UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
For the transition period from ________ to ________
Commission file number
(Exact Name of Registrant as Specified in Its Charter)
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
| (Address of Principal Executive Offices) | (Zip Code) |
(Registrant’s Telephone Number, IncludingArea Code)
Securities registered pursuant to Section 12(b)of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant:(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementsfor the past 90 days.
Indicate by check mark whetherthe registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch files).
Indicate by check mark whetherthe registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reportingcompany” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging Growth Company |
If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whetherthe registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares outstanding of the issuer’scommon stock, as of August 5, 2025 was
CORMEDIX INC. AND SUBSIDIARIES
INDEX
i
PART I
FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements.
CorMedixInc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Short-term investments | ||||||||
| Trade receivables, net | ||||||||
| Inventories | ||||||||
| Prepaid research and development expenses | ||||||||
| Other prepaid expenses and current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Other assets | ||||||||
| License intangible asset, net | ||||||||
| Restricted cash, long-term | ||||||||
| Operating lease right-of-use asset | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liability, short-term | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability, net of current portion | ||||||||
| TOTAL LIABILITIES | ||||||||
| COMMITMENTS AND CONTINGENCIES (Note 5) | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock - $ | ||||||||
| Common stock - $ | ||||||||
| Accumulated other comprehensive gain | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
See Accompanying Notes to Unaudited Condensed ConsolidatedFinancial Statements.
1
CorMedixInc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | $ | $ | $ | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross profit (loss) | ( | ) | ||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Selling and marketing | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| General and administrative | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Operating Expenses | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income (loss) From Operations | ( | ) | ( | ) | ||||||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Foreign exchange transaction loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Other Income | ||||||||||||||||
| Income (loss) before income taxes | ( | ) | ( | ) | ||||||||||||
| Tax (expense) benefit | ( | ) | ( | ) | ||||||||||||
| Net Income (Loss) | ( | ) | ( | ) | ||||||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Unrealized income (loss) from investments | ( | ) | ( | ) | ( | ) | ||||||||||
| Foreign currency translation (loss) gain | ( | ) | ( | ) | ||||||||||||
| Total Other Comprehensive (Loss) Income | ( | ) | ( | ) | ( | ) | ||||||||||
| Comprehensive Income (Loss) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Net Income (Loss) Per Common Share – Basic | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Net Income (Loss) Per Common Share - Diluted | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Weighted Average Common Shares Outstanding – Basic | ||||||||||||||||
| Weighted Average Common Shares Outstanding – Diluted | ||||||||||||||||
See Accompanying Notes to Unaudited CondensedConsolidated Financial Statements.
2
CorMedixInc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGESIN
STOCKHOLDERS’ EQUITY
(Unaudited)
For the three months ended June 30, 2025
| Common Stock | Preferred Stock- Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with public offering, net | - | |||||||||||||||||||||||||||||||
| Stock issued in connection with options exercised | - | |||||||||||||||||||||||||||||||
| Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | - | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net income | - | - | ||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
For the three months ended June 30, 2024
| Common Stock | Preferred Stock- Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | - | |||||||||||||||||||||||||||||||
| Stock issued in connection with options exercised | - | |||||||||||||||||||||||||||||||
| Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive gain | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
3
For the six months ended June 30, 2025
| Common Stock | Preferred Stock- Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at January 1, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | - | |||||||||||||||||||||||||||||||
| Stock issued in connection with options exercised | - | |||||||||||||||||||||||||||||||
| Stock issued in connection with public offering, net | - | |||||||||||||||||||||||||||||||
| Conversion of Series G preferred stock to common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net income | - | - | ||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
For the six months ended June 30, 2024
| Common Stock | Preferred Stock- Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at January 1, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | - | |||||||||||||||||||||||||||||||
| Stock issued in connection with options exercised | - | |||||||||||||||||||||||||||||||
| Issuance of vested restricted stock, net of shares withheld for employee withholding taxes | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Cancellation of shares held in escrow | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
See Accompanying Notes to Unaudited Condensed ConsolidatedFinancial Statements.
4
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| For the Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net income (loss) | $ | $ | ( | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Change in right-of-use assets | ||||||||
| Depreciation | ||||||||
| Amortization of intangible | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Decrease (increase) in trade receivables | ( | ) | ||||||
| Increase in inventory | ( | ) | ( | ) | ||||
| Increase in prepaid expenses and other assets | ( | ) | ( | ) | ||||
| Increase (decrease) in accounts payable | ( | ) | ||||||
| Decrease in accrued expenses | ( | ) | ( | ) | ||||
| Decrease in operating lease liabilities | ( | ) | ( | ) | ||||
| Net cash provided by (used in) operating activities | ( | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of short-term investments | ( | ) | ( | ) | ||||
| Maturity of short-term investments | ||||||||
| Purchase of equipment | ( | ) | ( | ) | ||||
| Net cash (used in) provided by investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from sale of common stock from public offering, net | ||||||||
| Payment of employee withholding taxes on vested restricted stock units | ( | ) | ( | ) | ||||
| Proceeds from sale of common stock from at-the-market program, net | ||||||||
| Proceeds from exercise of stock options | ||||||||
| Net cash provided by financing activities | ||||||||
| Foreign exchange effect on cash | ( | ) | ||||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | ( | ) | ||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH - END OF PERIOD | $ | $ | ||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental Disclosure of Non-Cash Investing Activities: | ||||||||
| Liability related to license agreement | $ | $ | ||||||
| Unrealized loss from investments | $ | ( | ) | $ | ( | ) | ||
See Accompanying Notes to Unaudited Condensed ConsolidatedFinancial Statements.
5
CORMEDIX INC. AND SUBSIDIARIES
NOTESTO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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
The Company’s primaryfocus is commercializing its lead product, DefenCath® (taurolidine and heparin) in the United States, or U.S. The nameDefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration, or FDA. CorMedix launched the product commerciallyin April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting.
Acquisition of Melinta
On August 7, 2025, the Company entered into an Agreement and Plan ofMerger (the “Merger Agreement”) with Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”),Coriander BidCo LLC, a Delaware limited liability company and a wholly owned subsidiary of the Company (“Merger Sub”), andDeerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative, agent and attorney-in-factof the Melinta equity holders (the “Members’ Representative”).
Pursuant to the terms of theMerger Agreement, and subject to the conditions contained therein, the Company has agreed to acquire Melinta via a merger in which MergerSub will merge with and into Melinta (the “Merger”), with Melinta surviving as a wholly owned subsidiary of the Company. Theclosing of the Merger is referred to herein as the “Closing.”
The boards of directors of the Company and Melinta have both unanimouslyapproved the proposed transaction, and the requisite members of Melinta, Deerfield Private Design Fund III, L.P. and Deerfield PrivateDesign Fund IV, L.P. (the “Consenting Melinta Members”), have approved the Merger. The Merger is subject to the expirationof the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Clearance”), and the satisfactionof other customary conditions, and the Merger currently is expected to be completed in September 2025.
Under the terms and subject to the conditions set forth in the MergerAgreement, at the effective time of the Merger (the “Effective Time” and the date of the Effective Time, the “ClosingDate”), the Company will (i) pay to the Melinta equityholders (including the Consenting Melinta Members) an aggregate of $
Convertible Notes Offering
On August 6, 2025, the Companyentered into subscription agreements (the “Subscription Agreements”) with certain investors to provide for the issuance of$
Upon issuance, the Notes willbe governed by an Indenture (the “Indenture”), by and between the Company and U.S. Bank Trust Company, National Association,as trustee (in such capacity, the “Trustee”). Upon issuance, the Notes will bear interest at a rate of
Basis of Presentation
The accompanying unauditedcondensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the UnitedStates of America, or GAAP, for interim financial information and with the instructions for Quarterly Reports on Form 10-Q and Article8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotesrequired by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidatedfinancial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interimresults. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31,2025, or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with theaudited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filedwith the Securities and Exchange Commission, or SEC, on March 25, 2025. The accompanying condensed consolidated balance sheet as of December31, 2024 has been derived from the audited financial statements included in such Annual Report on Form 10-K.
6
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Note 2 - Summary of Significant Accounting Policies and Liquidityand Uncertainties:
Liquidity and Other Uncertainties
The unaudited condensedconsolidated financial statements have been prepared in conformity with GAAP which contemplates continuation of the Company as agoing concern. For the first half of 2025, the Company generated net income and net cash from operating activities from the productsales of DefenCath. The Company’s future profitability will depend on the continued successful commercialization of DefenCath.The Company’s current commercial and development expenses for DefenCath and its other operating requirements are expected tobe funded for at least twelve months from the issuance of this Quarterly Report on Form 10-Q by the Company’s existing cash,cash equivalents and short-term investments at June 30, 2025, as well as the additional expected liquidity from commercialoperations. Also, as of June 30, 2025, approximately $
The Company’soperations are subject to other factors that can affect its operating results and cash flows over the next twelve months from theissuance of these financial statements. Such factors include, but are not limited to: the ability to continue to successfully marketDefenCath and generate necessary revenue in the time periods required; ability to continue to manufacture successfully with ourthird party contract manufacturers; competition from other products being sold or developed by other companies; the price of, andreimbursement environment for, the Company’s product; and the Company’s ability to negotiate favorable licensing orother manufacturing and marketing agreements for its products.
Use of Estimates
The preparation of financialstatements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financialstatements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptionsthat it believes are reasonable under the circumstances. The amounts of assets and liabilities and disclosure of contingent assets andliabilities in the Company’s condensed consolidated balance sheets and the reported amounts of revenue and expenses reported foreach of the periods presented are affected by estimates and assumptions. The more significant areas in which estimates and the exerciseof judgment relate include; variable consideration for product returns, Medicaid utilization rates; realization of receivables, valuationof inventory, share-based payment grant date valuation, deferred tax asset valuation changes and contingent liability recognition anddisclosures. Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances.They are continuously reviewed but may vary from the actuals.
Reclassifications
Certain reclassificationswere made to the prior year’s amounts to conform to the 2025 presentation.
Basis of Consolidation
The unaudited condensed consolidatedfinancial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts andtransactions have been eliminated in consolidation.
Trade Accounts Receivable and Allowances
The Company recognizes anallowance that reflects a current estimate of credit losses expected to be incurred over the life of a financial asset, including tradereceivables. The allowance for credit losses reflects the best estimate of expected credit losses of the accounts receivable portfoliodetermined on the basis of current information, forecasts of future economic conditions, industry knowledge and to some extent our historicalexperience. The Company determines its allowance methodology by pooling receivable balances at the customer level. The Company considersvarious factors, including individual credit risk associated with each customer, the current and future condition of the general economyand industry knowledge. These credit risk factors are monitored on a quarterly basis and updated as necessary. Also, to the extent anyindividual debtor is identified whose credit quality has deteriorated, the Company establishes allowances based on the individual riskcharacteristics of such customer. The Company makes concerted efforts to collect all outstanding balances due, however account balancesare charged off against the allowance when management believes it is probable the receivable will not be recovered. The Company does nothave any off-balance sheet credit exposure related to its customers. Allowances recorded for credit losses as of June 30, 2025 and December31, 2024 were approximately $
7
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Concentrations
The following table summarizesrevenue from each of the Company’s customers, who individually represent at least 10% of total revenue.
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Customer A | % | % | % | % | ||||||||||||
| Customer B | % | % | % | % | ||||||||||||
| Customer C | % | % | % | % | ||||||||||||
| Customer D | % | % | ||||||||||||||
The following table summarizesaccounts receivable concentrations for each of the Company’s customers, who individually represent at least 10% of total accountsreceivable.
| June 30, 2025 | December 31, 2024 | |||||||
| Customer A | % | % | ||||||
| Customer D | % | % | ||||||
| Customer B | % | % | ||||||
The Company currentlyhas one FDA approved source for each of our two key active pharmaceutical ingredients (“APIs”) for DefenCath, taurolidineand heparin sodium, respectively. With regards to taurolidine, the Company has a drug master file (“DMF”) filed with the FDA.There is a master commercial supply agreement between a third-party manufacturer which has been in place since August 2018. With respectto heparin sodium API, the Company has identified an alternate third-party supplier and may qualify such supplier under the DefenCathNDA over the next twelve months.
The Company received FDA approvalof DefenCath with finished dosage production from its European based contract manufacturing organization (“CMO”) Rovi PharmaIndustrial Services. The Company believes this CMO has adequate capacity to produce the volumes needed to meet near-term projected demandfor the commercial launch of DefenCath. The Company also qualified Siegfried Hameln as an alternate finished dosage manufacturing site.
Financial Instruments
Financial instruments thatpotentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investmentsand accounts receivable. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, thebalances of which, may exceed federally insured limits.
The following table is thereconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure offinancial instruments as shown on the Company’s consolidated statement of cash flows:
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Total cash, cash equivalents and restricted cash | $ | $ | ||||||
The appropriate classificationof marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketabledebt classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active marketsfor identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroboratedby observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporaryare reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest and dividendsearned 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, 2025 orDecember 31, 2024.
8
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
The Company’s marketablesecurities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper withoriginal maturities of more than 90 days. As of June 30, 2025 and December 31, 2024, all of the Company’s investments had contractualmaturities of less than one year.
| Amortized Cost | Gross Unrealized Losses | Gross Unrealized Gains | Fair Value | |||||||||||||
| June 30, 2025: | ||||||||||||||||
| Money Market Funds included in Cash Equivalents | $ | $ | ( | ) | $ | $ | ||||||||||
| U.S. Government Agency Securities | ( | ) | ||||||||||||||
| Commercial Paper | ( | ) | ||||||||||||||
| Subtotal | ( | ) | ||||||||||||||
| Total June 30, 2025 | $ | $ | ( | ) | $ | $ | ||||||||||
| December 31, 2024: | ||||||||||||||||
| Money Market Funds included in Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ||||||||||||||||
| Total December 31, 2024 | $ | $ | $ | $ | ||||||||||||
Fair Value Measurements
In accordance with AccountingStandards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instrumentsis required, whether or not recognized in the unaudited consolidated balance sheet, for which it is practicable to estimate that value.The Company’s financial instruments recorded in the unaudited consolidated balance sheets include cash and cash equivalents, accountsreceivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarilycash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based uponthe short-term nature of their maturity dates.
The Company categorizes itsfinancial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fairvalue. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowestpriority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, thecategory level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financialassets 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. |
9
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
The following table providesthe carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of June 30,2025 and December 31, 2024:
| Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| June 30, 2025: | ||||||||||||||||
| Money Market Funds and Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ||||||||||||||||
| Commercial Paper | ||||||||||||||||
| Subtotal | ||||||||||||||||
| Total June 30, 2025 | $ | $ | $ | $ | ||||||||||||
| December 31, 2024: | ||||||||||||||||
| Money Market Funds and Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ||||||||||||||||
| Total December 31, 2024 | $ | $ | $ | $ | ||||||||||||
Inventories
The Company engages thirdparties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costsrelated to the manufacturing of DefenCath incurred prior to FDA approval to support the preparation for commercial launch of its productwere expensed as research and development expenses (R&D) as incurred. Upon FDA approval, costs related to the manufacturing of inventoryare stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis.
Inventory is valued utilizingthe standard cost method. The Company regularly reviews inventory quantities on hand and writes down to its net realizable value any inventorythat it believes to be impaired. Management considers forecasted demand in relation to the inventory on hand, competitiveness of productoffering and sales volume assumptions, market conditions and product life cycle and expiration dating when determining net realizablevalue adjustments. Once inventory is written down and a new cost basis is established, it is not written back up if demand increases.The Company has not experienced any write-downs for any items listed above during the six months ended June 30, 2025.
Inventories consist of rawmaterials (including labeling and packaging), work-in-process, and finished goods for DefenCath.
| June 30, 2025 | December 31, 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Work in progress | ||||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
License Agreement
The Company’s rightsunder the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost. The Company amortizes the intangibleasset utilizing the straight-line method over the estimated economic life of the intangible asset based on the Company’s assessmentof 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 associated technology and various other competitive, developmentaland regulatory considerations, and contractual terms. See Note 5 – Commitments and Contingencies for further discussion.
10
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Leases
The Company determines ifan arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, currentportion of operating lease liabilities and operating lease liabilities, net of current portion, on the condensed consolidated balancesheets (see Note 7).
Operating lease ROU assetsand operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term atcommencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate basedon the information available at commencement date in determining the present value of future payments. The Company’s lease termsmay include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expensefor minimum lease payments is recognized on a straight-line basis over the lease term.
The Company has elected, asan accounting policy, not to apply the recognition requirements in ASC 842, Accounting for Leases, to short-term leases. Short-termleases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset thatthe Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-linebasis 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, accountfor them as a single component.
Revenue Recognition
The Company recognizes revenuefrom the sale of its product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers (“ASC606”). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) witha customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transactionprice to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
The Company recognizes revenuewhen it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or servicesthat will be transferred to the customer. The Company’s product revenue is recognized at a point in time when the performance obligationis satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contractswith 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 outpatient service providers and wholesale distributors.
Variable Consideration
The Company includes an estimateof variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variableconsideration includes:
| ● | Distribution service fees; | |
| ● | Prompt pay and other discounts; | |
| ● | Product returns; | |
| ● | Chargebacks; | |
| ● | Rebates; | |
| ● | Volume incentive rebates; | |
| ● | Shelf-stock adjustments; | |
| ● | Data fees. |
The Company assesses whetheror not an estimate of variable consideration is constrained based on the probability that a significant reversal in the amount of cumulativerevenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amountsof consideration ultimately received may vary from our estimates. If actual results in the future vary from estimates, the Company adjuststhese estimates, which would affect product sales and earnings in the period such variances become known.
The specific considerationsthat 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 netsales and the contractual fee rates negotiated with the customers in the distribution channel. The Company records these fees as contraaccounts receivable on the balance sheet.
11
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Prompt pay and other discounts– The Company provides customers with prompt pay discounts. The specific prompt pay terms vary by customer and are contractuallyfixed. Prompt pay discounts are expected to be taken by the Company’s customers, so an estimate of the discount is recorded at thetime 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 expirationdate by no more than six months. The Company determines its estimate for product returns based on: (i) data provided to the Company byits distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Companywith 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 thereturns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset forthe right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due tothe anticipated return). Estimated product returns are recorded as accrued expenses on the balance sheet.
