CorMedix Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited financial information and 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 Securities and Exchange Commission, or the SEC, on March 25, 2025.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited financial information and 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 Securities and Exchange Commission (the “SEC”), on March 25, 2025.

Previous wording

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 company to achieve the identified synergies; the ability to integrate the Melinta business into CorMedix and realize the anticipated strategic benefits of the transaction within the expected time-frames or at all; that such integration may be more difficult, time-consuming or costly than expected; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the proposed transaction or the public announcement of the proposed transaction; the retention of certain key employees of Melinta; the expected benefits and success of Melinta’s products and 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; general economic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policies and relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and future competitors.

Current wording

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 ability of the combined company to achieve the identified synergies; the ability to integrate the Melinta business into CorMedix and realize the anticipated strategic benefits of the transaction within the expected time-frames or at all; that such integration may be more difficult, time-consuming or costly than expected; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the closing of the transaction; the retention of certain key employees of Melinta; the expected benefits and success of Melinta’s products and product candidates; potential litigation relating to the 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; general economic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policies and relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and future competitors.

Previous wording

Our primary focus is commercializing our lead product, DefenCath® (taurolidine and heparin), in the U.S. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration (“FDA”). CorMedix launched the product commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting.

Current wording

Historically, our primary focus has been commercializing our lead product, DefenCath® (taurolidine and heparin), in the U.S. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration (“FDA”) on November 15, 2023. CorMedix launched the product commercially in 2024 in both the hospital inpatient and outpatient hemodialysis settings of care.

Previous wording

DefenCath is an FDA approved antimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (“CVC”). It is indicated for use in a limited and specific population of patients. CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to extended and often repeat hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality. We believe DefenCath can address a significant unmet medical need.

Current wording

DefenCath is an FDA approved antimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (“CVC”). It is indicated for use in a limited and specific population of patients. CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to extended and often repeat hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality. 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 a Phase 3 clinical study. The Company believes DefenCath can address a significant unmet medical need.

Previous wording

On January 25, 2024, CMS determined that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment system (“ESRD PPS”). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submitted an application for TDAPA on January 26, 2024, and received confirmation that our application was approved on April 18, 2024 for a July 1, 2024 implementation. We also submitted a Healthcare Common Procedure Coding System (“HCPCS”) application for a J-code to CMS on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application. The HCPCS J-code for DefenCath was published by CMS on April 2, 2024. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or manufacturers’ list price, respectively, if such data is unavailable). TDAPA and post-TDAPA add-on payment adjustments for DefenCath apply for five years (with such add-on payments applying to all ESRD PPS payments for years three through five). CMS confirmed a July 1, 2024 implementation date for HCPCS and TDAPA.

Current wording

On January 25, 2024, CMS determined that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment system (“ESRD PPS”). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submitted an application for TDAPA on January 26, 2024, and also submitted a Healthcare Common Procedure Coding System (“HCPCS”) application for a J-code to CMS on December 8, 2023. CMS implemented HCPCS and TDAPA for DefenCath on July 1, 2024.

Previous wording

Subsequent to the launch of DefenCath in April 2024, we announced U.S.-based multi-year commercial supply agreements consisting of a large and several mid-sized dialysis organizations. Each provider has customized an implementation plan to provide access to patients based on a variety of clinical and other factors. We believe the currently contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in terms of the total addressable patient market. During the second quarter of 2025, the Company’s large dialysis organization customer commenced ordering.

Current wording

Subsequent to the launch of DefenCath in April 2024, we announced U.S.-based multi-year commercial supply agreements consisting of a large and several mid-sized dialysis organizations. Each provider has customized an implementation plan to provide access to patients based on a variety of clinical and other factors. We believe the currently contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in terms of the total addressable patient market. During the second quarter of 2025, the Company’s large dialysis organization customer commenced ordering and patient utilization at the large dialysis organization commenced in the third quarter of 2025.

