What changed in this filing

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Item 1. Business

2026-03-05 compared with 2025-03-25 · 714 added, 423 removed, 313 unchanged (78% of the section changed)

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is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions.

Our primary focus is commercializing

our lead product, DefenCath® (taurolidine and heparin), in the U.S.

Our primary focus has been commercializing DefenCath® (taurolidine and heparin), in the U.S., which we launched in 2024 in the hemodialysis

The name DefenCath is the U.S.

proprietary name approved by the

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.

DefenCath is an FDA approved antimicrobial catheter lock solution (“CLS”)

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.

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

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

It is indicated for use in a limited and specific population of patients.

clinically confirmed subset of the epidemiological surveillance term, central line associated bloodstream infection (“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.

We believe DefenCath can address a significant unmet medical need.

Following the submission of a duplicate New Technology Add-On Payment

(“NTAP”) application to Centers for Medicare and Medicaid Services (“CMS”), CMS issued the Inpatient Prospective

Payment System (“IPPS”) 2024 proposed rule that includes a NTAP per hospital stay for DefenCath.

This NTAP represents reimbursement

to inpatient facilities of 75% of the wholesaler acquisition cost (“WAC”) price per 3 mL vial, and an average utilization

of 19.5 vials per hospital stay.

The final IPPS rule amended as of October 1, 2024 to reflect the current WAC of $249.99 per 3ml vial

resulting in a potential maximum NTAP of $3,656.10.

On November 15, 2023, we

announced that the FDA approved the new drug application (“NDA”) for DefenCath to reduce the incidence of CRBSI in adult

patients with kidney failure receiving chronic hemodialysis through a CVC.

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.

As a result of the November 2023

FDA approval, CorMedix launched the product commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis

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

The GAIN exclusivity extension of 5 years is the result of the January 2015 designation of DefenCath as a Qualified Infectious

Disease Product (“QIDP”).

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.

We announced on June 6, 2024

that CMS determined that DefenCath qualified for pass-through status under the hospital Out-Patient Prospective Payment System (“OPPS”).

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

We estimate that up to 100,000 hemodialysis-central venous catheter (“HD-CVC”) placements occur each year, and pass-through

status offers providers a separate reimbursement mechanism in this setting of care administration of DefenCath.

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 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.

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 Opportunity

Central Venous Catheters (“CVC”) or ‘central lines’

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

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administering long term antibiotic therapy, and administering total parenteral nutrition (complete or partial dietary support via intravenous

Bloodstream infections

resulting from the use of central venous catheters known as CLABSIs 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 CLBSI 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 250,000 CRBSI episodes per year

(Becker’s Hospital Review).

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 2022, there were nearly 816,000 End-Stage-Renal-Disease, or ESRD, patients on permanent hemodialysis in the U.S.

25% of these utilized a CVC for vascular access.

Of the total population, approximately 131,000 hemodialysis patients were new patients

diagnosed with ESRD during the year and nearly 85% 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, or AKI and Chronic Kidney Disease, or CKD, populations that progress into dialysis.

Kidney failure patients that

present in the hospital have an average length of stay of 13.3 days and additionally high 30-day readmission rates both for 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.

Intralumen infections are often caused by

the formation of biofilm.

Biofilm build up is 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.

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 blood stream.

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, in order to prevent clotting between dialysis treatments.

a heparin lock solution provides no protection from the risk of infection.

Other than DefenCath, there are no pharmacologic drug products approved

data from 2023, there were approximately 485,000 End-Stage-Renal-Disease (“ESRD”) patients on permanent hemodialysis in the

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

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

The presence of biofilm has many adverse effects, including the ability to release bacteria into the bloodstream.

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

for the prevention or reduction of CRBSIs in CVCs.

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in the hemodialysis patient population as well as for other patient populations utilizing central venous catheters such as total parenteral

nutrition and oncology/chemotherapy.

DefenCath, our FDA-approved product, is a non-antibiotic, broad-spectrum

antimicrobial and anticoagulant combination that is active against common microbes including antibiotic-resistant strains of certain pathogens

whose mechanism of action inhibits the first steps in biofilm formation.

We believe that using DefenCath as an antimicrobial catheter-lock

solution will significantly reduce the incidence of life-threatening catheter-related blood stream infections, thus reducing the need

for 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.

We announced on May 1, 2023

that the United States Patent and Trademark Office (“USPTO”) allowed our patent application directed to a locking solution

composition for treating and reducing infection and flow reduction in central venous catheters.

This application was granted on August

29, 2023 as U.S.

Our newly granted U.S.

Patent reflects the unique and proprietary formulation of our product,

DefenCath, for which we received FDA approval on November 15, 2023.

This patent supplements the coverage of our existing licensed U.S.

7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath through 2042.

We currently believe the

patent that is most material to our business is U.S.

11,738,120 (expiring April 15, 2042).

License Agreement with ND Partners, LLP

In 2008, we entered into

a License and Assignment Agreement (the “ND License Agreement”) with ND Partners, LLP (“NDP”).

Pursuant to the

ND License Agreement, NDP granted us exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating

and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign

patents and applications (the “NDP Technology”).

As consideration in part for the rights to the NDP Technology, upon execution

of the ND License Agreement, we paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest, consisting of 7,996

shares of our common stock.

Under the ND License Agreement, we are required to make cash and equity

payments to NDP upon the achievement of certain milestones.

Under the ND License Agreement, the maximum aggregate amount of cash payments

due upon achievement of applicable milestones was $2,500,000, with the balance being $2,000,000 as of December 31, 2024.

The outstanding

sales milestones were met in the third quarter of 2024 and, accordingly, we anticipate payment will be due in accordance with the agreement

terms at the end of the twelve month period post attainment.

Beginning in the second quarter of 2024, the license intangible asset

is amortized as cost of goods sold over its estimated economic life of approximately 10 years.

The amortization start period correlates

with the product launch of DefenCath and the first period in which revenue will be recognized.

Amortization expense of approximately $52,000

and $156,000 was recorded during the three and twelve month periods ending December 31, 2024, respectively.

