CorMedix (CRMD) 10-Q 14 Aug 24 2024 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Jun. 30, 2024	Aug. 12, 2024
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Entity Interactive Data Current	Yes
Amendment Flag	false
Document Period End Date	Jun. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Entity Information [Line Items]
Entity Registrant Name	CORMEDIX INC.
Entity Central Index Key	0001410098
Entity File Number	001-34673
Entity Tax Identification Number	20-5894890
Entity Incorporation, State or Country Code	DE
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Contact Personnel [Line Items]
Entity Address, Address Line One	300 Connell Drive
Entity Address, Address Line Two	Suite 4200
Entity Address, City or Town	Berkeley Heights
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07922
Entity Phone Fax Numbers [Line Items]
City Area Code	(908)
Local Phone Number	517-9500
Entity Listings [Line Items]
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	CRMD
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		55,859,964

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 28,540,633	$ 43,642,684
Restricted cash		77,453
Short-term investments	17,069,660	32,388,130
Trade receivables	206,337
Inventories	4,011,560	2,106,345
Prepaid research and development expenses	227,167	353,574
Other prepaid expenses and current assets	3,139,022	882,214
Total current assets	53,194,379	79,450,400
Property and equipment, net	1,915,569	1,866,224
License intangible asset, net	1,948,052
Restricted cash, long-term	104,426	103,055
Operating lease right-of-use asset	568,168	640,278
TOTAL ASSETS	57,730,594	82,059,957
Current liabilities
Accounts payable	3,344,803	4,279,679
Accrued expenses	7,607,537	6,970,217
Operating lease liability, short-term	159,077	150,619
Total current liabilities	11,111,417	11,400,515
Operating lease liability, net of current portion	435,246	517,013
TOTAL LIABILITIES	11,546,663	11,917,528
COMMITMENTS AND CONTINGENCIES (Note 5)
STOCKHOLDERS’ EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at June 30, 2024 and December 31, 2023	182	182
Common stock - $0.001 par value: 160,000,000 shares authorized; 55,274,791 and 54,938,258 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively	55,274	54,938
Accumulated other comprehensive gain	85,731	94,108
Additional paid-in capital	396,360,369	391,693,214
Accumulated deficit	(350,317,625)	(321,700,013)
TOTAL STOCKHOLDERS’ EQUITY	46,183,931	70,142,429
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$ 57,730,594	$ 82,059,957

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares	Jun. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,000,000	2,000,000
Preferred stock, shares issued	181,622	181,622
Preferred stock, shares outstanding	181,622	181,622
Common stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	160,000,000	160,000,000
Common stock, shares issued	55,274,791	54,938,258
Common stock, shares outstanding	55,274,791	54,938,258

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Revenue:
Net sales	$ 806,119		$ 806,119
Cost of sales	(509,839)		(1,328,377)
Gross profit (loss)	296,280		(522,258)
Operating Expenses:
Research and development	(650,988)	(4,794,758)	(1,488,432)	(8,202,260)
Selling and marketing	(7,386,841)	(3,256,047)	(13,724,061)	(5,897,223)
General and administrative	(7,559,277)	(3,753,777)	(16,270,310)	(8,722,278)
Total Operating Expenses	(15,597,106)	(11,804,582)	(31,482,803)	(22,821,761)
Loss From Operations	(15,300,826)	(11,804,582)	(32,005,061)	(22,821,761)
Other Income (Expense):
Interest income	657,366	550,183	1,514,551	996,567
Foreign exchange transaction loss	(1,473)	(13,368)	(5,481)	(1,023)
Other income	500,000		500,000
Interest expense	(6,556)	(5,851)	(16,391)	(14,627)
Total Other Income	1,149,337	530,964	1,992,679	980,917
Loss before income taxes	(14,151,489)	(11,273,618)	(30,012,382)	(21,840,844)
Tax benefit			1,394,770
Net Loss	(14,151,489)	(11,273,618)	(28,617,612)	(21,840,844)
Other Comprehensive Income (Loss):
Unrealized income (loss) from investments	2,030	(10,732)	(8,872)	5,661
Foreign currency translation gain	240	197	495	2,293
Total Other Comprehensive Income (Loss)	2,270	(10,535)	(8,377)	7,954
Comprehensive Loss	$ (14,149,219)	$ (11,284,153)	$ (28,625,989)	$ (21,832,890)
Net Loss Per Common Share - Basic (in Dollars per share)	$ (0.25)	$ (0.25)	$ (0.5)	$ (0.49)
Weighted Average Common Shares Outstanding - Basic (in Shares)	57,620,974	45,365,635	57,562,064	44,731,838

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Income Statement [Abstract]
Net Loss Per Common Share - Diluted	$ (0.25)	$ (0.25)	$ (0.50)	$ (0.49)
Weighted Average Common Shares Outstanding - Diluted	57,620,974	45,365,635	57,562,064	44,731,838

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	Additional Paid-in Capital	Accumulated Deficit	Total
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 issued in connection with options exercised	$ 57			233,799		233,856
Stock issued in connection with options exercised (in Shares)	57,375
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				3,273,640		3,273,640
Other comprehensive gain (loss)			7,954			7,954
Net loss					(21,840,844)	(21,840,844)
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
Balance at Mar. 31, 2023	$ 44,500	$ 182	101,232	339,709,852	(285,928,012)	53,927,754
Balance (in Shares) at Mar. 31, 2023	44,499,788	181,622
Stock issued in connection with ATM sale of common stock, net	$ 1,182			5,313,621		5,314,803
Stock issued in connection with ATM sale of common stock, net (in Shares)	1,181,829
Stock issued in connection with options exercised	$ 57			233,799		233,856
Stock issued in connection with options exercised (in Shares)	57,375
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				1,057,291		1,057,291
Other comprehensive gain (loss)			(10,535)			(10,535)
Net loss					(11,273,618)	(11,273,618)
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
Balance at Dec. 31, 2023	$ 54,938	$ 182	94,108	391,693,214	(321,700,013)	70,142,429
Balance (in Shares) at Dec. 31, 2023	54,938,258	181,622
Stock issued in connection with ATM sale of common stock, net	$ 231			1,009,369		1,009,600
Stock issued in connection with ATM sale of common stock, net (in Shares)	231,097
Stock issued in connection with options exercised	$ 49			186,433		186,482
Stock issued in connection with options exercised (in Shares)	49,165
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes	$ 78			(236,693)		(236,615)
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes (in Shares)	78,103
Cancellation of shares held in escrow	$ (22)			22
Cancellation of shares held in escrow (in Shares)	(21,832)
Stock-based compensation				3,708,024		3,708,024
Other comprehensive gain (loss)			(8,377)			(8,377)
Net loss					(28,617,612)	(28,617,612)
Balance at Jun. 30, 2024	$ 55,274	$ 182	85,731	396,360,369	(350,317,625)	46,183,931
Balance (in Shares) at Jun. 30, 2024	55,274,791	181,622
Balance at Mar. 31, 2024	$ 54,959	$ 182	83,461	394,040,254	(336,166,136)	58,012,720
Balance (in Shares) at Mar. 31, 2024	54,959,270	181,622
Stock issued in connection with ATM sale of common stock, net	$ 231			1,009,369		1,009,600
Stock issued in connection with ATM sale of common stock, net (in Shares)	231,097
Stock issued in connection with options exercised	$ 49			186,433		186,482
Stock issued in connection with options exercised (in Shares)	49,165
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes	$ 35			(139,532)		(139,497)
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes (in Shares)	35,259
Stock-based compensation				1,263,845		1,263,845
Other comprehensive gain (loss)			2,270			2,270
Net loss					(14,151,489)	(14,151,489)
Balance at Jun. 30, 2024	$ 55,274	$ 182	$ 85,731	$ 396,360,369	$ (350,317,625)	$ 46,183,931
Balance (in Shares) at Jun. 30, 2024	55,274,791	181,622

