CRMD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• 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 results of operations are driven …

• There have been no material changes to our business, strategy or key drivers of our results of operations from those described in our Annual Report on Form 10-K for the year ended December 31, 2025. Accordingly, this discussion should be read in conjunction with the information presented in the Form…

• Our operating results continue to be influenced by a number of factors, including product adoption and utilization trends, pricing and reimbursement dynamics, including those applicable to DefenCath, and the ongoing integration and performance of the Melinta portfolio. In addition, our results refle…

• We continue to focus on executing our commercial strategy, supporting product adoption across our portfolio, and advancing initiatives designed to optimize our operating model, improve efficiency within the broader organization, and support long-term growth. While our strategy and key drivers remain…

• REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults. On April 27, 2026, CorMedix announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases …

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• 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.

• 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 2…

• 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 hemodialys…

• DefenCath is listed in the Orange Book as having new chemical entity (“NCE”) exclusivity (5 years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now (“GAIN”) exclusivity extension of the NCE exclusivity (an additional 5 years) expiring on November 15, 2033. The GAIN exclusi…

• 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…

Text added vs the prior filing · source: 10-Q · 2026-05-14

• The U.S. dollar is the Company’s functional and reporting currency. The Company also engages in transactions denominated in currencies other than the U.S. dollar, most significantly the Euro. Because transactions denominated in these currencies represent a small portion of total transactions relativ…

• As of March 31, 2026, our convertible debt bears a fixed interest rate, so we have no variability as a result in changes in interest rates.

• Inflation has increased in recent periods and could continue to increase in the future. Inflationary factors, such as increases in the cost of our raw materials, supplies, interest rates and overhead costs, as well as costs associated with tariffs and trade and other international disputes, may adve…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• The Company is not required to provide the information called for in this item due to its status as a Smaller Reporting Company.

Text added vs the prior filing · source: 10-Q · 2026-05-14

• Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosu…

• of March 31, 2026 due to the material weakness in our internal control over financial reporting previously disclosed in Part II, Item 9A of our Annual Report on Form 10-K for the year ended December 31, 2025.

• As previously disclosed, management identified a material weakness in internal control over financial reporting related to the operational effectiveness of a control designed to ensure adequate and timely review of significant, non-routine transactions. This material weakness resulted from capacity …

• Management continues to implement remediation measures designed to address the material weakness. These measures include the implementation of enhanced review controls over the accounting for significant non-routine transactions, including the preparation of contemporaneous technical accounting memo…

• In addition, management is evaluating workforce capacity and resourcing needs, including the potential addition of internal and external resources, and is progressing the integration of financial systems and streamlining of the combined-company close process to increase capacity within the finance f…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Disclosure controls and procedures are 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 partici…

• There were no changes in our internal control over financial reporting that occurred during the period covered by this report, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-14

• On May 12, 2026, the Company entered into an amended and restated executive employment agreement (the “A&R Employment Agreements”) with each of (i) Susan Blum, the Company’s Executive Vice President and Chief Financial Officer, (ii) Elizabeth Hurlburt, the Company’s Executive Vice President and Chie…

• The A&R Employment Agreements provide that Mses. Blum, Hurlburt, and Zelnick Kaufman continue to receive their current annual base salaries of $503,000, $528,000, and $512,000, respectively. Each of the Officer’s target annual bonus opportunity remains at 45% of her base salary, with the actual amou…

• Upon a termination of the Officer’s employment by the Company other than for Cause (as defined in the A&R Employment Agreements) (other than as a result of death or disability) or by the Officer for Good Reason (as defined in the A&R Employment Agreements), and subject to the Officer’s execution and…

• The A&R Employment Agreements also contain customary confidentiality and non-disparagement covenants and non-competition and non-solicitation of employees and customers covenants that apply during employment and for a period of 12 months following any termination of employment.

• The foregoing description of the A&R Employment Agreements is qualified in its entirety by reference to the full text of the A&R Employment Agreements, copies of which are filed as Exhibits 10.1, 10.2 and 10.3 to this Quarterly Report on Form 10-Q and are incorporated by reference herein.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

• On November 10, 2025, the Company held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, the Company's stockholders approved an amendment (the “Plan Amendment”) to the Amended and Restated CorMedix Inc. 2019 Omnibus Stock Incentive Plan (the “2022 Plan”) to increase …

• The Plan Amendment became effective immediately upon stockholder approval at the Special Meeting. A more complete summary of the terms of the Plan Amendment is set forth in “Proposal No. 2 – Approval of the Incentive Plan Amendment Proposal” in the Company's definitive proxy statement filed with the…

• The above description of the Plan Amendment does not purport to be complete and is qualified in its entirety by the full text of the Plan Amendment, set forth in Exhibit 10.5 and incorporated herein by reference.

• The Company’s stockholders voted on the following proposals at the Special Meeting, casting their votes as described below.