Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, today announced that the Board of Directors has appointed
Russell H. Ellison, M.D., M.Sc. as President and Chief Executive
Officer, effective immediately. Dr. Ellison will continue to serve
as a member of the Company’s Board. Stuart Paul has resigned as
President and Chief Executive Officer and as a member of the
Company’s Board of Directors.
“Rockwell Medical is focused on transforming the
treatment of iron deficiency and anemia around the world to improve
outcomes for patients. To achieve that goal, we continue to develop
into a more medically- and scientifically-driven company. Given
that vision, we are pleased to appoint Russell as Chief Executive
Officer to lead our company through its important next phase of
growth, which will focus on leveraging the medical attributes of
our ferric pyrophosphate citrate technology. Our key milestones
include driving adoption of and product revenue from Dialysate
Triferic® and successfully bringing Triferic AVNU to the
hemodialysis market, as well as strategically identifying and
pursuing new potential indications for other diseases,” said John
P. McLaughlin, Chairman of the Board of Directors of Rockwell
Medical. “Russell’s extensive medical expertise, deep understanding
of the renal and anemia space based on his experience developing
therapeutic products, experience as a CEO of public and private
companies, and capital markets knowledge make him an ideal
candidate to drive our strategic direction. I would like to thank
Stuart for his service to our Company, including his tireless work
to launch Dialysate Triferic and bring Triferic AVNU, the IV
formulation, through U.S. regulatory approval.”
“Through my work to date with Rockwell Medical
as a consultant and a member of the Board, I have gained an
increased appreciation for the unique medical attributes of
Triferic and the various opportunities we have to help patients
with iron deficiency and create value for Rockwell Medical
shareholders,” said Dr. Ellison. “I am honored to lead the Company
and look forward to continuing to work with my colleagues and other
Rockwell Medical stakeholders to advance and deliver on the
Company’s strategy.”
Dr. Ellison’s broad experience and previous
leadership positions include Chief Executive Officer of the
privately held biotechnology company, Promedior, Inc. (acquired by
Roche); President and Chief Executive Officer of Bond Biosciences,
Inc., a biotech start-up developing a drug addressing the toxic
impact of iron overload in the body; Executive Director of Torreya
Advisors, LLC, a life sciences investment banking firm; Chairman
and Chief Executive Officer of Assembly Biosciences, Inc. (formerly
Ventrus Biosciences, Inc.); Executive Vice President of Paramount
Biosciences LLC, a global drug development and healthcare
investment firm; Vice President of Clinical Development of
FibroGen, Inc., where he played a key role in the early phase
development of roxadustat in anemia for chronic kidney disease
(CKD) patients; Vice President of Medical Affairs and Chief Medical
Officer of Sanofi-Synthelabo US, Inc.; and Vice President, Medical
Affairs and Chief Medical Officer of Hoffman La Roche, Inc. in the
United States.
Dr. Ellison previously served on the Board of
Directors for several private and public companies, including
Cougar Biotechnology Inc.; ProSanos Corporation; Cormedix Inc., a
cardio-renal clinical stage company; and Mt. Cook, a
urology-focused company. Dr. Ellison received a Master of Science
degree from the London School of Tropical Medicine and Hygiene, and
an M.D. from the University of British Columbia.
Q1 2020 and Business Update Conference
Call and Webcast
Additionally, the Company announced that
Rockwell Medical's management team will host a conference call and
audio webcast at 4:30 p.m. ET on Monday, May 11, 2020, to discuss
Q1 2020 financial results and provide a business update, including
an initial read-out from the Company’s real-world data
initiative.
To access the conference call, please dial (877)
383-7438 (local) or (678) 894-3975 (international) at least 10
minutes prior to the start time and refer to conference ID 9391556.
A live webcast of the call will be available under "Events &
Presentations" in the Investor section of the Company's
website, https://ir.rockwellmed.com/. An archived webcast will
be available on the Company's website approximately two hours after
the event and will be available for 30 days.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company
dedicated to transforming anemia management in a wide variety of
therapeutic areas and across the globe, improving the lives of very
sick patients. The Company’s initial focus is the treatment of
anemia in end-stage renal disease (ESRD). Rockwell Medical's
exclusive renal drug therapy, Triferic (ferric pyrophosphate
citrate), is the only FDA-approved therapeutic indicated for iron
replacement and maintenance of hemoglobin in hemodialysis patients.
