Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Document Information Line Items | ||
Entity Registrant Name | CORMEDIX INC. | |
Trading Symbol | CRMD | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 54,812,042 | |
Amendment Flag | false | |
Entity Central Index Key | 0001410098 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly 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, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Current assets | ||
Cash and cash equivalents | $ 53,313,811 | $ 43,148,323 |
Restricted cash | 84,546 | 124,102 |
Short-term investments | 33,273,259 | 15,644,062 |
Prepaid research and development expenses | 1,255,105 | 11,016 |
Other prepaid expenses and current assets | 1,135,656 | 623,672 |
Total current assets | 89,062,377 | 59,551,175 |
Property and equipment, net | 1,588,963 | 1,609,679 |
Restricted cash, long-term | 102,664 | 102,320 |
Operating lease right-of-use assets | 675,116 | 775,085 |
TOTAL ASSETS | 91,429,120 | 62,038,259 |
Current liabilities | ||
Accounts payable | 2,386,108 | 2,202,149 |
Accrued expenses | 5,138,243 | 3,973,941 |
Current portion of operating lease liabilities | 146,531 | 134,801 |
Total current liabilities | 7,670,882 | 6,310,891 |
Operating lease liabilities, net of current portion | 556,416 | 667,632 |
TOTAL LIABILITIES | 8,227,298 | 6,978,523 |
COMMITMENTS AND CONTINGENCIES (Note 4) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at September 30, 2023 and December 31, 2022 | 182 | 182 |
Common stock - $0.001 par value: 160,000,000 shares authorized; 54,812,042 and 42,815,196 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 54,813 | 42,815 |
Accumulated other comprehensive gain | 84,399 | 82,743 |
Additional paid-in capital | 390,008,412 | 330,294,782 |
Accumulated deficit | (306,945,984) | (275,360,786) |
TOTAL STOCKHOLDERS’ EQUITY | 83,201,822 | 55,059,736 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 91,429,120 | $ 62,038,259 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 181,622 | 181,622 |
Preferred stock, shares outstanding | 181,622 | 181,622 |
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 160,000,000 | 160,000,000 |
Common stock, shares issued | 54,812,042 | 42,815,196 |
Common stock, shares outstanding | 54,812,042 | 42,815,196 |
Condensed consolidated statemen
Condensed consolidated statements of operations and comprehensive loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Net sales | $ 6,817 | $ 35,706 | ||
Cost of sales | (1,469) | (3,328) | ||
Gross profit | 5,348 | 32,378 | ||
Operating Expenses: | ||||
Research and development | (2,663,976) | (2,339,268) | (10,866,236) | (7,836,327) |
Selling, general and administrative | (7,803,307) | (4,628,014) | (22,422,808) | (14,430,791) |
Total Operating Expenses | (10,467,283) | (6,967,282) | (33,289,044) | (22,267,118) |
Loss From Operations | (10,467,283) | (6,961,934) | (33,289,044) | (22,234,740) |
Other Income (Expense): | ||||
Interest income | 765,241 | 93,417 | 1,761,808 | 142,511 |
Foreign exchange transaction (loss) gain | (29,199) | 23,572 | (30,222) | 31,598 |
Interest expense | (13,113) | (8,776) | (27,740) | (17,740) |
Total Other Income | 722,929 | 108,213 | 1,703,846 | 156,369 |
Loss before income taxes | (9,744,354) | (6,853,721) | (31,585,198) | (22,078,371) |
Tax benefit | 585,617 | |||
Net Loss | (9,744,354) | (6,853,721) | (31,585,198) | (21,492,754) |
Other Comprehensive Income (Loss): | ||||
Unrealized (loss) income from investments | (4,571) | 15,811 | 1,090 | (19,677) |
Foreign currency translation (loss) gain | (1,727) | (9,558) | 566 | (21,681) |
Total Other Comprehensive (Loss) Income | (6,298) | 6,253 | 1,656 | (41,358) |
Comprehensive Loss | $ (9,750,652) | $ (6,847,468) | $ (31,583,542) | $ (21,534,112) |
Net Loss Per Common Share – Basic (in Dollars per share) | $ (0.17) | $ (0.17) | $ (0.65) | $ (0.54) |
Weighted Average Common Shares Outstanding – Basic (in Shares) | 56,553,174 | 41,183,585 | 48,715,585 | 39,741,555 |
Condensed consolidated statem_2
Condensed consolidated statements of operations and comprehensive loss (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net Loss Per Common Share – Diluted (in Dollars per share) | $ (0.17) | $ (0.17) | $ (0.65) | $ (0.54) |
Weighted Average Common Shares Outstanding – Diluted | 56,553,174 | 41,183,585 | 48,715,585 | 39,741,555 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) | Common Stock | Preferred Stock– Series C-3, Series E and Series G | Accumulated Other Comprehensive Income (Loss) | Additional Paid-in Capital | Accumulated Deficit | Total |
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 | $ 3,098 | 11,720,939 | 11,724,037 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 3,097,273 | |||||
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 | 3,195,469 | 3,195,469 | ||||
Other comprehensive gain (loss) | (41,358) | (41,358) | ||||
Net loss | (21,492,754) | (21,492,754) | ||||
Balance at Sep. 30, 2022 | $ 41,208 | $ 182 | 45,772 | 323,376,759 | (267,151,835) | 56,312,086 |
Balance (in Shares) at Sep. 30, 2022 | 41,208,210 | 181,622 | ||||
Balance at Jun. 30, 2022 | $ 41,107 | $ 182 | 39,519 | 321,956,046 | (260,298,114) | 61,738,740 |
Balance (in Shares) at Jun. 30, 2022 | 41,106,777 | 181,622 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 77 | 308,588 | 308,665 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 76,933 | |||||
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 | 983,524 | 983,524 | ||||
Other comprehensive gain (loss) | 6,253 | 6,253 | ||||
Net loss | (6,853,721) | (6,853,721) | ||||
Balance at Sep. 30, 2022 | $ 41,208 | $ 182 | 45,772 | 323,376,759 | (267,151,835) | 56,312,086 |
Balance (in Shares) at Sep. 30, 2022 | 41,208,210 | 181,622 | ||||
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 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 2,867 | 12,512,342 | 12,515,209 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 2,866,421 | |||||
Stock and pre-funded warrants issued in connection with public offering, net | $ 9,000 | 42,869,399 | 42,878,399 | |||
Stock and pre-funded warrants issued in connection with public offering, net (in Shares) | 9,000,093 | |||||
Stock issued in connection with options exercised | $ 64 | 253,924 | 253,988 | |||
Stock issued in connection with options exercised (in Shares) | 64,041 | |||||