Chargebacks – Certaincovered entities, group purchasing organizations (“GPO”) and government entities will be able to purchase the product at aprice discounted below wholesaler acquisition cost (“WAC”). The difference between the GPO, government or covered entity purchaseprice and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacksbased on the expected number of claims and related cost that is associated with the revenue being recognized for product that remainsin the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra accounts receivable on thebalance sheet.
Rebates – The Companyis or may become subject to negotiated discount obligations to different GPO, direct purchasers, other commercial organizations or governmentprograms, including Medicaid. 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 invoicedin arrears. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have notbeen 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 channelat 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 and indirect customers (primarily outpatient serviceproviders). Rebates are owed based on predetermined volume levels and payable per the terms in the customer contracts. The Company estimatesand 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.
Shelf-stock adjustments –The Company is subject to quarterly shelf-stock adjustments with certain direct customers to account for contract price changes as relatedto quarterly decreases to our published ASP. Inventory levels subject to shelf-stock adjustment are determined based on current customerutilization rates and current inventory levels at the customer. Shelf-stock adjustments are recorded as accrued expenses on the balancesheet.
Data fees – The Companyis subject to negotiated data fees with certain direct customers.
Provisions for the revenuevariable consideration described above totaled $
A roll forward of the majorcategories of variable consideration deductions for the six months ended June 30, 2025 is as follows:
| Volume Incentive Rebates | Medicaid and Commercial Rebates | Distribution Service Fees | Accrued Shelf- stock Liability | Accrued Returns Allowance | Prompt Pay and Other Discounts | |||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
| Provisions related to sales recorded in the period | ||||||||||||||||||||||||
| Credits/payments issued during the period | ( | ) | ( | ) | ( | ) | ( | |||||||||||||||||
| Effect of change in estimate | ||||||||||||||||||||||||
| Balance at March 31, 2025 | ||||||||||||||||||||||||
| Provisions related to sales recorded in the period | ||||||||||||||||||||||||
| Credits/payments issued during the period | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Effect of change in estimate | ||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
12
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
During the three and six months ended June 30, 2025, a change in estimatewas recorded for variable consideration pertaining to Medicaid and commercial rebates. During the three months ended June 30, 2025, newinformation was obtained by the Company surrounding Medicaid utilization rates for certain states that reimburse service providers usingDefenCath. The resulting change in accounting estimate negatively impacted net sales, income from continuing operations and net incomefor the three and six months ended June 30, 2025. For the three months ended June 30, 2025, net income was impacted by $
Income (Loss) Per Common Share
Income (loss) per common sharerequires consideration of the two-class method when an entity has participating securities. The Company’s outstanding shares ofSeries E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock,participating pro-rata in the earnings of the Company as if the Series E preferred stock was converted into common shares of the Company.As a result, the Series E preferred stock meets the definition of participating securities and the Company is required to apply the two-classmethod. 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 undistributedearnings. Since the Series E preferred stock does not have contractual obligations that require participation in the Company’s losses,the two-class method is not required for periods in which Company has a net loss.
Basic income (loss) per commonshare excludes dilution and is computed by dividing net income (loss) by the weighted average number of common shares, including applicableparticipating securities, outstanding during the period. For the three and six months ended June 30, 2025, basic income per common shareis calculated assuming the Series E preferred stock was converted into common shares and participates in the earnings of the Company ona pro-rata basis. As a result, net income for the three and six months ended June 30, 2025 is allocated pro-rata between the Company’sweighted average outstanding common shares and Series E preferred stock (on an as-if converted basis). On an as-if converted basis, theSeries E preferred stock is equal to
For periods of net income,diluted net income per share is computed using the more dilutive of the treasury method or two class method. Because the Company’sSeries E preferred stock does not contain non-forfeitable rights to dividends, the “two class” method results in the samediluted net income per share as the “treasury method.” Diluted net income (loss) per common share reflects the potential dilutionthat could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in theissuance of common stock that then shared in the earnings of the Company. The Company calculates dilutive potential common shares usingthe treasury stock method for stock options and restricted units, which assumes the Company will use the proceeds from the exercise ofstock options and vesting of restricted stock units to repurchase shares of common stock to hold in its treasury stock reserves. The Companycalculates dilutive potential common shares using the if-converted method for preferred stock, which assumes the preferred stock is convertedat the beginning of the period (or at time of issuance, if later).
For the three and six months ended June 30, 2024, the two-classmethod was not required since the Company was in a net loss position and the participating securities do not have contractual obligationsthat require participation in the Company’s losses.
A reconciliation of the Company’sbasic and diluted income (loss) per common share is as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net income (loss) | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Denominator: | ||||||||||||||||
| Basic weighted average common shares outstanding | ||||||||||||||||
| Effect of potentially dilutive securities | ||||||||||||||||
| Diluted weighted average common shares outstanding | ||||||||||||||||
13
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
The following potentiallydilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be antidilutive:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Number of Shares of Common Stock Issuable) | (Number of Shares of Common Stock Issuable) | |||||||||||||||
| Series C-3 non-voting preferred stock | ||||||||||||||||
| Series E non-voting preferred stock | ||||||||||||||||
| Series G non-voting preferred stock | ||||||||||||||||
| Shares issuable for payment of deferred board compensation | ||||||||||||||||
| Shares underlying outstanding stock options | ||||||||||||||||
| Shares underlying restricted stock units | ||||||||||||||||
| Total potentially dilutive shares | ||||||||||||||||
Stock-Based Compensation
Stock option-based compensationcost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for optionswith service conditions. Restricted stock unit (“RSU”) compensation is based upon the fair value of the Company’s commonstock on the date of the grant for RSU’s that vest upon service or performance conditions. Performance stock units (“PSU’s”)which vest upon market conditions, utilize a Monte-Carlo simulation model. Stock-based compensation is recognized as expense over therequisite service period on a straight-line basis. See Note 6.
Research and Development
Research and development costsare charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical researchorganizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract centraltesting laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues forcosts incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external serviceproviders. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs relatedto the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurredand considered a component of research and development expense.
Income Taxes
The Company accounts for income taxes under the asset and liabilitymethod. Under this method, deferred income tax assets and liabilities are recognized for the expected future tax consequences of temporarydifferences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. In assessingthe realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferredtax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable incomeduring the periods in which those temporary differences become deductible. Due to the uncertainty of the Company’s ability to realizethe benefit of the deferred tax assets, the net deferred tax assets are offset by a valuation allowance at June 30, 2025 and June 30,2024.
The provision for income taxesduring interim reporting periods is computed by applying an estimated annual effective tax rate to year-to-date income, adjusted for discreteitems occurring within the quarter. The estimated annual effective tax rate is updated quarterly based on changes in the forecast of full-yearincome and tax expense.
The effective income tax ratesfor the three and six months ended June 30, 2025 were and
The Company recorded an income tax expense of $
Based on consideration ofall available evidence, the Company has a full valuation allowance against all of the deferred tax assets as of both June 30, 2025 andDecember 31, 2024 due to cumulative historical losses incurred through December 31, 2024 and current year earnings being limited to thefirst two quarters of 2025. We will continue to maintain a full valuation allowance on our deferred tax assets until there is sufficientpositive evidence to support the reversal of all or some portion of these allowances. A release of the valuation allowance would resultin the recognition of certain deferred tax assets and a corresponding income tax benefit in the period the release is recorded. The amountof the valuation allowance release will be determined based on the available sources of future taxable income as of the period in whichthe release is recorded.
14
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Profit (Loss) before income taxes | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Provision (Benefit) for income taxes | $ | ( | ) | |||||||||||||
| Effective tax rate | % | % | % | % | ||||||||||||
Recent Accounting Pronouncements
From time to time, new accountingpronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Companyadopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issuedstandards have or may have a material impact on its consolidated financial statements or disclosures.
ASU 2024-03
In November 2024, the FASBissued ASU 2024-03, ASC 220- Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, whichrequires entities, in the notes to financial statements, with specified information about certain costs and expenses. The guidance iseffective for CorMedix’s annual reporting period ending December 31, 2027, with interim periods beginning with CorMedix’sinterim period ended March 31, 2028. Early adoption is permitted. CorMedix is assessing the impact of adopting this guidance on its condensedconsolidated financial statements.
ASU No. 2023-09
In December 2023, the FASB issued Accounting Standards Update (ASU)No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740). The standard requires disaggregation of theeffective rate reconciliation into standard categories, enhances disclosure of income taxes paid, and modifies other income tax-relateddisclosures. The guidance is effective for CorMedix’s annual reporting period ending December 31, 2025. CorMedix is currently assessingthe impact of adopting this guidance on the condensed consolidated financial statements.
Note 3 - Other Prepaid Expenses andCurrent Assets:
Other prepaid expenses andcurrent assets consist of the following:
| June 30, 2025 | December 31, 2024 | |||||||
| Prepaid API | $ | $ | ||||||
| Commercial | ||||||||
| FDA filing fee | ||||||||
| Medical affairs | ||||||||
| Subscriptions | ||||||||
| Insurance | ||||||||
| Clinical | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
Note 4 - Accrued Expenses:
Accrued expenses consist of the following:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Accrued gross-to-net-deductions | $ | $ | ||||||
| Accrued payroll and payroll taxes | ||||||||
| License agreement payable | ||||||||
| Professional and consulting fees | ||||||||
| Income tax payable | ||||||||
| Manufacturing related | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
15
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
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 UnitedStates 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 andlead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections11 and 15 of the Securities Act of 1933. On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that supersededthe original complaints in In re CorMedix Securities Litigation. On March 21, 2024, the Court denied Defendants’ motion to dismisswithout prejudice and granted lead plaintiff leave to amend the complaint. On April 22, 2024, lead plaintiff filed a third amended consolidatedcomplaint that superseded the second amended consolidated complaint. In the third amended complaint, the lead plaintiff seeks to representa 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 collectivelywith CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the CorMedix Defendants violated Section10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a). In general, the purported bases forthese claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequentcomplete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organizationand heparin supplier. The Company filed its motion to dismiss the third amended complaint on June 6, 2024, and received from Plaintiffstheir opposition to the Company’s motion to dismiss on July 22, 2024. The Company filed its response on August 21, 2024. On June30, 2025, the Court denied the CorMedix Defendants’ motion to dismiss the third amended complaint. On July 23, 2025, in responseto a letter from the CorMedix Defendants identifying errors in the motion to dismiss opinion, the Court withdrew its opinion, statingthat it was “entered in error” and that a “subsequent Opinion and Order will follow.” On July 23, 2025, the Courtso-ordered the parties’ proposed Pretrial Scheduling Order with deadlines for discovery. The Company intends to vigorously contestthe claims.
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 DistrictCourt for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “DerivativeLitigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, PauloF. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco along with the Company as Nominal Defendant. The complaint allegesbreaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution forpurported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. On January 21, 2022, pursuant to a stipulationbetween the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit described in theforegoing paragraph is pending. The stay may be terminated before the motion to dismiss is resolved according to certain circumstancesdescribed 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 StatesDistrict Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al., Case No. 2:23-cv-00150-JXN-CLW. DefendantsPaulo F. Costa, Janet D. Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch, Robert Cook,Matthew David, Phoebe Mounts, and John L. Armstrong along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciaryduty and unjust enrichment against the individual defendants.
16
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
On or about January 25, 2023,another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United StatesDistrict Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al., Case No. 2:23-cv-00406-ES-ESK. DefendantsKhoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and PhoebeMounts, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duties.
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, C.A. No. 2:21-cv-18493-JXN-LDW.The individual defendants intend to vigorously contest the claims set forth in the consolidated derivative action. The provisions of theOrder to Stay entered in the Voter Action on January 21, 2022, apply to the consolidated derivative action. On April 20, 2023,the consolidated derivative action was administratively terminated and removed from the Court’s docket until the motion to dismissthe class action is resolved and the Private Securities Litigation Reform Act, or PSLRA, stay is lifted. On June 30, 2025, the Court deniedthe CorMedix Defendants’ motion to dismiss the securities class action (as discussed in the preceding section, the Court withdrewits order on July 23, 2025). On July 16, 2025, the Court in the derivative litigation entered the parties’ Joint Stipulation GoverningSchedule, which provides that the derivative plaintiffs have until September 15, 2025 to file a consolidated complaint. The individualdefendants intend to vigorously contest the claims.
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 the Company,against certain current and former directors, officers, and/or other employees of the Company (the “Letter”), which the Boardbelieves are duplicative of the claims already asserted in the Derivative Litigation. As set forth in the Board’s response to theLetter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress ofthe Derivative Litigation.
Commitments
License and Assignment Agreement
In 2008, the Company enteredinto 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 inhibitinginfections, 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 Companypaid NDP an initial licensing fee of $
Under the ND License Agreement, the Company is required to make cashand equity payments to NDP upon the achievement of certain milestones. Under the ND License Agreement, the maximum aggregate amount ofcash payments due upon achievement of applicable milestones was $
17
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Beginning in the second quarterof 2024, the license intangible asset is amortized as cost of goods sold over its estimated economic life of approximately
The ND License Agreement willexpire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement ina given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, we willhave an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country. The ND License Agreementalso may be terminated by NDP if the Company materially breaches or defaults under the ND License Agreement and that breach is not curedwithin 60 days following the delivery of written notice to the Company, or by the Company on a country-by-country basis upon 60 days priorwritten notice in the event the Company’s Board determines not to proceed with the development of the NDP Technology. If the NDLicense Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP.
Other Commitments
In December 2024, the Companyentered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will providea dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. The Company has paidan up-front implementation and are obligated to pay a fixed monthly fee. Upon the twelve-month anniversary of the deployment date,expected to be in the second quarter of 2026, the agreement is cancelable upon 60 days’ written notice. As of June 30, 2025,the minimum amount committed under this agreement totals $
The Company entered into aseven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The leaseagreement, with a monthly average cost of approximately $
Note 6 - Stockholders’ Equity:
Common Stock
On May 9, 2024, the Companyfiled a shelf registration statement (the “2024 Shelf Registration Statement”) for the issuance of up to $
On June 30, 2025, the Companycompleted an underwritten public offering of common stock pursuant to the Company’s universal shelf registration statement on FormS-3, selling an aggregate of
18
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Preferred Stock
The Company is authorizedto issue up to
| As of June 30, 2025 | As of December 31, 2024 | |||||||||||||||||||||||
| Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | |||||||||||||||||||
| Series C-3 | $ | $ | $ | |||||||||||||||||||||
| Series E | $ | $ | $ | |||||||||||||||||||||
| Series G | - | $ | - | $ | $ | |||||||||||||||||||
| Total | $ | |||||||||||||||||||||||
In March 2025,
Restricted and Performance Stock Units
The Company has issued restrictedstock units (“RSUs”) and performance stock units (“PSUs”) to certain employees and non-employee directors as compensationfor services. The grant date fair value of the RSUs is based upon the fair value of the Company’s common stock on the date of thegrant for RSUs that vest upon service or performance conditions. For RSUs that vest upon market conditions, the grant date fair valueof RSUs is based upon a Monte-Carlo simulation model.
During the six months endedJune 30, 2025, the Company granted
During the six months ended June 30, 2024, the Company granted
In addition to the RSUs notedabove, during the six months ended June 30, 2025, the Company issued
| Assumption | Period 1 | Period 2 | Period 3 | |||||||||
| Share price | $ | |||||||||||
| Equity volatility | % | % | % | |||||||||
| Remaining term (years) | ||||||||||||
| Dividend yield | % | % | % | |||||||||
| Risk-free rate | % | % | % | |||||||||
Compensation expense relatedto these PSUs is recognized on a straight-line basis over the requisite service period, regardless of whether the market condition isultimately satisfied.
As of June 30, 2025, the Companyhas
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CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Stock Options
During the six months endedJune 30, 2025 no stock options were issued. During the six months ended June 30, 2024, the Company granted ten-year qualified and non-qualifiedstock options covering an aggregate of
During the six months endedJune 30, 2025, the Company issued
As of June 30, 2025, therewas approximately $
The Company uses the simplified method to calculate the expected termwhich takes into account the vesting term and the expiration date of the stock options. The expected term of the stock options grantedto consultants, if any, is based upon the full term of the respective option agreements. The expected stock price volatility for the Company’sstock options is calculated based on the historical volatility of the Company’s stock price for the expected term. The forfeituresof share-based awards were recognized in the period in which they occur. The expected dividend yield of
The total stock-based compensationexpense recognized in the condensed consolidated statements of operations is as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| Award type | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| RSUs | $ | $ | $ | $ | ||||||||||||
| PSUs | ||||||||||||||||
| Stock options | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The following table represents the allocation ofstock-based compensation expense by financial statement line item:
| Three Months Ended June 30, | SixMonths Ended | |||||||||||||||
| Financial statement line item | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Cost of sales | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Note 7 - Leases:
The Company entered into aseven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The leaseagreement, with a monthly average cost of approximately $
Operating lease expense inthe Company’s condensed consolidated statements of operations and comprehensive income (loss) for each of the three and six monthsended June 30, 2025 was approximately $
20
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
At June 30, 2025, the Companyhas a total operating lease liability of $
The weighted average remaininglease term as of June 30, 2025 and 2024 were
As of June 30, 2025, maturities of lease liabilitieswere as follows:
| 2025 (excluding the six months ended June 30, 2025) | $ | |||
| 2026 | ||||
| 2027 | ||||
| Total future minimum lease payments | ||||
| Less imputed interest | ( | ) | ||
| Total | $ |
Note 8 - Segment Reporting:
As noted above, the Company’sprimary focus is the commercialization of its lead product, DefenCath, indicated to reduce the incidence of catheter-related bloodstreaminfections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (“CVC”).
