Full Press Release Details
CorMedix Inc. Reports First Quarter Financial Results and Provides
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Recent Corporate and Clinical Highlights:
independent Data and Safety Monitoring Board (DSMB) review for
Phase 3 LOCK-IT 100 study of Neutrolin in hemodialysis
patients; Enrollment on track to exceed original target of 632
discussion with FDA regarding possible prospective changes to the
LOCK-IT 100 trial protocol; FDA agreed to include interim efficacy
analyses while the trial is ongoing
European commercial collaboration with Hemotech SAS to launch and
market Neutrolin in France and French overseas
in gross proceeds in a public offering of shares and
taurolidine effectiveness at killing emerging global health threat
of taurolidine-infused antimicrobial medical materials: sutures,
nanofiber meshes, hydrogels
Anticipated Milestones:
interim efficacy analysis, potentially in 4Q17 pending attainment
of the requisite number of bloodstream infections in the
for LOCK-IT 100 in 2Q18; Report top-line data in the second half of
discuss advances to taurolidine-based therapeutic and medical
device pipeline in 3Q17
Bedminster, NJ May 10, 2017 CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today provided
its corporate update for the first quarter ended March 31, 2017.
CorMedix will host a conference call today, May 10, 2017, at 4:30
p.m. Eastern Time to discuss the Company's recent corporate
developments and financial results.
Baluch, Chief Executive Officer of CorMedix, said, We are
continuing to advance Neutrolin , our
broad-spectrum, non-antibiotic anti-infective solution designed to
prevent costly and dangerous bloodstream infections associated with
the use of central venous catheters, toward the U.S. and
international markets. Our ongoing Phase 3 trial, LOCK-IT 100,
continues to enroll patients with end-stage renal disease receiving
hemodialysis through a central venous catheter, and an independent
data safety and monitoring unanimously concluded it was safe to
continue patient enrollment based on safety data from the first 279
patients. We currently anticipate exceeding our original enrollment
target of 632 patients by the fourth quarter of 2017, and will
continue to enroll additional patients until the requisite number
of catheter-related bloodstream infections occur in this
event-driven Phase 3 study. An interim efficacy analysis is
currently anticipated by the end of the year, which would give us
our first look into Neutrolin's potential to reduce
catheter-related bloodstream infections in the study
addition to advancing Neutrolin in the U.S., we were pleased to
announce that we'd secured our first European commercial
collaboration with Hemotech SAS to launch Neutrolin in France and
French overseas territories. This enables CorMedix to leverage
Hemotech's nearly 30 years of experience and significant
presence, which includes 92% of all French dialysis organizations
as well as major hospitals, where Neutrolin's CE Marking
allows it to be marketed as a catheter lock solution for oncology
and ICU patients with central venous catheters. We intend to pursue
additional partnerships designed to further expand ex-U.S. sales of
Neutrolin and begin augmenting our commercial presence in Europe.
We expect to begin generating initial sales revenue over the
quarters to come, which over time may partially offset our
operational and clinical development costs in the
Baluch continued, CorMedix is committed to taking advantage
of additional opportunities to generate value based on taurolidine,
the active component of Neutrolin. A particular area of focus is in
the medical device space, where taurolidine may be incorporated
into various medical and surgical materials to confer antimicrobial
or anti-inflammatory properties. Based on initial feasibility work,
we are advancing preclinical studies for three product candidates:
surgical meshes, suture materials, and hydrogels. We expect to
develop and pursue FDA clearance for these potential products by
the 510(k) pathway and will seek to establish
development/commercial partnerships as these programs advance. A
more robust R&D day' event will be scheduled
within the coming months to discuss these and our ongoing oncology
collaboration in greater detail.
first quarter 2017, the Company recorded a net loss of $7.6
million, or $0.19 per share, compared with a net loss of $4.1
million, or $0.11 per share for the first quarter 2016. Operating
expenses in the first quarter 2017 were $7.6 million, compared with
$6.5 million in the fourth quarter of 2016. The increase was due to
an increase in both R&D and G&A expense. Our cash used in
operations in the first quarter 2017 was $6.8 million, compared
with $6.5 million in the fourth quarter 2016. Cash was used
primarily to conduct our Phase 3 study of Neutrolin, other R&D
and related G&A activities. Our operating cash burn was funded
primarily via drawdown of our cash on hand. Approximately $0.3
million was provided by the use of the Company's At
the Market program during January 2017.
recently completed a public offering of common stock and warrants
resulting in gross proceeds of $14 million, before deducting
underwriting discounts and commissions and estimated offering
expenses. The offering included the full exercise of underwriter
H.C. Wainwright and Co.'s option to purchase additional
shares of common stock and warrants from CorMedix.
Baluch concluded, We are dedicated to bringing Neutrolin to
market, to help prevent potentially deadly catheter-related blood
stream infections in already vulnerable patient populations in the
U.S. and abroad. Our recent financing adds fuel to continue our
U.S. pivotal clinical program, while in parallel, we're
continuing to enhance our focus on driving additional value through