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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CorMedix Inc. Reports Second Quarter Financial Results and Provides
Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Time
Recent Corporate and Clinical Highlights:
●
Implemented several
key FDA-agreed changes to the LOCK-IT-100 trial designed to enhance
event capture and significantly reduced the number of events
required to complete the study
●
Hosted R&D Day
to announce advances to the taurolidine-based therapeutic and
medical device pipeline
●
Appointed Mehmood
Khan, M.D., Steven Lefkowitz, and Gary Gelbfish, M.D., to the Board
of Directors; Elected Myron Kaplan Chairman of the Board of
Directors
●
Generated initial
revenue via Hemotech stocking of distribution channels in France;
European commercialization efforts continue
●
Significantly
reduced Neutrolin’s cost of goods, providing an opportunity
to compete effectively in the U.S. and international
markets
●
Received
shareholder approval to increase the Company’s authorized
share capital to 160 million common shares
Anticipated Milestones:
●
Conduct LOCK-IT-100
interim efficacy analysis, potentially in 4Q17 pending attainment
of the requisite number of catheter-related bloodstream infection
(CRBSI) events in the study
●
Complete enrollment
for LOCK-IT-100 by 2Q18; Report top-line data in the second half of
2018
●
Advance
taurolidine-incorporated medical device pipeline through animal
proof-of-concept studies expected to be completed by yearend 2017
to support FDA submission in 2018
Bedminster, NJ – August 9, 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 second quarter and six months ended
June 30, 2017. CorMedix will host a conference call today, August
9, 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, “Our
priority remains to bring Neutrolin®, our
broad-spectrum, non-antibiotic anti-infective solution to the U.S.
market. We are very excited that our recent discussions with the
FDA have proven fruitful. As announced in April 2017, we sought
guidance from the FDA to address, in part, the apparent overall
lower rate of catheter-related blood stream infection (CRBSI)
events in the blinded study. This is critical because CRBSI events
represent the outcome measure for the primary efficacy endpoint of
the study. Based on the information provided for the ongoing
LOCK-IT-100 study and a revised plan that we submitted to them, the
FDA agreed to key changes to the study intended to facilitate more
comprehensive capture of CRBSI events, and therefore, our ability
to complete the ongoing Phase 3 study. We appreciate the FDA
working with us on a solution to help bring this study to a
meaningful conclusion.
“The
key changes, as agreed to by the FDA, have already been instituted
by CorMedix, and include the use of an independent Clinical
Adjudication Committee (CAC) to critically assess all suspected
CRBSIs and determine, on a blinded, case-by-case basis, if the
particular event will be included in the primary analysis of the
primary efficacy endpoint of the study. The CAC will also base its
determination on a single positive blood culture along with
supporting documentation (as compared to two positive blood
cultures under the original protocol). Importantly, the FDA also
agreed to allow the CAC to evaluate suspected CRBSIs
retrospectively based on patient records and other documentation,
enhancing our ability to capture potential events that may have
been lost when patients went to non-participating emergency rooms
or urgent care centers with a suspected CRBSI. Finally, based on
amended study assumptions, which include a reduction in statistical
power from 90% to 80% and a moderate increase in the target
treatment effect from 40% to 55%, the total number of CRBSI events
required to complete the study was reduced from 161 events to 56
events. We expect to conduct a single interim efficacy analysis,
based upon successful capture of 28 CRBSI events, in the fourth
quarter of this year. The interim analysis may also potentially
allow CorMedix to conclude the study earlier than projected if the
interim data show sufficient Neutrolin
efficacy.”
Mr.
Baluch continued, “We recently hosted an R&D Day to
showcase the exciting science on which we have been working: to
incorporate taurolidine into medical devices, and to highlight the
potential for a taurolidine-based therapy for cancer.
“We
are especially excited about the development of taurolidine-infused
medical devices, because we anticipate pursuing approval of these
products under the 510(k) device pathway, which requires less time
and reduced development costs as compared to an NDA process for
drugs. Within potential medical devices, our efforts are focused on
three initial areas; antimicrobial surgical sutures, meshes, and
hydrogels. Upon potential FDA clearance, all three of our product
candidates will enter large markets where we believe they can
achieve significant market share and improve patient outcomes at a
minimal incremental cost. We are currently conducting
proof-of-concept studies in animal models, based on encouraging in
vitro data, and these studies are expected to complete by yearend.