The Company has determinedthat it currently operates in a single segment - Drug Product, located in a single geographic location – the United States. Theaccounting policies of the segment are the same as those described in the summary of significant accounting policies. Since the Companyoperates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanyingbalance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development: | ||||||||||||||||
| Employee expense | $ | $ | $ | $ | ||||||||||||
| Other research and development | ||||||||||||||||
| Total research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| Employee and contracted employee expense | $ | $ | $ | $ | ||||||||||||
| Other selling and marketing | ||||||||||||||||
| Total selling and marketing expense | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Employee expense | $ | $ | $ | $ | ||||||||||||
| Other general and administrative | ||||||||||||||||
| Total general and administrative expense | ||||||||||||||||
| Total operating expenses | $ | $ | $ | $ | ||||||||||||
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CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Note 9 - Subsequent Events:
On July 4, 2025, the'One Big Beautiful Bill Act' (the “OBBBA”) was signed into law. This legislation includes significant changes to U.S. federaltax laws, notably restoring immediate expensing for domestic research and experimentation expenditures, reinstating
Acquisition of Melinta
On August 7, 2025, the Companyentered into the Merger Agreement with Melinta, Merger Sub, and the Members’ Representative.
Pursuant to the terms of theMerger Agreement, and subject to the conditions contained therein, the Company has agreed to acquire Melinta via a merger in which MergerSub will merge with and into Melinta (the “Merger”), with Melinta surviving as a wholly owned subsidiary of the Company.
The boards of directors of the Company and Melinta have both unanimouslyapproved the proposed transaction, and the requisite members of Melinta, Deerfield Private Design Fund III, L.P. and the Consenting MelintaMembers, have approved the Merger. The Merger is subject to the expiration of the waiting period under the Hart-Scott-Rodino AntitrustImprovements Act of 1976, and the satisfaction of other customary conditions, and the Merger currently is expected to be completed inSeptember 2025.
Under the terms and subject to the conditions set forth in the MergerAgreement, at the effective time of the Merger (the “Effective Time” and the date of the Effective Time, the “ClosingDate”), the Company will (i) pay to the Melinta equityholders (including the Consenting Melinta Members) an aggregate of $
Representations and Warranties;Covenants; Conditions to Closing; Termination
The Merger Agreement contains a number of representations and warrantiesmade by the Company, Merger Sub and Melinta as of the date of such agreement or other specific dates solely for the benefit of certainof the parties to the Merger Agreement, which in certain cases are subject to specified exceptions and materiality, Company Material AdverseEffect or Parent Material Adverse Effect (each as defined in the Merger Agreement), knowledge and other qualifications contained in theMerger Agreement or in information provided pursuant to certain disclosure schedules to the Merger Agreement. The representations andwarranties made under the Merger Agreement will not survive the Closing.
The Merger Agreement containscertain customary covenants for transactions of this type by the Company and Melinta. None of the covenants and agreements of the partiescontained in the Merger Agreement will survive the Closing, except for those covenants and agreements that by their terms expressly applyin whole or in part after the Closing.
The Merger is subject to variousclosing conditions, including, but not limited to: (i) HSR Clearance; (ii) the absence of any statute, rule, order, decree or regulationprohibiting the Merger; (iii) the absence of any Parent Material Adverse Effect or Company Material Adverse Effect (each as defined inthe Merger Agreement) on the Company or Melinta, respectively; and (iv) the accuracy of the representations and warranties and the complianceby each party with the covenants contained in the Merger Agreement, subject to the materiality standards and exceptions set forth in theMerger Agreement.
The Merger Agreement may beterminated under certain customary and limited circumstances prior to the closing of the Merger.
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CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
Contingent Payment Agreement
Pursuant to the terms of the Merger Agreement, simultaneously withthe Closing, the Company, Melinta, the Consenting Melinta Members and the Members' Representative will enter into a contingent paymentagreement (the "Contingent Payment Agreement"), pursuant to which in connection with the Merger Agreement and as part of theMerger Consideration payable to the Consenting Melinta Members, the Company will make certain payments to the Contingent Payment Holders(as defined in the Contingent Payment Agreement) as described below.
The Contingent Payment Agreementprovides for milestone and net sales based payments. Upon the issuance of the U.S. Food and Drug Administration (“FDA”) marketingapproval of (a) the product known as REZZAYOTM (rezafungin) as of the date hereof or as may be modified thereafter, or (b)any product that contains the active ingredient rezafungin, for the prevention or prophylaxis of invasive fungal infections in adult patientsundergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, the Company shallpay, in cash or common shares, par value $
| (i) | if the FDA-approved labeling includes candida, $ |
| (ii) | if the FDA-approved labeling includes aspergillus, $ |
| (iii) | if the FDA-approved labeling includes pneumocystis, $ |
Further, the Contingent PaymentAgreement provides that the Company will pay to the Contingent Payment Holders tiered royalties on REZZAYOTM (rezafungin) U.S.net sales and low-single-digit royalties on MINOCIN® (minocycline) U.S. net sales.
Registration Rights Agreement
Pursuant to the terms of theMerger Agreement, simultaneously with the Closing, the Company and the Consenting Melinta Members will enter into a registration rightsagreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company will agree to registerfor resale, pursuant to Rule 415 under the Securities Act, the Merger Shares, the shares of Common Stock issuable upon exercise of anyMerger Warrants (the “Merger Warrant Shares”) and other equity securities issued to the Consenting Melinta Members, if any,pursuant to the Contingent Payment Agreement. One third of the Merger Shares and Merger Warrant Shares will be subject to a 60-day lock-up,and one third of Merger Shares and Merger Warrant Shares will be subject to a 120 day lock-up.
Convertible Notes Offering
On August 6, 2025, the Companyentered into the Subscription Agreements with certain investors to provide for the issuance of $
Upon issuance, the Notes willbe governed by an Indenture (the “Indenture”), by and between the Company and U.S. Bank Trust Company, National Association,as trustee. Upon issuance, the Notes will bear interest at a rate of
Following issuance of theNotes, the Company intends to use the net proceeds from the Convertible Notes Offering to fund a portion of the purchase price payablein connection with the Merger, including related fees and expenses, and to the extent there are any remaining proceeds in excess of thefunds needed for the forgoing purposes, for such other general corporate purposes as the Company determines as appropriate.
The Company has the optionto redeem all, but not part, of the Notes if the Company publicly announces that the Merger Agreement has been terminated or that theMerger will not otherwise be consummated (the “Melinta Acquisition Redemption” and on such date, the “Melinta AcquisitionRedemption Date”), at a redemption price equal to the greater of (i)
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In addition, on or after August4, 2028 and prior to the 26th Scheduled Trading Day (as defined in the Indenture) immediately preceding the Maturity Date,the Company may redeem for cash all or any portion of the Notes, at its option, subject to certain conditions and requirements set forthin the Indenture, if the last reported sale price of the Company’s Common Stock has been at least
If the Company experiencesa Fundamental Change (as defined in the Indenture) at any time prior to the Maturity Date, any holder of the Notes may require the Companyto repurchase all of such holder’s Notes, or any portion of the principal amount thereof equal to $
Following issuance of theNotes, the Notes will be convertible at the option of the holders (i) during any calendar quarter commencing after the calendar quarterending on September 30, 2025 (and only during such calendar quarter), if the closing price of the Common Stock for at least 20 tradingdays (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of theimmediately preceding calendar quarter is equal to or greater than
Uponconversion, the Company will satisfy its conversion obligation by paying or delivering, as the case may be, cash, shares of the Company’sCommon Stock or a combination of cash and shares of Common Stock, at the Company’s election (provided that for so long as the ExchangeCap (as defined in the Indenture) applies, the Company may only elect Cash Settlement or Capped Combination Settlement (as such termsare defined in the indenture)), in the manner and subject to the terms and conditions provided in the Indenture. Notwithstanding the foregoing,prior to receipt of approval from the Company’s stockholders in accordance with Nasdaq rules, the Company will not issue any sharesof Common Stock under the Indenture (including any shares issued pursuant to conversions of the Notes), together with any transactionsaggregated with the foregoing (including any issuance of shares (including Merger Warrant Shares) contemplated by the Merger Agreementand any issuance of shares (including Merger Warrant Shares) pursuant to the Contingent Payment Agreement), if the issuance of such sharesof Common Stock would exceed
The conversion rate for theNotes will be determined upon issuance in accordance with the Indenture, and will be equal to an amount (rounded to four decimal places)equal to (i) $
The conversion rate is subjectto adjustment under certain circumstances in accordance with the Indenture. In connection with certain corporate events or if the Companyissues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert theirNotes in connection with such corporate event or during the relevant redemption period.
Amended andRestated Certificate of Designation
On August 6, 2025, the Companyfiled a Third Amended and Restated Certificate of Designation of the Series E Convertible Preferred Stock (the “Series E PreferredStock”) with the Secretary of State of the State of Delaware modifying certain of the covenants and other terms thereof includingthe stated value per share of Series E Preferred Stock. The Third Amended and Restated Certificate of Designation was effective upon acceptanceby the Secretary of State of the State of Delaware.
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Item 2. Management’s Discussion and Analysis of FinancialCondition and Results of Operations.
The following discussionand analysis of our financial condition and results of operations should be read in conjunction with the unaudited financial informationand the notes thereto included in this Quarterly Report on Form 10-Q and our audited 2024 Annual Report on Form 10-K, filed with the Securitiesand Exchange Commission, or the SEC, on March 25, 2025.
Forward Looking Statements
This Quarterly Report on Form10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identifiedby the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,”“could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,”“project,” “seek,” “should,” “target,” “will,” “would,” and similarexpressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts,regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements.Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, andreaders are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Reporton Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedixmay not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak onlyas of the date of this Quarterly Report on Form 10-Q. Investors should not place undue reliance on these statements. CorMedix assumesno obligation and does not intend to update these forward-looking statements, except as required by law.
Forward-looking statements involve estimates, expectations, projections,goals, forecasts, assumptions, risks and uncertainties. Actual outcomes or results may differ from anticipated results, sometimes materially.Factors that could cause actual results to differ include, but are not limited to: the ultimate outcome of the acquisition of Melinta;the satisfaction of the conditions to the closing of the proposed transaction in a timely manner; the ability of the combined companyto achieve the identified synergies; the ability to integrate the Melinta business into CorMedix and realize the anticipated strategicbenefits of the transaction within the expected time-frames or at all; that such integration may be more difficult, time-consuming orcostly than expected; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintainingrelationships with employees, customers or suppliers) may be greater than expected following the proposed transaction or the public announcementof the proposed transaction; the retention of certain key employees of Melinta; the expected benefits and success of Melinta’s productsand product candidates; potential litigation relating to the potential transaction that could be instituted against CorMedix or its directors;rating agency actions and CorMedix’s ability to access short- and long-term debt markets on a timely and affordable basis; generaleconomic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policiesand relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and futurecompetitors.
Overview
CorMedix Inc. (collectively,with our wholly owned subsidiaries, referred to herein as “we,” “us,” “our” or the “Company”)is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions.
Our primary focus is commercializingour lead product, DefenCath® (taurolidine and heparin), in the U.S. The name DefenCath is the U.S. proprietary name approvedby the U.S. Food and Drug Administration (“FDA”). CorMedix launched the product commercially in April 2024 in the inpatientsetting and July 2024 in the outpatient hemodialysis setting.
DefenCath is an FDA approvedantimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicatedto reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receivingchronic hemodialysis through a central venous catheter (“CVC”). It is indicated for use in a limited and specific populationof patients. CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to extended and oftenrepeat hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, relatedtreatment costs, as well as increased mortality. We believe DefenCath can address a significant unmet medical need.
Following the submission ofa duplicate New Technology Add-On Payment (“NTAP”) application to Centers for Medicare and Medicaid Services (“CMS”),CMS issued the Inpatient Prospective Payment System (“IPPS”) 2024 proposed rule that includes a NTAP per hospital stay forDefenCath. This NTAP represents reimbursement to inpatient facilities of 75% of the wholesaler acquisition cost (“WAC”) priceper 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS rule was amended as of October 1, 2024 to reflectthe current WAC of $249.99 per 3ml vial resulting in a potential maximum NTAP of $3,656.10, which CMS has extended through November 15,2026.
On November 15, 2023, we announcedthat the FDA approved the new drug application (“NDA”) for DefenCath to reduce the incidence of CRBSI in adult patients withkidney failure receiving chronic hemodialysis through a CVC, DefenCath is indicated for use in a limited and specific population of patients.DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in aPhase 3 clinical study. As a result of the November 2023 FDA approval, CorMedix launched the product commercially in April 2024 in theinpatient setting and July 2024 in the outpatient hemodialysis setting.
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DefenCath is listed in theOrange Book as having new chemical entity (“NCE”) exclusivity (5 years) expiring on November 15, 2028, and the GeneratingAntibiotic Incentives Now (“GAIN”) exclusivity extension of the NCE exclusivity (an additional 5 years) expiring on November15, 2033. The GAIN exclusivity extension of 5 years is the result of the January 2015 designation of DefenCath as a Qualified InfectiousDisease Product (“QIDP”).
On January 25, 2024, CMS determinedthat DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective paymentsystem (“ESRD PPS”). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drugadd-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submittedan application for TDAPA on January 26, 2024, and received confirmation that our application was approved on April 18, 2024 for a July1, 2024 implementation. We also submitted a Healthcare Common Procedure Coding System (“HCPCS”) application for a J-code toCMS on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application. The HCPCS J-code for DefenCath was publishedby CMS on April 2, 2024. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price ormanufacturers’ list price, respectively, if such data is unavailable). TDAPA and post-TDAPA add-on payment adjustments for DefenCathapply for five years (with such add-on payments applying to all ESRD PPS payments for years three through five). CMS confirmed a July1, 2024 implementation date for HCPCS and TDAPA.
We announced on June 6, 2024that the CMS has determined that DefenCath qualified for pass-through status under the hospital Out-Patient Prospective Payment System(“OPPS”). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in theoutpatient ambulatory setting for a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysiscan be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-basedalternative for patients. We estimate that up to 100,000 hemodialysis-central venous catheter (“HD-CVC”) placements occureach year, and pass-through status offers providers a separate reimbursement mechanism in this setting of care administration of DefenCath.
Subsequent to the launch ofDefenCath in April 2024, we announced U.S.-based multi-year commercial supply agreements consisting of a large and several mid-sized dialysisorganizations. Each provider has customized an implementation plan to provide access to patients based on a variety of clinical and otherfactors. We believe the currently contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in termsof the total addressable patient market. During the second quarter of 2025, the Company’s large dialysis organization customercommenced ordering.
Recent Developments
Acquisition of Melinta
On August 7, 2025, the Company entered into an Agreement and Plan ofMerger (the “Merger Agreement”) with Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”),Coriander BidCo LLC, a Delaware limited liability company and a wholly owned subsidiary of the Company (“Merger Sub”), andDeerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative, agent and attorney-in-factof the Melinta equity holders (the “Members’ Representative”).
Pursuant to the terms of theMerger Agreement, and subject to the conditions contained therein, the Company has agreed to acquire Melinta via a merger in which MergerSub will merge with and into Melinta (the “Merger”), with Melinta surviving as a wholly owned subsidiary of the Company. Theclosing of the Merger is referred to herein as the “Closing.”
The boards of directors of the Company and Melinta have both unanimouslyapproved the proposed transaction, and the requisite members of Melinta, Deerfield Private Design Fund III, L.P. and Deerfield PrivateDesign Fund IV, L.P. (the “Consenting Melinta Members”), have approved the Merger. The Merger is subject to the expirationof the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Clearance”), and the satisfactionof other customary conditions, and the Merger currently is expected to be completed in September 2025.
Under the terms and subject to the conditions set forth in the MergerAgreement, at the effective time of the Merger (the “Effective Time” and the date of the Effective Time, the “ClosingDate”), the Company will (i) pay to the Melinta equityholders (including the Consenting Melinta Members) an aggregate of $260 millionin cash (subject to adjustment for the Aggregate Exercise Price, Estimated Company Cash, Estimated Company Debt, Estimated Working Capitalas compared to the Working Capital Target, and Estimated Transaction Expenses (each as defined in the Merger Agreement)), and (ii) tothe Consenting Melinta Members an aggregate of $40 million worth of common shares, par value $0.001 per share, of the Company (the “MergerShares”) or, at the election of a Consenting Melinta Member, in lieu of any of the Merger Shares it is so entitled to receive, apre-funded warrant exercisable for such number of Merger Shares (each, a “Merger Warrant”). Additionally, the Consenting MelintaMembers and certain Company Optionholders (as defined in the Merger Agreement) will be eligible to receive certain contingent paymentspursuant to the terms of the Merger Agreement, the Contingent Payment Agreement (as defined and described below) and the Option TreatmentAgreements (as defined in the Merger Agreement). The cash consideration will be funded by a combination of the Company’s existingcash on hand and a $150 million Convertible Notes Offering (as defined below).
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Representations and Warranties;Covenants; Conditions to Closing; Termination
The Merger Agreement contains a number of representations and warrantiesmade by the Company, Merger Sub and Melinta as of the date of such agreement or other specific dates solely for the benefit of certainof the parties to the Merger Agreement, which in certain cases are subject to specified exceptions and materiality, Company Material AdverseEffect or Parent Material Adverse Effect (each as defined in the Merger Agreement), knowledge and other qualifications contained in theMerger Agreement or in information provided pursuant to certain disclosure schedules to the Merger Agreement. The representations andwarranties made under the Merger Agreement will not survive the Closing.
The Merger Agreement containscertain customary covenants for transactions of this type by the Company and Melinta. None of the covenants and agreements of the partiescontained in the Merger Agreement will survive the Closing, except for those covenants and agreements that by their terms expressly applyin whole or in part after the Closing.
The Merger is subject to variousclosing conditions, including, but not limited to: (i) HSR Clearance; (ii) the absence of any statute, rule, order, decree or regulationprohibiting the Merger; (iii) the absence of any Parent Material Adverse Effect or Company Material Adverse Effect (each as defined inthe Merger Agreement) on the Company or Melinta, respectively; and (iv) the accuracy of the representations and warranties and the complianceby each party with the covenants contained in the Merger Agreement, subject to the materiality standards and exceptions set forth in theMerger Agreement.
The Merger Agreement may beterminated under certain customary and limited circumstances prior to the closing of the Merger.
Contingent Payment Agreement
Pursuant to the terms of the Merger Agreement, simultaneously withthe Closing, the Company, Melinta, the Consenting Melinta Members and the Members' Representative will enter into a contingent paymentagreement (the "Contingent Payment Agreement"), pursuant to which in connection with the Merger Agreement and as part of theMerger Consideration payable to the Consenting Melinta Members, the Company will make certain payments to the Contingent Payment Holders(as defined in the Contingent Payment Agreement) as described below.
