Rockwell Medical, Inc.Announces $ 35 Million Debt Financing Agreement with Innovatus Capital Partners, LLC


First tranche of $ 22.5 million funded at closing

WIXOM, Michigan, March 17, 2020 (GLOBE NEWSWIRE) – Rockwell Medical, Inc. (RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improved patient outcomes globally, today announced that it has entered into a debt financing agreement with a subsidiary of Innovatus Capital Partners, LLC (“Innovatus”) to provide the Company with up to 35, $ 0 million in term loans.

“We are delighted to partner with Innovatus on this transaction,” said Stuart Paul, President and CEO of Rockwell Medical. “This funding will provide flexibility as we continue our mission to advance our new treatment, Triferic, and transform the way anemia is managed around the world,” Paul concluded.

On March 16, 2020, the Company entered into a loan and guarantee agreement (the “Loan Agreement”) with Innovatus pursuant to which Innovatus agreed to grant certain term loans in an aggregate principal amount of up to 35 . $ 0 million, with the first tranche of $ 22.5 million funded at closing. The Company will be eligible to draw on a second tranche of $ 5,000,000 upon completion of certain milestones, including approval by the United States Food and Drug Administration of the Company’s NDA for IV Triferic. The Company will be eligible to draw on a third tranche of $ 7.5 million upon reaching certain additional milestones, including reaching certain sales thresholds for Triferic. The Company is entitled to pay interest only for thirty months, or up to thirty-six months if certain conditions are met. The loans will mature on the fifth anniversary of the original funding date. The loan agreement includes the usual coverage of warrants and is secured by all of the assets of the company. The proceeds will be used for working capital purposes.

“We are delighted to partner with Rockwell Medical in their quest to transform the management of anemia in dialysis patients,” said Claes Ekstrom, CEO of Innovatus.

This transaction is the culmination of a multi-step financing process that Rockwell Medical initiated during the fourth quarter of 2019. At the request of shareholders, the Company has prioritized non-dilutive financing options as part of the process, and the Company completed the public offering of common shares in February 2020 to facilitate this non-dilutive financing.

Cantor Fitzgerald & Co acted as sole financial advisor to Rockwell Medical in this transaction.

Additional details regarding the Company’s funding 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 the management of anemia in a wide variety of therapeutic areas and around the world, improving the lives of critically ill patients. The Company’s initial objective is the treatment of anemia in end-stage renal disease (ESRD). Rockwell Medical’s proprietary renal therapy, Triferic (Ferric Pyrophosphate Citrate), is the only FDA approved therapy indicated for iron replacement and hemoglobin maintenance in hemodialysis patients. The Company has developed several formulations of Triferic (1) FDA-approved Triferic Dialysate and (2) IV Triferic, for which the Company filed a new drug application in May 2019. Rockwell Medical is also a manufacturer, supplier and operator. an established leader in delivering high quality hemodialysis concentrates / dialysates to dialysis suppliers and distributors in the United States and internationally.

Innovatus Capital Partners, LLC

Innovatus Capital Partners, LLC, is an independent advisor and portfolio management company with approximately $ 1.65 billion in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset classes with a unifying theme of capital preservation, income generation and upside option. The company has a dedicated team of life science investment professionals with extensive experience in the health field, including life sciences. Innovatus and its executives have significant experience in debt financing of medical device, diagnostics and biotechnology companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare spending. Further information can be found at www.innovatuscp.com.

About Triféric

Triferic is the only treatment approved by the FDA in the United States indicated to replace iron and maintain hemoglobin in patients receiving hemodialysis via dialysate during each dialysis treatment. Triferic has a unique and differentiated mechanism of action that has the potential to benefit patients and the healthcare economy. Triferic represents a potential innovative medical advance in the management of iron in hemodialysis patients, with the potential to become the future standard of care.

Triferic delivers about 5-7 mg of iron with each hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing stores of iron (ferritin). Triferic donates iron immediately and completely to the transferrin (iron transporter in the body) when it enters the bloodstream and is then transported directly to the bone marrow to be incorporated into the hemoglobin, without an increase in ferritin (stored iron). and inflammation) and no reports of anaphylaxis in more than 1,000,000 patient administrations, meeting a significant medical need to overcome functional iron deficiency (FID) in patients with ESRD.

Important safety information

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which are life threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, unconsciousness and / or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Staff and therapies must be immediately available for the treatment of severe hypersensitivity reactions. Hypersensitivity reactions were 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% more than placebo) in controlled clinical studies include:), peripheral edema (6.8%), dyspnea (5.8%), back pain (4 , 5%), fever (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) thrombosis of the fistula (3.4 %), and bleeding from the AV fistula site (3.4%).

Forward-looking statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of federal securities laws, including, but not limited to, Rockwell Medical’s expectations regarding the completion of the Offer, the terms and conditions. of the Offer and the satisfaction of customary closing conditions relating to the Offer and the intended use of the net proceeds of the Offer. Words such as “may”, “could”, “will”, “should”, “believe”, “expect”, “anticipate”, “estimate”, “continue”, “could”, “predict” “,” Forecast “,” project “,” intend “or similar expressions, or statements concerning current intention, belief or expectations, are forward-looking statements. Although Rockwell Medical believes these forward-looking statements are reasonable, we should not place undue reliance on these forward-looking statements, which are based on information available to us as of the date of this release. These forward-looking statements are based on current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC records), many of which are beyond our control and are subject to to change. Actual results could be materially different. Risks and uncertainties include: timing and regulatory approval process for our NDA filing for IV Triferic as filed with the FDA; timing and receipt of loan amounts from Innovatus; the ability of Rockwell Medical to achieve certain milestones under the loan agreement; and the intended use of the proceeds under the Loan Agreement, as well as the risks more fully discussed in the documents filed by Rockwell Medical with the SEC. Therefore, you should not place undue reliance on these forward-looking statements. Rockwell Medical expressly disclaims any obligation to update or modify any statement, 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, Site Communications, Inc.
Phone. : 212-452-2793
E: [email protected]

Source: Rockwell Medical, Inc.



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