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | $ 67 | (198,509) | (198,442) | |||
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes (in Shares) | 66,291 | |||||
Stock-based compensation | 4,276,474 | 4,276,474 | ||||
Other comprehensive gain (loss) | 1,656 | 1,656 | ||||
Net loss | (31,585,198) | (31,585,198) | ||||
Balance at Sep. 30, 2023 | $ 54,813 | $ 182 | 84,399 | 390,008,412 | (306,945,984) | 83,201,822 |
Balance (in Shares) at Sep. 30, 2023 | 54,812,042 | 181,622 | ||||
Balance at Jun. 30, 2023 | $ 45,806 | $ 182 | 90,697 | 346,116,054 | (297,201,630) | 49,051,109 |
Balance (in Shares) at Jun. 30, 2023 | 45,805,283 | 181,622 | ||||
Stock and pre-funded warrants issued in connection with public offering, net | $ 9,000 | 42,869,399 | 42,878,399 | |||
Stock and pre-funded warrants issued in connection with public offering, net (in Shares) | 9,000,093 | |||||
Stock issued in connection with options exercised | $ 7 | 20,125 | 20,132 | |||
Stock issued in connection with options exercised (in Shares) | 6,666 | |||||
Stock-based compensation | 1,002,834 | 1,002,834 | ||||
Other comprehensive gain (loss) | (6,298) | (6,298) | ||||
Net loss | (9,744,354) | (9,744,354) | ||||
Balance at Sep. 30, 2023 | $ 54,813 | $ 182 | $ 84,399 | $ 390,008,412 | $ (306,945,984) | $ 83,201,822 |
Balance (in Shares) at Sep. 30, 2023 | 54,812,042 | 181,622 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (31,585,198) | $ (21,492,754) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,276,474 | 3,195,469 |
Change in right-of-use assets | 99,970 | 92,559 |
Depreciation | 52,085 | 62,102 |
Changes in operating assets and liabilities: | ||
Decrease in trade receivables | 42,583 | |
Decrease in inventory | 2,739 | |
(Increase) Decrease in prepaid expenses and other current assets | (1,756,105) | 271,932 |
Increase (Decrease) in accounts payable | 183,903 | (441,319) |
Increase in accrued expenses | 1,164,571 | 154,588 |
Decrease in operating lease liabilities | (99,486) | (89,792) |
Net cash used in operating activities | (27,663,786) | (18,201,893) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term investments | (60,978,108) | (22,366,898) |
Maturity of short-term investments | 43,350,000 | 18,750,000 |
Purchase of equipment | (31,369) | (90,605) |
Net cash used in investing activities | (17,659,477) | (3,707,503) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock from at-the-market program, net | 12,515,209 | 11,724,037 |
Payment of employee withholding taxes on vested restricted stock units | (198,442) | |
Proceeds from public offering of common stock and pre-funded warrants, net | 42,878,399 | |
Proceeds from exercise of warrants | 128,625 | |
Proceeds from exercise of stock options | 253,988 | |
Net cash provided by financing activities | 55,449,154 | 11,852,662 |
Foreign exchange effect on cash | 385 | (24,464) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 10,126,276 | (10,081,198) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF PERIOD | 43,374,745 | 53,551,277 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH – END OF PERIOD | 53,501,021 | 43,470,079 |
Cash paid for interest | 27,739 | 17,740 |
Supplemental Disclosure of Non-Cash Investing Activities: | ||
Unrealized loss from investments | $ (1,090) | $ (19,677) |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
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”) is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions. The Company was incorporated in the State of Delaware on July 28, 2006 and its principal executive office is located in Berkeley Heights, New Jersey. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH and in 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U. The Company’s primary focus is the development of its lead product candidate, DefenCath ® ® Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions for Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2023 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 30, 2023. The accompanying consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements included in such Annual Report on Form 10-K. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 — Summary of Significant Accounting Policies: Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current development plans and potential commercial launch plans for DefenCath in the U.S. and its other operating requirements, the Company’s existing cash and cash equivalents, short-term investments and available resources at September 30, 2023, are expected to fund its operations for at least twelve months from the filing date of this Quarterly Report on Form 10-Q. The Company’s continued operations may 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 New Drug Application, or 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 September 30, 2023, the Company has $18,700,000 available under its At-the-Market Issuance Sales Agreement (the “ATM program”) and has $104,000,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities. 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; the ability to manufacture its products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to obtain favorable, or any reimbursement for the Company’s products from third party payors; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise enough capital to support its operations. Use of Estimates The preparation of condensed consolidated 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 condensed 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 condensed consolidated statement of cash flows: September 30, 2023 2022 Cash and cash equivalents $ 53,313,811 $ 43,254,116 Restricted cash 187,210 215,963 Total cash, cash equivalents and restricted cash $ 53,501,021 $ 43,470,079 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt classified as available-for-sale and equity securities are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in the condensed consolidated statement of operations. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other 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 September 30, 2023 or December 31, 2022. 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 September 30, 2023 and December 31, 2022, all of the Company’s investments had contractual maturities of less than one year. As of September 30, 2023, no allowance for credit loss was recorded. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2023 and December 31, 2022: Amortized Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2023: Money Market Funds included in Cash Equivalents $ 6,057,189 $ - $ - $ 6,057,189 U.S. Government Agency Securities 29,920,029 (430 ) 1,700 29,921,299 Commercial Paper 3,352,743 (783 ) - 3,351,960 Subtotal 33,272,772 (1,213 ) 1,700 33,273,259 Total September 30, 2023 $ 39,329,961 $ (1,213 ) $ 1,700 $ 39,330,448 December 31, 2022: Money Market Funds included in 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 Fair Value Measurements The Company’s financial instruments recorded in the condensed consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. 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. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs—Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022: Carrying Value Level 1 Level 2 Level 3 September 30, 2023: Money Market Funds and Cash Equivalents $ 6,057,189 $ 6,057,189 $ - $ - U.S. Government Agency Securities 29,921,299 29,921,299 - Commercial Paper 3,351,960 - 3,351,960 - Subtotal 33,273,259 29,921,299 3,351,960 $ - Total September 30, 2023 $ 39,330,448 $ 35,978,488 $ 3,351,960 $ - December 31, 2022: 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 $ - Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use, or ROU, assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. Loss Per Common Share Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Nine Months Ended 2023 2022 (Number of Shares of Common Stock Issuable) Series C non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 5,876,007 4,562,322 Shares underlying restricted stock units 103,735 207,469 Total potentially dilutive shares 11,428,673 10,218,722 Stock-Based Compensation Stock-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, stock-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, facilities expenses and costs related to the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval. The Company accrues for costs incurred as the services are being provided by monitoring the status of the activities and the invoices received from its external service providers. 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. Recently Issued Authoritative Pronouncements In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06, “ Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 3 — Accrued Expenses: Accrued Expenses Accrued expenses consist of the following: September 30, December 31, Professional and consulting fees $ 1,256,820 $ 514,354 Accrued payroll and payroll taxes 2,914,962 2,180,581 Manufacturing development related 911,698 1,214,550 Other 54,763 64,456 Total $ 5,138,243 $ 3,973,941 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 4 — Commitments and Contingencies: Contingency Matters In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.) On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933, as amended, or the Securities Act. 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. In re CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.) On or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, 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. On or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al. On or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al. On or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation Voter Demand Letter On or about June 23, 2022, the Company’s Board received a letter demanding it investigate and pursue causes of action, purportedly on behalf of Company, against certain current and former directors, officers, and/or other employees of the Company (the “Letter”), which the Board believes are duplicative of the claims already asserted in the Derivative Litigation. As set forth in the Board’s response to the Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress of the Derivative Litigation. Patent Infringement 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 Company sought injunctive relief and raised claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm 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 LLP’s 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 as it 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 German PTO declared that the Utility Model was invalid. The Company filed an appeal against the ruling on September 7, 2016. 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 that the Prosl European Patent would be invalidated. 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 order to avoid a dismissal, on January 12, 2023, the Company withdrew the infringement action with prejudice. Due to the withdrawal, there will be no decision on the merits, however, on March 9, 2023, the Court issued 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. The aggregate amount of security deposits made by the Company for such proceedings was 116,000 EUR (approximately $123,000). 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), was refunded to the Company. As of September 30, 2023, the aggregate remaining security deposit, including the 10,000 EUR that was received on October 16, 2023, was approximately 80,000 EUR (approximately $85,000), which the Company recorded as restricted cash on the consolidated balance sheets. To summarize, one of the infringement proceedings initiated on September 9, 2014 before the District Court of Mannheim, has been terminated after the Company’s withdrawal of the action; the parallel validity proceedings before the German Federal Patent Court are also terminated. The other infringement proceeding initiated on September 9, 2014 before the District Court of Mannheim is in its final stages; the parallel validity proceeding before the European Patent Office is also terminated. After the Company withdrew the infringement action and TauroPharm consented to the withdrawal, there is no decision on the merits, but the Court issued a decision that the Company has to bear the costs of the proceedings. The Defendants requested the Court to determine the amount of the cost to be paid by the Company at 46,000 EUR (approximately $49,000), of which 38,000 EUR (approximately $40,000) has been accrued. The Company’s outside counsel filed a submission arguing that the amount of the cost to be paid by the Company amounts to 38,000 EUR, and not 46,000 EUR, and on September 26, 2023, the Court decided the amount of such cost to be reimbursed to the Defendants by the Company is approximately 38,000 EUR plus interest. A complaint filed on January 16, 2015 against TauroPharm in the District Court of Cologne has also been withdrawn by the Company and the proceedings were closed. In connection with the aforementioned proceedings, the Company was required to provide security deposits to the District Courts of Mannheim and Cologne in the aggregate amount of 116,000 EUR (approximately $123,000) of which 36,000 EUR (approximately $38,000) was received in April 2023 and 10,000 EUR (approximately $11,000) was received on October 16, 2023. 