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 year end 2017 to support FDA submission in 2018
BEDMINSTER, NJ / ACCESSWIRE / August 9, 2017 / 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
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 year-end. 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
SOURCE: CorMedix Inc.