If successful, we anticipate pursuing marketing applications in the
second half of 2018. We intend to commercialize our medical devices
in the U.S. and Europe through appropriate partners.
“In
addition to medical devices, we have also been active in our
collaboration with the Pediatric Oncology Experimental Therapeutics
Investigators' Consortium, or POETIC, on preclinical development of
taurolidine-based therapies for cancer. CorMedix and POETIC are
advancing this program through preclinical studies and will
determine a potential clinical strategy once in vivo
proof-of-concept is achieved. This represents another capital
efficient strategy to explore new ways to capitalize on our
taurolidine opportunity and build future value for
CorMedix.”
Mr.
Baluch added, “We are pleased with the work undertaken by our
technical operations team over the last 18 months. They have been
successful in their mission to significantly reduce the cost of
goods for Neutrolin, providing us the opportunity to effectively
compete in the international market place at a competitive level.
Outside the U.S., our focus continues to be on identifying partners
that have the right capabilities, strong infrastructure, and
established presence with our customer base. Our agreement with
Hemotech in France is an example of this strategy and we expect to
announce similar distribution agreements in the quarters to come.
While our resources remain focused on advancing Neutrolin in the
U.S., we look forward to augmenting our commercial presence in
Europe and other territories where we can leverage our CE
Mark.”
For the
second quarter 2017, CorMedix recorded a net loss of $5.1 million,
or $0.10 per share, compared with a net loss of $4.9 million, or
$0.13 per share for the second quarter 2016, an increase of $0.2
million. For the six months ended June 30, 2017, the Company
recorded a net loss of $12.7 million, or $0.27 per share, compared
with a net loss of $9.1 million, or $0.25 per share for the same
period in 2016, an increase of $3.6 million. These increases were
driven by higher R&D expenses, partially offset by a $1.9
million gain on the change of fair value of warrants recorded as a
derivative liability due to an insufficient number of authorized
shares available to reserve for the possible exercise of warrants
issued in the May 2017 public offering. Due to the approval on
August 8 to increase the Company’s authorized share capital,
the derivative liability associated with these warrants will be
reclassified into Stockholder’s Equity in the third quarter
of 2017.
Operating
expenses in the second quarter 2017 were $7.1 million, compared
with $4.7 million in the second quarter of 2016, an increase of
$2.4 million. The significant increase in operating expense was due
primarily to a $2.3 million increase in R&D expense resulting
from higher enrollment in the LOCK-IT-100 trial. Operating expenses
for the six months ended June 30, 2017, were $14.7 million compared
with $9.0 million for the same period in 2016, an increase of $5.7
million, driven by higher R&D expenses due to the LOCK-IT-100
clinical trial.
At June
30, 2017, CorMedix had $18.8 million in cash and short-term
investments compared to $13.8 million at March 31, 2017, a net
increase of $5.0 million. Cash used in operations during the
six-month period ended June 30, 2017, was $14.5 million, of which
$7.8 million was used in the second quarter vs. $6.8 million used
in the first quarter. Cash was used primarily to conduct the Phase
3 study of Neutrolin, other R&D and related G&A activities.
Operating cash burn was funded during the first six months
primarily via $12.8 million net proceeds from the May 2017 public
offering and by a drawdown of cash on hand. Approximately $0.3
million was provided by the use of the Company’s “At
the Market” program during January 2017.
Mr.
Baluch concluded, “Securing FDA approval of Neutrolin in the
U.S. remains our primary focus. We are dedicated to bringing
Neutrolin to market, to help prevent potentially deadly
catheter-related blood stream infections in already vulnerable
patient populations. We are pleased that the FDA has approved our
requested changes to enhance our ability to capture CRBSI events
and facilitate completion of the ongoing Phase 3 study as
previously guided.
“In
parallel, we are developing our medical device pipeline in the most
capital efficient manner possible. These devices have the potential
to unlock multiple additional markets, taking advantage of the
unique properties of taurolidine to potentially prevent surgical
site inflammation and infection, utilizing a fraction of the
capital required for an NDA.”
Conference Call Information:
CorMedix
will host a conference call and webcast on Wednesday, August 9,
2017, at 4:30 PM Eastern Time to discuss recent corporate
developments and financial results.
Dial-In
(Toll Free)
|
888-567-1603
|
International
Dial-In
|
862-255-5347
|
The
live audio webcast will be accessible via the Events section of the
CorMedix website.