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (28,617,612)	$ (21,840,844)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	3,708,024	3,273,640
Change in right-of-use assets	72,110	65,901
Depreciation	46,750	34,292
Amortization of intangible	51,948
Changes in operating assets and liabilities:
Increase in trade receivables	(206,337)
Increase in inventory	(1,905,215)
Increase in prepaid expenses and other current assets	(2,130,587)	(1,502,179)
(Decrease) Increase in accounts payable	(934,870)	698,353
(Decrease) Increase in accrued expenses	(1,361,111)	370,099
Decrease in operating lease liabilities	(73,310)	(65,578)
Net cash used in operating activities	(31,350,210)	(18,966,316)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term investments	(19,806,594)	(42,901,487)
Maturity of short-term investments	35,116,192	25,850,000
Purchase of equipment	(96,095)	(21,124)
Net cash provided by (used in) investing activities	15,213,503	(17,072,611)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from at-the-market program, net	1,009,600	12,515,209
Payment of employee withholding taxes on vested restricted stock units	(236,615)	(198,442)
Proceeds from exercise of stock options	186,482	233,856
Net cash provided by financing activities	959,467	12,550,623
Foreign exchange effect on cash	(893)	2,531
NET DECREASE IN CASH AND CASH EQUIVALENTS	(15,178,133)	(23,485,773)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD	43,823,192	43,374,745
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - END OF PERIOD	28,645,059	19,888,972
Cash paid for interest	16,391	14,627
Supplemental Disclosure of Non-Cash Investing Activities:
Liability related to license agreement	2,000,000
Unrealized (loss) gain from investments	$ (8,872)	$ 5,661

Organization, Business and Basi

Organization, Business and Basis of Presentation	6 Months Ended
	Jun. 30, 2024
Organization, Business and Basis of Presentation [Abstract]
Organization, Business and Basis of Presentation	Note 1 - Organization, Business and Basis of Presentation: Organization and Business CorMedix Inc. (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The Company’s primary focus is on the commercialization of its lead product, DefenCath ® Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions for Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2024 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 12, 2024. The accompanying consolidated balance sheet as of December 31, 2023 has been derived from the audited financial statements included in such Annual Report on Form 10-K.

Summary of Significant Accounti

Summary of Significant Accounting Policies and Liquidity and Uncertainties	6 Months Ended
	Jun. 30, 2024
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract]
Summary of Significant Accounting Policies and Liquidity and Uncertainties	Note 2 - Summary of Significant Accounting Policies and Liquidity and Uncertainties: Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current commercial plans and development plans for DefenCath and its other operating requirements, the Company’s existing cash, cash equivalents and short-term investments at June 30, 2024 are expected to fund its operations for at least twelve months from the issuance of this Quarterly Report on Form 10-Q. In March 2024, the Company received $1,395,000, net of expenses, from the sale of its unused New Jersey net operating losses (“NOL”), that was eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”). The NJEDA Program allowed the Company to sell its available NOL tax benefits for the state fiscal year 2023 in the amount of approximately $1,529,000. The Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions and/or out-licensing. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of June 30, 2024, approximately $48,800,000 of the Company’s common stock remains available for sale under the 2024 ATM program, with $100,000,000 of remaining capacity under the 2024 Shelf Registration Statement for the issuance of Company securities (see Note 6). The Company’s operations are subject to a number of other factors that can affect its operating results and cash flow projections over the next twelve months from the issuance of these financial statements. Such factors include, but are not limited to: the ability to market DefenCath and generate necessary revenue in the time periods required; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated balance sheets and the reported amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions. As future events and their effects cannot be determined with precision, actual results could differ significantly from those estimates. Reclassifications Certain reclassifications were made to the prior year’s amounts to conform to the 2024 presentation. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. Trade Accounts Receivable and Allowances The Company complies with ASU 2016-13, Measurement of Credit Losses on Financial Instruments Major Customers The major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three and six months ended June 30, 2024, the Company had sales to one customer that accounted for 100% of its total revenue of $806,119. This customer also accounts for 100% of the Company’s accounts receivable as of June 30, 2024. Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and accounts receivable. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: June 30, 2024 2023 Cash and cash equivalents $ 28,540,633 $ 19,699,565 Restricted cash 104,426 189,407 Total cash, cash equivalents and restricted cash $ 28,645,059 $ 19,888,972 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 are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense). The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at June 30, 2024 or December 31, 2023. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of June 30, 2024 and December 31, 2023, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2024 and December 31, 2023: Amortized Gross Gross Fair Value June 30, 2024: Money Market Funds included in Cash Equivalents $ 21,230,822 $ - $ 22 $ 21,230,844 U.S. Government Agency Securities 15,898,364 (320 ) 524 15,898,568 Commercial Paper 1,171,108 (46 ) 30 1,171,092 Subtotal 17,069,472 (366 ) 554 17,069,660 Total June 30, 2024 $ 38,300,294 $ (366 ) $ 576 $ 38,300,504 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360 Fair Value Measurements In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of June 30, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 June 30, 2024: Money Market Funds and Cash Equivalents $ 21,230,844 $ 21,230,844 $ - $ - U.S. Government Agency Securities 15,898,568 15,898,568 - - Commercial Paper 1,171,092 - 1,171,092 - Subtotal 17,069,660 15,898,568 1,171,092 $ - Total June 30, 2024 $ 38,300,504 $ 37,129,412 $ 1,171,092 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ - Inventories The Company engages third parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costs related to the manufacturing of DefenCath incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as research and development expenses (“R&D”) as incurred. Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. Inventories expensed as R&D prior to FDA approval that can be used for commercial purposes amounted to approximately $6,359,000. Inventory is valued utilizing the standard cost method, which approximates costs determined on the first-in first-out basis. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of June 30, 2024 and December 31, 2023, no reserves were deemed necessary. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: June 30, December 31, Raw materials $ 919,801 $ 1,525,420 Work in progress 2,014,921 580,925 Finished goods 1,076,838 - Total $ 4,011,560 $ 2,106,345 Revenue Recognition The Company recognizes revenue from the sale of its product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers The Company recognizes revenue when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer. The Company’s product revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors and outpatient service providers. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes: ● Distribution service fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; ● Volume incentive rebates; The Company assesses whether or not an estimate of variable consideration is constrained based on the probability that a significant reversal in the amount of cumulative revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may vary from our estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect product sales and earnings in the period such variances become known. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees primarily to its wholesale distributors. The Company reserves these fees based on actual net sales and the contractual fee rates negotiated with the customers in the distribution channel. The Company records these fees as contra accounts receivable on the balance sheet. Prompt pay and other discounts – The Company provides customers with prompt pay discounts. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are expected to be taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the invoice price. Prompt pay discount estimates are recorded as contra accounts receivable on the balance sheet. Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than six months. The Company determines its estimate for product returns based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to both inpatient and outpatient facilities), and (ii) the estimated remaining shelf life of DefenCath held by the wholesale distributors and outpatient service providers. Since the returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Estimated product returns are recorded as accrued expenses on the balance sheet. Chargebacks – Certain covered entities, group purchasing organizations (GPO) and government entities will be able to purchase the product at a price discounted below WAC. The difference between the GPO, government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra accounts receivable on the balance sheet. Rebates – The Company is subject to negotiated discount obligations to different prescription benefit managers (PBM), other commercial organizations or government programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates are typically invoiced in arrears. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter based on expected product utilization, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as accrued expenses on the balance sheet. Volume Incentive Rebates – The Company is subject to negotiated volume incentive rebates with certain direct customers (primarily outpatient service providers). Rebates are owed based on predetermined volume levels and payable per the terms in the customer contracts. The Company estimates and records volume incentive rebates based on anticipated purchase volume with specific customers based on communications with the customer. Volume incentive rebates are recorded as accrued expenses on the balance sheet. Provisions for the revenue reserves described above totaled $194,000 for the three and six months ended June 30, 2024. As of June 30, 2024, reserves on the balance sheet associated with variable consideration were $194,000. License Agreement The Company’s rights under the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost and will amortize using the straight-line method over estimated economic life of the intangible asset. The Company will amortize the intangible asset over its useful life, based on its assessment of various factors impacting estimated useful lives and cash flows of the acquired rights. Such factors include the launch date of DefenCath, the strength of the intellectual property protection of DefenCath and various other competitive, developmental and regulatory considerations, and contractual terms. See Note 5 – Commitments and Contingencies for further discussion. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 7). Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore basic and diluted loss per share are the same for all periods presented. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Six Months Ended 2024 2023 (Number of Shares of Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 8,048,134 5,929,143 Shares underlying restricted stock units 303,994 103,735 Total potentially dilutive shares 13,801,059 11,481,809 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. Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. ASU No. 2023-09 In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures ASU No. 2023-07 In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting - Improving Reportable Segment Disclosures

