Full Press Release Details
CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL-YEAR 2017 FINANCIAL
RESULTS AND PROVIDES BUSINESS UPDATE
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Recent Corporate and Clinical Highlights:
cases of catheter-related bloodstream infections (CRBSIs)
identified by the Clinical Adjudication Committee, triggering the
interim analysis in the Phase 3 LOCK-IT-100 trial;
750 subjects enrolled to date in its multi-center Phase 3
LOCK-IT-100 trial in Neutrolin for hemodialysis patients with
central venous catheters;
orphan drug designation by the Food and Drug Administration for
taurolidine in the treatment of neuroblastoma.
Anticipated Milestones:
efficacy analysis of the LOCK-IT-100 study is anticipated to be
completed during the second quarter of 2018;
enrollment in the study is also expected to be completed in the
second quarter of 2018;
Results of animal model testing of
taurolidine-infused sutures, meshes and hydrogels are expected to
be reported by the end of April 2018.
Berkeley Heights, NJ March 19, 2018 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 fourth quarter and full year ended
December 31, 2017 and provided an update on recent business
CorMedix continues to make progress on our goal of bringing
Neutrolin , our broad-spectrum, non-antibiotic, anti-infective
solution to the U.S. market, said Khoso Baluch, Chief
Executive Officer of CorMedix. Our team is now
assessing and ensuring the completeness and accuracy of the blinded
data for the two secondary endpoints related to catheter removal
and catheter blockage, as well as the primary endpoint (CRBSI) and
safety information. We are reviewing
the source data at the clinical sites prior to locking the data and
proceeding to the interim analysis. This is a complex and
challenging study from the standpoint of having to collect so much
data per patient, much of which is generated at hospitals and other
locations outside of the enrolling sites. We are working to
complete this review as quickly as
At the same time, we have continued to enroll new subjects
into our multi-center LOCK-IT-100 Phase 3 trial and have over 750
subjects enrolled, exceeding our original enrollment target of 632
hemodialysis patients. The additional trial subjects should
help to bring us closer to our goals to achieve the requisite
number of catheter-related bloodstream infection (CRBSI) events in
the Phase 3 study more quickly. In parallel, we're continuing
to capture and investigate data, and prepare clinical packages of
subjects who have suffered a suspected CRBSI event. We have
achieved the requisite 28 cases triggering the planned interim
efficacy analysis, which is the most significant near-term catalyst
for CorMedix and which represents the first opportunity in the U.S.
to evaluate Neutrolin's potential ability to reduce
catheter-related bloodstream infections in subjects with end-stage
renal disease receiving hemodialysis through a central venous
We remain completely dedicated to the successful completion
of the Neutrolin Phase 3 program, and to bringing Neutrolin to
market in the U.S. Based on its broad spectrum antimicrobial
activity, we believe Neutrolin has the potential to significantly
reduce or eliminate costly and potentially deadly catheter-related
bloodstream infections.
Mr. Baluch added, In addition to Neutrolin, we continue to
develop our preclinical pipeline. This past quarter, we received
orphan drug designation from the U.S. Food and Drug Administration
for taurolidine in the treatment of neuroblastoma, a severe form of
cancer that originates in certain types of nerve tissues. Current
treatments for this rare form of cancer offer poor outcomes, and we
believe taurolidine could become an important therapy. Our goal is
to partner with an appropriate cancer-focused company to advance
taurolidine into clinical development and ultimately obtain
marketing approval. In addition, our studies of taurolidine-infused
sutures, meshes and hydrogels in animal models have been completed
and we expect to report the results of these studies very
Mr. Baluch concluded, Our strategy at CorMedix has not
changed. We are working as quickly and diligently as possible to
complete the quality assurance procedures necessary for the interim
efficacy analysis and subsequent review by the Data Safety
Monitoring Board (DSMB). Financially, our goal is to raise the
minimum amount of capital on the best terms available to ensure
that the company has sufficient cash on hand to complete the
interim analysis in the LOCK-IT-100 study. After the interim data
is reviewed by the DSMB and we know our path forward we will
re-evaluate our situation and determine both our ongoing cash needs
and our financing options. At all times, we will
continue in our efforts to minimize dilution and maximize value for
Fourth Quarter 2017 Financial Highlights
For the fourth quarter 2017, CorMedix recorded a net loss of $10.3
million, or $0.15 per share, compared with a net loss of $6.4
million, or $0.16 per share, in the fourth quarter 2016, an
increase of $3.9 million. Net loss in the fourth quarter was driven
by increased costs related to the ongoing LOCK-IT-100 clinical
study and by increases in CMC and clinical supplies.
Operating expenses in the fourth quarter 2017 were $10.4 million,
compared to $8.0 million in the third quarter of 2017, an increase
of approximately 30%. This increase was due primarily to a
$2.4 million, or 40% increase, in R&D expense, while SG&A
expense remained unchanged. Within R&D, the cost of the
LOCK-IT-100 clinical trial increased by $1.7 million and
CMC/clinical supply expenses increased by $0.7
Full-Year 2017 Financial Highlights