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 September 30, 2023 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 September 30, 2023 and December 31, 2022. 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 nine months ended September 30, 2023 and 2022. 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 | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders Equity [Abstract] | |
Stockholders' Equity | Note 5 — 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. In November 2020, the Company allocated to its at-the-market program (“ATM program”), an aggregate of $50,000,000 out of the $100,000,000 total under the 2020 Shelf Registration, which has been fully sold. In August 2021, the Company entered into an at-the-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, which was the remaining balance under the 2020 Shelf Registration, 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 September 30, 2023, the Company has $18,700,000 available under its ATM program relating to its 2020 Shelf Registration. Also, in August 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 of which $104,400,000 is currently available for the issuance of equity, debt or equity-linked securities. On June 28, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets, LLC and Truist Securities, Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an aggregate of 7,500,000 shares of the Company’s common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 2,500,625 shares of common stock to the underwriters. Pursuant to the Underwriting Agreement, the Company also granted the underwriters a 30-day option to purchase up to 1,500,093 additional shares of common stock. The offering, pursuant to the 2021 Shelf Registration, closed on July 3, 2023. Upon closing, the Company issued and sold an aggregate of 7,500,000 shares of its common stock at a public offering price of $4.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its commons stock at a price of $3.999 per pre-funded warrant (see Pre-Funded Warrants below). The Company realized net proceeds of approximately $37,300,000 from the sale of its common stock and the pre-funded warrants. On July 26, 2023, the underwriters’ representatives fully exercised the option to purchase additional shares of the Company’s common stock, and on July 28, 2023, the Company issued and sold an aggregate of 1,500,093 shares of its common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions, and the Company realized net proceeds of approximately $5,600,000. During the nine months ended September 30, 2023, the Company sold an aggregate of 2,866,421 shares of its common stock under the ATM program and realized net proceeds of $12,500,000. The Company did not sell any shares of its common stock under its ATM program during the three months ended September 30, 2023. For the three and nine months ended September 30, 2022, the Company sold an aggregate of 76,933 and 3,097,273 shares of its common stock, respectively, and realized net proceeds of $300,000 and $11,700,000, respectively. Restricted Stock Units In May 2023, 103,734 restricted stock units (“RSUs”) vested pursuant to a grant made to the Company’s chief executive officer, of which 66,291 shares of common stock were issued by the Company and 37,443 shares were withheld in lieu of withholding taxes. As of September 30, 2023, the Company had 103,735 outstanding RSUs. The Company recorded $53,000 and $207,000 compensation expense for the three and nine months ended September 30, 2023, respectively, and $88,000 and $138,000 for the three and nine months ended September 30, 2022, respectively. Unrecognized compensation expense for these RSUs amounted to $268,000 and the expected weighted average period for the expense to be recognized is 1.13 years at September 30, 2023. 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 and designated by the Company’s board of directors, all with par value of $0.001 per share, the following were outstanding: As of September 30, 2023 and Preferred Liquidation (Per Share) Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665 Stock Options During the nine months ended September 30, 2023 and 2022, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 2,021,200 and 1,552,850 shares of the Company’s common stock under the Amended and Restated 2019 Omnibus Stock Incentive Plan, respectively. The weighted average exercise price of these options is $4.40 and $3.84 per share, respectively. During the three and nine months ended September 30, 2023, the Company issued 6,666 and 64,041 shares of common stock, respectively, as a result of the exercise of stock options. The Company realized net proceeds of $20,000 and $254,000 from the exercise of stock options for the three and nine months ended September 30, 2023, respectively. During the three and nine months ended September 30, 2023, total compensation expense for stock options issued to employees, directors, officers and consultants was $950,000 and $4,069,000, respectively, and $895,000 and $3,057,000 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, there was approximately $6,500,000 in total unrecognized compensation expense related to stock options granted, which expense will be recognized over an expected remaining weighted average period of 1.5 years. The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model. The following assumptions were used for the Black-Scholes option pricing model for the stock options granted during the nine months ended September 30, 2023: Expected term 5 years Volatility weighted average 104.98 % Dividend yield weighted average 0.0 % Risk-free interest rate weighted average 3.69 % Weighted average grant date fair value of options granted during the period $ 3.43 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, if any, is based upon the full term of the respective option agreements. The expected stock price volatility for the Company’s stock options is calculated based on the historical volatility of the Company’s common stock. 