CorMedix Inc. to Report First Quarter 2020 Financial Results and Provide a Corporate Update on May 11

Rhea-AI Summary

CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company, announced it will report its first-quarter financial results on May 11, 2020, after market close. The company has a focus on developing Neutrolin®, an innovative antimicrobial solution aimed at preventing bloodstream infections related to central venous catheters. The Phase 3 clinical trial for Neutrolin showed a significant 71% reduction in infections compared to heparin controls. Neutrolin holds FDA Fast Track status, and the NDA submission process has commenced. Neutrolin is already CE Marked in Europe.

Positive

• Neutrolin® demonstrated a 71% reduction in catheter-related bloodstream infections in Phase 3 trials.
• FDA Fast Track status and QIDP designation potentially expedite marketing application review.
• NDA submission process is underway, indicating progress toward U.S. market entry.
• Neutrolin is already marketed as a CE Marked product in Europe.

Negative

• None.

BERKELEY HEIGHTS, N.J., May 04, 2020 (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 will report its financial results for the first quarter ended March 31, 2020, after the market close on Monday, May 11, and will host a corporate update conference call at 4:30pm Eastern Time.

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Monday, May 11th @ 4:30pm ET
12%; width:12%; min-width:12%;">Domestic:	88%; width:88%; min-width:88%;">800-949-2175
International:	646-828-8144
Conference ID:	3381536
Webcast:	http://public.viavid.com/index.php?id=139349

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 Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters for the U.S. market. The Company completed a Phase 3 clinical trial of Neutrolin in patients undergoing chronic hemodialysis, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0006) with a good safety profile. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval.  FDA has granted rolling submission and review of portions of the new drug application (NDA) and CorMedix has begun submission of the NDA. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active 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.  For more information, visit: www.cormedix.com.

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

 

FAQ

When will CorMedix report its Q1 2020 financial results?

CorMedix will report its Q1 2020 financial results on May 11, 2020.

What are the key findings from the Phase 3 trial of Neutrolin?

The Phase 3 trial of Neutrolin showed a 71% reduction in catheter-related bloodstream infections compared to the heparin control group.

What status has the FDA granted to Neutrolin?

Neutrolin has received FDA Fast Track status and is designated as a Qualified Infectious Disease Product (QIDP).

Is Neutrolin available in markets outside the U.S.?

Yes, Neutrolin is already marketed as a CE Marked product in Europe and other territories.

What is the significance of the FDA rolling submission for CorMedix?

The FDA's rolling submission allows CorMedix to submit portions of the New Drug Application for Neutrolin as they become available, facilitating a faster review process.