UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 10-K

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: December 31, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________________ to ______________________

Commission file number: 001-34673

CORMEDIX INC.
(Exact name of Registrant as Specified in Its Charter)

Delaware		20-5894890
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

389 Interpace Pkwy, Suite 450

Parsippany, NJ

07054

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (908) 517-9500

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

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

Securities registered pursuant to Section 12(g) of the Act: None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes ☐ No ☒

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 requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer ☐	Accelerated filer ☐
Non-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 news or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

Yes ☐ No ☒

The aggregate market value of the registrant’s voting common equity held by non-affiliates of the registrant, based upon the closing price of the registrant’s common stock on the last business day of the registrant’s most recently completed second fiscal quarter was approximately $909.7 million.

The number of outstanding shares of the registrant’s common stock was 79,050,395 as of March 2, 2026.

DOCUMENTS INCORPORATED BY REFERENCE

Specified portions of the registrant’s definitive Proxy Statement to be issued in conjunction with the registrant’s 2026 Annual Meeting of Stockholders, which is expected to be filed not later than 120 days after the registrant’s fiscal year ended December 31, 2025, are incorporated by reference into Part III of this Annual Report. Except as expressly incorporated by reference, the registrant’s Proxy Statement shall not be deemed to be a part of this Annual Report on Form 10-K.

CORMEDIX INC.

2025 Form 10-K Annual Report

Table of Contents

PART I		1

Item 1.	Business	1

Item 1A.	Risk Factors	17

Item 1B.	Unresolved Staff Comments	31

Item 1C.	Cybersecurity	31

Item 2.	Properties	32

Item 3.	Legal Proceedings	32

Item 4.	Mine Safety Disclosures	32

PART II		33

Item 5.	Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	33

Item 6.	[RESERVED]	33

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	33

Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	43

Item 8.	Financial Statements and Supplementary Data	43

Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	44

Item 9A.	Controls and Procedures	44

Item 9B.	Other Information	45

Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	45

PART III		46

Item 10.	Directors, Executive Officers, and Corporate Governance	46

Item 11.	Executive Compensation	46

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	46

Item 13.	Certain Relationships and Related Transactions and Director Independence	46

Item 14.	Principal Accounting Fees and Services	46

PART IV		47

Item 15.	Exhibits, Financial Statement Schedules	47

Item 16.	Form 10-K Summary	49

SIGNATURES		50

Forward-Looking Statements

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A 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 identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “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. 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 the Risk Factor Summary and section titled “Item 1A. Risk Factors” of this Annual Report on Form 10-K and in CorMedix’s other filings with the Securities and Exchange Commission (the “SEC”) 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 Annual Report on Form 10-K. 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.

PART I

Item 1. Business

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 has been commercializing DefenCath® (taurolidine and heparin), in the U.S., which we launched in 2024 in the hemodialysis setting. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration (“FDA”).

On August 29, 2025, the Company acquired Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”), which expanded the Company’s team, commercial platform and increased the commercial portfolio with six marketed, hospital- and clinic-focused infectious disease products, comprised of REZZAYO® (rezafungin for injection), MINOCIN® (minocycline) for Injection (“MINOCIN IV”), VABOMERE® (meropenem and vaborbactam), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin), and BAXDELA® (delafloxacin), as well as an additional well-established cardiovascular product, TOPROL-XL® (metoprolol succinate) (together, the “Melinta Portfolio,” and, together with DefenCath, “our Products”). The Melinta Portfolio supports a multi-channel strategy of delivering anti-infectives for serious gram-positive, gram-negative and fungal infections within hospitals and the hospital ecosystem, including emergency departments, outpatient clinics and home infusion care, and provides synergy opportunities to drive growth for DefenCath.

Business Strategy

Our corporate strategy is focused on increasing stockholder value by maximizing the value of our current portfolio, with promotional efforts focused on DefenCath, REZZAYO, MINOCIN IV and VABOMERE. In addition, we seek to create additional value through the pursuit of expanded indications for both DefenCath, for the reduction of central line associated bloodstream infection (“CLABSI”) in adult patients receiving total parental nutrition (“TPN”), and REZZAYO in the prophylaxis of invasive fungal infections in adult patients that are immune compromised. We also engage in the pursuit of business development opportunities that could be highly synergistic with our existing or future sales infrastructure deployment.

