Full Press Release Details
CORMEDIX INC. REPORTS SECOND QUARTER FINANCIAL RESULTS AND PROVIDES
LOCK-IT-100 trial results positive; trial halted for
Conference Call today at 4:30 p.m. Eastern Time
Berkeley Heights, NJ August 14, 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 second quarter and six months ended June
30, 2018 and provided an update on recent business
We were thrilled to have recently announced the best-case
scenario outcome for our LOCK-IT-100 interim analysis, with the
Data Safety Monitoring Board recommending the trial be halted for
efficacy and data submitted to the FDA, said Khoso Baluch,
Chief Executive Officer of CorMedix. Over the past few
months, our clinical team put in a tremendous effort to lock the
interim data set, and with these great results now in hand we are
winding down the trial and preparing to meet with the FDA to agree
on the next steps in the Neutrolin development plan. We expect to
meet with the FDA and to have agreement with respect to next steps
in the fourth quarter of 2018.
Mr. Baluch continued, We believe Neutrolin has the potential
to meaningfully improve patient care by significantly reducing or
eliminating costly and potentially deadly catheter-related
bloodstream infections, and we now have the data validating
Neutrolin's efficacy. We have sufficient capital to get us
beyond the FDA meeting, after which we will fully evaluate our
capital needs and options to get us ultimately to an NDA
Recent Corporate and Clinical Highlights:
the independent Data Safety Monitoring Board (DSMB) completed its
review and analysis of the LOCK-IT-100 interim data from the Phase
3 LOCK-IT-100 study for Neutrolin. The DSMB recommended the study
be terminated early as the pre-specified level of statistical
significance had been achieved and efficacy had been demonstrated.
No safety concerns were reported by the DSMB based on the interim
data. The Company has halted the study and is planning to meet with
the U.S. Food and Drug Administration during the fourth quarter of
2018 to agree on the next steps with respect to the Neutrolin
development program, leading ultimately to an NDA
Second Quarter and First Half 2018 Financial
For the second quarter 2018, CorMedix recorded a net loss of $8.6
million, or $0.10 per share, compared with a net loss of $5.1
million, or $0.10 per share, in the second quarter 2017, an
increase of $3.5 million. The increase in net loss in the second
quarter 2018 compared with the second quarter of 2017 was driven
primarily by increased costs related to the LOCK-IT-100 clinical
study, and by a $0.1 million reduction in gross profit. During the
second quarter of 2017, the Company also recorded a $1.9 million
non-cash gain related to a change in the fair value of warrants
issued in connection with a public offering.
Operating expenses in the second quarter 2018 were $8.6 million,
compared to $7.0 million in the second quarter of 2017, an increase
of approximately 19.7%. This increase was due primarily to a
$1.5 million, or 29.7% increase, in R&D expense, while SG&A
expense declined by 5.2%. Within R&D, the cost of the
LOCK-IT-100 clinical trial increased by $1.8 million due to higher
CRO expenses and an increase in CRA time and travel
For the six months ended June 30, 2018, CorMedix recorded a net
loss of $18.7 million, or $0.24 per share, compared with a net loss
of $12.7 million, or $0.27 per share, in the first half of 2017, an
increase of $6.0 million. The increase in net loss in the first
half of 2018 compared with the first half of 2017 was driven
primarily by increased costs related to the LOCK-IT-100 clinical
study. During the first half of 2017, the Company also recorded a
$1.9 million non-cash gain related to a change in the fair value of
warrants issued in connection with a public offering.
Operating expenses in the first half of 2018 were $18.8 million,
compared to $14.6 million in the first half of 2017, an increase of
approximately 47.1%. This increase was due primarily to a $4.9
million, or 48.6% increase, in R&D expense, while SG&A
expense declined by 18%.
cash on hand and short-term investments as of June 30, 2018 was
$4.7 million, excluding restricted cash of $0.2 million. The
Company believes that, based on the
Company's cash resources at June 30, 2018, the proceeds
received under its ATM program through August 10, 2018, and
the current status of its CRO negotiations, it has sufficient
resources to fund the costs of closing the LOCK-IT-100 study and
holding its meeting with the FDA. The Company will more fully
evaluate the amount of funding needed to complete Neutrolin
development and file an NDA after its planned meeting with the
Conference Call Information:
CorMedix CEO, Khoso Baluch will host a conference call and webcast
today, August 14, 2018, at 4:30 PM Eastern Time, to discuss recent
corporate developments and financial results. Call details and
dial-in information are as follows:
Tuesday, August 14 at 4:30pm Eastern Time
Domestic: 877-407-9124
International: 201-689-8584
Conference ID: 13681918
A replay will be available through August 28 by
Domestic: 877-481-4010
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 Neutrolin ,
a novel, non-antibiotic antimicrobial solution designed to prevent
costly and dangerous bloodstream infections associated with the use
of central venous catheters, currently in Phase 3 development for
patients undergoing chronic hemodialysis. Such infections cost the