The Contingent Payment Agreementprovides for milestone and net sales based payments. Upon the issuance of the U.S. Food and Drug Administration (“FDA”) marketingapproval of (a) the product known as REZZAYOTM (rezafungin) as of the date hereof or as may be modified thereafter, or (b)any product that contains the active ingredient rezafungin, for the prevention or prophylaxis of invasive fungal infections in adult patientsundergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, the Company shallpay, in cash or common shares, par value $0.001 per share, of the Company (“Common Stock”) at the Company’s election,to the Contingent Payment Holders and certain Company Optionholders the following payments:
| (i) | if the FDA-approved labeling includes candida, $20 million; |
| (ii) | if the FDA-approved labeling includes aspergillus, $2.5 million; and |
| (iii) | if the FDA-approved labeling includes pneumocystis, $2.5 million. |
Further, the Contingent PaymentAgreement provides that the Company will pay to the Contingent Payment Holders tiered royalties on REZZAYOTM (rezafungin) U.S.net sales and low-single-digit royalties on MINOCIN® (minocycline) U.S. net sales.
Registration Rights Agreement
Pursuant to the terms of theMerger Agreement, simultaneously with the Closing, the Company and the Consenting Melinta Members will enter into a registration rightsagreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company will agree to registerfor resale, pursuant to Rule 415 under the Securities Act, the Merger Shares, the shares of Common Stock issuable upon exercise of anyMerger Warrants (the “Merger Warrant Shares”) and other equity securities issued to the Consenting Melinta Members, if any,pursuant to the Contingent Payment Agreement. One third of the Merger Shares and Merger Warrant Shares will be subject to a 60-day lock-up,and one third of Merger Shares and Merger Warrant Shares will be subject to a 120 day lock-up.
Convertible Notes Offering
On August 6, 2025, the Companyentered into subscription agreements (the “Subscription Agreements”) with certain investors to provide for the issuance of$150,000,000 aggregate principal amount of its convertible senior notes due 2030 (the “Notes”) in a private placement, exemptfrom registration pursuant to Section 4(a)(2) of the Securities Act. Such offering is herein referred to as the “Convertible NotesOffering.” Upon issuance, the Notes will be eligible for resale to persons reasonably believed to be qualified institutional buyerspursuant to Rule 144A of the Securities Act. Subject to the terms and conditions of the Subscription Agreements, the Company expects theNotes to be issued on August 12, 2025 (the “Notes Closing Date”).
Upon issuance, the Notes willbe governed by an Indenture (the “Indenture”), by and between the Company and U.S. Bank Trust Company, National Association,as trustee (in such capacity, the “Trustee”). Upon issuance, the Notes will bear interest at a rate of 4.00% per annum, payablesemi-annually in arrears on February 1 and August 1 of each year, commencing on February 1, 2026. The Notes will mature on August 1, 2030(the “Maturity Date”) and will be senior, unsecured obligations of the Company.
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Following issuance of theNotes, the Company intends to use the net proceeds from the Convertible Notes Offering to fund a portion of the purchase price payablein connection with the Merger, including related fees and expenses, and to the extent there are any remaining proceeds in excess of thefunds needed for the forgoing purposes, for such other general corporate purposes as the Company determines as appropriate.
The Company has the optionto redeem all, but not part, of the Notes if the Company publicly announces that the Merger Agreement has been terminated or that theMerger will not otherwise be consummated (the “Melinta Acquisition Redemption” and on such date, the “Melinta AcquisitionRedemption Date”), at a redemption price equal to the greater of (i) 102% of the principal amount of the Notes to be redeemed, plusaccrued and unpaid interest, if any, to, but excluding, the Melinta Acquisition Redemption Date, and (ii) the sum of (a) 100% of the principalamount of such Notes, plus accrued and unpaid interest, if any, to but excluding, the Melinta Acquisition Redemption Date plus (b) 70%of the difference, if positive, between the Melinta Acquisition Redemption Conversion Value and the Initial Conversion Value (each suchterm as defined in the Indenture).
In addition, on or after August4, 2028 and prior to the 26th Scheduled Trading Day (as defined in the Indenture) immediately preceding the Maturity Date,the Company may redeem for cash all or any portion of the Notes, at its option, subject to certain conditions and requirements set forthin the Indenture, if the last reported sale price of the Company’s Common Stock has been at least 130% of the conversion price thenin effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on whichthe Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediatelypreceding the date on which it provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notesto be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.
If the Company experiencesa Fundamental Change (as defined in the Indenture) at any time prior to the Maturity Date, any holder of the Notes may require the Companyto repurchase all of such holder’s Notes, or any portion of the principal amount thereof equal to $1,000 or an integral multipleof $1,000, at a repurchase price equal to 100% of the principal amount of such Notes, respectively, plus accrued and unpaid interest,if any, to, but excluding, the date of repurchase.
Following issuance of theNotes, the Notes will be convertible at the option of the holders (i) during any calendar quarter commencing after the calendar quarterending on September 30, 2025 (and only during such calendar quarter), if the closing price of the Common Stock for at least 20 tradingdays (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of theimmediately preceding calendar quarter is equal to or greater than 130% of the applicable conversion price per share, which is $1,000divided by the then applicable conversion rate, on each applicable trading day, (ii) if the Company calls any or all of the Notes forredemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; (iii) uponthe occurrence of specified corporate events; or (iv) during the five business day period after any five consecutive trading day period(the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the MeasurementPeriod was less than 98% of the product of the last reported sale price of the Common Stock and the applicable conversion rate in effecton each such trading day. On or after May 1, 2030 until the close of business on the second scheduled trading day immediately precedingthe maturity date, holders may convert all or any portion of their Notes, in multiples of $1,000 principal amount, at the option of theholder regardless of the foregoing circumstances.
Uponconversion, the Company will satisfy its conversion obligation by paying or delivering, as the case may be, cash, shares of the Company’sCommon Stock or a combination of cash and shares of Common Stock, at the Company’s election (provided that for so long as the ExchangeCap (as defined in the Indenture) applies, the Company may only elect Cash Settlement or Capped Combination Settlement (as such termsare defined in the indenture)), in the manner and subject to the terms and conditions provided in the Indenture. Notwithstanding the foregoing,prior to receipt of approval from the Company’s stockholder in accordance with Nasdaq rules, the Company will not issue any sharesof Common Stock under the Indenture (including any shares issued pursuant to conversions of the Notes), together with any transactionsaggregated with the foregoing (including any issuance of shares (including Merger Warrant Shares) contemplated by the Merger Agreementand any issuance of shares (including Merger Warrant Shares) pursuant to the Contingent Payment Agreement), if the issuance of such sharesof Common Stock would exceed 19.99% of the aggregate number of shares of Common Stock issued and outstanding as of August 6, 2025.
The conversion rate for theNotes will be determined upon issuance in accordance with the Indenture, and will be equal to an amount (rounded to four decimal places)equal to (i) $1,000 divided by (ii) the greater of (x) 130% of the arithmetic average of the Daily VWAP (as defined in the Indenture)on each of the three consecutive trading days beginning on, and including, the trading day immediately after the public announcement ofthe execution of the Merger Agreement (i.e., August 7, 2025) and (y) 110% of the lowest bona fide sale price of the Common Stockon any national securities exchange or automated interdealer quotation system on August 6, 2025.
The conversion rate is subjectto adjustment under certain circumstances in accordance with the Indenture. In connection with certain corporate events or if the Companyissues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert theirNotes in connection with such corporate event or during the relevant redemption period.
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Follow-On Offering
On June 30, 2025, the Companycompleted an underwritten public offering of common stock pursuant to the Company’s universal shelf registration statement on FormS-3, selling an aggregate of 6,604,507 shares, at the price of $12.87 per share less an underwriting discount of $0.229 per share. TheCompany received aggregate net proceeds of approximately $82.4 million after deducting the underwriting discounts and commissions andoffering expenses payable by the Company. The Company intends to use the proceeds for general corporate purposes, which may include workingcapital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions,joint ventures or collaborations, involving companies, products or assets that complement our business. No payments were made by the Companyto directors, officers or persons owning 10% or more of the Company’s common stock or to their associates, or to the Company’saffiliates.
Financial Operations Overview
Revenue from Product Sales
We generate product revenuefrom commercial sales of DefenCath to a limited number of direct customers as well as distributors. Revenue from product sales is recognizedwhen our direct customers obtain control of the product and is recorded at the transaction price, net of estimates for variable considerationconsisting of chargebacks, discounts, returns, rebates, shelf-stock adjustments and data fees. Actual amounts of consideration ultimatelyreceived may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which willaffect revenue from product sales and earnings in the period such estimates are adjusted.
We continue to assess ourestimates of variable consideration as we accumulate additional historical data and will adjust these estimates accordingly.
Cost of Revenues
Cost of revenues includedirect and indirect costs related to the manufacturing and distribution of DefenCath, including product cost, packaging services, freight,amortization of the license intangible asset and an allocation of overhead costs that are primarily fixed such as salaries, benefits andinsurance.
Research and Development Expense
Research and development,or R&D, expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third-party contractresearch organizations, contract manufacturers, investigative sites, and consultants; (iii) technology and intellectual property licensecosts; (iv) manufacturing development costs; (v) personnel related expenses, including salaries, stock–based compensation expense,benefits, travel and related costs for the personnel involved in drug development; and (vi) activities relating to regulatory filingsand pre-clinical studies and clinical trials. All R&D is expensed as incurred.
The process of conductingpre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of successfor each product line and clinical trial may be affected by a variety of factors, including, among others, the quality of the productline’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a resultof the uncertainties associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determinethe duration and completion costs of future clinical stages of our product lines or when, or to what extent, we will generate revenuesfrom the commercialization and sale of any of our future product lines.
Development timelines, probabilityof success and development costs vary widely. We are currently focused on the commercialization of DefenCath in the U.S.
Selling and Marketing Expense
Selling and marketing, orS&M, expense includes the cost of salaries and related costs for personnel in sales and marketing including our contract sales force,brand building, advocacy, market research and consulting costs. Selling and marketing expenses are expensed as incurred.
General and Administrative Expense
General and administrative,or G&A, expenses consist principally of salaries and related costs for personnel in executive, finance and administrative functionsincluding payroll taxes and health insurance, stock-based compensation and travel expenses. Other general and administrative expensesinclude facility-related costs, insurance and professional fees for legal, patent review, consulting, and accounting services. Generaland administrative expenses are expensed as incurred.
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Foreign Currency Exchange Transaction Gain(Loss)
Foreign currency exchangetransaction gain (loss) is the result of re-measuring transactions denominated in a currency other than our functional currency and isreported in the consolidated statement of operations as a separate line item within other income (expense). The intercompany loans outstandingbetween our New Jersey-based company and our subsidiaries will not be repaid and the nature of the funding advanced was of a long-terminvestment nature. As such, unrealized foreign exchange movements related to long-term intercompany loans are recorded in other comprehensiveincome (loss).
Interest Income
Interest income consists ofinterest earned on our cash and cash equivalents and short-term investments.
Interest Expense
Interest expense consistsof interest incurred on financing of expenditures.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2025 and2024
The following is a tabularpresentation of our consolidated operating results for the three and six months ended June 30, 2025 and 2024 (in thousands):
| For the Three Months Ended June 30, | % Increase | For the Six Months Ended June 30, | % Increase | |||||||||||||||||||||
| 2025 | 2024 | (Decrease) | 2025 | 2024 | (Decrease) | |||||||||||||||||||
| Revenue | $ | 39,737 | $ | 806 | 4,829 | % | $ | 78,818 | $ | 806 | 9,678 | % | ||||||||||||
| Cost of sales | (1,862 | ) | (510 | ) | 265 | % | (3,459 | ) | (1,328 | ) | 160 | % | ||||||||||||
| Gross profit (loss) | 37,875 | 296 | 12,683 | % | 75,359 | (522 | ) | 14,530 | % | |||||||||||||||
| Operating Expenses: | ||||||||||||||||||||||||
| Research and development | (2,443 | ) | (651 | ) | 275 | % | (5,635 | ) | (1,489 | ) | 279 | % | ||||||||||||
| Selling and marketing | (6,384 | ) | (7,387 | ) | (14 | )% | (10,858 | ) | (13,724 | ) | (21 | )% | ||||||||||||
| General and administrative | (9,504 | ) | (7,559 | ) | 25 | % | (19,197 | ) | (16,270 | ) | 18 | % | ||||||||||||
| Total operating expenses | (18,331 | ) | (15,597 | ) | 18 | % | (35,690 | ) | (31,483 | ) | 13 | % | ||||||||||||
| Income (loss) from operations | 19,544 | (15,301 | ) | 227 | % | 39,669 | (32,005 | ) | 224 | % | ||||||||||||||
| Interest income | 829 | 657 | 26 | % | 1,396 | 1,514 | (8 | )% | ||||||||||||||||
| Foreign exchange transaction loss | (16 | ) | (1 | ) | 1,006 | % | (54 | ) | (6 | ) | 894 | % | ||||||||||||
| Other Income | - | 500 | (100 | )% | - | 500 | (100 | )% | ||||||||||||||||
| Interest expense | (7 | ) | (6 | ) | 2 | % | (17 | ) | (16 | ) | 2 | % | ||||||||||||
| Total other income | 806 | 1,150 | (30 | )% | 1,325 | 1,992 | (34 | )% | ||||||||||||||||
| Income (loss) before income taxes | 20,350 | (14,151 | ) | 244 | % | 40,994 | (30,013 | ) | 237 | % | ||||||||||||||
| Tax (expense) benefit | (522 | ) | - | - | (522 | ) | 1,395 | (137 | )% | |||||||||||||||
| Net income (loss) | 19,828 | (14,151 | ) | 240 | % | 40,472 | (28,618 | ) | 241 | % | ||||||||||||||
| Other comprehensive (loss) income | (5 | ) | 2 | (325 | )% | (11 | ) | (8 | ) | 34 | % | |||||||||||||
| Comprehensive income (loss) | $ | 19,823 | $ | (14,149 | ) | 240 | % | $ | 40,461 | $ | (28,626 | ) | 241 | % | ||||||||||
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Revenue. Revenuefor the three months ended June 30, 2025 was $39.7 million as compared to $0.8 million for the same period in 2024, an increase of $38.9million, or 4,829%. Revenue for the six months ended June 30, 2025 was $78.8 million as compared to $0.8 million for the same period in2024, an increase of $78.0 million, or 9,678%. Revenue consists of sales of DefenCath, which was approved by the FDA in November 2023and launched in the U.S in April 2024 (inpatient setting) and July 2024 (outpatient setting) and reflects the shipment of DefenCath todirect customers and specialty distributors, net of estimates for applicable variable consideration, which consists primarily of distributionservice fees, prompt pay and other discounts, product returns, chargebacks, rebates and volume incentive rebates, shelf-stock adjustmentsand data fees.
Cost of Revenue. Cost of revenue for the three months ended June 30, 2025 was $1.9 millionas compared to $0.5 million for the same period in 2024, an increase of $1.4 million, or 265%. Cost of revenue for the six months endedJune 30, 2025 was $3.5 million as compared to $1.3 million for the same period in 2024, an increase of $2.2 million, or 160%. Cost ofrevenues include direct and indirect costs related to the manufacturing and distribution of DefenCath, including product cost, packagingservices, freight, amortization of the license intangible asset and an allocation of overhead costs that are primarily fixed such as salaries,benefits and insurance. Product costs during the three and six month periods ended June 30, 2024 were minimal, and the costs recognizedpertained to indirect costs related to the proportion of supply chain and quality personnel, benefits and insurance expenses, representingexcess capacity in the production of sellable product. As unit sales increase, a greater proportion of these costs will be capitalizedas a component of inventory and expensed at the point-of-sale. The current cost of goods sold excludes certain API that was previouslyexpensed as R&D prior to the approval of DefenCath. We continue to utilize certain previously expensed API and expect to sell throughthe related inventory in the second half of 2026.
Research and DevelopmentExpense. R&D expense for the three months ended June 30, 2025 was $2.4 million, an increase of $1.7 million, or 275%, from $0.7million for the same period in 2024. R&D expense for the six months ended June 30, 2025 was $5.6 million, an increase of $4.1 million,or 279%, from $1.5 million for the same period in 2024. These increases were due primarily to the increases in personnel and clinicaltrial services in support of the ongoing clinical studies initiated in the fourth quarter of 2024.
Selling and Marketing Expense.S&M expense was $6.4 million for the three months ended June 30, 2025, a decrease of $1.0 million, or 14%, from $7.4 million forthe same period in 2024. S&M expense was $10.9 million for the six months ended June 30, 2025, a decrease of $2.8 million, or 21%,from $13.7 million for the same period in 2024. These decreases were primarily due to additional marketing costs related to the pre-launchand launch of DefenCath in 2024.
General and AdministrativeExpense. G&A expense for the three ended June 30, 2025 was $9.5 million, an increase of $1.9 million, or 25%, from $7.6 millionfor the same period in 2024. G&A expense for the six months ended June 30, 2025 was $19.2 million, an increase of $2.9 million, or18%, from $16.3 million for the same period in 2024. The increase for the three months ended June 30, 2025, was primarily driven by thenon-cash charges for stock-based compensation of $1.1 million and an increase in costs related to business development of $0.5 million.The increase for the six months ended June 30, 2025 was primarily due to non-cash charges for stock-based compensation of $2.4 millionand an increase in costs related to business development of $0.3 million.
Interest Income. Interestincome was $0.8 million for the three months ended June 30, 2025 compared to $0.7 million for the same period last year, an increase of$0.1 million, or 26%, primarily driven by higher average cash balances. Interest income was $1.4 million for the six months ended June30, 2025 compared to $1.5 million for the same period last year, a decrease of $0.1 million, or 8%, primarily driven by lower averageinterest rates.
Foreign Exchange TransactionIncome (Loss). Foreign exchange transaction income (loss) for the three and six months ended June 30, 2025 and 2024 were due to there-measuring of transactions denominated in a currency other than our functional currency. Balances and changes were immaterial for allperiods presented.
Interest Expense.Interest expense pertains to certain liabilities we chose to finance. Balances and changes were immaterial for all periods presented.