Previous wording

On August 7, 2025, the Company entered into an Agreement and Plan of Merger (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”), and Deerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative, agent and attorney-in-fact of the Melinta equity holders (the “Members’ Representative”).

Current wording

On August 29, 2025 (the “Closing Date”), we completed the acquisition of Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”), pursuant to that certain Agreement and Plan of Merger (the “Merger Agreement”) with Melinta, Coriander BidCo LLC, a Delaware limited liability company and a wholly owned subsidiary of the Company (“Merger Sub”), and Deerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative, agent and attorney-in-fact of the Melinta equity holders.

Previous wording

Pursuant to the terms of the Merger Agreement, and subject to the conditions contained therein, the Company has agreed to acquire Melinta via a merger in which Merger Sub will merge with and into Melinta (the “Merger”), with Melinta surviving as a wholly owned subsidiary of the Company. The closing of the Merger is referred to herein as the “Closing.”

Current wording

Pursuant to the terms of the Merger Agreement, we acquired Melinta via a merger in which Merger Sub merged with and into Melinta (the “Merger”), with Melinta surviving as a wholly-owned subsidiary of the Company. In consideration for the Merger, we (i) paid to the former Melinta equity holders an aggregate of $260.0 million in cash, subject to adjustment for estimated Company Cash and estimated Working Capital as compared to the Working Capital Target (each as defined in the Merger Agreement), and (ii) issued to certain of the former Melinta equity holders an aggregate of $40.0 million worth of common shares, par value $0.001 per share, of the Company (the “Merger Shares”). In addition, in connection with the Merger, we paid $23.2 million to acquire the Toprol XL product rights, which Melinta had licensed from a third party. The total cash consideration was funded by a combination of the Company’s existing cash on hand and net proceeds from the Company’s $150.0 million Convertible Notes Offering (as described below).

Previous wording

The Contingent Payment Agreement provides for milestone and net sales based payments. Upon the issuance of the U.S. Food and Drug Administration (“FDA”) marketing approval 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 patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, the Company shall pay, 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:

Current wording

Additionally, former Melinta equity holders are eligible to receive certain contingent payments pursuant to the terms of the Merger Agreement and the Contingent Payment Agreement, which provides for milestone and net sales-based payments. Upon the issuance of the U.S. Food and Drug Administration (“FDA”) marketing approval of REZZAYO (or any product that contains the active ingredient rezafungin), for the prevention or prophylaxis of invasive fungal infections in adult patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, we shall pay, in cash or common shares, par value $0.001 per share, of the Company at the Company’s election, to the former Melinta equity holders the following payments:

Previous wording

Further, the Contingent Payment Agreement 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.

Current wording

Further, the Contingent Payment Agreement provides that we will pay to the former Melinta equity holders tiered royalties on REZZAYO U.S. net sales and low-single-digit royalties on MINOCIN® U.S. net sales.

Previous wording

Pursuant to the terms of the Merger Agreement, simultaneously with the Closing, the Company and the Consenting Melinta Members will enter into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company will agree to register for resale, pursuant to Rule 415 under the Securities Act, the Merger Shares, the shares of Common Stock issuable upon exercise of any Merger 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.

Current wording

On the Closing Date, the Company and the Consenting Melinta Members entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company agreed to register for resale, pursuant to Rule 415 under the Securities Act, the Merger Shares, pursuant to the Contingent Payment Agreement. The Merger Shares were subject to lock-up, the final tranche of which will expire on December 27, 2025.

Previous wording

On August 6, 2025, the Company entered 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, exempt from registration pursuant to Section 4(a)(2) of the Securities Act. Such offering is herein referred to as the “Convertible Notes Offering.” Upon issuance, the Notes will be eligible for resale to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A of the Securities Act. Subject to the terms and conditions of the Subscription Agreements, the Company expects the Notes to be issued on August 12, 2025 (the “Notes Closing Date”).

