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 it will host a conference call on
Monday, August 10, 2020, at 4:30 p.m. ET to discuss its financial
results for the three months ended June 30, 2020, and recent
operational highlights.
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 7990808.
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 kidney disease
(ESKD). Rockwell Medical's exclusive renal drug
therapies, Triferic (ferric pyrophosphate citrate) Dialysate and
Triferic AVNU, are the only FDA-approved therapeutics 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 Dialysate and Triferic
AVNU
Triferic Dialysate and Triferic AVNU are the
only FDA-approved therapies in the U.S. indicated to
replace iron and maintain hemoglobin in hemodialysis patients
during each dialysis treatment. Triferic Dialysate and Triferic
AVNU have a unique and differentiated mechanism of action, which
has the potential to benefit patients and health care economics.
Triferic Dialysate and Triferic AVNU represent a potential
innovative medical advancement in hemodialysis patient iron
management – with the potential to become the future standard of
care.
Triferic Dialysate and Triferic AVNU both
deliver approximately 5-7 mg iron with every hemodialysis treatment
to the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which 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 ESKD 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 intention to commercialize Triferic Dialysate, and
Triferic AVNU. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, and
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, but are not
limited to: the potential impact of the COVID-19 pandemic
(including, applicable federal state or local orders) on business
and operating results, including our supply chain, dialysis
concentrates business and the commercial launch of Triferic AVNU;
statements about the challenges inherent in new product development
and other indications and therapeutic areas for our products; the
likelihood of success with our NDS filing with Health Canada;
the success and of our commercialization of Triferic Dialysate,
which was launched in May 2019; the success and timing of our
evaluation program for Triferic AVNU and our commercial launch of
Triferic AVNU in the United States and Canada; the
risk that topline clinical data and real world results may not be
predictive of future results; the anticipated number of future
clinics with which we may contract for use of Triferic Dialysate;
the expected number of annualized treatments for Triferic Dialysate
and Triferic AVNU; potential future milestone payments and
royalties under our applicable license agreements; expected
financial performance, including cash flows, revenues, growth,
margins, funding, liquidity and capital resources; and those risks
more fully discussed in the “Risk Factors” section of our Quarterly
Report on Form 10-Q for the period ended March 31,
2020 and of our Annual Report on Form 10-K for the year
ended December 31, 2019, as such description may be amended or
updated in any future reports we file with
the SEC. Rockwell Medical expressly disclaims any
obligation to update our forward-looking statements, except as may
be required by law.
Triferic® is a registered trademark
of Rockwell Medical, Inc. Triferic AVNU is pending with
the U.S. Patent and Trademark Office.
CONTACTS
Investors: Argot Partners 212.600.1902
Rockwell@argotpartners.com
Media: David Rosen Argot Partners 212.600.1902
david.rosen@argotpartners.com
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