Tax (Expense) Benefit.Tax expense for the three and six months ended June 30, 2025 of $0.5 million, is primarily related to the Company’s earnings andexpected state tax profile for the period. Tax benefit for the six months ended June 30, 2024 of $1.4 million, was due tothe sale of our unused NJ State net operating losses for fiscal year 2023, which were sold in fiscal year 2024, through the NJEDA Program.No net operating losses were sold during the six months ended June 30, 2025, or planned to be sold pertaining to unused net operatinglosses for fiscal year 2024.
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Other Comprehensive (Loss)Income. Unrealized foreign exchange movements related to long-term intercompany loans, the translation of the foreign affiliate financialstatements to U.S. dollars and unrealized movements related to short-term investment are recorded in other comprehensive (loss) income.Other comprehensive income (loss) is considered immaterial for all periods presented.
Liquidity and Capital Resources
Sources of Liquidity
We achieved profitabilityfor the three and six months ended June 30, 2025, driven by product sales of DefenCath. During the six months ended June 30, 2025, wereceived net proceeds of $6.8 million from the issuance of 620,444 shares of common stock under our at-the-market-issuance sales agreement,or ATM program. We may continue to utilize external sources of cash to further fund operations.
On June 30, 2025, the Companycompleted an underwritten public offering of common stock pursuant to the Company’s universal shelf registration statement on FormS-3, selling an aggregate of 6,604,507 shares, at the price of $12.87 per share less an underwriting discount of $0.229 per share. TheCompany received aggregate net proceeds of approximately $82.4 million after deducting the underwriting discounts and commissions andoffering expenses payable by the Company. The Company intends to use the proceeds for general corporate purposes, which may include workingcapital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions,joint ventures or collaborations, involving companies, products or assets that complement our business. No payments were made by the Companyto directors, officers or persons owning 10% or more of the Company’s common stock or to their associates, or to the Company’saffiliates.
During the six months endedJune 30, 2025, we received net proceeds of approximately $1.5 million through the issuance of 368,959 shares of common stock related tothe exercise of stock options.
In March 2024, we received$1.4 million, net of expenses, from the sale of our unused New Jersey net operating losses (“NOL”), that were eligible forsale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transferprogram (“NJEDA Program”). The NJEDA Program allowed us to sell our available fiscal 2023 NJ state NOL tax benefits in theamount of approximately $1.5 million.
Net Cash Provided by (Used in) OperatingActivities
Net cash provided by operating activities for the six months endedJune 30, 2025 was $49.7 million as compared to net cash used in operating activities of $31.4 million for the same period in 2024. Netcash provided by operating activities was primarily attributable to the net income of $40.5 million for the six months ended June 30,2025 compared to a net loss of $28.6 million in the comparison period in 2024, and a decrease in trade receivables of $8.9 million.
Net Cash (Used in) Provided by InvestingActivities
Net cash used in investingactivities for the six months ended June 30, 2025 was $20.4 million as compared to $15.2 million of net cash provided by investing activitiesfor the same period in 2024. The net cash used during the six months ended June 30, 2025, was mainly driven by increased short-term investments,as compared to the same period in 2024, offset by lower maturities of short-term investments.
Net Cash Provided by (Used in) FinancingActivities
Net cash provided by financingactivities for the six months ended June 30, 2025 was $89.3 million due to the net proceeds generated from the sale of our common stockin the underwritten offering and in our ATM program of $82.4 million and $6.8 million, respectively. Net cash provided by financing activitiesfor the six months ended June 30, 2024 was $1.0 million attributable to the net proceeds received from the sale of our common stock inour ATM program.
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Funding Requirements and Liquidity
Our total cash, cash equivalentsand short-term investments as of June 30, 2025, was $190.7 million, excluding restricted cash of $0.1 million, compared with $51.7 millionas of December 31, 2024, excluding restricted cash of $0.1 million. As of June 30, 2025, $23.2 million of the Company’s common stockremains available for potential sale under the ATM program. Additionally, we have $15.0 million of remaining capacity available underour 2024 Shelf Registration Statement for the issuance of Company securities, after taking effect of the $85.0 million public offeringthat closed on June 30, 2025.
We expect to continue to fundoperations from cash collections of accounts receivable, our cash on hand, cash equivalents and short-term investments, and through capitalraising sources, which may be dilutive to existing stockholders. In May 2024, we implemented an ATM program, which may be utilized tosupport our ongoing funding requirements. We may seek to sell additional equity or debt securities through one or more discrete transactions,but can provide no assurances that any such financing will be available on acceptable terms, or at all. Moreover, the incurrence of indebtednesswould result in increased fixed obligations and could contain covenants that would restrict our operations.
Our actual cash requirementsmay vary materially from those now planned due to a number of factors, including any material change in commercial operations pertainingto DefenCath or the focus and direction of our research and development programs, any acquisition or pursuit of development of new productcandidates, competitive and technical advances, the costs of commercializing any of our product candidates, and costs of filing, prosecuting,defending and enforcing any patent claims and any other intellectual property rights. Because our business has not generated consistentand sustained positive operating cash flow, we may need to raise additional capital in order to continue to fund our research and developmentactivities, as well as to fund operations generally and we can provide no assurances that financing or strategic relationships will beavailable on acceptable terms, or at all, if additional funds are needed. If we are unable to raise additional funds when needed, we maybe forced to slow or discontinue our commercial operations pertaining to DefenCath. We may also be required to delay, scale back or eliminatesome or all of our anticipated research and development programs. Each of these alternatives would likely have a material adverse effecton our business.
We currently estimate thatas of June 30, 2025, we have sufficient cash, cash equivalents and short-term investments to fund operations for at least twelve monthsfrom the issuance of these financial statements.
Contractual Obligations
We entered into a seven-yearoperating 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.
In December 2024, we enteredinto a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will provide a dedicatedinpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. We have paid an up-front implementationfee and are obligated to pay a fixed monthly fee. Upon the twelve-month anniversary of the deployment date, expected to be in thesecond quarter of 2026, the agreement is cancelable upon 60 day’s written notice. As of June 30, 2025, the minimum amountcommitted under this agreement totals $7.8 million.
In 2008, the Company enteredinto 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 inhibitinginfections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications(the NDP Technology). During the year ended December 31, 2024, net sales milestones in the amount of $2.0 million were achieved and areaccrued in our consolidated balance sheet. In April 2025, the Company paid the final milestone payments in the aggregate amount of $2.0million.
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Critical Accounting Estimates
We prepare our consolidatedfinancial statements in accordance with U.S. generally accepted accounting principles, which require our management to make estimatesthat affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates,as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differencesbetween these estimates and actual results, our financial condition or results of operations would be affected. We base our estimateson our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectationsfor the future based on available information. We evaluate these estimates on an ongoing basis. We consider an accounting estimate tobe critical if: (1) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accountingestimate was made, and (2) changes in the estimate that are reasonably likely to occur from period to period, or use of different estimatesthat we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations.Management has discussed the development and selection of these critical accounting estimates with the Audit Committee of our Board ofDirectors. In addition, there are other items within our financial statements that require estimation, but are not deemed critical asdefined above. Changes in estimates used in these and other items could have a material impact on our financial statements.
| ● | Litigation contingencies are assessed and judgments are madeto determine if an unfavorable outcome is considered probable or reasonably possible, and when considered reasonably possible but notprobable, the contingency is disclosed along with an estimate of the possible loss or range of loss. If a liability is possible or probable,but no reasonable estimation of loss can be made, we will disclose the nature of the contingency and state that such an estimate cannotbe made. Such estimates and judgements are based on information obtained through the discovery process, court filings and follow on filingsby the plaintiffs as well as the stage of litigation. |
| ● | We account for product revenue from the sale ofour product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”) which entails our estimatesand judgments primarily in determining the transaction price and more specifically as it relates to variable consideration associatedwith the contracts. Our customers are located in the United States and consist primarily of outpatient service providers and to a lesserextent specialty wholesale distributors. Variable consideration pertaining to an allowance for product returns of short-dated or expiredproduct requires estimation as our customers may have differing utilization, storage and distribution methods and we do not yet have significanthistorical trends. The Company’s product accrual takes into consideration estimates of product held by its customers, the distributionchannel, the shelf life of the product held by customers, as well as when the product is eligible for return based on our returns goodpolicy. We have established the estimate for returns based on specific customer circumstances, industry best practices and managementexperiences which will continuously be refined as new information is received. At June 30, 2025, the Company had $2.2 million in accruedreturns allowance. |
Variable consideration pertaining to accrued Medicaidrebates requires estimation as our customers may have differing utilizations rates of Medicaid coverage, different utilization withinStates which may be in either the primary or secondary positions, together with as well as general fluctuations in patient populationsover time. Based on the relatively short time since product launch and the inherent lag time in State Medicaid processing, the utilizationinformation the Company has received is limited and, as such, , there is a lack of significant historical trends for Medicaid utilization.The Company’s accrual does take into consideration its customers’ recent actual Medicaid utilization rates as well as anticipatedMedicaid utilization rates. At June 30, 2025, the Company had $3.8 million in accrued Medicaid rebates.
During the three and six months ended June 30, 2025, a change in estimatewas recorded for variable consideration pertaining to Medicaid and commercial rebates. During the three months ended June 30, 2025, newinformation was obtained by the Company surrounding Medicaid utilization rates for certain states that reimburse service providers usingDefenCath. The resulting change in accounting estimate negatively impacted net sales, income from continuing operations and net incomefor the three and six months ended June 30, 2025. For the three months ended June 30, 2025, net income was impacted by $2,029,000, basicand diluted earnings per share were negatively impacted by $0.03 and $0.02 cents per share, respectively, which would have caused earningsper share and diluted earnings per share to be $0.32 and $0.30, respectively. Excluding the impact of the change in accounting estimate,net income would have been $21,856,000. The resulting change in estimate negatively impacts year to date revenue, continuing operationsand net income in the amount of $1,695,000. Basic and diluted earnings per share were negatively impacted by $0.02 cents per share, whichwould have caused earnings per share and diluted earnings per share to be $0.62 and $0.60, respectively. Excluding the impact of the changein accounting estimate, net income would have been $42,167,000. |
| ● | As of June 30, 2025, we continue to maintain a full valuation allowance against our deferred tax assets. While we generated taxable income through the current quarter of 2025 and may be profitable for the full year, we believe that a full valuation allowance remains appropriate due to the uncertainty pertaining to the full year level of forecasted profitability as compared to our recent historical losses. We will continue to evaluate all available evidence, both positive and negative, in future periods. A sustained trend of profitability could result in a reduction of the valuation allowance, which would favorably impact our effective tax rate. |
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Item 3. Quantitative and Qualitative Disclosure about Market Risk.
The Company is not required to provide the informationcalled for in this item due to its status as a Smaller Reporting Company.
Item 4. Controls and Procedures.
Disclosure controls and proceduresare designed only to provide reasonable assurance that information to be disclosed in our Exchange Act reports is recorded, processed,summarized and reported within the time periods specified in the SEC’s rules and forms. Under the supervision and with the participationof our management, including our Chief Executive Officer and our Chief Financial Officer, we carried out an evaluation of the effectivenessof the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the ExchangeAct) as of June 30, 2025. Based on the foregoing evaluation, our Chief Executive Officer and our Chief Financial Officer concluded thatour disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports we fileor submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and formsof the SEC, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and ourChief Financial Officer, to allow timely decisions regarding required disclosures.
Changes in Internal Control Over Financial Reporting
There were no changes in ourinternal control over financial reporting that occurred during the period covered by this report, that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings.
For information regardingour legal proceedings, see Note 5, Commitments and Contingencies, included in Part I, Item 1, Financial Statements, in this QuarterlyReport on Form 10-Q, which is incorporated into this item by reference.
Item 1A. Risk Factors.
There were no material changesfrom the risk factors previously disclosed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the yearended December 31, 2024, except for the following:
Our proposed acquisition of Melinta issubject to significant uncertainties and risks, including that the Merger may not be completed on the terms or timeline currently contemplated,or at all, and the failure to complete the Merger may adversely affect our stock price, future business and financial results.
The consummation of the Mergeris subject to certain customary closing conditions being satisfied or waived. There can be no assurance that the conditions to closingwill be satisfied or waived or that other events will not intervene to delay or result in the termination of the proposed Merger. Ifthe Merger is not completed for any reason, the trading price of our common stock may decline to the extent that the market price of thecommon stock reflects positive market assumptions that the Merger will be completed and the related benefits will be realized.
Amendments made to the Merger Agreement may have a material impacton our business, financial results and the trading price of our common stock.
The Merger is expected to be consummated in accordance with the termsof the Merger Agreement. However, the Merger Agreement may be amended and the closing conditions may be waived at any time by the partiesthereto. Any amendment made to the Merger Agreement, or waiver of the conditions to the closing of the Merger, could have a material adverseeffect on our business, financial conditions and results of operations and could have an adverse effect on the trading price of our commonstock.
We do not currently control Melinta andwill not control Melinta until completion of the Merger.
We do not currently control Melinta. We will not obtain control ofMelinta until the completion of the Merger. We cannot assure you that Melinta will operate its businesses during the interim period inthe same way that we would. The business we acquire could be negatively impacted before or after the closing as a result of previouslyunknown events or conditions occurring or existing before the Merger closes. Adverse changes in Melinta’s business or operationscould occur or arise as a result of actions undertaken, legal or regulatory developments, deteriorating general business, market, industryor economic conditions, and other factors both within and beyond Melinta’s or our control. A significant decline in the value ofthe assets to be acquired or a significant increase in the liabilities to be assumed could negatively impact our future business, operatingresults, cash flows, financial conditions or prospects following the closing of the Merger.
Uncertainties associatedwith our acquisition of Melinta may cause a loss of management personnel and other key employees, which could adversely affect our futurebusiness, operations and financial results.
Theacquisition of Melinta could disrupt our and Melinta’s businesses. We are dependent on the experience and industry knowledge ofsenior management and other key employees to execute our business plans, which could be disrupted by the unanticipated departure of anykey member of our management team or employee base, as well as management or key employees of Melinta. Our and Melinta’s currentand prospective employees may experience uncertainty about their roles within our company, which may have an adverse effect on the abilityof each of us to attract or retain key management and other key personnel.
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Accordingly,no assurance can be given that we will be able to attract or retain our and Melinta’s key management personnel and other key employeesto the same extent that our companies have previously been able to attract or retain such employees. In addition, because of the specializedand technical nature of our business, our future performance is dependent on the continued service of, and on our ability to attract andretain, qualified management, engineering, technical, marketing and support personnel. Competition for such personnel is intense, andwe may be unable to continue to attract or retain such personnel.
We may not be able to enforce claims with respect to the representationsand warranties under the Merger Agreement.
In connection with the Merger, we were given certain limited customaryrepresentations and warranties related to Melinta’s performance and business operations. There can be no assurance that we willbe able to enforce any claims relating to any breaches of such representations and warranties. Our recourse for breaches of representationsand warranties is limited and there can be no assurance that such limited liability, to the extent enforced, will be adequate to coverany losses or damages resulting from any such breach of the representations and warranties. Moreover, even if we ultimately succeed inrecovering any amounts for any such breach, we may temporarily be required to bear these losses ourselves.
We may be unable to successfully integrate our and Melinta’sbusinesses in order to realize the anticipated benefits of the Merger or do so within the intended timeframe.
We will be required to devote significant management attention andresources to integrating the business practices and operations of Melinta with our business. We may be unable to realize the planned synergiesfrom the Merger or other benefits in the timeframe that we expect or at all. We continue to assess synergies that we may realize as acombined company, the realization of which will depend on a number of factors.
The success of the Merger, including anticipated synergies, benefitsand cost savings, will depend, in part, on our ability to successfully combine and integrate our current operations with Melinta’sbusiness. If we experience difficulties with the integration process or other unforeseen costs, the anticipated benefits and cost savingsof the Merger may not be realized fully or at all, or may take longer to realize than expected. The integration planning and implementationprocess will result in significant costs and divert management attention and resources. These integration matters could have an adverseeffect on our combined company for an undetermined period after completion of the Merger. In addition, the actual benefits of the Mergercould be less than anticipated, or otherwise offset by other factors.
Additionaldifficulties we may encounter as part of the integration process include the following:
| ● | thecosts of integration and compliance and the possibility that the full benefits anticipated to result from our acquisition of Melintawill not be realized; |
| ● | anydelay in the integration of management teams, strategies, operations, products, product candidates and services; |
| ● | diversionof the attention of each company’s management as a result of our acquisition of Melinta; |
| ● | differencesin business backgrounds, corporate cultures and management philosophies that may delay successful integration; |
| ● | theability to retain key employees; |
| ● | theability to create and enforce uniform standards, controls, procedures, policies and information systems; |
| ● | thechallenge of integrating complex systems, technology, networks and other assets of Melinta into those of ours in a seamless manner thatminimizes any adverse impact on customers, suppliers, employees and other constituencies; |
| ● | potential unknown liabilities and unforeseen increased expenses ordelays associated with the Merger, including costs to integrate Melinta beyond current estimates; and |
| ● | thedisruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, proceduresand policies. |
Any of these factors could adversely affect each company’s abilityto maintain relationships with customers, suppliers, employees and other constituencies or our ability to achieve the anticipated benefitsof the Merger or could reduce each company’s earnings or otherwise adversely affect our business and financial results after theMerger. These risks are not limited to our acquisition of Melinta and could also apply to our future acquisitions.
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Our results afterour acquisition of Melinta may suffer if we do not effectively manage our expanded operations following the acquisition.
Following our acquisition of Melinta, the size and complexity of ourbusiness will increase significantly beyond the current size of either our or Melinta’s existing business. Our future success depends,in part, upon our ability to manage this expanded business, which will pose substantial challenges for management, including challengesrelated to the management and monitoring of new products and product candidates and associated increased costs and complexity. There canbe no assurances that we will be successful after completion of the Merger or that we will realize the expected benefits currently anticipatedfrom our acquisition of Melinta.
The business ofMelinta may underperform relative to our expectations.
Wemay not be able to maintain the levels of revenue, earnings or operating efficiency that we and Melinta have achieved or might achieveseparately. The business and financial performance of Melinta is subject to certain risks and uncertainties, including the risk ofthe loss of, or changes to, its relationships with its customers. We may be unable to achieve the same growth, revenues and profitabilitythat Melinta has achieved in the past.