Current wording

On August 6, 2025, the Company entered into subscription agreements (the “Subscription Agreements”) with certain investors to provide for the issuance of $150.0 million aggregate principal amount of its convertible senior notes due 2030 (the “Notes”) in a private placement, exempt from registration pursuant to Section 4(a)(2) of the Securities Act. Such offering is herein referred to as the “Convertible Notes Offering.” Upon issuance, the Notes will be eligible for resale to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A of the Securities Act. The Notes were issued on August 12, 2025 (the “Notes Closing Date”).

Previous wording

Upon issuance, the Notes will be 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, payable semi-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.

Current wording

The Notes are 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”). The Notes bear interest at a rate of 4.00% per annum, payable semi-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 are senior, unsecured obligations of the Company.

Previous wording

Following issuance of the Notes, the Company intends to use the net proceeds from the Convertible Notes Offering to fund a portion of the purchase price payable in connection with the Merger, including related fees and expenses, and to the extent there are any remaining proceeds in excess of the funds needed for the forgoing purposes, for such other general corporate purposes as the Company determines as appropriate.

Current wording

Following issuance of the Notes, the Company used the net proceeds from the Convertible Notes Offering to fund a portion of the purchase price payable in connection with the Merger, including related fees and expenses.

Previous wording

In addition, on or after August 4, 2028 and prior to the 26 th 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 forth in the Indenture, if the last reported sale price of the Company’s Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which it provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.

Current wording

On or after August 4, 2028 and prior to the 26 th 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 forth in the Indenture, if the last reported sale price of the Company’s Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which it provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.

Previous wording

The conversion rate is subject to adjustment under certain circumstances in accordance with the Indenture. In connection with certain corporate events or if the Company issues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with such corporate event or during the relevant redemption period.

Current wording

The initial conversion rate for the Notes was set at the time of closing and is equal to 74.2515 shares of Common Stock per $1,000 principal amount of Notes. The initial conversion rate is subject to adjustment under certain circumstances in accordance with the Indenture. In connection with certain corporate events or if the Company issues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with such corporate event or during the relevant redemption period, not to exceed 96.5269 shares of Common Stock per $1,000 principal amount of Notes.

Previous wording

We generate product revenue from commercial sales of DefenCath to a limited number of direct customers as well as distributors. Revenue from product sales is recognized when our direct customers obtain control of the product and is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns, rebates, shelf-stock adjustments and data fees. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.

Current wording

We generate product revenue from commercial sales of DefenCath to a limited number of direct customers as well as distributors, and from the Closing Date of the Merger, we generate revenue from sales of the Melinta Portfolio. Revenue from product sales is recognized when our direct customers obtain control of the product and is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns, rebates, shelf-stock adjustments and data fees. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.

Previous wording

Cost of revenues include direct 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 and insurance.

Current wording

Cost of revenues include direct and indirect costs related to the manufacturing and distribution of our products, including product cost, packaging services, freight, and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. In addition, cost of revenues includes the amortization of intangible assets primarily associated with the fair value of the products acquired in the Melinta Portfolio that were recorded as a result of the Merger.

Previous wording

Development timelines, probability of success and development costs vary widely. We are currently focused on the commercialization of DefenCath in the U.S.

Current wording

Development timelines, probability of success and development costs vary widely. We are currently focused on the commercialization of our Products in the United States.

Previous wording

General and administrative, or G&A, expenses consist principally of salaries and related costs for personnel in executive, finance and administrative functions including payroll taxes and health insurance, stock-based compensation and travel expenses. Other general and administrative expenses include facility-related costs, insurance and professional fees for legal, patent review, consulting, and accounting services. General and administrative expenses are expensed as incurred.

Current wording

General and administrative, or G&A, expenses consist principally of salaries and related costs for personnel in executive, finance and administrative functions including payroll taxes and health insurance, stock-based compensation and travel expenses. Other general and administrative expenses include merger-related costs, facility-related costs, insurance and professional fees for legal, patent review, consulting, and accounting services. General and administrative expenses are expensed as incurred.

