Full Press Release Details
CORMEDIX INC. REPORTS FIRST QUARTER FINANCIAL RESULTS AND PROVIDES
Anticipate Data Safety Monitoring Board review of interim analysis
in July 2018; review was triggered in December 2017 with 28
confirmed cases of catheter-related bloodstream infections (CRBSIs)
identified in the Phase 3 LOCK-IT-100 trial
Granted U.S. FDA orphan drug designation for taurolidine for
treatment of neuroblastoma
Conference Call Today at 4:30 p.m. Eastern Time
Berkeley Heights, NJ
May 15, 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 first quarter ended March 31, 2018 and
provided an update on recent business
are continuing to make progress on our data collection efforts for
our Phase 3 LOCK-IT 100 study, which is ongoing, said Khoso
Baluch, Chief Executive Officer of CorMedix. Concurrent to
the work on the interim analysis, we continued to progress the
Phase 3 trial, having enrolled approximately 790 subjects,
exceeding our original enrollment target of 632 patients. The
additional trial subjects should help to bring us closer to our
goal of achieving the requisite number of catheter-related blood
stream infection ( CRBSI ) events in the Phase 3
study. We are working diligently to capture, investigate and
prepare clinical packages for review by the Clinical Adjudication
Committee ( CAC ) as quickly as
Baluch continued, We remain completely dedicated to the
successful completion of the Neutrolin registrational
program, and to bringing Neutrolin to market in the U.S. We
believe Neutrolin has the potential to meaningfully improve patient
care by significantly reducing or eliminating costly and
potentially deadly catheter-related bloodstream
respect to our taurolidine asset, we were pleased to receive orphan
drug designation during the first quarter for taurolidine in the
treatment of neuroblastoma. We received the results of the
preliminary animal studies in taurolidine-infused sutures, meshes,
and hydrogels and currently anticipate that any future development
will be dependent on receipt of marketing approval of Neutrolin in
the U.S., Mr. Baluch added. We continue to evaluate
our capital needs and options and are committed to ensuring the
company has sufficient cash on hand to complete the interim
analysis, with a near-term financial goal of minimizing dilution to
Recent Corporate and Clinical Highlights:
and source-verified 54% of the LOCK-IT 100 data. None of the 28
CAC-reviewed CRBSI cases are affected by this additional review. On
track to complete the review and source-verification efforts by the
end of the second quarter 2018.
the animal studies of taurolidine-infused sutures, meshes and
hydrogels. Further development primarily dependent on U.S.
marketing approval of Neutrolin.
Paul Chew as Chief Medical Officer consultant and advisor to
support completion of the Company's Neutrolin clinical
program and to further the neuroblastoma and medical device
approximately 790 subjects in its multi-center Phase 3
registrational trial for Neutrolin in hemodialysis patients with
central venous catheters.
orphan drug designation by the Food and Drug Administration for
taurolidine in the treatment of neuroblastoma.
2018 Financial Highlights
first quarter 2018, CorMedix recorded a net loss of $10.2 million,
or $0.14 per share, compared with a net loss of $7.6 million, or
$0.19 per share, in the first quarter of 2017, an increase of $2.6
million. Net loss in the first quarter of 2018 was driven by
increased costs related to the ongoing LOCK-IT-100 clinical study
while other expenses continued to decline or remained
expenses in the first quarter 2018 were $10.2 million, compared to
$10.4 million in the fourth quarter of 2017, a decrease of
approximately 2%. R&D expense decreased approximately 2%
to $8.3 million, due to a 77% decrease in manufacturing expense and
a 29% decline in other R&D, while clinical trial expense
increased by 21%. SG&A expense declined by 3%. Approximately
71% of total operating expenses during the first quarter of 2018
were related to the LOCK-IT 100 clinical trial.
CEO, Khoso Baluch will host a conference call and webcast today,
May 15, 2018, at 4:30 PM Eastern Time, to discuss recent corporate
developments and financial results. Call details and dial-in
information is as follows:
Tuesday, May 15 at 4:30pm Eastern Time
will be available through May 28 by dialing:
CorMedix 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
a novel, non-antibiotic antimicrobial solution designed to prevent
costly and dangerous bloodstream infections associated with the use
of central venous catheters, currently in a Phase 3 clinical trial
enrolling patients undergoing chronic hemodialysis. Such infections
cost the U.S. healthcare system approximately $6 billion annually
and contribute significantly to increased morbidity and mortality.
Neutrolin has FDA Fast Track status and is designated as a
Qualified Infectious Disease Product, which provides the potential
for priority review of a marketing application by FDA and
allows for 5 additional years of QIDP 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 antimicrobial medical devices, with active programs in
surgical sutures and meshes, and topical hydrogels. The