Our business may be adversely affectedby tariffs, trade sanctions or similar government actions.
As of the date of this QuarterlyReport on Form 10-Q, discussions remain ongoing in respect of certain trade restrictions and tariffs on imports from various foreign countries,as well as retaliatory tariffs enacted in response to such actions. In light of these events, there continues to exist significant uncertaintyabout the future relationship between the U.S. and other countries with respect to such trade policies, treaties, and tariffs. These developments,or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability ofglobal financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the UnitedStates. Any of these factors could depress economic activity and restrict our access to potential partners, suppliers or other third partieswe seek to do business with and, in turn, have a material adverse effect on the business and financial condition of such third parties,which in turn would negatively impact us.
International trade policies, including tariffs, sanctions andtrade barriers may adversely affect our business, financial condition, results of operationsand prospects.
We operate in a global economy, and our businessdepends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of ourdevelopment programs. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conductour business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policiesand export regulations that may adversely affect our business and operations.
We currently rely heavily on third-party manufacturersbased in Europe for the manufacture of DefenCath. In addition, excipients and components may be sourced globally by our manufacturers. Tariff policies,particularly those affecting pharmaceutical products, could increase our costs and reduce our profitability. Additionally, recentpolicy discussions have included potential targeted tariffs or other trade measures specifically aimed at pharmaceutical products andingredients as part of broader healthcare cost control or national security initiatives. For example, on July 28, 2025, the U.S. governmentannounced a trade deal with the European Union (the “EU”) in which the EU will pay the U.S. a 15% tariff rate on certain productsincluding pharmaceuticals. We are awaiting clarity from the U.S. government on the implementation of the 15% tariff.
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Unlike consumer goods, pharmaceuticals face uniqueregulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Should tariffs be imposed specificallytargeting pharmaceutical imports, our production costs could rise, and it would be difficult and costly to qualify alternative sourceswithin another country with a lower tariff rate or within the U.S., as developing and qualifying alternative sources typically requiressubstantial time, investment, and regulatory approvals.
Unlike many industries, our ability to pass increasedcosts to customers is limited by the structure of pharmaceutical pricing and reimbursement systems. As a result, cost increases due totariffs may be difficult or impossible to pass through to customers.
Current or future tariffs could also result inincreased research and development expenses, including with respect to increased costs associated with raw materials, laboratory equipmentand research materials and components. Trade restrictions affecting the import of materials necessary for clinical trials could resultin delays to our development timelines. Increased development costs and extended development timelines could place us at a competitivedisadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence andnegatively impact our business, results of operations, financial condition and growth prospects.
Trade disputes, tariffs, restrictions and otherpolitical tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationarypressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of currentor future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition,and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deteriorationin international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capitalmarkets or other financing sources, results of operations, financial condition and prospects. In addition, tariffs and other trade developmentshave and may continue to heighten the risks related to the other risk factors described elsewhere in this report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Default Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(a)On August 6, 2025, the Company filed a Third Amended and Restated Certificate of Designation of the Series E Convertible Preferred Stock(the “Series E Preferred Stock”) with the Secretary of State of the State of Delaware modifying certain of the covenantsand other terms thereof including the stated value per share of Series E Preferred Stock. The Third Amended and Restated Certificateof Designation was effective upon acceptance by the Secretary of State of the State of Delaware.
(c) Noneof our officers or directors, as defined in Rule 16a-1(f),
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Item 6. Exhibits.
The exhibit index set forthbelow is incorporated by reference in response to this Item 6.
| * | Filed herewith. |
| ** | Portionsof this exhibit have been omitted pursuant to Item 601(b)(2)(ii) of Regulation S-K. |
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SIGNATURES
Pursuant to the requirementsof the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersignedthereunto duly authorized.
| CORMEDIX INC. |
| Date: August 7, 2025 | By: | /s/ Joseph Todisco | |
| Name: | Joseph Todisco | ||
| Title: | Chief Executive Officer | ||
| (Principal Executive Officer) | |||
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Exhibit 3.1
THIRD AMENDED AND RESTATED
CERTIFICATE OF DESIGNATION
OF
SERIES E CONVERTIBLE PREFERRED STOCK
OF
CORMEDIX INC.
Pursuant to Section 242 of the
Delaware General Corporation Law
I, Joseph Todisco, Chief ExecutiveOfficer of CorMedix Inc. (the “Corporation”) a corporation organized and existing under the laws of the Stateof Delaware, DO HEREBY CERTIFY:
| A. | Pursuant to its Certificate of Incorporation, as amended (the “Certificate of Incorporation”), the Corporation is authorized to issue 2,000,000 shares of preferred stock, of which 92,440 shares have been previously designated as Series E Non-Voting Convertible Preferred Stock of which 89,623 shares are currently issued and outstanding. |
| B. | That pursuant to Section 242(b) of the Delaware General Corporation Law (the “DGCL”), the Board of Directors of the Corporation, on July 26, 2025, and the holders of all of the outstanding shares of Series E Non-Voting Convertible Preferred Stock, on August 6, 2025, approved this Third Amended and Restated Certificate of Designation of Series E Convertible Preferred Stock (this “Third Amendment and Restatement”). |
| C. | The Corporation’s common stockholders were not required to approve this Third Amendment and Restatement. |
| D. | The text of the Certificate of Designation of Series E Non-Voting Convertible Preferred Stock (the “Original Certificate”) which was filed on October 21, 2013, as amended and restated by that certain Amended and Restated Certificate of Designation of Series E Non-Voting Convertible Preferred Stock, filed on September 15, 2014, (the “First Amendment to the Certificate”), and that certain Second Amended and Restated Certificate of Designation of Series E Non-Voting Convertible Preferred Stock (together with the Original Certificate and the First Amendment to the Certificate, the “Certificate”) which was filed on September 5, 2019, is hereby amended and restated in its entirety as follows: |
SERIES E CONVERTIBLE PREFERRED STOCK
Section1. DEFINITIONS. For the purposes hereof, the following terms shall have the following meanings:
“Affiliate”means any person or entity that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under commoncontrol with a person or entity, as such terms are used in and construed under Rule 144 under the Securities Act. With respect to a Holder,any investment fund or managed account that is managed on a discretionary basis by the same investment manager as such Holder will bedeemed to be an Affiliate of such Holder.
“Alternate Consideration”shall have the meaning set forth in Section 7(d).
“Bankruptcy Event”means the Corporation shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trusteeor liquidator of itself or of all or a substantial part of its property or assets, (ii) make a general assignment for the benefit of itscreditors, (iii) commence a voluntary case under the United States Bankruptcy Code (as now or hereafter in effect) or under the comparablelaws of any jurisdiction (foreign or domestic), (iv) file a petition seeking to take advantage of any bankruptcy, insolvency, moratorium,reorganization or other similar law affecting the enforcement of creditors’ rights generally, (v) acquiesce in writing to any petitionfiled against it in an involuntary case under United States Bankruptcy Code (as now or hereafter in effect) or under the comparable lawsof any jurisdiction (foreign or domestic), (vi) issue a notice of bankruptcy or winding down of its operations or issue a press releaseregarding same, or (vii) take any action under the laws of any jurisdiction (foreign or domestic) analogous to any of the foregoing; and/ora proceeding or case shall be commenced in respect of the Corporation, without its application or consent, in any court of competent jurisdiction,seeking (i) the liquidation, reorganization, moratorium, dissolution, winding up, or composition or readjustment of its debts, (ii) theappointment of a trustee, receiver, custodian, liquidator or the like of it or of all or any substantial part of its assets in connectionwith the liquidation or dissolution of the Corporation or (iii) similar relief in respect of it under any law providing for the reliefof debtors, and such proceeding or case described in clause (i), (ii) or (iii) shall continue undismissed, or unstayed and in effect,for a period of thirty (30) days or any order for relief shall be entered in an involuntary case under United States Bankruptcy Code (asnow or hereafter in effect) or under the comparable laws of any jurisdiction (foreign or domestic) against the Corporation or action underthe laws of any jurisdiction (foreign or domestic) analogous to any of the foregoing shall be taken with respect to the Corporation orany of its subsidiaries and shall continue undismissed, or unstayed and in effect for a period of sixty (60) days.
“Beneficial OwnershipLimitation” shall have the meaning set forth in Section 6(c).
“Bloomberg”means Bloomberg, L.P.
“Business Day”means any day except Saturday, Sunday, any day which shall be a federal legal holiday in the United States or any day on which bankinginstitutions in the State of New York are authorized or required by law or other governmental action to close.
“Buy-In”shall have the meaning set forth in Section 6(e)(iii).
“Closing SalePrice” means, for any security as of any date, the last closing trade price for such security prior to 4:00 p.m., New YorkCity time, on the principal securities exchange or trading market where such security is listed or traded, as reported by Bloomberg (or,to the extent that Bloomberg is unavailable generally, an equivalent, reliable reporting service mutually acceptable to and hereafterdesignated by Holders of a majority of the then-outstanding Series E Preferred Stock and the Corporation), or if the foregoing do notapply, the last trade price of such security in the over-the-counter market on the electronic bulletin board for such security as reportedby Bloomberg, or, if no last trade price is reported for such security by Bloomberg, the average of the bid prices of any market makersfor such security as reported on the OTC Pink Market by OTC Markets Group, Inc. If the Closing Sale Price cannot be calculated for a securityon a particular date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market valueas determined in good faith by the Board of Directors of the Corporation.
“Commission”means the Securities and Exchange Commission.
“Common Stock”means the Corporation’s common stock, par value $0.001 per share, and stock of any other class of securities into which such securitiesmay hereafter be reclassified or changed into.
“Conversion Date”shall have the meaning set forth in Section 6(a).
“Conversion Price”shall mean $3.75, as adjusted pursuant to Section 7 hereof.
“Conversion Ratio”shall have the meaning set forth in Section 6(b).
“Conversion Shares”means, collectively, the shares of Common Stock issuable upon conversion of the shares of Series E Preferred Stock in accordance withthe terms hereof.
“Convertible Securities”means any stock, note, debenture or other security (other than Options) that is, or may become, at any time and under any circumstances,directly or indirectly, convertible into, exercisable or exchangeable for, or which otherwise entitles the holder thereof to acquire,any shares of Common Stock.
“Corporate Event”shall have the meaning set forth in Section 8(b).
“Daily FailureAmount” means the product of (x) 0.005 multiplied by (y) the Closing Sale Price of the Common Stock on the applicable ShareDelivery Date.
“DTC”shall have the meaning set forth in Section 6(a).
“DWAC Delivery”shall have the meaning set forth in Section 6(a).
“Eligible Market”means The New York Stock Exchange, the Nasdaq Global Select Market, the Nasdaq Global Market or the Principal Market.
“Exchange Act”means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
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“Fundamental Transaction”shall have the meaning set forth in Section 7(e).
“Holder”means any holder of Series E Preferred Stock.
“Initial IssueDate” shall mean the date that shares of Series E Preferred Stock are first issued by the Corporation.
“Junior Securities”shall have the meaning set forth in Section 5(a).
“Liquidation Event”shall have the meaning set forth in Section 5(b).
“Liquidation Preference”shall have the meaning set forth in Section 5(b).
“New Subsidiary”means, as of any date of determination, any Person in which the Corporation after the Initial Issuance Date, directly or indirectly, (i)owns or acquires any of the outstanding capital stock or holds any equity or similar interest of such Person or (ii) controls or operatesall or any part of the business, operations or administration of such Person, and all of the foregoing, collectively, “NewSubsidiaries.”
“Notice of Conversion”shall have the meaning set forth in Section 6(a).
“Options”means any rights, warrants or options to subscribe for or purchase shares of Common Stock or Convertible Securities.
“Parent Entity”of a Person means an entity that, directly or indirectly, controls the applicable Person and whose common stock or equivalent equity securityis quoted or listed on an Eligible Market, or, if there is more than one such Person or Parent Entity, the Person or Parent Entity withthe largest public market capitalization as of the date of consummation of the Fundamental Transaction.
“Parity Securities”shall have the meaning set forth in Section 5(a).
“Permitted Distributions”means dividends by Subsidiaries of the Corporation to the Corporation or other Subsidiaries of the Corporation and dividends requiredto be paid on the Parity Securities and pursuant to Section 3 hereof.
“Person”means any individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liabilitycompany, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Principal Market”means the NYSE American.
“Purchase Rights”shall have the meaning set forth in Section 8(a) below.
“Securities Act”means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“Series E PreferredStock Register” shall have the meaning set forth in Section 2(b).
“Share DeliveryDate” shall have the meaning set forth in Section 6(e)(i).
“Stated Value”shall mean $62.76 per share of Series E Preferred Stock.
“Trading Day”means a day on which the Common Stock is traded for any period on the Principal Market or if the Common Stock is not traded on the PrincipalMarket, on a day that the Common Stock is traded on another securities market on which the Common Stock is then being traded.
“Voting ConversionPrice” shall mean $7.93, as adjusted pursuant to Section 7 hereof.
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Section2. DESIGNATION, AMOUNT AND PAR VALUE; ASSIGNMENT.
(a) The series of preferredstock designated by this Certificate shall be designated as the Corporation’s “Series E Convertible Preferred Stock”(the “Series E Preferred Stock”) and the number of shares so designated shall be 92,440. Each share of SeriesE Preferred Stock shall have a par value of $0.001 per share.
(b) The Corporation shallregister shares of the Series E Preferred Stock, upon records to be maintained by the Corporation for that purpose (the “SeriesE Preferred Stock Register”), in the name of the Holders thereof from time to time. The Corporation may deem and treat theregistered Holder of shares of Series E Preferred Stock as the absolute owner thereof for the purpose of any conversion thereof and forall other purposes. The Corporation shall register the transfer of any shares of Series E Preferred Stock in the Series E Preferred StockRegister, upon surrender of the certificates evidencing such shares to be transferred, duly endorsed by the Holder thereof, to the Corporationat its principal place of business or such other office of the Corporation as may be designated by the Corporation. Upon any such registrationor transfer, a new certificate evidencing the shares of Series E Preferred Stock so transferred shall be issued to the transferee anda new certificate evidencing the remaining portion of the shares not so transferred, if any, shall be issued to the transferring Holder,in each case, within three (3) Business Days. The provisions of this Certificate are intended to be for the benefit of all Holders fromtime to time and shall be enforceable by any such Holder.
Section3. DIVIDENDS. Holders shall be entitled to receive, and the Corporation shall pay, dividends on shares of theSeries E Preferred Stock equal (on an as-if-converted-to-Common-Stock basis without giving effect for such purposes to the BeneficialOwnership Limitation set forth in Section 6(c) hereof) to and in the same form as dividends (other than dividends in the form of CommonStock) actually paid on shares of the Common Stock when, as and if such dividends (other than dividends in the form of Common Stock) arepaid on shares of the Common Stock.
Section4. VOTING RIGHTS. Holders of Series E Preferred Stock shall have the right to cast the number of votes for eachshare of Series E Preferred Stock equal to the quotient obtained by dividing the Stated Value by the Voting Conversion Price. Such sharesof Series E Preferred Stock shall vote together with the shares of Series G Preferred Stock and the shares of Common Stock as a singleclass on all matters submitted to a vote of the holders of Common Stock. In addition, as long as any shares of Series E Preferred Stockare outstanding, the Corporation shall not, whether by merger, consolidation or otherwise, without the affirmative vote of the Holdersof a majority of the then outstanding shares of the Series E Preferred Stock: (a) alter or change the powers, preferences or rights givento the Series E Preferred Stock as set forth herein or alter or amend this Certificate of Designation, (b) increase the number of authorizedshares of Series E Preferred Stock, or (c) enter into any agreement with respect to any of the foregoing; provided, however, that theforegoing shall not preclude the Corporation from designating or issuing any Junior Securities. The Corporation shall not pay or causeto be paid, directly or indirectly, to any Holder or any of its Affiliates any consideration of any type in connection with a vote ofHolders relating to Sections 4(a), (b) or (c). The Corporation shall not, directly or indirectly, redeem or repurchase any Series E PreferredStock unless such offer of redemption or repurchase is made pro rata to all Holders on identical terms.
Section5. RANK; LIQUIDATION.
(a) The Series E PreferredStock shall rank (i) senior to all of the Common Stock; (ii) senior to the Series C-3 Convertible Preferred Stock; (iii) senior to anyclass or series of capital stock of the Corporation hereafter created (clauses (i), (ii) and (iii), “Junior Securities”);and (iv) on parity with the Series G Preferred Stock and any class or series of share capital hereafter created, the terms of which classor series are not expressly subordinated or senior to the Series E Preferred Stock (“Parity Securities”), ineach case for clauses (i) through (iv) above, as to dividends and other distributions, amortization and/or redemption payments, and/orpayments upon a Liquidation Event (as defined below). The foregoing shall not preclude the Corporation from designating or issuing anyJunior Securities. Without the prior express written consent of Holders representing a majority of the outstanding shares of Series EPreferred Stock, the Corporation shall not hereafter authorize or issue additional or other capital stock that is of senior or paripassu rank to the Series E Preferred Stock in respect of the preferences as to dividends and other distributions, amortization and/orredemption payments, and/or payments upon a Liquidation Event.
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(b) Upon liquidation, dissolutionor winding up of the Corporation or a Bankruptcy Event, whether voluntary or involuntary (each, a “Liquidation Event”),each holder of shares of Series E Preferred Stock shall be entitled to receive, in preference to any distributions of any of the assetsor surplus funds of the Corporation to the holders of the Common Stock and Junior Securities and pari passu with any distributionto the holders of Parity Securities, an amount equal to the Stated Value per share of Series E Preferred Stock, plus an additional amountequal to any dividend declared but unpaid on such shares (the “Liquidation Preference”), before any paymentsshall be made or any assets distributed to holders of any class of Common Stock or Junior Securities. If, upon any such Liquidation Event,the assets of the Corporation shall be insufficient to pay the holders of shares of the Series E Preferred Stock the Liquidation Preference,then all remaining assets of the Corporation shall be distributed ratably to holders of the shares of the Series E Preferred Stock andParity Securities.