Previous wording

Interest expense consists of interest incurred on financing of expenditures.

Current wording

Interest expense consists of interest incurred primarily on the Notes.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Previous wording

The following is a tabular presentation of our consolidated operating results for the three and six months ended June 30, 2025 and 2024*(in thousands)*:

Current wording

The following is a tabular presentation of our unaudited consolidated operating results for the three and nine months ended September 30, 2025 and 2024*(in thousands)*:

Previous wording

*Revenue.*Revenue for 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 $38.9 million, 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 in 2024, an increase of $78.0 million, or 9,678%. Revenue consists of sales of DefenCath, which was approved by the FDA in November 2023 and launched in the U.S in April 2024 (inpatient setting) and July 2024 (outpatient setting) and reflects the shipment of DefenCath to direct customers and specialty distributors, net of estimates for applicable variable consideration, which consists primarily of distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates and volume incentive rebates, shelf-stock adjustments and data fees.

Current wording

For the three and nine months ended September 30, 2025, Product Sales were $101.6 million and $180.4 million, respectively. Product Sales during the periods consist primarily of sales of DefenCath, which was approved by the FDA in November 2023 and launched in the U.S in April 2024 (inpatient setting) and July 2024 (outpatient setting) and reflects the shipment of DefenCath to direct customers and specialty distributors, net of estimates for applicable variable consideration, which consists primarily of distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates and volume incentive rebates, shelf-stock adjustments and data fees. Revenue from the Melinta Portfolio represents $12.8 million of product sales for the period post-acquisition, or from August 29, 2025 through September 30, 2025.

Previous wording

*Cost of Revenue.*Cost of revenue for the three months ended June 30, 2025 was $1.9 million as 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 ended June 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 of revenues include direct 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 and insurance. Product costs during the three and six month periods ended June 30, 2024 were minimal, and the costs recognized pertained to indirect costs related to the proportion of supply chain and quality personnel, benefits and insurance expenses, representing excess capacity in the production of sellable product. As unit sales increase, a greater proportion of these costs will be capitalized as a component of inventory and expensed at the point-of-sale. The current cost of goods sold excludes certain API that was previously expensed as R&D prior to the approval of DefenCath. We continue to utilize certain previously expensed API and expect to sell through the related inventory in the second half of 2026.

Current wording

*Cost of Revenue.*Cost of revenue for the three months ended September 30, 2025 was $7.6 million as compared to $0.6 million for the same period in 2024, an increase of $6.8 million, or 1,092%. Cost of revenue for the nine months ended September 30, 2025 was $10.9 million as compared to $1.9 million for the same period in 2024, an increase of $9.0 million, or 471%. Cost of revenues include direct and indirect costs related to the manufacturing and distribution of DefenCath and Melinta Portfolio, including product cost, packaging services, freight, and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. Product costs during the three and nine month periods ended September 30, 2024 were minimal. The increase from 2024 to 2025 is primarily driven by higher product sales.

Previous wording

Research and Development Expense*. R&D expense for the three months ended June 30, 2025 was $2.4 million, an increase of $1.7 million, or 275%, from $0.7 million 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 clinical trial services in support of the ongoing clinical studies initiated in the fourth quarter of 2024.

Current wording

Research and Development Expense. R&D expense for the three months ended September 30, 2025 was $5.1 million, an increase of $4.4 million, or 601%, from $0.7 million for the same period in 2024. R&D expense for the nine months ended September 30, 2025 was $10.7 million, an increase of $8.5 million, or 384%, from $2.2 million for the same period in 2024. These increases were due primarily to the increases in personnel and clinical trial services in support of the ongoing clinical studies initiated in the fourth quarter of 2024 as well as severance costs and the incremental cost of Melinta’s operations from August 29, 2025 through September 30, 2025.

Previous wording

*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 for the 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-launch and launch of DefenCath in 2024.

