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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CORMEDIX INC. RECEIVES A CONTINUED LISTING STANDARD NOTICE FROM THE
NYSE AMERICAN
Berkeley Heights, NJ – June 19, 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 announced
that on June 14, 2018, it received a notice from the NYSE
American that, based on its Form 10-Q for the quarter ended March
31, 2018, filed on May 15, 2018, CorMedix does not meet a continued
listing standard of the NYSE American as set forth in Part 10 of
the NYSE American Company Guide. Specifically, it is not in
compliance with Section 1003(a)(i) (requiring stockholders’
equity of $2.0 million or more if it has reported losses from
continuing operations and/or net losses in two of its three most
recent fiscal years), Section 1003(a)(ii) (requiring
stockholders’ equity of $4.0 million or more if it has
reported losses from continuing operations and/or net losses in
three of its four most recent fiscal years); and Section
1003(a)(iii) (requiring stockholders’ equity of $6.0 million
or more if it has reported losses from continuing operations and/or
net losses in its five most recent fiscal years). The notice noted
that the Company reported stockholders’ equity of $0.8
million as of March 31, 2018, and net losses in its five most
recent fiscal years ended December 31, 2017. As a result, CorMedix
has become subject to the procedures and requirements of Section
1009 of the Company Guide. CorMedix must submit to the NYSE
American, no later than July 16, 2018, a plan of compliance to
address how it intends to regain compliance with Section
1003(a)(i), Section 1003(a)(ii) or Section 1003(a)(iii) of the
Company Guide by December 16, 2019 (the “Sections
1003(a)(i)-(iii) Plan Period”). If the plan is accepted by
the NYSE American, the Company may be able to continue its listing
during the Sections 1003(a)(i)-(iii) Plan Period, during which time
it will be subject to periodic review to determine whether it is
making progress consistent with the plan.
If the
Company is not in compliance with the NYSE American’s
continued listing standards of Section 1003(a)(i), Section
1003(a)(ii) or Section 1003(a)(iii) within the timeframe provided,
or does not make progress consistent with the plan during the
Sections 1003(a)(i)-(iii) Plan Period, the NYSE American will
initiate delisting proceedings.
The Company is
preparing a plan of compliance that it intends to submit to NYSE
American by the due date. The Company cannot assure that its plan,
once submitted, will be accepted. The Company’s common stock
will continue to trade on NYSE American during the period of
non-compliance unless and until the exchange delists
it. Receipt of the
Notice does not affect CorMedix’s business operations or its
Securities and Exchange Commission reporting
requirements.
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 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, including the interim analysis for the ongoing Phase 3
clinical trial; 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; the possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin®;
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 Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746