Other Prepaid Expenses and Curr

Other Prepaid Expenses and Current Assets	6 Months Ended
	Jun. 30, 2024
Other Prepaid Expenses and Current Assets [Abstract]
Other Prepaid Expenses and Current Assets	Note 3 – Other Prepaid Expenses and Current Assets: Other Prepaid Expenses and Current Assets Other prepaid expenses and current assets consist of the following: June 30, December 31, Manufacturing $ 994,481 $ - Commercial 595,484 171,393 Vendor settlement receivable 500,000 - Subscriptions 471,325 466,114 Medical affairs 259,145 - Insurance 107,078 126,616 Other 211,509 118,091 Total $ 3,139,022 $ 882,214

Accrued Expenses

Accrued Expenses	6 Months Ended
	Jun. 30, 2024
Accrued Expenses [Abstract]
Accrued Expenses	Note 4 - Accrued Expenses: Accrued Expenses Accrued expenses consist of the following: June 30, December 31, Professional and consulting fees $ 1,192,682 $ 2,270,022 Accrued payroll and payroll taxes 3,438,384 2,718,770 License agreement payable (see Note 5 – Commitments and Contingencies) 2,000,000 - Manufacturing related 389,993 1,835,101 Accrued gross-to-net deductions 150,188 - Other 436,290 146,324 Total $ 7,607,537 $ 6,970,217

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 2024
Commitments and Contingencies [Abstract]
Commitments and Contingencies	Note 5 - Commitments and Contingencies: Contingency Matters In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.) On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933. On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded the original complaints in In re CorMedix Securities Litigation. On March 21, 2024, the court denied Defendant’s motion to dismiss without prejudice and granted lead plaintiff leave to amend the complaint. On April 22, 2024, lead plaintiff filed a third amended consolidated complaint that superseded the second amended consolidated complaint. In the third amended complaint, the lead plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive. The third amended complaint names as defendants the Company and six (6) current and former officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a). In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier. The Company intends to vigorously contest such claims. The Company filed its motion to dismiss the third amended complaint on June 6, 2024, and received from Plaintiffs their opposition to the Company’s motion to dismiss on July 22, 2024. The Company will be filing its response on or before August 21, 2024. In re CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.) On or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. The individual defendants intend to vigorously contest such claims. On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit described in the foregoing paragraph is pending. The stay may be terminated before the motion to dismiss is resolved according to certain circumstances described in the stipulation available on the Court’s public docket. On or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al. On or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al. On or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation Voter Demand Letter On or about June 23, 2022, the Company’s Board received a letter demanding it investigate and pursue causes of action, purportedly on behalf of Company, against certain current and former directors, officers, and/or other employees of the Company (the “Letter”), which the Board believes are duplicative of the claims already asserted in the Derivative Litigation. As set forth in the Board’s response to the Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress of the Derivative Litigation. License and Assignment Agreement In 2008, the Company entered into a License and Assignment Agreement (the “ND License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the ND License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). As consideration in part for the rights to the NDP Technology, upon execution of the ND License Agreement, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 7,996 shares of the Company’s common stock. Under the ND License Agreement, the Company is required to make cash and equity payments to NDP upon the achievement of certain milestones. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. As of December 31, 2022, the shares remaining in escrow were cancelled in accordance with the terms of the escrow agreement. Under the ND License Agreement, the maximum aggregate amount of cash payments due upon achievement of milestones was $3,000,000, with the balance being $2,000,000 as of June 30, 2024 and December 31, 2023. The initial licensing fee of $325,000, the fair value of the 5% equity interest (7,996 shares of the Company’s common stock) and an additional $500,000, as a result of the achievement of one milestone, were recognized on the Company’s statement of operations in R&D in prior periods, as the related milestones were achieved by the Company prior to the FDA approval. During the six months ended June 30, 2024, the Company determined it was probable that the net sales milestones will be achieved in future periods and, as a result, the Company recorded a license intangible asset of $2,000,000 and a license agreement liability of $2,000,000, which is included within accrued expenses in the Company’s condensed consolidated balance sheet as of June 30, 2024. Beginning in the second quarter of 2024, the license intangible asset is amortized as cost of goods sold over its estimated economic life of approximately 10 years. The amortization start period correlates with the product launch of DefenCath and the first period in which revenue will be recognized. Amortization expense of approximately $52,000 was recorded during the three and six month periods ending June 30, 2024. The ND License Agreement will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in a given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, we will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country. The ND License Agreement also may be terminated by NDP if the Company materially breaches or defaults under the ND License Agreement and that breach is not cured within 60 days following the delivery of written notice to the Company, or by the Company on a country-by-country basis upon 60 days prior written notice in the event the Company’s Board determines not to proceed with the development of the NDP Technology. If the ND License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP.