Current wording

Selling and Marketing Expense. S&M expense was $11.2 million for the three months ended September 30, 2025, an increase of $4.5 million, or 66%, from $6.7 million for the same period in 2024. S&M expense was $22.0 million for the nine months ended September 30, 2025, an increase of $1.5 million, or 8%, from $20.5 million for the same period in 2024. These increases were primarily due to severance costs and the incremental cost of Melinta’s operations from August 29, 2025 through September 30, 2025, offset by additional marketing costs related to the pre-launch and launch of DefenCath in 2024.

Previous wording

General and Administrative Expense. 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 million for 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, or 18%, from $16.3 million for the same period in 2024. The increase for the three months ended June 30, 2025, was primarily driven by the non-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 million and an increase in costs related to business development of $0.3 million.

Current wording

General and Administrative Expense. G&A expense for the three ended September 30, 2025 was $25.5 million, an increase of $18.9 million, or 287%, from $6.6 million for the same period in 2024. G&A expense for the nine months ended September 30, 2025 was $44.6 million, an increase of $21.7 million, or 95%, from $22.9 million for the same period in 2024. These increases were primarily driven by the Merger-related transaction costs, severance costs and the incremental cost of Melinta’s operations from August 29, 2025 through September 30, 2025, non-cash charges for stock-based compensation and an increase in costs related to business development.

Previous wording

Interest Income. Interest income 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 June 30, 2025 compared to $1.5 million for the same period last year, a decrease of $0.1 million, or 8%, primarily driven by lower average interest rates.

Current wording

Interest Income. Interest income was $1.6 million for the three months ended September 30, 2025 compared to $0.6 million for the same period last year, an increase of $1.0 million, or 182%, primarily driven by higher average cash balances. Interest income was $3.0 million for the nine months ended September 30, 2025 compared to $2.1 million for the same period last year, an increase of $0.9 million, or 43%, driven by higher average cash balances.

Previous wording

Foreign Exchange Transaction Income (Loss). Foreign exchange transaction income (loss) for the three and six months ended June 30, 2025 and 2024 were due to the re-measuring of transactions denominated in a currency other than our functional currency. Balances and changes were immaterial for all periods presented.

Current wording

Foreign Exchange Transaction Income (Loss). Foreign exchange transaction income (loss) for the three and nine months ended September 30, 2025 and 2024 were due to the re-measuring of transactions denominated in a currency other than our functional currency. Balances and changes were immaterial for all periods presented.

Previous wording

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 and expected state tax profile for the period.* *Tax benefit for the six months ended June 30, 2024 of $1.4 million, was due to the 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 operating losses for fiscal year 2024.

Current wording

In addition to the income tax benefit, the Company recorded an income tax expense of $0.5 million for the three and nine months ended September 30, 2025, primarily related to state jurisdictions. For the nine months ended September 30, 2024, the company recorded a tax benefit of $1.4 million due to the sale of its unused NJ State net operating losses for fiscal year 2023.

Previous wording

We achieved profitability for the three and six months ended June 30, 2025, driven by product sales of DefenCath. During the six months ended June 30, 2025, we received 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.

Current wording

We achieved profitability for the three and nine months ended September 30, 2025, driven primarily by product sales of DefenCath. In addition, during the nine months ended September 30, 2025, we received 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, and we raised net proceeds of $144.4 million from the Convertible Notes Offering in August 2025 and $82.4 million from the Follow-On Offering in June 2025. We may continue to utilize external sources of cash to further fund operations.

Previous wording

Net cash provided by operating activities for the six months ended June 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. Net cash 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.

