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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CorMedix Announces NYSE American Acceptance of Plan to
Regain Listing Compliance
Berkeley Heights, NJ – August 31, 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 NYSE Regulation has accepted the
Company’s plan to regain compliance with the Exchange’s
continued listing standards set forth in Sections 1003(a)(i-iii) of
the NYSE American Company Guide. CorMedix submitted its plan on
July 16, 2018, and has been granted a plan period through December
16, 2019.
As
previously reported in a Current Report on Form 8-K filed with the
Securities and Exchange Commission on June 19, 2018, CorMedix was
notified on June 14, 2018, by the Exchange that the Company was not
in compliance with Section 1003(a)(i)-(iii) related to insufficient
stockholders’ equity.
This
notice from the Exchange has no immediate impact on the listing of
the Company’s common stock on the Exchange. The listing of
CorMedix’s common stock is being continued during the plan
period, during which time the Company will be subject to periodic
review to determine whether CorMedix is making progress consistent
with the accepted plan. If the Company does not make progress
consistent with the plan during the plan period, the NYSE may
initiate delisting proceedings as appropriate.
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 Phase 3 development for
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
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 resources needed to terminate the Phase 3 trial and
the costs and time needed to submit a new drug application to the
FDA; risks related to obtaining FDA approval of the new drug
application for Neutrolin; 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 continued development of Neutrolin and research for additional
uses for taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities
and operations; relying on preclinical results that may not be
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