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 the pricing of its underwritten public
offering of 3,191,489 shares of its common stock for gross proceeds
of approximately $7.5 million, before deducting the underwriting
discounts and commissions and other estimated offering expenses
payable by Rockwell Medical. The offering is expected to close on
or about February 6, 2020, subject to customary closing conditions.
In addition, Rockwell Medical has granted the underwriter a 30-day
option to purchase up to 478,723 additional shares of common stock.
Cantor Fitzgerald & Co. is acting as the sole book-running
manager for the offering.
The underwriter may offer the shares from time to time for sale
in one or more transactions on The Nasdaq Global Market, in the
over-the-counter market, through negotiated transactions or
otherwise at market prices prevailing at the time of sale, at
prices related to prevailing market prices or at negotiated prices.
On February 3, 2020, the last sale price of the shares as reported
on The Nasdaq Global Market was $2.78 per share.
Rockwell Medical anticipates using the net proceeds from the
offering for the commercialization of Dialysate Triferic and I.V.
Triferic, research and development and general corporate
purposes.
The securities described above are being offered by Rockwell
Medical pursuant to a shelf registration statement previously filed
with and declared effective by the Securities and Exchange
Commission (the “SEC”). A preliminary prospectus supplement
and the accompanying prospectus related to the offering have been
filed with the SEC and are available on the SEC’s website at
www.sec.gov. Copies of the final prospectus supplement and
the accompanying prospectus relating to this offering may be
obtained, when available, from Cantor Fitzgerald & Co., Attn:
Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022;
Email: prospectus@cantor.com.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of
these securities in any state or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
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. The Company has
developed multiple formulations of Triferic (1) FDA-approved
Dialysate Triferic, and (2) I.V. Triferic, for which the Company
filed a New Drug Application in May 2019. 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.
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 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,” “plan”,
“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: changes to the offering as a result of market conditions
or for other reasons, the risk that the offering will not be
consummated, and the impact of general economic, industrial or
political 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.
Contact
Investor Relations:Lisa M. Wilson, In-Site Communications,
Inc.T: 212-452-2793E: lwilson@insitecony.com
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