Promoted Commercial Products

DefenCath

On November 15, 2023, we announced that the FDA approved the new drug application (“NDA”) for DefenCath, an 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”). We launched DefenCath commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting, and it is the largest contributor to our net sales.

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 customer has customized an implementation plan to provide access to their 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.

Market Opportunity

CVCs or ‘central lines’ are an important and frequently used method for accessing the vasculature for hemodialysis (a form of dialysis where the patient’s blood is circulated through a dialysis filter), administering chemotherapy and basic fluids in cancer patients and for cancer chemotherapy, administering long term antibiotic therapy, and administering total parenteral nutrition (complete or partial dietary support via intravenous nutrients).

Bloodstream infections resulting from the use of central venous catheters known as CLABSIs and a subset of them, referred to as CRBSIs, can result in significant morbidity and increased rates of hospital admissions, readmissions, and mortality. One of the major and common risk factors for all patients requiring CVCs is the risk of acquiring a CLABSI and the clinical complications associated with them. The total annual cost for treating outpatient derived CRBSI episodes and their related complications in the U.S. is up to $2.3 billion, with approximately 80,000 CRBSI episodes and up to 28,000 deaths per year (Pronovost et al., The New England Journal of Medicine, 2006).

According to the 2025 United States Renal Disease System, reporting data from 2023, there were approximately 485,000 End-Stage-Renal-Disease (“ESRD”) patients on permanent hemodialysis in the U.S. and over 25% of these utilized a CVC for vascular access. Of the total population, approximately 108,000 hemodialysis patients were new patients diagnosed with ESRD during the year and 80% of those were receiving dialysis through a CVC. Patients are typically treated in various care settings including inpatient hospitals and outpatient dialysis clinics. Kidney failure patients can include both those affected by acute kidney injury and chronic kidney disease populations that progress into dialysis. Kidney failure patients who are admitted to the hospital have an average length of stay of approximately two weeks and additionally high 30-day readmission rates both for the same diagnosis and all-cause with the all-cause readmissions being higher.

The two primary causes of CLABSI are the external introduction of pathogens to the catheter site and the internal proliferation of pathogens within the catheter lumens. Intraluminal infections are caused by pathogens entering and proliferating within the sterile internal surfaces of the CVC and are often associated with late stages of biofilm dispersion. Biofilm build up can be the pathogenesis of both infections and thrombotic complications in central venous catheters. Prevention of CRBSI and inflammatory complications requires both removal of pathogens from the internal surface of the catheter to prevent the systemic dissemination of organisms contained within the biofilm as well as an anticoagulant to retain blood flow during dialysis that may be hindered by clot formation. Biofilm forms when bacteria adhere to surfaces in aqueous environments and begin to excrete a slimy, glue-like substance that can anchor them to various types of materials, including intravenous catheters. The presence of biofilm has many adverse effects, including the ability to release bacteria into the bloodstream. The current standard of catheter care is to instill a heparin lock solution at a concentration of 1000 u/mL into each catheter lumen immediately following treatment, to prevent clotting between dialysis treatments. However, a heparin lock solution has no antimicrobial activity and thus provides no protection from the risk of infection.

Other than DefenCath, there are no pharmacologic drug products FDA-approved in the U.S. for the prevention or reduction of CRBSIs in CVCs. We believe there is a significant need for reduction or prevention of CRBSIs in the hemodialysis patient population as well as for other patient populations utilizing central venous catheters such as total parenteral nutrition recipients.

DefenCath is a non-antibiotic, broad-spectrum antimicrobial and anticoagulant combination that is active against common microbes including antibiotic-resistant strains and also has a secondary mechanism of action that inhibits adherence of microorganisms to biological surfaces which is the first steps in biofilm formation. We believe that using DefenCath as an antimicrobial catheter-lock solution significantly reduces the incidence of life-threatening catheter-related blood stream infections, thus reducing the need for hospital admission and systemic antibiotics while prolonging catheter function. We are unaware of any drug products other than DefenCath approved by the FDA with an indication for use as a catheter lock solution.

CRBSIs, a clinically confirmed subset of the epidemiological surveillance term, CLABSI, 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, and as such, we believe it addresses a significant medical need. Additionally, in December 2025, we reported data from an interim analysis of a retrospective, real-world evidence (“RWE”) study that indicates a 70% reduction in annualized number of hospitalizations secondary to CRBSI, when dialysis-patient catheters are locked with DefenCath, demonstrating a significant value proposition to patients as well as to providers and payers.