The ND License Agreement

will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement

in a given country, or (ii) the payment of all milestone payments.

Upon the expiration of the ND License Agreement in each country, we

will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country.

The ND License

Agreement also may be terminated by NDP if we materially breaches or defaults under the ND License Agreement and that breach is not cured

within 60 days following the delivery of written notice to us, or by us on a country-by-country basis upon 60 days prior written notice

in the event our Board determines not to proceed with the development of the NDP Technology.

If the ND License Agreement is terminated

by either party, our rights to the NDP Technology will revert back to NDP.

Competitive Landscape

The drug and medical device

industries are highly competitive and subject to rapid and significant technological change.

DefenCath’s potential competitors

could include large as well as specialty pharmaceutical and biotechnology companies and large and specialty medical device companies.

Many of our potential competitors have substantially greater financial, technical and human resources than we do and significantly more

experience in the development and commercialization of drugs and medical devices.

Further, the development of new treatment methods could

render DefenCath non-competitive or obsolete.

We believe that the key competitive

factors that will affect the commercial success of DefenCath are established efficacy and safety, as well as pricing and reimbursement

mechanisms across the continuum of care.

Given that DefenCath is the only approved antimicrobial catheter lock solution in the U.S., we

believe that with adequate reimbursement there is an opportunity for DefenCath to become the new standard of care as a CLS in the U.S.

We are not aware of any potentially competitive CLS which are approved or under development by other companies in the U.S.

a means to reduce infections, some dialysis providers are using anti-infective infused catheter caps and/or compounded unapproved antibiotic

catheter lock solutions.

We expect sales of DefenCath

to generate substantially all of our product revenues for the foreseeable future.

Sales to one customer accounted for 86% of our total

revenue for the year ended December 31, 2024, and we had two customers that accounted for 87% and 12% of our accounts receivable, respectively,

for the year ended December 31, 2024.

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

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 and any

future product lines will depend, in part, on the extent to which such products 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 and any future product lines.

It is essential to obtain third-party

payor coverage policies and adequate payment in order to continue to successfully commercialize DefenCath.

We expect to sell DefenCath

primarily to outpatient dialysis clinics and inpatient hospitals.

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.

is essential to obtain third-party payor coverage policies and adequate payment to continue to successfully commercialize DefenCath.

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 (referred to herein as 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, or 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, or NTAP, if certain criteria are

There are three criteria required for new technologies to be eligible to receive NTAP:

Product must meet “newness” criteria;

Product must meet “substantial clinical improvement”

over existing technologies;

Product must meet certain cost thresholds.

CMS created several

alternative NTAP approval pathways for certain devices that obtain breakthrough designation and drugs that obtain Qualified Infectious

Disease Product, or QIDP, designation from the FDA.

Under these alternative pathways, the new technology need only meet the cost criterion

because CMS assumes that those products meet the newness and substantial clinical improvement criteria.

CMS has issued the IPPS 2024

proposed rule that includes a NTAP per hospital stay for DefenCath.

This NTAP represents reimbursement to inpatient facilities of 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 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.

With established reimbursement in the inpatient

setting, we launched DefenCath in hospitals first while outpatient reimbursement became effective July 1, 2024.

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.

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

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

As discussed above, in 2024

DefenCath was found to be subject to Medicare ESRD PPS, which provides bundled payment for renal dialysis services and affords a 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).

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).

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

The HCPCS J-code for DefenCath was published by CMS on April 2, 2024.

CMS confirmed a July 1, 2024 implementation

date for HCPCS and TDAPA.

CMS also 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

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.

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.

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.

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

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.

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.

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

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 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 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

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 agents approved for treatment of Acinetobacter species.

Acinetobacter infections are generally seen in the ICU, particularly in mechanically

ventilated and immunocompromised patients.

The IDSA Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections lists

MINOCIN IV as a recommended alternative in combination therapy for the treatment of CRAB infections when susceptibility is demonstrated,

reflecting its role in multidrug regimens used to manage these difficult-to-treat infections and helping address the treatment gaps identified

The product’s market opportunity is driven primarily by institutional

purchasing decisions, local antibiograms (hospital-specific summaries of antimicrobial susceptibility data), and infectious disease specialist

prescribing patterns rather than broad empiric use.

While overall antibiotic utilization in hospitals is moderated by stewardship efforts,

we believe that the need for differentiated IV therapies for resistant infections, treatment-limited patients, and complex clinical scenarios

supports continued demand for MINOCIN IV as part of the hospital anti-infective armamentarium.

VABOMERE is an IV antibiotic

that is a combination of meropenem, the leading carbapenem used in treatment of gram-negative infections, and vaborbactam, a novel beta-lactamase

inhibitor that inhibits certain types of resistance mechanisms used by bacteria.

VABOMERE received FDA approval in August 2017, for the

treatment of patients 18 years of age and older with complicated urinary tract infections (“cUTI”), including pyelonephritis,

caused by designated susceptible Enterobacteriaceae.

VABOMERE was specifically developed to address gram-negative bacteria that produce

beta-lactamase enzymes, particularly the Klebsiella pneumoniae carbapenemase (“KPC”) enzyme.

In addition, we have a partnership

with the Biomedical Advanced Research and Development Authority (“BARDA”) to advance VABOMERE for use in pediatrics (see

“Biomedical Advanced Research and Development Authority Contract” section below for further details).

Market Opportunity

The market opportunity for

VABOMERE is driven by the growing global prevalence of serious Gram-negative infections, particularly those caused by carbapenem-resistant

Enterobacterales (“CRE”), including infections mediated by Klebsiella pneumoniae carbapenemase (“KPC”)–producing

KPC-producing CRE are classified by the CDC to be an urgent antimicrobial resistance threat as they represent a significant

and persistent subset of carbapenem resistance in the United States and are associated with high morbidity, mortality, prolonged hospital

stays, and increased healthcare costs.

Hospitalized patients, including those in intensive care units or with significant comorbidities,

are at heightened risk for these infections and have limited treatment options, underscoring the ongoing need for effective, targeted

antibacterial therapies.