Stockholders_ Equity

Stockholders’ Equity	6 Months Ended
	Jun. 30, 2024
Stockholders’ Equity [Abstract]
Stockholders’ Equity	Note 6 - Stockholders’ Equity: Common Stock On June 28, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets, LLC and Truist Securities, Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an aggregate of 7,500,000 shares of the Company’s common stock, and in lieu of common stock to certain investors, pre-funded warrants to purchase 2,500,625 shares of common stock to the underwriters. Pursuant to the Underwriting Agreement, the Company also granted the underwriters a 30-day option to purchase up to 1,500,093 additional shares of common stock. The offering pursuant to the 2021 Shelf Registration Statement closed on July 3, 2023. Upon closing, the Company issued and sold an aggregate of 7,500,000 shares of its common stock at a public offering price of $4.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its commons stock at a price of $3.999 per pre-funded warrant (see Pre-Funded Warrants below). The Company realized net proceeds of approximately $37,300,000 from the sale of its common stock and the pre-funded warrants. On July 26, 2023, the underwriters’ representatives fully exercised the option to purchase additional shares of the Company’s common stock, and on July 28, 2023, the Company issued and sold an aggregate of 1,500,093 shares of its common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions, and the Company realized net proceeds of approximately $5,600,000. On May 9, 2024, the Company filed a shelf registration statement (the “2024 Shelf Registration Statement”) for the issuance of up to $150,000,000 of Company securities. Also on May 9, 2024, the Company entered into an At-The-Market Issuance Sales Agreement with Leerink Partners LLC, as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $50,000,000 of its common stock through the sales agents under the 2024 Shelf Registration Statement, subject to limitations imposed by the Company and subject to the sales agent’s acceptance (the “2024 ATM program “). The sales agent is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the 2024 ATM program. As of June 30, 2024, approximately $48,800,000 of the Company’s common stock remains available for sale under its 2024 ATM program, with $100,000,000 of capacity remaining under its 2024 Shelf Registration Statement for the issuance of Company securities. During the three and six months ended June 30, 2024, the Company sold an aggregate of 231,097 shares of its common stock, respectively, under the 2024 ATM program and realized net proceeds of approximately $1,010,000. For the three and six months ended June 30, 2023, the Company sold under its previous at-the-market program, an aggregate of 1,181,829 and 2,866,421 shares of its common stock, respectively, and realized net proceeds of $5,315,000 and $12,515,000, respectively. Restricted Stock Units In January 2024, the Company granted 283,333 restricted stock units (“RSUs”) to its executive officers under its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $3.47 per share. The fair market value of the RSUs was estimated to be the closing price of the Company’s common stock on the date of grant. These RSUs vest 25% on the grant date and 25% each on the first, second and third anniversaries of the grant date, subject to continued service as an employee or consultant through the applicable vesting date. During the six months ended June 30, 2024, the Company issued 42,844 shares upon the vesting of 25% of these RSUs on the grant date and 27,989 shares were withheld in lieu of withholding taxes. In May 2024 and 2023, 62,241 and 103,734 RSUs vested, respectively, pursuant to a grant made to the Company’s chief executive officer, of which 35,259 and 66,291 shares of common stock were issued by the Company, respectively, and 26,982 and 37,443 shares, respectively, were withheld in lieu of withholding taxes. As of June 30, 2024, the Company has 303,994 outstanding RSUs. The Company recorded $114,000 and $476,000 compensation expense for the three and six months ended June 30, 2024, respectively, and $68,000 and $154,000 for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, unrecognized compensation expense for these RSUs amounted to $886,000 and the expected weighted average period for the expense to be recognized is 1.7 years. Preferred Stock The Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of June 30, 2024 and Preferred Liquidation Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665 Stock Options During the six months ended June 30, 2024 and 2023, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 2,043,667 and 1,901,200 shares, respectively, of the Company’s common stock under the Amended and Restated 2019 Omnibus Stock Incentive Plan. The weighted average exercise price of these options is $3.62 and $4.43 per share, respectively. During the three and six months ended June 30, 2024, stock-based compensation expense for stock options issued to employees, directors, officers and consultants was $1,150,000 and $3,232,000, respectively, and $989,000 and $3,119,000 for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, there was approximately $8,464,000 in total unrecognized compensation expense related to stock options granted, which 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 six months ended June 30, 2024: Expected term (in years) 5.98 Volatility weighted average 98.95 % Dividend yield weighted average 0 % Risk-free interest rate weighted average 4.15 % Weighted average grant date fair value of options granted during the period $ 2.90 The Company uses the simplified method to calculate the expected term which takes into account the vesting term and the expiration date of the stock options. The expected term of the stock options granted to consultants, if any, is based upon the full term of the respective option agreements. The expected stock price volatility for the Company’s stock options is calculated based on the historical volatility of the Company’s stock price for the expected term. The expected dividend yield of 0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards.

Leases

Leases	6 Months Ended
	Jun. 30, 2024
Leases [Abstract]
Leases	Note 7 - Leases: The Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020. The Company entered into an operating lease for its office space in Germany that began in July 2017 and terminated in June 2024. The agreement had a monthly cost of 400 Euros. Operating lease expense in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 was approximately $52,000 and $104,000, respectively, and $52,000 and $104,000 for the three and six months ended June 30, 2023, respectively, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At June 30, 2024, the Company has a total operating lease liability of $594,000, of which $159,000 was classified as operating lease liabilities, short-term and $435,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. At December 31, 2023, the Company’s total operating lease liability was $668,000, of which $151,000 was classified as operating lease liabilities, short-term and $517,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating ROU assets as of June 30, 2024 and December 31, 2023 were $568,000 and $640,000, respectively. For each of the three and six months ended June 30, 2024, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $51,000 and $102,000, respectively, and $50,000 and $100,000 for the three and six months ended June 30, 2023, respectively. The weighted average remaining lease term as of June 30, 2024 and 2023 was 3.3 and 4.3 years, respectively, and the weighted average discount rate for operating leases was 9% at June 30, 2024 and 2023. As of June 30, 2024, maturities of lease liabilities were as follows: 2024 (excluding the six months ended June 30, 2024) $ 102,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 690,000 Less imputed interest (96,000 ) Total $ 594,000

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (14,151,489)	$ (11,273,618)	$ (28,617,612)	$ (21,840,844)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Jun. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Accounting Policies, by Policy

