CorMedix Inc. Announces Contract Extension of Liz Masson-Hurlburt as Executive Vice President and Head of Clinical Operations

Rhea-AI Summary

CorMedix (NASDAQ: CRMD) has signed a new three-year employment agreement with Liz Masson-Hurlburt, Executive VP and Head of Clinical Operations, running until March 2024. This appointment comes as the company pursues FDA approval for its product, DefenCath, aimed at preventing infections linked to hemodialysis. Masson-Hurlburt's leadership has been pivotal in successfully completing the LOCK-IT 100 clinical study. CorMedix is also expanding DefenCath's applications into oncology and total parenteral nutrition. The FDA has designated DefenCath as Fast Track and a Qualified Infectious Disease Product.

Positive

• New three-year employment agreement established with Liz Masson-Hurlburt, ensuring leadership continuity during critical FDA approval phase for DefenCath.
• DefenCath's designation as Fast Track and Qualified Infectious Disease Product grants five years of additional marketing exclusivity upon approval.
• Successful completion of LOCK-IT 100 clinical study indicates strong progress in clinical operations.
• Plans to expand DefenCath applications beyond hemodialysis may open new market segments and revenue streams.

Negative

• A Complete Response Letter from the FDA indicates unresolved deficiencies at the third-party manufacturing facility, delaying approval.
• Dependence on third-party manufacturers raises concerns about production reliability and timely product launch.

BERKELEY HEIGHTS, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ: 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 entered into a new three-year Employment Agreement with Liz Masson-Hurlburt, currently Executive Vice President and Head of Clinical Operations. The new agreement terminates in March 2024, and may be extended annually thereafter upon mutual agreement.

“I am delighted that Liz has agreed to continue in her current role at this critical time as we are continuing to work toward a potential FDA approval of DefenCath and in parallel laying the groundwork for programs to advance DefenCath into other patient segments beyond hemodialysis,” said Khoso Baluch, Chief Executive Officer of CorMedix. “She has been instrumental in bringing the LOCK-IT 100 clinical study to a successful completion and assisting in the responses to the FDA during the review of the New Drug Application. Her expertise in clinical operations will be important as we develop potential indications for DefenCath in oncology and total parenteral nutrition.”

Ms. Masson-Hurlburt joined CorMedix in March 2018 and was instrumental in bringing the LOCK-IT-100 clinical study to a successful completion. Prior to CorMedix, she held several progressive management roles in clinical operations, most recently at Gemphire Therapeutics, as Vice President, Clinical Operations. Responsible for strategic and operational development activities, Liz has a passion for growing and developing highly engaged teams and assuring the highest standards for program execution. Liz received her B.A. in Leadership and Organizational Management from Bay Path College.

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 a New Drug Application (NDA). The NDA was filed with FDA and the Company has been informed in a Complete Response Letter (CRL) that approval requires resolution of deficiencies at the third-party manufacturing facility. 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; the resources needed to secure approval of the new drug application for DefenCath from the FDA, including manufacturing at a third-party facility; 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

What recent agreement did CorMedix announce related to Liz Masson-Hurlburt?

CorMedix announced a new three-year employment agreement with Liz Masson-Hurlburt, effective until March 2024.

What is the significance of DefenCath for CorMedix?

DefenCath is a key product for CorMedix, designed to prevent infections in patients undergoing hemodialysis.

What FDA designations has DefenCath received?

DefenCath has been designated as Fast Track and a Qualified Infectious Disease Product by the FDA.

What challenges does CorMedix face regarding FDA approval?

CorMedix received a Complete Response Letter from the FDA due to deficiencies at the third-party manufacturing facility.

How will the new employment agreement affect CorMedix's operations?

The new agreement ensures leadership continuity during a crucial period as CorMedix seeks FDA approval for DefenCath.