Pricing and Reimbursement

Sales of DefenCath depend, in large part, on the extent to which it will be covered by third-party payors, such as Medicare, Medicaid, and other federal and state government programs, managed care entities, commercial insurers, and other organizations, as well as the level of reimbursement such third-party payors provide for DefenCath. It is essential to obtain third-party payor coverage policies and adequate payment to continue to successfully commercialize DefenCath. We expect to continue to sell DefenCath primarily to outpatient dialysis clinics and inpatient hospitals.

Inpatient Reimbursement

For Medicare, inpatient acute-care hospitals are paid under the inpatient prospective payment system (the “IPPS”). The IPPS pays a flat rate based on the average charges across all hospitals for a specific diagnosis, regardless of whether that particular patient costs more or less. Under the IPPS, each case is categorized into a diagnosis-related group (“DRG”), which is weighted and multiplied by a standardized amount (updated each year for inflation and other factors), to yield a fixed payment for that DRG and adjusted for hospital-specific factors (e.g., wages, teaching hospitals) to cover care furnished during the inpatient stay. Additional, temporary payment is available for new medical services and technologies called New Technology Add-on Payment (“NTAP”) if certain criteria are met.

The Centers for Medicare & Medicaid Services (“CMS”) issued the IPPS 2024 proposed rule that included an NTAP per-hospital stay for DefenCath. This NTAP represents reimbursement to inpatient facilities of up to 75% of the WAC price per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS rule was published in early August 2023 and subsequently amended as of October 1, 2024 to reflect the then current WAC of $249.99 per 3ml vial.

NTAP is granted for a period of 2-3 years after the date of FDA approval. Although NTAP is intended to identify and ensure adequate payment for qualifying new technologies, it may have a limited effect depending on the DRG assignment after the NTAP period ends. The NTAP for DefenCath will expire on November 14, 2026 (three years post-approval).

Outpatient Reimbursement

The Medicare ESRD IPPS provides bundled payment for renal dialysis services and affords a Transitional Drug Add-on Payment Adjustment (“TDAPA”), which provides temporary, additional payments for certain new drugs and biologicals. 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 from July 1, 2024, (with such add-on payments applying to all ESRD IPPS payments for years three through five). The HCPCS J-code for DefenCath was published by CMS on April 2, 2024. DefenCath TDAPA began on July 1, 2024 and will transition into the post-TDAPA Add-On Payment phase on July 1, 2026. 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, we anticipate there will be a corresponding reduction to the net pricing for DefenCath for the third and fourth quarters of 2026. The 2027 post-TDAPA add-on adjustment will be effective on January 1, 2027. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, we estimate the value of the Add-On Adjustment will be three to five-times higher than that granted for the third and fourth quarters of 2026, which we expect would result in higher DefenCath sales prices in 2027 relative to the second half 2026. After January 1, 2027, the post-TDAPA Add-On Payment will be reassessed again and be made effective on January 1, 2028 and January 1, 2029, covering the three-year period through June 30, 2029. There can be no assurance that the level of reimbursement determined by CMS will improve. Further changes in these reimbursement rates could lead to significant fluctuations in our operating income and could have a negative impact on our revenues, earnings and cash flows.

CMS determined that DefenCath qualified for pass-through status under the hospital Out-Patient Prospective Payment System (“OPPS”) in June 2024. Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the outpatient ambulatory setting for a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysis can be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. We estimate that up to 100,000 HD-CVC placements occur each year, and pass-through status offers providers a separate reimbursement mechanism in this setting of care administration of DefenCath.

Additional Indications

As a brand expansion opportunity, in the second quarter of 2025, we initiated a Phase 3, randomized, double-blind, adaptive, two-arm, clinical study assessing the safety and efficacy of DefenCath in reducing CLABSIs in adult patients receiving TPN via CVC. The study protocol stipulates a total of up to 200 subjects for a total of 12 months treatment, with the primary endpoint being efficacy of DefenCath as a CLS, when compared to heparin, in delaying time to CLABSI. We currently expect to complete the study in the first half of 2027.

