47,683,000 | $ 44,085,000 |
Net operating loss carryforwards – State | 1,592,000 | 3,717,000 |
Net operating loss carryforwards – Foreign | 10,000 | 5,000 |
Capitalized licensing fees | 304,000 | 449,000 |
Stock-based compensation | 5,270,000 | 4,430,000 |
Accrued compensation | 172,000 | 320,000 |
Section 174 capitalization | 2,702,000 | |
Other | 28,000 | (17,000) |
Totals | 57,761,000 | 52,989,000 |
Less valuation allowance | (57,761,000) | (52,989,000) |
Deferred tax assets |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Federal [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | $ 227,068,000 | $ 209,930,000 |
State [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | 22,389,000 | 52,280,000 |
Foreign [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | $ 38,000 | $ 20,000 |
Income Taxes (Details) - Sche_4
Income Taxes (Details) - Schedule of effective tax rate varied from the statutory rate | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Effective Tax Rate Varied from the Statutory Rate [Abstract] | ||
Statutory federal tax rate | 21% | 21% |
State income tax rate (net of federal) | (4.30%) | 3.50% |
Change in foreign NOL | (0.20%) | (8.30%) |
NJ NOL adjustment | 1.90% | 4.20% |
Other permanent differences | (0.80%) | (0.90%) |
Effect of valuation allowance | (15.70%) | (15.30%) |
Effective tax rate | 1.90% | 4.20% |
Income Taxes (Details) - Sche_5
Income Taxes (Details) - Schedule of deferred tax asset valuation allowance - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Deferred Tax Asset Valuation Allowance [Abstract] | ||
Deferred tax asset valuation allowance, beginning | $ 52,989,000 | $ 48,480,000 |
Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) | 4,805,000 | 4,541,000 |
Increase (Decrease) Charged (Credited) to OCI | (32,000) | (32,000) |
Deferred tax asset valuation allowance, ending | $ 57,762,000 | $ 52,989,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 1 Months Ended | 12 Months Ended | ||||||
Feb. 08, 2023 USD ($) | Aug. 12, 2021 USD ($) | Dec. 31, 2008 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2014 shares | Feb. 08, 2023 EUR (€) | |
Commitments and Contingencies (Details) [Line Items] | ||||||||
Reimbursement costs | $ 30,000 | |||||||
Reimburse costs | $ 41,000 | |||||||
Aggregate deposit amount | 124,000 | |||||||
Aggregate amount | $ 50,000,000 | |||||||
Aggregate deposit amount | $ 75,000 | |||||||
Amount of initial licensing fee | $ 325,000 | |||||||
Shares of common stock (in Shares) | shares | 7,996 | |||||||
Number of shares issuable (in Shares) | shares | 29,109 | |||||||
Number of shares released in escrow (in Shares) | shares | 7,277 | |||||||
Number of share held In escrow of common stock (in Shares) | shares | 21,832 | |||||||
Maximum aggregate amount of cash payments due upon achievement of milestones | $ 3,000,000 | |||||||
Balance of cash payments due upon achievement of milestones | $ 2,500,000 | $ 2,500,000 | ||||||
NDP [Member] | ||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||
Equity interest percentage | 5% | |||||||
Subsequent Event [Member] | ||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||
Cash amount (in Euro) | € | € 10,000 | |||||||
Aggregate amount | $ 49,000 | |||||||
Euro Member Countries, Euro | Subsequent Event [Member] | ||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||
Cash amount (in Euro) | € | € 36,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 12 Months Ended | ||||
May 10, 2022 | Aug. 12, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 13, 2022 | |
Stockholders' Equity (Details) [Line Items] | |||||
Aggregate amount (in Dollars) | $ 50,000,000 | ||||
Gross proceeds percentage | 3% | ||||
Available amount (in Dollars) | $ 31,600,000 | ||||
Common Stock, Shares, Issued | 42,815,196 | 38,086,437 | |||
Common stock cashless exercise | 70,269 | ||||
Net proceeds (in Dollars) | $ 129,000 | $ 165,000 | |||
Restricted stock units | 207,469 | ||||
Weighted average grant date fair value per share (in Dollars per share) | $ 3.38 | ||||
Weighted average period term | 1 year 4 months 24 days | ||||
Preferred stock, shares authorized | 2,000,000 | 2,000,000 | |||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 | |||
