October 21, 2019

Pre-NDA Meeting Scheduled

Berkeley Heights, NJ – October 16, 2019 – 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 completed its interaction with the FDA related to the chemistry, manufacturing and
controls (CMC) package that will be needed to support Neutrolin’s new drug application (NDA).
The FDA was supportive of Neutrolin’s proposed manufacturing program, including the
active pharmaceutical ingredients (API), the container closure and testing, and indicated that it
will conduct a thorough review of all of the CMC information as well as assess the commercial
readiness of the various manufacturing facilities at the time of NDA filing. No further CMC
meetings with FDA are planned prior to NDA submission.

A pre-NDA meeting has now been scheduled and CorMedix is looking forward to discussing with
the FDA the filing of the NDA for Neutrolin®, including the FDA programs intended to facilitate
and expedite review of the application, such as Priority Review designation, rolling submission,
and LPAD.

Khoso Baluch, President and CEO of CorMedix commented, “We are very pleased with FDA’s
feedback on the CMC package and with the scheduling of a pre-NDA meeting. We are continuing
to move forward with preparations for the filing of the NDA for Neutrolin in accordance with our
plans, which are focused on obtaining an approval for Neutrolin in adult hemodialysis. We
anticipate that Neutrolin can be approved in the second half of 2020 and we intend to launch
Neutrolin commercially in the US promptly after its approval either by ourselves or with a

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, currently in Phase 3 development for
patients undergoing chronic hemodialysis. 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. 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:

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 information, costs and time needed to submit to the FDA a new drug
application for Neutrolin in adult hemodialysis, including; risks related to obtaining FDA approval
of the new drug application for Neutrolin; relying on preclinical results that may not be indicative
of success in clinical trials and might not be replicated in any subsequent studies or trials; the
risks and uncertainties associated with research for additional uses for taurolidine; 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 Neutrolin
and research for additional uses for taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities and operations; and the ability to
retain and hire necessary personnel to staff our operations appropriately. 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 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