VABOMERE was designed to

address this unmet medical need by combining a carbapenem antibiotic with a beta-lactamase inhibitor active against KPC enzymes, which

are among the most prevalent carbapenemase enzymes in the United States.

The market opportunity for VABOMERE is supported by continued

clinical demand for resistance-directed therapies for KPC-producing CRE, increasing use of rapid diagnostic testing to identify specific

carbapenemase enzymes, and antimicrobial stewardship practices that prioritize agents with activity against defined resistance pathways.

While the antibacterial market is highly competitive and subject to pricing pressure, hospital formulary adoption and use in appropriate

patient populations provide an opportunity for VABOMERE to address a defined segment of serious Gram-negative infections where limited

therapeutic alternatives exist.

Additionally, VABOMERE is included in the IDSA guidelines as one of the recommended options for the treatment

of CRE when the isolate is susceptible and particularly when KPC–producing organisms are involved.

Purchasing decisions for

VABOMERE are typically made by hospital pharmacy and therapeutics committees and are affected by factors such as clinical efficacy and

safety data, labeled indications, resistance patterns within the institution, availability of alternative therapies, pricing, and reimbursement.

Other Commercial Products

While not directly marketed by our sales team,

the following brands have limited and targeted promotional activities, including certain market access and contracting support:

ORBACTIV and KIMYRSA

ORBACTIV and KIMYRSA (the

“ORI Franchise”) are long-acting IV antibiotics indicated for the treatment of adult patients with acute bacterial skin and

skin structure infections (“ABSSSI”) caused by susceptible Gram-positive pathogens, including MRSA, with no dose adjustment

for mild/moderate renal or hepatic impairment or for age, weight, gender, or race.

ORBACTIV and KIMYRSA obtained U.S.

marketing approval

in August 2014 and March 2021, respectively.

Treatment decision-making

in ABSSSI is increasingly shaped by site-of-care optimization:

avoiding potentially preventable hospital admissions, shortening length

of stay, and reducing the operational burden of multi-day IV regimens and OPAT logistics.

ORBACTIV and KIMYRSA address these dynamics

by delivering a complete course of therapy in a single dose administration, supporting use across multiple settings ( e.g.

departments, outpatient infusion centers, hospital outpatient departments) where a single-visit approach can improve adherence and reduce

the need for extended IV access such as placement of a peripherally inserted central catheter (“PICC”).

Within the ORI Franchise,

KIMYRSA provides a 1-hour infusion option, while ORBACTIV is administered over 3 hours, enabling clinicians and health systems to select

an approach aligned to workflow and capacity constraints, while maintaining single-dose therapy for eligible patients.

In contrast to

the current standard of care (6 to 10 days of IV therapy), which generally requires a PICC line or hospital stay, single-dose ABSSSI

therapy with the ORI Franchise alternatives increases patient convenience, ensures patient adherence with a single dose, and allows for

treatment in alternative, lower cost care settings.

In addition, oritavancin, the active ingredient

in ORBACTIV and KIMYRSA, is a semisynthetic lipoglycopeptide antibiotic with a distinctive triple mechanism of action against susceptible

Gram-positive pathogens.

Specifically, oritavancin (i) inhibits transglycosylation (polymerization of peptidoglycan chains), (ii) inhibits

transpeptidation (cross-linking of peptidoglycan), and (iii) disrupts bacterial cell membrane integrity, leading to rapid, concentration-dependent

bactericidal activity.

This multi-targeted activity differentiates oritavancin from agents that act through a single pathway and contributes

to its potency against key Gram-positive pathogens, including MRSA, as well as activity against certain organisms with reduced susceptibility

to other glycopeptides

BAXDELA is a novel fluoroquinolone that is approved for the treatment

of adult patients with ABSSSI or community-acquired bacterial pneumonia (“CABP”).

BAXDELA has a broad-labeled spectrum including

Staphylococcus aureus (including MRSA) as well as certain Gram-negative organisms and is available to initiate therapy on either an IV

or oral formulation.

While we do not promote BAXDELA, our partnership with BARDA includes support to advance BAXDELA, as described below

for use in pediatrics and for use against certain biothreat pathogens (see “Biomedical Advanced Research and Development Authority

Contract” section below for further details).

TOPROL XL (metoprolol succinate extended-release) is a cardioselective

beta-blocker indicated for the treatment of hypertension, which has been on the U.S.

market since 1992.

The Toprol XL brand lost market

exclusivity in 2007, lending to market dynamics of a mature, highly competitive beta-blocker class, with broad availability of generic

metoprolol succinate extended-release alternatives, intense payer/formulary pressure, and prescription decisions influenced by total cost

of care and patient adherence considerations.

While we do not actively promote TOPROL XL, there remains some brand demand which tends

to concentrate in segments where prescribers and patients value a long-established extended-release option and consistent once-daily dosing

in chronic cardiovascular management, but overall growth is constrained by generic substitution and pricing pressure typical of long-marketed

cardiovascular therapies.

Competitive Landscape

The drug and medical device industries are highly competitive and subject

to rapid and significant technological change.

Competitors (and potential competitors) for our Products include large and specialty pharmaceutical

and biotechnology companies and medical device companies.

Many of our competitors have substantially greater financial, technical and

human resources than we do and significantly more experience in the development and commercialization of drugs and medical devices.

the development of new treatment methods, antimicrobial resistance, or products could render our commercial products non-competitive or

We believe that the key competitive factors that will affect the commercial

success of DefenCath are established efficacy and safety, as well as pricing and reimbursement mechanisms across the continuum of care.

Given that DefenCath is the only FDA-approved antimicrobial catheter lock solution in the U.S., we believe that with adequate reimbursement

there is an opportunity for DefenCath to become the new standard of care as a CLS in the U.S.

Further, as the Company continues

to demonstrate both short and long-term reductions in healthcare costs via the results from our real-world evidence study, we believe

that the overall reduction in both infections and hospitalizations could drive greater utilization and create new opportunities for reimbursement.