Conversion of preferred shares, description | During the year ended December 31, 2021, 50,000 Series C-3 preferred shares were converted into 100,000 shares of the Company’s common stock by an unrelated party and 10,001 Series G preferred shares were converted into 556,069 shares of the Company’s common stock by a related party. | ||||
Common stock per share price (in Dollars per share) | $ 5 | ||||
Common stock, Percentage | 9.99% | ||||
Payment equal (in Dollars per share) | $ 10 | ||||
Voting convertible preferred stock, Description | Each share of Series E preferred stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided in the certificates of designation for the Series E preferred stock) at a per share price of $3.75 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series E preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99% of the total number of shares of our common stock then issued and outstanding. | ||||
Aggregate principal amount (in Dollars) | $ 10,000,000 | ||||
Letters of credit outstanding (in Dollars) | $ 5,000,000 | ||||
Weighted average exercise price (in Dollars per share) | $ 6.21 | $ 7.53 | |||
Expected dividend yield | 0% | 0% | |||
Net proceeds (in Dollars) | $ 586,000 | $ 1,250,000 | |||
Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Shelf registration, description | In November 2020, the Company filed a shelf registration statement, (the “2020 Shelf Registration”), under which the Company could issue and sell up to an aggregate of $100,000,000 of shares of its common stock, $0.001 par value per share. On November 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (the “Amended Sales Agreement”) with FBR Securities, Inc. (formerly known as B. Riley FBR Inc.) and Needham & Company, LLC as sales agents. The Amended Sales Agreement relates to the sale of shares of up to $50,000,000 of its common stock under its at-the-market program (the “ATM program”), of which the Company may issue and sell common stock from time to time through the sales agents, subject to limitations imposed by the Company and subject to the sales agents’ acceptance, such as the number or dollar amount of shares registered under the 2020 Shelf Registration to which the offering relates. Sales agents are entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the year ended December 31, 2021, the ATM program under the Amended Sales Agreement had been fully sold. | ||||
Common Stock, Shares, Issued | 150,000,000 | ||||
Shares of common stock | 4,704,259 | 3,737,862 | |||
Net proceeds (in Dollars) | $ 137,000 | ||||
Common stock cashless exercise | 70,269 | ||||
Warrants shares | 95,286 | ||||
Stock options | 32,734 | ||||
Shares of common stock | 24,500 | 31,407 | |||
Warrant [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Common stock cashless exercise | 24,500 | 31,407 | |||
Warrants shares | 95,286 | ||||
Net proceeds (in Dollars) | $ 129,000 | $ 165,000 | |||
Preferred Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Preferred stock, shares authorized | 2,000,000 | ||||
Preferred stock, par value (in Dollars per share) | $ 0.001 | ||||
Stock Options [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Weighted average period term | 1 year 6 months | ||||
Aggregate of shares | 1,627,850 | 1,664,700 | |||
Weighted average exercise price (in Dollars per share) | $ 3.83 | $ 7.98 | |||
Total compensation expense (in Dollars) | $ 3,843,000 | $ 5,043,000 | |||
Total unrecognized compensation expense (in Dollars) | $ 4,985,000 | ||||
Expected dividend yield | 0% | ||||
Employees [Member] | Stock Options [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Expected term | 5 years | ||||
Non-employees [Member] | Stock Options [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Expected term | 10 years | ||||
Stock Options [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Additional shares | 4,800,000 | ||||
Series C-3 preferred shares [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Common stock cashless exercise | 656,069 | ||||
Series C-3 preferred shares [Member] | Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Conversion of shares | 50,000 | ||||
Series G Preferred Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Preferred stock, par value (in Dollars per share) | $ 187.36452 | ||||