Accounting Policies, by Policy (Policies)	6 Months Ended
	Jun. 30, 2024
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract]
Liquidity and Uncertainties	Liquidity and Uncertainties The condensed consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. Based on the Company’s current commercial plans and development plans for DefenCath and its other operating requirements, the Company’s existing cash, cash equivalents and short-term investments at June 30, 2024 are expected to fund its operations for at least twelve months from the issuance of this Quarterly Report on Form 10-Q. In March 2024, the Company received $1,395,000, net of expenses, from the sale of its unused New Jersey net operating losses (“NOL”), that was eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”). The NJEDA Program allowed the Company to sell its available NOL tax benefits for the state fiscal year 2023 in the amount of approximately $1,529,000. The Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions and/or out-licensing. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of June 30, 2024, approximately $48,800,000 of the Company’s common stock remains available for sale under the 2024 ATM program, with $100,000,000 of remaining capacity under the 2024 Shelf Registration Statement for the issuance of Company securities (see Note 6). The Company’s operations are subject to a number of other factors that can affect its operating results and cash flow projections over the next twelve months from the issuance of these financial statements. Such factors include, but are not limited to: the ability to market DefenCath and generate necessary revenue in the time periods required; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated balance sheets and the reported amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions. As future events and their effects cannot be determined with precision, actual results could differ significantly from those estimates.
Reclassifications	Reclassifications Certain reclassifications were made to the prior year’s amounts to conform to the 2024 presentation.
Basis of Consolidation	Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.
Trade Accounts Receivable and Allowances	Trade Accounts Receivable and Allowances The Company complies with ASU 2016-13, Measurement of Credit Losses on Financial Instruments
Major Customers	Major Customers The major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three and six months ended June 30, 2024, the Company had sales to one customer that accounted for 100% of its total revenue of $806,119. This customer also accounts for 100% of the Company’s accounts receivable as of June 30, 2024.
Financial Instruments	Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and accounts receivable. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: June 30, 2024 2023 Cash and cash equivalents $ 28,540,633 $ 19,699,565 Restricted cash 104,426 189,407 Total cash, cash equivalents and restricted cash $ 28,645,059 $ 19,888,972 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 are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense). The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at June 30, 2024 or December 31, 2023. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of June 30, 2024 and December 31, 2023, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2024 and December 31, 2023: Amortized Gross Gross Fair Value June 30, 2024: Money Market Funds included in Cash Equivalents $ 21,230,822 $ - $ 22 $ 21,230,844 U.S. Government Agency Securities 15,898,364 (320 ) 524 15,898,568 Commercial Paper 1,171,108 (46 ) 30 1,171,092 Subtotal 17,069,472 (366 ) 554 17,069,660 Total June 30, 2024 $ 38,300,294 $ (366 ) $ 576 $ 38,300,504 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360
Fair Value Measurements	Fair Value Measurements In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of June 30, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 June 30, 2024: Money Market Funds and Cash Equivalents $ 21,230,844 $ 21,230,844 $ - $ - U.S. Government Agency Securities 15,898,568 15,898,568 - - Commercial Paper 1,171,092 - 1,171,092 - Subtotal 17,069,660 15,898,568 1,171,092 $ - Total June 30, 2024 $ 38,300,504 $ 37,129,412 $ 1,171,092 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ -
Inventories	Inventories The Company engages third parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costs related to the manufacturing of DefenCath incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as research and development expenses (“R&D”) as incurred. Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. Inventories expensed as R&D prior to FDA approval that can be used for commercial purposes amounted to approximately $6,359,000. Inventory is valued utilizing the standard cost method, which approximates costs determined on the first-in first-out basis. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of June 30, 2024 and December 31, 2023, no reserves were deemed necessary. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: June 30, December 31, Raw materials $ 919,801 $ 1,525,420 Work in progress 2,014,921 580,925 Finished goods 1,076,838 - Total $ 4,011,560 $ 2,106,345
Revenue Recognition	Revenue Recognition The Company recognizes revenue from the sale of its product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers The Company recognizes revenue when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer. The Company’s product revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors and outpatient service providers.
Variable Consideration	Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes: ● Distribution service fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; ● Volume incentive rebates; The Company assesses whether or not an estimate of variable consideration is constrained based on the probability that a significant reversal in the amount of cumulative revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may vary from our estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect product sales and earnings in the period such variances become known. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees primarily to its wholesale distributors. The Company reserves these fees based on actual net sales and the contractual fee rates negotiated with the customers in the distribution channel. The Company records these fees as contra accounts receivable on the balance sheet. Prompt pay and other discounts – The Company provides customers with prompt pay discounts. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are expected to be taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the invoice price. Prompt pay discount estimates are recorded as contra accounts receivable on the balance sheet. Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than six months. The Company determines its estimate for product returns based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to both inpatient and outpatient facilities), and (ii) the estimated remaining shelf life of DefenCath held by the wholesale distributors and outpatient service providers. Since the returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Estimated product returns are recorded as accrued expenses on the balance sheet. Chargebacks – Certain covered entities, group purchasing organizations (GPO) and government entities will be able to purchase the product at a price discounted below WAC. The difference between the GPO, government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra accounts receivable on the balance sheet. Rebates – The Company is subject to negotiated discount obligations to different prescription benefit managers (PBM), other commercial organizations or government programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates are typically invoiced in arrears. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter based on expected product utilization, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as accrued expenses on the balance sheet. Volume Incentive Rebates – The Company is subject to negotiated volume incentive rebates with certain direct customers (primarily outpatient service providers). Rebates are owed based on predetermined volume levels and payable per the terms in the customer contracts. The Company estimates and records volume incentive rebates based on anticipated purchase volume with specific customers based on communications with the customer. Volume incentive rebates are recorded as accrued expenses on the balance sheet. Provisions for the revenue reserves described above totaled $194,000 for the three and six months ended June 30, 2024. As of June 30, 2024, reserves on the balance sheet associated with variable consideration were $194,000.
License Agreement	License Agreement The Company’s rights under the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost and will amortize using the straight-line method over estimated economic life of the intangible asset. The Company will amortize the intangible asset over its useful life, based on its assessment of various factors impacting estimated useful lives and cash flows of the acquired rights. Such factors include the launch date of DefenCath, the strength of the intellectual property protection of DefenCath and various other competitive, developmental and regulatory considerations, and contractual terms. See Note 5 – Commitments and Contingencies for further discussion.
Leases	Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 7). Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component.
Loss Per Common Share	Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding pre-funded warrants. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore basic and diluted loss per share are the same for all periods presented. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Six Months Ended 2024 2023 (Number of Shares of Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 8,048,134 5,929,143 Shares underlying restricted stock units 303,994 103,735 Total potentially dilutive shares 13,801,059 11,481,809
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.
Research and Development	Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.
Recent Accounting Pronouncements	Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. ASU No. 2023-09 In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures ASU No. 2023-07 In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting - Improving Reportable Segment Disclosures