We are not aware of any potentially competitive CLSs that are approved or under development by other companies in the U.S.

prevention of infection.

As a means to reduce infections, some dialysis providers are using anti-infective infused catheter caps and/or

compounded FDA-unapproved antibiotic containing catheter lock solutions.

Across the Melinta Portfolio,

critical success factors in a highly competitive anti-infective market include clear clinical differentiation and strong alignment with

evolving treatment guidelines.

Competitive positioning depends on demonstrating meaningful advantages versus generic and branded alternatives

in areas such as spectrum of activity against resistant organisms, safety and tolerability, reduced drug–drug interactions, dosing

convenience (including long-acting or infrequent dosing regimens), and suitability for both inpatient and outpatient care settings.

is also influenced by effective engagement with key hospital stakeholders—including infectious disease physicians, antimicrobial

stewardship program personnel, pharmacists, and hospital administrators—supported by compelling clinical evidence, real-world data,

and health-economic value propositions.

In addition, securing and preserving formulary access, navigating pricing and reimbursement pressures,

and adapting to changes in standard-of-care guidelines and competitive product launches are essential to sustaining demand and market

share for these products.

Intellectual Property

Due to the length of time

and expense associated with bringing new products to market, biopharmaceutical companies have traditionally placed considerable importance

on obtaining and maintaining patent protection for significant new technologies, products and processes.

The term of individual patents

depends upon the legal term of the patents in the countries in which they are obtained.

In most countries in which we file, the patent

term is 20 years from the earliest date of filing a non-provisional patent application.

In the U.S., a patent’s term may be lengthened

by Patent Term Adjustment, which compensates a patentee for administrative delays by the U.S.

Patent and Trademark Office (“USPTO”)

in granting a patent, or may be shortened if a patent is terminally disclaimed over another patent.

In the U.S., and certain other countries,

the patent’s term may also be lengthened by patent term extension or restoration, which compensates a patentee for administrative

delays in granting a regulatory approval by the FDA, or similar agency in other countries.

While we pursue patent protection

and enforcement of all our Products, product candidates, and aspects of our technologies when appropriate, we also rely on trade secrets,

know-how and continuing technological advancement to develop and maintain our competitive position.

To protect this competitive position,

we regularly enter into confidentiality and proprietary information agreements with third parties, including employees, independent contractors,

suppliers and collaborators.

Our employment policy requires each new employee to enter into an agreement containing provisions generally

prohibiting the disclosure of confidential information to anyone outside of the Company and providing that any invention conceived by

an employee within the scope of his or her employment duties is our exclusive property.

We have a similar policy with respect to independent

contractors, generally requiring independent contractors to enter into agreements containing provisions generally prohibiting the disclosure

of confidential information to anyone outside of the Company and providing that any invention conceived by an independent contractor

within the scope of his or her services is our exclusive property with the exception of contracts with universities and colleges that

may be unable to make such assignments.

Furthermore, our know-how that is accessed by third parties through collaborations and research

and development contracts and through our relationships with scientific consultants is generally protected through confidentiality agreements

with the appropriate parties.

On August 29, 2023, the USPTO granted U.S.

11,738,120, which

was our patent application directed to a locking solution composition for treating and reducing infection and flow reduction in central

venous catheters (expiring April 15, 2042).

We have a supplemental patent (U.S.

7,696,182), which we believe has potential

to provide an additional layer of patent protection for DefenCath through 2042.

DefenCath is listed in the Orange Book as having new chemical entity

(“NCE”) exclusivity (five years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now (“GAIN”)

exclusivity extension of the NCE exclusivity (an additional five years) expiring on November 15, 2033.

The GAIN exclusivity extension

of five years is the result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product (“QIDP”).

CorMedix holds an exclusive

license from Mundipharma, our European licensor and the current holder of REZZAYO intellectual property and the NDA, to develop and sell

the brand in the U.S.

Under the terms of the license, we are required to make certain future milestone payments to Mundipharma (See Contractual

Obligations , included within this Annual Report, for additional details on the arrangement with Mundipharma).

REZZAYO has NCE exclusivity

with GAIN extension until 2033, orphan drug exclusivity through 2035 and composition of matter and treatment patent coverage until 2038.

We have patents relating to

the MINOCIN IV product formulation and certain methods of treatment comprising intravenously administering minocycline, which are set

to expire between May 2031 and October 2032.

We are also prosecuting other patent applications relating to minocycline formulations and

methods of treatment in the U.S.

In 2020, Nexus Pharmaceuticals

(“Nexus”) filed an Abbreviated New Drug Application (“ANDA”) with Paragraph IV (“PIV”) certification

against the only Orange Book listed patents at the time, specifically patents ‘802 and ‘105 (“Minocin Treatment Patents”),

on the alleged basis that the Minocin Treatment Patents were invalid and, in the alternative, that its ANDA did not infringe.

Melinta filed suit against

Nexus in the US District Court for the Northern District of Illinois (the “Court”), asserting that the Minocin Treatment Patents

were valid and accordingly, Nexus’s ANDA for its generic version of MINOCIN infringed these patents.

In November 2024, the

Court found that the Minocin Treatment Patents are valid, enforceable and infringed and issued a permanent injunction against the Nexus

ANDA as part of that decision.

Nexus subsequently filed an appeal with the U.S.

Court of Appeals for the Federal Circuit.

The appeal is

Additionally, in February

2025, Melinta received a PIV certification for all four Orange Book listed patents from Gland Pharma (“Gland”) on the alleged

basis that the patents were invalid, and in the alternative that its ANDA did not infringe these patents.

Melinta filed a suit against

Gland in the same Court in April 2025.

The case is ongoing.

VABOMERE received five years

of NCE exclusivity following its 2017 FDA approval, with an additional five-year GAIN/QIDP extension, resulting in regulatory exclusivity

through August 2027.

We hold a portfolio of patents relating to VABOMERE, including the vaborbactam compound, for which we have patent

coverage until 2031, and methods of treatment, for which we have coverage until 2039.

