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CorMedix Inc. to Begin Trading on the Nasdaq Stock Exchange

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CorMedix Inc. (NYSE American: CRMD) has received approval to list on the Nasdaq Global Market, transitioning on February 2, 2021. This move aims to boost visibility among institutional investors and improve liquidity. CEO Khoso Baluch highlighted the significance of this change in light of the upcoming February 28, 2021 PDUFA date for the Defencath NDA review by the FDA. CorMedix focuses on developing Defencath, an antibacterial solution for preventing bloodstream infections in hemodialysis patients.

Positive
  • Approval to list on the Nasdaq Global Market, enhancing visibility and liquidity.
  • Upcoming PDUFA date on February 28, 2021, for Defencath NDA review.
Negative
  • Uncertainty regarding the potential need for a second Phase 3 clinical trial for Defencath approval.
  • Risks associated with limited cash resources affecting research and development.

BERKELEY HEIGHTS, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has been approved for listing on the Nasdaq Global Market. The company’s shares will continue to trade under its current symbol “CRMD”. Trading on the Nasdaq Global Market is expected to commence on Tuesday, February 2, 2021. The Company’s shares of common stock will continue to trade on the NYSE American until the close of the market on Monday, February 1, 2021.

Khoso Baluch, CorMedix CEO commented, “We are excited to have Nasdaq as our new exchange partner. As a late stage biopharma company, we feel that Nasdaq is a natural fit and already includes many of our peers in the space. With the February 28, 2021 PDUFA date for completion of FDA’s review of the Defencath NDA on the horizon, the year ahead is likely to hold significant growth for CorMedix as we set our sights on becoming a commercial entity in the US. We believe this move will further enhance our visibility in the marketplace, expose our company to a larger audience of institutional investors and ultimately increase liquidity and shareholder value.”

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Defencath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. Defencath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also intends to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels.  The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  Neutrolin™ is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the Defencath development path, including whether a second Phase 3 clinical trial will be required for approval of Defencath’s marketing approval; the resources needed to secure approval of the new drug application for Defencath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Defencath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. At this time, we are unable to assess whether, and to what extent, the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

 


FAQ

When will CorMedix start trading on the Nasdaq?

CorMedix is expected to begin trading on the Nasdaq Global Market on February 2, 2021.

What is the significance of the PDUFA date for CorMedix?

The PDUFA date on February 28, 2021, is critical for the FDA's review of the Defencath NDA, impacting the company's future growth.

What is Defencath and its purpose?

Defencath is an antibacterial and antifungal solution aimed at preventing bloodstream infections in patients undergoing chronic hemodialysis.

What are the potential risks mentioned in CorMedix's PR?

Risks include uncertainty about FDA requirements for Defencath and challenges in managing limited cash resources.

CorMedix Inc.

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Biotechnology
Pharmaceutical Preparations
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United States of America
BERKELEY HEIGHTS