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. Pre-Funded Warrants On July 3, 2023, pursuant to the Underwriting Agreement, the Company’s issued pre-funded warrants to purchase 2,500,625 shares of its common stock to certain investors. The pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of the Company’s commons stock had a price of $3.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant pursuant to the Underwriting Agreement. The Company realized net proceeds of approximately $9,400,000 from the sale of the pre-funded warrants. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 6 — Leases: The Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000 commenced in September 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. Operating lease expense in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 was approximately $52,000 and $155,000, respectively, and $52,000 and $157,000 for the three and nine months ended September 30, 2022, respectively, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At September 30, 2023, the Company has a total operating lease liability of $703,000, of which $147,000 was classified as operating lease liabilities, short-term and $556,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. At December 31, 2022, the Company’s total operating lease liability was $803,000, of which $135,000 was classified as operating lease liabilities, short-term and $668,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating ROU assets as of September 30, 2023 and December 31, 2022 are $675,000 and $775,000, respectively. For each of the three and nine months ended September 30, 2023 and 2022, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $50,000 and $150,000, respectively. The weighted average remaining lease term as of September 30, 2023 and 2022 was 4.1 and 6.0 years, respectively, and the weighted average discount rate for operating leases was 9% at September 30, 2023 and 2022. As of September 30, 2023, maturities of lease liabilities were as follows: Remainder of 2023 $ 51,000 2024 205,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 844,000 Less imputed interest (141,000 ) Total $ 703,000 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Liquidity and Uncertainties | Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current development plans and potential commercial launch plans for DefenCath in the U.S. and its other operating requirements, the Company’s existing cash and cash equivalents, short-term investments and available resources at September 30, 2023, are expected to fund its operations for at least twelve months from the filing date of this Quarterly Report on Form 10-Q. The Company’s continued operations may 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 New Drug Application, or 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 September 30, 2023, the Company has $18,700,000 available under its At-the-Market Issuance Sales Agreement (the “ATM program”) and has $104,000,000 available under its current shelf registration for the issuance of equity, debt or equity-linked securities. 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; the ability to manufacture its products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to obtain favorable, or any reimbursement for the Company’s products from third party payors; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise enough capital to support its operations. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated 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 condensed 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 condensed consolidated statement of cash flows: September 30, 2023 2022 Cash and cash equivalents $ 53,313,811 $ 43,254,116 Restricted cash 187,210 215,963 Total cash, cash equivalents and restricted cash $ 53,501,021 $ 43,470,079 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt classified as available-for-sale and equity securities are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in the condensed consolidated statement of operations. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other 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 September 30, 2023 or December 31, 2022. 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 September 30, 2023 and December 31, 2022, all of the Company’s investments had contractual maturities of less than one year. As of September 30, 2023, no allowance for credit loss was recorded. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2023 and December 31, 2022: Amortized Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2023: Money Market Funds included in Cash Equivalents $ 6,057,189 $ - $ - $ 6,057,189 U.S. Government Agency Securities 29,920,029 (430 ) 1,700 29,921,299 Commercial Paper 3,352,743 (783 ) - 3,351,960 Subtotal 33,272,772 (1,213 ) 1,700 33,273,259 Total September 30, 2023 $ 39,329,961 $ (1,213 ) $ 1,700 $ 39,330,448 December 31, 2022: Money Market Funds included in 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 |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments recorded in the condensed consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. 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. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs—Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022: Carrying Value Level 1 Level 2 Level 3 September 30, 2023: Money Market Funds and Cash Equivalents $ 6,057,189 $ 6,057,189 $ - $ - U.S. Government Agency Securities 29,921,299 29,921,299 - Commercial Paper 3,351,960 - 3,351,960 - Subtotal 33,273,259 29,921,299 3,351,960 $ - Total September 30, 2023 $ 39,330,448 $ 35,978,488 $ 3,351,960 $ - December 31, 2022: 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 $ - |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use, or ROU, assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. |
