Conference Call Today at 4:30 p.m. Eastern Time
BEDMINSTER, NJ / ACCESSWIRE / November 10, 2016 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on
developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, today
reported financial results for the third quarter ended September 30, 2016, and highlighted recent business updates. The Company
will host a conference call today at 4:30 p.m. Eastern Time.
Key Business and Financial Updates:
Corporate:
- Appointed former Lilly and UCB executive Khoso Baluch as CEO, bringing >30 years of operational and product
launch experience, both U.S. and internationally - Entered into collaboration with Pediatric Oncology Experimental Therapeutics
Investigators Consortium (POETIC) to develop taurolidine-based therapies for treating rare pediatric cancers
Neutrolin® Phase 3 Program:
- Recently completed a comprehensive assessment of LOCK-IT 100, involving principle investigators
and other clinical staff from multiple clinical trial sites - Continued to enroll hemodialysis patients and engage new clinical
sites; currently expect to complete patient enrollment in LOCK-IT 100 in the fourth quarter of 2017 - Final LOCK-IT 200 Phase 3
study is planned to be conducted in oncology patients with chronic central venous catheters; timing of initiation will be based on
the final trial protocol and funding
Financial:
- $26.7 million in cash and short-term investments as of September 30, 2016, vs $28.6 million at June 30, 2016 -
Net change in cash during the third quarter was $1.9 million; net cash used in operation in the third quarter was $6.5 million -
Filed for a new $40 million at-the-market (ATM) program to replace, when available, the current ATM program that has $4.1 million
remaining
"Neutrolin has the potential to alleviate the significant public health and pharmacoeconomic burden caused by catheter-related
bloodstream infections, to the benefit of patients and healthcare systems worldwide," said Khoso Baluch, CorMedix CEO. "In the face
of antibiotic resistance and a vulnerable patient population, we expect Neutrolin to emerge as a powerful anti-infective with a
broad spectrum mechanism of action against most types of bacterial and fungal infections, including MRSA, without any evidence of
microbial resistance."
"Completing the Phase 3 program for Neutrolin as expeditiously as possible remains our highest priority. Following a
comprehensive assessment of LOCK-IT 100, which involved our principle investigators and other clinical staff from multiple clinical
sites in the study, as well as a number of our Key Opinion Leaders, regulatory counsel and biostatisticians, we have developed a
multi-pronged strategy to enhance our trial processes and accelerate patient enrollment. Based on current projections, we expect to
complete enrollment by the fourth quarter of 2017. We are committed and energized to bring this much-needed product candidate to
market, and to deliver long-term value to our shareholders through successful commercialization."
Mr. Baluch continued, "Beyond Neutrolin, we are excited about the prospects of our taurolidine-based platform based upon the
broad applicability of its anti-microbial and potentially therapeutic properties. To that end, we are evaluating the feasibility of
new indications and formulations of taurolidine by establishing several early research collaborations. Our newest collaboration
with POETIC to develop taurolidine as a therapy for rare, orphan indications like pediatric neuroblastoma and osteosarcoma is a
prime example of how, if feasible, CorMedix may unlock significant future value and build a pipeline of product candidates based on
the unique attributes of our taurolidine platform."
Selected Financial Results for the Three Months and Nine Months Ended September 30, 2016
For the three months ended September 30, 2016, CorMedix reported a net loss of $9.1 million, or $0.23 per share, compared to a
net loss of $4.7, or $0.14 per share for the same period last year, an increase of $4.4 million. For the nine months ended
September 30, 2016, the Company reported an operating loss of $18.2 compared to an operating loss of $14.3 million for the same
period last year, an increase of $3.9 million. The increase in operating loss from the previous quarter reflects the increased
activity in the on-going Phase 3 LOCK-IT-100 trial, manufacturing and product development.
The Company had $26.7 million in cash and short-term investments as of September 30, 2016, compared to $28.6 million as of June
30, 2016, a net reduction of $1.9 million. For the third quarter 2016, the Company used $6.5 million to fund operations, primarily
focused on conducting our Neutrolin Phase 3 program and related G&A activities. The cash used to fund operations was partially
offset by cash from financing sources. CorMedix received approximately $438,800 from the exercise of stock options for 567,500
common shares and $4.2 million from the sale of 2,541,716 common shares under the ATM program. As of September 30, 2016, there was
approximately $4.1 million remaining available under the current ATM program. CorMedix will have an additional $40 million
available under a new ATM program, once it receives a waiver from Elliott Associates, L.P. of participation rights and the
associated registration statement is declared effective by the SEC. Upon the new ATM becoming effective, the $4.1 million remaining
under the current ATM will expire.
