Full Press Release Details
CorMedix Inc. Reports Third Quarter Financial Results and Provides
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Recent Corporate and Clinical Highlights:
combined Securities Purchase and Backstop Agreement
advance Phase 3 LOCK-IT 100 clinical study of Neutrolin , surpassing
original enrollment target of 632 patients
funding from the National Institutes of Health (NIH) to develop
antimicrobial hydrogel to treat severe burns
in vitro data demonstrating
susceptibility of deadly fungal pathogen Candida auris to taurolidine at two
global infectious disease conferences
headquarters; Sublease agreement allows rent-free occupancy until
Anticipated Milestones:
interim efficacy analysis, expected completion in early 2018,
pending confirmation of the requisite number of catheter-related
bloodstream infection (CRBSI) events
for LOCK-IT-100 by 2Q18 and report top-line data in the second half
of 2018, pending confirmation of the requisite number of CRBSI
taurolidine-incorporated medical device pipeline through animal
proof-of-concept studies, expected by year end 2017, supporting
anticipated 510(k) submissions in 2H 2018
Berkeley Heights, NJ November 9, 2017
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 provided its corporate update for the third quarter
and nine months ended September 30, 2017. CorMedix will host a
conference call today, November 9, 2017, at 4:30 p.m. Eastern Time,
to discuss the Company's recent corporate developments and
Baluch, Chief Executive Officer of CorMedix, said, Our
priority remains to bring Neutrolin , our
broad-spectrum, non-antibiotic anti-infective solution to the U.S.
market. To that end, we are working tirelessly to meet the
regulatory benchmarks that were agreed upon by the FDA earlier this
year. First, we've continued to enroll new subjects and have
now exceeded our original enrollment target of 632 hemodialysis
patients. As discussed previously, we are continuing to enroll
additional subjects in order to achieve the requisite number of
CRBSI events in the Phase 3 study. In parallel, we're
continuing to capture, investigate and prepare clinical packages of
subjects who have already completed the LOCK-IT 100 trial to
determine, through our independent clinical adjudication committee
(CAC), if cases where subjects presented with possible bloodstream
infections at non-participating hospitals and emergency clinics
could be confirmed by CAC as CRBSI events for the primary efficacy
endpoint of the study.
most significant near-term catalyst for CorMedix is the planned
interim efficacy analysis, 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 catheter. The interim analysis will occur after we capture
and the CAC confirms half of the total required CRBSI events (28/56
total). Based on our current projections, we expect the interim
analysis to occur early in the first quarter 2018. We remain
completely dedicated to the successful completion of the Neutrolin
registrational 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
Baluch added, In addition to Neutrolin, we have continued
developing our preclinical pipeline of taurolidine-infused medical
devices, focused in the areas of antimicrobial sutures, surgical
meshes and hydrogels. We are currently completing proof-of-concept
studies in animal models and expect to report the data by year end.
If successful, and upon FDA acceptance of our suggested predicate
devices, we anticipate pursuing marketing applications in the
second half of 2018. Upon potential FDA clearance, all three of our
product candidates will enter large markets where we believe they
can achieve significant market share and improve patient outcomes.
We intend to commercialize our medical devices in the U.S. and
Europe through appropriate partners. In August, we announced that
CorMedix was awarded an NIH grant to finance the development of an
advanced taurolidine-based hydrogel designed to reduce the risk of
potentially life-threatening infection and promote healing of
severe burn injuries. We're very pleased to receive this
non-dilutive funding and add another valuable medical device
candidate to our pipeline at minimal incremental cost to the
have also continued to advance our collaboration with the Pediatric
Oncology Experimental Therapeutics Investigators' Consortium
(POETIC) for the preclinical development of taurolidine-based
therapies for cancer. Preclinical studies focused on demonstrating
in vivo proof-of-concept
remain ongoing. The results of these studies will determine a
potential clinical strategy for future taurolidine-based
chemotherapy candidate(s).
Baluch concluded, Finally, today we've announced the
execution of a $5 million combined investment and backstop facility
with an existing CorMedix investor, consisting of the purchase of
Series F Convertible Preferred Stock, of which $2 million is
expected to close in the coming days, subject to customary closing
conditions. This new investment, plus the approximately $3.1
million raised in October under our existing ATM program, is
expected to provide CorMedix with sufficient funding through the
first quarter 2018, including our anticipated reporting of interim
Phase 3 efficacy data.
third quarter 2017, CorMedix recorded a net loss of $10 million, or
$0.17 per share, compared with a net loss of $9.1 million, or $0.23
per share, in the third quarter 2016, an increase of $0.9 million.
For the nine months ended September 30, 2017, the Company recorded