(c) After payment to the holdersof shares of the Series E Preferred Stock of the amount required under Section 5(b), the remaining assets or surplus funds of the Corporation,if any, available for distribution to stockholders shall be distributed ratably among the holders of the Series E Preferred Stock, anyother class or series of capital stock that participates with the Common Stock in the distribution of assets upon any Liquidation Eventand the Common Stock, with the holders of the Series E Preferred Stock deemed to hold that number of shares of Common Stock into whichsuch shares of Series E Preferred Stock are then convertible (without giving effect for such purposes to the Beneficial Ownership Limitationset forth in Section 6(c) hereof).
Section6. CONVERSION.
(a) Conversions at Optionof Holder. Each share of Series E Preferred Stock along with the aggregate accrued but unpaid dividends thereon shall be convertible,at any time and from time to time from and after the date of the issuance thereof, at the option of the Holder thereof, into a numberof shares of Common Stock equal to the Conversion Ratio in effect at the time of such conversion. A Holder shall effect a conversion byproviding the Corporation with the form of conversion notice (via overnight courier, facsimile or email) attached hereto as AnnexA (a “Notice of Conversion”), duly completed and executed. For purposes of clarification, the Corporationor its transfer agent shall not require a Holder to obtain a medallion guaranty, notary attestation or any similar deliverable in orderto effectuate the conversion of all or a portion of such Holder’s shares of Series E Preferred Stock. Other than a conversion followinga Fundamental Transaction, the Notice of Conversion must specify at least a number of shares of Series E Preferred Stock to be convertedequal to the lesser of (x) 10,000 shares (such number subject to appropriate adjustment following the occurrence of an event specifiedin Section 7(a), 7(b), 7(c) and 7(d) hereof) and (y) the number of shares of Series E Preferred Stock then held by the Holder. Providedthe Corporation’s Common Stock transfer agent is participating in the Depository Trust Company (“DTC”)Fast Automated Securities Transfer program, the Notice of Conversion may specify, at the Holder’s election, whether the applicableConversion Shares shall be credited to the account of the Holder’s prime broker with DTC through its Deposit/Withdrawal at Custodiansystem (a “DWAC Delivery”). The date on which a conversion of Series E Preferred Stock shall be deemed effective(the “Conversion Date”) shall be defined as the Trading Day that the Notice of Conversion, completed and executed,and a copy of the original certificate(s) representing such shares of Series E Preferred Stock being converted, is sent (via overnightcourier, facsimile or email) to, and received during regular business hours by, the Corporation. The calculations set forth in the Noticeof Conversion shall control in the absence of manifest or mathematical error.
(b) Conversion Ratio.The “Conversion Ratio” for each share of Series E Preferred Stock shall be equal to (i) one-third of the sumof the Stated Value and accrued but unpaid dividends thereon, divided by (ii) the Conversion Price.
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(c) BeneficialOwnership Limitation. Notwithstanding anything herein to the contrary, the Corporation shall not effect any conversion of the SeriesE Preferred Stock, and a Holder shall not have the right to convert any portion of its Series E Preferred Stock, to the extent that, aftergiving effect to an attempted conversion set forth on an applicable Notice of Conversion, such Holder (together with such Holder’sAffiliates, and any other Person whose beneficial ownership of Common Stock would be aggregated with the Holder’s for purposes ofSection 13(d) of the Exchange Act and the applicable rules and regulations of the Commission, including any “group” of whichthe Holder is a member) would beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation (asdefined below). For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially owned by such Holderand its Affiliates shall include the number of shares of Common Stock issuable upon conversion of the Series E Preferred Stock subjectto the Notice of Conversion with respect to which the determination of such sentence is being made, but shall exclude the number of sharesof Common Stock which are issuable upon (A) conversion of the remaining, unconverted shares of Series E Preferred Stock beneficially ownedby such Holder or any of its Affiliates, and (B) exercise or conversion of the unexercised or unconverted portion of any other securitiesof the Corporation beneficially owned by such Holder or any of its Affiliates (including, without limitation, any convertible notes, convertiblestock or warrants) that are subject to a limitation on conversion or exercise analogous to the limitation contained herein. Except asset forth in the preceding sentence, for purposes of this Section 6(c), beneficial ownership shall be calculated in accordance with Section13(d) of the Exchange Act and the applicable rules and regulations of the Commission. In addition, for purposes hereof, “group”has the meaning set forth in Section 13(d) of the Exchange Act and the applicable rules and regulations of the Commission. For purposesof this Section 6(c), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstandingshares of Common Stock as reflected in (A) the Corporation’s most recent Form 10-K, Form 10-Q, Current Report on Form 8-K or otherpublic filing with the Commission, as the case may be, (B) a more recent public announcement by the Corporation or (C) a more recent noticeby the Corporation or the Corporation’s transfer agent to the Holder setting forth the number of shares of Common Stock then outstanding.For any reason at any time, upon the written or oral request of a Holder (which may be by email), the Corporation shall, within two (2)Business Days of such request, confirm orally and in writing to such Holder (which may be via email) the number of shares of Common Stockthen outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to any actualconversion or exercise of securities of the Corporation, including shares of Series E Preferred Stock, by such Holder or its Affiliatessince the date as of which such number of outstanding shares of Common Stock was last publicly reported or confirmed to the Holder. The“Beneficial Ownership Limitation” shall be 4.99% of the number of shares of the Common Stock outstanding immediatelyafter giving effect to the issuance of shares of Common Stock pursuant to such Notice of Conversion (to the extent permitted pursuantto this Section 6(c)). The Corporation shall be entitled to rely on representations made to it by the Holder in any Notice of Conversionregarding its Beneficial Ownership Limitation. The provisions of this Section 6(c) shall be construed, corrected and implemented in amanner so as to effectuate the intended beneficial ownership limitation herein contained and the shares of Common Stock underlying theSeries E Preferred Stock in excess of the Beneficial Ownership Limitation shall not be deemed to be beneficially owned by the Holder forany purpose including for purposes of Section 13(d) or Rule 16a-1(a)(1) of the Exchange Act.
(d) OMITTED.
(e) Mechanics of Conversion.
(i) Delivery of Certificateor Electronic Issuance Upon Conversion. Not later than three (3) Trading Days after the applicable Conversion Date (the “ShareDelivery Date”) the Corporation shall: (a) deliver, or cause to be delivered, to the converting Holder a physical certificateor certificates representing the number of Conversion Shares being acquired upon the conversion of shares of Series E Preferred Stock(which certificate or certificates shall not have any legends on it) or (b) in the case of a DWAC Delivery, electronically transfer suchConversion Shares by crediting the account of the Holder’s prime broker with DTC through its DWAC system. If in the case of anyNotice of Conversion such certificate or certificates are not delivered to or as directed by or, in the case of a DWAC Delivery, suchshares are not electronically delivered to or as directed by, the applicable Holder by the Share Delivery Date, the applicable Holdershall be entitled to elect to rescind such Conversion Notice by written notice to the Corporation at any time on or before its receiptof such certificate or certificates for Conversion Shares or electronic receipt of such shares, as applicable, in which event the Corporationshall promptly return to such Holder any original Series E Preferred Stock certificate delivered to the Corporation and such Holder shallpromptly return to the Corporation any Common Stock certificates or otherwise direct the return of any shares of Common Stock deliveredto the Holder through the DWAC system, representing the shares of Series E Preferred Stock unsuccessfully tendered for conversion to theCorporation.
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(ii) Obligation Absolute.Subject to any limitations on the beneficial ownership of Series E Preferred Stock to which a Holder may be subject and subject to suchHolder’s right to rescind a Conversion Notice pursuant to Section 6(e)(i) above, the Corporation’s obligation to issue anddeliver the Conversion Shares upon conversion of Series E Preferred Stock in accordance with the terms hereof are absolute and unconditional,irrespective of any action or inaction by a Holder to enforce the same, any waiver or consent with respect to any provision hereof, therecovery of any judgment against any Person or any action to enforce the same, or any setoff, counterclaim, recoupment, limitation ortermination, or any breach or alleged breach by such Holder or any other Person of any obligation to the Corporation or any violationor alleged violation of law by such Holder or any other Person, and irrespective of any other circumstance which might otherwise limitsuch obligation of the Corporation to such Holder in connection with the issuance of such Conversion Shares. Subject to any limitationson the beneficial ownership of Series E Preferred Stock to which a Holder may be subject and subject to such Holder’s right to rescinda Conversion Notice pursuant to Section 6(e)(i) above, in the event a Holder shall elect to convert any or all of its Series E PreferredStock, the Corporation may not refuse conversion based on any claim that such Holder or anyone associated or affiliated with such Holderhas been engaged in any violation of law, agreement or for any other reason, unless an injunction from a court, on notice to such Holder,restraining and/or enjoining conversion of all or part of the Series E Preferred Stock of such Holder shall have been sought and obtainedby the Corporation, and the Corporation posts a surety bond for the benefit of such Holder in the amount of 150% of the value of the ConversionShares into which would be converted the Series E Preferred Stock which is subject to such injunction, which bond shall remain in effectuntil the completion of arbitration/litigation of the underlying dispute and the proceeds of which shall be payable to such Holder tothe extent it obtains judgment. In the absence of such injunction, the Corporation shall, subject to any limitations on the beneficialownership of Series E Preferred Stock to which a Holder may be subject and subject to such Holder’s right to rescind a ConversionNotice pursuant to Section 6(e)(i) above, issue Conversion Shares upon a properly noticed conversion. If the Corporation fails to deliverto a Holder such certificate or certificates, or electronically deliver (or cause its transfer agent to electronically deliver) such sharesin the case of a DWAC Delivery, pursuant to Section 6(e)(i) on or prior to the third (3rd) Trading Day after the Share Delivery Date applicableto such conversion (other than a failure caused by incorrect or incomplete information provided by such Holder to the Corporation), then,unless the Holder has rescinded the applicable Conversion Notice pursuant to Section 6(e)(i) above, the Corporation shall pay (as liquidateddamages and not as a penalty) to such Holder an amount payable in cash equal to the product of (x) the number of Conversion Shares requiredto have been issued by the Corporation on such Share Delivery Date, (y) an amount equal to the Daily Failure Amount and (z) the numberof Trading Days actually lapsed after such third (3rd) Trading Day after the Share Delivery Date during which such certificates have notbeen delivered, or, in the case of a DWAC Delivery, such shares have not been electronically delivered. The foregoing liquidated damagesis not intended to be, and is not, an exclusive remedy. Nothing herein shall limit a Holder’s right to pursue actual damages forthe Corporation’s failure to deliver Conversion Shares within the period specified herein and such Holder shall have the right topursue all remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/orinjunctive relief; provided that Holder shall not receive duplicate damages for the Corporation’s failure to deliver ConversionShares within the period specified herein. The exercise of any such rights shall not prohibit a Holder from seeking to enforce damagespursuant to any other Section hereof or under applicable law.
(iii) Compensation for Buy-Inon Failure to Timely Deliver Certificates Upon Conversion. If the Corporation fails to deliver to a Holder the applicable certificateor certificates or to effect a DWAC Delivery, as applicable, by the Share Delivery Date pursuant to Section 6(e)(i) (other than a failurecaused by incorrect or incomplete information provided by such Holder to the Corporation) (a “Conversion Failure”),and if after such Share Delivery Date such Holder is required by its brokerage firm to purchase (in an open market transaction or otherwise),or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by such Holder ofthe Conversion Shares which such Holder was entitled to receive upon the conversion relating to such Share Delivery Date (a “Buy-In”),then the Corporation shall (A) pay in cash to such Holder (in addition to any other remedies available to or elected by such Holder) theamount by which (x) such Holder’s total purchase price (including any brokerage commissions) for the shares of Common Stock so purchasedexceeds (y) the product of (1) the aggregate number of shares of Common Stock that such Holder was entitled to receive from the conversionat issue multiplied by (2) the actual sale price at which the sell order giving rise to such purchase obligation was executed (includingany brokerage commissions) and (B) at the option of such Holder, either reissue (if surrendered) the shares of Series E Preferred Stockequal to the number of shares of Series E Preferred Stock submitted for conversion or deliver to such Holder the number of shares of CommonStock that would have been issued if the Corporation had timely complied with its delivery requirements under Section 6(e)(i). For example,if a Holder purchases shares of Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted conversionof shares of Series E Preferred Stock with respect to which the actual sale price (including any brokerage commissions) giving rise tosuch purchase obligation was a total of $10,000 under clause (A) of the immediately preceding sentence, the Corporation shall be requiredto pay such Holder $1,000. The Holder shall provide the Corporation written notice, within three (3) Trading Days after the occurrenceof a Buy-In, indicating the amounts payable to such Holder in respect of such Buy-In together with applicable confirmations and otherevidence reasonably requested by the Corporation. Nothing herein shall limit a Holder’s right to pursue any other remedies availableto it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respectto the Corporation’s failure to timely deliver certificates representing shares of Common Stock upon conversion of the shares ofSeries E Preferred Stock as required pursuant to the terms hereof; provided, however, that the Holder shall not be entitled to both (i)require the reissuance of the shares of Series E Preferred Stock submitted for conversion for which such conversion was not timely honoredand (ii) receive the number of shares of Common Stock that would have been issued if the Corporation had timely complied with its deliveryrequirements under Section 6(e)(i).
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(iv) Reservation of SharesIssuable Upon Conversion. The Corporation covenants that it will at all times reserve and keep available out of its authorized andunissued shares of Common Stock for the sole purpose of issuance upon conversion of the Series E Preferred Stock, free from preemptiverights or any other actual contingent purchase rights of Persons other than the Holders of the Series E Preferred Stock, not less thansuch aggregate number of shares of the Common Stock as shall be issuable (taking into account the adjustments of Section 7) upon the conversionof all outstanding shares of Series E Preferred Stock. The Corporation covenants that all shares of Common Stock that shall be so issuableshall, upon issue, be duly authorized, validly issued, fully paid and nonassessable.
(v) Fractional Shares.No fractional shares or scrip representing fractional shares of Common Stock shall be issued upon the conversion of the Series E PreferredStock. As to any fraction of a share which a Holder would otherwise be entitled to receive upon such conversion, the Corporation shallat its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by theConversion Price or round up to the next whole share.
(vi) Transfer Taxes.The issuance of certificates for shares of the Common Stock upon conversion of the Series E Preferred Stock shall be made without chargeto any Holder for any documentary stamp or similar taxes that may be payable in respect of the issue or delivery of such certificates,provided that the Corporation shall not be required to pay any tax that may be payable in respect of any transfer involved in the issuanceand delivery of any such certificate upon conversion in a name other than that of the registered Holder(s) of such shares of Series EPreferred Stock and the Corporation shall not be required to issue or deliver such certificates unless or until the Person or Personsrequesting the issuance thereof shall have paid to the Corporation the amount of such tax or shall have established to the satisfactionof the Corporation that such tax has been paid.
(f) Status as Stockholder.Upon each Conversion Date: (i) the shares of Series E Preferred Stock being converted shall be deemed converted into shares of CommonStock and (ii) the Holder’s rights as a holder of such converted shares of Series E Preferred Stock shall cease and terminate, exceptingonly the right to receive certificates for or electronic delivery of such shares of Common Stock and to any remedies provided herein orotherwise available at law or in equity to such Holder because of a failure by the Corporation to comply with the terms of this Certificateof Designation. In all cases, the holder shall retain all of its rights and remedies for the Corporation’s failure to convert SeriesE Preferred Stock.
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Section7. CERTAIN ADJUSTMENTS.
(a) Adjustments for StockSplits and Combinations. If the Corporation shall at any time or from time to time after the Initial Issuance Date effect a stocksplit of the outstanding Common Stock, the applicable Conversion Price in effect immediately prior to the stock split shall be proportionatelydecreased. If the Corporation shall at any time or from time to time after the Initial Issuance Date, combine the outstanding shares ofCommon Stock, the applicable Conversion Price in effect immediately prior to the combination shall be proportionately increased. Any adjustmentsunder this Section 7(a) shall be effective at the close of business on the date the stock split or combination occurs.
(b) Adjustments for CertainDividends and Distributions. If the Corporation shall at any time or from time to time after the Initial Issuance Date make or issueor set a record date for the determination of holders of Common Stock entitled to receive a dividend or other distribution payable inshares of Common Stock, then, and in each event, the applicable Conversion Price in effect immediately prior to such event shall be decreasedas of the time of such issuance or, in the event such record date shall have been fixed, as of the close of business on such record date,by multiplying the applicable Conversion Price then in effect by a fraction:
(i) the numerator of which shallbe the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the close of businesson such record date; and
(ii) the denominator of whichshall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the closeof business on such record date plus the number of shares of Common Stock issuable in payment of such dividend or distribution.
(c) Adjustment for OtherDividends and Distributions. If the Corporation shall at any time or from time to time after the Initial Issuance Date make or issueor set a record date for the determination of holders of Common Stock entitled to receive a dividend or other distribution payable inother than shares of Common Stock, then, and in each event, an appropriate revision to the applicable Conversion Price shall be made andprovision shall be made (by adjustments of the Conversion Price or otherwise) so that the Holders shall receive upon conversions thereof,in addition to the number of shares of Common Stock receivable thereon, the number of securities of the Corporation or other issuer (asapplicable) or other property that they would have received had the shares of Series E Preferred Stock been converted into Common Stockon the date of such event and had thereafter, during the period from the date of such event to and including the Conversion Date, retainedsuch securities (together with any distributions payable thereon during such period) or assets, giving application to all adjustmentscalled for during such period under this Section 7(c) with respect to the rights of each Holder; provided, however, that if such recorddate shall have been fixed and such dividend is not fully paid or if such distribution is not fully made on the date fixed therefor, theConversion Price shall be adjusted pursuant to this paragraph as of the time of actual payment of such dividends or distributions; andfurther provided, that, this Section 7(c) shall not apply to any dividends actually paid to the Holders pursuant to Section 3 hereof.
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(d) Adjustments for Reclassification.Exchange or Substitution. If the Common Stock at any time or from time to time after the Initial Issuance Date shall be changed tothe same or different number of shares or other securities of any class or classes of stock or other property, whether by reclassification,exchange, substitution or otherwise (other than by way of a stock split or combination of shares or stock dividends provided for in Section7(a), Section 7(b), and Section 7(c), or a reorganization, merger, consolidation, or sale of assets provided for in Section 7(e)), then,and in each event, an appropriate revision to the Conversion Price shall be made and provisions shall be made (by adjustments of the ConversionPrice or otherwise) so that each Holder shall have the right thereafter to convert shares of Series E Preferred Stock into the kind andamount of shares of stock or other securities or other property receivable upon reclassification, exchange, substitution or other change,by holders of the number of shares of Common Stock into which such shares of Series E Preferred Stock might have been converted immediatelyprior to such reclassification, exchange, substitution or other change, all subject to further adjustment as provided herein.
