Cormedix 8-K Filings

CorMedix Inc. reported that the U.S. District Court for the District of New Jersey has granted preliminary approval of a proposed settlement resolving consolidated stockholder derivative suits and a related New Jersey state derivative action. A final settlement hearing is scheduled for September 23, 2026, and the outcome will bind stockholders who held CorMedix common stock on January 19, 2026, if the settlement receives final approval. The actions allege fiduciary-duty breaches related to disclosures around FDA review of DefenCath; the defendants continue to deny wrongdoing.

The settlement is non-monetary for stockholders and instead requires CorMedix to adopt and maintain for at least 3.5 years a package of corporate governance reforms. These include a new management-level Disclosure Committee overseeing SEC filings and earnings releases, enhanced Nominating and Governance Committee oversight of legal and regulatory compliance, expanded executive and director training, and a strengthened whistleblower “Speak Up Program.” The company also highlights previously implemented changes such as appointing a Chief Manufacturing Officer and separating legal, regulatory and compliance roles. CorMedix’s board, including independent directors, determined that the litigation was a material factor in adopting these measures and that the reforms will benefit the company.

Plaintiffs’ counsel intend to seek up to $3,900,000.00 in attorneys’ fees and expenses, plus potential service awards of up to $5,000 per plaintiff, to be paid by CorMedix if approved; defendants reserve the right to oppose the fee request. The notice explains how current CorMedix stockholders can object or appear at the settlement hearing, with written objections due in advance of the court date.

CorMedix Inc. reported a change in its executive leadership structure. The Board appointed current Chief Operating Officer Elizabeth Hurlburt to a newly created role of Chief Operating and Commercial Officer, giving her oversight of all commercial functions along with medical affairs, regulatory and clinical. She will continue to report to Chairman and CEO Joseph Todisco. As part of this restructuring, Michael Seckler has left the company.

CorMedix Inc. changed its independent registered public accounting firm, appointing Ernst & Young LLP (EY) as auditor for the fiscal year ending December 31, 2026. The Audit Committee dismissed CBIZ CPAs P.C. on June 25, 2026. CBIZ’s report on the 2025 financial statements contained no adverse opinion or qualification. The only reportable event during CBIZ’s tenure was a previously disclosed material weakness in internal control over financial reporting related to timely review of significant, non-routine transactions, first reported in the 2025 Form 10-K filed March 5, 2026. CBIZ has been authorized to respond fully to EY about this matter and has provided a letter to the SEC agreeing or commenting on the company’s statements.

CorMedix Inc. reported results from its 2026 annual meeting of stockholders held on June 23, 2026. Stockholders elected all seven director nominees, each receiving more votes for than withheld. They also approved, on a non-binding advisory basis, 2025 compensation for named executive officers and ratified CBIZ CPAs P.C. as independent auditor for the 2026 fiscal year.

Several proposed amendments to the company’s charter did not receive sufficient support, including ratification of Certificate of Designation amendments, technical charter changes, updates to class voting on preferred stock terms, an exclusive forum provision, and expanded officer liability protections permitted by Delaware law.

CorMedix Inc. reported that the U.S. Court of Appeals for the Federal Circuit has affirmed a prior district court judgment in patent litigation over MINOCIN® for Injection. The court agreed that Nexus Pharmaceuticals’ proposed generic minocycline product infringes two CorMedix patents and rejected Nexus’s invalidity challenge.

The Federal Circuit also upheld a permanent injunction that prevents Nexus from marketing its generic minocycline product before the MINOCIN® patents expire. This decision strengthens the intellectual property protection around CorMedix’s intravenous minocycline reformulation, an antibiotic used primarily in hospital and acute care settings.

CorMedix Inc. reported strong first-quarter 2026 results, with net revenue of $127.4 million and net income of $38.6 million. Adjusted EBITDA reached $70.0 million, reflecting profitability after integrating the Melinta acquisition.

DefenCath generated $97.5 million of net revenue, helped by higher outpatient dialysis use and a one-time $9.0 million favorable change in sales allowance estimates, while the acquired Melinta portfolio contributed $29.9 million. The company raised full-year 2026 guidance to $325–$345 million in net revenue and $115–$135 million in adjusted EBITDA.

CorMedix also highlighted positive Phase III topline results from the ReSPECT trial of REZZAYO for prophylaxis in allogeneic stem cell transplant patients and progress in a Phase 3 taurolidine/heparin study in TPN patients. Cash and short-term investments were $178.1 million as of March 31, 2026, supporting continued growth investments.

CorMedix Therapeutics furnished an update on its Phase III ReSPECT trial of REZZAYO (rezafungin) in adults undergoing allogeneic stem cell transplantation. The study met its primary endpoint, showing non-inferiority in fungal-free survival at Day 90, with 60.7% fungal-free survival for rezafungin versus 59.0% for a standard antimicrobial regimen. Safety was comparable, with fewer toxicity-related discontinuations and a favorable profile for drug–drug interactions. CorMedix estimates a potential U.S. prophylaxis market opportunity for REZZAYO exceeding $2 billion and plans a pre-NDA meeting followed by an sNDA submission in 2H26 to seek an expanded indication.

