Full Press Release Details
CORMEDIX INC. REPORTS FIRST QUARTER 2019 FINANCIAL
AND PROVIDES BUSINESS UPDATE
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Berkeley Heights, NJ May 13, 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
financial results for the first quarter ended March 31, 2019 and
provided an update on recent business events.
Recent Corporate and Clinical Highlights:
that the Company has completed the
statistical analyses of data and additional information requested
by FDA for the primary and secondary efficacy endpoints of the
Company's LOCK-IT-100 clinical study. These analyses support
the strong topline results previously
has granted the Company's meeting request to continue its
dialogue on the data from LOCK-IT-100 and its support as
substantial evidence of safety and effectiveness of Neutrolin
as a catheter-lock solution in hemodialysis patients for the New
Presented results of the Company's Phase 3
LOCK-IT-100 Study at the National Kidney Foundation Spring 2019
Clinical Meetings. A total of 41
catheter-related blood stream infections (CRBSIs) was determined by
the Clinical Adjudication Committee (CAC) in the full data set,
compared with 28 CRBSI cases in the interim analysis. The
full data set showed a 71% reduction in the risk of occurrence of
CRBSIs compared with the active control of heparin, which is well
in excess of the study's assumed treatment effect size of a
55% reduction and statistically significant with a p-value of
Appointed Dr. Phoebe Mounts, Esq. as Executive Vice President and
General Counsel, leading the Company's legal, compliance and
regulatory affairs. Dr. Mounts has been a trusted legal advisor to
the Company since 2013 and has been responsible for developing the
FDA regulatory strategies for Neutrolin.
the previously announced sale of $5.4 million of NOL tax benefits
to two unrelated, profitable New Jersey corporations through the
New Jersey Economic Development Authority's New Jersey
Technology Business Tax Certificate Transfer program for State
Fiscal Year 2018. As a result, the Company has received
approximately $5.1 million in cash from the sale of these NOL tax
that the Company had regained compliance with the NYSE American
listing requirements.
cash equivalents and short-term investments at March 31, 2019
amounted to $26.4 million.
Khoso Baluch, CorMedix CEO, commented, We are pleased that
our current discussions with the FDA are continuing and we look
forward to completing the clinical study report, which is required
to demonstrate the safety and efficacy of Neutrolin as a
catheter-lock solution for hemodialysis patients. The team
continues in parallel to prepare the additional components required
for an NDA filing. In our view, the results of the LOCK-IT-100
study strongly support our case for Neutrolin's efficacy and
safety as a catheter lock solution in hemodialysis
Mr. Baluch continued, We are also pleased with our financial
results this quarter and with the receipt of $5.1 million in
funding through the NJ NOL program. As a result, our liquidity at
March 31 is the highest in several years. We believe the funds we
have available are sufficient for us to complete the regulatory
discussion with the FDA and file an NDA if the FDA agrees with our
request to file based on a single study.
First Quarter 2019 Financial Highlights
first quarter 2019, CorMedix recorded a net loss of $5.2 million,
or $0.22 per share, compared with a net loss of $10.2 million, or
$0.68 per share, in the first quarter of 2018, a decrease of $5.0
million. Net loss in the first quarter of 2019 was driven by
decreased costs related to the LOCK-IT-100 clinical study due to
the winding down of the study while other expenses continued to
decline or remained flat.
expenses in the first quarter 2019 were $4.9 million, compared to
$10.2 million in the fourth quarter of 2018, a decrease of
approximately 52%. R&D expense decreased approximately 65%
to $2.9 million, due to a 77% decrease in clinical trial expense.
SG&A expense increased by 4%.
Conference Call Information:
The management team of CorMedix will host a conference call and
webcast today, May 13, 2019, at 4:30 PM Eastern Time, to discuss
recent corporate developments and financial results. Call details
and dial-in information are as follows:
will be available through May 28, 2019:
management team will share the slide presentation that was made on
May 10, 2019 at the National Kidney Foundation (NKF) Spring 2019
Clinical Meetings during the webcast. Please log into the investor
section of the Company's website for a link to the slide
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 have
significant treatment costs and lead to increased morbidity and
mortality. Neutrolin has FDA Fast Track status and is designated as
a Qualified Infectious Disease Product, which provide the potential
for priority review of a marketing application by FDA and
allow for a total of ten years of 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