Currently, there is no pharmaceutical standard of care for prevention of bloodstream infections for TPN patients utilizing a CVC and those patients are highly susceptible to CLABSI. CLABSIs occur in up to 26% of TPN patients with a CVC, and TPN is associated with a 4-fold increase in odds ratio for acquiring CLABSIs. In addition, CLABSIs are associated with an excess hospital length of stay of 2 to 3 weeks, and patients who develop a CLABSI are 35% to 40% more likely to be readmitted. We believe that the total addressable market for TPN is between $500 million and $750 million in the inpatient and home infusion settings – equating to more than 4.5 million potential infusions.

Also in 2025, we initiated our post-marketing requirement for a pediatric hemodialysis (“HD”) study. We are currently obligated by the FDA to conduct the HD study as communicated in our NDA approval letter: an open-label, two-arm (DefenCath vs. standard of care) study to assess safety and time to CRBSI in subjects from birth to less than 18 years of age with kidney failure receiving hemodialysis via a central venous catheter. Pediatric studies for an approved product conducted under the Pediatric Research Equity Act (the “PREA”) may qualify for pediatric exclusivity, which, if granted, provides an additional six months of exclusivity that attaches to the end of existing marketing exclusivity and patent periods for DefenCath. Depending on the timing of final report submission, DefenCath could potentially receive an additional 0.5 years of exclusivity associated with this pediatric study (a total marketing exclusivity period of 10.5 years). There are factors that could affect whether this exclusivity is received or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years of exclusivity associated with this pediatric study.

In 2024, we launched the Expanded Access Program (“EAP”) for DefenCath, which is designed to provide access to a broader population of adult and pediatric patients using CVCs for various serious medical conditions to protect their central line from serious infection. A key aspect of this EAP is its focus on individuals who, due to their unique clinical circumstances, are either ineligible for participation in ongoing clinical trials or do not meet the criteria outlined in the current approved FDA label for DefenCath.

We may pursue additional indications for DefenCath use as a CLS in populations with unmet medical needs that may also represent potentially significant market opportunities, and we are regularly assessing these areas. In addition, we may seek CMS reimbursement for DefenCath in other catheter indications beyond ESRD, including but not limited to through (i) relevant hospital inpatient DRGs, (ii) additional NTAP payments, or (iii) outpatient ambulatory payment classifications (“APCs”). Payment under these Medicare benefit categories is not guaranteed for these potential additional indications.

REZZAYO

We acquired distribution and marketing rights to REZZAYO in the U.S. in connection with the acquisition of Melinta in August 2025. REZZAYO is a next generation, once-weekly, IV-formulation echinocandin, which was approved in the U.S. in March 2023 in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. While our licensor Napp Pharmaceutical Group Limited, a member of Mundipharma independent associated companies (“Mundipharma”), currently holds the product NDA and intellectual property rights, upon the earlier of thirty-days following the receipt of the marketing approval for the prophylaxis indication or on June 30, 2028, Mundipharma shall assign and transfer to CorMedix all rights, title and interest in and to the U.S. NDA and sNDAs for REZZAYO. See Contractual Obligations, included in Managements’ Discussion and Analysis included within this Annual Report, for additional details on the arrangement with Mundipharma.

Market Opportunity

REZZAYO offers a convenient alternative to the standard of care, daily echinocandin dosing regimen, with its once-weekly dosing schedule, highly simplifying management of candidemia and invasive candidiasis. In practice, REZZAYO’s once-weekly intravenous dosing and efficacy compared to daily echinocandins make it attractive not only in inpatient settings but also in outpatient patient antimicrobial therapy (“OPAT”) where clinical stability permits transition from hospital care. Available alternatives to REZZAYO include marketed echinocandins—caspofungin, micafungin, and anidulafungin—which share a similar mechanism of action and are used in first-line therapy for candidemia and invasive candidiasis, typically require once-daily intravenous dosing. Azole antifungals (e.g., posaconazole, voriconazole, isavuconazole, fluconazole) are also used for candidemia and invasive candidiasis and may be limited by clinically significant drug-to-drug interactions, tolerability considerations in complex regimens and increasing resistance in some candida species.

Candidemia and invasive candidiasis conditions are typically encountered in acute care hospitals, intensive care units (“ICUs”), and tertiary care centers where patients are critically ill, often immunocompromised, and at high risk for life-threatening fungal infections. The decision to use REZZAYO typically is made by infectious disease specialists, hospitalists, and critical care physicians managing these severe candida infections, especially in situations where daily echinocandin therapy is burdensome or where simplifying antifungal treatment is desirable. Pharmacy and therapeutics committees are also responsible for formulary decisions in hospitals and health systems evaluating antifungal treatment options that may reduce administration frequency and resource utilization without compromising clinical outcomes.

There are an estimated 25,000 cases of candidemia and 50,000 invasive candidiasis each year in the U.S., and REZZAYO is currently indicated for the treatment of such infections. We believe that the total addressable market for the treatment indication is approximately $250 million to $350 million.

Additional Indications

REZZAYO is currently being evaluated for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (“BMT”) (“ReSPECT clinical trial”). The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly REZZAYO versus a standard antimicrobial regimen (“SAR”) for the prevention of invasive fungal diseases (“IFDs”) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. This Phase III study, which is being conducted by our licensor Mundipharma, completed enrollment in September 2025, and we expect to announce top-line data in the second quarter of 2026.

In BMT settings, antifungal prophylaxis remains a critical but operationally complex component of care. Current standard options, particularly azole antifungals, are effective but introduce significant drug–drug interaction risk, often affecting conditioning chemotherapy, targeted oncology agents, and post-transplant immunosuppressants. These interactions can necessitate dose reductions, regimen modifications, and intensive therapeutic drug monitoring, increasing clinical burden and the risk of suboptimal cancer treatment delivery. Additional challenges include variable oral absorption, overlapping hepatic and cardiac toxicities, and the need for daily administration, all of which complicate care during the most vulnerable phases of transplant.

REZZAYO represents a differentiated approach to antifungal prophylaxis that directly addresses these limitations. As a once-weekly intravenous echinocandin with minimal drug–drug interaction potential, REZZAYO offers a more predictable and safer option for use alongside complex oncology and transplant regimens. Its extended half-life enables convenient dosing while preserving antifungal efficacy without requiring routine dose adjustments of concomitant therapies. By reducing interaction-driven compromises, simplifying administration, and supporting consistent prophylaxis during high-risk treatment windows, REZZAYO has the potential to meaningfully improve clinical workflow and risk management in transplant care, positioning it as a compelling alternative within the evolving antifungal prophylaxis landscape.

We believe that a prophylaxis indication of REZZAYO could be a key potential growth driver to the business. We estimate that the total addressable market for antifungal prophylaxis in the U.S. is greater than $2 billion.

MINOCIN IV

MINOCIN IV is an intravenous formulation of a highly differentiated tetracycline-class antibiotic with safety, tolerability and strong placement in the Infectious Diseases Society of America (“IDSA”) guidelines. MINOCIN IV is indicated for the treatment of infections caused by susceptible Gram-positive and Gram-negative organisms, including Acinetobacter species, Staphylococcus aureus, Streptococcus species, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Neisseria species, and certain atypical pathogens, and has been on the U.S. market since 2015.

Market Opportunity

MINOCIN IV addresses a defined but persistent market opportunity within the U.S. hospital anti-infectives market, particularly in the treatment of serious infections where intravenous therapy is required and alternative agents may be limited by resistance, tolerability, or route of administration. Demand for hospital-administered antibiotics remains supported by the ongoing prevalence of serious infections, including multidrug-resistant, Gram-negative organisms such as Acinetobacter baumannii. Hospitals continue to require multiple therapeutic options to manage these infections under antimicrobial stewardship protocols, particularly when oral therapy is not appropriate and susceptibility testing supports MINOCIN IV use.

Acinetobacter baumannii (“CRAB”) as an “urgent” antimicrobial resistance threat in its 2019 national Antibiotic Resistance Threats in the United States report, first listing CRAB at the highest threat level due to its limited treatment options and potential to spread resistant genes. Estimates from CDC data indicate that CRAB accounted for approximately 8,500 infections and about 700 deaths annually in the United States from 2019–2020, with resistant strains often impervious to multiple antibiotic classes and associated with difficult-to-treat hospital-acquired infections. CDC surveillance updates during 2021–2022 continued to show CRAB among key healthcare-associated resistant pathogens with infection burdens rising compared to pre-pandemic levels, reflecting ongoing clinical challenges in prevention and management. The pathogen’s resistance profile and associated mortality, combined with its designation as an urgent threat by the CDC, underscore its significance as a dangerous source of drug-resistant infection in U.S. healthcare settings.

MINOCIN IV is one of the few agent

SEC Form 10-K filed by CorMedix Inc.