DefenCath® (taurolidine and heparin) catheter lock solution is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.


Conference Call Scheduled for Today at 4:30 p.m. Eastern Time

Berkeley Heights, NJ – May 11, 2020 – 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
financial results for the first quarter ended March 31, 2020 and provided an update on recent
business events.

Recent Business Highlights:

  • CorMedix announced the appointment of Matt David, M.D. as the Company’s Chief Financial
  • FDA has conditionally accepted the proposed proprietary name, Defencath™, for the
    Company’s lead product candidate, a novel, non-antibiotic antimicrobial solution designed to
    prevent bloodstream infections associated with the use of central venous catheters in
    hemodialysis patients. A final decision and formal acceptance of the proprietary name will
    be completed during the review of the New Drug Application (NDA), which has been granted
    rolling submission and review by the U.S. Food and Drug Administration (FDA). The name
    “Defencath” will be used in the U.S. and potentially other international markets, while the
    name “Neutrolin®” will continue to be used in Europe and other territories where the product
    is CE-marked and commercially distributed as a medical device.
  • The Company is continuing its focus on preparing the required information in the NDA
    modules to ensure a complete submission and facilitate an efficient review by the FDA.
    CorMedix remains optimistic for a potential approval of the NDA in the second half of 2020,
    subject to possible delays that would prevent approval of the NDA.
  • CorMedix was granted a Small Business Waiver by the FDA, exempting the Company from the
    need to pay the $2.9 million NDA filing fee. The fee was deposited with the FDA during the
    first quarter 2020 and was returned to the Company in April.
  • The Company will host a call with Key Opinion Leaders (KOLs) on the potential of
    Defencath/Neutrolin for addressing antimicrobial resistance and catheter-related
    bloodstream infections (CRBSIs) on Tuesday, May 19th at 12pm Eastern Time. The call will
    feature three presentations by noted KOLs, who will discuss antimicrobial resistance, the
    current CRBSI landscape in patients with hemodialysis catheters, and Defencath’s/
    Neutrolin’s potential for preventing CRBSIs in these patients.
  • Completed the previously announced sale of $5.5 million of NOL tax benefits to unrelated,
    profitable New Jersey corporation through the New Jersey Economic Development
    Authority’s New Jersey Technology Business Tax Certificate Transfer program for State Fiscal
    Year 2019. As a result, the Company has received approximately $5.2 million in cash from
    the sale of these NOL tax benefits.

Khoso Baluch, CorMedix CEO commented, “We are pleased to have made significant progress
during the first quarter despite the limitations placed on us by the nation’s response to the
COVID-19 pandemic. We have been working remotely since mid-March, a transition we have
made with little disruption and as a result we are maintaining our guidance for an anticipated
decision on approval of the NDA in the second half of 2020. I am also pleased to welcome Matt
David as CorMedix Chief Financial Officer and look forward to working with him as we progress
towards an anticipated marketing approval for Defencath.”

First Quarter 2020 Financial Highlights

For the first quarter 2020, CorMedix recorded a net loss of $5.6 million, or $0.21 per share,
compared with a net loss of $5.2 million, or $0.22 per share, in the first quarter of 2019, an
increase of $0.4 million or 7.7%. Net loss in the first quarter of 2020 was driven by a $0.7 million
increase in operating expenses, partially offset by a $0.1 million increase in gross profit on sales.

Operating expenses in the first quarter 2020 were $5.6 million, compared with $4.9 million in the
first quarter of 2019, an increase of approximately 14%. The increase was driven by higher SG&A,
which rose by 59% to $3.2 million primarily due to preparations in anticipation of NDA approval,
notably staffing and consulting expenses and legal fees, accounting and insurance expenses. R&D
expense decreased approximately 14% to $2.5 million, due to a significant decline in clinical trial
expense partially offset by higher CMC and other technical operations expenses.

The Company reported cash and short term investments of $23.2 million at March 31, 2020. On
a pro forma basis, the refund in April of the NDA filing fee of $2.9 million plus the net proceeds
from the sale of the New Jersey NOLs increased the Company’s total available cash to $31.3
million. The Company believes that, based on its current cash resources, it has sufficient
resources to fund operations into the second quarter of 2021, including initial preparations for
commercial launch.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 11, 2020,
at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call
details and dial-in information are as follows:

Monday, May 11th @ 4:30pm ET
Domestic: 800-949-2175
International: 646-828-8144
Conference ID: 3381536

Following the live webcast, an archived version will be available through May 26, 2020 on the
Company’s website

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/Neutrolin®, a novel, nonantibiotic
antimicrobial solution designed to prevent costly and dangerous bloodstream
infections associated with the use of central venous catheters. The Company completed a Phase
3 clinical trial of Defencath/Neutrolin in patients undergoing hemodialysis for end-stage renal
disease, 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. CRBSIs cost the U.S.
healthcare system approximately $6 billion annually and contribute significantly to increased
morbidity and mortality. Defencath/Neutrolin has Fast Track designation from FDA, which
provides the potential for priority review of a marketing application, and Qualified Infectious
Disease Product designation, which allows for 5 additional years of marketing exclusivity when
approved for commercial distribution by FDA. 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 CE Marked and commercially distributed as a medical device 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 Defencath/Neutrolin in adult hemodialysis; risks related to the timing of and our ability to
obtain FDA approval of the new drug application for Defencath/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 Defencath/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. 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 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
For the Three Months Ended
March 31,
2020 2019
Net sales $ 74,054 $ 163,692
Cost of sales (48,517) (226,955)
Gross loss 25,537 (63,263)
Operating Expenses
Research and development (2,472,117) (2,874,996)
Selling, general and administrative (3,165,168) (1,984,922)
Total operating expenses (5,637,285) (4,859,918)
Loss from Operations (5,611,748) (4,923,181)
Other Income (Expense)
Interest income 63,678 58,822
Foreign exchange transaction loss (3,221) (1,477)
Interest expense (6,276) (302,048)
Total other income (expense) 54,181 (244,703)
Net Loss (5,557,567) (5,167,884)
Other Comprehensive Loss
Unrealized loss from investment (5,633) (1,008)
Foreign currency translation loss (888) (305)
Total other comprehensive loss (6,521) (1,313)
Comprehensive Loss $ (5,564,088) $ (5,169,197)
Net Loss Per Common Share – Basic and Diluted $ (0.21) $ (0.22)
Weighted Average Common Shares Outstanding – Basic and Diluted 26,059,625 23,074,049

March 31, December 31,
2020 2019
Cash, cash equivalents and restricted cash $ 12,376,162 $ 16,525,187
Short-term investments $ 10,983,190 $ 11,984,157
Total Assets $ 27,399,689 $ 29,475,910
Total Liabilities $ 5,806,239 $ 5,829,650
Accumulated deficit $ (200,978,739) $ (195,421,172)
Total Stockholders’ Equity $ 21,593,450 $ 23,646,260

For the Three Months Ended
March 31,
2020 2019
Cash Flows from Operating Activities:
Net loss $ (5,557,567) $ (5,167,884)
Net cash used in operating activities (7,966,926) (7,367,470)
Cash Flows Used in Investing Activities:
Net cash provided by (used in) investing activities (985,418) (7,964,777)
Cash Flows from Financing Activities:
Net cash provided by financing activities 2,834,664 15,967,575
Net (Decrease) Increase in Cash and Cash Equivalents (4,149,025) 633,229
Cash and Cash Equivalents and Restricted Cash –
Beginning of Period 16,525,187 17,795,323
Cash and Cash Equivalents and Restricted Cash – End of
Period $ 12,376,162 $ 18,428,552