Current wording

Net cash provided by operating activities for the nine months ended September 30, 2025 was $80.6 million as compared to net cash used in operating activities of $45.0 million for the same period in 2024. Net cash provided by operating activities was primarily attributable to the net income of $149.0 million for the nine months ended September 30, 2025 compared to a net loss of $31.4 million in the comparison period in 2024.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025 was $20.4 million as compared to $15.2 million of net cash provided by investing activities for 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.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 was $311.7 million as compared to $21.5 million of net cash provided by investing activities for the same period in 2024. The net cash used during the nine months ended September 30, 2025, was mainly driven by the acquisition of Melinta.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $89.3 million due to the net proceeds generated from the sale of our common stock in the underwritten offering and in our ATM program of $82.4 million and $6.8 million, respectively. Net cash provided by financing activities for the six months ended June 30, 2024 was $1.0 million attributable to the net proceeds received from the sale of our common stock in our ATM program.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $239.9 million was attributable to the Convertible Notes Offering in August 2025, the Follow-On Offering in June 2025, and from our ATM program. Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.0 million attributable to the net proceeds received from the sale of our common stock in our ATM program and stock option exercises.

Previous wording

Our total cash, cash equivalents and short-term investments as of June 30, 2025, was $190.7 million, excluding restricted cash of $0.1 million, compared with $51.7 million as of December 31, 2024, excluding restricted cash of $0.1 million. As of June 30, 2025, $23.2 million of the Company’s common stock remains available for potential sale under the ATM program. Additionally, we have $15.0 million of remaining capacity available under our 2024 Shelf Registration Statement for the issuance of Company securities, after taking effect of the $85.0 million public offering that closed on June 30, 2025.

Current wording

Our total cash, cash equivalents and short-term investments as of September 30, 2025, was $55.7 million, excluding restricted cash of $1.0 million, compared with $51.7 million as of December 31, 2024, excluding restricted cash of $0.1 million. As of September 30, 2025, $23.2 million of the Company’s common stock remains available for potential sale under the ATM program. Additionally, we have $15.0 million of remaining capacity available under our 2024 Shelf Registration Statement for the issuance of Company securities, after taking effect of the $85.0 million public offering that closed on June 30, 2025.

Previous wording

We expect to continue to fund operations from cash collections of accounts receivable, our cash on hand, cash equivalents and short-term investments, and through capital raising sources, which may be dilutive to existing stockholders. In May 2024, we implemented an ATM program, which may be utilized to support 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 indebtedness would result in increased fixed obligations and could contain covenants that would restrict our operations.

Current wording

We expect to continue to fund operations from cash collections of accounts receivable, our cash on hand, cash equivalents and short-term investments, and through potential capital raising sources, which may be dilutive to existing stockholders. 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 indebtedness would result in increased fixed obligations and could contain covenants that would restrict our operations.

Previous wording

Our actual cash requirements may vary materially from those now planned due to a number of factors, including any material change in commercial operations pertaining to DefenCath or the focus and direction of our research and development programs, any acquisition or pursuit of development of new product candidates, 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 consistent and sustained positive operating cash flow, we may need to raise additional capital in order to continue to fund our research and development activities, as well as to fund operations generally and we can provide no assurances that financing or strategic relationships will be available on acceptable terms, or at all, if additional funds are needed. If we are unable to raise additional funds when needed, we may be forced to slow or discontinue our commercial operations pertaining to DefenCath. We may also be required to delay, scale back or eliminate some or all of our anticipated research and development programs. Each of these alternatives would likely have a material adverse effect on our business.

Current wording

Our actual cash requirements may vary materially from those now planned due to a number of factors, including any material change in commercial operations pertaining to our Products or the focus and direction of our research and development programs, any acquisition or pursuit of development of new product candidates, 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.

Previous wording

We entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020.

Current wording

We entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020 and has a term through October 2027.

Previous wording

In December 2024, we entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will provide a dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. We have paid an up-front implementation fee 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 day’s written notice. As of June 30, 2025, the minimum amount committed under this agreement totals $7.8 million.

Current wording

In December 2024, we entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will provide a dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. The Company has paid an up-front implementation fee and is obligated to pay a fixed monthly fee. The Company signed a termination agreement, effective October 1, 2025 whereas the related services to the Company will be completed on December 31, 2025. As of October 1, 2025, the minimum amount committed under this agreement, net of prepayments totaled $4.6 million.