Summary of Significant Accoun_2

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Tables)	6 Months Ended
	Jun. 30, 2024
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Abstract]
Schedule of Cash and Cash Equivalents	The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: June 30, 2024 2023 Cash and cash equivalents $ 28,540,633 $ 19,699,565 Restricted cash 104,426 189,407 Total cash, cash equivalents and restricted cash $ 28,645,059 $ 19,888,972
Schedule of Marketable Securities	The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2024 and December 31, 2023: Amortized Gross Gross Fair Value June 30, 2024: Money Market Funds included in Cash Equivalents $ 21,230,822 $ - $ 22 $ 21,230,844 U.S. Government Agency Securities 15,898,364 (320 ) 524 15,898,568 Commercial Paper 1,171,108 (46 ) 30 1,171,092 Subtotal 17,069,472 (366 ) 554 17,069,660 Total June 30, 2024 $ 38,300,294 $ (366 ) $ 576 $ 38,300,504 December 31, 2023: Money Market Funds included in Cash Equivalents $ 32,541,230 $ - $ - $ 32,541,230 U.S. Government Agency Securities 29,701,677 - 10,506 29,712,183 Commercial Paper 2,677,372 (1,425 ) - 2,675,947 Subtotal 32,379,049 (1,425 ) 10,506 32,388,130 Total December 31, 2023 $ 64,920,279 $ (1,425 ) $ 10,506 $ 64,929,360
Schedule of Carrying and Fair Value of Financial Assets	The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of June 30, 2024 and December 31, 2023: Carrying Level 1 Level 2 Level 3 June 30, 2024: Money Market Funds and Cash Equivalents $ 21,230,844 $ 21,230,844 $ - $ - U.S. Government Agency Securities 15,898,568 15,898,568 - - Commercial Paper 1,171,092 - 1,171,092 - Subtotal 17,069,660 15,898,568 1,171,092 $ - Total June 30, 2024 $ 38,300,504 $ 37,129,412 $ 1,171,092 $ - December 31, 2023: Money Market Funds and Cash Equivalents $ 32,541,230 $ 32,541,230 $ - $ - U.S. Government Agency Securities 29,712,183 29,712,183 - - Commercial Paper 2,675,947 - 2,675,947 - Subtotal 32,388,130 29,712,183 2,675,947 - Total December 31, 2023 $ 64,929,360 $ 62,253,413 $ 2,675,947 $ -
Schedule of Inventories	Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for DefenCath. Inventories consist of the following: June 30, December 31, Raw materials $ 919,801 $ 1,525,420 Work in progress 2,014,921 580,925 Finished goods 1,076,838 - Total $ 4,011,560 $ 2,106,345
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share	The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Six Months Ended 2024 2023 (Number of Shares of Series C-3 non-voting preferred stock 4,000 4,000 Series E non-voting preferred stock 391,953 391,953 Series G non-voting preferred stock 5,004,069 5,004,069 Shares issuable for payment of deferred board compensation 48,909 48,909 Shares underlying outstanding stock options 8,048,134 5,929,143 Shares underlying restricted stock units 303,994 103,735 Total potentially dilutive shares 13,801,059 11,481,809

Other Prepaid Expenses and Cu_2

Other Prepaid Expenses and Current Assets (Tables)	6 Months Ended
	Jun. 30, 2024
Other Prepaid Expenses and Current Assets [Abstract]
Schedule of Other Prepaid Expenses and Current Assets	Other prepaid expenses and current assets consist of the following: June 30, December 31, Manufacturing $ 994,481 $ - Commercial 595,484 171,393 Vendor settlement receivable 500,000 - Subscriptions 471,325 466,114 Medical affairs 259,145 - Insurance 107,078 126,616 Other 211,509 118,091 Total $ 3,139,022 $ 882,214

Accrued Expenses (Tables)

Accrued Expenses (Tables)	6 Months Ended
	Jun. 30, 2024
Accrued Expenses [Abstract]
Schedule of Accrued Expenses	Accrued expenses consist of the following: June 30, December 31, Professional and consulting fees $ 1,192,682 $ 2,270,022 Accrued payroll and payroll taxes 3,438,384 2,718,770 License agreement payable (see Note 5 – Commitments and Contingencies) 2,000,000 - Manufacturing related 389,993 1,835,101 Accrued gross-to-net deductions 150,188 - Other 436,290 146,324 Total $ 7,607,537 $ 6,970,217

Stockholders_ Equity (Tables)

Stockholders’ Equity (Tables)	6 Months Ended
	Jun. 30, 2024
Stockholders’ Equity [Abstract]
Schedule of Preferred Stock	The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of June 30, 2024 and Preferred Liquidation Total Series C-3 2,000 $ 10.00 $ 20,000 Series E 89,623 $ 49.20 $ 4,409,452 Series G 89,999 $ 187.36 $ 16,862,213 Total 181,622 $ 21,291,665
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 six months ended June 30, 2024: Expected term (in years) 5.98 Volatility weighted average 98.95 % Dividend yield weighted average 0 % Risk-free interest rate weighted average 4.15 % Weighted average grant date fair value of options granted during the period $ 2.90

Leases (Tables)

Leases (Tables)	6 Months Ended
	Jun. 30, 2024
Leases [Abstract]
Schedule of Maturities of Lease Liabilities	As of June 30, 2024, maturities of lease liabilities were as follows: 2024 (excluding the six months ended June 30, 2024) $ 102,000 2025 208,000 2026 211,000 2027 169,000 Total future minimum lease payments 690,000 Less imputed interest (96,000 ) Total $ 594,000

Organization, Business and Ba_2

Organization, Business and Basis of Presentation (Details)	6 Months Ended
	Jun. 30, 2024
CorMedix Inc. [Member]
Organization, Business and Basis of Presentation [Line Items]
Entity incorporation date	Jul. 28, 2006

Summary of Significant Accoun_3

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - USD ($)	1 Months Ended	3 Months Ended		6 Months Ended		12 Months Ended
	Mar. 31, 2024	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Line Items]
NOL tax benefits						$ 1,529,000
Current shelf registration amount				$ 48,800,000
Common stock remaining capacity				100,000,000
Total revenue		$ 806,119		806,119
Inventories expensed as research and development				6,359,000
Provisions for the revenue reserves		$ 194,000		$ 194,000
Shares underlying outstanding (in Shares)		2,500,625		2,500,625
New Jersey [Member]
Summary of Significant Accounting Policies and Liquidity and Uncertainties [Line Items]
Net of expenses	$ 1,395,000

Summary of Significant Accoun_4

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Cash and Cash Equivalents - USD ($)	Jun. 30, 2024	Dec. 31, 2023	Jun. 30, 2023	Dec. 31, 2022
Schedule of Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 28,540,633	$ 43,642,684	$ 19,699,565
Restricted cash	104,426		189,407
Total cash, cash equivalents and restricted cash	$ 28,645,059	$ 43,823,192	$ 19,888,972	$ 43,374,745

