Exhibit 99.1
CORMEDIX INC. REPORTS FIRST QUARTER 2019 FINANCIAL
RESULTS
AND PROVIDES BUSINESS UPDATE
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Time
Berkeley Heights, NJ – May 13, 2019 – 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, 2019 and
provided an update on recent business events.
Recent Corporate and Clinical Highlights:
●
Announced
that the Company has completed the
statistical analyses of data and additional information requested
by FDA for the primary and secondary efficacy endpoints of the
Company’s LOCK-IT-100 clinical study. These analyses support
the strong topline results previously
announced.
●
FDA
has granted the Company’s meeting request to continue its
dialogue on the data from LOCK-IT-100 and its support as
substantial evidence of safety and effectiveness of Neutrolin®
as a catheter-lock solution in hemodialysis patients for the New
Drug Application.
●
Presented results of the Company’s Phase 3
LOCK-IT-100 Study at the National Kidney Foundation Spring 2019
Clinical Meetings. A total of 41
catheter-related blood stream infections (CRBSIs) was determined by
the Clinical Adjudication Committee (CAC) in the full data set,
compared with 28 CRBSI cases in the interim analysis. The
full data set showed a 71% reduction in the risk of occurrence of
CRBSIs compared with the active control of heparin, which is well
in excess of the study’s assumed treatment effect size of a
55% reduction and statistically significant with a p-value of
0.0006.
●
Appointed Dr. Phoebe Mounts, Esq. as Executive Vice President and
General Counsel, leading the Company’s legal, compliance and
regulatory affairs. Dr. Mounts has been a trusted legal advisor to
the Company since 2013 and has been responsible for developing the
FDA regulatory strategies for Neutrolin.
●
Completed
the previously announced sale of $5.4 million of NOL tax benefits
to two unrelated, profitable New Jersey corporations through the
New Jersey Economic Development Authority’s New Jersey
Technology Business Tax Certificate Transfer program for State
Fiscal Year 2018. As a result, the Company has received
approximately $5.1 million in cash from the sale of these NOL tax
benefits.
●
Announced
that the Company had regained compliance with the NYSE American
listing requirements.
●
Cash,
cash equivalents and short-term investments at March 31, 2019
amounted to $26.4 million.
Khoso Baluch, CorMedix CEO, commented, “We are pleased that
our current discussions with the FDA are continuing and we look
forward to completing the clinical study report, which is required
to demonstrate the safety and efficacy of Neutrolin as a
catheter-lock solution for hemodialysis patients. The team
continues in parallel to prepare the additional components required
for an NDA filing. In our view, the results of the LOCK-IT-100
study strongly support our case for Neutrolin’s efficacy and
safety as a catheter lock solution in hemodialysis
patients.”
Mr. Baluch continued, “We are also pleased with our financial
results this quarter and with the receipt of $5.1 million in
funding through the NJ NOL program. As a result, our liquidity at
March 31 is the highest in several years. We believe the funds we
have available are sufficient for us to complete the regulatory
discussion with the FDA and file an NDA if the FDA agrees with our
request to file based on a single study.”
First Quarter 2019 Financial Highlights
For the
first quarter 2019, CorMedix recorded a net loss of $5.2 million,
or $0.22 per share, compared with a net loss of $10.2 million, or
$0.68 per share, in the first quarter of 2018, a decrease of $5.0
million. Net loss in the first quarter of 2019 was driven by
decreased costs related to the LOCK-IT-100 clinical study due to
the winding down of the study while other expenses continued to
decline or remained flat.
Operating
expenses in the first quarter 2019 were $4.9 million, compared to
$10.2 million in the fourth quarter of 2018, a decrease of
approximately 52%. R&D expense decreased approximately 65%
to $2.9 million, due to a 77% decrease in clinical trial expense.
SG&A expense increased by 4%.
Conference Call Information:
The management team of CorMedix will host a conference call and
webcast today, May 13, 2019, at 4:30 PM Eastern Time, to discuss
recent corporate developments and financial results. Call details
and dial-in information are as follows:
Domestic:
877-407-9124
International:
201-689-8584
Passcode:
13690433
Webcast (with
slides):
https://www.investornetwork.com/event/presentation/48100
Replay
will be available through May 28, 2019:
Domestic:
877-481-4010
International:
919-882-2331
Conference
ID:
48100
The
management team will share the slide presentation that was made on
May 10, 2019 at the National Kidney Foundation (NKF) Spring 2019
Clinical Meetings during the webcast. Please log into the investor
section of the Company’s website for a link to the slide
presentation.
About CorMedix
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 have
significant treatment costs and lead to increased morbidity and
mortality. Neutrolin has FDA Fast Track status and is designated as
a Qualified Infectious Disease Product, which provide the potential
for priority review of a marketing application by FDA and
allow for a total of ten years of 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 company is
also working with top-tier researchers to develop taurolidine-based
therapies for rare pediatric cancers. For more information,
visit: www.cormedix.com.
