CorMedix(CRMD)

PARSIPPANY, NJ

Biotechnology

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Focus: Small Molecules

CorMedix is a life sciences company focused on Small Molecules.

Infectious DiseasesNephrologyCardiovascularUnknown

Funding Stage

PUBLIC

Open Jobs

1

Products & Portfolio (6)

delafloxacin meglumine

INTRAVENOUS · POWDER

12.1 Mechanism of Action BAXDELA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration ( f AUC/MIC) for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli based on animal models of infection. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 51 healthy subjects received BAXDELA 300 mg IV, BAXDELA 900 mg IV, oral moxifloxacin 400 mg, or placebo. Neither BAXDELA 300 mg nor BAXDELA 900 mg (three times the intravenous therapeutic dose) had any clinically relevant adverse effect on cardiac repolarization. Photosensitivity Potential A study of photosensitizing potential to ultraviolet (UVA and UVB) and visible radiation was conducted in 52 healthy volunteers (originally 13 subjects per treatment group). BAXDELA, at 200 mg/day and 400 mg/day (0.22 and 0.44 times the approved recommended daily oral dosage, respectively) for 7 days, and placebo did not demonstrate clinically significant phototoxic potential at any wavelengths tested (295 nm to 430 nm), including solar simulation. The active comparator (lomefloxacin) demonstrated a moderate degree of phototoxicity at UVA 335 nm and 365 nm and solar simulation wavelengths. 12.3 Pharmacokinetics The pharmacokinetic parameters of delafloxacin following single- and multiple-dose (every 12 hours) oral (450 mg) and intravenous (300 mg) administration are shown in Table 6. Steady-state was achieved within approximately three days with accumulation of approximately 10% and 36% following IV and oral administration, respectively. Table 6 Mean (SD) Delafloxacin Pharmacokinetic Parameters Following Single and Multiple Oral and Intravenous Administration Parameters Tablet Intravenous Injection Single Dose 450 mg Steady State 450 mg Q12h Q12h is every 12 hours Single Dose 300 mg Steady State 300 mg Q12h C max = maximum concentration; T max = time to reach C max ; AUC = area under the concentration-time curve; CL = systemic clearance; CL/F = apparent oral clearance; R ac = accumulation ratio T max (h) Median (range) 0.75 (0.5, 4.0) 1.00 (0.50, 6.00) 1.0 (1.0, 1.2) 1.0 (1.0, 1.0) C max (µg/mL) 7.17 (2.01) 7.45 (3.16) 8.94 (2.54) 9.29 (1.83) AUC (µg∙h/mL) AUC is AUCτ (AUC from time 0 to 12 hours) for single dose and multiple-dose administration 22.7 (6.21) 30.8 (11.4) 21.8 (4.54) 23.4 (6.90) CL or CL/F(L/h) CL is reported for intravenous injection. CL/F is reported for tablet 20.6 (6.07) 16.8 (6.54) 14.1 (2.81) 13.8 (3.96) CLr (L/h) - - 5.89 (1.53) 6.69 (2.19) R ac - 1.36 - 1.1 Absorption The absolute bioavailability for BAXDELA 450 mg oral tablet administered as a single dose was 58.8%. The AUC of delafloxacin following administration of a single 450 mg oral (tablet) dose was comparable to that following a single 300 mg intravenous dos

skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA]methicillin-susceptible [MSSA] isolates)Staphylococcus haemolyticus+17 more

delafloxacin meglumine

12.1 Mechanism of Action BAXDELA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration ( f AUC/MIC) for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli based on animal models of infection. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 51 healthy subjects received BAXDELA 300 mg IV, BAXDELA 900 mg IV, oral moxifloxacin 400 mg, or placebo. Neither BAXDELA 300 mg nor BAXDELA 900 mg (three times the intravenous therapeutic dose) had any clinically relevant adverse effect on cardiac repolarization. Photosensitivity Potential A study of photosensitizing potential to ultraviolet (UVA and UVB) and visible radiation was conducted in 52 healthy volunteers (originally 13 subjects per treatment group). BAXDELA, at 200 mg/day and 400 mg/day (0.22 and 0.44 times the approved recommended daily oral dosage, respectively) for 7 days, and placebo did not demonstrate clinically significant phototoxic potential at any wavelengths tested (295 nm to 430 nm), including solar simulation. The active comparator (lomefloxacin) demonstrated a moderate degree of phototoxicity at UVA 335 nm and 365 nm and solar simulation wavelengths. 12.3 Pharmacokinetics The pharmacokinetic parameters of delafloxacin following single- and multiple-dose (every 12 hours) oral (450 mg) and intravenous (300 mg) administration are shown in Table 6. Steady-state was achieved within approximately three days with accumulation of approximately 10% and 36% following IV and oral administration, respectively. Table 6 Mean (SD) Delafloxacin Pharmacokinetic Parameters Following Single and Multiple Oral and Intravenous Administration Parameters Tablet Intravenous Injection Single Dose 450 mg Steady State 450 mg Q12h Q12h is every 12 hours Single Dose 300 mg Steady State 300 mg Q12h C max = maximum concentration; T max = time to reach C max ; AUC = area under the concentration-time curve; CL = systemic clearance; CL/F = apparent oral clearance; R ac = accumulation ratio T max (h) Median (range) 0.75 (0.5, 4.0) 1.00 (0.50, 6.00) 1.0 (1.0, 1.2) 1.0 (1.0, 1.0) C max (µg/mL) 7.17 (2.01) 7.45 (3.16) 8.94 (2.54) 9.29 (1.83) AUC (µg∙h/mL) AUC is AUCτ (AUC from time 0 to 12 hours) for single dose and multiple-dose administration 22.7 (6.21) 30.8 (11.4) 21.8 (4.54) 23.4 (6.90) CL or CL/F(L/h) CL is reported for intravenous injection. CL/F is reported for tablet 20.6 (6.07) 16.8 (6.54) 14.1 (2.81) 13.8 (3.96) CLr (L/h) - - 5.89 (1.53) 6.69 (2.19) R ac - 1.36 - 1.1 Absorption The absolute bioavailability for BAXDELA 450 mg oral tablet administered as a single dose was 58.8%. The AUC of delafloxacin following administration of a single 450 mg oral (tablet) dose was comparable to that following a single 300 mg intravenous dos

skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA]methicillin-susceptible [MSSA] isolates)Staphylococcus haemolyticus+17 more

taurolidine and heparin

N/A · SOLUTION

protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots. Taurolidine Taurolidine is an antimicrobial drug [see ] .

catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC)incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC)

oritavancin diphosphate

INTRAVENOUS · POWDER

12.1 Mechanism of Action Oritavancin is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antimicrobial activity of oritavancin appears to correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) based on animal models of infection. The AUC from time zero to 72 hours correlates with antimicrobial activity in both preclinical and clinical studies. Exposure-response analyses from both preclinical and clinical studies support the treatment of clinically relevant gram-positive microorganisms (e.g. S. aureus and S. pyogenes ) causative of ABSSSI with a single 1,200 mg dose of oritavancin. Cardiac Electrophysiology In a thorough QTc study of 135 healthy subjects at a dose 1.3 times the 1,200 mg recommended dose, oritavancin did not prolong the QTc interval to any clinically relevant extent. 12.3 Pharmacokinetics The mean (±SD) pharmacokinetic parameters of oritavancin products (KIMYRSA and oritavancin) in patients with ABSSSI are presented in Table 3. Table 3: Mean (±SD) Pharmacokinetic Parameters following a single 1,200 mg dose of KIMYRSA by intravenous infusion over 1 hour (N= 50) and Oritavancin by intravenous infusion over 3 hours (N=50) in Patients with ABSSSI Pharmacokinetic Parameter KIMYRSA (1 hour) Mean (± SD) Oritavancin (3 hour) Mean (± SD) C max , Maximum plasma concentration; AUC 0-72 , Area under the plasma concentration-time curve from time zero to 72 hours; SD, Standard deviation. C max (µg/mL) 148 (±43.0) 112 (±34.5) AUC 0-72 (h∙µg /mL) 1460 (±511) 1470 (±582) Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg. The mean, population-predicted oritavancin concentration-time profile displays a multi-exponential decline with a long terminal plasma half-life. Distribution Oritavancin is approximately 85% bound to human plasma proteins. Based on population pharmacokinetic (PK) analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating that oritavancin is extensively distributed into the tissues. Exposures of oritavancin in skin blister fluid were approximately 20% of those in plasma (AUC 0-24 ) after single 800 mg dose in healthy subjects. Metabolism/Excretion Non-clinical studies, including in vitro human liver microsome studies, indicated that oritavancin is not metabolized. No mass balance study has been conducted in humans. In humans, oritavancin is slowly excreted unchanged in feces and urine, with less than 1% and 5% of the dose recovered in feces and urine, respectively, after 2 weeks of collection. Oritavancin has a terminal half-life of approximately 245 hours and a clearance of 0.445 L/h, based on population PK analyses. Specific Populations No dosage adjustments of KIMYRSA are required for patients with mild-to-moderate renal or mild-to-moderate hepatic impairment or other subpopulations, including age, gender, race, and weight. Renal Impairment The PK of oritavancin was examined in the Phase 3 AB

skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptiblemethicillin-resistant isolates)Streptococcus pyogenes+3 more

INTRAVENOUS · POWDER

Cytochrome P450 2C19 Inhibitors

metoprolol succinate

LOE Approaching

ORAL · TABLET, EXTENDED RELEASE

Pipeline & Clinical Trials

Taurolidine and Heparin

Catheter-related Bloodstream Infection

N/A

Clinical Trials (1)

NCT06707480Expanded Access Program for Patients At Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials

N/A

CRMD-001-Deferiprone

Contrast-Induced Acute Kidney Injury

Phase 2

Clinical Trials (1)

NCT01146925Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

Phase 2

deferiprone

Acute Kidney Injury

Phase 3

Clinical Trials (1)

NCT01391520Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent

Phase 3

Neutrolin

Kidney Failure, Chronic

Phase 3

Clinical Trials (1)

NCT02651428Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

Phase 3

Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLA

Central Line Associated Blood Stream Infections (CLABSI)

Phase 3

Clinical Trials (1)

NCT06822426Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

Phase 3

Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Sub

Catheter-Related Infections

Phase 4

Clinical Trials (1)

NCT06714864Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age

Phase 4

Open Jobs (1)

National Field Trainer

Interview Prep Quick Facts

Portfolio: 6 approved products, 6 clinical trials

Top TAs: Nephrology, Infectious Diseases, Cardiovascular

SEC Filings: 2 available

Open Roles: 1 active job

Portfolio Health

Growth1 (17%)

Peak4 (67%)

LOE Approaching1 (17%)

6 total products

Therapeutic Area Focus

1 marketed3 pipeline

Infectious Diseases

3 marketed

1 marketed

Marketed

Pipeline

Financials (FY2025)

Revenue

$43M0%

R&D Spend

$4M(9%)70%

Net Income

-$18M

Cash

$41M

Source: SEC 10-K Filing