The Company had 40.4 million, 37.3 million, and 36.1 million shares of common stock outstanding as of September 30, 2016, June
30, 2016, and March 30, 2016, respectively.
Mr. Baluch concluded, "Our goal is to remain focused on clinical execution in our Phase 3 studies while operating the company as
efficiently as possible, managing potential shareholder dilution against our ability to reach key value inflection points. We
believe this strategy has the potential to deliver maximum value for our shareholders upon clinical success for Neutrolin."
Readers are referred to, and encouraged to read in its entirety, the Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016, filed with the Securities and Exchange Commission, which includes updates on the Neutrolin Phase 3 clinical
program as well as the Company's business plans and operations, financial condition and results of operations.
Conference Call Information:
The live conference call is scheduled to begin today at 4:30 p.m. Eastern Time. Please call five minutes before the conference
call is scheduled to begin.
Dial-In (Toll Free) 877-407-9210 International Dial-In 201-689-8049
A replay of the teleconference will be available until November 17, 2016, 11:59 p.m. Eastern Time
Replay Number: 877-481-4010 Replay International: 919-882-2331 Conference ID: 10105
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 study in patients undergoing
chronic hemodialysis via a central venous catheter. The company is planning to conduct its second Phase 3 study 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, contributing to potentially FDA
priority review and up to 10 years of market exclusivity upon potential U.S. approval. It is already a CE Marked product in Europe
and other territories. CorMedix is also seeking to unlock additional value for its taurolidine-based technology by establishing
collaborative partnerships in oncology and medical device applications. 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 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; obtaining additional
financing to support CorMedix's research and development and clinical activities and operations; the risks and uncertainties
associated with CorMedix's ability to manage its limited cash resources; obtaining regulatory approvals to conduct clinical trials
and to commercialize CorMedix's product candidates, including marketing of Neutrolin in countries other than Europe; the risks
associated with the launch of Neutrolin in new markets; CorMedix's ability to enter into, execute upon and maintain collaborations
with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the
outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and
effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's
collaborations; 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 September 30, For the Nine Months Ended September 30, 2016 2015 2016 2015 Revenue $ 44,451 $ 35,947 $ 102,390 $
187,184 Cost of sales (43,922 ) (35,396 ) (281,342 ) (154,514 ) Gross profit (loss) 529 551 (178,952 ) 32,670 Operating Expenses:
Research and development (6,840,413 ) (1,764,468 ) (11,702,965 ) (4,796,571 ) Selling, general and administrative (2,318,091 )
(2,948,643 ) (6,449,608 ) (7,996,922 ) Total operating expenses (9,158,504 ) (4,713,111 ) (18,152,573 ) (12,793,493 ) Loss from
operations (9,157,975 ) (4,712,560 ) (18,331,525 ) (12,760,823 ) Interest income 32,866 25,019 93,928 30,817 Foreign exchange
transaction gain (loss) (1,091 ) 674 (5,622 ) (5,352 ) Value of warrants issued in connection with backstop financing - - -
(1,583,252 ) Interest expense - (1,609 ) (992 ) (2,635 ) Total Income (Expense) 31,775 24,084 87,314 (1,560,422 ) Net loss
(9,126,200 ) (4,688,476 ) (18,244,211 ) (14,321,245 ) Other comprehensive income (loss) (6,847 ) 7,082 21,168 814 Comprehensive
loss $ (9,133,047 ) $ (4,681,394 ) (18,223,043 ) (14,320,431 ) Net Loss Per Common Share – Basic and Diluted $ 0.23 $ 0.14 $ 0.49 $
0.48 CORMEDIX INC. AND SUBSIDIARY CONDENSED BALANCE SHEET INFORMATION September 30, 2016 (Unaudited) December 31, 2015* Assets
Cash, cash equivalents and short-term investments $ 26,653,659 $ 35,385,804 Total Assets $ 28,840,431 $ 37,101,729 Total
Liabilities $ 5,061,065 $ 3,090,241 Accumulated Deficit $ (112,635,806 ) $ (94,391,595 ) Total Stockholders' Equity $ 23,779,366 $
34,011,488
*Condensed from audited financial statements.
SOURCE: CorMedix Inc.