Loss Per Common Share | Loss Per Common Share Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Nine Months Ended 2023 2022 (Number of Shares of Common Stock Issuable) Series C non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 5,876,007 4,562,322 Shares underlying restricted stock units 103,735 207,469 Total potentially dilutive shares 11,428,673 10,218,722 |
Stock-Based Compensation | Stock-Based Compensation Stock-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, stock-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, facilities expenses and costs related to the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval. The Company accrues for costs incurred as the services are being provided by monitoring the status of the activities and the invoices received from its external service providers. 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. |
Recently Issued Authoritative Pronouncements | Recently Issued Authoritative Pronouncements In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06, “ Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s condensed consolidated statement of cash flows: September 30, 2023 2022 Cash and cash equivalents $ 53,313,811 $ 43,254,116 Restricted cash 187,210 215,963 Total cash, cash equivalents and restricted cash $ 53,501,021 $ 43,470,079 |
Schedule of Marketable Securities | The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2023 and December 31, 2022 Amortized Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2023: Money Market Funds included in Cash Equivalents $ 6,057,189 $ - $ - $ 6,057,189 U.S. Government Agency Securities 29,920,029 (430 ) 1,700 29,921,299 Commercial Paper 3,352,743 (783 ) - 3,351,960 Subtotal 33,272,772 (1,213 ) 1,700 33,273,259 Total September 30, 2023 $ 39,329,961 $ (1,213 ) $ 1,700 $ 39,330,448 December 31, 2022: Money Market Funds included in 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 |
Schedule of Carrying and Fair Value of Financial Assets | The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022: Carrying Value Level 1 Level 2 Level 3 September 30, 2023: Money Market Funds and Cash Equivalents $ 6,057,189 $ 6,057,189 $ - $ - U.S. Government Agency Securities 29,921,299 29,921,299 - Commercial Paper 3,351,960 - 3,351,960 - Subtotal 33,273,259 29,921,299 3,351,960 $ - Total September 30, 2023 $ 39,330,448 $ 35,978,488 $ 3,351,960 $ - December 31, 2022: 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 $ - |
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Nine Months Ended 2023 2022 (Number of Shares of Common Stock Issuable) Series C non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 5,876,007 4,562,322 Shares underlying restricted stock units 103,735 207,469 Total potentially dilutive shares 11,428,673 10,218,722 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: September 30, December 31, Professional and consulting fees $ 1,256,820 $ 514,354 Accrued payroll and payroll taxes 2,914,962 2,180,581 Manufacturing development related 911,698 1,214,550 Other 54,763 64,456 Total $ 5,138,243 $ 3,973,941 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity (Tables) [Line Items] | |
Schedule of Preferred Stock | Company’s board of directors, all with par value of $0.001 per share, the following were outstanding: As of September 30, 2023 and Preferred Liquidation (Per Share) Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665 |
Black-Scholes Option [Member] | |
Stockholders' Equity (Tables) [Line Items] | |
Schedule of Fair Value Assumptions | The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model. The following assumptions were used for the Black-Scholes option pricing model for the stock options granted during the nine months ended September 30, 2023: Expected term 5 years Volatility weighted average 104.98 % Dividend yield weighted average 0.0 % Risk-free interest rate weighted average 3.69 % Weighted average grant date fair value of options granted during the period $ 3.43 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Maturities of Lease Liabilities | As of September 30, 2023, maturities of lease liabilities were as follows: Remainder of 2023 $ 51,000 2024 205,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 844,000 Less imputed interest (141,000 ) Total $ 703,000 |
Organization, Business and Ba_2
Organization, Business and Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Business and Basis of Presentation [Abstract] | |
Entity incorporation date | Jul. 28, 2006 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | |
Summary of Significant Accounting Policies [Abstract] | |
Market issuance sales agreement amount | $ 18,700,000 |
Equity debt | $ 104,400,000 |
Weighted average shares (in Shares) | shares | 2,500,625 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of Cash and Cash Equivalents - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Summary of Significant Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 53,313,811 | $ 43,148,323 | $ 43,254,116 |
Restricted cash | 187,210 | 215,963 | |
Total cash, cash equivalents and restricted cash | $ 53,501,021 | $ 43,470,079 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of Marketable Securities - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 39,329,961 | $ 22,956,564 |
Gross Unrealized Losses | (1,213) | (4,140) |
Gross Unrealized Gains | 1,700 | 3,537 |
Fair Value | 39,330,448 | 22,955,961 |
Money Market Funds included in Cash Equivalents [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 6,057,189 | 7,311,327 |
Gross Unrealized Losses | ||
Gross Unrealized Gains | 572 | |
Fair Value | 6,057,189 | 7,311,899 |
U.S. Government Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 29,920,029 | 12,072,127 |
Gross Unrealized Losses | (430) | (3,184) |
Gross Unrealized Gains | 1,700 | 2,056 |
Fair Value | 29,921,299 | 12,070,999 |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,352,743 | 888,875 |
Gross Unrealized Losses | (783) | (773) |
Gross Unrealized Gains | ||
Fair Value | 3,351,960 | 888,102 |
Subtotal [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 33,272,772 | 15,645,237 |
Gross Unrealized Losses | (1,213) | (4,140) |
Gross Unrealized Gains | 1,700 | 2,965 |
Fair Value | $ 33,273,259 | 15,644,062 |
Corporate Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,684,235 | |
Gross Unrealized Losses | (183) | |
Gross Unrealized Gains | 909 | |