We are currently prosecuting related patent applications

relating to VABOMERE’s pharmaceutical composition and its use in the U.S.

and in certain foreign countries.

ORI Franchise

patents relating

to methods of treatment expiring in 2029 and 2030, as well as a U.S.

patent relating to high purity oritavancin that expires in 2035.

Numerous foreign counterparts have been filed, including in Europe and Eurasia, for these more recent methods of treatment and compositions.

We are also prosecuting a number of patent applications relating to the ORI Franchise and its uses in the U.S.

and certain foreign jurisdictions.

We have a license, both exclusive and nonexclusive, from Wakunaga Pharmaceutical

Company, Ltd.

to certain patents and patent applications, and to certain patents and patent applications of AbbVie Inc.

We have also licensed

technology from CyDex Pharmaceuticals, Inc.

(now a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated) for the use of Captisol,

a sulfobutylether beta-cyclodextrin excipient, in connection with BAXDELA.

We have developed and patented additional technology independently.

The patent portfolio for BAXDELA and delafloxacin meglumine, the active pharmaceutical ingredient in BAXDELA, is related to compositions

of matter, pharmaceutical compositions, manufacturing methods and methods of use.

In addition to the licensed and owned U.S.

the portfolio includes pending U.S.

patent applications and corresponding foreign national or regional counterpart patents or applications.

We expect that the patents and the patent applications in the portfolio, if issued, will expire between 2026 and 2034.

Manufacturing/Supply Chain

6 unchanged sentences

We intend to continue this practice in the future.

We currently have one FDA approved source for each of our two key active

pharmaceutical ingredients (“APIs”) for DefenCath, taurolidine and heparin sodium, respectively.

With regards to taurolidine,

we have a drug master file (“DMF”) filed with the FDA.

There is a master commercial supply agreement between a third-party

manufacturer and the Company which has been in place since August 2018.

In addition, we are working with our existing manufacture to source

sufficient quantities of taurolidine API to cover at least 24 months of potential future demand.

With respect to heparin sodium API, we

have identified an alternate third-party supplier and may qualify such supplier under the DefenCath NDA over the next twelve months.

We received FDA approval

of DefenCath with finished dosage production from our European based contract manufacturing organization (“CMO”) Rovi Pharma

Industrial Services.

We believe this CMO has adequate capacity to produce the volumes needed to meet near-term projected demand for the

commercial launch of DefenCath.

We have also qualified Siegfried Hameln as an alternate finished dosage manufacturing site.

We note that CMOs and our

API suppliers are subject to FDA oversight and inspection regarding compliance with Current Good Manufacturing Practices (“cGMP”),

and if deemed non-compliant with cGMP by FDA, we could face shortages or risk with respect to producing sufficient quantities of drug

product or drug substance.

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.

While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs

in total parenteral nutrition patients using a central venous catheter and in certain oncology patients using a central venous catheter.

In June 2024, we announced that the FDA provided feedback to our request

to discuss development plans for additional indications for DefenCath.

In response to these comments, we created and submitted three clinical

protocols specifically, the post-marketing requirement of a pediatric hemodialysis (“HD”) study as an obligation under the

Pediatric Research Equity Act (“PREA”), a Phase 3 study protocol to reduce the risk of central-line associated bloodstream

infections (“CLABSI”) for adult patients receiving total parenteral nutrition (“TPN”) through a CVC and Expanded

Access Program (“EAP”) to FDA that allows for pediatric and adult patients, utilizing a CVC for the treatment or maintenance

of many serious illness, to access DefenCath to protect their central line from serious infection.

We launched the EAP at the end of 2024

and expect to begin enrollment for the adult TPN and pediatric HD studies in the first half of 2025.

As part of the DefenCath approval letter, the FDA communicated the

existence of a required pediatric assessment under the PREA.

PREA requires sponsors to conduct pediatric studies for, among other things,

NDAs for a new active ingredient, such as taurolidine in DefenCath, unless a waiver or deferral is obtained from the FDA.

A deferral acknowledges

that a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA.

deferred submission of the pediatric study for DefenCath because the product is ready for approval for use in adults and the pediatric

study has not been completed.

We are currently obligated to conduct the study as communicated in the 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.

Because this is a required post-marketing study, we would be

required to make annual reports to the FDA.

Pediatric studies for an approved product conducted under 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 the 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.

We may seek CMS reimbursement for DefenCath in other catheter indications

beyond ESRD, such as oncology patients and total parenteral nutrition patients, including through (i) relevant hospital inpatient diagnosis-related

groups (“DRGs”), (ii) additional NTAP payments, or (iii) outpatient ambulatory payment classifications, or APCs, and payment

under these Medicare benefit categories is not guaranteed for these additional potential indications.

For DefenCath, we currently

have one FDA-approved source (contract manufacturing organization, or “CMO”) for each of our two key active pharmaceutical

ingredients (“APIs”), taurolidine and heparin sodium, respectively.

With regards to taurolidine, the Company has a drug master

file (“DMF”) filed with the FDA.

There is a master commercial supply agreement between a third-party manufacturer which has

been in place since August 2018.

With respect to heparin sodium API, the Company has identified an alternate third-party supplier and

may qualify such supplier under the DefenCath NDA in the future.

The Company received FDA

approval of DefenCath with finished dosage production from its European based CMO Rovi Pharma Industrial Services.

In addition, the Company

also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling production at the

Each of the products in the

Melinta Portfolio has one FDA-approved contract manufacturing organization, primarily in Europe or in the U.S.

The Company has ongoing

technology transfers intended to reduce costs of goods sold as well as to onshore the manufacture of several of its products, which it

expects to complete over the next two to three years.

CMOs and our API suppliers are subject to FDA oversight and inspection

regarding compliance with Current Good Manufacturing Practices (“cGMP”), and if deemed non-compliant with cGMP by the FDA,

we could face shortages or risk with respect to producing sufficient quantities of drug product or drug substance.