Summary of Significant Accoun_5

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Marketable Securities - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Marketable Securities [Line Items]
Amortized Cost	$ 38,300,294	$ 64,920,279
Gross Unrealized Losses	(366)	(1,425)
Gross Unrealized Gains	576	10,506
Fair Value	38,300,504	64,929,360
Money Market Funds included in Cash Equivalents [Member]
Schedule of Marketable Securities [Line Items]
Amortized Cost	21,230,822	32,541,230
Gross Unrealized Losses
Gross Unrealized Gains	22
Fair Value	21,230,844	32,541,230
U.S. Government Agency Securities [Member]
Schedule of Marketable Securities [Line Items]
Amortized Cost	15,898,364	29,701,677
Gross Unrealized Losses	(320)
Gross Unrealized Gains	524	10,506
Fair Value	15,898,568	29,712,183
Commercial Paper [Member]
Schedule of Marketable Securities [Line Items]
Amortized Cost	1,171,108	2,677,372
Gross Unrealized Losses	(46)	(1,425)
Gross Unrealized Gains	30
Fair Value	1,171,092	2,675,947
Subtotal [Member]
Schedule of Marketable Securities [Line Items]
Amortized Cost	17,069,472	32,379,049
Gross Unrealized Losses	(366)	(1,425)
Gross Unrealized Gains	554	10,506
Fair Value	$ 17,069,660	$ 32,388,130

Summary of Significant Accoun_6

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Carrying and Fair Value of Financial Assets - Fair Value, Recurring [Member] - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	$ 38,300,504	$ 64,929,360
Level 1 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	37,129,412	62,253,413
Level 2 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	1,171,092	2,675,947
Level 3 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
Money Market Funds and Cash Equivalents [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	21,230,844	32,541,230
Money Market Funds and Cash Equivalents [Member] | Level 1 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	21,230,844	32,541,230
Money Market Funds and Cash Equivalents [Member] | Level 2 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
Money Market Funds and Cash Equivalents [Member] | Level 3 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
U.S. Government Agency Securities [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	15,898,568	29,712,183
U.S. Government Agency Securities [Member] | Level 1 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	15,898,568	29,712,183
U.S. Government Agency Securities [Member] | Level 2 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
U.S. Government Agency Securities [Member] | Level 3 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
Commercial Paper [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	1,171,092	2,675,947
Commercial Paper [Member] | Level 1 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
Commercial Paper [Member] | Level 2 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	1,171,092	2,675,947
Commercial Paper [Member] | Level 3 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value
Subtotal [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	17,069,660	32,388,130
Subtotal [Member] | Level 1 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	15,898,568	29,712,183
Subtotal [Member] | Level 2 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value	1,171,092	2,675,947
Subtotal [Member] | Level 3 [Member]
Schedule of Carrying and Fair Value of Financial Assets [Line Items]
Carrying Value

Summary of Significant Accoun_7

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Inventories - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Inventories [Abstract]
Raw materials	$ 919,801	$ 1,525,420
Work in progress	2,014,921	580,925
Finished goods	1,076,838
Total	$ 4,011,560	$ 2,106,345

Summary of Significant Accoun_8

Summary of Significant Accounting Policies and Liquidity and Uncertainties (Details) - Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share - shares	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	13,801,059	11,481,809
Series C-3 non-voting preferred stock [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	4,000	4,000
Series E non-voting preferred stock [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	391,953	391,953
Series G non-voting preferred stock [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	5,004,069	5,004,069
Shares issuable for payment of deferred board compensation [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	48,909	48,909
Shares underlying outstanding stock options [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	8,048,134	5,929,143
Shares underlying restricted stock units [Member]
Schedule of Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share [Line Items]
Total potentially dilutive shares	303,994	103,735

Other Prepaid Expenses and Cu_3

Other Prepaid Expenses and Current Assets (Details) - Schedule of Other Prepaid Expenses and Current Assets - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Other Prepaid Expenses and Current Assets [Abstract]
Manufacturing	$ 994,481
Commercial	595,484	171,393
Vendor settlement receivable	500,000
Subscriptions	471,325	466,114
Medical affairs	259,145
Insurance	107,078	126,616
Other	211,509	118,091
Total	$ 3,139,022	$ 882,214

Accrued Expenses (Details) - Sc

Accrued Expenses (Details) - Schedule of Accrued Expenses - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Accrued Expenses [Abstract]
Professional and consulting fees	$ 1,192,682	$ 2,270,022
Accrued payroll and payroll taxes	3,438,384	2,718,770
License agreement payable (see Note 5 – Commitments and Contingencies)	2,000,000
Manufacturing related	389,993	1,835,101
Accrued gross-to-net deductions	150,188
Other	436,290	146,324
Total	$ 7,607,537	$ 6,970,217

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	3 Months Ended	6 Months Ended		12 Months Ended
	Jun. 30, 2024	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Commitments and Contingencies [Line Items]
Amount of initial licensing fee		$ 325,000
Shares of common stock (in Shares)		7,996
Number of shares released in escrow (in Shares)		7,277
Maximum aggregate amount of cash payments		$ 3,000,000
Balance of cash payments due upon achievement of milestones		2,000,000		$ 2,000,000
Additional amount of achievement milestone		500,000
License agreement intangible	$ 2,000,000	2,000,000
License agreement payable	$ 2,000,000	2,000,000
Amortization expense		$ 51,948
License [Member]
Commitments and Contingencies [Line Items]
Estimated economic life	10 years	10 years
Amortization expense	$ 52,000	$ 52,000
ND Partners, LLP [Member]
Commitments and Contingencies [Line Items]
Equity interest percentage	5%	5%
ND License Agreement [Member]
Commitments and Contingencies [Line Items]
Amount of initial licensing fee		$ 325,000
Shares of common stock (in Shares)		7,996
ND License Agreement [Member] | ND Partners, LLP [Member]
Commitments and Contingencies [Line Items]
Equity interest percentage	5%	5%

Stockholders_ Equity (Details)