Fair Value | $ 2,684,961 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets - Fair Value, Recurring [Member] - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | $ 39,330,448 | $ 22,955,961 |
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 | 6,057,189 | 7,311,899 |
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 | 29,921,299 | 12,070,999 |
Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 3,351,960 | 888,102 |
Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 33,273,259 | 15,644,062 |
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 | |
Level 1 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 35,978,488 | 19,382,898 |
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 | 6,057,189 | 7,311,899 |
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 | 29,921,299 | 12,070,999 |
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 | 29,921,299 | 12,070,999 |
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 2 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 3,351,960 | 3,573,063 |
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] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 3,351,960 | 888,102 |
Level 2 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of Carrying and Fair Value of Financial Assets [Line Items] | ||
Carrying Value | 3,351,960 | 3,573,063 |
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 | |
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] | 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 | ||
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 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) - Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 11,428,673 | 10,218,722 |
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 stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 5,876,007 | 4,562,322 |
Shares underlying restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 103,735 | 207,469 |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of Accrued Expenses - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Professional and consulting fees | $ 1,256,820 | $ 514,354 |
Accrued payroll and payroll taxes | 2,914,962 | 2,180,581 |
Manufacturing development related | 911,698 | 1,214,550 |
Other | 54,763 | 64,456 |
Total | $ 5,138,243 | $ 3,973,941 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
Oct. 16, 2023 USD ($) | Oct. 16, 2023 EUR (€) | Sep. 26, 2023 EUR (€) | Oct. 10, 2022 | Apr. 30, 2023 USD ($) | Apr. 30, 2023 EUR (€) | Sep. 30, 2023 USD ($) shares | Sep. 30, 2023 EUR (€) shares | Dec. 31, 2020 USD ($) | Dec. 31, 2014 shares | Sep. 30, 2023 EUR (€) | Feb. 08, 2023 USD ($) | Feb. 08, 2023 EUR (€) | Dec. 31, 2022 USD ($) | |
Commitments and Contingencies [Line Items] | ||||||||||||||
Number of legal actions filed | 2 | |||||||||||||
Security deposits to cover legal fees in the event of TauroPharm | € | € 116,000 | |||||||||||||
Security deposit received | € | € 10,000 | |||||||||||||
Restricted cash | $ 84,546 | € 80,000 | $ 124,102 | |||||||||||
Defendants settlements | 49,000 | € 46,000 | ||||||||||||
Accruals legal settlements | 40,000 | 38,000 | ||||||||||||
Legal Settlement arguing amount to be paid | € | 38,000 | |||||||||||||
Defendant requested the amount of the cost to be paid | € | € 46,000 | |||||||||||||
Court decided to reimbursed amount of the Defendant | € | € 38,000 | |||||||||||||
Refunded Security Deposit | $ 11,000 | € 10,000 | ||||||||||||
Amount of initial licensing fee | $ 325,000 | |||||||||||||
Shares of common stock | shares | 7,996 | 7,996 | ||||||||||||
Number of shares issuable | shares | 29,109 | 29,109 | ||||||||||||
Number of shares released in escrow | shares | 7,277 | |||||||||||||
Number of share held In escrow of common stock | shares | 21,832 | 21,832 | ||||||||||||
Maximum aggregate amount of cash payments | $ 3,000,000 | |||||||||||||
Balance of cash payments due upon achievement of milestones | $ 2,500,000 | |||||||||||||
NDP License Agreement | 60 days | 60 days | ||||||||||||
District Courts of Mannheim and Cologne [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Security deposits to cover legal fees in the event of TauroPharm | $ 123,000 | |||||||||||||
Refunded Security Deposit | $ 38,000 | € 36,000 | ||||||||||||
NDP [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Equity interest percentage | 5% | 5% | ||||||||||||
TauroPharm [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Patent Infringement were paid the Reimbursement cost | $ 30,000 | |||||||||||||
Reimbursed Approximate Cost | $ 41,000 | |||||||||||||
Security deposits to cover legal fees in the event of TauroPharm | 123,000 | € 116,000 | ||||||||||||
Approximately Security deposit | $ 49,000 | |||||||||||||
TauroPharm [Member] | 81 HL 448/15 [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Security deposit | € | € 36,000 | |||||||||||||
TauroPharm [Member] | 81 HL 903/19 [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Security deposit | € | € 10,000 | |||||||||||||
Patent Infringement [Member] | ||||||||||||||
Commitments and Contingencies [Line Items] | ||||||||||||||
Restricted cash | $ 85,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Jul. 28, 2023 | Jul. 03, 2023 | May 31, 2023 | Aug. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 28, 2023 | Dec. 31, 2022 | Nov. 30, 2020 | |
Stockholders' Equity [Line Items] | |||||||||||
Aggregate value | $ 54,813 | $ 54,813 | $ 42,815 | ||||||||
Public Offering Price (in Dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Available under its At-the-Market Issuance Sales Agreement | $ 18,700,000 | ||||||||||
Available for issuance of equity, debt or equity-linked securities | $ 104,400,000 | ||||||||||
Common stock shares issued (in Shares) | 1,500,093 | 7,500,000 | 54,812,042 | 54,812,042 | 42,815,196 | ||||||
Proceeds from issuance of common stock | $ 5,600,000 | $ 300,000 | $ 12,515,209 | $ 11,724,037 | |||||||
Sale of aggregate shares (in Shares) | 76,933 | 3,097,273 | |||||||||
Period of unrecognized compensation expense | 1 year 1 month 17 days | ||||||||||
Preferred stock, shares authorized (in Shares) | 2,000,000 | 2,000,000 | 2,000,000 | ||||||||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Proceeds from stock options | $ 20,000 | $ 253,988 | |||||||||
Total unrecognized compensation expense | $ 6,500,000 | $ 6,500,000 | |||||||||
