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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CorMedix Inc. Reports First Quarter Financial Results and Provides
Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Time
Recent Corporate and Clinical Highlights:
●
Completed
independent Data and Safety Monitoring Board (DSMB) review for
Phase 3 “LOCK-IT 100” study of Neutrolin® in hemodialysis
patients; Enrollment on track to exceed original target of 632
patients by 4Q17
●
Currently in
discussion with FDA regarding possible prospective changes to the
LOCK-IT 100 trial protocol; FDA agreed to include interim efficacy
analyses while the trial is ongoing
●
Secured first
European commercial collaboration with Hemotech SAS to launch and
market Neutrolin in France and French overseas
territories
●
Raised $14 million
in gross proceeds in a public offering of shares and
warrants
●
Demonstrated
taurolidine effectiveness at killing emerging global health threat
C. auris
●
Advancing studies
of taurolidine-infused antimicrobial medical materials: sutures,
nanofiber meshes, hydrogels
Anticipated Milestones:
●
Conduct LOCK-IT 100
interim efficacy analysis, potentially in 4Q17 pending attainment
of the requisite number of bloodstream infections in the
study
●
Complete enrollment
for LOCK-IT 100 in 2Q18; Report top-line data in the second half of
2018
●
Host R&D day to
discuss advances to taurolidine-based therapeutic and medical
device pipeline in 3Q17
Bedminster, NJ – May 10, 2017 – CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today provided
its corporate update for the first quarter ended March 31, 2017.
CorMedix will host a conference call today, May 10, 2017, at 4:30
p.m. Eastern Time to discuss the Company’s recent corporate
developments and financial results.
Khoso
Baluch, Chief Executive Officer of CorMedix, said, “We are
continuing to advance Neutrolin®, our
broad-spectrum, non-antibiotic anti-infective solution designed to
prevent costly and dangerous bloodstream infections associated with
the use of central venous catheters, toward the U.S. and
international markets. Our ongoing Phase 3 trial, LOCK-IT 100,
continues to enroll patients with end-stage renal disease receiving
hemodialysis through a central venous catheter, and an independent
data safety and monitoring unanimously concluded it was safe to
continue patient enrollment based on safety data from the first 279
patients. We currently anticipate exceeding our original enrollment
target of 632 patients by the fourth quarter of 2017, and will
continue to enroll additional patients until the requisite number
of catheter-related bloodstream infections occur in this
event-driven Phase 3 study. An interim efficacy analysis is
currently anticipated by the end of the year, which would give us
our first look into Neutrolin’s potential to reduce
catheter-related bloodstream infections in the study
population.”
1
“In
addition to advancing Neutrolin in the U.S., we were pleased to
announce that we’d secured our first European commercial
collaboration with Hemotech SAS to launch Neutrolin in France and
French overseas territories. This enables CorMedix to leverage
Hemotech’s nearly 30 years of experience and significant
presence, which includes 92% of all French dialysis organizations
as well as major hospitals, where Neutrolin’s CE Marking
allows it to be marketed as a catheter lock solution for oncology
and ICU patients with central venous catheters. We intend to pursue
additional partnerships designed to further expand ex-U.S. sales of
Neutrolin and begin augmenting our commercial presence in Europe.
We expect to begin generating initial sales revenue over the
quarters to come, which over time may partially offset our
operational and clinical development costs in the
U.S.”
Mr.
Baluch continued, “CorMedix is committed to taking advantage
of additional opportunities to generate value based on taurolidine,
the active component of Neutrolin. A particular area of focus is in
the medical device space, where taurolidine may be incorporated
into various medical and surgical materials to confer antimicrobial
or anti-inflammatory properties. Based on initial feasibility work,
we are advancing preclinical studies for three product candidates:
surgical meshes, suture materials, and hydrogels. We expect to
develop and pursue FDA clearance for these potential products by
the 510(k) pathway and will seek to establish
development/commercial partnerships as these programs advance. A
more robust ‘R&D day’ event will be scheduled
within the coming months to discuss these and our ongoing oncology
collaboration in greater detail.”
For the
first quarter 2017, the Company recorded a net loss of $7.6
million, or $0.19 per share, compared with a net loss of $4.1
million, or $0.11 per share for the first quarter 2016. Operating
expenses in the first quarter 2017 were $7.6 million, compared with
$6.5 million in the fourth quarter of 2016. The increase was due to
an increase in both R&D and G&A expense. Our cash used in
operations in the first quarter 2017 was $6.8 million, compared
with $6.5 million in the fourth quarter 2016. Cash was used
primarily to conduct our Phase 3 study of Neutrolin, other R&D
and related G&A activities. Our operating cash burn was funded
primarily via drawdown of our cash on hand. Approximately $0.3
million was provided by the use of the Company’s “At
the Market” program during January 2017.
CorMedix
recently completed a public offering of common stock and warrants
resulting in gross proceeds of $14 million, before deducting
underwriting discounts and commissions and estimated offering
expenses. The offering included the full exercise of underwriter
H.C. Wainwright and Co.’s option to purchase additional
shares of common stock and warrants from CorMedix.
Mr.
Baluch concluded, “We are dedicated to bringing Neutrolin to
market, to help prevent potentially deadly catheter-related blood
stream infections in already vulnerable patient populations in the
U.S. and abroad. Our recent financing adds fuel to continue our
U.S. pivotal clinical program, while in parallel, we’re
continuing to enhance our focus on driving additional value through
European commercialization and advancement of our taurolidine-based
therapeutic and medical device pipeline.”
