Blueprint
Exhibit
99.1
CORMEDIX INC. REPORTS SECOND QUARTER FINANCIAL RESULTS AND PROVIDES
BUSINESS UPDATE
LOCK-IT-100 trial results positive; trial halted for
efficacy
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
developments.
“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
filing.”
Recent Corporate and Clinical Highlights:
●
Announced
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
filing.
Second Quarter and First Half 2018 Financial
Highlights
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
costs.
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%.
Total
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
FDA.
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
Webcast:
http://www.investorcalendar.com/event/35301
A replay will be available through August 28 by
dialing:
Domestic: 877-481-4010
Replay PIN: 35301
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 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
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 resources needed to terminate the Phase 3 trial and
the costs and time needed to submit a new drug application to the
FDA; risks related to obtaining FDA approval of the new drug
application for Neutrolin; 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; relying on preclinical results that may not be
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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
|
|
For the Three
Months Ended June 30,
|
For the Six
Months Ended June
30,
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
Net
sales
|
$7,551
|
$136,168
|
$30,760
|
$175,727
|
|
Cost of
sales
|
(33,663)
|
(18,052)
|
(62,238)
|
(111,624)
|
|
Gross profit
(loss)
|
(26,112)
|
118,116
|
(31,478)
|
64,103
|
|
Operating
Expenses:
|
|
|
|
|
|
Research and
development
|
(6,600,215)
|
(5,089,624)
|
(14,880,658)
|
(10,013,891)
|
|
Selling, general
and administrative
|
(1,945,825)
|
(2,051,093)
|
(3,848,838)
|
(4,691,819)
|
|
Total Operating
Expenses
|
(8,546,040)
|
(7,140,717)
|
(18,729,495)
|
(14,705,710)
|
|
Loss
From Operations
|
(8,572,152)
|
(7,022,601)
|
(18,760,973)
|
(14,641,607)
|
|
Other
Income (Expense):
|
|
|
|
|
|
Interest
income
|
10,196
|
28,578
|
24,971
|
52,009
|
|
Foreign exchange
transactions loss
|
5,043
|
(5,537)
|
(4,154)
|
(6,823)
|
|
Change in fair
value of derivative liability
|
-
|
1,853,365
|
-
|
1,853,365
|
|
Interest
expense
|
-
|
-
|
(1,873)
|
-
|
|
Total Other Income
(Expense)
|
15,239
|
1,876,406
|
18,944
|
1,898,551
|
|
Net
Loss
|
(8,556,913)
|
(5,146,195)
|
(18,742,029)
|
(12,743,056)
|
|
Other
Comprehensive Income (Loss):
|
|
|
|
|
|
Unrealized gain
(loss) from investments
|
-
|
300
|
-
|
10,413
|
|
Foreign currency
translation gain (loss)
|
394
|
6,077
|
(1,030)
|
5,085
|
|
Total Other
Comprehensive Income (Loss)
|
394
|
6,377
|
(1,030)
|
15,498
|
|
Comprehensive
Loss
|
(8,556,519)
|
(5,139,818)
|
(18,743,059)
|
(12,727,558)
|
|
Net
Loss Per Common Share – Basic and Diluted
|
$(0.10)
|
$(0.10)
|
$(0.24)
|
$(0.27)
|
|
Weighted
Average Common Shares Outstanding – Basic and
Diluted
|
82,354,273
|
52,583,177
|
78,692,987
|
46,637,083
|
CORMEDIX INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
Cash, cash
equivalents and restricted cash
|
$4,873,531
|
$10,551,282
|
|
Short-term
investments
|
$-
|
$1,604,198
|
|
Total
Assets
|
$5,926,549
|
$13,453,933
|
|
Total
Liabilities
|
$12,404,566
|
$6,260,582
|
|
Accumulated
deficit
|
$(170,900,158)
|
$(152,174,866)
|
|
Total
Stockholders’ Equity (Deficit)
|
$(6,478,017)
|
$7,193,351
|
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six Month
Periods Ended June 30,
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
Net
loss
|
$(18,742,029)
|
$(12,743,056)
|
|
Net cash used in
operating activities
|
(11,389,784)
|
(14,509,911)
|
|
CASH FLOWS USED IN
INVESTING ACTIVITIES:
|
|
|
|
Net cash provided
by investing activities
|
1,565,973
|
1,221,216
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
Proceeds from sale
of common stock from at-the-market program
|
4,149,713
|
347,361
|
|
Proceeds from the
public offering of common stock and warrants
|
-
|
12,798,325
|
|
Proceeds from
exercise of stock options
|
-
|
6,800
|
|
Net cash provided
by financing activities
|
4,149,713
|
13,152,486
|
|
NET DECREASE IN
CASH
|
(5,677,751)
|
(127,102)
|
|
CASH - BEGINNING OF
PERIOD
|
10,551,282
|
8,236,043
|
|
CASH - END OF
PERIOD
|
$4,873,531
|
$8,108,941
|