Expected remaining weighted average period, term | 1 year 6 months | ||||||||||
Expected dividend yield, percentage | 0% | ||||||||||
Expected term | 5 years | ||||||||||
Shelf Registration 2020 [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Public Offering Price (in Dollars per share) | $ 0.001 | ||||||||||
Preferred Stock [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Preferred stock, shares authorized (in Shares) | 2,000,000 | 2,000,000 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in Shares) | |||||||||||
Common Stock [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in Shares) | 6,666 | 64,041 | |||||||||
Maximum [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Available for issuance of equity, debt or equity-linked securities | $ 150,000,000 | ||||||||||
Stok Option [Mrember] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Total compensation expense | $ 950,000 | $ 895,000 | $ 4,069,000 | $ 3,057,000 | |||||||
Weighted average exercise price (in Dollars per share) | $ 4.4 | $ 3.84 | $ 4.4 | $ 3.84 | |||||||
Proceeds from stock options | $ 254,000 | ||||||||||
Underwriting Agreement [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Common stock shares issued (in Shares) | 7,500,000 | ||||||||||
Warrants purchase shares (in Shares) | 2,500,625 | ||||||||||
ATM Program [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Gross proceeds percentage | 3% | ||||||||||
Available under its At-the-Market Issuance Sales Agreement | 18,700,000 | ||||||||||
Proceeds from issuance of common stock | $ 12,500,000 | ||||||||||
Sale of aggregate shares (in Shares) | 2,866,421 | ||||||||||
ATM Program [Member] | Shelf Registration 2020 [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Aggregate value | $ 100,000,000 | ||||||||||
ATM Program [Member] | Maximum [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
sale of aggregate amount | $ 50,000,000 | ||||||||||
Pre-Funded Warrants [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Common stock, issued (in Shares) | 2,500,625 | ||||||||||
Aggregate of common stock (in Shares) | 2,500,625 | ||||||||||
Price per pre-funded warrant (in Dollars per share) | $ 3.999 | ||||||||||
Exercise price (in Dollars per share) | $ 0.001 | ||||||||||
Net proceeds issuance of warrants | $ 9,400,000 | ||||||||||
Common Stock [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Public Offering Price (in Dollars per share) | $ 4 | ||||||||||
Proceeds from issuance of common stock | $ 37,300,000 | ||||||||||
Shares of common stock (in Shares) | 2,021,200 | ||||||||||
Common Stock [Member] | ATM Program [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Proceeds from issuance of common stock | $ 11,700,000 | ||||||||||
Common Stock [Member] | ATM Program [Member] | Maximum [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Aggregate value | 100,000,000 | ||||||||||
Common Stock [Member] | ATM Program [Member] | Minimum [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Aggregate value | $ 50,000,000 | ||||||||||
Employee [Member] | Stok Option [Mrember] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Expected term | 5 years | ||||||||||
Non-employees [Member] | Stok Option [Mrember] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Expected term | 10 years | ||||||||||
ATM Program [Member] | Common Stock [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Shares of common stock (in Shares) | 1,552,850 | ||||||||||
RSUs [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Vested shares issued (in Shares) | 103,734 | ||||||||||
Shares issued for withheld in lieu of withholding taxes (in Shares) | 37,443 | ||||||||||
Outstanding shares (in Shares) | 103,735 | 103,735 | |||||||||
Total compensation expense | $ 53,000 | $ 88,000 | $ 207,000 | $ 138,000 | |||||||
Unrecognized compensation expense | $ 268,000 | $ 268,000 | |||||||||
RSUs [Member] | Chief Executive Officer [Member] | |||||||||||
Stockholders' Equity [Line Items] | |||||||||||
Granted shares issued (in Shares) | 66,291 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of Preferred Stock - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Schedule of Preferred Stock [Abstract] | ||
Preferred Shares Outstanding | 181,622 | 181,622 |
Total Liquidation Preference | $ 21,291,665 | |
Series C-3 [Member] | ||
Schedule of Preferred Stock [Abstract] | ||
Preferred Shares Outstanding | 2,000 | |
Liquidation Preference (Per Share) | $ 10 | |
Total Liquidation Preference | $ 20,000 | |
Series E [Member] | ||
Schedule of Preferred Stock [Abstract] | ||
Preferred Shares Outstanding | 89,623 | |
Liquidation Preference (Per Share) | $ 49.2 | |
Total Liquidation Preference | $ 4,409,452 | |
Series G [Member] | ||
Schedule of Preferred Stock [Abstract] | ||
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 | 9 Months Ended |
Sep. 30, 2023 $ / shares | |
Schedule of Fair Value Assumptions [Abstract] | |
Expected term | 5 years |
Volatility weighted average | 104.98% |
Dividend yield weighted average | 0% |
Risk-free interest rate weighted average | 3.69% |
Weighted average grant date fair value of options granted during the period (in Dollars per share) | $ 3.43 |
Leases (Details)
Leases (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2023 EUR (€) | |
Leases [Abstract] | |||||||
Payments for leasing costs | $ 17,000 | ||||||
Rental agreement expense (in Euro) | € | € 400 | ||||||
Operating lease expense | $ 52,000 | $ 52,000 | $ 155,000 | $ 157,000 | |||
Operating lease liability | 703,000 | 703,000 | $ 803,000 | ||||
Operating lease liabilities, short-term | 147,000 | 135,000 | |||||
Operating lease liabilities, net of current portion | 556,000 | 556,000 | 668,000 | ||||
Operating lease ROU assets | 675,000 | 675,000 | $ 775,000 | ||||
Operating leases | $ 50,000 | $ 50,000 | $ 150,000 | $ 150,000 | |||
Weighted average remaining lease term | 4 years 1 month 6 days | 6 years | 4 years 1 month 6 days | 6 years | 4 years 1 month 6 days | ||
Weighted average discount rate | 9% | 9% | 9% | 9% | 9% |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Maturities of Lease Liabilities - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Remainder of 2023 | $ 51,000 | |
2024 | 205,000 | |
2025 | 208,000 | |
2026 | 211,000 | |
2027 | 169,000 | |
Total future minimum lease payments | 844,000 | |
Less imputed interest | (141,000) | |
Total | $ 703,000 | $ 803,000 |