2
Conference Call Information:
Please
call five minutes before the conference call is scheduled to
begin.
Dial-In
(Toll Free)
|
877-407-9124
|
International
Dial-In
|
201-689-8584
|
The
live audio webcast will be accessible via the Events section of the
CorMedix
website.
A
replay of the teleconference will be available until 11:59 p.m. on
May 17, 2017.
Replay
Number:
|
877-481-4010
|
Replay
International:
|
919-882-2331
|
Conference
ID:
|
10381
|
About CorMedix Inc.
CorMedix Inc. is a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease. 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. Such
infections cost the U.S. healthcare system approximately $6 billion
annually and contribute significantly to increased morbidity and
mortality. Neutrolin is currently in a Phase 3 clinical trial in
patients undergoing chronic hemodialysis via a central venous
catheter. The Company is planning to conduct its second Phase 3
clinical trial in patients with cancer receiving IV parenteral
nutrition, chemotherapy and hydration via a chronic central venous
catheter, subject to sufficient resources. If successful, the two
pivotal studies may be submitted to the FDA for potential approval
for both patient populations. 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 upon U.S. approval. It
is already a CE Marked product in Europe and other territories. For
more information, visit:
www.cormedix.com.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua
Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine
McCargo: jmccargo@tiberend.com; (646) 604-5150
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
timing and results of the planned interim efficacy analyses of the
LOCK-IT 100 trial and the impact of those results on that trial;
the cost, timing and results of the planned and ongoing Phase 3
trials for Neutrolin® in the U.S.,
including variances in the expected rate of CRBSI events, 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; CorMedix’s ability to obtain
financing to support its research and development and clinical
activities and operations; the risks associated with the launch of
Neutrolin in new markets; obtaining regulatory approvals to
conduct clinical trials and to commercialize CorMedix's product
candidates, including the planned Phase 3 trial of Neutrolin in
oncology patients and the marketing of Neutrolin in countries other
than Europe; the outcome of clinical trials of CorMedix's product
candidates and whether they demonstrate these candidates' safety
and effectiveness; CorMedix's ability to enter into, execute upon
and maintain collaborations with third parties for its development
and marketing programs; CorMedix's dependence on its collaborations
and its license relationships; CorMedix's ability to maintain its
listing on the NYSE MKT; CorMedix's dependence on preclinical and
clinical investigators, preclinical and clinical research
organizations, manufacturers, sales and marketing organizations,
and consultants; and protecting the intellectual property developed
by or licensed to CorMedix. 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.
3
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
AND
COMPREHENSIVE LOSS
(Unaudited)
|
Three
Month Periods Ended March 31,
|
|
|
2017
|
2016
|
Revenue
|
|
|
Net
sales
|
$39,559
|
$41,427
|
Cost
of sales
|
(93,571)
|
(50,229)
|
Gross
profit (loss)
|
(54,012)
|
(8,802)
|
|
|
|
Operating
Expenses
|
|
|
Research and
development
|
(4,924,267)
|
(2,089,592)
|
Selling,
general and administrative
|
(2,640,726)
|
(2,050,143)
|
Total
operating expenses
|
(7,564,993)
|
(4,139,735)
|
Loss
From Operations
|
(7,619,005)
|
(4,148,537)
|
Other
Income (Expense)
|
|
|
Interest
income
|
23,431
|
31,636
|
Foreign
exchange transaction loss
|
(1,286)
|
(487)
|
Interest
Expense
|
-
|
(992)
|
Total income
(expense)
|
22,145
|
30,157
|
Net
Loss
|
(7,596,860)
|
(4,118,380)
|
Other
Comprehensive Income Gain (Loss)
|
|
|
Unrealized
gain (loss) from investment
|
10,113
|
(793)
|
Foreign
currency translation gain (loss)
|
(992)
|
31,645
|
Total
comprehensive income
|
9,121
|
30,852
|
Comprehensive
Loss
|
$(7,587,739)
|
$(4,087,528)
|
Net
Loss Per Common Share – Basic and Diluted
|
$(0.19)
|
$(0.11)
|
Weighted
Average Common Shares Outstanding – Basic and
Diluted
|
40,624,920
|
36,012,756
|
4
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
March
31,
|
December
31,
|
|
2017
|
2016
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$6,818,668
|
$8,064,490
|
Short-term
investments
|
$6,950,960
|
$12,100,920
|
Total
Assets
|
$14,933,152
|
$21,906,386
|
|
|
|
Total
Liabilities
|
$3,889,963
|
$4,091,860
|
Accumulated
deficit
|
$(126,761,812)
|
$(119,164,952)
|
Total
Stockholders’ Equity
|
$11,043,189
|
$17,814,526
|
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
Three
Month Periods Ended March 31,
|
|
|
2017
|
2016
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net
loss
|
$(7,596,860)
|
$(4,118,380)
|
Net cash used in
operating activities
|
(6,758,726)
|
(5,450,588)
|
CASH FLOWS USED IN
INVESTING ACTIVITIES:
|
|
|
Net cash provided
by investing activities
|
5,158,075
|
6,547,842
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from sale
of common stock from at-the-market program
|
347,361
|
149,276
|
Proceeds from
exercise of stock options
|
6,800
|
116,700
|
Net cash provided
by financing activities
|
354,161
|
265,976
|
NET INCREASE
(DECREASE) IN CASH
|
(1,245,822)
|
1,367,358
|
CASH - BEGINNING OF
PERIOD
|
8,064,490
|
11,817,418
|
CASH - END OF
PERIOD
|
$6,818,668
|
$13,184,776
|
5