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.

CorMedix reports strong Q3 results, eyes FDA approvals for growth

CorMedix's Q3 performance exceeded expectations, showing revenue growth and operational improvements.
While facing challenges in revenue guidance variability and increased expenses, the company is poised for EBITDA positivity in Q4.
Strengths lie in product acceptance, market expansion, and commitment to research, with opportunities in new agreements, studies, and FDA approvals.
Careful financial management and successful regulatory milestones will be key to capitalizing on growth opportunities and maintaining profitability.

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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., 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.

Cormedix Inc. To Present At The Jefferies Healthcare Conference

BERKELEY HEIGHTS, N.J., May 16, 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 New Drug Application for DefenCath was resubmitted to the U.S. Food and Drug Administration, and the submission has been acknowledged as received for processing.

CorMedix Inc. Announces Resubmission of New Drug Application for DefenCath

CorMedix Inc. (NASDAQ:CRMD ) Q1 2023 Earnings Call May 15, 2023 4:30 PM ET Company Participants Joe Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Erin Mistry - Executive Vice President and Chief Commercial Officer Conference Call Participants Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the CorMedix First Quarter 2023 Earnings Conference Call. All participants will be in a listen-only mode.

CorMedix Inc. (CRMD) Q1 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., May 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 conditions and diseases, today announced that it will report its financial results for the first quarter ended March 31, 2023, after market close on Monday, May 15, 2023, and will host a corporate update conference call at 4:30pm Eastern Time.

CorMedix Inc. To Report First Quarter 2023 Financial Results and Provide a Corporate Update on May 15, 2023

BERKELEY HEIGHTS, N.J., May 01, 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) allowed its patent claims directed to the composition of a catheter lock solution for preventing infection and also preventing reduced blood flow in central venous catheters. CorMedix's newly allowed U.S. Patent Application (No. 17/721,699) reflects the unique and proprietary formulation of its product, DefenCath™, for which the Company expects to resubmit its New Drug Application (NDA) to the Food and Drug Administration (FDA) by mid-May.

CorMedix Inc. Announces Notice of Allowance for U.S. Patent Application Covering Lead Product DefenCath

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After losing some value lately, a hammer chart pattern has been formed for CorMedix (CRMD), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Here's Why CorMedix (CRMD) Looks Ripe for Bottom Fishing

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BERKELEY HEIGHTS, N.J., April 17, 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 the appointment of Robert A. Stewart to the CorMedix Board of Directors. Following the appointment of Mr. Stewart, the Board will comprise 8 directors, 7 of which are independent.

Cormedix Inc. Announces Appointment of Robert A. Stewart to Its Board of Directors

The average of price targets set by Wall Street analysts indicates a potential upside of 198.2% in CorMedix (CRMD). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

How Much Upside is Left in CorMedix (CRMD)? Wall Street Analysts Think 198.21%

CorMedix Inc. (NASDAQ:CRMD ) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET Company Participants Dan Ferry – Managing Director-LifeSci Advisors Joe Todisco – Chief Executive Officer Matt David – Executive Vice President and Chief Financial Officer Phoebe Mounts – Executive Vice President and General Counsel Erin Mistry – Executive Vice President and Chief Commercial Officer Conference Call Participants Jason Butler – JMP Securities Joon Lee – Truist Securities Serge Belanger – Needham & Co. Operator Greetings, and welcome to the CorMedix Inc. Fourth Quarter and Full Year 2022 Earnings Call. At this time, all participants are in a listen-only mode.

CorMedix Inc. (CRMD) Q4 2022 Earnings Call Transcript

Conference Call Scheduled for Today at 8:30 a.m. Eastern Time Conference Call Scheduled for Today at 8:30 a.m. Eastern Time

CorMedix Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

BERKELEY HEIGHTS, N.J., March 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 conditions and diseases, today announced that it will report its financial results for the fourth quarter and year ended December 31, 2022, before the market opens on Thursday, March 30, 2023, and will host a corporate update conference call at 8:30am Eastern Time.

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