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EX-10.1 - FORM OF INDEMNIFICATION AGREEMENT - CorMedix Inc. | exhibit101.htm |
8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CorMedix Inc. Appoints Mehmood Khan, M.D. and Steven Lefkowitz to
its Board of Directors
Gary Gelbfish, M.D. Appointed as Observer to the Company’s
Board of Directors by Elliott Management
Bedminster, NJ – June 26, 2017 – CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today announced
the appointment of Mehmood Khan, M.D., and Steven
Lefkowitz to its Board of
Directors, effective immediately. The Company also announced that
Gary Gelbfish, M.D., has been appointed by CorMedix’s largest
shareholder, Elliott Management, as an observer to the
Company’s Board of Directors.
Directors
Taunia Markvicka and Michael George have resigned their positions
on CorMedix’s Board, effective immediately.
Khoso
Baluch, CorMedix Chief Executive Officer and a member of the Board
stated, “I am excited to have Dr. Khan and Mr. Lefkowitz join
the Company and to have Dr. Gelbfish as an observer to the
Board. We thank Dr. Markvicka and Mr. George for their
service to the Company and wish them well in their future
endeavors. We believe we have positioned the Company for success,
but we continue our efforts to identify candidates with relevant
expertise to supplement our restructured Board of
Directors.”
Company shareholder Elliott Management said “We believe Dr.
Khan, Mr. Lefkowitz, and Dr. Gelbfish (as an observer) are
excellent additions to the CorMedix Board and will be able to
provide important guidance to the Company in core areas at this
critical time in its history. All CorMedix shareholders
including Elliott have been understandably frustrated by the
Company’s stock price, but with these changes we support the
Board and CEO Khoso Baluch who have taken a significant step in
addressing shareholder concerns.”
Mr. Baluch continued, “Dr. Khan brings a wealth of
pharmaceutical and regulatory knowledge, and has extensive
experience with Board-level governance and decision making. We
believe his robust background in clinical trial management and
expertise in overseeing large, complex research and development
enterprises will be invaluable to CorMedix as we continue to
advance our lead product Neutrolin®
in the ongoing Phase 3 LOCK-IT 100
trial, as well as develop our other Taurolidine-based
products.”
Dr. Khan commented, “I am pleased to join the CorMedix Board
at this exciting time in the Company’s development. I believe
CorMedix presents a compelling opportunity for future success in
the treatment and prevention of infectious and inflammatory
disease. I look forward to contributing to the Company’s
development based on my previous work in the medical field and more
generally my experience with clinical trials and regulatory
compliance.”
Dr. Khan currently serves as Vice Chairman and Chief Scientific
Officer of Global Research and Development for PepsiCo, where he
leads global R&D and oversees the company’s 2025
sustainability agenda, which includes plans for the further
transformation of its current food and beverage portfolio as well
as expansion of offerings containing positive nutrition with a
focus on reaching more underserved communities and consumers with
healthier choices.
Previously, Dr. Khan served as President of Takeda
Pharmaceuticals’ Global Research & Development Center,
where he created and maintained a budget in excess of $1 billion
for the company’s global R&D pipeline excluding Japan,
leading a team of thousands including outsourced staff. Earlier in
his career Dr. Khan was a faculty member at the Mayo Clinic and
Mayo Medical School in Rochester, MN, serving as Director of the
Diabetes, Endocrine and Nutritional Trials Unit in the division of
endocrinology. Prior to the Mayo Clinic, Dr. Khan spent nine years
leading programs in diabetes, endocrinology, metabolism, and
nutrition for the Hennepin County Medical Center in Minneapolis.
His practice included extensive work with patients with diabetes
requiring hemodialysis as well as parenteral
nutrition.
In his current and prior R&D roles, Dr. Khan has recruited
highly regarded scientists and medical experts, launched research
projects with leading universities worldwide, and opened new global
R&D centers. He also currently serves as a member of the board
of directors for
HemoShear Therapeutics, a biotechnology company focused on
discovering novel biological targets and developing drugs to treat
rare juvenile metabolic disorders. He earned his medical degree from the University
of Liverpool Medical School, England.
Mr. Lefkowitz is the Founder of Wade Capital Corporation a
financial advisory services company focused on small and middle
markets and has been its President since June 1990. Mr.
Lefkowitz has also served as a director of both publicly traded and
privately held companies. He has been a director of AIS, RE,
a privately held reinsurance company since 2001. Mr.
Lefkowitz was a director of Franklin Credit Management Corporation,
formerly known as Franklin Credit Holding Corporation, a public
specialty consumer finance company from 1996 through 2015, and a
director and chairman of the board of MedConx, Inc., a privately
held medical devices connector company from 2007 through
2015. Mr. Lefkowitz received his A.B. from Dartmouth College
in 1977 and his M.B.A. from Columbia University in
1985.
Mr. Lefkowitz returns to the board of CorMedix where, as a director
from August 2011 to June 2016, he brought his extensive experience
in financing micro-cap biotech companies and helped the Company
successfully complete multiple capital raises. He served as
the interim Chief Financial Officer of CorMedix from August
15, 2013 to July 20, 2014.
Mr. Lefkowitz said, “I’m excited to return to the Board
of Directors of CorMedix. I intend to bring my prior experience as
a CorMedix board member, in addition to my 30 years of corporate
finance experience, including investment banking, private equity
and microcap financing, back to the leadership of this company as
it works toward the completion of its pivotal Phase 3 trial and
also explores new ways to leverage its expertise in Taurolidine for
the benefit of patients, shareholders and
employees”.
Dr Gary Gelbfish has practiced vascular surgery since 1990,
specializing exclusively in treating hemodialysis patients. As such
he has a deep understanding and significant practical experience
with dialysis units and in the placement, care and complications of
central venous ports and catheters. He has published and lectured
widely on vascular access.
Dr. Gelbfish graduated from Columbia University College of
Physician and Surgeons, is board certified by the American Board of
Surgery and is a Fellow of the American college of Surgeon. He is
an Assistant Clinical Professor of Surgery at the Mount Sinai
School of Medicine in NYC.
Dr. Gelbfish was a director of CorMedix from December 2009 and
chairman from 2012 until June 2014. During this period, CorMedix
received the European CE mark for Neutrolin, began the Neutrolin
Usage Monitoring Program (NUMP) and he spearheaded the company
effort to delineate with the FDA the study design and parameters of
the ongoing Phase III study.
Dr. Gelbfish has invented two FDA approved 510(k) devices and
currently serves as CEO and Chairman of Metrodora Therapeutics LLC,
a clinical stage biotechnology company with an active IND.
Its biologic is currently in Phase I trials for patients with
anemia associated with Crohn’s disease.
The
Company continues to engage in constructive dialogue with its
shareholders and remains committed to achieving a timely and
successful completion of the Phase 3 LOCK-IT 100 trial for
Neutrolin®. CorMedix will
hold an R&D Day event on July 12, 2017, where the Company will
provide an overview of its entire Taurolidine-based development
pipeline.
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.
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 ability to identify and attract qualified director
candidates; 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 and
the impact on planned or future research, including for additional
uses for taurolidine; 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;
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.
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