There will not be live Q&A. To submit a question by email to be
answered on the call, please contact CorMedix@tiberend.com.
A
replay of the teleconference will be available until 11:59 p.m. on
August 16, 2017.
Replay
Number:
|
877-481-4010
|
Conference
ID:
|
19772
|
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.
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,
|
||
|
2017
|
2016
|
2017
|
2016
|
Revenue:
|
|
|
|
|
Net
sales
|
$136,168
|
$16,511
|
$175,727
|
$57,939
|
Cost of
sales
|
(18,052)
|
(187,192)
|
(111,624)
|
(237,421)
|
Gross profit
(loss)
|
118,116
|
(170,681)
|
64,103
|
(179,482)
|
Operating
Expenses:
|
|
|
|
|
Research and
development
|
(5,089,624)
|
(2,772,959)
|
(10,013,891)
|
(4,862,551)
|
Selling, general
and administrative
|
(2,051,093)
|
(1,968,580)
|
(4,691,819)
|
(4,131,516)
|
Total Operating
Expenses
|
(7,140,717)
|
(4,741,539)
|
(14,705,710)
|
(8,994,067)
|
Loss
From Operations
|
(7,022,601)
|
(4,912,220)
|
(14,641,607)
|
(9,173,549)
|
Other
Income (Expense):
|
|
|
|
|
Interest
income
|
28,578
|
29,426
|
52,009
|
61,062
|
Foreign exchange
transactions loss
|
(5,537)
|
(4,005)
|
(6,823)
|
(4,492)
|
Change in fair
value of derivative liability
|
1,853,365
|
-
|
1,853,365
|
-
|
Interest
expense
|
-
|
(41)
|
-
|
(1,033)
|
Total Other Income
(Expense)
|
1,876,406
|
25,380
|
1,898,551
|
55,537
|
Net
Loss
|
(5,146,195)
|
(4,886,840)
|
(12,743,056)
|
(9,118,012)
|
Other
Comprehensive Income (Loss):
|
|
|
|
|
Unrealized gain
(loss) from investments
|
300
|
24,791
|
10,413
|
23,997
|
Foreign currency
translation gain (loss)
|
6,077
|
(27,627)
|
5,085
|
4,018
|
Total Other
Comprehensive Income (Loss)
|
6,377
|
(2,836)
|
15,498
|
28,015
|
Comprehensive
Loss
|
(5,139,818)
|
(4,889,676)
|
(12,727,558)
|
(9,089,997)
|
Net
Loss Per Common Share – Basic and Diluted
|
$(0.10)
|
$(0.13)
|
$(0.27)
|
$(0.25)
|
Weighted
Average Common Shares Outstanding – Basic and
Diluted
|
52,583,177
|
36,447,467
|
46,637,083
|
36,230,111
|
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
June
30,
|
December
31,
|
|
2017
|
2016
|
|
|
|
ASSETS
|
|
|
Cash and cash
equivalents
|
$7,937,388
|
$8,064,490
|
Short-term
investments
|
$10,884,175
|
$12,100,920
|
Total
Assets
|
$21,155,502
|
$21,906,386
|
|
|
|
Total
Liabilities
|
$5,789,729
|
$4,091,860
|
Accumulated
deficit
|
$(131,908,008)
|
$(119,164,952)
|
Total
Stockholders’ Equity
|
$15,365,773
|
$17,814,526
|
CORMEDIX
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
Six Month
Periods Ended June 30,
|
|
|
2017
|
2016
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net
loss
|
$(12,743,056)
|
$(9,118,012)
|
Net cash used in
operating activities
|
(14,509,911)
|
(9,218,167)
|
CASH FLOWS USED IN
INVESTING ACTIVITIES:
|
|
|
Net cash provided
by investing activities
|
1,221,216
|
6,999,597
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from sale
of common stock from at-the-market program
|
347,361
|
2,010,327
|
Proceeds from the
public offering of common stock and warrants
|
12,798,325
|
-
|
Proceeds from
exercise of stock options
|
6,800
|
410,700
|
Net cash provided
by financing activities
|
13,152,486
|
2,421,027
|
NET INCREASE
(DECREASE) IN CASH
|
(127,102)
|
203,562
|
CASH - BEGINNING OF
PERIOD
|
8,064,490
|
11,817,418
|
CASH - END OF
PERIOD
|
$7,937,388
|
$12,020,980
|