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 has entered into a debt financing
agreement with an affiliate of Innovatus Capital Partners, LLC
("Innovatus") to provide the Company with up to $35.0 million in
term loans.
"We are pleased to partner with Innovatus on this transaction,"
said Stuart Paul, President and Chief Executive Officer of Rockwell
Medical. "This financing will provide flexibility as we continue
our mission to advance our novel therapeutic, Triferic, and to
transform the way anemia is managed around the world," concluded
Mr. Paul.
On March 16, 2020, the Company entered into a loan and security
agreement (the "Loan Agreement") with Innovatus pursuant to which
Innovatus has agreed to make certain term loans in the aggregate
principal amount of up to $35.0 million, with the funding of the
first $22.5 million tranche funded at closing. The Company will be
eligible to draw on a second tranche of $5,000,000 upon achievement
of certain milestones, including the U.S. Food and Drug
Administration approval of the Company’s NDA for I.V. Triferic. The
Company will be eligible to draw on a third tranche of $7.5 million
upon the achievement of certain additional milestones, including
the achievement of certain Triferic sales thresholds. The Company
is entitled to make interest-only payments for thirty months, or up
to thirty-six months if certain conditions are met. The loans will
mature on the fifth anniversary of the initial funding date. The
Loan Agreement includes customary warrant coverage and is secured
by all of the Company’s assets. Proceeds will be used for working
capital purposes.
"We are delighted to partner with Rockwell Medical in its
pursuit of transforming anemia management for dialysis patients,"
stated Claes Ekstrom, Managing Director at Innovatus.
This transaction is the culmination of a multi-step financing
process that Rockwell Medical initiated during the fourth quarter
of 2019. At the urging of shareholders, the Company prioritized
non-dilutive financing options as part of the process, and the
Company consummated the public offering of common stock in February
2020 to help facilitate this non-dilutive financing.
Cantor Fitzgerald & Co acted as sole financial advisor to
Rockwell Medical on this transaction.
Additional details regarding the Company's financing are
included in the Company’s Current Report on Form 8-K which is
expected to be filed with the Securities and Exchange Commission
within four business days of the date of this press release.
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.
Innovatus Capital Partners, LLC
Innovatus Capital Partners, LLC, is an independent adviser and
portfolio management firm with approximately $1.65B in assets under
management. Innovatus adheres to an investment strategy that
identifies disruptive and growth opportunities across multiple
asset categories with a unifying theme of capital preservation,
income generation, and upside optionality. The firm has a dedicated
team of life sciences investment professionals with deep experience
in healthcare, including life sciences. Innovatus and its
principals have significant experience providing debt financing to
medical device, diagnostics, and biotechnology companies that
address unmet medical needs, improve patient outcomes, and reduce
overall healthcare expenditures. Further information can be found
at www.innovatuscp.com.
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, 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: the timing and regulatory approval process for our NDA
filing for I.V. Triferic as filed with the FDA: the timing and
receipt of the loan amounts from Innovatus; Rockwell Medical’s
ability to achieve certain milestones under the Loan Agreement; and
the anticipated use of proceeds under the Loan Agreement, 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: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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