Voting convertible preferred stock, Description | Each share of Series G preferred stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment as provided in the certificate of designation for the Series G preferred stock) at a per share price of $3.37 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series G preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99% of the total number of shares of our common stock then issued and outstanding. | ||||
Conversion price (in Dollars per share) | $ 7.93 | ||||
Aggregate principal amount (in Dollars) | $ 10,000,000 | ||||
Letters of credit outstanding (in Dollars) | $ 5,000,000 | ||||
Series G Preferred Stock [Member] | Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Preferred shares related party | 10,001 | ||||
Series E Preferred Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Preferred stock, par value (in Dollars per share) | $ 49.2 | ||||
Conversion price (in Dollars per share) | $ 7.93 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Compensation expenses (in Dollars) | $ 226,000 | ||||
Unrecognized compensation expense (in Dollars) | 475,000 | ||||
ATM program [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Net proceeds (in Dollars) | $ 17,770,000 | $ 41,456,000 | |||
First Anniversary [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
RSUs vested percentage | 50% | ||||
Second Anniversary [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
RSUs vested percentage | 30% | ||||
Third Anniversary [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
RSUs vested percentage | 20% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of preferred stock - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 181,622 | 181,622 |
Total Liquidation Preference | $ 21,291,665 | |
Series C-3 [Member] | ||
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 2,000 | |
Liquidation Preference (Per Share) | $ 10 | |
Total Liquidation Preference | $ 20,000 | |
Series E [Member] | ||
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 89,623 | |
Liquidation Preference (Per Share) | $ 49.2 | |
Total Liquidation Preference | $ 4,409,452 | |
Series G [Member] | ||
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 89,999 | |
Liquidation Preference (Per Share) | $ 187.36 | |
Total Liquidation Preference | $ 16,862,213 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of fair value assumptions - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity (Details) - Schedule of fair value assumptions [Line Items] | ||
Expected dividend yield | 0% | 0% |
Weighted-average grant date fair value of options granted during the period (in Dollars per share) | $ 2.9 | $ 5.56 |
Minimum [Member] | ||
Stockholders' Equity (Details) - Schedule of fair value assumptions [Line Items] | ||
Risk-free interest rate | 1.76% | 0.50% |
Expected volatility | 89.68% | 102.93% |
Expected term (years) | 2 years 9 months | 1 year 11 months 19 days |
Maximum [Member] | ||
Stockholders' Equity (Details) - Schedule of fair value assumptions [Line Items] | ||
Risk-free interest rate | 4.31% | 1.26% |
Expected volatility | 107.20% | 107.10% |
Expected term (years) | 5 years | 5 years |
Stockholders' Equity (Details_3
Stockholders' Equity (Details) - Schedule of fair value of each stock option award estimated | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Schedule of fair value of each stock option award estimated [Abstract] | |
Shares Underlying Stock Options, Beginning Balance | shares | 3,358,131 |
Weighted- Average Exercise Price, Beginning Balance | $ / shares | $ 7.53 |
Weighted- Average Remaining Contractual Term (Years) | 6 years 9 months 18 days |
Aggregate Intrinsic Value, Beginning Balance | $ | $ 337,075 |
Shares Underlying Stock Options, Granted | shares | 1,627,850 |
Weighted- Average Exercise Price, Granted | $ / shares | $ 3.83 |
Aggregate Intrinsic Value, Granted | $ | $ 793,792 |
Shares Underlying Stock Options, Exercised | shares | |
Weighted- Average Exercise Price, Exercised | $ / shares | |
Aggregate Intrinsic Value, Exercised | $ | |
Shares Underlying Stock Options, Expired/Canceled | shares | (60,053) |
Weighted- Average Exercise Price, Expired/Canceled | $ / shares | $ 8 |
Aggregate Intrinsic Value, Expired/Canceled | $ | $ 4,968 |
Shares Underlying Stock Options, Forfeited | shares | (471,559) |
Weighted- Average Exercise Price, Forfeited | $ / shares | $ 7.16 |
Aggregate Intrinsic Value, Forfeited | $ | $ 12,849 |
Shares Underlying Stock Options, Ending Balance | shares | 4,454,369 |