Rockwell Medical is also an established manufacturer, supplier and
leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in
the U.S. and abroad.
About Triferic®
Triferic is the only FDA-approved therapy in the
U.S. indicated to replace iron and maintain hemoglobin in
hemodialysis patients via dialysate during each dialysis treatment.
Triferic has a unique and differentiated mechanism of action which
has the potential to benefit patients and health care economics.
Triferic represents a potential innovative medical advancement in
hemodialysis patient iron management – with the potential to become
the future standard of care. The Company has two FDA-approved
formulations of Triferic (1) Triferic Dialysate and (2) Triferic
AVNU.
Triferic delivers approximately 5-7 mg iron with
every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Triferic
donates iron immediately and completely to transferrin (carrier of
iron in the body) upon entry into the blood and is then transported
directly to the bone marrow to be incorporated into hemoglobin,
with no increase in ferritin (stored iron and inflammation) and no
reports of anaphylaxis in over 1,000,000 patient administrations,
addressing a significant medical need in overcoming Functional Iron
Deficiency (FID) in ESRD patients.
Important Safety
Information
Serious hypersensitivity reactions, including
anaphylactic-type reactions, some of which have been
life-threatening and fatal, have been reported in patients
receiving parenteral iron products. Patients may present with
shock, clinically significant hypotension, loss of consciousness,
and/or collapse. Monitor patients for signs and symptoms of
hypersensitivity during and after hemodialysis until clinically
stable. Personnel and therapies should be immediately available for
the treatment of serious hypersensitivity reactions.
Hypersensitivity reactions have been reported in 1 (0.3%) of 292
patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis
blood samples. Post dialysis serum iron parameters may overestimate
serum iron and transferrin saturation.
The most common adverse reactions (≥3% and at
least 1% greater than placebo) in controlled clinical studies
include: procedural hypotension (21.6%), muscle spasms (9.6%),
headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%),
dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract
infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous
(AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage
(3.4%).
Forward-Looking Statements
Certain statements in this press release may
constitute “forward-looking statements” within the meaning of the
federal securities laws, including, but not limited to, Rockwell
Medical’s expectations regarding the consummation of the offering,
the terms of the offering, and the satisfaction of customary
closing conditions with respect to the offering and the anticipated
use of the net proceeds of the offering. Words such as “may,”
“might,” “will,” “should,” “believe,” “expect,” “anticipate,”
“estimate,” “continue,” “could,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or similar expressions, or
statements regarding intent, belief, or current expectations, are
forward-looking statements. While Rockwell Medical believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward-looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Rockwell
Medical’s SEC filings), many of which are beyond our control and
subject to change. Actual results could be materially different.
Risks and uncertainties include: statements about the issuance of a
unique J code for our Triferic powder packet; timing and regulatory
approval process for Triferic Dialysate in China; the potential
market and commercialization opportunity of Triferic Dialysate in
China upon regulatory approval; the commercialization opportunity
and launch process for Triferic AVNU; the potential domestic and
international market opportunity for Triferic AVNU, as well as
other Rockwell Medical products; CMS’ announced final rule relating
to the eligibility criteria for TDAPA; liquidity and capital
resources; expected duration of Rockwell Medical’s existing working
capital; the success of our commercialization of Triferic
Dialysate, which commenced in May 2019; and the timing and success
of our efforts to maintain, grow and improve the profit margin of
the Company’s concentrate business; and the impact of general
economic, industrial or political conditions, as well as recent
health conditions in the United States or internationally, as well
as those risks more fully discussed in Rockwell Medical’s SEC
filings. Accordingly, you should not place undue reliance on these
forward-looking statements. Rockwell Medical expressly disclaims
any obligation to update or alter any statements whether as a
result of new information, future events or otherwise, except as
required by law.
Triferic® is a registered trademark of Rockwell
Medical, Inc.
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Sep 2023 to Sep 2024