CorMedix Inc. furnished an updated investor presentation and reaffirmed its prior guidance that full-year 2027 DefenCath sales are estimated at $100–$140 million, clarifying an inadvertent reference to $100–$125 million on a recent earnings call. The presentation outlines a broader growth plan, including 2026 revenue guidance of $300–$320 million and adjusted EBITDA of $100–$125 million, driven by DefenCath and a diversified anti-infective portfolio. Pro forma 2025 net revenue is shown at $401 million, with Q4 2025 DefenCath sales of $91 million and 79.1 million common shares outstanding as of December 31, 2025. CorMedix also highlights late-stage expansion opportunities for DefenCath in total parenteral nutrition and for REZZAYO in fungal prophylaxis, alongside a cash and short-term investment balance of $149 million.

CorMedix Inc. reported a strong finish to 2025, with fourth-quarter net revenue of $128.6 million, including $91.2 million from DefenCath and $37.4 million from the newly acquired Melinta portfolio, up sharply from $31.2 million in the prior-year quarter.

For full-year 2025, total revenue rose to $311.7 million and pro forma revenue, assuming a full year of Melinta, reached $401.3 million. The company generated net income of $163.1 million, or $2.04 per diluted share, reversing a $17.9 million loss in 2024, and delivered adjusted EBITDA of $77.2 million in Q4 2025. Operating expenses roughly doubled as CorMedix absorbed Melinta and invested in DefenCath and late-stage studies, while cash, cash equivalents and short-term investments totaled $148.5 million as of December 31, 2025.

CorMedix Inc. filed a current report describing preliminary results and leadership changes. The company issued a press release with preliminary financial results for the quarter and year ended December 31, 2025, noting that the figures are preliminary and subject to completion of audit and accounting procedures.

The report also details an amended and restated employment agreement with CEO Joseph Todisco. His annual base salary increased from $665,000 to $750,000 effective January 1, 2026, and his target annual bonus rose from 65% to 75% of base salary beginning with the 2026 fiscal year. He will continue as Chief Executive Officer and, effective January 8, 2026, will also serve as Chairman of the board of directors. The agreement provides severance protections, including up to 18 months of salary continuation, enhanced benefits and equity acceleration if certain termination or change-in-control conditions occur, and includes confidentiality, non-disparagement, non-compete and non-solicitation covenants.

CorMedix Inc. (CRMD) furnished an update on its business by announcing financial results for the quarter ended September 30, 2025. The company disclosed the results through a press release attached as Exhibit 99.1.

The information was provided under Item 2.02 and is being treated as “furnished,” not “filed,” which means it is not subject to Section 18 of the Exchange Act nor incorporated by reference unless specifically stated.

CorMedix Inc. filed Amendment No. 1 to a prior current report to provide additional financial information related to its completed acquisition of Melinta Therapeutics, LLC. The amendment relates to the merger that closed on August 29, 2025 under the Agreement and Plan of Merger dated August 7, 2025.

The filing adds audited consolidated financial statements of Melinta for the years ended December 31, 2024 and 2023, unaudited condensed consolidated financial statements for the six months ended June 30, 2025, and unaudited pro forma condensed combined financial information for the year ended December 31, 2024 and the six months ended June 30, 2025. These materials are included as Exhibits 99.2, 99.3 and 99.4, along with an auditor consent.

CorMedix Inc. filed an 8-K that includes a press release dated September 2, 2025 and is signed by CEO Joseph Todisco. The filing discloses contingent payment obligations tied to potential FDA-approved labeling: $20 million if labeling includes candida, $2.5 million if labeling includes aspergillus, and $2.5 million if labeling includes pneumocystis. Portions of an exhibit have been omitted pursuant to Item 601(b)(2)(ii) of Regulation S-K. The document also contains contact information and standard exchange-act checkbox items, but the text provided here appears truncated and does not include the full press release or additional financial detail.

CorMedix Inc. completed its previously announced private placement of $150,000,000 aggregate principal amount of convertible senior notes due 2030, issued in reliance on Section 4(a)(2) of the Securities Act. The company entered into an indenture with U.S. Bank Trust Company, National Association, as trustee, and the indenture and form of note are filed as Exhibits 4.1 and 4.2.

The notes bear a stated rate reflected in the form of the notes as 4.00% and have an initial conversion rate of 74.2515 shares per $1,000 principal amount (approximately $13.47 per share implied by that rate). The notes and any common stock issuable upon conversion have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption.

CorMedix (NASDAQ:CRMD) held its 2025 Annual Meeting of Stockholders on June 24, 2025. Shareholders voted on three key proposals: election of seven directors, advisory vote on executive compensation, and ratification of the independent auditor.

All seven director nominees were successfully elected with Joseph Todisco receiving the highest approval (18.3M votes). The non-binding advisory vote on executive compensation passed with 16.1M votes in favor. Shareholders also approved CBIZ CPAs P.C. as the independent auditor with 45.5M votes in favor.

On 23 June 2025, CorMedix Inc. (CRMD) filed a Form 8-K under Item 7.01 (Regulation FD). The company disclosed that it had released a press release (attached as Exhibit 99.1) providing an update on its Large Dialysis Organization (LDO) customer and confirmed that implementation is planned for the second half of 2025. No financial metrics, contractual terms, or quantitative guidance were included in the filing. Because the information is being furnished, not filed, it is exempt from Section 18 liability and will not be automatically incorporated into other SEC filings unless specifically referenced.