(e) Adjustments for Reorganization,Merger, Consolidation or Sales of Assets. In case of any reorganization of the Corporation (or any other corporation the stock orother securities of which are at the time receivable on the conversion of the shares of Series E Preferred Stock) after the Issuance Date,or in case, after such date, the Corporation (or any such other corporation) shall consolidate with or merge into another corporationor entity or convey all or substantially all its assets to another corporation or entity (any such reorganization or other event hereafterbeing referred to as a “Fundamental Transaction”), then and in each such case the shares of Series E PreferredStock, upon conversion, as and at any time after the consummation of such Fundamental Transaction, shall be converted into, in lieu ofthe stock or other securities and property into which the shares of Series E Preferred Stock would have been convertible prior to suchFundamental Transaction, such stock or other securities or property to which the shares of Series E Preferred Stock would have convertedif the shares of Series E Preferred Stock had been converted immediately prior to any such Reorganization (the “AlternateConsideration”), subject to further adjustment as provided in Section 7(a), Section 7(b), Section 7(c) and Section 7(d)in each such case. To the extent necessary to effectuate the foregoing provisions, any successor to the Corporation or surviving entityin such Fundamental Transaction shall file a new Certificate of Designation with the same terms and conditions and issue to the Holdersnew preferred stock consistent with the foregoing provisions and evidencing the Holders’ right to convert such preferred stock intoAlternate Consideration. The terms of any agreement to which the Corporation is a party and pursuant to which a Fundamental Transactionis effected shall include terms requiring any such successor or surviving entity to comply with the provisions of this Section 7(e) andensuring that the Series E Preferred Stock (or any such replacement security) will be similarly adjusted upon any subsequent transactionanalogous to a Fundamental Transaction. In the event of the merger or consolidation of the Corporation with or into another corporation,the Series E Preferred Stock shall maintain their relative rank, powers, designations and preferences provided for herein (for the avoidanceof doubt, the Series E Preferred Stock shall be senior to all other classes of capital stock of the successor entity) and no merger shallhave a result inconsistent therewith. The Corporation shall cause to be delivered (via overnight courier, facsimile or email) to eachHolder, at its last address as it shall appear upon the books and records of the Corporation, written notice of any Fundamental Transactionat least ten (10) calendar days prior to the date on which such Fundamental Transaction is expected to become effective or close.
(f) Record Date. Incase the Corporation shall take record of the holders of its Common Stock for the purpose of entitling them to subscribe for or purchaseCommon Stock or Convertible Securities, then the date of the issue or sale of the shares of Common Stock shall be deemed to be such recorddate.
(g) No Impairment.The Corporation shall not, by amendment of its Certificate of Incorporation or through any reorganization, transfer of assets, consolidation,merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance ofany of the terms to be observed or performed hereunder by the Corporation, but will at all times in good faith assist in the carryingout of all the provisions of this Section 7 and in the taking of all such action as may be necessary or appropriate in order to protectthe conversion rights of each Holder against impairment.
(h) Certificates as toAdjustments. Upon occurrence of each adjustment or readjustment of the Conversion Price or number of shares of Common Stock issuableupon conversion of the shares of Series E Preferred Stock pursuant to this Section 7, the Corporation, at its expense, shall promptlycompute such adjustment or readjustment in accordance with the terms hereof and furnish to each Holder a certificate setting forth suchadjustment and readjustment, showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, uponwritten request of a Holder, at any time, furnish or cause to be furnished to such Holder a like certificate setting forth such adjustmentsand readjustments, the applicable Conversion Price in effect at the time, and the number of shares of Common Stock and the amount, ifany, of other securities or property which at the time would be received upon the conversion of the shares of Series E Preferred Stock.
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Section8. RIGHTS UPON ISSUANCE OF PURCHASE RIGHTS AND OTHER CORPORATE EVENTS.
(a) Purchase Rights.In addition to any adjustments pursuant to Section 7 above, if at any time the Corporation grants, issues or sells any Options, ConvertibleSecurities or rights to purchase stock, warrants, securities or other property pro rata to all or substantially all of the record holdersof any class of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon theterms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held thenumber of shares of Common Stock acquirable upon complete conversion of the Holder’s shares of Preferred Stock (without taking intoaccount any limitations or restrictions on the convertibility of the Preferred Stock) immediately before the date on which a record istaken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holdersof Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’sright to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holdershall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock asa result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder untilsuch time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).
(b) Other Corporate Events.In addition to and not in substitution for any other rights hereunder, prior to the consummation of any Fundamental Transaction pursuantto which holders of shares of Common Stock are entitled to receive securities or other assets with respect to or in exchange for sharesof Common Stock (a “Corporate Event”), the Corporation shall make appropriate provision to insure that the Holderwill thereafter have the right to receive upon a conversion of the Holder’s shares of Preferred Stock (i) in addition to the sharesof Common Stock receivable upon such conversion, such securities or other assets to which the Holder would have been entitled with respectto such shares of Common Stock had such shares of Common Stock been held by the Holder upon the consummation of such Corporate Event (withouttaking into account any limitations or restrictions on the convertibility of the Preferred Stock) or (ii) in lieu of the shares of CommonStock otherwise receivable upon such conversion, such securities or other assets received by the holders of shares of Common Stock inconnection with the consummation of such Corporate Event in such amounts as the Holder would have been entitled to receive had the Holder’sshares of Preferred Stock initially been issued with conversion rights for the form of such consideration (as opposed to shares of CommonStock) at a conversion rate for such consideration commensurate with the Conversion Rate. Provision made pursuant to the preceding sentenceshall be in a form and substance reasonably satisfactory to the Holder. The provisions of this Section 8(b) shall apply similarly andequally to successive Corporate Events and shall be applied without regard to any limitations on the conversion of the Preferred Stock.
Section9. OMITTED.
Section10. COVENANTS. So long as any shares of the Series E Preferred Stock are outstanding, without the prior expresswritten consent of Holders representing 66 2/3% of the outstanding shares of Series E Preferred Stock, the Corporation shall not, andshall not permit any Subsidiary, to, directly or indirectly:
| (i) | redeem, repurchase or pay any cash dividend or distribution on any of its capital stock (other than Permitted Distributions); |
| (ii) | engage in any material line of business substantially different from those lines of business conducted by the Corporation and each of its Subsidiaries on the Initial Issue Date or any business substantially related or incidental thereto. The Corporation shall not, and the Corporation shall cause each of its Subsidiaries to not, directly or indirectly, modify its or their corporate structure or purpose; |
| (iii) | acquire or form any New Subsidiary if such New Subsidiary would not be wholly-owned, directly or indirectly, by the Corporation; |
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| (iv) | fail to maintain and preserve all of its properties which are necessary or useful in the proper conduct of its business in good working order and condition, ordinary wear and tear excepted, and fail to comply at all times with the provisions of all leases to which it is a party as lessee or under which it occupies property, in each case so as to prevent any material loss or forfeiture thereof or thereunder; | |
| (v) | fail to maintain insurance with responsible and reputable insurance companies or associations (including, without limitation, comprehensive general liability, hazard, rent and business interruption insurance) with respect to its properties (including all real properties leased or owned by it) and business, in such amounts and covering such risks as is required by any governmental authority having jurisdiction with respect thereto or as is carried generally in accordance with sound business practice by companies in similar businesses similarly situated; |
| (vi) | other than in the ordinary course of business and consistent with past practice, lend money or credit (by way of guarantee or otherwise) or make advances to any Person other than a wholly-owned Subsidiary; |
| (vii) | sell, lease, license, assign, transfer, convey or otherwise dispose of any assets or rights of the Corporation or any Subsidiary owned or hereafter acquired whether in a single transaction or a series of related transactions, other than (i) sales, leases, licenses, assignments, transfers, conveyances and other dispositions of such assets or rights by the Corporation and its Subsidiaries that, after giving effect thereto, would not materially change or interfere with the business of the Corporation and its Subsidiaries as operated immediately prior to such disposition and (ii) sales of product, inventory or receivables in the ordinary course of business; or |
| (viii) | amend, alter, add or repeal any provision of the Company’s Certificate of Incorporation in a manner adversely affecting the rights of the holders of shares of Series E Preferred Stock. |
Section11. MISCELLANEOUS.
(a) Notices. Any andall notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice ofConversion, shall be in writing and delivered personally, by email, facsimile, or sent by a nationally recognized overnight courier service,addressed to the Corporation, at 400 Connell Drive, Suite 5000, Berkeley Heights, New Jersey 07922, facsimile number (908) 375-8272, orsuch other facsimile number or address or email address as the Corporation may specify for such purposes by notice to the Holders deliveredin accordance with this Section. Any and all notices or other communications or deliveries to be provided by the Corporation hereundershall be in writing and delivered personally, by facsimile, or sent by a nationally recognized overnight courier service or email addressedto each Holder at the facsimile number or address of such Holder appearing on the books of the Corporation, or if no such facsimile numberor address appears on the books of the Corporation, at the principal place of business of such Holder. Any notice or other communicationor deliveries hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communicationis delivered via facsimile or email at the facsimile number or email address specified in or pursuant to this Section prior to 5:30 p.m.(New York City time) on any date, (ii) the date immediately following the date of transmission, if such notice or communication is deliveredvia facsimile or mail at the facsimile number or email address specified in or pursuant to this Section between 5:30 p.m. and 11:59 p.m.(New York City time) on any date, (iii) the second (2nd) Business Day following the date of mailing, if sent by nationally recognizedovernight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.
(b) Lost or Mutilated SeriesE Preferred Stock Certificate. If a Holder’s Series E Preferred Stock certificate shall be mutilated, lost, stolen or destroyed,the Corporation shall execute and deliver, in exchange and substitution for and upon cancellation of a mutilated certificate, or in lieuof or in substitution for a lost, stolen or destroyed certificate, a new certificate for the shares of Series E Preferred Stock so mutilated,lost, stolen or destroyed, but only upon receipt of evidence of such loss, theft or destruction of such certificate, and of the ownershipthereof, reasonably satisfactory to the Corporation and, in each case, customary and reasonable indemnity, if requested. Applicants fora new certificate under such circumstances shall also comply with such other reasonable regulations and procedures and pay such otherreasonable third-party costs as the Corporation may prescribe.
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(c) Waiver. Any waiverby the Corporation or a Holder of a breach of any provision of this Certificate of Designation shall not operate as or be construed tobe a waiver of any other breach of such provision or of any breach of any other provision of this Certificate of Designation or a waiverby any other Holders. The failure of the Corporation or a Holder to insist upon strict adherence to any term of this Certificate of Designationon one or more occasions shall not be considered a waiver or deprive that party (or any other Holder) of the right thereafter to insistupon strict adherence to that term or any other term of this Certificate of Designation. Any waiver by the Corporation or a Holder mustbe in writing.
(d) Severability. Ifany provision of this Certificate of Designation is invalid, illegal or unenforceable, the balance of this Certificate of Designationshall remain in effect, and if any provision is inapplicable to any Person or circumstance, it shall nevertheless remain applicable toall other Persons and circumstances. If it shall be found that any interest or other amount deemed interest due hereunder violates theapplicable law governing usury, the applicable rate of interest due hereunder shall automatically be lowered to equal the maximum rateof interest permitted under applicable law.
(e) Next Business or TradingDay. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day or a Trading Day, such paymentshall be made on the next succeeding Business Day or Trading Day, as the case may be.
(f) Headings. The headingscontained herein are for convenience only, do not constitute a part of this Certificate of Designation and shall not be deemed to limitor affect any of the provisions hereof.
(g) Status of ConvertedSeries E Preferred Stock. If any shares of Series E Preferred Stock shall be converted or reacquired by the Corporation, such sharesshall resume the status of authorized but unissued shares of preferred stock and shall no longer be designated as Series E Preferred Stock.
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IN WITNESS WHEREOF,the Corporation has caused this Third Amendment and Restatement to be signed by its duly authorized officer this 6th day of August, 2025.
| CORMEDIX INC. | |||
| By: | /s/ Joseph Todisco | ||
| Name: | Joseph Todisco | ||
| Title: | Chief Executive Officer | ||
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ANNEX A
NOTICE OF CONVERSION
(TO BE EXECUTED BY THE REGISTERED HOLDER IN ORDERTO CONVERT SHARES OF SERIES E CONVERTIBLE PREFERRED STOCK)
The undersigned Holder hereby irrevocably electsto convert the number of shares of Series E Convertible Preferred Stock indicated below, represented by stock certificate No(s). __________(the “Preferred Stock Certificates”), into shares of common stock, par value $0.001 per share (the “CommonStock”), of CorMedix Inc., a Delaware corporation (the “Corporation”), as of the date written below. If securitiesare to be issued in the name of a person other than the undersigned, the undersigned will pay all transfer taxes payable with respectthereto. Capitalized terms utilized but not defined herein shall have the meaning ascribed to such terms in that certain Third Amendedand Restated Certificate of Designation (the “Certificate of Designation”) of Series E Convertible Preferred Stock(the “Series E Preferred Stock”) filed by the Corporation on August 6, 2025.
As of the date hereof, the number of shares ofCommon Stock beneficially owned by the undersigned Holder (together with such Holder’s Affiliates, and any other Person whose beneficialownership of Common Stock would be aggregated with the Holder’s for purposes of Section 13(d) of the Exchange Act and the applicableregulations of the Commission, including any “group” of which the Holder is a member), including the number of shares of CommonStock issuable upon conversion of the Series E Preferred Stock subject to this Notice of Conversion, but excluding the number of sharesof Common Stock which are issuable upon (A) conversion of the remaining, unconverted Series E Preferred Stock beneficially owned by suchHolder or any of its Affiliates, and (B) exercise or conversion of the unexercised or unconverted portion of any other securities of theCorporation (including any warrants) beneficially owned by such Holder or any of its Affiliates that are subject to a limitation on conversionor exercise similar to the limitation contained in Section 6(c) of the Certificate of Designation, is ____________. For purposes hereof,beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the Commission.In addition, for purposes hereof, “group” has the meaning set forth in Section 13(d) of the Exchange Act and the applicableregulations of the Commission.
CONVERSION CALCULATIONS:
| Date to Effect Conversion: | |
| Number of shares of Series E Preferred Stock owned prior to Conversion: | |
| Number of shares of Series E Preferred Stock to be Converted: | |
| Number of shares of Common Stock to be Issued: |
| Address for delivery of physical certificates: | |
For DWAC Delivery, please provide the following:
| Broker no: | ||
| Account no: |
| [HOLDER] | ||
| By: | ||
| Name: | ||
| Title: | ||
| Date: | ||
-15-
Exhibit 31.1
CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Todisco, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of CorMedixInc.; |
| 2. | Based on my knowledge, this report does not contain any untruestatement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances underwhich such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financialinformation included in this report, fairly present in all material respects the financial condition, results of operations and cashflows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsiblefor establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internalcontrol over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) | Designed such disclosure controls and procedures, or causedsuch disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant,including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which thisreport is being prepared; |
| b) | Designed such internal control over financial reporting,or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regardingthe reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generallyaccepted accounting principles; |
| c) | Evaluated the effectiveness of the registrant’s disclosurecontrols and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures,as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the registrant’sinternal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’sfourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed,based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committeeof the registrant’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in thedesign or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’sability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves managementor other employees who have a significant role in the registrant’s internal control over financial reporting. |
| c) | Any incidents of cybersecurity that have a significant impacton internal controls over financial reporting and financial statements. |
| Date: August 7, 2025 | By: | /s/ Joseph Todisco |
| Name: | Joseph Todisco | |
| Title: | Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Matthew David, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of CorMedixInc.; |
| 2. | Based on my knowledge, this report does not contain any untruestatement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances underwhich such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financialinformation included in this report, fairly present in all material respects the financial condition, results of operations and cashflows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsiblefor establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internalcontrol over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| e) | Designed such disclosure controls and procedures, or causedsuch disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant,including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which thisreport is being prepared; |
| f) | Designed such internal control over financial reporting,or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regardingthe reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generallyaccepted accounting principles; |
| g) | Evaluated the effectiveness of the registrant’s disclosurecontrols and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures,as of the end of the period covered by this report based on such evaluation; and |
| h) | Disclosed in this report any change in the registrant’sinternal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’sfourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed,based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committeeof the registrant’s board of directors (or persons performing the equivalent functions): |
| d) | All significant deficiencies and material weaknesses in thedesign or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’sability to record, process, summarize and report financial information; and |
| e) | Any fraud, whether or not material, that involves managementor other employees who have a significant role in the registrant’s internal control over financial reporting. |
| f) | Any incidents of cybersecurity that have a significant impacton internal controls over financial reporting and financial statements. |
| Date: August 7, 2025 | By: | /s/ Matthew David |
| Name: | Matthew David | |
| Title: | Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACTOF 2002
In connection with the Quarterly Report of CorMedix Inc., a Delawarecorporation (the “Company”), on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commissionon the date hereof (the “Report”), I, Joseph Todisco, Chief Executive Officer of the Company, hereby certify, pursuant to18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
| 1. | The Report fully complies with the requirements of Section13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the Report fairly presents,in all material respects, the financial condition and results of operations of the Company. |
| Date: August 7, 2025 | By: | /s/ Joseph Todisco |
| Name: | Joseph Todisco | |
| Title: | Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACTOF 2002
In connection with the Quarterly Report of CorMedix Inc., a Delawarecorporation (the “Company”), on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commissionon the date hereof (the “Report”), I, Matthew David, Chief Financial Officer of the Company, hereby certify, pursuant to 18U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
| 1. | The Report fully complies with the requirements of Section13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the Report fairly presents,in all material respects, the financial condition and results of operations of the Company. |
| Date: August 7, 2025 | By: | /s/ Matthew David |
| Name: | Matthew David | |
| Title: | Chief Financial Officer (Principal Financial Officer) |