Blueprint
Exhibit
99.1
CorMedix Inc. Provides Update on its Financing Plans in Connection
with its Ongoing LOCK-IT 100 Clinical Study
Berkeley Heights, NJ – February 27, 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 provided
guidance regarding the actions it may undertake to meet any
additional capital needs prior to the anticipated interim efficacy
analysis of its LOCK-IT 100 clinical study.
Khoso Baluch, Chief Executive Officer of CorMedix stated, “We
are working as quickly and as diligently as possible to complete
the quality assurance procedures necessary for the interim efficacy
analysis and subsequent review by the Data Safety Monitoring Board
(DSMB). We understand the financial impact of each week we spend in
this effort, and at the same time we recognize the need to ensure
the accuracy and completeness of the data required for conducting
the interim efficacy analysis. Given our poor current market
valuation, we intend to minimize dilution to our shareholders by
adhering to our financial strategy of raising as small an amount of
capital as necessary to get us through the DSMB’s
review.”
Based on the Company’s current cash resources, the estimated
cost of continuing the LOCK-IT 100 clinical study until the interim
efficacy analysis is completed, and by reducing or delaying other
activities until after the results of the interim efficacy analysis
are known, the Company believes it will be able to fund operations
into June 2018 and anticipates that any remaining short-term
capital needs may be met through small opportunistic
financings similar to those it
completed during the fourth quarter of 2017.
The Company expects to report its fourth quarter and full year 2017
financial results on March 19, 2018.
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 a Phase 3 clinical trial
enrolling 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,
including with respect to possible uses of taurolidine, 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 possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin®;
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; 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
ongoing LOCK-IT 100 trial and research for additional uses for
taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities
and operations; preclinical results are
not 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
Contacts:
Dan
Ferry
Managing
Director
LifeSci
Advisors