UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 5, 2026

CORMEDIX INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-34673		20-5894890
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

300 Connell Drive, Suite 4200

Berkeley Heights, New Jersey 07922

(Address of Principal Executive Offices) (Zip Code)

(908) 517-9500

Registrant’s telephone number, including area code

N/A

(Former Name, or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

(Title of each class)		(Trading Symbol)		(Name of exchange on which registered)
Common Stock, $0.001 Par Value		CRMD		Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On January 8, 2026, CorMedix Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 2025. The preliminary results are subject to the completion of audit and accounting procedures and are therefore subject to adjustment. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On January 5, 2026, the Company entered into an amended and restated executive employment agreement (the “A&R Employment Agreement”) with Joseph Todisco, the Company’s Chief Executive Officer. Pursuant to the A&R Employment Agreement, Mr. Todisco will continue to serve as the Company’s Chief Executive Officer and will also serve as the Chairman of the Company’s board of directors (the “Board”). Mr. Todisco’s appointment as Chairman of the Board, effective January 8, 2026, was approved by the Board on January 5, 2026.

Pursuant to the A&R Employment Agreement, Mr. Todisco’s annual base salary increased from $665,000 to $750,000 effective as of January 1, 2026 and his target annual bonus opportunity increased from 65% to 75% of his base salary, beginning with the Company’s 2026 fiscal year, with the actual amount of any annual bonus to be determined based on achievement of Company and individual objectives set by the Board (or its compensation committee) after consultation with Mr. Todisco. Mr. Todisco will also be eligible to receive grants pursuant to the Company’s 2019 Omnibus Stock Incentive Plan or any successor thereto (the “Equity Plan”) from time to time as determined by the Board (or its compensation committee).

Upon a termination of Mr. Todisco’s employment by the Company other than for Cause (as defined in the A&R Employment Agreement) (other than as a result of death or disability) or by him for Good Reason (as defined in the A&R Employment Agreement), and subject to Mr. Todisco’s execution and non-revocation of a customary release of claims, Mr. Todisco will be entitled to the following severance benefits: (i) continuation of base salary for 18 months (or, if such termination occurs within 24 months following a Corporate Transaction (as defined in the Equity Plan), 200% of the sum of base salary and target bonus, paid over 24 months), (ii) payment of a prorated annual bonus for the year of termination based on the actual achievement of the specified bonus objectives, (iii) subsidized COBRA premiums for up to 18 months (or, if such termination occurs within 24 months following a Corporate Transaction, for up to 24 months), (iv) acceleration of unvested equity awards scheduled to vest on or before the next succeeding anniversary of the date of his termination, provided that performance-based awards will not accelerate unless and until their performance conditions are satisfied (or, if such termination occurs within 24 months following a Corporate Transaction, full acceleration of all unvested equity awards), and (v) any then-unpaid bonus in respect of service during the year preceding the year of termination.

The A&R Employment Agreement also contains 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 18 months following any termination of employment.

The foregoing description of the A&R Employment Agreement is qualified in its entirety by reference to the full text of the A&R Employment Agreement, a copy of which will be filed with Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025.

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Item 8.01 Other Events.

On January 8, 2026 the Company issued a press release announcing updates to its Board and leadership team.

A copy of this press release is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release issued by CorMedix Inc., dated January 8, 2026.
99.2		Press Release issued by CorMedix Inc., dated January 8, 2026.
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 8, 2026	CORMEDIX INC.

	By:	/s/ Joseph Todisco
		Joseph Todisco
		Chief Executive Officer

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Exhibit 99.1

CorMedix THERAPEUTICS announces preliminary Fourth quarter and

full year 2025 results and provides business updates

‒ Q4 2025 Unaudited Net Revenue of Approximately $127 million ‒

‒ FY 2025 Unaudited Pro Forma Net Revenue of Approximately $400 million ‒

‒ Expects Q4 Adjusted EBITDA of Between $77 million and $81 million ‒

‒ Unaudited Cash and Short-term Investments of Approximately $148 million ‒

Berkeley Heights, NJ – January 8, 2026 – CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter 2025 and full-year 2025 results, and provides guidance and an update on its business. These include the following key updates:

●

CorMedix announces preliminary, unaudited financial results for Q4 and FY 2025, including net revenue of approximately $127 million and $310 million, for Q4 2025 and FY 2025, respectively, FY 2025 Pro Forma net revenue⁽¹⁾ of approximately $400 million, and Q4 2025 adjusted EBITDA⁽²⁾ in the range of $77 million to $81 million.

●

The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2025, of approximately $148 million.

●

CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO^® (rezafungin for injection) in the prophylaxis of invasive fungal infection in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in early 2027.

●

The Company continues to see strong utilization and patient growth for DefenCath^® (taurolidine and heparin) by its outpatient dialysis organization customers. On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in Q3 and Q4 of 2026. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, CorMedix estimates the value of the Add-On Adjustment will be 3x – 5x higher than that granted for Q3 and Q4 of 2026, which the Company expects would result in higher DefenCath sales prices in 2027 relative to H2 2026.

