CorMedix

CorMedix, Inc. operates as a pharmaceutical and medical device company. The firm seeks to license, develop and commercialize prophylactic and therapeutic products for the prevention and treatment of infectious and inflammatory diseases. It is developing its product Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. The company was founded by Antony E. Pfaffle in 2006 and is headquartered in Berkeley Heights, NJ.

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CorMedix progresses on DefenCath NDA resubmission amidst financial challenges

CorMedix is actively working towards resubmitting the DefenCath NDA and preparing for commercialization, despite facing challenges in FDA interactions and financial performance. The company's strong cash position provides operational flexibility and readiness for potential NDA approval, with opportunities for growth in addressing CRBSIs.

CorMedix plans DefenCath launch in 2024, strengthens IP protection

CorMedix is strategically positioning for the potential commercial launch of DefenCath in early 2024, pending FDA approvals.
Despite financial challenges in Q1 2023, the company's strong IP protection and engagement strategies offer growth opportunities.

CorMedix reports key milestones and strong financial position in Q2 2023

CorMedix's Q2 2023 Earnings Call highlighted key achievements, financial updates, and strategic initiatives, showcasing the company's progress and readiness for upcoming milestones.
Despite facing challenges such as a net loss increase and operational complexities, CorMedix's strong financial position, milestones achieved, and strategic focus position it well for future growth and success.
With opportunities to drive commercialization, expand market access, and establish partnerships, CorMedix is poised to capitalize on its strengths and navigate challenges effectively in the evolving healthcare landscape.

CorMedix prepares for DefenCath launch with strong cash position

CorMedix is strategically positioned for the commercial launch of DefenCath, with a strong cash position and ongoing discussions with regulatory bodies for reimbursement. Despite challenges in operating expenses and net loss in Q3 2023, the company's focus on key catalysts in 2024 presents significant growth opportunities.

CorMedix reports Q4 loss, eyes profitability in 2024 amid milestones

CorMedix faces challenges with rising operating expenses impacting profitability but has achieved key milestones and optimized field operations.
Opportunities lie in label expansions, reimbursement approvals, and gradual market penetration strategies.
Maintaining financial discipline while pursuing growth initiatives will be crucial for CorMedix's success.
Overall, CorMedix's strategic focus on commercial launch and potential expansions sets the stage for future growth.

CorMedix progresses with DefenCath launch, eyes profitability by 2024

CorMedix is making strides with DefenCath's commercial launch and engaging key dialysis providers for procurement contracts.
Financially, the company aims for breakeven by end of 2024, supported by a credit facility and ample cash reserves.
Challenges include managing operating expenses and evaluating potential M&A opportunities for strategic growth.
Opportunities lie in outpatient commercialization, label expansion, and demonstrating DefenCath's value through real-world evidence studies.

CorMedix sees strong sales growth with DefenCath launch success

CorMedix's successful DefenCath launch generated $5.2 million in sales, with inpatient sales expected to rise in Q4. The company is focused on securing reimbursement from Medicare Advantage plans and funding clinical initiatives without significant dilution.

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CorMedix, Inc. is a pharmaceutical and medical device company, which engages in the development and commercialization of therapeutic products for the prevention and treatment of diseases and conditions. The company was founded by Antony E. Pfaffle on July 28, 2006 and is headquartered in Berkeley Heights, NJ.

BERKELEY HEIGHTS, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business.

CorMedix Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

BERKELEY HEIGHTS, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2023, before the market opens on Tuesday, March 12, 2024, and will host a corporate update conference call at 8:30am Eastern Time.

CorMedix Inc. to Report Fourth Quarter and Full Year 2023 Financial Results and Provide a Corporate Update on March 12, 2024

BERKELEY HEIGHTS, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced updates related to its business and anticipated launch of DefenCath®.

CorMedix Inc. Announces Commercial and Reimbursement Updates

BERKELEY HEIGHTS, N.J., Jan. 08, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced several commercial and operational updates related to its business and anticipated launch of DefenCath®.

CorMedix Inc. Announces Commercial and Operational Updates

BERKELEY HEIGHTS, N.J., Dec. 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced the appointment of Beth Zelnick Kaufman, Esq. as EVP, Chief Legal Officer, and Corporate Secretary, effective December 12, 2023. The Company also announced that, upon mutual agreement with the Company, Dr. Phoebe Mounts will no longer serve as the Company's General Counsel, effective December 12, 2023, and will be separating from CorMedix effective December 31, 2023, to pursue other opportunities.

CorMedix Inc. Announces Appointment of Chief Legal Officer

– CorMedix to advocate for patient safety and infection prevention as part of  Leapfrog's Partners Advisory Committee

CorMedix Inc. Announces Partnership With The Leapfrog Group

– First and only FDA-approved antimicrobial catheter lock solution in the U.S. – Company expects DefenCath to be available in Q1 2024 in the inpatient setting BERKELEY HEIGHTS, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).

CorMedix Inc. Announces FDA Approval of DefenCath® to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients

The U.S. Food and Drug Administration (FDA) on Wednesday approved CorMedix's antimicrobial drug that aims to reduce catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, the regulator said.

