Full Press Release Details
INC. ANNOUNCES REGULATORY UPDATE
NJ - September 7, 2021 - 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 provided an update with respect to
its resubmission timeline for the DefenCath New Drug Application ("NDA"). CorMedix has encountered delays at its third-party
contract manufacturer ("CMO"). The Company was informed by the CMO that there are issues that are unrelated to DefenCath manufacturing
activities. The timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath
NDA is uncertain at this time. We will provide an update when more information becomes available.
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 (QIDP), and the
NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for 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
committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved,
which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response
Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing
facility, including in-process controls for the filling operation. 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 for marketing authorization; 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. We
continue to assess 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.