Biomedical Advanced Research and Development

Authority (“BARDA”) Contract

In July 2023, Melinta entered into partnership with BARDA to advance

BAXDELA and VABOMERE for use in pediatrics and to partner on the development of BAXDELA against certain biothreat pathogens (“BARDA-Supported

Under this agreement, BARDA reimburses certain percentages of costs incurred, as defined in the agreement, in connection

with the BARDA-Supported Studies.

As of December 31, 2025, BARDA has awarded a total of $47.5 million of funding with the potential of

additional funding of $97.1 million, amounting to total funding up to $144.6 million, if all options are exercised.

If all contract options

are exercised, the contract is expected to continue through 2034.

Through December 31, 2025, we have recognized BARDA reimbursement totaling

$19.4 million.

The BARDA contract contains

a number of terms and conditions that are customary for government contracts of this nature, including provisions giving the government

the right to terminate the contract at any time for its convenience.

United States Government Regulation

13 unchanged sentences

Any agency enforcement action and/or any related impact could have a material adverse effect on us.

Drug Approval Process

The research, development,

and approval process in the U.S.

and elsewhere is intensive and rigorous and generally takes many years to complete.

The typical process

required by the FDA before a therapeutic drug may be marketed in the U.S.

Pre-clinical laboratory

and animal tests performed under the FDA’s Good Laboratory Practices(“GLP”), regulations;

submission to the FDA of

an investigational new drug application (“IND”), which must become effective before human clinical trials may commence;

human clinical studies

to evaluate the drug’s safety and effectiveness for its intended uses;

FDA review of whether the

facility in which the drug is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued

quality and compliance with cGMPs, and FDA review of clinical trial sites to determine whether the clinical trials were conducted

in accordance with Good Clinical Practices (“GCPs”);

submission of a NDA, to

the FDA, and approval of the application by the FDA to allow sales of the drug.

Clinical Trial Programs

Clinical trial programs in

34 unchanged sentences

Following the completion

of a clinical trial, the data are analyzed by the sponsoring company to determine whether the trial successfully demonstrated safety

and effectiveness and whether a product approval application may be submitted.

In the United States, if the product is regulated as a

new drug, an NDA must be submitted and approved by the FDA before commercial marketing may begin.

The NDA must include a substantial

amount of data and other information concerning the safety and effectiveness of the compound from laboratory, animal, and human clinical

testing, as well as data and information on manufacturing, product quality and stability, and proposed product labeling.

of a clinical trial, the data is analyzed by the sponsoring company to determine whether the trial successfully demonstrated safety and

effectiveness and whether a product approval application may be submitted.

In the United States, if the product is regulated as a new

drug, an NDA must be submitted and approved by the FDA before commercial marketing may begin.

The NDA must include a substantial amount

of data and other information concerning the safety and effectiveness of the compound from laboratory, animal, and human clinical testing,

as well as data and information on manufacturing, product quality and stability, and proposed product labeling.

Once accepted for filing,

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considers such recommendations carefully when making decisions.

Approval Process

After evaluating the NDA

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impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a Risk Evaluation and Mitigation

Strategy, or a REMS, or otherwise limit the scope of any approval.

In addition, under the Pediatric

Research Equity Act, or PREA, an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen, or

route of administration must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications

in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product

is safe and effective.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some

or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.

Such deferred studies become required post-marketing studies upon approval of the product.

Strategy (“REMS”) or otherwise limit the scope of any approval.

In addition, under the PREA,

an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration must

contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric

subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until

after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.

Such deferred studies

become required post-marketing studies upon approval of the product.

Special FDA Expedited Review and Approval

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establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated

New Drug Application, or ANDA.

An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage

form, strength, route of administration, labeling, performance characteristics, and intended use, among other things, to a previously

New Drug Application (“ANDA”).

An ANDA provides for marketing of a generic drug product that has the same active ingredients,

dosage form, strength, route of administration, labeling, performance characteristics, and intended use, among other things, to a previously

approved product.

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Five years of exclusivity

are available to New Chemical Entities, or NCEs.

A NCE is a drug that contains no active moiety that has been approved by the FDA in

any other NDA submitted under Section 505 of the FDCA.

An active moiety is the molecule or ion, excluding those appended portions of

the molecule, that cause the drug to be an ester, salt, including a salt with hydrogen or coordination bonds, or other noncovalent derivatives,

such as a complex, chelate, or clathrate, of the molecule, responsible for the physiological or pharmacological action of the drug substance.

During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA application submitted by another company

that contains the previously approved active moiety, except that an ANDA or 505(b)(2) that contains a certification that the patents

listed by the NCE sponsor in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, are

invalid or will not be infringed by the manufacture, use, or sale of the drug product for which approval is sought, may be submitted

one year before NCE exclusivity expires.

are available to NCEs.

A NCE is a drug that contains no active moiety that has been approved by the FDA in any other NDA submitted under

Section 505 of the FDCA.

An active moiety is the molecule or ion, excluding those appended portions of the molecule, that cause the drug

to be an ester, salt, including a salt with hydrogen or coordination bonds, or other noncovalent derivatives, such as a complex, chelate,

or clathrate, of the molecule, responsible for the physiological or pharmacological action of the drug substance.

During the exclusivity

period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA application submitted by another company that contains the previously

approved active moiety, except that an ANDA or 505(b)(2) that contains a certification that the patents listed by the NCE sponsor in FDA’s

list of Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”), are invalid or will not be infringed

by the manufacture, use, or sale of the drug product for which approval is sought, may be submitted one year before NCE exclusivity expires.

Five-year exclusivity will also not delay the submission or approval of a 505(b)(1) NDA;

an applicant submitting a 505(b)(1) NDA would be required to conduct or obtain a right of reference to all the pre-clinical studies and

adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.

however, an applicant submitting a 505(b)(1)

NDA would be required to conduct or obtain a right of reference to all the pre-clinical studies and adequate and well-controlled clinical

trials necessary to demonstrate safety and efficacy.

