Full Press Release Details
CORMEDIX INC. REPORTS THIRD QUARTER FINANCIAL RESULTS AND PROVIDES
Conference Call today at 4:30 p.m. Eastern Time
Berkeley Heights, NJ November 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 third quarter and nine months ended
September 30, 2018 and provided an update on recent business
After the Data and Safety Monitoring Board recommended our
LOCK-IT 100 trial be halted for efficacy, we began the methodical
process of closing the study and are well on our way to completing
locking the data set, said Khoso Baluch, Chief Executive
Officer of CorMedix. Additionally, we are simultaneously
preparing to file an NDA with the Food and Drug Administration for
Neutrolin in anticipation of receiving a favorable response from
the FDA at our upcoming meeting to discuss Neutrolin's development
path. Our clinical team has put in a tremendous effort and we are
pleased with the progress on all fronts. We look forward to
commercializing Neutrolin and meaningfully advance patient care by
significantly reducing or eliminating costly and potentially deadly
catheter-related bloodstream infections.
Recent Corporate and Clinical Highlights:
the process of locking the data set from the LOCK-IT 100 trial,
which the Company halted for efficacy on the recommendation of the
independent Data and Safety Monitoring Board (DSMB) after it
completed its review and analysis of the interim data. 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.
a confidential settlement agreement with its CRO in which the
Company agreed to make certain payments to its CRO through January
2019, plus investigator fees and third party costs that have not
been invoiced as of September 30, 2018. The settlement agreement
will result in full satisfaction of the balance of the accounts
payable and accrued expenses recorded as of September 30, 2018 in
connection with the Master Services Agreement. Additionally, in
parallel with the settlement agreement, a new work order under the
Master Service Agreement was executed specifying certain services
the CRO will continue to provide to the Company related to the
closeout of the study.
a binding term sheet with the Company's largest investor (the
Investor ) for a proposed new $7.5 million secured
convertible debt financing, which subject to completion of
documentation, will be closed and drawn before year end 2018. The
three year note will bear interest at 10% per annum and will be
convertible into the Company's common stock at a conversion
price of $1.50 per share.
Third Quarter and Nine Month 2018 Financial Highlights
For the third quarter 2018, CorMedix recorded a net loss of $10.2
million, or $0.11 per share, compared with a net loss of $10.0
million, or $0.17 per share, in the third quarter 2017, an increase
of $0.2 million. The increase in net loss in the third quarter 2018
compared with the third quarter of 2017 was driven primarily by
increased costs related to the LOCK-IT-100 clinical study. During
the third 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 third quarter 2018 were $10.3 million,
compared to $8.0 million in the third quarter of 2017, an increase
of approximately 28.8%. This increase was due primarily to a
$2.3 million, or 38.3% increase, in R&D expense, while SG&A
expense remained unchanged. Within R&D, the cost of the
LOCK-IT-100 clinical trial increased by $1.7 million due to higher
investigator site fees resulting from the accelerated efforts to
complete patient dosing and the one month safety follow-up, and to
record all trial related data as quickly as possible in order to
permit timely site closure.
For the nine months ended September 30, 2018, CorMedix recorded a
net loss of $29.0 million, or $0.35 per share, compared with a net
loss of $22.7 million, or $0.44 per share, in the first nine months
of 2017, an increase of $6.3 million. The increase in net loss in
the first nine months of 2018 compared with the first nine months
of 2017 was driven primarily by increased costs related to the
LOCK-IT-100 clinical study. During the first nine months 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 completed in May 2017.
Operating expenses in the nine months ended September 30, 2018 were
$29.0 million, compared to $22.7 million in the nine months ended
September 30, 2017, an increase of approximately 27.8%. This
increase was due primarily to a $7.1 million, or 44.5% increase, in
R&D expense, while SG&A expense declined by $0.8
cash on hand and short-term investments as of September 30, 2018
was $6.4 million, excluding restricted cash of $0.2 million. The
Company believes that, based on the
Company's cash resources at September 30, 2018, the proceeds
received under its ATM program through the filing date of its
report on Form 10-Q, the financial impact of the CRO settlement
agreement, and the anticipated closing of the convertible
debt transaction it has sufficient resources to fund the
Company's operations into the second quarter of 2019. 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 FDA.
Conference Call Information:
CorMedix CEO, Khoso Baluch will host a conference call and webcast
today, November 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: