Full Press Release Details
CorMedix Inc. Reports Fourth Quarter and Full Year
Financial Results and Provides Business Update
Conference Call Scheduled for Today at 8:30 a.m. Eastern
Recent Corporate and Clinical Highlights:
enrollment midpoint in pivotal Phase 3 LOCK-IT 100
study of Neutrolin in hemodialysis
patients; On track to complete enrollment as planned
leadership team with appointment of Robert W. Cook as Chief
Financial Officer; Judith R. Abrams, M.D., as Chief Medical
Officer; and John L. (Jack) Armstrong as Executive Vice President
of Technical Operations and Head of Human Resources
the preclinical work with the POETIC group to evaluate CRMD-005 in
combination with vincristine to treat pediatric
Anticipated Milestones:
in LOCK-IT 100 study by year-end 2017; Report top-line data in the
commencement of the second Phase 3 LOCK-IT 200 study
in oncology patients by year-end 2017
studies of taurolidine-based cancer therapy under POETIC
Bedminster, NJ March 17, 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 fourth quarter and full year ended
December 31, 2016. CorMedix will host a conference call today,
March 17, 2017, at 8:30 a.m. Eastern Time to discuss the
Company's recent corporate developments and financial
Baluch, Chief Executive Officer of CorMedix, said, The
fourth quarter of 2016 and early 2017 are marked by significant
clinical execution for our lead candidate Neutrolin for the
prevention of central venous catheter-related bloodstream
infections. Through our successful efforts to overcome certain
challenges and accelerate enrollment of hemodialysis patients into
our Phase 3 LOCK-IT 100 study in the U.S., we are pleased to report
that we have surpassed the midpoint of study enrollment. We are
currently enrolling patients at greater than 50% of our target
clinical trial sites and we continue to activate and enroll
patients regularly at additional sites. Importantly, we remain on
track to complete study enrollment as planned by year-end 2017. Our
core focus remains on securing FDA approval and commercializing
Neutrolin in the U.S., and we believe we are well on our way toward
achieving that goal.
Baluch continued, A critical component of our success will
be the senior leadership we have in place to ensure our programs
run efficiently. Recently, we were pleased to add Robert Cook, Dr.
Judith Abrams, and Jack Armstrong to our management team, bringing
decades of clinical, fundraising, strategic and operational
expertise that will benefit CorMedix as we advance Neutrolin and
explore additional opportunities to build value for our
taurolidine-based pipeline.
beyond Neutrolin, we are excited to work with the leading cancer
centers that comprise the POETIC group to pursue development of a
novel taurolidine-based combination therapy for the treatment of
pediatric cancers, including neuroblastoma and osteosarcoma. We
look forward to the in vitro and in vivo studies to explore the
potential of this combination therapy, and its potential
advancement to human clinical studies in the
full year 2016, the Company recorded a net loss of $24.6 million,
or $0.65 per share, compared with a net loss of $18.2 million, or
$0.58 per share during 2015. The 2016 net loss was driven by a Loss
from Operations of $24.8 million, which resulted from a significant
increase in clinical trial expenses, CMC and other
Neutrolin-related development expenses, and new product development
expenses, partially offset by a decline in SG&A expenses. Cash
used in operations during 2016 amounted to $22.2 million, a 78%
increase over 2015's cash use of $12.5 million, primarily due
to the ramp up of the LOCK IT 100 clinical trial and other R&D
expenses. $6.2 million of the cash use was funded via the
Company's At the Market program, with the
balance drawn from existing cash on hand. As of December 31, 2016,
the Company has availability of an additional $4.1 million via the
hand as of December 31, 2016, was $20.2 million, including short
term investments, compared with $35.4 million as of December 31,
2015. Based on the Company's cash resources at year-end and
the expected cost of the Phase 3 clinical trial in hemodialysis
catheters in the U.S., the Company expects that its existing cash
and short-term investments will be insufficient to fund operations
through 2017. The Company is exploring various funding
opportunities while it aims to optimize its cash.
Baluch concluded, We are committed to unlocking significant
long term value for our shareholders by successfully completing our
Phase 3 studies and launching Neutrolin into a broad and sizable
U.S. market upon potential approval. We look forward to continued
clinical execution over the coming months.
Conference Call Information:
call five minutes before the conference call is scheduled to
live audio webcast will be accessible via the Events section of the
replay of the teleconference will be available until 11:59 p.m. on
Inc. is a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease. 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. Such infections cost the U.S. healthcare
system approximately $6 billion annually and contribute
significantly to increased morbidity and mortality. Neutrolin is
currently in a Phase 3 clinical study in patients undergoing
chronic hemodialysis via a central venous catheter. The Company is
planning to conduct its second Phase 3 study in patients with
cancer receiving IV parenteral nutrition, chemotherapy and