●

CorMedix is introducing FY 2026 Revenue guidance of $300 million to $320 million, which includes $150 million to $170 million for DefenCath. 2026 DefenCath revenue guidance is heavily weighted toward H1 2026 and assumes modest utilization growth, which the Company expects will offset some of the price erosion over the course of the year. Based on the assumption of a higher net selling price in 2027 relative to H2 2026, the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million. DefenCath guidance for 2026 and 2027 assumes the maintenance of its current outpatient dialysis utilization run-rate with existing customers, and excludes any potential upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting, or any change in reimbursement due to pending TDAPA legislation.

●

In addition, management has operationalized synergies of approximately $35 million, on a full-year run rate basis, related to the acquisition of Melinta and is now focused on driving growth strategies for the business. The Company is estimating FY 2026 operating expenses of $145 million to $160 million, excluding non-cash items and one-time expenses, with the upper end of the spending range contingent upon positive Phase 3 data related to the ReSPECT study and a potential acceleration of enrollment in the DefenCath TPN study. Based on these estimates, CorMedix estimates FY 2026 Adjusted EBITDA in the range of $100 million to $125 million.

●

CorMedix is excited to announce that it will hold an Analyst Day on February 10, 2026, during which it will provide significant background on the medical need and the market potential for its key pipeline assets of REZZAYO in prophylaxis and DefenCath in TPN, as well as insights on the future strategic direction for the business. Details will be forthcoming.

Joseph Todisco, CorMedix Therapeutics CEO, commented, “I’m proud to announce our preliminary Q4 and FY 2025 results today, including surpassing our guidance for 2025. 2025 was a transformational year for CorMedix, as we evolved beyond a single-product company to an organization with multiple growth drivers and pipeline assets. We closed 2025 in a strong cash position, which we expect to further bolster over the coming year, providing the Company with financial flexibility to drive value for shareholders. With our new leadership team in place and multiple near-term pipeline catalysts, I am excited about the long-term potential for CorMedix Therapeutics.”

The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures.

(1)

FY 2025 Unaudited Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025.

(2)

Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization and stock-based compensation, and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 financial results. Such reconciliation is not included in this release because CorMedix is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath^® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN^® (minocycline) for Injection, REZZAYO^® (rezafungin), VABOMERE^® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA^® (delafloxacin), and KIMYRSA^® (oritavancin), as well as TOPROL-XL^® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by 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 similar expressions 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 including, but not limited to statements regarding financial guidance, sales, revenue and operating expense estimates, expectations regarding product utilization, product reimbursement rates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on 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. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors

[email protected]
(617) 430-7576

Exhibit 99.2

CorMedix Therapeutics announces leadership and board updates

Berkeley Heights, NJ – January 8, 2026 – CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced an addition to its executive leadership team and updates to its Board of Directors. CorMedix CEO Joseph Todisco has signed an extended employment contract, reaffirming his long-term commitment to the organization. In addition to his role as CEO, Mr. Todisco will also assume the role of Chairman of the Board of Directors, succeeding Myron Kaplan. Mr. Kaplan will transition into a newly created board position of Lead Independent Director.

“Under the leadership of Mr. Todisco, CorMedix has evolved from a single product, development stage company into a multi-product, diversified commercial operation with positive cashflow and a strong pipeline,” says former Chairman and new Lead Independent Director, Myron Kaplan. “His succession to Chairman strengthens CorMedix Therapeutics and best positions the company for future success.”

CorMedix is also pleased to announce the appointment of Mr. Mike Seckler to the role of EVP & Chief Commercial Officer. Mr. Seckler joins CorMedix with a wealth of experience across multiple therapeutic areas including hematology and oncology, and most recently served as CEO of Evome Medical Technologies Inc. Mr. Seckler’s previous experience includes roles as COO of FerGene Inc., a Blackstone Life Sciences and Ferring Pharmaceuticals joint partnership gene therapy company, as well as head of Global Marketing and Corporate Communications for Ferring International.

Joseph Todisco, CEO of CorMedix, commented, “I’m excited to announce the addition of Mike Seckler to our leadership team as Chief Commercial Officer. As CorMedix Therapeutics now has commercial and pipeline products spanning multiple therapeutic areas, his deep experience as a commercial leader will provide critical expertise as we look to increase our base business as well as prepare for new launches. I’m also honored to assume the role of Chairman of the Board of Directors from Myron Kaplan, and I am sincerely grateful for his mentorship and guidance over these past few years. With a strong leadership team in place, I am excited about the future for CorMedix Therapeutics.”

About CorMedix

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by 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 similar expressions 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 including, but not limited to statements regarding financial guidance, sales estimates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on 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. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors

[email protected]
(617) 430-7576