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| 8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL-YEAR 2017 FINANCIAL
RESULTS AND PROVIDES BUSINESS UPDATE
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Time
Recent Corporate and Clinical Highlights:
●
28
cases of catheter-related bloodstream infections (CRBSIs)
identified by the Clinical Adjudication Committee, triggering the
interim analysis in the Phase 3 LOCK-IT-100 trial;
●
Over
750 subjects enrolled to date in its multi-center Phase 3
LOCK-IT-100 trial in Neutrolin for hemodialysis patients with
central venous catheters;
●
Granted
orphan drug designation by the Food and Drug Administration for
taurolidine in the treatment of neuroblastoma.
Anticipated Milestones:
●
Interim
efficacy analysis of the LOCK-IT-100 study is anticipated to be
completed during the second quarter of 2018;
●
Subject
enrollment in the study is also expected to be completed in the
second quarter of 2018;
●
Results of animal model testing of
taurolidine-infused sutures, meshes and hydrogels are expected to
be reported by the end of April 2018.
Berkeley Heights, NJ – March 19, 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 fourth quarter and full year ended
December 31, 2017 and provided an update on recent business
highlights.
“CorMedix continues to make progress on our goal of bringing
Neutrolin®, our broad-spectrum, non-antibiotic, anti-infective
solution to the U.S. market,” said Khoso Baluch, Chief
Executive Officer of CorMedix. “Our team is now
assessing and ensuring the completeness and accuracy of the blinded
data for the two secondary endpoints related to catheter removal
and catheter blockage, as well as the primary endpoint (CRBSI) and
safety information. We are reviewing
the source data at the clinical sites prior to locking the data and
proceeding to the interim analysis. This is a complex and
challenging study from the standpoint of having to collect so much
data per patient, much of which is generated at hospitals and other
locations outside of the enrolling sites. We are working to
complete this review as quickly as
possible.”
“At the same time, we have continued to enroll new subjects
into our multi-center LOCK-IT-100 Phase 3 trial and have over 750
subjects enrolled, exceeding our original enrollment target of 632
hemodialysis patients. The additional trial subjects should
help to bring us closer to our goals to achieve the requisite
number of catheter-related bloodstream infection (CRBSI) events in
the Phase 3 study more quickly. In parallel, we’re continuing
to capture and investigate data, and prepare clinical packages of
subjects who have suffered a suspected CRBSI event. We have
achieved the requisite 28 cases triggering the planned interim
efficacy analysis, which is the most significant near-term catalyst
for CorMedix and 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.”
“We remain completely dedicated to the successful completion
of the Neutrolin Phase 3 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 infections.”
Mr. Baluch added, “In addition to Neutrolin, we continue to
develop our preclinical pipeline. This past quarter, we received
orphan drug designation from the U.S. Food and Drug Administration
for taurolidine in the treatment of neuroblastoma, a severe form of
cancer that originates in certain types of nerve tissues. Current
treatments for this rare form of cancer offer poor outcomes, and we
believe taurolidine could become an important therapy. Our goal is
to partner with an appropriate cancer-focused company to advance
taurolidine into clinical development and ultimately obtain
marketing approval. In addition, our studies of taurolidine-infused
sutures, meshes and hydrogels in animal models have been completed
and we expect to report the results of these studies very
soon.”
Mr. Baluch concluded, “Our strategy at CorMedix has not
changed. We are working as quickly and diligently as possible to
complete the quality assurance procedures necessary for the interim
efficacy analysis and subsequent review by the Data Safety
Monitoring Board (DSMB). Financially, our goal is to raise the
minimum amount of capital on the best terms available to ensure
that the company has sufficient cash on hand to complete the
interim analysis in the LOCK-IT-100 study. After the interim data
is reviewed by the DSMB and we know our path forward we will
re-evaluate our situation and determine both our ongoing cash needs
and our financing options. At all times, we will
continue in our efforts to minimize dilution and maximize value for
our shareholders.”
Fourth Quarter 2017 Financial Highlights
For the fourth quarter 2017, CorMedix recorded a net loss of $10.3
million, or $0.15 per share, compared with a net loss of $6.4
million, or $0.16 per share, in the fourth quarter 2016, an
increase of $3.9 million. Net loss in the fourth quarter was driven
by increased costs related to the ongoing LOCK-IT-100 clinical
study and by increases in CMC and clinical supplies.
Operating expenses in the fourth quarter 2017 were $10.4 million,
compared to $8.0 million in the third quarter of 2017, an increase
of approximately 30%. This increase was due primarily to a
$2.4 million, or 40% 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 and
CMC/clinical supply expenses increased by $0.7
million.
Full-Year 2017 Financial Highlights
For the year ended December 31, 2017, the Company recorded a net
loss of $33.0 million, or $0.60 per share, compared with $24.6
million, or $0.65 per share for the year ended December 31, 2016.
These increases were driven by increasing R&D expenses related
to the LOCK-IT-100 clinical trial.
Operating expenses for the year ended December 31, 2017 were $33.1
million, compared to $24.6 million for the year ended December 31,
2016. This increase was due to R&D expenses related to the
LOCK-IT 100 clinical trial.
At December 31, 2017, CorMedix had $12.0 million in cash and
short-term investments. During the fourth quarter, the Company
raised net proceeds of approximately $5.2 million through its
At-the-Market (ATM) program, selling its common stock at an average
price of $0.61 per share. On November 9, 2017, CorMedix
executed a combined $5 million investment and backstop facility
with Elliott Associates, L.P. and Elliott International, L.P., (the
“Elliott Funds”), long-term institutional investors in
CorMedix, consisting of $2 million of Series F Convertible
Preferred Stock and a $3 million Backstop Facility to purchase
additional Series F Convertible Preferred Stock, at
CorMedix’s sole discretion, beginning January 15, 2018,
through March 31, 2018. No drawings under the backstop
facility have been made. The Company has signed a binding term
sheet with Elliott Management Corporation for a proposed new $3
million Backstop Facility, which subject to completion of
documentation, would be available for drawing between April 16,
2018 and July 31, 2018.