Weighted- Average Exercise Price, Ending Balance | $ / shares | $ 6.21 |
Weighted- Average Remaining Contractual Term (Years) | 6 years 7 months 6 days |
Aggregate Intrinsic Value, Ending Balance | $ | $ 1,113,050 |
Shares Underlying Stock Options, Vested | shares | 2,638,516 |
Weighted- Average Exercise Price, Vested | $ / shares | $ 7.26 |
Weighted- Average Remaining Contractual Term (Years), Vested | 5 years |
Aggregate Intrinsic Value, Vested | $ | $ 366,528 |
Shares Underlying Stock Options, Expected to vest in the future | shares | 1,815,853 |
Weighted- Average Exercise Price, Expected to vest in the future | $ / shares | $ 4.69 |
Weighted- Average Remaining Contractual Term (Years), Expected to vest in the future | 8 years 10 months 24 days |
Aggregate Intrinsic Value, Expected to vest in the future | $ | $ 746,522 |
Stockholders' Equity (Details_4
Stockholders' Equity (Details) - Schedule of warrant activities | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Schedule of preferred stock [Abstract] | |
Number of Shares Underlying Warrants, Beginning | shares | 56,455 |
Weighted Average Exercise Price, Beginning | $ / shares | $ 5.25 |
Weighted Average Remaining Contractual Life, Beginning | 7 months 9 days |
Number of Shares Underlying Warrants, Exercised | shares | (24,500) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 5.25 |
Weighted Average Remaining Contractual Life | |
Number of Shares Underlying Warrants, Expired | shares | (31,955) |
Weighted Average Exercise Price, Expired | $ / shares | $ 5.25 |
Weighted Average Remaining Contractual Life, Expired | |
Number of Shares Underlying Warrants, Ending | shares | |
Weighted Average Exercise Price, Ending | $ / shares | |
Weighted Average Remaining Contractual Life, Ending |
Concentrations (Details)
Concentrations (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Concentrations (Details) [Line Items] | ||
Net accounts receivable from customers | 10% | |
Revenue Benchmark [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk percentage | 10% | 10% |
Customers One [Member] | ||
Concentrations (Details) [Line Items] | ||
Net accounts receivable from customers | 100% | |
Customers One [Member] | Revenue Benchmark [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 55% | 60% |
Customers Two [Member] | Revenue Benchmark [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 29% | 14% |
Customers Three [Member] | Revenue Benchmark [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 10% |
Leases (Details)
Leases (Details) | 1 Months Ended | 12 Months Ended | ||
Sep. 16, 2020 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2022 EUR (€) | |
Leases [Abstract] | ||||
Operating lease agreement, description | 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. | |||
Payments for leasing costs | $ 17,000 | |||
Rental agreement expense (in Euro) | € | € 400 | |||
Operating lease expense | $ 208,000 | $ 209,000 | ||
Operating lease liability | 803,000 | 924,000 | ||
Operating lease liabilities, net of current portion | 135,000 | 668,000 | ||
Operating lease ROU assets | 775,000 | 900,000 | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 199,000 | $ 195,000 | ||
Weighted average remaining, description | As of December 31, 2022 and 2021, the weighted average remaining lease term were 4.8 years and 5.8 years, respectively and the weighted average discount rate of 9% and 9% at December 31, 2022 and 2021, respectively. |
Leases (Details) - Schedule of
Leases (Details) - Schedule of maturities of lease liabilities | Dec. 31, 2022 USD ($) |
Schedule of Maturities of Lease Liabilities [Abstract] | |
2023 | $ 202,000 |
2024 | 205,000 |
2025 | 208,000 |
2026 and thereafter | 380,000 |
Total future minimum lease payments | 995,000 |
Less imputed interest | (192,000) |
Total | $ 803,000 |
Subsequent Events (Details)
Subsequent Events (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
ATM program description | Through March 30, 2023, the Company sold an aggregate of 1,684,592 shares of its common stock under the ATM program (see Note 9) and realized net proceeds of approximately $7,200,000. As of the filing of this Annual Report on Form 10-K, the Company has $24,200,000 available balance under its ATM program and it has $150,000,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities. |