Forward-Looking Statements
This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks and uncertainties. All statements, other
than statements of historical facts, regarding management’s
expectations, beliefs, goals, plans or CorMedix’s prospects,
future financial position, financing plans, future revenues and
projected costs should be considered forward-looking. Readers are
cautioned that actual results may differ materially from
projections or estimates due to a variety of important factors,
including: the results of our discussions with the FDA regarding
the Neutrolin development path; the resources needed to complete
the information required to submit a new drug application for
Neutrolin to the FDA; the risks and uncertainties associated with
CorMedix’s ability to manage its limited cash resources and
the impact on current, planned or future research, including the
continued development of Neutrolin and research for additional uses
for taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities
and operations; risks relating to the effect of the reverse stock
split on the Company’s stock price and its overall market
capitalization; preclinical results are not indicative of success
in clinical trials and might not be replicated in any subsequent
studies or trials; and the ability to retain and hire necessary
personnel to staff our operations appropriately. These and other
risks are described in greater detail in CorMedix’s filings
with the SEC, copies of which are available free of charge at the
SEC’s website at www.sec.gov or upon request from CorMedix.
CorMedix may not actually achieve the goals or plans described in
its forward-looking statements, and investors should not place
undue reliance on these statements. CorMedix assumes no obligation
and does not intend to update these forward-looking statements,
except as required by law.
Investor Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
|
|
For the Three
Months Ended
March
31,
|
|
|
|
2019
|
2018
|
|
Revenue
|
|
|
|
Net
sales
|
$163,692
|
$23,210
|
|
Cost
of sales
|
(226,955)
|
(28,575)
|
|
Gross
loss
|
(63,263)
|
(5,365)
|
|
Operating
Expenses
|
|
|
|
Research and
development
|
(2,874,996)
|
(8,280,442)
|
|
Selling, general
and administrative
|
(1,984,922)
|
(1,903,016)
|
|
Total operating
expenses
|
(4,859,918)
|
(10,183,458)
|
|
Loss
from Operations
|
(4,923,181)
|
(10,188,823)
|
|
Other
Income (Expense)
|
|
|
|
Interest
income
|
58,822
|
14,775
|
|
Foreign exchange
transaction loss
|
(1,477)
|
(9,197)
|
|
Interest
expense
|
(302,048)
|
(1,873)
|
|
Total other income
(expense)
|
(244,703)
|
3,705
|
|
Net
Loss
|
(5,167,884)
|
(10,185,118)
|
|
Other
Comprehensive Income (Loss)
|
|
|
|
Unrealized gain
from investment
|
(1,008)
|
-
|
|
Foreign currency
translation loss
|
(305)
|
(1,425)
|
|
Total comprehensive
income (loss)
|
(1,313)
|
(1,425)
|
|
Comprehensive
Loss
|
$(5,169,197)
|
$(10,186,543)
|
|
Net
Loss Per Common Share – Basic and Diluted
|
$(0.22)
|
$(0.68)
|
|
Weighted
Average Common Shares Outstanding – Basic and
Diluted
|
23,074,049
|
15,071,282
|
CORMEDIX INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
|
March
31,
|
|
|
|
2019
|
2018
|
|
|
|
|
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$18,256,999
|
$17,623,770
|
|
Short-term
investments
|
$7,944,549
|
$-
|
|
Total
Assets
|
$27,308,220
|
$18,825,914
|
|
Total
Liabilities
|
$10,766,255
|
$13,891,658
|
|
Accumulated
deficit
|
$(184,155,982)
|
$(178,988,098)
|
|
Total
Stockholders’ Equity
|
$16,541,965
|
$4,934,256
|
CORMEDIX INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
For the Three
Months Ended
March
31,
|
|
|
|
2019
|
2018
|
|
|
|
|
|
Cash
Flows from Operating Activities:
|
|
|
|
Net
loss
|
$(5,167,884)
|
$(10,185,118)
|
|
Net cash used in
operating activities
|
(7,367,470)
|
(7,054,303)
|
|
Cash
Flows Used in Investing Activities:
|
|
|
|
Net cash (used in)
provided by investing activities
|
(7,964,777)
|
1,565,972
|
|
Cash
Flows from Financing Activities:
|
|
|
|
Net cash provided
by financing activities
|
15,967,575
|
3,269,163
|
|
Net
Increase (Decrease) in Cash
|
633,229
|
(2,217,695)
|
|
Cash
- Beginning of Period
|
17,795,323
|
10,551,282
|
|
Cash
- End of Period
|
$18,428,552
|
$8,333,587
|