The FDCA also provides three

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This six-month exclusivity

may be granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data.

do not need to show the product to be effective in the pediatric population studied;

may be granted if an NDA sponsor submits pediatric data that fairly responds to a written request from the FDA for such data.

does not need to show the product to be effective in the pediatric population studied;

rather, if the clinical trial is deemed to fairly

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superiority over the product with orphan exclusivity.

certain infectious disease products, the above discussed exclusivity periods may be further extended if the product is designated as

a QIDP and receives GAIN Act exclusivity.

A qualified infectious disease product, or QIDP, is an antibacterial or antifungal drug for

human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant

pathogen, including novel or emerging infectious pathogens;

or qualifying pathogens designated by the FDA that have the potential to

pose a serious threat to public health.

Subject to the specified statutory limitations, a drug that is designated as a QIDP and is approved

for the use for which the QIDP designation was granted will receive a 5-year extension to any exclusivity for which the application qualifies

upon approval.

For example, if the FDA approves an NDA for a drug designated as a QIDP, the NCE exclusivity period is extended to ten

years and the FDA may not accept applications for nine years.

Moreover, if a product is designated as a QIDP and an orphan product, the

orphan product exclusivity period is extended to twelve years.

These extensions are in addition to any extension that an application

may be entitled to under the pediatric exclusivity provisions.

To receive a QIDP designation, the sponsor must request that the FDA designate

the product as such prior to the submission of an NDA.

This designation may not be withdrawn except if the FDA finds that the request

for designation contained an untrue statement of material fact.

certain infectious disease products, the above discussed exclusivity periods may be further extended if the product is designated as a

QIDP and receives GAIN Act exclusivity.

A qualified infectious disease product, or QIDP, is an antibacterial or antifungal drug for human

use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen,

including novel or emerging infectious pathogens;

or qualifying pathogens designated by the FDA that have the potential to pose a serious

threat to public health.

Subject to the specified statutory limitations, a drug that is designated as a QIDP and is approved for the use

for which the QIDP designation was granted will receive a 5-year extension to any exclusivity for which the application qualifies upon

For example, if the FDA approves an NDA for a drug designated as a QIDP, the NCE exclusivity period is extended to ten years,

and the FDA may not accept applications for nine years.

Moreover, if a product is designated as a QIDP and an orphan product, the orphan

product exclusivity period is extended to twelve years.

These extensions are in addition to any extension that an application may be entitled

to under the pediatric exclusivity provisions.

To receive a QIDP designation, the sponsor must request that the FDA designate the product

as such prior to the submission of an NDA.

This designation may not be withdrawn except if the FDA finds that the request for designation

contained an untrue statement of material fact.

QIDPs are also eligible for Fast Track status and priority review.

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Manufacturers report Average

Sales Price (ASP) data for Part B-covered drugs and biologicals and related items, services, supplies, and products that are paid as

drugs or biologicals.

We also participate in the MDRP and report ASP, Best Price and other metrics related to our participation in such

Sales Price (“ASP”) data for Part B-covered drugs and biologicals and related items, services, supplies, and products that

are paid as drugs or biologicals.

We also participate in the MDRP and report ASP, Best Price and other metrics related to our participation

in such program.

We pay rebates to state Medicaid agencies based on those metrics on Medicaid beneficiary utilization of products.

we are required to sell our covered outpatient drugs at or below the 340B Ceiling Price to 340B Covered Entities.

We are also required

to discount our products to authorized users of the Federal Supply Schedule, under which additional laws and requirements apply.

of these programs require submission of pricing data and calculation of discounts and/or rebates pursuant to complex statutory formulas

addition, we are required to sell our covered outpatient drugs at or below the 340B Ceiling Price to 340B Covered Entities.

required to discount our products to authorized users of the Federal Supply Schedule, under which additional laws and requirements apply.

Each of these programs require submission of pricing data and calculation of discounts and/or rebates pursuant to complex statutory formulas

and regulatory guidance, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations,

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These initiatives include, among others:

to reevaluate, reduce or limit the prices of drugs and make them more affordable for patients;

● implementation

of additional data collection and transparency reporting regarding drug pricing, rebates, fees and other remuneration provided by drug

manufacturers;

to rules associated with ESRD PPS Transitional Drug Add-on Payment Adjustment;

revisions to rules associated with the calculation of average sales price;

to rules associated with the calculation of average manufacturer price and best price under Medicaid;

to the MDRP, including through a May 2023 CMS-proposed rulemaking for this program, that could significantly increase manufacturer rebate

● implementation

of the inflation Reduction Act of 2022 (Inflation Reduction Act), including provisions that generally require manufacturers of Medicare

Part B and Part D drugs to pay inflation rebates to the Medicare program if pricing metrics associated with their products increase faster

than the rate of inflation;

elimination of the AKS discount safe harbor protection for manufacturer rebate arrangements with Medicare Part D plan sponsors;

● reevaluation

of safe harbors under the AKS.

efforts to reevaluate, reduce or limit the prices of drugs and make

them more affordable for patients;

implementation of additional data collection and transparency reporting

regarding drug pricing, rebates, fees and other remuneration provided by drug manufacturers;

revisions to rules associated with ESRD PPS Transitional Drug Add-on

Payment Adjustment;

potential revisions to rules associated with the calculation of average

revisions to rules associated with the calculation of average manufacturer

price and best price under Medicaid;

changes to the MDRP, including through a May 2023 CMS-proposed rulemaking

for this program, that could significantly increase manufacturer rebate liability;

implementation of the inflation Reduction Act of 2022 (Inflation Reduction

Act), including provisions that generally require manufacturers of Medicare Part B and Part D drugs to pay inflation rebates to the

Medicare program if pricing metrics associated with their products increase faster than the rate of inflation;

potential elimination of the AKS discount safe harbor protection for

manufacturer rebate arrangements with Medicare Part D plan sponsors;

reevaluation of safe harbors under the AKS.

Governments have shown significant

interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution

of generic products.