The Company anticipates that its cash and short-term investments at
December 31, 2017 plus the proceeds of its ATM program and the
proposed new $3 million Backstop Facility will fund its
requirements into the third quarter of 2018.
Conference Call
Information:
CorMedix CEO, Khoso Baluch will host a conference call and webcast
today, March 19, 2018, at 4:30 PM Eastern Time, to discuss recent
corporate developments and financial results. Call details and
dial-in information is as follows:
Domestic:
877-407-9124
International:
201-689-8584
Passcode:
13677521
Webcast:
http://www.investorcalendar.com/event/26867
Replay
will be available through April 2:
Domestic:
877-481-4010
International:
919-882-2331
Conference
ID:
26867
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 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 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,
including with respect to possible uses of taurolidine, 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 risk of negotiating a definitive agreement for and
closing the proposed backstop financing transaction; the possible
inability to capture sufficient CRBSI events in the ongoing Phase 3
clinical trial for Neutrolin® even with the
reported changes to that trial; the cost, timing and results of the
ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and
the resources needed to commence and complete those trials; the
risks and uncertainties associated with CorMedix’s ability to
manage its limited cash resources and the impact on planned or
future research, including completion of the interim analysis of
the ongoing Phase 3 LOCK-IT 100 trial for Neutrolin and for
additional uses for taurolidine; obtaining additional financing to
support CorMedix’s research and development and clinical
activities and operations; 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 INCOME (LOSS)
|
|
For the Three
Months
Ended December
31,
|
For the Years
Ended
December
31,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
Revenue:
|
|
|
|
|
|
Net
sales
|
$92,526
|
$121,716
|
$329,327
|
$224,105
|
|
Cost of
sales
|
63,312
|
(85,331)
|
(114,964)
|
(366,673)
|
|
Gross profit
(loss)
|
155,838
|
36,385
|
214,363
|
(142,568)
|
|
Operating
Expenses:
|
|
|
|
|
|
Research and
development
|
(8,457,971)
|
(4,032,335)
|
(24,486,122)
|
(15,735,300)
|
|
Selling, general
and administrative
|
(1,968,398)
|
(2,433,443)
|
(8,652,351)
|
(8,883,050)
|
|
Total Operating
Expenses
|
(10,426,369)
|
(6,465,778)
|
(33,138,473)
|
(24,618,350)
|
|
Loss
From Operations
|
(10,270,531)
|
(6,429,393)
|
(32,924,110)
|
(24,760,918)
|
|
Other
Income (Expense):
|
|
|
|
|
|
Interest
income
|
21,550
|
32,846
|
110,714
|
126,774
|
|
Foreign exchange
transaction loss
|
(2,243)
|
(2,703)
|
(13,758)
|
(8,172)
|
|
Change in fair
value of derivative liability
|
(56,487)
|
-
|
(177,141)
|
-
|
|
Interest
expense
|
(2,809)
|
(165)
|
(5,619)
|
(1,311)
|
|
Total Other Income
(Expense)
|
(39,989)
|
29,978
|
(85,804)
|
117,291
|
|
Net
Loss
|
(10,310,520)
|
(6,399,415)
|
(33,009,914)
|
(24,643,627)
|
|
Other
Comprehensive Income (Loss):
|
|
|
|
|
|
Unrealized gain
(loss) from investments
|
90
|
(6,205)
|
13,103
|
11,027
|
|
Foreign currency
translation gain (loss)
|
3,632
|
4,093
|
4,144
|
8,029
|
|
Total Other
Comprehensive Income (Loss)
|
3,722
|
(2,112)
|
17,247
|
19,056
|
|
Comprehensive
Loss
|
(10,306,798)
|
(6,401,527)
|
(32,992,667)
|
(24,624,571)
|
|
Net
Loss Per Common Share – Basic and Diluted
|
$(0.15)
|
$(0.16)
|
$(0.60)
|
$(0.65)
|
|
Weighted
Average Common Shares Outstanding – Basic and
Diluted
|
66,722,074
|
40,381,500
|
55,141,133
|
37,967,373
|
CORMEDIX INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
|
December
31,
|
|
|
|
2017
|
2016
|
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$10,379,729
|
$8,064,490
|
|
Short-term
investments
|
$1,604,198
|
$12,100,920
|
|
Total
Assets
|
$13,453,933
|
$21,906,386
|
|
Total
Liabilities
|
$6,260,582
|
$4,091,860
|
|
Accumulated
deficit
|
$(152,174,866)
|
$(119,164,952)
|
|
Total
Stockholders’ Equity
|
$7,193,351
|
$17,814,526
|
CORMEDIX INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
Years
Ended December 31,
|
|
|
|
2017
|
2016
|
|
Cash
Flows From Operating Activities:
|
|
|
|
Net
loss
|
$(33,009,914)
|
$(24,643,627)
|
|
Net cash used in
operating activities
|
(28,587,180)
|
(22,265,395)
|
|
Cash
Flows Used In Investing Activities:
|
|
|
|
Net cash provided
by investing activities
|
10,357,838
|
11,419,770
|
|
Cash
Flows From Financing Activities:
|
|
|
|
Net cash provided
by financing activities
|
20,524,997
|
7,092,452
|
|
Net
Increase (Decrease) In Cash
|
2,315,239
|
(3,752,928)
|
|
Cash
- Beginning Of Period
|
8,064,490
|
11,817,418
|
|
Cash
- End Of Period
|
$10,379,729
|
$8,064,490
|