U.S. FDA approves CorMedix's antimicrobial drug

CorMedix Inc. (NASDAQ:CRMD ) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - CEO Matt David - EVP and CFO Phoebe Mounts - EVP and General Counsel Conference Call Participants Jason Butler - JMP Securities Leszek Sulewski - Truist Securities Gregory Renza - RBC Capital Markets Operator Good afternoon, and welcome to CorMedix Third Quarter 2023 Earnings Conference Call. Today's call is being recorded.

CorMedix Inc. (CRMD) Q3 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events.

CorMedix Inc. Reports Third Quarter and Nine Month 2023 Financial Results and Provides Business Update

BERKELEY HEIGHTS, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that it will report its financial results for the third quarter ended September 30, 2023, after the market closes on Tuesday, November 14, 2023, and will host a corporate update conference call at 4:30pm Eastern Time.

CorMedix Inc. to Report Third Quarter 2023 Financial Results and Provide a Corporate Update on November 14, 2023

BERKELEY HEIGHTS, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that an abstract has been accepted for presentation at the IDWeek 2023 meeting being held in Boston, Massachusetts, October 11 – 15.

CorMedix Inc. Announces Abstract Presentation at Upcoming IDWeek Conference

BERKELEY HEIGHTS, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be giving a company presentation at the Cantor Fitzgerald Global Healthcare Conference being held in New York City on September 26 – 28, 2023.

CorMedix Inc. to Present at the Cantor Fitzgerald Global Healthcare Conference

BERKELEY HEIGHTS, N.J., Sept. 08, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced the publication of its Phase 3 LOCK IT-100 study results in the Clinical Journal of the American Society of Nephrology, or CJASN. The study compared the efficacy and safety of DefenCath®, a catheter lock solution that combines taurolidine 13.5 mg/mL and heparin 1000 USP units/mL, versus heparin alone, in preventing Catheter Related Bloodstream Infections (CRBSIs) in study subjects receiving hemodialysis via central venous catheter (CVC).

CorMedix Inc. Announces Publication of Phase 3 LOCK IT-100 Study Data in the Clinical Journal of The American Society of Nephrology

BERKELEY HEIGHTS, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be giving a company presentation at the H.C. Wainwright Global Investment Conference being held in New York City on September 11 – 13, 2023.

CorMedix Inc. to Present at the H.C. Wainwright Annual Global Investment Conference

BERKELEY HEIGHTS, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly issued U.S. Patent, for which CorMedix previously announced the allowance of patent claims, reflects the unique and proprietary nature of DefenCath®, and will extend the Company's current intellectual property protection with an expiration date of April 15, 2042.

CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath

CorMedix Inc. (NASDAQ:CRMD ) Q2 2023 Earnings Conference Call August 8, 2023 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Elizabeth Hulbert - EVP, Clinical and Medical Affairs Erin Mistry - Executive Vice President and Chief Commercial Officer Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities. Rohit Bhasin - Needham & Company Operator Greetings, and welcome to CorMedix, Inc. Second Quarter 2023 Earnings Call.

CorMedix Inc. (CRMD) Q2 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the second quarter and six months ended June 30, 2023 and provided an update on recent business events.

CorMedix Inc. Reports Second Quarter and Six Month 2023 Financial Results and Provides Business Update

CorMedix's lead therapy is DefenCath. The company is awaiting word from the FDA on the therapy's approval.

Why Shares of CorMedix Are Slumping Thursday

Cormedix (NASDAQ: CRMD ) stock is falling hard on Thursday after the company priced a public offering of its shares. That public offering has the company selling 7.5 million shares of CRMD stock at a price of $4 per share.

Why Is Cormedix (CRMD) Stock Down 23% Today?

BERKELEY HEIGHTS, N.J., June 28, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced the pricing of its previously announced underwritten public offering of 7,500,000 shares of its common stock at a public offering price of $4.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its common stock at a price of $3.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The total gross proceeds from the offering to the Company are expected to be approximately $40 million, before deducting the underwriting discounts and commissions and other offering expenses. In addition, CorMedix granted the underwriters a 30-day option to purchase up to an additional 1,500,093 shares of its common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about July 3, 2023, subject to the satisfaction of customary closing conditions.

CorMedix Inc. Announces Pricing of $40 Million Public Offering of Common Stock and Pre-Funded Warrants

BERKELEY HEIGHTS, N.J., June 28, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that it intends to offer and sell shares of its common stock, and in lieu of common stock to certain investors that so chose, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. All of the shares and pre-funded warrants to be sold in the offering will be offered by CorMedix. In addition, CorMedix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants), at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

CorMedix Inc. Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

BERKELEY HEIGHTS, N.J., June 21, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023.

CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath

BERKELEY HEIGHTS, N.J. , June 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced its first-of-kind strategic initiative with Boston Medical Center to enhance patient safety and reduce health disparities in structurally marginalized populations at risk for bloodstream infections while undergoing dialysis.

Cormedix Inc. Announces Strategic Initiative With Boston Medical Center to Reduce Health Disparities in Patients at Risk for Bloodstream Infections

BERKELEY HEIGHTS, N.J., May 30, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be presenting and participating in investor meetings at the Jefferies Healthcare Conference being held in New York on June 7 – 9, 2023.

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