For example, President Trump signed multiple executive orders aimed at reducing prescription drug costs in the U.S.,

the Lowering Drug Prices by Once Again Putting Americans First executive order issued on April 15, 2025, which provided several

actions the Secretary of the Department of HHS must take to optimize healthcare regulations designed to provide access to prescription

drugs at lower costs, and the Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients executive order issued on

May 12, 2025, which sought to establish “most favored nation” drug pricing policy that would tie U.S.

drug prices to the

prices paid for drugs in other countries.

The Trump administration has continued to exert pressure on drug manufacturers to implement

“most favored nation” pricing, including by suggesting that the administration may impose significant tariffs on pharmaceuticals

if such manufacturers do not reach agreements to implement “most favored nation” pricing and by reaching agreements with

certain drug manufacturers to offer most-favored-nation pricing on certain existing and future products.

On November 6, 2025, CMS announced

a new voluntary payment initiative called the GENEROUS Model (GENErating cost Reductions for U.S.

Medicaid Model) a limited duration

payment model conducted through the CMS Innovation Center to allow drug manufacturers to voluntarily provide coordinated supplemental

rebates to state Medicaid agencies that match international prices in certain enumerated countries.

Failure to participate in the model

could result in less favorable Medicaid coverage against competitors that choose to participate.

Additionally, on December 19, 2025,

CMS issued two additional notices of proposed rulemaking to test alternative calculations for manufacturer rebates aimed at bringing

drug prices closers to those paid in identified economically similar countries:

the GLOBE Model (Global Benchmark for Efficient Drug

Pricing) for certain Medicare Part B drugs and the GUARD Model (Guarding U.S.

Medicare Against Rising Drug Costs) for certain Medicare

Part D drugs.

Under these proposals, CMS would replace existing domestic inflation-based rebate calculations with new rebate obligations

tied to international reference pricing benchmarks in a basket of economically comparable countries.

In addition, at the state

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provisions of the pertinent state and federal authorities.

Contracts and Regulation

We currently contract with

the federal government (see section entitled “ Biomedical Advanced Research and Development Authority Contract” above).

As a government contractor, we are subject to complex and wide-ranging federal and agency-specific regulations and contractual requirements

that not only govern how we perform under the contract but also impose other requirements that affect our operations, including socioeconomic

obligations such as obligations related to affirmative action and maintaining a drug-free workplace.

Failure to comply with government

contracting requirements could result in termination of our contract and the imposition of penalties.

Regulatory Requirements

We have not made any filings

seeking approval for DefenCath outside of the United States.

In order to market any product outside of the United States, we would need

to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing, among other

things, clinical trials, marketing authorization, commercial sales and distribution of our products.

We have not made any filings seeking approval for our Products outside

For us to market any product outside of the U.S., we would need to comply with numerous and varying regulatory requirements

of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial

sales and distribution of our products.

In lieu of this, we have licensing relationships with pharmaceutical companies outside

under which we license rights to commercialize our Products in exchange for payments, potentially including upfront licensing

fees, milestone fees and royalties on sales of the applicable Product or Products in their respective territories.

The revenue associated

with these licensing relationships is not expected to be material to our current or future financial statements, representing 5% or less

of total revenue in 2025.

For details on these arrangements, see Note 2 to the Consolidated Financial Statements in this Annual Report

on Form 10-K.

Employees and Human Capital Resources

As of February 28, 2026 we employed approximately 191 full-time employees,

and one part-time employee, who work out of our corporate offices in Berkeley Heights, NJ or work remotely in various locations throughout

the United States..

In December 2024, the company engaged Syneos Health Commercial Services, LLC to build and provide to the Company a

dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems.

In light of this, the Company

terminated a large percentage of its internal field sales team, which was expected to cover both inpatient and outpatient settings.

The Company also engaged WSI

PBG, LLC, a subsidiary of Golden State Medical Supply, to promote DefenCath to healthcare providers in facilities operated by the Department

of Veterans Affairs and other federal facilities.

These individuals started in the field in early January 2025.

We invest in our workforce

by offering competitive salaries and benefits.

We endeavor to foster a strong sense of ownership by offering stock options under our

stock incentive program.

We also offer comprehensive and benefits for all eligible employees.

We recognize and support the growth and

development of our employees and we provide performance feedback and conduct employee goal and development discussions.

who work out of our corporate headquarters in Parsippany, NJ, our corporate office in Lake Forest, IL, or remotely in various locations

throughout the U.S.

We invest in our workforce by offering competitive salaries and benefits.

We endeavor to foster a strong sense of ownership by offering equity awards under our stock incentive program.

We also offer comprehensive

benefits for all eligible employees.

We recognize and support the growth and development of our employees through a number of programs

including annual performance feedback reviews and employee goal and development discussions.

None of our employees are

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Inc.” on January 18, 2007.

Our principal executive offices are located at 300 Connell Drive, Suite 4200, Berkeley Heights, New

Jersey 07922.

Our principal executive offices are located at 389 Interpace Parkway, Suite 450, Parsippany, New Jersey,

Available Information

We maintain our website at

www.cormedix.com.

This Annual Report on Form 10-K and all of our filings under the Exchange Act, including copies of annual reports on

Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports, are available free of charge

through our website on the date we file those materials with, or furnish them to, the SEC.

Such filings are also available to the

public on the internet at the SEC’s website at www.sec.gov.

The information contained on, or that can be accessed through,

the websites referenced in this Annual Report on Form 10-K is not a part of, nor shall it be deemed to be, incorporated by reference

into this filing or any of our other filings with the SEC.

Further, the Company’s references to website URLs are intended to be

inactive textual references only.

We maintain our website at www.cormedix.com.

Annual Report on Form 10-K and all of our filings under the Exchange Act, including copies of annual reports on Form 10-K, quarterly

reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports, are available free of charge through our website

on the date we file those materials with, or furnish them to, the SEC.

Such filings are also available to the public on the internet

at the SEC’s website at www.sec.gov.

The information contained on, or that can be accessed through, the websites referenced

in this Annual Report on Form 10-K is not a part of, nor shall it be deemed to be, incorporated by reference into this filing or any

of our other filings with the SEC.

Further, the Company’s references to website URLs are intended to be inactive textual references

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business