Stockholders’ Equity (Details) - USD ($)						1 Months Ended	3 Months Ended		6 Months Ended		12 Months Ended
	May 31, 2024	May 09, 2024	Jul. 28, 2023	Jun. 28, 2023	May 31, 2023	Jan. 31, 2024	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	May 31, 2024	Dec. 31, 2023
Stockholders Equity [Line Items]
Common stock shares issued							55,274,791		55,274,791			54,938,258
Purchase of additional shares				1,500,093
Amount of common stock company may sell (in Dollars)									$ 1,009,600	$ 12,515,209
Common stock par value (in Dollars per share)							$ 0.001		$ 0.001			$ 0.001
Common stock available for sale (in Dollars)		$ 150,000,000
Gross proceeds percentage									3%
Capacity remaining program (in Dollars)							$ 100,000,000		$ 100,000,000
Stock sold (in Shares)							231,097		231,097
Net proceeds (in Dollars)									$ 1,010,000
Vested shares issued	62,241				103,734
Compensation expense RSUs (in Dollars)							$ 114,000	$ 68,000	$ 476,000	$ 154,000
Period of unrecognized compensation expense									1 year 6 months
Preferred stock, shares authorized							2,000,000		2,000,000			2,000,000
Preferred stock, par value (in Dollars per share)							$ 0.001		$ 0.001			$ 0.001
Expected dividend yield, percentage									0%
Underwriting Agreement [Member]
Stockholders Equity [Line Items]
Common stock shares issued				7,500,000
Warrants purchase shares				2,500,625
Common Stock [Member]
Stockholders Equity [Line Items]
Stock sold (in Shares)								1,181,829		2,866,421
Shares of common stock in lieu of withholding taxes							35,259	66,291	78,103	66,291
2024 ATM Program [Member]
Stockholders Equity [Line Items]
Common stock available for sale (in Dollars)									$ 48,800,000
Stock Options [Member]
Stockholders Equity [Line Items]
RSUs vested percentage						25%
Outstanding RSUs							303,994		303,994
Unrecognized compensation expense (in Dollars)							$ 886,000		$ 886,000
Period of unrecognized compensation expense									1 year 8 months 12 days
Stock Options [Member] | Second Anniversary [Member]
Stockholders Equity [Line Items]
RSUs grant percentage						25%
Stock Options [Member] | First Anniversary [Member]
Stockholders Equity [Line Items]
RSUs grant percentage						25%
Stock Options [Member] | Third Anniversary [Member]
Stockholders Equity [Line Items]
RSUs grant percentage						25%
Stock Options [Member]
Stockholders Equity [Line Items]
Granted aggregate shares							2,043,667	1,901,200	2,043,667	1,901,200
Employee Stock Option [Member]
Stockholders Equity [Line Items]
Unrecognized compensation expense (in Dollars)							$ 8,464,000		$ 8,464,000
Leerink Partners LLC [Member]
Stockholders Equity [Line Items]
Amount of common stock company may sell (in Dollars)		$ 50,000,000
Executive Officers [Member] | Stock Options [Member] | 2019 Omnibus Stock Incentive Plan [Member]
Stockholders Equity [Line Items]
Granted shares issued						283,333
Weighted average grant date fair value (in Dollars per share)						$ 3.47
Executive Officers [Member]
Stockholders Equity [Line Items]
Common stock shares issued	35,259				66,291						35,259
Shares of common stock in lieu of withholding taxes					37,443						26,982
Executive Officers [Member] | Stock Options [Member]
Stockholders Equity [Line Items]
RSUs vested percentage									25%
Vested shares issued									42,844
Shares of common stock in lieu of withholding taxes									27,989
Board of Directors [Member]
Stockholders Equity [Line Items]
Preferred stock, shares authorized							2,000,000		2,000,000
Employees And Directors [Member]
Stockholders Equity [Line Items]
Stock-based compensation (in Dollars)							$ 1,150,000	$ 989,000	$ 3,232,000	$ 3,119,000
Common Stock [Member]
Stockholders Equity [Line Items]
Common stock shares issued			1,500,093
Common stock par value (in Dollars per share)			$ 4
Net proceeds (in Dollars)								$ 5,315,000		$ 12,515,000
Common Stock [Member] | Warrant [Member]
Stockholders Equity [Line Items]
Common stock shares issued			2,500,625
Common stock per share price (in Dollars per share)			$ 3.999
Common Stock [Member] | Stock Options [Member] | 2019 Omnibus Stock Incentive Plan [Member]
Stockholders Equity [Line Items]
Weighted average exercise price (in Dollars per share)							$ 3.62	$ 4.43	$ 3.62	$ 4.43
IPO [Member]
Stockholders Equity [Line Items]
Amount of common stock company may sell (in Dollars)			$ 5,600,000
IPO [Member] | Common Stock [Member]
Stockholders Equity [Line Items]
Common stock shares issued			7,500,000
Common stock per share price (in Dollars per share)			$ 4
Pre-Funded Warrants [Member]
Stockholders Equity [Line Items]
Amount of common stock company may sell (in Dollars)			$ 37,300,000

Schedule of Preferred Stock (De

Schedule of Preferred Stock (Details) - Schedule of Preferred Stock - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items]
Preferred Stock, Shares Outstanding	181,622	181,622
Preferred Stock, Liquidation Preference, Value	$ 21,291,665	$ 21,291,665
Series C-3 [Member]
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items]
Preferred Stock, Shares Outstanding	2,000	2,000
Preferred Stock, Liquidation Preference Per Share	$ 10	$ 10
Preferred Stock, Liquidation Preference, Value	$ 20,000	$ 20,000
Series E Preferred Stock [Member]
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items]
Preferred Stock, Shares Outstanding	89,623	89,623
Preferred Stock, Liquidation Preference Per Share	$ 49.2	$ 49.2
Preferred Stock, Liquidation Preference, Value	$ 4,409,452	$ 4,409,452
Series G Preferred Stock [Member]
Schedule of Preferred Stock (Details) - Schedule of Preferred Stock [Line Items]
Preferred Stock, Shares Outstanding	89,999	89,999
Preferred Stock, Liquidation Preference Per Share	$ 187.36	$ 187.36
Preferred Stock, Liquidation Preference, Value	$ 16,862,213	$ 16,862,213

Stockholders_ Equity (Details)

Stockholders’ Equity (Details) - Schedule of Fair Value Assumptions	6 Months Ended
	Jun. 30, 2024 $ / shares
Schedule of Fair Value Assumptions [Line Items]
Expected term (in years)	5 years 11 months 23 days
Volatility weighted average	98.95%
Dividend yield weighted average	0%
Risk-free interest rate weighted average	4.15%
Weighted average grant date fair value of options granted during the period (in Dollars per share)	$ 2.9

Leases (Details)

Leases (Details) - USD ($)		3 Months Ended		6 Months Ended
	Sep. 16, 2020	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Loans and Leases Receivable Disclosure [Line Items]
Payments for leasing costs	$ 17,000
Rental agreement expense		$ 400		$ 400
Operating lease expense		52,000	$ 52,000	104,000	$ 104,000
Operating lease liability		594,000		594,000		$ 668,000
Operating lease liability current		159,077		159,077		150,619
Operating lease liability non current		435,246		435,246		517,013
Operating lease right of use asset		568,168		568,168		$ 640,278
Operating leases		$ 51,000	$ 50,000	$ 102,000	$ 100,000
Weighted average remaining lease term		3 years 3 months 18 days	4 years 3 months 18 days	3 years 3 months 18 days	4 years 3 months 18 days
Weighted average discount rate		9%	9%	9%	9%

Leases (Details) - Schedule of

Leases (Details) - Schedule of Maturities of Lease Liabilities - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Schedule of Maturities of Lease Liabilities [Abstract]
2024 (excluding the six months ended June 30, 2024)	$ 102,000
2025	208,000
2026	211,000
2027	169,000
Total future minimum lease payments	690,000
Less imputed interest	(96,000)
Total	$ 594,000	$ 668,000